HOW TO WRITE A PROVISIONAL

PATENT

APPLICATION © Copyright 2018

John J. Connors, patent attorney inventorbeware.com All rights reserved

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No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, recording or otherwise, without the prior written permission of the copyright holder.

Testimonial

I’ve been working with John as my patent attorney since before founding ICU Medical, Inc. He wrote the patent on the Click Lock® connector, my first invention, and he has been a director of the company for over 20 years. The strategy presented in his book Patent it and Grow Rich is the way to protect inventions. The chapter “You Shall Beware of Bridge Loans’’ is based on his experience during the period when venture capitalist attempted to gain control of the company. Every inventor and entrepreneur should read Patent it and Grow Rich

Dr. George A. Lopez, M. D.

CONSIDERING YOUR OPTIONS

How to Write a Provisional Patent Application

From here your choices are simple. When you have studied and mastered the information

in this book, choose your option and you are on your way.

1: You can do it yourself. Write the provisional patent and file it on line atwww.uspto.gov. Pay the

filing fee based on your status

2: Write the provisional patent yourself and send it to Inventor Beware for review and filing with

US patent office. This option Includes:

A: Review by an IP professional.

B: Recommended changes for easy expectance and filing.

C: Analysis of Status and Paying Filing Fee.

D: If rejected, changes made and refiled at no charge to you.

E: Follow up message when it is time to file your patent.

F: A credit for the full amount of this option on the final preparation

cost of a patent if you chose to complete it with our recommended

legal team.

Order this option at inventorbeware.com/file-for-you-ppa - $149.99

3: Write the provision patent and send it to Inventor Beware for review and filing with the US

patent office. This option includes everything from option 2 plus a ½ hour telephone conference

with the author, John J. Connors, patent attorney.

Order this option at http://inventorbeware.com/file-for-you-ppa-plus-phone-call

- $449.99

4. You can have a ½ hour telephone conference with the author, John J. Connors, patent

attorney.

Order this option at http://inventorbeware.com/30-min-phone-call - $300.00

Table of Contents how to write a provisional patent Testimonial ................................................................................................................................................... 3

CONSIDERING YOUR OPTIONS ............................................................................................................... 2

I-Introduction .............................................................................................................................................. 4 II- Purpose of Provisional Application ................................................................................................. 4

III- Requirements of Provisional Application ................................................................................... 4

IV- The Written Specification .................................................................................................................. 5

V- Ownership of the Provisional Application .................................................................................... 6 VI- One Year Rule ......................................................................................................................................... 6

VII- Looking To The Future ..................................................................................................................... 7

VIII- How To Start ........................................................................................................................................ 7 IX- Outline of Provisional Patent Application ................................................................................ 10

X- Draft Sample Claims .......................................................................................................................... 10

XI- Draft Written Description Using Answers Of The Questionnaire And The Draft Claims .......................................................................................................................................................... 10

Considering Your Options .................................................................................................................... 20

Appendix A ................................................................................................................................................. 21 FTC INVENTION PROMOTION FIRMS ................................................................................................ 21

Appendix B ................................................................................................................................................. 25 INVENTION QUESTIONNAIRE .............................................................................................................. 25

Title: Appendix D ..................................................................................................................................... 30 TEMPLATE FOR PROVISIONAL PATENT APPLICATION ............................................................. 30

Appendix E ................................................................................................................................................. 33

PROVISIONAL PATENT APPLICATION TRANSMITTAL SHEET ................................................. 33

Appendix F ................................................................................................................................................. 38 ABOUT THE AUTHOR ............................................................................................................................. 75

Disclaimer .................................................................................................................................................. 77

CONSIDERING YOUR OPTIONS ............................................................................................................ 78

I-Introduction The reason you are reading this addendum is to help you draft your own provisional patent application and avoid paying a patent attorney to do it for you. We recommend that at least have a patent attorney review your draft application before filing with the United States Patent and Trademark. An attorney, not an agent, licensed to practice before the United States Patent and Trademark (herein Patent Office) should be able to assist you. The Patent Office lists all registered patent attorneys at: https://oedci.uspto.gov/OEDCI/ we also caution you about inventor-help companies that may have a few meager successes. Before engaging such a company to find a licensee or buyer for your invention, we encourage you to obtain your own independent attorney not associated with such an inventor-help company. Also read what the Federal Trade Commission (FTC) has to say about these companies (see Appendix A).

II- Purpose of Provisional Application The main reason to file a provisional patent application is to establish a filing date. Under the recently amended U.S. patent law a patent is awarded to the inventor who first files an application describing the invention. This sounds simple enough. What constitutes an adequate description of the invention, however, is a legal question. The validity of a patent based on your provisional application may be challenged if the provisional application has an inadequate description of your invention. In general, the more details the better. Also, not everything is patentable subject matter. To be patentable the invention must fall into at least one of the categories identified in Title 35 of the United States Code, Section 101 (35 USC §101). Your invention must be “…a new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof…” as stated in 35 USC §101.

III- Requirements of Provisional Application The Patent Office treats a provisional patent application as a utility application that is governed by the provisions Title 35 of the United States Code, Section 111, paragraph (b), subparagraphs (1) through (8), [35 USC §111(b)]. These provisions require:

The application must be filed or authorized by the inventor and must meet the requirements that mandate an enabling written description of your invention and a drawing when needed to illustrate your invention. A claim will be required when the non-provisional application is based on the provisional application, however is not required in a provisional application. A fee may be paid by the applicant subsequent to filing the application; however, if submission of the fee is not met within a prescribed time, the application will be judged abandoned.

A provisional patent application isn’t provisional. It is a utility patent application that is not examined on its merits. It is, however, the beginning of a record in the Patent Office that will be

scrutinized by your adversary’s attorney, the court, and the jury, if you must someday enforce your patent rights. What goes on trial is the patent itself! Most likely the validity of the patent will be challenged if your invention is a commercial success. The importance of the provisional patent application cannot be overstated, because it is the first step in creating a record in the Patent Office.

With the filing of a provisional patent application you are beginning to tell the story of your invention. The main difference between your provisional patent application and a subsequently filed non-provisional utility patent application is your non-provisional patent application includes one or more claims. Both these utility patent applications, provisional and non-provisional, must meet all the substantive requirements of the patent statutes and Patent Office rules, except for claims. Only your non-provisional patent application must include at least one claim.

The story of your invention presented in the non-provisional utility patent application should not be substantially different than that presented in the provisional patent application. Thus, the terms you select to describe your invention in the provisional application will most likely be used in the non- provisional utility patent application. These terms can be critical in deciding whether the claims allowed by the patent examiner are held valid and enforceable. Although a provisional patent application does not require claims, the best practice is to first draft claims when preparing to write the provisional patent application. As discussed subsequently in Section IX, these draft claims are a useful outline of your provisional patent application.

IV- The Written Specification The specification must provide a written description of the invention. This written description must adequately disclose of the invention defined by the claims. Just by reading the written description a person skilled in the art to which the invention is related can practice the invention. In other words, this skilled person could independently make and use the disclosed invention after reading the specification. This is the enabling disclosure requirement. Failure to clearly and comprehensibly provide a written description of your invention in the provisional application may under some circumstances result in an invalid patent.

Typically a drawing illustrating the invention is included in most patent applications. If possible make a detailed set of figures depicting at least one embodiment of the invention being claimed.

No new matter may be added to a patent application after being filed. Consequently, the provisional patent application must include an enabling, written disclosure of the invention that is ultimately the claimed subject matter of the granted patent claiming priority of the provisional patent application. Claiming priority is discussed subsequently in Sections VI and VII.

Since claims must accompany the written specification filed with the non-provisional patent application, ideally the written description of the provisional patent application is identical to the written description accompanying the non-provisional application. All that is added of substance is the claims. Ideally, these claims are identical to those filed with, or used in preparing, the written specification of the provisional patent application.

To successfully claim priority based on a provisional patent application, the crucial elements of the claimed invention must be disclosed in the provisional application as required by Title 35 of the United States Code, Section 112(a). The claims establish the strategy of the “prosecution” as the application proceeds through examination. The written specification describing the invention is used to interpret the meaning of the claims. A claim is important, if and only if, it covers a commercially successful invention and competing products that are within the scope of the claim. So the provisional patent application must use concrete terms that distinguish the claimed invention from prior art cited by the patent examiner during prosecution of the non-provisional utility patent application.

V- Ownership of the Provisional Application

The provisional patent application must consider inventorship and ownership of the ultimately claimed invention. The inventor or co-inventors are the owners of the claimed invention. Who is an inventor or co-inventor of the claimed invention is ultimately a legal question based on the individual or individuals contributing to the inventive concept as defined by the claim or claims of the granted patent. It may be necessary to record with the Patent Office a copy of a written assignment of the invention and provisional application by the inventor(s) to another party; for example, a start-up company that is commercializing the invention.

VI- One Year Rule

Within one year after filing the provisional patent application you must file a follow-on non- provisional utility patent application meeting all the requirements of the patent law and claim priority of the provisional application. This includes specifically in writing claiming the priority of a provisional patent application as set forth in Title 35 of the United States Code, Section 119, paragraph (c), subparagraphs (1) through (3), [35 USC §119(c)]. Failure to do this results in the loss of the benefit of the filing date of the provisional application. For example, if your invention was in public use when you filed the provisional application and you failed to file a follow-on non- provisional utility application with claims, you are bared from obtaining a valid patent. Moreover, relevant publications by others after the filing date of the provisional application can be cited as prior art by the examiner in a subsequent utility application directed to the invention if you do not properly claim priority. You do not claim priority in the provisional application itself.

If you are filing a provisional patent application after the invention has been in public use, on sale, or described in a publication, the provisional application must be filed within one year of such use, sale or publication. Moreover, you must be sure that your invention is adequately disclosed as discussed above. Filing your own provisional application under such circumstance is especially risky because the application’s written, enabling disclosure must include all the critical limitations of the invention that distinguishes the invention from the prior art.

VII- Looking To The Future

Your provisional application may be the basis for both United States and foreign or international applications. Typically, an international patent application under the Patent Cooperation Treaty (PCT) is filed in order to defer substantial foreign filing costs for about 18 additional months. Both the United States and foreign or international applications must be filed with one year after the filing date of the provisional application and priority date (the filing date of the provisional application) of the provisional is claimed in the documents filed with these subsequent applications.

When the non-provisional patent application is filed, it is assigned to an examiner. Prior to assigning the application to the examiner, however, the Patent Office makes sure that the filing fees are paid, the written specification nominally appears to be acceptable, and the drawing meets the Patent Office requirements. In many non-provisional applications, the examiner makes an initial determination that the claims define more than one invention. Thus, an election must be made as to which group of claims is to be examined at this time. A divisional application may be subsequently filed prior to issuance of a patent on the elected claims. Almost always the examiner finds some prior art that is used to reject the original claims as lacking novelty or being obvious. Sometimes the examiner also rejects the claims directed to non- patentable subject matter, namely, a phenomenon of nature, an abstract idea, or a mental process. In responding to the examiner’s objection, new claims are often submitted. Typically, it is critical that such new claims be supported by the original written disclosure in the provisional application. Again we stress that the written disclosure of the provisional application be as close as possible to what will later be submitted when filing the non-provisional application. Commonly during prosecution of the non-provisional application, a telephone interview in conducted with the examiner prior to replying to the office action in writing as required. Sometimes, though infrequently, it is necessary to appeal the examiner’s decision to the Patent Trial and Appeal Board (PTAB), or even to the Court of Appeals for the Federal District (CAFC).

VIII- How To Start

You need to do a search using Google to determine as best you can if there currently is anything like your invention on the market. Also search the Patent Office website www.uspto.gov.

Once you satisfied yourself that your invention is new, answer the questions in the invention questionnaire of II. We will illustrate how to do this in connection with writing a provisional patent application of the medical connector shown in the Drawing of Appendix II. The claims of U.S. Patent No. 4,752,292 Appendix V cover this medical connection.

INVENTION QUESTIONNAIRE 1. Are you trying to solve a problem?

Yes

2. If so: What is the problem?

A patient died because of an accidental disconnect at the piggyback port in a conventional IV system.

A piggyback port uses an exposed needle that results in accidental sticks.

Why is it important to solve the problem?

Avoid the death of patients and minimize spread of infectious disease.

Describe your solution in less than 100 words.

The sealed piggyback port is connected to a cap member having within it a needle that penetrates the port’s seal on connection of the cap member to the port. The cap member has a cavity with an open mouth with the needle being disposed lengthwise along the longitudinal axis of the cavity. The needle’s tip is displaced inwardly from the open mouth a sufficient distance to recess the needle deep within the cavity so that it is unlikely to be contaminated. The open mouth has a restricted diameter that prevents the tip of the little finger of a typical adult from being inserted into the cavity.

How have others tried to solve the problem, and explain how your solution differs from the earlier ways that others tried to solve the problem.

To our knowledge no one has recognized the significant problems of the current system.

3. What are the main structural components of your invention or steps if a method invention.

A sealed piggyback port.

A cap member having therein a needle that penetrates the port’s seal on connection of the cap member to the port.

The cap member has a cavity with an open mouth in the cap member.

The needle is disposed lengthwise along the longitudinal axis of the cavity.

The needle’s tip is displaced inwardly from the open mouth a sufficient distance to recess the needle deep within the cavity so that it is unlikely to be contaminated.

A restricted diameter of the open mouth prevents the tip of the little finger of a typical adult from being inserted into the cavity.

4. Depict your invention using at least one drawing that has one or more figures illustrating your invention’s main components, or steps if a method invention, and how your invention functions. Attach drawing, Appendix II

Figures 1-6 attached

5. Describe the experiments or tests, if any, you did to perfect the invention.

Currently building improved product designed for manufacture and approval of FDA

6. Describe the advantages your invention has over prior art.

Discussed above in answer to question 2 on why important to solve problems.

7. Does your invention have any surprising, unusual, unexpected or unpredictable results?

No

If so, describe.

8. Has your invention been shown or disclosed to others without any agreement to keep your invention secret?

No

IX- Outline of Provisional Patent Application Using the template of Appendix III we will illustrate drafting the provisional application for the medical device illustrated in the drawing of Appendix II following the best practices. Therefore, we start with drafting claims.

X- Draft Sample Claims The words you use in the draft claims will be the same words used in writing the specification.

Here is an example of a draft claim that the define structure of the medical device.

1. A medical device for feeding medication from a remote source through tubing means having one end securely connected to and in communication with a patient,

said device including

a port formed by a first tubular wall element having an open end sealed by a seal,

a cap member configured to be connected to the port and having therein a needle which

penetrates the seal on connection of the cap member to the port to allow medication to flow from said source through the needle into said tubing means,

said cap member having a cavity therein formed by a tubular wall element which provides and

open mouth with said needle being disposed lengthwise along a longitudinal axis of said cavity, with said tip of said needle being displaced inwardly from said open mouth a sufficient distance to recess the needle deep within the cavity so that it is unlikely to be contaminated,

said open mouth having a restricted diameter that prevents the tip of the little finger of a

typical adult from being inserted into the cavity, and

a connector for detachably locking the cap member and port together securely when said port is inserted into the cavity, said locking connector being adapted for repeated manual operation.

XI- Draft Written Description Using Answers Of The Questionnaire And The Draft Claims

Starting with Appendix III as a template, we have shown how this template is used in writing the specification for the medical device and method of use invented by Dr. George A. Lopez, M.D. and Mr. Virgil Laul. The following shows how the outline is modified for this example:

Title

A MEDICAL DEVICE AND METHOD OF USE Identification of inventor or inventors and

their respective residences by City, State and Country:

For example,

INVENTOR: George A. Lopez, M. D.

RESIDENCE:

INVENTOR: Virgil Laul

RESIDENCE:

Status of Entity Filing the Provisional Application:

For example,

Small Entity? Large Entity? Micro Entity? In this case, Dr. Lopez and Mr. Laul qualified for status as a small entity. Small entities pay

reduced fees.

Introduction

INCORPORATION BY REFERENCE

Any and all U. S. patents, U. S. patent applications, and other documents, hard copy or

electronic, cited or referred to in this application are incorporated herein by reference and made a

part of this application.

DEFINITIONS

The words “comprising,” “having,” "containing," “holding,” and “including,” and other

grammatical forms thereof, are intended to be equivalent in meaning and be open ended in that an

item or items following any one of these words is not meant to be an exhaustive listing of such item

or items, or meant to be limited to only the listed item or items.

BACKGROUND

It is a common practice in treating patients, particularly patients who must be cared for under

emergency conditions, with medication introduced into the patient intravenously. An intravenous

solution, commonly referred to as parenteral liquid, is fed from a container holding this liquid. The

liquid flows through tubing into a needle which has been inserted into the patient's vein. The needle

is taped securely to the patient's body and is not likely to pull loose if the patient moves.

Medication needed to sustain the life of the patient, for example, drugs which maintain the blood

pressure of the patient at the desired level, are added to the parenteral liquid. The conventional

practice is to introduce the medication through a second needle inserted into a sealed entry port in

the tubing through which the parenteral liquid flows.

One problem with this conventional practice is that the needle may be pulled loose from the sealed

port relatively easily. Such accidental removal of the needle from the sealed port can have very

serious consequences and could even lead to the death of the patient. Although many hospitals

require nurses to tape the needle securely to the tubing, this is not always done, because taping is a

burdensome and time consuming task.

A second problem with the conventional practice is needle sticks. From time to time a nurse in

attempting to insert the needle into the sealed entry port will accidentally stick himself or herself

with the needle. This often occurs under emergency conditions when the nurse is under pressure to

complete this task as quickly as possible. Not only is the accomplishment of the task delayed, but

the nurse must stop working and have a blood test performed. Such a test is needed in case the

nurse becomes infected, because the hospital will be responsible financially. Consequently, needle

sticks not only result in increased hospital cost, but are a possible life treating event to the nurse.

A third problem with the conventional practice is infection. All too often a patient's life is seriously

endangered by bacteria gaining entry into a patient's blood stream and infecting the patient. In a

vast number of cases it is unknown how the bacteria gain entry. We have observed conditions in

hospitals and identified that one likely way the bacteria gain entry is by contamination of the needle

inserted into the sealed entry port. This happens when the nurse notices that the needle has been

pulled loose and simply reinserts it even though it may now have on its surface bacteria picked up

by direct contact with, for example, the patient's bedding. Another possible way that bacteria may

gain entry into the patient's blood stream is through contamination of the tape used to hold the

needle to the connector.

Summary and Description of the Drawing

SUMMARY

Our medical device and method of use has one or more of the features depicted in the embodiments

discussed in the section entitled “DETAILED DESCRIPTION OF SOME ILLUSTRATIVE

EMBODIMENTS.”

DESCRIPTION OF THE DRAWING

Some embodiments of our medical device and method of use are discussed in detail in

connection with the accompanying drawing, which is for illustrative purposes only. This drawing

includes the following figures, with like numerals and letters indicating like parts:

FIGURE 1 is a schematic view illustrating administering medication intravenously to a patient in

accordance with conventional practice.

FIGURE 2 is a cross-sectional view of a piggyback connector for introducing parenteral liquid and

medication intravenously to the patient shown in FIG. 1.

FIGURE 3 is a perspective view of the first embodiment of our medical connector that employs a

slip-on/twist lock type means for securing the cap member to the port structure.

FIGURE 4 is a cross-sectional view of the connector shown in FIG. 3 taken along line 4--4 of FIG.

3.

FIGURE 4a is a perspective view showing how the cap member prevents needle sticks.

FIGURE 5 is a perspective view of the second embodiment of our medical connector that employs

a snap-on type means for securing the cap member to the port structure.

FIGURE 6 is a cross-sectional view of the connector shown in FIG. 5 taken along line 6--6 of FIG.

5.

Written Description and Enabling Disclosure

DETAILED DESCRIPTION OF SOME ILLUSTRATIVE EMBODIMENTS

Conventional Connector System

As shown in FIGURES 1 and 2, the current way of intravenously introducing parenteral liquid into

a patient is by the conventional feeding system 10. This feeding system 10 includes a container 12

for the parenteral liquid, a tube 14 extending from the container and connected to a Y or

"piggyback" connector 16, and a tube 18 from the piggyback connector to a needle (not shown)

inserted into a vein of the patient. The needle is taped to the patient so that movement of the patient

will not result in the needle being pulled from the patient's vein.

As best illustrated in FIGURE 2, medication from the container 20 is introduced through the

piggyback connector 16 into the parenteral liquid flowing through the feeding system 10. This

piggyback connector 16 consists of two tubular conduits 22 and 24 which merge into a third tubular

conduit 26. The tubing 14 from the container 12 of parenteral liquid is inserted into the inlet port 28

of the conduit 22 and secured in position, for example, by an adhesive which bonds the external

surface of this tube to the internal wall surface of the conduit. There is a stop 30 which limits the

extent to which this tube 14 can be inserted into the conduit. In a similar fashion, the tube 18 is

secured to the outlet port 32 of the piggyback connector. This tube 18 is inserted into the outlet port

32 until it abuts a stop 34 in the internal wall of the conduit. This tube 18 is secured by an adhesive

to the internal wall of the conduit 26.

The sealed entry port structure of the conventional feeding system 10 is provided by the branch

conduit 24 which has a standard latex rubber seal 36 at its inlet port 38 to seal this port.

Consequently, bacteria cannot enter the piggyback connector 16 via the inlet port 38 because of the

seal 36. This seal 36 is of conventional design and includes coaxial annular aprons 40 and 42 which

fit over the conduit wall 24a and grip the external and internal wall surfaces to hold the seal

securely to the conduit 24. A suitable seal may be obtained from the West Company of

Phoenixville, Pa.

The medication is introduced into the parenteral liquid flowing through the piggyback connector 16

by a needle 44 which is inserted through the central part of the seal 36 into the branch conduit 24.

This needle 44 is connected by a suitable connector 46 to a tube 48 which is connected to the

container 20 (FIG. 1) for the medication. As parenteral liquid flows through the piggyback

connector 16 into the inlet port 28 and out the outlet port 32, the medication is drawn into this

stream of liquid, flowing from the container 20 via the tube 48 and through the open tip or end 44a

of the needle 44 into the parenteral liquid.

After studying FIGURES 1 and 2, the several problems associated with the conventional practice

can now be more fully understood. If the patient moves, for example, rolls or moves his or her arm,

the needle 44 may be pulled from the seal 36. If this occurs, the latex seal 36 has sufficient

resiliency to close off the hole in the seal produced by the needle 44. The parenteral liquid will

continue to flow into the patient's system, but the necessary medication is no longer being

introduced into it. The consequences of this condition are very grave and, if this condition is

unnoticed by the nurse, it could result in the death of the patient or serious complications in the

patient's treatment. Even if the nurse notices that the needle 44 has been removed from the seal 36

and reinserts it into the seal, it is possible that the needle has been contaminated with bacteria. The

use of such a contaminated needle 44 is unacceptable, but nevertheless this sometimes happens.

The needle 44 may be taped to the conduit 24, and many hospitals instruct nurses to do this. When

this task is done, the needle 44 is secured, but cannot be conveniently removed and then reinserted.

And even when taping the needle 44, if this is not done carefully, the needle may still be

contaminated by the nurse touching the needle or the tape being contaminated. Also, because the

nurse holds the conduit 24 with one hand while inserting the needle 44, the nurse may accidentally

stick the needle directly into the hand holding this conduit, or stick the needle through the conduit

wall 24a into this hand.

These problems associated with the conventional practice are eliminated by the several different

embodiments of our medical device disclosed hereinafter.

First Embodiment of Our Medical Device

As illustrated in FIGURES 3 and 4, the first embodiment of our medical device, connector 49,

employs a cap member 50 housing deep within the needle 44. As will be discussed in greater detail

hereinafter, the cap member 50 is secured by a slip-on/twist lock type of locking mechanism to the

piggyback connector 16 so that movement of the patient does not result in the needle 44 being

pulled from the seal 36. The parenteral liquid is introduced via the conduit 24, and the conduit 22

carries the seal 36 that covers the inlet port 28. In this embodiment, this sealed conduit 28

constitutes the entry port structure 27. The cap member 50, is detachably secured to the entry port

structure 27, with the needle 44 penetrating the seal center of the seal 36 when the cap member 50

mates with the port structure 27.

The cap member 50 comprises a cylindrical connector section 56 having a hollow interior forming

the chamber or cavity 52 housing the needle 44. This needle 44 is disposed lengthwise along the

longitudinal axis of the cavity 52 and is centrally located. The cavity 52 has an open mouth 52a

which allows the cap member to be seated over the port structure 27. The mouth 52a, however, is

constricted so that, as illustrated in FIGURE 4a, it prevents the little finger of a typical adult user

from being inserted into the cavity 52. The tip or end 44a of the needle is safely displaced inwardly

from the open mouth 52a so that even if the user intentionally inserted his or her finger into the

open mouth, the tip of the needle would not stick this finger. Typically, the open mouth 52a has a

maximum width of no greater than about one centimeter, and the minimum distance between the

mouth 52a and the tip 44a is about one centimeter.

The locking mechanism includes the threads 69a formed in the end 54 of the interior cavity wall 55

and the threads 69b in the exterior wall of the conduit 22. These threads 69a and 69b engage upon

connection of the cap member 50 to the port structure 27 by screwing the cap member to the

conduit 22. The top of the cap member 50 has a pair of outwardly extending wings 58 which

facilitate screwing the cap member 50 to the conduit 22. As this is done, the interior wall 55,

sliding over the exterior surface of the conduit 22, guides the needle 44 so that it penetrates the

center of the seal 36. To further ensure that the needle 44 penetrates the center of the seal 36, the

threads 69b could be lowered further beneath the seal so that the cap member would fit

telescopically over the conduit 22 and then be screwed into position. Thus, the cap member 50,

serving as the female component, and conduit 22, serving as the male component, mate in a male-

female relationship, with the needle 44 always being housed safely within the center of the cavity

in an unexposed condition and positioned to pierce the center of the seal 36.

A spindle 59 is provided to enable the cap member 50 to be screwed onto the port structure 27

without twisting the tube 48. This spindle 59 is received within an opening 61 within the cap

member 50. The body of the spindle 59 has a cylindrical neck section with a groove 63 in an end

which protrudes from the opening 61. The cylindrical body expands outwardly slightly to provide a

shoulder 65 which engages a stop 66 when the spindle 59 is placed in the opening, and a TRU seal

O-ring 67 is received in the groove 63 to hold the spindle in position but allowing the cap member

to revolve about the spindle as it is screwed onto the port structure 27.

Along the longitudinal axis of the spindle 59 is a passageway 60. The tube 48 from the container 20

holding the medication is inserted into the one end 60a of the passageway 60 and is bonded to the

internal surface of this passageway, for example, by means of an adhesive. The other end 60b of the

passageway terminates in a threaded connector section 62 to which the needle 44 is secured. This

needle has an adapter 64 which has an internal thread which engages the threads of the connector

section 62. Thus, the needle 44 is extends outwardly from this adapter 64. Thus, the needle 44 is

held secure to the piggyback connector 16, penetrating the center of the seal 56 with its point 44a

safely displaced away from the inside wall 55 of the conduit 22.

This connector 49 embodies many of the features our medical device. For example, the cap

member 50 safely houses the needle 44, and the threads on the guiding walls provide means for

detachably securing the cap member to the port structure without taping. But it has several

components, and therefore is costly to manufacture, it is time consuming to screw the cap member

50 to the port structure, and it does not provide an audible signal when the cap member is safety

secured to the port structure. This later feature is provided by the second and third embodiments of

our medical device.

Second Embodiment of Our Medical Device

The second embodiment of our medical device, connector 71, is shown in FIGURES 5 and 6. In

this embodiment a cap member 70, similar to cap member 50, is simply snapped onto the

piggyback connector 16. The snap-on type locking mechanism of this connector 71 is easier to use

and less costly to manufacture than the slip-on/twist type of the first embodiment.

In this embodiment, the cap member 70 includes a hollow cylindrical element 72 which carries on

its exterior two clips 74 which have catch tips 76 that snap into a groove 78 in the external wall of

the conduit 22. The clips 74 are mounted by hinges 75 to the element 72, and are integral with the

element 72. A plug assembly 80 carries the tubing 48 and the needle 44, which is mounted on an

adapter 64 such as shown in FIGURE 4. This plug assembly 80 is glued or otherwise bonded to the

open end of the cylindrical member 72. The cap member 70, including clips 74 and hinges 75, are

molded from the same material, for example, nylon, which is a material having the desired

resiliency.

To attach the cap member 70, one simply slips the member 70 over the conduit 22. The clips 74

bend outwardly slightly and, when the catch tips 76 of the clips are opposite the groove 78, the

clips snap in place as shown in solid lines in FIG. 6. The centrally mounted needle 44 is guided into

the center of the seal 36 by the cap member 70, which, like a telescope, slides over the tubular

conduit 22. There is shoulder 82 which serves as a stop to limit the movement of the cap member

70. This shoulder 82 brings the catch tips 76 of the clips into registration with the groove 78. The

hinges 75, being of the same material as the clips 74, provide an internal bias or spring action due

to the resiliency of the material from which these clips and hinges are made. Consequently, the

clips 74 snap into a locking position, locking the cap member to the conduit 22 when the catch tips

76 are in registration with the groove 78. To release the cap member from the piggyback connector

16, the clips 74 are simply depressed and the cap member 70 is removed.

One of the features of the slip-on type locking mechanism is that with one simple inwardly push the

needle 44 is inserted directly into the center of the seal 36 and the cap member is locked to the port

structure. Another feature of this connector 71 is that when the tips 76 of the clips snap into the

groove 78 a "click" sound is made by the tips striking the body of the cap member. With repeated

use, however, the hinges 75, due to internal stress produced in the nylon material, loose some of

their spring action. Consequently, the tips 76 are not held with sufficient force in the groove 78, nor

do they strike the body of the cap member to produce the desired "click" sound. Moreover, the

material will eventually crack along the flex line of the hinge and a break will occur.

SUMMARY

In summary: Our connector is safe because (a) the needle is recessed deeply within the cap member

and, therefore, is not likely to be contaminated by bacteria, (b) the cap member and port structure

upon engagement guide the needle into the center of the seal, avoiding scraping particles from the

inside wall of the port structure, (c) the cap member, housing the needle safely within it, protects

the nurse against needle stricks, and (d) the locking of the cap member and port structure together

prevents accidental disconnects and (e) the "click" signals the nurse when the connector system is

locked securely in position. Our connector is convenient to use because (a) the walls of the cap

member and port structure, interacting with each other, provide a guideway for quick connection,

(b) the locking mechanism eliminates the burdensome and time consuming task of taping, and (c)

the connector is very simple to use so that it is ideal for home care of patients.

I do not recommend that you submit claims with your provisional

application, but use the claims to help you draft the written

description and enabling disclosure.

Considering Your Options

From here your choices are simple. When you have studied and mastered the information

in this book choose your option and you are on your way.

1: You can do it yourself. Write the provisional patent and submit it to the www.uspto.gov for

their approval or rejection. Pay filing fee if rejected or accepted.

2: Write the provisional patent yourself and send it to Inventor Beware for review and filing with

US patent office. This option Includes:

A: Review by an IP professional.

B: Recommended changes for easy expectance and filing.

C: Analysis of Status and Paying Filing Fee.

D: If rejected, changes made and refiled at no charge to you.

E: Follow up message when it is time to file your patent.

F: A credit for the full amount of this option on the final preparation

cost of a patent if you chose to complete it with our recommended

legal team.

Order this option at inventorbeware.com/file-for-you-ppa - $149.99

3: Write the provision patent and send it to Inventor Beware for review and filing with the US

patent office. This option includes everything from option 2 plus a ½ hour telephone conference

with the author, John J. Connors, patent attorney.

Order this option at http://inventorbeware.com/file-for-you-ppa-plus-phone-call

- $449.99

4. You can have a ½ hour telephone conference with the author, John J. Connors, patent

attorney.

Order this option at http://inventorbeware.com/30-min-phone-call - $300.00

Appendix A

FTC INVENTION PROMOTION FIRMS

Federal Trade Commission Consumer Information español Main Menu Search You are here Home › Jobs & Making Money › Working from Home Vea esta página en español

Invention Promotion Firms Share this page Facebook Twitter Linked-In Think you have a great idea for a new product or service? You're not alone. Every year, tens of thousands of people try to develop their ideas and commercially market them. Some people try to sell their idea or invention to a manufacturer that would market it and pay royalties. But finding a company to do that can be difficult. As an alternative, others use the services of an invention promotion firm. Indeed, some inventors pay thousands of dollars to firms that promise to evaluate, develop, patent, and market inventions... and then do little or nothing for their fees.

Unscrupulous promoters take advantage of an inventor's enthusiasm for a new product or service. They not only urge inventors to patent their ideas or invention, but they also make false and exaggerated claims about the market potential of the invention. The facts are:

• few inventions ever make it to the marketplace; and • although a patent can provide valuable protection for a successful invention, getting a patent doesn't

necessarily increase the chances of commercial success.

There's great satisfaction in developing a new product or service and in getting a patent. But when it comes to determining market potential, inventors should proceed with caution as they try to avoid falling for the sweet-sounding promises of a fraudulent promotion firm.

Using Invention Promotion Firms

Advertisements for invention promotion firms are on television, radio and the Internet, and in newspapers and magazines. These ads target independent inventors with offers of free information on how to patent and market their inventions. Often, however, the only information you get is about the promoter.

If you respond to the ads — which may urge you to call a toll-free number — you may hear back from a salesperson who will ask for a sketch of the invention and information about you and your idea. As an inducement, a firm may offer to do a free preliminary review of your invention.

Some invention promotion firms may claim to know or have special access to manufacturers who are likely to be interested in licensing your invention. In addition, some firms may claim to represent manufacturers on the look-out for new product ideas. Ask for proof, such as contacts at manufacturers, before you sign a contract with any invention promotion firm that claims special relationships with manufacturers. If the promoter provides only one or two names, be careful: The contacts may be "shills" — people hired to give favorable testimonials.

After giving your invention a preliminary review, a firm might tell you it needs to do a market evaluation of your idea — for a fee that can be several hundred dollars. Many questionable firms don't do any genuine research or market evaluations. Sometimes the "research" is bogus, and the "positive" reports are mass-produced in an effort to sell clients on additional invention promotion and marketing services. Fraudulent invention promotion firms don't offer an honest appraisal of the merit, technical feasibility, or market potential of an invention.

Some invention promotion firms also may offer a contract in which they agree to help you market and license your invention to manufacturers. Unscrupulous promoters may require you to pay a fee of several thousand dollars in advance, or to agree to make credit payments instead. Reputable licensing agents usually don't rely on large advance fees. Rather, they depend on royalties from the successful licensing of client inventions. How can they make money when so few inventions achieve commercial success? They're choosy about which ideas or inventions they pursue. If a firm is enthusiastic about the market potential of your idea — but wants to charge you a large fee in advance — take your business elsewhere.

Inventor Protections If you're interested in working with an invention promotion firm, here's information that can help you avoid making a costly mistake.

The American Inventors Protection Act of 1999 gives you certain rights when dealing with invention promoters. Before an invention promoter can enter into a contract with you, it must disclose the following information about its business practices during the past five years:

• how many inventions it has evaluated, • how many of those inventions got positive or negative evaluations, • its total number of customers, • how many of those customers received a net profit from the promoter's services, and • how many of those customers have licensed their inventions due to the promoter's service

This information can help you determine how selective the promoter has been in deciding which inventions it promotes and how successful the promoter has been.

• Many fraudulent invention promotion firms offer inventors two services in a two-step process: one involves a

research report or market evaluation of your idea that can cost you hundreds of dollars. The other involves patenting or marketing and licensing services, which can cost you several thousand dollars. Early in your discussion with a promotion firm, ask for the total cost of its services, from the "research" about your invention through the marketing and licensing. Walk away if the salesperson hesitates to answer.

• Many fraudulent companies offer to provide invention assistance or marketing services in exchange for advance fees that can range from $5,000 to $10,000. Some even offer to finance the full amount to entice inventors into making a quick decision. Reputable licensing agents rarely rely on large up-front fees.

• Unscrupulous invention promotion firms tell all inventors that their ideas are among the relative few that have market potential. The truth is that most ideas don't make any money.

Check References Ask the promoter to give you the names of many previous purchasers so that you can pick and choose who to call for references. Again, beware of shills.

• Unscrupulous firms often promise that they will exhibit your idea at trade shows, but don't actually go to these

trade shows, much less market your idea effectively. Check with previous clients and trade show sponsors about whether their ideas were exhibited.

• Many unscrupulous firms agree in their contracts to identify manufacturers by coding your idea with the U.S. Bureau of Standard Industrial Code (SIC). Lists of manufacturers that come from classifying your idea with the SIC usually are of limited value.

Tips Before Moving Forward Contracting for the services of an invention promotion firm is no different from making many other major purchases. Apply some common sense.

• Question claims and assurances that your invention will make money. No one can guarantee your invention's

success. • Investigate the company before you make any commitment. Call the USPTO at 1-866-767-3848, and

the Better Business Bureau, the consumer protection agency, and the Attorney General in your state or city, and in the state or city where the company is headquartered. Under the American Inventors Protection Act of 1999, invention promoters must give you the names and addresses of all invention promotion companies they have been affiliated with over the past 10 years. Use this information to determine whether the company you're considering doing business with has been subject to complaints or legal action.

If a promoter causes you financial injury by failing to make the required disclosures, by making any false or fraudulent statements or representations, or by omitting any fact, you have the right to sue the promoter and recover the amount of your injury plus costs and attorneys' fees.

In addition, while the USPTO has no civil authority to bring law enforcement actions against invention promoters, it will accept your complaint and post it online if you complete the form, Complaint Regarding Invention Promoter. The USPTO also will forward your complaint to the promoter, and publish its response online. To read complaints and responses, visit Inventor Resources.

• Make sure your contract contains all the terms you agreed to — verbal and written — before you sign. Often the contract says one thing but the salesperson says something quite different. If possible, ask an attorney to review the agreement.

• Remember that once a dishonest company has your money, you may never get it back. You may have to sue the company under the American Inventors Protection Act of 1999, which permits a customer to recover for injuries, costs, and legal fees if a promoter has failed to make disclosures, made any false or fraudulent statement or representation, or omitted any material fact, to a customer. You have the burden to show that the law has been violated.

For More Information U.S. Patent and Trademark Office

The USPTO offers information about patents and trademarks. Write: U.S. Patent and Trademark Office, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450; call toll-free at 1-800-PTO-9199; or visit uspto.gov. For more

information about Provisional or Non-provisional Applications call 1-800-PTO-9199. In addition, every state has a Patent and Trademark Depository Library that maintains collections of current and previously-issued patents and Patent and Trademark reference materials. To order a copy of the American Inventors Protection Act, call 1-800-PTO-9199, or visit the United States Patent and Trademark Office's website.

National Congress of Inventor Organizations

NCIO offers free articles, information, resources, and an online magazine America's Inventor Online. To contact NCIO, call toll-free 1-323-878-6952, or visit NICO's website.

United Inventors Association

UIA offers free articles, information, resources, referrals to local support groups for inventors, and online copies of its newsletter. To contact UIA, call 1-585-359-9310, or visit its website.

Produced in cooperation with the U.S. Patent and Trademark Office

Tagged with: business, business opportunity, work at home September 2011

Appendix B

INVENTION QUESTIONNAIRE

1. Are you trying to solve a problem?

2. If so, what is the problem?

why is it important to solve the problem?

describe your solution in less than 500 words.

how have others tried to solve the problem, and explain how your solution differs from the earlier ways that others tried to solve the problem.

3. What are the main structural components of your invention or steps if a method invention?

4. Depict your invention using at least one drawing that has one or more figures illustrating your invention’s main components, or steps if a method invention, and how your invention functions. Attach drawing.

5. Describe the experiments or tests, if any, you did to perfect the invention.

6. Describe the advantages your invention has over prior art.

7. Does your invention have any surprising, unusual, unexpected or unpredictable results? If so, describe.

8. Has your invention been shown or disclosed to others without any agreement to keep your invention secret?

I

FIGURE 2

FIGURE

58

FIGURE 4

FIGURE 3

FIGURE 4a

"''6

26

18

FIGURE 6

FIGURE 5

6

Title: Appendix D

TEMPLATE FOR PROVISIONAL PATENT APPLICATION

Title

Inventor(s):

Residence

Small Entity?Large Entity?Micro Entity? Any essential or important subject matter related to the invention should NOT be incorporated by

reference. Rather it must be specifically disclosed in writing in this application.

Do NOT use the word “invention” except as specifically used in the template application.

INCORPORATION BY REFERENCE

Any and all U. S. patents, U. S. patent applications, and other documents, hard copy or

electronic, cited or referred to in this application are incorporated herein by reference and made a

part of this application.

DEFINITIONS

The words “comprising,” “having,” "containing," and “including,” and other forms thereof,

are intended to be equivalent in meaning and be open ended in that an item or items following any

one of these words is not meant to be an exhaustive listing of such item or items, or meant to be

limited to only the listed item or items.

The words “consisting,” “consists of,” and other forms thereof, are intended to be

equivalent in meaning and be closed ended in that an item or items following any one of these

words is meant to be an exhaustive listing of such item or items and limited to only the listed item

or items.

The word "rectangular " includes square.

The word “rhomboidal” shall mean shaped somewhat like a rhombus or rhomboid.

The word “trapezoidal” shall mean shaped somewhat like a trapezoid.

BACKGROUND

Any specific problem that the invention solves?

Anything unexpected results?

This background discussion is not intended to be an admission of prior art.

SUMMARY

Our My has one or more of the features depicted in the embodiments discussed in the

section entitled “DETAILED DESCRIPTION OF ONE (SOME) ILLUSTRATIVE

EMBODIMENT (S).” These features are not listed in any rank order nor is this list intended to be

exhaustive. The claims that follow define my _ and method of , distinguishing them from

the prior art; however, without limiting the scope of my and method of as expressed by

these claims, in general terms, some, but not necessarily all, of their features are:

My (our) method comprises

The steps of (my) our method do not need to be preformed in the above sequence.

DESCRIPTION OF THE DRAWING

One/Some embodiments of my our are discussed in detail in connection with the

accompanying drawing, which is for illustrative purposes only. This drawing includes the

following figures (Figs.), with like numerals and letters indicating like parts:

Fig. 1 is a perspective view of one embodiment of the .

Fig. 2 is a cross-sectional view taken along line – of Fig.

Fig. 3 is an exploded perspective view of the embodiment of the shown in Fig.

Fig. 4 is an enlarged fragmentary view taken along line – of Fig.

Fig. 5 is a side view of the embodiment of the

Fig. 6 is a top plan view of the embodiment of the

shown in Fig.

shown in Fig.

Fig. 7 is a bottom plan view of the embodiment of the shown in Fig.

Fig. 8 is a front view of the embodiment of the _ shown in Fig.

Fig. 9 is a rear view of the embodiment of the shown in Fig.

Fig. 10 is a

Fig. 11 is a

Fig. 12 is a

,with sections broken away

DETAILED DESCRIPTION OF ONE ILLUSTRATIVE EMBODIMENT

Or

DETAILED DESCRIPTION OF SOME ILLUSTRATIVE EMBODIMENTS

Discuss benefits but don’t use word “benefit” or advantages. Instead “cause” and “effect”

language.

Appendix E PROVISIONAL PATENT APPLICATION TRANSMITTAL SHEET

https://www.uspto.gov/sites/default/files/forms/sb0016.pdf T

this is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c). Priority Mail Express® Label No _________________________________

INVENTOR(S)

Given Name (first and middle [if any]) Family Name or Surname Residence (City and either State or Foreign Country)

Additional inventors are being named on the separately numbered sheets attached hereto.

TITLE OF THE INVENTION (500 characters max):

Direct all correspondence to: CORRESPONDENCE ADDRESS

The address corresponding to Customer Number:

OR Firm or Individual Name

Address

City State Zip

Country Telephone Email

ENCLOSED APPLICATIONPARTS (checkall that apply) Application Data Sheet. See 37 CFR 1.76.

Drawing(s) Number of Sheets

CD(s), Number of CDs

Other (specify)

Specification (e.g., description of the invention) Number of Pages

Fees Due: Filing Fee of $280 ($140 for small entity) ($70 for micro entity). If the specification and drawings exceed 100 sheets of paper, an application size fee is also due, which is $400 ($200 for small entity) ($100 for micro entity) for each additional 50 sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 CFR 1.16(s).

METHOD OF PAYMENT OF THE FILING FEE AND APPLICATION SIZE FEE FOR THIS PROVISIONAL APPLICATION FOR PATENT

USE ONLY FOR FILING A PROVISIONAL APPLICATION FOR PATENT This collection of informationis required by 37 CFR 1.51. The informationis required to obtain or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 10 hours to complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DONOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.

If you need assistance in completing the form, call 1-800-PTO-9199 and select option 2.

The Director is hereby authorized to charge the filing fee and application size fee (if applicable) or credit any overpayment to Deposit Account Number: .

TOTAL FEE AMOUNT ($)

Applicant asserts small entity status. See 37 CFR 1.27. Applicant certifies micro entity status. See 37 CFR 1.29. Applicant must attach form PTO/SB/15A or Bor equivalent.

A check or money order made payable to the Director of the United States Patent and Trademark Office is enclosed to cover the filing fee and application size fee (if applicable). Payment by credit card. Form PTO-2038 is attached.

WARNING: Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may contribute to identity theft. Personal information suchas social security numbers, bank accountnumbers, or credit card numbers (other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTO to support a petition or an application. If this type of personal information is included in documents submitted to the USPTO, petitioners/applicants should consider redacting such personal information from the documents before submitting them to the USPTO. Petitioner/applicantis advised that the record of a patent application is available to the public after publication of the application (unless a non-publication request in compliance with 37 CFR 1.213(a) is made in the application) or issuance of a patent. Furthermore, the record from an abandoned application may alsobe available to the public if the application is referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms PTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.

SIGNATURE _ _ _ _ _ _ _ _ _ __ DATE _ _ _ _

TYPED OR PRINTED NAME REGISTRATION NO. _ (if appropriate)

TELEPHONE _ _ _ _ _ _ _ DOCKET NUMBER _ _ _ _ _

The invention was made by an agency of the United States Government or under a contract with an agency of the United States Government. (NOTE: Providing this information on a provisional cover sheet, such as this Provisional Application for Patent Cover Sheet (Form PTO/SB/16), does not satisfy the requirement of 35 U.S.C. 202(c)(6), which requires that the specification contain a statement specifying that the invention was made with Government support and that the Government has certain rights in the invention.)

No.

Yes, the invention was made by an agency of the U.S. Government. The U.S. Government agency name is:

Yes, the invention was made under a contract with an agency of the U.S. Government.

The contract number is:

The U.S. Government agency nameis:

In accordance with 35 U.S.C. 202(c)(6) and 37 CFR 401.14(f)(4), the specifications of any United States patent applications and any patent issuing thereon covering the invention, including the enclosed provisional application, must state the following:

‘‘This invention was made with government support under [IDENTIFY THE CONTRACT] awarded by [IDENTIFY THE FEDERAL AGENCY]. The government has certain rights in the invention.”

Privacy Act Stateme nt

The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which mayresult in termination of proceedings or abandonment of the application or expiration of the patent.

The information provided byyou in this form will be subject to the following routine uses:

1. The information on this form will be

treated confidentially to the extent allowed under the Freedom of Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records may be disclosed to the Department of Justice to determine whether disclosure of these records is required by the Freedom of Information Act.

2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counselin the course of settlement negotiations.

3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual, to whom the record pertains, when the individual

has requested assistance from the Member with respect to the subject matter of the record.

4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in order to perform a contract. Recipients of information shall be required to complywith the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).

5. A record related to an International Application filed under the Patent Cooperation Treatyin this system of records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.

6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of National Securityreview (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).

7. A record from this system of records maybe disclosed, as a routine use, to the Administrator, General Services, or his/her designee, duringan inspection of records conductedbyGSA as part of that agency’s responsibility to recommend improvements in records management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such

disclosure shall not be used to make determinat ions about individuals .

8. A record from this system of records may be disclosed, as a routine use, to the public after either publicatio n of the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclose d, subject to the limitatio ns of 37 CFR 1.14, as a routine use, to the public if the record was filed in an applicati on which became abandon ed or in which the

proceedings were terminated and which application is referenced by either a published application, an application open to public inspection or an issued patent.

9. A record from this system of records maybe disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation.

Appendix F

U.S. PATENT NO. 4,752,292

[11]Patent Number:4, 752,292 45]Date of Patent: Jun. 21, 1988

United States Patent c191 Lopez et al.

[54] MEDICAL CONNECTOR [56]

[75] Inventors: George A. Lopez, Huntington Beach; Virgil R. Laul, Dana Point, both of Calif.

[73] Assignee: ICU Medical, Inc., Mission Viejo, Calif.

References Cited

U.S. PATENT DOCUMENTS 3,502,097 3/1970 Muller ................................... 604/86 3,986,508 10/1976 Barrington ........................... 604/905 4,019,512 4/1977 Tenczar ............................... 604/905 4,187,846 2/1980 Lolachi et al. ....................... 604/411 4,338,933 7/1982 Bayard et al. ........................ 604/411 4,367,156 12/1982 Feller et al ......................... 604/165 4,439,193 3/1984 Larkin ................................. 604/411 4,457,749 7/1984 Bellotti et al ....................... 604/411

[21] Appl. No.: 1,709 Primary Examiner-Stephen C. Pellegrino Attorney, Agent, or Firm-Whann & Connors

[22] Filed: Jan. 9, 1987 [57] ABSTRACT Disclosed is a connector for introducing medication

Related U.S. Application Data [63] Continuation of Ser. No. 606,679, May 3, 1984, aban-

doned, which is a continuation-in-part of Ser. No. 543,248, Oct. 19, 1983, which is a continuation-in-part of Ser. No. 460,585, Jan. 24, 1983.

[51] Int. CJ.4 ........................................... A61M 5/00 [52] U.S. CI .................................... 604/244; 604/283;

604/905 [58] Field of Search ............ 604/86, 88, 411, 4b8-410,

604/263, 283, 412-414, 905,244

into a patient in a safe, convenient way. It comprises a pair of plastic tubular members adapted to be manually pushed together to engage in a male-female relation- ship, and a locking mechanism that detachably secures the members together. The male member has a sealed entry port at its end, and the female member safely houses within it a needle which centrally pierces the seal of the port upon engagement of the members. Pref- erably, the locking mechanism provides a "click" sound when it locks the members together.

4 Claims, 9 Drawing Sheets

U.S. Patent Jun. 21, 1988 Sheet 1 of 9 4,752,292 I

FIGURE 2

U.S. Patent Jun.21,1988 Sheet 2 of 9 4,752,292

58

26

FIGURE 4

'-,s

FIGURE 3

FIGURE 4a

U.S. Patent Jun. 21, 1988 Sheet 3 of 9 4,752,292

18

FIGURE 6

FIGURE 5

U.S.Patent Jun.21,1988 Sheet 4 of 9 4,752,292

FIGURE 8

FIGURE 7

92a

U.S. Patent Jun.21,1988 Sheet 5 of 9 4,752,292

FIGURE 9

FIGURE 10

100

108

FIGURE IOa

U.S. Patent Jun. 21, 1988 Sheet 6 of 9 4,752,292 FIGURE 11

92

122 FIGURE 12

FIGURE 13

130 134

128 122

124

FIGURE 15

U.S. Patent Jun. 21, 1988 Sheet 7 of 9 4,752,292

FIGURE 20

14 4

----146

FIGURE 16

FIGURE 17

FIGURE 18

FIGURE 19

U.S. Patent Jun.21,1988 Sheet 8 of 9 4,752,292

21

12

FIGURE 22

U.S. Patent Jun. 21, 1988 Sheet 9 of 9 4,752,292

23

FIGURE 24

FIGURE

10

4,752,292 1 2

cases it is unknown how the bacteria gain entry. We

MEDICAL CONNECTOR

RELATED PATENT APPLICATIONS This application is a continuation of U.S. patent appli- 5

cation Ser. No. 606,679, filed May 3, 1984, and entitled "Medical Connector", now abandoned, which is a con- tinuation-in-part application of U.S. patent application Ser. No. 543,248, filed Oct. 19, 1983, (now abandoned) and entitled "Medical Connector System," which was a continuation-in-part application of U.S. patent applica- tion Ser. No. 460,585, filed Jan. 24, 1983, and entitled "Device for Intravenously Introducing Medication Into a Patient," (now abandoned). These previously filed patent applications, which are incorporated herein by 15 reference and made part of this patent application, dis- close the experimental versions of this invention. These experimental versions are also disclosed herein.

have observed conditions in hospitals and identified that one likely way the bacteria gain entry is by contamina- tion of the needle inserted into the sealed entry port. This happens when the nurse notices that the needle has been pulled loose and simply reinserts it even though it may now have on its surface bacteria picked up by direct contact with, for example, the patient's bedding. Another possible way that bacteria may gain entry into the patient's blood stream is through contamination of the tape used to hold the needle to the connector.

MAJOR FEATURES OF THE INVENTION The problems discussed above present a serious

health hazard to patients and their nurses. The present invention eliminates these problems and provides a medical connector which is both safe and convenient to use.

There are several features of this invention which BACKGROUND OF THE INVENTION 20 contribute to its safety and convenience, no single one

1. Field of the Invention This invention relates to medical connectors used in

the treatment of the injured or sick, and in particular to a connector for introducing medication into a patient in a safe, convenient way. 25

2. Background Discussion It is a common practice in treating patients, particu-

larly patients who must be cared for under emergency conditions, with medication introduced into the patient

of which is solely responsible for these desirable attri- butes. Many of these features were present in our exper- imental versions of the invention, which were improved

after testing. Without limiting the scope of this inven- tion as expressed by the claims, its more prominent features will now be discussed briefly. After consider- ing this discussion, and particularly after reading the section of this application entitled DETAILED DE- SCRIPTION OF THE DRAWING, one will under- intravenously. An intravenous solution, commonly re- 30 stand how the features of this invention provide the

ferred to as parenteral liquid, is fed from a container holding this liquid. The liquid flows through tubing into a needle which has been inserted into the patient's vein. The needle is taped securely to the patient's body and is

attributes of safety and convenience. One safety feature of this invention is the use of a cap

member to enclose the needle to be inserted into the sealed entry port structure. This cap member fits snugly

not likely to pull loose if the patient moves. Medication 35 over the entry port structure, connecting with the port needed to sustain the life of the patient, for example, drugs which maintain the blood pressure of the patient at the desired.level, are added to the parenteral liquid. The conventional practice is to introduce the medica- tion through a second needle inserted into a sealed entry 40 port in the tubing through which the parenteral liquid flows.

One problem with this conventional practice is that the needle may be pulled loose from the sealed port relatively easily. Such accidental removal of the needle 45 from the sealed port can have very serious conse- quences and could even lead to the death of the patient. Although many hospitals require nurses to tape the needle securely to the tubing, this is not always done,

structure in a male-female mating relationship. The needle pierces the seal when the cap member is seated on the port structure. This needle is housed deep within a cavity in the cap member that terminates in an open mouth into which the sealed end of the port structure fits. This open mouth is narrow in width so that the finger of the nurse or patient cannot fit into the cavity and contact the needle. Since the needle is so mounted within the cap member, the likelihood of bacterial con- tamination is avoided or reduced and the nurse is pro- tected against accidental needle sticks.

A second safety feature is provided by the wall de- sign of the cap member and port structure. These walls

because taping is a burdensome and time consuming 50 are of preferably cylindrical configuration and engage task.

A second problem with the conventional practice is needle sticks. From time to time a nurse in attempting to insert the needle into the sealed entry port will acciden- tally stick himself or herself with the needle. This often 55 occurs under emergency conditions when the nurse is under pressure to complete this task as quickly as possi- ble. Not only is the accomplishment of the task delayed, but the nurse must stop working and have a blood test

each other like a telescope. The interior surface of the wall of the cap member slides over the exterior surface of the wall of the mating port structure, with these walls engaging each other to guide the needle into the center of the seal. This ensures that the needle does not scrape against the inside surface of the wall of the port struc- ture. Particles scraped from this wall could make their way into the patient's blood stream and result in death. This potentially lethal condition is inherent in the de-

performed. Such a test is needed in case the nurse be- 60 sign of conventional devices. But the connector of this comes infected, because the hospital will be responsible financially. Consequently, needle sticks not only result in increased hospital cost, but are a possible life treating event to the nurse.

invention, with the guideway wall design of the cap member and port structure, ensures that the needle is directed into the center of the seal so that it avoids scraping against the inside surface of the wall of the port

A third problem with the conventional practice is 65 structure. This guideway wall design also permits the

infection. All too often a patient's life is seriously endan- gered by bacteria gaining entry into a patient's blood stream and infecting the patient. In a vast number of

nurse quickly to connect the cap member to the port structure. This makes the connector of this invention not only more convenient to use, but in emergencies,

4,752,292 3 4

enables the nurse to administer medication to a patient faster than with conventional devices and doing it with- out the danger of needle sticks.

A third safety feature of the invention is that a lock- ing mechanism detachably secures the cap member to 5 the port structure. Because of this feature, movement of the patient does not result in accidental removal of the needle from the seal. Although many different types of locking mechanisms may be employed, the preferred one provides a sound upon locking engagement of the 10 cap member and port structure. We have devised such a locking mechanism which produces a sound such as a "click." This "click" is an audible signal which tells the nurse that the cap member is locked safely to the port structure and cannot be accidentally jarred loose by 15 movement of the patient.

Several embodiments of the invention illustrating all the features of this invention will now be discussed in detail. These embodiments show the invention being used for administering medication intravenously to a 20 patient. This invention may also be used to administer medication to a patient in other ways, for example, intracranially or intraperitonially.

BRIEF DESCRIPTION OF THE ORAWINGS 25 The drawing, wherein the numerals indicate like

parts, depicts four embodiments of this invention in which:

FIG. 1 is a schematic view illustrating administering medication intravenously to a patient in accordance 30

_;:With conventional practice. . FIG. 2 is a cross-sectional view of a piggyback con- _0-nector for introducing parenteral liquid and medication

intravenously to the patient shown in FIG. 1. FIG. 3 is a perspective view of the first embodiment 35

of the medical connector of the present invention which ,_.employs a slip-on/twist lock type means for securing ....the.cap member to the port structure. :· FIG. 4 is a cross-sectional view of the connector

FIG. 11 is a top plan view of the cap member. FIG. 12 is a bottom view of the handle of the locking

mechanism shown in FIGS. 8 through 11. FIG. 13 is a side elevational view of the handle of the

locking mechanism. FIG. 14 is a side elevational view of the cap member

with the handle of the locking mechanism removed. FIG.15 is a top plan view of the cap member with the

handle of the locking mechanism removed. FIG. 16 is an enlarged cross-sectional view of a por-

tion of the hinge of the locking mechanism. FIG. 17 is an enlarged cross-sectional view of the

position of the handle just prior to being secured to the cap member.

FIG. 18 is a cross-sectional view similar to that shown in FIG. 17 depicting the handle coupled to the cap member.

FIG. 19 is a cross-sectional view taken along line 19-19 of FIG. 18.

FIG. 20 is a perspective view showing the

medical connector of FIG. 7 having one end coupled to a tube extending from a patient's arm and another end coupled to a tube extending from a container holding medica- tion.

FIG. 21 is a perspective view of a medical connector like that shown in FIG. 7, except the port structure has the lip which engages the handle of the locking mecha- nism as an integi::al part of a conventional piggyback connector.

FIG. 22 is a schematic view showing a medical con- nector of the type shown in FIG. 7 designed to intro- duce medication into a patient's chest.

FIG. 23 is a perspective view of a fourth embodiment of the medical connector of this invention which em- ploys a slip-on/twist lock type means for securing the cap member to the post structure.

FIG. 24 is an enlarged cross-sectional view taken · _.shown in FIG. 3 taken along line 4-4 of FIG. 3. 40 along line 24-24 of FIG. 23, showing the cap member

FIG. 4a is a perspective view showing how the cap ..member prevents needle sticks.

FIG. 5 is a perspective view of the second embodi- ment of the medical connector of the present invention which employs a snap-on type means for securing the 45 cap member to the port structure.

FIG. 6 is a cross-sectional view of the connector shown in FIG. 5 taken along line 6-6 of FIG. 5.

FIG. 7 is an exploded perspective view of the third

being connected to the sealed entry port structure. DETAILED DESCRIPTION OF THE ORAWING

Conventional Connector System As shown in FIGS. 1 and 2, the current way of intra-

venously introducing parenteral liquid into a patient is by the conventional feeding system 10. This feeding system 10 includes a container 12 for the parenteral liquid, a tube 14 extending from the container and con- nected to a Y or "piggyback" connector 16, and a tube

embodiment of the medical connector of the present 50 18 from the piggyback connector to a needle (not invention which employs a snap-on type means for securing the cap member to the port structure.

FIG. 8 is a side elevational view, with sections broken away, of the embodiment shown in FIG. 7. In this FIG. 8 the handle of the locking mechanism attached to the 55

cap member just engages the lip of the port structure. FIG. 9 is the same view as shown in FIG. 8, except the

handle of the locking mechanism is flexed and just about to snap into locking engagement with the lip of

shown) inserted into a vein of the patient. The needle is taped to the patient so that movement of the patient will not result in the needle being pulled from the patient's vein.

As best illustrated in FIG. 2, medication from the container 20 is introduced through the piggyback con- nector 16 into the parenteral liquid flowing through the feeding system 10. This piggyback connector 16 con- sists of two tubular conduits 22 and 24 which merge into

the port structure. 60 a third tubular conduit 26. The tubing 14 from the con- FIG. 10 is the same view as shown in FIGS. 8 and 9,

except the handle of the locking mechanism is now engaging the lip of the port structure in the locking position.

FIG. 10a is the same view as shown in FIGS. 8, 9 and 65 10, except the handle of the locking mechanism is flexed to permit removal of the cap member from the port structure.

tainer 12 of parenteral liquid is inserted into the inlet port 28 of the conduit 22 and secured in position, for example, by an adhesive which bonds the external sur- face of this tube to the internal wall surface of the con- duit. There is a stop 30 which limits the extent to which this tube 14 can be inserted into the conduit. In a similar fashion, the tube 18 is secured to the outlet port 32 of the piggyback connector. This tube 18 is inserted into

4,752,292 5 6

the outlet port 32 until it abuts a stop 34 in the internal wall of the conduit. This tube 18 is secured by an adhe­ sive to the internal wall of the conduit 26.

The sealed entry port structure of the conventional feeding system 10 is provided by the branch conduit 24 5 which has a standard latex rubber seal 36 at its inlet port 38 to seal this port. Consequently, bacteria cannot enter the piggyback connector 16 via the inlet port 38 because of the seal 36. This seal 36 is of conventional design and

duced via the conduit 24, and the conduit 22 carries the seal 36 that covers the inlet port 28. In this embodiment, this sealed conduit 28 constitutes the entry port struc­ ture 27. The cap member 50, is detachably secured to the entry port structure 27, with the needle 44 penetrat­ ing the seal center of the seal 36 when the cap member 50 mates with the port structure 27.

The cap member 50 comprises a cylindrical connec­ tor section 56 having a hollow interior forming the

includes coaxial annular aprons 40 and 42 which fit over 10 chamber or cavity 52 housing the needle 44. This needle the conduit wall 24a and grip the external and internal wall surfaces to hold the seal securely to the conduit 24. A suitable seal may be obtained from the West Com­ pany of Phoenixville, Pa.

44 is disposed lengthwise along the longitudinal axis of the cavity 52 and is centrally located. The cavity 52 has an open mouth 52a which allows the cap member to be seated over the port structure 27. The mouth 52a, how­

The medication is introduced into the parenteral liq­ 15 ever, is constricted so that, as illustrated in FIG. 4a, it

uid flowing through the piggyback connector 16 by a needle 44 which is inserted through the central part of the seal 36 into the branch conduit 24. This needle 44 is connected by a suitable connector 46 to a tube 48 which

prevents the little finger of a typical adult user from being inserted into the cavity 52. The tip or end 44a of the needle is safely displaced inwardly from the open mouth 52a so that even if the user intentionally inserted

is connected to the container 20 (FIG. 1) for the medi­ 20 his or her finger into the open mouth, the tip of the cation. As parenteral liquid flows through the piggy­ back connector 16 into the inlet port 28 and out the outlet port 32, the medication is drawn into this stream of liquid, flowing from the container 20 via the tube 48

and through the open tip or end 44a of the needle 44 25 into the parenteral liquid.

After studying FIGS. 1 and 2, the several problems associated with the conventional practice can now be more fully understood. If the patient moves, for exam­

needle would not stick this finger. Typically, the open mouth 52a has a maximum width of no greater than about one centimeter, and the minimum distance be­ tween the mouth 52a and the tip 44a is about one centi­ meter.

The locking mechanism includes the threads 69a formed in the end 54 of the interior cavity wall 55 and the threads 69b in the exterior wall of the conduit 22. These threads 69a and 69b engage upon connection of

ple, rolls or moves his or her arm, the needle 44 may be 30 the cap member 50 to the port structure 27 by screwing pulled from the seal 36. If this occurs, the latex seal 36 has sufficient resiliency to close off the hole in the seal produced by the needle 44. The

parenteral liquid will continue to flow into the patient's system, but the neces­

the cap member to the conduit 22. The top of the cap member 50 has a pair of outwardly extending wings 58 which

facilitate screwing the cap member 50 to the conduit 22. As this is done, the interior wall 55, sliding

sary medication is no longer being introduced into it. 35 over the exterior surface of the conduit 22, guides the The cQnsequences of this condition are very grave and, if this condition is unnoticed by the nurse, it could result in the. death of the patient or serious complications in the patient's treatment. Even if the nurse notices that

needle 44 so that it penetrates the center of the seal 36. To further ensure that the needle 44 penetrates the center of the seal 36, the threads 69b could be lowered further beneath the seal so that the cap member would

the needle 44 has been removed from the seal 36 and 40 fit telescopically over the conduit 22 and then be reinserts it into the seal, it is possible that the needle has been contaminated with bacteria. The use of such a contaminated needle 44 is unacceptable, but neverthe­ less this sometimes happens. The needle 44 may be taped to the conduit 24, and many hospitals instruct 45 nurses to do this. When this task is done, the needle 44 is secured, but cannot be conveniently removed and then reinserted. And even when taping the needle 44, if this is not done carefully, the needle may still be con­

screwed into position. Thus, the cap member 50, serv­ ing as the female component, and conduit 22, serving as the male component, mate in a male­ female relationship, with the needle 44 always being housed safely within the center of the cavity in an unexposed condition and positioned to pierce the center of the seal 36.

A spindle 59 is provided to enable the cap member 50

to be screwed onto the port structure 27 without twist­ ing the tube 48. This spindle 59 is received within an

taminated by the nurse touching the needle or the tape 50 opening 61 within the cap member 50. The body of the being contaminated. Also, because the nurse holds the conduit 24 with one hand while inserting the needle 44, the nurse may accidentally stick the needle directly into the hand holding this conduit, or stick the needle through the conduit wall 24a into this hand.

These problems associated with the conventional practice are eliminated by the several different embodi­ ments of this invention disclosed hereinafter.

First Embodiment of the Invention

spindle 59 has a cylindrical neck section with a groove 63 in an end which protrudes from the opening 61. The cylindrical body expands outwardly slightly to provide a shoulder 65 which engages a stop 66 when thespindle

55 59 is placed in the opening, and a TRU seal O­ring 67 is received in the groove 63 to hold the spindle in position but allowing the cap member to revolve about the spin­ dle as it is screwed onto the port structure 27.

Along the longitudinal axis of the spindle 59 is a pas­

As illustrated in FIGS. 3 and 4, the 60 sageway 60. The tube 48 from the first embodiment of this invention, connector 49, employs a cap member 50 housing deep within the needle 44. As will be dis­ cussed in greater detail hereinafter, the cap member 50

container 20 holding the medication is inserted into the one end 60a of the passageway 60 and is bonded to the internal surface of this passageway, for example, by means of an adhesive. The other end 60b of the passageway terminates in a

is secured by a slip­on/twist lock type of locking mech­ 65 anism to the piggyback connector 16 so that movement of the patient does not result in the needle 44 being pulled from the seal 36. The parenteral liquid is intro­

threaded connector section 62 to which the needle 44 is secured. This needle has an adapter 64 which has an internal thread which engages the threads of the con­ nector section 62. Thus, the needle 44 is extends out­

4,752,292 7 8

wardly from this adapter 64. Thus, the needle 44 is held secure to the piggyback connector 16, penetrating the center of the seal 56 with its point 44a safely displaced away from the inside wall 55 of the conduit 22.

This connector 49 embodies many of the features of 5 this invention. For example, the cap member 50 safely houses the needle 44, and the threads on the guiding walls provide means for detachably securing the cap member to the port structure without taping. But it has several components, and therefore is costly to manufac­ 10 ture, it is time consuming to screw the cap member 50 to the port structure, and it does not provide an audible signal when the cap member is safety secured to the port structure. This later feature is provided by the

strike the body of the cap member to produce the de­ sired "click" sound. Moreover, the material will eventu­ ally crack along the flex line of the hinge and a break will occur. The reliability of this connector 71 is sub­ stantially improved by the third embodiment of this invention which employs a unique locking mechanism.

Third Embodiment of the Invention As shown in FIG. 7, the third

embodiment of this invention, connector 90, includes a sealed port structure 91 and a cap member 92 having a locking mechanism 94 for detachably securing the cap member 92 to the port structure 91. The cap member 92 is similar to the cap members of the other embodiments and houses within

second and third embodiments of this

invention. Second Embodiment

of the Invention

The second embodiment of the present invention,

connector 71, is shown in FIGS. 5 and 6. In this embodi­ ment a cap member 70, similar to cap member 50, is 20 simply snapped onto the piggyback connector 16. The snap­on type locking mechanism of this connector 71 is easier to use and less costly to manufacture than the slip­on/twist type of the first embodiment.

In this embodiment, the cap member 70 includes a 25 hollow cylindrical element 72 which carries on its exte­ rior two clips 74 which have catch tips 76 that snap into a groove 78 in the external wall of the conduit 22. The clips 74 are mounted by hinges 75 to the element 72, and

.,are integral with the element 72. A plug assembly 80 30

,,.carries the tubing 48 and the needle 44, which is .;,mounted on anadapter 64 suchas shown in FIG. 4.This

15 its cavity 92a (FIG. 8) the needle 44. The cavity 92a has a tapered side wall 93 to better direct the needle 44 into the center of the seal 36.

The port structure 91 is a tubular conduit 102 having, at one end, a reduced diameter nipple 104 over which

:,plug assembly 80 is glued or otherwise bonded to the ­Open end of the cylindrical member 72. The cap mem­ ber 70, including clips 74 and hinges 75, are molded 35 from the same material, for example, nylon, which is a material having the desired resiliency.

To­attach the cap member 70, one simply slips the

.,member 70 over the conduit 22. The clips 74 bend out­ :.wardly slightly and, when the catch tips 76 of the clips 40 · :are opposite the groove 78, the clips snap in place as .,shown in solid lines in FIG. 6. The centrally mounted needle 44 is guided into the center of the seal 36 by the cap member 70, which, like a telescope, slides over the tubular conduit 22. There is shoulder 82 which serves as 45 a stop to limit the movement of the cap member 70.

This shoulder 82 brings the catch tips 76 of the clips into registration with the groove 78. The hinges 75, being of the same material as the clips 74, provide an internal bias or spring action due to the resiliency of the material 50 from which these clips and hinges are made. Conse­ quently, the clips 74 snap into a locking position, lock­ ing the cap member to the conduit 22 when the catch tips 76 are in

the seal 36 fits and, at the other end, a tapered barrel 103. The seal 36 is of the same type employed in con­ ventional devices such as shown in FIG. 2. Material is removed from the barrel 103 to reduce cost. This results in the formation of flutes 103a in the barrel 103. At the base of the barrel 103, adjacent the end of the port structure 91, is an annular, disk­

registration with the groove 78. To release like piece which pro­ vides a lip 106. When the cap member 92 is placed over the port structure 91, a handle 96, which is a component of the locking mechanism 94, engages this lip 106. The handle 96 is hinged to the body 98 of the cap member by a two component hinge 100.

As best shown in FIGS. 14 and 15, a hook 114 is one component of the hinge 100 and the other component of the hinge is a crossrod 108 (FIG. 18) carried by the handle 96. The hook 114 projects outwardly from the body 98 of the cap member and has adjacent to it a ramp 116, which as shown in FIG. 18, holds the crossrod 108 when the handle 96 is attached to the body of the cap member. A section of the crossrod 108

is cut away to provide a miter slot 118 which engages the ramp 116.

The handle 96 is best shown in FIGS. 12 and 13. It has a pair of spaced apart plates 110 and 112 extending downwardly from the underside of the handle and the crossrod 108 is disposed between these plates, with the opposed ends of the crossrod being integral with the plates. Opposite the crossrod 108 and parallel to it is a third plate 120,

which is integral with the underside of the handle 96 and is at a right angle to and connects with the forward ends of the plates 110 and 112. Dis­ posed on the underside of the handle 96 between the catch tip 122 and the plate 120 is a clapper bar 126. The clapper bar 126 produces the "click" sound when it strikes the body 98 of the cap member. This clapper bar 126 extends away from the plate 120 at a right angle and

the cap member from the piggyback connector 16, the 55 is integral, at one end of the handle, with the catch tip clips 74 are simply depressed and the cap member 70 is removed.

One of the features of the slip­on type locking mecha­ nism is that with one simple inwardly push the needle 44

122 and, at its opposite end, with the plate 120. The leading edge 124 of the catch tip 122 is beveled to facili­ tate the slippage of this tip up and over the lip 106 which is also beveled. At the point where the clapper

is inserted directly into the center of the seal 36 and the 60 bar 126 merges with the inside of the catch tip 122, there cap member is locked to the port structure. Another feature of this connector 71 is that when the tips 76 of the clips snap into the groove 78 a "click" sound is made by the tips striking the body of the cap member. With repeated use, however, the hinges 75, due to internal 65 stress produced in the nylon material, loose some of their spring action. Consequently, the tips 76 are not held with sufficient force in the groove 78, nor do they

is a notch 128, which, as shown in FIG. 10, receives the lip 106 when the handle 96 is in the locking position. At the rearend of the handle 96 is a leaf spring 130 which has one end free and its opposed end integral with the handle 96. At the free end of the leaf spring 130 are two spaced apart tracks 132 and 134

(FIG. 12). When the handle 96 is attached to the body of the cap member as shown in FIGS. 8 through 10, a finger 136

on the body

4,752,292 9 10

98 of the cap member is received within the channel 138 Thus the handle 96 pivots about the hinge100, depress- between the tracks 132 and 134. On the

underside of the ing the spring 130. With the handle 96 and lip 106 in this handle 96 are two downwardly projecting reinforcing position

and the spring 130 depressed, as soon as the lip strips 140 and 142 (FIG. 12) which provide structural 106 clears the edge of the catch tip 122, the

spring ro- rigidity to the handle. 5 tates the handle in a counterclockwise direction, mov- The way in which the handle 96 is pivotably con- ing it to

the position shown in FIG. 10 with ample force nected to the cap member 92 by the two component so that the clapper bar 126 strikes the body 98 of the cap hinge 100 is illustrated by FIGS. 16 through 19. To member

to produce the "click" sound. This "click" attach this handle 96 to the body 98 of the cap member, sound is the audible signal which the nurse

may rely first one positions the handle over the body of the cap 10 upon to indicate that the cap member 96 is locked to the member opposite the hook 114 and then moves the

port structure 91. Under certain hospital conditions, handle into contact with the cap member so that the

particularly in the intensive care unit where there is not crossrod 108 touches the rearend of the ramp 116. The a great

deal of light, this is an important feature because spring 130 is depressed at this time. Next, the handle 96 it provides additional assurance that the

cap member 92 is moved towards the left, as shown in FIG. 17, with the 15 is locked to the port structure 91. crossrod 108 sliding up the ramp 116 until it engages the As shown in FIG. 10, with the handle 96 in this leading edge 140 of the hook 114. The dimension be- locked position, the needle 44 has penetrated the central tween the edge 142 of the ramp 116 and the edge 140 of portion of the seal 36, directed by the tappered side- the hook 114 is less than the diameter of the crossrod walls of the cavity 92a and the barrel 103. Medication 108. Consequently, the hook 114 must flex slightly up- 20 now flows through the connector 90. into the patient. wardly in a counterclockwise direction, as viewed in Note, the handle 96 is not depressed as the cap member FIG. 17, until the crossrod 108 clears the edge 142 of 92 is slid over the port structure 91. To remove the cap the ramp and snaps into the position shown in FIG. 18. member 92, the handle 96 is depressed, moving it to the The hook 114 thus returns to the unflexed condition position shown in FIG. 10a. With the handle 96 in this shown in FIG. 18, wrapping around the crossrod 108. 25 position, the cap member 92 is pulled off the port struc- The miter slot 118 then engages the edge 142 of the ture 91. ramp, with this edge abutting the junction 118a of the Except for the seal 36, the connector 90 is made en- slot 118 (FIG. 18). The ramp 116 thus holds the cross- tirely of a transparent plastic. The use of a transparent rod 108 in position, preventing the handle from becom- plastic is preferred because this allows the nurse to see ing dislodged from the hook 114 and preventing the 30 that the needle 44 is correctly inserted into the seal 36, handle 96 from tilting to-and-fro about its longitudinal and thus provides additional safety. Also, the use of axis. When the handle 96 is so mounted to the body 98 plastic makes the connector 90 a low cost, disposable of the cap member, the finger 136 slips into the channel item. The plastic most suitable is a polycarbonate made 138 between the tracks 132 and 134 and holds the rea- by Cyrolite Industries in Azusa, California sold under rend of the handle so that it does not tend to move 35 the tradename Cyrolite. This plastic, which is com- laterally. The handle 96 is, however, free to pivot about monly employed to make medical devices, has been the hinge 100. approved for such uses by the United States Federal

Unlike the hinges 75 of the second embodiment of Drug Administration. this invention, the two component hinge 100 does not The connector 90 is particularly adapted to beused in

break due to fatigue. Thus, in accordance with one 40 a variety of different applications. For example, as illus- feature of connector 90, the handle 96 may be moved trated in FIG. 20, it may be connected directly in line

between a locked position (FIG. 10) and unlocked posi- with a container 144 of medication to be supplied intra- tion (FIG. 8) as often as one wishes without breaking. venously to a patient. In this instance, the cap member

At the same time, the handle 96, coating with the body 92 has a tube 146 extending from it which has at its one 98 of the cap member 92, generates a "click" sound 45 end a male component 148 of a conventional luer lock when the cap member is locked to the portstructure 91. connector. This male component 148 engages and locks

This "click" sound, as best illustrated in FIGS. 9 and 10, with a mating female luer component 150 attached to occurs when the handle 96 moves between the flexed the end of a line 146 extending from the container 144. position shown in FIG. 9 and the locked position shown In a similar manner, the port structure 91 has extending

in FIG. 10. 50 from it a tube 154 which has at its end a female luer The connector 90 is highly reliable under actual hos- component 158 of a second luer lock connector. The pital working conditions, and the way connector 90 is male component 156 of this second luer lock connector used is best shown in FIGS. 8 through 10a. First, the is attached to the end of a tube 160 that is connected to nurse inserts the end of the port structure carrying the a needle inserted into the vein of the patient. The luer seal 36 into the open mouth 93 of the cap member 92 to 55 lock connectors may be obtained from Burron Medical,

bring the lip 106 into engagement with the catch tip 122 Inc. in Bethlehem, Pa. of the handle 96 as shown in FIG. 8. As this is done, the FIG. 21 illustrates the connector 90 integrated into a tapered side wall 93 of the cap member and the tapered conventional piggyback connector 162. The branch line

barrel 103 slide along each other to direct the needle 44 164 from the piggyback connector 162 has attached to it into the center of the seal 36. Simultaneously, the bev- 60 and integral therewith the port structure 91 including eled edge 124 of the catch tip rides over the beveled lip the lip 106 that engages the catch tip 122 of the locking 106 until the lip just engages the underside edge of this mechanism 94. Thus, a conventional feeding system 10 tip as shown in FIG. 9. This causes the handle 96 to employing a piggyback connector may be modified by rotate in a clockwise direction as viewed in FIG. 9, with simply including a lip 106 adjacent the seal 36. This lip the crossroad 108 turning while in the grasp of the hook 65 106 will then serve as the site for detachably connecting 114. There is enough clearance between the miter slot the cap member 92 to the piggyback connector 162. 118 and the edge 142 of the ramp to allow the crossrod The connector 90, as shown in FIG. 22, also lends to tum sufficiently so the catch tip 122 clears the lip 106. itself to be used with central venous catheters which are

invention since we are

sticks are avoided. Second,

4,752,292 11 12

inserted into the chest of the patient. Frequently, pa­ tients under home care use such catheters, and conse­ quently, even simpler and safer devices and techniques must be employed. However, a serious problem with such catheters is the way the ends of the lumens or tubes 166 and 168 extending from the patient are sealed. Pres­ ently, the ends of these tubes 166 and 168 are sealed using conventional luer locks. When it is time for the patient or the nurse to introduce medication into the

174 and 176 which slide along these slits as the port structure 172 matingly engages the cap member 183.

To use this connector system 170, the nurse aligns the port structure 172 with the open mouth 183a of the cap

5 member so that the pins 174 and 176 are in alignment with the entryway to the J­type slits 180 and 182. Then the nurse pushes the port structure 172 into the open mouth 183a, sliding the port structure into the cavity within the cap member 183. The pins 174 and 176 first

catheter, an intermediate portion of the tubes 166 and 10 engage the entryway of the J­ type slits 180 and 182 and 168 must be clamped while being connected to the source of medication so that air is not drawn into the blood stream of the patient. Any large intake of air into the patient's blood stream will seriously injure or even kill the patient. With children, even a small amount of 15 air may be fatal. That is why clamps are used to close off the tubes 166 and 168 until the connection is made with the source of medication. This results in the tubes 166 and 168 wearing out, requiring that they be re­ paired. Not only is this a dangerous system, but it is 20 extremely inconvenient for the patient

or nurse to use. As illustrated in FIG. 22, the connector system 90 overcomes

these difficulties by simply having at each of

then slide along the slits until they reach the base of the slits. At this·point, the nurse twists or rotates the cap member 183 and port structure 172 in counter­rotating directions so that the pins 174 and 176 will then slide respectively into the hooks 180a and 182a of the slits and be secured. This embodiment does not provide an audible signal upon locking the cap member 183 to the port structure 172, but is very economical to manufac­ ture.

Function of the Cap Member and Port Structure As will be appreciated from the above description,

the cap member provides several functions in a single snturmucbteurret.o(aWney will no longer refer by

the respective ends of the tubes 166 and 168 port struc­ 25 one of the components of the

tures 91. When the patient needs medication, he or she simply connects two of the cap members 92 to the re­ spective port structures 91, and when finished, discon­ nects the cap members. The medication is fed by the

now discussing in general how the cap member and port structure function to provide the attributes of safety and convenience.) First, the cap member surrounds the needle and provides a housing in which the needle is

needles 44 through the seals 36 and into the respecttve 30 lodged safely so that needle

tubes 166 and 168. The cap members 92, when de­

.. tached, withdraw the needles 44 from the seals 36,

··· which are self sealing. Thus, the nurse does not need to

_ damp off the tubes 166 and 168 nor is periodic repair of

the tubes required. Since the seal 36 is self­ sealing, upon 35 removal of the cap member 92 there is no danger of air

· being drawn through the port structure 91 into the

. patient's blood stream. Consequently, connector 90 is

· '.· both safer and more convenient to use than the conven­ · tional central venous catheters. 40

The connector 90 is also adapted to be used repeat­

. edly without damaging the seal 36. Thus it is even more suitable for such applications as illustrated in FIG. 22 than conventional devices, because of the accuracy

because the needle is so lodged within the housing, if the nurse did, for example, lay the cap member on the patient's bed, the needle would not come into direct contact with the bedding which might be infested with harmful bacteria. Thus, this arrangement of the needle deep within the cavity in the cap member provides protection for the patient against bacterial contamina­ tion and protection for the nurse against accidental needle sticks.

The port structure also provides more than one func­ tion. First, it serves as the site to attach the cap member, and, by means of a simple locking element such as a lip, thread, groove, pin or the like, provides an economical way to modify the conventional piggyback connector

cwaipthmwehmicbhert.hSeenceoenddl,eth44emay be repeatedly directed 45 so that it may be used with the

into the center of the seal 36. When the needle 44 is repeatedly stuck into and withdrawn from the seal 36, the seal will have numerous holes in it and begin to develop a "swiss cheese" like appearance. Eventually, a core is cut away from the seal by several of these holes 50 interconnecting, rendering the seal useless because it is no longer self­ sealing. Consequently, the seal would have a very short life. By carefully controlling the di­ mensions of the molds used to make connector 90, the cap member 92 and port structure 91 will be precision 55 made parts. Consequently, with repeated use, the needle 44 will essentially always penetrate the same hole in the seal 36, thus avoiding the "coring" problem.

FInovuernthtioEnmbodiment of the

combination of a self­sealing seal and adjacent element that locks with the cap member provides a simple way to modify connectors so that they have enhanced safely and convenience.

The cap member and port structure function in com­ bination to direct the needle into the center of the seal, lock these pieces together, and enable quick connection. The nurse or patient simply aligns the sealed end of the port structure with the open mouth of the cap member and pushes the two pieces together. The internal wall of the cap member and the exterior wall of the port struc­ ture engage to align the two pieces so that their respec­ tive axes coincide, guiding the needle into the center of the seal as they are pushed together. Consequently, the

The fourth embodiment of this 60 needle does not scrape the inside wall

invention, the connec­ tor 170, is illustrated by FIGS. 23 and 24. In connector 170 the port structure 172 is similar to that shown in the other embodiments except it has a pair of pins on oppo­ site sides of its body 178 which co­act with J­type slits 65

180 and 182 in the sidewall of a cap member 183 housing the needle 44.

of the port struc­ ture so that particles of plastic are not introduced into the patient's blood stream and the coring problem is virtually eliminated. The cap member and port struc­ tures each carry elements of a locking mechanism

These J­type slits 180 and 182 are op­ posed to each other and provide a guideway for the pins

which engage and lock the pieces together when the needle has pierced the seal, preventing accidental dis­ connect. Although other geometric forms may be em­ ployed, quick connection is facilitated by the cylindrical

4,752,292 13 14

configuration of the walls of the cap member and port structure and the circular open mouth of the cavity. In particular, the first through third embodiments of this invention are very quickly connected because no extra step is required to align the cap member and port struc­ 5 ture. All that the nurse need do is insert the port struc­ ture into the open mouth without any special concern for their relative positions, and, when using the second and third embodiments, simply push these two pieces together until the locking mechanism engages. When 10 using the first or fourth embodiments, the extra step of rotating the two pieces relative to each other isrequired to engage the locking mechanism. When using the forth embodiment, the pins must also first be aligned with the entryways to the J­slits prior to pushing the port struc­ 15 ture into the cavity in the cap member.

Because of the features embodiment in the cap mem­ ber and port structure, this invention may be used under normal hospital conditions without creating any addi­ tional work for the nurse, while substantially reducing 20 the likelihood of harm to the patient due to carelessness and protecting the nurse against infection and making his or her job easier and faster.

SUMMARY 25

In summary: Our connector is safe because (a) the needle is recessed deeply within the cap member and, therefore, is not likely to be contaminated by bacteria, (b) the cap member and port structure upon engage­ ment guide the needle into the center of the seal, avoid­ 30 ing scraping particles from the inside wall of the port structure, (c) the cap member, housing the needle safely within it, protects the nurse against needle stricks, and (d) the locking of the cap member and port structure together prevents accidental disconnects and (e) the 35 "click" signals the nurse when the

connector system is locked securely in position. Our connector is conve­ nient to use because (a) the walls of the cap member and port structure, interacting with each other, provide a guideway for quick connection, (b) the locking mecha­ 40 nism eliminates the burdensome and time consuming task of taping, and (c) the connector is very simple to use so that it is ideal for home care of patients.

SCOPE OF THE INVENTION 45

The above description presents the best mode con­ templated of carrying out the present invention as de­ picted by the four embodiments disclosed. The combi­ nation of features illustrated by these embodiments pro­

means on connection of the cap member to the port means to allow medication to flow

from said source through the needle into said tubing means, said sealing means being of a

self­sealing type so that holes produced in said sealing means by repeated penetration

therethrough by said needle are closed off each time said needle is withdrawn from said

sealing means, said cap member having a cavity therein

formed by a tubular wall element which provides and open mouth with said needle being disposed lengthwise along the longitudinal axis of the said cavity, with said tip of said needle being displaced inwardly from said open mouth a sufficient distance to recess the needle deep within the cavity so that it is un­ likely to be contaminated, said open mouth having a restricted diameter that prevents the tip of the little finger of a typical adult from being inserted into the cavity,

said first tubular wall element of said port means being adapted to pass through said open mouth upon insertion of said port means into said cavity of said cap member, with said first and second wall elements being coaxially aligned and engaging in a male­female mating relationship as the port means enters said open mouth of said cavity, with the interior surface of said

second wall element sliding over the exterior surface of said first wall element, said surfaces serving as guide means for directing said needle into the central portion of said sealing means so that said tip of said needle does not scrape particles from the inside surface of said first wall element, and

means for detachably locking the cap member and port means together securely when said port means is inserted into the cavity, said locking means being adapted for repeated manual operation and and being of a snap­on type where locking is achieved by pushing the cap member over the port means without relative rotation between the cap member and port means, and including one locking element on the cap member, and another locking element on the port means, said locking elements interact­ ing to lock together as the cap member is pushed over the port means.

2. The system according to claim 1 wherein the lock- ing snap-on type means includes a hingedly mounted element which flexes outwardly and inwardly to allow the cap member to be connected and removably at-

vide the safety and convenience of this invention. This 50 tached to the port means. invention is, however, susceptible to modifications and alternate constructions from the embodiments shown in the drawing and described above. Consequently, it is not the intention to limit it to the particular embodi­ ments disclosed. On the contrary, the intention is to 55 cover all modifications and alternate constructions fall­ ing within the scope of the invention as generally ex­ pressed by the following claims:

We claim: 1. A system for feeding medication from a remote

60 source through tubing means having one end securely connected to and in communication with a patient, said system including,

a port means at a point upstream from said one end, said port means being formed by a first tubular wall 65

element having an open end sealed by sealing means and being

connected to a cap member hav­ ing therein a needle which penetrates the sealing

3. A medical connector including, a port element formed by a first tubular

wall element having at one end sealing means which is of the self­sealing type so that holes produced therein by repeated penetration therethrough by a needle are closed off each time said needle is withdrawn therefrom,

a cap member formed by a second tubular wall ele­ ment to provide a cavity therein having an open mouth, said cap member being adapted to fit over said port element with the ealing means being received in the cavity,

a needle having at one end a tip, said needle being disposed within the cavity and aligned so that the needle tip penetrates the sealing means upon inser­ tion of the port element into the cavity and is dis­ placed inwardly from said open mouth a sufficient distance to recess the needle deep within the cavity

15

so that it is unlikely to be contaminated, said open mouth having a restricted diameter that prevents the tip of the little finger of a typical adult from being inserted into the cavity, and

means for detachably locking the cap member and 5 port element together when said port element is inserted into the cavity, said locking means being adapted for repeated manual operation and being of the type where locking is achieved by pushing the cap member over the port means without rela- 10 tive rotation between the cap member, and indud-

4,752,292 16

74

ABOUT THE AUTHOR

In 1983 John J. Connors, patent attorney, founded Connors & Associatespc,

a network of international and domestic attorneys penalizing in intellectual property and patent law. Through this network Connors & Associatespc creates for its clients valuable property and contractual rights in their ideas.

Mr. Connors has served as a board director of startup and publicly traded companies, the most successful being a medical device manufacturer, ICU Medical, Inc. (NASDAQ) of San Clemente, California. He served on the ICU board for over two decades as a member of the audit, compensation and governance committees, retiring as a lead director in 2015.

John J Connors, Founder of Connors & Associates and Author of “Patent It and

John J Connors with Dr. George A. Lopez, M. D , Founder of ICU Medical, Inc.

He believes that the knowledge gained while serving as a director of startup and publically traded companies is unique – unobtainable unless gained through direct experience involving business planning, licensing intellectual property, stock offerings, operations management, and most importantly, selection of the chief executive officer

Mr. Connors was patent counsel to several major corporations, including the Standard Oil Company (Indiana), the Brunswick Corporation, and TRW. At TRW be managed the patent and licensing department of TRW’s Aerospace and Energy Group, and served on the Advanced Electronics Panel chaired by Simon Ramo and the Patent Committee for the Aerospace Industry Association. He testified as an expert witness in Jacobsen v Kawasaki, involving the Jet Ski®, and served as an arbitrator for the American Arbitration Association, and as a Los Angeles assistant district attorney pro tempore.

Mr. Connors is a member of the California Bar, the Orange County Bar Association, the Orange County Intellectual Property Law Association, the Los Angeles Intellectual Property Law Association, the American Intellectual Property Law Association, the National Association of Corporate Directors, and is an expert­in­ residence as the University of California Irvine Applied Innovation Program and former member of the Association of Corporate Patent Counsel. He has been a guest lecturer on University, Saddleback College, USC, the Chapman University, has published articles on intellectual property law, and is the author of the book Patent It and Grow Rich

John J Connors, patent attorney and founded of Connors & Associatespc with son John Connors, president of Inventor Beware.com at L.A. Times Festival of Books.

Mr. Connors is admitted to practice before the United States Supreme Court, the United States of Appeals for the Federal Circuit, and the Federal Central District of California, and the California Supreme Court. He earned a Juris Doctor Degree from John Marshall Law School, Chicago, Illinois, and a Bachelor of Science Degree in Chemistry from the University of St. Thomas, St. Paul, Minnesota

76

Disclaimer

This book is a guide to intellectual property law and related legal and business issues. Although legal strategies, forms, restatements of the law, agreements, etc. are offered for your consideration, this book is not intended as a substitute for obtaining competent legal advice directed to your specific situation. Each invention, trademark, copyrightable work, and its related legal and business issues, calls for individual analysis. Moreover, the laws keep changing, and you need advice based on an understanding of the most current law and business trends.You are purchasing this book with the understanding and agreement that the author and publisher have no liability to anyone for any loss or damage caused, or alleged to be caused, directly or indirectly, by the use of information in this book.

77

CONSIDERING YOUR OPTIONS

From here your choices are simple. When you have studied and mastered the

information in this book, choose your option and you are on your way.

1: You can do it yourself. Write the provisional patent and file it on line at

www.uspto.gov. Pay the filing fee based on your status.

2: Write the provisional patent yourself and send it to Inventor Beware for review and

filing with US patent office. This option Includes:

A: Review by an IP professional.

B: Recommended changes for easy expectance and filing.

C: Analysis of Status and Paying Filing Fee.

D: If rejected, changes made and refiled at no charge to

you.

E: Follow up message when it is time to file your patent.

F: A credit for the full amount of this option on the final

preparation cost of a patent if you chose to complete it

with our recommended legal team.

Order this option at inventorbeware.com/file-for-you-ppa - $149.99

3: Write the provision patent and send it to Inventor Beware for review and filing with

the US patent office. This option includes everything from option 2 plus a ½ hour

telephone conference with the author, John J. Connors, patent attorney.

Order this option at http://inventorbeware.com/file-for-you-ppa-plus-

phone-call - $449.99

4. You can have a ½ hour telephone conference with the author, John J. Connors,

patent attorney.

Order this option at http://inventorbeware.com/30-min-phone-call -

$300.00

78