petition for inter partes review of u.s. patent no...

Petition for Inter Partes Review of U.S. Patent No. 5,755,725

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

Brainlab, AGand

Varian Medical Systems, Inc.Petitioners

v.

Sarif Biomedical LLCPatent Owner

Patent No. 5,755,725PCT Filing Date: Sept. 6, 1994

Issue Date: May 26, 1998

Title: COMPUTER-ASSISTED MICROSURGERY METHODSAND EQUIPMENT

Inter Partes Review No.: Unassigned

PETITION FOR INTER PARTES REVIEW UNDER 35 U.S.C. § 311-

319 AND 37 C.F.R. § 42.100, ET SEQ.


TABLE OF CONTENTS

I.

II.

INTRODUCTION

MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)

Page(s)

1

2

A. Real Parties-In-Interest Under 37 C.F.R. § 42.8(b)(1) 2

B. Related Matters Under 37 C.F.R. § 42.8(b)(2) 2

C. Lead and Back-Up Counsel under 37 C.F.R. § 42.8(3)(3) 2

D. Service Information Under 37 C.F.R. § 42.8(b)(4) 3

III. PAYMENT OF FEES UNDER 37 C.F.R. § 42.103 3

IV. REQUIREMENTS FOR INTER PARTES REVIEW 4

A. Grounds For Standing 4

B. Identification of Challenges 4

1. Claims for which inter partes review is requested 4

2. The specific art and statutory grounds on which thechallenge is based 4

3. The proposed alternative grounds are not redundant 5

V. SUMMARY OF THE '725 PATENT 6

A. Summary of the background technology 6

B. Supposed invention of the '725 patent 7

C. The cited prior art 12

D. Summary of the prosecution history 14

VI. DETAILED CLAIM CONSTRUCTION 15

A. Person of Skill in the Art 15

B. Broadest reasonable construction of "articulated tool support" 16


C. Broadest reasonable construction of "image data base comprisingimages in an image reference frame R," 17

D. Broadest reasonable construction of "computer adaptedto...control position and displacements of the tool as a functionof control signals originating from a control unit" 19

E. Broadest reasonable construction of "means for determiningcoordinates of the tool in the fixed reference system Rc based ondata from the image data base." 22

F. Broadest reasonable construction of "automatically controllingthe tool in real time in relation to a target in the image data base." 24

VII. THERE IS A LIKELIHOOD THAT AT LEAST ONE CLAIM OFTHE '725 PATENT IS UNPATENTABLE. 26

VIII. SPECIFIC GROUNDS FOR PETITION 27

A. Ground 1: Claim 1 is Anticipated by Allen Under 35 U.S.C.§ 102(b) 27

B. Ground 2: Claim 1 is Obvious over Allen Under 35 U.S.C. § 103 33

C. Ground 3: Claim 1 is Obvious over Schulz in view of Taylor. 35

D. Dependent Claims 2-9 are Obvious 42

1. Claims 2 and 5 are obvious 42

(a) Ground 4: Claims 2 and 5 are obvious in view ofAllen and Heilbrun 42

(b) Ground 5: Claims 2 and 5 are obvious in view ofSchulz and Taylor in view of Heilbrun 43

2. Ground 6: Claims 3, 4, 6, and 7 are Obvious 44

(a) Claims 3 and 6 are obvious in view of Schulz,Taylor, and Heilbrun in view of Henrion 44

(b) Claims 4 and 7 are obvious in view of Schulz, Taylorand Heilbrun, in view of Henrion 45

ii


3. Claim 8 is Obvious 45

(a) Ground 7: Claim 8 is obvious over Allen and Schulz 46

(b) Ground 8: Claim 8 is obvious over Schulz andTaylor 47

4. Ground 9: Claim 9 is obvious in view of Schulz, Taylor,Heilbrun, Henrion, and Allen 47

E. Ground 10: Claim 10 is obvious over Schulz in view of Heilbrun 48

Ground 11: Claim 11 is obvious over Schulz, Heilbrun, andGlassman 53

IX. CONCLUSION 56

111


TABLE OF AUTHORITIES

Page(s)

Cases

CCS Fitness Inc. v. Brunswick Corp.,288 F.3d 1359 (Fed. Cir. 2002) 20

Ex Parte Erol,No.2011-001143, 2013 WL 1341107, at *9 (P.T.A.B. Mar. 11, 2013) 20

Intel Corp. v. VIA Technologies,319 F.3d 1357 (Fed. Cir. 2003) 20

Laitram Corp. v. Rexnord, Inc.,939 F.2d 1533 (Fed. Cir. 1991) 23

Lighting Ballast Controll LLC v. Philips Elecs.,23498 Fed.Appx 986 (Fed. Cir. 2013)

Lighting World, Inc. v. Brichwood Lighting, Inc.,20288 F.3d 1354 (Fed. Cir. 2004)

Mayo Collaborative Servs. v. Prometheus Labs.,132 S.Ct. 1289 (2012) 15

Statutes

35 U.S.C. § 101 15

35 U.S.C. § 102(b) 4,5,27

35 U.S.C. § 103 4,5,34

35 U.S.C. § 112 20,23

Other Authorities

37 C.F.R. § 42.103 3

37 C.F.R. § 42.104 4

37 C.F.R. § 42.15(a)(1-4) 3

37 C.F.R. § 42.8(a)(1) 2

iv


37 C.F.R. § 42.8(b)(1) 2

37 C.F.R. § 42.8(b)(2) 2

37 C.F.R. § 42.8(b)(3) 2

37 C.F.R. § 42.8(b)(4) 3

37 C.F.R. § 42.10(a) 2


LIST OF EXHIBITS

Ex. 1001

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U.S. Patent

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No.

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5,755,725

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Druais

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Ex. 1002 U.S. Patent No. 5,389,101 to HeilbrunEx. 1003 International Publication No. WO 91/04711 to Henrion (U.S. Patent

No. 5,868,675 (Ex. 1011)Ex. 1004 U.S. Patent No. 5,622,170 to SchulzEx. 1005 U.S. Patent No. 4,991,579 to AllenEx. 1006 U.S. Patent No. 5,445,166 to TaylorEx. 1007 U.S. Patent No. 5,871,445 to BucholzEx. 1008 U.S. Patent No. 5,086,401 to GlassmanEx. 1009 International Publication No. WO/1995/007055 to DruaisEx. 1010 International Search Report for International Publication No.

WO/1995/007055Ex. 1011 U.S. Patent No. 5,868,675 to HenrionEx. 1012 U.S. Patent No. 5,251,127 to RaabEx. 1013 File History of U.S. Patent No. 5,755,725Ex. 1014 Declaration of Timothy Solberg, Ph. D.Ex. 1015 Print out of http://www.merriam-webster.com/dictionary/automatic

Print out ofhttp: / /macmillandictionary.com/dictionary/american/automatically

Ex. 1016

Ex. 1017 International Preliminary Examination Report for InternationalPublication No. WO/1995/007055 to Druais

Ex. 1018 Declaration of Steven Izen, Ph. D.Ex. 1019 Print out of http://dictionary.reference.com/browse/articulated?s=t

vi


I. INTRODUCTION

The challenged claims of the '725 patent (Ex. 1001) cover nothing more than

previously-known apparatus and methods for image-guided surgery. They merely

were drafted with a few mathematical symbols that made what was old look new.

The '725 patent is based on a sparse French patent application and an even

sparser examination. The PCT examining authority identified only one application as

relevant. The U.S. phase of prosecution identified only a single U.S. patent. Yet there

was a significant amount of united prior art that is far more relevant and that

overcomes the exact problems to which the '725 is directed. Indeed, the subject

matter of the '725 patent seems to be a step backwards from much of the prior art.

The claims of the '725 patent generally relate to the problem of correlating the

position of a tool with corresponding preoperative images of the patient. In this way

the surgeon can see an MRI image of the specific area of the patient on which the

procedure is being performed. This is hardly new. Indeed, several uncited prior art

patents—including those to Bucholz, Schulz, Allen, Heilbrun, Taylor, and Glassman

for example—disclose such an image guided surgical system. Moreover, the '725

patent is vague in the extreme, failing to provide any disclosure for many of the

elements and steps claimed.

The Petitioners assert that it is more likely than not that at least one of the

challenged claims is unpatentable and request that the Board institute inter partes

review.


II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)

The following mandatory notices are provided as part of this Petition as

required by 37 C.F.R. § 42.8(a) (1).

A. Real Parties-In-Interest Under 37 C.F.R. § 42.8(b)(1)

Brainlab AG and Varian Medical Systems, Inc. are the real parties-in-interest

for Petitioners. The patent owner's direct parent company is Sarif Biomedical

Acquisition LLC, which is a 100% wholly-owned subsidiary of Marathon Patent

Group, Inc.

B. Related Matters Under 37 C.F.R. § 42.8(b)(2)

The '725 patent is presently the subject of a patent infringement lawsuit that

Sarif Biomedical LLC. brought against Brainlab, Inc., Brainlab AG, Brainlab

Medizinische Computersysteme GmbH, and Varian Medical Systems, Inc. in the

District of Delaware, case No. 13-846-LPS. Brainlab, Inc. is a wholly owned

subsidiary of Brainlab AG. Brainlab Medizinische Computersysteme GmbH is a

nonexistent company.

The '725 patent is also the subject of a lawsuit that Sarif Biomedical LLC

brought against Accuray Inc. in the District of Delaware, case No.

1:13-cv-00151-LPS. Neither Brainlab nor Varian is a party in the Accuray suit.

C. Lead and Back-Up Counsel under 37 C.F.R. § 42.8(b)(3)

Petitioners provide the following designation of counsel under 37 C.F.R.

§ 42.8(b) (3) and 42.10(a):

2


Jay R. Campbell (Reg. No. 33,660)[email protected] ELLIS LLP950 Main Avenue, Suite 1100Cleveland, OH 44113-7213Telephone: 216-696-5639Fax: 216-592-5009Counsel for Brainlab

Joe Greco (pro hac vice to be filed)igrecogbeckllp.com BECK, BISMONTE & FINLEY, LLP150 Almaden Blvd., 10th FloorSan Jose, CA 95113Telephone: 408-938-7900Fax: 408-938-0790Counsel for Varian

Joshua M. Ryland (pro hac vice to be filed)[email protected] ELLIS LLP950 Main Avenue, Suite 1100Cleveland, OH 44113-7213Telephone: 216-696-5270Fax: 216-592-5009Counsel for Brainlab

Jeremy Duggan (Reg. No. 55133)[email protected] BECK, BISMONTE & FINLEY, LLP150 Almaden Blvd., 10th FloorSan Jose, CA 95113Telephone: 408-938-7900Fax: 408-938-0790Counsel for Varian

A power of attorney accompanies this petition.

D. Service Information Under 37 C.F.R. § 42.8(b)(4)

Service information for lead and back-up counsel is provided in the designation

of lead and back-up counsel, above.

III. PAYMENT OF FEES UNDER 37 C.F.R. § 42.103

Payment of $23,000.00 for the fees required in 37 C.F.R. § 42.15(a)(1-4) is

authorized to be charged to Deposit Account 50-0902. Because 11 claims are

challenged, no excess fees are required. The undersigned authorizes payment for any

additional fees due in connection with this Petition to be charged to Deposit Account

No. 50-0902.

3


IV. REQUIREMENTS FOR INTER PARTES REVIEW

Each requirement of 37 C.F.R. § 42.104 for interpartes review of claims 1-11 of

the '725 patent is satisfied.

A. Grounds For Standing

Petitioners certify that the '725 patent is available for interpartes review and that

Petitioners are not barred or estopped from petitioning for interpartes review on the

grounds relied upon. The '725 patent has not been subjected to a previous

estoppel-based proceeding and the complaint referenced above in section II.B. was

served on Brainlab and Varian within the last 12 months.

B. Identification of Challenges

Petitioners request that the PTAB cancel as unpatentable claims 1-11 of the

`725 Patent.

1. Claims for which interpartes review is requested

Petitioners request interpartes review of claims 1-11 of the '725 patent.

2. The specific art and statutory grounds on which thechallenge is based

Petitioners request review in view of the following references, each of which is

prior art to the '725 patent under 35 U.S.C. § 102(b) and § 103 (pre-AIA).

Exhibit

Ex. 1002

Description l EffectiveFiling Date

Apr. 21, 1992U.S. Patent No. 5,389,101 to Heilbrun

Ex. 1003 International Publication No. WO 91/04711 toHenrion

Oct. 5, 1990

Ex. 1004 U.S. Patent No. 5,622,170 to Schulz Oct. 19, 1990

Ex. 1005 U.S. Patent No. 4,991,579 to Allen Nov. 10, 1987

4


Ex. 1006 U.S. Patent No. 5,445,166 to Taylor Jun. 13, 1991Ex. 1007 U.S. Patent No. 5,871,445 to Bucholz Apr. 26, 1993Ex. 1008 U.S. Patent No. 5,086,401 to Glassman May 11, 1990Ex. 1011 U.S. Patent No. 5,868,675 to Henrion Oct. 5, 1990

The only reference considered by the Examiner during the prosecution of the

application that resulted in the '725 patent is the Henrion reference (Ex. 1003). A

discussion of each reference and its applicability to the claims of the '725 patent is

provided in Section VIII.

Ground

1

Claims

1

Description

Anticipated under 35 U.S.C. § 102(b) under Allen2 1 Obvious under 35 U.S.C. § 103 over Allen3 1 Obvious under 35 U.S.C. § 103 over Schulz and Taylor4 2, 5 Obvious under 35 U.S.C. §103 over Allen and Heilbrun5 2, 5 Obvious under 35 U.S.C. § 103 over Schulz, Taylor, and

Heilbrun.6 3,4, 6,7 Obvious under 35 U.S.C. § 103 over Schulz, Taylor,

Heilbrun, and Henrion7 8 Obvious under 35 U.S.C. § 103 over Allen and Schulz8 8 Obvious under 35 U.S.C. § 103 over Schulz and Taylor9 9 Obvious under 35 U.S.C. § 103 over Schulz, Taylor,

Heilbrun, Henrion, and Allen10 10 Obvious under 35 U.S.C. § 103 over Schulz and Heilbrun11 11 Obvious under 35 U.S.C. § 103 over Schulz, Heilbrun, and

Glassman

3. The proposed alternative grounds are not redundant

Petitioner's proposed grounds for institution are not redundant because several

differences exist between the prior art compositions being asserted against the '725

patent claims The proposed grounds also set forth different statutory bases of

unpatentability based on the different prior art.

5


V. SUMMARY OF THE '725 PATENT

A. Summary of the background technology

The '725 patent (Ex. 1001) relates to an apparatus and method for making

preoperative images of a patient, such as those obtained by an MRI or CT scan,

available in real time during surgery.

According to the '725 patent, the prior art did not allow images of a patient to

be created prior to surgery and then recalled in real time during surgery:

In the stile of the att. the image-acquisition systems fordiagnostic purposes that do not require an intensive or

umatic intervention cannot be exploited for periaperativePutiv

Ex. 1001, 2:29-32.

As a result, according to the '725 patent, the patient's head had to be

immobilized relative to a tool during surgery to allow for calibration of the

preoperative image data base with the surgical space during surgery:

In fact, perioperative imaging requires the use ofstereotactic techniques which are restrictive for the patientand for the operative personnel. These techniques notablyinvolve a painful phase involving the implantation of amechanical structure in the form of a frame which isindispensable for acquiring the images in relation to aknown fixed reference system to enable satisfactory cali-bration of the images, and to assure the immobilization ofthe patient's head, or more generally of the operative zone.in relation to a given reference system.

Ex. 1001, 2:32-41. To this end the '725 patent cites to a number of French patent

applications that preoperatively determine the location of a lesion relative to a

6


therapeutic apparatus and then fix the patient relative to the tool. See, for example,

Ex. 1001, 1:30-31; 1:39-41; 1:64-2:5.

The object of the '725 patent was to overcome the restrictions of this prior art

by separating the acquisition of the image data base from the actual surgery:

The object of the present invention is to resolve thesedrawbacks by proposing an installation of ergonontic usewhich makes it possible to separate the image-acquisitionphase and th►e phase involving the exploitation of the imagesfor surgical purposes.

Ex. 1001, 2:24-28.

According to the patent, the goal of separating the image acquisition from the

surgery, yet allowing access to the requisite image in real time, was to create an

absolute reference system that is independent of both the patient and of the image

acquisition system:

In order to attain this goal, the installation in ccordawith the invention has an absolute reference system which isthe fixed reference system Rr linked to a structure totallyindependent of the patient or of the imaging or viswilizationsystem.

Ex. 1001, 2:50-54.

B. Supposed invention of the '725 patent

The '725 patent relates to what various people were doing in image-guided

surgery at the time: making preoperative images of the patient available to the surgeon

during surgery. Apparently, the applicant was not aware of the wealth of prior art in

the image-guided surgery field as very little was cited to the patent office.

The '725 patent requires:

7


• obtaining a pre-operative image data set of the patient, such as the head,

with an MRI or CT scan;

• correlating the image data set to the patient;

• tracking the positions of the patient and a tool in real time;

• determining and displaying the pre-operative image that corresponds to

the position of the tool relative to the patient;

• and, in some more aspirational than disclosed embodiments, controlling

the tool.

As seen in Figures la and lc below, prior to surgery a trihedron 21, is fixed to

the tool support and a separate trihedron 31 is fixed to the patient in the same

position as during image acquisition. Ex. 1001, 5:60-65; 4:37-43. A set of sensors,

like the cameras 3, 4, and 5 in Figure lb, are affixed in the room, such as by mounting

them to the ceiling, and form a fixed reference frame lc Id., 4:27-31.

8


30

FIG. lb

FIG. l c

The cameras have a view of the trihedron 31 on the patient 30 and the trihedron 21

on a tool support 2. Consequently the cameras can track the patient and the tool in

real time in the camera reference frame lc. Id.

Determining the image slice in the image database that corresponds to the

position of the tool relative to the patient is simple math using standard homogenous

transformations.

To explain, each trihedron 21, 31 establishes its own independent fixed

reference frame Rini (fixed tool reference frame) and Rm2 (fixed patient reference

frame), respectively. Id., 6:36-37. Because the trihedron 31 on the patient is also

present in the preoperative data set (in the reference frame It) when it is obtained, the

transformation roadmap 1Tni2 between the reference frame Ri of the preoperative

9


image data base and fixed patient reference frame Rm2 is known. According to the

`725 patent, the transformation miT° between the reference frame of the tool R. and

the fixed tool reference frame Rmi is "known by construction." Id., 8:5-8.

The real time position of the trihedron 21 as sensed by the cameras, in the

camera reference frame, is known by the transformation ̀Tml(t)• Id., 10:34-37.

Similarly, the real time position of the trihedron 31 in the camera coordinates is ̀ Tm2(t)•

Id., 8:17-21,

Determining then the image in the image data base that corresponds to the

position of the tool in real time is simply the multiplication of each of the

transformation road maps:

iTo(t) 1Tm2 m2Tc(t) CTml(t) miTo

Id., 10:46-52. Conversely, determining where the tool would have to be to correspond

to the desired image in the image data base, i °Ti(t), is thus the inverse of the

transformation 1T°(t) above. Id., 10:53-56.

The '725 patent further describes in some embodiments an articulated tool

support that is integral with the fixed reference frame of the cameras. In other words,

the articulated tool support is mounted to the same structure as the cameras. The

articulated tool support is shown in Figure 1a.

Independent claim 1 relates generally to an apparatus where a pair of sensors

tracks independently the articulated tool support and patient and displays the image

from the image data base corresponding to the position of a tool relative to the

10


patient. According to claim 1, the apparatus also includes a "computer adapted to

...control position and displacements of the tool as a function of control signals

originating from a control unit," and a "means for determining coordinates of the tool

in the fixed reference system Rc based on data from the image data set." Neither of

these elements is disclosed in the '725 patent. Indeed, there is no mention at all in the

detailed description of a "control unit" or "control signals" or an algorithm that

would generate the control signals. There is also no discussion in the patent of how

coordinates of the tool in the fixed reference system can be determined "based on

data from the image data set."

Claims 2 through 9 depend from claim 1.

Independent claim 10 is directed to calculating of a series of known

mathematical transformations and using the result to perform microsurgery. Claim 10

determines the positions of a tool and a patient by known transformations and then

displays the patient image from an image data base that corresponds to the position of

the tool.

Independent claim 11 is directed to a method of controlling a microsurgery

tool based on a series of mathematical transformations Like claim 10, claim 11

determines the positions of a tool and a patient by known transformations. It then

automatically controls a tool—through some mechanism or algorithm disclosed

nowhere in the patent—using the inverse of the same transformations recited in claim

10.

11


C. The cited prior art

The '725 patent is based on a PCT application (Ex. 1009), which was in turn

based on a French patent application filed on September 7, 1993. Claims 1 through

11 of the 725 patent are very similar to claims of the PCT application but for

amendments to address issues relating to indefiniteness and nonstatutory subject

matter.

The International Search Report (Ex. 1010) identified only one reference, WO

91/04711 ("Henrion") (Ex. 1003) as defining the general state of the art. U.S. patent

No. 5,868,675 (Ex. 1011) is the U.S. equivalent of WO A 91/04711 (Ex. 1003) and is

referenced here because the disclosure is in English. In the apparatus of this

reference, tomographic data containing markers was obtained preoperatively for the

patient's head in a reference frame R1. Ex. 1011, 4:37-46. A surgeon reviewed the

data and determined an optimal strategy for computer-guided intervention. Id. at

2:1-4. Later, during a surgical procedure, as seen in the figure below, the patent's head

was fixed to a table 10 by the means 2. Id. at 3:41-44. A robotic arm 3 with a tip 30

that determined the position of the patient's head in the reference frame R2 of the

table was likewise fastened to the table. Id. at 3:55-62.

12


During a surgical procedure, the coordinates of the patient in the reference

frame R2 are obtained by the arm 3. Ex. 1011, 3:55-62. Through a series of

optimized mathematical transformations from the patient image set R1 to the fixed

reference frame for the surgery R2, the monitor 1 displays the images of the patient's

head relative to a surgical intervention tool 50 in real time. Id. at 3:66-4:13; 5:1-5.

Based on this image information, a surgical intervention tool 50 is controlled in real

time to perform surgical intervention on the target area of the patient. Id. at 2:1-9.

Henrion varies only slightly from the '725 patent. For example, the '725 patent

criticizes Henrion because in Henrion the patient and the surgical tool are attached

together through the operating table and are in the same coordinate system R2. Ex.

1001, 1:64-2:5.

13


During the U.S. examination the only additional reference found was U.S.

Patent No. 5,251,127 to Raab (Ex. 1012). Like Henrion, in Raab the patient and the

tool share a coordinate system and the patient is attached mechanically to the tool.

The prior art is, however, replete with image guided surgical systems where the

patient and tool are tracked independently in different coordinate systems. See, for

example, prior art U.S. Patent No. 5,871,445 (Ex. 1007) that includes a comprehensive

list of over 150 relevant prior art patents and many technical publications. Included in

that list are many prior art patents where the patient and tool are tracked optically so

that preoperative images can be used to guide the surgery.

D. Summary of the prosecution history

The '725 patent had a very limited prosecution history (Ex. 1013) in the U.S.,

citing only the Raab reference (Ex. 1012) and having no prior art rejections. The

examiner also did not provide any reasons for allowance of the claims. Ex. 1013 at

pages 160-166.

Original claims 1 through 8 were rejected based on indefiniteness—mostly

because of a lack of antecedent basis for certain claim terms. The examiner did

indicate that claims 1 through 6 would be allowable if amended to correct the

antecedent basis issues. Claims 7 and 8—which correspond to claims 10 and 11 in

the '725 patent—were rejected based on 35 U.S.C. § 101. The examiner stated that

the claimed subject matter of claims 7 and 8 is simply "a mathematical exercise." Ex.

1013 at page 147.

14


In response, the applicant substituted new claims correcting the antecedent

basis problems identified by the Examiner. The applicant also argued that it added to

what became claim 10 "a non-mathematical step of performing microsurgery," and to

claim 11 "a non-mathematical step of automatically controlling the tool." Ex. 1013 at

page 159. In essence, the applicant added the phrase "performing microsurgery based

on the real-time display of the section" in new claim 10. And in the claim that

became claim 11, changed "enablingin real time the automatic control of the tool"

to "automatically controlling the tool in real time." The claims were then allowed.1

VI. DETAILED CLAIM CONSTRUCTION

Solely for the purposes of this review, Petitioners construe the claim language

as required for an interpartes review under their broadest reasonable interpretation in

light of the specification of the '725 patent. Petitioners interpret claim terms not

specifically addressed below in accordance with their plain and ordinary meaning as

would be afforded by a person of ordinary skill in the art.

A. Person of Skill in the Art

A person of skill in the art at the time of the supposed invention of the '725

patent would have a graduate degree in engineering or medicine and at least 5-10 years

of experience in the field or equivalent experience. See Ex. 1014, ¶31.

Under more recent precedent, those claims are likely unpatentable under 35 U.S.C.§ 101. See, Mayo Collaborative Servs. v. Prometheus Labs., 132 S.Ct. 1289, 1300 (2012).Nevertheless, Petitioners believe that the Board can and should invalidate these claimsunder § 103.

15


B. Broadest reasonable construction of "articulated tool support"

Proposed construction of"articulated tool support"

A computer-controlled mechanismadapted to move a microsurgery toolthrough plural axes, the mechanismincluding at least one arm having atleast one joint between its ends.

The phrase "articulated tool support" appears in claim 1. The '725 patent

shows the articulated tool support 1 in Figure la:

11

5

12

16

15

e V /

17

14

16

16

19

18

22

FIG. la 21 25 24

2

The articulated tool support 1 includes three "arms," each composed of two

arm sections (12 & 17, 13 & 18, 14 & 19) separated by a joint 16. At one end, each

arm is connected to a base 11 by "independently controlled" motors 15. Ex. 1001,

4:10-12. The base 11 is in turn integral with a fixed reference system Rc. Id. The

other end of each arm is attached to a mechanism 20 including a tool carrier stage 2.

Id. at 14-22.

16


Although the 725 patent is vague in the extreme, the apparent reason that the

tool support is articulated is to permit it to be controlled to move the attached tool to

a target on the patient:

One also obtains the transformation `Tim inverse of`Tom. making it possible to autoanatically control the tool inreal time in irtatial to a target defined in the image database.

Id., 10:53-56. While the specification does not describe how the tool is controlled,

claim 1 states that a "computer [is] adapted to...control position and displacement of

the tool...." Id., 11:5-15.

While "articulated" has several definitions, in the '725 patent it is used in the

mechanical sense, meaning, "having a joint or joints; jointed; an articulated

appendage" Ex. 1019.

Petitioners submit that a person of ordinary skill in the art would construe an

"articulated tool support" as "a computer-controlled mechanism adapted to move a

microsurgery tool through plural axes, the mechanism including at least one arm

having at least one joint between its ends." Ex. 1014, ¶ 36

C. Broadest reasonable construction of "image data base comprisingimages in an image reference frame Ili"

Proposed construction of "imagedata base"

Petitioners' construction: A data baseof images of a patient obtained pre-operatively from a source other thanthe "at least two sensors,"

"Image data base" appears in claims 1 and 11. As described in the '725 patent,

the image data base is created preoperatively and not created by images from the

17


sensors in the operating room. This is the object of the '725 patent—separating the

pre-operative image acquisition phase, such as by CT or MRI scanning, from the

surgical exploitation of those images:

The object of the present invention is to resolve thesedrawbacks by proposing an installation of ergonomic usewhich makes it possible to separate the image-acqu itionphase and the phase involving the exploitation of the irnagesfor surgical purposes.

Ex. 1001, 2:24-28. In fact the specification describes in length the process of creating

the "image data base prior to transferring the patient to the operating room where

the sensors are located:

The patient. after preparation. enters into a first room inkith image acquisition equipmeat is Installed. In this

MOM, one proceeds in a known manner to the instmmenta-tion of the patient. the acquisition of the raw images andverification lithe images obtained. The images are digitizedand stored in an imps data base. These images are thenprocessed on a work station, in the absence of the patient, bycalks-Won and segmentation of the images, indexing of theimages and possible programming of the operative trajec-toties and strategies.The patient is then transferred to the mug room.

Id., 4:52-62. See also, Id., 5:48-50 ("After this image processing step and the virtual

exploitation of the image data base, the patient is transferred to the operating room.").

Nowhere in the specification are the sensors or cameras described as providing

images that are stored in any fashion, much less in the "image data base." Ex, 1014,

36. Rather, the specification states the cameras "output an electrical signal

enabling calculation at any moment of the position of the center of gravity of the

trihedron...and its orientation, in the fixed reference system Rc...." Ex. 1001,

18


4:26-33, 37-43 (emphasis added). A person of skill in the art would in fact understand

that an "image data base," consisted of stored preoperative images and not real time

images generated in the operating room. See Ex. 1014, ¶ 36.

The broadest reasonable interpretation that a person of skill in the art would

give to an "image data base" is "a data base of images of a patient obtained

pre-operatively from a source other than the at least two sensors."' Ex. 1014, ¶36.

D. Broadest reasonable construction of "computer adaptedto...control position and displacements of the tool as a function ofcontrol signals originating from a control unit"

Proposed construction of "computeradapted to...control position anddisplacements of the tool as afunction of control signalsoriginating from a control unit"

Petitioners believe this term is ameans-plus-function clause thatcannot be construed becausestructural support is lacking in thespecification.

Assumed Sarif construction: Acomputer that controls the positionand displacements of the tool basedon control signals from a control unit

This element is found in claim 1, although an equivalent method step is found

in claim 11. "A computer adapted to...control position and displacements of the

tool" is a means-plus-function clause governed by 35 U.S.C. § 112, ¶ 6. Although the

claim does not use the presumptive "means for language, when a "claim term fails to

recite sufficiently definite structure or else recites function without reciting sufficient

structure for performing that function" it may still invoke 35 U.S.C. § 112, ¶ 6.

LightingWorld, Inc. v. Brichwood Lighting, Inc., 288 F.3d 1354, 1358 (Fed. Cir.

19


2004)(quoting CCS Fitness Inc. v. Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002).

That is the case here.

The phrase "compute?' by itself does not denote adequate structure to carry

out the recited function of controlling position and displacements of the tool. Ex.

1014, ¶ 37. In essence, the phrase "computer adapted to" is merely a substitute for

the more conventional "means for language. Indeed, this Board has determined that

"a processor adapted to" perform various functions invoked 35 U.S.C. § 112, ¶ 6. Ex

Parte Erol, No.2011-001143, 2013 WL 1341107, at *9 (P.T.A.B. Mar. 11, 2013). See

also, Intel Corp. v. VIA Technologies, 319 F.3d 1357, 1365 (Fed. Cir. 2003) ("element

adapted to" and "selection device adapted to" were means-plus-function clauses).

The '725 patent merely discloses a "computer 8" without explaining that it is a

particular type or model of computer. Ex. 1014, ¶ 37. Indeed, the computer is

referenced only twice outside of the Abstract and the Summary of the Invention. In

the first instance, Figure 1d is simply referenced as having "a computer (8)." In the

second instance, the computer is stated to solve certain equations determining the

concordance between tool reference frame and fixed reference frame:

The resolution of this equation system is performed by analgorithm known by the computer of the installation inaccordance with the invention. which will not be discussedin greater detail'in the context of the present description.since the expert in the field is in a position to implementsuitable data processing solutions.

20


`725 patent, 9:55-60. But, there is no discussion there or anywhere in the '725 patent

of how the computer controls the position and displacements of the tool. Ex. 1014,

¶ 37. Nor is there an algorithm disclosed for controlling the tool. Ex. 1014, ¶ 37.

Moreover, according to claim 1, the computer is provided "control signals"

generated by a "control unit' to control the position and displacements of the tool.

The phrases "control signal" and "control unit" appear only in claim 1, the Abstract,

and in the rephrasing of claim 1 in the Summary of the Invention. There is no

representation or discussion of the "control unit" or "control signals" in the drawings

or in the remainder of the specification.

At best, there is a sparse description of how to find a point in the tool

coordinate system R. based on an equivalent point in the image reference frame Ri:

C)ne also obtains the transformation 'Tim inverse ofmaking it possible to automatically control the tool in

rea1 time in relation to a target defined in the image database,

Ex. 1001, 10:53-56. Even then, the specification teaches only that the inverse of 70(t)

"mak[es] it possible to automatically control the tool..." Id., emphasis added. It does

not, however, say how to control the tool, provide a schematic, or describe an

algorithm. Ex. 1014, ¶ 37. Indeed, the specification does not even disclose whether it

is the computer or the control unit that performs the inverse transformation. Ex.

1014,¶37.

21


Petitioners submit that the specification does not disclose adequate structure

corresponding to the "computer adapted to...control position and displacements of

the tool..." and thus that this phrase cannot be construed. Petitioners, however,

believe that Sarif will likely assert that the phrase is not a means plus function clause

and should be construed as set forth above.

E. Broadest reasonable construction of "means for determiningcoordinates of the tool in the fixed reference system itc based ondata from the image data base."

Proposed construction of "means fordetermining coordinates of the toolin the fixed reference system itcbased on data from the image database."

Petitioners believe this term is ameans-plus-function clause thatcannot be construed becausestructural support is lacking in thespecification.

Assumed Sarif construction: acomputer that determines thecoordinates of the tool in the fixedreference frame Rc based on imagesobtained from the "at least twosensors."

The "means for determining' appears in claims 1 and 5. Petitioners submit

that the "means for determining" is a means-plus-function claim element under 35

U.S.C. § 112, ¶ 6. Aside from the telltale "means," the element recites no structure at

all. Ex. 1014, ¶ 38. Only a function is recited: "determining coordinates of the tool is

the fixed reference frame Rc based on data from the image data base." Ex. 1014, ¶ 38.

'When a term only indicates what the recited means 'does, not what it is structurally,'

the claim is properly construed under 35 U.S.C. § 112, ¶ 6." LightingBallast Controll

22


LLC v. Philips Elecs., 498 Fed.Appx 986, 990 (Fed. Cir. 2013), quoting, Laitram Corp. v.

Rexnord, Inc., 939 F.2d 1533, 1536 (Fed. Cir. 1991).

The specification of the '725 patent describes the structure for determining the

position of the tool support in the reference frame lc as cameras that detect the

trihedron 21 on the tool support:

The thedrort (21) is acqmired by theet :of whiCh outixit an ele is signal

f~akiau at'any moment of the per ;+ theeentet of qty of`the tritiedron (21) and its &imitation, inthe fixed reference system k. and thus to determine thepassage matrix between the fixed reference system R,, andthe tool-carrier reference system

Ex. 1001, 4:27-33. There is no mention in this passage of using data from the image

data base to find the coordinates of the tool in the camera coordinate system lc

Likewise, column 10 of the patent states that one knows the position of the

tool in the camera reference frame lc by infrared measurement:

Step 2: the position of the tool in the reference frame ofthe cameras by the transformation n; IT„, (known byconstruction) and °T„1 (t) (determined in real time byinfrared measurement);

Id., 10:34-37. Again, there is no mention of the use of data from the image data base.

Lastly, the Summary of the Invention states that the means for determining the

coordinates of the tool in the reference frame lc is a pair of cameras without any

mention of the image data base:

Advantageously. the means for determining the coordi-nates of the tool in said fixed reference system R, areconstituted by at least two acquisition cameras integral withthe fixed reference system Rc. and positioned such that theirfi Id of observation contains the mobility space of the tool.

23


Id., 3:39-43. See also claim 5.

In fact, the '725 patent does not anywhere describe how the position of the

tool could be found in the camera coordinate system Rc "based on data from the

image data base." Ex. 1014, ¶38. Indeed, the data in the image data base is in the

reference frame R1—not k. Ex. 1001, 6:27; 10:66-67.

Petitioners submit that the "means for determining coordinates of the

tool...based on data from the image data base" lacks any support in the '725 patent

and thus is indefinite. It is Petitioners' belief that Sarif will assert that this element

should be construed as "a computer that determines the coordinates of the tool in the

fixed reference frame lc based on images obtained by the at least two sensors."'

Consequently, as discussed above, Petitioners will construe the phrase in this fashion

for the purposes of the interpartes review.

F. Broadest reasonable construction of "automatically controllingthe tool in real time in relation to a target in the image data base."

Proposed construction of"automatically controlling the toolin real time in relation to a target inthe image data base."

Petitioners' construction: Moving themicrosurgery tool independently ofthe patient to a location in thereference frame Rc based on a targetin the image data set without theintervention of a person.

"Automatically controlling the tool in real time in relation to a target" appears

in claim 11. There is only one mention of the word "automatically" in the '725 patent

aside from claim 11:

24


One also obtains the transformation 'Tim inverse ofTom, making it possible to automatically control the tool inreal time in relation to a target defined in the image database.

Ex. 1001, 10:53-56. As discussed above, how the tool is controlled is never described.

Ex. 1014, ¶ 37. Nor is there any context for "automatically" in the '725 patent. Ex.

1014., ¶ 40.

Consequently, the ordinary construction of "automatic" or "automatically"

should be used. Automatic is defined generally in dictionaries to mean a function that

is performed without the aid of a person:

Automatic: Of a machine or a device: having controls that allowsomething to work or happen without being directly controlled by aperson.

http://www.merriam-webster.com/dictionary/automatic Ex. 1015.

Automatically: by a machine, without people doing anythingThe computer automatically numbers the lines.

http : /www.macmillandictionary.com/dictionary/american/automatically Ex. 1016.

Moreover, the tool is required in the claim to be controlled "in relation to a

target in the image data base." As such, it is controlled to move independently of the

patient. Ex. 1014, ¶¶ 39, 40. Indeed, as noted above with relation to the articulated

tool support, that is a purpose of the supposed invention. Ex. 1001, 5:51-59.

As such, Petitioners propose that a person of ordinary skill in the art would

accept the definition denoted above.

25


VII. THERE IS A LIKELIHOOD THAT AT LEAST ONE CLAIM OF THE '725 PATENT IS UNPATENTABLE.

According to the International Preliminary Examination Report (IPER) for the

PCT equivalent to the '725 patent, the '725 patent solved the problem of "ensuring a

real-time correlation between the images obtained by a medical imaging system and

the patient's actual position during the operation." Ex. 1017, ¶2.2. The solution

"ensure[d] that the tool reference system is made to correspond in real time with that

of the patient, and which enable[d] the change in tool position to be followed in the

image shown on a control screen." Id.

While the IPER concluded that this "problem and solution are in no way

suggested by the prior art citations," the prior art discussed below recognized the

problem and solved it in the same manner as the '725 patent. Id. For example, U.S.

patent No. 4,991,579 to Allen discloses an imaging system for correlating preoperative

image data of a patient with a computer-controlled surgical laser in real time,

displaying the image data, and automatically controlling the laser during a surgical

procedure. Ex. 1005, 15:3-17. Likewise, U.S. Patent No. 5,622,170 to Schulz

discloses a system using cameras to track both a patient and a tool in real time and

then display the position of the tool on a corresponding preoperative image. Ex.

1004, 13:20-64.

Indeed, the very things that the IPER found lacking in the prior art are

disclosed exactly in Allen and Schultz. In fact, U.S. patent No. 5,871,445 to Bucholz

26


discloses these elements as well. Ex. 1007. Simply put, Allen, Schultz, and Bucholz

are far more relevant than any of the art cited in the prosecution of the '725 patent.

VIII. SPECIFIC GROUNDS FOR PETITION

A. Ground 1: Claim 1 is Anticipated by Allen Under 35 U.S.C.§ 102(b)

If the Board determines that claim 1's terms are sufficiently definite to be

construed, under the broadest reasonable constructions of the claim terms, Allen's

disclosure anticipates claim 1 (Ground 1) or renders claim 1 obvious (Ground 2). Ex.

1014, ¶¶42, 46.

Allen discloses an image guided surgical system that marries preoperative

images taken of the patient with a system with sensors that track the location of the

patient in the operating room. These images may be obtained by CT, MRI, or PET

scans and are placed in an internal coordinate system (reference frame). Ex. 1005,

5:5-38; 6:4-11. As such, the preoperative images can be converted into a coordinate

system used to control a surgical laser and display the progress of the laser on the

preoperative images. As set forth below, if the claim is not fatally indefinite and can

be construed (see Section VI.D. and VI.E., supra), Allen discloses a computer assisted

microsurgery installation including each element of claim 12:

(a) an articulated tool support, one end of which is integral witha fixed reference frame itc;

2 For the convenience of the Board, claim charts matching each claim element to theprior art are provided in the Declaration of Timothy Solberg, Ph.D. (Ex. 1014).

27


Allen discloses two articulated supports capable of moving a tool, and each is

integral with a fixed reference frame. Both can be seen in Figure 7:

100

42

OPERATORCONTROL PANEL

F.110

104

PROGRAMMABLECOMPUTER

/82

IMAGER

3O1061 -

II

10B

DISPLAY

112

COORDINATES OFTARGET DISPLAY

36 (01

I 000.20)

The robot arm 34 is used to move a sensor 40 that identifies the location of fiducial

implants in the patient. Ex. 1005, 14:25-37. Its "base 36 can be chosen as the origin

(0,0,0) of the external coordinate system B." Ex. 1005, 14:28-31.

The radiation source 20 is used to apply radiation to the patient. As shown in

figure 7, it is supported by an articulated arm. "The radiation source 30 and where it

is aimed is known by the computer relative to the external coordinate system B." Ex.

1005, 14:60-66.

Allen's "tool" is a laser. Ex. 1005, 15:3-17. While the mechanism that controls

the laser in Allen is not explicitly disclosed, one having ordinary skill would

understand that it is moved by some articulated structure because Allen states that the

laser is "guided" and "controlled" by a computer. Ex. 1005, 15:3-17. And Allen

explicitly discloses multiple articulated supports (element 1(a)) that can hold tools.

28


Therefore, one of ordinary skill in the art would read Allen as inherently moving the

laser using one of the disclosed articulated tool supports. Ex. 1014, ¶ 44.

(b) an image data base comprising images in an image referenceframe Ri;

In Allen, as in '725 patent, the patient is first "placed in an imaging system

and images of a series of cross-sectional slices are obtained that include, for

example, the volume of the tumor which is the primary target of interest." Ex.

1005, 5:23-26. Those images are used to "define a fixed internal coordinate

system" in the patient. Ex. 1005, 6:2.

(c) at least two sensors, integral with the fixed reference frame lc,supplying a signal that is a function of the position of a referenceframe RI, of a patient in the fixed reference frame lc;

Allen describes determining patient position using two systems: a robotic arm

with a number of sensors (Ex. 1005, Fig. 7, item 34, 40, col. 14:25-56), and an imaging

system (Id , 15:3-17). The robotic arm is integral with the fixed reference system, as

set forth above. It provides patient position information, moving to touch a sensor

40 to a fiducial implant in the patient's skull to determine the correlation between the

external coordinate system of the operating room and the internal coordinate system

of the patient (Id., 14:25-56).

29


When the tip 38 of the arm 34 rests on the Mu-cial implant 103 in the skull 18, the location of the inter-nal coordinate system A defined by the fiducial implants10 is known with respect to the external coordinatesystem B. Supplying the Euler angles of rotation andthe location of the tumor which is known relative to theInternal coordinate system A to the computer, provides'the ability to determine the location of the tumor in the

ternal coordinate system B.

The imaging system is integral with the operating theater and tracks the position of a

surgical instrument, using the example of a laser, within the patient, in real time.

In surgery, the internal coordinate system defined bythe three fiducial points can allow, for example, a laserto be followed as it cuts through tissue to a tumor. Animaging system present in the operating theater wouldbe positioned to continually take imaging data that isprovided to a computer system which also guides thelaser based on the inputted data. As the laser cutsthrough the tissue, the change in the tissue is apparentthrough the imaging system and can be followed withrespect to the fixed interned coordinate system. When apredetermined position is reached by the laser, or apredetermined portion of tissue has been removed by,the laser, the computer controlling the laser and pro-cessing the imaging data would discontinue the opera-tion of the laser.

(Id., 15:3-17).

(d) a computer adapted to:(1) determine correspondence of a reference frame R. of the tool with

the patient reference frame RI, and the image reference frame Ili asa function of the signal from the at least two sensors;

Allen includes a computer for determining the relationship between the patient

position and the tool . Id., 14:56-60, 15:9-17. The fiducial data from the robot arm

can be used to determine the location of the tumor. Ex. 1005, 14:56-60. The

30


computer then uses that information to track and provide images of the laser within

the patient in the internal coordinate system. Ex. 1005, 15:3-17.

(2) output a display signal for visualization of position of the tool inthe image reference frame Ri on a control screen; and

Allen further describes displaying images from the imaging system on a screen

(element d(2)): "The imaging data experiences signal processing, as described above,

and the desired images are displayed on display 108." (Id. 13:43-51). That imaging

data includes images of the laser cutting through tissue: "As the laser cuts through the

tissue, the change in the tissue is apparent through the imaging system and can be

followed with respect to the fixed internal coordinate system." (Id., 15:9-13).

(3) control position and displacements of the tool as a function ofcontrol signals originating from a control unit, wherein the fixedreference frame lc is independent of the patient reference frameRp and of the image reference frame Ri; and

Regarding element d(3), as explained above, Petitioners do not believe

adequate—or any—structure for performing the claimed function is described in the

725 patent specification. If the Board determines that there is adequate structure and

construes the claim as Petitioners believe Sarif would contend (see Section VI.D,

above), then the "compute?' would be the structure corresponding to the means. In

that case, Allen includes a computer that performs the claimed function of

,̀ control[ling] position and displacements of the tool." Allen's computer uses the

31


imaging system signal to "guide I] the laser based on the inputted data." Ex. 1005,

15:8-9.

As described in Allen, the fixed reference frame is independent of the patient

and image reference frames (element 1(d)(3)). Allen's sensors' positions are known

with respect to the external coordinate system B. (Id., 14:37-41, 15:09-17). The

sensors and computer are then used to determine the relationship between that

independent reference frame and the internal coordinate system A of the patient and

image database. (Id., 14:38-60, 15:3-17).

(e) means for determining coordinates of the tool in the fixedreference system Re based on data from the image data base.

Regarding element 1(e), as explained above, Petitioners do not believe that the

claimed function, or structure for performing the claimed function, is described in the

`725 patent specification. Petitioners believe that in order to try to salvage the claim,

Sarif would have to contend that the function "determining the coordinates of the

tool in the fixed reference system lc" was meant to be claimed as being based on the

input from the sensors alone (not the data from the image database, as claimed), and

that therefore the proper corresponding structures are the sensors and computer. See

Section VI.E, above. While Petitioners do not believe that the claim can be rewritten

in that way, if the Board determines that the element can be construed in accord with

Sarif s assumed construction, then Allen describes a computer performing the

function of determining the position of the laser in the internal coordinate system

32


based on the input from the sensors of the imaging system: "As the laser cuts

through the tissue, the change in the tissue is apparent through the imaging system

and can be followed with respect to the fixed internal coordinate system. When a

predetermined position is reached by the laser, or a predetermined portion of tissue

has been removed by the laser, the computer controlling the laser and processing the

imaging data would discontinue the operation of the laser." Ex. 1005, 15:9-17. Allen

further discloses that prior to the operation, the computer determines the location of

the tumor in the external coordinate system: "Supplying the Euler angles of rotation

and the location of the tumor which is known relative to the internal coordinate

system A to the computer, provides the ability to determine the location of the tumor

in the external coordinate system B." Id., 14:52-56. Allen's disclosure of determining

the laser's location in the internal coordinate system thus also discloses the same

determination in the external coordinate system.

Allen therefore discloses each and every element of claim 1 of the '725 patent

and anticipates claim 1. Ex. 1014, ¶¶ 42, 46.

B. Ground 2: Claim 1 is Obvious over Allen Under 35 U.S.C. § 103

If the Board were to determine that Allen does not inherently use one of the

disclosed articulated tool supports to move the laser, then Allen renders claim 1

obvious. Ex. 1014, ¶¶43-46.

Allen shows the radiation source (such as an x-ray machine for killing cancer

cells) on a jointed arm that moves it around plural axes. Ex. 1005, Fig. 7, item 20. In

33


addition, Allen describes a sensor 40 for determining patient position as being

supported by a robotic arm including a jointed arm that moves through multiple axes.

Id., Fig. 7, item 34.

One of ordinary skill in the art would recognize that the laser or other surgical

tool could also be positioned on one of Allen's disclosed articulated supports to

provide more flexibility of movement. Ex. 1014, ¶ 45. Indeed, the Allen patent

explicitly states that "a computer system H guides the laser based on imputed data"

from the imaging system. Ex. 1005, 15:5-9. One of skill in the art would understand

that the laser cannot move on its own. Thus such a person would recognize that the

disclosed articulated tool supports could be combined with the laser to provide the

functionality required by Allen. Ex. 1014, ¶ 45. Thus, because all the other elements

of claim 1 are present in Allen, as shown above, the claim is obvious in view of Allen.

Ex. 1014, ¶¶ 45, 46.

34


C. Ground 3: Claim 1 is Obvious over Schulz in view of Taylor.

If the Board determines that claim l's terms are sufficiently definite to be

construed, under the broadest reasonable constructions of the claim terms, the

combination of Schulz (Ex. 1004) and Taylor (Ex. 1006) also renders the claim

obvious.

This combination is not cumulative to the disclosure of Allen alone. Taylor

includes a description of an articulated support used for a tool and provides a better

description of the manipulation of the tool than Allen. Ex. 1006, 3:55-60; 12:02-10;

7:08-29. Schulz provides a more detailed description of the coordinate systems used

than does Allen. Ex. 1004, 6:35-65; 12:48-13:61.

Schulz discloses a system using sensors to track a surgical tool and an object,

such as the head of a patient. Ex. 1004, 5:42-53. Images of the patient, such as CT or

MRI images, are taken preoperatively and stored in an image data base. Id., 6:17-26.

Based on the information provided by the sensors, a preoperative image from the

image data base can be displayed corresponding to the location of the surgical tool.

Id., 5:60-6:2. In this way, the surgeon can control the tool based on the display.

Schulz discloses every element of claim 1 but for the computer controlled articulated

tool support as can be seen in the figure below:

35


Fig. 2

Taylor's system also relates to the use of computers in surgery, but includes a

robotic arm manipulating the surgical tool. The robotic arm can be controlled by a

computer. As can be seen by an excerpt from Taylor's Fig. 3, below, the robotic arm

has at least one joint between its ends, is controlled by a computer and can move a

microsurgery tool through plural axes.

36


While Schulz does not explicitly describe an articulated tool support or

automatic control of the tool, Schulz specifically mentions the possibility of an

automatically-controlled robot arm in his Background of the Invention section. Ex.

1004, 1:45-57; Ex. 1014, ¶48. In any event a combination with Taylor fills any gap for

the "articulated tool support" element. One of ordinary skill in the art would

recognize the benefits of combining the Schulz and Taylor disclosures. Ex. 1014,

1148. They are from the same field and seek to overcome the same set of problems.

Ex. 1014, ¶ 48. It would be advantageous to add automatic tool control to Schulz's

disclosure to prevent mistakes and to allow the surgeon to focus on other things

besides manipulating the tool. Ex. 1014, ¶ 48.

The elements of claim 1 are discussed individually below:

(a) an articulated tool support, one end of which is integral witha fixed reference frame Re;

As mentioned, Taylor describes an articulated tool support ("positioning

apparatus") that can be either manually or computer controlled (element 1(a)). Ex.

1006, 7:08-29. "The positioning apparatus 10, in the embodiment shown, generally

comprises a bulk or coarse motion manipulator 12 and a fine motion manipulator 14."

Ex. 1006, 6:38-40. Taylor's positioning apparatus includes numerous links, arms, and

hinges to manipulate a surgical tool in plural axes. Id., Figs. 1, 3, 4; 6:38-9:64. Thus

the combination satisfies the requirement in claim 1(a) for an articulated tool support.

Ex. 1014, VII 47, 48, 52.

37


(b) an image data base comprising images in an image referenceframe Ri;

Schulz takes preoperative images of the patient that are stored in an

image data base for later recall by the system:

other purposes in many various non-medical fields In the;&scribal embodiment, tie physical object 13 of interest isthe head or cranium of a patient, and the model of thecranium is constructed using a series of parallel internalimage slices (of known mutual spatial relationship) such asthose obtained by means of computed tomography (C1) ornuclear magnetic resonance (NMR). These image slices arethen digitized, forming a three-dimensional computer modelof the patient's cranium which is then stored in the eler -tronically accessible database 40.

Ex. 1004, 6:17-26. The "model of the cranium" in the quote above consists of

"CT or NMR image slice[s] stored in the data base 40" representing the "image data

base in the '725 patent. Id., 6:52-59. The image data base has a coordinate system

that can be used to identify images in the data base relative to external features on the

patient, such as emitters 71, 73, 75. Id. at 12:48-63. Element (b) of claim 1 is found

in the combination of Schulz and Taylor. Ex. 1014, ¶49, 52.

(c) at least two sensors, integral with the fixed reference frame lc,supplying a signal that is a function of the position of a referenceframe Rp of a patient in the fixed reference frame lc;

Schulz describes three sensors supplying information regarding patient

position. The sensors determine the position of markers on the patient's body, which

are then used to relate the current position of the patient with the image database.

38

Petition for Inter Partes Review of U.S. Patent No. 5,755 725

Ex. 1004, 12:48-13:44. Thus element (c) of claim 1 is found in the combination. Ex.

1014, ¶¶49, 52.

(d) a computer adapted to:

(1) determine correspondence of a reference frame R. of the tool withthe patient reference frame Rp and the image reference frame Ri asa function of the signal from the at least two sensors;

(2) output a display signal for visualization of position of the tool inthe image reference frame Ri on a control screen; and

(3) control position and displacements of the tool as a function ofcontrol signals originating from a control unit, wherein the fixedreference frame lc is independent of the patient reference frameRp and of the image reference frame Ri; and

Schulz further describes a "computer adapted to perform all of the functions

of element 1(d). Schulz first determines the relationship between the patient "model"

(image database) and a "predetermined coordinate system." Ex. 1004, 12:48-13:44.

Schulz then uses sensors to determine the location of the tool in the predetermined

coordinate system. Id., 6:35-46. The relationship between the tool and the image data

base is then determined:

Once the computer 36 has calcu-lated the location of the probe tip 18 with respect to thepredetermined coordinate system 80, the computer 36 thenuses the relationship between the model of the craniumstored in the database 40 and the coordinate system 80 tocalculate the location of the probe tip 18 in relation to themodel 11.

Id., 6:46-52. Thus the requirements of element 1(d)(1) are met. Ex. 1014, ¶¶49-52.

39


Schulz further discloses a display signal showing the tool on a control screen

(element 1(d)(2)). Schulz's computer "access [es] a CT or MRI image slice 13 stored in

the database 40 that is closest to the location of the probe tip 18, and then

superimposes a suitable icon 76 representing the tip 18 on the image." Ex. 1004,

6:52-65. Thus the surgeon can see the tool's position in the image from the image

database, and element 1(d)(2) is satisfied. Ex. 1014, ¶¶49-52.

Regarding element d(3), if the Board determines that there is adequate structure

and construes the claim as Petitioners believe Sarif would contend (see Section VI.D,

above), then the "computer" would be the structure corresponding to the means. In

that case, Taylor describes a computer controlling the position of the tool within the

patient. "In normal use, the tool 110 can be adjusted such that a desired point on the

surgical instrument or a desired point on a body part held on the surgical instrument

is located at the center of motion M of the manipulator 70." Ex. 1006, 12:10-14. Any

of myriad motions possible with Taylor's "positioning apparatus" for a surgical

instrument (articulated tool support) "may be either manually controlled or computer

controlled, or both." Ex. 1006, 7:08-29.

As described in Schulz, the fixed reference frame is independent of the patient

and image reference frames. Schulz's sensors "are mounted in fixed, spaced

relationship to each other and are located at known positions and orientations with

respect to a predetermined reference coordinate system frame 80." Ex. 1004, 5:38-42

(Schulz's fixed reference frame). The sensors and computer are used to determine the

40


relationship between that reference frame and those of the patient and image

database. (Id., 12:48-13:44). A transformation between the image and the sensor

coordinate systems is necessary because the patient and the image data base

coordinate systems are independent of the fixed reference frame of the sensors. Id.,

step 45, Figure 7; Ex. 1014, ¶49. Thus element 1(d)(3) is met by the combination of

Schulz and Taylor.

(e) means for determining coordinates of the tool in the fixedreference system it, based on data from the image data base.

Regarding element 1(e), if the Board determines that the element can be

construed in accord with Sarif s assumed construction (See Section VI.E, above),

Schulz includes a description of a computer determining the position of the tool

based on input from the sensors. In Schulz, "position sensors 20, 22, and 24 detect

the locations of the emitters 14, 16" attached to the tool. Ex. 1004, 6:26-35. The

computer then uses that information to determine the tool's position in the

"predetermined coordinate system" (fixed reference system). Ex. 1004, 6:35-45.

Thus the location of the tool in the fixed coordinate system is found.

The combination of Schulz and Taylor thus renders claim 1 obvious. Ex. 1014,

¶¶49-52.

41


D. Dependent Claims 2-9 are Obvious

1. Claims 2 and 5 are obvious

Claims 2 and 5 of the '725 patent are dependent on claim 1. Claim 2 requires

the additional requirement that the two sensors "comprise at least two acquisition

cameras integral with the fixed reference system Rc and positioned such that their

field of observation includes a surgical intervention zone." Claim 5 adds that same

limitation to the "means for determining coordinates of the tool," which, as discussed

above, includes the sensors.

(a) Ground 4: Claims 2 and 5 are obvious in view ofAllen and Heilbrun

Allen discloses an "imaging system," for the surgical area, but not specifically

cameras. Ex. 1005, Ex. 1014, ¶54. Heilbrun supplies the cameras of claims 2 and 5

that are missing in Allen. Ex. 1014, ¶55. Heilbrun describes a surgical setup for

determining the location of a tool relative to a patient's body similar to that described

in Allen. Ex. 1002, Abstract. As its sensors, Heilbrun uses a pair of video cameras

"positioned for making a pair of images along respective sightlines 204, 206, of a

medical workspace 208 which includes a patient's body region." Ex. 1002, Fig. 2, 5:6-

17; Ex. 1014, ¶55. The cameras are further described as being integral with a fixed

workspace framework: "The apparatus develops a calibrated 3 dimensional

framework of the workspace from a pair of 2D images made from different fixed

locations, and aligns the workspace framework with a 3D scan framework defined by

42


a volume scan. A pair of video cameras is the present preferred imaging means for

obtaining the 2D image pairs." Ex. 1002, 3:10-15; Ex. 1014, ¶55. As Heilbrun states,

the use of two cameras allows the construction of a 3 dimensional framework of the

workspace, similar to the work done by Allen's imaging system and robotic arm. Ex.

1014, ¶55. One of ordinary skill in the art would recognize that the use of two

cameras is likely a cheaper alternative to Allen's proposal, and would be just as

effective. Ex. 1014, ¶¶55, 65. In addition, Heilbrun's video cameras provide the

added benefit of making it possible to record the surgery without additional

equipment. Ex. 1014, 55¶.

(b) Ground 5: Claims 2 and 5 are obvious in view ofSchulz and Taylor in view of Heilbrun

Petitioners have shown above that Schulz in view of Taylor renders obvious

claim 1. That combination includes Shulz's "light sensors" 20, 22, 24 for viewing the

surgical area, but does not specifically disclose cameras. Ex. 1004, 5:42-46; Ex. 1014,

¶54. Heilbrun discloses the cameras lacking in that combination. The cameras in

Heilbrun perform the same role as Schulz's sensors, namely tracking fiducials such as

the tip of a scalpel. Ex. 1002, 4:36-44. The cameras of Heilbrun would also provide

the added benefit of live video. Ex. 1014, ¶56. One of ordinary skill in the art would

appreciate that the cameras of Heilbrun could be readily substituted for the "light

sensors" of Schulz. Ex. 1014, 56¶. Claims 2 and 5 are thus obvious. Ex. 1014, 7155,

65.

43


2. Ground 6: Claims 3, 4, 6, and 7 are Obvious

Claims 2 and 5 are obvious over Schul7 and Taylor in view of Heilbrun, which

added cameras. Claim 3 is dependent on claim 2 and adds the limitation of "a first

geometrically defined trihedron, presenting at least four non coplanar punctiform light

sources integral with the tool, with the mobility space of the first trihedron being

contained in the fields of vision of the acquisition cameras." Claim 6 is dependent on

claim 5 and adds that same additional quoted limitation.

Claim 4 is dependent on claim 3 and adds the limitation of "a second

geometrically defined trihedron...." Claim 7 is dependent on claim 6 and adds the

equivalent limitation.

(a) Claims 3 and 6 are obvious in view of Schulz, Taylor,and Heilbrun in view of Henrion

Schulz describes the use of light emitters attached to the tool to determine the

tool's location. Ex. 1004, 6:27-52. While Schulz does not describe a trihedron, a

trihedron was a known shape for defining a position, as stated in Henrion: "The

reference frame R2 can arbitrarily be defined as a tri rectangular reference trihedron

tied to the operating table TO." Ex. 1011, 3:52-54. As stated in Schulz, two emitters

are enough to determine the location of the probe tip, but "[t]hree or more emitters

provides full orientation information." Ex. 1004, 7:14-15. Indeed, one of ordinary

skill would understand that for certain tools it is required to understand the full

44


orientation of the tool and would understand that a trihedron mounted to the tool

could provide this information. Ex. 1014, ¶¶57, 58, 65.

(b) Claims 4 and 7 are obvious in view of Schulz, Taylorand Heilbrun, in view of Henrion

The '725 patent describes that the trihedron related to the patient can be

replaced with implants: "The geometrically defined trihedron can also be

implemented in the form of implants installed on the patient before acquisition of the

images". Ex. 1001, 4:44-49. Thus, in the '725 inventor's view, trihedrons were

obvious substitutes for implants. Ex. 1014, ¶60. Schulz describes the use of such

implants ("non colinear reference points 71, 73, and 75") to determine patient

position. Ex. 1004, 12:48-63. As discussed above with respect to claims 3 and 6,

Schulz further describes the use of light emitters to determine the position of the tool,

and Henrion describes the use of a trihedron shape. It would be obvious to one of

skill in the art to use a trihedron with light emitters in place of Schulz's implants. Ex.

1014, ¶60. As stated in Henrion, a trihedron placed on the operating table can be

used to track a patient's movements. Ex. 1011, 3:52-54. One of ordinary skill would

recognize this as a less invasive alternative to Schulz's implants. Ex. 1014, ¶60.

These claims are thus obvious. Ex. 1014, 7160, 65.

3. Claim 8 is Obvious

Claim 8 is dependent on claim 1 and adds the limitation of "an additional

sensor comprising a pointing end and at least two light points...." This "additional

45


sensor" is described in the '725 patent as a "stylus-shaped pointer (32), carrying two

reference points detectable by the camera system...." Ex. 1001, 6:4-6. The function

of the pointer is to "allow[] designation, and thus input into the memory of the

position of different characteristic points of the patient." Id., 6:4-11.

(a) Ground 7: Claim 8 is obvious over Allen and Schulz

Petitioners have shown above that (i) Allen anticipates or renders obvious

claim 1. While Allen does not disclose the exact sensor of claim 8—Allen uses the tip

of a robot arm—Schulz very clearly does.

Schulz describes a sensor—called a "probe 12" in Schulz—having a tip 18 and

two points light points or "emitters 14, 16." Ex. 1004, 5:33-37. "Three light sensors

20, 22, and 24 sense the light projected by the individual light emitters 14, 16 and

generate electrical output signals from which are derived the location of the probe 12

and, consequently, the probe tip 18...." Id., 5:42-45. Further, Schulz describes using

the pointing device to designate characteristic points on the patient in the same way as

the sensor of claim 8 is described in the '725 patent. Ex. 1004, 13:2-8.

Allen describes a sensor 40 at the tip of a robotic arm 34 detecting

characteristic points on the patient, such as implants. Ex. 1005, 14:35-37. The

sensor's location is determined by movement sensors located at the arm joints. Ex.

1005,14:37-44. One of ordinary skill in the art would understand that the sensor and

robot arm could be replaced by the probe disclosed in Schulz as they are related to the

solution of the same problem. Ex. 1014, ¶62. Indeed, one of ordinary skill in the art

46


would understand that Schulz's emitters and light sensors would be a cheaper

alternative to Allen's robotic arm. Ex. 1014, ¶62.

(b) Ground 8: Claim 8 is obvious over Schulz and Taylor

Claim 8 is also rendered obvious by the combination of Schulz and Taylor

discussed relative to claim 1. Ex. 1014, ¶¶62, 65. As discussed immediately above,

Schulz discloses the sensor of claim 8 and with Taylor discloses all other limitations of

claim 1. While Schulz describes only a single probe (that is also a surgical tool), it

would be obvious to one of ordinary skill in the art that a second, identical probe

could be used for identifying reference points on the body. Id.

4. Ground 9: Claim 9 is obvious in view of Schulz, Taylor,Heilbrun, Henrion, and Allen

Claim 9 is the "kitchen sink" of the claims in the 725 patent. It is dependent

on claim 1, but also includes the additional elements found in claims 2, 3, 4, and 8.

Petitioners have shown above that claims 2, 3, 4 and 8 are obvious over various

combinations of Allen, Schu17, Taylor, Heilbrun, and Henrion. For the same

underlying reasons, claim 9 is rendered obvious by the combination of these

references. Ex. 1014, ¶¶64, 65. One of ordinary skill would be motivated to combine

the references based on the benefits outlined above, namely that (1) a video camera

(as described in Heilbrun) can provide images in addition to positions of objects (See

Section VIII.D.1.b (Ground 5) above); (2) a trihedron of emitters (as described in

Henrion (Ex. 1011)) can better define the location of a tool than two emitters (See

47


Section VIII.D.2(Ground 6) above); (3) a trihedron of emitters (as described in

Henrion (Ex. 1011)) is less invasive than implants in a patient; and (4) the pointer of

Schulz would render Allen's robotic arm motion sensor unnecessary. Ex. 1014, ¶¶64,

65.

E. Ground 10: Claim 10 is obvious over Schulz in view of Heilbrun.

Under the broadest reasonable constructions of the claim terms, the

combination of Schulz and Heilbrun renders claim 10 unpatentable. Schulz in fact,

discloses every element of claim 10 but instead of reciting "cameras" discloses "light

sensors." Ex. 1014, ¶66. Heilbrun supplies the missing teaching of "cameras." Id.

Claim 10 essentially recites the inherent mathematical transformations

necessary to correlate the three-dimensional coordinate system of the preoperative

images to the position of a surgical tool in the fixed coordinate system of the

operating room. Ex. 1018, ¶13. Indeed, the transformations are just the

mathematical representations of the steps recited in the claims. Ex. 1018, ¶13. The

Schulz patent performs each step of claim 10 and inherently practices the

mathematical transformations recited, as would be readily apparent to a person of

ordinary skill in the art. Id., ¶14.

Schulz discloses an image-guided surgical system for performing microsurgery

on a patient as shown in Figure 1B below. Ex. 1004, 5:4-8. Prior to surgery images of

the patient are taken, such as by a CT or MRI scanner, and the images are stored in a

database 40. Id, 6:17-26. During surgery, three optical sensors 20, 22, 24, track the

48


position of a surgical tool 12 and the head 11 of a patient in real time. Id., 5:42-49,

13:44-49. A computer 36 then displays an image of the patient from the database

corresponding to the position of the tip of the surgical instrument. Id., 14:4-11. As

guided by the displayed image, a surgeon performs the required surgery. Id., 5:4-8;

Figure 2.

CORRELATIONINFORMATION

42

10 44

-/ 40COMPUTER

MODEL

CONTROL UNIT30

SENSOR 22--- SENSOR

74 56 r77-/72 \ N

14

18 \--12

SENSOR

/26

Fig. 1B

The recited steps of claim 10 are discussed individually below:

(a) determining the position of the tool in a reference frame itcof a camera by a transformation miTc , giving the relationbetween a reference frame R. of the tool and a fixedreference frame R.il, and a transformation c11.,1(,), giving therelation between the camera reference frame Rc and the

49


fixed reference frame 11.1 determined in real time by optical

measurement;3

In Schulz, a tool 12 includes at least light emitters 14, 16 forming a fixed

reference frame, in this example, Rin1.4 Ex. 1004, 5:35-37. Ex. 1018, ¶ 16. The

relationship between the light emitters and the point of the probe tip 18 is known.

Ex. 1004, 6:40-46. The tip of the probe is equivalent to R0 in claim 10. Ex. 1018,

16. The light sensors track the light emitters in a fixed coordinate system 80. Ex.

1004, 2:40-46, see also box 39 in Figure 7. The fixed coordinate system 80 is

equivalent to lc in the claim. Ex. 1018, ¶ 15. Consequently, the transformation nilTo

is known. Ex. 1018, ¶ 16.

"The sensors 20, 22, and 24, the control unit 30, and the computer 36

determine the three-dimensional location of each emitter 14, 16, and compute its

coordinates in the predetermined coordinate system 80. The computer 36 can then

calculate the location of the tip 18 of the probe 12 with respect to the predetermined

coordinate system 80 and the dimensions of the probe...." Ex. 1004, 6:36-43. This

calculation over time is thus ̀ Tnii(t). Ex. 1018 ¶ 17.

3The transformation miT, should be 'To since the conversion of coordinates is from

the tool reference frame Ro to the reference frame of the tool support Roil. Sarif hasnot corrected the error.4A general primer on reference systems and the transformations to convert from one

reference system to another is included in paragraphs 10-12 of the Izen Declaration.Ex. 1018,411110-12.

50


Claim 10 requires "determining the position of the tool in a reference frame itt

of a camera...." Schulz uses "light sensors" 20, 22, 24 to determine the position of

the tool in the equivalent reference system R but does not specifically recite cameras.

Heilbrun does recite cameras and uses them for the same purpose as Schulz (Ex.

1004) uses light sensors: to optically track surgical instruments. Ex. 1002, 3:10-15,

7:56-68. A person of ordinary skill in the art would appreciate that cameras—such as

those disclosed in Heilbrun for the same purpose—could be substituted for the light

sensors disclosed in Schulz. Ex. 1014, ¶67.

(b) determining a transformation Im2 giving the relation between animage reference frame Ri and a fixed reference frame Rm2;

Conceptually, the transformation 1Tm2 is the three-dimensional road map

between coordinates in the fixed reference frame of the patient Rm2 and the reference

frame of the preoperative images Ex. 1018, ¶ 18. In the Schulz patent, prior to

making the preoperative images of the patient's head, three reference points 71, 73, 75

are placed on the patient's head. Ex. 1004, 12:48-55. "The coordinates of these

reference points are measured and recorded relative to the coordinate system of the

imaging device." Ex. 1004, 12:48-55. The "coordinate system of the imaging device"

is what claim 10 calls the image reference frame Ex. 1018, ¶ 18. In the

embodiment of Figure 1B, the points 71, 73, 75 are replaced by reference emitters 70,

72, 74. Ex. 1004, 13:36-40. The reference emitters 70, 72, 74 attached to the patient

define the reference frame Rm2. Ex. 1018, ¶ 18. The correlation between the

51


reference systems of the image and the emitters on the patient is mathematically

expressed as the transformation ̀ Tm2 using the convention of claim 10. Ex. 1018,

If 18.

(c) determining the position of the fixed reference frame R,, inrelation to the camera reference frame itc by a transformationmqicw determined in real time by optical measurement;

The transformation m2Tc(,) simply represents the change in the position of the

patient over time in the camera coordinate system k. Ex. 1018, ¶ 19. In the,

embodiment of Figure 1B, the locations of the reference emitters 70, 72, 74 on the

patient, Rm2, are tracked by the sensors 20, 22, 24 in the fixed camera coordinate

system 80, i.e., Rt. Ex. 1004, 13:36-40. The tracking of the patient can performed

continuously, in other words in real time:

In fact, the correlation phasecould be frequently but briefly repeated from time to time(continuously or initiated by the operator), interspersed inthe operational phase for the purpose of recalculating thelinear transformations M and MI should the object (such asa surgical patient) move relative to the sensors 20, 22, 24.

Ex. 1004, 13:44-49. The position of the patient in the reference system 80 as

determined by the optical sensors 20, 22, 24 over time, is thus expressed in the

convention of claim 10 as m2Tc(t). Ex. 1018, ¶ 19. In Schu]7 the transformation that

results from steps (b) and (c) in claim 10 is shown schematically as box 45 in Figure 7.

Ex. 1004, Figure 7; Ex. 1018, ¶ 19.

(d) calculating a transformation '11.0) = "l270(t) givingthe relation between the image reference frame Ri and the toolreference frame R0, to display in real time a section corresponding

52


to a point of interest indicating the position of the tool in relationto a prerecorded image; and

The transformation equationiTo(t) = 1Tmz 1112To(t) cTml(t) 1111T0 is simply the

mathematical expression that describes the result of steps a-c to yield the coordinates

in the image data base that corresponds to the position of the tool tip. Ex. 1018, 20.

Indeed, this equation is shown schematically in Figure 7 of Schulz. Ex. 1004, Figure

7; Ex. 1018, ¶ 20. The final step in Figure 7 is to display the slice from the image

data base graphically on the monitor 44. The image displayed is "at the current

position of the probe tip," and thus the display is in real time Ex. 1004, 14:11-13.

(e) performing the microsurgery based on the real-time display of thesection.

Figure 2 of Schulz illustrates "a surgeon performing intracranial surgery on a

patient, and showing a cursor on the display screen that marks the corresponding

position of the invasive tip of the probe within the image of previously obtained

model data." Id, 5:4-8.

As each step of claim 10 is found in the combination of Schulz and Heilbrun,

claim 10 is obvious and invalid. Ex. 1014, T66-68.

F. Ground 11: Claim 11 is obvious over Schulz, Heilbrun, andGlassman

Under the broadest reasonable constructions of the claim terms, Schulz and

Heilbrun in combination with Glassman (Ex. 1008) renders obvious claim 11 of the

53


`725 patent. Steps (a) through (d) in claim 10, with the exception of the display

requirement, are repeated nearly verbatim in claim 11.5

Claim 11 departs from the method of claim 10 by adding the steps e) and f) for

automatically controlling a microsurgery tool in real time in reaction to a target

defined in the image data base. The target in the tool coordinates is determined by

the inverse of the transformation yielded in step (d). Ex. 1018, 1121.

Schulz and Heilbrun disclose every element of steps (a) through (d) as

discussed above for claim 10 and Petitioners rely on that analysis here. Glassman

supplies the step of automatically controlling the tool in real time. Ex. 1014, ¶70.

Steps (e) and (f) are discussed in detail below:

(e) calculating a transformation °Tio), which is the inverse oftransformation 'Tow;

The transformation from the image coordinate system to the tool coordinate

system through an inverse is well known in the art. Ex. 1018, ¶ 21. Indeed, Schulz

discusses using an inverse transform to switch between the tool coordinate systems

and the "model." or image coordinate system. Ex. 1004, 12:10-20.

(f) automatically controlling the tool in real time in relation to a targetdefined in the image data base using the transformation °T;(0.

The invention of Schulz is directed to a handheld tool, but Schulz discussed a

"similar" system in the background that used a computer-driven robot arm to

5 The transformation in step (d) of claim 11 incorrectly reads as ̀Troll, but should be`Tint Sarif has not corrected the error in the claim.

54


automatically position a surgical tool. Id, 1:45-57. While Schulz does not specifically

disclose "automatically controlling the tool," Glassman does. Glassman's

image-directed robotic surgery system is used, for example, in hip replacement

surgery. Like Schulz, Glassman discloses making a preoperative image database of

scans of a patient. Ex. 1008, 8:38-47. The images are taken with alignment pins in

the patient's leg to determine a set of bone reference coordinates. Id, 8:36-45. A

surgeon then determines the implant shape (that is, the shape of tissue to be removed

from the patient) and places it at the desired position within the image database scans

of the patient. Id, 8:47-54. That information is given to the robot controller for

planning the surgery. Id, 8:68-9:06.

In the treatment room, the surgeon guides the robot to locate the alignment

pins in the patient. Id, 9:35-68. The robot then automatically performs the surgery:

then ndlis correct shape to re-plant. The monitors the progtess of

operation both by d` obsery ttandthrough observatitm of the onlinep y 48 hen ader edon of the ita-plan modd

Ex. 1008, 10:4-9. Glassman's robot is controlled in real time. "[T]he robot controller

24 is enabled through various 'part subrdutines' to determine during surgery the

sequence of effector motions required to form the implant-shaped cavity at the

surgeon-specified location within the femur." Id, 8:68-9:06 (emphasis added).

55


One of ordinary skill in the art would know to combine the teachings of Schul7

and Glassman to achieve an automatic system, which is mentioned in Schulz. Ex.

1014, 770,71. It would be advantageous to add automatic tool control to Schulz's

disclosure to prevent mistakes and to allow the surgeon to focus on other things

besides manipulating the tool. Ex. 1014, ¶70 .

The combination of Schulz, Heilbrun, and Glassman renders claim 11 obvious.

Ex. 1014,1[69-71.

IX. CONCLUSION

The information presented in this petition shows that there is a reasonable

likelihood that the Petitioners would prevail with respect to at least one of the claims

challenged in the petition. Accordingly, the Petitioners respectfully request that a

Trial be instituted and that claims 1-11 of the U.S. patent No. 5,755,725 be canceled

as unpatentable.

Respectfully submitted,

Ja R. Campbell (Reg. No. 3,660)[email protected] M. Ryland (pro hac vice to be filed)[email protected] ELLIS LLP950 Main Avenue, Suite 1100Cleveland, OH 44113-7213Telephone: 216-696-5639Fax: 216-592-5009Counsel for Brainlab, AG

56


Joseph A. Greco (pro hac vice to be filed)[email protected] Duggan (Reg. No. 55133)jduggan@beckllpBECK, BISMONTE & FINLEY, LLP150 Almaden Blvd., 10th FloorSan Jose, CA 95113Telephone: 408-938-7900Fax: 408-938-0790Counsel for Varian Medical Systems, Inc.

013659.000009.1999717.8


CERTIFICATE OF SERVICE

Pursuant to 37 C.F.R. §§42.6(e) and 42.105, this is to certify that I caused to be

served a true and correct copy of the foregoing by Federal Express, on this 14th day of May,

2014, on the Patent Owner at the following correspondence address of record for U.S.

Patent No. 5,755,725:

Ascenda Law Group, PC84 W. Santa Clara St.

Suite 550San Jose CA 95113

I also certify that I caused to be served a true and correct copy of the foregoing by electronic

service at the following address of counsel for Sarif Biomedical LLC. in the District of

Delaware Case No. 13-846-LPS. Electronic service is used in that action by agreement of

counsel.

Fredricka [email protected]

Russ August & Kabat12424 Wilshire Boulevard, 12th Floor

Los Angeles, CA 90025310 826-7474

310 826-6991 Fax

Respectfully Submitted,

dtk-41Jay air pbell, Reg. 133,[email protected] ELLIS LLP950 Main Avenue, Suite 1100Cleveland, OH 441137213Telephone: 2166965639Fax: 2165925009Attorng for Petitioners

petition for inter partes review of u.s. patent no...

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