Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_14-cv-00451/USCOURTS-azd-2_14-cv-00451-2/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

---

WO IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA 

CAYENNE MEDICAL, INC., )

) 

 Plaintiff, ) 

) 

vs. ) 

)

MEDSHAPE, INC., a Georgia corporation, )

KURT JACOBUS, KEN GALL, TIMOTHY )

NASH, AND JOSHUA RAY, ) 

) No. 2:14-cv-0451-HRH

 Defendants. )

__________________________________________) 

O R D E R

Motion for Partial Summary Judgment

Defendant moves for summary judgment that Claims 6-11 and 13 of the ‘294 patent

are invalid.1 This motion is opposed.2 Oral argument was requested and has been heard.

Facts

Plaintiff Cayenne Medical, Inc. has alleged that defendant MedShape, Inc. is

infringing Claims 6-11, 13, and 16-18 of U.S. Patent No. 8,435,294. The ‘294 patent is

directed to methods and devices for attaching soft tissue to bone. 

1Docket No. 133. 

2Docket No. 134. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 1 of 15
Claim 6 is an independent claim. Claims 7-11 and 13 are dependent on Claim 6 and

thus include all claim limitations cited in Claim 6. 

Claim 6 is an apparatus claim and reads: 

A material fixation system, comprising an implant

which is placeable in a space defined by bone, said implant

comprising:

 a body having a longitudinal axis, a distal end, and 

proximal end; 

a first member on said body which is movably

expandable outwardly; 

a second member on said body which is disposed

axially from said first member and is also 

movably expandable outwardly, said second

 member being of a substantially different 

construction than said first member; 

 a distal end of said body comprising a space for receiving

soft tissue therethrough, said space being defined

by surfaces of said body which are oriented both

generally parallel to said longitudinal axis and

generally transverse to said longitudinal axis; and

a deployment device which is movable in a generally 

axial direction to deploy at least one of said first 

and second members.[3]

During the prosecution of the ‘294 patent, the PTO examiner rejected the claims in

view of a patent to Levy and others.4 To overcome the rejection, the inventors amended

3

‘294 Patent, col. 25, lns. 31-49, Exhibit C, Defendant MedShape Inc.’s Motion for

Partial Summary Judgment [etc.], Docket No. 133. 

4Non-Final Rejection (dated July 9, 2012), Exhibit 1, Cayenne Medical, Inc.’s

Memorandum in Opposition [etc.], Docket No. 134. 

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what became Claim 6 to include the phrase “substantially different construction.”5 The

inventors told the Examiner that

[t]he claim has been amended to now recite that the recited

second memberis of a substantially different construction than

the recited first member.... [B]oth of the expandable members

210 of Levy are shown and disclosed as having a substantially

identical construction,[6

] whereas the claim now requires the

second recited member to have a substantially different

construction than the first recited member.[7]

After the inventors made this amendment, the Examiner issued a notice of allowance.8

On March 19, 2015, defendant petitioned for an inter partes review (IPR) before the

Patent Trial and Appeal Board (PTAB) of Claims 6-11, 13, and 16-18 of the ‘294 patent. 

During an IPR, validity challenges are limited to anticipation and/or obviousness. 

Synopsys, Inc. v. Mentor Graphics Corp., 814 F.3d 1309, 1316 (Fed. Cir. 2016). The patent

owner may “file a preliminary response to the petition, ... that sets forth reasons why no

inter partes review should be instituted....” 35 U.S.C. § 313. “The response ... can include

5Amendment, Exhibit 2, Cayenne Medical, Inc.’sMemorandum in Opposition [etc.],

Docket No. 134. 

6U.S. Patent No. 6,554,833 at Sheet 2 of 10, Exhibit 3, Cayenne Medical, Inc.’s

Memorandum in Opposition [etc.], Docket No. 134. 

7Amendment at 9, Exhibit 2, Cayenne Medical, Inc.’s Memorandum in Opposition

[etc.], Docket No. 134. 

8Exhibit 4, Cayenne Medical, Inc.’s Memorandum in Opposition [etc.], Docket No.

134. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 3 of 15
supporting evidence[,]” but it cannot include “new testimony evidence ... beyond that

already of record[.]” 37 C.F.R. § 42.107(a), (c).

On September 14, 2015, the PTAB authorized the institution of an IPR as to Claims

16-18.9 The PTAB did not consider the merits of defendant’s arguments that Claims 6-11

and 13 were anticipated and/or obvious in part because the PTAB found that the phase

“substantially different construction” was indefinite.10 The PTAB explained that 

[t]he phrase “substantially different” is highly subjective and,

on its face, provides little guidance to one of skill in the art. 

Sufficient guidance is lacking in the written description of the

‘294 patent as well. The specification of the ‘294 patent does

not contain the phrase “substantially different construction”

outside of the claims, and neither party has directed us to any

disclosure in the written description relevant to determining a

standard for measuring the necessary degree of difference

which is to be defined as “substantially different.” Likewise,

neither party has directed us to any disclosure in the prosecution history that illuminates the relationship between the

written description and the “substantially different construction” claim phrase. As noted above, the claim phrase was

added in an amendment during prosecution, but the prosecution amendment at issue provides no disclosure to further

illuminate the meaning of “substantially different construction.”[11

]

9Decision at 2, Exhibit A, Defendant MedShape Inc.’s Motion for Partial Summary

Judgment [etc.], Docket No. 133. 

10

Id. at 6-10. 

11

Id. at 9. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 4 of 15
Defendant now moves for summary judgment that Claims 6-11 and 13 of the ‘294

patent are invalid. Defendant argues that the court, like the PTAB, should find the phrase

“substantially different construction” indefinite, which would render Claims 6-11 and 13

of the ‘294 patent invalid. 

Discussion

Summary judgment is appropriate when there are no genuine issues of material fact

and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). 

A patent is presumed to be valid and “a defendant bears the burden of proving

invalidity by clear and convincing evidence[.]” Shire LLC v. Amneal Pharmaceuticals,

LLC, 802 F.3d 1301, 1306 (Fed. Cir. 2015) (citation omitted). “[A] patent is invalid for

indefiniteness if its claims, read in light of the specification delineating the patent, and the

prosecution history, fail to inform, with reasonable certainty, those skilled in the art about

the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124

(2014). “The definiteness standard ‘must allow for a modicum of uncertainty’ to provide

incentives for innovation, but must also require ‘clear notice of what is claimed, thereby

appris[ing] the public of what is still open to them.’” Interval Licensing LLC v. AOL, Inc.,

766 F.3d 1364, 1370 (Fed. Cir. 2014) (quoting Nautilus, 134 S. Ct. at 2128, 2129). “What the

statute requires ... ‘is that a patent’s claims, viewed in light of the specification and

prosecution history, inform those skilled in the art about the scope of the invention with

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 5 of 15
reasonable certainty.’” Id. (quoting Nautilus, 134 S. Ct. at 2129). “The claims, when read

in light of the specification and the prosecution history, must provide objective boundaries

for those of skill in the art.” Id. at 1371. “Although absolute or mathematical precision is

not required, it is not enough ... to identify some standard for measuring the scope of the

phrase.” Id. at 1370-71 (citation omitted).

“There is no dispute that, under controlling precedent, the ultimate question of

indefiniteness is one of law.” Dow Chemical Co. v. Nova Chemicals Corp. (Canada), 809

F.3d 1223, 1224-25 (Fed. Cir. 2015). But, “[i]ndefiniteness ... sometimes requires resolution

of underlying questions of fact.” Id. at 1225. “There is likewise no dispute that, under

controlling precedent, extrinsic evidence may play a significant role in the indefiniteness

analysis.” Id.

Claims 6-11 and 13 of the ‘294 patent each require that the first and second members

of the claimed implant have “substantially different construction.” Defendant argues that

this phrase is indefinite. Plaintiff argues that it is not. 

As an initial matter, the court notes that the phrase “substantially different

construction” contains a termofdegree. “[T]erms of degree” are not “inherently indefinite. 

Claim language employing terms of degree has long been found definite where it provided

enough certainty to one of skill in the art when read in the context of the invention.” 

Interval Licensing, 766 F.3d at 1370. Also, the fact that the parties offered proposed

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 6 of 15
constructions of this phrase during the Markman proceedings has no bearing on the issue

of indefiniteness. “Even if a claim term’s definition can be reduced to words, the claim is

still indefinite if a person of ordinary skill in the art cannot translate the definition into

meaningfully precise claim scope.” Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d

1244, 1251 (Fed. Cir. 2008).

Turning then to the question of whether the phrase “substantially different

construction” is indefinite, plaintiff contends that defendant’s argument is based almost

entirely on the PTAB’s decision. But, plaintiff reminds the court that the PTAB’s decision

is not binding on this court, that the PTAB is not authorized to invalidate patent claims on

indefiniteness grounds, and that defendant must present clear and convincing evidence to

invalidate any of the claims of the ‘294 patent. Plaintiff also points out that it was not

allowed to present rebuttal evidence (in the form of expert testimony) in the IPR

proceeding, evidence which plaintiff contends demonstrates that the phrase “substantially

different construction” can be understood by a person of ordinary skill in the art with

reasonable certainty. Plaintiff also points out that the PTAB’s decision is unappealable. See

St. Jude Medical, Cardiology Div., Inc. v. Volcano Corp., 749 F.3d 1373, 1375 (Fed. Cir. 2014)

(holding that there is no appeal from a denial of a petition for inter partes review).

Although the PTAB’s finding on indefiniteness is not binding on this court,

“[d]ecisions of the Patent Trademark Office Trademark Trial and Appeal Board ... are to

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be given great weight.” Lahoti v. Vericheck, Inc., 636 F.3d 501, 506 n.1 (9th Cir. 2011). The

PTAB’s finding is compelling evidence that the term “substantially different construction”

is indefinite. 

Plaintiff argues, however, that the ‘294 patent and its prosecution history include

sufficient context for a person of ordinary skill in the art to understand the phrase

“substantially different construction” with reasonable certainty. First, plaintiff argues that

a skilled artisan could look to the claims themselves and find guidance as to the objective

boundaries of the phrase. Plaintiff contends that Claims 9 and 12 provide examples of first

and second members of substantially different construction. Claim 9 states that the “first

member comprises an arm which is pivotable outwardly[.]”12 Claim 12 states that the

“second member comprises a mid-section which may be actuated to a collapsed

orientation[.]”13 Plaintiff argues that these claims, which correspond to the embodiment

depicted in Figure 48,14offer a skilled artisan one example of members with “substantially

different construction.” Plaintiff supports this argument with the declaration of Kevin L.

12

‘294 Patent at col. 26, lns. 2-3, Exhibit C, Defendant MedShape Inc.’s Motion for

Partial Summary Judgment of Invalidity [etc.], Docket No. 133. 

13

Id. at col. 26, lns. 13-15. 

14

Id. at col. 22, ln. 66 - col. 23, ln. 14 and Sheet 48 of 50. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 8 of 15
Ohashi, one of the named inventors of the ‘294 patent, and who avers that he has been

retained by plaintiff to offer expert opinions in this case.15

 Ohashi avers that 

[o]ne of ordinary skill in the art would recognize that these

dependent claims provide an example of a device with

members having substantially different construction. As

described above, these members have unique features and

componentsbasedon their different shapes and position on the

implant.[16]

First of all, plaintiff’s reliance on Ohashi’s testimony17is misplaced. “It is

particularly inappropriate to consider inventor testimony obtained in the context of

litigation in assessing validity under section 112, paragraph 2, in view of the absence of

probative value of such testimony.” Solomon v. Kimberly Clark Corp., 216 F.3d 1372, 1379

(Fed. Cir. 2000). Secondly, one example does not provide any limits as to the possible

variations of the device being claimed. Dependent claims 9 and 12, at best, provide some

standard for measuring the scope of the phrase “substantially different construction.” But

some standard is not sufficient. “The Supreme Court explained that a patent does not

satisfy the definiteness requirement of § 112 merely because ‘a court can ascribe some

meaning to a patent’s claims.’ The claims, when read in light of the specification and the

15Declaration of Kevin L. Ohashi, PhD, MBA [etc.] at 1, ¶¶ 2 & 5, Exhibit 11, Cayenne

Medical, Inc.’s Memorandum in Opposition [etc.], Docket No. 134. 

16

Id. at 10, ¶ 41. 

17The court assumes without deciding that the extrinsic evidence offered by plaintiff

in opposition to the instant motion is timely. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 9 of 15
prosecution history, must provide objective boundaries for those of skill in the art.” 

Interval Licensing, 766 F.3d at 1371 (quoting Nautilus, 134 S. Ct. at 2130). The ‘294 patent’s

specification and prosecution history do not provide objective boundaries as to the scope

of the phrase “substantially different construction.” Plaintiff’s arguments to the contrary

are unavailing.

Plaintiff argues that the specification for the ‘294 patent discloses numerous

examples that a person of ordinary skill in the art could use to practice the invention and

create implantswith members of “substantially different construction.” Plaintiff againcites

to Figure 48, contending that members 482 and 483 in the figure

18 have a “substantially

different construction” because they have different shapes and positions on the implant. 

Ohashi avers that 

[a] person of ordinary skill would be able to ascertain the

boundaries of what constitutes components of “substantially

identical construction” with what constitutes components of

“substantially different construction” by simplycomparing the

shapes and functions of the two components. When compared

to Levy, for example, Figure 48 of the ‘294 Patent would have

been understood to have two engagement members with more

than a minor difference in shape and structure. One of

ordinary skill would have understood that the arms at the

proximal end of the implant have a substantially different

shape and structure than the collapsible middle portion of the

implant, which is attached at either side of the implant and

includes an equidistant notch that allows it to buckle outward

18

‘294 Patent at Sheet 48 of 50, Exhibit C, Defendant MedShape Inc.’s Motion for

Partial Summary Judgment of Invalidity [etc.], Docket No. 133. 

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upon deployment. Further, one of ordinary skill would note

that the first member identified in Figure 48, the pair of center

arms, functions to press soft tissue against the bone while the

second member, the collapsible middle portion, functions to

directly engage the bone. This is significant when compared to

Levy, where both sets of splines serve the same purpose and

move the same way to do so.[19]

Plaintiff also contends that Figures 39-4720 depict embodiments thatinclude first and

second members with substantially different constructions. Plaintiff contends that these

figures show devices that have lateral arms and center arms that are constructed with

different shapes, unique extruding tabs, and differences inholes/facets.21 Ohashi avers that 

a skilled artisan would have understood Figures 39-47 to

depict expanding components that are substantially different

constructions. The different positions and shapes of tabs and

facets on the arms of the device cause the sets of arms to be

substantially different constructions and allow the arms to

perform their unique functions of either pressing the tendon

into the bone or directly engaging the bone through varied

forces.[22]

19Ohashi Declaration at 12-13, ¶ 50, Exhibit 11, Cayenne Medical, Inc.’s Memorandum in Opposition [etc.], Docket No. 134. 

20

‘294 Patent at Sheets 39-47, Exhibit C, Defendant MedShape Inc.’s Motion for

Partial Summary Judgment of Invalidity [etc.], Docket No. 133. 

21

‘Id. at col. 21, lns. 35-47; col. 21, ln. 66- col. 22, ln. 5; col. 22, lns. 35-38; col. 22, lns.

44-45; col. 22, lns. 60-65. 

22Ohashi Declaration at 13, ¶ 51, Exhibit 11, Cayenne Medical, Inc.’s Memorandum

in Opposition [etc.], Docket No. 134. 

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Plaintiff also offers the declaration of Dr. James Dreese in support of its argument. 

Dreese, an orthopaedic surgeon, has been retained by plaintiff as an expert in this case.23

Dreese avers that 

Figures 39-47 show devices that include four expanding arms. 

The arms for each embodiment can be separated into two pairs: 

a “center arm” pair, and a “lateral arm” pair. The pairs are

opposite to one another on the implant, so that adjacent arms

alternate between being a center arm and a lateral arm. The

center arms are designed to press the tendon into the bone.

Thus, they generally include a flatter surface with fewer

protrusions to avoid damaging the tendon graft. The lateral

arms are designed to directly engage the bone. Thus, they may

include additional tabs or tabs with more pronounced shapes. 

The sets of arms are substantially different constructions based

on these differences in their shape and structure.[24

]

Plaintiff also points out that with respect to Figure 39, the specification states that “[t]he

flattened or curvilinear shape of the center arms ... is designed to optimize the implant to

tendon contact area” while “[t]he lateral arms ... directly contact the bone surface and can

have various protrusions or extensions ... that anchor the implant ... into the bone.”

25

Plaintiff argues that a skilled artisan reviewing these embodiments would have been able

23Declaration of James C. Dreese, MD [etc.] at 1, ¶¶ 2 & 6, Exhibit 12, Cayenne

Medical, Inc.’s Memorandum in Opposition [etc.], Docket No. 134. 

24

Id. at 7, ¶ 25. 

25

‘294 Patent at col. 21, lns. 37-44, Exhibit C, Defendant MedShape Inc.’s Motion for

Partial Summary Judgment of Invalidity [etc.], Docket No. 133. 

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Case 2:14-cv-00451-HRH Document 138 Filed 05/06/16 Page 12 of 15
to use these examples to understand the meaning of the phrase “substantially different

construction” with reasonable certainty. In fact, Dreese avers that 

when the claim talks about a second member that has a

“substantially different construction” from the first member,

the claim is referring to two sets of expanding components

seen at least in figures 39-47 and 48 of the patent. As discussed

above, those two sets of components have different shapes and

structures that allow the two sets of components to engage

with bone in different ways. I believe that my fellow orthopedic surgeons would appreciate this from reading the specification and claims. Thus, I believe orthopedic surgeons of

ordinary skill would understand “substantially different

construction” to mean having a “substantially different shape

or structure compared to the other member.”[26] 

The problem with plaintiff’s argument is that there is nothing in the ‘294 patent

specification that would direct a skilled artisan to focus on these specific figures. And even

if a skilled artisan were to focus on these figures, the artisan would still be left to wonder

what other possible features described in the ‘294 specification or other embodiments fall

within the meaning and scope of the claim limitation. If the skilled artisan could tell by

focusing on Figures 39-47 that “different construction” means “different shape or

structure”, as plaintiff’s experts vaguely contend, there is still nothing in the figures or

anywhere else in the specification that provides any objective boundaries for the term

“substantially.” There is nothing in the intrinsic evidence that would allow one skilled in

26Dreese Declaration at 9, ¶ 29, Exhibit 12, Cayenne Medical, Inc.’s Memorandum

in Opposition [etc.], Docket No. 134. 

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the art to determine, with reasonable certainty, when the magnitude of change in the

“construction” of the first and second member is no longer insubstantial but rather has

become “substantially” different.

Plaintiff’s reliance on the prosecution history is also unavailing. As set out above,

the inventors amended what became Claim 6 by adding the phrase “substantially different

construction” after the Examiner rejected the claims in view of Levy. Ohashi avers that 

Levy discloses a devise with components that would be

understood to have substantially identical construction. Levy

states that: “although the first and second sets of splines 710,

740 are shown as having substantially the same length, it will

be appreciated that different length splines may be provided.” 

Cayenne Exhibit 3 at 16:5-7. Thus, we understood that amending the claims to recite merely “different construction” would

not properly distinguish Levy. In light of this, we amended the

claims to recite “substantially different construction.”[27

]

Plaintiff insists that the inventors’ comments distinguishing Levy, when considered in

conjunction with Levy’s disclosure and the ‘294 patent embodiments, provides instructive

guidance that allows a skilled artisan to understand the objective limits of the phrase

“substantially different construction.” Plaintiff also argues that the fact that the Examiner

withdrew his rejection and allowed the claims after receiving the inventors’ response and

amendment supports the conclusion that the phrase “substantially different construction”

is definite. See Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1367 (Fed. Cir. 2011)

27Ohashi Declaration at 11, ¶ 45, Exhibit 11, Cayenne Medical, Inc.’s Memorandum

in Opposition [etc.], Docket No. 134. 

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(“a party challenging validity shoulders an enhanced burden if the invalidity argument

relies on the same prior art considered during examination by the U.S. Patent and

Trademark Office”).

Ohashi avers that the inventors added the term “substantially” to the phrase

“different construction” in order to distinguish Levy. But this does not provide any

guidance to one skilled in art as to the objective boundaries of the phrase. Nothing in the

prosecution history informs the skilled artisan, with reasonably certainty, when the

construction of the second member becomes sufficiently dissimilar to the construction of

the first member to be considered “substantially different.”

Conclusion

Defendant’s motion for partial summary judgment28

is granted. The phrase

“substantially different construction” is indefinite, thereby rendering Claims 6-11 and 13

of the ‘294 patent invalid.

DATED at Anchorage, Alaska, this 6th day of May, 2016. 

/s/ H. Russel Holland 

United States District Judge

28Docket No. 133. 

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