- Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentablePTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision
Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.
RulingsFinal written decision- Expert testimonyOther
“3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7
- Skill levelOther
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed
“as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21
Patent outcomesUS 9,271,731 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,271,731 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.No claims unpatentablePTAB · Dec 28, 2018 · IPR2017-00435 · APJ Robert L Kinder · IPR · Final written decision
Claims 1–4, 6–18, and 20 were not shown unpatentable over Malecki; the contingent motion to amend was denied as moot.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“construction more persuasive because it is grounded in, and most consistent with, the specification of the ’731 patent. Contrastingly, Petitioner does not offer a specific interpretation of “inner walls” and its arguments are generally based on extrinsic evidence, including claim charts from the related district court litigation (Pet. 15), arguments from related proceedings (Pet. Reply 3), and the prior art reference (Malecki) relied on to challenge the claims (id. at 3–4). Petitioner criticizes the Patent Owner’s position but provides no express interpretation of “inner walls of the first and second clip arms;” instead, Petitioner argues why Patent Owner’s proposed construction is wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise persuasively explain the definition of “inner walls” in his declarations either. See generally Exs. 1037, 1095, and 1109.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’731 patent would have possessed the knowledge and skill of an engineer or similar professional 5 The parties have not introduced evidence of secondary considerations in this proceeding. with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it based on the final record before us. It is also consistent with the level of skill evidenced by the references.” slip op. at 15
- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id.” slip op. at 25
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id. Finally, Petitioner seems to recognize that a modification would be” slip op. at 25
Patent outcomesUS 9,271,731 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,271,731 - Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentablePTAB · Nov 15, 2018 · IPR2017-00135 · APJ Robert L Kinder · IPR · Final written decision
Claims 1, 3–5, and 10 are unpatentable as obvious over Kimura (claims 1, 3–5) and Kimura with Sackier (claim 10); claims 7, 11–15, and 17 were not shown unpatentable.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’371 patent would have possessed the knowledge and skill of an engineer or similar professional with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 8 (citing Ex. 1029 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it for purposes of this Decision.” slip op. at 15
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“The issue we have with Patent Owner’s contentions, as pointed out by Petitioner, is that Patent Owner does not establish persuasively how its claims require the “reversible open/close” feature and the “tactile feel features.” See Pet. Reply 27–29. Even presuming that these features did indeed drive tremendous commercial success and industry praise for the commercial products, Patent Owner does not adequately explain in its analysis how the claims of the challenged patent require these particular features that drive commercial success. Patent Owner seems to suggest that a break section in the control wire will fracture and that this feature in the commercial product relates to the tactile feel. PO Resp. 57 (citing Ex. 2029 ¶¶ 91–93) (“After the yoke has disengaged, if the handle spool is moved further proximally, a break section in the control wire will fracture, leaving the ball within the yoke and uncoupling the control wire from the distal components of the device.”). This “break section in the control wire” is not, however, claimed or covered in claim 1, the claim that purportedly embodies the commercial product. The claims alleged to cover the product do not specifically require any “tactile feel feature.”3 Likewise, while the claims may allow for an opening and closing of the clip assembly, there is no requirement in these claims that the clip assembly, as “demanded” by physicians, repeatedly open and close. Thus, both of the drivers of commercial success and industry praise are not commensurate in scope with the claims of the patented invention. See Ex. 1046 ¶¶ 23–29 (explaining how features are not claimed).” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“district court proceeding, Petitioner contends that “coupled to the sheath” means “slideable inside the sheath” and “the sheath confines the bushing.” Pet. 9. Petitioner provides no additional support. The district court tentatively rejected this broad interpretation. See Ex. 2003, 27–28 (“[T]he Court recommends that ‘coupled to the sheath’ be construed as ‘linked together, connected, or joined, but not slidable inside the sheath.’”). Patent Owner contends that Petitioner’s proposed construction of “coupled to the sheath” is “unreasonably broad,” but provides little citation to the intrinsic record before us. Prelim. Resp. 13–14. Instead, Patent Owner notes that the plain and ordinary meaning of coupled is “linked together, connected, or joined,” citing to an unrelated Federal Circuit decision as well as the related district court determination. Id. at 14; Ex. 2003, 28. In our proceeding, Petitioner has not provided persuasive evidence or argument to support its claim interpretation by merely pointing to what Patent Owner purportedly argued in district court. Based on the final record before us, “coupled to the sheath” means “linked together, connected, or joined” to the sheath. Our construction is consistent with the district court’s analysis and reflects the common understanding of the term “coupled” in the mechanical arts to require more than simply abutting or contacting. See generally Ex Parte Paul Robert Homrich, Appeal 2014-005786, 2016 WL 3541285, at *3 (PTAB, June 27, 2016) (“When used in mechanical systems, the plain and ordinary meaning of ‘coupled’ means to link together or connect,” and coupled requires more than contact or abut.).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are not persuaded that Petitioner has demonstrated sufficiently that Adams discloses “a bushing extending between a proximal end coupled to the sheath,” (Ex. 1027, 17:4–5) as required by claim 1 of the ’371 patent. Based on the final record, Petitioner’s contention that retainer 110 [bushing] is slidable inside the sheath, or confined by the sheath, does not establish persuasively that the proximal end of the bushing is coupled to the sheath as required by claim 1. The claimed coupling must be “proximal coupling” and Petitioner can only point to distal coupling via distal tabs 118, 119 (Pet. Supp. Reply 6) – this is not “proximal” coupling. Further, for the bushing and the sheath to be coupled requires them to be “linked together, connected, or joined” in some manner and Petitioner has not established any such connection for proximal coupling. Petitioner also has failed to establish a persuasive reason for linking or connecting retainer 110 and sheath 112 – indeed, doing so would negatively impact the ability of retainer 110 to freely slide out of sheath 112. See Prelim. Resp. 27. Adams suggest that when control wire 108 is actuated and the clip is locked into the lock sleeve, retainer release 109 pulls retainer 110 back, disengaging retainer tabs 118, 119 from the two retainer holes as depicted in Figure 4.” Ex. 1023, 7:26–44 Finally, we note that our decision would not change if we adopted the district court’s claim interpretation. The district court adopted a claim construction of “a bushing extending between a proximal end coupled to the sheath” as “linked together, connected, or joined, but not slidable inside the sheath.” Ex. 2003, 28 (emphasis added). Should the district court’s interpretation be the correct one, Patent Owner’s position is much stronger whereas Petitioner’s theory is based on slidable movement. See Pet. 9 (arguing for “slideable inside the sheath” and “the sheath confines the bushing”); Pet. Supp. Reply 6. Having now considered the evidence in the complete record established during trial, we are not persuaded that Petitioner has demonstrated by a preponderance of the evidence that claim 1 would have been anticipated by Adams. Petitioner has not established persuasively that Adams discloses “a bushing extending between a proximal end coupled to the sheath.” For this reason, Petitioner has failed to prove by a preponderance of the evidence that Adams anticipates claim 1.” slip op. at 22
Patent outcomesUS 8,974,371 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,974,371 - K/S Himpp v. III Holdings 4, LLCNo claims unpatentablePTAB · Jun 28, 2018 · IPR2017-00496 · APJ James T Moore · IPR · Final written decision
Claims 1–17 were not shown unpatentable under § 103 over Topholm and Michael because the cited art did not teach adjusting a hearing aid profile.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“The problem we find with this position is that the Petitioner is reading claim elements into the description of these references. Patent Owner points out that the profiles are not being adjusted, but rather being selected from twenty-four previously stored profiles. Resp. 30–31. While the ear module operational profile changes, we observe that this is because it is using a different profile, which was just uploaded from the control unit. The act of moving the finger around on the screen to us perhaps appears to change the profile, when it is in fact moving through a set of preexisting profiles and uploading them to the hearing aid instead, changing operation of the hearing aid itself but not adjusting the profile itself. Michael states: This permits the user to select a hearing profile by simply moving visual indicator 924 over main region 922 while listening to a sound stream broadcast by ear 35 module 10; the sound stream being heard by the user reflects the hearing profile corresponding to the current position of the visual indicator 924 in real-time. Ex. 1005, 8:32–37.” slip op. at 21
- Expert testimonyPetitioner expert creditedOther
“4 Petitioner also relies upon the declaration testimony of Dr. Robert E. Morley, Jr. (Ex. 1002). Both references appear to be prior art under 35 U.S.C. § 102(b). We find Dr. Morley, by virtue of his education and experience, qualified to testify to the subject matter of this proceeding. Ex. 1002 ¶¶ 2–14 and Exhibit A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. PO Resp. 34–36. We give Dr. Morley’s testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2006. We decline to assign generally no weight to his testimony, however.” slip op. at 3
- Skill levelSkill level petitioner adoptedOther
“These underlying factual considerations consist of: (1) the “level of ordinary skill in the pertinent art,”5 (2) the “scope and content of the prior art,” (3) the “differences between the prior art and the claims at issue,” and (4) “secondary considerations” of non-obviousness such as “commercial success, long felt but unsolved needs, failure of others, etc.”6 KSR, 550 U.S. at 406 (quoting Graham, 383 U.S. at 17–18). 5 Petitioner defines the level of ordinary skill in the art as someone with a B.S. degree in electrical or computer engineering, or the equivalent, and at least two years of experience in the design of audiological products. Pet. 7-8 (citing Ex. 1002, ¶ 32). Patent Owner does not challenge this level. PO Resp., passim. The references in the record tend to support a finding that this is the appropriate level.” slip op. at 12
Patent outcomesUS 8,761,421 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,761,421 - PTAB · Jun 28, 2018 · IPR2017-00414 · APJ James T Moore · IPR · Final written decision
Claims 1–7 were not shown unpatentable under § 103 over either Cohen and Martin or Holmes and Martin because the combinations did not establish the claimed separate shaping before mixing.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“As used herein, the term “hearing aid profile” refers to a collection of acoustic configuration settings for hearing aid 102, which are used by a processor 110 to shape electrical signals related to sounds to compensate for the user's hearing loss. Ex. 1001, 3:11–15. Petitioner states that Patent Owner defined this term in the ’538 patent as “a collection of acoustic configuration settings for hearing aid 102, which are used by processor 110 to shape electrical signals related to sounds to compensate for the user’s hearing loss.” Pet. 15. According to Petitioner, this construction is consistent with the plain and ordinary meaning of the term, relying upon the testimony of its witness Dr. Les Atlas. Pet. 15 (citing Ex. 1003 ¶ 38).10 Patent Owner does not dispute Petitioner’s proposed construction. Resp. 10–11. 10 Dr. Les Atlas is the Petitioner’s witness in this matter. We find him qualified to testify as to the subject matter of this proceeding, by virtue of his education and experience. See Ex. 1003 ¶ 4, and Appendix A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. Resp. 31–34. We give Dr. Atlas’ testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2005. We decline to assign generally no weight to his testimony, however. supports, and is consistent with, Petitioner’s proposal. Ex. 1001, 3:12–16. Accordingly, we determine that the broadest reasonable construction, in light of the specification of the ’538 patent, of the term “hearing aid profile” is a “collection of acoustic configuration settings for hearing aid, which are used by a processor to shape electrical signals related to sounds to compensate for a user’s hearing loss.”” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“For the purposes of our decision, we determine that no other claim terms need explicit construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (citation omitted).” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“11 Petitioner defines the level of ordinary skill in the art as someone with a Bachelor’s degree in electrical engineering and at least two years of experience in the field of audio engineering. Pet. 14 (citing Ex. 1003 ¶ 25). Patent Owner does not challenge Petitioner’s definition. Resp. passim. The references in the record support a finding that this is the appropriate level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of skill in the art). 12 The record contains no allegations or evidence of secondary considerations.” slip op. at 10
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“We find the testimony of Dr. Atlas on the key point of obviousness of pre-mixing processing to be less persuasive than that of Mr. Brown. We also find Dr. Atlas’ testimony falls short of adequately explaining how the combination of Cohen and Martin teaches a nexus (i.e., the “based on both the first [shaped] output signal and the second [shaped] output signal” (emphasis added) (hereinafter, “based on both limitation”) limitation recited in claim 1) between the claim 1 requirements of: (1) a condition precedent of shaping both a first output signal and a second output signal; and (2) a subsequent result of using both the first shaped output signal and the second shaped output signal if the hearing aid is in a third mode. Dr. Atlas assumes that one of ordinary skill in the art would process separately each signal and then mix them. Ex. 1003 ¶ 66. We find Dr. Atlas’ assumption is flawed. Specifically, in making this assumption, Dr. Atlas does not address adequately how the combination of Cohen and Martin opines “it would have been obvious to a person of ordinary skill in the art” (emphasis added), his later sentences appears to base his opinion principally on the reason one of ordinary skill in the art could do it. Id. In particular, he testifies: Because Cohen’s hearing aid applies different hearing aid profiles to different input sources, it would have been obvious to a person of ordinary skill in the relevant art to add the functionality of the combination mode as taught by Martin to Cohen’s hearing aid such that the speaker would produce an audible sound based on the output signals of the processor. Combining two signals such that both signals are sent to a speaker to an audible combination of sounds, that is where each signal is sufficiently perceived, was well within the technical ability of a person of ordinary skill in the art. To accomplish this would require that each one of the two signals is passed through an appropriate hearing aid profile. For example, it would have been obvious to a person of ordinary skill in the art that a different hearing aid profiles could be used for an audio coil inputs and that of a neighboring conversation and environmental sounds through a microphone. Namely, it is commonly known that the different frequency sensitivity of an audio telecoil versus a microphone can be beneficially compensated for. (Rodriquez, Ex. 1011, Abstract)” slip op. at 24
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,649,538 - Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentablePTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision
Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28
Patent outcomesUS 7,009,034 unpatentableClaim construction§ 103 obviousnessPatents in suitUS 7,009,034 - Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing deniedPTAB · Jan 22, 2018 · IPR2017-01262 · APJ Robert A Pollock · IPR · Rehearing
The Board denied rehearing, leaving institution denied because Petitioner did not show the prior art disclosed or enabled access to the mammalian FUT8 gene sequence required by claims 1–6.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- Expert testimonyPetitioner expert discountedDecided for patent owner
“6, 2000 concerning the means and methods for creating cells in which the gene for the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 12. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6- fucosyltransferase, focusing, instead, on the “basic enabling techniques described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 14 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269(20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 73. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 17. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how that the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 6
NonePatents in suitUS 7,425,446 - Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing deniedPTAB · Jan 22, 2018 · IPR2017-01254 · APJ Robert A Pollock · IPR · Rehearing
The Board denied Petitioner’s rehearing request, leaving in place the denial of institution on claims 1–5 because Petitioner did not show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- BurdenDecided for patent owner
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Because Petitioner raised none 1 Genbank entry AB025198.1. “Mus musculus mRNA for alpha-1,6- fucosyltransferase, complete cds,” https://www.ncbi.nlm.nih.gov/nuccore /%20AB025198. 2 Yanagidani et al., Purification and cDNA Cloning of GDP-i-Fuc:N-acetyl- β-d-glucosaminyl fucosyltransferase (α1-6FucT) from Human Gastric CancerMKN45 Cells, 121 J. Biol. Chem. 626-632 (1997). 3 Naofumi Uozumi, Purification and cDNA Cloning of Porcine Brain GDPL-Fuc:N-Acetyl-β-D-Glucosaminide α1→6Fucosyltransferase, 271 J. Biol. Chem. 27810-27817 (1996). of the above arguments in the Petition, nor timely submitted any of Exhibits 1039, 1042, and 1043, Petitioner has not established that we misapprehended or overlooked this evidence. Cf. DeSilva v. DiLeonardi, 181 F.3d 865, 866– 67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archeologist with the record.”). slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“of Drs. Van Ness and Jefferis. Req. Reh’g 12–14 (citing Ex. 1007 ¶¶ 18–20, 40–43, 77; Ex. 1026 ¶¶ 11–13). With respect to the latter, Petitioner points to Dr. Jefferis’s statement that a person of ordinary skill in the art “would have had knowledge of the scientific literature no later than October 6, 2000 concerning the means and methods for creating cells in which the gene for the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 11. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6-fucosyltransferase, focusing, instead, on the “basic enabling techniques described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 13 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269(20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 68. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 16–17. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 5
NonePatents in suitUS 8,067,232 - Aragen Bioscience, Inc. / Transposagen Biopharmaceuticals, Inc. v. Kyowa Hakko Kirin Co., Ltd.Rehearing deniedPTAB · Jan 22, 2018 · IPR2017-01252 · APJ Robert A Pollock · IPR · Rehearing
The Board denied the petitioner’s rehearing request, leaving in place the denial of institution on claims 1–12 because the petition did not establish access to the necessary mammalian FUT8 genetic material.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. When reconsidering a decision on institution, we review the decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion may be determined if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“isolated fucosyltransferase knock-out host cell.” Consistent with Patent Owner’s position, we construed the fucosyltransferease knock-out as “a disruption of FUT8, the gene encoding α1,6-fucosyltransferase.” Dec. 13. In denying the Petition, we found that Petitioner did not establish that the prior art disclosed or rendered obvious the challenged claims because it failed to present sufficient evidence that one of ordinary skill in the art would have had access to the necessary genetic starting material. Dec. 19– 24. In particular, we determined that “Petitioner fails to establish adequately that DNA encoding a mammalian α1,6-fucosyltransferase was either available, or could be routinely obtained by those of ordinary skill in the art.” Id. at 24. According to Petitioner, our finding is “clearly erroneous” and based on “misunderstandings about the record evidence, as well as a failure to weigh, in full, unrebutted expert testimony before the Board.” Req. Reh’g 1. We do not find Petitioner’s argument persuasive.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for patent owner
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). Because Petitioner raised none of the above arguments in the Petition, nor timely submitted any of Exhibits 1 Genbank entry AB025198.1. “Mus musculus mRNA for alpha-1,6- fucosyltransferase, complete cds,” https://www.ncbi.nlm.nih.gov/nuccore /%20AB025198. 2 Yanagidani et al., Purification and cDNA Cloning of GDP-i-Fuc:N-acetyl- β-d-glucosaminyl fucosyltransferase (α1-6FucT) from Human Gastric CancerMKN45 Cells, 121 J. Biol. Chem. 626-632 (1997). 3 Naofumi Uozumi, Purification and cDNA Cloning of Porcine Brain GDPL-Fuc:N-Acetyl-β-D-Glucosaminide α1→6Fucosyltransferase, 271 J. Biol. Chem. 27810-27817 (1996). 1038, 1041, and 1042, Petitioner has not established that we misapprehended or overlooked this evidence. Cf. DeSilva v. DiLeonardi, 181 F.3d 865, 866– 67 (Fed. Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archeologist with the record.”). slip op. at 4
- Expert testimonyPetitioner expert discountedDecided for patent owner
“the fucose-adding enzyme fucosyltransferase was knocked out, resulting in a modified sugar chain giving improved antibodies.” See id. at 12; Ex. 1026 ¶ 11. But Dr. Jefferis provides no definitive statement with respect to the availability of DNA encoding a mammalian α1,6-fucosyltransferase, focusing, instead, on the “basic enabling techniques to create the modified-antibody-producing mammalian cells described in the patent claims.” See Ex. 1026 ¶ 12; see also id. ¶ 13 (discussing statement in prosecution history “that construction of gene constructs and knock-out CHO cells were ‘standard methods’ in the prior art”). Accordingly, we do not find Dr. Jefferis’s testimony relevant to the availability of a mammalian FUT 8 gene sequence. Dr. Van Ness, in contrast, referenced “the known genetic sequence of the α1,6-fucosyltransferase gene,” after asserting that “[t]he human fucosyltransferase gene sequence had been cloned in 1994 by Sasaki et al. (269 (20) J. BIOL. CHEM. 14730–37 (1994)).” Ex. 1007 ¶¶ 40, 77. As discussed in our Decision, Sasaki does not disclose a mammalian α1,6- fucosyltransferase recited in claim 1, but an α1,3-fucosyltransferase. Dec. 20–21. As such, Sasaki fails to support Dr. Van Ness’s generic reference to “the known genetic sequence of the α1,6-fucosyltransferase gene.” Because neither Dr. Van Ness nor Petitioner presented any evidence demonstrating how the nucleotide sequence of an α1,3-fucosyltransferase teaches or suggests that of the α1,6-fucosyltransferase recited in claim 1, we accorded little weight to Dr. Van Ness’s opinion. Id.” slip op. at 6
NonePatents in suitUS 6,946,292
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.