- Aurobindo Pharma USA, Inc.No claims unpatentablePTAB · Dec 28, 2018 · IPR2017-01648 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–25 were not shown unpatentable over Timmins and Cheng because Petitioner did not establish that the combination would have targeted the claimed mean Tmax range.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“In the Patent Owner Response, Patent Owner acknowledged the Board’s characterization of the knowledge of an ordinarily skilled artisan as consistent with the proposals of both parties (PO Resp. 12–13), and neither party further addressed the proper level of ordinary skill in the art or disagreed with our characterization from the Institution Decision. See PO Resp., Reply. Our determination regarding the patentability of the challenged claims does not turn on the differences between the parties’ definitions. We adopt Petitioner’s assessment, but note that our conclusions would be the same under Patent Owner’s assessment. C. Testimony of Dr. Akhlaghi” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We agree with Petitioner that Dr. Akhlaghi’s qualifications and deposition testimony, when read in context, indicate that Dr. Akhlaghi is sufficiently experienced to opine on the knowledge of one of skill in the art at the time of the ’866 patent. As noted in the August 13, 2018 update to our Trial Practice Guide: An expert witness must be qualified as an expert by knowledge, skill, experience, training, or education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008). See Notice of Update to Office Patent Trial Practice Guide, 83 Fed. Reg. 156, (Aug. 13, 2018) (text of update available at https://www.uspto.gov/sites/default/files/documents/2018_Revised_Trial_Pr actice_Guide.pdf). In addition, we are well able to consider the value of an expert opinion and afford it appropriate weight. Perreira v. Secretary of the Dept. of HHS, 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994) (“An expert opinion is no better than the soundness of the reasons supporting it.”) D. Claim Interpretation” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for patent owner
“Tmax” In our Institution Decision, we noted that the term “Tmax” appears in each of the challenged claims, and that both parties agreed that Tmax should be construed as stated in the Specification: “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours).” Inst. Dec. 7 (citing Pet. 24; Prelim Resp. 18; Ex. 1001, col. 7, ll. 49–53). We concluded that the proposed definition was consistent with the Specification and defined the claim term with reasonable clarity, deliberateness, and precision, and we adopted the parties’ construction. Neither party addressed the issue of construction of Tmax in further briefing, but the parties disagree about how Dr. Akhlaghi applied the definition in her testimony. See, eg., Pet. Reply 9–10. For purposes of analyzing the patentability of the challenged claims, we continue to interpret the term as “the time period which elapses after administration of the dosage form at which the plasma concentration of the drug attains the highest plasma concentration of drug attained within the dosing interval (i.e., about 24 hours),” because that definition is consistent with the Specification, and because the parties themselves agreed to the definition of Tmax. Inst. Dec. 7. E. Overview of the Prior Art slip op. at 11
- BurdenNot shown unpatentable
“Based on our review of the record, we determine that Petitioner has not shown sufficiently that combining the teachings of Timmins and Cheng as Petitioner contends would have resulted in a dosage form that provides a mean Tmax of metformin from 5.5 to 7.5 hours after administration.” slip op. at 19
Patent outcomesUS 6,866,866 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,866,866 - 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 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · Nov 6, 2018 · IPR2017-01149 · APJ Karl D Easthom · IPR · Final written decision
Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and the respective additional reference in each trial.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 126
Patent outcomesUS 6,418,556 unpatentableNonecites PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · Nov 6, 2018 · IPR2017-01150 · APJ Karl D Easthom · IPR · Final written decision
Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and Moro, Reiter, or Remillard.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“III. CONCLUSION For the foregoing reasons, Petitioner has shown, by a preponderance of the evidence, that the subject matter of claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 would have been obvious over the combination of Young ’801, Young ’121, Strubbe, and either Moro (48Pet.), Reiter (49Pet.), or Remillard (50Pet.).” slip op. at 126
- ExcludeMotion to exclude, deniedDenied
“12. Motion to Exclude Patent Owner moves to exclude paragraphs 8, 24, 27–30, 32 and 38 of” slip op. at 123
Patent outcomesUS 6,418,556 unpatentable§ 103 obviousnesscites PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · Nov 6, 2018 · IPR2017-01148 · APJ Karl D Easthom · IPR · Final written decision
Claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 are unpatentable as obvious over the stated combinations in each of the three trials.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“of the evidence, that the subject matter of claims 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 would have been obvious over the combination of Young ’801, Young ’121, Strubbe, and either Moro (48Pet.), Reiter (49Pet.), or Remillard (50Pet.). IV. ORDER ORDERED that 5–10, 15, 17, 18, 29, 31, 32, 34–38, and 41–48 of U.S. Patent No. 6,418,556 B1 are unpatentable as a result of each trial as a separate matter, IPR2017-01148, IPR2017-01149, and IPR2017-01150;” slip op. at 126
- ExcludeMotion to exclude, deniedDenied
“observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 126
Patent outcomesUS 6,418,556 unpatentable§ 103 obviousnesscites PhillipsPatents in suitUS 6,418,556 - Comcast Cable Communications, LLC v. Rovi Guides, Inc.All claims unpatentablePTAB · Nov 6, 2018 · IPR2017-01151 · APJ Karl D Easthom · IPR · Final written decision
Claims 23 and 25–27 are unpatentable as obvious over Young ’801, Young ’121, Strubbe, and any one of Moro, Reiter, or Remillard.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“would not have interpreted Young ’801’s system as restricted to a single page limited to time slots ranging from 11:00 am to 12:30 pm as depicted in Figure 6 of Young ’801. See Ex. 1720 ¶ 24 (describing Dr. Bovik’s restricted view of Young ’801 as unreasonable). This restricted reading of Young ’801 unreasonably constrains the use of the guide to 1.5 hours, something the Petitions do not do, contrary to Patent Owner’s arguments that the Reply shifts to new theories. See Rep. Opp. Mot. Exc. 2–5. To elaborate and address Patent Owner’s arguments and Dr. Bovik’s testimony, Mr. Wechselberger responds with a citation documenting well-known cursor navigation aspects of the same concept involved in spreadsheets (Ex. 1722) and elaborates about minimal program guide layout or format changes that go hand-in-hand with the Petitions’ assertions of guide size reduction. See Ex. 1720 ¶ 24; Opp. Mot. Exc. 9–11 (discussing Ex. 1720 ¶¶ 36–37, 129– 131, 136–137, 158), 11 (noting Dr. Bovik stated in his deposition “a user would have been ‘confined to the visible screen’”) (citing Ex. 1721, 56:16– 23, 108:25–109:8, 116:17–117:2; Ex. 2706 ¶¶ 51–52). In summary, the Petition cites to portions of Young ’801 that describe the page mode and generally advance the theory of moving a cursor across, upward, and to the right to obtain consecutively displayed and successive portions of schedule information, citing portions that describe new pages and cursor jumps. Petitioner did not create a new theory about how the page guide operates but responded to Patent Owner’s arguments. Patent Owner chose not to avail itself of the opportunity to depose Dr. Wechselberger about his second declaration and thereafter file observations from that deposition or seek authorization to file a sur-reply. In view of these circumstances, we deny Patent Owner’s Motion to Exclude.” slip op. at 92
- Skill levelSkill level petitioner adoptedDecided for petitioner
“materially similar description of a person of ordinary skill in the art. See PO Resp. 14–15 (citing Ex. 2706 ¶¶ 1–19). During the Oral Hearing, Patent Owner indicated any differences between Petitioner’s and Patent Owner’s descriptions do not create a dispositive issue. See Tr. 66:11–18. On this record, Petitioner’s description comports with the level of ordinary skill implied by the prior art references discussed further below. Accordingly, we adopt it.” slip op. at 38
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“8. Young ’801, Young ’121, Strubbe, and Moro Petitioner persuasively shows that claims 23 and 25–27 the” slip op. at 47
Patent outcomesUS 6,418,556 unpatentable§ 103 obviousnessPatents in suitUS 6,418,556 - Argentum Pharmaceuticals LLC v. Alcon Research, Ltd.No claims unpatentablePTAB · Sep 20, 2018 · IPR2017-01053 · APJ Grace Karaffa Obermann · IPR · Final written decision
Claims 1–28 were not shown unpatentable under § 103 because the proposed combinations lacked a persuasive reason to make the required modifications and meet the claimed limitations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Petitioner submits that such a person would have had a Doctorate in microbiology or chemistry (or a related field) with at least a few years of experience in the development of ophthalmic formulations. Pet. 7. Alternatively, in Petitioner’s view, that person would have had a Bachelor’s or Master’s Degree combined with significant (5 years or more) practical experience developing ophthalmic formulations. Id. Patent Owner, for its part, advances a definition that “does not differ materially” from that proposed by Petitioner. Resp. 5. Petitioner’s definition is comparable to the level of skill reflected in the asserted prior art. The prior art itself is sufficient to demonstrate the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect appropriate level of ordinary skill in the art). To the extent more specified findings are required, we adopt the definition proposed by Petitioner. Pet. 7. We observe, however, that there is no appreciable difference between the parties’ respective definitions that would “materially” alter the outcome of this decision based on our acceptance of one definition over the other. Resp. 5.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of the ’299 patent, which states that “[t]he multi-dose compositions of the present invention, which do not contain a conventional antimicrobial preservative, are referred to herein as being ‘self-preserved’.” Ex 1001, 3:27–29. The specification identifies BAC as an example of a conventional antimicrobial preservative excluded from the self-preserved composition of the challenged claims. Id. at 4:23–25. No other claim term requires express construction for the purposes of this decision. See, e.g., Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only claim terms in controversy need be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 7
- Prior constructionPrior construction adoptedDecided for patent owner
“Petitioner argues that we should adopt the claim construction resolved in the Apotex IPR, as we did in the decision on institution in this case. Pet. 5–7; Dec. 7–8. Patent Owner tacitly agrees. See Resp. 1 (stating that a “self-preserved” composition is “one that has sufficient antimicrobial activity to pass standard tests for ‘preservative efficacy’ without needing a conventional preservative”). Accordingly, for reasons set forth in our decision instituting review in the Apotex IPR, we determine that: (a) The preamble term “self-preserved” breathes life and meaning into the claims, and is construed as a limitation of claims 1–28; and (b) The broadest reasonable interpretation of “self-preserved” compositions is “compositions that do not contain a conventional antimicrobial preservative.” Apotex IPR, Paper 9, 5–6; Dec. 7–8. Schneider, which is asserted in each ground of unpatentability stated in the Petition, informs that edetate disodium (“EDTA”) and benzalkonium chloride (“BAC”) were conventional antimicrobial preservatives known and available at the time of the invention—an issue not meaningfully disputed by Petitioner. Ex. 1007, 7:14–21; Pet. 15. Our claim construction findings are supported by the specification of” slip op. at 6
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Petitioner asserts that an ordinarily skilled artisan “would have retained as much of” Formulation A “as feasible, as this was already an FDA-approved formulation, marketed as Travatan®.” Pet. 15; Ex. 1002 ¶¶ 46–47. But Petitioner’s challenge incongruously depends on at least six modifications to Formulation A; seven, if attaining UPS preservative efficacy requirements is not an inherent property of the modified composition. Petitioner does not address, much less explain, how or why an ordinarily skilled artisan, undertaking those six or seven modifications, would have done so with a reasonable expectation of success in arriving at a “self-preserved” composition using zinc as the sole preservative—in a field where zinc “had never before been the sole preservative in a marketed ophthalmic drug.” Resp. 9; Ex. 2023 ¶ 46; Ex. 2025 ¶ 30. The Petition does not articulate a rational reason why a person of ordinary skill in the art, setting out to improve Formulation A, would have selected the particular combination of ingredients required by claim 1. Formulation A bears almost no resemblance to the composition of claim 1, lacking three of the four required ingredients (zinc ions, sorbitol, and propylene glycol) and containing two others (BAC and EDTA) that are excluded by the “self-preserving” terms of the claim. Compare Ex. 1001, claim 1, with Ex. 1007, 9:25–42 (Table, Formulation A). And even if we set aside those hurdles, the challenge fails for lack of persuasive evidence showing how or why an ordinarily skilled artisan would have resolved to include the claimed ingredients in the specified concentrations, while at the same time limiting anionic species (to the extent included) to a concentration of “less than 15 mM.” Ex. 1001, claim 1. Petitioner fails to establish that the subject matter of claim 1 would have been obvious over the combined disclosures of Schneider, Xia, and Chowhan—with or without the additional disclosure of Gadd. Pet. 2–3.” slip op. at 26
Patent outcomesUS 8,268,299 not shown unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,268,299 - Coherus Biosciences, Inc. v. Hoffmann-Laroche Inc.Rehearing deniedPTAB · Jul 13, 2018 · IPR2017-02066 · APJ Wesley B Derrick · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution because Petitioner did not consistently define the claimed hinge or show an abuse of discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW 37 C.F.R. § 42.71(d) provides that: 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, opposition, or a reply. See also Office Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565, 1567 (Fed. Cir. 1988) (citations omitted).” slip op. at 3
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“matters in construing the claims does not address our reasoning set forth in the decision. Contrary to Petitioner’s contentions, we did not construe the claims to be limited to fusion proteins comprising a hinge having the full amino acid sequence encoded by the corresponding hinge exon, including three cysteine residues. Although we did construe the claims to exclude “any protein with less than all of the amino acid sequence of the hinge domain of human IgG (or IgG1) immunoglobulin heavy chain, even if functional,” see Dec. 7, we could not discern from Petitioner’s discussion of the claims and the art any consistent demarcation in the amino acid sequence of human IgG (or IgG1) concerning where the first domain ends and the hinge domain begins. As we explained, the phrase “all of the domains of the constant region . . . other than the first domain of said constant region” leaves unsettled “where in the constant region the divide lies between the first domain of the constant region and the hinge domain.” Dec. 7–8. What is settled, however, is that the ordinary and customary meaning of the terms in the phrase requires that all constant region amino acid sequence that is not part of the first domain must be included in the fusion protein. Id. at 7. As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained:” slip op. at 4
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“As made explicit in the Decision, Petitioner failed to define in a consistent manner where the divide lies between the first domain of the constant region and the hinge domain. It was in light of this deficiency that we determined that Petitioner had not met the requisite burden for instituting inter partes review. Id. at 8. As we further explained: [W]ith respect to Zettlmeissl, Petitioner appears to assert that “all of the hinge domain” requires the hinge segment encoded by the hinge exon, including three cysteine residues. But with respect to Watson, Petitioner appears to assert that “all of the hinge domain” simply requires a portion of sequence that includes the two cysteine residues involved in joining the heavy chains. Id. at 14. Notwithstanding the apparent differences in amino acid sequence, unacknowledged in the Petition, “Petitioner relies on Zettlmeissl and Watson as teaching the use of the same, identical portion of the IgG heavy chain, and relies on that portion for use in the fusion protein.” Id. at 10 (citing Pet. 5); see also id. at 6, 12–14, Pet. 5 (stating “both [Watson and Zettlmeissl] reported optimal results by employing the identical portion of the IgG heavy chain as claimed in the ’182 patent”).” slip op. at 5
Claim constructionPatents in suitUS 8,063,182
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.