• Argentum Pharmaceutical LLC v. Novartis AGNo claims unpatentable
  PTAB · Oct 5, 2020 · IPR2016-01479 · APJ Christopher L Crumbley · IPR · Final written decision

  Claims 1–3 were not shown unpatentable because the asserted prior-art combinations did not establish a reasonable expectation of success in treating advanced PNETs after chemotherapy failure.

  RulingsFinal written decision

  • Skill levelOther

    “demonstrate by a preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time of the invention to a person having ordinary skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations.10 See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The level of ordinary skill in the art may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundDecided for patent owner

    “Judged by the correct standard, the evidence leaves little doubt that a person of ordinary skill in the art would have been motivated to pursue everolimus as a potential treatment option for advanced PNETs after failure of cytotoxic chemotherapy. Novartis does not seriously contend otherwise, focusing its arguments instead on whether the motivation to pursue everolimus was greater than the motivation to pursue other possible treatments. Not only does Öberg 2004 discusses rapamycin as an “interesting new compound” that suggests clinical trials with rapamycin in combination with cytotoxic chemotherapy, it specifically provides a treatment algorithm that shows rapamycin among the potential “experimental therapies” following failure of cytotoxic chemotherapy. Ex. 1027, 60, Fig 1. And O’Donnell specifically demonstrates that administration of everolimus to human cancer patients was safe. Ex. 1029, 200. We credit Dr. Ratain’s testimony that by 2005, there was a “significant body” of data on the administration of everolimus to humans, but no reported clinical data on rapamycin. Ex. 1003 ¶ 135. Given the difference in information on everolimus and rapamycin, we find that the skilled artisan would have been motivated to pursue everolimus as an alternative to the rapamycin disclosed in Öberg 2004. Even if a person of ordinary skill would have had reason to pursue everolimus, however, our inquiry does not end there. Argentum must also prove that the skilled artisan “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). That “expectation of success need only be reasonable, not absolute.” Id. at 1364. “Whether an ordinarily skilled artisan would have reasonably expected success . . . is measured as of the date of the invention.” Amgen Inc. v. F. Hoffman–La Roche Ltd., 580 F.3d 1340, 1362 (Fed. Cir. 2009).” slip op. at 15

  • Obviousness (§103) › Analogous artNot shown unpatentableDecided for patent owner

    “the only prior art clinical trial of everolimus presented to us, was a Phase I trial designed to test dosages, not efficacy. Ex. 1029, 803. While Öberg 2004 does disclose the promise of rapamycin, we agree with the District Court that at the time of the invention the mTOR pathway was insufficiently understood, such that a person of ordinary skill in the art would not have reasonably expected rapamycin’s “promise,” as reported in Öberg 2004, to translate to everolimus. Ex. 1027, 60. And in regard to Boulay 2004, Novartis argues that the record lacks sufficient evidence to support Argentum’s contention that the CA20948 rat pancreatic tumor model described therein was applicable to the treatment of PNETs. Ex. 1005, 253. On this point, again we agree with the District Court. District Court Decision, 287 F. Supp. 3d at 526 (“I find that Defendant has failed to establish by clear and convincing evidence that CA20948 is a PNET model.”). Upon evaluating the full record before us, we find that the CA20948 tumor model line originated from a pancreatic adenocarcinoma, which is distinct from a neuroendocrine tumor (NET). Ex. 2038, 197–99; Ex. 2041 ¶¶ 132–134. We credit and rely on Dr. Kulke’s testimony that pancreatic adenocarcinomas and PNETs were known to differ in their origin, incidence, clinical behavior, molecular genetics, and responses to pharmacotherapies. Ex. 2041 ¶¶ 57, 135–136. Argentum does not dispute the distinction between CA20948 and PNETs, but instead argues that tests performed on CA20948 would nevertheless be understood to be applicable to PNETs. Reply 17–18. Argentum’s primary support for this argument derives from the De Jong reference, which discloses the use of the CA20948 pancreatic tumor line in a study of the treatment of neuroendocrine tumors. Ex. 1010, Abstract. As based treatment of tumors using radioactive somatostatin-analogues. PO Resp. 33; Ex.1010, 356–58. Both neuroendocrine tumors and CA20948 express somatostatin receptors; it is this commonality that made CA20948 useful as a model for NETs in De Jong’s study of radiation treatment. Ex. 2041 ¶¶ 139, 141. But just because some features of a cell line make it useful in studies of tumors where those features are relevant, it does not necessarily follow that the cell line is relevant to all studies of those tumors. See Tr. 14:15–25. As Dr. Kulke credibly explains, the person of ordinary skill in the art would not have understood from the De Jong radiation treatment study that CA20948 could be used as a model for NETs in a pharmacotherapy study. Ex. 2041 ¶ 143–146. For these reasons, we agree with the District Court that Argentum has not proven CA20948 to be a PNET model; nor is there reason to believe that a person of ordinary skill in the art would have considered CA20948 to be applicable to studying the treatment of PNETs with mTOR inhibitors, much less such treatment after the failure of cytotoxic chemotherapy.” slip op. at 18

  • ExcludeMotion to exclude, deniedMixed

    “We agree. If Argentum had submitted only certain portions of Dr. Kulke’s testimony into the record before us, Novartis would be entitled to rely on FRE 106 to request that the Board admit other portions of his testimony that, in fairness, should be considered. But that is not what Novartis requests here; nor could it, given that Exhibits 1070, 1095, and 1119 were already admitted in their entirety. And in any event, Novartis’ request would not have been proper as part of a motion to exclude. Upon reviewing the Motion, it is clear that Novartis is using its FRE 106 arguments as a vehicle for introducing additional citations to, and discussion of, Dr. Kulke’s testimony that were not introduced in the multiple other opportunities for merits briefing that Novartis had during this trial. For this” slip op. at 28

  Patent outcomesUS 9,006,224 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,006,224
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCNo claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00146 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, and 5 were not shown unpatentable because Nakamura did not disclose the claimed spacer, and Petitioner did not establish a basis to modify it.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “level of skill in the art than that proposed by Petitioner. PO Resp. 11‒12. In particular, Patent Owner disagrees with Petitioner’s requirement for an advanced degree in mechanical engineering or a closely related field as it would, for example, exclude both the named inventors of the ’679 patent as well as “a large majority of active workers in the field at the time of the invention.” Id. at 12 (citing Ex. 2002 ¶ 80). Rather, Patent Owner contends that the person of ordinary skill in the art at the time of the invention would have a Bachelor of Science degree in engineering and at least 3 years of experience working or studying in the field of heat pipes; or an equivalent level of education, training, and work experience. Id. at 11 (citing Ex. 2002 ¶¶ 77‒79). Dr. Pokharna comports with the qualifications a person would have needed to understand and implement the teachings of the ’679 patent and the prior art of record. Cf. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (recognizing that the prior art itself may reflect an appropriate level of skill in the art). Moreover, Petitioner concedes that this dispute as to the appropriate level of skill in the art “is immaterial because the challenged claims are invalid under both sides’ definitions.” Reply 1 n.2. We agree with Petitioner that the outcome of this proceeding is not dependent on our application of one party’s definition as compared to the other. Nonetheless, because Petitioner’s and Dr. Pokharna’s definition better reflects the level of ordinary skill in the art, we adopt and apply it here. C.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “extending between and contacting said first and second plates,” claim 1 separately recites “a depression formed in said first plate,” which projects into said vapor chamber and is bonded to said second plate. PO Resp. 25–26 (emphasis added) (citing Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (“Where a claim lists elements separately, the clear implication of the claim language is that those elements are distinct components of the patented invention.”)); see Ex. 2002 ¶ 114. Whereas claim 1 requires that a spacer contact both the first and second plates, it makes clear (as do claims 4 and 6) that a depression formed in a first plate is bonded to only the opposing plate. See Ex. 1001, claim 7 (reciting that a “depression formed in said second plate . . . is in contact with an inner surface of said first plate”). We, thus, infer from the structure of the recited in claim 1 are distinct components with distinct properties. In particular, the claimed “spacer . . . extending between and contacting said first and second plates” is a distinct element between and in contact with two plates, whereas the claimed “depression” is a part of one plate that contacts, or is bonded to, an opposing plate.” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “whether a reference is a printed publication. Suffolk Techs., LLC v. AOL Inc., 752 F.3d 1358, 1364 (Fed. Cir. 2014). The determination of whether a given reference qualifies as a prior art “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding its disclosure to members of the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). The key inquiry is whether the reference was made “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989); see In re Wyer, 655 F.2d 221, 226 (CCPA 1981). “A given reference is ‘publicly accessible’ upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citation omitted). Bruckelmyer and Wyer specifically addressed the public accessibility of laid open patent applications.” slip op. at 24

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “The relevant language of independent claim 1 is not merely “spacer” but “spacer. . . extending between and contacting said first and second plates,” which we construe as referring to a “structure separate from and in 16 Petitioner also addresses obviousness under the construction of “spacer” that Patent Owner proposed before the district court but that we do not adopt here. See id. at 36–41; section II(C)(2), n.7, above. 17 Petitioner and its expert also reference Nakamura’s Figures 5 and 6, which show embossed depressions in only one plate. Pet. 39–40; Ex. 1002 ¶ 64. Nonetheless, we agree with Patent Owner that “Petitioner’s grounds are based on the concavities 9 described and illustrated with respect to Figure 4 of Nakamura,” and Petitioner’s passing reference to the alternative embodiment of Nakamura’s Figures 5 and 6 does not substantially affect our analysis, which focuses on the embodiment of Figure 4. See PO Resp. 46 (citing Inst. Dec. 15–18). clearance between the plates.” See section II(C)(2), above. Applying this panel’s construction, we agree with Patent Owner that Petitioner has neither shown how Nakamura discloses this limitation, nor identified any rationale or motivation to modify Nakamura to provide a “spacer. . . extending between and contacting said first and second plates,” as recited in claim 1. See PO Resp. 46–47. As discussed above, Petitioner seeks to satisfy this limitation by pointing to the “H-shaped structure” defined by concavities pressed into opposing plates of the heat pipe illustrated in Nakamura’s Figure 4. But as Patent Owner points out, “these concavities are integral with the portions of the container in which they are formed, and a concavity cannot be said to contact the same plate in which it is formed without rendering the term ‘contacting’ in claim 1 meaningless.” Id. (citing Ex. 2002 ¶¶ 116, 145).” slip op. at 35

  Patent outcomesUS 7,100,679 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,100,679
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00337 · APJ Linda E Horner · IPR · Final written decision

  Claims 9, 10, and 13 were held unpatentable as obvious; claims 11 and 12 were not shown unpatentable.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 35

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “inherency, then the assertions of obviousness are mere conclusory statements. We are unable to recognize any proffered reasoning underlying the assertions of obviousness. “[Challenges] on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). As yet another possible alternative, Petitioner may be basing its case on improper hindsight by relying on and quoting the Specification of the ’240 patent in its obviousness analysis. See Pet. 27. That, too, is unpersuasive. Regardless as to its theory of the case, we determine that Petitioner has failed to explain sufficiently why the claimed heat pipe having a configuration of two plates having bonded together circumferential edge lips would have been obvious. Accordingly, Petitioner has not shown by a preponderance of the evidence that claim 12 is unpatentable over Morikawa alone.” slip op. at 55

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 82

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Cooler Masters Co., Ltd. v. Aavid Thermalloy LLCSome claims unpatentable
  PTAB · Jun 4, 2020 · IPR2019-00144 · APJ Linda E Horner · IPR · Final written decision

  Claims 9–12 were not shown unpatentable; claim 13 was shown unpatentable as obvious over Nakamura and Takahashi.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “The existence of a published abstract that would have allowed one skilled in the art exercising reasonable diligence to locate the foreign patent application and the fact that the application was classified and indexed in the patent office, were central to the Wyer court’s conclusion that the application was “publicly accessible.”” slip op. at 36

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

    “made using related processes, however, says nothing about why one of ordinary skill in the art would combine them in a manner that renders the claimed subject matter obvious. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1368 (Fed. Cir. 2012) (quoting Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (“We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.”)). Petitioner’s argument that the references are “similar and analogous” is not adequate reasoning, by itself, to support a conclusion of obviousness.” slip op. at 54

  • ExcludeMotion to exclude, deniedMixed

    “as not relevant under FRE 104 on the grounds that Petitioner failed “to introduce sufficient proof that Exhibit 1004 was publicly accessible such that it qualifies as a prior art printed publication under United States law.” Paper 46, 3; see also id. at 4 (citing Fed. R. Evid. 104, 401). As set forth in section II.D, above, the evidence of record leads us to an entirely different conclusion regarding Nakamura’s prior art status. Because Petitioner persuades us that Nakamura qualifies as a prior art printed publication as of the earliest possible effective filing date of the challenged claims of the ’240 patent, we deny Patent Owner’s request on its merits.” slip op. at 73

  Patent outcomesUS 7,066,240 mixed
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,066,240
• Becton, Dickinson And Company v. Baxter Corporation EnglewoodNo claims unpatentable
  PTAB · Apr 29, 2020 · IPR2019-00119 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–13 and 22 were not shown unpatentable because the asserted obviousness combinations failed to establish required claim elements.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “The parties agree that a person of ordinary skill in the art as of the relevant date would have several years of experience with remote pharmacy work supervision and verification systems and a familiarity with basic pharmacy processes and have been aware of relevant regulations. Pet. 10– 11; PO Resp. 6 (referencing Inst. Dec. 9). As noted by Petitioner, the Board 10 previously applied this definition in an inter partes review of the Alexander reference asserted here. Pet. 10–11 (referencing IPR2015-00883, Paper 29 at 43). As the parties’ undisputed proposed definition is consistent with the cited prior art, we adopt it consistent with our Institution Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–164 (Fed. Cir. 1985)).” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “We address below the two claim terms provisionally construed in our Institution Decision, as well as element [8j], subsequently raised by the parties. No other terms require express construction. See 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.”).” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “Whereas the plain language of element [8j] mandates that each step “must be verified before the operator can continue,” the parties initially appear to disagree about who––or what––is responsible for the verification. Patent Owner contends that element [8j] embodies the concept of a “hard stop,” wherein “the system will not allow the operator to proceed to the next step until the prior step has been verified.” PO Resp. 24; Sur-reply 1. To 14 the extent Patent Owner uses the term “hard stop” as a short hand for the words of element [8j], we agree with this portion of its construction.8 As we further understand Patent Owner’s position, however, verification that a step is properly completed requires input from a remote pharmacist overseeing the operator. See PO Resp. 27 (distinguishing Alexander as not requiring “the remote pharmacist must verify each and every step before the operator is allowed to proceed”). But reading claim 8 (directed to a system) to require a method step performed by a pharmacist would appear to “combine . . . two separate statutory classes of invention.” See IPXL Holdings, L.L.C. v. Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). Moreover, claim 8 makes no mention of a pharmacist and Patent Owner fails to explain adequately why we should import such a limitation from the Specification into the claim. Accordingly, we decline to apply Patent Owner’s construction of element [8j] to the extent it requires input from a remote pharmacist. We, nevertheless, note that in the Sur-reply, Patent Owner indicates that element [8j] may be satisfied where “the workstation . . . captur[es] the image and scan[s] the barcode in order to verify the step has been performed.” Sur-reply 6 (emphasis added).” slip op. at 14

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artReference is prior artMixed

    “issuance of Alexander would evidence prior invention under § 102(g)(2), our governing statute provides that “[a] petitioner in an inter partes review may request to cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C § 311(b). Although Alexander is a printed publication, Petitioner does not seek to use it as such under § 102(g)(2) but, instead, as evidence of prior invention, which is not a legitimate basis for challenge in inter partes review.10 For the above reasons, and as set forth at pages 15–17 of our Institution Decision, Alexander is not available as prior art in this proceeding under 35 U.S.C § 102(g)(2).” slip op. at 22

  Patent outcomesUS 8,554,579 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,554,579
• Trans Ova Genetics, LC v. Xy, LLCNo claims unpatentable
  PTAB · Jun 26, 2019 · IPR2018-00250 · APJ David Cotta · IPR · Final written decision

  Claims 1–16 were not proven unpatentable because Petitioner failed to establish that Lu, relied on in every asserted obviousness ground, was prior art.

  RulingsFinal written decision

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artNot shown unpatentable

    “Inc. v. Apotex Inc., 754 F.3d 952, 968 (Fed. Cir. 2014); In re Katz, 687 F.2d 450, 454 (Fed. Cir. 1982). “The question of whether a reference is a work of others for the purposes of § 102(a) is, like that of inventorship, a question of law based on underlying facts.” Allergan, 754 F.3d at 969 (citing Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998)). In determining whether a reference is the work of the named inventor(s), the inquiry focuses on whether the relevant content of the reference – which includes “the design, trial, and analysis of results” – was solely the work of the inventor(s). See Allergan, 754 F.3d at 969; Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 1356 (Fed. Cir. 2003) (“What is significant is not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity.”).” slip op. at 14

  • Expert testimonyPatent owner expert creditedOther

    “9 We acknowledge that Mr. Miles, as a former board member of XY, as well as XY’s long-time patent counsel and the filer of the ’769 priority provisional applications, may have some interest in the outcome of this IPR and that Mr. Miles is being compensated by XY for time spent relating to his testimony. Ex. 2003 ¶¶ 4–7; Ex. 1033, 21:7–14, 158:8–22. However, we note that Mr. Miles’ testimony was under oath and subject to cross-examination. We find Mr. Miles’ testimony to be credible as to the facts for which it is cited herein.” slip op. at 10

  • ExcludeMotion to exclude, deniedMixed

    “Exclude. Paragraph 12 of the Miles Declaration reads as follows: “Also[,] in the late 1990s, XY had a collaborative research agreement with a bull stud called Cogent in the United Kingdom.” Ex. 2003 ¶ 12.11 This statement is not itself hearsay because it was asserted by Mr. Miles while testifying in this proceeding, i.e., “at the current trial.” See Fed. R. Evid. 801(c). Petitioner contends that paragraph 12 is inadmissible because it is based, at least in part, on statements contained in Exhibits 2001 and 2002. We are not persuaded by this argument because paragraph 12 does not rely on Exhibits 2001 and 2002. See Ex. 2003 ¶ 12; Ex. 1033, 59:22–62:18 (Mr. Miles’ testimony on basis and meaning of paragraph 12 of his declaration). Petitioner also argues that paragraph 12 should be excluded as improper opinion testimony because it is based on Exhibits 2001 and 2002, to which, according to Petitioner, Mr. Miles is not competent to testify. Mot. 13–14. We are not persuaded by Petitioner’s argument because, as discussed, paragraph 12 does not rely on Exhibits 2001 and 2002.” slip op. at 22

  Patent outcomesUS 8,652,769 not shown unpatentable
  § 102 anticipation
  Patents in suitUS 8,652,769
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01374 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable because Kurrle and Queen 1990 were not prior art …

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “with respect to the ’213 patent. See Pet. 12–13; Prelim. Resp. 17–18; PO Resp. 17–18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 10–11. Petitioner does not contest this definition in its Reply and we find no reason to revise our earlier determination. We further note that the prior art itself demonstrates this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings on ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “Patent Owner’s proposed construction derives from the ’213 patent’s definition of consensus sequence as “refer[ing] to an amino acid sequence which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Ex. 1001, 11:32–38. In the context of the patent as a whole, however, we do not understand the term to require a consensus of “all” human immunoglobulins in the literal sense because the embodiments in the patent were generated using the most common residue at each position identified in Kabat 1987.11 See id. at 10:34–63, 11:55–60; Ex. 2016 ¶¶ 25– 26. And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. See PO Resp. 47. Moreover, at oral argument, Patent Owner did not contest Petitioner’s assertion that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” Tr. 15:4–16:4.12 Accordingly, we adopt the parties proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

  • Prior constructionDecided for patent owner

    “We previously stated that the language of claim 63, “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” IPR2017-01488, Paper 27 at 10–12. Patent Owner does not dispute this interpretation. See PO Resp. 19. Petitioner argues that the recited reduction in immunogenicity is both an inherent aspect of the claimed humanized antibodies, and “the stated goal of all humanization projects, including that of Queen 1990 and Kurrle.” Pet. Reply, 28, 43. Petitioner also contends that the term is not a claim limitation and “simply a statement of the intended result of the claimed compositions,” but, nevertheless, states: “For the purpose of the present petition only, Petitioner will assume that the preambles are limiting.” Pet. 13 n.3. On balance, we see no need to alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody. Nevertheless, to the extent Petitioner is correct that the preambles should be accorded no weight, such a determination would not alter the outcome of this proceeding.” slip op. at 15

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

    “The ’213 patent issued from application number 08/146,206 (“the ’206 application”), which is an application that entered the national stage on November 17, 1993, from a PCT application filed on June 15, 1992. Ex. 1001, (21), (22), (86). The ’206 application is also a continuation-in-part of the ’272 application, filed on June 14, 1991. Id. at (63). Kurrle was published on December 19, 1990 (Ex. 1071, (43)), and Queen 1990 was published on July 26, 1990 (Ex. 1050, (43)), both of which predate the earliest possible priority date, June 14, 1991, shown on the face of the ’213 patent. Accordingly, Petitioner has satisfied its initial burden of showing that Kurrle and Queen 1990, on their face, qualify as prior art to the challenged claims. We next consider whether Patent Owner has antedated these references.” slip op. at 18

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-01373 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 are unpatentable; claims 65, 72, 75–77, and 79 are not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedOther

    “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 10 (citing Pet. 12; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Id. at 10–11. During trial, the parties did not dispute this finding. Having considered the complete record developed at trial, we see no reason to change our assessment. We further note that, in this case, the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Dec. 7; Ex. 1001, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. Indeed, counsel for Patent Owner acknowledged that the term refers to “all reasonably available[,] all known at the time of the invention.” Tr. 47:21–48:5. Dr. Wilson, the expert witness for Patent Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 207 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1140, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1142, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1142, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1140, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1142, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”). Thus, although we reiterate our previous construction of “consensus” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “combination of Queen 1989 and the PDB database, together with the knowledge of an ordinary artisan, teaches or suggests each limitation of claims 12, 63, 66, 67, 71, 73, 74, and 78, and that a person of ordinary skill in the art would have had a reason to combine the references, and would have had a reasonable expectation of producing humanized antibodies with the substitutions and properties recited in those claims. We further determine that evidence of secondary considerations is not sufficient to outweigh the strong evidence of obviousness associated with the other Graham factors. As a result, we conclude that Petitioner has established by a preponderance of the evidence that claims 12, 63, 66, 67, 71, 73, 74, and 78 are unpatentable over Queen 1989 and the PDB database.” slip op. at 37

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,407,213
• Celltrion, Inc. / Pfizer, Inc. v. Genentech, IncAll claims unpatentable
  PTAB · Oct 3, 2018 · IPR2017-02063 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–14 are unpatentable as obvious over Baselga 1996, Seidman 1996, and the 1995 TAXOL PDR entry; the contingent motion to amend is denied for lack of written-description support.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner

    “Id. The applicant responded that [T]he expression[] “extend the time to disease progression”. . . [is] clear from the specification . . . and would be readily understood by the skilled oncologist. Clearly, the combination of anti-ErbB2 antibody and taxoid is administered in an amount effective to extend the time to disease progression relative to an untreated patient. Id. at 416 (Response dated January 17, 2002) (emphasis added). In the next office action, the examiner withdrew the rejection. See Ex. 1004, 624 (Office Action dated March 27, 2002) (stating “[a]ll claims were allowable” but suspending prosecution due to potential interference). In other words, the applicant overcame the indefiniteness rejection by providing a specific definition of the term “extend the time to disease progression;” and our construction merely reflects that choice. See Paulsen, 30 F.3d at 1480 (holding an applicant may choose to be his own lexicographer).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Even if we were to disregard Petitioner’s reliance on the four principles of combination therapy, we still would find an ordinary artisan would have had a reason to combine trastuzumab and paclitaxel for metastatic HER2-positive breast cancer. Indeed, as detailed below, the prior art repeatedly and explicitly teaches this combination. Baselga 1996 teaches that “rhuMAb HER2 is well tolerated and” slip op. at 20

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “Patent Owner further argues that Yu13 discourages the use of taxoids in HER2-positive patients. PO Resp. 42. According to Patent Owner, Yu explicitly warns that “breast cancers that overexpress p185 [i.e., HER2] will not respond well to Taxol.” Id. (citing Ex. 2029, 1362). Yu drew that conclusion, however, based on an in vitro study, using cell lines growing on culture plates. Ex. 2029, 1360–62. On this issue, we agree with Dr. Earhart and Petitioner that an ordinary artisan “would have regarded the in vivo preclinical and clinical results reported in Baselga-1996 and Seidman-1996, which were obtained from studies of actual tumor cells in live animals and human patients, as being far more predictive than Yu’s results, which were obtained in artificially-engineered cells on culture plates.” Reply 6 (citing Ex. 1054 ¶ 17); see also Ex. 1040, 222:11–224:9 (Dr. Kerbel, Patent Owner’s expert witness, testifying that a living animal model, though imperfect, is “closer” to a human and “better than a petri dish”). Moreover, in an obviousness inquiry, we must analyze the prior art as a whole, not individually. See In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004). Other evidence of record shows paclitaxel was known at the relevant time to be effective in treating HER2-positive cancers (see, e.g., Ex. 1011), demonstrates “strong synergy” of paclitaxel and an anti-ErbB2 antibody in human breast cancer xenografts (see, e.g., Ex. 1010,14 5; Ex. 1019, 4; 13 Yu et al., Overexpression of c-erbB-2/neu in Breast Cancer Cells Confers Increased Resistance to Taxol Via mdr-1-independent Mechanisms, 13 ONCOGENE 1359–65 (1996) (Ex. 2029). 14 Seidman et al., Memorial Sloan-Kettering Cancer Center Experience with Paclitaxel in the Treatment of Breast Cancer, 22 SEMINARS in ONCOL. (Suppl.) 108–16 (1995) (Ex. 1010, “Seidman 1995”) Ex. 1021,15 3), and suggests clinical trials of the claimed combination therapy (see, e.g., Ex. 1010, 5; Ex. 1020, 9). Weighing all evidence of record, we are not persuaded that Yu, a single reference based on an in vitro study, would have dissuaded an ordinary artisan from combining paclitaxel and an anti-ErbB2 antibody in treating HER2-positive cancers. See also MTA Sur-reply 6 (citing Ex. 1043,16 6–9 (noting a review paper regarding paclitaxel sensitivity in breast cancer does not cite Yu, but “cites Seidman ’96, Baselga ’96 and the Baselga xenograft studies as suggesting that HER2+ tumors are sensitive to paclitaxel, and that combining trastuzumab with paclitaxel increased its antitumor activity”).” slip op. at 24

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “For objective evidence of secondary considerations to be accorded substantial weight, its proponents must establish a nexus between the evidence and the merits of the claimed invention.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011). Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.” Id. We find that the nexus between the merits of the invention and the evidence of long-felt-butunmet need, praise, and commercial success, if any, is weak. Patent Owner asserts that Herceptin is the commercial embodiment of the ’441 patent. PO Resp. 65. For commercial success, “if the marketed product embodies the claimed features, and is coextensive with them, then a nexus is presumed.” Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000). The patent challenger, however, may rebut the presumed nexus. Id. And here, Petitioner has sufficiently rebutted that presumption. For example, each challenged claim in this proceeding requires the combination of an anti-HER2 antibody and a taxoid. Herceptin, however, was also approved for single-agent use. Reply 25 (citing Ex. 2012). Patent Owner has not shown what portion of the sales of Herceptin is attributable to the claimed combination, and not the single-agent use.29 Id. Furthermore, “evidence related solely to the number of units sold slip op. at 41

  Patent outcomesUS 7,846,441 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,846,441

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.