• Candela Corporation v. Nikolai TankovichNo claims unpatentable
  PTAB · Jun 5, 2024 · IPR2023-00234 · APJ Sheridan K Snedden · IPR · Final written decision

  The Board held claims 1–28 not shown unpatentable because the asserted combinations did not establish simultaneous delivery of overlapping and non-overlapping laser beams.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Pet. 19; Ex. 1002 ¶ 77. Patent Owner does not dispute this proposed level of skill, but offers that a “POSA may have alternatively held a degree in electrical engineering.” PO Resp. 10; Ex. 4–10, 13, 15–17. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record, and also consider Patent Owner’s additional proposal. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed patent owner constructionDecided for patent owner

    “In this case, the Specification is devoted to the teaching simultaneous delivery of multiple laser beams. The Specification begins by stating that “[t]here are no lasers or laser handpieces on the market today that can simultaneously deliver two or more wavelengths of laser energy in spacial, fractional form.” Ex. 1001, 1:12–14. The Specification explains that “laser treatment usually requires different modalities of energy in order [to] successfully treat the pathologies to which they are applied,” but that “the sequential application of multiple wavelengths of laser energy compromises the treatment.” Id. at 1:16–25. The Specification then continues to explain various problems associated with the sequential application of multiple wavelengths. Id. at 1:25–52. The Specification concludes its introduction as follows: What is needed in the art therefore is an effective laser therapy system that can simultaneously deliver multiple wavelengths of laser energy through the use of a single laser unit without producing interference between the wavelengths within the treated tissue.” slip op. at 13

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

    “summarized above, we find Patent Owner to have the better position. In particular, we agree with Patent Owner that the combination of Hsia and Black fail to teach or suggest simultaneously delivering non-overlapping beams. The combination also fails to teach or suggest producing beam patterns that include both overlapping and non-overlapping beams. PO Resp. 34. To begin, while we recognize that Hsia discloses overlapping and non-overlapping treatment patterns, those patterns are achieved by the sequential delivery of laser beams as a user physically moves a single handpiece that delivers a single beam across the skin of a patient. Ex. 1004 ¶ 68, Figs. 8 and 9; Ex. 2001 ¶¶ 73–74. Black does not cure that deficiency as Black does not disclose treatment with non-overlapping beams. Ex. 2001 ¶ 99. Black discloses using a “refractive optics, mirror-based optical delivery device” for the simultaneous delivery of multiple overlapping laser beams. Ex. 1006 ¶¶ 12– 13. The beams align on an optical path and, using different laser beam parameters, deliver treatment at various depths within a combined beam path. Id. ¶¶ 54, 58–59. Thus, while Black may be characterized as creating overlapping beams, we do not find sufficient support for a finding that Black teaches or suggests creating non-overlapping beams for simultaneous delivery, and the claims require both. We also do not find sufficient support for Petitioner’s claim that a POSA would have found it obvious to combine Black and Hsia to simultaneously produce both overlapping beams and nonoverlapping beams, based on the disclosures in these references. See, e.g.,” slip op. at 31

  • BurdenFwd all claims patentableNot shown unpatentable

    “Claims Claims Not 35 U.S.C. § Reference(s)/ Claims Shown Shown Basis Unpatentable Unpatentable 1–28 103 Hsia, Black 1–28 Hsia, Black, 23 103 23 Negus Hsia, Black, 27, 28 103 27, 28 Altshuler Altshuler, 1–28 103 1–28 Black Altshuler, 23 103 23 Black, Negus Overall Outcome 1–28 IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has not shown by a preponderance of the evidence that claims 1–28 of the ’481 patent are unpatentable; and” slip op. at 41

  Patent outcomesUS 10,675,481 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,675,481
• Restem, LLC. v. Jadi Cell, LLCNo claims unpatentable
  PTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision

  Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38

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

    “Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64

  Patent outcomesUS 9,803,176 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,803,176
• Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentable
  PTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision

  The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert discountedOther

    “It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that 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 11

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

    “C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner

    “Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16

  Patent outcomesUS 10,561,659 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,561,659
• Aurobindo Pharma USA, Inc.No claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,866,866
• Mylan Pharmaceuticals Inc. / Wockhardt Bio AG et al. v. Astrazeneca ABNo claims unpatentable
  PTAB · Aug 18, 2017 · IPR2015-01340 · APJ Rama G Elluru · IPR · Final written decision

  Petitioners failed to prove claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 unpatentable under the instituted §103 grounds, chiefly because the proposed modifications lacked a reasonable expectation of success.

  RulingsFinal written decision

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “C. Credibility of the Experts We give more weight to the testimony of Patent Owner’s expert, Dr. Weber, over that of Petitioners’ expert, Dr. Rotella, with respect to testimony that is in direct conflict. We favor Dr. Weber’s testimony because of her extensive experience in the design and development of DP 4 inhibitors for type-2 diabetes treatment. See Ex. 2056 ¶¶ 9–12; Ex. 2210, 1– 2. Moreover, Dr. Weber entered the DP 4 field at the relevant time, i.e., the time of invention, around 2000. Ex. 1073, 108:16–21; Tr. 35:16–22. We find that her testimony has been consistent, not just throughout this proceeding, but also with evidence predating this proceeding. See, e.g., Ex. 2056 ¶¶ 88, 115–118; 154–162; Ex. 1073, 51:2–54:14, 113:6–16, 119:19– 121:9; Ex. 2161, 558.” slip op. at 9

  • Skill levelSkill level board ownOther

    “The parties’ formulations as to the level of ordinary skill in the art are similar, and neither side identifies with specificity an error in the opposing side’s formulation. See PO Resp. 21; Pet. Reply 10. On the record presented, we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either side’s proposed formulation.” slip op. at 8

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

    “On the full record before us, we determine that Petitioners have not demonstrated by a preponderance of the evidence that a skilled artisan would have chosen Ashworth I’s compound 25 as a “lead compound.” Although Ashworth I indicates that compounds 24–29 were non-toxic in T cell assays up to 72 hours, and further indicates compound 25 was one among four compounds that were comparable to boroprolines, no further data is provided to guide the skilled artisan to select compound 25 among the other 2-cyanopyrrolidides as a lead compound for further modification to develop a DP 4 inhibitor. Ex. 1007, 1165–66. More importantly, the data reported in Ashworth I was based on in vitro data at room temperature, not in vivo data. PO Resp. 25 (citing Ex. 2174, 82:23–83:11). Indeed, Dr. Rotella states, “those studies were carried out at room temperature, which is roughly 20 degrees [Celsius]. I’ll point out that body temperature is higher than that, and that temperature has a direct effect on half-life. As you elevate temperature, you can expect half-life to decrease.” Ex. 2174, 82:23-83:11. Dr. Rotella further admits that he is not aware of any disclosure describing testing of Ashworth compounds in humans. Ex. 2174, 60:23-61:9. In addition, Ashworth I acknowledged that these compounds exhibited an intramolecular cyclization problem and that further work on optimization of the pyrrolidine ring was necessary and would be reported shortly. Ex. 1007, 1163–65. Others in the prior art also continued to seek solutions to the problem of intramolecular cyclization, such as those posed by Ashworth I compounds. See PO Resp. 27–28.” slip op. at 16

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

    “(4) No Reasonable Expectation of Increasing Stability We are not persuaded that the skilled artisan would have had a reasonable expectation of success in achieving increased stability of Ashworth I’s compound 25 based on Hanessian I’s teachings concerning the cyclopropanation of proline. See Pet. 29. There was no disclosure in the prior art of cylopropanating the pyrrolidine ring of compound 25, or any similar compound. Indeed, Dr. Rotella admitted “that there wasn’t anything in the literature prior to the invention of saxagliptin that actually suggested that cyclopropanation of an Ashworth-One type DPP4 inhibitor would improve its stability.” Ex. 2174, 142:3-9. In addition, there is not sufficient evidence as to how the modified cyano-moiety would have been understood to affect compound 25’s stability. Given the structural differences, we find there is insufficient evidence suggesting that the skilled artisan could have reasonably predicted how cyclopropanating compound 25’s P1 group (as opposed to the proline compound discussed in Hanessian I) would have affected the cyano moiety’s (as opposed to the substituent in Hanessian I) orientation in space. Furthermore, there is insufficient evidence as to whether that modified orientation would have sufficiently decreased intramolecular cyclization. Indeed, Dr. Rotella testified that: [I]n the process of that modification of orientation in space [when you fuse two rings together], you may observe effects on potency, you may observe effects on solution stability, you may observe other effects on other properties that one might measure in connection with a drug discovery project. Ex. 2174, 119:10–120:2. When asked, “[a]nd those effects might be either positive or negative; correct?” Dr. Rotella replied, “[t]hey might be, yes.” Ex. 2174, 120:3–5. Dr. Rotella also testified that at the time of the invention, the objective of adding a cyclopropyl substituent to the pyrrolidine ring of compound 25 would have been exploratory. He testified: Q. Well, what is the objective of putting the cyclopropane on the molecule, in your opinion? A. There are two possible objectives based on the data -- there are at least two possible objectives based on the data available surrounding compound 25. Q. And what are they? A. One would be to explore whether or not you could improve potency. A second would be whether or not you could improve solution stability. One might also explore how that -- those changes, either by themselves or in combination with two changes, might also improve or change -- sorry -- to improve solid-state stability. Furthermore, since nothing is known, at least at this point in time, about other properties associated with compound 25, you’d want to understand what those properties were and adjust them as need be. Generally speaking, those properties are things that we call, collectively, pharmaceutical properties. Ex. 2174, 115:11–116:13 (emphasis added). This testimony does not sufficiently support Petitioners’ contention that a skilled artisan would have reasonably expected cyclopropanating the pyrrolidine ring of compound 25 to increase its stability.” slip op. at 26

  Patent outcomesUS RE44,186 not shown unpatentable
  § 103 obviousnesscites KSR · Graham
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision

  Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “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.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundMixed

    “Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32

  • Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner

    “Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135
• EMC Corporation v. Acqis LLCNo claims unpatentable
  PTAB · Mar 8, 2016 · IPR2014-01462 · APJ Robert J Weinschenk · IPR · Final written decision

  Claims 54 and 56–61 were not shown unpatentable because the evidence did not establish that the cited references rendered the claimed PCI transaction communication obvious.

  RulingsFinal written decision

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

    “construction in the Decision on Institution. The evidence indicates that the term “Peripheral Component Interconnect (PCI) bus transaction” refers to a particular industry standard, not just any communication with an interconnected peripheral component. Industry literature and dictionaries use the proper noun “Peripheral Component Interconnect” and the abbreviation “PCI” to refer to a particular industry specification for a local bus. See, e.g., Ex. 2001, 1; Ex. 2002, 6–7; Ex. 2003, 7–8. The challenged claims recite “Peripheral Component Interconnect” as a proper noun and abbreviate it as “PCI,” indicating that the challenged claims use those terms consistent with the understood industry meaning. Ex. 1001, col. 43, ll. 48–49, col. 44, l. 6; see Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1348 (Fed. Cir. 2014). The written description similarly uses the abbreviation “PCI” to refer to a particular industry standard, and uses the common noun “peripheral bus” to refer to a generic peripheral bus. Compare Ex. 1001, col. 5, ll. 31–33 (“The present invention . . . interface[s] two PCI or PCI-like buses”), with id. at col. 10, ll. 53–55 (“Additionally, the peripheral controller is coupled to a clock control logic, a configuration signal, and a peripheral bus.”) (emphasis added).” slip op. at 6

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

    “obvious over Horst and LVDS Owner’s Manual; claims 56 and 59 would have been obvious over Horst, LVDS Owner’s Manual, and Pocrass; and claim 58 would have been obvious over Horst, LVDS Owner’s Manual, and Deters. Pet. 58–59. A claim is unpatentable as obvious 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 the invention was made to a person having ordinary skill in the art to which the subject matter pertains. 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) any objective indicia of non-obviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). We have considered the parties’ arguments and supporting evidence, and we determine that Petitioner has not shown by a preponderance of the evidence that claims 54 and 56–61 would have been obvious over the cited references.” slip op. at 7

  • ExcludeMotion to exclude, deniedMixed

    “Owner argues that paragraphs 10–24 and 31–37 of Exhibit 1031 should be excluded as irrelevant and prejudicial because Petitioner relies on those paragraphs to support improper arguments in the Reply. PO Mot. 8. Petitioner argues in the Reply that the TNet transaction in Horst includes PCI address bits, and that claim 54 only requires communicating two bits of a PCI bus transaction. PO Mot. 1. Patent Owner contends that both arguments exceed the scope of a proper reply, as set forth in 37 C.F.R. § 42.23(b), and that the portions of Exhibit 1031 that Petitioner relies upon to support those arguments should be excluded as irrelevant and prejudicial. PO Mot. 2–4, 6, 7. Patent Owner’s argument is not persuasive. Patent Owner argues in the Response that the TNet transaction in Horst does not include PCI address bits. PO Resp. 27–29. As such, Petitioner’s argument in the Reply that the TNet transaction includes PCI address bits is responsive to an argument raised in the Response. See 37 C.F.R. § 42.23(b) (generally permitting a reply to respond to arguments raised in a response). Patent Owner also argues in the Response that claim 54 requires communicating a 32-bit PCI address. PO Resp. 8–11. As such, Petitioner’s argument in the Reply that claim 54 only requires communicating two bits of a PCI bus transaction is responsive to an argument raised in the Response. Because we are not persuaded that the identified arguments in the Reply are improper, the premise of Patent Owner’s Motion to Exclude Exhibit 1031 fails. Therefore, Patent Owner’s Motion to Exclude paragraphs 10–24 and 31–37 of Exhibit 1031 is denied.” slip op. at 16

  Patent outcomesUS 8,041,873 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,041,873
• EMC Corporation v. Acqis LLCNo claims unpatentable
  PTAB · Mar 8, 2016 · IPR2014-01469 · APJ Robert J Weinschenk · IPR · Final written decision

  Claims 24 and 31–33 were not shown unpatentable because Petitioner failed to prove obviousness over either asserted reference combination, including failure to establish Bogaerts as prior art.

  RulingsFinal written decision

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

    “Interconnect (PCI) bus transaction” to mean “a data signal communication with an interconnected peripheral component.” Pet. 13. Patent Owner agrees with the construction in the Decision on Institution that the claim term “Peripheral Component Interconnect (PCI) bus transaction” means “Peripheral Component Interconnect (PCI) industry standard bus transaction.” PO Resp. 21–22. We see no reason now to deviate from the construction in the Decision on Institution. The evidence indicates that the term “Peripheral Component Interconnect (PCI) bus transaction” refers to a particular industry standard, not just any communication with an interconnected peripheral component. Industry literature and dictionaries use the proper noun “Peripheral Component Interconnect” and the abbreviation “PCI” to refer to a particular industry specification for a local bus. See, e.g., Ex. 2001, 1; Ex. 2002, 6–7; Ex. 2003, 7–8. The challenged claims recite “Peripheral Component Interconnect” as a proper noun and abbreviate it as “PCI,” indicating that the challenged claims use those terms consistent with the understood industry meaning. Ex. 1001, col. 27, ll. 24–25, col. 28, ll. 35–36; see Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1348 (Fed. Cir. 2014). The written description similarly uses the abbreviation “PCI” to refer to a particular industry standard, and uses the common noun “peripheral bus” to refer to a generic peripheral bus. Compare Ex. 1001, col. 19, ll. 31–33 (“the present invention may interface two PCI or PCI-like buses”), with id. at col. 7, ll. 4–6 (“Additionally, the host controller is coupled to a clock control logic, a configuration signal, and a peripheral bus.”) (emphasis added). Petitioner and Petitioner’s declarant, Mr. Bruce Young, acknowledge that the term “Peripheral Component Interconnect (PCI)” refers to an industry standard. Ex. 1003 ¶ 58; Ex. 2006, 1, 3; Ex. 2031, 16:8–12. The evidence Petitioner identifies in support of its proposed construction is the claim construction order issued in ACQIS LLC v. Appro International, Inc., No. 6:09-cv-00148 (E.D. Tex. Feb. 3, 2011). Pet. 12–13 (citing Ex. 1013). In that case, though, the parties did not appear to dispute that the term “Peripheral Component Interconnect (PCI)” refers to an industry standard. See Ex. 1013, 7 (“The parties’ primary dispute is whether the term is limited to the conventional, parallel PCI Local Bus, and, therefore excludes PCI Express bus architecture and bus transaction protocol.”). Moreover, the district court subsequently reconsidered its construction and clarified that the term “PCI bus transaction” refers to a PCI industry standard bus transaction. Ex. 1030, 8–10. Therefore, we construe the claim term “Peripheral Component Interconnect (PCI) bus transaction” to mean “Peripheral Component Interconnect (PCI) industry standard bus transaction,” and we construe the claim term “PCI bus transaction” to mean “PCI industry standard bus transaction.”” slip op. at 6

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

    “Horst outputs address and data bits of a PCI bus transaction in serial form over the TNet links. Pet. 31–34. Petitioner’s argument is not persuasive. The TNet processor interface in Horst translates a CPU transaction into a TNet transaction. Ex. 1009, 5 (“The interface to the destination CPU or I/O device provides mapping and validation hardware translating this virtual TNet address to the appropriate physical memory address.”), Figs. 5, 7; Ex. 2021 ¶ 94 (“The TNet Processor Interface generates TNet transactions from CPU front-side bus transactions.”). The TNet processor interface then encodes the TNet transaction using an 8B/9B encoder so that it can be output over the 9-bit serial TNet links. Ex. 1003 ¶¶ 48, 146; Ex. 1009, 3, Figs. 3, 4 (showing “8B/9B encoder”), Table 1; Ex. 2021 ¶ 105. Petitioner does not identify persuasive evidence indicating that either the CPU transaction or the TNet transaction is a PCI industry standard bus transaction. Pet. 31–34 (citing Ex. 1009, 3–8, Figs. 2, 3, 5, 7–9, Table 1; Ex. 1003 ¶¶ 159[24C(i)], 159[24C(iv)], 159[24C(v)], 159[31B(i)], 159[31B(iii)]); Ex. 2021 ¶ 129. Thus, the evidence identified in the Petition does not indicate that the information output by the TNet processor interface over the TNet links includes address and data bits of a PCI industry standard bus transaction in serial form. Petitioner points out that, after a TNet transaction is communicated over the TNet links, a TNet bus interface in the console may use information in the TNet transaction to create a PCI industry standard bus transaction if a particular I/O device is connected to a PCI bus. Pet. 31–32 (citing Ex. 1009, 7, Fig. 8). But claims 24 and 31 require more than just communicating information over serial channels that subsequently might be used in the console to create a PCI industry standard bus transaction. Claims 24 and 31, when read in light of the specification, require that the information actually communicated over the serial channels includes address and data bits of a PCI industry standard bus transaction in serial form. Ex. 1001, col. 20, ll. 60–65, col. 21, ll. 15–21, col. 27, ll. 34–38, col. 28, ll. 34–39; Ex. 2022, 15:12–16:2, 22:11–16. As discussed above, the evidence identified in the Petition does not indicate that the information output by the TNet processor interface over the TNet links includes address and data bits of a PCI industry standard bus transaction in serial form.” slip op. at 11

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “The evidence identified by Patent Owner indicates that the date “2 October 1996” on Bogaerts is when it was submitted to the CERN/LHCC committee. Ex. 2021 ¶¶ 170, 171, 173; Ex. 2026, 12. Although it is possible that Bogaerts was available in the CERN Library at or around the same time, Petitioner has not shown that by a preponderance of the evidence. For example, Petitioner does not cite persuasive evidence indicating that the “Submitted by 2 Oct 1996” entry in the CERN Document Server record means that Bogaerts was available in the CERN Library on that date. Tr. 23:1–12, 25:5–25; Pet. Reply 21–25. In addition, Petitioner acknowledges that the CERN Document Server record itself was not created until December 18, 2014. Tr. 25:5–25; Ex. 2011, 439. Therefore, Petitioner has not shown sufficiently that Bogaerts is a prior art printed publication based on its availability in the CERN Library.” slip op. at 17

  • ExcludeMotion to exclude, deniedDenied

    “should be excluded for lack of authentication under Fed. R. Evid. 901. PO Mot. 2–6. Federal Rule of Evidence 901 requires that the proponent produce evidence sufficient to support a finding that an item is what the proponent claims it is. Here, Patent Owner does not dispute that Exhibit 1011 is what Petitioner claims it is, namely a reference entitled “RD24 Status Report: Application of the Scalable Coherent Interface to Data Acquisition at LHC.” Id. What Patent Owner disputes is whether Petitioner has shown by a preponderance of the evidence that Bogaerts is prior art with respect to the ’814 patent. Id. Patent Owner attempts to characterize this dispute as a question of authentication, arguing that Petitioner has not produced “evidence that [Exhibit 1011] is a true and correct copy of a publication that was publicly available as of the date asserted by Petitioner.” Id. at 3. But this is a question of sufficiency of proof, not admissibility. Therefore, Patent Owner’s Motion to Exclude Exhibit 1011 is denied.” slip op. at 20

  Patent outcomesUS RE42,814 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
• Kaiser Aluminum v. Constellium Rolled Products Ravenswood, LLCNo claims unpatentable
  PTAB · Nov 2, 2015 · IPR2014-01002 · APJ Jo-Anne M Kokoski · IPR · Final written decision

  Claim 10 was not shown unpatentable under § 103 over Balmuth1, the Starke Reference, or ’662 Balmuth combined with ’910 Pickens.

  RulingsFinal written decision

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

    “Claim Interpretation We interpret claims of an unexpired patent using the “broadest reasonable construction in light of the specification of the patent in which [the claims] appear[].” 37 C.F.R. § 42.100(b). Under this standard, claim terms are given their ordinary and customary meaning in view of the specification, as would be understood by one of ordinary skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For purposes of our Decision to Institute, we determined that the terms in the challenged claims did not need to be construed expressly, and we see no reason to modify that determination in light of the record developed at trial. B.” slip op. at 4

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

    “Given the complexities involved in developing a thick plate composition from a thin sheet, and the breadth of potential applications within the aerospace industry, we determine that Mr. Balmuth and Dr. Starke fail to provide sufficient reasoning as to why one of ordinary skill in the art would have attempted to manufacture thick plates having the claimed properties from the thin sheets described in the prior art. See, e.g., InTouch Techs., Inc. v. VGO Commc’ns, Inc., 751 F.3d 1327, 1348–49 (Fed. Cir. 2014) (holding expert testimony to be impermissible hindsight for failing to explain what reason or motivation one of ordinary skill in the art at the time of the invention would have had to place the prior art together). In an obviousness determination, we must avoid analyzing the prior art through the prism of hindsight. Instead, we must “cast the mind back to the time the invention was made” and “occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.” W.L. Gore & Assoc., Inc. v. Garlock, 721 F.2d 1540, 1553 (Fed. Cir. 1983). Here, Petitioner attempts to imbue one of ordinary skill in the art with knowledge of the claimed invention, when there is insufficient evidence of record to convey or suggest that knowledge. Rather, Petitioner’s arguments that a person having ordinary skill in the art would have only needed to use routine experimentation to manufacture a thick plate alloy having the claimed properties appears to be premised on Petitioner’s knowledge of the ’509 patent itself. See, e.g., Pet. 20 (“In this case, the ’509 patent confirmed that the chemistry in the Balmuth1 reference relating to sheet material could be used for plate products without adjusting the chemistry to arrive at the beneficial strength and toughness properties using merely routine testing procedures.”). Petitioner’s contentions that it would have been obvious to try to manufacture thick plates having the claimed properties and that “one of ordinary skill in the art had a ‘good reason to pursue the known options within his . . . technical grasp’” to do so similarly are insufficient. See Pet. 22; id. at 21–24. The Federal Circuit has held that “a finite number of identified, predictable solutions” may support an inference of obviousness, but “[t]o the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these ‘identified, predictable solutions’ may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.” Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008) (citing KSR, 550 U.S. at 421 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has a good reason to pursue known options within this or her technical grasp.”)). As set forth above, we credit Dr. Pickens’s testimony that designing a thick plate alloy product having the claimed properties from a thin sheet alloy product would be costly and unpredictable. Accordingly, Petitioner has not shown sufficiently that a person having ordinary skill in the art would have considered it obvious to try to manufacture a thick plate composition with the properties recited in claim 10 of the ’509 patent.” slip op. at 15

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

    “In an obviousness determination, we must avoid analyzing the prior art through the prism of hindsight. Instead, we must “cast the mind back to the time the invention was made” and “occupy the mind of one skilled in the art who is presented only with the references, and who is normally guided by the then-accepted wisdom in the art.” W.L. Gore & Assoc., Inc. v. Garlock, 721 F.2d 1540, 1553 (Fed. Cir. 1983). Here, Petitioner attempts to imbue one of ordinary skill in the art with knowledge of the claimed invention, when there is insufficient evidence of record to convey or suggest that knowledge. Rather, Petitioner’s arguments that a person having ordinary skill in the art would have only needed to use routine experimentation to manufacture a thick plate alloy having the claimed properties appears to be premised on Petitioner’s knowledge of the ’509 patent itself. See, e.g., Pet. 20 (“In this case, the ’509 patent confirmed that the chemistry in the Balmuth1 reference relating to sheet material could be used for plate products without adjusting the chemistry to arrive at the beneficial strength and toughness properties using merely routine testing procedures.”). Petitioner’s contentions that it would have been obvious to try to manufacture thick plates having the claimed properties and that “one of ordinary skill in the art had a ‘good reason to pursue the known options within his . . . technical grasp’” to do so similarly are insufficient. See Pet. 22; id. at 21–24. The Federal Circuit has held that “a finite number of identified, predictable solutions” may support an inference of obviousness, but “[t]o the extent an art is unpredictable, as the chemical arts often are, KSR’s focus on these ‘identified, predictable solutions’ may present a difficult hurdle because potential solutions are less likely to be genuinely predictable.” Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353, 1359 (Fed. Cir. 2008) (citing KSR, 550 U.S. at 421 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has a good reason to pursue known options within this or her technical grasp.”)). As set forth above, we credit Dr. Pickens’s testimony that designing a thick plate alloy product having the claimed properties from a thin sheet alloy product would be costly and unpredictable. Accordingly, Petitioner has not shown sufficiently that a person having ordinary skill in the art would have considered it obvious to try to manufacture a thick plate composition with the properties recited in claim 10 of the ’509 patent.” slip op. at 16

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “to be persuasive. In order to rely on inherency to establish the existence of a missing claim limitation in an obviousness analysis, “the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharma., Inc. v. TWI Pharmas., Inc., 773 F.3d 1186, 1195–96 (Fed. Cir. 2014). Neither Mr. Balmuth’s nor Dr. Starke’s statements regarding the inherent properties of a thick plate with the same chemistry as a thin sheet are supported by sufficient objective evidence or analysis demonstrating that the claimed properties would necessarily be present in the thick plate. Mr. Balmuth and Dr. Starke simply state that such a thick plate would inherently have the properties necessitated by the chemistry involved, without providing sufficient and credible explanations as to why that would be the case. See Ex. 1006 ¶ 13; Ex. 1008 ¶ 32. Mr. Balmuth, for example, states that “it is generally understood that the strength and fracture toughness properties of a plate are less than those of a sheet having similar chemistry,” but that “one of ordinary skill in the art would predict improved properties for a plate upon a showing of improved properties in a sheet having similar chemistry,” and does not expound upon the reasons why a person skilled in the art would understand that to mean that the thick plate would display the same mechanical properties as the thin sheet. See Ex. 1006 ¶ 14. Based upon the evidence presented, we find that the opinions of Mr. Balmuth and Dr. Starke are not persuasive as they are not supported by the evidence of record. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (stating a lack of objective support for an expert opinion “may render the testimony of little probative value in [a patentability] determination”). Patent Owner, in contrast, provides reasoning as to why a person having ordinary skill in the art would not have understood that a thick plate would have similar properties to a thin sheet having the same chemistry. PO Resp. 13–14, 34–35, 37–40, 42–44. For example, Patent Owner notes that since according to Mr. Balmuth you ‘don’t have the ability’ or ‘any interest’ in measuring toughness in the S-T direction in sheet, Petitioner has not established that the strength and toughness properties in sheet would necessarily be predictive of the strength and toughness properties of plate, such as described in Claim 10. Id. at 14. Dr. Pickens also testified to the complexities involved in developing thick plate aluminum-lithium alloys: For example, quench sensitivity, stress-corrosion cracking resistance, in plane anisotropy, through thickness heterogeneity, and lower short transverse fracture toughness are a few factors that make developing thick plate aluminum-lithium alloys very complicated. Furthermore, lithium lowers the thermal conductivity of aluminum which is problematic in several areas. Heat is more difficult to extract during direct-chill casting thereby exacerbating metallurgical segregation problems. Hot rolling can break down segregation, such as heterogeneous segregations at grain boundaries, so that it may be less harmful, although there is a practical limit on how thick aluminum alloy rolling ingot can be cast. The reduction ratio, i.e. scalped ingot thickness to final product gauge, is an important real-world processing variable when developing a thick plate aluminum lithium alloy. Ex. 2043 ¶ 11; see also PO Resp. 16–17 (discussing the “recognition in the art of complex differences between sheet and thick plate”). Patent Owner further notes that Dr. Pickens testified “that he would not have been motivated to add Mn in the claimed amount to an Al-Cu-Li-Mg-Ag alloy with a thickness of at least about 3 inches, or scale up a sheet alloy to the” slip op. at 11

  Patent outcomesUS 7,229,509 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 7,229,509

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.