• 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
• Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyNo claims unpatentable
  PTAB · Dec 22, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Final written decision

  Claims 1–15 were not shown unpatentable as obvious over Cohen, Shire, and Carpenter because Petitioner did not establish a reasonable expectation of success.

  RulingsFinal written decision

  • Expert testimonyPetitioner expert creditedOther

    “suggests a trial-and-error approach to protein formulation. See Ex. 2011 (“Very often, proteins have to be evaluated individually and stabilized on a trial-and-error basis.”). Thus, we credit Dr. Staples’s testimony regarding the use of trial-and-error optimization because it appears that this was a known approach for formulating proteins. We do not agree that because the approach was known, it was necessarily expected to be successful. Petitioner cites to the statement in Carpenter that the authors were “quite confident” the generalized high throughput formulation procedure they describe “can be coupled successfully with high throughput screening strategies of protein drugs and facilitate drug development within the inherent time and resource constraints of the pharmaceutical industry.” Ex. 1004, 195. We note that, although in isolation Carpenter’s proclamation of being “quite confident” appears to demonstrate a reasonable expectation of success, when considered in context it refers to a general trend in the industry, not to the ability to formulate specific proteins. The full statement does not indicate that there was confidence that any particular drug could be successfully formulated as a liquid. Thus, this evidence is not persuasive.” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation foundNot shown unpatentable

    “parties, we determine, on balance, that Petitioner has not established sufficiently that an ordinary artisan would have had a reasonable expectation of success in formulating CTLA4Ig as a stable liquid formulation as recited in the challenged claims. Specifically, in the challenge to Patent Owner’s claims, Petitioner relies on Carpenter to show that an ordinarily skilled artisan would have known how to prepare a stable liquid formulation of CTLA4Ig for subcutaneous administration. Pet. 33–40. The statements in Carpenter are the most significant evidence of whether there would have been an expectation of success in achieving the claimed formulation. But Carpenter expressly states that “[i]t [could] be assumed that most proteins will not exhibit sufficient stability in aqueous solution to allow a liquid formulation to be developed.” Ex. 1004, 188; PO Resp. 16. Carpenter also states that although a stable liquid formulation is desirable, “for most proteins maintaining physical and chemical stabilities in aqueous solution for an extended period of time is extremely difficult.” Ex. 1004, 184. These statements indicate that there would not have been a reasonable expectation of success in achieving the claimed formulations. Dr. Staples’s testimony about routine trial-and-error optimization does not overcome these statements. Petitioner’s citation to Paborji (Ex. 1016) does not persuade us otherwise. Even though Paborji states that CTLA4Ig in phosphate buffer is “relatively stable,” without testimony to explain how this would be interpreted by a skilled artisan, the strong doubt about success expressed in Carpenter is not overcome.” slip op. at 13

  Patent outcomesUS 8,476,239 not shown unpatentable
  § 103 obviousnesscites KSR
  Patents in suitUS 8,476,239
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2016-00283 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–12 were not shown unpatentable because Par failed to establish that the prior art would have motivated a skilled artisan to dose based on about 60% conversion.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on 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 skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Horizon, on the other hand, contends that a person of ordinary skill in the art would have the following qualifications: (a) An M.D. or equivalent degree; (b) At least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics; and (c) At least five years of experience treating patients with nitrogen retention disorders, including UCDs. Corr. PO Resp. 26. Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “First, regardless of whether one of ordinary skill in the art would have understood Brusilow ’91 to teach 80% to 90% conversion, or something closer to 100% conversion, we credit Dr. Sondheimer’s testimony that one of ordinary skill in the art would have sought out prior art references “discuss[ing] the conversion of PAA to PAGN” (Ex. 1002 ¶ 42) if only “[b]ecause Brusilow ’91 involved a single subject and observed a range of conversion rates” (id. at 43). As for the parties’ diametrically opposed views on whether Dr. Brusilow preselected all three doses administered to the patient, or adjusted the dose in Period III to account for the 90% conversion observed in Period II (see Ex. 1012, Table 1), we find we need not resolve the controversy, because, even if we accept that the dose in Period III was adjusted based on the results in Period II, it would not change our ultimate disposition of the case.” slip op. at 27

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012
• Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentable
  PTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision

  Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on 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 skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9

  • Expert testimonyDecided for petitioner

    “several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10

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

    “encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11

  Patent outcomesUS 8,642,012 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 8,642,012

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.