- Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00874 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was unpatentable, failing to show Bansal's claimed light intensity arrangement.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An obviousness determination requires finding both ‘that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.’” CRFD Research, Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017) (quoting Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367– 68 (Fed. Cir. 2016)). Obviousness grounds must be supported with “articulated reasoning with some rational underpinning” and not by “mere conclusory statements.” See KSR Int’l Co., 550 U.S at 418. slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“agree with Patent Owner that Petitioner has not sufficiently shown for institution that Bansal teaches or suggests arranging light sources “such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges,” as required by the challenged claims. Instead, Petitioner demonstrates how Bansal describes varying the density of light source distribution throughout the array to provide a higher density of light in the entire peripheral area of the array, which includes the areas proximal to both the first and second edges, as compared to the central area of the array. See Pet. 36–37; Ex. 1005 ¶ 25. In this regard, Petitioner relies on Bansal’s Figure 9b, asserting that it “shows one embodiment where more light sources are placed near the edges of the panel compared to the light sources in the center.” Pet. 36–37. The comparison of Bansal’s light density between the entire periphery and the central area of the array is insufficient. What is missing from Petitioner’s argument and discussion of Bansal is how Bansal teaches or suggests a configuration that provides a higher density of light proximate to the second shorter edges of the periphery in comparison to the remaining areas of the array, which includes the first longer edges of the periphery. Without that discussion, we find that Petitioner has not shown sufficient for institution that Bansal is persuasively relied upon for the light source arrangement limitation of the challenged claims. likelihood of prevailing in its obviousness challenge of independent claims 1, 5, 16, 20, or 21, or dependent claims 2, 4, 6–8, and 17–19 over Larsen, Bansal, and Jones.” slip op. at 17
- Skill levelOther
“would have had at least a Bachelor of Science in electrical engineering, physics, biomedical engineering, computer engineering, chemical engineering, material science, or a related scientific or engineering field, and at least one year of work or research experience in optics, optoelectronics, radiometry, photometry, photodynamic diagnosis (PD), photodynamic therapy (PDT), phototherapy (PT), or a related field. Pet. 8. Petitioner asserts that, alternatively, a “POSITA in the relevant time frame would have had at least four years of industry or academic experience in optics, optoelectronics, radiometry, photometry, PD, PDT, PT, or a related field.” Id. (citing Ex. 1003 ¶ 37). According to Patent Owner, a person of ordinary skill in the art at the time the application for the ’028 patent was filed, “would have had a M.D. and/or a Ph.D. in an electrical engineering, physics, optical sciences, optical engineering, or a related scientific or engineering field, and at least one to two years of work or research experience in optical engineering, optics, optoelectronics, phototherapy (‘PT’), PDT, or a related field.” Prelim. Resp. 16. Patent Owner asserts that, “[a]lternatively, a POSITA could have a Bachelor’s degree in one of the above areas and at least three to four years of work or research experience in that area.” Id. (citing Ex. 2001 ¶¶ 30–31). We note that the parties’ proposed definitions are largely similar. To the extent that the proposed definitions differ, we do not need to resolve those differences as our findings and conclusion in this Decision would be the same under any of the proposed definitions.” slip op. at 9
§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,697,028 - Dr. Reddy’S Laboratories, Inc. v. Genentech, Inc., Hoffman-La Roche AG, And Abbvie Inc.No claims unpatentablePTAB · Apr 16, 2024 · IPR2023-00052 · APJ Jeffrey N Fredman · IPR · Final written decision
The Board held claims 1–4, 8–14, and 18–26 not shown unpatentable because they were entitled to priority before the November 2018 Venclexta Label, which therefore was not prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“We do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner did not expressly recite hematological malignancies, Petitioner did refer to expertise in clinical oncology, which would encompass the blood cancers recited in the claims. Neither party identifies a difference in the analysis or conclusions that would be based on differences in the ordinary skill in the art analysis. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not identify any issue relating to the preamble that would impact our analysis. We recognize that Patent Owner is suggesting that Petitioner’s expert, at least, is reading the word “clinical” into the treatment language of claim 1. However, the plain language of the claim 1 preamble states “treating lymphoma or leukemia in a human patient” and is supported by a straightforward definition in the Specification of the ’087 patent, expressly limiting the invention to treatment of human patients. See Ex. 1001, 16:25–38. We therefore find that the preamble terms do not need claim construction because there is no actual dispute suggesting that, for example, claim 1 implicitly recites the term “clinical.” See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledEntitled to earlier dateDecided for patent owner
“d. Analysis Considering the Wands factors as a whole, we find that the limited breadth of the claims, presence of several working examples, significant amount of direction and guidance provided by the ’087 patent, predictability in treating blood cancers with Bcl-2 inhibitors like GDC-0199, and high level of skill in the art are balanced against a large quantity of experimentation. Based on our consideration of the entirety of the evidence, we find that a preponderance of the evidence supports the conclusion that undue experimentation would not have been required to make and use the invention commensurate in scope with the claims of the ’087 patent. One underlying theme of Petitioner’s contentions and Petitioner’s expert testimony is the repeated contention that clinical trials were not completed by Patent Owner. See, e.g., Pet. 48 (“venetoclax (GDC-0199) was not FDA-approved”); Ex. 1020 ¶ 193. We find these arguments unpersuasive as we agree with Patent Owner that “[i]t is well established that a patent may be secured, and typically is secured, before the conclusion of clinical trials.” In re Montgomery, 67 F.3d 1375, 1382 (Fed. Cir. 2012). Particularly as to the dependent claims, a preponderance of the evidence of record does not support a finding that undue experimentation would have been required to administer three different doses of GDC-0199 starting with 100 mg, to use multiple daily dosing cycles of one day, to continue until disease progression occurs, or to combine with other treatment compounds. We find that a preponderance of the evidence does not support Petitioner’s position that any of the dependent claims fail to comply with the enablement requirement.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner
“Applying Rai and Wertheim to the instant facts, we agree with Patent Owner that, factually and legally, in the ’087 patent “the claimed dosages of 100 mg, 200 mg, and/or 400 mg of GDC-0199 are adequately supported.” PO Second Suppl. Brief 2 (citing PO Resp. 11, 27–29; PO Sur-reply 19, 21– 22; Ex. 1001, 24:20–29.) In particular, the ’087 patent describes all three specific dosage values 100 mg, 200 mg, and 400 mg in the context of an escalating drug dosage series and Petitioner points to no persuasive statements in the specification that dispute either the effectiveness or the operability of GDC-0199 at any of these dosages.” slip op. at 32
Patent outcomesUS 11,110,087 not shown unpatentableClaim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 11,110,087 - PTAB · Oct 12, 2023 · IPR2023-00614 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–3, 6–18, 21–24, and 27–29 on all asserted grounds, finding a reasonable likelihood of obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Patent Owner has not persuaded us to exercise our discretion to deny institution. Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, 8. We focus our analysis on Ducharme, one of the primary references asserted in the Petition. Although Ducharme was “not before the Office during examination of the [’]895 Patent,” Patent Owner asserts that it is cumulative to a reference that “was presented to the Office during examination by IDS.” Prelim. Resp. 42–43. Patent Owner does not point to, and we have not found, any evidence showing discussion or application of the previously presented reference by the Examiner during prosecution of the ’895 patent or its related patents. In other words, “the record of the Office’s previous consideration of the art is not well developed or silent.” Advanced Bionics, 10. In such situations, “a petitioner may show the Office erred by overlooking something persuasive.” Id.; see also id. at 8 n.9 (“An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.”). On this record, Petitioner has shown sufficiently that the Examiner overlooked Ducharme’s teachings of the limitations that were the basis for allowing the challenged claims. Indeed, the Examiner allowed the challenged claims, stating that the closest prior art references lack the teachings of the emitted light being suitable for the commercial image recording when the emitted light is simultaneously at least 1000 lumens when either the first or the second LEDs are lit, is broad-spectrum white light having a color deviation corresponding to less than 5 points of both green and magenta of color compensation, and has a color rendering index of light emitted from each of the first or the second LEDs (whichever is lit) that is greater than 90. Ex. 1002, 150. Petitioner’s evidence indicates that Ducharme teaches an LED light suitable for commercial image recording that includes a plurality of first white LEDs having a first spectrum and a plurality of second white LEDs having a second spectrum. See, e.g., Ex. 1005, 4:1–7. Petitioner’s evidence also indicates that a person of ordinary skill in the art would have had reason to select first white LEDs with a daylight spectrum and second white LEDs with a tungsten spectrum. See, e.g., Ex. 1003 ¶ 449; Ex. 1006 ¶ 53. Further, Petitioner’s evidence indicates that LEDs satisfying the light quality parameters recited in the challenged claims were known to those of ordinary skill in the art. See, e.g., Ex. 1003 ¶ 480; Ex. 1005, 25:36–43; Ex. 1007, 7:11–15; Ex. 1008, 4:1–3. Thus, the evidence cited in the Petition demonstrates that the Office” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 14; Prelim. Resp. 14. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LEDs.” Pet. 14 (citing Ex. 1003 ¶ 32). Patent Owner does not dispute Petitioner’s definition of the skill level at this stage of the proceeding. Prelim. Resp. 13. For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,566,895 - PTAB · Oct 10, 2023 · IPR2023-00611 · APJ Christopher L Crumbley · IPR · Institution
The Board instituted IPR on claims 1, 3, 4, 7–13, 23, 25, 26, 28, 29–39, and 41–45 on all asserted grounds, finding a reasonable likelihood of success over Mueller, Ansems, and Simon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2022). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“whether the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. Central to this analysis is factor (c) of Becton, Dickinson, which “focuses on the record developed by the Office in previously reviewing the art or arguments.” Id. at 10. In cases where the Office raised a specific teaching of a reference during prosecution, and the petitioner disagrees with that specific finding of record, “then ordinarily the petitioner’s required showing of material error must overcome persuasively that specific finding of record.” Id. On the other hand, we are often presented with circumstances such as those found in the present case, where the prior art that was previously presented to the Office was not substantively remarked upon or applied in a rejection of the claims. This often occurs in the context of art submitted on an IDS, which is the manner in which the majority of the references identified by Colt in this case were incorporated into the file history. Ex. 1002, 216 (Kit, Ducharme ’261, Mueller ’029), 217 (Katzir). Only Simon” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Skill Quasar asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 16 (citing Ex. 1003 ¶¶ 32–33). Colt does not dispute Quasar’s characterization of the level of skill, arguing that “the proposed level of ordinary skill does not affect the ultimate analysis.” Prelim. Resp. 15. At this stage of the proceeding, we adopt Quasar’s definition of the level of skill in the art, which is consistent with the disclosure of the ’224 patent and asserted prior art of record. If the parties disagree with our preliminary finding, they are invited to further brief the issue of level of ordinary skill in the art and, in particular, which disputed issues material to patentability turn on the definition adopted by the Board.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“35 U.S.C. § 282(b), as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and its progeny. See 37 C.F.R. § 42.100(b) (2022). Under this standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. See Phillips, 415 F.3d at 1312–13. Both parties agree that the terms of the claims of the ’224 patent should be given their ordinary and customary meaning, but neither party further elaborates on what those meanings are for any particular claim term. Pet. 16–17; Prelim. Resp. 15. We interpret the parties’ positions to be that no claim term of the ’224 patent requires express construction for purposes of deciding whether to institute trial. Upon review of the record and the parties’ arguments, we agree. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only 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))).” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,197,224 - PTAB · Oct 10, 2023 · IPR2023-00613 · APJ Robert J Weinschenk · IPR · Institution
Instituted IPR on claims 1–3, 6–14, 16–19, 21–24, and 26–31 on all petitioned grounds; petitioner showed a reasonable likelihood of prevailing on obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain. Pet. 47–75. For the reasons discussed below, Petitioner demonstrates a reasonable likelihood of prevailing in showing that claims 1–3, 6–14, 16–19, 21–24, and 26–31 would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 13 (citing Ex. 1003 ¶ 32). Petitioner’s description of the level of ordinary skill in the art is supported by the testimony of Petitioner’s declarant, Mr. Fred Holmes. Ex. 1003 ¶ 32. Patent Owner does not dispute Petitioner’s description at this stage of the proceeding. Prelim. Resp. 12. We adopt Petitioner’s description for purposes of this Decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction In an inter partes review proceeding, a patent claim is construed using the same standard used in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of the claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Neither party proposes an express construction for any claim terms at this stage of the proceeding. Pet. 13; Prelim. Resp. 12–14. We determine that no claim terms require express construction for purposes of this Decision.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 10,411,582 - Cisco Systems, Inc. v. Ramot At Tel Aviv University, Ltd.No claims unpatentablePTAB · Oct 3, 2023 · IPR2022-00576 · APJ Monica S Ullagaddi · IPR · Final written decision
Claims 13, 14, and 23–29 were not shown unpatentable as obvious over Roberts and Taraschuk, with or without Wright, because the asserted combinations did not teach or suggest the claimed delta features.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not discern a substantial difference between the parties’ definitions for the level of ordinary skill in the art. Instead, we determine that the parties’ definitions are substantially similar. We adopt Petitioner’s definition of the level of skill in the art, which is consistent with the disclosure of the ’872 patent and asserted prior art of record. The findings and conclusions rendered in this Decision would not change had we adopted Patent Owner’s definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not construe any claim term in our Decision in order to resolve the issues before us. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for terms that are in dispute, and only as necessary to resolve the controversy).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“for a LUT having the recited deltas except for Dr. Blumenthal’s analysis. Although Wright generally teaches compensating for mismatches, Dr. Blumenthal’s analysis fills in limitations 13.8 and 13.9––Petitioner does not set forth a sufficiently supported reason for using the specific values recited in limitations 13.8 and 13.9. At best, Petitioner presents an “obvious to try rationale”: In addition to the reasons mentioned above, a POSITA would have found it obvious to try a mapping scheme in which entries in the look-up table as taught by Taraschuk are selected such that successively decreasing inputs correspond to digital output entries with either decreasing, increasing, or similar deltas between their values. . . . Doing so would have involved choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. In that regard, the deltas between values of the corresponding digital outputs can either increase, decrease, or stay the same. Accordingly, there are only three possible relationships between deltas of successive digital outputs. With so few possibilities, a POSITA would have found it obvious to try each of them. Pet. 59 (citing Ex. 1003 ¶ 265). The analysis for 13.8 is incorporated by reference in 13.9. See Pet. 60. Although there are three possible relationships between two, consecutive deltas, there are many possible sequences of deltas––Petitioner does not sufficiently show a finite number of solutions in its challenge.” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner’s argument that the portions of Taraschuk in column 7, lines 61–67 and column 8, lines 13–15 cited by Petitioner in its challenge to claim 13 teach “an end-to-end approach” “because that calculation involves predistortion of the input M-bit word by subtracting a digitized analog sample of the ultimate output,” and as such, teach “[a]n approach that necessarily does one combined correction for all of the nonlinearities that occur in-between those ends—whether bit mismatches in the digital logic or non-linearities in the Mach-Zehnder modulator.” PO Sur-reply 18 (citing PO Resp. 30–36; Ex. 2018 ¶¶ 48, 49, 85–87, 89, 103; Ex. 1006, 7:34–39, 7:61–67). We further agree with Patent Owner’s assertion that [Patent Owner] and Prof. Dallesasse are not suggesting that Dr. Blumenthal should model the logic-level mismatches. But rather pointing out that calculating an idealized sinusoidal response in isolation is not obvious (or flowing naturally) from a reference that can only deal with compensating the combined response of the modulator and digital logic mismatches together—via real-time pre-distortion fed back from the ultimate output and subtracted from the input. Dallesasse testifies that Dr. Blumenthal starts with the premise that all that is required is deriving a complementary function to the sinusoidal response. . . . But this ignores that the disclosure of Taraschuk describes compensating “the sinusoidal response of the modulator” and “logic level mismatches through the D/A converter” together. . . . Dr. Blumenthal’s complementary sinusoidal correction curve won’t do that. The combined non-linearity from the multiple sources likely won’t simply be evenly sinusoidal. Taraschuk does not disclose, or in my opinion render obvious, any pre-calculation solution. (Taraschuk mentions a real-time analog feedback loop to pre-distort, which would not involve pre-calculation.) And it certainly does not suggest one that could deal with the combined and likely complex non-linearities described.” slip op. at 28
Patent outcomesUS 11,133,872 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,133,872 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “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(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Cisco Systems, Inc. v. Ramot At Tel Aviv University, Ltd.No claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00575 · APJ Monica S Ullagaddi · IPR · Final written decision
Claims 1–12, 15–22, and 30 were not shown unpatentable under § 103 over Roberts and Taraschuk because the combination did not teach or suggest the claimed mapping.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Inst. Dec. 25–26 (citing Ex. 1006, 8:2, 8:8, 6:61–65; Ex. 1003 ¶ 147; Prelim. Resp. 46). Based on our review of the complete record developed during trial, we are persuaded to modify our preliminary determinations. For the reasons discussed below, we are persuaded that the scope of claim 1 does not encompass linear compensation methods effected by analog pre-distortion because the ’872 patent specification distinguishes analog pre-distortion (see Ex. 1001, 1:55–2:34) and the prosecution history specifically distinguishes analog pre-distortion from the claimed approach (see Ex. 1002, 172). We find persuasive Dr. Dallesasse’s testimony that “a person of ordinary skill in the art reading the [’872] patent would understand that th[e] [claimed] approach differs from pre-distortion based on real-time measured analog modulator output.” Ex. 2018 ¶ 33 (citing-in-part Ex. 1001, 2:3–7 (’872 patent disclosing common, prior art solutions such as “an analog predistortion circuit to feed the modulator”)); see also Ex. 1001, (the ’872 patent describing the need for a “digital to analog converter” that would “improve[] linearity of response without sacrificing efficiency or dynamic range” as in the common, prior art solutions). Dr. Dallesasse explains how “the prosecution history of the ’872 patent [illustrates] that when [Patent Owner] changed ‘correct for non-linearities’ to the more specific language ‘determined based on a pattern for actuating drive voltages that alters the linearity of an optical response of the modulator,’” “the Examiner then allowed the claims over a rejection based on Roberts, which “suggests that there are ways to ‘correct for non-linearities’ that do not meet the amended Ex. 2009, 2; Ex. 2003). During prosecution, Patent Owner argued: Roberts does not disclose a “digital-to-digital mapping,” where, “for a given plurality of N digital input data bits, the mapping to the corresponding M digital output data bits is determined based on a pattern for actuating drive voltages that alters the linearity of an optical response of the modulator,” as recited in amended claim 1. Instead, the linear compensation in Roberts is performed pursuant to a compensation function c(t) when the Vx(n) multi-bit sample streams are generated. Importantly, this linear compensation in Roberts occurs before the mapping of Vx(n) to Sx(n). As a result, the mapping between Vx(n) to Sx(n) in Roberts, such as the mapping shown in Table 1 of Roberts, is not a part of the linear compensation operation performed in Roberts. Ex. 1002, 172 (emphasis added). We interpret the quoted passage to exclude analog pre-distortion because we interpret the argument distinguishing Robert’s compensation as happening “before the mapping” to refer to pre-distortion techniques––in particular, those accomplished by analog compensation function, c(t). Id. Both the ’872 patent and Patent Owner’s arguments during prosecution support Dr. Dallesasse’s testimony and Patent Owner’s position that the scope of claim 1 does not encompass linear compensation methods effected by analog pre-distortion.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“mapping is based on an analog feedback loop, by . . . quoting from the reference and leaving out the very next sentence” has merit. Sur-Reply 8 (citing Pet. Reply 23). Petitioner does not sufficiently address the cited teachings and in particular, Taraschuk’s teachings of calculating a difference between a “sampled analog output signal (S) and corresponding M-bit word” to a calculate a mapping “required to obtain the desired output analog signal level.” Ex. 1006, 7:34–39. We are persuaded Petitioner does not sufficiently rebut Patent Owner’s contention that Roberts’ and Taraschuk’s teachings of linear compensation are implemented by analog pre-distortion. Petitioner cannot ignore these teachings of Taraschuk and consider only the portions that support its challenge. See Pet. Reply 17 (citing Pet. 43–45; Ex.1006, 7:56–60) (“Patent Owner’s emphasis on Taraschuk’s digital feedback loop is also misplaced because the Petition simply relied on Taraschuk’s linearizer 44 as a discrete, known device for performing non-linear compensation of a Mach-Zehnder modulator.” (emphasis added)). Petitioner cannot set forth the teachings of Taraschuk in such a piecemeal sufficiently explain why the converter of Taraschuk relies on analog pre-distortion, or explain why analog pre-distortion is encompassed by the invention recited in independent claim 1, Petitioner does not sufficiently carry its burden.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableNot shown unpatentable
“Second, Petitioner concludes that “a POSITA would have found it obvious to map input bits to output bits within the look-up table such that the output bits correspond to voltage values to be transmitted to electrodes of an optical modulator,” but offers no support other than Robert’s teaching that the DSP’s output is a multi-bit parallel binary signal. See id. at 51 (citing Ex. 1005, 6:40–42). That is, the sole basis for Petitioner’s conclusion that it would have been obvious to perform the claimed method is that the output is the same. Id. This is impermissible hindsight. Third, Petitioner essentially argues that a person would have found it obvious to perform the mapping because Taraschuk teaches a look-up table and non-linear compensation. Id. at 51–52. Yet the claim recites how the mapping is performed, which is left unaddressed by Petitioner. Id. That is, Petitioner has not shown where Taraschuck teaches mapping a given number look-up table, so that the output bits compensate for the non-linear effects of the optical modulator. Id. at 52. Rather, Petitioner provides a piecemeal analysis that uses the ’872 patent’s specification as a blueprint to pull together a look-up table, non-linear compensation, and a modulator to arrive at the claimed invention. See id. Thus, all three rationales for limitation 1.9 are deficient. See PO Resp. 27.” slip op. at 30
- Skill levelSkill level petitioner adoptedOther
“We do not discern a substantial difference between the parties’ definitions for the level of ordinary skill in the art. Instead, we determine that the parties’ definitions are substantially similar. We adopt Petitioner’s definition of the level of skill in the art, which is consistent with the disclosure of the ’872 patent and asserted prior art of record. The findings and conclusions rendered in this Decision would not change had we adopted Patent Owner’s definition.” slip op. at 8
Patent outcomesUS 11,133,872 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,133,872 - Hope Medical Enterprises, Inc. v. Fennec Pharmaceuticals, Inc.No claims unpatentablePTAB · Sep 1, 2023 · IPR2022-00125 · APJ Julia Heaney · IPR · Final written decision
The Board granted the revised noncontingent motion to amend, canceled claims 18 and 20, and entered substitute claims 28 and 29, which were not proven obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner, relying on the testimony of Dr. Rogers, contends that a person of ordinary skill in the art would have [had] a bachelor’s degree or equivalent in any of the pharmaceutical sciences with at least 5 years of experience in solid state chemistry; a master’s degree in any of the pharmaceutical sciences with at least 3 years of experience in solid state chemistry; or a Ph.D. in any of the pharmaceutical sciences with 1 year of experience in solid state chemistry. Pet. 8 (citing Ex. 1008 ¶¶ 24–28). Petitioner further states that such “[a] person could also have qualified as a [person of ordinary skill in the art] with some combination of (1) more formal education and less technical or professional experience or (2) less formal education and more technical or professional experience.” Id. Patent Owner does not dispute Petitioner’s proposed definition of a person of ordinary skill. See generally MTA, RMTA. Having considered the parties’ arguments and evidence, we adopt the level of ordinary skill in the art proposed by Petitioner, because it is consistent with the disclosures of the ’363 patent and the prior art of record. We note, however, that neither party contends that the outcome of this case would differ based on our adoption of any particular definition of a person of ordinary skill in the art.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“In our Preliminary Guidance, we construed “for a pharmaceutical composition” to mean “in combination with pharmaceutically acceptable excipients,” based on the ’363 patent’s definition providing that “[t]he terms ‘formulation’ or ‘pharmaceutical composition’ as used herein refers to the drug in combination with pharmaceutically acceptable excipients.” Prelim. Guid. 5–6 (citing Ex. 1001, 12:26–28; Ex. 2010, 17:11–12; Ex. 2011, 26:26– 27). We also encouraged the parties to address whether “for a pharmaceutical composition,” which appears in the preamble of substitute claims 28 and 29, is limiting, as opposed to a statement of intended use or purpose. Id. at 6. Following our Preliminary Guidance, the parties submitted further arguments concerning the term “for a pharmaceutical composition.” Patent Owner argues the term requires that the claimed process provide STS that is sufficiently pure for use in a pediatric patient (see RMTA 8–11) and that the word “drug” in the ’363 patent’s definition of “pharmaceutical composition” requires that the anhydrous STS is of sufficient purity for pharmaceutical use. Reply RMTA 3. Petitioner argues that the construction set forth in our Preliminary Guidance was correct. See Sur-reply RMTA 2–3. Having considered the arguments and evidence, we do not further construe the term “for a pharmaceutical composition” in this Decision because, as discussed in our analysis of obviousness below, it is not necessary to construe the term in order to determine whether Petitioner has met its burden of demonstrating by a preponderance of the evidence that proposed substitute claims 28 and 29 are unpatentable. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only 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))).” slip op. at 13
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, grantedGranted
“1. Reasonable Number of Substitute Claims A motion to amend must “propose a reasonable number of substitute claims.” 35 U.S.C. § 316(d)(1)(B); see 37 C.F.R. § 42.121(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are cancelled, i.e., a one-to-one substitution for a total of two substitute claims. MTA 2; RMTA. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4; see 37 C.F.R. § 42.121(a)(3). Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner proposes a reasonable number of substitute claims. 2. Support in the Original Disclosure Patent Owner has identified written description support in the originally filed disclosure of the ’363 patent for the new limitations added for the proposed substitute claims. See RMTA 5–8. We have reviewed Patent Owner’s assertions of support in the original disclosure for the proposed revised substitute claims and determine that sufficient support exists. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 3. Respond to a Ground of Unpatentability “A motion to amend may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial.” 37 C.F.R. § 42.121(a)(2)(i). Patent Owner asserts that the proposed revised substitute claims are patentable over the combination of references that forms the basis of the obviousness ground on which we instituted trial. RMTA 12–13. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement. 4. Scope of the Claims Patent Owner asserts that the proposed revised substitute claims do not enlarge the scope of original claims 18 and 20. RMTA 5. We have reviewed Patent Owner’s assertion that the purity amendments of proposed revised substitute claims 28 and 29 narrow the claims’ scope. Id. Petitioner does not argue otherwise. See generally Opp. RMTA. Therefore, we determine that Patent Owner has met this requirement.” slip op. at 17
- BurdenNot shown unpatentable
“determine the evidence relied on by Petitioner does not support Petitioner’s position that a person of ordinary skill in the art would have been motivated to combine Levenson, Sherman, Edwards, and USP. Petitioner’s contention that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman is based on Dr. Rogers’s testimony that “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151; see Pet. 36, 38. Dr. Rogers further testified it would have been obvious to add Edwards’s dehydrating step to the preparation of STS pentahydrate “which is obtained following the teachings of Levenson and Sherman” because “Edwards itself discloses dehydrating [STS] pentahydrate.” Id. ¶ 154. The Petition included these arguments even though they were inconsistent with Petitioner’s previous statement, during the Sherman prosecution, that Levenson taught STS heptahydrate, and therefore “does not provide any teaching with respect to [STS] pentahydrate.” Ex. 2013, 97. This prior inconsistent statement undercuts Petitioner’s rationale for combining Levenson, Sherman, and Edwards in this proceeding. Moreover, Petitioner’s rationale for combining the references in this proceeding is inconsistent with its statements about Levenson during the Sherman prosecution. Recognizing this inconsistency, Petitioner now takes the position that the Petition and Dr. Rogers’s testimony were incorrect. Paper 32; see Tr. 21:14–22:7, 59:1–2 (reemphasizing that “Petitioner maintains the statements that it made in the Sherman prosecution regarding Levenson”). Petitioner attempts to rationalize the inconsistency between its statements in the Sherman prosecution (including that “Levenson does not provide any teaching with respect to [STS] pentahydrate”) and its position in this proceeding by arguing that Dr. Rogers relies on Levenson as teaching surface activation “regardless of any particular hydrates Levenson discloses.” Tr. 22:8–9. That argument is not persuasive, because Dr. Rogers’s declaration clearly states the primary reason for his opinion that it would have been obvious to a person of ordinary skill in the art to combine the teachings of Levenson with Sherman: “[b]oth references disclose synthesis of sodium thiosulfate pentahydrate.” Ex. 1008 ¶ 151. Contrary to Petitioner’s argument, Dr. Roger’s reliance on the surface activation teachings of Levenson is because he believes that both references pertain to STS pentahydrate; the surface activation teachings are not stated as an independent reason to combine the references. Id. Petitioner provides no further explanation of how a person of ordinary skill in the art would have been motivated to combine Levenson’s teachings regarding manufacture of STS heptahydrate with Sherman’s and Edwards’s teachings regarding STS pentahydrate, or how a person of ordinary skill would have regarded the difference between STS hydrates. Dr. Rogers’s acknowledgement of stability differences among STS hydrates highlights the insufficiency of Petitioner’s showing in this regard. See Ex. 2005, 35, 39. Having changed its position at the close of trial and having effectively withdrawn Dr. Rogers’s testimony as to similarities between Levenson and” slip op. at 24
Patent outcomesUS 10,792,363 not shown unpatentableClaim constructioncites KSR · GrahamPatents in suitUS 10,792,363
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.