- Mara Renewables Corporation v. DSM IP Assets, B.V.Institution deniedPTAB · Apr 18, 2024 · IPR2024-00070 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–15 were anticipated by Radianingtyas or obvious over either asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 314, 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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“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). Under this standard, we construe the claim term “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.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (holding that the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application”). 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 construe any claim term.” slip op. at 6
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not provide a definition of the level of ordinary skill in the art. See Prelim. Resp. 19. Patent Owner also states that any differences between the parties’ proposed definition of the skill level would not impact its arguments. Id. 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 level of ordinary skill at the relevant time. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“triglyceride, DHA, and heptadecanoic acid content recited therein. In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements arranged as in the claim.” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quotation marks omitted). A reference, however, can anticipate a claim “even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017) (quotation marks and brackets omitted). As explained below, here, Petitioner has not shown Radianingtyas discloses a microbial oil comprising the required triglyceride, DHA and heptadecanoic acid content. Specifically, although the exemplified strain ONC-T18 produces oil that meets the claimed triglyceride fraction and heptadecanoic acid level, Petitioner has not shown the same oil contains the recited DHA level.” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 8,207,363 - Zimvie, Inc. / Zimmer Biomet Spine, Inc. v. Roger P. JacksonInstitution deniedPTAB · Apr 1, 2024 · IPR2023-01433 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving any challenged claim unpatentable, chiefly because the cited art did not disclose the claimed curved leading faces.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of inter partes review.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“and consistent with the plain meaning, a POSA would have understood that a ‘start structure’ is the beginning of a thread and the ‘leading face’ is the forward most surface of the thread in the direction the thread is to be rotated.” Pet. 15–16 (citing Ex. 1001, 9:38–42, Fig. 5; Ex. 1003 ¶¶ 158, 159). Petitioner further asserts that the concave portion is “inwardly curving,” and the convex portion is “outwardly curving.” Id. at 16 (citing Ex. 1003 ¶ 161). Patent Owner does not propose any claim construction for these terms. See Prelim. Resp. 7. Instead, Patent Owner asserts that “there are no express constructions for the Board to consider or the Patent Owner to address.” Id. We disagree with Patent Owner’s allegation because Petitioner sufficiently explains the plain meaning of the terms “start structure,” “leading face,” “concave surface portion,” and “convex surface portion.” Pet. 15–16. On this record, and for purposes of this Decision, we adopt Petitioner’s proposed constructions of these terms. 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 other claim term. slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“As Patent Owner correctly points out, the ’477 publication does not describe, or even identify, the line in Figure 10 that Petitioner relies on as the leading face. Prelim. Resp. 20. Thus, the only evidence purportedly supports Petitioner’s argument that the unidentified and undescribed line is the leading surface is Dr. McMillin’s testimony. See Ex. 1003 ¶¶ 186, 234. In paragraph 186, Dr. McMillin’s testimony merely repeats, nearly verbatim, Petitioner’s argument, without any explanation or other evidentiary support. See id. ¶ 186. As a result, we accord limited weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In paragraph 234, Dr. McMillin testifies that an ordinarily skilled artisan would have recognized the unidentified and undescribed line of Figure 10 “as the leading face of the thread, at least because it is the only feature shown that matches with leading face shown in Fig. 8.” Ex. 1003 ¶ 234. We find this testimony inconsistent with the disclosures in Figures 7 and 8.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“For the foregoing reasons, Petitioner does not persuade us that the unidentified and undescribed line in Figure 10 of the ’477 publication represents a leading surface having a partially concave surface and a partially convex surface as required in claim 1.7 For this reason alone, on this record, Petitioner has not established a reasonable likelihood that it would prevail in its challenge of claim 1 based on the ’477 publication. Each of claims 2 and 4–9 depends from claim 1. For the same reasons as explained above, Petitioner has not established a reasonable likelihood that it would prevail in its obviousness challenge of these claims either. b. Substantially Equal Radius of Curvature Claim 1 requires “the partial concave and partial convex surfaces each defined by a radius of curvature that is substantially equal with respect to 7 We also express doubt on whether Petitioner adequately shows the line in Figure 10 is partially concave and partially convex, as required in the disputed limitation. Petitioner’s argument on this point is predicated on an enlarged section of a small drawing, showing a single unidentified and undescribed line that was not apparently intended to demonstrate the direction of any curvature. Ultimately, we do not need to address this issue, because Petitioner does not sufficiently persuade us that the line depicts the leading face recited in the disputed limitation.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 11,129,646 - Mara Renewables Corporation v. DSM IP Assets, B.V.Institution deniedPTAB · Feb 23, 2024 · IPR2023-01342 · APJ Jon B Tornquist · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was anticipated or obvious over the asserted references.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“information presented in the petition . . . shows that 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) (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’959 patent. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that, as of the earliest claimed priority date of the ’959 patent, an ordinarily skilled artisan “would have had a Master of Science degree in an academic discipline emphasizing chemistry, chemical engineering, or biochemistry, in combination with training or at least two to three years of related work experience with lipid chemistry technologies, including but not limited to lipid extraction technologies.” Pet. 6 (citing Ex. 1003 ¶¶ 63–64). Alternatively, Petitioner proposes that an ordinarily skilled artisan “could have also had a Doctorate degree in a relevant academic discipline with one to two years of related work experience in the same discipline.” Id. Petitioner argues that an ordinarily skilled artisan “would have been familiar with microbial oils” and “would have understood the benefits of polyunsaturated fats (PUFAs), microbial sources for obtaining them, and methods for culturing and extracting oils from those microbial sources.” Id. (citing Ex. 1003 ¶¶ 36–48, 64). Patent Owner does not provide a definition of the level of ordinary skill in the art, but “reserves its right to proffer what it contends to be the appropriate level of ordinary skill in the art should the Board institute review.” Prelim. Resp. 15. Patent Owner asserts, however, that a person of ordinary skill in the art would have a detailed understanding of the information provided in its Technology Background section, including “the expected impact of cellular biomass growth characteristics on the proportion of triglycerides and phospholipids produced during a microbial fermentation.” Id. For purposes of this Decision, we adopt Petitioner’s definition of the skill level of an ordinarily skilled artisan as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). As to the background knowledge possessed by the ordinarily skilled artisan, we agree that such an artisan would have been aware of methods for culturing and extracting oils from microbial sources, including the impact of growth characteristics on the proportions of triglycerides and phospholipids produced during microbial fermentation. Pet. 6; Prelim. Resp. 15.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner contends that all claim terms of the ’959 patent “should be given their plain and ordinary meaning.” Pet. 3. Patent Owner does not contend that any claim terms require construction. Prelim. Resp. 14–15. For purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“3. Analysis In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Radianingtyas discloses microbial oils with various levels of DHA and arachidonic acid. There is no disclosure of an individual microbial oil, however, that contains at least 45% DHA and 1.5% or less arachidonic acid by weight as required by claim 1. With respect to the level of DHA, although Radianingtyas might be interpreted to disclose that some microorganisms can produce up to 60% DHA,8 Radianingtyas discloses that the DHA content of ONC-T18 is “typical[ly]” 35% of the total intracellular fatty acids, and in each experiment disclosed in Radianingtyas DHA was produced by ONC-T18 at 8 Radianingtyas discloses that “the oil producing microbe can produce a lipid composition comprising from about 25% to about 40% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1007, 26:31–33. It then gives examples that include 15%, 20%, 45%, 50%, 55%, and 60%, which are outside of the disclosed range. Id. at 26:33–34. Dr. Curtis contends the disclosure as a whole should be read as “from about 15% to about 60% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1003, 39 n.1. Dr. Curtis identifies no microbe in Radianingtyas, however, that is shown to produce more than 40% DHA, and Radianingtyas expressly notes that the typical DHA content produced by ONC-T18 is 35%. Thus, we question Dr. Curtis’ conclusions regarding the DHA content disclosure of Radianingtyas. levels less than “at least 45%.”9 Ex. 1007, 32:21–25 (noting that the “typical composition of fatty acids” produced by ONC-T18 includes 25% DHA), 34:4–37:14 (noting that the control microorganism produced 13.54%, 19.98%, 18.77%, 18.77%, 21.48%, 28.48%, and 14.13% DHA) (Figure 12), 91 (Table 5) (noting that total DHA produced by ONC-T18 was from 24- 34.2%), 99:22–24 (“Of particular interest is ONC-T18 which produces up to 90% of its C20 to C22 content as DHA which is approximately 35% of the total intracellular fatty acids.”). Thus, we are not persuaded that Radianingtyas discloses microbial oils produced by ONC-T18 that have a DHA content of “at least 45%.” As noted by Petitioner, Radianingtyas provides a definition of “purify” and “purifying,” and notes that when these terms are used, it means that a composition could be, for example, 90% pure. Pet. 11; Ex. 1007, 7:26–8:2. As an example of how the term “purified” may be used, Radianingtyas states “[f]or example, if a disclosed eukaryotic microorganism, for example, produces 35% DHA, this could be further ‘purified’ such that the final lipid composition was greater than 90% DHA.” Id. at 8:2–4. We are directed to no actual microbial oil in Radianingtyas, however, that was purified to have increased levels of DHA. Rather, Petitioner only proffers what Radianingtyas might say if such an oil existed or had been purified to increase levels of DHA.10” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,757,959 - PTAB · Sep 25, 2023 · IPR2023-00760 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted anticipation or obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 314, 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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that an ordinarily skilled artisan should encompass the inventor. See Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256–57 (Fed. Cir. 2007). On this record, we also decline to include publication of academic articles as a requirement. After reviewing the record, for purposes of this Decision, we adopt Patent Owner’s definition as 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 › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingTerm construed patent owner constructionDecided for patent owner
“In general, “a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Catalina, 289 F.3d at 808 (quotation marks omitted). But even then, “[w]hether a preamble stating the purpose and context of the invention constitutes a limitation of the claimed process is determined on the facts of each case in light of the overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history.” Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 1572–73 (Fed. Cir. 1996). We determine that, read in view of the Specification, the preamble, even though it states an intended purpose, is limiting, because “it is necessary to give life, meaning, and vitality to the claim.” See Catalina, 289 F.3d at 808 (quotation marks omitted). The ’308 patent discloses “an adoptive cellular immunotherapy composition comprising a genetically modified helper T lymphocyte cell [i.e., CD4+ T cell] preparation that augments the genetically modified cytotoxic T lymphocyte cell [i.e., CD8+ T cell] preparation[’]s ability to mediate a cellular immune response.” Ex. 1001, 9:4–8, see also id. at 9:36–42 (disclosing that in some embodiments, an adoptive cellular immunotherapy composition “comprises an antigen-reactive chimeric antigen receptor modified naïve CD4+ T helper cell that augments the CD8+ immune response.”), 9:48–51 (the same). The ’308 patent also discloses that in some embodiments, an adoptive cellular immunotherapy composition further “comprises a chimeric antigen receptor modified tumor-specific CD8+ cytotoxic T lymphocyte cell preparation that elicits a cellular immune response.” Id. at 9:14–17, 23–26.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“the claimed composition are surface positive for “CD62L and/or CD45RA,” and the CAR-modified CD8+ T cells are surface positive for “CD62L and/or CD45RO.” Petitioner proposes that the term “and/or” includes “embodiments having the element preceding ‘and/or,’ the element following ‘and/or,’ or both the element preceding ‘and/or’ and the element following ‘and/or’.” Pet. 20 (citing Ex. 1002 ¶ 86). Under this construction, Petitioner argues, the CD4+ T cells recited in claim 1 can be surface positive for CD62L, for CD45RA, or both. Id. (citing Ex. 1002 ¶ 87). And because CD62L+ can be either TN or TCM cells, Petitioner contends “claim 1’s CAR-modified CD4+ T cells can be either majority TCM or TN.” Id. at 17 (citing Ex. 1002 ¶¶ 62–66). For similar reasons, Petitioner argues that “claim 1’s CD8+ T cells can be majority TN, TCM, TEM, or TE.” Id. (citing Ex. 1002 ¶¶ 67–70); Id. at 20 (citing Ex. 1002 ¶¶ 87–88). At this stage, Patent Owner does not dispute Petitioner’s proposed construction or provide its own construction of “and/or.” Based on the current record, we agree with Petitioner’s proposed construction because it is supported by the claim language and the Specification of the ’308 patent.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,987,308 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Institution deniedPTAB · Aug 22, 2023 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Institution
Institution was denied for claims 1–17, 20–21, 24–26, and 29–34 because petitioner did not show a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that 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) (2018). Upon consideration of the briefing and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“Ex. 1018, 42–43. The Examiner found that Lees discloses NHS vinyl sulfone as a heterobifunctional linker used to attach a derivatized polysaccharide to one end and a protein to the other and found that this compound anticipated formula 55 of the Specification, which was encompassed by claim 1. Id. at 42–43.” slip op. at 22
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“For the reasons discussed above regarding claim interpretation of Y, Z, Q and T, Patent Owner has the better argument for claims 1 and 2. Specifically, Y and Z are independent groups that function without reliance this ground for claims 1 and 2 rely on sulfone to assist vinyl to enable the reaction above, Petitioner is unlikely to prevail in establishing that Morales- Sanfrutos discloses the Y or Z limitations and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 1 and 2. With regard to claims 3, 6, 24, 25, and 33 we are persuaded by Patent Owner’s argument that Petitioner’s assignment of sulfone for the Q moiety is incorrect because that group becomes complexed to HRP through a vinylsulfone mediated reaction, making a derivatized protein, e.g., HRP-11. Prelim. Resp. 48 (citing Ex. 1005, 4046). In this structure, sulfone is no longer an independent group available to be identified as Q because it has been complexed to the Cb moiety, making the Q moiety limitation not shown in the HRP-11 conjugate. Thus, Petitioner has not established a reasonable likelihood of prevailing in showing that Morales-Sanfrutos discloses the Q limitation and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 3, 6, 24, 25, and 33.17” slip op. at 28
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“d) Petitioner’s allegations of obviousness A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). In this section, we determine whether Petitioner shows sufficiently, for purposes of institution, that claims 1, 20, 21, and 29–31 would have been rendered obvious by Harris.” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution deniedPTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution
The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - 10x Genomics, Inc. v. Bio-Rad Laboratories, Inc.Institution deniedPTAB · May 14, 2021 · IPR2021-00132 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution because Hindson was not prior art; claims 1–26 were entitled to priority and were not shown likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has not demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’115 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“We have considered the parties’ arguments, summarized above, but determine that Patent Owner has the better position. In particular, we are not persuaded by Petitioner’s contentions that the claims fail the written description requirement for the claimed “partitions” because the term “gel beads” are not adequately described. Pet. 19–20. The claims do not recite the term “gel beads”. Ex. 1001, 49:2–50:41. Rather, the claims of the ’115 patent are directed to compositions (claim 1–13) and devices (clam 14–26) having a plurality of second partitions containing first partitions, wherein the second partitions may be droplets (claims 4–6 and 18–20). Id. To the extent that Petitioner contends that the ’115 patent does not provide adequate written description support for those elements of the challenged claims, we disagree. For example, claim 1 recites a composition “comprising a plurality of second partitions containing first partitions” where “first partitions are contained within the second partitions.” Support for those elements is found, for example, in the following portions of the ’115 patent:” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable
“Accordingly, in view of the above, we are not persuaded by Petitioner’s arguments that the claims of the ’115 patent lack written description support and, thus, are not entitled to claim the benefit of priority to the ’121 application. Consequently, we determine that Hindson does not qualify as prior art to the ’115 patent and therefore cannot anticipate the claims of the ’115 patent.” slip op. at 12
§ 102 anticipationPatents in suitUS 10,190,115 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 20, 2020 · IPR2019-01453 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–11 and 13 unpatentable over Szekeres, Smith, or their combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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 that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Neither Szekeres nor Smith was cited during examination of the ’509 patent. Pet. 87–88. Instead, they “were considered during examination of a subsequently filed application.” Id. at 88; see also Prelim. Resp. 20 (Patent Owner conceding that “the Examiner considered Petitioner’s asserted references in the ’191 patent after the ’509 patent issued”). Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to decide whether institution should be denied on a discretionary basis under § 325(d).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“facts unique to each patent. See, e.g., Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373–76 (Fed. Cir. 2019) (affirming construction that result or efficacy language appearing in a wherein clause was limiting in light of the intrinsic evidence as a whole). Indeed, determining whether allegedly non-limiting language in a preamble or otherwise “involves examination of the entire patent record to determine what invention the patentee intended to define and protect.” Rowe v. Dror, 112 F.3d 473, 478–80 (Fed. Cir. 1997); Allergan, 935 F.3d at 1374 (holding the court “must read the claims in view of the entire specification” and prosecution history) (internal quotation marks and citations omitted). Based on the entire intrinsic record, we find “protection” is at the heart of the ’509 patent’s invention. In the body of claim 1, step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1001, 12:41–42 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis. Also, the preamble provides meaning about the nature of the infection recited in the body of the claim: “a self-replicating infection by an immunodeficiency retrovirus.”4 Id. at 12:38–39.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, the brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not 18 ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983); see also Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”). Here, Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada.5 Pet. 38–42. But Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. In sum, Szekeres does not disclose step (b).” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,044,509 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 20, 2020 · IPR2019-01454 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–11 and 13 unpatentable; claims 12 and 14–17 were disclaimed.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority under 35 U.S.C. § 314, 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.” 35 U.S.C. § 314(a). For the reasons provided below, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“Neither Szekeres nor Smith was cited during examination of the ’333 patent. Pet. 87. Instead, they “were considered during examination of a subsequently filed application.” Id. at 88; see also Prelim. Resp. 20 (Patent Owner concedes that “the Examiner considered Petitioner’s asserted references in the ’191 patent after the ’333 patent issued”). Under such circumstances, and because, as explained below, we deny institution based on substantive analysis of the Petition, we decline to decide whether institution should be denied on a discretionary basis under § 325(d).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“facts unique to each patent. See, e.g., Allergan Sales, LLC v. Sandoz, Inc., 935 F.3d 1370, 1373–76 (Fed. Cir. 2019) (affirming construction that result or efficacy language appearing in a wherein clause was limiting in light of the intrinsic evidence as a whole). Indeed, determining whether allegedly non-limiting language in a preamble or otherwise “involves examination of the entire patent record to determine what invention the patentee intended to define and protect.” Rowe v. Dror, 112 F.3d 473, 478–80 (Fed. Cir. 1997); Allergan, 935 F.3d at 1374 (holding the court “must read the claims in view of the entire specification” and prosecution history) (internal quotation marks and citations omitted). Based on the entire intrinsic record, we find “protection” is at the heart of the ’333 patent’s invention. In the body of claim 1, step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1003, 12:51–52 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis. Also, the preamble provides meaning about the nature of the infection recited in the body of the claim: “a self-replicating infection by an immunodeficiency retrovirus.”5 Id. at 12:48–49. Furthermore, the body of claims 1 and 13 requires administering “a pharmaceutically effective amount” of each agent. The preamble and other allegedly non-limiting portions of the claims provide necessary context for the “effective amount” language. That is, these are amounts that can bring 5 Reliance on the preamble also appears in claim 13. There, step (a) recites “selecting an uninfected human that does not have the self-replicating infection.” Ex. 1003, 14:1–2 (emphases added). 11 on the recited efficacy—in claim 1, “protecting” the host from infection.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“Moreover, the brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP 22 treatment that satisfies step (b) of the claims. When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983); see also Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”). Here, Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously describes PrEP combination therapy with Truvada. Pet. 38–42. For example, Petitioner argues that Szekeres’s teaching of a potential for mutation and resistance with FTC monotherapy “would have been understood by the skilled person as indicating FTC should be co-administered with another antiretroviral.” Id. at 39. From that, Petitioner contends Szekeres suggests FTC should be combined with TDF (the known agent actually being investigated in the PrEP studies described in Szekeres), with Truvada hence representing the combination of those therapeutic agents. Id. at 39–40. But 23 Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. In sum, Szekeres does not disclose step (b). Efficacy Requirement” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 9,579,333 - Gilead Sciences, Inc. v. The United States Of America, Represented By The Secretary Of The Department Of Health & Human ServicesInstitution deniedPTAB · Feb 5, 2020 · IPR2019-01456 · APJ Timothy G Majors · IPR · Institution
The Board denied institution on claims 1–19 because the petition did not show a reasonable likelihood that any challenged claim was unpatentable over Szekeres or Smith and Szekeres.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008); In re Chudik, 851 F.3d 1365, 1372 (Fed. Cir. 2017) (“[A] prior art reference anticipates a claim only if it discloses all the elements in the same form and order as in the claim.”) (internal quotation marks and citation omitted). Turning to obviousness, a claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) 19 objective evidence of nonobviousness when presented. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). A party who petitions the Board for a determination of unpatentability” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“claim’s preamble is limiting when it is “necessary to give life, meaning, and vitality to the claim.” MBO Labs., Inc. v. Becton Dickinson & Co., 474 F.3d 1323, 1330 (Fed. Cir. 2007). As an initial matter, we observe that claim 1’s step (a) recites “selecting a primate host not infected with the immunodeficiency retrovirus.” Ex. 1007, 13:1–2 (emphases added). The “immunodeficiency retrovirus” in step (a), therefore, requires the preamble language for antecedent basis, and the preamble provides further meaning about the nature of the infection to which the claim is directed—“a self-replicating infection by an immunodeficiency retrovirus.”16 Id. at 12:65–67;” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“It is not clear that further interpretation of this phrase is needed to resolve the dispute presented here. Nevertheless, Petitioner provides sufficient support for its interpretation on this record and, as it is unopposed at present by Patent Owner, we will adopt Petitioner’s interpretation of this phrase for purposes of this Decision.” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInherency not foundNot shown unpatentable
“The brief, high-level mention in Szekeres of Truvada’s FDA-approval does not sufficiently describe Truvada’s use in a PrEP treatment that satisfies step (b) of the claims. Although claim language need not appear ipsissimis verbis in the allegedly anticipating prior art,24 the test remains one of “strict identity.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (explaining that the “test for novelty” requires “strict identity”). When anticipation is the issue, close is not enough. Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (holding “anticipation is not shown by a prior art disclosure which is only ‘substantially the same’ as the claimed invention”), overruled on other grounds, A.C. Aukerman Co. v. R.L. Chaides Constr. Co., 960 F.2d 1020 (Fed. Cir. 1992) (en banc). Indeed, “[a] prior art disclosure that ‘almost’” discloses all the elements arranged exactly as in the claim, “may render the claim invalid under § 103, [but] it does not ‘anticipate.’” Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (internal citation omitted). Petitioner’s theory pieces together a host of disclosures, such as a potential for resistance with certain agents, and then filters and combines those disclosures based on what an ordinarily skilled person allegedly would have “understood” to ultimately conclude that Szekeres unambiguously 24 In re Schaumann, 572 F.2d 312, 317 (CCPA 1978). 40 describes PrEP combination therapy with Truvada. Pet. 38–42 (asserting that Szekeres “teaches orally administering Truvada in a tablet to an uninfected individual before an HIV exposure”).25 But Szekeres simply does not describe in any adequate detail actual or prophetic use of Truvada in a PrEP regimen. To our eyes, Petitioner’s theory invokes obviousness (if anything), not anticipation. See Net MoneyIN, 545 F.3d at 1371 (Fed. Cir. 2008) (“[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.”).” slip op. at 40
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,335,423
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.