- Beckman Coulter, Inc. v. Sysmex Corporation And Sysmex America, Inc.Institution deniedPTAB · Feb 22, 2021 · IPR2020-01500 · APJ Elizabeth M Roesel · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3–16, and 18–28 were unpatentable on 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) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)); see also 37 C.F.R. § 42.104(b) (requiring a petition for inter partes review to identify how the challenged claim is to be construed and where each element of the claim is found in the prior art patents or printed publications relied upon). A patent claim is unpatentable under 35 U.S.C. § 103 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 said subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved based on underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) when presented, objective evidence of nonobviousness, i.e., secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Additionally, the obviousness inquiry typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements,” but “must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Bachelor’s or Master’s degree in biologic science, biomedical engineering, and/or electrical engineering or a related field” and “at least five years of experience in developing hardware and/or software for hematology analyzers.” Pet. 12. Petitioner further contends that such a person “would have been familiar with the design and operation of hematology analyzers available in the market, including Patent Owner’s XE-Series analyzers, the Coulter LH-700 analyzers, and other commercially available hematology analyzers.” Id. Patent Owner states that a POSA “would have possessed a Bachelor’s or Master’s degree in biological science, biomedical and/or electrical engineering, or a related field, or would have had at least three years of experience in developing or using hardware and/or software for analyzers for blood or other body fluids.” Prelim. Resp. 46–47. Patent Owner further states that “[t]he difference between the level of ordinary skill in the art proposed by Patent Owner and Petitioner’s level does not affect the arguments” in the Preliminary Response. Id. at 47. Petitioner’s definition is more complete and more consistent with the disclosure of the ’350 Patent and the scope and content of the asserted prior art because Petitioner’s definition requires familiarity with “the design and operation of hematology analyzers available in the market, including Patent Owner’s XE-Series analyzers, the Coulter LH-700 analyzers, and other commercially available hematology analyzers.” Pet. 13. We find that such familiarity is consistent with the ’350 Patent, which discloses that a blood cell analyzer capable of measuring cells in body fluid was known in the art and that “the functions of the present invention can be realized in a conventional blood cell analyzer by installing the computer program in a conventional blood cell analyzer.” Ex. 1001, 1:45–61, 15:52–58. The parties’ definitions of a POSA differ in additional respects, including the duration of a POSA’s practical experience, whether such practical experience is in addition to or possibly as a substitute for an educational component, and whether a POSA’s practical experience could be merely using hardware and/or software for an analyzer, as opposed to developing such hardware and/or software. In each of these respects, we find that Petitioner’s proposal is more reasonable than Patent Owner’s. Accordingly, for purposes of determining whether to institute an inter partes review, we apply Petitioner’s definition of a POSA.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“language supports Patent Owner’s proposed constructions for two reasons. First, we agree with Patent Owner that, by separately reciting “a blood measuring mode” and “a body fluid measuring mode,” the claim language implies that the two modes are distinct. Becton, Dickinson & Co. v. Tyco Healthcare Group, LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (“Where a claim lists elements separately, ‘the clear implication of the claim language’ is that those elements are ‘distinct component[s]’ of the patented invention.” (quoting Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004)); see Prelim. Resp. 49. Second, the above-quoted claim language supports Patent Owner’s contention that “a blood measuring mode” and “a body fluid measuring mode” should each be construed as “a sample analyzer operation mode . . . used for measuring cells.” Prelim. Resp. 48. Independent claims 1 and 12 include the following “wherein” clause: wherein a respective sequence of operations for measuring cells in the blood sample and in the body fluid sample comprises (a) a sensing operation comprising: operations of preparing for measurement and operating a detector to sense the cells in the sample and (b) an analyzing operation comprising operations of analyzing sample measurements and displaying analysis results, the sensing operation performed in the body fluid measuring mode being different, at least partially, from the sensing operation performed in the blood measuring mode. Ex. 1001, 16:55–65, 18:31–41 (emphasis added). We find that this claim language is consistent with Patent Owner’s constructions for “a blood measuring mode” and “a body fluid measuring mode.” In our view, the above-quoted claim limitation provides one example of a possible difference between the body fluid measuring mode and the blood fluid measuring mode. It does not suggest that, in the absence of this limitation, the body” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Petitioner shows that XE2100 (Ex. 1004) describes a hematology analyzer having a controller and that XE-BFA (Ex. 1005) describes a “Body Fluid Application” for the same analyzer. But Petitioner does not show sufficiently that these documents, even when combined with a POSA’s knowledge, disclose or suggest “a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode,” as recited in the challenged claims. Nor does Petitioner present argument or evidence sufficient to show that a POSA would have modified the XE-2100 analyzer to include such a programmed controller. Missing from Petitioner’s argument addressing CL4 is any discussion of modifying or reprogramming the controller of the XE-2100 analyzer so that it selectively operates the sample analyzer in two different operation modes, one for blood and another for body fluid. There is no dispute that XE2100 does not teach “a controller programmed to selectively operate the sample analyzer in a blood measuring mode or a body fluid measuring mode,” as recited in the independent claims. XE2100 describes the operation of a hematology analyzer to measure blood samples, not body fluid samples. Petitioner argues that “XE-BFA describes . . . operation of the XE-2100 analyzer in the body fluid measuring mode.” Pet. 34. Under our claim construction for “body fluid measuring mode,” we are not persuaded by Petitioner’s argument. We agree with Patent Owner that “XE-BFA does not disclose a separate body fluid measuring mode; it XE2100.” Prelim. Resp. 57. Although Petitioner directs us to XE-BFA’s disclosure of “Principles & Technologies” as “WBC: Fluorescent Flow Cytometry; RBC: DC-sheath flow” (Ex. 1005, 2), XE2100 discloses these same principles and technologies for measuring blood samples. Ex. 1004, 7- 2, 7-3, 7-7. XE-BFA discloses: “The XE Series analyzers with XE pro software now brings the power of fluorescent flow cytometry to body fluid analysis.” Ex. 1005, 2. Petitioner does not argue that the “XE pro software” introduces a different mode of operation—a body fluid measuring mode—to the XE- 2100 analyzer. Patent Owner presents evidence that the “XE pro software” predates the introduction of the “Body Fluid Application.” Prelim. Resp. 58 (citing Ex. 2018; Ex. 2042, 3; Ex. 2043, 1). Patent Owner’s evidence reinforces our finding that Petitioner’s arguments and evidence are insufficient to show a controller programmed as recited in the challenged claims. We have considered the paragraphs of the Roche Declaration relied” slip op. at 20
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,401,350 - Bluecatbio Ma Inc. v. Yantai Ausbio Laboratories Co., Ltd.Rehearing deniedPTAB · Feb 11, 2021 · PGR2020-00051 · APJ Elizabeth M Roesel · PGR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no overlooked evidence or improper burden shifting in its decision to institute review.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“persuaded that we misapprehended or overlooked either a deficiency in Petitioner’s evidence or Patent Owner’s rebuttal arguments. Nor are we persuaded that we abused our discretion in determining that the Petition meets the threshold for institution of inter partes review. B. The Board did not Improperly Shift the Burden of Proof to Patent Owner” slip op. at 5
- BurdenDecided for petitioner
“as improper burden-shifting. Our statements identify arguments that were not made by Patent Owner in the Preliminary Response or by Dr. Katz in his declaration. After reviewing the record again, we determine that the statements are accurate. We did not shift the burden of persuasion or the burden of production to Patent Owner. Immediately following the first sentence quoted above, the Decision states: “[o]n this record, Petitioner’s video (Ex. 1012) is sufficient to show that at least the main part of the liquid expelled from the reaction vessel unit is driven into the drain of the Gyro Washer.” Dec. 26. Following the second sentence quoted above, the Decision states: We are mindful that the burden of proof is on Petitioner, not Patent Owner. We have considered Patent Owner’s criticisms of Petitioner’s evidence, and although they cast some doubt on Petitioner’s contentions, we determine that, on this preliminary record, Petitioner’s experimental and testimonial evidence is sufficient to meet the threshold for institution of post-grant review. Dec. 27. The Decision correctly placed the burden on Petitioner to show that the claim limitations are met by the Gyro Washer.” slip op. at 5
NonePatents in suitUS 10,338,063 - Longi Green Energy Technology Co., Ltd. / Longi Solar Technology Co., Ltd. et al. v. Hanwha Q Cells & Advanced Materials CorporationAll claims unpatentablePTAB · Dec 3, 2020 · IPR2019-01072 · APJ Christopher L Crumbley · IPR · Final written decision
Claims 12–14 are unpatentable as obvious over Hagino and over Hagino with Duerinckx and Hoex 2006; the Bhattacharyya grounds did not prove them unpatentable.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Upon review, Petitioner’s Motion to Exclude fails to establish that Petitioner is entitled to the remedy it seeks. To the extent the Motion seeks exclusion of evidence under FRE 403 as overly prejudicial, Petitioner does not adequately explain what prejudice it would suffer if we were to simply disregard or give little weight to the uncited paragraphs of Dr. Lebby’s testimony, rather than excluding them from the record. Indeed, as the Board is not a jury, it would appear that the risk of unfair prejudice against which Rule 403 guards is diminished, if not eliminated entirely. See, e.g., Schultz v. Butcher, 24 F.3d 626, 632 (4th Cir. 1994) (“in the context of a bench trial, evidence should not be excluded under 403 on the ground that it is unfairly prejudicial”); see also Gulf States Utils. Co. v. Ecodyne Corp., 635 F.2d 517, 519 (5th Cir. 1981). The Board is capable of hearing relevant evidence and weighing its probative value, including determining the weight to be given Dr. Lebby’s testimony or disregarding it entirely.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“shall be construed 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),” which is articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2019). Under the Phillips standard, 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 effective filing date of the patent application.” Phillips, 415 F.3d at 1312–13 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Only those terms in controversy need to be construed and only to the extent necessary to resolve the controversy. 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)). In our Institution Decision, we determined that no term of the challenged claims required an express construction. Dec. on Inst. 8. During trial, neither party proposed that we adopt any specific construction of a claim term. Upon review of the record and the parties’ positions, we agree that no term appearing in the challenged claims requires express construction. slip op. at 10
- Skill levelSkill level petitioner adoptedOther
“Petitioner relies on the Declaration of Sanjay Banerjee, Ph. D. (Ex. 1003). Dr. Banerjee testifies that a person having ordinary skill in the art would have “an advanced degree involving the discipline of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field,” or alternatively, “a bachelor’s degree in electrical engineering, applied physics, chemistry, or materials science, and at least three years designing, developing, or researching in the field.” Ex. 1003 ¶ 46. We adopted this definition for purposes of deciding whether to institute trial. Dec. on Inst. 9. For purposes of this inter partes review, Patent Owner “does not contest this level of skill.” PO Resp. 2. In view of this agreement, we adopt Dr. Banerjee’s definition of the level of ordinary skill in the art.” slip op. at 12
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Dr. Banerjee’s testimony supports the conclusion that a person of ordinary skill in the art would have interpreted Hagino’s disclosure in this manner. Dr. Banerjee states that paragraph 29 of Hagino is “certainly . . . the only described method for forming ‘silicon nitride’ layers” in the reference. Ex. 1003 ¶ 211. We noted in our Institution Decision that this appeared to not be the case, because silicon nitride could also be applied through spin coating Solution A. Dec. on Inst. 30 n.10. But on the full record now before us, we credit Dr. Banerjee’s testimony, because upon further evaluation the Solution A spin-coating method does not pertain to the deposition of a silicon nitride layer. We have also reviewed Dr. Lebby’s testimony on this issue in evaluating how a person of ordinary skill would have interpreted Hagino. disclose using a CVD deposition method (Ex. 2008 ¶ 87), he does not address how a person of ordinary skill in the art would have understood Hagino to deposit a silicon nitride layer in the First Embodiment without using CVD. In particular, Dr. Lebby did not indicate, in Hagino or elsewhere, any disclosure that spin coating was a recognized method for depositing a silicon nitride layer. The only method for depositing silicon nitride recognized by Dr. Lebby was CVD as disclosed by the ’215 patent, and he testified that CVD deposition of a silicon nitride layer in the presence of silane leads to the “cracking” of silane and “typically you would . . . see hydrogen as part of a deposited layer.” Ex. 1053, 55:6–57:20. Based on the foregoing, we find that Hagino discloses deposition of a surface layer of silicon nitride using CVD that corresponds to the second layer of claim 12. We also credit Dr. Banerjee’s uncontradicted testimony that performing CVD deposition of silicon nitride in the presence of silane, as Hagino discloses (Ex. 1006 ¶ 29), would necessarily result in hydrogen being embedded in the layer. Ex. 1003 ¶¶ 206–213.” slip op. at 20
Patent outcomesUS 9,893,215 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,893,215 - PTAB · Oct 13, 2020 · PGR2019-00045 · APJ Christopher C Kennedy · PGR · Final written decision
The Board cancelled claims 13, 18, and 19, but denied substitute claims 23–25 because their percentage-and-range limitations introduced new matter.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“3. Scope of Proposed Substitute Claims A motion to amend “may not enlarge the scope of the claims of the patent.” 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(a)(2)(ii). Although Patent Owner does not appear to separately address this requirement in the Revised Motion to Amend, see generally Revised MTA, we have reviewed the proposed substitute claims and determine that they do not enlarge the scope of the claims of the patent because they add limitations that render each proposed substitute claim narrower than original challenged claim 13.2 Petitioner does not contend otherwise. See generally Opp. On this record, we determine that the Revised Motion to Amend satisfies this requirement.” slip op. at 9
- 112 supportMotion to amend, deniedDenied
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateDecided for petitioner
“description support for numerical ranges identified by the parties is General Hospital Corp. v. Sienna Biopharmaceuticals, Inc., 888 F.3d 1368, 1372 (Fed. Cir. 2018).4 In that case, the Federal Circuit explained: The disclosure of a broad range of values does not by itself provide written description support for a particular value within that range. Instead, where a specification discloses a broad range of values and a value within that range is claimed, the disclosure must allow one skilled in the art to immediately discern the limitation at issue in the claims. Id. (emphasis added); cf. Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 1000 (Fed. Cir. 2006) (“[T]he disclosure of a range is no more a disclosure of the end points of the range than it is of each of the intermediate points.”). The Federal Circuit has also stated that, “[i]n the absence of blazemarks” that point to a particular species or sub-genus, “simply describing a large genus of compounds is not sufficient to satisfy the written description requirement.” Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). We find those cases to be instructive because we discern no guidance in the original disclosure that points to the percentage+range limitation of proposed substitute claim 23. Nor do we find anything in the original disclosure that would “allow one skilled in the art to immediately discern” 4 Despite the fact that Sienna was cited in (1) Petitioner’s opposition to Patent Owner’s original Motion to Amend, Paper 24 at 11; (2) the Preliminary Guidance issued by the Board, PG at 8; and (3) Petitioner’s opposition to Patent Owner’s Revised Motion to Amend, Opp. at 12, Patent Owner fails to cite or discuss Sienna, see generally Revised MTA; Reply. the percentage+range limitation. See Sienna, 888 F.3d at 1372. Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to any mesh sieve number range other than 3–35, and Patent Owner has not persuasively identified any portion of the original disclosure that attributes any significance to having a particular proportion of particles (e.g., 61 wt%) falling within some narrower mesh sieve number range. See Ex. 1021 (Coffield Decl.) ¶¶ 23–24.” slip op. at 14
§ 112 disclosurePatents in suitUS 10,071,852 - Argentum Pharmaceutical LLC v. Novartis AGNo claims unpatentablePTAB · Oct 5, 2020 · IPR2016-01479 · APJ Christopher L Crumbley · IPR · Final written decision
Claims 1–3 were not shown unpatentable because the asserted prior-art combinations did not establish a reasonable expectation of success in treating advanced PNETs after chemotherapy failure.
RulingsFinal written decision- Skill levelOther
“demonstrate by a preponderance of the evidence that the claims are unpatentable. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time of the invention to a person having ordinary skill in the art. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations.10 See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). The level of ordinary skill in the art may be reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundDecided for patent owner
“Judged by the correct standard, the evidence leaves little doubt that a person of ordinary skill in the art would have been motivated to pursue everolimus as a potential treatment option for advanced PNETs after failure of cytotoxic chemotherapy. Novartis does not seriously contend otherwise, focusing its arguments instead on whether the motivation to pursue everolimus was greater than the motivation to pursue other possible treatments. Not only does Öberg 2004 discusses rapamycin as an “interesting new compound” that suggests clinical trials with rapamycin in combination with cytotoxic chemotherapy, it specifically provides a treatment algorithm that shows rapamycin among the potential “experimental therapies” following failure of cytotoxic chemotherapy. Ex. 1027, 60, Fig 1. And O’Donnell specifically demonstrates that administration of everolimus to human cancer patients was safe. Ex. 1029, 200. We credit Dr. Ratain’s testimony that by 2005, there was a “significant body” of data on the administration of everolimus to humans, but no reported clinical data on rapamycin. Ex. 1003 ¶ 135. Given the difference in information on everolimus and rapamycin, we find that the skilled artisan would have been motivated to pursue everolimus as an alternative to the rapamycin disclosed in Öberg 2004. Even if a person of ordinary skill would have had reason to pursue everolimus, however, our inquiry does not end there. Argentum must also prove that the skilled artisan “would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007). That “expectation of success need only be reasonable, not absolute.” Id. at 1364. “Whether an ordinarily skilled artisan would have reasonably expected success . . . is measured as of the date of the invention.” Amgen Inc. v. F. Hoffman–La Roche Ltd., 580 F.3d 1340, 1362 (Fed. Cir. 2009).” slip op. at 15
- Obviousness (§103) › Analogous artNot shown unpatentableDecided for patent owner
“the only prior art clinical trial of everolimus presented to us, was a Phase I trial designed to test dosages, not efficacy. Ex. 1029, 803. While Öberg 2004 does disclose the promise of rapamycin, we agree with the District Court that at the time of the invention the mTOR pathway was insufficiently understood, such that a person of ordinary skill in the art would not have reasonably expected rapamycin’s “promise,” as reported in Öberg 2004, to translate to everolimus. Ex. 1027, 60. And in regard to Boulay 2004, Novartis argues that the record lacks sufficient evidence to support Argentum’s contention that the CA20948 rat pancreatic tumor model described therein was applicable to the treatment of PNETs. Ex. 1005, 253. On this point, again we agree with the District Court. District Court Decision, 287 F. Supp. 3d at 526 (“I find that Defendant has failed to establish by clear and convincing evidence that CA20948 is a PNET model.”). Upon evaluating the full record before us, we find that the CA20948 tumor model line originated from a pancreatic adenocarcinoma, which is distinct from a neuroendocrine tumor (NET). Ex. 2038, 197–99; Ex. 2041 ¶¶ 132–134. We credit and rely on Dr. Kulke’s testimony that pancreatic adenocarcinomas and PNETs were known to differ in their origin, incidence, clinical behavior, molecular genetics, and responses to pharmacotherapies. Ex. 2041 ¶¶ 57, 135–136. Argentum does not dispute the distinction between CA20948 and PNETs, but instead argues that tests performed on CA20948 would nevertheless be understood to be applicable to PNETs. Reply 17–18. Argentum’s primary support for this argument derives from the De Jong reference, which discloses the use of the CA20948 pancreatic tumor line in a study of the treatment of neuroendocrine tumors. Ex. 1010, Abstract. As based treatment of tumors using radioactive somatostatin-analogues. PO Resp. 33; Ex.1010, 356–58. Both neuroendocrine tumors and CA20948 express somatostatin receptors; it is this commonality that made CA20948 useful as a model for NETs in De Jong’s study of radiation treatment. Ex. 2041 ¶¶ 139, 141. But just because some features of a cell line make it useful in studies of tumors where those features are relevant, it does not necessarily follow that the cell line is relevant to all studies of those tumors. See Tr. 14:15–25. As Dr. Kulke credibly explains, the person of ordinary skill in the art would not have understood from the De Jong radiation treatment study that CA20948 could be used as a model for NETs in a pharmacotherapy study. Ex. 2041 ¶ 143–146. For these reasons, we agree with the District Court that Argentum has not proven CA20948 to be a PNET model; nor is there reason to believe that a person of ordinary skill in the art would have considered CA20948 to be applicable to studying the treatment of PNETs with mTOR inhibitors, much less such treatment after the failure of cytotoxic chemotherapy.” slip op. at 18
- ExcludeMotion to exclude, deniedMixed
“We agree. If Argentum had submitted only certain portions of Dr. Kulke’s testimony into the record before us, Novartis would be entitled to rely on FRE 106 to request that the Board admit other portions of his testimony that, in fairness, should be considered. But that is not what Novartis requests here; nor could it, given that Exhibits 1070, 1095, and 1119 were already admitted in their entirety. And in any event, Novartis’ request would not have been proper as part of a motion to exclude. Upon reviewing the Motion, it is clear that Novartis is using its FRE 106 arguments as a vehicle for introducing additional citations to, and discussion of, Dr. Kulke’s testimony that were not introduced in the multiple other opportunities for merits briefing that Novartis had during this trial. For this” slip op. at 28
Patent outcomesUS 9,006,224 not shown unpatentable§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,006,224 - Intel Corporation / Globalfoundries U.S., Inc. et al. v. Daniel L. FlammAll claims unpatentablePTAB · Sep 30, 2020 · IPR2017-00279 · APJ Christopher L Crumbley · IPR · Final written decision
Claims 13–26, 64, and 65 are unpatentable as obvious under § 103 over the combinations of prior art listed in the decision.
RulingsFinal written decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“not entitled to claim priority to a filing date any earlier than the September 11, 1997 filing date of the ’650 provisional application, and, therefore, each of the asserted references qualify as prior art to the challenged claims. See Pet. 9. Specifically, Petitioner contends that the ’264 patent is not entitled to claim priority to the December 4, 1995 filing date of the ’224 application because the ’224 application fails to disclose a chuck having a “thermal mass” or selecting that thermal mass to” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“in the art at the relevant time would have had (i) a Bachelor’s degree in chemical engineering, materials science engineering, electrical engineering, physics, chemistry, or a similar field, and three or four years of work experience in semiconductor manufacturing or related fields; or (ii) a Master’s degree in chemical engineering, materials science engineering, electrical engineering, physics, chemistry, or a similar field, and two or three years of work experience in semiconductor manufacturing or related fields; or (iii) a Ph.D. in chemical engineering, materials science engineering, electrical engineering, physics, chemistry, or a similar field. Pet. 19–20 (citing Ex. 1006 ¶¶ 21). Patent Owner does not contest Petitioner’s description of the level of ordinary skill in its Response. Based on our review of the ’264 patent, the cited prior art, and the testimony of the parties’ declarants, we agree with Petitioner’s assessment of the level of ordinary skill in the art and apply it for purposes of this Decision. See Okajima, 261 F.3d at 1355 (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”).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownTerm construed petitioner constructionDecided for petitioner
“terms appearing in the challenged claims. Dec. on Inst. 10–11. First, we construed selected thermal mass to mean “thermal mass selected by selecting the mass of the substrate holder, the material of the substrate holder, or both.” Id. at 10. Second, we adopted Petitioner’s proposed 13 Neither party disputes that the ’264 patent is expired. The earliest patent application referenced for the benefit of priority under 35 U.S.C. § 120 for the ’264 patent was filed on December 4, 1995, and the patent has no term extensions. The term of the ’264 patent, therefore, expired no later than December 4, 2015. See 35 U.S.C. § 154(a)(2) (2012 & Supp. III 2015) (stating that the term of a patent grant ends twenty (20) years from the date on which the application for the patent was filed in the United States, “or, if the application contains a specific reference to an earlier filed application or applications under section 120, 121, 365(c), or 386(c), from the date on which the earliest such application was filed”). 13 construction of thermal mass . . . selected for a predetermined temperature change within a specific interval of time as meaning “the material and/or mass of the substrate holder are chosen to effect a predetermined change in substrate holder temperature from a selected first temperature to a selected second temperature within a specific time period.” Id. at 11. During the instituted trial, neither party disagreed with these constructions; nor did either party ask that we construe additional claim terms. We, therefore, leave our prior constructions in place unaltered.” slip op. at 13
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“claimed invention. PO Resp. 15–19. As Patent Owner correctly notes, art is analogous if it is either: (1) from the same field of endeavor as the claimed invention; or (2) reasonably pertinent to the problem faced by the inventor. Id. at 15–16 (citing MPEP § 2141.01(a)). As we find below that Hinman satisfies the second prong of this test, we need not address Patent Owner’s arguments regarding field of endeavor. A reference is “reasonably pertinent” to a problem if it “logically would have commended itself to an inventor’s attention in considering his problem.” In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656, 658, 23 USPQ2 1058, 1061 (Fed. Cir. 1992)). Petitioner argues that Hinman and the ’264 patent address the same problem, namely “controlling temperature to increase throughput.” Reply 5; Ex. 1025 ¶¶ 45, 48. Patent Owner disagrees, alleging that the ’264 patent is “concerned with achieving or improving etch selectivity in a high throughput etch process for semiconductor processing,” 32 and that this is different than the problems addressed by the prior art. PO Resp. 18. In defining the problem addressed by the inventor, the specification of the challenged patent is often instructive. Here, the ’264 patent notes that prior art substrate etching processes used “batch” modes in which etching was done at a single temperature, and that the invention improves upon these processes by providing a multi-stage etching process using different temperatures. Ex. 1001, 1:65–2:11. As such, the invention allegedly overcame disadvantages of prior art processes, which required lowered throughput and etch rate in order to avoid excessive damage to a workpiece. Id. at 2:11–14. Despite Patent Owner’s arguments, we cannot agree that etch selectivity, as opposed to throughput, is the problem addressed by the ’264 patent. As Dr. Bravman points out, “[t]he specification of the ’264 patent is devoid, however, of description of improved or high selectivity processes or explanation of how the purported invention achieves both high selectivity and high etch rates.” Ex. 1025 ¶ 46. This is in contrast to the specification’s direct statement that the invention “overcomes serious disadvantages of prior art methods in which throughput and etching rate were lowered in order to avoid excessive device damage.” Ex. 1001, 2:11– 14 (emphasis added). It is clear to us that the problem faced by the ’264 patent is one of throughput and etching rate. The applicability of the cited prior art, including Hinman, to” slip op. at 32
Patent outcomesUS RE40,264 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham - Shieldmark, Inc. v. Clifford A. LoweRehearing deniedPTAB · Sep 4, 2020 · PGR2019-00058 · APJ Sheldon M Mcgee · PGR · Rehearing
The Board accepted the late rehearing request but denied rehearing, leaving in place denial of PGR because Petitioner failed to establish the patent's PGR eligibility.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed.” slip op. at 5
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Before considering the merits of a post grant review challenge, we must first determine whether the subject patent is eligible for post grant review. It is Petitioner’s burden to establish such eligibility, a threshold that Petitioner recognizes by devoting an entire section of its Petition arguing why it believes the ʼ664 patent is eligible for post-grant review (Pet. 28–43) prior to detailing its specific challenges (id. at 43–62). Petitioner’s argument in the Request suggests that, to appreciate the full scope of its eligibility arguments presented at pages 33–36 of its Petition, we were to mine other portions of the Petition (i.e., pages 53–55) for additional lack of enablement and written description arguments for a “width of the lateral edge portion” limitation. We, however, are not required to undertake such efforts on Petitioner’s behalf. See DeSilva v. DiLeonardi, 181 F.3d 865, 867 (7th Cir. 1999) (“A brief must make all arguments accessible to the judges, rather than ask them to play archaeologist with the record.”); Dec. 23 (“Because Petitioner has failed to demonstrate that the ʼ664 patent is eligible for post-grant review, we need not address Petitioner’s specific unpatentability challenges to claims 1–6, 10–16, 20–22 thereof. Pet. 43–62.”).” slip op. at 6
NonePatents in suitUS 10,214,664 - Clear-Vu Lighting LLC v. University Of StrathclydeAll claims unpatentablePTAB · Jul 8, 2020 · IPR2019-00431 · APJ Jeffrey W Abraham · IPR · Final written decision
Claims 1–4 are unpatentable: claims 1 and 3 as obvious over Ashkenazi and Nitzan, and claims 2 and 4 as obvious over Ashkenazi, Nitzan, and Jones.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“proposed construction of a photosensitizer as a substance that makes a target substance more sensitive to light accords with the plain and ordinary meaning of the term in the context of the claims and specification of the ’706 patent, whereas Petitioner’s proposed construction is unduly narrow. Although a photosensitizer may be “a light-reactive substance that, when exposed to light, initiates a change in another substance,” as Petitioner proposes, we are not persuaded that the claim term should be limited to only this specific type of photosensitizer. Neither the claims nor the specification expressly qualify or otherwise limit the word “photosensitizer” in any way. The Specification includes a discussion of two prior art references (Biel and Albrecht) that apply light-reactive dyes as photosensitizers, and states that the methodologies used in these references “suffer[] from the significant practical disadvantage that photosensitising agents must be applied to the bacteria that are to be inactivated.” Ex. 1001, 2:10–15. According to the ’706 patent, “[t]he need for photosensitising agents is a significant limitation of these techniques.” Ex. 1001, 2:17–19. We agree with Patent Owner that these statements in the ’706 patent specification refer to the “practical disadvantage” of applying photosensitizers in general, which is an inherent disadvantage in any photosensitizer applied before inactivation. See PO Resp. 11, 14–15. We are not persuaded by Petitioner’s argument that the ’706 patent was referring” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Ex. 10235 ¶¶ 68–76). Patent Owner does not address the definition of a person of ordinary skill in the art in its Response or Sur-reply, but Patent Owner’s declarant, Raymond Goodrich, Ph.D., testified that a person of ordinary skill in the art “would have had a combination of experience and education in chemistry, photochemistry, biochemistry, bacteriology, microbiology and/or infectious disease” including “at least a bachelor degree of science degree in one or more of these areas and at least two years of work experience in at least one of these fields.” Ex. 20016 ¶ 23. Dr. Goodrich also indicated that all of his opinions would apply equally under Petitioner’s definition of a person of ordinary skill in the art. Ex. 2001 ¶ 24. In view of the large degree of overlap between the parties’ definitions, and Dr. Goodrich’s statement that his opinions would apply under either definition, we adopt Petitioner’s proposed definition, such that a person of ordinary skill in the art would have had “at least a bachelor of science degree in one of the areas of molecular biology, biochemistry, microbiology, or infectious diseases, and likely a doctoral degree in one of these subjects, with several to many years of experience with bacterial inactivation techniques.” Pet. 18. This level of skill is consistent with the field of endeavor of the ’706 patent and the disclosures of the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); see also PO Resp. 36 (noting that Dr. Sulzinski based his definition of the level of ordinary skill on the” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We are not persuaded by Petitioner’s argument. Although Petitioner cites to a paragraph in the Sulzinski Reply Declaration to support the argument that the MRSA would have been rinsed of any ALA, Dr. Sulzinski merely states that this is his opinion, and offers no evidence to support that statement. Ex. 1033 ¶ 77. Without disclosing the underlying facts or data forming the basis for this opinion, this testimony is entitled to little or no weight. 37 C.F.R. § 42.65(a). Additionally, even if we were to agree that all of the MRSA would have been rinsed of any ALA prior to exposing it to light, the outcome here would not change because Nitzan used a photosensitizer when it incubated the MRSA in ALA. The fact that Nitzan later rinsed the MRSA does not change the fact that Nitzan used a photosensitizer as part of its method, as precluded by claims 1 and 3.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“(internal citations omitted). It is also undisputed that Nitzan tested the photoinactivation of MRSA with and without the addition of ALA, and that MRSA, like the P. acnes tested in Ashkenazi, is a Gram-positive bacteria. Ex. 1009, 431; Ex. 1010, 17; PO Resp. 35; Pet. 45–46. Further, as Petitioner points out, Nitzan identified studies showing the successful inactivation of P. acnes when discussing “approach[es] for photoinactivation of bacteria.” Ex. 1009, 430; Reply 2. This evidence supports Petitioner’s argument that a person of ordinary skill in the art would have been prompted to employ and adapt “Ashkenazi’s known technique of inactivating P. acnes in the absence of exogenous ALA for the purpose and benefit of inactivating MRSA in the absence of exogenous ALA.” Pet. 45–46; Ex. 1023 ¶ 163. The evidence also supports Petitioner’s arguments that it would have been obvious to try to inactivate MRSA in the absence of exogenous ALA using Ashkenazi’s techniques. Pet. 47; KSR, 550 U.S. at 421. Ashkenazi showed one type of Gram-positive bacteria could be inactivated with 407– 420 nm light in the absence or presence of ALA. Nitzan showed another type of Gram-positive bacteria (MRSA) could be inactivated with the same visible light in the presence of exogenous ALA. These facts support Petitioner’s assertion that “the next logical step” would be to try inactivating MRSA in the absence of exogenous ALA using the same visible light used in Ashkenazi. Pet. 47.” slip op. at 32
Patent outcomesUS 9,839,706 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,839,706 - Cisco Systems, Inc. v. Ramot At Tel Aviv University Ltd.Institution deniedPTAB · May 15, 2020 · IPR2020-00122 · APJ Jason M Repko · IPR · Institution
The Board denied institution of review of claims 1, 2, 4, and 5 under § 314(a), finding the Fintiv factors favored denial despite the petition’s merits.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“To institute an inter partes review, we must determine “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). But the Board has discretion to deny a petition even when a petitioner meets that threshold. Id.; see, e.g., Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”); Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) (precedential as to § II.B.4.i); NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-00752, Paper 8 (PTAB Sept. 12, 2018) (precedential); Patent Trial and Appeal Board Consolidated Trial Practice Guide 64 (Nov. 20, 2019), http://www.uspto.gov/TrialPracticeGuideConsolidated (identifying considerations that may warrant exercise of this discretion).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“Because the trial date is substantially earlier than the projected statutory deadline for the Board’s final decision, this factor weighs in favor of discretionary denial.” slip op. at 8
Discretionary denialPatents in suitUS 10,033,465 - Cisco Systems, Inc. v. Ramot At Tel Aviv University Ltd.Institution deniedPTAB · May 15, 2020 · IPR2020-00123 · APJ Jason M Repko · IPR · Institution
The Board denied institution of review of claims 1 and 2 under § 314(a), finding the Fintiv factors—especially overlapping issues and the earlier trial date—weighed against institution.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivInstitution denied
“6. Conclusion All Fintiv factors weigh in favor of exercising our discretion to deny institution under § 314(a) except for one, which is neutral. We have reviewed the Petition and determine that its merits do not outweigh the Fintiv factors—especially considering the number of overlapping issues in district court, which strongly favors denial under factor 4, and the trial date, which is substantially earlier than the projected statutory deadline for the Board’s final decision. On balance, instituting would be an inefficient use of Board, party, and judicial resources. See NHK, Paper 8 at 20. Thus, efficiency and integrity of the system are best served by denying review. See Consolidated TPG at 58 (quoting 35 U.S.C. § 316(b)).” slip op. at 11
Discretionary denialPatents in suitUS 10,270,535
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.