• Satco Products, Inc. v. The Regents Of The University Of CaliforniaInstitution denied
  PTAB · Nov 8, 2021 · IPR2021-00661 · APJ Steven M Amundson · IPR · Institution

  The Board denied institution of review for claims 1 and 2 under § 314(a), finding the Fintiv factors weighed against review because of the advanced, overlapping ITC investigation.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied

    “The Fintiv factors “relate to whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Fintiv, IPR2020-00019, Paper 11 at 6. A stay of parallel litigation pending resolution of a Board proceeding “allays concerns about inefficiency and duplication of efforts.” Id. That the E.D.N.Y. case was stayed “at its earliest stage,” however, does not “allay[] concerns about inefficiency and duplication of efforts” in view of the 1220 investigation. Additionally, the E.D.N.Y. case was stayed “pending completion” of the 1220 investigation, not because of any Board proceeding. Ex. 3002, 1. With dates set in the 1220 investigation for the ALJ’s initial determination and the ITC’s final determination, a stay seems highly unlikely, especially with the initial determination date about a week away. Hence, factor (1) weighs against institution. See Fitbit, Inc. v. Koninklijke Philips N.V., IPR2020-00771, Paper 14 at 16–17 (PTAB Oct. 19, 2020).” slip op. at 18

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied

    “to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 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). But we have discretion to deny a petition even when a petitioner satisfies the “reasonable likelihood” threshold standard for instituting trial. 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.”). Based on the current record and for the reasons explained below, we exercise our discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review.” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Not reached

    “essentially the same argument about the ’557 patent’s effective filing date for its challenge based on Nakamura-959 and Nakamura-949 as for its invalidity defense based on insufficient written-description support for claim 1. See Pet. 7, 12–21, 37; Ex. 2004, 29–33; Ex. 2005, 245–48; Ex. 2014, 64–65, 70. As we understand the arguments, resolving the ’557 patent’s effective filing date does not require interpreting any part of § 1.57. See Pet. 12–21; Prelim. Resp. 29–31. Instead, the issue turns on whether the ’154 application supports claim 1 according to § 112’s first paragraph. See Pet. 12–21; Prelim. Resp. 29–31. Also, the challenges based on Tanda present a similar issue whether the ’447 provisional supports claim 1 according to § 112’s first paragraph. See Pet. 12–21, 61; Prelim. Resp. 29–31, 36–37. “[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Under the circumstances here, the ITC can apply the test for sufficiency of disclosure to the ’154 application and the ’447 provisional just as well as the Board.” slip op. at 27

  § 112 disclosureDiscretionary denial
  Patents in suitUS 10,658,557
• Commonwealth Scientific And Industrial Research Organisation v. BASF Plant Science Company GmbHAll claims unpatentable
  PTAB · Oct 1, 2021 · PGR2020-00057 · APJ Robert A Pollock · PGR · Final written decision

  Claims 1–17 are unpatentable based on lack of written description, lack of enablement, and anticipation or obviousness over Bauer, Napier, and Petrie I; the Petrie II obviousness ground was not proven.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Although the precise definition of the person of ordinary skill in the art is not dispositive of Petitioner’s grounds, we find it useful in framing the field of the invention. While we agree with Petitioner’s emphasis on plant recombinant DNA techniques, Patent Owner’s focus on plant genetics and plant lipids is well taken. As noted in the Patent Owner Response, the challenged claims are “directed to plant seed oils produced by a transgenic 10 Petitioner does not contest Patent Owner’s assertions regarding the similarities between the subject matter of the ’870 patent and the patents at issue in the Virginia litigation but asserts that its arguments in the Virginia litigation differed from those presented here, that those arguments were not accepted by the judge, and that “CSIRO ended up giving BASF a covenant not to sue on every single patent that had the language ‘at least a number with no upper limit.’” See Ex. 2005, 5–16; Ex. 2003, 14–16; Tr. 75:25– 76:11. plant,” whereas the portions of the Specification most relevant to those claims describe “genetically modified plants capable of producing certain oils, lipids, and fatty acids, and the genetic techniques related thereto.” PO Resp. 24–25 (citing Ex. 2012 ¶ 54); see also section I.D, above. Considering the above, as well as the ’870 patent and cited art, we view a person of ordinary skill in the relevant art as having a working knowledge of plant recombinant DNA techniques, a Ph.D. in plant molecular biology, lipid biochemistry, or lipid metabolism, and three years of work experience (excluding Ph.D. thesis studies) in lipid biochemistry or lipid metabolism as applied to plants. B.” slip op. at 17

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

    “In light of the above, the many variables affecting DHA production render the functional upper bound of “at least 1% docosahexaenoic acid (DHA)” a moving target. We thus return to the intrinsic evidence and the plain language of the independent claims. Applying the ordinary and customary meaning in accord with Phillips, we adopt Petitioner’s proposed construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). See Pet. 30; Ex. 1002 ¶ 57. For similar reasons, and because Patent Owner does not expressly argue the meaning of the remaining terms, we further adopt Petitioner’s proposed construction of “a ratio of DHA to [DPA] of at least 2,” as covering a ratio from 2 up to infinity; and “a conversion rate of DPA to DHA of at least 75%,” as covering a conversion rate of 75% to 100%. See Pet. 30–31; Ex. 1002 ¶ 57; Dec. 13–14. We further adopt Petitioner’s uncontested explanation that the “ratio of DHA to DPA of 2.9” recited in claims 6 and 15 indicates “an implicit upper limit of 73.6% DHA.” See Pet. 56 n.15.” slip op. at 29

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable

    “We consider, first, the evidence of record under our construction of “at least 1% docosahexaenoic acid (DHA)” as covering amounts of DHA from 1% to 99% (since the claims also require a minimum amount of 1% EPA). Patent Owner argues that such levels are “impossible” and does not contest Petitioner’s assertion that the challenged claims are unpatentable for lack of written description under this construction. PO Resp. 27, 28. Indeed, Dr. Sederoff admitted that the ’870 patent neither describes nor enables one 15 The arguments and evidence adduced in this proceeding do not address whether the conversion of 18:2 and 18:3 to DHA could be accomplished using a subset of the enzyme activities shown in Figure 1 by omitting some of the enzymes that permit formation of alternative intermediates. To the extent this is possible, it would not alter the thrust of our reasoning throughout this Decision. of ordinary skill in the art to make a transgenic Brassica plant (as recited in claims 5 and 13) that produces more than 50% DHA. Ex. 1016, 64:23–66:2, 67:24–68:4. But although reaching the upper limit of “at least 1% docosahexaenoic acid (DHA)” may be impossible under any of the constructions considered herein, the Federal Circuit “repeatedly and consistently has recognized that courts may not redraft claims, whether to make them operable or to sustain their validity.” Chef Am., Inc. v. Lamb- Weston, Inc., 358 F.3d 1371, 1374 (Fed. Cir. 2004) (collecting cases). For the above reasons, we find that a preponderance of the evidence supports Petitioner’s contention that claims 1–17 do not comply with the written description requirement as set forth in Ground 1 under our construction of “at least 1% docosahexaenoic acid (DHA),” with respect to any plant including Arabidopsis. Considering claims 5 and 13, in particular, the ’870 patent does not describe a transgenic Brassica plant that produces more than 50% DHA.” slip op. at 35

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “In view of the above, we find that one of ordinary skill in the art would have understood that even in high copy number lines, unpredictable effects such as gene silencing could prevent the accumulation of high levels of enzymes such as those listed in Table 4 of the ’870 patent. Moreover, even if high enzyme levels were achieved, the extent to which those enzymes would catalyze the desired reactions would have been unknown. Accordingly, from a quantitative standpoint, the evidence adduced points to a high level of unpredictability in the art. Focusing on the last step of the pathway illustrated in Figure 1 of the ’870 patent, Patent Owner also asserts that the ordinarily skilled artisan “knew how to introduce multiple additional copies of the key enzyme responsible for the rapid and efficient conversion of DPA to DHA, the Δ4 desaturase from Emiliana huxleyi, to achieve ratios of DHA to DPA approaching infinity, and conversion rates approaching 100%.” Sur-reply 21 (citing Ex. 2021 ¶¶ 136, 142 (stating that “no technical limitation prevents reaching a ratio nearing infinity,” i.e., 100% conversion of DPA to DHA)). Ex. 2012 ¶¶ 100, 113, 136, 142. Although we accept that the ordinarily skilled artisan could understand how and why to carry out those steps, the evidence discussed above persuades us that achieving the stated conversion efficiency for this step alone would have entailed undue experimentation. Considering that Patent Owner’s proposed construction requires, not just one, but every step of the pathway illustrated in Figure 1 proceed with (or at least near) 100% efficiency, the evidence of record persuades us that it would have required undue experimentation to achieve the claimed invention under any construction of “at least 1%” DHA advanced in this proceeding. In light of the above, and considering all the evidence, we find that a” slip op. at 61

  Patent outcomesUS 10,351,870 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips
  Patents in suitUS 10,351,870
• BASF Corporation v. Ingevity South Carolina, LLCNo claims unpatentable
  PTAB · Sep 9, 2021 · PGR2020-00037 · APJ Julia Heaney · PGR · Final written decision

  Claims 1–10, 14–28, 32–38, 51, 52, 55–57, 59, 64–72, and 76–82 were not shown unpatentable for indefiniteness or obviousness over Hiltzik, Clontz WIPO, and Clontz SAE.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “art include “(1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field.” Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Petitioner argues a person of ordinary skill in the art at the time of the invention “would possess at least a B.S. in chemistry or chemical or mechanical engineering and would have at least one year of experience working on control of automotive evaporative emissions,” and “would also understand the chemistry and physics associated with the phenomena of fuel vapor adsorption, desorption, and diffusion.” Pet. 28 (citing Ex. 1003 ¶ 17). Patent Owner does not dispute the level of ordinary skill in the art. We adopt Petitioner’s definition of the level of ordinary skill in the art because it is consistent with the ’553 patent and the asserted prior art.” slip op. at 11

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and standards that confirm persons of ordinary skill in the art understood that gravimetric and volumetric measurement techniques would provide consistent results when proper experimental protocols are followed and the instruments’ accuracy and precision are taken into consideration. See Ex. 2022 ¶¶ 88–91, 119–127. This evidence is essentially unrebutted by Petitioner. We find that the evidence submitted by Patent Owner as to the gravimetric and volumetric measurement techniques demonstrates that they were well established in the art as comparable methods of measuring adsorption capacity, and accordingly, not a basis for determining claim” slip op. at 16

  • ExcludeMotion to exclude, grantedGranted in part

    “Exhibit 2027. Paper 57 (“Pet. Mot.”). We do not discuss or cite Exhibit 2080 or paragraph 39 of Exhibit 2027 in this Decision, and consideration of them played no part in our determinations set forth herein. Because their presence in the record would not affect our analysis in this Decision, we dismiss as moot Petitioner’s motion with respect to these exhibits. B. Patent Owner’s Motion to Exclude Patent Owner filed a motion to exclude Exhibits 1015–1016, 1023– 1025, 1032, 1038–1039, 1042 (certain paragraphs), 1044, 1046–1049, and 1052–1054. Paper 56 (“PO Mot.”). Patent Owner groups these exhibits into four categories, which we apply in discussing the motion below. 1. Patent Owner moves to exclude Exhibits 1015 and 1046 as “irrelevant determinations from other adjudicative bodies regarding different patents.” PO Mot. 1. We do not discuss or cite these exhibits in this Decision, and have not considered them in reaching our decision herein. Because the presence of these exhibits in the record would not affect our analysis in this Decision, we dismiss as moot Patent Owner’s motion with respect to these exhibits. 2. Patent Owner moves to exclude Exhibits 1023, 1024, 1025,” slip op. at 46

  • Disclosure Requirements (§112) › Definiteness (Nautilus)Written description adequateNot shown unpatentable

    “Petitioner has not shown by a preponderance of the evidence that the gravimetric and volumetric methods provide fundamentally different measurements of adsorption capacity. Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and” slip op. at 16

  Patent outcomesUS 10,323,553 not shown unpatentable
  § 103 obviousness§ 112 disclosurecites KSR · Graham · Nautilus
  Patents in suitUS 10,323,553
• Red Diamond, Inc. v. Southern Visions, LLPOther
  PTAB · Mar 31, 2021 · IPR2020-00001 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board canceled claims 1, 5, 8, and 10–12, but denied entry of substitute claims 20–25 because claims 20 and 24 were indefinite and claims 21–23 and 25 were obvious.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it pertains to brewed beverages and (2) sugar particle size screening.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019- 00045, Paper 9 at 6–8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 7–8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 7–8), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 5

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “consider” the Revised Motion to Amend and cancel original claims 1, 5, 8, and 10–12. Revised MTA 1. Because Patent Owner has not indicated that our consideration of the Revised Motion to Amend is contingent on a determination that original challenged claims 1, 5, 8, and 10–12 are unpatentable, we grant Patent Owner’s request to cancel original challenged claims 1, 5, 8, and 10–12. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018- 01129, Paper 15 at 3 (PTAB Feb. 25, 2019) (precedential) (“Lectrosonics”) (“A request to cancel claims will not be regarded as contingent.”). The remaining issue before us is whether to grant the Revised Motion to Amend as to proposed substitute claims 20–25.” slip op. at 6

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable

    “sugar, which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 9; Reply 4.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “sugar in its products (Ex. 1008, 11:2–5), and Mr. Ebersole’s testimony demonstrates that a person of ordinary skill in the art would have known that Standard Grade and Medium Grade sugars are commercial grade granulated sugars and that the particles in Standard Granulated and Medium Granulated sugars “are almost entirely within the range of U.S. mesh nos. 3–35” (Ex. 2076 ¶ 51). The evidence of record thus supports Petitioner’s assertion that following the typical industry practice of using 1 ounce of tea particles and 1 pound of sugar per gallon of tea, and using a commercial grade granulated sugar (as taught by Cooper) such as Standard Granulated or Medium Granulated sugar (which are known to be “almost entirely within the range of U.S. mesh nos. 3–35”), would yield a product having a blend ratio of tea particles to sugar granules having a size in the range of U.S. mesh sieve nos. 3–35 in the range of 1:16–1:25, as recited in proposed substitute claims 21 and 23. Opp. 20–21; Ex. 1008, 11:2–5; Ex. 1001, 17–20, 57–65. In view of the foregoing, we find Petitioner has established sufficiently that the teachings of Cooper, considered in view of admitted prior art sweetening practices, teaches or suggests all of the limitations of proposed substitute claims 21 and 23. Petitioner has presented evidence demonstrating sufficiently that Cooper teaches the use of sugar having particle sizes falling “almost entirely” within the range of mesh 3–35, that following typical industry practices using such sugar would result in the claimed blend ratio of tea to sugar having a size in the range of mesh 3–35, and that a person of ordinary skill in the art would have had reason to brew commercial-sized batches of tea, with a reasonable expectation of success in doing so, as Cooper allows.” slip op. at 26

  § 103 obviousness§ 112 disclosurecites KSR · Nautilus
  Patents in suitUS 9,549,634
• Red Diamond, Inc. v. Southern Visions, LLPAll claims unpatentable
  PTAB · Mar 31, 2021 · IPR2019-01671 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board canceled claims 1, 6, and 10–12 and denied entry of substitute claims 18–22, finding claims 18–21 indefinite and claim 22 obvious.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 6–7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6–8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 11–12), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 5

  • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part

    “II. MOTION TO AMEND A. ORIGINAL CHALLENGED CLAIMS As noted above, Patent Owner requests that we “unconditionally consider” the Revised Motion to Amend and cancel original claims 1, 6, and 10–12. Revised MTA 1. Because Patent Owner has not indicated that our consideration of the Revised Motion to Amend is contingent on a determination that original challenged claims 1, 6, and 10–12 are unpatentable, we grant Patent Owner’s request to cancel original challenged claims 1, 6, and 10–12. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018- 01129, Paper 15 at 3 (PTAB Feb. 25, 2019) (precedential) (“Lectrosonics”) (“A request to cancel claims will not be regarded as contingent.”). The remaining issue before us is whether to grant the Revised Motion to Amend as to proposed substitute claims 18–22.” slip op. at 6

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable

    “Particle size is a critical factor for proposed substitute claims 18 and 20, which require a comparison of the particle size of the sugar used in the recited mesh pouch against the particle size of Sugar in the Raw. For all of the reasons discussed above, we find a person of ordinary skill in the art would not have understood that the trademark Sugar in the Raw identifies sugar having particles of a particular size with sufficient specificity to allow the comparison of particle sizes that proposed substitute claims 18 and 20 require. Accordingly, proposed substitute claims 18 and 20 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021)6; MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 18

  • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

    “analogous art. Reply 7. “A reference qualifies as prior art for an obviousness determination under § 103 only when it is analogous to the claimed invention.” In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Even if we were to agree with Patent Owner that Thijssen is not from the same field of endeavor because, inter alia, it involves the use of a packed bed, we still find Thijssen to be analogous art because it is reasonably pertinent to the problem with which the inventors were involved. The ’330 patent teaches that “[t]he larger sugar granules allow the water to flow around it at the same time you are extracting tea from the tea blend.” Ex. 1001, 7:15–17. This indicates that among the problems “with which the inventor[s were] involved” were extraction of flavor from tea and the flow of water around the particles involved in the tea brewing process. Thijssen likewise addresses the flow of solvent through solid particles during extraction of a beverage product. See, e.g., Ex. 1022, 2:46–48. In view of this, we find Thijssen is “reasonably pertinent to the particular problem with which the inventor[s were] involved.” Bigio, 381 F. 3d at 1325.” slip op. at 33

  Patent outcomesUS 9,468,330 unpatentable
  § 103 obviousness§ 112 disclosurecites Nautilus
  Patents in suitUS 9,468,330
• Red Diamond, Inc. v. Southern Visions, LLPOther
  PTAB · Mar 31, 2021 · IPR2019-01662 · APJ Jeffrey W Abraham · IPR · Final written decision

  The Board canceled claims 1, 8, 13, and 17; it denied entry of substitute claims 23–26 because claims 23 and 25 lacked written-description support and claims 24 and 26 were indefinite.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it 1 “One degree Brix is one gram of sucrose in 100 grams of solution . . . . Brewed sweetened tea has a typical Brix level of 10½ to 11.” Ex. 1001, 1:35–43. pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6– 8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 12–13), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 4

  • 112 supportMotion to amend, deniedDenied

    “Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

    “Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20

  • Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable

    “which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 7–10; Reply 4. Proposed substitute claims 24 and 26 compare the dissolution of the claimed beverage brewing product against the dissolution of a product using typical grocery store sugar (i.e., EFG). Patent Owner explains that the size of the particles affects dissolution – namely that larger sugar is more advantageous – in the claimed invention. See, e.g., Revised MTA 5; Ex. 1001, 9:23–27, 10:19–22. This suggests that an EFG sugar product having a greater percentage of large particles will be capable of dissolving “more of granulated sugar” as compared to an EFG sugar product having a lower percentage of large particles. As a result, using the dissolution properties of “typical grocery store sugar” as a comparator in the claims is problematic as there is a potential for inconsistent results based on which particular EFG sugar product is used. The potential for inconsistent results undermines Patent Owner’s argument that these claims satisfy the definiteness requirement because a person of ordinary skill in the art “can buy EFG . . . and perform brew tests with it in order to determine the scope of the claims.” Reply 4. Particle size is a critical factor for proposed substitute claims 24 and 26, which require a comparison of dissolution properties of the sugar used in the recited brewing product and typical grocery store sugar. Patent Owner contends “[t]here is an ‘informed and confident’ choice for ‘typical grocery store sugar’ - EFG sugar.” Reply 4. The evidence of record, however, shows the number of large particles (3–35 mesh) varies among EFG sugars. Ex. 2003, 42; Ex. 1004, at pages 51–53. In view of this, we find a person of ordinary skill in the art would not have understood “typical grocery store sugar” identifies sugar having particles of a particular size with sufficient specificity to allow the comparisons that proposed substitute claims 24 and 26 require. Accordingly, proposed substitute claims 24 and 26 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021); MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 25

  § 112 disclosurecites Nautilus
  Patents in suitUS 9,725,232
• Red Diamond, Inc. v. Southern Visions, LLPOther
  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 disclosure
  Patents in suitUS 10,071,852
• Intel Corporation / Globalfoundries U.S., Inc. et al. v. Daniel L. FlammAll claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
• Lassen Therapeutics 1, Inc. v. Singapore Health Services Pte Ltd., And National University Of SignaporeInstitution denied
  PTAB · Feb 6, 2020 · PGR2019-00053 · APJ Jamie T Wisz · PGR · Institution

  The Board denied institution because Petitioner did not show it was more likely than not that claims 1–10 were unpatentable on any asserted ground.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

    “review under 35 U.S.C. § 324 and 37 C.F.R. § 42.4(a). We may not institute a post-grant review 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.” 35 U.S.C. § 324(a). Applying that standard, and upon consideration of the information presented in the Petition and the Preliminary Response, we determine that the information presented fails to demonstrate it is more likely than not that at least 1 of the challenged claims of the ’603 patent is unpatentable. Accordingly, we deny institution of post-grant review of claims 1–10 of the ’603 patent.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of the preliminary response only, it does not challenge Petitioner’s definition of a person of ordinary skill in the art. Prelim. Resp. 19. Based on the current record and for the purposes of this Decision, we adopt Petitioner’s proposed description of the person of ordinary skill in the art. Furthermore, we find that the prior art of record reflects this level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

    “We agree with Patent Owner that “Interleukin 11 receptor α (IL- 11Rα) antibody” should not be construed to include antibodies that bind to IL-11Rα of non-human species but not to the human version of this protein because such a construction does not comport with the language of claim 1, which is clearly directed to treating a human subject. See Pause Tech. v. TiVo, 419 F.3d 1326, 1331 (Fed. Cir. 2005) (rejecting interpretation of claim element that ignored “other language appearing later in the claim” in stating that ‘“[p]roper claim construction . . . demands interpretation of the entire claim in context, not a single element in isolation.’”) (citing Hockerson– Halberstadt, Inc. v. Converse Inc., 183 F.3d 1369, 1374 (Fed.Cir.1999)). Construing this term to include antibodies that bind solely to non-human IL- 11Rα would be inconsistent with a claim directed to treatment of a human. Accordingly, for purposes of this decision, we construe “Interleukin 11 receptor α (IL-11Rα) antibody” to mean “any natural or synthetic, monoclonal or polyclonal antibody made using any animal system including phage, or fragment or derivative thereof, that binds to human IL-11Rα.”” slip op. at 9

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “We agree with Patent Owner that Petitioner appears to have overlooked the ’603 patent Specification’s disclosure of anti-IL-11Rα antibodies. Specifically, the ’603 patent lists “monoclonal antibody clone 025 (Sino Biological), clone EPR5446 (Abcam), clone 473143 (R & D Systems), clones 8E2 and 8E4 described in US 2014/0219919 A1 [Edwards] and the monoclonal antibodies described in Blanc et al (J. Immunol Methods. 2000 Jul. 31; 241(1–2); 43–59).” Ex. 1001, 18:41–46; Ex. 1003 ¶ 176.6 Edwards, which Petitioner relies on for its obviousness and anticipation grounds, is directed to antibodies “that bind to IL-11Rα and neutralize IL-11 signaling.” Ex. 1008 ¶ 13. Table 1 of Edwards lists clones 8E2 and 8E4 and sixty-three other antibodies (including variants of 8E2) as “exemplary IL-11Rα-binding proteins.” Id. ¶ 362. Table 1 of Edwards also includes the sequence ID numbers for the heavy and light chains of the variable regions of each of these sixty-five clones and the amino acid sequences for each are disclosed in the sequence listing. Id. ¶ 362, p. 46– 104.7” slip op. at 12

  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · Graham
  Patents in suitUS 10,106,603
• Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, Inc.Some claims unpatentable
  PTAB · Nov 29, 2018 · IPR2017-02139 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1, 2, 4, 25, 29–31, 33, 62–64, 66, 67, 69, 72, 78, 80, and 81 are unpatentable; the remaining challenged claims were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted

    “Petitioner Samsung Bioepis Co., Ltd. (“Bioepis”) timely submitted a Petition presenting substantially the same challenges as set forth in Pfizer’s Petition along with a request for joinder to IPR2017-01488. IPR2017- 02139. Paper 1. We granted Bioepis’s Petition and associated request for joinder to this case. IPR2017-02139, Paper 11, 6–7.” slip op. at 3

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “B. Person of Ordinary Skill in the Art The parties propose similar definitions of a person of ordinary skill for the ’213 patent. See Pet. 15–16; Prelim. Resp. 18; PO Resp. 18. In our institution decision, we adopted Patent Owner’s proposal that “[a] person of ordinary skill for the ’213 patent would have had a Ph.D. or equivalent in chemistry, biochemistry, structural biology, or a closely related field, and experience with antibody structural characterization, engineering, and/or biological testing, or an M.D. with practical academic or industrial experience in antibody development.” Dec. 8. Petitioners do not contest this definition in its Reply and we find no reason to revise our earlier determination.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “variable domain,” which appears in claims 4, 33, 62, and 69, to mean “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure.” Prelim. Resp. 18–19; PO Resp. 19. Patent Owner correctly points out that this “construction comes directly from the definition provided in the ’213 patent.” Prelim. Resp. 19 (citing Ex. 1001, 11:32–38). Petitioners expressly adopt this construction in their Reply. Pet. Reply 5–6. We do not agree, however, that the claims demand a consensus of “all” human immunoglobulins in the literal sense. Indeed, Petitioners point out that “the ‘consensus’ sequence used for the patent variants was generated using the most common residue at each position identified in [Kabat 198711].” Pet. Reply 15 (citations omitted). And though Patent Owner attempts to distinguish Queen 1990 as describing “a consensus framework from many human antibodies,’ not all as in the ’213 patent,’” it presents no argument as to why we should interpret the claim in this manner. 11 Kabat et al., Sequences of Proteins of Immunological Interest: Tabulation and Analysis of Amino Acid and Nucleic Acid Sequences of Precursors, V- Regions, C-Regions, J-Chain, T-Cell Receptor for Antigen, T-Cell Surface Antigens β2-Microglobulin, Major Histocompatibility Antigens, Thy-1 Complement, C-Reactive Protein, Thymopoietin, Post-Gamma Globulin, and α2-Macroblobulin, 41–175 (4th Ed. 1987). Ex. 1052. See PO Resp. 47. Moreover, in a parallel proceeding involving the same patent, Patent Owner did not dispute that the reference to “all sequences” in the patent, “refer[s] to all known sequences and there’s no dispute . . . that was really synonymous with Kabat 1987.” See IPR2017-01374 Paper 82, Tr. 15:4–16:4; see Ex. 1202 ¶ 157; Ex. 2105 ¶¶ 24–25; Ex. 2107 ¶¶ 18–19; Ex. 1198, 56:20–61:24; Ex. 1199, 27:14–28:13, 29:25–36:2, 57:1–58:6, 115:7–17, 165:17–169:9. Indeed, in a similar parallel proceeding, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to “all reasonably available[,] all known at the time of the invention.” IPR2017-01373, Paper 83, 47:21–48:5. Accordingly, we adopt the parties’ proposed construction, with a clarifying modification, specifically, “a human variable domain which comprises the most frequently occurring amino acid residues at each location in all human immunoglobulins of any particular subclass or subunit structure, as set forth in Kabat 1987.”” slip op. at 13

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

    “lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient.” In our institution decision, we determined that this claim language “refer[s] to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” Dec. 10–12. Neither party disputes this interpretation. See PO Resp. 19; Pet. Reply 5–6. Consistent with claim 63’s express comparison between the immunogenicity of the claimed humanized antibody and that of its non-human parent, the Specification states that one object of the invention is to “to provide methods for the preparation of antibodies which are less antigenic in humans than non-human antibodies but have desired antigen binding and other characteristics and activities.” Ex. 1001, 4:24–28. The Specification similarly states that embodiments within the scope of the claims have “low immunogenicity,” or are designed to “minimize the potential immunogenicity of the resulting humanized antibody in the clinic.” Id. at 52:54–58, 61:56–61. Moreover, with reference to claim 63 in particular, Patent Owner points to the ’272 application as “explain[ing] that the purpose of humanizing antibodies using its consensus sequence approach is to reduce immunogenicity versus the non-human parent antibody. (Id., 6:24–30, 84:24–30.).” Prelim. Resp. 42 (citing Ex. 2032 (File History for U.S. Patent Application No. 07/715,272 (“the ’272 application”)); see also id. at 38 (indicating that the limitation is satisfied where “[o]nly 1 out of 885 patients experienced an immunogenic response . . . which was a substantial improvement over the murine 4D5 antibody”). In light of the above, we do not alter our prior determination that “[a] humanized antibody which lacks immunogenicity compared to a non-human parent antibody upon repeated administration to a human patient,” refers to a humanized antibody having reduced immunogenicity in a human patient as compared to its non-humanized parent antibody.” slip op. at 14

  Patent outcomesUS 6,407,213 mixed
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 6,407,213

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.