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  • PTAB · Nov 1, 2024 · IPR2023-01035 · APJ Tina E Hulse · IPR · Final written decision

    The Board granted cancellation of claims 1–6, 8–10, and 22–28, and denied substitute claims 29–44 because Wright ’451 rendered them obvious.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art at the time of the invention (“POSA” or “POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner took no position on the level of ordinary skill in the art in its Preliminary Response. Prelim. Resp. 8. In our Institution Decision, we adopted Petitioner’s definition. Dec. Inst. 6–7. In its Motion to Amend, Patent Owner states that it accepts the Board’s definition for purposes of this proceeding. MTA 24. We, therefore, see no reason to disturb our definition of the level of ordinary skill in the art as it appears to be consistent with the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 8

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

      “Although neither party expressly proposes a construction for the term “conversion,” the parties appear to differ in their interpretations of that term. Petitioner interprets “conversion” to mean the percent conversion of the 1- alcohol. See Pet. Opp. RMTA 6–7 (interpreting “conversion” as percentage of remaining 1-alcohol); Ex. 1040, 109:2–11. Patent Owner, on the other hand, interprets “conversion” to mean the total percentage of alkenes that have been produced. Ex. 2010 ¶ 123 (interpreting “conversion” as percentage of total alkenes). During oral argument, counsel for Patent Owner conceded that “conversion can mean either.” Tr. 27:18–28:13. Without the benefit of briefing by the parties, we decline to expressly construe the term “conversion,” as our Decision would be the same under either interpretation, as discussed further below. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (finding only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). Moreover, we do not find it necessary to expressly construe any other claim terms for purposes of this Decision. Id.” slip op. at 10

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “2. Analysis A patent claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said claimed invention pertains. See also 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 skill in the art; and (4) objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Objective evidence of nonobviousness may include” slip op. at 13

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner

      “We are not persuaded. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). We must, therefore, first consider what results were expected to determine what a POSA would have considered to be unexpected. Id. As seen by the table below, Wright ’451’s disclosure fully encompasses the temperature ranges and purported unexpected results recited by substitute claim 29 and shown in Table 2 of the ’048 Patent: Reference Reaction Calcination Conversion Regioselectivity Rate13 Temperature Temperature Wright ’451 about 220 °C about 200 °C greater than about 90% to to about to 600 °C about 95% about 99% 440 °C Substitute 240 °C to about 420 °C at least 95% to about Claim 29” slip op. at 23

    Patent outcomesUS 10,995,048 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 10,995,048
  • PTAB · Jan 9, 2024 · IPR2023-00532 · APJ John G New · IPR · Final written decision

    Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach Grounds 2–6.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “Decision. See Ex. 3001, 12–23. As an initial matter, we are not persuaded by Patent Owner’s reliance on Sanofi and Eli Lilly. See PO Resp. 9. In Sanofi, a non-precedential decision, the Federal Circuit held that the preamble to the claims at issue, reciting “[a] method of increasing survival comprising administering to a patient in need thereof” was limiting upon the claims, in conformance with the court’s prior decisions in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). Sanofi, 757 F. App’x at 992–93. Furthermore, the court held that, because the preamble was limiting, and recited a “method of increasing survival” the proposed claims would now clearly require “increasing survival.” Id. at 994. The preamble to claim 1 of the ’681 patent, however, recites no such “increase” with respect to efficacy, but merely recites “A method for treating an angiogenic eye disorder in a patient,” and the remainder of the claim requires no specific efficacy requirement. Nor does Eli Lilly support Patent Owner’s position. In Eli Lilly, the court upheld the Board’s conclusion that the preamble reciting “a method for treating headache in an individual” was limiting upon the claims. Eli Lilly, 8 F.4th at 1343. However, it noted, in upholding the Board’s conclusion, the Board also “found that while the claims encompass a clinical result, they do not require such a result.” Id. (emphasis added). We also find that the similar language of the preamble to challenged claim 1 of the ’681 patent, although encompassing clinical efficacy, does not require it, let alone a “high degree of efficacy.”” slip op. at 33

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

      “the preamble’s recitation of a “method for treating” requires a high level of efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar argument because it required improperly importing limitations into the claims. See Ex. 3001, 22. Specifically, the Board found that: [W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder. We find that, as in Eli Lilly, although the claims “encompass a clinical result, they do not require such a result.” Eli Lilly, 8 F.4th at 1343. We consequently reject” slip op. at 35

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

      “The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration. Ex. 1001, col. 3 ll. 34–44. Petitioner also notes that the Specification further explains that “the immediately preceding dose” means “in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001, col. 3, ll. 54–59; Ex. 1002 ¶¶ 44–45). We adopt Petitioner’s proposed construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses that are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001, col. 3, ll. 36–44.” slip op. at 37

    • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

      “As Petitioner states, Patent Owner relies upon these Exhibits as objective secondary evidence of non-obviousness. See, e.g., PO Resp. 65– 69. However, and as we explain below, because we find that the challenged claims are anticipated by Dixon, we do not reach Patent Owner’s arguments that the claims are non-obvious (Grounds 4–6) or its contentions regarding secondary considerations of non-obviousness. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (holding that “secondary considerations are not an element of a claim of anticipation”). Consequently, we dismiss Petitioner’s motion to dismiss the Financial Documents as moot.” slip op. at 10

    Patent outcomesUS 10,130,681 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 10,130,681
  • PTAB · Jun 16, 2023 · PGR2021-00085 · APJ Barry L Grossman · PGR · Final written decision

    The Board granted the motion to amend but held amended claim 64 unpatentable as anticipated by NanoCool 98596-type products and obvious over the cited combinations; all other amended claims were not shown unpatentable.

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

      “VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that Petitioner has demonstrated by a preponderance of the evidence that amended claim 64 is unpatentable; FURTHER ORDERED that Patent Owner’s Non-Contingent Motion to Amend is granted for claims 64 and denied for all other amended claims; and” slip op. at 77

    • ExcludeMotion to exclude, deniedDenied

      “A. Status as Prior Art Is a Substantive Issue, Not an Evidentiary Issue. A motion to exclude is not an appropriate mechanism for challenging the sufficiency of evidence, such as whether a reference qualifies as prior art, or the proper weight that should be afforded an argument. See Flir Systems, Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 113, 4, 8–9 (PTAB September 3, 2015); PTAB Consol. Trial Practice Guide 79 (Nov. 30 Mr. Zumwalt testifies that other NanoCool products, designated by product number 85430 and 98630, also have the same configuration as the 98830 product and are made by the same process. Thus, “the 98830, 85430, and 98630 products can be collectively referred to as ‘98830-type’ products all having the same relevant design.” Ex. 1030 ¶ 17. 2019) (“A motion to exclude . . . may not be used to challenge the sufficiency of the evidence to prove a particular fact. A motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments regarding weight should appear only in the merits documents.”); Caterpillar Inc. v. Wirtgen Am., Inc., IPR2017-02187, Paper 42,17 (PTAB May 21, 2019) (status as prior art “is a substantive issue, not an evidentiary issue.”) Thus, whether the NanoCool 98830 product is prior art is not the proper basis for Patent Owner’s Motion to Exclude evidence concerning the NanoCool 98830 product.” slip op. at 29

    • Skill levelSkill level board ownOther

      “Neither Petitioner nor Mr. Harber provide any analysis of the factors pertinent to a determination of the level of ordinary skill, identified above, to support their conclusory statements. We give Mr. Harber’s conclusory testimony minimal probative weight. 37 C.F.R. § 42.64(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Moreover, there is no persuasive evidence to which we have been directed of the need for specific education or experience in biological or chemical technologies related to the claimed containers and inserts.” slip op. at 26

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “With regard to the level of ordinary skill in the art, Petitioner asserts that a person of ordinary skill would have had “a bachelor’s degree or higher degree in biological, chemical or mechanical engineering, or related sciences, and at least two to five years of experience in designing and testing ISCs [insulated shipping containers] depending on education level.” Pet. 9 (emphasis added) (citing Ex. 1002 ¶¶ 23–24). Exhibit 1002 is the Declaration testimony of Mr. Paul Haber. Mr. Harber actually states a slightly different level of ordinary skill. Mr. Harber testifies: The hypothetical POSITA would have: (i) at least a bachelor’s degree in biological, chemical or mechanical engineering, or related sciences, and have at least three to five years of experience in designing and testing ISCs [Insulated Shipping Containers][29]. Such a person may also have (ii) a higher level degree, such as a PhD and/or Master’s degree in engineering, or related sciences, and have at least two to three years of experience in designing and testing ISCs. 29 See Ex. 1002 ¶ 23. Ex. 1002 ¶ 24 (emphasis added). Mr. Harber also testifies that “[t]hese descriptions are approximate, and a higher level of education or specific skill might make up for less experience, and vice-versa.” Id.” slip op. at 25

    Patent outcomesUS 10,766,685 mixed
    Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham
    Patents in suitUS 10,766,685
  • PTAB · Jan 6, 2023 · PGR2021-00107 · APJ Robert A Pollock · PGR · Final written decision

    The Board canceled claim 3, found substitute claim 22 unpatentable as anticipated by Gille503, Gille501, and Mohl996, and granted the motion to amend in part.

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

      “claims.” 35 U.S.C. § 326(d)(1)(B); see 37 C.F.R. § 42.221(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are canceled, i.e., a one-to-one substitution of claim 3 with proposed substitute claim 22. MTA 1. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4. Petitioner does not argue otherwise.” slip op. at 28

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In our Institution Decision we provisionally adopted Petitioner’s proposed definition of a person of ordinary skill in the relevant art (sometimes referred to herein as a “POSA”) as having “an M.D. or a Bachelor’s or Master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices” or would have “a Ph.D. in mechanical or biomedical engineering, or in a similar field.” DI 10 (citing Pet. 15; Ex. 1002 ¶ 72). This definition is uncontested and we continue to apply it here. See MTA 4–5. D.” slip op. at 32

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

      “Patent Owner’s contention that we should read “baseline blood pressure measurement” as limited to a single measurement determined prior to, or at the beginning of a procedure, nothing in claim 22 prohibits the device from recalculating a baseline blood pressure measurement, or comparing current blood pressure to the updated baseline. Proposed substitute claim 22 is not a method claim, but is directed to a device that is agnostic as to when a “baseline blood pressure measurement” is determined, as well as its source. Thus, even if the flow diagrams shown in Figure 11A and 11B of the ’069 Patent do not contain instructions to update the baseline pressures acquired in steps 302 and 354, respectively, this is not forbidden by proposed substitute claim 22 as written, and Patent Owner does not persuade us that such a limitation should be imported into the meaning of “baseline blood pressure measurement.”” slip op. at 34

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “For the reasons discussed above, we do not read the exemplary embodiments described in paragraph 14 of Gille503 as representative of the reference as a whole. Rather, we find more persuasive Dr. Day’s testimony that Gille503 satisfies Element 22[h] because one of ordinary skill in the art would have understood that “comparisons performed by the feedback loop would detect a change in blood pressure either when current sensed blood pressure ceases to equal the target blood pressure, or when current sensed blood pressure begins to equal target blood pressure after previously not equaling the target pressure.” Ex. 1014 ¶ 114; see generally, id. ¶¶ 111–119. Dr. Leschinsky also opines that the analysis in our Preliminary Guidance fails to satisfy the requirements of claim 22 because “the control module must specifically perform a comparison between a baseline measurement and another measurement.” Ex. 2006 ¶ 69 (emphasis added). We find it self-evident that this function is carried out by a control module, and agree with Petitioner and its expert that one of ordinary skill would understand Gille503 to describe a feedback loop comprising a control module “controlling balloon inflation based on sensor data to achieve a ‘target’ pressure.” Opp. MTA 13; Ex. 1014 ¶¶ 120–125. In view of the above, we find that one of ordinary skill in the art would understand Gille503 to disclose the “in a vein” and “comparing” limitations of the proposed substitute claim (elements 22[c]/[e] and 22[h], respectively). We have also considered Petitioner’s arguments and evidence with respect to the uncontested limitations. Considering the record as a whole, Petitioner has shown by a preponderance of the evidence that claim 22 is unpatentable as anticipated by Gille503. F.” slip op. at 45

    Patent outcomesUS 10,926,069 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,926,069
  • 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
  • PTAB · Aug 12, 2020 · PGR2019-00032 · APJ David Cotta · PGR · Final written decision

    The Board granted cancellation of claim 8 and denied entry of substitute claim 11 because Petitioner showed it would have been obvious over Omura, Tsuji, and the knowledge of a person of ordinary skill.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “In our Institution Decision, we agreed with the position Patent Owners took in their Preliminary Response – i.e, that the focus of the challenged claims was enzyme-based biosensors and thus the POSA would have more than just a familiarity with enzyme-based biosensors and protein chemistry. Inst. Dec. 8–9. Accordingly, based on the record before us at the time, we accepted the definition provided in Patent Owners’ Preliminary Response, which was consistent with the level of skill reflected in the asserted prior art references and in the specification of the ‘987 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). Neither party challenges the identification of the POSA set forth in our Institution Decision. See generally, R. Mot.; Opp.; Reply; Sur-reply. Additionally, we find that the fully developed trial record supports the POSA identification we made in our Institution Decision. Accordingly, in this decision, we apply the identification of the POSA set forth in our Institution Decision. Inst. Dec. 9.” slip op. at 9

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

      “Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). For purposes of this decision, we need not expressly construe any claim terms.” slip op. at 10

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

      “first, substitute claim 11 would have been obvious over Omura in view of the knowledge of the POSA, and second, substitute claim 11 would have been obvious over the combination of Omura and Tsuji in view of the knowledge of the POSA. Opp. 7–24. We have considered the question of patentability in view of all the evidence and arguments presented in this proceeding. Based on the record developed during this proceeding, we determine that Petitioner has shown by a preponderance of the evidence that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA. Because Petitioner has proven that substitute claim 11 would have been obvious, as discussed in detail below, we do not consider whether Patent Owners’ motion otherwise complies with the statutory and regulatory requirements for a motion to amend. See, 35 U.S.C. § 326(d)(1)(B) (requiring that the amendment propose a “reasonable number of substitute claims” and requiring that the substitute claims do “not enlarge the scope of the claims of the patent or introduce new matter”); 37 C.F.R. § 42.221 (additionally providing, inter alia, that a motion to amend “may be denied where . . . [t]he amendment does not respond to a ground of unpatentability involved in the trial”). Similarly, because we have determined that substitute claim 11 would have been obvious over the combination of Omura, Tsuji, and the knowledge of the POSA, as discussed in detail below, we do not reach the question of whether substitute claim 11 would also have been obvious over only Omura in view of knowledge of the POSA.” slip op. at 11

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

      “includes “research experience and/or knowledge in enzymology . . . and biosensors,” we agree with Petitioner that it would have been obvious to a POSA to substitute FAD-conjugated glucose dehydrogenase derived from the claimed strain of Aspergillus oryzae for FAD-conjugated glucose dehydrogenase derived from Aspergillus terreus as disclosed in Omura.” slip op. at 18

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,976,125
  • PTAB · Nov 29, 2018 · IPR2017-01489 · APJ Zhenyu Yang · IPR · Final written decision

    The Board held claims 1, 2, 4, 12, 25, 29–31, 33, 42, 60, 62–64, 66, 67, 69, 71, 73, 74, 78, 80, and 81 unpatentable as obvious; claims 65, 72, 75–77, and 79 were not …

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “Level of Ordinary Skill in the Art In the Decision to Institute, we found the parties’ proposed definitions of a person of ordinary skill for the ’213 patent are similar. Dec. 7 (citing Pet. 16; Prelim. Resp. 17). We adopted Patent Owner’s proposed definition 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.” Id. During trial, Patent Owner points out that Petitioner’s proposed definition “encompasses persons without advanced degrees but who have ‘knowledge gained through 4–5 years of work experience.’” PO Resp. 17. A person of ordinary skill in the art is a hypothetical person who is presumed to know the relevant prior art. Custom Accessories, Inc. v. Jeffrey–Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The artisan may gain such knowledge through either formal education or extensive work experience. Thus, we do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Having considered the complete record developed at trial, we see no reason to change our assessment.” slip op. at 9

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

      “In the Decision to Institute, we agreed with Patent Owner that the ’213 patent expressly defined “consensus human 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.” Dec. 9–10; Ex. 1501, 11:32–38. During trial, the parties did not argue otherwise, and we see no reason to change our position as to claim construction. See PO 17–18; Reply 5. We, however, clarify that “all” in the consensus of “all human immunoglobulins” is not in the literal sense. In fact, Patent Owner does not appear to argue otherwise.7 Dr. Wilson, the expert witness for Patent 7 In a parallel proceeding involving the same patent, counsel for Patent Owner acknowledged that the term “all human immunoglobulins” refers to Owner, testified that the consensus sequence of the ’213 patent was “derived from ‘all’ known antibody sequences of any particular subclass or subunit structure.” Ex. 2041 ¶ 210 (emphasis added); see also PO Resp. 52 (arguing the same); Ex. 1698, 59:22–60:1 (Dr. Carter testifying that the consensus sequence, as defined in the ’213 patent, “only describes what was known at that time or it’s only available sequences at that -- at that time”); Ex. 1699, 35:9–16 (Dr. Presta explaining that the consensus sequence of the ’213 patent had the most common residue at every position “for the sequences that were available”). And evidence of record shows that at the priority date of the ’213 patent, the sequences that were listed in Kabat 1987 “were the sequences available.” Ex. 1699, 35:9–20; see also Ex. 2016 ¶ 25 (Kabat 1987 “collected known sequence data of antibodies”); Ex. 1698, 60:13–25 (Dr. Carter explaining the consensus sequence was derived from Kabat 1987, which is what was available at the time of the ’213 patent); Ex. 1699, 27:19–25 (Dr. Presta stating that “Elvin Kabat had taken all known human/mouse/rabbit antibody sequences, published them in a government publication, and that there were human subgroups of sequences within the heavy and the light chains”).” slip op. at 11

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

      “For the purpose of this Decision, we see no need to expressly construe any other claim terms. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 13

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

      “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. KSR, 550 U.S. at 421. Here, Queen 1989 recognizes the need to substitute framework residues in order to “reduce immunogenicity while retaining high binding affinity.” See Ex. 1534, 3. Thus, even if Queen 1990 is not available as prior art, we find that an ordinary artisan would have identified the candidates for substitution, as recited in claims 12, 42, 60, 71, 73, and 74. Indeed, Dr. Wilson testified that he performed a “good analysis” and identified 19 amino acid positions in the light chain and 19 in the heavy chain, including 66L (recited in claims 12 and 42), 73H (recited in claim 71), 78H (recited in claims 60 and 73), 93H (recited in claim 74). Ex. 1697, 242:4–6; Ex. 2041 ¶ 186, Appendix 1. Claims 12, 66, 67, 71, 73, 74, and 78” slip op. at 22

    Patent outcomesUS 6,407,213 mixed
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 6,407,213
  • PTAB · Oct 1, 2015 · IPR2014-00714 · APJ Kevin W Cherry · IPR · Final written decision

    The Board canceled claims 11, 74, and 81 and denied substitute claims 154–156 because they broadened claim scope, lacked written-description support, and were not shown patentable over Mostov.

    RulingsFinal written decision
    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “A petition for inter partes review must identify “all real parties in interest.” 35 U.S.C. § 312(a)(2). The Office Patent Trial Practice Guide provides guidance regarding factors to consider in determining whether a party is a real party in interest. 77 Fed. Reg. 48,756, 48,759–60 (Aug. 14, 2012). Considerations may include whether a non-party “funds and directs and controls” an IPR petition or proceeding. Id. at 48,760. Additional relevant factors include: the non-party’s relationship with the petitioner; the non-party’s relationship to the petition itself, including the nature or degree of involvement in the filing; and the nature of the entity filing the petition. Id. Generally, a party does not become a “real party-in-interest” merely through association with another party in an unrelated endeavor. Id. A party also is not considered a real party in interest in an inter partes review solely because it is a joint defendant with a petitioner in a patent infringement suit or is part of a joint defense group with a petitioner in the suit. Id. Whether a party who is not a named participant in a given proceeding is a “real party-in-interest” to that proceeding “is a highly fact-dependent question.” Id. at 48,759. There is no “bright line test.” Id. Courts invoke the term “real party-in-interest” to describe relationships and considerations sufficient to justify applying conventional principles of estoppel and preclusion. Id. Here, even assuming this contention is timely, Patent Owner has failed to provide any evidence, besides the mere fact that the other parties are co-defendants in a lawsuit or alleged infringers, to support the contention that Petitioner has failed to name all of the real parties in interest. That one fact, without any further proof of control or involvement by these parties in this proceeding, is insufficient to establish that Petitioner has failed to name” slip op. at 11

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “ii. Petitioner’s Expert Patent Owner asks that we “dismiss [Petitioner’s] Expert Declaration and disqualify [Petitioner’s Declarant] for making and using a false writing.” PO Resp. 9. Patent Owner contends that Petitioner’s Declarant falsely claimed that certain patent applications were patents by listing them under the heading “Patents” in his Resume. Id. at 8–9. A Patent Owner Response is not the proper vehicle to seek to exclude testimony. See 37 C.F.R. § 42.64(c). Moreover, even if it were the proper vehicle, we are not persuaded that the alleged “falsehood” that Patent Owner identified—listing patent applications, which are clearly identified as such, under a heading titled “Patents”—is, in any way, misleading. Thus, we decline Patent Owner’s request that we dismiss Dr. Vishwanath’s testimony.3 C. Motion to Amend As discussed above, in the Motion to Amend, Patent Owner requests” slip op. at 12

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “i. Level of Ordinary Skill in the Art Neither party puts forward a succinct definition of the level of ordinary skill in the art. Petitioner’s declarant, however, has put forward a detailed discussion of various references dated before April 20064 (the date Patent Owner now alleges is the priority date) related to subject matter of the ’990 patent. See Ex. 1005 ¶¶ 20–74, 94–99. We have reviewed that discussion and the references cited in those paragraphs. We have found it accurately reflects the teachings of the references. Moreover, we agree with Petitioner’s declarant that the references are analogous to the claimed invention, and, as such, represent the level of skill in the relevant art at the time of the invention. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board did not err in concluding that the level of ordinary skill was best determined by the references of record); In re Oelrich, 579 F.2d 86, 91(CCPA 1978) (“[T]he PTO usually must evaluate . . . the level of ordinary skill solely on the cold words of the literature.”); see 4 We accept this date as the priority date only for the sake of argument. also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown.”’).” slip op. at 13

    • ScopeMotion to amend, deniedDenied

      “We agree with Petitioner and find, based on the Patent Owner’s own arguments, that these terms improperly broaden the scope of the claims. As Patent Owner explains, the added language is broad enough to include the removed items, and is intended to reflect the entire genus of “monitoring equipment” and “communications devices” that “are capable of communication and capable of receiving signals.” Mot. to Amend 4, 5. Thus, the claim has been broadened to not only include the listed species that have been removed, but anything falling within the claimed genus. Accordingly, we find that this amendment impermissibly broadens the claim. As for the second change in the claim language, we find that Patent Owner has failed to show why removal of the entire passage “wherein, the communication device receives a signal via any of one or more products listed in any of the plurality of product grouping categories,” would not impermissibly broaden the scope of claim 154. The deletion of this limitation necessarily broadens the claim in that limitation’s aspect. See In re Clement, 131 F.3d 1464, 1468 (Fed. Cir. 1997) (“For example, a reissue claim that deletes a limitation or element from the patent claims is broader in that limitation’s aspect.”). Given that Patent Owner has entirely deleted this limitation and Patent Owner bears the burden of showing entitlement to the amendment, it was incumbent on Patent Owner to explain why removing this entire passage from claim 154 would not broaden the scope of the claim. See In re Bennett, 766 F.2d 524, 526 (Fed. Cir. 1985) (en banc) (“[A] claim is broadened if it is broader in any respect than the original claim, even though it may be narrowed in other respects.”).” slip op. at 17

    § 102 anticipation
  • PTAB · Oct 28, 2014 · IPR2013-00266 · APJ Christopher L Crumbley · IPR · Final written decision

    The Board denied entry of substitute claims 20–26 as obvious, and granted cancellation of challenged claims 1, 2, 4, 11, 12, 17, 18, and 19.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

      “1. the cleavable linker and the protecting group are cleavable under identical conditions Proposed substitute claim 20 recites, inter alia, “a base that is linked to a detectable label via a cleavable linker,” a “protecting group attached via the 3' oxygen atom” of the nucleotide, and a step of “removing the label and the protecting group of the nucleotide . . . under a single set of chemical cleavage conditions.” Mot. 2 (emphasis added). These limitations are similar to those present in original claim 1, which we construed in our Decision on Institution. Specifically, we construed removal of the label and the protecting group under a single set of conditions “to mean what its plain language indicates: removal of the label and the protecting group under a single set of conditions.” Dec. 6. Neither of the parties contested this construction subsequent to institution, and we discern no reason to modify our initial construction for the purposes of this decision. Proposed claim 20 also requires that the cleavable linker comprise a disulfide linkage, but does not specify the protecting group. Thus, “a single set of chemical cleavage conditions,” under the broadest reasonable interpretation standard, limits the structure of the protecting group to one which can be cleaved under the same conditions as a disulfide linkage, but does not require a specific structure, such as a disulfide linkage.” slip op. at 8

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
    • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for patent owner

      “Illumina was essentially 100%. This is a significant and unexpected improvement over the disulfide cleavages of Ruby (~86%) and Herman (87%).” Ex. 2004 ¶ 84. There is no testimony, however, that the stated results were due to the claimed nucleotide rather than the reducing agent. While Dr. Romesberg refers to the “disulfide cleavage yield” as being unexpected, he does not testify that this yield was attributable to the claimed nucleotide configuration, rather than the reducing agent which performs the disulfide bond cleavage. Illumina has not distinguished the Vermaas results from the prior art by showing that the nucleotide is responsible for the disulfide yield, rather than it being a property of the disulfide bond and the yield being “the mere recognition” of the bond’s “latent properties,” which “does not render nonobvious an otherwise known invention.” Baxter, 952 F.2d at 392; In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Absent such evidence, Illumina has not shown that the claimed subject matter possesses “unexpected results relative to the prior art.” Galderma Labs., LP v. Tolmar, Inc., 737 F3d 731, 738 (Fed. Cir. 2013). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416.” slip op. at 28

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

      “After considering all the evidence as a whole, we conclude that Illumina has not met its burden in showing that the proposed substitute claims are patentable over the prior art considered in this Decision. The Motion to Amend is DENIED to the extent that it requests entry of substitute claims 20–26.” slip op. at 28

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 8,158,346
  • PTAB · Jul 25, 2014 · IPR2013-00128 · APJ Richard M Lebovitz · IPR · Final written decision

    The Board granted cancellation of claims 1–8 but denied entry of substitute claims 9–12 because Illumina did not show they were patentable over the prior art.

    RulingsFinal written decision
    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

      “[l]abeling moieties are favorably in communication with or coupled to nucleotides via a linker of sufficient length to ensure that the presence of said labeling moieties on said nucleotides will not interfere with the action of a polymerase enzyme on said nucleotides.” Ex. 2015, p. 32, ll. 10-13. Rabani specifically mentions disulfide linkages as useful when a cleavable linker is desired: Linkages comprising disulfide bonds within their length have been developed to provide for cleavability24; reagents comprising such linkages are commercially available25 and have been used to modify nucleotides26 in a manner which may be conveniently reversed by treatment with mild reducing agents such as dithiothreitol. Id. at p. 32, ll. 29-33. Footnotes 24 and 26 of the above quoted passage cite to Ruby, S.W. et al. (1990), Methods in Enzymology, 181:97, which is Exhibit 2016. Id. at 49. Footnote 25 references “for example, from Pierce Chemical Co., [ ] of Rockford, IL., U.S.A.” Id. Rabani, therefore, would have given a skilled worker reason to have used a cleavable linker with a disulfide bond to ensure that the labeling moieties on the nucleotides will not interfere with the action of a polymerase enzyme during the synthesis reaction. Church IBS cited Church as evidence of the obviousness of using a disulfide linker in a sequencing reaction. Paper 53, 2. Church provides another example of the use of a disulfide linker to attach a label to base of a nucleotide, further establishing its conventionality at the time of the invention. Ex. 1031, 17:10-18, 68:12-21. Church describes a working example in which a label was attached to a nucleotide base using a disulfide linker and then cleaving it off with DTT. Id. at 86:6-30. slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner

      “Secondly, the cleavage agents are different. The cleavage agent used in Ruby is DTT (Ex. 2016, 10, “Elution buffer” A and B) and in Herman, the cleavage agent is described as “a reducing agent such as DTT” (Ex. 2017, col. 7, ll. 47-48) with DTT being used in its example (id. at col. 10, ll. 47-54, col. 11, ll. 11-22; col. 12, ll. 3-8). Mr. Vermaas describes an experiment that utilized another cleavage agent, 2 mM tris- (hydroxymethyl)phosphine. Ex. 2028 ¶ 10. Illumina did not offer an explanation as to why the phosphine compound was used instead of DTT as used by both Ruby and Herman. Indeed, Church used DTT in a DNA sequencing reaction, similar to the sequencing carried out in the Vermaas experiments, providing an additional reason to have used DTT in Dr. Varmaas’s comparison to the prior art. Ex. 1031, Fig. 5; 68, ll. 12-13; 86, ll. 20-23. There is no testimony that the stated results were due to the claimed nucleotide rather than the reducing agent. Dr. Romesberg testified: “Therefore, the disulfide cleavage yield achieved by Illumina was essentially 100%. This is a significant and unexpected improvement over the disulfide cleavages of Ruby (~86%) and Herman (87%).” Ex. 2009 ¶ 74. Dr. Romesberg refers to the “disulfide cleavage yield” as being unexpected, but he did not testify that this yield was attributable to the claimed nucleotide configuration, rather than the reducing agent which performs the disulfide bond cleavage. Illumina has not distinguished the Vermaas results from the prior art by showing that the nucleotide is responsible for the disulfide yield, rather than it being a property of the disulfide bond and the yield being “the mere recognition” of the bond’s “latent properties,” which “does not render nonobvious an otherwise known invention.” Baxter, 952 F.2d at 392; In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997). Absent such evidence, Illumina has not shown that the claimed subject matter possesses “unexpected results relative to the prior art.” Galderma Labs., LP v. Tolmar, Inc., 737 F3d 731, 738 (Fed. Cir, 2013).” slip op. at 28

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

      “Patent Owner bears the burden of proof to establish that it is entitled to the relief requested in the Motion to Amend. 37 C.F.R. § 42.20(c). Patent Owner, therefore, bears the burden of showing the patentability of the amended claims. Patent Owner must show that the conditions for novelty and non- obviousness are met for the prior art available to one of ordinary skill in the art at the time the invention was filed, not just the prior art cited in the Petition. See Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR 2012-00027, slip op. at 7 (PTAB June 11, 2013) (Paper 26). Also, a motion to amend “must include a claim listing, show the changes clearly, and set forth: (1) The support in the original disclosure of the patent for each claim that is added or amended.” 37 C.F.R. § 42.121(b)(1).” slip op. at 6

    • ExcludeMotion to exclude, deniedMixed

      “characterizations of Figure 6 from Ex. 1031, and all arguments based on it be excluded as evidence from this inter partes review. Illumina argues that the Figure should be excluded “because it includes poor quality black and white reproductions of images that do not accurately reflect the original underlying data.” Paper 70, 1. We agreed with Illumina that the figure of Church is of poor quality and gave it no weight. We, therefore, did not rely on Figure 6 of Church in reaching our decision. Accordingly, Illumina’s motion is dismissed as moot.” slip op. at 29

    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,057,026
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