- Colgate-Palmolive Company v. Noble Innovations NC L.L.C.All claims unpatentablePTAB · Jan 23, 2025 · IPR2023-01254 · APJ Ryan H Flax · IPR · Final written decision
Claims 1, 2, and 5–18 are unpatentable under § 103 over Grounds 1–4; each ground relies on the Board’s combinations of Wolcott or Young with Davidson, with or without Fitz-Gibbon.
RulingsFinal written decision- BurdenUnpatentable
“Patent Owner’s arguments. Petitioner has sufficiently, and we find accurately, mapped the limitations of the challenged claims to the disclosures of Wolcott, Davidson, and Fitz-Gibbon, identified reasons with rational underpinnings why the ordinarily skilled artisan would have combined the teachings of the references, and shown that there would have been a reasonable expectation of success in such a predictable endeavor. Regarding the reasons to combine Wolcott, Davidson, and Fitz- Gibbon, they are each analogous art as each is directed to solving the problem of retaining dentifrice, a pellet or any dentifrice, on a toothbrush, within a dedicated space between its bristles. Donner Technology, LLC v. Pro Stage Gear LLC, 979 F.3d 1353, 1359 (Fed. Cir. 2020) (the prior art is from the same field of endeavor as the invention and also addresses the particular problem with which the invention/inventor is involved); see generally Ex. 1009; 1010; 1011; see also Ex. 1008 ¶¶ 115–122, 199–207 (Mr. Fletcher testifying to the same). We agree that the prior art combination and asserted modifications would be predictable and well within the level of ordinary skill to accomplish, making success entirely expected. Ex. 1008 ¶¶ 115–122, 199–207; Ex. 1009; 1010; 1011. Furthermore, we agree with Petitioner that the advantages disclosed by Davidson regarding its bristles 13 and well 12 retaining any type of dentifrice would similarly advantage Wolcott’s toothbrush, which is designed to similarly retain a dentifrice pellet in a recess using bristles. See Ex. 1009, 1:1–41, 2:39–3:1, 3:55–4:9, Figs. 4, 5; Ex. 1010, 2:11–14, 2:24– 27, 3:20–24, Figs. 1–3; see also Ex. 1008 ¶¶ 121–122. Similarly, Fitz-Gibbon discloses its toothbrush’s bristles or, more accurately, tufts of bristles 13, are disposed at an angle toward, and to hold, dentifrice in a chamber/pocket; we find this feature, which Fitz-Gibbon describes as “exceedingly valuable,” would also have been reasonably incorporated into the toothbrush achieved by the combination of Wolcott and Davidson, with an expectation of success. Ex. 1008 ¶¶ 204–207; Ex. 1011, 2:58–87. Thus, we agree with Petitioner that a skilled artisan would have had ample reason to combine Wolcott and Davidson, or Wolcott, Davidson, and Fitz-Gibbon, and the result of doing so would have been obvious.” slip op. at 38
- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill in the art or POSITA, but Patent Owner neither proposes a definition of the ordinarily skilled artisan nor opposes Petitioner’s proposed definition. See generally Resp. Patent Owner’s witness, Mr. Kodama, testifies that an ordinarily skilled artisan as of the invention date would be defined identically as proposed by Petitioner. Ex. 2001 ¶ 46. We accept and use Petitioner’s proposed and unopposed definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’332 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as 10 Petitioner uses the acronym POSITA to reference the person of ordinary skill in the art. evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the bristles must be angled and disagree with Patent Owner. As explained above, it remains generally uncontested that the claim language “angled capsule retaining elements” includes within its scope angled bristles. This is well supported by the intrinsic record: only one type of angled structure is disclosed in the ’332 patent as functioning to retain an oral care capsule on a toothbrush, and that structure is “a plurality of angled bristles adapted to retain an oral care capsule in the capsule receiving zone.”12 Ex. 1001, 2:57–67, 4:62–5:13. The ’332 patent explains 11 Patent Owner actually cites “‘627 patent app” at paragraph 36,” without ever mentioning any exhibit of record in the proceeding. We understand Patent Owner to refer to Petitioner’s Exhibit 1003, as this is the only occurrence of the ’627 application of record. 12 The ’332 patent also describes “a movable retaining element,” which is a separate structure from the angled bristles that comprise the angled capsule retaining elements, that is described as some sort of openable access to the that bristles are angled toward the center of a capsule receiving zone such that an oral care capsule can be loaded there-into by spreading apart the angled bristles, inserting the oral care capsule past the angled bristles, and depositing the oral care capsule in the capsule receiving zone; thereafter the angled bristles relax to their angled state and retain the oral care capsule. Id.; see also id.at 7:19–42, 9:54–10:11 (describing how a dispensing device can accomplish this loading).” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner’s arguments. Petitioner has sufficiently, and we find accurately, mapped the limitations of the challenged claims to the disclosures of Wolcott, Davidson, and Fitz-Gibbon, identified reasons with rational underpinnings why the ordinarily skilled artisan would have combined the teachings of the references, and shown that there would have been a reasonable expectation of success in such a predictable endeavor. Regarding the reasons to combine Wolcott, Davidson, and Fitz- Gibbon, they are each analogous art as each is directed to solving the problem of retaining dentifrice, a pellet or any dentifrice, on a toothbrush, within a dedicated space between its bristles. Donner Technology, LLC v. Pro Stage Gear LLC, 979 F.3d 1353, 1359 (Fed. Cir. 2020) (the prior art is from the same field of endeavor as the invention and also addresses the particular problem with which the invention/inventor is involved); see generally Ex. 1009; 1010; 1011; see also Ex. 1008 ¶¶ 115–122, 199–207 (Mr. Fletcher testifying to the same). We agree that the prior art combination and asserted modifications would be predictable and well within the level of ordinary skill to accomplish, making success entirely expected. Ex. 1008 ¶¶ 115–122, 199–207; Ex. 1009; 1010; 1011. Furthermore, we agree with Petitioner that the advantages disclosed by Davidson regarding its bristles 13 and well 12 retaining any type of dentifrice would similarly advantage Wolcott’s toothbrush, which is designed to similarly retain a dentifrice pellet in a recess using bristles. See Ex. 1009, 1:1–41, 2:39–3:1, 3:55–4:9, Figs. 4, 5; Ex. 1010, 2:11–14, 2:24– 27, 3:20–24, Figs. 1–3; see also Ex. 1008 ¶¶ 121–122. Similarly, Fitz-Gibbon discloses its toothbrush’s bristles or, more accurately, tufts of bristles 13, are disposed at an angle toward, and to hold, dentifrice in a chamber/pocket; we find this feature, which Fitz-Gibbon describes as “exceedingly valuable,” would also have been reasonably incorporated into the toothbrush achieved by the combination of Wolcott and Davidson, with an expectation of success. Ex. 1008 ¶¶ 204–207; Ex. 1011, 2:58–87. Thus, we agree with Petitioner that a skilled artisan would have had ample reason to combine Wolcott and Davidson, or Wolcott, Davidson, and Fitz-Gibbon, and the result of doing so would have been obvious.” slip op. at 38
Patent outcomesUS 8,881,332 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,881,332 - Symrise AG / Symrise Inc. v. Inolex Investment CorporationAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,995,048 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681 - Pelican Biothermal, LLC v. Va-Q-Tec AGSome claims unpatentablePTAB · 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 mixedClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 10,766,685 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,926,069 - Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentablePTAB · Dec 12, 2022 · IPR2021-00858 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–19 were not shown unpatentable because Petitioner failed to establish that the asserted prior-art combinations would have been made with a reasonable expectation of success.
RulingsFinal written decision- Skill levelSkill level board ownOther
“The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 26; PO Resp. 8–9. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not assert that any claim term requires express construction. See Pet. 7 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). To the extent further discussion of the meaning of any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“Having considered the parties’ positions and evidence of record, summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCTguided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “control system” of the claims and all of its programmed surgical functionality. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed by a surgeon using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention. We recognize that Petitioner directs us to the testimony of Dr. Izatt who opines that a person of ordinary skill in the art would have found it obvious to, for example, use a controller to determine the claimed scanning pattern. Ex. 1001 ¶ 159; Pet. 32–33; Reply 3–5; see also Ex. 1123 ¶ 31 (“Once the anterior capsule is identified, it is a relatively simple process to determine the location to place the capsulotomy.”). Here, however, we agree with Patent Owner that the Petition and supporting testimony fails to provide the requisite reasoned analysis with sufficient evidence to support Petitioner’s position on obviousness. In particular, absent some evidentiary support beyond Dr. Izatt’s and Dr. Tipperman’s bare opinions that it would have been obvious to program a controller to bridge the gap between the functionality disclosed in Swinger and the required functionality of the challenged claims, we are unwilling to accept this line of reasoning. PO Resp. 27; Sur-Reply 4–7; Ex. 1001 ¶ 159; see also DSS, 885 F.3d at 1374 (Fed. Cir. 2018) (A skilled artisan’s “common sense” or “common knowledge” can potentially “fill in a missing limitation only when ‘the limitation in question was unusually simple and the technology particularly straightforward.’” (emphasis omitted)).” slip op. at 25
- Strike new argumentNew argument disregardedDecided for patent owner
“Inter partes review must proceed in accordance with the Petition and the arguments set forth therein. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the ground for the challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Arguments made in a different document, such as an expert’s declaration, may not be incorporated-by-reference in the Petition. 37 C.F.R. § 42.6(a)(3); see also General Access Solutions, Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir. 2020) (noting that the Board did not abuse its discretion in enforcing its rules under 37 C.F.R. § 42.6(a)(3)) (non-precedential)).” slip op. at 35
Patent outcomesUS 8,425,497 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 8,425,497 - Commonwealth Scientific And Industrial Research Organisation v. BASF Plant Science Company GmbHAll claims unpatentablePTAB · 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 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents 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 · GrahamPatents in suitUS 9,976,125 - Pfizer, Inc. / Samsung Bioepis Co., Ltd. v. Genentech, IncSome claims unpatentablePTAB · 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 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents 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.