- Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- BurdenMixed
“Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed
“Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19
Patent outcomesUS 8,252,316 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,252,316 - Dermira, Inc. v. Purepharm, Inc.Some claims unpatentablePTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6
- Skill levelSkill level board ownOther
“The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16
- Expert testimonyPetitioner expert creditedDecided for petitioner
“not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11
Patent outcomesUS 8,679,524 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,679,524 - Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb CompanyNo claims unpatentablePTAB · Dec 22, 2016 · IPR2015-01537 · APJ Deborah Katz · IPR · Final written decision
Claims 1–15 were not shown unpatentable as obvious over Cohen, Shire, and Carpenter because Petitioner did not establish a reasonable expectation of success.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedOther
“suggests a trial-and-error approach to protein formulation. See Ex. 2011 (“Very often, proteins have to be evaluated individually and stabilized on a trial-and-error basis.”). Thus, we credit Dr. Staples’s testimony regarding the use of trial-and-error optimization because it appears that this was a known approach for formulating proteins. We do not agree that because the approach was known, it was necessarily expected to be successful. Petitioner cites to the statement in Carpenter that the authors were “quite confident” the generalized high throughput formulation procedure they describe “can be coupled successfully with high throughput screening strategies of protein drugs and facilitate drug development within the inherent time and resource constraints of the pharmaceutical industry.” Ex. 1004, 195. We note that, although in isolation Carpenter’s proclamation of being “quite confident” appears to demonstrate a reasonable expectation of success, when considered in context it refers to a general trend in the industry, not to the ability to formulate specific proteins. The full statement does not indicate that there was confidence that any particular drug could be successfully formulated as a liquid. Thus, this evidence is not persuasive.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation foundNot shown unpatentable
“parties, we determine, on balance, that Petitioner has not established sufficiently that an ordinary artisan would have had a reasonable expectation of success in formulating CTLA4Ig as a stable liquid formulation as recited in the challenged claims. Specifically, in the challenge to Patent Owner’s claims, Petitioner relies on Carpenter to show that an ordinarily skilled artisan would have known how to prepare a stable liquid formulation of CTLA4Ig for subcutaneous administration. Pet. 33–40. The statements in Carpenter are the most significant evidence of whether there would have been an expectation of success in achieving the claimed formulation. But Carpenter expressly states that “[i]t [could] be assumed that most proteins will not exhibit sufficient stability in aqueous solution to allow a liquid formulation to be developed.” Ex. 1004, 188; PO Resp. 16. Carpenter also states that although a stable liquid formulation is desirable, “for most proteins maintaining physical and chemical stabilities in aqueous solution for an extended period of time is extremely difficult.” Ex. 1004, 184. These statements indicate that there would not have been a reasonable expectation of success in achieving the claimed formulations. Dr. Staples’s testimony about routine trial-and-error optimization does not overcome these statements. Petitioner’s citation to Paborji (Ex. 1016) does not persuade us otherwise. Even though Paborji states that CTLA4Ig in phosphate buffer is “relatively stable,” without testimony to explain how this would be interpreted by a skilled artisan, the strong doubt about success expressed in Carpenter is not overcome.” slip op. at 13
Patent outcomesUS 8,476,239 not shown unpatentable§ 103 obviousnesscites KSRPatents in suitUS 8,476,239 - Seabery North America Inc. v. Lincoln Global, Inc.Rehearing deniedPTAB · Nov 17, 2016 · IPR2016-00840 · APJ Thomas L Giannetti · IPR · Rehearing
The Board denied rehearing, leaving institution denied for claims 32, 51, 70–79, and 105–111 because Petitioner did not show Aiteanu taught or suggested comparing performance data to known parameters.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“When rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” Section 42.71(c), in turn, references 37 C.F.R. § 42.71(d), which provides in relevant part: The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply. slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“claims, we did not rely on the lack of disclosure of an algorithm in the ’398 patent in concluding that Petitioner had failed to carry its burden of demonstrating obviousness. Instead, we considered Petitioner’s analysis of Aiteanu and found it insufficient to persuade us that the “comparison” element was met: The description in that analysis does not teach or suggest a comparison to known parameters. See [Pet.] 19–21. Because we conclude that Aiteanu does not teach or suggest such a comparison, we determine that Petitioner has failed to establish a reasonable likelihood of succeeding on its challenge to these claims. Dec. 22–23. These insufficiencies in the Petition are not cured by attacking the ’398 patent’s disclosure, nor is Petitioner relieved its burden of proving the claims unpatentable. In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016) (“In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.”) (citation omitted).” slip op. at 7
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Id. at 16 (emphasis added) (citation omitted). The Board found Petitioner’s analysis of this element in relation to Aiteanu insufficient to describe a comparison to known parameters to arrive at this quality characteristic. Dec. 22. Petitioner’s main argument in its Rehearing Request focuses on a different alleged “quality characteristic” in Aiteanu, namely torch position. Req. Reh’g 5–6. The Petition did not present such an argument, and therefore the Board could not have been overlooked or misapprehended it. Instead, we addressed the argument presented by Petitioner: that calculated weld seam thickness was based on a comparison of known parameters. Pet. 16. For the reasons stated in our Institution Decision and in the Preliminary Response (at pp. 38–39), we concluded that Petitioner did not present sufficient proof that Aiteanu met this condition.” slip op. at 5
§ 103 obviousness - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentablePTAB · Nov 3, 2016 · IPR2016-00283 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–12 were not shown unpatentable because Par failed to establish that the prior art would have motivated a skilled artisan to dose based on about 60% conversion.
RulingsFinal written decision- BurdenNot shown unpatentable
“In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Horizon, on the other hand, contends that a person of ordinary skill in the art would have the following qualifications: (a) An M.D. or equivalent degree; (b) At least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics; and (c) At least five years of experience treating patients with nitrogen retention disorders, including UCDs. Corr. PO Resp. 26. Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9
- Expert testimonyPetitioner expert creditedDecided for petitioner
“First, regardless of whether one of ordinary skill in the art would have understood Brusilow ’91 to teach 80% to 90% conversion, or something closer to 100% conversion, we credit Dr. Sondheimer’s testimony that one of ordinary skill in the art would have sought out prior art references “discuss[ing] the conversion of PAA to PAGN” (Ex. 1002 ¶ 42) if only “[b]ecause Brusilow ’91 involved a single subject and observed a range of conversion rates” (id. at 43). As for the parties’ diametrically opposed views on whether Dr. Brusilow preselected all three doses administered to the patient, or adjusted the dose in Period III to account for the 90% conversion observed in Period II (see Ex. 1012, Table 1), we find we need not resolve the controversy, because, even if we accept that the dose in Period III was adjusted based on the results in Period II, it would not change our ultimate disposition of the case.” slip op. at 27
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11
Patent outcomesUS 8,642,012 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,642,012 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCNo claims unpatentablePTAB · Nov 3, 2016 · IPR2015-01117 · APJ Toni R Scheiner · IPR · Final written decision
Claims 1–12 were not shown unpatentable; Par failed to establish that the asserted obviousness combinations supported calculating dosage using about 60% conversion.
RulingsFinal written decision- BurdenFwd all claims patentableNot shown unpatentable
“In the absence of analysis of these subsequent references, we conclude that Par has not established that the prior art cited in its challenge adequately represents the state of the art at the time of the invention. Moreover, we note that Horizon points out that Shiple, relied on by Par for its teaching that normal subjects and UCD patients fed PAA experience suppressed urea production (Pet. 17 (citing Ex. 1017, 620, 623; Ex. 1002 ¶ 4), additionally discloses that about 95% of a 10 g dose of phenylacetic acid was excreted as phenylacetyl glutamine in a 24-hour urine sample. Corr. PO Resp. 32 (citing Ex. 1017, 623, Table II). Consequently, we determine that Par has not established by a preponderance of the evidence that one of ordinary skill in the art would have had a reason to calculate the dose of PBA or HPN-100 for a UCD patient based on a mean conversion rate of about 60% (even if we accept that about 60% encompasses a mean conversion rate of 53–67%, as Par argues), given the apparent correspondence between Brusilow ’91’s observation of an 80% to 90% conversion rate, and the similar stated observations in Exhibits 2027 and 2025 (95% and 80–100 %, 29 respectively)—not to mention Shiple’s disclosure of a 95% conversion rate for a 10 g dose of PAA. Again, Petitioner bears the burden of proving unpatentability of the challenged claims in an inter partes review, and that burden never shifts to Patent Owner. Obviousness is resolved based on underlying factual determinations, including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of skill in the art; and (4) objective evidence of nonobviousness, i.e., secondary considerations. See Graham v. John Deere Co., 383 U.S. 1, 17– 18 (1966). It is not enough to address only those teachings that support the challenge, when there is evidence of record on its face at odds with the underlying premise of the challenge. See e.g., Corr. PO Resp. 5, 15, 22, 32, 49 (discussing Exs. 2025, 2027, 1017).” slip op. at 29
- Skill levelSkill level patent owner adoptedDecided for patent owner
“Horizon contends that Par’s definition “does not require . . . any experience treating patients with urea cycle disorders or other nitrogen retention disorders,” but “simply requires ‘specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCD and other nitrogen retention disorders.’” Id. Horizon contends because “the challenged claims specifically relate to methods of treating UCD patients,” one of ordinary skill in the art should have experience treating UCD patients. Id. Horizon’s point is well taken—that is, we agree that one of ordinary skill in the art should have experience treating, as well as diagnosing, UCD patients. In any case, our ultimate disposition of this case would not change under either Par’s or Horizon’s definition.” slip op. at 9
- Expert testimonyDecided for petitioner
“several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies involving the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. Horizon does not take issue with Dr. Sondheimer’s qualifications, and we find Dr. Sondheimer qualified to provide opinions on the subject matter at issue.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“encompassing a range of mean conversion between 53–67%.” Pet. 10–12. Horizon did not address this issue in its Preliminary Response, and we determined it was not necessary to construe the term for purposes of institution. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (Quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). In its Corrected Patent Owner Response, Horizon contends that “the claim term ‘about 60%’ has its plain and ordinary meaning and would be understood by a [person of ordinary skill in the art] to encompass 67%” (Corr. PO Resp. 27), but nothing in the claims, specification or prosecution history of the ’012 patent supports Par’s “assertion that ‘about 60%’ should be construed to encompass 53%” (id.). Nevertheless, we again determine that it is not necessary to expressly construe the term for purposes of this decision. To the extent Par relies on the term as “encompassing a range of mean conversion between 53–67%,” however, we reject its proposed construction.” slip op. at 11
Patent outcomesUS 8,642,012 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 8,642,012 - Par Pharmaceutical, Inc. / Lupin Ltd. et al. v. Horizon Therapeutics, LLCAll claims unpatentablePTAB · Sep 29, 2016 · IPR2016-00284 · APJ Deborah Katz · IPR · Final written decision
Claims 1–11 are unpatentable under § 103 over the three combinations of references identified in the decision.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“Petitioners argue that Patent Owner’s Exhibits 2022 and 2024 should be excluded because they are not prior art to the ’215 patent. Paper 25, 1–2. Even considering Exhibits 2022 and 2024, we are still persuaded that a preponderance of the evidence shows claims of the ’215 are unpatentable. Accordingly, Petitioners’ motion is dismissed as moot. Petitioners also argue that Patent Owner relies on attorney argument to rebut Petitioners’ challenges, effectively providing impermissible expert evidence, which Petitioners seek to exclude. (Paper 25, 2–6.) We dismiss Petitioners’ argument because attorney argument is not evidence. See Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977) (“Argument of counsel cannot take the place of evidence lacking in the record.”). Therefore, Petitioners’ argument is improperly presented in a motion to exclude evidence. Nevertheless, the issue of evidentiary support for Patent Owner’s arguments is addressed above. Patent Owner argues that evidence relied upon by Petitioners should be excluded. Paper 33. Specifically, Patent Owner seeks to exclude certain portions of Dr. Sondheimer’s cross-examination testimony and Exhibits 1031–1033. Patent Owner acknowledges that “[i]n its Reply (Paper 28), Petitioner has not attempted to rely upon the portions of Dr. Sondheimer’s deposition transcript or the documents Patent Owner seeks to exclude.” Paper 33, 2–3. We dismiss Patent Owner’s motion as being moot. Because Patent Owner cannot point to where Petitioners rely on the testimonial evidence, having apparently not relied on it, we have no basis on which to determine whether the evidence is inadmissible and no basis on which to exclude it. Furthermore, because Exhibits 1031–1033 have not been made of record in this proceeding (see Paper 33, 1), they cannot be excluded.” slip op. at 23
- Skill levelOther
- Expert testimonyPetitioner expert creditedOther
“Petitioners rely on the testimony of Neal Sondheimer, M.D., Ph.D. (Ex. 1002). Dr. Sondheimer testifies that he currently holds several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies about the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. We find Dr. Sondheimer to be qualified to provide opinions on the subject matter at issue. Patent Owner does not present the testimony of its own witness to support its arguments.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner
“We look to the language of the claim itself and to language in the specification to determine the scope of a claim. To limit a claim beyond what its plain language appears to convey, the patentee “may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1365 (Fed. Cir. 2004) The plain language of independent claims 1–3 recites only the steps of “measuring,” “comparing,” and “administering.” The claims do not include a “targeting” step or steps such as repeated measuring, comparing, and administering, until the fasting blood ammonia level is less than half the upper limit of normal. See Pet. Reply 5–6. Although Patent Owner cites to evidence of the background of the invention, we have not been directed to evidence within the specification of the ’215 patent that clearly limits the claimed methods from being applied at any blood ammonia level greater than half the upper limit of normal. In addition, Patent Owner does not direct us to testimony or other evidence indicating that those skilled in the art would have considered the language of the claims to require “targeting” a certain blood ammonia level or to specify administering drug dosages only when the blood ammonia level is at about that targeted level. On the contrary, the plain terms of the claims contain no such limitations and are broad enough to embrace the administration of drug at higher blood ammonia levels. Accordingly, we conclude that the correct interpretation of Patent Owner’s claims is a method of measuring a fasting blood ammonia level, comparing this level to the upper limit of normal, and administering drug when the level is any level greater than half the upper limit of normal for blood ammonia level.” slip op. at 14
Patent outcomesUS 8,404,215 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 8,404,215 - Toyota Motor Corporation v. Blitzsafe Texas, LLCRehearing deniedPTAB · Aug 31, 2016 · IPR2016-00419 · APJ Hung H Bui · IPR · Rehearing
The Board denied Toyota’s rehearing request, leaving in place the denial of institution for claims 49–57, 62–64, 66, 68, 70, 71, 73–80, 94, 95, 97, 99–103, 106, 109–111, 113, 115, and 120 because Ohmura did …
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We have reviewed Petitioner’s request for rehearing and carefully considered Petitioner’s arguments. However, we are not persuaded that the Board misapprehended or overlooked Petitioner’s arguments presented with respect to the patentability of claims 49–57, 62–64, 66, 68, 70, 71, 73–80, 94, 95, 97, 99–103, 106, 109–111, 113, 115, and 120 of the ’342 patent.” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In contrast, all challenged claims of the ’342 patent require (1) “the portable device” to play (i.e., decode) an audio file, and (2) “the integration subsystem” to receive “audio generated by the portable device.” As explained in the Decision, we referred to the requirement that audio generated by the portable device as the result of playing the audio file as “the audio generated by the portable device” limitation, which was consistent with Dr. Thomas Matheson’s Declaration at ¶¶ 50–53. Decision 23; see also Matheson’s Declaration (Ex. 1120 ¶¶ 50–53).” slip op. at 5
- Strike new argumentNew argument disregardedDenied
“Second, Petitioner identifies numerous portions of Ohmura, for the first time, that it did not identify in the Petition or Reply. In particular, Petitioner contends the Board “misapprehended or overlooked the cited portions of Ohmura that disclose the functions of the construed ‘integration subsystem.’” See Req. Reh’g 10. However, we could not have misapprehended or overlooked portions of Ohmura that were not presented in the Petition or Reply. A request for rehearing is not an opportunity to present new arguments.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“As explained in the Decision, we rejected Petitioner’s proposed construction of “integration subsystem” because Petitioner’s proposed construction required the claimed “integration subsystem” to be a microprocessor or processor programmed to perform a method for wirelessly integrating a portable device for use with a car audio/video system, shown in FIG. 24. Decision 13–15. Instead, we construed the term “integration subsystem” as performing the functions as expressly defined by the Specification of the ’342 patent. Id. at 15 (citing Ex. 1101, 8:64–9:3).” slip op. at 7
Claim constructionPatents in suitUS 8,155,342 - LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentablePTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision
Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were not shown unpatentable under §103 over Oe and Etsuo because the proposed combinations lacked sufficient reasoned support.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(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.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component.” slip op. at 20
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“We have reviewed the testimony from both Dr. Escuti, and Patent Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.5 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 5 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“disclosure in the specification of the ’600 patent to support Patent Owner’s proposed claim construction of “height” and “width.” Indeed, our review of the specification of the ’660 patent reveals that these terms are not defined explicitly or implicitly. For example, the specification states that “the deformities may vary in shape and/or size along the length and/or width of the panel members.” Ex. 1001, 5:43–44 (emphasis added). With respect to the planar optical conductor, claims 1 and 33 each recite, in relevant part, that the input edge has “at least one input edge with a greater cross-sectional width than thickness.” Ex. 1001, 9:11–12, 10:65–67 (emphasis added). Both claims 1 and 33 recite that the output distribution generated by the plurality of light sources is “defined by a greater width component than height component.”4 Id. at 9:15–16, 11:5–6 (emphasis added). Claim 33 recites that the plurality of LED light sources each have “a greater width than height.” Id. at 11:1–2 (emphasis added). Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam-” slip op. at 10
Patent outcomesUS 7,404,660 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,404,660 - LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentablePTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision
Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were held not unpatentable under § 103 over Oe and Etsuo because the combination lacked an adequately supported reason to combine.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.4 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 4 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam- 3 In a related district court proceeding, the claim term “output distribution defined by a greater width component than height component” was determined to have its plain meaning. Ex. 2008, 47. See TR. 21:24–22:8. Webster.com, http://www.merriam-webster.com/dictionary/height, (last viewed July 10, 2015). Within the context of the claims, we are not persuaded by Patent Owner’s contentions that the term “width” is used other than according to its ordinary and customary meaning with respect to the shape of the input edge of the optical conductor, the output distribution of the light source, and the shape of the LED light source. Along this vein, we are not persuaded by Patent Owner’s contentions that the term “height” is used other than according to its ordinary and customary meaning with respect to the light output distribution. Based on this usage in the claims, no express construction is necessary.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(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.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component. We also consider Petitioner’s argument in the Reply that, in addition to Etsuo, Petitioner also relies on Oe’s explicit disclosure of “a plurality of point-like sources of light.” Reply 16–17. Petitioner directs us to the passage of Oe cited in its claim chart (Pet. 40), describing how the light source could be “a plurality of point-like sources of light arranged along the incident surface” (Ex. 1024, 7:30–31). Id. at 16. But Petitioner’s arguments in this regard do not address specifically its proffered reason to combine Oe and Etsuo. Indeed, Petitioner does not explain the relevance of the point-like sources of light to the claim element in question. See 37 C.F.R. § 42.22(a)(2) (requiring a full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent). Patent Owner contends that “Petitioner never argues that ‘point-like sources’ are equivalent to LEDs.” PO Resp. 10. We agree. Petitioner’s argument that “Oe discloses a plurality of light sources 4 adjacent to the input edges” (Pet. 35 (citing Ex. 1024, 6:5–13; Ex. 1004 ¶ 161)) makes no mention of the specific passage in Oe concerning the point-like sources of light. Indeed, the cited passage states that:” slip op. at 20
Patent outcomesUS 7,404,660 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,404,660
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.