- Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentablePTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision
Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.
RulingsFinal written decision- BurdenNot shown unpatentable
“In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7
- Skill levelOther
“We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29
Patent outcomesUS 6,667,061 not shown unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,667,061 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Nov 8, 2017 · IPR2016-01028 · APJ Christopher G Paulraj · IPR · Final written decision
Claim 1 is unpatentable as obvious over Palermo, the Handbook, and McGinity, and also over McGinity, Joshi, Bastin, and the PDR.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 22–23 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 25. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the broadest reasonable construction of “PEG applied onto the core matrix” is a “PEG coating of the core matrix.” Petitioner’s proposed construction would read “applied onto the core matrix” (emphasis added) out of the claim, which we decline to do. See Bicon, Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006) (noting that claim language “should not [be] treated as meaningless”).” slip op. at 14
Patent outcomesUS 9,060,976 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,060,976 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Nov 8, 2017 · IPR2016-01027 · APJ Christopher G Paulraj · IPR · Final written decision
Claim 1 is unpatentable as obvious over McGinity, Joshi, and Palermo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“DISCUSSION A. Level of Skill in the Art Petitioner contends that a person of ordinary skill in the art for the ’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 24 (citing Ex.1009 ¶ 17). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 26. We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The Specification teaches the following: The term “sustained release” is defined for purposes of the present invention as the release of the opioid analgesic from the oral dosage form at such a rate that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over an extended period of time, e.g., from about 12 to about 24 hours as compared to an immediate release product. Preferably the sustained release is sufficient to provide a twice-a-day or a once-a-day formulation. Ex. 1001, 4:56–64. The use of “e.g.” in the above definition for “sustained release” plainly indicates that a 12 to about 24 hour time period is exemplary. Thus, we decline to limit the claim term as Patent Owner would have us do. Rather, we construe “extended release” as “release of the opioid analgesic from the oral dosage form at a rate such that blood (e.g., plasma) concentrations (levels) are maintained within the therapeutic range but below toxic levels over a period of time longer than that of an immediate release of the opioid analgesic.”” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“We are unpersuaded by Patent Owner’s arguments. Claim 1 is drawn to a dosage form—a composition. Patent Owner does not point out how the recitation of “abuse deterrent” in the preamble modifies the structurally complete dosage form recited in the body of claim 1. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (“[A] preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.Cir.1997)). We conclude, therefore, that the term “abuse deterrent” is a goal of the invention, that is, it is merely a statement of intended use that is not entitled to patentable weight.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Decided for patent owner
“iv. “core matrix” The parties agree that the broadest reasonable construction of “core matrix” is “a blended mixture having: (a) PEO having a molecular weight of from about 300,000 to about 5,000,000 daltons, (b) magnesium stearate, and (c) oxycodone or a pharmaceutically acceptable salt of oxycodone.” Ex. 3001. We adopt that agreed-upon construction for purposes of this Decision. v.” slip op. at 14
Patent outcomesUS 9,060,976 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 9,060,976 - Lupin Ltd. / Lupin Pharmaceuticals, Inc. v. Horizon Therapeutics, Inc.All claims unpatentablePTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision
Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15
- Skill levelSkill level board ownOther
“Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “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.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent necessary to resolve the controversy.’ Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11
Patent outcomesUS 9,095,559 unpatentableClaim construction§ 103 obviousnesscites KSRPatents in suitUS 9,095,559 - Osi Pharmaceuticals, LLC / Genentech, Inc. v. Arch Development Corp.All claims unpatentablePTAB · Sep 11, 2017 · IPR2016-01034 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–3, 5, and 6 are unpatentable: claims 1–3, 5, and 6 as obvious over Akinaga, Seynaeve, Friedman, and Tam; claim 6 also over Honma.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“Person of Ordinary Skill in the Art. The parties agree that a person of ordinary skill in the art as of the effective filing date of the ’512 patent, “would have held an M.D. or Ph.D. in molecular biology, biochemistry, pharmacology, or a related field and have had several years of experience working in cancer research.” Pet. 17 (citing Ex. 1002 ¶ 19); PO Resp. 4. This level of ordinary skill is consistent with the prior art asserted in the Petition. See Chore-Time Equip., Inc. v. Cumberland Corp., 713 F.2d 774, 779 n.2 (Fed. Cir. 1983) (indicating that the prior art itself may reflect the appropriate level of ordinary skill in the art). Accordingly, we adopt the parties’ definition for the purpose of this Decision. C.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Plain and ordinary meaningTerm construed board ownDecided for patent owner
“which defines a “therapeutically effective amount” as “an amount of a DNA damaging agent and tyrosine kinase inhibitor that, when administered to an animal in combination, is effective to kill cells within the animal.” Id. at 5. The challenged claims, however, use “therapeutically effective amount” in a context different from the express definition set forth in the Specification. As noted by Petitioner, the definition at column 4, lines 16 to 19 of the Specification refers to “a combined amount of the DNA damaging agent and the tyrosine kinase inhibitor, while the claims require that only the tyrosine kinase inhibitor be administered in a ‘therapeutically effective amount.’” See Pet. 20.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“Specification suggest that the inventors contemplated the induction of a differentiation pathway. See Ex. 2011 ¶ 4. To the contrary, and as discussed above in Section 1(C), the Specification focuses on the use of DNA damaging agents in combination with tyrosine kinase inhibitors to force damaged cells to override the G2 arrest checkpoint and enter mitosis before completing DNA repairs. See, e.g., Ex. 1001, 3:46–48 (“By preventing delays in G2, cells will enter mitosis before the DNA is repaired and therefore the daughter cells will likely die.”). Accordingly, we agree with Patent Owner that, in light of the Specification, one of ordinary skill in the art would not understand the terms “enhanc[ing] cell death” and “enhancing apoptosis” to encompass the a process by which cancer cells are differentiated, become mortal, and, subsequently, “live out their days and die.” See Pet. 29; Ex. 1002, ¶ 127.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“The parties agree that the preamble of each challenged claim, as well as the “thereby” clause of claims 1–3 (“thereby improving chemotherapeutic intervention”), are non-limiting. Pet. 17–18, 21–22; Prelim. Resp. 5, 8; Ex. 2001, 15. On the present record, we adopt the parties’ proposed Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (instructing that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy). D.” slip op. at 16
Patent outcomesUS 7,838,512 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,838,512 - Topgolf International, Inc. v. Amit AgarwalRehearing deniedPTAB · Sep 5, 2017 · IPR2017-00928 · APJ Lora M Green · IPR · Rehearing
The Board denied Patent Owner’s rehearing request and left in place institution of inter partes review of claims 1 and 6 based on the reasonable likelihood of obviousness over Bertoncino and Foley.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end.” We note that the term “significantly lower” is a relative term, and Patent Owner does not offer a construction of that term.1 Nor does Patent Owner point us to anything in the prosecution history as providing a construction for that term. In addition, we note further that the Specification of the ’389 patent also does not define the relative term “significantly lower.” The Specification of the ’389 patent, however, teaches that each target green includes a target flag and a receptacle hole that is located near the front section of the green. Ex. 1001, 4:29‒32. According to the Specification of the ’389 patent, the target green is sloped downhill and has the general shape of a concave surface so that the receptacle hole is at the lowest portion of the green. Id. at 4:32‒35. Figure 4C of the ’389 patent is reproduced below: 1 We acknowledge that the ’389 patent expired as of September 2012, and we are, thus, guided by the principle that the words of a claim “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (internal citation omitted). But, “[i]n determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Figure 4C shows a cross-sectional view of a target green. Id. at 3:28‒29. As taught by the ’389 patent, “[t]arget green 30 would appear to the golfer at the teeing area to have a sudden drop off near the front portion of the green, and then a gradual slope upwardly toward the back of the green.” Id. at 4:37‒40. Thus, at best, the Specification of the ’389 patent appears to support a construction of the claim limitation of a target green profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end” as a green that has a sudden drop off near the front portion of the green and then a gradual slope upward toward the back of the green.” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“established sufficiently a reasonable likelihood that the challenged claims were rendered obvious by the combination of Bertoncino and Foley. Dec. 22. In particular, as to the limitation that the target green has a profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end,” for purposes of institution, we determined: that Petitioner has shown a reasonable likelihood that this claim limitation is rendered obvious by Bertoncino. In particular, Figure 5 of Bertoncino clearly shows that the front ends of the target green on the driving range are substantially lower than the back ends. Ex. 1004, Fig. 5. In addition, we determine that to the extent they are not, Petitioner has reasonably demonstrated that Bertoncino makes such a green obvious by teaching that the ability to see the lie of the ball is dependent on the ability to visually follow the path of the ball (id. at 1:26‒ 29), as well as teaching a “sloped driving range” (id. at 4:12‒ 13; see also id. at 5:37‒39 (“Each target . . . preferably comprises a surface generally sloped towards the tee stands area)). Id. at 19.” slip op. at 3
- BurdenDecided for petitioner
“Pet. 49. Figure 5 of Bertoncino, as addressed above, is a schematic perspective of a sloped driving range of Bertoncino. Petitioner also relied on its version of Figure 4 of Bertoncino, which was altered in line with the teaching of that reference that the target green may have only the inner section 22 (Ex. 1004, 6:61–65), and including the slope of the driving range shown in Figure 5 of Bertoncino, reproduced below: Pet. 49 (citing Ex. 1003 ¶ 92). Figure 4 of Bertoncino is a cross-sectional view of the sloped circular target of Figure 3. Ex. 1004, 4:8‒9. That is supported by Petitioner’s expert, Mr. Robbins, who declares that “[a] person of skill in the art would interpret Bertoncino to disclose a range with a plurality of target greens, each of which is composed of a single section with the slope profile of inner section 22” as depicted above. Ex. 1003 ¶ 92. Thus, as we concluded in the Decision on Institution (Dec. 17‒18), Petitioner in its Petition has established reasonably that Bertoncino teaches a target green having a profile wherein the “profile’s forward most end located at the forward portion of the target green having an elevation that is significantly lower than at its rearmost end.” That is, Petitioner has established reasonably for purposes of institution that the target green of Bertoncino meets the “significantly lower” limitation as construed above, as it has as a green that has a sudden drop off near the front portion of the green due to the concave shape of the target green and then a gradual slope upward toward the back of the green. See Ex. 1004, 6:3‒11, 12:6‒12, Figure 4.” slip op. at 12
Claim constructioncites PhillipsPatents in suitUS 5,370,389 - L’Oréal USA, Inc. v. Liqwd, Inc.Institution deniedPTAB · Jul 19, 2017 · PGR2017-00011 · APJ Christopher M Kaiser · PGR · Institution
The Board denied institution of PGR on claims 1–10 because Petitioner did not show that any claim was more likely than not unpatentable under § 112.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard for instituting a post-grant review is set forth in 35 U.S.C. § 324(a), which provides that a post-grant review may not be instituted “unless the Director determines . . . it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed patent owner constructionDecided for patent owner
“Moreover, “[a]pplicants can define . . . claim scope during prosecution,” just as they can in a patent specification. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1343 (Fed. Cir. 2015). Here, during prosecution of the ’419 patent, the applicant stated that “[t]he term ‘hair coloring agent’ refers to a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” Ex. 1005, 7. To define specific terms used to describe an invention, the applicant need only set out the definition “with reasonable clarity, deliberateness, and precision,” “so as to give one of ordinary skill in the art notice of the change” in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). On the present record, the definition of the term “hair coloring agent” set out in the prosecution history of the ’419 patent is sufficiently clear, deliberate, and precise to give a person of ordinary skill in the art notice that the term is used in the ’419 patent in a manner that does not include substances other than “colorant[s] or pigment[s] that [are] customarily used in hair care products,” even if those other substances might be described as “hair coloring agents” outside the context of the ’419 patent. Ex. 1005, 7. Accordingly, we should give effect to that definition. Because Patent Owner’s proposed construction of “wherein the mixture does not contain a hair coloring agent” gives effect to the prosecution history’s definition of “hair coloring agent,” we adopt Patent Owner’s proposed construction for purposes of the present decision. Thus, on the present record, and for purposes of the present decision, we construe “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.”” slip op. at 6
- Disclosure Requirements (§112) › Definiteness (Nautilus)Not shown unpatentable
“to determine the scope of the claims. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown that it is more likely than not that claims 1–10 of the ’419 patent are indefinite.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“wherein the mixture does not contain a hair coloring agent.” Pet. 36–39; Prelim. Resp. 39–40. If “a hair coloring agent” encompasses bleaching agents, then the claims all require a bleaching formulation and simultaneously exclude a bleaching agent, a scope that Petitioner argues is not described in the specification of the ’419 patent. As discussed above, however, we interpret “wherein the mixture does not contain a hair coloring agent” as “wherein the mixture applied to the hair does not have a colorant or pigment that is customarily used in hair care products, which changes the color or tone of the hair it is applied to based on visual inspection.” We have not been directed to evidence of record that a person of ordinary skill in the art would have considered a bleaching agent to be “a colorant or pigment.” Pet. 7 (describing bleaching as a “process[] that destroy[s] pigment to change hair color,” as opposed to a “process[] that deposit[s] dyes, pigments, or other substances onto the hair to change hair color”); Ex. 1006 ¶¶ 14–15 (contrasting “dyeing,” meaning “processes that alter or change hair color by depositing dyes, pigments, or other substances onto the hair,” with “bleaching,” meaning “the application of an oxidizing agent to hair to destroy the natural or artificial pigment”). Accordingly, on the present record, we are not persuaded that Petitioner has shown it is more likely than not that claims 1–10 of the ’419 patent lack written description support. slip op. at 12
Claim construction§ 112 disclosurePatents in suitUS 9,498,419 - Apple Inc. v. Virnetx Inc.All claims unpatentablePTAB · Jun 22, 2017 · IPR2016-00331 · APJ Karl D Easthom · IPR · Final written decision
Claims 1–11, 14–25, and 28–30 are unpatentable as obvious over Beser and RFC 2401.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner’s contentions are not persuasive. Patent Owner fails to explain sufficiently why the notion of “performing an additional evaluation” constitutes an implicit part of the claimed intercept clause. Addressing similar arguments by Patent Owner, a Board panel made a similar determination in the ’237 FWD relied upon by Petitioner. ’237 FWD 11 (“the record show[s] that the additional functionality urged by Patent Owner should not be imported into the intercepting phrase”).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“broadest reasonable interpretation in light of the specification. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard under 37 C.F.R. § 42.100(b)). Under this standard, absent any special definitions, claim terms or phrases are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). For the purposes of this Decision, only the claim terms or clauses below need express construction. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (only those terms in controversy need to be construed and only to the extent necessary to resolve the controversy).” slip op. at 7
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“We find Dr. Tamassia’s testimony as to public accessibility of RFCs in general to be credible, especially given the independent support of RFC 2026 (Ex. 1036), the contents of which Patent Owner does not challenge.7 As part of routine discovery, see 37 C.F.R. § 42.51(b)(1)(ii), Patent Owner had the opportunity to cross-examine Dr. Tamassia, but does not point us to any discussion of this issue. Moreover, RFC 2401’s contents are consistent with the publication process described by RFC 2026 and Dr. Tamassia, including the inclusion of a date “November 1998” on the top right corner of the first page of the document. Ex. 1008, 1. In addition, this document—a request for suggestions and improvements for an Internet standards protocol, 7 As addressed below, Patent Owner objects and moves to dismiss a number of Exhibits based on hearsay and relevancy. See Paper 20 (Motion to Exclude). having no indication of being a mere draft or internal paper—is precisely the type of document whose very purpose is public disclosure, including on the Internet. Both of the magazine articles, Exhibits 1064 and 1065, further corroborate the indicia of availability on the face of RFC 2401, although they are not necessary to our finding of public accessibility. We do not rely on the testimony of Sandy Ginoza, Exhibits 1060 and 1063, which Patent Owner seeks to exclude as discussed further below.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner does not articulate a persuasive reason for giving Dr. Tamassia’s declaration, as a whole, little or no weight in our analysis. We agree with Petitioner that experts are not required to opine on every relevant factual and legal issue in order to be accorded substantial weight. The cases upon which Patent Owner relies do not show otherwise. For example, Patent Owner cites Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304, 1315 (Fed. Cir. 2002), for the proposition that “[expert] testimony . . . ‘must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference.’” PO Resp. 52–53. Patent Owner’s quotation, however, mischaracterizes Schumer by omitting introductory words necessary to the meaning of the quoted sentence. In its entirety, the quoted portion of Schumer states the following: Typically, testimony concerning anticipation must be testimony from one skilled in the art and must identify each claim element, state the witnesses’ interpretation of the claim element, and explain in detail how each claim element is disclosed in the prior art reference. The testimony is insufficient if it is merely conclusory. Schumer, 308 F.3d at 1315–16. The Federal Circuit then adds that it is not the task of the courts to “attempt to interpret confusing or general testimony to determine whether a case of invalidity has been made out” and “if the testimony relates to prior invention and is from an interested party, as here, it must be corroborated.” Id. at 1316. So, instead of laying out a specific, required format for the content of all testimony regarding invalidity, as asserted by Patent Owner, this portion of Schumer confirms the unremarkable proposition that conclusory, overly general, confusing, and self-interested testimony should not be relied upon. Id.; see also Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381 F.3d 1142, 1152 (Fed. Cir. 2004) (“General and conclusory testimony, such as that provided by Dr. Kazmer in this case, does not suffice as substantial evidence of invalidity.”). Patent Owner does not show that the whole of Dr. Tamassia’s testimony suffers from any of these failings. Under 35 U.S.C. § 316(e), the preponderance of the evidence standard governs in determining whether Petitioner establishes unpatentability. We exercise discretion to determine the appropriate weight to accord the evidence presented, including expert opinions, based on the underlying facts supporting the opinion. We accord relevant portions of Dr. Tamassia’s testimony the appropriate weight based on that particular testimony and supporting evidence.” slip op. at 14
Patent outcomesUS 8,504,696 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,504,696 - Generico, LLC / Flat Line Capital LLC et al. v. Dr. Falk Pharma GmbHAll claims unpatentablePTAB · May 19, 2017 · IPR2016-00297 · APJ Elizabeth M Roesel · IPR · Final written decision
Claims 1 and 16 are unpatentable as obvious over the Sept. 2007 Press Release, Endonurse, and Davis-1985 in view of either Marakhouski or Brunner.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“is an express definition for the term “remission.” In the Specification, the term, “DAI score,” is expressly defined in the following passage: Ulcerative colitis disease activity was assessed using a modified Sutherland Disease Activity Index1 (DAI), which is a sum of four subscores based on stool frequency, rectal bleeding, mucosal appearance on endoscopy, and physician’s rating of disease activity. Each subscore can range from 0 to 3, for a total possible DAI score of 12. Ex. 1001, 17:7–12.4 When the express definitions for “remission” and “DAI score” are read together, the claim 1 phrase “remission is defined as a DAI” slip op. at 9
- Skill levelSkill level board ownOther
“The ’688 patent relates to a method for administering granulated mesalamine to treat ulcerative colitis. The claimed method is the result of pharmacokinetic studies and clinical studies conducted by the inventors. Ex. 2036 ¶¶ 7, 10–12, 19, 21 (inventor declaration describing pharmacokinetic and clinical studies); Exs. 2029, 2045, 2048–2050 (reports and protocol for pharmacokinetic and clinical studies). Most of the written description of the ’688 patent relates to these studies. Ex. 1001, 6:27–35, 6:43–7:25, 16:1–45, 17:1–35, 21:17–33:64, Figs. 1–3 (clinical studies); id. at 7:26–31, 14:5–15:67, 16:47–67, 17:38–21:15 (pharmacokinetic, in vitro, and animal studies). According to Dr. Johnson’s testimony, neither of the inventors is a medical doctor, and neither has experience treating patients. Ex. 1067, 16:23–17:8, 22:19–23:3. Co-inventor William Forbes has a doctorate in pharmacy (“Pharm.D.”) and was Vice President of Research and Development for Salix at the relevant time. Ex. 1012, 1; Ex. 1067, 24:14– 25:17. Co-inventor Lorin Johnson5 has a Ph.D. in molecular biology and” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for patent owner
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
Patent outcomesUS 8,865,688 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,865,688 - Steadymed Ltd. v. United Therapeutics CorporationAll claims unpatentablePTAB · Mar 31, 2017 · IPR2016-00006 · APJ Jacqueline T Harlow · IPR · Final written decision
Claims 1–22 are unpatentable under § 102(b) and § 103(a), based on the Board’s anticipation and obviousness grounds.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“proposed construction (PO Resp. 17). Indeed, if any conclusion can be drawn from the specification excerpts highlighted by UTC, it is that the claim term “product” is defined solely by the recited claim limitations. See Ex. 1001, 5:45–46 (referring to the purportedly improved impurity of the “product of the process according to the present invention.”).” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“2. Discussion Each of the challenged claims, including independent claims 1 and 9,” slip op. at 24
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“below, we are persuaded by SteadyMed’s showing that an ordinarily skilled artisan, at the time of invention of the ’393 patent, would have had reason to combine, and a reasonable expectation of success in combining, Moriarty and Phares. “[T]he skilled artisan need not be motivated to combine [the prior art] for the same reason contemplated by [the inventor].” In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006). In this regard, we note that in addition to teaching that intermediate purification is unnecessary to the production of treprostinil diethanolamine salt by the disclosed process (Ex. 1005, 40–42), Phares explicitly describes the Moriarty process in disclosing the production of (-)-treprostinil, the enantiomer of (+)-treprostinil (id. at 42). Ex. 1009 ¶¶ 50, 77–78. Accordingly, we are persuaded that an ordinarily skilled artisan would have modified the process of Moriarty to incorporate the step of adding and dissolving diethanolamine to treprostinil as taught by Phares (Ex. 1005, 24) to eliminate the requirement for intermediate purification, thus, improving synthetic efficiency and reducing cost.” slip op. at 47
- Obviousness (§103) › Objective indicia / secondary considerationsDecided for patent owner
“minimize all impurities in all pharmaceuticals to the extent possible, such a general agency preference for improved purity is insufficient to establish a long-felt but unmet need for improved treprostinil, in particular. See Tex. Instruments v. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.”). Indeed, adherence to UTC’s position would dictate a conclusion of nonobvious for any pharmaceutical product exhibiting any improvement in purity over prior art versions of that same product.” slip op. at 61
Patent outcomesUS 8,497,393 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,497,393
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.