- Taro Pharmaceuticals U.S.A., Inc. v. Apotex Technologies, Inc.Rehearing deniedPTAB · Jan 11, 2018 · IPR2017-01446 · APJ Jeffrey N Fredman · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, finding no abuse of discretion in instituting review because the record showed a reasonable likelihood of inherent anticipation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When rehearing a decision on institution, the Board will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. 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. Patent Owner “submits that the evidence of record fails to show that” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“THRESHOLD – The Director may not authorize an inter partes review to be instituted unless the Director determines that the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. As also noted in the decision on institution, we have considered both the Petition and Patent Owner Preliminary Response, and determined that the information presented in the Petition demonstrates that there is a reasonable likelihood that Petitioner would prevail with respect to the challenged claims. Dec. 2. Therefore, we applied the correct threshold standard for instituting the inter partes review.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundOther
“We agree with Patent Owner on the legal standard for inherency. As we acknowledged in our Decision, “[i]nherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14. However, we remain persuaded at this stage of the proceeding on the current factual record based on Hoffbrand 1998 and the Mehta Declaration, that Petitioner established a “reasonable likelihood” that Hoffbrand 1998 necessarily disclosed treatment of patients with “an iron overload condition of the heart” with a therapeutically effective amount of deferiprone. See Dec. 16–20; 35 U.S.C. § 314(a). Patent Owner does not identify a definition of the phrase “iron overload condition of the heart” in the ’328 patent Specification that distinguishes the claimed patient population from Hoffbrand’s disclosure of “10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie, falling within the range that has been associated with cardiac disease.” Ex. 1007, 297. The reasonable understanding of Hoffbrand’s teaching of this association between liver iron content and cardiac disease is that all ten patients with the elevated iron levels also necessarily fell into the spectrum of having “an iron overload condition of the heart.” Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching that liver iron content above 15.0 mg/g identifies patients with cardiac disease, and, therefore, with “an iron overload condition of the heart.” Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients suffered fatal complications. . . . Four of the five reported fatalities resulted from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003 ¶ 37. That statement supports the position that Hoffbrand 1998 treated patients who inherently had an ultimately fatal “iron overload condition of the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328 patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001, 28:33–37. We recognize that Dr. Pennell stated that “a patient with a liver iron content above 15 mg/g dry weight is at risk of developing cardiac disease not that such liver iron content definitely establishes cardiac disease.” Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits cited by Dr. Pennell do not identify evidence showing a single patient with a liver iron content that exceeds 15.0 mg/g but failed to display an “iron overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states “while whole liver iron levels >15 mg/g dry weight . . . have been shown to predict patients at highest risk of cardiac death, it is not known how these variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient data is provided in Exhibit 2007 comparing liver iron levels of particular patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016 also do not identify any patients with elevated liver iron content >15 mg/g dry weight with normal cardiac iron levels. Therefore, the evidence currently of record in Hoffbrand 1998,” slip op. at 3
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Regarding the second argument, Dr. Mehta relied upon specific facts within the Olivieri Abstract 1995 itself to support the conclusion that “lower TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states “MRI demonstrates changes consistent with reduction in cardiac iron in L1 [deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of 23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010. Olivieri Abstract 1995’s identification of the value of “32” as normal for TRT levels with lower values such as “23.9±6.4” as associated with elevated cardiac iron levels that require treatment with deferiprone, provides factual support for Dr. Mehta’s conclusion that patients with these lower TRT values inherently have “an iron overload condition of the heart.” See Ex. 1002 ¶ 75.” slip op. at 6
§ 102 anticipationPatents in suitUS 7,049,328 - Green Cross Corporation v. Shire Human Genetic Therapies, Inc.No claims unpatentablePTAB · Mar 22, 2017 · IPR2016-00258 · APJ Robert A Pollock · IPR · Final written decision
The Board held claims 1–3, 16, and 17 not shown unpatentable under § 103 because Jin was not prior art.
RulingsFinal written decision- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference not prior artDecided for patent owner
“are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. 35 U.S.C. § 316(e); see Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that the challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). However, because Petitioner offered Jin into evidence, which qualifies on its face as prior art under §102(e), Patent Owner bears the burden of producing evidence supporting a date of invention prior to the critical date of Jin. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015). As discussed below, Patent Owner elected to antedate, and thereby remove, Jin as prior art by showing that the inventor actually reduced the claimed invention to practice prior to Jin’s 102(e) priority date(s). As a result, the burden of production returned to Petitioner to demonstrate that the invention set forth in the challenged claims was not actually reduced to practice as of the date alleged. Id. at 1380. In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006). “Sufficiency of corroboration is determined by using a ‘rule of reason’ analysis, under which all pertinent evidence is examined when determining the credibility of an inventor's testimony.” Id. at 1170 (citation omitted). “[I]t is not[, however,] necessary to produce an actual over-the-shoulder observer. Rather, sufficient circumstantial evidence of an independent nature can satisfy the corroboration requirement. Furthermore, an actual reduction to practice does not require corroboration for every factual issue contested by the parties.” Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed. Cir. 1998) (internal citations omitted). “[E]ach corroboration case must be decided on its own facts with a view to deciding whether the evidence as a whole is persuasive.” Id. at 1331 (citation omitted),” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“provided sufficient evidence to show that it reduced to practice an embodiment encompassing all elements of the challenged claims prior to the critical date of Jin, and Petitioner does not convince us otherwise. Accordingly, we find that Jin is not § 102(e) prior art, as Petitioner contends. Because Petitioner’s ground for challenging the ’556 Patent as obvious depends on Jin, we conclude that Petitioner has not proven by a preponderance of the evidence that the challenged claims are unpatentable. F.” slip op. at 24
- ExcludeMotion to exclude, deniedDenied
“Motions i. Patent Owners Motion to Exclude Evidence (Paper 74) Patent Owner moves to exclude Exhibits 1035, 1036, 1037, 1038, 1039, 1400, 1049, and 1051, each of which relates to Petitioner’s obviousness case. As discussed above, Petitioner has failed to satisfy the threshold issue of demonstrating that Jin, the primary reference relied upon in its obviousness ground, is prior art to the ’556 Patent. Accordingly, we do not address the substance of Petitioner’s obviousness arguments and, thus, do not rely on the challenged exhibits in our analysis. Accordingly, we deny Patent Owner’s Motion as moot. ii. Petitioner’s Motion to Exclude Evidence (Paper 75) Petitioner moves to exclude Exhibit 2207 (“Webb Exhibit 4”) which is purportedly an unredacted version of the TKT report (Exhibit 2115). See Paper 81, 1. As we have no need to rely on the challenged exhibit or associated testimony in our analysis, Petitioner’s motion is denied as moot.” slip op. at 24
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“iii. Petitioner’s Request for Expungement of Papers 71 and 72 In its Response to Patent Owner’s Motions for Observations Regarding Cross-Examination of Drs. Carbonell and Webb, Petitioner requests that we expunge, or accord no weight to, Patent Owner’s Motions for Observations because Patent Owner “made no effort to faithfully quote any testimony, and its ‘observations,’ which are often crammed with multiple citations, improperly narrate and mischaracterize the testimony cited, are rife with legal argument, and include references to unauthorized exhibits.” Paper 80, 1–3 (footnotes omitted); Paper 82, 1–3 (same). Although we are not convinced that Patent Owner “color[s] so far outside the lines” as Petitioner contends, we do not rely in our analysis on Patent Owner’s Motions for Observations. Accordingly, Petitioner’s request is denied as moot.” slip op. at 25
Patent outcomesUS 9,051,556 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 9,051,556 - Douglas Dynamics, L.L.C. / Douglas Dynamics, Inc. v. Meyer Products LLCSome claims unpatentablePTAB · Mar 1, 2017 · IPR2015-01839 · APJ Jacqueline T Harlow · IPR · Final written decision
Claims 1, 2, 4–7, 28–31, 36, 38, 39, 43, and 44 are unpatentable under § 103(a); claims 8, 32, 33, and 48–54 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner
“The disclosure of the ’829 patent is expressly addressed to the problem of, and a solution for, unreliable and vulnerable electrical connections caused by splicing auxiliary lights into OEM headlight wiring. The Background of the Invention explains that “[t]raditionally, the auxiliary lights were spliced into the existing wiring for the headlights of the vehicle.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“As an initial matter, we observe that whether or not the preamble term “light circuit” is limiting has little bearing on the ultimate disposition of this inter partes review, as it is undisputed that Douglas has identified, for each asserted ground of unpatentability, disclosure of a light circuit. See PO Resp. 11–12. Furthermore, we agree with Douglas that “light circuit” does not connote any structure beyond that explicitly recited in the body of the claims. Indeed, it is unclear that either Meyer or Mr. Ricca disputes such conclusion. For example, Meyer states in its Patent Owner Response that” slip op. at 18
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“As a general rule, the words “a” or “an” in a patent claim carry the meaning of “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342–43 (Fed. Cir. 2008). That rule is particularly applicable 15 where, as here, those words are used in combination with the open-ended antecedent “comprising.” See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997). “An exception to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule.” Baldwin Graphic, 512 F.3d at 1342–43. We discern no such exception here. First, Meyer has not identified, and we do not discern, any requirement in the language of the claims to support the conclusion that the recited “an auxiliary light connector to connect an auxiliary light” must be a single auxiliary light connector.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“As set forth above, Möller explicitly teaches the incorporation of microprocessors and microcontrollers to improve relay-circuitry-based vehicle electronics systems. Ex. 1006, 4:41–48. Contemporaneous prior art 33 references, including Gould and COP8, disclose advantages obtained through the incorporation of microprocessors and microcontrollers into relay circuitry for controlling end devices, further underscoring that an ordinarily skilled artisan would have sought to modify the relay circuitry of Knepel with the microprocessors and microcontrollers of Möller. See Ex. 1010, 9, 11; Ex. 1011, 14. Moreover, Dr. Neuhalfen testifies, without challenge, that it was well-known at the time of invention of the ’829 patent to use microprocessors to control original vehicle lights, as well as auxiliary lights, and identifies numerous advantages that the proposed combination would afford. Ex. 1014 ¶ 59. Indeed, Meyer’s expert, Mr. Ricca, agrees that it would not have been difficult for an ordinarily skilled artisan to supplement the circuit of Knepel to provide microprocessor control of the relays in that circuit. Ex. 1033, 182:6–11. In view of the teachings of Möller itself, and the contemporaneous prior art, as well as the testimony of Dr. Neuhalfen and Mr. Ricca, we find that a person of ordinary skill in the art at the time of the invention would have recognized the value of using known elements, i.e., microprocessors and microcontrollers, as taught by Möller, to improve the relay circuitry for controlling original vehicle lights and auxiliary lights of Knepel. We likewise find that a person of ordinary skill in the art would have appreciated that the microprocessors of Möller could be incorporated into, i.e., used to supplement, the relay circuitry of Knepel. See KSR, 550 U.S. at 418 (an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account” slip op. at 33
Patent outcomesUS 6,265,829 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,265,829 - Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Some claims unpatentablePTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision
Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10
- Skill levelOther
“We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable
“Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18
Patent outcomesUS 7,754,702 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,754,702 - Amerigen Pharmaceuticals Limited v. Shire LLCRehearing deniedPTAB · Dec 28, 2016 · IPR2015-02009 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied Amerigen’s rehearing request, leaving claims 1–3, 5, 8, 9, and 11 uninstituted because Mehta did not disclose the claimed release limitation.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW When reconsidering a decision on institution, the Board reviews the 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.” 37 C.F.R. § 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Amerigen’s arguments with these principles in mind.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“These arguments are not persuasive. First, Petitioner cites no authority for the proposition that a generic disclosure, such as that discussed above, is an express disclosure of every possible permutation of that generic disclosure. Second, even if we were to accept, for the sake of argument, that Mehta’s combined disclosures constitute an express disclosure of a composition capable of delayed release of “essentially all [of the drug] . . . within about 60 minutes,” non-instituted claims 1–3, 5, 8, 9, and 11 further require that the delayed release is enteric (i.e., the composition releases the second dose of the drug in the intestines, not the stomach). As we noted in the Decision, however, Mehta does not use the word “enteric,” nor does Mehta discuss delivery of the delayed dose to the intestines. Dec. 28. Nevertheless, we considered the possibility that Mehta might inherently disclose a composition that releases into the intestine not less than 80% of the second dose of the drug within about 60 minutes of the delayed release. Accordingly, we turned to Mehta’s Examples 1–5, but determined that not one of the exemplified delayed release compositions achieved a release of “essentially all” of the drug from a delayed release coating within about 60 minutes—regardless of whether the delay was long enough to be considered enteric.3 Id. at 24. As we noted in the Decision,” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“This argument is not persuasive. We considered, for example, Dr. Elder’s testimony that one of ordinary skill in the art would expect “that the number of variables and number of experimental runs to optimize the coating for the amphetamine would present no unusual problems of technology or expense” because one “can use statistical experimental design to optimize a formulation within the 21 trials that Mehta discloses to design one for amphetamine salts” (Ex. 1005 ¶ 471), as well as Dr. Elder’s testimony that one would expect “that routine optimization of the coating using the parameters identified by Mehta would provide enough guidance for controlling the release timing” (id. ¶ 512). Nevertheless, we found the actual results reported by Mehta to be more compelling. As we stated in the Decision: [N]one of Mehta’s delayed release formulations that could be considered to be enteric by virtue of their delay periods (i.e., those with delays of 4 or 5 hours) had release rates of “essentially all” of the drug anywhere near the required time period. Even if Mehta could be read to suggest that a delay of 4 or 5 hours followed by a release of essentially all of the delayed dose within 60 minutes would be desirable, we are not persuaded that Mehta’s disclosure that “the amount of drug released is influenced by: amount of coating, ratio of the two 4 Amerigen supported its challenges with the Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph., executed September 30, 2015 (“Elder Declaration”) (Ex. 1005). polymers, amount of talc, and curing time” is adequate guidance for one of ordinary skill in the art to achieve such a dosage form. In general, Mehta demonstrates that longer delays are accompanied by longer release times, with formulations that could be considered to provide enteric release (i.e., a release after a 4 or 5 hour [delay]) having 85% release times of 8 or more hours. Dec. 33–34 (citing Ex. 1003, Table 1).” slip op. at 8
§ 102 anticipation§ 103 obviousness - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratory, Inc. v. Helsinn Healthcare S.A.Institution deniedPTAB · Aug 17, 2016 · PGR2016-00008 · APJ Toni R Scheiner · PGR · Institution
The Board denied institution because Petitioner did not show that claims 1–19 lacked written-description support or violated the AIA on-sale bar.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“35 U.S.C. § 324(c); 37 C.F.R. § 42.4(a). The standard is set forth in § 324(a), which provides that a post-grant review shall not be instituted unless “the Director determines that the information presented in the petition filed under section 321, if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” After considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate that it is more likely than” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what 7 Patent Owner additionally provides Appendix A to the Preliminary Response. Appendix A purportedly maps the requirements of claims 1–19 to the specification. 11 is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.” slip op. at 11
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)Not shown unpatentableNot shown unpatentable
“A person shall be entitled to a patent unless—(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention . . . . As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1). Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar.” slip op. at 18
§ 102 anticipation§ 112 disclosurePatents in suitUS 9,173,942 - Bioactive Laboratories v. BTG International Inc.Rehearing deniedPTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing
The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable
“anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable
“[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2
Claim construction§ 102 anticipation§ 112 disclosurePatents in suitUS 8,048,414 - The Johns Hopkins University v. Biocon LimitedInstitution deniedPTAB · May 12, 2016 · IPR2016-00175 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood of proving claim 1 anticipated by or obvious over Bedi.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“CONCLUSION Taking account of the information presented in the Petition and Preliminary Response, we determine that the Petition fails to show that there is a reasonable likelihood that Petitioner would prevail at trial with respect to claim 1 of the ’247 patent. ORDER It is ORDERED that the Petition is denied and no trial is instituted.” slip op. at 10
- BurdenDenied
“A. Anticipation by Bedi To establish anticipation, each and every element in a claim, “arranged or combined in the same way as recited in the claim,” must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Claim 1 requires a chimeric fusion protein comprising an “immunomodulating moiety” that “is SEQ ID NO: 4.” Ex. 1001, 69:45, 70:38. Claim 1 specifies that “SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Id. at 70:42–44. In claim 1, “the amino acid spacer is selected from SEQ ID NO: 3 or SEQ ID NO: 11.” Id. at 70:38–39.” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“The Petition fails to explain how, in spite of that difference, the “heavy chain” fusion protein depicted in Bedi’s Figure 3 anticipates claim 1. Pet. 17, 19. On that point, the Petition states that Bedi’s Figure 3 depicts a “construct comprising” the requisite components of the invention, but does not explain why Bedi’s disclosure of a lysine residue, on the C-terminus of the heavy chain sequence, teaches the specific fusion protein recited in claim 1. Id. at 19; see id. at 17 (admitting that Bedi’s heavy chain sequence includes a lysine residue, and that the addition of that residue distinguishes Bedi’s fusion protein from the fusion protein of claim 1); Prelim. Resp. 16– 19. We agree with Patent Owner that the Petition does not address adequately the differences between the “heavy chain” fusion protein depicted in Bedi’s Figure 3 and the claimed invention. Id. at 18. Nor does the Petition address adequately how Bedi’s Figure 3 depicts a fusion protein wherein the immunomodulating moiety “is attached via the amino acid spacer to the C-terminus of” the light chain sequence, specified in claim 1 as SEQ ID NO: 6. Ex. 1001, 70:43–44. We agree with Petitioner that Bedi depicts the same light chain sequence (identified as SEQ ID NO: 71 in Figure 3) as SEQ ID NO: 6 in claim 1. Ex. 1003, Fig. 3. The Petition, however, lacks supported analysis explaining how or why a person of ordinary skill in the art would understand Bedi to disclose in Figure 3 a fusion protein in which the immunomodulating moiety is attached via the amino acid spacer to the “light chain” sequence identified as SEQ ID NO: 71 in Bedi. Pet. 19 (arguing, without any evidentiary support, that Figure 3 depicts “attaching to anti-EGFR1 heavy or light chain (SEQ ID NO: 2 or 71, respectively)”). That attachment is not depicted in Figure 3, and the Petition directs us to no disclosure supporting the view that an ordinary artisan would have understood Figure 3 to illustrate an alternative fusion protein in which the immunomodulating moiety is attached via the amino acid spacer sequence to the C-terminus of the light chain sequence. “[D]ifferences between the prior art reference and a claimed invention, however slight, invoke the question of obviousness, not anticipation.” Net MoneyIN, Inc., 545 F.3d at 1371. On this record, we determine that the Petition does not direct us to information sufficient to show that Bedi anticipates claim 1.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“Petitioner’s obviousness challenge is interlaced with unsupported factual contentions. Pet. 20–29. The Petition rests on bare argument to establish how two asserted background references (Ex. 1007 and Ex. 1008) would have informed the understanding of an ordinary artisan’s reading of Bedi. Pet. 24–27. A lack of evidence also undermines Petitioner’s attempt to explain why “[o]ne of skill in the art would have been motivated to take the teachings of Bedi and apply them to constructing a fusion protein” according to claim 1 (id. at 27), “wherein SEQ ID NO: 4 is attached via the amino acid spacer to the C-terminus of SEQ ID NO 5 or SEQ ID NO: 6.” Ex. 1001, 70:42–44. The Petition, moreover, directs us to no support for the argument that “one of ordinary skill in the art would appreciate that the Fox3+CD25+CD4 Tregs described in (Ex. 1007 and 1008) will inherently express EGFR under inflammatory conditions, and that EGFR-positive Treg cells are more immunosuppressive than EGFR-negative Treg cells.” Pet. 27. Compounding that evidentiary deficit, the Petition advances bare attorney argument that “one so skilled would be motivated to use the EGFR targeting moiety of Bedi, to target the most immunosuppressive Treg populations set forth in Bedi and” a background reference. Id.” slip op. at 8
§ 102 anticipation§ 103 obviousnesscites KSRPatents in suitUS 8,815,247 - PTAB · Apr 8, 2016 · IPR2015-00720 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied rehearing and maintained denial of institution for claims 1–8 because Petitioner did not show the posters qualified as prior art printed publications.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co. Inc., 840 F.2d 1565,” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“In our Decision, we stated that we were “not persuaded that Petitioner has made a threshold showing that the posters were sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b).” Dec. 5 (emphasis added). We also stated that Petitioner had “not demonstrated adequately” that either poster constituted prior art to the ’685 patent. Id. (emphasis added). In other words, when considering the Petition and information before us, Petitioner did not demonstrate sufficiently that either poster constituted prior art, and consequently, Petitioner did not establish that there was a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition, as required under § 314(a). Petitioner’s assertions regarding the “proper standard” do not persuade us that we made a legal error in denying the Petition on that basis.” slip op. at 3
- Strike new argumentNew argument disregardedDecided for patent owner
“Once again, Petitioner essentially reargues, and attempts to bolster with new arguments now, the same contentions that we already considered and expressly addressed in our Decision. Dec. 3–5. As noted above, mere disagreement with the Board’s analysis or determination is not a proper basis for rehearing. Moreover, we will not consider new arguments made for the first time in a Request for Rehearing, especially when an opportunity to present arguments and information regarding the posters clearly existed at the time Petitioner filed its Petition. See, e.g., Berk-Tek LLC v. Belden Tech. Inc., Case IPR2013-00057, slip op. at 3 (PTAB May 15, 2013) (Paper 21) (“A request for rehearing is not an opportunity to submit new analysis, after the Decision has noted the deficiencies in the petitioner’s original analysis.”).” slip op. at 5
§ 102 anticipationPatents in suitUS 8,663,685 - PTAB · Apr 8, 2016 · IPR2015-00817 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied rehearing and left in place the denial of institution because Petitioner did not show the posters were publicly accessible printed publications qualifying as prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion occurs when a “decision was based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.”” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In our Decision, we stated that we were “not persuaded that Petitioner has made a threshold showing that the posters were sufficiently publicly accessible to qualify as a ‘printed publication’ under § 102(b).” Dec. 5 (emphasis added). We also stated that Petitioner had “not demonstrated adequately” that either poster constituted prior art to the ’826 patent. Id. at 5–6 (emphasis added). In other words, when considering the Petition and information before us, Petitioner did not demonstrate sufficiently that either poster constituted prior art, and consequently, Petitioner did not establish that there was a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition, as required under § 314(a). Petitioner’s assertions regarding the “proper standard” do not persuade us that we made a legal error in denying the Petition on that basis.” slip op. at 3
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“exactly when, where, and to whom the Hayes and Goodman posters were presented at scientific meetings. Dec. 3–6.” slip op. at 5
- Strike new argumentNew argument disregardedOther
“with new arguments now, the same contentions that we already considered and expressly addressed in our Decision. Dec. 3–6. As noted above, mere disagreement with the Board’s analysis or determination is not a proper basis for rehearing. Moreover, we will not consider new arguments made for the first time in a Request for Rehearing, especially when an opportunity to present arguments and information regarding the posters clearly existed at the time Petitioner filed its Petition. See, e.g., Berk-Tek LLC v. Belden Tech. Inc., Case IPR2013-00057, slip op. at 3 (PTAB May 15, 2013) (Paper 21) (“A request for rehearing is not an opportunity to submit new analysis, after the Decision has noted the deficiencies in the petitioner’s original analysis.”).” slip op. at 5
§ 102 anticipationPatents in suitUS 8,007,826
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.