- PTAB · Dec 22, 2016 · IPR2015-00554 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving intact its determination that claims 1–11 are unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Expert testimonyDecided for patent owner
“and 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,668,730 - PTAB · Dec 22, 2016 · IPR2015-00547 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–6 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,765,107 - PTAB · Dec 22, 2016 · IPR2015-00551 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–15 unpatentable for obviousness over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“PO Resp. 60. We did not find such testimony persuasive, or particularly credible, in view of Korfhage’s express disclosures, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037, 276–77; Ex. 1054, 317:13–320:12; Ex. 2047 ¶ 57–59). Patent Owner’s argument is not persuasive given that the ACA drug distribution system was designed to allow a pharmacist to identify and resolve duplicate prescriptions before deciding whether to distribute the drug to a patient (or delete a duplicate caused by data redundancy). Ex. 1003, 184:24–185:7; Ex. 1005, 314 ¶ 6. We also were persuaded by Dr. Valuck’s testimony that it would have been obvious for one of ordinary skill to modify the ACA system “such that the data stored in the central data repository was distributed across multiple databases, as disclosed by Korfhage in order to accommodate cost, efficiency, and the number of prescription requests and associated data.” Ex. 1007 ¶ 157 (cited at Dec. 57–581).” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We also agree with Petitioner that Korfhage does not teach away from the use of distributed databases systems, particularly given the acknowledgement of Dr. Bergeron that Korfhage offered solutions to the problems identified. Id. at 59 (citing Ex. 1037, 276–77; Ex. 1054, 317:13–320:12). We did not overlook or misapprehend Patent Owner’s argument and evidence, rather, we declined to credit them in view of the text of Korfhage, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 56– 59. The pages of Korfhage cited and quoted in our Decision disclose multiple factors “driving information systems to the use of distributed document sets and distributed processing,” and set up “[t]hree major problems” only to discuss “simple solution[s],” a position supported by Dr. Valuck. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037 at 276–77). Under cross-examination by Petitioner’s counsel, Dr. Bergeron readily acknowledged that Korfhage’s discussion of data redundancy and matching document evaluation “problems” were paired with disclosed solutions, which undercut his declaration testimony (Ex. 2047 ¶¶ 56–65) relied upon by Patent Owner. Ex. 1054, 317:13–320:12. Our Decision credits Dr. Bergeron’s deposition testimony, which acknowledges the distributed database system solutions disclosed in Korfhage, rather than the speculative new problems hypothesized in his declaration and Patent Owner’s Response.” slip op. at 4
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state, and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims. Dec. 19 (emphasis added). We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims. Id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:22–24, 2:41–42, 4:7–8, 4:8–14, 4:18–20, 4:20–22, 4:7–5:67, 8:4–7, 8:40–44, 10:20–23, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 8
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,457,988 - PTAB · Dec 22, 2016 · IPR2015-00545 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Patent Owner’s rehearing request and reaffirmed that claims 19–25 are unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Expert testimonyPatent owner expert discountedDecided for patent owner
“cite to Dr. Bergeron’s Declaration testimony in support. PO Resp. 26–29 (citing Ex. 2047 ¶¶ 27–30); Req. Reh’g 2–5 (citing Ex. 2047 ¶¶ 27–30). Although we did not cite to Dr. Bergeron’s Declaration testimony in our Decision regarding claims 19–25, we did consider Dr. Bergeron’s Declaration testimony. Dec. 2. Dr. Bergeron’s Declaration testimony simply restates Patent Owner’s Response arguments, including the argument that the ACA discloses “the verification is being done by a human, not a computer processor.” Ex. 2047 ¶ 28. We take this opportunity to make explicit that we are not persuaded by Dr. Bergeron’s cited Declaration testimony (Ex. 2047 ¶¶ 27–30) on the issue of whether the ACA discloses or suggests the “verifying” step in claim 19, for the same reasons given in our Decision and above.” slip op. at 7
NonePatents in suitUS 8,589,182 - PTAB · Dec 22, 2016 · IPR2015-00548 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–16 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,895,059 - PTAB · Dec 22, 2016 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable as obvious over the Advisory Committee Art under § 103(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
- Claim Construction › Extrinsic evidence (dictionaries, experts)Decided for petitioner
“Id. at 20–22 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48, 4:13–6:4, 8:4–7, 40–44, 9:56–60, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45– 49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).” slip op. at 6
Claim constructioncites PhillipsPatents in suitUS 7,765,106 - Mexichem Amanco Holdings S.A De C.V. v. Honeywell International, Inc.Some claims unpatentablePTAB · Dec 9, 2016 · IPR2015-01309 · APJ Jon B Tornquist · IPR · Final written decision
Claims 1, 3, 5, 6, 10–13, 16, and 19 are unpatentable as obvious; claims 7–9, 14, and 15 were not shown unpatentable.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner and Patent Owner propose constructions for all, or a portion of, the term “Formula I, XCF3(I), where X is a C2 unsaturated, substituted, alkyl radical.” Pet. 17–19 (proposing a construction for the term “C2 unsaturated, substituted, alkyl radical”); PO Resp. 12–15. Neither party contends, however, that express construction of this claim term, or any other term in the ’808 patent, would impact any of Petitioner’s or Patent Owner’s arguments in this proceeding. Accordingly, we determine that no claim terms require construction for purposes of this Final Written Decision. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 7
- Skill levelSkill level patent owner adoptedDecided for patent owner
“art. Patent Owner, relying upon the testimony of Dr. Bivens, asserts that one of ordinary skill in the art would have had either: “(1) a bachelor of science degree in a specialty area (such as chemical engineering or chemistry) and five years of work experience in developing/testing refrigerants, blowing agents, and propellants, or (2) a Ph.D. or masters of science degree and 2-3 years of work experience.” PO Resp. 12 (citing Ex. 2034 ¶¶ 21–24). Patent Owner’s identification of a person of ordinary skill in the art is uncontroverted and is consistent with the prior art of record. Accordingly, we adopt Patent Owner’s identification for purposes of this Final Written Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the prior art itself may reflect the level of ordinary skill in the art).” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundMixed
“Accordingly, we are persuaded that: (1) Petitioner has identified where every limitation of claim 1 is disclosed or suggested in the combination of Kruse, Inagaki, and Butler; (2) Petitioner has set forth reasoned explanations supported by factual underpinnings to explain why one of ordinary skill in the art, prior to the earliest filing date of the ’808 patent, would have sought to combine Kruse, Inagaki, and Butler to achieve the invention set forth in claim 1 of the ’808 patent; and (3) Petitioner has set forth reasoned arguments, supported by record evidence, to show why a person of ordinary skill in the art would have had a reasonable expectation of success in combining Kruse, Inagaki, and Butler to achieve the composition of claim 1.” slip op. at 17
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“patent met a long-felt but unresolved need or were commercially successful, we have been directed to no persuasive evidence to demonstrate these propositions. See Graham, 383 U.S. at 17–18 (noting that “long felt but unsolved needs” and commercial success may be utilized as indicia of nonobviousness). Indeed, we have been directed to no persuasive evidence that a mixture of CO2 and a fluoroalkene of claim 1 has ever been used commercially, or that such a mixture was considered by those of ordinary skill in the art to have met a long felt but previously unresolved need.9, 10 See Tr. 51:24–52:7; Pet. Reply 9 (asserting that Patent Owner “has provided no evidence, post- or pre- issuance of the ’808 patent, of the commercial advantages or uses of the claimed compositions”). With respect to Petitioner’s prior patent applications, although Patent Owner initially characterizes these applications as relating to CO2 and partially fluorinated hydrocarbons, Patent Owner later notes that these patents are directed to blends of HFO-1234yf, CO2, and R-134a. PO Resp. 44; Ex. 2024, 12 (arguing in support of patentability that “[t]he specific 9 To be relevant, Patent Owner must show that the asserted secondary considerations are attributable to “the merits of the claimed invention beyond what was readily available in the prior art.” Asyst Techs. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008). Here, Inagaki discloses using compounds within the scope of claim 1 of the ’808 patent as refrigerants. Patent Owner presents no persuasive evidence that the addition of CO2 to the compounds of Inagaki, or the particular ranges recited in claim 1, resulted in a product that met a long felt but unresolved need or resulted in a commercially successful product beyond what was provided in Inagaki. Thus, we are also not persuaded that there is any nexus between the asserted secondary considerations and the features of claim 1 that are not disclosed in Inagaki. 10 As Patent Owner has not demonstrated any commercial use of the claim 1 compounds for any purpose, or provided evidence that those of skill in the art considered the claimed compounds to have met an unresolved need in the art, this analysis applies equally to the dependent claims of the ’808 patent, which each depend, directly or indirectly, from claim 1. combination of trans-R1234ze and R134a and CO2 simply is not suggested in Singh, let alone in the amounts defined in claim 1”). Patent Owner does not explain sufficiently why Petitioner’s arguments directed to the patentability of a blend of three compounds, utilized in specific proportions, are necessarily applicable to the combination of Kruse, Inagaki, and Butler proposed by Petitioner, or why these arguments are otherwise strong evidence of the nonobviousness of claim 1 of the ’808 patent. Based on the foregoing, and upon review of Patent Owner’s arguments as a whole, we are not persuaded that Patent Owner’s proffered objective evidence of nonobviousness is strong or tends to refute Petitioner’s arguments and evidence with respect to the obviousness of claim 1 of the ’808 patent.” slip op. at 25
Patent outcomesUS 8,623,808 mixedClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,623,808 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Monosol RX, LLCInstitution deniedPTAB · Dec 5, 2016 · IPR2016-01111 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–3, 9, 15, 62–65, 69–73, or 75 were unpatentable over either asserted § 103 combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the Petition and Preliminary Response, we determine that the Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we decline to institute an inter partes review of any challenged claim.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“Petitioner proposes a construction for one claim phrase: “dried without the loss of substantial uniformity,” appearing in independent claims 1 and 62. Pet. 15. According to Petitioner, that claim phrase should be construed broadly to mean “any method of drying.” Id. In support of that construction, Petitioner asserts only that Patent Owner’s expert witness in a co-pending litigation “testified that the claims were not limited to any particular form of drying, or any particular drying parameters.” Id. Patent Owner correctly notes that Petitioner has not explained why it has failed to account for the phrase “without the loss of substantial uniformity” in its proposed construction. Prelim. Resp. 8. Further, Patent Owner proposes that, under the broadest reasonable construction standard, the claim phrase “dried without the loss of substantial uniformity” should be given its plain meaning. Id. Based on the record, we agree.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Nor has Petitioner explained persuasively that a skilled artisan would have understood that individual doses of a pharmaceutical film cut by a rotary die can only be manufactured this way if the film does not vary more than 10%. Pet. 31–32. Petitioner’s argument and Dr. Celik’s testimony in that regard rely upon a statement in the challenged patent that “[c]urrently, as required by various world regulatory authorities, dosage forms may not vary more than 10% in the amount of active present.” Pet. 32; Ex. 1003 ¶ 101; Ex. 1001, 2:42–45. Petitioner and Dr. Celik acknowledge, however, that not all regulatory authorities require that limit. Specifically, Petitioner and Dr. Celik recognize that in the United States, “any given dose of the drug must have the same amount of active as any other dose, within a variance of 15%,” referring to the standard set by the United States Food and Drug Administration. Pet. 22; Ex. 1003 ¶ 81. Thus, at best, Petitioner’s reliance on the disclosure of the challenged patent regarding the standards set by the FDA or “various world regulatory authorities” provides a motivation for a person of skill in the art to modify the cited prior art to achieve a product film wherein the individual unit doses do not vary by more than 15%, or perhaps not more than 10%. However, even if such motivation exists, Petitioner has not shown how that the cited prior art or other knowledge in the art at the time of the invention would have informed an artisan how to reach that goal. As Patent Owner correctly asserts, “[r]ecognition of a need does not render obvious the achievement that meets that need.” Prelim. Resp. 17 (quoting Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 381 F.3d 1371, 1377 (Fed. Cir. 2004) and Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. Cir. 2008)). Insofar as Petitioner asserts that a person of ordinary skill in the art would have needed only routine experimentation to make films within the claimed variance limitation, we are unpersuaded. Pet. 27, 34. In a somewhat cursory manner, Petitioner supports that contention by asserting that a person of skill in the art “would have understood that mixing, de-gassing, viscosity and drying are all important variables to control in order to ensure uniformity, and would have been able to make routine adjustments of these variables in Chen’s process to meet the 10% limit.” Pet. 34. Dr. Celik makes a similar statement in his declaration. Ex. 1003 ¶ 104. However, neither statement by Petitioner or Dr. Celik includes a discussion of facts allegedly supporting those assertions.” slip op. at 15
- Expert testimonyPetitioner expert discountedDecided for patent owner
“indicating near-maximal release, and that the final values for the drug release “are clustered within ±10% of 100.” Ex. 1003 ¶ 103. According to Dr. Çelik, “[f]rom these data, a person of ordinary skill would reasonably have concluded that the films were within the claimed 10% limit.” Id. We are unpersuaded. In particular, what is missing from Dr. Çelik’s testimony is an explanation of his data analysis. Chen’s Figure 5 is reproduced below: Ex. 1005, Fig. 5. Chen’s Figure 5 shows the release profile of four active agents from films according to Chen’s Examples 5–8. Ex. 1005, 16:27–28. Chen does not discuss the data represented in Figure 5 or otherwise provide it.2 Nor does 2 Petitioner asserts that the Board “has found on appeal in three reexaminations directed to similar subject matter that Chen discloses substantial uniformity.” Pet. 35. As discussed, infra, those decisions did not Dr. Çelik present his opinion regarding the relevant specific data points reflected in Figure 5. Rather, Dr. Çelik opines, in a conclusory fashion, that the data shows, despite the unexplained error bars in the figure and lack of specific data points provided, that “the final recorded values for the data collected . . . fall at or within ‡ 10% of 100% (i.e., 90% to 110%),” and that a person of skill in the art would, therefore, conclude that “Chen’s films had at least the claimed uniformity.” Ex. 1003, 38 n.7. Because Dr. Çelik has not provided a reliable factual basis for his opinion on this matter, those opinions are not entitled to persuasive weight. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48763 (Aug. 14, 2012) (a declaration expressing an opinion of an expert without disclosing underlying facts may be given no weight).” slip op. at 13
Claim construction§ 103 obviousnessPatents in suitUS 8,603,514 - Dr. Reddy’S Laboratories, Ltd. / Dr. Reddy’S Laboratories, Inc. v. Monosol RX, LLCInstitution deniedPTAB · Dec 5, 2016 · IPR2016-01112 · APJ Erica A Franklin · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood of establishing that any challenged claim was unpatentable over the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the Petition and Preliminary Response, we determine that the Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the challenged claims. Accordingly, we decline to institute an inter partes review of any challenged claim.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for patent owner
“Patent Owner correctly notes that Petitioner does not rely on its proposed claim construction in the Petition. Prelim. Resp. 7. Nor does Petitioner provide any discussion supporting its position that the construction that it proposes represents the broadest reasonable construction in light of the specification of the patent, other than asserting that it is the same construction that was proffered in a district court proceeding. For purposes of this decision, we agree with Patent Owner that the plain and ordinary meaning of the phrases apply. Id. at 7. In any event, this Decision does not turn on the claim phrases for which Petitioner has proposed a construction.” slip op. at 6
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“particular, Petitioner has not explained adequately why a person of skill in the art at the time of the invention would have had a reason to combine the teachings of Chen and Shiraldi. As discussed, supra, Chen describes using a mixture of two or more types of the same hydrocolloid that differ only in molecular weights and Shiraldi describes selecting and blending various polymers. Petitioner has not shown that a person of skill in the art would have understood that Shiraldi teaches or suggests selecting various polymers based upon high and low molecular weights. Nor has Petitioner established that Chen’s teaching to combine two or more types of the same hydrocolloid having differing molecular weights involved selecting a mixture of high and low molecular weights in the manner claimed. Indeed, neither reference provides a teaching or an example of such a practice. The example in Chen relied upon by Petitioner includes only a low molecular weight polyethylene oxide. Pet. 32 (referring to Chen Example 11 using a polyethylene oxide having an average molecular weight of 100,000 Da). In contrast to Chen, Schiraldi preferred and exemplified only high molecular weight polyethylene, in a range well beyond that recited in the claims for that component. That is, Schiraldi describes the ethylene oxide useful for its invention as having “a relatively high molecular weight” and preferring molecular weights above 3,000,000, whereas the claims recite a molecular weight range of 600,000 to 900,000. See Ex. 1004, 4:25–31. Moreover, Petitioner has not shown that the cited prior art, alone or in combination, taught or suggested a film comprising both low and high molecular weight polyethylene oxide in the respective ranges recited by the claims, or with the specific percentage of the low molecular weight component required. The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 10
- Expert testimonyPetitioner expert discountedDecided for patent owner
“The portions of Dr. Mumper’s declaration cited by Petitioner do not provide any further support for Petitioner’s position. We note that Dr. Mumper does not explain why the polyethylene oxides molecular weights limitation would have been obvious to a person of ordinary skill over the combined teachings of the prior art. Instead, Dr. Mumper opines only that the skilled artisan “would be highly motivated to vary the amounts of the low and high molecular weight polyethylene oxide to achieve the desired effects including, but not limited to drug solubility, mucoadhesion and drug release rate.” Ex. 1003 ¶ 30. That opinion does not address a skilled artisan’s motivation, ability, or reasonable expectation of successfully achieving a film comprising the specific ranges and proportion of low and high molecular weight polyethylene oxides required by the claims. See In re Fine, 837 F.2d at 1074 (a showing of obviousness must be supported by evidence, as shown by some objective teaching in the prior art or by knowledge generally available to one of ordinary skill in the art that would have led that individual to combine the relevant teachings of the references to arrive at the claimed invention).” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurePatents in suitUS 8,017,150 - Presidio Components, Inc. v. Avx CorporationNo claims unpatentablePTAB · Dec 1, 2016 · IPR2015-01332 · APJ Matthew R Clements · IPR · Final written decision
Claims 1–5 and 7–12 were not shown unpatentable because the evidence did not establish a sufficient reason to modify Galvagni’s capacitor.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“Harperizing, or “corner rounding,” is typical. It merely describes one exemplary capacitor manufacturing process in which “the surfaces are cleaned of adhering lead contaminations and the edges and corners are eroded, i.e., rounded off, so that after the scrubbing the inside electrodes . . . are made substantially flush to the end faces of the monolithic ceramic body.” Florian, 10:16–22. On the other hand, Patent Owner’s expert, Dr. Shanfield, testifies that “Galvagni does not Harperize or corner round its components,” and that “a person of ordinary skill in the art would have avoided Harperization not least because it would have added processing time to an already labor-intensive process of Galvagni that could lead to longer cycle time, as well as dimensional variability that could lead to lower yield.”) Shanfield Decl. ¶¶ 71–72; see also id. at ¶ 73 (not Harperizing to contain or reduce manufacturing cost). On this record, we credit the testimony of Dr. Shanfield. We are not persuaded that a person of ordinary skill in the art would have understood that it was “typical” to Harperize the ends 18 of capacitor 16 taught in Galvagni prior to the vapor deposition of layer 21 illustrated in Figure 4 of Galvagni.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“In our Decision on Institution, we construed the phrase “negligibly over the top surface” (independent claims 1 and 12) to mean “a small amount of material is formed on the top surface.” Dec. to Inst. 7–9. Neither party disputes our determination or proposes additional terms for construction. Based on the record developed during this proceeding, we maintain this construction.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“On this issue, we agree with Patent Owner. Galvagni’s teachings of in-circuit testing of individual components are limited to using the ends, not the tops, of those components. Ex. 1002, 3:7–10, 6:24–30. Petitioner’s argument that testing probes of 0.05 mm were commercially available is not persuasive because Petitioner makes a comparison only to the dimensions taught in the ’547 patent without providing sufficient evidence that any negligible termination resulting from Harperization of Galvagni’s capacitor would also have been 0.05 mm. Even if it were, any negligible termination on a top surface of Galvagni’s capacitor would be very small relative to the end surface of Galvagni’s capacitor, and, therefore, would not “make it easier to access the capacitor for in-circuit test” (Pet. 17). Finally, even assuming Petitioner is right that a person of ordinary skill in the art would have been motivated to “test the individual components in a manner that minimizes wasted PCB (printed circuit board) space” (Pet. 15), Petitioner has not presented persuasive evidence that such a person would have valued that factor more highly than the other considerations identified by Dr. Shanfield—i.e., (1) the efficiency of testing groups of components rather than individual components, or (2) using pads on the PCB to reduce the risk of damage to components. After weighing the arguments and evidence, including the testimony of both parties’ experts, we are not persuaded that a person of ordinary skill in the art would have been motivated by the purported advantages for in-circuit testing to modify Galvagni’s capacitor 16 to include terminations extending negligibly over a top surface.” slip op. at 13
- ExcludeNot reached
“We decline to assess the merits of Patent Owner’s Motion to Exclude. As discussed above, even considering the identified evidence, we have concluded that Petitioner has not demonstrated, by a preponderance of the evidence, that the challenged claims are unpatentable. Accordingly, Patent Owner’s Motion to Exclude is dismissed as moot.” slip op. at 20
Patent outcomesUS 6,144,547 not shown unpatentableClaim construction§ 103 obviousnessPatents in suitUS 6,144,547
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.