- Mylan Pharmaceuticals Inc. / Wockhardt Bio AG et al. v. Astrazeneca ABNo claims unpatentablePTAB · Aug 18, 2017 · IPR2015-01340 · APJ Rama G Elluru · IPR · Final written decision
Petitioners failed to prove claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 unpatentable under the instituted §103 grounds, chiefly because the proposed modifications lacked a reasonable expectation of success.
RulingsFinal written decision- Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner
“C. Credibility of the Experts We give more weight to the testimony of Patent Owner’s expert, Dr. Weber, over that of Petitioners’ expert, Dr. Rotella, with respect to testimony that is in direct conflict. We favor Dr. Weber’s testimony because of her extensive experience in the design and development of DP 4 inhibitors for type-2 diabetes treatment. See Ex. 2056 ¶¶ 9–12; Ex. 2210, 1– 2. Moreover, Dr. Weber entered the DP 4 field at the relevant time, i.e., the time of invention, around 2000. Ex. 1073, 108:16–21; Tr. 35:16–22. We find that her testimony has been consistent, not just throughout this proceeding, but also with evidence predating this proceeding. See, e.g., Ex. 2056 ¶¶ 88, 115–118; 154–162; Ex. 1073, 51:2–54:14, 113:6–16, 119:19– 121:9; Ex. 2161, 558.” slip op. at 9
- Skill levelSkill level board ownOther
“The parties’ formulations as to the level of ordinary skill in the art are similar, and neither side identifies with specificity an error in the opposing side’s formulation. See PO Resp. 21; Pet. Reply 10. On the record presented, we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either side’s proposed formulation.” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“On the full record before us, we determine that Petitioners have not demonstrated by a preponderance of the evidence that a skilled artisan would have chosen Ashworth I’s compound 25 as a “lead compound.” Although Ashworth I indicates that compounds 24–29 were non-toxic in T cell assays up to 72 hours, and further indicates compound 25 was one among four compounds that were comparable to boroprolines, no further data is provided to guide the skilled artisan to select compound 25 among the other 2-cyanopyrrolidides as a lead compound for further modification to develop a DP 4 inhibitor. Ex. 1007, 1165–66. More importantly, the data reported in Ashworth I was based on in vitro data at room temperature, not in vivo data. PO Resp. 25 (citing Ex. 2174, 82:23–83:11). Indeed, Dr. Rotella states, “those studies were carried out at room temperature, which is roughly 20 degrees [Celsius]. I’ll point out that body temperature is higher than that, and that temperature has a direct effect on half-life. As you elevate temperature, you can expect half-life to decrease.” Ex. 2174, 82:23-83:11. Dr. Rotella further admits that he is not aware of any disclosure describing testing of Ashworth compounds in humans. Ex. 2174, 60:23-61:9. In addition, Ashworth I acknowledged that these compounds exhibited an intramolecular cyclization problem and that further work on optimization of the pyrrolidine ring was necessary and would be reported shortly. Ex. 1007, 1163–65. Others in the prior art also continued to seek solutions to the problem of intramolecular cyclization, such as those posed by Ashworth I compounds. See PO Resp. 27–28.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable
“(4) No Reasonable Expectation of Increasing Stability We are not persuaded that the skilled artisan would have had a reasonable expectation of success in achieving increased stability of Ashworth I’s compound 25 based on Hanessian I’s teachings concerning the cyclopropanation of proline. See Pet. 29. There was no disclosure in the prior art of cylopropanating the pyrrolidine ring of compound 25, or any similar compound. Indeed, Dr. Rotella admitted “that there wasn’t anything in the literature prior to the invention of saxagliptin that actually suggested that cyclopropanation of an Ashworth-One type DPP4 inhibitor would improve its stability.” Ex. 2174, 142:3-9. In addition, there is not sufficient evidence as to how the modified cyano-moiety would have been understood to affect compound 25’s stability. Given the structural differences, we find there is insufficient evidence suggesting that the skilled artisan could have reasonably predicted how cyclopropanating compound 25’s P1 group (as opposed to the proline compound discussed in Hanessian I) would have affected the cyano moiety’s (as opposed to the substituent in Hanessian I) orientation in space. Furthermore, there is insufficient evidence as to whether that modified orientation would have sufficiently decreased intramolecular cyclization. Indeed, Dr. Rotella testified that: [I]n the process of that modification of orientation in space [when you fuse two rings together], you may observe effects on potency, you may observe effects on solution stability, you may observe other effects on other properties that one might measure in connection with a drug discovery project. Ex. 2174, 119:10–120:2. When asked, “[a]nd those effects might be either positive or negative; correct?” Dr. Rotella replied, “[t]hey might be, yes.” Ex. 2174, 120:3–5. Dr. Rotella also testified that at the time of the invention, the objective of adding a cyclopropyl substituent to the pyrrolidine ring of compound 25 would have been exploratory. He testified: Q. Well, what is the objective of putting the cyclopropane on the molecule, in your opinion? A. There are two possible objectives based on the data -- there are at least two possible objectives based on the data available surrounding compound 25. Q. And what are they? A. One would be to explore whether or not you could improve potency. A second would be whether or not you could improve solution stability. One might also explore how that -- those changes, either by themselves or in combination with two changes, might also improve or change -- sorry -- to improve solid-state stability. Furthermore, since nothing is known, at least at this point in time, about other properties associated with compound 25, you’d want to understand what those properties were and adjust them as need be. Generally speaking, those properties are things that we call, collectively, pharmaceutical properties. Ex. 2174, 115:11–116:13 (emphasis added). This testimony does not sufficiently support Petitioners’ contention that a skilled artisan would have reasonably expected cyclopropanating the pyrrolidine ring of compound 25 to increase its stability.” slip op. at 26
Patent outcomesUS RE44,186 not shown unpatentable§ 103 obviousnesscites KSR · Graham - Black Swamp IP, LLC v. Virnetx Inc.Rehearing deniedPTAB · Jul 24, 2017 · IPR2016-00957 · APJ Stephen C Siu · IPR · Rehearing
The Board denied VirnetX’s rehearing request, leaving claims 27 and 51 unpatentable as anticipated by Kiuchi.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
- BurdenDecided for petitioner
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
NonePatents in suitUS 7,921,211 - Black Swamp IP, LLC v. Virnetx Inc.Rehearing deniedPTAB · Jul 24, 2017 · IPR2016-00693 · APJ Stephen C Siu · IPR · Rehearing
The Board denied VirnetX’s rehearing request, leaving intact its determination that claims 27 and 51 are anticipated by Kiuchi.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
- BurdenDecided for petitioner
“path to address the claimed ‘first location’” and relies on In re Magnum Oil Tools Int’l., Ltd., 829 F.3d 1364 (Fed. Cir. 2016) to support Patent Owner’s implied contention that the Final Decision may not address new arguments raised by Patent Owner in Patent Owner’s Preliminary Response and/or Patent Owner’s Response. Req. Reh’g. 6. We disagree. In the present matter and in accordance with Magnum Oil, the ultimate burden of proof remained with Petitioner and was never shifted to Patent Owner at any time during the proceedings and, as discussed above, at no time was an “entirely new path to address the claimed ‘first location’” introduced in the Decision.” slip op. at 3
NonePatents in suitUS 7,418,504 - Apple Inc. v. Virnetx Inc.All claims unpatentablePTAB · Jun 22, 2017 · IPR2016-00332 · APJ Karl D Easthom · IPR · Final written decision
Claims 1–11, 14–25, 28, and 30 are unpatentable based on the instituted grounds.
RulingsFinal written decision- ExcludeMotion to exclude, deniedMixed
“Petitioner’s argument is persuasive. Patent Owner has not met its burden of explaining why Exhibits 1064 and 1065 must be excluded as hearsay. The statements are offered to show that skilled artisans believed the RFC 2401 document and other RFC documents were available at the time of publication. Patent Owner does not challenge the publication dates of the magazines as hearsay. As noted above, Patent Owner does not state what aspects of the documents are hearsay. See Paper 20, 7–10; Paper 24, 4 n.1 (Patent Owner “disagrees” with Petitioner about the documents status as hearsay). In any event, Petitioner shows that the documents also satisfy the residual hearsay exception. They have circumstantial guarantees of trustworthiness as written prior to litigation by disinterested parties in periodical trade magazines that almost qualify as ancient documents. Both magazine articles bear specific volumes and issue numbers along with the publication dates. See Ex. 1064 (Aug. 16, 1999, vol. 21, iss. 33); Ex. 1065 (March 15, 1999, vol. 16, no. 11); Paper 23, 3–8; Fed. Rule Evid. 803 (16) (ancient authentic documents of 20 years old are not hearsay). In addition,” slip op. at 84
Patent outcomesUS 8,504,696 unpatentableNonecites Phillips · KSRPatents in suitUS 8,504,696 - 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 - Black Swamp IP, LLC v. Virnetx Inc.All claims unpatentablePTAB · Jun 12, 2017 · IPR2016-00693 · APJ Stephen C Siu · IPR · Final written decision
Claims 1, 2, 5, 6, 15, 16, 27, 33, 36, 37, 39, 40, 51, 57, and 60 are unpatentable as anticipated by Kiuchi under § 102.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“configured to “comprise an indication that the domain name service system supports establishing a secure communication link.” Patent Owner argues that “it is improper to equate establishing a secure communication link with indicating whether the domain name service system supports establishing a secure communication link” because claim 1 “separately recit[es] ‘establishing a secure communication link,’ . . . and ‘an indication that the domain name service system supports establishing a secure communication link.’” PO Resp. 22, 30 (citing Ex. 2015 ¶ 34, 46). Patent Owner does not explain sufficiently how a system that establishes a secure link somehow does not “indicate” that it supports doing so if the system establishes the secure link. One of skill in the art would have understood a system that establishes a secure link would support doing so at least as a matter of common sense. If the system did not support establishing a secure link, one of skill in the art would have expected such a system not to actually establish a secure link (the system not supporting such an action). This is contrary to Kiuchi’s system, for example, in which a secure link is established (thereby “indicating” that it supports doing so). For example, the “domain name service system” is recited in claim 1 as “establishing a secure communication link,” and comprising “an indication that the . . . system” may support the recited function of “establishing a secure communication link.” We do not observe, nor does Patent Owner point out in a meaningful way, any conflicts between a recited system comprising an “indication” that the system supports a recited function by performing the function that it supports and a recitation that the system is designed to perform that function.” slip op. at 6
- Strike new argumentNew argument consideredDecided for petitioner
“(“New Issue #1” and “New Issue #2”) in Petitioner’s Reply Brief. PO Identification 1–5. After careful consideration of Patent Owner’s arguments and for reasons set forth below, we determine that Patent Owner’s arguments regarding alleged New Issue #1 are moot because we do not rely upon Petitioner’s arguments regarding that issue in this opinion. We also determine that alleged New Issue #2 was responsive to arguments raised by Patent Owner.” slip op. at 14
Patent outcomesUS 7,418,504 unpatentable§ 102 anticipationPatents in suitUS 7,418,504 - Black Swamp IP, LLC v. Virnetx Inc.All claims unpatentablePTAB · Jun 12, 2017 · IPR2016-00957 · APJ Stephen C Siu · IPR · Final written decision
Claims 1, 2, 5, 6, 15, 16, 23, 27, 36, 37, 39, 40, 47, 51, and 60 are unpatentable as anticipated by Kiuchi under § 102.
RulingsFinal written decision- Strike new argumentNew argument consideredDecided for petitioner
“Given that Patent Owner raises this issue (that the claim terms “indicating” and “establishing” are separate and distinct) for the first time in Patent Owner’s Response, even assuming that Patent Owner is correct that Petitioner argues in the Reply Brief “that ‘the ‘indicate’/’indicating’ claim elements and the alleged ‘establishing’ claim elements are not separate claim elements’” (PO Identification 4 (citing Pet. Reply 14, 17)), such an argument by Petitioner would merely be responsive to Patent Owner’s arguments presented in Patent Owner’s Response and, therefore, would not “go beyond properly responding to VirnetX’s Patent Owner Response,” as Patent Owner alleges. PO Identification 1.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“communication link.” Patent Owner argues that “it is improper to equate establishing a secure communication link with indicating whether the domain name service system supports establishing a secure communication link” because claim 1 “separately recit[es] ‘establishing a secure communication link,’ . . . and ‘an indication that the domain name service system supports establishing a secure communication link.’” PO Resp. 22, 30 (citing Ex. 2015 ¶¶ 34, 46). Patent Owner does not explain sufficiently how a system that establishes a secure link somehow does not “indicate” that it supports doing so if the system establishes the secure link. One of skill in the art would have understood a system that establishes a secure link would support doing so at least as a matter of common sense. If the system did not support establishing a secure link, one of skill in the art would have expected such a system not to actually establish a secure link (the system not supporting such an action). This is contrary to Kiuchi’s system, for example, in which a secure link is established (thereby “indicating” that it supports doing so).” slip op. at 6
- BurdenDecided for petitioner
“communication link.” Patent Owner argues that “it is improper to equate establishing a secure communication link with indicating whether the domain name service system supports establishing a secure communication link” because claim 1 “separately recit[es] ‘establishing a secure communication link,’ . . . and ‘an indication that the domain name service system supports establishing a secure communication link.’” PO Resp. 22, 30 (citing Ex. 2015 ¶¶ 34, 46). Patent Owner does not explain sufficiently how a system that establishes a secure link somehow does not “indicate” that it supports doing so if the system establishes the secure link. One of skill in the art would have understood a system that establishes a secure link would support doing so at least as a matter of common sense. If the system did not support establishing a secure link, one of skill in the art would have expected such a system not to actually establish a secure link (the system not supporting such an action). This is contrary to Kiuchi’s system, for example, in which a secure link is established (thereby “indicating” that it supports doing so).” slip op. at 6
Patent outcomesUS 7,921,211 unpatentable§ 102 anticipationPatents in suitUS 7,921,211 - Clearcorrect Operating, LLC v. Align Technology, Inc.All claims unpatentablePTAB · Mar 24, 2017 · IPR2016-00270 · APJ James J Mayberry · IPR · Final written decision
Claims 1, 2, 9, and 10 are unpatentable under § 103(a) over Snow, Hultgren, and Kesling.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Factual indicators of the level of ordinary skill in the art include “the various prior art approaches employed, the types of problems encountered in the art, the rapidity with which innovations are made, the sophistication of the technology involved, and the educational background of those actively working in the field.” Jacobson Bros. v. United States, 512 F.2d 1065, 1071 (Ct. Cl. 1975); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983) (quoting with approval Jacobson Bros.). We find that the prior art of record is primarily directed to computer modeling an individual patient’s teeth and orthodontics. For example, Snow is primarily focused on creating a three-dimensional computerized dental record for an individual patient. Ex. 1003, Abstract. Hultgren is related to generating electronic data by scanning dental and soft tissue of a specific patient. Ex. 1004, Abstract. The ’037 patent’s “Description of the Background Art” describes tooth positioners for orthodontic treatment and digital imaging for designing orthodontic appliances and orthodontic treatment. See Ex. 1001, 2:21–63; see also id. at 9:44–47 (“General techniques for producing plaster casts of teeth and generating digital models using laser scanning techniques are described, for example, in U.S. Pat. No. 5,605,459.”). Align contends “that digital modeling was in its very early stages in the relevant timeframe and that practitioners were still in the process of determining how best to measure 3D tooth models.” PO Resp. 35 (citing to Dr. Mah’s deposition testimony). This contention contradicts the ’037 patent, which discloses that generating three-dimensional digital data representing the shape and position of a patient’s tooth was known in the prior art. See, e.g., Ex. 1001, 9:44–48 (incorporating by reference into the ’037 patent U.S. Patent No. 5,605,459, which discloses generating three-dimensional electronic data representing a patient’s teeth); id. at 2:50–52 (identifying as background art U.S. Patent No. 5,011,405, which discloses a number of ways to generate accurate digital information defining the shape and location of a patient’s tooth).4 As ClearCorrect contends, the record is replete with evidence that the level of ordinary skill of a practicing orthodontist encompasses knowledge of making three-dimensional representations of the shape and location of an individual patient’s teeth. See Reply 14–15. Accordingly, based on our underlying factual findings discussed above, we determine that the level of ordinary skill in the art is a practicing orthodontist, including a person having a doctorate in dental science and three to five years of training and practical experience in orthodontics or a person with expertise in digital modeling and analysis and substantive knowledge of orthodontics.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Claim construction begins with the language of the claims. Source Vagabond Sys. Ltd. v. Hydrapak, Inc., 753 F.3d 1291, 1299 (Fed. Cir. 2014). We discern no language in the “providing” steps themselves that require that the digital data be three-dimensional representation of a patient’s actual teeth. The express phrase “plurality of digital data sets” is not further limited to the underlying source of the digital data, whether it be two-dimensional or three-dimensional data. Further, the claim language characterizes a plurality of digital data sets as representing a progression from an initial tooth arrangement, through at least one successive tooth arrangement, to a final tooth arrangement. Align fails to adequately explain how this language requires the initial and successive tooth arrangements to include the actual shape of individual teeth. As we discuss in greater detail below, claims 1 and 9 recite that the digital data sets representing these successive tooth arrangements serve as the basis for fabricating incremental position adjustment appliances, but the claim language does not otherwise limit these appliances to appliances requiring to fit precisely the actual shape of the patient’s tooth. See, e.g., Ex. 1001, 8:50–54 (defining appliances broadly to include, for example, retainers, which would not necessarily include tooth-receiving cavities that must be precisely fit to a patient’s actual tooth).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“obviousness determination is a pure question of fact.’” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014) (quoting Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006)). ClearCorrect reasons that a person of ordinary skill in the art at the time of the invention of the ’037 patent would have combined the teachings of Snow, Hultgren, and Kesling to arrive at the invention of claims 1 and 9 to provide more precise dental appliances and save manufacturing costs. Pet. 22. ClearCorrect explains that a skilled artisan would have been motivated to create a plurality of digital data sets and digitally reposition the teeth, as taught by Snow, and to use the digital data sets representing the repositioned teeth to control a fabrication machine to produce a plurality of positive casts of the successive tooth arrangements, as described by Hultgren. The positive casts would then be used for producing the plurality of dental incremental position adjustment appliances well known in the art, as negatives of the positive casts taught by Kesling. Id. (citing Ex. 1007 ¶¶ 54-55; Ex. 1008 ¶¶ 101-102). ClearCorrect further explains that Snow, Hultgren, and Kesling are all in the field of dentistry and are concerned with creating or manipulating three-dimensional models of a patient’s teeth. Pet. 22. ClearCorrect contends that the combination would result in more precise dental appliances as Snow’s digital data represents more precise tooth arrangements as compared to Kesling’s manual process. Id. at 22–23. Also, machine fabrication of positive models would save manufacturing costs as it replaces Kesling’s labor-intensive process. Id. at 23. As ClearCorrect further explains, the combination represents merely automating a known manual process. Id. Finally, ClearCorrect explains that the predictability in the art would have suggested to the artisan of ordinary skill that there was a reasonable likelihood of success. Id. (citing Ex. 1007 ¶ 55 and Ex. 1008 ¶ 105).” slip op. at 33
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“For objective evidence to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). “[T]here is a presumption of nexus for objective considerations when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘is the invention disclosed and claimed in the patent.’” WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1329 (Fed. Cir. 2016) (internal citation omitted); see also PPC Broadband, Inc. v. Corning Optical Commc’ns RF, LLC, 815 F.3d 734, 747 (Fed. Cir. 2016) (“Because the evidence shows that the SignalTight connectors are ‘the invention disclosed and claimed in the patent,’ we presume that any commercial success of these products is due to the patented invention . . . . This is true even when the product has additional, unclaimed features.”) (internal citations omitted). “The presumption of nexus is rebuttable: a patent challenger may respond by presenting evidence that shows the proffered objective evidence was ‘due to extraneous factors other than the patented invention.’ Such extraneous factors include additional unclaimed features and external factors, such as improvements in marketing.” WBIP, LLC, 829 F.3d at 1329 (internal citation omitted). We find that Align is entitled to the presumption of a nexus. Align offers evidence that its method claimed in claims 1, 2, 9, and 10 is used in producing it products. See PO. Resp. 45–47. As discussed in greater detail below, we further find, however, that the record evidence rebuts this presumption. Accordingly, we afford little weight to Align’s commercial success evidence. We find that the record evidence demonstrates that the commercial success is attributable, in greater part, to the aesthetic appeal and convenience of products in addition to any computer implementation and fabrication reflected in the challenged claims. For example, Align’s 10-K for 2000 states that its products “significantly reduces the aesthetic and other limitations associated with braces.” Ex. 2018, 5.14 Align states that benefits of its products include excellent aesthetics, comfort, improved oral hygiene, reduced treatment time, reduced root absorption, and reduced emergency situations as broken aligners can be replaced. Id. at 8. Align fails to explain how these benefits are attributed to claimed features of the challenged claims. See also Ex. 2019, 7–8 (providing a 10-K for 2003 that provides benefits to dental professionals and patients, with only one benefit— 14 In referencing Align’s 10-K exhibits, we cite to the exhibit page number, not the 10-K page number. “[a]bility to visualize treatment and likely outcomes”—attributable to claimed features of the challenged claims); Ex. 2020, 7–8 (providing the 10- K for 2006 stating the same benefits); Ex. 2021, 10–11 (providing 10-K for 2008 stating same benefits); Ex. 2022, 12 (providing 10-K for 2011 stating favorability with respect to key competitive factors are “effectiveness of treatment; price; software features; aesthetic appeal of the treatment method; customer support; customer online interface; brand awareness; innovation; distribution network; comfort associated with the treatment method; oral hygiene; ease of use; and dental professionals’ chair time”); Ex. 2023, 13 (providing 10-K for 2014 with same statement as in 2011 regarding favorability with respect to key competitive factors); Ex. 2024, 12 (providing 10-K for 2015 with same statement as in 2011 regarding favorability with respect to key competitive factors). Other record evidence also supports a finding that any commercial success of Align’s products is attributable, at least in part, to unclaimed features. For example, Exhibit 2025 indicates that features such as the invisible nature of the aligners and comfort attribute to the products’ success. See Ex. 2025, A Stealth Substitute for Braces, Designed Only for Adults, col. 2. The article also notes Align’s $38 million advertising campaign. Id. at col. 3; see also Ex. 2012, 2 (explaining that Align initiated “the first effort by an orthodontics products company to appeal directly to consumers through television”). Further, the article quotes Dr. Jerrold, program director of postgraduate orthodontics at New York University’s School of Medicine, as saying “[t]he only reason that this is a better mousetrap is that it’s invisible.” Id. at col. 4. Further, as ClearCorrect argues, Dr. Valley testified that Align’s product success was attributable to factors that includes aligners that are less noticeable than braces, more comfortable than braces, and allows for better oral hygiene than braces. See Reply 21; Ex. 1056, 34:8–35:5. Still further, a finding that any commercial success of Align’s slip op. at 41
Patent outcomesUS 6,699,037 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 6,699,037 - Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentablePTAB · Mar 15, 2017 · IPR2016-01368 · APJ Scott C Moore · IPR · Final written decision
Claims 3–26, 28–32, and 35 are unpatentable as obvious under the listed combinations of Kato and additional references.
RulingsFinal written decision- Skill levelSkill level board ownOther
“The parties’ formulations as to the level of ordinary skill in the art are similar to one another, and neither party identifies with specificity an error in the opposing party’s formulation. The parties also agree that none of the disputes in this case turn on differences between the parties’ respective formulations. Tr. 33:1–6, 67:20–68:1. On the record presented we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either party’s proposed formulation.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“usage, could encompass motorcycles. Tr. 41:12–23. Patent Owner further concedes that the ’034 patent does not contain an express lexicographic definition of the term “vehicle,” (Tr. 41:24–43:8), and instead argues that “the disclosure of the patent in the claims and the problem to be solved” make clear that the term “vehicle” excludes motorcycles (id. at 42:19–43:5). Patent Owner, however, does not sufficiently identify the portions of the specification that allegedly support its claim construction argument. See PO Resp. 6–7 (indicating that Patent Owner’s claim construction argument is based on “certain discussion throughout the specification of the ’034 patent, as noted throughout this Response”). Patent Owner cites to Paragraph 38 of the Katona Declaration (see PO Resp. 7), but this declaration testimony relates to the Kato reference and does not identify any portion of the ’034 patent that supports Patent Owner’s argument (see Ex. 2002 ¶ 38; Ex. 1007 ¶¶ 4–5). Moreover, we find that the “Claim Interpretation” section of the Katona Declaration is conclusory in nature because it does not identify any specific portion of the ’034 patent specification that supports Patent Owner’s argument. See Ex. 1002 ¶ 44. For the foregoing reasons, and based on the current record and our review of the specification of the ’034 patent, we are not persuaded that the intrinsic record contains a lexicographic definition or a disclaimer that would exclude motorcycles from the scope of the term “vehicle.” To the contrary, the specification makes clear that the term ”vehicle” is a broad term that is intended to encompass any type of vehicle. Accordingly, we determine that the term “vehicle,” as used in the specification and claims of the ’034 patent, encompasses motorcycles.” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“directed to different fields of endeavor, depends on its argument that the term “vehicle,” as used in the ’034 patent, excludes motorcycles. As discussed above, we reject this argument. In view of our determination that the ’034 patent’s use of the term “vehicle” does not exclude motorcycles, we are persuaded by Petitioner’s arguments (see Reply 7–8; Ex. 1037 ¶ 23) and find that Kato is directed to the same field of endeavor as the ’034 patent, i.e., automatic directional control systems for vehicle headlights. Compare Ex. 1001, 1:57–67, with Ex. 1007 ¶ 1. Even if the ’034 patent’s controller and Kato’s motorcycle controller were directed to different fields of endeavor, Kato’s controller would still be reasonably pertinent to the problem addressed by the ’034 patent. In particular, we find that Patent Owner is incorrect in its assertion that “[n]o crossover applicability exists [] between control devices for a motorcycle headlight and those of four-wheeled vehicles.” PO Resp. at 19. For example, Kato’s controller adjusts a headlight’s optical axis based upon changes to pitch angle or steering angle of a motorcycle. Ex. 1007 ¶ 11; see Ex. 1037 ¶ 33. The controller of the ’034 patent adjusts the aiming angle of vehicle headlights to account for operating conditions such as “steering angle” and “pitch.” Ex. 1001, 2:3–20. In view of the fact that the ’034 patent and Kato both disclose controllers that automatically adjust headlights of motorized vehicles according to steering angle and pitch, we are persuaded by Petitioner’s arguments (see Reply 8–13; Ex. 1037 ¶¶ 24–29) that Kato would “logically have commended itself” to the attention of an inventor considering the problem addressed by the ’034 patent, even if the problem addressed by the ’034 patent only related to four wheeled vehicles. See In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007). On this record, we find that Kato qualifies as analogous art.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundMotivation foundDecided for petitioner
“teaches away from the use of Takahashi’s thresholds, or that such thresholds would render Kato’s system unsuitable for its intended purpose. Kato’s stated “Object of the Invention” is “to provide a headlight optical axis control device that can stably ensure a beam irradiation range of a headlight even when pitch, bank, steering angle or the like change while driving a motorcycle.” Ex. 1007 ¶ 6. Kato does disclose an embodiment that is able to correct direction of a headlamp “immediately” (id. ¶ 8), but we do not find that the portions of Kato cited by Patent Owner “criticize, discredit, or otherwise discourage investigation” into the use of a threshold of the type taught by Takahashi. Galderma Labs. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); see PO Resp. 28–29, Ex. 2002 ¶¶ 57–58. We also do not find that such thresholds would render Kato’s system unsuitable for its intended purpose. See PO Resp. 30–31; Ex. 2002 ¶¶ 57–58. Rather, we agree with Petitioner that a skilled artisan would have realized that Takahashi’s threshold values could have been set to minimize time delays while still realizing the advantages of Takahashi’s invention (i.e., avoiding unnecessary headlight adjustments due to short-term disturbances, such as those caused by a rough road surface). Reply 17–18; Ex. 1037 ¶¶ 34–39. Patent Owner also has failed to cite any persuasive evidence of improper hindsight. See PO Resp. 29, 33. We find on this record that combining Takahashi’s reference values with the Kato’s headlight optical axis control system would result in an obvious “combination of familiar elements according to known methods . . . [that] does no more than yield predictable results.” See KSR, 550 U.S. at 416. We also find on this record that a person of ordinary skill would have recognized that Takahashi’s thresholds could have been used to improve Kato’s motorcycle headlight controller in the same way they were used to improve Takahashi’s headlight controller. See id. at 417.” slip op. at 20
Patent outcomesUS 7,241,034 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,241,034 - Koito Manufacturing Co., Ltd / SL Corporation v. Adaptive Headlamp Technologies, Inc.All claims unpatentablePTAB · Mar 15, 2017 · IPR2016-00079 · APJ Scott C Moore · IPR · Final written decision
Claims 3–26, 28–32, and 35 are unpatentable under § 103(a) over the ten instituted combinations of prior art.
RulingsFinal written decision- Skill levelSkill level board ownOther
“The parties’ formulations as to the level of ordinary skill in the art are similar to one another, and neither party identifies with specificity an error in the opposing party’s formulation. The parties also agree that none of the disputes in this case turn on differences between the parties’ respective formulations. Tr. 33:1–6, 67:20–68:1. On the record presented we hold that the cited prior art is representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evidenced by the cited references themselves). Specifically, the references are consistent with the parties’ formulations and demonstrate the level of skill in the art. Our determinations regarding the patentability of the challenged claims would remain the same under either party’s proposed formulation.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The specification of the ’034 patent uses the term “vehicle” in a broad sense. For example, the Background of the Invention section of the ’034 patent uses the term “vehicle” to encompass “land vehicles, and many other types of vehicles (such as boats and airplanes, for example).” Ex. 1001, 1:20–21. The specification also makes clear that the claims are not limited to the specific vehicle types described in the Detailed Description of the Preferred Embodiment. See, e.g., id. at 2:60–3:3 (“The illustrated headlight 11 is, of itself, conventional in the art and is intended to be representative of any device that can be supported on any type of vehicle for the purpose of illuminating any area.”) (emphasis added).” slip op. at 9
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner’s first argument, that Kato and the ’034 patent are directed to different fields of endeavor, depends on its argument that the term “vehicle,” as used in the ’034 patent, excludes motorcycles. As discussed above, we reject this argument. In view of our determination that the ’034 patent’s use of the term “vehicle” does not exclude motorcycles, we are persuaded by Petitioner’s arguments (see Reply 7–8; Ex. 1037 ¶ 23) and find that Kato is directed to the same field of endeavor as the ’034 patent, i.e., automatic directional control systems for vehicle headlights. Compare Ex. 1001, 1:57–67, with Ex. 1007 ¶ 1. Even if the ’034 patent’s controller and Kato’s motorcycle controller were directed to different fields of endeavor, Kato’s controller would still be reasonably pertinent to the problem addressed by the ’034 patent. In particular, we find that Patent Owner is incorrect in its assertion that “[n]o crossover applicability exists [] between control devices for a motorcycle headlight and those of four-wheeled vehicles.” PO Resp. at 19. For example, Kato’s controller adjusts a headlight’s optical axis based upon changes to pitch angle or steering angle of a motorcycle. Ex. 1007 ¶ 11; see Ex. 1037 ¶ 33. The controller of the ’034 patent adjusts the aiming angle of vehicle headlights to account for operating conditions such as “steering angle” and “pitch.” Ex. 1001, 2:3–20. In view of the fact that the ’034 patent and Kato both disclose controllers that automatically adjust headlights of motorized vehicles according to steering angle and pitch, we are persuaded by Petitioner’s arguments (see Reply 8–13; Ex. 1037 ¶¶ 24–29) that Kato would “logically have commended itself” to the attention of an inventor considering the problem addressed by the ’034 patent, even if the problem addressed by the ’034 patent only related to four wheeled vehicles. See In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007). On this record, we find that Kato qualifies as analogous art.” slip op. at 18
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“Takahashi’s thresholds operate to “prevent the illumination of the lamp [] from being corrected inadvertently when a sudden change in the posture of the vehicle occurs temporarily or due to the wrong operation of the lamp [] caused by external disturbances.” Ex. 1007 ¶ 6. We are not persuaded that Takahashi’s thresholds could not be used to prevent the direction of Kato’s motorcycle headlight from being corrected inadvertently in the event of a temporary change in vehicle posture or external disturbance. Mr. Katona, Patent Owner’s expert, identifies several differences between motorcycles and four-wheeled vehicles, but does not persuasively and credibly explain why these differences would have prevented the use of such thresholds to prevent Kato’s headlight from being adjusted inadvertently in the event of a sudden and transient disturbance. See Ex. 1002 ¶¶ 54–56. We find credible the testimony of Petitioner’s expert, Dr. Wilhelm, that a skilled artisan would have realized that Takahashi’s thresholds could be used to prevent a motorcycle headlight controller from making undesirable adjustments to the headlight. Ex. 1019 ¶¶ 61–62; Ex. 1037 ¶¶ 34–36. We also are not persuaded by Patent Owner’s argument that Kato teaches away from the use of Takahashi’s thresholds, or that such thresholds would render Kato’s system unsuitable for its intended purpose. Kato’s stated “Object of the Invention” is “to provide a headlight optical axis control device that can stably ensure a beam irradiation range of a headlight even when pitch, bank, steering angle or the like change while driving a motorcycle.” Ex. 1007 ¶ 6. Kato does disclose an embodiment that is able to correct direction of a headlamp “immediately” (id. ¶ 8), but we do not find that the portions of Kato cited by Patent Owner “criticize, discredit, or otherwise discourage investigation” into the use of a threshold of the type taught by Takahashi. Galderma Labs. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013); see PO Resp. 28–29, Ex. 2002 ¶¶ 57–58. We also do not find that such thresholds would render Kato’s system unsuitable for its intended purpose. See PO Resp. 30–31; Ex. 2002 ¶¶ 57–58. Rather, we agree with Petitioner that a skilled artisan would have realized that Takahashi’s threshold values could have been set to minimize time delays while still realizing the advantages of Takahashi’s invention (i.e., avoiding unnecessary headlight adjustments due to short-term disturbances, such as those caused by a rough road surface). Reply 17–18; Ex. 1037 ¶¶ 34–39. Patent Owner also has failed to cite any persuasive evidence of improper hindsight. See PO Resp. 29, 33. We find on this record that combining Takahashi’s reference values with the Kato’s headlight optical axis control system would result in an obvious “combination of familiar elements according to known methods . . . [that] does no more than yield predictable results.” See KSR, 550 U.S. at 416. We also find on this record that a person of ordinary skill would have recognized that Takahashi’s thresholds could have been used to improve Kato’s motorcycle headlight controller in the same way they were used to improve Takahashi’s headlight controller. See id. at 417.” slip op. at 20
Patent outcomesUS 7,241,034 unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 7,241,034
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.