• Advanced Micro Devices, Inc. v. LG Electronics Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01409 · APJ Garth D Baer · IPR · Final written decision

  Claims 4, 8, and 9 are unpatentable under § 103; claim 30 was not shown unpatentable because the prior art did not teach shutdown based on total processor use below a threshold.

  RulingsFinal written decision

  • BurdenOther

    “III. ANALYSIS A. PRINCIPLES OF LAW Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish the facts supporting its challenge by a preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).” slip op. at 7

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “Public accessibility” is the touchstone in determining whether a reference is a “printed publication.” In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986). A reference is publicly accessible upon a satisfactory showing that such document has been made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it. Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008) (quoting SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008)). slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b). We presume a claim term carries its “ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only those claim terms necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).” slip op. at 8

  • Expert testimonyPetitioner expert creditedDecided for patent owner

    “We decline to disregard all of Mr. Gafford’s testimony. In light of Mr. Gafford’s education and experience (a Bachelor of Science Degree in Electrical Engineering and over 43 years working for corporations in the design, manufacturing, and support for computer systems and microprocessors, see Ex. 1011 ¶¶ 14–20), we see no reason why Mr. Gafford’s frequent participation in other cases—even to ultimately mixed results—makes his testimony here unhelpful in understanding the evidence in this case. See Fed. R. Evid. 702(a). In assessing the merits of this case, we have considered the proffered testimony from Mr. Gafford, as well as Patent Owner’s Declarant Dr. Friedman, and accorded weight based on the testimony’s substantive persuasiveness.” slip op. at 29

  Patent outcomesUS 7,636,863 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,636,863
• Elekta, Inc. v. Varian Medical Systems, Inc.All claims unpatentable
  PTAB · Dec 23, 2016 · IPR2015-01401 · APJ Garth D Baer · IPR · Final written decision

  Claims 1, 4–7, 14, 15, 53, 60, and 61 are unpatentable over Jaffray 2001 under §§ 102(b) and 103(a), and over the stated Jaffray combinations under § 103(a).

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner

    “ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only those claim terms necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). 2. “capable of implementing a treatment plan” Patent Owner takes the position that to be “capable of implementing a treatment plan,” a radiation treatment system cannot still be in development and must pass industry-established quality assurance validations that are prerequisites to commissioning such systems for use on real patients. See PO Resp. 17–18. We decline to read in these additional limitations. Neither the claims nor the Specification has any support for excluding devices that are still early in development, or those that have not yet been validated against established quality standards. The broadest reasonable construction of the term requires no more than a system capable of implementing one or more treatment plans. 3. “communications network” slip op. at 7

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

    “Patent Owner asserts “[a] communications network is a communication system that facilitates communication between many devices and that uses a networking protocol to selectively route messages to their intended devices.” PO Resp. 28. In Reply, Petitioner proposes a broader construction: “a link between two or more components of the radiation treatment system that allows information to be shared between them.” Reply 11. We agree with Petitioner. In the three instances when the ’021 patent Specification recites “communications network,” it describes only a generic connection between components. See Ex. 1001, 2:36–40 (explaining that “[t]he couch 218 may be connected to the therapy simulator rotatable gantry via a communications network”), 4:16–18 (explaining that “the computer 220 connects to the simulator 100 and the command processor 225 via a communications network 240”), 6:16–18 (explaining that “box 451, processor 425, and computer 450 connect to simulator 400 via communications network 440”). Figures 1 and 3 of the ’021 patent depict the communications network (items 240 and 440) simply as arrows connecting various components. Notably absent from the ’021 patent is any reference to networking protocols or a routing mechanism, and nothing in the term’s plain language requires a networking protocol or selectively routing messages as Patent Owner suggests. We agree with Petitioner under the broadest reasonable construction, a communications network is simply a link between two or more components of the radiation treatment system that allows information to be shared between them. 4. “a high energy radiation source” and “a cone-beam radiation source”” slip op. at 7

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

    “i. Jaffray 2001 Teaches “a radiation treatment system capable of implementing a treatment plan” All of the challenged claims require a “radiation treatment system capable of implementing a treatment plan.” We agree with Petitioner that because Jaffray 2001 teaches “[t]he adaptation of this system to a medical linear accelerator for on-line image-guided radiation therapy demonstrates the suitability of this technology for intra-therapeutic guidance,” Jaffray 2001 discloses a system capable of implementing a treatment plan. See Pet. 18 (quoting Ex. 1003, 800); Ex. 2024 ¶¶ 25–28 (explaining that “a medical linear accelerator, by its very nature, is capable of implementing a treatment plan”), ¶¶ 29–30 (explaining that Fig. 2(a) from Patent Owner’s Exhibit 2015 confirms that Jaffray 2001’s medical linear accelerator is capable of implementing a treatment plan). In contesting this element, Patent Owner notes that one of the other Jaffray references—Jaffray JRO 1999 (Ex. 1007)—states its design “allows normal operation of the accelerator with the imagers removed and the kV xray tube retracted.” Ex. 1007, 775. Patent Owner interprets Jaffray JRO 1999’s statement to mean in all of Jaffray’s systems, removing the imaging system was “necessary” before the linear accelerator could implement a treatment plan. PO Resp. 8–9; Ex. 2020 ¶ 58. Patent Owner argues further Jaffray 2001’s system was not capable of implementing a treatment plan because it was still in development and had not been tested or validated against established industry standards that must be met before the FDA will commission such devices for medical use. See PO Resp.17–18; Ex. 2020 ¶¶ 49–52. We disagree. As explained above, under our claim construction, the claim limitation at issue requires only a system capable of implementing one or more treatment plans, not one that is ready to certify for actual medical use on real patients. Jaffray JRO 1999’s reference to allowing normal operation with the imagers removed does not undermine that teaching; it simply indicates the disclosed system permits radiation therapy with the imagers removed, a feature beneficial for “limited situations in which the treatment plan may require extreme angulation.” Reply 3; see Ex. 1024 ¶¶ 7–8. We find Jaffray 2001 discloses a radiation treatment system capable of implementing a treatment plan as the challenged claims require.” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “challenged claims, the claimed subject matter would have been obvious over Jaffray 2001 at the time of the invention. See Pet. 26–27. As explained above, we find Jaffray 2001 discloses every limitation from the challenged claims. In addition, Petitioner explains—with unrefuted support from Dr. Hamilton and the prior art—by 1981 translatable treatment couches moveable in three planes plus angulation and coupled to the gantry via a communications network were standard on linear accelerators. See Pet. 26– 27 (citing Ex. 1016 ¶ 36; Ex. 1015, 220; Ex. 1010, 1, 2, 12, 39–48). Petitioner also explains—again with unrefuted support from Dr. Hamilton— none of the Jaffray references suggest any changes to these standard features and one skilled in the art would understand the linear accelerator depicted in Jaffray 2001 is the Elekta SL20, which had a translatable treatment couch including the same standard features. Pet. 27 (citing Ex. 1016 ¶ 128). In addition, Petitioner explains that to the extent Jaffray 2001 fails to disclose a computing unit to capture and store image projection data, it would have been obvious to one skilled in the art to include one because “to process the image projection data to generate volumetric images, it is necessary to store the image projection data in the computer which will process the data.” Pet. 27 (citing 1016 ¶ 207). Thus, in addition to demonstrating the necessary disclosures in the prior art (through incorporating its anticipation argument), Petitioner identified sufficient reasons that would have prompted a person of ordinary skill in the relevant field to combine the elements the way the claimed invention does. See KSR, 550 U.S. at 418. In contesting obviousness based on Jaffray 2001, Patent Owner reiterates its argument that Jaffray 2001 does not disclose a system capable of implementing a treatment plan (as required in all of the challenged claims), a computing unit coupled to the rotatable gantry via a communications network (as required in claims 1, 4, and 5), or a translatable treatment couch coupled to the rotatable gantry via a communications network (as required in claims 14, 15, and 60). PO Resp. 45. Patent Owner asserts also we should reject Petitioner’s obviousness challenge as an improper attempt to “bootstrap” obviousness to anticipation, without identifying any differences between the claimed subject matter and the prior art or explaining why those elements would have been obvious to a person of ordinary skill in the art. Id. at 43. We disagree with Patent Owner’s arguments addressing Jaffray 2001’s ability to implement a treatment plan and communications network for the reasons explained in our anticipation analysis above. Moreover, we do not view Petitioner’s obviousness challenge as a mere “bootstrap” to anticipation because Petitioner identified potential differences between Jaffray 2001 and claimed subject matter (i.e., the claimed translatable treatment couch and computing unit to store image projection data) as well as rationale explaining why one skilled in the art would have known to include those elements.” slip op. at 19

  Patent outcomesUS 7,945,021 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,945,021
• Broad Ocean Technologies, LLC v. Nidec Motor CorporationNo claims unpatentable
  PTAB · Dec 21, 2016 · IPR2015-01617 · APJ Patrick M Boucher · IPR · Final written decision

  Claims 7–13 were not shown unpatentable because Beifus did not disclose the claimed torque table with alternate torque settings.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “Beifus states that Figure 6 “is a chart illustrating an induction motor speed-torque curve that is programmed into a memory of an ECM.” Ex. 1007 ¶ 11. Because “[a] claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference,” the dispositive issue in this proceeding is well defined: does Figure 6 (and related disclosure) of Beifus teach “selecting a torque table associated with the adjustment factor, the torque table including alternate torque settings,” as recited in independent claim 7? See Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987).” slip op. at 9

  • Strike new argumentNew argument disregardedDecided for patent owner

    “reasoning of Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376 (Fed. Cir. 2015). Petitioner contends that “[u]pon reading Beifus, a person of ordinary skill would immediately recognize that the ECM control circuit could handle the torque values in two ways – storing a set of torque values in a memory or by calculating the torque values ‘on the fly.’” Reply 18. Kennametal explains that “a reference can anticipate a claim even if it ‘do[es] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal at 1381 (citing In re Petering, 301 F.2d 676, 681 (CCPA 1962)). Petitioner did not raise the Kennametal theory of anticipation in its Petition, and the argument based on it in the Reply is, therefore, improper. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition, patent owner preliminary response, or patent owner response.”) (emphasis added); CBS Interactive, Inc. v. Helferich Pat. Lic., LLC, Case IPR2013-00033, slip op. at 3 (PTAB Aug. 9, 2013) (Paper 79) (“Should there be improper arguments or evidence presented with a reply, the Board, exercising its discretion, may exclude the reply and related evidence in their entirety, or alternatively, decline to consider the improper arguments and/or related evidence.”). Although Patent Owner addressed this theory in its Response (PO Resp. 21–24), Patent Owner appears to have done so only prophylactically after the theory was raised by Petitioner in redirect examination of Dr. Sidman. See PO Resp. 21 (“During Dr. Sidman’s redirect examination by [Petitioner’s] counsel, he was asked the following leading question . . . .”) (“The Board should disregard any of this new evidence and argument if [Petitioner] intends to rely on it.”). Because this is a new argument, not raised in the Petition, we do not consider it.” slip op. at 18

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “the ambiguity when Figure 6 is actually described in detail in the specification.” Id. at 16. As Patent Owner asserts, “Beifus makes it clear that Figure 6 is a plot of values derived from key characteristics which are motor parameters of the emulated motor.” Id. (citing Ex. 1007 ¶ 36; Ex. 2002 ¶¶ 15–16, 31). This understanding of Beifus is confirmed by testimony of Patent Owner’s expert, Mark N. Horenstein, Ph.D. Ex. 2002 ¶¶ 15–16. Dr. Horenstein explains that a person of ordinary skill in the art would understand that the parameters stored in the ECM are key parameters used with the formula reproduced above to describe the torque-speed curve of the induction motor being emulated, namely the no-load speed, breakdown speed, and shape description number n. Id. ¶ 15. Dr. Horenstein further testifies that, “although square and diamond symbols appear along the curves in Figure 6, nowhere does Beifus describe the storing of these individual points.” Id. ¶ 16. Rather, Dr. Horenstein expresses his opinion that “a person of skill would understand these symbols to be included simply to identify which curve applies to Option 1 and which to Option 2 [i.e., different options for the induction motor breakdown speed], as indicated by the legend to the right of the plots.” Id. Petitioner challenged Dr. Horenstein’s opinion at his deposition, in part by comparing a drawing from one of Dr. Horenstein’s own patents that included a series of curves with data marked by different symbols: Q. So if a person of ordinary skill in the art looking at Figure 6 of the Beifus patent sees diamonds and squares, wouldn’t they come to an understanding that those are data points? A. I don’t think so. And the reason is that a formula is given that explains how the curves are computed. Figure 19 of [Dr. Horenstein’s patent], those are discretely measured points performed by experiment, and there really is no formula that applies to those curves per se, they’re just data points that have some scatter relative to each other and they happen to be connected by lines, but those lines do not represent a formula. Ex. 1013, 54:2–16. We disagree with Petitioner’s characterization of this testimony as explaining that “the reason a person of ordinary skill in the art would understand that the diamonds and squares appearing in Figure 19 of [Dr. Horenstein’s] patent are data points, as opposed to mere curve identifiers, is because the diamonds and squares are connected by lines.” Reply 15. Rather, Dr. Horenstein’s testimony makes clear that his opinion is grounded in Beifus’s disclosure of a formula that allows calculation of the illustrated points and that connection of data points measured by experiment with lines is incidental. Dr. Horenstein’s testimony is more persuasive than the testimony of Petitioner’s expert, Michael D. Sidman, Ph.D., on the identification of “key characteristic points” disclosed by Beifus. For example, Dr. Sidman appeared to suggest at his deposition that the entire speed-torque curve of Beifus’s Figure 6 is itself a “key characteristic point,” but qualified that position when challenged by Patent Owner. See Ex. 2001, 23:22–25:15. Nevertheless, Dr. Sidman agrees that (1) a curve can be generated from a mathematical formula and graphed (Ex. 2001, 30:8–11); (2) Beifus’s two formulas correspond to the formulas for “Option 1” and “Option 2” shown in Figure 6 (id. at 33:12–36:19); (3) operating speed, breakdown speed, no load speed, and shape-description number n are variables used in the formula disclosed by Beifus (id. at 22:23–23:10); (4) the calculation disclosed by Beifus could be performed on the fly in a motor controller (id. at 47:6–14); and (5) Beifus does not explicitly disclose that any precalculations are performed (id. at 43:1–23). These aspects of Dr. Sidman’s testimony are consistent with Patent Owner’s reading of Beifus.” slip op. at 13

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “We see no compelling reason to modify these constructions based on the positions of the parties as developed during the trial, and adopt them for this Decision. With respect to the construction of “torque table,” Patent Owner asserts: If the Board’s construction means that the table need not be in any particular format in the memory, but the table must still store the alternative torque values required by the claim “in a memory connected to the motor,” then Patent Owner accepts this interpretation for the purposes of this proceeding. However, if the Board’s construction including reference to “a torque curve graphically representing a set of torque values” does not require the torque values shown on the curve to be stored in memory, it is erroneous. PO Resp. 9. We agree with Patent Owner’s position, namely that “[t]he broadest reasonable interpretation of ‘table’ still must require the torque values to be stored in the table.” Id. As Patent Owner points out, “[t]he only intrinsic evidence available in this proceeding demonstrates a ‘torque table’ stores alternative torque settings.” Id. In particular, the ’092 patent consistently uses “table” to refer to discrete data that are stored in a memory, such as in the “speed tables” described as alternatives to “torque tables.” See Ex. 1001, col. 11, ll. 5–24, col. 16, ll. 63–66 (“Instead of adjusting the torque as described above, the motor controller 18 could store a plurality of different torque or speed tables and select one of the torque/speed tables based on an input provided by the torque adjustment mechanism.”). This aspect of the construction of “torque table” is reflected in its reference to including a graphical representation of “a set” of torque values in a memory connected to a motor.” slip op. at 7

  Patent outcomesUS 7,990,092 not shown unpatentable
  Claim construction§ 102 anticipation
  Patents in suitUS 7,990,092
• Atlanta Gas Light Company v. Bennett Regulator Guards, Inc.Rehearing denied
  PTAB · Dec 6, 2016 · IPR2015-00826 · APJ Patrick M Boucher · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable, and granted sanctions for Petitioner’s failure to timely update real-party-in-interest notices.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “IV. REQUEST FOR REHEARING On rehearing, the burden of showing that the Decision should be modified lies with Patent Owner, the party challenging the Decision. 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id.” slip op. at 10

  • PTAB / AIA Trials › Real party in interest / privityDecided for patent owner

    “With respect to Southern Company Gas, Petitioner’s assertion ignores the fact that Southern Company Gas did not result merely from a name change, but rather also from a merger with AMS Corp. that occurred before the name change. See Paper 34, 3. In the related IPR, the Board specifically found that AGLR is a real party in interest, and it follows that the merged entity is also a real party in interest. Atlanta Gas, slip op. at 13 (PTAB Jan. 6, 2015) (Paper 88). The merger with AMS Corp. has meaningful effects that impose an obligation on Petitioner to apprise the Board that Southern Gas Company is a real party in interest. Petitioner’s failure to file timely the updated mandatory notice is especially significant in light of the central nature that the issue of AGLR’s status as a real party in interest played in the related IPR. See Atlanta Gas, Paper 87, 46:6–9 (“The problem that we have, and you will remember, we had to fight like tooth and nail to get these documents. At every turn there was an objection to producing documents related to the real party in interest issue or the privity issue.” (statement by Patent Owner at oral hearing in the related IPR)). With respect to The Southern Company, we do not credit Petitioner’s argument that The Southern Company is not a real party in interest in light of Petitioner’s explicit notification to the contrary. Petitioner cannot have it both ways, identifying The Southern Company as a real party in interest (even “out of an abundance of caution”) to ensure compliance with 35 U.S.C. § 312(b), while simultaneously maintaining that it is not a real party in interest to evade the obligations of 37 C.F.R. § 42.8(a)(3). In light of these various considerations, we conclude that Petitioner has performed conduct that warrants a sanction.” slip op. at 5

  • PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Granted

    “be to expunge the Decision and the request for rehearing, dismiss the Petition with prejudice, and order [Petitioner] to pay compensatory expenses and attorney fees to [Patent Owner].” Mot. 5. We disagree that this proposed sanction is proportionate to the harm suffered by Patent Owner. In particular, as Petitioner contends, the harm suffered by Patent Owner is limited because “the estoppel provisions apply to the petitioner and ‘the real party in interest or privy of the petitioner.’” Opp. 6 (citing 35 U.S.C. § 325(e)(1)) (emphasis by Petitioner). There is no requirement that a petitioner identify all of its privies in a petition, and Patent Owner’s ability to address whether The Southern Company was a privy that would give rise to estoppel was not impacted by Petitioner’s original failure to file an updated mandatory notice. Furthermore, “[a] sanction imposed under this rule must be limited to what suffices to deter repetition of the conduct or comparable conduct by others similarly situated.” 37 C.F.R. § 42.11(d)(4) (emphasis added). We have considered, but are not persuaded by, Patent Owner’s argument that “[a]ny remedy short of termination with prejudice would encourage future petitioners to try to suppress the identification of real parties-in-interest.” Mot. 6. A more limited sanction will have sufficient deterrent effect. We determine that an appropriate sanction, proportionate to the harm suffered by Patent Owner, is to award costs and fees incurred in association with this proceeding from the time after issuance of the Final Written Decision until the date of this Decision. 37 C.F.R. § 42.12(b)(6).” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “Although we agree with Patent Owner in the abstract that the “ordinary and customary meaning” standard applied to expired patents requires that evidence be viewed through the eyes of one of ordinary skill in the art, Patent Owner stretches that principle too far. See id. at 9–10. “[A] claim construction analysis must begin and remain centered on the claim language itself.” Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 382 F.3d 1111, 1116 (Fed. Cir. 2004). Patent Owner asks us to deviate far from this cardinal principle by incorporating features of the Fisher S254 regulator that are not recited in the claims themselves, under circumstances in which the Fisher S254 regulator is not explicitly identified as such anywhere in the specification of the ’029 patent. “Reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim, to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” In re Prater, 415 F.2d 1393, 1404–05 (CCPA 1969). This is particularly the case when the standard we are obliged to apply does not afford Patent Owner a presumption of validity of the patent’s claims. For these reasons, we are not persuaded that we misapprehended or overlooked any aspect of Patent Owner’s claim-construction arguments. Nor are we persuaded that Patent Owner’s evidence in support of those arguments was inadequately considered.” slip op. at 16

  Claim constructioncites Phillips
  Patents in suitUS 5,810,029
• Vista Outdoor Operations LLC v. Liberty Ammunition, LLCRehearing denied
  PTAB · Oct 31, 2016 · IPR2016-00539 · APJ Michael L Woods · IPR · Rehearing

  The Board denied rehearing and left in place the denial of institution for claims 1–42 on all six grounds, finding no overlooked or misapprehended matter.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply. Furthermore, when rehearing a decision on a motion, the Board will review the decision for an abuse of discretion. Id. at § 42.71(c).” slip op. at 2

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “The Board found that these embodiments were distinct, and determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “determined that Petitioner failed to establish a reasonable likelihood of success on its challenges when combining features from these distinct embodiments. See Decision 13–16, 19, 20. With respect to the anticipation ground (Ground 1), the Board explained that “it is not enough that the prior art reference discloses multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.” Id. at 13 (citing Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371–72 (Fed. Cir. 2008)). With respect to Grounds 2 and 3, the Board determined that Petitioner failed to explain adequately how Woodring’s distinct embodiments are being combined with one another and the cited art to arrive at the claimed invention. Id. at 18, 20.” slip op. at 4

  § 102 anticipation§ 103 obviousness
  Patents in suitUS 7,748,325
• Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01096 · APJ Michael P Tierney · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over Thalomid PI in view of Cunningham, Keravich, Zeldis, and Mundt.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedOther

    “representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003, 1006, 1009, 1012, 1018. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1021 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “for close constant monitoring to identify noncompliance or other problems, but concluded by stating that Celgene was committed to making the program succeed and would be willing to make any modifications to the program necessary to ensure its effectiveness. Ex. 1012 at 329. This willingness to make any modifications is consistent with the understanding that the underlying drug remains a safety concern because controlling the distribution of the drug does not negate the actual side effects of the underlying drug. In dealing with such drugs, such as those capable of causing severe birth defects, the highest level of safety is desired. Under such circumstances, consistent with the teachings of Zeldis and the art of record one skilled in the art would understand that where significant safety risks exist with a drug, one would continuously search for safer ways to control the distribution of the drug. Put simply, where significant safety concerns exists, one of ordinary skill in the art would not wait until an accident occurred to seek out improvements.” slip op. at 23

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “limitations recited in independent claims 1 and 28, with the exception of the generation of a prescription approval code to be retrieved by a pharmacy before the prescription is filled. Pet. 52. Petitioner states that one skilled in the art, following the teachings of Thalomid PI and seeking to avoid treating pregnant women with thalidomide, would have implemented the methods disclosed in Cunningham to limit dispensation of a drug associated with adverse effects to certain risk groups. Id. at 54. We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 20

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720
• Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01103 · APJ Michael P Tierney · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over Mitchell and Dishman in view of Cunningham and the additional cited references.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). The prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2067. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 43–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “their broadest reasonable interpretation in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b). Generally, Petitioner states that the claim terms are presumed to take on the ordinary and customary meaning that they would have to one of ordinary skill in the art. Pet. at 10. Petitioner proposes constructions for several claim terms including “consulted,” “teratogenic effect,” and “adverse side effect.” Id. at 10–11. Patent Owner does not propose distinct constructions of the identified terms. We determine that the identified claim terms should be given their ordinary and customary meaning, as would be understood by one with ordinary skill in the art, and need not be construed explicitly at this time for purposes of this Decision.” slip op. at 12

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 14

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720
• Coalition For Affordable Drugs Vi, LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01102 · APJ Michael P Tierney · IPR · Final written decision

  Claims 1–32 are unpatentable as obvious over Powell and Dishman in view of Cunningham and the additional cited references.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Based 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 prior art references, like the ’720 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); see generally Exs. 1003; 1008; 1011; 2062; 2066. Consistent with the prior art, Petitioner’s Declarant, Dr. Fudin, testifies that the types of problems encountered by one of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1027 ¶¶ 44–50. Accordingly, the prior art demonstrates that one of ordinary skill in the art would have experience in controlling the distribution of a drug. To the extent a more specific definition is required, we hold, for the reasons provided below, that a person of ordinary skill in the art would have several years of experience in risk management relating to pharmaceutical drug products, which encompasses experience as a pharmacist.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

    “The specification defines prescription approval code such that the prescription approval code is not provided unless certain conditions are met. Ex. 1001, 13:42–52. The conditions include the prescriber, pharmacy, patient, patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Id. Specifically, the ’720 patent specification describes “approval code” as follows: In certain embodiments of the invention, the methods may require that the registered pharmacy consult the computer readable medium to retrieve a prescription approval code before dispensing the drug to the patient. This approval code is preferably not provided unless the prescriber, the pharmacy, the patient, the patient’s risk group and the patient’s informed consent have been properly registered in the storage medium. Additionally, depending upon the risk group assignment, generation of the prescription approval code may further require the registration in the storage medium of the additional set of information, including periodic surveys and the results of diagnostic tests, as have been defined as being relevant to the risk group assignment. Id. The specification also states that if a patient’s risk group assignment so indicates, a prescription approval code “generally” will not be generated until specific periodic diagnostic tests have been performed and satisfactory results entered into the storage medium. Id. at 14:37–15:6. As apparent from the specification, the prescription approval code is “preferably” or “generally” not provided unless certain information is properly registered in a storage medium. An affirmative risk assessment, however, is not mentioned in the specification as a mandatory requirement for generation of the prescription approval code.” slip op. at 13

  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

    “We understand Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects). For the reasons provided below, we conclude that Petitioner has demonstrated by a preponderance of the evidence that the challenged claims are obvious over the cited prior art.” slip op. at 22

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “Patent Owner states that Cunningham’s pharmacy approval code is part of a method of tracking and managing the dispensing of pharmaceutical trial products and has no connection to patient information at all. Id. at 38. Patent Owner also states that Cunningham’s pharmacy approval code is merely a number or identifier associated with samples of pharmaceutical products. Id. at 39. Patent Owner contends that a person of ordinary skill in the art would have therefore understood that Cunningham’s pharmacy approval code is not the same as the claimed prescription approval code. Id. at 39–40. Cunningham describes a method of dispensing, tracking, and managing pharmaceutical products whereby prescribers and pharmacies are linked to a central computing station. Ex. 1008, 1:6–11. Certain pharmaceutical drugs, such as thalidomide, were known in the art to require a prescription in order for a patient to be provided the drug whereby a prescriber would authorize a patient to receive a drug from a pharmacy. “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at 421. Dr. Fudin testified that the use of an approval code of Cunningham could be like that of a consumer credit card approval code, and is used to track things and the technology should allow you to combine it with other materials that you could track. Ex. 2061 at 412:17–25, 429:18–430:10. Based on the record presented, we hold that a person of ordinary skill in the art would understand that an approval code used by prescribers and pharmacies to track and manage pharmaceutical products could likewise be used by prescribers and pharmacies to track and manage prescription pharmaceutical products. We further hold that the claimed improvement recited in the challenged claims represents a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using both a prescription and an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects).” slip op. at 25

  Patent outcomesUS 6,315,720 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,315,720
• Coalition For Affordable Drugs Vi LLC v. Celgene CorporationAll claims unpatentable
  PTAB · Oct 26, 2016 · IPR2015-01092 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–10 are unpatentable as obvious under § 103 over Powell, Mitchell, and Dishman.

  RulingsFinal written decision

  • Skill levelSkill level board ownPetitioner expert creditedDecided for petitioner

    “qualifications of an ordinary artisan, over the somewhat different qualifications proposed by Petitioner, would materially alter the obviousness inquiry. The prior art references asserted in the Petition are representative of the level of ordinary skill in the art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (absence of specific findings on “level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent that a more specific definition of the ordinary artisan is required, we hold that the definition encompasses pharmacists and other persons having experience restricting the distribution of teratogenic drugs. Specifically, we find that the prior art references, like the ’501 patent specification, focus on controlling the distribution of a drug. See, e.g., Ex. 1001, 1:13–16 (describing “the distribution to patients of drugs, particularly teratogenic drugs, in ways wherein such distribution can be carefully monitored and controlled”); Ex. 1005, 901 (Powell, disclosing guidelines for restricting the distribution of thalidomide); Ex. 1006, 101 (Mitchell, describing a method for restricting the distribution of the teratogenic drug Accutane); Ex. 1007, 899 (Dishman, describing a national registry for restricting distribution of the psychoactive drug Clozaril). Consistent with the prior art, Dr. Fudin testifies that the types of problems encountered by a person of ordinary skill in the art included creating a restricted drug distribution program to prevent adverse side effects, such as teratogenic risks. Ex. 1002 ¶¶ 33–55. The prior art demonstrates that a person of ordinary skill in the art would have experience in controlling the distribution of a drug. We credit Dr. Fudin’s testimony that a person of ordinary skill in the art would encompass a pharmacist. Ex. 1002 ¶ 15. We also credit Dr. Frau’s testimony that an ordinary artisan would not be limited to pharmacists but also would encompass persons having at least two years of experience in risk management relating to pharmaceutical products, as pharmacists are not the only persons having restricted drug distribution experience and knowledge. Ex. 2059 ¶ 60. Accordingly, we find that a person of ordinary skill in the art would include pharmacists and persons having at least two years of experience in risk management relating to pharmaceutical products as pharmacists. Additionally, we determine that, even if we were to adopt verbatim Dr. Frau’s definition of ordinary skill in the art, Patent Owner has failed to present sufficient and credible evidence to persuade us that Patent Owner’s defined person of ordinary skill in the art would be led to a different outcome regarding the obviousness of the challenged claims. Specifically, Dr. DiPiro, testifying for Patent Owner, acknowledged that many” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “No claim term requires express construction for the purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). One issue of claim construction, however, requires some discussion. Patent Owner argues that the term “computer readable storage medium” in claim 1 should be read to require a “centralized” computer readable storage medium—namely “a centralized database that includes all registration information regarding the claimed prescribers, pharmacies, and patients.” Resp. 22, 35. We are not persuaded that the wording of the claim, or the disclosure of the ’501 patent specification, supports Patent Owner’s view.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “distribution of Accutane and Dishman’s method for controlling distribution of Clozaril—and apply those features to controlling the distribution of another potentially hazardous drug (thalidomide, which Powell discusses as requiring controlled distribution). Patent Owner’s contention that a person of ordinary skill in the art would not have recognized or applied the teachings of Mitchell or Dishman to the problem identified in Powell lacks merit. Resp. 49–53. On that point, Patent Owner itself identifies in the Response an article, which explains that Patent Owner’s “plan [for thalidomide] is built on experience with restrictions on such other drugs with severe side effects as Accutane . . . and Clorazil.” Ex. 2063, 1136; see Resp. 6 (quoting Ex. 2063, 1135). Furthermore, both of Patent Owner’s witnesses acknowledged the relevance of the programs disclosed in Mitchell and Dishman to the problem at hand, namely, controlling distribution of thalidomide. Specifically, Dr. DiPiro testified that, “in some of the literature where isotretinoin [Accutane] and clozapine [Clorazil] systems were discussed,” even researchers employed by Patent Owner recognized “that the results from these systems could guide an individual in either direction, as a way to do it or as a way not to do it. So in that sense they are relevant.” Ex. 1066, 326:23–327:5. Dr. Frau similarly acknowledged that the clozapine program was a restricted distribution program (Ex. 1067, 112:7–15; 113:3–8) and, thus, addressed the very same problem that would have been focused upon by a person of ordinary skill in the art. We find unpersuasive Patent Owner’s assertions that a person of ordinary skill in the art would not have been led to consider the combined disclosures of Mitchell, Dishman and Powell—all of which pertain to controlling the distribution of a drug to a subpopulation of patients likely to suffer serious side effects. Resp. 31–32, 38–41 (arguing that various features of known methods for controlling distribution of Accutane and Clozaril, as disclosed or suggested by the combined prior art, would not have been applied to controlling distribution of thalidomide in the manner claimed). Patent Owner, in essence, argues that an ordinary artisan would understand each applied reference only for its express teachings and would not have applied those teachings beyond the specific uses disclosed in the particular prior art reference. However, “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S. at 418. In that regard, we are persuaded that the invention of claim 1 represents the “predictable use of prior art elements according to their established functions.” KSR Int’l, 550 U.S. at 417. Claim 1 is directed to a combination of known steps (registering patients, prescribers, and pharmacies in a computer readable storage medium; identifying and counseling a subpopulation of patients whose access to a teratogenic drug should be restricted; and authorizing drug therapy only for non-pregnant patients) to accomplish a known purpose (prescribing drug only to non-pregnant patients) and achieve a predictable result (preventing fetal exposure to the drug). Pet. 36–41 (claim chart). We agree with Petitioner that Patent Owner approaches this dispute as if the ground set for trial was based on anticipation. Reply 14 (pointing out that Patent Owner’s Response “reads as if [the ground set for trial] was based on an anticipation”). For example, Patent Owner focuses on specific features not present in one applied reference, without meeting head on the question whether all the features would have been suggested by the combined disclosures of the prior art. See Resp. 25–29, 31–32, 36–37 (attacking disclosures of each applied reference in isolation). Patent Owner’s attack on the individual disclosures of Powell, Mitchell, and Dishman is ineffective to counter Petitioner’s evidence that the subject matter of claim 1 would have been obvious over the combined disclosures of those prior” slip op. at 22

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “As an initial matter, we determine that Petitioner complies with our rules, and precedent of our reviewing court, by presenting Mann as objective support for Dr. Fudin’s opinion testimony. See 37 C.F.R. § 42.65(a) (opinion testimony that does not disclose underlying facts “is entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (lack of objective support for expert opinion “may render the testimony of little probative value in a validity determination”). We have considered, but find unpersuasive, Patent Owner’s counterview that the Board should disregard Mann because, according to Patent Owner, the reference is directed “to teratologists or reproductive toxicologists, not pharmacists or [] those focusing on risk management.” Resp. 44. Patent Owner’s position on that point is not persuasive in view of Patent Owner’s own prior reliance on information supplied by teratologists in connection with the controlled distribution of thalidomide. Reply 16–17 (citing Ex. 2094, 7, 130, 137). Taking account of the full record developed during trial, we credit Dr. Fudin’s testimony that a person of ordinary skill in the art would have recognized the desirability of identifying a subpopulation of male patients in view of Mann. Ex. 1002 ¶¶ 95–98. We are persuaded that Mann reveals the state of the art at the time of the invention, and supports Dr. Fudin’s testimony that an ordinary artisan would have 7 Passage of Chemicals into Human and Animal Semen: Mechanisms and Significance, Thaddeus Mann and Cecelia Lutwak-Mann, CRC Critical Reviews in Toxicology (1982) 11:1, 1–14 (Ex. 1018, “Mann”). understood the necessity of counseling males, capable of impregnating females, about the risks that attend fetal exposure to a teratogenic drug. Pet. 23 (quoting Ex. 1002 ¶¶ 95–98 (citing Ex. 1018, 7–8) (Mann, suggesting that thalidomide was known to become “strongly adsorbed by spermatozoa” and adversely affect the pregnancy in female rabbits mated to males that were administered thalidomide prior to conception)). We have considered, but are not persuaded by, Patent Owner’s counterview that one would not have considered Mann’s discussion of rabbit sperm to apply to human sperm. Resp. 44–45. As Petitioner points out, Patent Owner previously admitted that studies relating to rabbit sperm were relevant to evaluating the effects of thalidomide on human sperm. Reply 17 (citing Ex. 2064, 951). Dr. Fudin’s opinion—that it would have been “apparent that the sperm of male patients could be damaged by teratogenic drugs and consequently result in birth defects, if the male was to impregnate a female”—is supported by objective factual evidence, namely, Mann. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Ex. 1018, 7–8)). We recognize that Powell’s Patient Information Sheet, under a heading relating to “side effects,” contains this statement: “No effects on male sperm are recognized.” Ex. 1005, 903; Resp. 45. That isolated statement in Powell, standing alone, does not defeat the sufficiency of Petitioner’s evidence that one of ordinary skill in the art would have recognized that the sperm of male patients, treated with teratogenic drugs, could result in birth defects. Pet. 23 (quoting Ex. 1002 ¶ 96) (citing Mann (Ex. 1018, 7–8)). Significantly, the statement in Powell is preceded by a discussion of the necessity of using “adequate contraception throughout the duration of thalidomide therapy.” Ex. 1005, 903. When read in the context of the surrounding disclosure, Powell suggests that no contraceptive “effects on male sperm are recognized” as a side effect of thalidomide therapy. Id.” slip op. at 16

  Patent outcomesUS 6,045,501 unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 6,045,501
• The Mangrove Partners Master Fund, Ltd. / Apple Inc. et al. v. Virnetx Inc.Rehearing denied
  PTAB · Oct 20, 2016 · IPR2015-01047 · APJ Stephen C Siu · IPR · Rehearing

  The Board denied VirnetX’s rehearing request, rejecting its real-party-in-interest arguments and finding the challenged claims remained unpatentable based on the Petition and Kiuchi.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “The applicable standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d), which provides in relevant part: A party dissatisfied with a decision may file a request for rehearing, without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, opposition, or a reply.” slip op. at 2

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “Paper 82, 8. We are not persuaded by Patent Owner’s argument. Even assuming that Petitioner, in fact, “admitted that the US Feeder and the Cayman Feeder are ‘controlling shareholders’ of the Mangrove Petitioner,” as Patent Owner asserts, Patent Owner does not demonstrate persuasively that Petitioner also “admitted” that the “US Feeder and the Cayman Feeder” exerted control over the filing or preparation of the Petition. Nor does Patent Owner provide sufficient evidence demonstrating such control.” slip op. at 2

  • Expert testimonyDecided for petitioner

    “1003 is entitled to no weight and reverse its findings of unpatentability that improperly rely on Exhibit 1003.” Paper 82, 14. Reference to Exhibit 1003 in the Decision was made in conjunction with the Petition in describing the Kiuchi disclosure with respect to claim features. Decision 5. We note that Exhibit 1003 merely confirms what is already apparent in the Petition and/or the Kiuchi reference itself (both of which are also relied upon in consideration of the Kiuchi reference with respect to claim features). Hence, to the extent that any modifications might have been made to the relevant portions of Exhibit 1003, we conclude that such alleged potential modifications (if any) are of insubstantial relevance in view of the fact that analysis of the Petition and the Kiuchi reference itself (without reliance on Exhibit 1003 in this regard) indicate that Petitioner has met its burden by a preponderance of the evidence that claims 1, 2, 6–8, and 12–14 of the ’151 patent are unpatentable, as indicated in the Decision. See, e.g., Decision 1-4, 6-24, and 26-38. Reference to Exhibit 1003 in the Decision was also made in the Petition as corroboration that RFC documents are “publications [that] are prepared and distributed,” “published and widely distributed” for “a period for others to provide comments on the document,” “can be obtained from a number of Internet hosts using . . . document-retrieval systems,” and contain a date “in the top right corner of the first page of the document.” Decision 25. Such testimony merely corroborates what is already clear on its face. For example, the fact that RFC documents are prepared and distributed, are for others to provide comments, are published on a specific date, and that the top right corner of such documents specify a date is clear on simple inspection of the RFC document itself. Therefore, we determine that the importance of any alleged modifications to Dr. Guerin’s testimony confirming what is already apparent on its face is of insubstantial importance. Also, Patent Owner does not demonstrate sufficiently that any modifications were, in fact, made to Dr. Guerin’s testimony that RFC documents are published on a specific date and that the top right corner of such documents specify a date.” slip op. at 6

  None
  Patents in suitUS 7,490,151

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.