Ex Parte 7955614 et al

Patent Trials and Appeals BoardSep 28, 2018

95002099 - (D) (P.T.A.B. Sep. 28, 2018)

UNITED STATES PATENT AND TRADEMARKOFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/002,099 08/24/2012 7955614 091505-0022/8002.US 1171 108547 7590 09/27/2018 McDermott Will & Emery LLP 500 North Capitol Street NW Washington, DC 20001 EXAMINER WITZ, JEAN C ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 09/27/2018 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ NANO PRECISION MEDICAL Requester and Appellant v. DELPOR, INC. Patent Owner and Respondent ____________ Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and RAE LYNN P. GUEST, Administrative Patent Judges. Opinion for the Board filed by GUEST, Administrative Patent Judge. Opinion Dissenting-in-part filed by FREDMAN, Administrative Patent Judge. FINAL DECISION ON APPEAL UNDER 37 C.F.R. § 41.77(f) Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 3 STATEMENT OF THE CASE United States Patent 7,955,614 B2 (hereinafter the “’614 Patent”), which is the subject of the current inter partes reexamination, issued to Francis J. Martin and Anthony A. Boiarski on June 7, 2011. On August 9, 2016, the Patent Trial and Appeal Board issued a Decision on Appeal (“Decision”). The Decision included the following new grounds rejecting claims 1, 4-6, 8-16, 19-22, and 30-38 of the ’614 patent (Decision 43-44): Claims 1, 10-16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai;1 Claims 1, 9, 10-16, 19-22 and 30-34 under 35 U.S.C. § 103(a) as being unpatentable over Desai alone or further in view of Wong;2 1 Tejal A. Desai et al., “Characterization of micromachined silicon membranes for immunoisolation and bioseparation applications,” J. Membrane Sci., Vol. 159, pp. 221-231 (1999) (“Desai”). 2 WO 01/30323 A2, published May 3, 2001, and naming Vernon G. Wong, et al. as inventors (“Wong”). Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 4 Claims 4-6, and 83 under 35 U.S.C. § 103(a) as being unpatentable over Desai in view of Atkinson;4 Claims 21, 22, 31, and 32 under 35 U.S.C. § 103(a) as being unpatentable over Desai in view of Haak5 and/or Wong; Claims 35 and 36 under 35 U.S.C. § 103(a) as being unpatentable over Desai in view of Yamagata;6 and Claims 37 and 38 under 35 U.S.C. § 103(a) as being unpatentable over Desai in view of Keller7 and Dunn.8 See Decision 43-44. Because the Decision included new grounds of rejection, Patent Owner was provided with two options under 37 C.F.R. §41.77(b): (1) to file 3 The rationale behind the rejection of claims 4-6 and 8 was discussed in the Decision (see Decision 30-31). However, the actual rejection was inadvertently left off the list of rejections both in the Summary of New Grounds based on Obviousness (see Decision 33) and in the listing of rejections at the end of the Decision (see Decision 43-44). Because Patent Owner acknowledges the rationale behind the rejection and presents arguments in response thereto (PO Request i (Table of Contents), 5 (listing of rejections), 30-31; PO Comments 1-2, 22-23; PO Reply 9, 13), which are addressed below, and the Examiner and Requester, in turn, acknowledge and addresses Patent Owner’s arguments (Determination 3, n. 1, 24-26, 45; Req. Comments 17-18; Req. Reply 19)), we determine that Patent Owner had sufficient notice of the rejection and adequate opportunity to respond thereto, such that our maintenance of a rejection of claims 4-6 and 8 based on Atkinson does not constitute a new ground of rejection of these claims. 4 U.S. Patent 5,443,461, issued August 22, 1995, to Linda E. Atkinson et al. (“Atkinson”). 5 U.S. 5,158,537, issued October 27, 1992 to Ronald P. Haak, et al. (“Haak”). 6 U.S. 5,628,993, issued May 13, 1997, to Yutaka Yamagata et al. (“Yamagata”). 7 WO 95/24472, published September 14, 1995, naming Christopher G. Keller, et al., as inventors (“Keller”). 8 U.S. Patent 5,888,533, issued March 30, 1999, to Richard L. Dunn (“Dunn”). Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 5 a response requesting reopening of prosecution before the examiner; OR (2) request that the proceeding be reheard before the Board upon the same record. Decision 44-45. Patent Owner timely filed a rule-compliant response requesting reopening of prosecution under 37 C.F.R. §41.77(b)(1). Request to Reopen Prosecution, filed December 15, 2016 (“PO Request”). Patent Owner’s Request included amendments to claims 1 and 20 and new evidence in the form of Declarations of Dr. Frances J. Martin (“2nd Martin Decl.”)9 and Dr. Phyllis Gardner (“Gardner Decl.”) and exhibits thereto. Third Party Requester, Nano Precision Medical (“Requester”), filed Comments under 37 C.F.R. § 41.77(c) in response to the Patent Owner’s Request on January 13, 2017, with additional evidence in the form of the Declaration of Dr. Tejal A. Desai and exhibits thereto (“2nd Desai Decl.”).10 The Board entered an Order on April 20, 2017, entering the amendments to claims 1 and 20 and remanding the case back to the Examiner for a determination under 37 C.F.R. § 41.77(d), which was mailed September 1, 2017 (“Determination”). In the Determination, the Examiner determined that claims 1, 10-16, 19, and 30 are not anticipated by Desai under 35 U.S.C. §102(b), claims 1, 4-6, 8-16, 19, and 30 are obvious over Desai alone or in view of Wong or Atkinson under 35 U.S.C. §103(a), and 9 We also acknowledge Dr. Martin’s Declaration of December 15, 2016 (“1st Martin Decl.”), previously of record. 10 We also recognize Dr. Desai’s earlier Declaration of October 24, 2014 (“1st Desai Decl.”), previously of record. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 6 claims 20-22 and 31-38 are not obvious over Desai alone or in view of Wong. Determination 44-45. Requester submitted Comments under 37 C.F.R. § 41.77(e) on September 29, 2017 (“Req. Comments”). Patent Owner submitted Comments under 37 C.F.R. § 41.77(e) on October 2, 2017 (“PO Comments”). In response to thereto, respectively, Patent Owner submitted a reply under 37 C.F.R. § 41.77(e) on October 27, 2017 (“PO Reply”), and Requester submitted a reply under 41.77(e) on October 31, 2017 (“Req. Reply”). Jurisdiction now returns to the Board for reconsideration and a final decision under 37 C.F.R. § 41.77(f). Claims 1 and 20 are illustrative of the appealed subject matter and read as follows (with underlining showing added text relative to the original patent claims and brackets showing deleted text relative to the original claims and italics representing amendments to the claims made by Patent Owner in the Request filed after our Decision): 1. A drug delivery device, comprising: a capsule for implantation into the body, wherein said capsule comprises a fluid impermeable wall defining a reservoir, [for containing a substance] said wall comprising at least one port; a drug contained in the reservoir in an amount to provide therapy for a period of several weeks to about 6 months, the drug having molecular dimensions; and a nanopore membrane [in communication with] seated on said port to separate the reservoir from an environment external to the device, said membrane having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions of the drug, such that the pores [dimensioned to] Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 7 control the rate of diffusion of said [substance] drug to achieve zero-order release of the drug from said [capsule] reservoir for the period. 20. A method for delivering a therapeutic agent to the body in a controlled manner, said method comprising: (a) providing a device comprising a capsule comprised of a fluid impermeable wall that defines a reservoir [for containing a therapeutic agent], said wall having at least one port, a therapeutic agent contained in the reservoir in an amount to provide therapy for a period of several weeks to about 6 months, the therapeutic agent having molecular dimensions [for allowing said therapeutic agent to diffuse from said reservoir]; said capsule also comprising a nanopore membrane in communication with said port, said membrane having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions of the therapeutic agent, [such that] the pores [dimensioned to] control the rate of diffusion of said therapeutic agent by providing release kinetics which approach zero-order release of the therapeutic agent from said at least one exit port for the period; and (b) surgically implanting said device into the body, whereby the release kinetics provide a substantially constant therapeutic level of the therapeutic agent in the body for the period. PO Request 2, 5, Claims App’x (paragraph breaks also added for clarity). Claim Interpretation We do not alter our claim interpretation set forth in the Decision, particularly that, with respect to claim 1, the presence of the drug itself does not patentably distinguish a drug delivery device having an identical Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 8 structure that is otherwise capable of containing such a drug within its reservoir. See Decision 6-10. Claim 1 has been newly amended to further recite that the nanopore membrane is “seated on said port to separate the reservoir from an environment external to the device.” We note that claim 1 requires that the device be a capsule featuring no more than (1) a wall defining a reservoir and comprising a port and (2) a nanopore membrane seated on said port. A prior art apparatus reading on this device need not have more than these features. Anticipation based on Desai Claim 1 Claim 1 stands rejected under 35 U.S.C. § 102(b) as anticipated by Figure 5 of Desai.11 Decision 11-15. Claim 1 is directed to a drug delivery device comprising a capsule with a fluid impermeable wall defining a reservoir comprising at least one port and a nanopore membrane. The newly amended claim 1 adds that the nanopore membrane is “seated on said port to separate the reservoir from an environment external to the device.” The Patent Owner argues that Figure 5 of Desai, reproduced below, does not teach the nanopore membrane is seated to separate the reservoir from an environment external to the device. PO Request 11-12. 11 Because the new ground of rejection relies on the teachings of Figure 5 of Desai, we decline to opine on arguments by either party directed to Figure 2 of Desai. Similarly, as there are no pending rejections based on Keller before the Board, we decline to opine regarding the teachings of Keller. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 9 Figure 5 depicts a schematic view of a rotating diffusion chamber used to test microfabricated membranes comprising two 2 mL chambers, Compartments A and B, each having sampling injection ports and separated by a microfabricated membrane array. Desai 226, Figure 5, caption and 224, col. 2, last full ¶. The Examiner finds that the “device” of Figure 5 of Desai constitutes both Compartment A and Compartment B and, accordingly, the nanopore membrane separating the two compartments does not separate the reservoir from an environment external to the device as required by the claim. For this reason, the Examiner agrees with Patent Owner and determined that claim 1 is not anticipated by Desai. We cannot agree with the Examiner’s findings, which are not consistent with the requirements of a device according to the language of the claim. Rather, the device claims read directly on Compartment A (i.e., a capsule comprising a wall defining a reservoir and comprising a port) and the nanopore membrane, as found in the Decision. Decision 13. Indeed, the Decision identifies Compartment A as being a reservoir having a volume of 2 mL and a port, which, along with the nanopore membrane, “meets all the Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 10 structural limitations of the claimed drug delivery device.” Id. Thus, Compartment B itself constitutes an environment exterior to the device, so much as the “device” is defined by the language of the claim, requiring only a reservoir and a membrane seated on a port thereof. Patent Owner argues that the membrane of Figure 5 of Desai is not seated on Compartment A but rather Compartment A and Compartment B are separated by the membrane, sealed with o-rings, and screwed together. PO Comments 16-20; PO Reply 9. We are not persuaded by this argument because Compartment B constitutes an environment outside of the device as recited in the claims. The phrase “seated on” does not preclude the structure described in Figure 5, with or without the presence of Compartment B. Indeed, the claim recites no structural requirement as to how the membrane is seated on a port but rather, structurally, requires no more than a membrane being disposed adjacent the port. The Patent Owner contends that the device of Figure 5 of Desai is designed to test the diffusion of the substance in Compartment A through the nanopore membrane by collecting and testing the substance in Compartment B. PO Comments 7. The Patent Owner points to the declaration of Dr. Martin, who duplicated the device of Desai, to show that when the device is thrown into water, none of the substance of Compartment A diffuses into the water, only into Compartment B. PO Request 20-21 (citing 2nd Martin Decl. ¶¶ 10-17). This argument does not change or address our analysis that Compartment B constitutes an environment outside of the device, as the device as recited in claim 1 reads directly on the structure of Compartment A Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 11 and the nanopore membrane. The claim does not structurally require that the “external environment” be a body in which the device is implanted. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477–78 (Fed. Cir. 1997). We have found Compartment A plus the attached membrane includes all of the structural features recited in the claims and further find that the Desai Compartment A and membrane would have been capable of being implanted, as the volume (2 mL) is consistent with the sizes described for insertion in the ’614 Patent (col. 5, ll. 35-38), and, with such finding, shift the burden to Patent Owner to show that Compartment A and the membrane would not have been capable of functioning as an implantable drug delivery device. Decision 13-14. Patent Owner argues that the testing device of Figure 5 in Desai is meant to rotate and is, therefore, not capable of being used as an implantable device. PO Comments 16. Patent Owner’s argument is not persuasive because all of the structural requirements recited in the claim are met. The device of Figure 5 is rotated when used for in vitro testing “to ensure adequate mixing of the solutions throughout the course of the diffusion experiment.” Desai 224, col. 2, last full ¶. Patent Owner has not explained why such rotation would be necessary were the same device (Compartment A and the membrane) used as an implantable drug delivery device. Patent Owner presents no separate arguments for any of claims 10-16, 19 or 30 apart from the arguments addressing claim 1. See PO Request 12. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 12 Accordingly, we maintain our rejection of claims 1, 10-16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai. Obviousness based on Desai Claim 1 – Desai alone or further in view of Wong The Decision relied both on Figure 5 of Desai and, alternatively, on modifying Figure 2 of Desai to have a larger volume, such as taught by the alternative structure Figure 5 of Desai or Wong. Decision 19-20. For the reasons discussed above, we maintain the rejection with respect to Figure 5 without modification of the device. After all, it is well established that lack of novelty is the ultimate or epitome of obviousness. In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982) (“Though the composition might have been obvious, though not anticipated, it cannot have been anticipated and not have been obvious. Thus evidence establishing lack of all novelty in the claimed invention necessarily evidences obviousness.”). Further, the Examiner determined that it would have been obvious to modify the device of Figure 5 so that Compartment B is not present because it is not necessary. Determination 10, 16. Without Compartment B, the nanopore membrane separates the compartment carrying the reservoir with an environment external to the device, even under Patent Owner’s more narrow proposed interpretation of the teachings of the art vis-à-vis the claims. Id. We agree with the Examiner that this modification would have been obvious to one of ordinary skill in the art particularly because, as explained below, Desai teaches alternative ways of collecting material that crosses the membrane barrier. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 13 Patent Owner argues that the device of Desai was intended for testing and without the addition of Compartment B would defeat the intended purpose of the device. PO Request 20; PO Comment 7; PO Reply 10. We do not find this argument persuasive. Desai teaches alternative methods of collecting and analyzing material from a device other than collection via an attached compartment. Indeed, Desai teaches exposing a capsule comprising polystyrene beads to “the medium surrounding the biocapsules” wherein the medium was “collected and bead concentration was measured using a spectrofluorimeter.” Desai 224, ¶ spanning cols. 1-2.12 Thus, the skilled artisan would have recognized that diffusion of material from Compartment A through the membrane could be similarly tested by measuring the amount of material in a medium surrounding a device that simply includes Compartment A and a membrane, without the presence of Compartment B. Thus, without Compartment B, the device is capable of being used both as an implantable device and as a nanopore testing device. Patent Owner argues that because the membrane is positioned between Compartment A and Compartment B, sealed with o-rings, and screwed together, that Desai does not teach or suggest removal of Compartment B and provides no direction on how to secure the nanopore membrane without Compartment B. PO Request 31; PO Comments 16-20. This argument is not persuasive. 12 Dr. Martin used a substantially identical method to measure the presence, or lack thereof, of material in a surrounding medium in his declaration. 2nd Martin Decl. ¶ 13. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 14 First, Desai is generally directed to implantable biodelivery devices. See Desai 221, Abstract (“The application of microfabrication technology to create precise separation and isolation membranes for biomedical applications is described. . . . Microfabrication technology may also be applied to other materials of interest for the development of highly controlled membranes.”). Thus, the skilled artisan would consider using the device recited in the claims, i.e., Compartment A and the membrane, without the need for Compartment B for collecting diffused material. Second, as discussed, the claim recites no structural requirement as to how the membrane is seated on a port, but rather, structurally, requires no more than a membrane being disposed adjacent the port. Finally, Patent Owner’s argument does not consider the skill of the ordinary artisan in attaching a membrane to a reservoir. Indeed, Desai suggest that the membrane can be attached via screws and sufficient sealing (via o-rings). Thus, if Compartment B were removed to permit the material that crosses the membrane to be collected by an alternative means, such as in a larger vessel, one of ordinary skill in the art would have known how to attach the membrane to Compartment A. There is no evidence to suggest the skilled artisan would not have known how to attach a membrane directly to Compartment A without the presence of Compartment B. Indeed, the ’614 patent provides no particular guidance to the skilled artisan on how to seat a membrane on a port, thus, it is presumed that the skilled artisan is aware of suitable techniques for doing so. In an obviousness analysis, it is proper to “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 15 KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “A person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. Patent Owner further argues that the device of Figure 5 is described to be used while being rotated, and that this requirement would render the device unsatisfactory for implantation into the body. We disagree. As discussed above, Desai does not teach that the device must be rotated when implanted, only that it must be rotated for use in testing “to ensure adequate mixing of the solutions throughout the course of the diffusion experiments.” Desai 224, col. 2, last full ¶. Patent Owner has not explained why such rotation would be necessary were the same device (Compartment A and the membrane) used as an implantable drug delivery device. Once again, because Desai teaches a device (Compartment A and the membrane) that is identical to the device recited in the claims (i.e., a reservoir plus a membranes seated on a port thereof), the burden shifts to Patent Owner to show that the structure would not be capable of functioning as recited in the claims. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). In light of these findings and determinations set forth above with respect to Figure 5 of Desai, we need not address the alternative reasoning with respect to Figure 2 of Desai in further detail.13 Indeed, all of Patent Owner arguments with respect to dependent claims 9-16, 19 or 30 are only directed to the Decision’s alternative rejection of claim 1 based on modifying Figure 2 of Desai to have a larger volume. 13 However, we note the Examiner’s finding that Figure 2 does not teach or suggest a membrane seated on a port of a reservoir, but rather teaches a membrane fabricated along with walls of the reservoir in a single structure from a silicon substrate, a finding with which we agree. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 16 See PO Request 27-31. Accordingly, we maintain our rejection of claims 1, 9-16, 19, and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone. Claims 4-6 and 8– Desai in view of Atkinson With respect to the rejection based on Figure 5 of Desai in view of Atkinson, Patent Owner presents no argument separate from those made with respect to claim 1. PO Request 31; PO Comments 22-23; PO Reply 9. Accordingly, we maintain the rejection of claims 4-6 and 8 for the same reasons discussed in the Decision. Decision 30-31. Claim 20 – Desai alone or further in view of Wong Claim 20 describes an affirmative step of providing a capsule having a reservoir and providing in that reservoir at least a several week supply of a therapeutic agent, such that the pore size of the nanopore membrane is 1–5 times the molecular dimensions of the drug. Desai does not expressly teach a step of providing a therapeutic agent having these features. In the Decision, we stated the following: The skilled artisan would also have been capable of modifying the membrane pore-size for an optimal rate of release for any particular drug, including a zero-order release rate, because Desai particularly teaches improved pore-size control using the particular membrane manufacturing process described therein and “[t]he ability of microfabricated biocapsule membranes to perform size-based exclusion of biomolecules.” Desai 224, ¶ spanning col. 1-2. For example, Desai measures the amounts of various sized polystyrene beads and IgG that diffuse out of capsules with various pore sizes. See 224, ¶ spanning col. 1-2 and 226, Section 2.5, spanning col. 1- 2. Desai also describes testing the diffusion of insulin, glucose, Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 17 and IgG molecules with respect to pore-size. Desai 224, last full ¶ and ¶ spanning pp. 224 and 225. The results of these test suggest the skilled artisan would design a membrane pore size with respect to the dimensions of the desired drug whose delivery is sought. See 227, Section 3.1, spanning col. 1-2 and 228, Section 3.3, spanning col. 1-2. Decision 24-25 (footnote omitted). Patent Owner argues, inter alia, that the step of selecting a ratio of the pore size of the membrane to the size of the molecular dimensions of the therapeutic agent recited in the claims results a zero-order release rate, which is an unexpected deviation from Fickian (concentration dependent) diffusion that was well recognized in the art. PO Request 45. Patent Owner presents evidence from Dr. Martin discussing the unexpected nature of determining that pore size can control release rate and describing acknowledgment of Martin’s discovery in the field (PO Request 45-47 (citing 2nd Martin Decl. ¶¶ 6, 10-17)), as well as NIH grant funding awarded to Dr. Martin which, according to Patent Owner, “demonstrates appreciation of the significance and innovation of the invention by contemporaries in the field” particularly those in the field “who evaluate the grant application.” PO Request 47 (citing 2nd Martin Decl. ¶ 7). Requester relies on the First Declaration of Dr. Desai, the author of the Desai reference, who testifies that Figures 8 and 9 demonstrate a zero order release rate that does not follow Fick’s law. Req. Comments 23-24 (citing 1st Desai Decl. ¶¶ 5, 7, 8, 13, 15). Requester does not comment regarding Patent Owner’s evidence of unexpected results or acclaim. See generally Req. Comments. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 18 The Examiner finds that Desai does not teach zero-order release kinetics (Determination 28), and thus does not teach all the feature recited in method claim 20. Id. at 44. The Examiner further determines that the pore size to drug size ratio “is unexpected and has been acclaimed by professional colleagues in articles,” referencing the grant award to Dr. Martin. Determination 44 (citing PO Request 46 and 2nd Martin Decl. ¶ 7). The Examiner adds that “[e]ven Dr. Desai recognized this non-Fickian diffusion principle by citing to the first Martin et al. paper that disclosed this finding.” Id. (citing PO Request 46-47). We agree with the Examiner that Figures 8 and 9 of Desai are not sufficient evidence that, as the time of the invention, that it would have been obvious to obtain a zero-order release for a pore size to drug size ratio falling within the range recited in the claim. Initially, we agree with Dr. Gardner (see Gardner Decl. ¶ 15),14 that the actually profiles shown in Figures 8 and 9, reproduced below, are insufficient to show that linear release profiles were suggested in the teachings of Desai. 14 Although not directly addressed in our Decision, upon consideration of this evidence in the first instance, we were similarly not so persuaded by Requester’s arguments based on the express teachings of Desai. Nonetheless, we need not have addressed this argument in entering new grounds on an alternative rationale as recited in the Decision. Decision 24- 25. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 19 Moreover, there is no evidence of record to support a finding of recognition in the teachings of Desai that a zero-order release profile could have been achieved or that a pore size to drug size ratio would lead to such a release profile. Rather, there is sufficient evidence to establish that Desai teaches only a Fickian diffusion profile. Gardner Decl. ¶ 18; Desai 228, ¶ spanning cols. 1-2. Dr. Desai’s testimony regarding the profiles shown in Figures 8 and 9 is based on extrapolating the data beyond the limited time period of data presented in Desai. 1st Desai Decl. ¶¶ 6-7. We cannot find this evidence persuasive because it is speculative and not based on the actual data shown in Desai, but rather on extrapolated data that may or may not be borne out by actual experiments. Further, even if Dr. Desai is correct that “Desai clearly shows a zero order rate of release of IgG at all pore sizes,” Desai does not recognize or attribute any criticality to a particular pore size to drug size ratio, as recited in the claims. Moreover, we are persuaded by the evidence of record that, even if it would have been obvious to optimize a pore size for any given drug as noted in our Decision, such an optimization does not necessarily lead the skilled artisan to the pore size to drug size ratio recited in the claims nor is a zero- Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 20 order release rate predictably achieved from such optimization. Indeed, based on the testimony of Dr. Martin (see Martin Decl. ¶ 6), we are persuaded that this ratio and its resulting release profile are unexpected over the art of record, which suggests only Fickian diffusion. The Examiner further found persuasive Dr. Martins evidence of that the invention “has been acclaimed by professional colleagues” in the art and of Dr. Martin’s awarded grant by the National Institutes of Diabetes and Digestive Kidney Diseases. Determination 44. We do not find the mere “independent confirmation” of Dr. Martin’s findings to be “acclaim” for Dr. Martin’s findings, as does the Examiner. However, we agree with the Examiner that the undisputed testimony of Dr. Martin and the evidence of record weighs in favor of finding that the skilled artisan would not have expected diffusion through a porous membrane of Desai to exhibit zero- order release behavior or the ratio between pore-size and drug-size recited in the claims. Thus, while it is undoubtedly true that selection of a membrane pore size for optimal release rate of any given drug would have been obvious, as was the fact that for many drugs a zero-order release rate was desirable (see Decision 24, n.14), the evidence weighs in favor of determining that the ratio set forth in the claims being the key to achieving a zero-order release rate for any given drug size was not obvious from the art of record. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 21 DECISION In sum, we sustain the rejection of: Claims 1, 9, 10–16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai, Claims 1, 9, 10-16, 19 and 30 under 35 U.S.C. § 103(a) as being unpatentable over Desai alone or further in view of Wong; and Claims 4-6 and 8 under 35 U.S.C. §103(a) over Desai alone or in view of Wong and further in view of Atkinson. However, we do not sustain any of the new grounds of rejections of claims 20-22 and 31-38 under 35 U.S.C. § 103(a). In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this Decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1, 1.983. Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 22 PATENT OWNER: McDermott Will & Emery LLP 500 North Capitol Street NW Washington, DC 20001 THIRD-PARTY REQUESTER: ALEXANDER R. TRIMBLE KILPATRICK, TOWNSEND & STOCKTON LLP ONE EMBARCADERO CENTER, 8 TH FLOOR SAN FRANCISCO, CA 94111-3834 Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 23 FREDMAN, Administrative Patent Judge, dissenting-in-part. While I concur with the Majority’s decision to not sustain any of the new grounds of rejections of claims 20-22 and 31-38 under 35 U.S.C. § 103(a), I respectfully dissent from the Majority’s decision to sustain the rejection of claims 1, 9, 10–16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai and to sustain the rejections of claims 1, 4-6, 8, 9, 10- 16, 19 and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone or combined with Wong or Atkinson. Anticipation over Desai As in my earlier dissent, I begin with claim construction, because this is the essence of my disagreement with the Majority, and fundamental to properly applying the prior art of Desai. Claim 1 is drawn to a “drug delivery device” that comprises three elements: “a capsule” that comprises a reservoir; “a drug” that is contained in the reservoir “in an amount to provide therapy for a period of several weeks to about 6 months”; and “a nanopore membrane” that is “seated on” a port of the capsule wall, functions to “separate the reservoir from an environment external to the device” and controls release of the drug from the reservoir. “a drug contained in the reservoir” As I interpret claim 1, the requirement for “a drug . . . in an amount to provide therapy for a period of several weeks to about 6 months” is not intended use, but rather is a structural limitation of the claim. And while the drug is in a capsule reservoir and is released through a nanopore membrane, the reservoir and membrane do not “act” on the drug but rather contain the drug or permit release of the drug. “[C]laims are interpreted with an eye Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 24 toward giving effect to all terms in the claim.” Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006). Unlike Schreiber, relied upon by the Majority, where any conical device with an appropriate size opening may function to dispense popcorn, the structure of conical devices that actually contain either popcorn or motor oil differ if the popcorn or motor oil is actually in the device. The average cinema buff might be dismayed to find motor oil in their snack or popcorn in the oil can used to fill their car’s engine. Similarly, the device of claim 1 structurally differs based on the presence of a drug or water, or of insulin or warfarin, as well as the amount of that drug. As applied to the anticipation rejection of Desai, Desai does not teach the presence of the drug as required. As the Examiner correctly noted “Desai does not contemplate or even suggest [a] device with an amount of drug (e.g., IgG) that provides therapy for a period of several weeks to about 6 months when released at a zero-order rate, as claimed” (Ex. Ans. 15-16). I find that for this reason, Desai does not anticipate claim 1. I also note that because Desai does not contain any drug, Desai does not, and indeed cannot, inherently teach a “membrane having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions of the drug” as required by claim 1. Even if Desai teaches pores of the correct pore size, Desai does not teach a device contains drugs with the proper dimensional relationship. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 25 “membrane . . . to separate the reservoir from an environment external to the device” I also interpret the “nanopore membrane” in claim 1 that separates the “reservoir from an environment external to the device” as requiring that the membrane must function to release the drug into the environment, not into another chamber within the device itself. Figure 5 of Desai is reproduced below: Figure 5 depicts a device that consists of “two compartments A and B with fixed volumes of 2 ml, separated by the biocapsule membrane, sealed with o-rings, and finally screwed together” (Desai 224, col. 2). Desai does not teach a device with a membrane that functions “to separate the reservoir from an environment external to the device” as required by claim 1. I therefore disagree with the Majority’s interpretation reliance on Figure 5 of Desai, finding that “[c]ompartment B constitutes an environment Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 26 outside of the device as recited in the claims.” (see Decision supra). Instead, I agree with the Examiner that Neither the device of Fig. 2 nor Fig. 5 of Desai anticipates instant claim 1. In the device of Fig. 2, the nanopore membrane separates the reservoir from an environment external to the device but the nanopore membrane is not seated on the port, rather the membrane has been cut directly into the biocapsule wall. The device of Fig. 5 does not anticipate instant claim 1 because the nanopore membrane fails to separate the reservoir from an environment external to the device. (Examiner’s Determination 9/1/17 at 4). I conclude this device is structurally different than that required by claim 1 because compartment B is reasonably understood as part of the device and not “an environment external to the device” as required by claim 1 for the physical location of the membrane. For these reasons, I would not sustain the rejection of claims 1, 9, 10– 16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated by Desai. Obviousness over Desai, Wong, or Atkinson I find the claims nonobvious because I find that Desai does not teach a device that contains both drug and nanopore membrane with the “membrane having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions of the drug” as required by claim 1. I disagree with the Majority’s finding obviousness as the epitome of anticipation for the reasons already given. Instead, I review the record to determine whether there is evidence of a suggestion or at least some reason to modify Desai to obtain a device that addresses the nanopore membrane limitation that renders the claim obvious. I conclude that no obviousness Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 27 rationale has been established and that the evidence of record does not support a finding an obviousness finding. I am not persuaded by the Examiner’s reasoning that: A person of ordinary skill in the art would have found it obvious to slightly modify compartment A of the mini-diffusion device of Fig. 5 in Desai in order to seat the nanopore membrane fully without the necessity of screwing compartments A and B together for the purpose of creating a drug delivery device where both the reservoir volume and the pore size of the microfabricated nanopore membrane can be adjusted to allow for proper delivery of a specific drug. (Examiner’s Determination 9/1/17 at 10). The Examiner states a conclusion, but provides neither evidentiary basis nor persuasive reasoning why the proposed modification to Desai would have been made. Nor am I persuaded by Requester’s argument that “it would not require ‘a leap of inventiveness’ to combine FIG. 2 and FIG. 5 to arrive at the predictable solution” (Requester Comment 9/29/2017 at 12). For an obviousness rejection, there must be “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Neither the Examiner, Requester, nor the Majority provide a reason I find persuasive to modify the device of Figure 5 of Desai to remove compartment B so that the device might then be implantable and to obtain the specific ratio between the membrane pore size and molecular dimensions of the drug. I also conclude that the evidence currently of record does not support an obviousness finding. The device of Desai was designed “to immunoprotect transplanted pancreatic islets by hindering the passage of IgG molecules while permitting the passage of glucose and insulin” (Desai 230, col. 1). While an Appeal 2018-003281 Reexamination Control 95/002,099 Patent 7,955,614 B2 28 ordinary artisan may have found it obvious to use Desai’s device for implantation into the body, Desai never suggests, contemplates or provides reasons for replacing the pancreatic islet cells with a drug, much less a particular relationship between the pore size and the molecular dimensions of the drug. I recognize that Wong teaches a drug delivery device with controlled release of drugs including zero order kinetics (see Wong 4:18–21) for periods of weeks to years (see Wong 11:31 to 12:1). However, there is no indication that Wong ever contemplates the use of a nanopore membrane for zero order kinetic release of drug, instead using an orifice (i.e. opening) in an outer layer of the device (see Wong 18:1–31). Even if an opening was deemed a known equivalent to a membrane, an equivalence for which there is no evidentiary support, there is no evidence establishing that Desai or Wong suggest the relationship of a “membrane having pores with a pore size (i) between 2-100 nm and (ii) 1-5 times the molecular dimensions of the drug” as required by claim 1. I also am not persuaded by the Requester’s reliance on the Desai Declaration which, at best, suggests the use of Desai’s device for drug delivery but provides no basis to select the particular relationship between membrane pore size and molecular dimensions of the drug recited in claim 1 (see, e.g., Desai Decl. ¶ 8). I also note that Atkinson is not relied upon for these features. For these reasons, I would not sustain the rejection of claims 1, 9, 10– 16, 19, and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone or combined with Wong and Atkinson. I do concur with the Majority’s decision to not sustain any of the new grounds of rejections of claims 20-22 and 31-38 under 35 U.S.C. § 103(a).