Foulds, Ian G. et al.Download PDFPatent Trials and Appeals BoardOct 21, 201914867393 - (D) (P.T.A.B. Oct. 21, 2019) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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. 14/867,393 09/28/2015 Ian G. Foulds 0338-143-2/2014-029-02 9110 144099 7590 10/21/2019 Patent Portfolio Builders, PLLC P.O. Box 7999 Fredericksburg, VA 22404-7999 EXAMINER FREDRICKSON, COURTNEY B ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 10/21/2019 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Mailroom@ppblaw.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte IAN G. FOULDS, ULRICH BUTTNER, and YING YI ____________________ Appeal 2019-001820 Application 14/867,393 Technology Center 3700 ____________________ Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. HILL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1–12 and 21–28.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as King Abdullah University of Science and Technology. Appeal Br. 2. 2 Claims 13–20 are withdrawn from consideration. Final Act. 1. Appeal 2019-001820 Application 14/867,393 2 CLAIMED SUBJECT MATTER Appellant’s invention relates to implantable drug delivery devices. Independent claims 1 and 21 are pending. Claim 1, reproduced below, illustrates the claimed invention: 1. A drug delivery device, comprising: a pump and a reservoir associated with the pump, the pump being an electrolytic pump including a chamber and a plurality of electrodes positioned within the chamber, the plurality of electrodes configured to be coupled to a power supply such that at least one of the electrodes is configured as an anode and at least another of the electrodes is configured as a cathode, the chamber being a sealed chamber configured to hold an electrolyte, the chamber having a side including a flexible impermeable membrane, the pump further including a reformer positioned within the chamber, the reformer configured to recombine gases generated by the electrolytic pump from the electrolyte contained within the chamber, the reservoir positioned in association with the membrane of the pump, and the reservoir storing a drug in solid form and having an inlet orifice through which a bodily fluid passes into the reservoir, dissolves the solid drug, and the bodily fluid including the dissolved drug is expelled through an outlet orifice from the reservoir upon deflection of the membrane. Appeal 2019-001820 Application 14/867,393 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Gordon US 2006/0116641 A1 June 1, 2006 Liu US 2006/0186046 A1 Aug. 24, 2006 Gutierrez US 9,222,819 B2 Dec. 29, 2015 Ellis Meng and Tuan Hoang, MEMS-enabled implantable drug infusion pumps for laboratory animal research, preclinical, and clinical applications, Advanced Drug Delivery Reviews, 64(14), 1628–1638 (2012) (hereinafter “Meng”). REJECTIONS3 I. Claims 1–5 and 8 stand rejected under 35 U.S.C. § 103 as unpatentable over Gutierrez, Meng, and Gordon. Final Act. 4. II. Claims 6, 7, and 9–12 stand rejected under 35 U.S.C. § 103 as unpatentable over Gutierrez, Meng, Gordon, and Liu. Final Act. 8. III. Claims 21, 22, and 24 stand rejected under 35 U.S.C. § 103 as unpatentable over Gutierrez and Gordon. Final Act. 10. IV. Claims 23, 25, and 28 stand rejected under 35 U.S.C. § 103 as unpatentable over Gutierrez, Gordon, and Meng. Final Act. 12. V. Claims 26 and 27 stand rejected under 35 U.S.C. § 103 as unpatentable over Gutierrez, Gordon, Meng, and Liu. Final Act. 14. 3 A rejection of claims 1–12 and 21–28 under 35 U.S.C. § 101 is withdrawn in the Answer. Ans. 14; see also Final Act. 3. Appeal 2019-001820 Application 14/867,393 4 OPINION Rejection I – Gutierrez, Meng, and Gordon Appellant argues claims 1–5 and 8 as a group. We select independent claim 1 as representative of the group. See 37 C.F.R. § 41.37(c)(1)(iv) (2017). Claims 2–5 and 8 stand or fall with claim 1. The Examiner finds that Gutierrez discloses most of the limitations of the drug delivery device of claim 1, including a pump having a chamber and a reservoir, but does not disclose a reformer positioned within the chamber or the reservoir storing a solid drug. Final Act. 5. The Examiner relies on Meng to teach a reformer, concluding that it would have been obvious to modify Gutierrez to add Meng’s reformer to “render the electrolysis reversible and quickly reforms the gas back into liquid which is necessary for subsequent drug delivery.” Id. at 6. The Examiner relies on Gordon to teach a reservoir storing a solid drug, concluding that it would have been obvious “to have modified the drug of Gutierrez to be a drug in solid form for the purpose of choosing a drug most suited for the intended therapeutic goal of the procedure or patient.” Id. Render Inoperable/Unsatisfactory Appellant argues that, because Gutierrez measures impedence in a fluid, “if the drug in solid form is placed in the device of Gutierrez as suggested by the final Office Action, this modification would render inoperative the drug delivery device of Gutierrez for its intended purpose.” Appeal Br. 7. Specifically, Appellant contends that if a drug in solid form is placed inside chamber 101 of Gutierrez’s device, Gutierrez’s electrodes “would determine an impedance that is neither the impedance of the fluid Appeal 2019-001820 Application 14/867,393 5 nor the impedance of the solid, but rather a mixture of the two impedances.” Id. at 8. According to Appellant, “detecting an impedance that corresponds neither to the fluid nor to the solid, [] would not help with the accuracy of ‘fluid delivery,’ which is the intended purpose of the device in Gutierrez.” Id. Appellant asserts that placing a drug in solid form in the device of Gutierrez “would degrade the impedance measurements that are used to detect the volume changes and flow rate, which would [render] unsatisfactory the Gutierrez’s device for its intended purpose,” and thus, “one skilled in the art would not modify the device of Gutierrez . . . as proposed by the final Office Action, because the device of Gutierrez is designed to work only with fluids, not solids.” Id. The Examiner responds that one skilled in the art “would understand that a fluid composed of a combination of materials (bodily fluid and dissolved drug) would also necessar[ily] exhibit an impedance as a part of the fluid’s overall properties that would be measurable by the impedance system of Gutierrez.” Ans. 15. The Examiner asserts that, because a solid drug placed in the device of Gutierrez would be “dissolved in bodily fluid and is, therefore, a fluid itself which has a measurable impedance . . . the fluid comprising dissolved drug is wholly compatible with the system of Gutierrez since the system is configured to measure the impedance of a fluid.” Ans. 15–16. Appellant replies that “there is no evidence supporting the Examiner’s assertion that the solid drug, if placed in the device of Gutierrez, would dissolve [] to form a fluid” allowing Gutierrez’s impedance measurement system 103 to determine the impedance of the fluid. Reply Br. 6. Appellant contends that using a solid drug in Gutierrez and measuring its impedance Appeal 2019-001820 Application 14/867,393 6 “is not supported by any evidence and the burden is on the Office to support the proposed modification, and not on the Appellant to show that the modification would not work.” Id. The Examiner has the better argument here. Gutierrez relates to fluid dosing devices and discloses that its Figure 4 depicts an embodiment based on an electrochemical drug pump. Gutierrez, 1:42; 6:42–44. Similarly, Gordon “relates in general to a fluid delivery device that includes an electrochemical pump for controllably delivering small volumes of fluid with high precision and accuracy.” Gordon ¶ 2. Gordon’s fluid is “defined as a liquid, gel, paste, suspension (with or without dispersant), or other semi- solid state material that is capable of being delivered out of a reservoir.” Gordon ¶ 46. The Examiner finds that, even if Gordon’s device may include drugs that are solid at some point, “the solid drug [of Gordon] is dissolved in bodily fluid and is, therefore, a fluid itself which has a measurable impedance.” Ans. 15. The Examiner’s findings are supported by Gordon, which discloses that a solid drug “is dissolved,” and that “[t]he release of the drug is controlled by the solubility of the drug in gastric fluid.” Gordon ¶ 6. Thus, although Gordon’s drug may start out solid, it is dissolved. Appellant does not persuade us that an impedance of the dissolved drug would not be measurable. A preponderance of the evidence, therefore, supports the Examiner’s position that the bodily fluid having a drug dissolved therein is a fluid similar to those measured by Gutierrez, and has a measurable impedance. We are apprised of no intended purpose of Gutierrez for which the modified device would be unsuitable. Appeal 2019-001820 Application 14/867,393 7 Inlet and Outlet Orifices Appellant next argues that the Examiner fails to establish prima facie obviousness, because the rejection relies on both the embodiment of Figure 4 of Gutierrez having one port, and the embodiment of Figure 1 of Gutierrez having two ports, without explaining why Figure 4 would be modified to have two ports. We are not persuaded by this argument. See Appeal Br. 8– 10; see also Reply Br. 7–8. Gutierrez discloses that “FIG. 4 illustrates an example of a portion of a fluid dosing device that uses electrolysis-based actuation in the chamber compressor illustrated in FIG. 1.” Gutierrez, 2:52–54. Thus, Gutierrez explicitly suggests use of the embodiments of its Figures 1 and 4 together. Moreover, as the Examiner correctly notes, Gutierrez also discloses that the features of the invention comprise “[i]nclusion of one or more paths for fluid exchange to the fluid container such that the container may be filled or emptied through the paths. The inlet and outlet paths may be the same or separate, and multiple paths may be used for either filling or emptying.” Gutierrez, 8:30–34; see also Ans. 16. Because Gutierrez discloses that the inlet and outlet paths may be the same or separate, the Examiner need not provide an additional reason for making the paths separate. Dissolving a Solid Drug Appellant argues that claim 1’s recitation of “the reservoir stor[ing] a drug in solid form,” is a structural difference that is not disclosed by the applied art combination. Appeal Br. 11. Appellant contends that the Examiner relies on an unsupported assertion that “the device in Gutierrez is capable of performing such features, but there is no indication that indeed Appeal 2019-001820 Application 14/867,393 8 the device in Gutierrez can perform such features when the device has only one port and no drug in solid form.” Id. The Examiner responds that the combination of Gutierrez and Gordon discloses a solid drug in the reservoir, and “once combined, the pump of modified Gutierrez is fully capable of performing the function of the claimed electrolytic pump since the device comprises all of the required elements.” Ans. 17. The Examiner notes that the modified Gutierrez pump “is fully capable of performing the stated function since Gutierrez discloses that the singular fluid path may be replaced with two separate fluid paths to act as an inlet and outlet [paths]. Id. (citing Gutierrez, 8:30–36). Appellant’s arguments are not persuasive. Moreover, Gordon discloses using a solid drug in a reservoir. Gordon ¶ 46. As discussed above, Gutierrez discloses a drug delivery device having an inlet through which a bodily fluid passes to a reservoir. See Final Act. 4–5. We discern no error in the Examiner’s determination that Gutierrez’s reservoir is capable of holding a drug in solid form (see Gordon ¶ 46) that is dissolved by a bodily fluid (see Gordon ¶ 6) and expelled through an outlet. See Final Act. 5; see also Ans. 17. Thus, Appellant’s argument is not persuasive, because it does not address the combination of references proposed by the Examiner, which includes the inlet and outlet of Gutierrez and the solid drug of Gordon that is dissolved by a bodily fluid. Reformer Appellant argues that the Examiner erred in finding that Meng’s catalyst corresponds to the claimed reformer, because “it is not clear whether (1) the catalyst is also the electrode because both of them are made of Appeal 2019-001820 Application 14/867,393 9 platinum or (2) the catalyst is added separately from the electrode.” Appeal Br. 12. The Examiner responds that Meng distinguishes the electrodes from the catalyst because “Meng consistently refers to the at least two electrodes as ‘the electrodes.’ When discussing the existence of a reformer, which is designed to recombine gasses in the pump, Meng discloses the reformer as ‘a catalyst.’ This notable change in terminology signifies the reformer being separate from the electrodes.” Ans. 17. The Examiner has the better position. Meng discloses that “electrolysis actuation may be harnessed in different ways, an actuator typically consists of at least two electrodes (typically gold, palladium, or platinum).” Meng, 1633, col. 1, para. 5. Meng further discloses that “electrolysis occurs at the electrode surface producing oxygen (anode) and hydrogen (cathode) gases (Eq. (1)). This reaction is reversible and proceeds quickly when the voltage polarity is reversed in the presence of a catalyst such as platinum, resulting in the recombination of hydrogen and oxygen gases back to water.” Meng, 1633, col. 2, para. 1. As such, Meng distinguishes between electrodes (anode and cathode) that actuate electrolysis (produce oxygen and hydrogen), and a catalyst that if present speeds the reaction when voltage polarity is reversed resulting in recombination and reforming. Although we appreciate that Meng’s electrodes and catalyst both could be platinum, because Meng’s electrodes could also be gold or palladium that are used with a platinum catalyst, a preponderance of the evidence supports the Examiner’s position that the catalyst (reformer) is separate from the electrode. Cf. Spec. 10:12–13 and 13:2. Appeal 2019-001820 Application 14/867,393 10 We have considered each of Appellant’s arguments for the patentability of claim 1, and are not persuaded of Examiner error. Accordingly, we sustain the Examiner’s rejection under 35 U.S.C. § 103 of claim 1 as unpatentable over Gutierrez, Meng, and Gordon. Claims 2–5 and 8 fall with claim 1. Rejection II – Gutierrez, Meng, Gordon, and Liu Appellant makes no argument that claims 6, 7, and 9–12 would be patentable over Gutierrez, Meng, Gordon, and Liu, if claim 1 is not patentable over Gutierrez, Meng, and Gordon. For the reasons set forth above, we sustain Rejection II. Rejection III – Gutierrez and Gordon Appellant notes that independent claim 21 differs from claim 1 because claim 21 does not recite a reformer as in claim 1 and because claim 21 recites “an orifice” instead of an inlet orifice and an outlet orifice. Appeal Br. 13. Appellant contends that the arguments regarding Gutierrez and Gordon “above are also applicable to Claim 21,” and “are incorporated herein by reference,” and that reversal of Rejection III is warranted based on those arguments. Id. For the reasons set forth above, Appellant’s arguments do not persuade us of Examiner error. For the same reasons as in Rejection I, we sustain Rejection III. Rejections IV and V – Gutierrez, Gordon, Meng, Liu Regarding Rejection IV, Appellant makes no argument that claims 23, 25, and 28 would be patentable over Gutierrez, Gordon, and Meng, if claim Appeal 2019-001820 Application 14/867,393 11 21 is not patentable over Gutierrez and Gordon. For Rejection V, Appellant makes no argument that claims 26 and 27 would be patentable over Gutierrez, Gordon, and Liu, if claim 21 is not patentable over Gutierrez and Gordon. For the reasons set forth above, we sustain Rejections IV and V. CONCLUSION The Examiner’s rejection of claims 1–5 and 8 under 35 U.S.C. § 103 as unpatentable over Gutierrez, Meng, and Gordon is AFFIRMED. The Examiner’s rejection of claims 6, 7, and 9–12 under 35 U.S.C. § 103 as unpatentable over Gutierrez, Meng, Gordon, and Liu is AFFIRMED. The Examiner’s rejection of claims 21, 22, and 24 under 35 U.S.C. § 103 as unpatentable over Gutierrez and Gordon is AFFIRMED. The Examiner’s rejection of claims 23, 25, and 28 under 35 U.S.C. § 103 as unpatentable over Gutierrez, Gordon, and Meng is AFFIRMED. The Examiner’s rejection of claims 26 and 27 under 35 U.S.C. § 103 as unpatentable over Gutierrez, Gordon, Meng, and Liu is AFFIRMED. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1–5, 8 103 Gutierrez, Meng, Gordon 1–5, 8 6, 7, 9–12 103 Gutierrez, Meng, Gordon, Liu 6, 7, 9–12 21, 22, 24 103 Gutierrez, Gordon 21, 22, 24 23, 25, 28 103 Gutierrez, Gordon, Meng 23, 25, 28 Appeal 2019-001820 Application 14/867,393 12 Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 26, 27 103 Gutierrez, Gordon, Meng, Liu 26, 27 Overall Outcome 1–12, 21–28 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation