Ex Parte RyanDownload PDFPatent Trial and Appeal BoardMay 18, 201813431933 (P.T.A.B. May. 18, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/431,933 03/27/2012 Timothy J. Ryan 23410 7590 05/18/2018 Vista IP Law Group LLP 100 Spectrum Center Drive Suite 900 IRVINE, CA 92618 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 ATTORNEY DOCKET NO. CONFIRMATION NO. RYAN-002US 1899 EXAMINER BARIA, DINAH N ART UNIT PAPER NUMBER 3774 MAIL DATE DELIVERY MODE 05/18/2018 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 Ex parte TIMOTHY J. RY AN Appeal2017-005472 Application 13/431,933 Technology Center 3700 Before RYAN H. FLAX, TIMOTHY G. MAJORS, and DAVID COTTA, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to an implantable medical system/apparatus, e.g., a vascular graft. Claims 1, 4, 5, 7, 8, 11, 23, 50-52, 56-58, and 60-62 are on appeal as rejected under 35 U.S.C. § 112, first and second paragraphs, and§ 103. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. Appeal2017-005472 Application 13/431,933 STATEMENT OF THE CASE The Specification states "[ t ]he present invention relates generally to devices that may be implanted within a patient's body, and, more particularly, to electrically charged implants, e.g., which may reduce susceptibility to infection, thrombosis, and/or undesired tissue growth, and to apparatus and methods for making and using them." Spec. 1: 10-13. Independent claims 1, 23, and 56 are reproduced below: 1. An implantable medical system, comprising: an implantable medical device comprising an elongate tubular member sized for implantation at least partially within a patient's body, the device comprising an at least partially electrically conductive portion that is disposed within a patient's body upon implantation; and a power source coupled to the at least partially electrically conductive portion by one or more leads such that a small DC electric current flows to the at least partially electrically conductive portion substantially continuously to maintain a substantially constant charge for an extended period of time. 23. An implantable medical apparatus, comprising: an implantable vascular graft comprising an elongate tubular member including proximal and distal ends and an at least partially electrically conductive portion; an electrode coupled directly to the at least partially electrically conductive portion; and a direct current (DC) power source coupled to the electrode for providing an electric current to the at least partially electrically conductive portion to cause the current to flow at a substantially slow rate for an extended period of time, thereby maintaining a desired voltage on the graft. 5 6. A vascular graft, comprising: 2 Appeal2017-005472 Application 13/431,933 a tubular member comprising a luminal surface, at least a portion of the luminal surface being electrically conductive; and means for applying an electrical current comprising a direct current (DC) voltage source directly coupled to the luminal surface of the graft such that a small current flows at a substantially slow rate, thereby maintaining a desired voltage on the luminal surface for an extended period of time. Appeal Br. 22, 24, 25 (Claims App'x). The following rejections are appealed: Claims 1, 4, 5, 7, 8, 11, 23, 50-52, 56-58, and 60-62 stand rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. Final Action 3. Claims 1, 4, 5, 7, 8, 11, 23, 50-52, 56-58, and 62 stand rejected under 35 U.S.C. § 112, second paragraph, as indefinite. 1 Id. at 7. Claims 1, 4, 7, 60, and 61 stand rejected under 35 U.S.C. § I03(a) over Busiashvili2 and Heller. 3 Id. at 9. Claim 5 stands rejected under 35 U.S.C. § I03(a) over Busiashvili, Heller, and Torgerson. 4 Id. at 11. Claims 8, 11, 57, and 58 stand rejected under 35 U.S.C. § I03(a) over Busiashvili, Heller, and Weber. 5 Id. at 12. Claims 23, 51, 52, 56, and 62 stand rejected under 35 U.S.C. § I03(a) over Busiashvili and Weber. Id. at 13. 1 This rejection was withdrawn as to claims 60 and 61. Answer 13. 2 US 2006/0106451 Al (pub. May 18, 2006) ("Busiashvili"). 3 US 2008/0288019 Al (pub. Nov. 20, 2008) ("Heller"). 4 US 2009/0132009 Al (pub. May 21, 2009) ("Torgerson"). 5 US 2007/0224244 Al (pub. Sept. 27, 2007) ("Weber"). 3 Appeal2017-005472 Application 13/431,933 Claim 50 stands rejected under 35 U.S.C. § 103(a) over Busiashvili, Weber, and Banning. 6 Id. at 15. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Written Description Requirement "In order to satisfy the written description requirement [of 35 U.S.C. § 112, first paragraph], the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue." Purdue Pharma L.P. v. Paulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. See id. Regarding claim 1, the Examiner determined the claim element, "a power source coupled to the at least partially electrically conductive portion by one or more leads such that a small DC electric current flows to the at least partially electrically conductive portion substantially continuously" ( emphasis added), is "never mentioned in the originally filed [S]pecification." Final Action 3. The Examiner finds that the claim specifies current flowing to the partially electrically conductive portion, while the originally filed specification describes a low voltage being delivered thereto. Id. at 3--4. The Examiner further finds a lack of support 6 US 4,906,207 (issued Mar. 6, 1990) ("Banning"). 4 Appeal2017-005472 Application 13/431,933 for the claimed concept (also in claim 4) of such current flow happening substantially continuously. Id. at 4. Regarding claim 1 (and claims 4, 60, and 61, which depend therefrom), the Examiner determined the claim element, "DC electric current," "is never mentioned in the originally filed [S]pecification." Final Action 4. The Examiner determined, Regarding claims 23 and 56, the last three lines of both claims set forth the parameter of a DC power source, coupled to the at least partially electrically conductive portion ( the luminal surface in claim 56), to cause the current (small current in claim 56) to flow at a substantially slow rate (for an extended period of time in claim 23), thereby maintaining a desired voltage on the graft/luminal surface (for an extended period of time in claim 56); however, these parameters are never mentioned anywhere in the originally filed disclosure. Final Action 5. The Examiner determined that, while the Specification may describe using a semi-conductive, current-leaky surface for such slow rate current flow to maintain a voltage, it does not describe that a DC power source causes such an effect. Id. (citing Spec. 7:10-12, claim 8). The Examiner determined that the small current density of 0-5 mA/ cm2 is "not a flow rate of current from the power source." Id. at 6. Further, the Examiner determined the claim element, "the current flowing at a 'substantially slow rate for an extended period of time'," is not mentioned in the Specification. Id. Appellant argues, claim 1 recites "a power source coupled to the at least partially electrically conductive portion by one or more leads such that a small DC electric current flows to the at least partially 5 Appeal2017-005472 Application 13/431,933 electrically conductive portion substantially continuously to maintain a substantially constant charge for an extended period of time." A person of ordinary skill would understand that the description teaches a power source wherein a small DC electric current flows to the at least partially electrically conductive portion. Appel Br. 7. Appellant cites the Specification at page 18 as disclosing a battery for maintaining a substantially constant electric charge to the device (0 to -0.5 V) for an indefinite time and at page 7 as disclosing the conductive layer of the device may be semi-conductive so as to leak current, meaning current flows at a substantially slow rate to maintain a desired voltage on the device with minimal current and power consumption. Id. Appellant further argues that, given that the implant creates a circuit within the patient's body (e.g., as explained at page 9, lines 14-16), current may flow substantially continuously given that the charge on the implant is being maintained in an environment in which tissues and/or fluids may drain current. However, such flow is at a substantially slow rate to "maintain a substantially constant charge for an extended period of time." Id. at 7-8. Appellant also argues, If current "leaks" from the conductive layer 34, i.e., flows at a substantially slow rate, as described at page 7, lines 10-13, then similar current must flow throughout the entire closed circuit - current cannot be flowing substantially continuously in one region of the circuit without also flowing through the rest of circuit. A person of ordinary skill would understand that operation of the power source substantially continuously, particularly in combination with a conductive layer that causes current to "leak," would result in current flowing substantially continuously. Reply Br. 3. 6 Appeal2017-005472 Application 13/431,933 On balance, we find the evidence of record supports Appellant's position. The power source disclosed in the Specification is a DC battery and it is disclosed to supply electricity (essentially directly, i.e., without intervening circuitry) to the conductive (or semi-conductive) portion of the device. See, e.g., Spec. 9. Without the battery being so connected, nothing electrical happens. The Specification describes an embodiment where current may leak from the conductive portion to the body tissue/blood in a continuous manner. Id. at 7, 11. Thus, if current is flowing at the conductive portion, it is flowing throughout the circuit from the battery to the conductive portion to the body tissue/blood. That current drain/flow is described as slow and the battery is described as potentially lasting a lifetime, or at least decades. Id. at 7, 12. Regardless of whether the Specification explicitly identifies that current is flowing throughout this described circuit, it is implausible that a skilled artisan would not understand that it must. Regardless of whether the Specification indicates that such current is a DC current, because the power source is a DC battery, the current would also be direct ( absent some intervening components, which are not disclosed). We reverse the written description rejection. Indefiniteness "[A] claim is indefinite when it contains words or phrases whose meaning is unclear," i.e., "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1310-13 (Fed. Cir. 2014); see also MPEP § 2173.02(!) (Rev. 07.2015, Nov. 2015) (advising examiners that a rejection 7 Appeal2017-005472 Application 13/431,933 for indefiniteness is appropriate "after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear"). Regarding claims 1 and 4, the Examiner determined that the inclusion of the relative term "substantially" to describe the claimed continuous current flow was not defined and is without a way to ascertain the requisite degree. Final Action 7. The term "substantially" is interpreted consistent with essentially completely, with some leeway for less than completely. 7 Thus, if the battery supplies electrical charge almost always, that is substantially continuously as claimed, and if current flows almost always so as to almost always provide a charge, that is a substantially constant charge as claimed. We conclude this term and its usage in the context of the claim is not indefinite. Regarding claims 1, 23, and 56, the Examiner determined the claim term, "an extended period of time," is unclear, i.e., it is unclear as to what time frame it would entail. Final Action 7. We agree that this claim term is indefinite. An extended period of time is not clear within the context of the claim and is not explicitly defined in the Specification. The Specification says, for example, the charge can last for the life of the battery equating to the life of the implant, e.g., decades. Spec. 12:3---6. From this, we know that an extended period of time can include decades, but the term "extended" is 7 See, e.g., Merriam-Webster Dictionary, substantial, https://www.merriam- webster.com/dictionary/substantially (last visited May 15, 2018) ("being largely but not wholly that which is specified"). 8 Appeal2017-005472 Application 13/431,933 ambiguous as to the metes and bounds of its scope. Therefore, this term and the claims using this term are indefinite. Regarding claim 8, the Examiner determined that the claim term, "flow at a substantially slow rate," is confusing and unclear; the 0-5 mA/cm2 current density disclosed in the Specification does not clarify the term. Final Action 7. We agree that this claim term is indefinite. The term "slow rate" is not clear from the context of the claim and is not explicitly defined in the Specification. Appellant argues the disclosure of 0-5mA/ cm2 as a current density sufficiently defines what a slow rate would be. While current density and current and time and charge are all related variables, the current density, current, and time are not directly related, and without also knowing what the cross-sectional area and current are, a skilled artisan could not necessarily determine the time so as to determine the flow rate and whether it was "slow" or not (slow compared to what is also unclear). This claim term and the claims using this term are indefinite. For the reasons above, we affirm the indefiniteness rejection. Obviousness Obviousness criteria includes: 1) scope and content of prior art; 2) differences between prior art and claims at issue; 3) level of ordinary skill in the art at the time invention was made; and 4) objective evidence of non- obviousness. Graham v. John Deere Co., 383 U.S. 1 (1966). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "In determining whether the 9 Appeal2017-005472 Application 13/431,933 subject matter of a patent claim is obvious, ... [ w ]hat matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under§ 103." Id. at 419. When a prima facie case of obviousness has not been established, the rejection must be reversed. In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988). "[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious." In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992). 1. Claims 1, 4, 7, 60, and 61 and Busiashvili-Heller Combination The Examiner determined the rejected claims would have been obvious over the Busiashvili-Heller combination. Final Action 9--11 (citing Busiashvili ,r,r 14, 15, 24, 25, 27, Fig. 1; Heller ,r 23); see also Busiashvili abstract; Heller ,r 54. Appellant argues that because Busiashvili teaches that its coaxially paired stents are separated by an insulation layer they are incapable of having a current flow for an extended period of time. Appeal Br. 12-13 ( quoting https :// en. wikipedia. org/wiki/ Capacitor). Appellant argues Busiashvili fails to teach the claimed "small DC electric current flows" or the claimed "current flows substantially continuously to maintain a substantially constant charge for an extended period of time." Appeal Br. 14 ( emphasis omitted). Appellant cites Busiashvili ,r 16 as disclosing that, if its stent did not function as a capacitor (i.e., if current continuously flowed), it would lose its charge within an unacceptably short time. Id. at 15. Appellant also argues Heller cannot be properly combined with Busiashvili because it "is completely unrelated to the field of the Busiashvili reference." Appeal Br. 16. Appellant argues Heller's focus on treating pain or itch using electrochemical generation of oxidants "has nothing to do with 10 Appeal2017-005472 Application 13/431,933 preventing restenosis within arteries," as is the focus of Busiashvili. Id. at 17. Appellant's arguments are persuasive, as we explain below. We conclude that the cited prior art combination would lead the skilled artisan to an implantable capacitor, which, as argued by Appellant, would have flowing current for only the (likely brief) time needed to charge its plates (here, implantable stents small enough to fit in a blood vessel). The Examiner's rationale agrees that Busiashvili's disclosed device is a capacitor. Answer 17. Even if a capacitor is disclosed in the Specification as an embodiment of the invention, it is not the claimed embodiment because the claimed embodiment requires current flow to be continuous ( and is disclosed as needing a leaky conductive portion to do so). Therefore, we conclude the cited prior art combination fails to teach or suggest the claimed "power source coupled to the at least partially electrically conductive portion by one or more leads such that a small DC electric current flows to the at least partially electrically conductive portion substantially continuously to maintain a substantially constant charge for an extended period of time" ( emphasis added). Furthermore, regarding combining Heller's disclosure of a power supply providing a current density like that disclosed in Appellant's Specification and comporting with the claimed "small ... current," we agree with Appellant that evidence of motivation to make such a combination is lacking. Busiashvili and Heller may both be directed to electrically charged implantable devices, thus they are not totally unrelated; however, Busiashvili' s device is charged to prevent cells from adhering to the implant 11 Appeal2017-005472 Application 13/431,933 and causing thrombosis (Busiashvili abstract ), while Heller's device is charged to treat pain (Heller ,r 6). Thus, while Heller teaches that "a current density of less than 5 mA/cm2" is useful to prevent or mitigate pain or itching (Heller ,r 23), it offers no insight as to what current density ( or current flow rate) might be useful to prevent cell adhesion. For the reasons set forth above, we reverse this obviousness rejection. 2. Claim 5 and Busiashvili-Heller-Torgerson Combination The Examiner determined the rejected claim would have been obvious over the Busiashvili-Heller-Torgerson combination. Final Action 11-12 ( citing Busiashvili and Heller as they were cited for the preceding obviousness rejection; citing Torgerson ,r 62, Figure 4). Appellant does not present an argument specific to this rejection, but we understand Appellant to stand on the arguments presented regarding claim 1, from which claim 5 depends. As discussed above, these arguments are persuasive over the Busiashvili-Heller combination; no evidence is presented that Torgerson can overcome what is shown deficient therein. For the reasons set forth above, we reverse this rejection. 3. Claims 8, 11, 57, and 58 and Busiashvili-Heller-Weber Combination The Examiner determined the rejected claims would have been obvious over the Busiashvili-Heller-Weber combination. Final Action 12- 13 ( citing Busiashvili and Heller as they were cited for the preceding obviousness rejection; citing Weber ,r,r 3, 50, 60). Regarding claims 11, 57, and 58, the Examiner determined Busiashvili taught a vascular graft at ,r 21. Final Action 12. 12 Appeal2017-005472 Application 13/431,933 Appellant argues "none of these references [Busiashvili, Heller, and Weber], alone or in combination, discloses, teaches, or suggests a semi- conductive surface of an implantable medical device configured to cause current to flow at a substantially slow rate, thereby maintaining a desired voltage on the device." Appeal Br. 19. Appellant argues the biodegradable, metallic/polymeric materials of Weber would not be applied to the stents or insulating layer of Busiashvili because they are intended to be temporary, to dissolve, and not remain in a subject for an extended period of time. Id. at 20. Appellant argues, again, that any modification to Busiashvili that caused current to flow in its device would be contrary to its intended functioning. Id. As discussed above, Appellant's arguments are persuasive over the Busiashvili-Heller combination; no evidence is presented that Weber can overcome what is shown deficient therein. For the reasons set forth above, we reverse this rejection. 4. Claims 23, 51, 52, 56, and 62 and Busiashvili-Weber Combination The Examiner determined the rejected claims would have been obvious over the Busiashvili-Weber combination. Final Action 13-14. Appellant presents no specific argument to rebut this rejection, but we understand Appellant to stand on the relevant arguments made over other rejections. As discussed above, these arguments are persuasive over the Busiashvili-Heller combination; no evidence is presented that Weber can overcome what is shown deficient regarding Busiashvili. For the reasons set forth above, we reverse this rejection. 13 Appeal2017-005472 Application 13/431,933 5. Claim 50 and Busiashvili-Weber-Banning Combination The Examiner determined the rejected claims would have been obvious over the Busiashvili-Weber-Banning combination. Final Action 15 (adding cites to Banning 1 :6-8, 2:57-59). Appellant presents no specific argument to rebut this rejection, but we understand Appellant to stand on the relevant arguments made over other rejections. As discussed above, these arguments are persuasive over the Busiashvili-Heller combination; no evidence is presented that Banning can overcome what is shown deficient regarding Busiashvili and Weber. For the reasons set forth above, we reverse this rejection. SUMMARY The rejection of the claims under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement is reversed. The rejection of the claims under 35 U.S.C. § 112, second paragraph, as indefinite is affirmed. Each obviousness rejection under 35 U.S.C. § 103 is reversed. 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)(l )(iv). AFFIRMED 14 Copy with citationCopy as parenthetical citation