Ex Parte Poletto et alDownload PDFPatent Trial and Appeal BoardJul 5, 201613074808 (P.T.A.B. Jul. 5, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/074,808 03/29/2011 71996 7590 07/07/2016 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR CHRISTOPHER POLETTO 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. 1123-027US01/P0039189.00 1482 EXAMINER HILL, KEVIN KAI ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 07/07/2016 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): pairdocketing@ssiplaw.com medtronic _neuro _ docketing@cardinal-ip .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTOPHER POLETTO, JONATHON E. GIFTAKIS, and WILLIAM F. KAEMMERER Appeal2014-006709 Application 13/074,808 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to a medical system. The Examiner rejected the claims as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Medtronic, Inc. (see App. Br. 3). Appeal2014-006709 Application 13/074,808 Statement of the Case Background "Electrical stimulation of neural tissue serves as the core of many neurological therapies, and can provide relief for a variety of disorders, improving the quality of life for many patients" (Spec. i-f 2). The Claims Claims 27--44 and 46-52 are on appeal. 2 Independent claim 27 is representative and reads as follows: 27. A medical system comprising: a viral vector comprising a genetic agent encoding for one or more light-sensitive proteins; a biological vector delivery device configured to deliver the viral vector to a delivery site within a patient, wherein the viral vector comprises at least one of retrograde or anterograde transport properties such that the viral vector is configured to transduce the genetic agent into cells at the delivery site and into cells in a plurality of sites proximal and remote to the delivery site; a sensor configured to sense a bioelectrical signal indicative of a neurological condition of the patient; and an optical stimulator configured to deliver light to one or more of the cells transduced with the genetic agent by the viral vector based on the bioelectrical signal sensed by the sensor. The Issues A. The Examiner rejected claims 27-35, 37, 39--44, 46, 48, and 51 under 35 U.S.C. § 102(b) as anticipated by Zhang3 (Final Act. 3--4). 2 Claims 1-26 and 45 were withdrawn (Br. 3). 3 Zhang et al., WO 2008/089003 A2, published July 24, 2008. 2 Appeal2014-006709 Application 13/074,808 B. The Examiner rejected claims 27--44, 46, 48, and 51under35 U.S.C. § 103(a) as obvious over Decharms,4 Zhang, and Liu5 (Final Act. 6-9). C. The Examiner rejected claims 47, 49, 50, and 52 under 35 U.S.C. § 103(a) as obvious over Decharms, Zhang, Liu, and Pless6 (Final Act. 10- 12). A. 35 U.S.C. § 102(b) over Zhang The Examiner finds that: Zhang et al disclose a medical system comprising: a) a device configured to deliver a viral vector ... b) a sensor configured to sense a bioelectrical signal related to a neurological condition of a patient ... e.g. providing feedback that measures the voltage or current across a cell membrane ... and c) an optical stimulator configured to deliver light to one or more cells transduced with the viral vector based on the bioelectrical signal sensed by the sensor (Final Act. 3--4). The Examiner finds that "Zhang et al disclose the viral vector is an adeno-associated virus (AA V)" (id. 4). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion Zhang anticipates the claims? Findings of Fact 1. Zhang teaches an implantable device delivers gene transfer vector, such as a virus, which induces expression of photosensitive bio- 4 Decharms, WO 2006/055582 A2, published May 26, 2006. 5 Liu et al., US 2004/0101514 Al, published May 27, 2004. 6 Pless, US 2007/0213783 Al, published Sept. 13, 2007. 3 Appeal2014-006709 Application 13/074,808 molecular membrane proteins. The device has a light generator, responsive to (for example, charged by or triggered by) an external signal, to generate light and a biological arrangement that includes the photosensitive bio-molecular protein that responds to the generated light by interacting with target cells in vivo. In this manner, the electronic portions of the device may be used to optically stimulate target cells. Stimulation may be manifested as either upregulation (e.g., increased neuronal firing activity), or downregulation (e.g., neuronal hyperpolarization, or alternatively, chronic depolarization) of activity at the target. (Zhang 3: 16-25). 2. Zhang teaches that "the present invention has utility in the treatment of a wide spectrum of medical conditions, from Parkinson's disease and brain injuries to cardiac dysrh[y ]thmias, to diabetes, and muscle spasm" (Spec. 4:5-7). 3. Zhang teaches, regarding viral vectors, that "gene transfer vectors inducing the expression of photosensitive bio-molecules are used to target a specific type of cell. For instance, viral-based proteins (e.g., lentiviruses, adeno-associated viruses or retroviruses) can created to target specific types of cells" (Zhang 13:5-8). 4. The Specification teaches that a "number of viral vectors with retrograde and/or anterograde transport properties may be employed in examples according to this disclosure. In one example, an adeno-associated viral (AA V) vector is capable of transduction of a genetic agent encoding for light-sensitive protein(s)" (Spec. i-f 28). 5. Zhang teaches, regarding the light sensitive protein, that the "targeted cells are then infected by the viral-based gene-transfer proteins, 4 Appeal2014-006709 Application 13/074,808 and begin to produce a new type of ion channel (for example ChR2), thereby becoming photosensitive" (Zhang 13:9-11). 6. The Specification teaches that in "one example, a first opsin or set of opsins, also referred to as a light-activated cation channel proteins (or 'LACC'), comprises the protein, or portions of the protein Channelrhodopsin-2 (ChR2)" (Spec. i-f 33). 7. Zhang teaches, regarding the sensor, that "a sensor can be used provide feedback to the light source 1602. For instance, this feedback could be a measurement of the voltage or current across the cell membrane. Thus, the light source could be configured to maintain a constant current or voltage (e.g., clamp) across the cell" (Zhang 33:33 to 34:2). Zhang further teaches that "feedback could monitor the voltage response of the target cells, including the amount of action potential firing" (Zhang 34: 15-16). 8. The Specification teaches that the "sensor is configured to sense a bioelectrical signal" (Spec. i-f 5). 9. Zhang teaches, regarding the optical stimulator, that "[f]iber optic cable 1706 may include a bundle of optical cables, each capable of carrying and directing light independently. Thus, fiber optic cable 1706 can be configured to deliver light having one or more wavelengths to multiple locations" (Zhang 34:9-11 ). 10. The Specification teaches that "[i]mplantable stimulator 4 may be configured to deliver optical stimulation, such as light 15, to patient 6 via implantable optical fibers 11" (Spec. i-f 20). 5 Appeal2014-006709 Application 13/074,808 Principles of Law "An [] intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates." Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 3--4; FF 1-10) and agree that the claims are anticipated by Zhang. We address Appellants' arguments below. Claims 2 7 and 44 Appellants contend that Zhang "fails to disclose or suggest that the sensor is configured to sense a bioelectrical signal indicative of a neurological condition of the patient" (App. Br. 7). Appellants contend that "Zhang fails to disclose or suggest that the current or voltage across the membrane of a single cell is a bioelectrical signal that is indicative of a neurological condition of a patient" (id.). Appellants contend that the "Examiner failed to provide any basis in fact to support the assertion that the voltage or current across a cell membrane of a single cell 1608 disclosed by Zhang is equivalent to the 'action potentials' disclosed in Applicant's specification" (id. at 8-9). We are not persuaded. The phrase "configured to sense a bioelectrical signal indicative of a neurological condition" merely states an intended use or purpose for the claimed sensor. Appellants do not identify any necessary structural difference between the sensor of Zhang and the claimed sensor, 6 Appeal2014-006709 Application 13/074,808 with both sensors detecting bioelectric signals (FF 7-8). Appellants' use of the detected bioelectric signals as "indicative of a neurological condition" is reasonably interpreted as an intended use recitation for this system claim, because Appellants fail to provide any specific structure or configuration of the sensor itself in the claim that serves to distinguish Zhang' s bioelectric signal detecting sensor (FF 7) or that performs the intended use function of indicating "a neurological condition". "It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Appellants contend that Zhang also fails to disclose the optical stimulator of Applicant's claim 27. The Examiner characterized a light source disclosed by Zhang as the optical stimulator of claim 27. Zhang, however, fails to disclose or suggest that the light source is configured to deliver light to one or more of the cells based on a bioelectrical signal indicative of a neurological condition (App. Br. 9). We are not persuaded. The "configured to deliver light ... based on the bioelectrical signal" merely states an intended use or purpose for the optical stimulator. Appellants do not identify any necessary structural difference between the optical stimulator of Zhang and the claimed optical stimulator, and both are composed of optical fibers for light delivery (FF 9- 10). Zhang expressly teaches that the "sensor can be used provide feedback to the light source" where the "feedback could monitor the voltage response of the target cells" (FF 7), thereby expressly teaching that the optical stimulator delivers light based on the bioelectric signal detected by the 7 Appeal2014-006709 Application 13/074,808 sensor. Therefore, the "configured" language simply represents one intended use of the optical stimulator. Schreiber, 128 F.3d at 1477. Claim 46 Appellant contends that the "Examiner asserted that Zhang anticipates claim 46, but admitted that Zhang does not disclose a sensor configured to sense a bioelectrical signal related to epilepsy. On this admission alone, the rejection of claim 46 under 35 U.S.C. § 102(b) as allegedly being anticipated by Zhang should be reversed" (App. Br. 11 ). We are not persuaded. Claim 46 recites "a sensor configured to sense a bioelectrical signal related to epilepsy", but imposes no specific requirements on the sensor that distinguish sensors "configured" for detection of electrical signals associated with epilepsy from Zhang' s sensor for detection of electrical signals (FF 7). As discussed above, this "configured to" language merely represents an intended use of the sensor. Appellants do not, in their arguments, contend or evidence that the claim or Specification provides any detailed guidance on particular "configurations" of a sensor which function to separately distinguish epilepsy or other neurological conditions. Therefore, the "configured" language simply represents one intended use of the sensor. Schreiber, 128 F.3d 1477. Despite failing to provide any guidance on using bioelectrical signals for epilepsy detection in their own Specification, Appellants further contend that "even if 'action potentials' may reasonably be characterized as a bioelectrical signal related to epilepsy, the Examiner failed to establish that Zhang discloses a sensor configured to sense such 'action potentials"' (App. Br. 12). 8 Appeal2014-006709 Application 13/074,808 This statement is incorrect. Zhang teaches that "feedback could monitor the voltage response of the target cells, including the amount of action potential firing" (FF 7). Thus, consistent with Appellants' admission that "action potentials" are bioelectrical signals related to epilepsy, Zhang teaches a sensor that measures action potential firing (FF 7), thereby demonstrating the functional capacity to satisfy the "configured to" intended use language. We also recognize, but find unpersuasive, Appellants contention that "the Examiner has failed to establish that Zhang necessarily discloses a sensor configured to sense a bioelectrical signal related to epilepsy, and an optical stimulator configured to deliver light based on the bioelectrical signal" (App. Br. 13). These arguments do not interpret the "configured to" limitation as an intended use, but rather as a structural limitation. However, the Examiner has established that the sensor can detect bioelectrical signals such as action potentials, and that the sensor can feedback this information to the optical stimulator for treatment (FF 7, 9). Appellants, in contrast, have provided no evidence that any specific "configuration" is disclosed in the Specification that structurally distinguishes the device of Zhang, nor have Appellants provided any evidence rebutting the Examiner's findings that Zhang teaches the required elements of the claim (see Ans. 16).Claim 51 Appellants contend that "[i]t is improper for the Examiner to rely on Appellant's specification to support the assertion that the AA V disclosed by Zhang has anterograde transport properties" (App. Br. 14). 9 Appeal2014-006709 Application 13/074,808 We are not persuaded. It is appropriate to consult the Specification to confirm an inherent property of product. In re Huai-Hung Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011) ("substantial evidence supports the Board's finding of inherency. The Office further responds that the Board's reliance upon the specification of the '859 Application to support this conclusion is entirely proper. . . . This court agrees with the Office"). Just as Kao relied upon the Specification to demonstrate inherency, the Examiner here properly relies upon Appellants' Specification to evidence that adeno-associated viruses (AA V) inherently have anterograde transport properties (FF 4). The Examiner reasonably finds that the AA V disclosed by Zhang will necessarily and inherently have the same properties as the identical AA V disclosed in the Specification (FF 3--4, see Ans. 17). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Conclusion of Law The evidence of record supports the Examiner's conclusion Zhang anticipates the claims. B. 35 U.S.C. § 103(a) over Decharms, Zhang, and Liu The Examiner finds that Decharms teaches a medical system comprising: a) a device configured to deliver a therapeutic agent (Figure l; [0034, 150-151, 155]), b) a sensor configured to sense a bioelectrical signal related to a neurological condition of a patient [0046, 49], to wit, epilepsy [ 00141], and c) an optical stimulator configured to deliver light to one or more target cells based on the bioelectrical signal sensed by the sensor [0012-13]. 10 Appeal2014-006709 Application 13/074,808 (Final Act. 6-7). The Examiner acknowledges that "De[]charms does not disclose a delivery device that comprises a viral vector" (Id. at 7) but relies upon Zhang as discussed above to teach AA V viral vectors comprising light sensitive proteins (id. at 8). The Examiner finds it obvious to substitute a first delivery device capable of delivering a viral vector, as taught by De[]charms, with a second delivery device comprising a viral vector (Zhang et al), ... in a medical system with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill. (Final Act. 9). The issue with respect to these rejection is: Does the evidence of record support the Examiner's conclusion that Decharms, Zhang, and Liu render the claims obvious? Findings of Fact 11. Decharms teaches "a system for stimulating target tissue comprising: a light source for providing stimulation pulses; an implantable light conducting lead coupled to said light source adapted for stimulation of a predetermined site in a subject. In one aspect, the light conducting lead is an optical fiber" (Decharms i-f 12). 12. Decharms teaches that "stimulating said at least one predetermined site in said nervous system of said body using said at least one light-emitter. In one aspect of the invention, the disorder being treating is Parkinson's disease, Alzheimer's disease, depression, or epilepsy" (Decharms i-f 13). 11 Appeal2014-006709 Application 13/074,808 13. Dec harms teaches that: "Pharmacological treatment, as used herein, refers to the administration of any type of drug or medication" (Decharms i-f 34). 14. Decharms teaches that "[t]his method provides for stimulation within or adjacent to epileptic tissue in order to disrupt or prevent an epileptic seizure. Seizure activity may be monitored through measurement of brain electrical activity" (Decharms i-f 141 ). 15. Dec harms teaches that the methods disclosed here may be used to stimulate fibers synapsing onto a group of neurons whose activation is measured electrically, including glutamatergic synapsing fibers. The electrical potential in a target cell or population of cells may be recorded that results from light stimulation of the fibers using this method. Then, a drug such as a potential glutamate antagonist may be applied, for example in fluid 35 through catheter 34. The electrical potential may be compared in the presence and absence of the drug to determine the drugs effect. Similarly, methods may be used to monitor the effect of a drug on a physiological response induced using light stimulation in VIVO. (Decharms i-f 155). Principles of Law "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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 6-9; FF 1-15) and agree that 12 Appeal2014-006709 Application 13/074,808 the claims are rendered obvious by Decharms, Zhang, and Liu. We address Appellants' arguments below. Claims 27, 44, and 46 Appellants contend that the applied art fails to provide any basis for asserting that the light delivered by the Decharms device would have caused the proteins induced by the gene transfer vector disclosed by Zhang to respond, and, thus, the gene transfer vector disclosed by Zhang would have served no apparent purpose in the Decharms system. (App. Br. 15). We are not persuaded. Decharms teaches a system for light stimulation of neural tissue for treatment of diseases including epilepsy (FF 12) and specifically teaches that light stimulation effects electrical potential of cells treated with a pharmacologic agent (FF 15). Zhang teaches a system using a viral vector to introduce a protein responsive to light stimulation (FF 1) for treatment of a wide variety of diseases (FF 2) where the treatment effects electrical potential of cells and may be monitored by a sensor (FF 7). We agree with the Examiner that the "optical device of both Decharms and Zhang et al are configured to modulate the electrical impulses of neural target cells. Thus, the Examiner maintains the position that the gene transfer vector of Zhang et al would, in fact, serve purpose in the Decharm[s'] system" (Ans. 18). Our obviousness conclusion is consistent with Wrigley, where the Federal Circuit found a "strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one ... agent for 13 Appeal2014-006709 Application 13/074,808 another." Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Appellants contend that "[ o ]ne having ordinary skill in the art would not have considered the 'drugs or pharmacological agents' disclosed by Decharms and the gene transfer vector disclosed by Zhang to be 'equivalents known in the prior art for the same purpose"' because "the light disclosed by Zhang controls the proteins induced by the gene transfer vector, whereas the optical energy disclosed by Decharms causes an electrical impulse to propagate in the neurons" (App. Br. 16). We are not persuaded. Decharms expressly teaches a system that is open to any "drug or medication" (FF 13), a broad disclosure that encompasses Zhang' s specific treatment with AA V that expresses "ion channel (for example ChR2), thereby becoming photosensitive" (FF 5) in order to enhance light treatment of neuronal stimulation (FF 1 ). Thus, Zhang directly evidences a medicament identified as useful in the treatment of medical conditions including neural conditions, demonstrating the equivalence for the purpose of treatment (FF 2). Appellants contend that the "Examiner has impermissibly used Appellant's claim as a roadmap to find references that allegedly disclose the features of claims 27. This reliance on hindsight has resulted in a proposed modification to Decharms that lacks a rational underpinning" (App. Br. 17). We are not persuaded. While we are fully aware that hindsight bias often plagues determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly stated that the "combination of familiar elements according to known 14 Appeal2014-006709 Application 13/074,808 methods is likely to be obvious when it does no more than yield predictable results." KSR, 550 U.S. at 416. The combination of Zhang's system of light treatment using AA V delivery for neuronal diseases with Decharms' system of light treatment for neuronal diseases such as epilepsy is just such a predictable combination, with both systems using delivery systems (FF 3, 13), optical stimulators (FF 9, 11 ), sensors to monitor electrical activity (FF 7, 14) with Decharms' suggesting delivery of medicaments generally (FF 13) while Zhang teaches the use of a specific viral vector medicament that encodes a light sensitive protein (FF 5). Thus, the Examiner's obviousness rejection simply demonstrates that familiar elements in Decharms and Zhang would have been predictably combined to obtain the system required by claims 27, 44, and 46. Appellants provide no evidence of unexpected results or other secondary considerations to rebut this finding. Claim 51 We find Appellants' argument regarding the anterograde transport properties of AA V unpersuasive for the reasons already given. Conclusion of Law The evidence of record supports the Examiner's conclusion that Decharms, Zhang, and Liu render the claims obvious. C. 35 U.S.C. § 103(a) over Decharms, Zhang, Liu, and Pless Claims 47, 49, and 52 Appellants do not separately argue claims 47, 49, and 52, relying upon their reasons regarding claims 27 and 46. We remain unpersuaded by this argument. Having affirmed the obviousness rejection of claims 27 and 46 15 Appeal2014-006709 Application 13/074,808 over Decharms, Zhang, and Liu for the reasons given above, we also find that the further obvious combinations render the remaining claims obvious for the reasons given by the Examiner (see Final Act. 10-12). Claim 50 Appellants contend that the "Examiner's assertion that a processor disclosed by Pless has the ability to select one or more optical fibers from the plurality of optical fibers to deliver the light based on a sensed bioelectric signal is insufficient to establish that Pless discloses a processor configured to do so" (App. Br. 21 ). We are not persuaded. Pless teaches that "different patients and different targets will react differently to different light colors, intensities, stimulation pulse widths, and stimulation burst durations" (Pless i-f 89) and that while it "is possible to use a single device ... with multiple leads to reach multiple detection and therapy targets in the body. However, remote modules do facilitate combination therapies, with stimulation and drugs being used in different areas to maximum effect" (Pless i-f 121 ). We agree with the Examiner that the ordinary artisan, interested in treating different targets within a patient with different stimulation protocols in different areas of the body would have found it obvious to configure the processor to deliver the appropriate signal by selecting optical fibers in the correct body area with the correct stimulation parameters (see Ans. 23). "[T]he test [for obviousness] is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425 (CCPA 1981). 16 Appeal2014-006709 Application 13/074,808 SUMMARY In summary, we affirm the rejection of claims 27, 44, 46, and 51 under 35 U.S.C. § 102(b) as anticipated by Zhang. Claims 28-35, 37, 39- 43, and 48 fall with claims 27, 44, 46, and 51. We affirm the rejection of claims 27, 44, 46, and 51under35 U.S.C. § 103(a) as obvious over Decharms, Zhang, and Liu. Claims 28--43, and 48 fall with claims 27, 44, 46, and 51. We affirm the rejection of claims 47, 49, 50, and 52 under 35 U.S.C. § 103(a) as obvious over Decharms, Zhang, Liu, and Pless. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 17 Copy with citationCopy as parenthetical citation