Medtronic, Inc.Download PDFPatent Trials and Appeals BoardFeb 9, 20212020003960 (P.T.A.B. Feb. 9, 2021) 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. 14/627,843 02/20/2015 Jamu K. Alford 1123-191US01/ C00005761.US 6280 71996 7590 02/09/2021 SHUMAKER & SIEFFERT , P.A 1625 RADIO DRIVE , SUITE 100 WOODBURY, MN 55125 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 02/09/2021 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 rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMU K. ALFORD and STEVEN M. GOETZ Appeal 2020-003960 Application 14/627,843 Technology Center 3700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. PESLAK, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1–25. See Final Act. 1. 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 parties in interest as Medtronic, Inc. and Medtronic plc. Appeal Br. 3. Appeal 2020-003960 Application 14/627,843 2 THE CLAIMED SUBJECT MATTER Appellant’s invention relates to systems and methods for preventing neural degeneration using ultrasound. Claims 1, 12, and 20 are independent. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for reducing or preventing neural degeneration within a brain of a patient, the method comprising: selecting a set of ultrasound parameter values to define ultrasound energy deliverable via one or more ultrasound transducers; and delivering, via the one or more ultrasound transducers, ultrasound energy focused to a targeted region of the brain of the patient according to the set of ultrasound parameter values, wherein the set of ultrasound parameter values are selected to define ultrasound energy delivered via the one or more ultrasound transducers that reduces or prevents neural degeneration within at least a portion of the brain instead of reducing at least one of symptom frequency or symptom severity caused by the neural degeneration. REJECTIONS2 1. Claims 1–25 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. 2 The rejections of claims 1–25 under 35 U.S.C. § 103 based on Mishelevich (US 2013/0281890 A1), published Oct. 24, 2013, Khanna (US 2012/0265123 A1), published Oct. 18, 2012, and Fowler (US 2009/0099622 A1), published Apr. 16, 2009, are withdrawn in the Answer. Ans. 3. Although the Examiner states, “The Office withdraws the 103 rejection,” because none of the rejections set forth on pages 5–9 of the Final Action are repeated in the Examiner’s Answer, and because there is no response to Appellant’s arguments regarding these rejections, we consider each of the rejections under 35 U.S.C. § 103, including the rejection of claims 1–5, 7, 8, 10, 12–17, and 19–25 under 35 U.S.C. § 102(a)(1) or, in the alternative, under 35 U.S.C. 103, as being withdrawn. See generally Ans. Appeal 2020-003960 Application 14/627,843 3 2. Claims 1–25 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. OPINION Rejection 1; Written Description The Examiner finds that the Specification does not reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention, at the time the application was filed. Final Act. 2. According to the Examiner, the Specification does not describe adequately how to achieve the claimed result of reducing or preventing neural degeneration. Id. In particular, the Examiner asserts that the Specification fails to disclose specific steps or treatment parameters that reduce or prevent neural degeneration. Id. at 2–3. Although Appellant groups each independent claim under separate headings, Appellant does not present arguments for independent claims 12 and 20 other than those for claim 1. Appeal Br. 17–22. We select claim 1 as representative and claims 2–25 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appellant argues that the written description requirement is satisfied because the Specification provides examples of delivering ultrasound energy to reduce or prevent neural degeneration, which include ultrasound parameter values and brain target locations. Appeal Br. 17; see also Reply Br. 8–9. In particular, Appellant asserts that ranges for waveforms that target “the subthalamic nucleus” to reduce neuron degeneration for Parkinson’s disease, as well as specific target regions for Alzheimer’s disease are disclosed. Id. (citing Spec. ¶¶ 30, 78). According to Appellant, because one skilled in the art would have been aware of various publications Appeal 2020-003960 Application 14/627,843 4 in the area of brain stimulation, Appellant need not explicitly recite every specific detail related to ultrasound delivery to evidence that the inventors were in possession of the claimed subject matter. Id. at 18. Specifically, Appellant asserts that disclosure of all treatment parameters is not required in order to show possession, and that Appellant’s disclosure of “certain frequency ranges and target locations for ultrasound delivery in order to reduce or prevent neural degeneration . . . would have been sufficient to show possession of the claimed subject matter.” Id. at 19. The Examiner responds that Appellant’s Specification recognizes that treatment parameters include more than just ultrasound frequency, and include at least intensity, treatment time, amplitude, and duty cycle. Ans. 10 (citing Spec. ¶ 44). According to the Examiner, possession is not shown by just disclosing one of numerous ultrasound treatment parameters. Id. The Examiner asserts that just because ultrasound therapy was known in the art does not evidence possession of the claimed subject matter because none of the references relied on by Appellant reduce or prevent neurodegeneration. Ans. 10–11. For the following reasons, we sustain the Examiner’s written description rejection. To satisfy the written description requirement of the first paragraph of 35 U.S.C. § 112, a specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562–63 (Fed. Cir. 1991). Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art and show that the inventor actually invented the claimed invention. Id.; Ariad Pharms., Inc. v. Appeal 2020-003960 Application 14/627,843 5 Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In addition, the specification must “demonstrate that the patentee possessed the full scope of the invention recited in [the] claim.” LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005). “The primary consideration is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976). Appellant’s Specification describes various frequency ranges for neuroprotective ultrasound waveforms. For example, the Specification describes “a frequency ranging between approximately 0.1 MHz and 20 MHz.” Spec. ¶ 30. However, as the Examiner correctly notes, the Specification does not explicitly describe what intensity, treatment time, amplitude, or duty cycle would be used with those frequency ranges to reduce or prevent neurodegeneration. See Ans. 10–11. Thus, resolution of the present appeal depends on whether one of ordinary skill in the art would discern from the Specification and the knowledge possessed by one of ordinary skill in the art that Appellants possessed the full scope of the invention recited in claim 1. Although Appellant asserts that the Spieles-Engemann3 article and the Bystritsky4 article evidence that low energy ultrasound provides neuroprotective benefits and that ultrasound therapy was known in the art, these references do not support Appellant’s contention that “the frequency 3 Spieles-Engemann et al., Stimulation of the Rat Subthalamic Nucleus is Neuroprotective Following Significant Nigral Dopamine Neuron Loss, National Institutes of Health, Neurobiol. Dis. 2010 July; 39(1):105–115 4 Bystritsky et al., A review of low-intensity focused ultrasound pulsation, Brain Stimulation (2011) 4, 125–36 Appeal 2020-003960 Application 14/627,843 6 and location to deliver ultrasound would have been sufficient to show possession of the claimed subject matter.” Appeal Br. 19. Spieles- Engemann discloses stimulation at a “frequency of 130 Hz, 60 μs pulse width, and an intensity of 30–50 μA” (Spieles-Engemann, 5) for a duration of 2 weeks (“it appears that 2 weeks of stimulation of the STN can halt the nigral THir neuron degeneration” (Spieles-Engemann, 9). Similarly, Bystritsky discloses various frequency ranges as well as the duration of the pulse and the pulse energy. For example, Bystritsky discloses “Frequency: 0.661 and 0.1986 MHz[.] Duration: continuous for 30 s, or pulsed at 1 ms or 10 ms at 10 or 20 Hz[.] Energy: 100–875 W/cm2;” and “Frequency: 0.48 MHz[.] Duration: 1 ms or 100–1600 Hz for 20 ms. Energy: 0.01-2.5 W/cm2.” Bystritsky, 130–132. Thus, both Spieles-Engemann and Bystritsky disclose more than frequency to achieve their results. Indeed, Bystritsky queries “what parameters (ie, intensity, frequency, and duration of US bursts and the length of interpulse interval) should be used for either stimulation or inhibition of neuronal tissue?” Bystritsky, 127. Moreover, Appellant’s Specification discloses that “[c]ontroller device 28 controls the transducers of array 23 to generate waveforms corresponding to a set of ultrasound parameters.” Spec. ¶ 24 (emphasis added). The Specification discloses that “ultrasound parameters may include, but are not limited to, identification of active ultrasound transducers, waveform shape, waveform amplitude, waveform frequency, duty cycle, the waveform phase, the number of waveforms within each burst of waveforms, and the frequency of bursts of waveforms.” Id. Neither the Specification nor the articles cited by Appellant provide support for Appeal 2020-003960 Application 14/627,843 7 Appellant’s assertion that controlling waveform frequency by itself is sufficient to provide written description support for the claimed invention. Our reviewing court states “it is ‘not a question of whether one skilled in the art might be able to construct the patentee’s device from the teachings of the disclosure . . . [r]ather, it is a question whether the application necessarily discloses that particular device.’” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (quoting Jepson v. Coleman, 314 F.2d 533, 536 (CCPA 1963)). See also Ariad Pharmaceuticals, 598 F.3d at 1352. (“[W]e have repeatedly stated that actual “possession’ or reduction to practice outside of the specification is not enough. Rather . . . it is the specification itself that must demonstrate possession.”). This reasoning is applicable here. Appellant’s contentions would substitute speculation by a skilled artisan regarding what treatment parameters from a “set of ultrasound parameter values” might be used with the disclosed frequency to prevent neural degeneration for the required disclosure in the Specification demonstrating possession of the claimed invention. Appellant’s contention that the claims are supported by the written description because the prior art provides a “foundation of information and the additional information provided by Appellant’s specification (e.g., example frequencies, target locations, and low energy ultrasound) . . . provide[s] sufficient detail showing that the inventors had possession of the claimed subject matter,” is not supported by evidence. Reply Br. 9–10. For example, Spieles-Engemann and Bystritsky are directed to work on small mammals (rats), and Bystritsky discloses that “it is still unclear that low- intensity US pulsations would be able to penetrate into deep areas of the Appeal 2020-003960 Application 14/627,843 8 brain and be precisely navigated through an intact human skull,” and that “a more systematic, and broader, evaluation is needed of the duration of optimal treatment in different neuronal circuits, and structures, as well as how many treatments are needed to modify the circuits for a prolonged period.” Bystritsky 133–134. We have considered all of Appellant’s arguments, the Specification in its entirety, and the evidence presented by Appellant concerning the purported knowledge possessed by one of ordinary skill in the art at the time of Appellant’s invention. For the foregoing reasons, we agree with the Examiner that the Specification does not provide written description support for the claimed invention in accordance with 35 U.S.C. § 112, first paragraph, because one of ordinary skill in the art would not reasonably understand that, at the time the application was filed, Appellant possessed the full scope of the invention recited in claim 1, i.e., a set of ultrasound parameter values that reduce or prevent neural degeneration. Therefore, we sustain the rejection of claim 1. Claims 2–25 fall with claim 1. Rejection 2; Enablement Based on an analysis of the Wands factors, the Examiner finds that the Specification does not enable one skilled in the art to make and/or use the claimed invention. Final Act. 3; In re Wands, 858 F.2d 731 (Fed. Cir. 1988). In particular, the Examiner determines that, “the ordinary person in the art would need [to perform an] undue amount of experimentation” to use the invention. Id. at 5. Appellant argues that the “[S]pecification provides example ultrasound parameter values and target locations of the brain that define Appeal 2020-003960 Application 14/627,843 9 delivery of the claimed ultrasound energy such that a skilled person would be able to make and use the subject matter of the claimed without undue experimentation.” Appeal Br. 8. In particular, Appellant asserts that each of the Wands factors support Appellant’s position that “one skilled in the art would have been able to make or use the claimed subject matter without undue experimentation.” Id. at 9–14. According to Appellant, the Examiner’s position that “one skilled in the art of ultrasound delivery for therapy would need undue experimentation to identify a few parameters such as duration or intensity of ultrasound delivery,” is not supported. Id. at 14–15. For the following reasons, we sustain the Examiner’s enablement rejection. We note that the Wands court elected to consider “all of the factors.” Wands, 858 F.2d at 740. However, it is not necessary to review all the Wands factors to find an enabling disclosure. Rather, the Wands factors “are illustrative, not mandatory” and what is relevant to an enablement determination depends upon the facts of the particular case. See Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991); see also Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999); Warner-Lambert Co. v. Teva Pharms. USA, Inc., 418 F.3d 1326, 1337 (Fed. Cir. 2005). Bearing this in mind, although the Examiner’s omission of the “level of one of ordinary skill” detracts from the Examiner’s Wands analysis, we do not agree with Appellant that it is fatal to the Examiner’s enablement analysis. See Appeal Br. 11. The enablement provision in the first paragraph of 35 U.S.C. § 112 requires that “there must be sufficient disclosure, either through illustrative examples or terminology, to teach Appeal 2020-003960 Application 14/627,843 10 those of ordinary skill [in the art] how to make and how to use the invention as broadly as it is claimed.” In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991). We agree with the Examiner that although the Specification discloses a frequency of the waveform (see Ans. 4), claim 1 recites a “set of ultrasound parameter values are selected to define ultrasound energy delivered via the one or more ultrasound transducers that reduces or prevents neural degeneration.” The Specification does not disclose what values of ultrasound parameters other than frequency are required. That is, whereas “[c]ontroller device 28 may control array 23” for neuroprotective waveform emissions, the Specification does not disclose which “different ultrasound parameter sets are used to define the neuroprotective waveforms.” Spec. ¶ 29. The Specification enumerates several ultrasound parameters (“The ultrasound parameters may include, but are not limited to, identification of active ultrasound transducers, waveform shape, waveform amplitude, waveform frequency, duty cycle, the waveform phase, the number of waveforms within each burst of waveforms, and the frequency of bursts of waveforms.”) (Spec. ¶ 24) that may be iteratively adjusted (Spec. ¶ 44). The Specification, however, provides no working examples of a particular combination of ultrasound parameters, or the requisite threshold values thereof, if any, that denote a reduction in or prevention of neural degeneration within a brain. Further, the Specification is silent as to how, if at all, the value of one ultrasound parameter might impact the significance of another ultrasound parameter in indicating whether there is a reduction in or prevention of neural degeneration. Appeal 2020-003960 Application 14/627,843 11 Additionally, the claims are broad in scope, in that they seek to cover any and all ultrasound parameters that will reduce or prevent neural degeneration without disclosing sufficient ultrasound parameter values to accomplish that function. Appellant’s assertion that “the art supplements and supports the specification’s teaching” is not persuasive. The Federal Circuit explains that: [Although] a specification need not disclose what is well known in the art . . ., that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. . . . [W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997). Indeed, Spieles-Engemann’s disclosure of a frequency of 130 Hz (see Spieles-Engemann 4–5) is outside Appellant’s disclosed range of 0.1 MHz to 20 MHz, and as noted above Spieles-Engemann also discloses duration, pulse width, and intensity for stimulation and, thus, neither supplements nor supports the specification’s teachings of which set of ultrasound parameter values will reduce or prevent neural degeneration. Similarly, Bystritsky’s disclosure of various frequencies, including some frequencies outside Appellant’s disclosed range, coupled with Bystritsky’s disclosure of duration and intensity and that adjusting these parameters affect bioelectric activity neither supplements nor supports the Specification’s teachings of which set of ultrasound parameter values will reduce or prevent neural degeneration. Appeal 2020-003960 Application 14/627,843 12 We have considered all of Appellant’s arguments, the Specification in its entirety, and the evidence presented by Appellant concerning the purported knowledge possessed by one of ordinary skill in the art at the time of Appellant’s invention. For the above reasons, the subject matter of claims 1–25 is not disclosed in the present application so as to enable one skilled in the art to make and/or use the claimed invention. Accordingly, claims 1–25 fail to satisfy the enablement requirement of 35 U.S.C. § 112(a). CONCLUSION The Examiner’s rejection is affirmed. More specifically, DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–25 112(a) Written Description 1–25 1–25 112(a) Enablement 1–25 Overall Outcome: 1–25 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