Ex Parte Harris et al

Patent Trial and Appeal BoardDec 12, 2018

13977536 (P.T.A.B. Dec. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/977,536 123907 7590 Mintz Levin/EES One Financial Center Boston, MA 02111 12/11/2013 12/14/2018 FIRST NAMED INVENTOR Jason L. Harris 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. END69l5USPCT/095N01US 9118 EXAMINER NGANGA, BONIFACE N ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 12/14/2018 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): ipdocketingbos@mintz.com ipfileroombos@mintz.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JASON L. HARRIS, LEE M. KAPLAN, DAVIDN. PLESCIA, TAYLOR W. ARONHALT, JAMES W. VOEGELE, and NICHOLAS STYLOPOULOS Appeal2017-010569 1 Application 13/977,536 Technology Center 3700 Before RICHARD M. LEBOVITZ, JOHN E. SCHNEIDER, and RACHEL H. TOWNSEND, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to methods of delivering light energy to brown adipose tissue to increase its energy expenditure. The Examiner rejected the claims under 35 U.S.C. Â§ 103 as obvious and under 35 U.S.C. Â§ 112 as indefinite. Appellants appeal the Examiner's determination that the claims are unpatentable. We have jurisdiction under 35 U.S.C. Â§ 6(b). The Examiner's decision is AFFIRMED. 1 The Appeal Brief ("Appeal Br.") identifies Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio, a Johnson & Johnson company, and The General Hospital Corporation d/b/a Massachusetts General Hospital of Boston, Massachusetts, as the real-parties-in-interest. Appeal2017-010569 Application 13/977,536 STATEMENT OF THE CASE Claims 1-3, 6-9, and 11-21 stand rejected by the Examiner under pre-AIA 35 U.S.C. Â§ I03(a) as obvious in view of Vase et al. (US 2010/0312295 Al; pub. Dec. 9, 2010, "Vase"), Webb et al. (US 2007/0060984 Al; pub. Mar. 15, 2007, "Webb '984"), and Webb (An Infrared laser-based nerve stimulation system eliminates electrical stimulation artifacts, and Improves nerve target specificity, Optical Systems Improve Nerve Stimulation, Aculight Corporation (May 1, 2006), http://www. techbriefs. com/ component/ content/ article/ntb/tech- briefs/photonics/12077, last visited Nov. 25, 2018 ("Webb article"). Ans. 3- 4. Claims 11, 12, 15 and 16 under 35 U.S.C. Â§ 112(b) or pre-AIA 35 U.S.C. Â§ 112, second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Ans. 2-3. There are two independent claims on appeal, claims 1 and 18. Claim 1, which is illustrative of the claimed subjected matter, is reproduced below: 1. A medical method, comprising: positioning a device in contact with tissue of a patient proximate to a depot of brown adipose tissue; and activating the device to deliver light energy to the patient to activate the brown adipose tissue and increase energy expenditure of the brown adipose tissue, wherein the light energy is continuously delivered to the patient for a predetermined amount of time in a range of one day to four weeks. 2 Appeal2017-010569 Application 13/977,536 OBVIOUSNESS REJECTION The Examiner found that Vase describes a method of positioning a stimulation electrode in contact with brown adipose tissue ("BAT") and administering electrical stimulation to the BAT, or nerves innervating BAT, to increase energy expenditure as recited in claim 1 ("to activate the brown adipose tissue and increase energy expenditure of the brown adipose tissue"). Final Act. 5. The Examiner found that Vase differs from claim 1 "in that electrical energy rather than light energy [as claimed] is delivered for neuromodulation by stimulating nerves associated with BAT." Id. at 11. To meet this deficiency, the Examiner cited Webb '984 which teaches that a nerve may be stimulated in a number of different ways, including by electrical and optical stimulation, and describes advantages of using optical energy ("light energy" as recited in claim 1) to stimulate a nerve instead of electrical energy. Id. The Examiner found it would have been obvious to have used optical light energy to stimulate BAT in Vase's method for the advantages described by Webb '984. Id. Claim 1 also requires that "the light energy is continuously delivered to the patient for a predetermined amount of time in a range of one day to four weeks." The Examiner concludes this limitation would have been obvious based on Vase's teachings. Final Act. 5-6. Continuous delivery of light energy Appellants contend that Vase does not disclose electrical energy that is "continuously delivered to the patient for a predetermined amount of time in a range of one day to four weeks." Appeal Br. 7. 3 Appeal2017-010569 Application 13/977,536 The following disclosures from Vase were relied upon by the Examiner in finding that the claim limitation is met by Vase: Various stimulation patterns, ranging from continuous to intermittent, can be utilized. With intermittent stimulation, energy is delivered for a period of time at a certain frequency during the signal-on time as shown in FIG. 4. The signal-on time is followed by a period of time with no energy delivery, referred to as signal-off time. Superimposed on the stimulation pattern are the parameters of pulse frequency and pulse duration. The treatment frequency may be continuous or delivered at various time periods within a day or week. The treatment duration may last for as little as a few minutes to as long as several hours. Vase ,r 69. As explained in paragraph 68 of Vase, the stimulation pattern may be "continuous" or "intermittent." Figure 4 of Vase shows an intermittent stimulation pattern in which a series of electrical pulses having a current amplitude and a pulse width are delivered for a period of time ("signal on time") at a pulse frequency, are turned off for a period of time ("signal off time"), and then back on, and so on, repeating the pattern of signal on and signal off. A continuous stimulation pattern would be understand to constitute the delivery of pulses continuously with no signal off time. Paragraph 68 does not limit the duration during which the continuous stimulation pattern is delivered. In paragraph 69, Vase refers to a "treatment frequency" and "treatment duration." We understand treatment frequency to mean how often the electrical stimulation treatment is administered. We further 4 Appeal2017-010569 Application 13/977,536 understand the treatment duration to be the duration or time period over which the stimulation treatment is administered. The treatment as explained in paragraph 68 can be an intermittent or continuous series of pulses. The Examiner relied upon the teaching in Vase in paragraph 69 that "treatment frequency may be continuous or delivered at various time periods within a day or week" to establish that the recited continuous delivery of energy to BAT "in a range of one day to four weeks" is met by Vase. Ans. 4. Appellants contend that the Examiner misinterpreted Vase. Appeal Br. 8. Appellants argue that Vase teaches that the continuous treatment "may last for as little as a few minutes to as long as several hours" (Vase ,r 69), which Appellants state is much less than the claimed delivery of light energy which is "continuously delivered to the patient for a predetermined amount of time in a range of one day to four weeks." Appeal Br. 8. Vase states that the duration "may last" for "as little as a few minutes to as long as several hours." Vase ,r 69. Because Vase utilizes the term "may," which indicates a permissibility or possibility, 2 we do not understand this disclosure to necessarily limit the time to "several hours" over which continuous stimulation is administered. Consistently, paragraph 68, when disclosing the continuous stimulation mode, does not impose a limit on its duration. Nonetheless, Appellants are correct that the examples in Vase utilize pulse stimulation patterns in which a continuous series of electrical pulses ( a 2 See www.merriam-webster.com/dictionary/may (last accessed November 25, 2018). 5 Appeal2017-010569 Application 13/977,536 "dose") is administered in "doses" for shorter time periods, such as "about a half hour long" (Vase ,r 92), "15 minutes and less than about 60 minutes" (id. ,r 96), "5-7 minutes" (id. ,r 97), "30 min dose" (id. ,r 98), and 10, 30, and 80 minutes (id. ,r,r 101, 103). Paragraph 69 also discloses that the "treatment frequency may be continuous or delivered at various time periods within a day or week." The Examiner interpreted this paragraph as teaching that stimulation "is continuously delivered to the patient for a range of one day to four weeks." Ans. 4. However, this statement in paragraph 69 describes delivery "at various time periods within a day or week" which appears to mean "intermittent" treatments when the signal goes on and then off within a day or week, and as an alternative to "continuous" delivery. Namely, delivery of the pulses occurs at various time intervals in a single day or in a week in contrast to continuous delivery. At most, we do not find this paragraph, alone, to establish continuous delivery over the claimed range of "in a range of one day to four weeks." The Examiner also referred to Figure DDS of Vase as supporting a continuous delivery within the scope of the claim. For clarity, we reproduce Figs. DD4 and DDS below because these figures are related to each other. 6 Appeal2017-010569 Application 13/977,536 FIG DD4 {~ l 0' ( ., 1:j - l~" V' ,c~ ,Â·Â·1 l\/1 q ,,Â· l J 11 "'".YtÂ· i â€¢") Yt ,C\. b ~ l:.. l l "-Â· tl J. ... \... t \.. . i:.:-1. "l \, ! 1 CU:1:--~Jc..,~I A~gc,t'll'h11:\ B (