Ex Parte Underwood

Patent Trial and Appeal BoardMar 1, 2019

14431383 (P.T.A.B. Mar. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/431,383 03/26/2015 23598 7590 03/05/2019 BOYLE FREDRICKSON S.C. 840 North Plankinton A venue MILWAUKEE, WI 53203 FIRST NAMED INVENTOR Mark Y. Underwood 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. 3155.133 5252 EXAMINER ULM,JOHND ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 03/05/2019 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): docketing@boylefred.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARK Y. UNDERWOOD Appeal2018-001945 Application 14/431,383 1 Technology Center 1600 Before JEFFREY N. FRED MAN, ERICA A. FRANKLIN, and ELIZABETH A. LA VIER, Administrative Patent Judges. LA VIER, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), Appellant seeks review of the Examiner's rejection of claims 1-11, 15, and 16. We have jurisdiction under 35 U.S.C. Â§ 6(b). For the reasons set forth below, we AFFIRM. BACKGROUND The Specification relates to the use of apoaequorin-containing compositions to alleviate symptoms associated with multiple sclerosis (MS). Spec. ,r 1. Claim 1 is illustrative: 1 Appellant identifies the real party in interest as Quincy Bioscience, LLC. Br. 3. Appeal2018-001945 Application 14/431,3 83 1. A method for alleviating a symptom associated with Multiple Sclerosis, comprising administering to a subject in need of such treatment an effective amount of apoaequorin. Br. 20 (Claims Appendix). REJECTION MAINTAINED ON APPEAL Claims 1-11, 15, and 16 stand rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Underwood '562 2 and Stauderman. 3 Ans. 2; Final Action 2. DISCUSSION The Examiner relies on Underwood '562 as "expressly t[eaching] the administration of apoaequorin-containing compositions to individuals for the purpose of treating symptoms or disorders associated with calcium imbalance ... including but not limited to sleep quality, energy quality, mood quality, pain and memory quality." Non-Final Action 54 (citing Underwood '562 ,r,r 3, 10, 11). As the Examiner points out, Underwood '562 does not expressly identify MS as a disease with symptoms associated with calcium imbalance. See id. As such, the Examiner turns to Stauderman, which discloses MS as a disease treatable by the administration of compounds that can modulate intracellular calcium levels. See id. at 5---6 (citing Stauderman ,r,r 134, 137). The Examiner finds it would have been obvious to administer an apoaequorin-containing composition of Underwood '562 to an individual afflicted with MS as described in Stauderman, "with at 2 Underwood, US 2011/0124562 Al, published May 26, 2011. 3 Stauderman et al., US 2008/0293092 Al, published Nov. 27, 2008. 4 Non-Final Action dated Oct. 21, 2015. 2 Appeal2018-001945 Application 14/431,3 83 least the expectation that such administration would result in an improvement in the sleep quality, energy quality, mood quality, pain and memory quality of that individual, and a 'general improvement of a subject's mental and physical health' relative to an untreated individual." Id. at 6 (quoting Underwood '562 ,r 14). Before addressing Appellant's specific arguments, we first consider Appellant's reliance on the Underwood Declaration. 5 We accord the statements therein no persuasive weight in our analysis, for two reasons. First, as the Examiner points out, the Underwood Declaration "contains no evidence that declarant is an expert in the art of neurobiology or in the treatment of neurodegenerative disease and, in particular, MS." Ans. 3. Second, the Underwood Declaration cites no extrinsic support for the assertions and conclusions posited by the declarant. Accordingly, it is argumentative, not evidentiary. See In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) ("[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroborations warrants discounting the opinions expressed in the declarations."). Appellant presents three interrelated arguments in support of claim 1 : treating MS is highly unpredictable; Stauderman is speculative and not specific to MS; and there would have been no reasonable expectation of success. See generally Br. 13-18. These arguments do not persuade us of any reversible error by the Examiner. Obviousness does not require absolute 5 Declaration under Rule 1.132 of Mark Y. Underwood, dated Nov. 16, 2016. 3 Appeal2018-001945 Application 14/431,3 83 predictability, only a reasonable expectation that the beneficial result will be achieved. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). As discussed above, Underwood '562 already teaches the administration of apoaequorin-containing compositions for the treatment of symptoms related to sleep quality, energy quality, mood quality, pain and memory quality. These are precisely the goals recited in some of the present dependent claims. See Br. 20 (Claims Appendix), claims 2 (sleep quality), 3 ( energy quality), 4 (mood quality), 5 (pain), 6 (memory quality). And as the Examiner points out, Appellant "has provided absolutely no evidence to support a position that one skilled in this art would expect a subject afflicted with MS to respond to general therapeutics .... in a manner that is distinct from responses observed in the general population. Ans. 2. Thus we agree with the Examiner that, from Underwood '562 alone, "one had more than a reasonable expectation that a subject afflicted with MS would enjoy the same or similar benefits from apoaequorin treatment as those subjects employed in Examples 1 to 3 of [Underwood '562]." Id. at 2-3. Stauderman "merely provides additional motivation to specifically apply the method described in [Underwood '562] to individuals afflicted with MS in particular." Id. Put differently, the gap between Underwood '562 and claim 1 is small, and filling it (as motivated by Stauderman) would have only required the ordinary artisan to treat MS patients experiencing the recited symptoms with the same compound used to treat patients with calcium imbalance generally. Cf KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."). 4 Appeal2018-001945 Application 14/431,3 83 Appellant points out that MS is one among many conditions listed in Stauderman, and that Stauderman's examples do not involve animal models of MS. See Br. 14--16. But the prior art must be considered for all of its teachings, including non-preferred embodiments. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (citation omitted). As discussed above, the Examiner relies on Stauderman for a very limited purpose: the motivation to treat calcium imbalance-related disorders already comes from Underwood '562, and Stauderman simply provides a set of calcium imbalance-related disorders (including MS). The Examiner is not relying on Stauderman for the mechanism 6 or course of treatment. Hence Appellant's attempt to distinguish Stauderman from Underwood '562 (or the present application) based on the alleged mechanism of action (see Br. 17- 18) is not persuasive. See In re Keller, 642 F.2d 413,426 (CCPA 1981) ("But one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references."). Furthermore, although Appellant cites to paragraph 36 of the Specification for the proposition that "apoaequorin appears to modulate calcium levels by binding to calcium ions already present in the surrounding solution" (id. at 6 Hence Appellant's attempt to distinguish Stauderman from Underwood '562 (or the present application) based on the alleged mechanism of action (see Br. 17-18) is not persuasive. Furthermore, although Appellant cites to paragraph 3 6 of the Specification for the proposition that "apoaequorin appears to modulate calcium levels by binding to calcium ions already present in the surrounding solution" (id. at 17 (citing Spec. ,r 36)) in an attempt to draw a contrast with Stauderman's inhibition of calcium channel activity, this paragraph of the Specification is not so specific. The Underwood Declaration makes the same claim, but cites no evidence apart from paragraph 3 6 of the Specification. 5 Appeal2018-001945 Application 14/431,3 83 17 (citing Spec. ,r 36)) in an attempt to draw a contrast with Stauderman's inhibition of calcium channel activity, this paragraph of the Specification is not so specific. Paragraph 36 of the Specification provides in full: Apoaequorin is classified as a "calcium-binding protein" which is necessary for the process of calcium regulation in nerve cells. Apoaequorin has proven neuroprotective capabilities, protecting cells from the damage of calcium overload. Calcium is a critical part of cell communication. Without calcium providing the "electricity" to the cell, we wouldn't be able to think, move, or experience emotion. Excess calcium can cause overstimulation of the cell and trigger other mechanisms, which lead to a break down in cell function. Research on the effects of apoaequorin on the brain and body have shown promise for enhancing and improving memory, improving sleep quality, increasing brain cell survival and improving cognitive function. Spec. ,r 36. The Underwood Declaration makes the same claim (see Underwood Deel. ,r 17), but cites no evidence apart from paragraph 36 of the Specification. Having considered Appellant's arguments in favor of the patentability of claim 1, we are not persuaded of any reversible error by the Examiner in rejecting claim 1. Accordingly, for the reasons described herein and those already of record, we sustain the Examiner's rejection of claim 1. Claims 2- 8, 11, 15, and 16 are not argued separately, and fall with claim 1. See 37 C.F .R. Â§ 41.3 7 ( c )(1 )(iv). In regard to claims 9 and 10, which require a subject diagnosed with a particular form (and, as to claim 10, a relapsed state) of MS (see Br. 21 (Claims Appendix)), Appellant argues: Underwood and Stauderman do not recognize the improved effect of apoaequorin in individuals who had been diagnosed with either Relapsing Remitting Multiple Sclerosis or Secondary Progressive Multiple Sclerosis or were in a relapse 6 Appeal2018-001945 Application 14/431,3 83 status prior to beginning apoaequorin. Mere speculation that apoaequorin could be used to treat multiple sclerosis would not make predictable the greater success in the specific populations recited in the claims. Br. 18-19. This argument is not persuasive. For the reasons discussed above with respect to claim 1, the Examiner's rejection is not speculative; this applies equally to MS-related symptoms generally and to the specific conditions of claims 9 and 10. Appellant points to paragraph 51 of the Specification as evidence of the "greatest overall effect" seen in relapsed patients (Br. 18 ( citing Spec. ,r 51) ), but fails to establish that this effect is unexpected or otherwise not obvious in view of the prior art. Accordingly, we discern no reversible error in the Examiner's rejection of claims 9 and 10, and we sustain the rejection of these claims. CONCLUSION The rejection of claims 1-11, 15, and 16 underÂ§ 103(a) is sustained. No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. Â§ 1.13 6( a)( 1 )(iv). AFFIRMED 7