Ex Parte Kasubick et alDownload PDFPatent Trial and Appeal BoardJul 29, 201612466893 (P.T.A.B. Jul. 29, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/466,893 05/15/2009 26813 7590 07/29/2016 MUETING, RAASCH & GEBHARDT, P.A. P.O. BOX 581336 MINNEAPOLIS, MN 55458-1336 FIRST NAMED INVENTOR Robert V. Kasubick 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. 365.00070101 6824 EXAMINER BERRY,LAYLAD ART UNIT PAPER NUMBER 1673 MAILDATE DELIVERY MODE 07/29/2016 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 Exparte ROBERT V. KASUBICK and JOHN A. ST. CYR Appeal2014-000423 Application 12/466,893 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method for treating restless legs syndrome. The Examiner rejected the claims as obvious and on the grounds of obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify the Real Party in Interest as Bioenergy, Inc., also known as RiboCor, Inc. (see Br. 1 ). Appeal2014-000423 Application 12/466,893 Statement of the Case Background Appellants' invention relates to "a method for treating a human patient having restless legs syndrome" which "includes administering to the patient in need thereof a therapeutically effective amount of a composition including D-ribose" (Spec. i-f 5). The Claims Claims 1-11 are on appeal. Independent claim 1 is representative and reads as follows: 1. A method for treating a human patient having restless legs syndrome, the method comprising administering to the patient in need thereof a therapeutically effective amount of a composition comprising D-ribose. The Issues A. The Examiner rejected claims 1-11under35 U.S.C. § 103(a) as obvious over Butler '2452 and Yunus3 (Ans. 3--4). B. The Examiner rejected claims 1-11 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-5 of Butler '3704 or claims 1-5 of Butler '7625 and Yunus (Ans. 5- 6). 2 Butler et al., US 2004/0162245 Al, published Aug. 19, 2004 3 Yunus et al., Restless legs syndrome and leg cramps infibromyalgia syndrome: a controlled study, 312 BMJ 1339 (1996). 4 Butler et al., US 6,703,370 Bl, issued Mar. 9, 2004. 5 Butler et al., US 7,094,762 B2, issued Aug. 22, 2006. 2 Appeal2014-000423 Application 12/466,893 A. 35 U.S.C. § 103(a) over Butler '245 and Yunus The Examiner finds that Butler '245 teaches "the use of ribose to treat fibromyalgia [see abstract]" and Yunus teaches "an association between fibromyalgia, restless legs syndrome" (Ans. 4). The Examiner concludes that "[i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to administer ribose to patients suffering from restless legs syndrome" because "Yunus teaches that fibromyalgia, restless legs syndrome, and leg cramps often occur together" (id.). The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that Butler '245 and Yunus render the claims prima facie obvious? Findings of Fact 1. Butler '245 teaches that "patients may experience a disturbed sleep cycle, tension headaches, irritable bowel syndrome, premenstrual tension syndrome, cold intolerance, deconditioning, reduced exercise tolerance and restless leg syndrome" (Butler '245 i-f 4; see also Ans. 4). 2. Butler '245 teaches that "ribose also alleviates symptoms of pain and fatigue as well as painful irritable bowel syndrome in fibromyalgia patients" (Butler '245 i-f 1 O; see also Ans. 4). 3. Butler '245 teaches that The amount necessary to alleviate symptoms of fibromyalgia can be between 2 and 50 grams per day depending on severity of the condition and the individual response to ribose ingestion. The preferred dose is around 20 grams per day taken in 10 gram doses twice a day or 5 gram doses 4 times per day. (Butler '245 i-f 12; see also Ans. 4.) 3 Appeal2014-000423 Application 12/466,893 4. Yunus teaches Our study shows an association between fibromyalgia syndrome and restless legs syndrome as well as leg cramps and confirms a previously reported association between rheumatoid arthritis and restless legs.[] . . . It has been suggested that restless legs syndrome and periodic limb movement disorder, along with other dysfunctional syndromes such as irritable bowel syndrome, form a spectrum with overlapping features and a common biophysiological mechanism of neuroendocrine abnormality.[] ... In conclusion, restless legs syndrome and leg cramps are significantly more prevalent in patients with fibromyalgia syndrome and those with rheumatoid arthritis than in normal controls. An awareness of this association will help doctors manage the distressing leg symptoms among patients with fibromyalgia. (Yunus 1339, second col.; see also Ans. 4.) Principles of Law "[T]he [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'! v. Teleflex Inc., 550 U.S. 398, 418 (2007). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." Id. at 416. "If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability." Id. at 417. Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3-6; FF 1--4) and agree that the 4 Appeal2014-000423 Application 12/466,893 claims are obvious over Butler '245 and Yunus. We address Appellants' arguments below. Appellants contend that Butler et al. '245 "relates to methods and compositions for the treatment of fibromyalgia" (paragraph [0007] of Butler '245). Notably, Butler et al. '245 state that "it is not known whether the pain and fatigue in fibromyalgia are due to neuronal, endocrine, physiological, or genetic factors" (paragraph [0009] of Butler '245).[] Thus, the present application indicates that the biophysiological mechanism that causes fibromyalgia is not known. (Br. 3.) We do not find this argument persuasive. Appellants' contention fails to account for Yunus' contributions to the combination of Butler '245 and Yunus. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). See also In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) ("Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references .... [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole."). The ordinary artisan, informed by Yunus and Butler that restless leg syndrome is associated with fibromyalgia, and prevalent in fibromyalgia patients (FF 1, 4) would have predictably administered known fibromyalgia treatments to these patients including the ribose treatment of Butler and done so with a reasonable expectation of success (FF 2-3). Appellants contend that "Yunus et al. clearly state that there is an association between fibromyalgia syndrome and restless legs syndrome, and that the basis of this association is not clear" (Br. 4). 5 Appeal2014-000423 Application 12/466,893 We are not persuaded. We agree with the Examiner that Yunus is very clear on the point that there is an association, which can be seen from the paragraph reproduced at the top of page 4 of Appellant's arguments. Yunus also teaches that an awareness of the association will help doctors manage the distressing leg symptoms among patients with fibromyalgia (last paragraph of Yunus). (Ans. 6-7; FF 4 ("Our study shows an association between fibromyalgia syndrome and restless legs syndrome" and "An awareness of this association will help doctors manage the distressing leg symptoms among patients with fibromyalgia").) Appellants argue that "Appellants' Representatives could find no teaching or suggestion in Yunus et al. thatfibromyalgia and restless legs syndrome have a common biophysiological mechanism" and that "because the biophysiological mechanism that causes fibromyalgia is not known, as discussed herein above, it would not be possible to provide documentary evidence that fibromyalgia and restless legs syndrome are caused by a common biophysiological mechanism" (Br. 4 ). We are not persuaded. As the Examiner explains, Yunus states (in the paragraph reproduced on page 4 of Appellant's arguments) that restless legs syndrome and periodic limb movement disorder, and other syndromes such as irritable bowel syndrome form a spectrum with overlapping features and a common biophysiological mechanism of neuroendocrine abnormality. Yunus refers to a spectrum of disorders, in the context of an article which is directed to restless legs syndrome and cramps in fibromyalgia syndrome. The skilled artisan would read Yunus' s teachings in the context of the article, and reasonably infer from Yunus that fibromyalgia syndrome is within the spectrum of disorders taught by Yunus. 6 Appeal2014-000423 Application 12/466,893 (Ans. 7; FF 4 ("It has been suggested that restless legs syndrome and periodic limb movement disorder, along with other dysfunctional syndromes such as irritable bowel syndrome, form a spectrum with overlapping features and a common biophysiological mechanism of neuroendocrine abnormality")). The Examiner further explains that Butler teaches that one agent - ribose - is used to treat fibromyalgia and its associated pain, fatigue, and irritable bowel syndrome. Butler also recognizes that fibromyalgia patients may experience restless legs syndrome. The spectrum of disorders recognized by Yunus has significant overlap with the spectrum of disorders recognized by Butler to be treatable using ribose. In addition, even if the skilled artisan were to completely disregard Yunus's teaching that there is an association between fibromyalgia syndrome and restless legs syndrome, Yunus does explicitly state that restless legs syndrome and IBS have a common biophysiological mechanism of neuroendocrine abnormality, and Butler teaches that ribose treats IBS. (Ans. 7; FF 2 ("ribose also alleviates symptoms of pain and fatigue as well as painful irritable bowel syndrome in fibromyalgia patients"), FF 1 ("patients may experience a disturbed sleep cycle, tension headaches, irritable bowel syndrome, premenstrual tension syndrome, cold intolerance, deconditioning, reduced exercise tolerance and restless leg syndrome")). Moreover, even if some unpredictability remained because the exact biophysiological mechanism underlying the association was unknown, that would not mean the claims are nonobvious. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) ("[O]bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art ... , the expectation of success need only be reasonable, not absolute.") 7 Appeal2014-000423 Application 12/466,893 Accordingly, we agree with the Examiner that "Yunus teaches a population of patients having both restless legs syndrome and fibromyalgia. The skilled artisan would administer ribose to these patients having restless legs syndrome and fibromyalgia in order to treat the fibromyalgia" (Ans. 7- 8). See KSR, 550 U.S. at 417, 418. B. Obviousness-type double patenting over claims 1-5 of Butler '370 or claims 1-5 of Butler '7626 and Yunus Claim 1 of Butler '3 7 0 recites " [a] method to alleviate the symptoms of fibromyalgia syndrome comprising administering an effective amount of ribose to a patient suffering from fibromyalgia syndrome" (Butler '370, Claim 1; see also Ans. 6). Claim 1 of Butler '762 recites "[a] composition for alleviation of the symptoms of fibromyalgia syndrome comprising crystalline ribose and malic acid" (Butler '7 62, Claim 1; see also Ans. 6). Appellants contend that "Appellants respectfully traverse this rejection for at least the reasons discussed herein above" (Br. 5). Therefore, we affirm the obviousness-type double patenting rejection for the reasons discussed above. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Butler '245 and Yunus. Claims 2-11 fall with claim 1. 6 Appellants indicate that "absent the claims, Butler et al. '370, Butler et al. '762, and Butler et al. '245 all have the same disclosure" (Br. 5). 8 Appeal2014-000423 Application 12/466,893 We atlirm the rejection of claim 1 under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-5 of Butler '370 or claims 1-5 of Butler '762 and Yunus. Claims 2-11 fall with claim 1. 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 9 Copy with citationCopy as parenthetical citation