Ex Parte Kawakami et alDownload PDFPatent Trial and Appeal BoardJan 9, 201813236034 (P.T.A.B. Jan. 9, 2018) 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. 13/236,034 09/19/2011 Hiroshi KAWAKAMI P40738 4855 7055 7590 01/11/2018 GREENBLUM & BERNSTEIN, P.L.C. 1950 ROLAND CLARKE PLACE RESTON, VA 20191 EXAMINER MACAULEY, SHERIDAN R ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 01/11/2018 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): gbpatent@gbpatent.com greenblum.bernsteinplc@gmail.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HIROSHI KAWAKAMI, SATOSHI HIGURASHI, and HIROAKI MATSUYAMA Appeal 2017-002301 Application 13/236,0341 Technology Center 1653 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims 1 and 3—8 (App. Br. 3).2 Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the real party in interest as “MEGMILK SNOW BRAND Co., Ltd.” (App. Br. 3.) 2 Pending claims 10, 12, 13, and 16—21 stand withdrawn from consideration (App. Br. 3). Appeal 2017-002301 Application 13/236,034 STATEMENT OF THE CASE Appellants’ disclosure “relates to a blood-adiponectin-concentration increase accelerator and/or decrease inhibitor containing a culture and/or cells itself of lactic acid bacteria of the genus lactobacillus (lactobacilli (particularly Lactobacillus gasseri. . .) as an active ingredient,” wherein a “decrease in blood-adiponectin-concentration is considered to cause metabolic syndrome that may result in cardiovascular disease (e.g., [] insulin resistance . . .)” (Spec. 1). Claim 1 is representative and reproduced below: 1. A method for increasing blood-adiponectin-concentration or preventing a decline in blood-adiponectin-concentration in a subject, comprising: administering a composition comprising Lactobacillus gasseri to a subject in need of increasing blood-adiponectin- concentration or preventing a decline in blood-adiponectin- concentration having a condition selected from the group consisting of insulin resistance, abnormal glucose metabolism, and hypertension due to visceral fat accumulation; wherein the composition comprises Lactobacillus gasseri in an amount effective to (1) result in an increase in blood- adiponectin-concentration in the subject or (2) prevent a decline in blood-adiponectin-concentration in the subject. (App. Br. 17.) The claims stand rejected as follows: Claims 1 and 3—8 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Tanaka3 and Park.4 3 Tanaka Hiroshi et al., JP 2003-252772, published Sept. 10, 2003 (PTO 14- 0757 translation relied upon). For clarity, we adopt Examiner and Appellants’ nomenclature of referring to this reference as “Tanaka.” 4 Park et al., US 2002/0037577 Al, published Mar. 28, 2002. 2 Appeal 2017-002301 Application 13/236,034 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Tanaka discloses an “agent for prevention, improvement and treatment of an age-related metabolic disorder, characterized by containing [, inter alia,] a . . . bacterium belonging to the species Lactobacillus gasseri. . . that has colonization ability in the human intestinal tract” (Tanaka p. 2; see id. at | 5 (Lactobacillus gasseri has the ability to colonize the “human intestinal tract”); id. at 17; Ans. 4—5). FF 2. Tanaka discloses that “[ejxamples of diseases which are considered to be caused by a metabolism disorder that is caused [by] age include hyperlipemia, which is caused by obesity” (Tanaka 13; see id. at p. 2 (characterizing an age-related metabolic disorder as “a lipid metabolism disorder”); Ans. 5—6). FF 3. Examiner finds that Tanaka fails to disclose the administration of a composition, within the scope of Tanaka, to an individual that “has or is at risk of having a metabolic syndrome characterized by insulin resistance” (Ans. 5). FF 4. Park relates to microorganisms for the treatment or the prevention of obesity or diabetes mellitus, which reduce the amount of monosaccharide or disaccharide which may be absorbed into human body by converting monosaccharides such as glucose, fructose, galactose et al. and disaccharides into polymeric materials which cannot be absorbed by the intestine, and relates 3 Appeal 2017-002301 Application 13/236,034 to a pharmaceutical composition containing the [] microorganisms. (Park, Abstract; see id. at || 1, 34; id. at |249 (Park discloses that microorganisms within the scope of Park’s disclosure are “capable of controlling the occurrence of diabetes mellitus, obesity and circulatory diseases”); Ans. 5—6.) FF 5. Park discloses: There are several types of diabetes mellitus that are caused by various etiological factors and whose pathogenesis is different from each other. For example, genuine diabetes mellitus is characterized by high level of blood glucose and glycosuria, and is a chronic disorder of carbohydrate metabolism due to a disturbance of the normal insulin mechanisms. Non-Insulin-Dependent Genuine Diabetes Mellitus (NIDDM), or the type II diabetes mellitus is found in adults who have insulin-resistance in a peripheral target tissue, despite of normal generation and function of insulin. Non-Insulin- Dependent Genuine Diabetes Mellitus[](NIDDM) can be caused by three important metabolic disorders, i.e., insulin- resistance, functional disorder of insulin secretion stimulated by nutrients, and overproduction of glucose in liver. (Park || 5—6; id. 12 (“[i]t is understood that obesity induces . . . diabetes mellitus”); see Ans. 5.) FF 6. Park discloses that microorganisms that can be used [in Park’s] . . . pharmaceutical composition . . . [include those in the] Lactobacillus genus . . ., which are capable of living in the intestine and not harmful to human body, and are capable of converting oligosaccharides into polysaccharides that cannot be absorbed into human body. (Park 135; see Ans. 5.) FF 7. Park discloses that the term “composition,” as used in Park’s disclosure, “means not only [] medicinal products but also . . . functional 4 Appeal 2017-002301 Application 13/236,034 foods and health complementary foods” (Park | 54; see also Tanaka 1 5 (Tanaka discloses “a food or drink product having an effect on preventing, improving and treating an age-related metabolic disorder,” wherein the food or drink product comprises a “bacterium belonging to the species Lactobacillus gasseri”); see Ans. 4—5). FF 8. Appellants discloses that an “amount effective” of L. gasseri to “(1) result in an increase in blood-adiponectin-concentration in [a] subject or (2) prevent a decline in blood-adiponectin-concentration in [a] subject is 10 to 200 grams per day,” “0.1 to 5000 miligrams per day,” “a single daily liquid dose of 1 x 105 cells per milliliter to 1 x 1010 cells per milliliter,” “a single daily solid dose of 1 x 105 cells per gram to 1 x 1010 cells per gram,” or “108 colony forming units to 1012 colony forming units per day” (see App. Br. 17—18 (claims 4—8)). FF 9. Tanaka discloses the administration of a bacterial strain, within the scope of Tanaka’s disclosure, wherein the daily dose per adult is in a range of from 0.5 g to 10 g in terms of a dried form and is preferably divided so as to be administered several times a day. In particular, by administering each of the bacterial strains as live bacteria in a dose of from 108 [colony forming units (cfu)/day] to 1012 cfu/day per adult, in the intended effect of the present invention can be developed. (Tanaka 12; see Ans. 4—5.) FF 10. Examiner finds that Tanaka fails to disclose an “effective amount [that] is a single daily liquid dose of 1 x 105 to 1 x 1010 cells per ml of the bacteria or a single daily solid dose of 1 x 105 to 1 x 1010 cells per [gram] of the bacteria” (Ans. 5). 5 Appeal 2017-002301 Application 13/236,034 FF 11. Park discloses that the term “effective amount”: [M]eans the minimum amount of the microorganisms of the present invention, which can reduce the amount of oligosaccharide absorbed into the body through the intestines of mammalian animals. The amount of microorganisms administered into a body with the pharmaceutical composition of the present invention may be adjusted depending on the administration method and the administration subject. An oral administration unit of an adult patient contains microorganisms[, within the scope of Park’s disclosure,] ... in an amount, desirably, 0.1 g or more, and the composition . . . contains 0.1 to 10 g per one time administration, desirably 0.5 to 5 g. The effective amount of microorganisms ... is 0.1 g per 1 day. (Park 11 50, 52.) FF 12. Park discloses: the administration amount can vary depending on the weight and the severity of obesity of the patient, supplemental active ingredients included and microorganisms used therein. In addition, it is possible to divide up the daily administration amount and to administer continuously, if needed. Therefore, range of the administration amount does not limit the scope of the present invention in any way. (Park 153.) ANALYSIS Park discloses the administration of a microorganism in the Lactobacillus genus to an individual for the treatment of, inter alia, type II diabetes mellitus, which is found in adults who have insulin resistance, which is known to be induced by obesity (FF 4—6). Tanaka discloses the administration of L. gasseri to individuals for the treatment of age-related 6 Appeal 2017-002301 Application 13/236,034 metabolic disorder metabolic disorders, including hyperlipemia, which is caused by obesity (FF 1—2). The combination of Tanaka and Park suggests the administration of a microorganism within the Lactobacillus genus, specifically L. gasseri, as a component of a food or drink product (FF 7; see also Ans. 7—8). In addition, Park discloses the oral administration of microorganisms, within the Lactobacillus genus, to individuals, in an amount of 0.1 g or more,” wherein compositions contain “0.1 to 10 g per one time administration” (FF 11). Similarly, Tanaka discloses the administration of L. gasseri to individuals in a “daily dose per adult [] in a range of from 0.5 g to 10 g in terms of a dried form” (FF 9; see also id. (Tanaka discloses the administration of “live bacteria in a dose of from 108 [cfu/day] to 1012 cfii/day per adult”)). Thus, the effective amounts of Lactobacillus, specifically L. gasseri, disclosed by each of Tanaka and Park would have “(1) resulted] in an increase in blood-adiponectin-concentration in [a] subject or (2) prevented] a decline in blood-adiponectin-concentration in [a] subject (see FF 8). See In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997) (Overlapping ranges support a prima facie case of obviousness); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004) (“[Wjhere there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness”). Therefore, we find no error in Examiner’s conclusion that, based on the combination of Tanaka and Park, it would have been prima facie obvious, at the time of Appellants’ claimed invention, to treat, inter alia, insulin resistance by administering a composition comprising an effective 7 Appeal 2017-002301 Application 13/236,034 amount of L. gasseri to an individual in need thereof (see Ans. 6 (“one of ordinary skill in the art would [have] recognize[d] that. . . the method [suggested by the combination] of Tanaka [and Park] would [have] been effective for the treatment of. . . insulin resistance”)). Claim 1: Appellants’ claim 1 is reproduced above. For the foregoing reasons, we are not persuaded by Appellants’ contention that based on the combination of Tanaka and Park “one of ordinary skill in the art would have no reason to identity insulin resistance as a condition or disease which could be treated or prevented by administering Lactobacillus gasseri” (App. Br. 10 (emphasis removed)). Park discloses that the species of Lactobacillus useful in its method are those, capable of living in the intestine and [are] not harmful to [the] human body” (FF 6). Tanaka discloses that L. gasseri has the ability to colonize the “human intestinal tract” (FF 2; cf FF 6). In addition, a person of ordinary skill in this art would have recognized that because Tanaka discloses the administration of L. gasseri to the human body, the microorganism would not be harmful to the human body (see FF 1—2; cf. FF 6). Further, there is no evidence on this record that L. gasseri, a microorganism within the genus taught to be useful in Park’s method, would be incapable “of converting oligosaccharides into polysaccharides that cannot be absorbed into [the] human body” (see generally FF 6). Therefore, we are not persuaded by Appellants’ contention that Park “fails to disclose, teach, or suggest that Lactobacillus gasseri is capable of living within the intestines and converting oligosaccharides produced by the digestive 8 Appeal 2017-002301 Application 13/236,034 enzymes into non-digestible polysaccharides,” which fails to account for Tanaka’s contribution to the combination of Tanaka and Park (App. Br. 11; see also id. at 13). For the same reasons, we are not persuaded by Appellants’ contentions relating to whether or not Tanaka discloses the treatment of obesity (Reply Br. 3—4). For the foregoing reasons, we are not persuaded by Appellants’ contention that “[o]ne of ordinary skill in the art would . . . never have had a reason to or have been motived to administer Lactobacillus gasseri of Tanaka ... to the subjects of Park . . ., and could have had no reasonable expectation of success in doing so” (App. Br. 11). To the contrary, for the reasons set forth above, a person of ordinary skill in this art would have had a reasonable expectation of success in “administer[ing] Lactobacillus gasseri of Tanaka ... to the subjects of Park” (cf. id.). See In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success ... all that is required is a reasonable expectation of success”). For the reasons set forth above, we are not persuaded by Appellants’ contention that Examiner’s conclusion of obviousness is based on “the impermissible use of hindsight” or “impermissibly picking and choosing [] isolated portions of Tanaka . . . and Park ... in an effort to establish the rejection” (App. Br. 12). For the same reasons, we are not persuaded by Appellants’ contentions regarding the treatment of obesity (Reply Br. 2—7). 9 Appeal 2017-002301 Application 13/236,034 Claim 3: Appellants’ claim 3 depends from and further limits the method of Appellants’ claim 1 to require that “the composition is in the form of a food or pharmaceutical product” (see App. Br. 17 (claim 3)). For the reasons set forth above, we are not persuaded by Appellants’ contention that “at least for the reasons given above, one of ordinary skill in the art would have had no reason to administer the Lactobacillus gasseri of Tanaka ... to the subjects of Park” (id. at 14; cf. FF 7). Claim 4\ Appellants’ claim 4 depends from and further limit the method of Appellants’ claim 1 to require that “the amount [of L. gasseri] effective to (1) result in an increase in blood-adiponectin-concentration in [a] subject or (2) prevent a decline in blood-adiponectin-concentration in [a] subject is 10 to 200 grams per day” (see App. Br. 17 (claim 4)). Park discloses the administration of a microorganism within the Lactobacillus genus to an individual in an amount of “0.1 to 10 g per one time administration” (FF 11). Tanaka discloses the administration of L. gasseri, a species of Lactobacillus that falls within the scope of Park’s disclosure, to an individual in an amount “of from 0.5 g to 10 g . . . per day” (FF 9). Both Tanaka and Park disclose the administration of Lactobacillus, which may be L. gasseri, to an individual in an amount of 10 g per day (FF 9, 11). Thus, the combination of Tanaka and Park suggests the administration of L. gasseri in an amount that overlaps the range required by Appellants’ claim 4. Overlapping ranges support a prima facie case of obviousness. In re Geisler, 116 F.3d at 1468. Therefore, we are not 10 Appeal 2017-002301 Application 13/236,034 persuaded by Appellants’ contention that “the amounts described in Tanaka . . . are not for treatment of or prevention of insulin resistance,” which fails to account for Park’s contribution to the combination of Tanaka and Park (see App. Br. 15). The administration of 10 g/day of Lactobacillus gasseri will necessarily “(1) result in an increase in blood-adiponectin-concentration in [a] subject or (2) prevent a decline in blood-adiponectin-concentration in [a] subject is 10 to 200 grams per day” (see App. Br. 17 (claim 4); cf. FF 8). Therefore, we are not persuaded by Appellants’ contention that “[t]he amounts and concentrations disclosed in Tanaka [and Park] ... are not for blood adiponectin secretion” (App. Br. 15). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claims 1, 3, and 4 under 35 U.S.C. § 103(a) as unpatentable over the combination of Tanaka and Park is affirmed. Claims 5—8 are not separately argued and fall with claim 1. 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). AFFIRMED 11 Copy with citationCopy as parenthetical citation