Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s amendment filed 24 June 2026 is entered. Claims 1 and 4 are amended. Claims 1-6 are pending.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 includes an unnecessary hyphen in “food composition-consists of” on line 12. The hyphen should be replaced with a space.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim Interpretation
Claims 1 and 4 recite the phrase “wherein the pharmaceutical composition [or health functional food] reduces one or more selected from the group consisting of total cholesterol, triglycerides, low density lipoprotein cholesterol (LDL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and reduces blood sugar fluctuations, fasting blood sugar levels, and fasting insulin levels”, which are intended functions or effects of the claimed pharmaceutical and health functional food compositions that does not recite any additional active method steps. Claims 2-3 and 5-6 also recite intended functions or effects of the pharmaceutical and health functional food compositions which are administered to the patient, but do not recite any additional active method steps. If the prior art teaches the active steps of the claimed methods, as well as all of the structural limitations of their administered compositions, these intended effects of the compositions are interpreted to necessarily occur, and claims 1-6 will be considered to be rendered obvious under 35 USC §103.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Holzapfel et al. (KR102266314B1, published 16 June 2021) in view of Yuan et al. (Rutin ameliorates obesity through brown fat activation, The FASEB Journal, Vol 31, pg. 333-345, January 2017).
Regarding claims 1 and 4, Holzapfel teaches the administration of pharmaceutical and health functional food compositions consisting of Lactobacillus plantarum strain HAC03 accession No: KCTC 13242BP to prevent obesity (Holzapfel [0001], [0006]-[0009], [115]-[118], and Figs. 5-6), and that the compositions are administered in therapeutically effective amounts and can be administered in combination with other therapeutic agents (Holzapfel [0050]). Holzapfel administered the Lactobacillus plantarum strain HAC03 composition to a murine model for obesity, C57BL/6J mice fed a high fat diet (Holzapfel [0115]), and the results of that administration showed lower body and adipose tissue weight in the Lactobacillus plantarum strain HAC03 treated group as compared to the controls (Holzapfel [0118] and Fig. 5). Holzapfel also teaches that the compositions alleviate levels of glucose and cholesterol in the blood (Holzapfel [0020]).
Holzapfel does not teach rutin in the compositions administered in their method of preventing obesity, or that the administration of the compositions regulates the expression levels of fatty acid synthase (FAS), acetyl CoA carboxylase (ACC), peroxisome proliferator-activated receptor gamma (PPAR-gamma), sterol regulatory element binding protein 1C (SREBP1C), peroxisome proliferator-activated receptor a (PPAR-alpha), peroxisome proliferator-activated receptor gamma coactivator 1 alpha (PGCl-alpha), carnitine palmitoyltransferase 1 (CPT1), acyl-CoA oxidase 1 (ACOX1), uncoupling protein 1 (UCP1), or PR/SET domain 16 (PRDM16).
Yuan teaches that administering rutin ameliorates obesity (Yuan title and abstract), and has antidiabetic properties in vivo and in vitro (Yuan pg. 334 para. 2). Yuan administered rutin to C57BL/6J high fat diet murine model for obesity (Yuan pg. 334 sec. Animals), and that this administration reduced the body weight of the obese mice as compared to controls (Yuan Fig. 2A-B). Yuan also teaches that rutin administration upregulated UCP1, PRDM16, PGC1-alpha, and PPAR-gamma mRNA expression (Yuan Fig. 1) and significantly reduced cholesterol and triglyceride levels in the treated obese mice (Yuan pg. 337 para. 1), and also improved glucose homeostasis in the treated and unfed mice (reduced blood sugar fluctuations and fasting blood sugar levels) (Yuan Fig. 2M-N).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to combine Holzapfel’s Lactobacillus plantarum HAC03 strain of accession No: KCTC 13242BP and Yuan’s rutin to form a single pharmaceutical or health functional food composition consisting of Lactobacillus plantarum HAC03 strain of accession No: KCTC 13242BP and rutin, and then administer that composition to prevent obesity in a subject. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the prior art taught that both Lactobacillus plantarum HAC03 and rutin are able to prevent obesity in a subject when they are administered and because Yuan teaches the additional therapeutic benefit of upregulated UCP1, PRDM16, PGC1-alpha, and PPAR-gamma mRNA expression (Yuan Fig. 1) and significantly reduced cholesterol and triglyceride levels in the treated obese mice (Yuan pg. 337 para. 1), and also improved glucose homeostasis in the treated and unfed mice (reduced blood sugar fluctuations and fasting blood sugar levels) (Yuan Fig. 2M-N). Furthermore, MPEP §2144.06(I) states "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art."
It also would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to optimize the dosage of the combined composition to treat and/or prevent obesity in a subject. MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. In the instant case, one of ordinary skill in the art would have been motivated to optimize the dosage of the combined composition in order to maximize the effectiveness of the combined composition to treat and/or prevent obesity in a subject.
Regarding claims 2 and 5, Yuan taught that rutin directly activated brown adipose tissue (BAT) oxidation, and that numerous genes involved in thermogenesis and fatty acid oxidation were upregulated (Yuan pg. 343-344 bridging para.). Since the composition used in the obvious method of Holzapfel in view of Yuan and Duminy consists of rutin, it would have been obvious to one of ordinary skill in the art the anti-obesity effects of increasing fat oxidation and body thermogenesis within the patient upon administration of the composition.
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Holzapfel in view of Yuan as applied to claims 1-2 and 4-5 above, and as evidenced by Gao et al. (Rutin Suppresses Palmitic Acids-triggered Inflammation in Macrophages and Blocks High Fat Diet-induced Obesity and Fatty Liver in Mice, Pharm Res. 2013 November; 30(11): 2940–2950).
Neither Holzapfel nor Yuan teach the end result of reducing insulin resistance by regulating the expression level of glucose-6-phosphate dehydrogenase (G6P) gene or phosphoenolpyruvate carboxykinase (PEPCK) gene. However, this effect is not unexpected and would necessarily be present, based on the evidence provided by Gao that administering rutin to HFD mice protects them from high-fat diet-induced obesity and insulin resistance (Gao abstract), and also decreases mRNA expression levels of glucose-6-phosphate dehydrogenase (G6P) and phosphoenolpyruvate carboxykinase (PEPCK) (Gao Fig. 9C).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to perform the obvious method of administering a composition consisting of Lactobacillus plantarum strain HAC03 accession No: KCTC 13242BP and rutin to a patient as taught by Holzapfel in view of Yuan and Duminy above would inherently prevent insulin resistance in the patient by regulating the expression level of glucose-6-phosphate dehydrogenase (G6P) and phosphoenolpyruvate carboxykinase (PEPCK) genes, as evidenced by Gao.
Response to Arguments
Applicant's arguments filed 24 June 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Examiner's claim interpretation is invalid because the cited prior art does not teach or suggest the same or substantially the same claimed composition, and Duminy discloses a multi-component formulation rather than the claimed HAC03 + rutin only composition (Remarks pg. 6 paras. 2-4), as discussed in the rejection above, it would have been obvious to one of ordinary skill in the art to combine Holzapfel’s Lactobacillus plantarum HAC03 strain of accession No: KCTC 13242BP and Yuan’s rutin to form a single pharmaceutical or health functional food composition consisting of Lactobacillus plantarum HAC03 strain of accession No: KCTC 13242BP and rutin, and then administer that composition to prevent obesity in a subject. Holzapfel and Yuan teach the effects of Lactobacillus plantarum HAC03 and rutin on obesity, respectively. It would have been obvious to one of ordinary skill in the art to administer a composition consisting of Lactobacillus plantarum HAC03 and rutin to treat obesity because both ingredients have been taught to treat obesity when administered on their own. Regarding Applicant’s arguments that Duminy does not teach the claimed two-component composition consisting of Lactobacillus plantarum HAC03 and rutin (Remarks pg. 7 para. 2 through pg. 8 last para.). In response, Duminy is not relied upon in the new rejection as necessitated by amendment.
Regarding Applicant’s arguments that Yuan does not teach the claimed combination of Lactobacillus plantarum HAC03 and rutin (Remarks pg. 9 para. 1 through pg. 10 para. 1), Yuan is not relied upon alone in the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). When the references Holzapfel, Yuan, and Duminy are combined, it would have been obvious to one of ordinary skill in the art to administer a composition consisting of Lactobacillus plantarum HAC03 and rutin to treat obesity because both ingredients have been taught to be able to treat obesity when administered on their own.
Regarding Applicant’s arguments that Gao does not disclose Lactobacillus plantarum HAC03, nor its combination with rutin, and does not disclose any interaction made between the two components (Remarks pg. 10 para. 2), Gao is cited to provide evidence that one of ordinary skill in the art would have known that administering rutin protects them from HFD induced obesity and insulin resistance, and decreases expression of G6P and PEPCK. Gao is not relied upon alone in the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). When the references Holzapfel and Yuan are combined, it would have been obvious to one of ordinary skill in the art to administer a composition consisting of Lactobacillus plantarum HAC03 and rutin to treat obesity because both ingredients have been taught to treat obesity when administered on their own. When these references are then combined with the evidenced presented in Gao, one of ordinary skill in the art would have understood that the obvious method of Holzapfel and Yuan would also advantageously prevent insulin resistance in the patient.
Regarding Applicant’s arguments that Gao’s results differ from Yuan’s BAT-centered thermogenesis findings, where Yuan reports rutin increased UCP1 expression in BAT, but Gao reports that neither HFD-feeding or rutin treatment significantly changed transcription levels of Ucp1 (Remarks pg. 10 para. 4 through pg. 11 para. 4), the differences between Gao’s results and Yuan’s results are not contradictory to the point of demonstrating unpredictability. One of ordinary skill in the art would recognize from Gao’s Figs. 6-7 that Ucp1 does trend to be upregulated relative to the chow diet and HFD diet mice when rutin is administered. Additionally, any differences in the concluded mechanisms of Gao and Yuan in treating obesity and insulin resistance do not uproot the overall conclusion that both Gao and Yuan make, which is that rutin is an effective ingredient for treating aspects of obesity and insulin resistance in a subject in need of being treated for such diseases.
Regarding Applicant’s arguments that Holzapfel does not teach rutin compositions administered to prevent obesity, nor does it teach regulation of expression levels of fatty acid synthase (FAS), acetyl CoA carboxylase (ACC), peroxisome proliferator-activated receptor gamma (PPAR-gamma), sterol regulatory element binding protein 1C (SREBP1C), peroxisome proliferator-activated receptor a (PPAR-alpha), peroxisome proliferator-activated receptor gamma coactivator 1 alpha (PGCl-alpha), carnitine palmitoyltransferase 1 (CPT1), acyl-CoA oxidase 1 (ACOX1), uncoupling protein 1 (UCP1), or PR/SET domain 16 (PRDM16) (Remarks pg. 11 para. 4 through pg. 12 para. 3), Holzapfel is not relied upon alone in the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). When the references Holzapfel and Yuan are combined, it would have been obvious to one of ordinary skill in the art to administer a composition consisting of Lactobacillus plantarum HAC03 and rutin to treat obesity because both ingredients have been taught to be able to treat obesity when administered on their own. Although Holzapfel does not teach rutin in the compositions administered in their method of preventing obesity, or that the administration of the compositions regulates the expression levels of fatty acid synthase (FAS), acetyl CoA carboxylase (ACC), peroxisome proliferator-activated receptor gamma (PPAR-gamma), sterol regulatory element binding protein 1C (SREBP1C), peroxisome proliferator-activated receptor a (PPAR-alpha), peroxisome proliferator-activated receptor gamma coactivator 1 alpha (PGCl-alpha), carnitine palmitoyltransferase 1 (CPT1), acyl-CoA oxidase 1 (ACOX1), uncoupling protein 1 (UCP1), or PR/SET domain 16 (PRDM16), the rejection clearly states that Yuan teaches a composition consisting of rutin ameliorates obesity (Yuan title and abstract), and has antidiabetic properties in vivo and in vitro (Yuan pg. 334 para. 2), and that rutin upregulates UCP1, PRDM16, PGC1-alpha, and PPAR-gamma mRNA expression (Yuan Fig. 1). The rutin component within the obvious administered composition would provide the benefit of upregulation of these enzymes.
Regarding Applicant’s arguments that the claimed combination of Lactobacillus plantarum HAC03 and rutin into a single composition does not predictably produce the claimed effects, and the specification shows that regulation of lipogenesis-related genes and changes in intestinal microorganism diversity and distribution changes, which are not identified by Holzapfel, Yuan, and Duminy (Remarks pg. 12 para. 4 through pg. 13 para. 4), these claimed effects are not claimed, nor do they establish that the combination of Lactobacillus plantarum HAC03 and rutin would be unpredictable in the aspect of treating obesity and insulin resistance. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander M Duryee whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on (571)-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657
/Alexander M Duryee/Examiner, Art Unit 1657
Prosecution Insights