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
On 14 January 2026, claims 1-2 and 4-5 are amended.
Claims 1-6 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 January 2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “regulating the expression levels proteins selected from the group consisting of…” in line 5. The phrase is missing the term “of one or more” in between “expression levels” and “proteins”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 4 recite that the pharmaceutical composition or health functional food composition consists of Lactobacillus plantarum HAC03 strain having accession number KCTC 13242BP and rutin as active ingredients. The term “as active ingredients” renders the claims indefinite and can reasonably be interpreted as: (1) the pharmaceutical composition or health functional food consists of Lactobacillus plantarum HAC03 strain having accession number KCTC 13242BP and rutin as active ingredients, and further includes other ingredients that are not active ingredients; or (2) the pharmaceutical composition or health functional food composition Lactobacillus plantarum HAC03 strain having accession number KCTC 13242BP and rutin only, with no other ingredients.
Claims 2-3 depend on claim 1, and claims 5-6 depend on claim 4, so those claims are indefinite for the same reasons.
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.
Additionally, the broadest reasonable interpretation of claims 1 and 4 is that the pharmaceutical composition or health functional food consist of Lactobacillus plantarum strain HAC03 accession No: KCTC 13242BP and rutin as active ingredients, and non-active ingredients.
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) and Duminy et al. (US 20220143070 A1, published 12 May 2022).
Regarding claims 1 and 4, Holzapfel teaches the administration of pharmaceutical and health functional food compositions comprising Lactobacillus plantarum strain HAC03 accession No: KCTC 13242BP to prevent obesity (Holzapfel [0001], and [0006]-[0009]), 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 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).
However, Holzapfel and Yuan do not teach the administration of a composition comprising both Lactobacillus plantarum and rutin.
Duminy teaches the administration of a pharmaceutical composition comprising both Lactobacillus plantarum and rutin for the prevention and/or treatment of dysbiosis associated with obesity (Duminy claims 11, 13, and 21, and [0037]).
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 Lactobacillus plantarum HAC03 strain of accession No: KCTC 13242BP and rutin to form a single pharmaceutical or health functional food composition, 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 Duminy taught that both Lactobacillus plantarum and rutin can be combined in the same composition and administered to a subject with obesity. 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 comprises 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 and Duminy 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).
Holzapfel, Yuan, and Duminy do not teach reducing insulin resistance by regulating the expression level of glucose-6-phosphate dehydrogenase (G6P) gene or phosphoenolpyruvate carboxykinase (PEPCK) gene.
Gao provides the evidence 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 comprising 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, see Remarks filed 23 September 2025 and 14 January 2026, with respect to the 35 USC §112(a) enablement rejection of claims 1-6 for biological material public availability have been fully considered and are persuasive. Applicant’s statement that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting the patent (Remarks 23 September 2025 pg. 6), and their confirming statement that the deposit was a Budapest Treaty deposit (Remarks 14 January 2026 pg. 6), satisfies the biological deposit requirements. The 35 USC §112(a) enablement rejection of claims 1-6 has been withdrawn.
Applicant’s arguments with respect to the 35 USC §103 rejections of claims 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are directed to how the claim amendment’s new limitations differentiate the claims from the cited prior art. The rejections have been updated accordingly to address these new limitations.
Conclusion
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.
/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
Prosecution Insights