DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Priority
This application is a 371 of PCT/KR2020/019347 filed 12/29/2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on application KR 10- 2019-0178951 filed 12/31/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1, 2, 13-20, 22 and 23 are pending. Claims 2, 13, 22 and 23 are amended. Claims 1 and 2 were previously withdrawn. Claims 3-12 and 21 are cancelled.
Claims 13-20 and 22-23 (claim set filed 12/15/2025) are examined on the merits herein.
Withdrawal of Rejections
The response and amendment filed on 12/15/2025 are acknowledged. All of the amendment and arguments have been thoroughly reviewed and considered.
For the purposes of clarity of the record, the reasons for the Examiner's withdrawal and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner's response to arguments section.
The previous claims 13, 14 and 16 rejection under 35 U.S.C. 102(a)(1) or in the alternative 35 U.S.C. 103 has been withdrawn necessitated by Applicant’s arguments and amendment of claim 13.
New Rejection
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 13-20, 22 and 23 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.
Claim 13 recites: “Lactobacillus plantarum strain (Accession No. KCTC 14107BP)”. It is not clear if strain identifier in parenthesis is limiting the scope of the claims. The scope and boundaries of claim 13 are not certain since Lactobacillus plantarum is the broader scope and the accession number is the narrower scope, making claim 13 indefinite. The examiner suggests using the language such as: Lactobacillus plantarum strain with Accession No. KCTC 14107BP.
Claims 14-20, 22 and 23 do not resolve the issue mentioned above and are rejected.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lee (Lee et al. Nutrients, 2018, 10, 643, 1-15 on record in IDS).
Regarding claim 13 and 14, Lee teaches that administration of Lactobacillus plantarum Ln4 attenuates obesity (Abstract). Lee describes that strain L. plantarum Ln4 was selected from 400 lactic acid bacteria strains as potent anti-obesity and diabetic probiotics (Abstract). L. plantarum Ln4 significantly reduced weight gain and epididymal fat mass in mice fed on a high-fat diet (Abstract). Lee mentions the high potential of L. plantarum Ln4 as a therapeutic probiotic agent for metabolic disorders (Abstract).
Regarding Lactobacillus plantarum strain, as described in 112(b) rejection above it is not clear if strain accession number is included in the scope of the claim 13 and if claim is directed to any L. plantarum strain or to a specific strain with accession No. KCTC 14107BP. If accession number is not included in the scope of the claim, then Lee teaching anticipates claims 13 and 14.
However, if accession No. KCTC 14107BP is included in the scope of claim 13, Lee does not teach claimed L. plantarum strain (Accession No. KCTC 14107BP). However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that L. plantarum Ln4 strain of Lee teaching is an obvious variant of the claimed strain with similar properties and which can be used for the same purpose absent evidence to the contrary. One would be motivated to use L. plantarum Ln4 from Lee teaching for prevention and treatment of metabolic disease such as obesity because its administration was shown by Lee to significantly reduced weight gain and epididymal fat mass in mice fed on a high-fat diet and therefore L. plantarum Ln4 would be expected to have other properties of the claimed strain. Thus, Lee teaching anticipates or in alternative renders claims 13 and 14 obvious.
Regarding claims 15 and 16, Lee teaches that administration of L. plantarum Ln4 to mice fed on high-fat diet (HFD) resulted in significant reduction of epididymal fat (which is white adipose tissue (p. 7, 2nd paragraph)) and brown adipose tissue compared to mice on HFD without L. plantarum Ln4 administration (p. 7, 1st paragraph, Figure 2C) . Thus, Lee teaching anticipates or in alternative renders claims 15 and 16 obvious.
Regarding claim 17, Lee teaches that L. plantarum Ln4 inhibits fat accumulation in liver: “ … mice fed HFD for five weeks developed a fatty liver phenotype showing morphological changes that were caused by lipid deposition (Figure 2D). Ln4 administration also alleviated fatty liver, indicating the inhibitory effect of Ln4 on hepatic lipid accumulation in mice fed HFD” (p. 7, 1st paragraph, p. 8, Figure 2D). Thus, Lee teaching anticipates or in alternative renders claim 17 obvious.
Regarding claim 18, Lee teaches that administration of L. plantarum Ln4 to mice fed on HFD reduces a blood glucose level compared to mice on HFD without L. plantarum Ln4 administration (p. 11, Table 2). Thus, Lee teaching anticipates or in alternative renders claim 18 obvious.
Regarding claim 19, Lee describes verification of the improvement of insulin sensitivity by L. plantarum Ln4 by measurement of insulin resistance index, conducting oral glucose tolerance test (OGTT) and insulin tolerance test (ITT) (p. 8, 1st paragraph). Lee discloses that the insulin resistance index was highly elevated in response to HFD feeding and L. plantarum Ln4 administration induced a 40.6% reduction of that index (p. 8, 1st paragraph, p. 10, Figure 4A). The ITT showed that the insulin resistance caused by HFD was reduced by L. plantarum Ln4 administration (p. 8, 1st paragraph, p. 10, Figure 4C). Thus, Lee teaching anticipates or in alternative renders claim 19 obvious.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Lee et al. Nutrients, 2018, 10, 643, 1-15 on record in IDS) in view of Leser (US 20130336942 A1).
The teaching of Lee has been set forth above.
Lee does not teach L. plantarum strain to regulate concentration of the metabolic hormone GLP- 1 and does not teach L. plantarum strain to be comprised in a food and feed compositions.
Regarding claim 20, Leser teaches a method to reduce body weight in obese or overweight subject comprising providing a composition consisting essentially of Lactobacillus paracasei CRL431 strain (claim 1). Leser discloses detection of the levels of several signaling molecules, including GLP-1 during administration of CRL431 strain (paragraph 0035). Leser mentions that GLP-1 is released in circulation in response to nutrient digestion and has a number of physiological effects, including improvement of glycemic control and reduction in body weight and that GLP-1 was determined to reduce appetite and caloric intake (paragraphs 0008 and 0009). Leser describes that the level of GLP-1 in venous effluent increases by 330% when pig intestine is perfused with CRL431 (paragraph 0055). Leser concludes that CRL431 increases the levels of secreted GLP-1 (paragraph 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow guidance of Leser and include measurement of the level of metabolic hormone GLP-1 in blood for evaluation of the efficiency of obesity treatment with L. plantarum Ln4 of Lee teaching. One would have been motivated to do so since Leser teaches that GLP-1 reduces appetite, caloric intake and body weight. A skilled artisan would have reasonably expected success in that because Lee and Leser teach Lactobacillus strains for treatment of obesity. Thus, Lee and Leser teachings render claim 20 obvious.
Regarding claim 22 and 23, Leser teaches human or animal food or feed compositions comprising CRL431 strain or its metabolite to control or stabilize the weight gain of a mammal (paragraph 0062). Leser describes a method of manufacturing food or feed product comprising CRL431 strain (paragraph 0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow guidance of Leser on preparation of food or feed compositions comprising Lactobacillus strain and prepare food or feed compositions comprising L. plantarum Ln4 strain of Lee teaching. One would have been motivated to do so to control or stabilize the weight gain of a mammal as taught by Leser. A skilled artisan would have reasonably expected success in the combination because Lee and Leser describe Lactobacillus strains preventing or treating obesity. Thus, Lee and Leser teachings render claims 22 and 23 obvious.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered but they are not persuasive.
Applicant argues (addressing p. 4-5 of the Remarks) that Lee does not teach the claimed strain and “provides no indication of any method for artificially preparing a specific strain, let alone a strain corresponding to the species Lactobacillus plantarum.”. Applicant further argues that Lactobacillus is a large and diverse genus and that the claimed strain cannot be reproduced in identical form from Lee strain and its efficacy cannot be predicted. These arguments are not persuasive because:
Examiner acknowledged in the previous Office Action that Lee strain is not identical to instant L. plantarum strain and for that reason the 35 U.S.C. 102 rejection was withdrawn in the previous Office Action. However, after reconsideration of claim 13, the 112(b) rejection was applied, since claim teaches the broad range for Lactobacillus plantarum strain followed by the narrow range in parenthesis which is the strain with accession No. KCTC 14107BP and that creates uncertainty for the scope of the claim. For that reason the 102/103 rejection based on prior art of Lee was applied. If only the broad range of the strain is considered to be in the scope of the claim, then Lee clearly anticipates claims 13-19 because Lee teaches administration of Lactobacillus plantarum strain for treatment of obesity (Abstract) and 102 rejection is appropriate. In the alternative, claims 13-19 are rejected under obviousness 103 rejection if the claims are interpreted to be directed to the specific strain with accession No. KCTC 14107BP. Lee teaches natural strain identified as L. plantarum strain by 16S rRNA sequencing (p. 3, 2nd paragraph) administration of which was shown to attenuate obesity, i.e. to reduce weight gain, epididymal fat mass and insulin sensitivity (Abstract). One of ordinary skill in the art would be motivated to conclude that L. plantarum Ln4 of Lee teaching is an obvious variant of instant L. plantarum strain since strains belong to the same species and have similar properties of inhibiting obesity symptoms. Therefore, absent evidence of unexpectedness, the use of the obvious variant of instant L. plantarum with similar function and for the same purpose is obvious. Therefore, claims 13-19 are rejected under 35 U.S.C. 102 as anticipated or in the alternative 35 U.S.C. 103 as obvious.
Applicant’s arguments (addressing p. 5-6 of the Remarks) with respect to 35 U.S.C. 102/103 rejection have been fully considered and are persuasive. The prior art of Xiang is directed to the barley extract fermented with Lactobacillus plantarum dy-1, however not containing the strain itself, and hence Xiang does not teach the amended claim 13, requiring administration of L. plantarum strain or culture thereof comprising the strain. The 35 U.S.C. 102/103 rejection of claims 13, 14 and 16 has been withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 13, 22 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of copending Application No. 18/550,644 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 13 of instant application is drawn to a method of preventing or treating a metabolic disease comprising administering a Lactobacillus plantarum strain (KCTC 14107BP) or a culture thereof comprising the strain to a subject.
Regarding claim 13, claim 7 of reference application recites a method for preventing or treating cancer comprising administering the instant strain of L. plantarum GB104 (KCTC 14107BP) or a culture product thereof to subject other than human. Recitation “preventing or treating a metabolic disease” in instant claim 13 is interpreted as intended use. Similarly, the recitation “preventing or treating cancer” in reference claim 7 is interpreted as intended use. Regarding “subject”, “subject” in instant claim 13 includes human and non-human subject as defined in the specification” “… the subject may be a mammal, preferably human” (p. 16, line 5). Since instant claim 13 and reference claim 7 recite the same strain and the same method of use, i.e. by administration to a subject, reference claim 7 anticipates instant claim 13.
Claim 22 of instant application is directed to a method of claim 13 wherein L. plantarum (KCTC 14107BP) is comprised in a food composition.
Regarding claim 22, reference claim 5 teaches a food composition for preventing or inhibiting cancer comprising L. plantarum GB104 or a culture product thereof as an active ingredient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer L. plantarum GB104 in the form of food composition taught by reference application. One would have been motivated to do so with reasonably expected success because food composition is a standard composition for administration of probiotics and food composition can include additional components, e.g. prebiotics to increase efficiency L. plantarum GB104 strain action. Thus, reference claims 5 and 7 render claim 22 obvious.
Claim 23 of instant application is directed to a method of claim 13 wherein L. plantarum (KCTC 14107BP) is comprised in a feed composition.
Regarding claim 23, reference claim 6 teaches a feed composition for preventing or inhibiting cancer comprising L. plantarum GB104 or a culture product thereof as an active ingredient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer L. plantarum GB104 in the form of feed composition taught by reference application. One would have been motivated to do so with reasonably expected success because feed composition is regularly used for feeding animals and L. plantarum GB104 strain can be easily added to the feed composition. Thus, reference claims 6 and 7 render claim 23 obvious.
Thus, since instant claims 1, 22 and 23 and reference claims 5-7 are directed to the same subject matter, they are rejected under obviousness double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In response to Applicant’s arguments (addressing p. 6 of the Remarks) that: “Because the subject application has an earlier patent term filing date than that of the reference application, Applicant defers addressing this ground of rejection till it is the only rejection. Applicant respectfully requests the rejection be withdrawn pursuant to MPEP 804 (I)(B)(l)(b)(i), once no other rejections remain ”, the double patenting rejection is maintained since other rejections remain.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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