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
Claims 1-13 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/23/2024 and 06/19/2025 are acknowledged and have been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 17. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically Lactobacillus paracasei strain BCC-LP-02 with accession number KCTC14808BP and Lactobacillus plantarum strain BCC-LPL-53 with accession number KCTC 14809BP. Since the biological materials are essential to the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
The specification does not disclose a repeatable process to obtain the biological materials and it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited Lactobacillus paracasei strain BCC-LP-02 with accession number KCTC14808BP and Lactobacillus plantarum strain BCC-LPL-53 with accession number KCTC 14809BP (p. 1 of the specification), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Claims 9-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reducing body fat and decreasing obesity, does not reasonably provide enablement for preventing obesity. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In making a determination that a disclosure does not satisfy the enablement requirement, the factors that may be considered include: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
Nature of the invention. The claims are drawn to a method of prevention or treatment or amelioration of obesity comprising administering a composition comprising Lactobacillus paracasei strain BCC-LP-02 with accession number KCTC14808BP or a culture thereof and/or Lactobacillus plantarum strain BCC-LPL-53 with accession number KCTC 14809BP or a culture thereof.
Breadth of the claims. The breadth of the clamed invention is exceedingly large and fails to receive adequate support in the specification. claims 9-13 encompass preventing obesity.
State of the prior art and Unpredictability. The state of the art is limited to treating o reducing obesity. No prior art teachings show the prevention of obesity. Prior art Chiang (cited in 103 rejection) reports that probiotic Lactobacillus paracasei subsp. paracasei NTU 101 strain produces anti-obesity effects (Abstract, page 914 left column second para.). Cai (Food & nutrition research 66 (2022): 10-29219) shows that Lactobacillus plantarum FRT4 alleviates obesity by modulating gut microbiota and liver metabolome in high-fat diet-induced obese mice (Title, Abstract). Sohn (Diabetes & metabolism journal 47.1 (2023): 92-103) reports that Lactobacillus plantarum LMT1-48 strain lowers the visceral fat area and the subcutaneous fat area (Fig. 1). Therefore, the claimed method of prevention of obesity comprising administering a composition comprising Lactobacillus paracasei strain BCC-LP-02 with accession number KCTC14808BP or a culture thereof and/or Lactobacillus plantarum strain BCC-LPL-53 with accession number KCTC 14809BP or a culture thereof is highly unpredictable.
Guidance in the specification and working examples. The guidance in the specification is not commensurate in scope with the claimed invention. Example 11 discloses test where animals were administered the claimed strains. Group 1 received a normal diet (ND), group 2 received a high-fat diet (HFD) and group 3 received a high-fat diet plus probiotic (HFD+F). Table 4 and FIG. 10 disclose groups 2 and 3 gained weight compared to group 1, with group 2 gaining more weight than group 3. The specification fails to provide guidance pertaining to prevent obesity by administering the claimed strains.
Amount of experimentation necessary. The above-mentioned details establish that one skilled in the art would not be able to make or use the full scope of claimed invention with a reasonable expectation of success and without undue experimentation.
Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of the claimed invention. Thus, the claims are not fully enabled by the disclosure.
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.
Claim 7 is 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.
In claim 7, the set of parentheses around the phrase "glyceric acid, malic acid, orotic acid, lactose" renders the claim indefinite because it is unclear whether the limitations inside the set of parentheses are part of the claimed invention.
In claim 7, the limitation “which maintains a complementary relationship in the utilization of metabolome (glyceric acid, malic acid, orotic acid, lactose) and helps growth” renders the claim indefinite. It is not clear if it is the strains or their co-culture that maintains a complementary relationship, and it is not clear if the “helps growth” refers to the strains or something else.
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.
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.
Claims 1, 3, 5-7, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang (Chiang et al. "Beneficial effects of Lactobacillus paracasei subsp. paracasei NTU 101 and its fermented products." Applied Microbiology and Biotechnology 93.3 (2012): 903-916) and as evidenced by GenBank CP167253.1
Regarding claims 1, 3, 5, 6, 9, and 12-13, Chiang teaches administering a probiotic Lactobacillus paracasei subsp. paracasei NTU 101 strain and teaches the strain is isolated from newborn infants and that it inhibits the fat tissue and produces anti-obesity effects (Abstract, page 914 left column second para.). Chiang teaches that lactic acid bacteria (LAB) inhibit the adipocyte differentiation and that NTU 101 strain produces exopolysaccharides (page 914 left column para. 3, page 908 left column para. 2)). Evidentiary reference GenBank CP167253.1 reports the genome of the NTU 101 strain and shows that it comprises a nucleic acid sequence 100% identical to instant SEQ ID NO: 1 (See pages 3-4 for alignment). Chiang does not teach the limitation of “BCC-LP-02 with accession number KCTC 14808BP”.
However, Chiang teaches a strain of the same species of L. paracasei, same isolation source from babies as instant strain (specification page 16), and has the same therapeutic effect on fat inhibition. MPEP 2144.08 II discusses the obviousness of species when prior art teaches genus, while taking into consideration the teachings of structural similarity and similar properties or uses. Since Chiang teaches a strain with similar structure and similar properties of uses to the instant strain, it is understood that Chiang’s strain and the instant strain are the same or obvious variants.
Regarding claims 7 and 10-11, the limitations “wherein the BCC-LP-02 strain and the BCC-LPL-53 strain exhibit a synergistic effect in a co-culture of the BCC-LP-02 strain and the BCC-LPL-53 strain, which maintains a complementary relationship in the utilization of metabolome (glyceric acid, malic acid, orotic acid, lactose) and helps growth”, “ wherein when administered to an individual, the composition reduces the rate of weight gain, reduces food efficiency, or reduces body fat” and “wherein the composition has the effect of inhibiting fat absorption, inhibiting carbohydrate absorption, and/or inhibiting adipocyte differentiation in small intestinal cells or the digestive tract” do not require a step to be performed and thus do not limit the method. MPEP 2111.04 states that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed.
Claims 2, 4, 6-7, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Park (Park et al. "Lactobacillus plantarum HAC01 regulates gut microbiota and adipose tissue accumulation in a diet-induced obesity murine model." Applied Microbiology and Biotechnology 101.4 (2017): 1605-1614.) and as evidenced by NZ_CP029349.1 (NCBI Reference Sequence NZ_CP029349.1 Lactiplantibacillus plantarum strain HAC01 chromosome, complete genome, 2026).
Regarding claims 2, 4, 6, 9, and 12-13, Park teaches administering Lactobacillus plantarum HAC01 strain to a high-fat diet (HFD)-induced obesity murine
model and teaches that the strain lowered the body weight and mesenteric fat mass (Fig. 1). Evidentiary reference NZ_CP029349.1 reports the genome of the HAC01 strain and shows that it comprises a nucleic acid sequence 100% identical to instant SEQ ID NO: 2 (See pages 3-4 for alignment). Park does not teach the limitation “BCC-LPL-53 with accession number KCTC 14809BP”.
However, Park teaches a strain of the same species of L. plantarum, comprising SEQ ID NO: 2 and has the same therapeutic effect on reducing fat. MPEP 2144.08 II discusses the obviousness of species when prior art teaches genus, while taking into consideration the teachings of structural similarity and similar properties or uses. Since Park teaches a strain with similar structure and similar properties of uses to the instant strain, it is understood that Park’s strain and the instant strain are the same or obvious variants.
Regarding claims 7 and 10-11, the limitations “wherein the BCC-LP-02 strain and the BCC-LPL-53 strain exhibit a synergistic effect in a co-culture of the BCC-LP-02 strain and the BCC-LPL-53 strain, which maintains a complementary relationship in the utilization of metabolome (glyceric acid, malic acid, orotic acid, lactose) and helps growth”, “ wherein when administered to an individual, the composition reduces the rate of weight gain, reduces food efficiency, or reduces body fat” and “wherein the composition has the effect of inhibiting fat absorption, inhibiting carbohydrate absorption, and/or inhibiting adipocyte differentiation in small intestinal cells or the digestive tract” do not require a step to be performed and thus do not limit the method. MPEP 2111.04 states that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chiang as applied to claim 6 above, and further in view of Park.
Regarding claim 8, Chiang teaches a milk composition comprising L. paracasei subsp. paracasei NTU 101 and a Lactobacillus plantarum NTU 102 strain (page 904 right column second para.). Chiang does not teach the composition comprises Lactobacillus plantarum BCC-LPL-53 with accession number KCTC 14809BP. Park is relied upon for teaching Lactobacillus plantarum HAC01 strain. It is understood that Park’s strain and the instant BCC-LPL-53 strain are the same or obvious variants, as explained above.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Chiang’s composition by adding Lactobacillus plantarum HAC01 strain, as suggested by Park. One of ordinary skill in the art would be motivated to do so in order to treat obesity and reduce body fat. MPEP §2144.06(I) states that “[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. Since Chiang and Park teach a desire to reduce body fat, there is a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
