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 .
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.
Biological Deposit
Claims 1-17 are rejected under 35 U.S.C.§ 112, first paragraph, as containing 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.
• It is apparent that Lacticaseibacillus paracasei strain HCS17-040 specified in the instant application as Lactobacillus paracasei HCS17-040 (hereafter “HCS17-040”) is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the aforementioned bacterial strains.
• The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Applicant claims the use of a specific strain of bacteria in the composition of claim 1 and its dependent claims, 2-17. Therefor it is by definition, not possible to practice the method of claim 1 without access to the specified strain of bacteria HCS17-040. It would be effectively impossible to reisolate that exact strain of bacteria from known sources of the same species, and would require an undue investment of time and resources for one skilled in the art to even attempt it. Since such an endeavor would require isolating and sequencing Lacticaseibacillus spp. until one with the same sequence is found by chance. This would be overcome by providing access to HCS17-040 via an acceptable deposit of viable culture, that is made available to the public.
• It is noted that upon searching the prior art, CN 111996147 A (27NOV20) revealed the prior publication of HCS17-040 with a CGMCC deposit number 19747. A search of the CGMCC catalog for a deposit under 19747 did not yield any results, a search of the bacterial species did not yield any results with the strain designation of HCS17-040. See CGMCCSearchNotes16JAN26.pdf.
• If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. It is noted that such a statement is not present in the instant application.
Indefiniteness
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 1-17 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.
The independent claim 1 recites a list of 4 steps for “a preparation method of the mulberry leaf extract” however applicant does not clearly state that the recited steps are required to make the mulberry leaf extract of claim 1, which renders the claim indefinite. For this reason the recited steps are not considered to further limit the product claimed. Thus, for the purposes of examination, claim 1 is construed to claim the composition of L. paracasei HCS17-040 and a mulberry leaf extract with the intended use of weight loss. The dependent claims to compositions of matter 2-8 &17 and methods of making those respective compositions 9-16 are also rendered indefinite by virtue of their dependence on claim 1. Claims 3, 4 & 8 are also indefinite, in that they recite further limitations to the non-limiting steps recited in claim 1 using the phrase “wherein at least one of the following is involved:”. This language is unclear whether the following steps are actually required or whether the steps are optional. Thus, for the purposes of examination the recited further limitations to the non-limiting steps of claim 1 in claims 3, 4 & 8 are construed as non-limiting. For the purposes of examination claims 3, 4 & 8 are construed to claim the composition of claim 1.
Claim 17 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. This is because, the above claims the “Use of the weight loss symbiotic according to claim 1”, it is unclear what applicant is claiming and therefor the claim is rendered indefinite. For the purposes of examination claim 17 is construed as claiming the composition of claim 1 with the intended use as a medicine for weight loss or fat reduction.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 17 claims the use of the composition of claim 1. Claims must clearly recite a process, machine manufacture or composition of matter to be eligible for a patent in the United States. Claim 17 is construed as claiming a composition of matter since the claim does not recite an active step which is required for a process claim.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shimakawa et. al. (WO 2012011174 A1, Lipid Metabolism Improving Agent, Agent for Enhancing Lipid Metabolism Improving Action, Anti-Obesity Agent, and Agent for Enhancing Anti-Obesity Action, 26JAN12, hereafter “Shimakawa”) and Cao et. al. (CN 111996147 A, Lactobacillus Paracasei With Function Of Reducing Triglyceride And Application Thereof, 27NOV20, hereafter “Cao”).
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shimakawa, and further in view of Cao.
Shimakawa teaches an anti-obesity composition comprising probiotics (comprising L. paracasei) and an alpha-glucosidase inhibitor(comprising mulberry leaf extract) (paragraphs 33 & 35 of Description of Embodiments section). Shimakawa further teaches proportions between 0.0001% to 99% for the alpha glucosidase inhibitor (comprising mulberry leaf extract) relative to probiotic bacteria by mass and vice versa (paragraph 68 of Description of Embodiments section). Shimakawa also teaches obtaining a uniform mixture of the two components (alpha glucosidase inhibitor and probiotic bacteria) (paragraph 73 of Description of Embodiments section)..
Although Shimakawa does not teach the specific strain of L. paracasei HCS17-040, Shimakawa teaches that L. paracasei strains from various sources are suitable for use in an anti-obesity composition with mulberry leaf extract (paragraph 36 of the Description of Embodiment section). However, Cao teaches the use of L. paracasei HCS17-040 for the purpose of reducing triglyceride or treating hyperlipidemia (Claims 1 & 2).
This would suggest that a person of ordinary skill in the art would be able to make a composition comprising mulberry leaf extract and L. paracasei HCS17-040 in an even/uniform mixture, at proportions between 1-67% (claim 1) or 6-29% (claim 2) by weight bacteria to mulberry leaf extract, for the purpose of losing weight, and expect success. This is because Shimkawa teaches the use of essentially any available strain of L. paracasei in their anti-obesity composition comprising a uniform mixture of L. paracasei and mulberry leaf extract at proportions between 0.0001-99% by mass bacteria to mulberry leaf extract. Mulberry leaf extract is a known product for weight loss, HCS17-040 is a known strain (Cao), to evenly mix and obtain a uniform mixture are obvious variants (claims 9-16 of instant application) and the ratios by weight of 1-67% (claim 1) or 6-29% (claim 2) of bacteria to mulberry leaf extract are encompassed by 0.0001-99% by mass taught in Shimakawa. One would be motivated to use that specific strain HCS17-040 because of its demonstrated ability to lower triglycerides and treating hyperlipidemia, which would be a highly desirable added benefit besides just weight loss (Cao, claims 1 & 2).
Conclusion
Claims 1-17 are rejected under 35 U.S.C.§ 112 (Biological Deposit & Indefiniteness).
Claim 17 is rejected under 35 U.S.C. § 101 (Statutory Category).
Claims 1-17 are rejected under 35 U.S.C. § 103, over Shimakawaand Cao.
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/G.A.W./ Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651