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 .
Priority
The instant application claims benefit to PCT/KR2023/015414 (filed 10/06/23) and KR10-2023-0116275 (filed on 09/01/2023) and is acknowledged. The instant claims herein are examined using the effective filing date of 09/01/2023 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/21/2023 and 02/13/2024 were properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) were considered.
Claim Objections
Claim 2-9 objected to because of the following informalities: claims 2-9 recite “the composition of Claim 1” or “Claim 3” (see claim 4). It is suggested to Applicant to amend the claims to recite “claim 1” or “claim 3” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 1-9 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 claim(s) contains 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 claims in question recite Limosilactobacillus reuteri LM1071 and Lactobacillus gasseri LM1065, as well as the deposit information under KCCM12650P and KCCM13018P. It is apparent that the recited bacterial strains are required to practice the claimed invention. However, it is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further, it is unclear if the starting materials were readily available to the public at the time of invention.
A document filed 12/21/2023 indicates the deposit of Limosilactobacillus reuteri LM1071 and Lactobacillus gasseri LM1065. It is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. The Applicant has not averred that all restrictions on the availability to the public of the materials so deposited will be irrevocably removed upon the granting of a patent. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g., see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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 6-9 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 6-9 recite, inter alia, “composition comprising one or more of the mixed strains of Claim 1 or a culture, fragments, and extracts of the strain as active ingredients.” It is unclear what a fragment of a strain is, or what portion of the strains this limitation would potentially encompass. Thus, the claims are indefinite.
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.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Here, the claims recite a compound microbial inoculum. This is a composition of matter, therefore the claim falls within a statutory category of invention. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). Because the claim recites a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitations are a product of nature exception (see MPEP 2106.04(c)(I)). This analysis is performed by comparing the nature-based product limitations in the claims to its naturally occurring counterparts to determine if it has markedly different characteristics (see MPEP 2106.04(c)(II)).
Claim 1 requires, inter alia, “a composition comprising mixed strains of Limosilactobacillus reuteri LM1071 deposited to Korean Culture Center of Microorganisms under the accession number KCCM12650P and Lactobacillus gasseri LM1065 deposited to Korean Culture Center of Microorganisms under the accession number KCCM13018P) and capable of improving whey protein proteolysis and lactose intolerance.” (aka Lactobacillus reuteri and Lactobacillus gasseri, respectively). The specification indicates in Table 1 that the strains were isolated from human breast milk (see Table 1). Thus, the examiner is interpreting the instantly claimed strains to encompass the naturally occurring forms. Claims 6-9 recite food/health functional food/infant formula/and pharmaceutical composition comprising one or more of the mixed strains of claim 1 or a culture, fragments, and extracts of the strain as active ingredients. The appropriate natural counterpart to the mixed strain composition, cultures, fragments, and extracts are naturally occurring Lactobacillus reuteri and Lactobacillus gasseri bacterial cells. The second step in the analysis requires identifying appropriate characteristics to compare. In this case, the appropriate characteristics pertain to the physical, structural, and functional characteristics of the bacterium.
Delgado et al (Front. Microbiol., 13 January 2015 Sec. Food Microbiology Volume 5 – 2014; hereinafter “Delgado”) evidences Lactobacillus species and their ability to be used as probiotics against gastric microbial dysbiosis (see title, abstract). Delgado evidences that L. reuteri strains produce reuterin, which inhibits H. pylori growth, and contains a- and b-galactosidase activity (see pg. 4 and 6; Table 2 and Fig. 3), Delgado evidences that both L. gasseri and L. reuteri have glycosidic activity, antioxidative activity, and fermentative ability (see pg. 2-4). Thus, the Lactobacillus reuteri and the Lactobacillus gasseri as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus reuteri and Lactobacillus gasseri bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart, such as the bacterium as found in human breast milk (see Table 1 of the instant specification).
The specification further recognizes the strains have excellent protein proteolysis and thus can produce BCAA (valine, leucine, and isoleucine), arginine, and phenylalanine, which are helpful in forming muscles and suppressing muscle loss, by degrading whey proteins, and has excellent a- and β-galactosidase activity and thus can hydrolyze lactose (see paragraph 0019 and 0096). Thus, the mixed strain composition as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus reuteri and Lactobacillus gasseri bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart. The structure and function of the claimed occurring Lactobacillus reuteri and Lactobacillus gasseri bacterial cells are the same as the naturally occurring counterpart.
Furthermore, the claimed capability to improve whey protein proteolysis and lactose intolerance as recited in claim 1 is, absent evidence to the contrary, inherent to each of the strains individually, as nothing in the instantly filed specification suggests that the improved whey protein proteolysis and improved lactose intolerance occurred when the strains were combined together or any synergy. Nothing new flows from the “hand of man” action of combining the two naturally occurring strains. [STEP 2A, Prong 1: YES]
Thus, the claim recites a judicial exception, a natural product. Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application. Claim 1-9 is limited to only the judicial exception (naturally occurring Lactobacillus reuteri and Lactobacillus gasseri), even if claims 6-9 require fragments, extracts, and cultures of the strains. In this regard, the claims fail to recite any additional elements that integrate the judicial exception natural product into a practical application. [Step 2A, Prong 2: NO]
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). The claimed composition does not add a meaningful limitation or extra-solution activity to the claimed product, and the product as a whole is nothing more than an attempt to generically link the product of nature to a particular technological environment (e.g., culturing cells for use in food products, infant formula, and health food products).
Thus, the claims fail to recite any additional elements that are sufficient to amount to significantly more than the judicial exception. [Step 2B: NO]
Therefore, the claims do not qualify as eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1, 3, and 5-9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Klaenhammer et al (US 20130224153 A1; hereinafter “Klaenhammer”) as evidenced by Mutaguchi et al (Production of d-Branched-Chain Amino Acids by Lactic Acid Bacteria Carrying Homologs to Isoleucine 2-Epimerase of Lactobacillus buchneri. Front Microbiol. 2018 Jul 13;9:1540; hereinafter “Mutaguchi”) and Delgado.
Klaenhammer teaches mixtures of probiotic Lactobacillus bacterium for the treatment of inflammatory gastrointestinal disorders and alleviating lactose intolerance (see abstract, title, paragraph 0004-0006, 0023), including Lactobacillus reuteri and Lactobacillus gasseri (a composition comprising mixed strains of Limosilactobacillus reuteri and Lactobacillus gasseri capable of improving lactose intolerance as in claim 1; see paragraph 0026). The microorganisms in the reference appear to be identical to the claimed strains and it considered to anticipate the claimed microorganisms, as they belong to the same bacterial species and are shown to improve lactose intolerance. Please note that Klaenhammer does not explicitly teach the bacteria is capable of improving whey protein proteolysis. However, absent evidence to the contrary, this feature has been interpreted as an inherent feature of the claimed bacterial strains (see 35 U.S.C. 101 rejection above).
In the alternative, even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, one of ordinary skill in the art would have understood the claimed strains to be an obvious variant of the prior art Limosilactobacillus reuteri LM1071 and Lactobacillus gasseri LM1065 since the prior art L. reuteri and L. gasseri exhibit the same characteristics as disclosed by Applicant (see paragraphs 0012, 19, 47, 96; Table 8 of the specification as instantly filed), and is capable of similar biological effects. As such, in view of the clear, close relationship between the claimed strains and the prior art L. reuteri and L. gasseri, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have combined and used the claimed strains with a reasonable expectation of successfully treating inflammatory gastric disorders like lactose intolerance. Please note that simply depositing a bacterial strain in another depositary that is identical to the prior art does not, by itself, impart any patentable distinction over the prior art.
Regarding claim 3, Klaenhammer teaches the claimed strains and Mutaguchi evidences that L. reuteri is capable of producing branched chain amino acids (see abstract and page 4). Furthermore, the specification evidences that both strains have potential of producing branched chain amino acids, arginine, and phenylalanine (see paragraph 0019 and 0096). Thus, as Klaenhammer teaches identical strains in the prior art, absent evidence to the contrary, the strains of Klaenhammer are also capable of producing branched chain amino acids, arginine, and phenylalanine.
Regarding claim 5, Klaenhammer teaches the claimed strains and Delgado evidences L. reuteri contains a- and b-galactosidase activity (see pg. 4 and 6; Table 2 and Fig. 3), and both L. gasseri and L. reuteri have glycosidic activity, antioxidative activity, and fermentative ability (see pg. 2-4). Thus, absent evidence to the contrary, the strains of Klaenhammer have a- and b-galactosidase activity.
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Regarding claim 6, Klaenhammer teaches using the bacterial strains in a food product (see paragraph 0076).
Regarding claim 7, Klaenhammer teaches using the bacterial strains in a nutritional supplements and health bars (see paragraph 0076-78).
Regarding claim 8, Klaenhammer teaches using the bacterial strains in a food product (see paragraph 0076) that can be administered to infants (see paragraph 0063).
Regarding claim 9, Klaenhammer teaches using the bacterial strains in a pharmaceutical composition (see paragraph 0076-0079).
Claim Rejections - 35 USC § 103
Claim 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Klaenhammer.
As discussed above, the teachings of Klaenhammer anticipates, or in the alternative, renders prima facie obvious the composition of claim 1.
Klaenhammer does not explicitly teach the mixed strains in a ratio of 2:8 to 4:6 (claim 2) or 9:1 to 6:4 (claim 4).
However, Klaenhammer explicitly teaches providing therapeutically effective amounts of the mixed bacterial strains based on various parameters including: determining dosage based on the intended goal of treatment, the subject to be treated, the state of the subject and the protection desired, the judgment of the practitioner, the patient's age, weight, height, sex, general medical condition and previous medical history (see paragraph 0083). As such, the amount of mixed bacteria in the composition would have been the result of routine optimization using standard laboratory techniques available at the time of filing, as Klaenhammer teaches the amount can be optimized for optimal treatment of inflammatory gastric diseases (see MPEP 2144.05).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGIANA C REGLAS whose telephone number is (571)270-0995. The examiner can normally be reached M-Th: 8:00am-2:00pm.
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/G.C.R./Examiner, Art Unit 1651 /THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672