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 CN202310879961.3 (filed on 07/18/2023) and is acknowledged. The instant claims herein are examined using the effective filing date of 07/18/2023 for the basis of any prior art rejections.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 07/02/2025 was properly filed in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement(s) was considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claim 1-4 in the reply filed on 09/15/2025 is acknowledged.
Claims 5-7 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/15/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites, inter alia, “the China general microbiological culture Collection center of China Committee for culture Collection of microorganisms”. It is suggested to Applicant to capitalize the name of the depository for consistency purposes (i.e., “the China General Microbiological Culture Collection Center of China Committee for Culture Collection of Microorganisms”). Appropriate correction is required.
Claim Interpretation
Claim 1 recites, inter alia, “A lactobacillus plantarum 121-5 with a preservation number of CGMCC No.27418, and the lactobacillus plantarum 121-5 is preserved in the China general microbiological culture Collection center of China Committee for culture Collection of microorganisms” . This claim has been interpreted under broadest reasonable interpretation to encompass a composition of the bacterium (i.e., bacterial cells, a formulation, an inoculum, etc.).
Claims 2-4 recite, inter alia, “an application of the lactobacillus plantarum 121-5 of claim 1 for degrading beta-glucosidase activity”, “for utilizing beta-glucosidase activity”, and “for the conversion of polydatin to resveratrol” (respectively). The specification does not define the term “application” or “application for”. As such, the examiner has interpreted these limitations under broadest reasonable interpretation to be intended uses of the L. plantarum strain composition of claim 1. Please note that the language after the word “application of” does not impart any meaningful limitation to the claimed invention. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP 2111.02). Please note that as the claims are interpreted as intended uses of the composition of claim 1, any prior art L. plantarum composition, would, absent evidence to the contrary, be suitable for the claimed intended uses (see 35 U.S.C. 102/103 rejection below).
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 1-4 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 Lactobacillus plantarum 121-5. 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.
The specification discloses the depository as well as the address of the deposited material (see para 0008). However, it is not clear from the disclosure 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(b)
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 4 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.
Claim 4 recites the limitation "the conversion" in line 1. There is insufficient antecedent basis for this limitation in the claim, as there is no previous recitation of any “conversion” earlier in the claim or in claim 1. Thus, the claim is indefinite.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and the claim(s) 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 Lactobacillus plantarum. 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 lactobacillus plantarum 121-5 with a preservation number of CGMCC No.27418, and the lactobacillus plantarum 121-5 is preserved in the China general microbiological culture Collection center of China Committee for culture Collection of microorganisms” (aka Lactobacillus plantarum, respectively). The specification (see para 0027) shows that bacteria was isolated from fermented vegetables in the Xi'an region of Shaanxi. As such, absent evidence to the contrary, the claimed L. plantarum is a naturally occurring bacterium. The appropriate natural counterpart to the claimed strain is naturally occurring Lactobacillus plantarum. 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.
de Vries et al (Lactobacillus plantarum—survival, functional and potential probiotic properties in the human intestinal tract. International Dairy Journal 16 (2006) 1018–1028) evidences “L. plantarum is a versatile lactic acid bacterium, that is encountered in a range of environmental niches including dairy, meat and many vegetable fermentations (Table 1). Moreover, it is commonly found in the human gastrointestinal-tract (GI-tract). Furthermore, . . . L. plantarum has the coding capacity for the uptake and utilization of many different sugars, uptake of peptides, and formation of most amino acids. The large number of surface-anchored proteins suggests that L. plantarum has the potential to associate with many different surfaces and potential substrates for growth. In addition, the relatively high number of genes encoding regulatory functions indicated the ability to adapt to many different conditions.” (see pg. 1019, col 2). Thus, the Lactobacillus plantarum as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus plantarum bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart.
The specification (see, e.g., paragraph 0034) further discloses that L. plantarum has beta glucosidase activity as an intracellular enzyme and is capable of converting polydatin to resveratrol. Thus, the bacterium as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus plantarum bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart. Thus, Lactobacillus plantarum bacterial cells are the same as the naturally occurring counterpart.
Furthermore, nothing in the instantly filed specification suggests that the bacterium was manipulated in any way to impart any new characteristics to it. Nothing new flows from the “hand of man” action of isolating the naturally occurring strain. [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 is limited to only the judicial exception (naturally occurring Lactobacillus plantarum). Furthermore, the recitation in claims 2-4 (regarding the “application” of the strain for degrading beta-glucosidase activity, utilizing beta-glucosidase activity, and conversion of polydatin to resveratrol) to not impart any meaningful limitation to the product of nature (see claim interpretation above). 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 and applications (see claims 2-4) 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., transformation of polydatin to resveratrol).
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.
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 1-4 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 Basholli-Salihu et al. (Bioconversion of piceid to resveratrol by selected probiotic cell extracts. Bioprocess Biosyst Eng. 2016 Dec;39(12):1879-1885; cited in 07/02/2025 IDS; hereinafter “Basholli-Salihu”).
Basholli-Salihu teaches a strain of L. plantarum ATCC 15697, capable of converting piceid (i.e., polydatin) to resveratrol using beta-glucosidase activity (see pg. 1880, col 2; pg. 1881, col 1, paragraph 2; Table 1; pg. 1882, col 2, paragraph 1). The microorganism in the reference appears to be identical to the claimed strain and it is considered to anticipate the claimed microorganism as it belongs to the same bacterial species and is shown to be applicable for the production of resveratrol from polydatin and has beta-glucosidase activity (as in claims 2-4) (see pg. 1880, col 2; pg. 1881, col 1, paragraph 2; Table 1; pg. 1882, col 2, paragraph 1).
In the alternative, even if the claimed microorganism is not identical to the referenced strain with regard to some unidentified characteristics, one of ordinary skill in the art would have understood the claimed strain to be an obvious variant of the prior art L. plantarum since the prior art L. plantarum exhibits the same characteristics as disclosed by Applicant (see paragraphs 0037; Fig. 7 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. plantarum, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the claimed strain with a reasonable expectation of successfully producing of resveratrol from polydatin. 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.
Conclusion
NO CLAIMS ALLOWED.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
CN 102605006 B: discusses production of resveratrol using recombinant bacterial strains and fermentation techniques (see abstract; throughout).
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