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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 9 and 10 and the following species: Lactobacillus sp. for claim 3, Lactobacillus plantarum for claim 4 and Lactobacillus plantarum CJLP133 for claim 5 in the reply filed on 08/25/2026 is acknowledged.
Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/25/2026.
Claims 1-5, 9 and 10 (claim set filed 08/25/2026) are examined on the merits herein.
Priority
This application is a 371 of PCT/KR2023/004987 filed 04/13/2023. 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 REPUBLIC OF KOREA 10-2022-0045756 filed 04/13/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/11/2024 and 12/10/2025 comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 5 is 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.
It is apparent that strain Lactobacillus plantarum CJLP133 (elected species) recited in claim 5 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 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. The specification describes several lactic acid bacteria strains including strain CJLP133 (p.6, 8th paragraph). The specification states: “The strains are deposited at the gene bank of Korea Research Institute of Bioscience and Biotechnology and can be easily obtained (p. 5, 9th paragraph). However, the confirmation on the depository information, statements of viability and public availability are not present in the application.
The prior art of Shin (US 20190029311 A1) teaches encapsulation of lactic acid bacteria strains with calcium-alginate beads (paragraphs 0009). Shin describes addition of the cryoprotective agents including sucrose and trehalose during encapsulation to prevent lactic acid bacteria from damage due to freeze-drying (paragraph 0039). Shin teaches several Lactobacillus plantarum strains corresponding to strains of claim 5 (paragraph 0013). Thus, a person skilled in the art could not make or use the invention defined without access to the specific biological material.
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.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration Applicant, 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 would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the 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 depositary for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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 1-5, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Shin (US 20190029311 A1).
Regarding claims 1 and 9, Shin teaches method of coating lactic acid bacteria to improve storage stability and intestinal survival (paragraph 0005). The method includes culturing lactic acid bacteria (paragraph 0007), recovering bacterial cells by centrifugation (paragraph 0017), mixing the lactic acid bacteria with a solution containing alginate (paragraph 0008) and adding the mixture to calcium-containing solution to form calcium-alginate beads (paragraph 0009). That corresponds to claimed method steps. Although Shin teaches additional components, such as coating agent, edible oil or fat and extracellular polymeric substances (paragraph 0008), instant claim 1 has “comprising” language that does not exclude addition of other components. Shin describes that the cryoprotective agent can be added to the step of mixing bacteria with alginate solution to prevent lactic acid bacteria from damage due to freeze-drying (paragraphs 0038, 0039). The recited cryoprotective agents include claimed sucrose and trehalose or their mixtures (paragraph 0039). Thus, Shin teaches presence of sucrose in the claimed method step (b), i.e. during mixing of bacteria with alginate solution. Although Shin does not expressly teach addition of the cryoprotectant to the calcium solution, Shin mentions that the protective agent can be added at any stage prior to freeze-drying (paragraph 0041) and hence in can be envisioned that trehalose is added with the calcium-containing solution. Shin provides examples of improved survival of encapsulated in alginate-calcium beads bacteria (Comparative Example 3) after freeze-drying for incubation in acidic conditions and during storage (paragraphs 0079, 0083).
Claims 1 and 9 have the same method steps and different preambles. Shin describes that alginate is crosslinked with the calcium to form a matrix and as a result the lactic acid bacteria are encapsulated in calcium-alginate beads (paragraph 0043) that corresponds to the preamble of claim 1. Regarding claim 9, the recitation “for improving the production yield of calcium-alginate beads for encapsulating lactic acid bacteria” in the preamble is interpreted as recitation of the intended use. The intended use is given weight to the extent that it imparts a structural limitation and the prior art needs to be capable of performing the intended use. See MPEP 2111.02, section II. The specification describes the method of calculating “production yield” in Experimental Example 1 (p. 20). The method includes measuring the number of bacteria in the alginate solution and prepared beads after smearing on MRS agar medium and comparing the total measured number of bacteria. Tables 9-11 present production yield as survival ratio (%) of bacteria after encapsulation. Thus, Shin teaches the instantly claimed method steps and improvement of survival of encapsulated bacteria and improvement of production yield in instant application is determined by survival. Therefore, the method described in prior art is capable of achieving the same goal, i.e. to improve the production yield of calcium-alginate beads for encapsulating lactic acid bacteria.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use method of producing lactic acid bacteria encapsulated in alginate-calcium beads in the presence of cryoprotectants as taught by Shin. One would have been motivated to do that since Shin describes improvement of survival of encapsulated bacteria after freeze-drying in acidic conditions and during storage. A skilled artisan would have reasonably expected success in that following instructions of the prior art. Thus, Shin teaching renders claims 1 and 9 obvious.
Regarding claim 2, Shin teaches further step of freeze-drying of the calcium alginate beads comprising lactic acid bacteria (paragraph 0052). Thus, Shin teaching renders claim 2 obvious.
Regarding claims 3-5, Shin teaches selection of Lactobacillus sp. (elected species), including Lactobacillus plantarum (elected species) and more specifically Lactobacillus plantarum CJLP133 strain (elected species) (paragraph 0013). Thus, Shin teaching renders claims 3-5 obvious.
Regarding claim 10, Shin teaches method of coating lactic acid bacteria to improve storage stability and intestinal survival (paragraph 0005). Method includes culturing lactic acid bacteria acid bacterium (paragraph 0007) and recovering bacterial cells by centrifugation (paragraph 0017), that corresponds to claimed step (a); mixing the lactic acid bacteria with a solution containing alginate (paragraph 0008), that corresponds to claimed step (b); adding the mixture to calcium-containing solution to form calcium-alginate beads (paragraph 0009), that corresponds to claimed step (c) and freeze-drying of the calcium alginate beads comprising lactic acid bacteria (paragraph 0052), that corresponds to claimed step (d). Although Shin teaches additional components, such as coating agent, edible oil or fat and extracellular polymeric substances (paragraph 0008), instant claim 10 has “comprising” language that does not exclude addition of other components.
Shin describes that the cryoprotective agent can be added to the step of mixing bacteria with alginate solution to prevent lactic acid bacteria from damage due to freeze-drying (paragraphs 0038, 0039). The recited cryoprotective agents include claimed sucrose and trehalose or their mixtures (paragraph 0039). Thus, Shin teaches presence of sucrose in the claimed method step (b), i.e. during mixing of bacteria with alginate solution. Although Shin does not expressly teach addition of the cryoprotectant to the calcium solution, Shin mentions that the protective agent can be added at any stage prior to freeze-drying (paragraph 0041) and hence in can be envisioned that trehalose is added with the calcium-containing solution. Shin provides examples of improved survival of encapsulated in alginate-calcium beads bacteria (Comparative Example 3) after freeze-drying in acidic conditions and during storage (paragraphs 0079, 0083).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use method of producing lactic acid bacteria encapsulated in alginate-calcium beads in the presence of cryoprotectants to improve survival of bacteria after freeze-drying as taught by Shin. One would have been motivated to do that since Shin describes improvement of survival of encapsulated bacteria after freeze-drying in acidic conditions and during storage. A skilled artisan would have reasonably expected success in that following instructions of the prior art. Thus, Shin teaching renders claim 10 obvious.
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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