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 3-13 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 3-10, in the reply filed on 05/13/2026 is acknowledged. Claims 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 3-10 are examined.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 05/17/2024 and 07/08/2025 are acknowledged and have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is not within the range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 3 and 6-10 are objected to because of the following informalities:
In claims 3 and 7-10, “Leuconostoc mesenteroides” should be italicized since it is a scientific name of a bacterium.
Claim 6 is appearing twice in the document. Applicant may consider deleting “Claim 6 (cancelled)”.
Appropriate correction is required.
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 3-10 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.
The invention appears to employ novel biological materials, specifically Leuconostoc mesenteroides deposited under accession number KCCM13059P and Leuconostoc mesenteroides deposited under accession number KCCM13060P. 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 Leuconostoc mesenteroides deposited under accession number KCCM13059P and Leuconostoc mesenteroides deposited under accession number KCCM13060P (p. 23 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.
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 9-10 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 9-10 recite “a cultured strain of the Leuconostoc mesenteroides”. The claims are indefinite because it is not clear what strains are required. It is not clear if the cultured strains are the deposited Leuconostoc mesenteroides strains or variants thereof. Applicant may consider amending claim 9 to recite “wherein the composition is prepared by drying or freeze-drying a culture medium comprising Leuconostoc mesenteroides deposited under accession number KCCM13059P.”
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 3-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception of laws of nature, natural phenomena, and products of nature (a nature-based product) without significantly more.
The claims recite a composition (Step 1: YES) comprising Leuconostoc mesenteroides deposited under Accession number KCCM13059P and/or Leuconostoc
mesenteroides deposited under Accession number KCCM13060P; or a culture thereof, and further comprising a pharmaceutically acceptable edible carrier. Applicant discloses Leuconostoc mesenteroides deposited under Accession number KCCM13059P and Leuconostoc mesenteroides deposited under Accession number KCCM13060P are isolated from kimchi (page 11 Example 1). A pharmaceutically acceptable edible carrier such as lactose is a natural product. Claim 4 recites the composition is dried or freeze-dried. Claim 5 recites the composition is in a powder form or granule form. Claims 9-10 recite the strains or their cultures are dried or freeze-dried. Claims 9 and 10 do not exclude the presence of water or a liquid carrier, which would revert the dried or freeze-dried bacteria or their cultures to their natural forms. There is no markedly different characteristic of the recited products compared to their naturally occurring counterpart in its natural state (same structure or form, same biological and chemical properties), and combining them into the recited composition does not change any of their natural characteristics individually or in combination. The claimed product lacks markedly different characteristics and is a product of nature (Step 2A prong 1: YES). This judicial exception is not integrated into a practical application because formulating these natural products into a food by simply mixing multiple naturally-occurring components is nothing more than an attempt to generally link the product of nature to a particular technological environment. Pertaining to claims 4-5, dried, powder, and granule forms are all natural physical states of bacteria and do not impart any markedly different characteristics from any counterpart found in nature. The claims do not effect a transformation or reduction of a particular bacterium to a different state or thing. (Step 2A prong 2: NO). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: NO).
Applicant may consider amending claim 3 to recite “a freeze-dried composition comprising Leuconostoc mesenteroides…” in order to obviate the rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-23 and 30 of copending Application 18/711378 in view of Chin (WO-2021177600, published 09/10/2021, of record in IDS filed on 07/08/2025, reference is made to the corresponding English language application EP-4134089A1).
Regarding instant claims 3-10, copending claim 19 recites a Leuconostoc mesenteroides strain or a culture thereof. Copending claims 20 and 22 recite Leuconostoc mesenteroides deposited under accession number KCCM13059P. Copending claims 22 and 23 recite Leuconostoc mesenteroides deposited under accession number KCCM13060P. Copending claim 30 recites the strain or the culture is administered as a food.
Copending claims 19-23 and 30 do not recite strains are freeze-dried or the composition comprises a pharmaceutically acceptable edible carrier.
However, Chin teaches a composition comprising Leuconostoc mesenteroides or a culture thereof ([0001], [0023], [0051]), and teaches that the strain can be freeze-dried and combined with an edible carrier such as starch ([0024], [0029]).
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 the composition recited in copending claims 19-23 and 30 by freeze-drying the strains and adding starch, as suggested by Chin. One of ordinary skill in the art would be motivated to do so in order to increase the bacterium’s shelf life and form a stable composition.
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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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657
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