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 .
Status of the Claims
Claims 1-11 are pending (claim set as filed on 8/3/2026). Claims 2 and 4-11 are withdrawn due to a restriction/election requirement. Claims 1 and 3 are under examination.
Election/Restrictions
Claims 2 and 4-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected composition and method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/3/2026.
Applicant's election with traverse of the inventions of Group I in the reply filed on 8/3/2026 is acknowledged. The traversal is on the ground that there exists no undue administrative burden to search and consider all claims. This argument is not found persuasive because the inventions are directed towards distinctly different subject matter such as a bacterial strain, methods of administering a strain to patients, skin improvement compositions, and methods of preparing products. Each group of inventions also require their own independent prior art searches based off their subject matter and distinct CPC codes as well. Therefore, there is a serious undue burden on the examiner to search for all the claimed subject matter and the requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR10-2023-0096239, filed on 7/24/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 and thus the effective filing date of this application is 7/24/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/23/2024 and 5/19/2026 were considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: the genus and species “Lactobacillus sakei” and “Achillea millefolium” are not properly italicized. 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 1 and 3 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 invention appears to employ novel biological materials, specifically a Lactobacillus sakei strain deposited in the Korean Culture Center of Microorganisms (KCT). Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable 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.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance 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.
Although Applicants have noted on pg. 34, ¶ 5 of the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
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 and 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a natural product without significantly more.
With regards to Step 1, the bacterial strain Lactobacillus sakei LGHNH22021 in claims 1 and 3 is a composition of matter.
With regards to Step 2A, prong one, claims 1 and 3 recite a deposited bacterial strain Lactobacillus sakei LGHNH22021. Dependent claim 3 recites an additional element of a wherein clause describing the origin of the strain from Achillea millefolium (yarrow). The claimed bacterial strain Lactobacillus sakei LGHNH22021 is a judicial exception as it is a natural product merely isolated from a Achillea millefolium plant (see specification pg. 34, ¶ 4), and thus was isolated from nature and deposited with no further modifications. It should be noted that the mere isolation of a bacterial species is not considered to be patent eligible. The additional element the origin of the strain from Achillea millefolium in claim 3 is also a judicial exception as a derivation from a plant is also a natural product with no further modifications. Nor do these elements interact in a way to form a materially different structure.
With regards to Step 2A, prong two, claims 1 and 3 do not recite any additional elements to the bacterial strain Lactobacillus sakei LGHNH22021 to integrate it into the instant application. Claim 3 recites a wherein clause describing the origin of the strain, but it does not change the inherent functionality of the strain or practically integrate it. As such, there are no additional elements that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claims 1 and 3 do not recite any additional elements that amount to significantly more than the judicial exception itself and therefore are not patent eligible.
For the following reasons, claims 1 and 3 are not deemed to encompass subject matter eligible material under 35 USC § 101. Claim 3 is rejected for depending on claim 1.
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.
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.
Claims 1 and 3 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 Park (Park et al., “Latilactobacillus sakei Wikim0066 Protects Skin through MMP Regulation on UVB-Irradiated In Vitro and In Vivo Model”, 2023 Feb 1, Nutrients, 15, pgs. 1-14).
Park’s disclosure relates to the administering of a Lactobacillus sakei strain to alleviate wrinkles and inflammation in mice (see abstract and pg. 1, ¶ 3).
Regarding claim 1, Park teaches a bacterial strain Lactobacillus sakei (see abstract). However, Park does not specify that the Lactobacillus sakei strain was specifically LGHNH22021, although it teaches a Lactobacillus sakei strain that has the same function to improve skin wrinkles and inflammation (see Park abstract and pg. 1, ¶ 3) as the deposited LGHNH22021 does (see specification pg. 4, ¶ 5-6). Therefore, it appears the prior art strain teaches the same strain since the prior art teaches the same strain and species with the same function used for the same purpose. Additionally it is noted that the specification indicates that the claimed strain is merely isolated and does not indicate the strain has been modified in any manner to differentiate it from Park et al. “When the prior art discloses a product which reasonably appears to be either identical with or only slightly different, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.".
Alternatively, if the strains are not the same but are instead obvious variants, it would be obvious to one of ordinary skill in the art at the time of the effective filing date to use an obvious variant. One would be motivated to do so because Park teaches the Lactobacillus sakei strain has the same function to improve skin wrinkles and inflammation (see Park abstract and pg. 1, ¶ 3) as the deposited LGHNH22021 does (see specification pg. 4, ¶ 5-6). So it would be prima facie obvious to do a simple substitution of one Lactobacillus sakei strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Thus, Park et al teach the strain or an obvious variant for the rationale discussed above.
Regarding claim 3, Park teaches the Lactobacillus sakei strain (see abstract). However, Park does not specify that the strain was derived from Achillea millefolium (yarrow), although it teaches a Lactobacillus sakei strain that has the same function to improve skin wrinkles and inflammation (see Park abstract and pg. 1, ¶ 3) as the deposited LGHNH22021 strain derived from Achillea millefolium does (see specification pg. 4, ¶ 5-6). Further, the instant specification notes that the strain may be isolated from Achillea millefolium, but is not limited thereto as long as the strain has the same characteristics as the deposited Lactobacillus sakei strain does (see specification pg. 5, ¶ 3). Therefore, absent evidence that the source of the strain imparts a structural difference, it appears the prior art strain teaches the same strain.
Regarding claim 3, alternatively, if the strain derived from Achillea millefolium has a slight difference, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use a Lactobacillus sakei strain derived from any source which has the same function. One would be motivated to do so because Park teaches the Lactobacillus sakei strain has the same function to improve skin wrinkles and inflammation (see Park abstract and pg. 1, ¶ 3) as the deposited LGHNH22021 does (see specification pg. 4, ¶ 5-6) and the instant specification further notes that the strain may be isolated from Achillea millefolium, but is not limited thereto as long as the strain has the same characteristics as the deposited Lactobacillus sakei strain does (see specification pg. 5, ¶ 3). So it would be prima facie obvious to do a simple substitution of one Lactobacillus sakei strain for another as they are functionally the same and one would have had a reasonable expectation of success in doing so.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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