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 .
The amendment and response filed on May 26, 2026 are received.
Claims 7-12, 14, 15 and 17 are canceled by Applicant.
Claims 1-6, 13 and 16 are pending in this application and claims 1-6, 13 and 16 are being examined.
Restriction/Election:
Applicant’s election of Group I, claims 1-6, in the reply filed on 05/26/2026 is acknowledged.
The election of the species “3-isopropylmalate dehydratase or a gene encoding the same“ in the same reply is also acknowledged.
Because, applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Objection(s):
Claim(s):
Claim 13 is objected to because of the following informalities:
In claim 13, line 1, replace “the” with –The--.
Appropriate correction is required.
Specification:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 16 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Cutibacterium sp. strains (KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P or KCCM13037P).
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.
It appears that deposit were made in this application as filed as noted in applicant’s specification (page 11). However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, 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.
Copy of deposit receipt is/are required.
Double Patenting Rejection:
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 1-6, 13 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6 and 11-12 of copending Application No. 18/704,774 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other in view of the side by side comparison below of the limitations of claimed method of instant application and method of claims 1-4, 6 and 11-12 of copending Application No. 18/704,774.
Claims of copending application No.18704774:
Claims of instant application No.18705390:
1. A method for skin improvement, comprising administering a Cutibacterium sp. strain, a culture product of the strain, or a combination thereof, into a subject in need of the skin improvement, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and(b) a lactococcin 972 family bacteriocin or a gene encoding the same.
1. A method for preventing, alleviating or treating inflammatory skin disease, comprising administering a Cutibacterium sp. strain, a culture product of the strain, or a combination thereof into a subject in need of preventing, alleviating or treating the inflammatory skin disease, wherein the Cutibacterium sp. strain comprises (a) an Lrp/AsnC family transcriptional regulator or a gene encoding the same, and (b) a lactococcin 972 family bacteriocin or a gene encoding the same.
2. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise at least one protein selected from the group consisting of the following (1) to (6) or a gene encoding the same: (1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type l-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
2. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise at least one protein selected from the group consisting of the following (1) to (6) or a gene encoding the same:(1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type I-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
3. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise-the following (1) to (6) or a gene encoding the same: (1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type l-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
3. The method according to claim 1, wherein the Cutibacterium sp. strain does not comprise the following (1) to (6) or a gene encoding the same:(1) beta-glucuronidase or a gene encoding the same, (2) 2-isopropylmalate synthase or a gene encoding the same, (3) 3-isopropylmalate dehydratase or a gene encoding the same, (4) type I-E CRISPR-associated protein Cse1/CasA or a gene encoding the same, (5) type I-E CRISPR-associated protein Cas7/Cse4/CasC or a gene encoding the same, and (6) CRISPR-associated helicase/endonuclease Cas3 or a gene encoding the same.
4. The method according to claim 1, wherein the Cutibacterium sp. strain comprises a 16S rRNA gene of SEQ ID NO: 8.
4. The method according to claim 1, wherein the Cutibacterium sp. strain comprises a 16S rRNA gene of SEQ ID NO: 8.
5. The method according to claim 1, wherein the Cutibacterium sp. strain has anti-inflammatory activity; or preventing, alleviating or treating activity of inflammatory skin disease.
6. The method according to claim 1, wherein the skin improvement is at least one selected from the group consisting of scalp protection, hair loss prevention, hair moisture supply, and hair nutrition supply.
6. The method according to claim 1, wherein the inflammatory skin disease is at least one selected from the group consisting of hair loss, rosacea, erythema nodosum, erythema multiforme, keratosis pilaris, psoriasis, eczema, atopic dermatitis and acne.
11. The method according to claim 1, wherein the Cutibacterium sp. strain is deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P or KCCM13037P.
16. The method according to claim 1, wherein the Cutibacterium sp. Strain is deposited under Accession number KCCM13032P, KCCM13033P, KCCM13034P, KCCM13035P, KCCM13036P or KCCM13037P.
12. The method the Cutibacterium sp. strain, or the culture product of the strain, or the combination thereof is administered in any one formulation selected from the group consisting of solution, suspension, emulsion, paste, gel, cream, powder, ointment, patch, cosmetic water, essence, gel, lotion, mask, pack, powder, capsule and spray.
13. the method according to claim 1, wherein the Cutibacterium sp. strain, the culture product of the strain, or the combination thereof is administered as a food or feed composition.
Therefore, in view of the above side by side comparison of claimed methods, the method as disclosed by claims 1-4, 6 and 11-12 of copending Application No. 18/704,774 anticipate or make obvious the claimed method as disclosed by claims 1-6, 13 and 16 of instant application. In addition, regarding claim 5, the claimed properties of, anti-inflammatory activity; or preventing, alleviating or treating activity of inflammatory skin disease, are inherent to the claimed method taught by claims 1-4, 6 and 11-12 of copending Application No. 18/704,774.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571)272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KADE ARIANI/Primary Examiner, Art Unit 1651
Prosecution Insights