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 with traverse of invention Group I, claim 24, in the reply filed on 02/17/2026, is acknowledged.
In Applicant’s reply, Applicant states that “the presently specified Lactobacillus
rhamnosus 11-7 strain having accession number CCTCC NO: M 2021185, which is required in
each and every pending claim, exhibits significantly superior properties over known prior art
strains such as that recited in Mohammedsaeed”, and concludes that “the restriction requirement is untenable and should be withdrawn” (remarks, page 8).
The Examiner responds that the specification compares the claimed strain to a cornmercially available Lactobacillus rhamnosus (specification, see Comparative Example 4 on page 26), and does not provide further information that would identify the recited commercially available strain of Lactobacillus rhamnosus as the Lactobacillus strain taught by Mohammedsaeed et al. (“Lactobacillus rhamnosus GG Inhibits the Toxic Effects of Staphylococcus aureus on Epidermal Keratinocytes”, published on 07/11/2014, Applied and Environmental Microbiology, Vol. 80, No. 18, pages 5773-5781), hereinafter ‘Mohammedsaeed 1’. As such, the specification does not teach wherein the claimed strain is compared to Mohammedsaeed 1’s strain.
As previously discussed in the Restriction/Election requirement, regarding the shared technical feature Lactobacillus rhamnosus 11-7 strain, which is preserved in the China Center for Type Culture Collection (CCTCC) with accession number CCTCC NO: M 2021185, Mohammedsaeed 1 teaches a ferment lysate prepared from a Lactobacillus rhamnosus strain that has antibacterial properties (page 5774, left column, paragraphs 2-3; see abstract and Table 1).
Mohammedsaeed 1 does not teach wherein the Lactobacillus rhamnosus strain is Lactobacillus rhamnosus 11-7 strain, which is preserved in the China Center for Type Culture Collection (CCTCC) with accession number CCTCC NO: M 2021185. However, the instant specification describes that a ferment lysate prepared from the claimed Lactobacillus rhamnosus strain has antibacterial properties (see specification, page 4, paragraphs 3-4).
Based on Mohammedsaeed 1’s teachings, it is highly likely that Mohammedsaeed 1’s strain and the instant strain are the same strain since the ferment lysates prepared from each strain both have antibacterial properties. However, if there should be a slight variation between Mohammedsaeed 1’s strain and the instantly recited strain, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted Mohammedsaeed 1’s L. rhamnosus strain with the instantly recited L. rhamnosus strain since ferment lysates prepared from Mohammedsaeed 1’s strain and from the instant strain both have antibacterial properties.
In conclusion, Applicant’s arguments are not found persuasive. The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 02/17/2026 has been entered. Claims 24-43 are pending (claim set as filed on 02/17/2026). Claims 25-43 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/17/2026.
Claim 24 is currently under examination and was examined on its merits.
Priority
This application filed on 09/25/2023 claims priority to PCT application no. PCT/CN2022/082787, filed on 03/24/2022, and claims foreign priority to application no. CN202110316031.8, filed on 03/24/2021. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 1/30/2025 and 09/25/2023 have been received and considered.
Drawings
The drawings are objected to because Figures 1, 2A-F, and 3A-F are visually unclear. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a combination of judicial exceptions without significantly more. The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972
(2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S.,132 S.
Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an
eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must
(a) not be directed to a judicial exception or must (b) contain additional elements that
amount to significantly more than the judicial exception itself.
'Directed to a judicial exception' analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claim 24 recites “Lactohacillus rhamnosus 11-7” which is considered a natural phenomenon, since it is a natural isolate (see specification, page 4, paragraph 3).
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No additional elements are cited that would integrate the judicial exception into a practical application.
'Significantly more' analysis:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not include any additional elements other than the judicial exception.
Therefore, claim 24 is directed to subject matter that is not patent-eligible and is rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(a)
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 24 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.
The microorganism Lactobacillus rhamnosus 11-7 strain is recited in the claim and, thus, is essential to the claimed invention. Because the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological materials are readily available to the public. It is noted that applicant has deposited the organisms (see, for example, claim 24 and specification pages 4 and 8), 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 a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain 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.” It is noted that the instant specification fails to provide any information about whether the deposit was made under the Budapest Treaty or whether the deposited organism is available to the public; the specification should be amended to include this information.
Claim Rejections - 35 USC § 102/103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim 24 is 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 O’Neill et al. (US 2017/0196919 A1, published on 07/13/2017), hereinafter ‘O’Neill’, as evidenced by Mohammedsaeed et al. (“Lactobacillus rhamnosus GG Lysate Increases Re-Epithelialization of Keratinocyte Scratch Assays by Promoting Migration”, published on 11/05/2015, Scientific Reports, Vol. 5, 16147, pages 1-11), hereinafter ‘Mohammedsaeed 2’.
O’Neill’s general disclosure relates to “probiotic bacteria and particularly, although not exclusively, to anti-bacterial compositions derived from probiotic bacteria” (see entire document, including paragraph [0001]).
Regarding claim 24, pertaining to the Lactobacillus rhamnosus strain, O’Neill teaches the Lactobacillus rhamnosus strain GG with the accession number ATCC 53103 (paragraph [0013]). O’Neill discloses wherein a ferment lysate prepared from the Lactobacillus rhamnosus strain has antibacterial properties (paragraphs [0080], [0105]-[0106], [0112]; see Fig. 5A-C and Table 1) and promotes viability of infected keratinocytes (paragraphs [0005], [0101]-[0104]; see Figures 2-3, and 4B).
In addition, lysates of L. rhamnosus GG ATCC 53103 increase the expression level of genes related to the antimicrobial response in keratinocytes, thereby improving skin immunity, as evidenced by Mohammedsaeed 2 (see Table 1).
O’Neill does not teach wherein the Lactobacillus rhamnosus strain is Lactobacillus rhamnosus 11-7 strain, which is preserved in the China Center for Type Culture Collection (CCTCC) with accession number CCTCC NO: M 2021185. However, the instant specification describes that a ferment lysate prepared from the claimed Lactobacillus rhamnosus strain has antibacterial properties, and up-regulates the expression level of genes related to the antimicrobial response in skin cells, thereby improving skin immunity (see specification, page 4, paragraphs 3-4).
Based on O’Neill’s teachings on strain ATCC 53103 and its inherent skin immunity promoting activity as evidenced by Mohammedsaeed 2, it is highly likely that O’Neill’s strain and the claimed strain are the same strain since the ferment lysates prepared from each strain both have antibacterial properties and increase the expression level of genes related to the antimicrobial response in skin cells, thereby promoting skin immunity. However, if there should be a slight variation between O’Neill’s strain and the instantly recited strain, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted O’Neill’s L. rhamnosus strain with the instantly claimed L. rhamnosus strain since ferment lysates prepared from O’Neill’s strain and from the instant strain both have antibacterial properties and promote skin immunity.
Claim 24 is 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 Dumas et al. (WO2020127581A1, published on 06/25/2020), hereinafter ‘Dumas’.
Dumas’ general disclosure relates to a “composition comprising a novel extract of Lactobacillus rhamnosus, in particular a lysate of Lactobacillus rhamnosus (CNCM 1-5313), and its beneficial effects on keratinous materials, in particular the skin” (page 3, lines 5-6)
Regarding claim 24, pertaining to the Lactobacillus strain, Dumas teaches Lactobacillus rhamnosus strain CNCM 1-5313 (page 3, lines 9-10). Dumas discloses wherein a ferment lysate prepared from the Lactobacillus rhamnosus strain stimulates the expression of antimicrobial peptide genes in keratinocytes, thereby improving skin immunity (see Example 1 on pages 7-9, especially page 9, lines 1-10; note, Probiotic LB is lysate from Lactobacillus rhamnosus CNCM I-5313, as indicated on page 7, lines 22, and 44-46).
Dumas does not teach wherein the Lactobacillus rhamnosus strain is Lactobacillus rhamnosus 11-7 strain, which is preserved in the China Center for Type Culture Collection (CCTCC) with accession number CCTCC NO: M 2021185. However, the instant specification describes that a ferment lysate prepared from the claimed Lactobacillus rhamnosus strain upregulates the expression level of antimicrobial peptides in skin cells, thereby improving skin immunity (see specification, page 4, paragraphs 3-4).
Based on Dumas’ teachings on strain CNCM 1-5313, it is highly likely that Dumas’ strain and the instant strain are the same strain since the ferment lysates prepared from each strain upregulate the expression level of antimicrobial peptides in skin cells. However, if there should be a slight variation between Dumas’ strain and the instantly recited strain, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted Dumas’ L. rhamnosus strain with the instantly recited L. rhamnosus strain since ferment lysates prepared from Dumas’ strain and from the instant strain both upregulate the expression level of antimicrobial peptides in skin cells, thereby improving skin immunity.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila 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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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
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/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653