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 .
The amendment filed 6/12/2026 has been entered. Claims 1-11, 13-14 and 20-26 are pending and are under examination.
Election/Restrictions
Applicant’s election without traverse of the species “suffering from pain secondary to diabetic neuropathy” in the reply filed on 6/12/2026 is acknowledged.
Since the claims have been amended to specify the subject is suffering from pain secondary to diabetic neuropathy, claims 1-11, 13-14 and 20-26 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/02/2025 have been and initialed copy is enclosed.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 83 recites “S. epidermitis” and should be corrected to S. epidermidis”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2 and 21 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 2 and 21 recite that the pharmaceutical composition comprises live S. epidermidis bacteria. The metes and bounds of these claims is indefinite. The instant specification discloses in paragraph 59 “as used herein, Staphylococcus epidermidis lipoteichoic acid (SELTA) may refer to isolated or synthesized LTA from S. epidermidis”. Thus, the composition of claim 1 and claim 14 comprises isolated or synthesized LTA from S. epidermidis”. For this reason, it is not clear whether the live S. epidermidis bacteria is in addition to the isolated or synthesized Staphylococcus epidermidis lipoteichoic acid (SELTA) in composition of claim 1 and 14.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 6-10, 13-14, 20-21 and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henn et al. US 20140199281 7-17-2014.
Claims 1-2, 14 and 21: Henn et al disclose a method of treating diabetic neuropathy in a subject in need thereof, the method comprising administering to the subject a composition comprising live (colony forming units CFU) S. epidermidis which comprises effective amounts of lipoteichoic acid (SELTA). See paragraph 8-13, paragraph 31, paragraphs 38-39, paragraph 62, paragraph 66, table 1 page 56 and table 8 p. 256.
Since diabetic neuropathy symptoms include pain or neurogenic pain, the method of Henn et al comprising administering live S. epidermidis to a subject to treat diabetic neuropathy, the method of Henn et al necessarily also treats the pain or neurogenic pain due to the diabetic neuropathy.
Claim 10: Henn et al discloses that the composition is administered orally. See paragraph 118.
Claim 11: the subject of Henn et al is suffering from diabetic neuropathy which results in neurogenic pain. The instant specification at paragraph 6 teaches that pain is secondary to diabetic neuropathy.
Claim 13: Since Henn et al discloses the same claimed method of claim 1, the method of Henn et al also modulates the expression of endogenous opioids in the subject.
Claim 20: Since Henn et al discloses the same claimed method of claim 14, the method of Henn et al also reduces calcitonin related gene peptide (CRGP) in the subject.
Claims 6-9 and 25-26: The instant specification discloses that S. epidermidis comprise SELTA having the structure set forth in claims 6-9 and 25-26 (see paragraph 59).
Status of Claims
Claims 1-2, 6-11, 13-14, 20-21 and 25-26 are rejected.
Claims 3-5 and 22-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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