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 .
Response to Amendment
Applicant’s amendment filed 01/15/2026 is acknowledged. Claims 17, 19, 22, 23, 24, 29, 31, 35 and 36 are amended, claims 25 and 26 are newly canceled and claims 37 and 38 are new.
Claims 17-24 and 27-38 are under examination.
Sequence Rules
The sequence listing filed 01/20/2026 is acknowledged. No errors were found by the USPTO during validation of the sequence listing. Thus, this application complies with the requirements of 37 CFR 1.821 through 1.825.
Objections/Rejections Withdrawn
Any previous rejections over claims 25 and 26 are hereby withdrawn in response to Applicant’s cancelation of those claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The objection to claims 24 and 36 for minor informalities is withdrawn in response to Applicant’s amendment of the claims to delete the duplicative phrase “has amino acids”.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 23 and 35 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment of the claims to remove exemplary language.
Claim Rejections - 35 USC § 102
The rejection of claims 17-24 and 29-36 under 35 U.S.C. 102(a)(1) as being anticipated by Brand et al. (US20110182903—on IDS filed 10/17/2022) is withdrawn in response to Applicant’s amendment of the claims removing reference to treating cutaneous, mucosal and intestinal wounds. The claims are now limited to inducing hair growth or preventing hair loss, which Brand et al. do not teach.
Rejections Maintained
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.
Scope of Enablement
The rejection of claims 17-23 and 27-35 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for scope of enablement, is maintained for reasons of record and the following. In addition, new claims 37 and 38 are hereby included in this rejection. Further, Applicant has amended the independent claims to recite preventing hair loss, thus, claims 24 and 36, not previously included in this rejection, are now included, as necessitated by Applicant’s amendment.
As noted in the previous Office action mailed 10/15/2025, the specification is enabling for the claimed methods comprising administering a soluble CD83 comprising:
amino acid residues 20-145 of SEQ ID NO: 2;
amino acid residues 1-130 of SEQ ID NO: 8;
amino acid residues 1-130 of SEQ ID NO: 10, or
amino acid residues 8-133 or 1-133 of SEQ ID NO 12.
The specification, does not, however, reasonably provide enablement for the claims as broadly recited. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Regarding prevention, the specification discloses a wound healing study in a mouse model (see Example 1, pages 26-36) and how to express sCD83 in Pichia pastoris (see Example 3, pages 38-39). The specification also discloses that administration of the soluble CD83 protein (sCD83) of the invention induced hair growth in a mouse model, including regrowth following wounding or depilation, and increasing eyelash number and length (see Example 2, pages 36-38). Therefore, the specification clearly teaches that sCD83 can induce hair or growth or regrowth in response to injury, but does not teach or suggest that sCD83 can be used to prevent hair loss from occurring. The specification is silent with respect to 100% prevention of hair loss occurring after administration of sCD83.
Response to Arguments
Applicant argues at pages 11-12 of the Remarks filed 01/15/2026 that the variations are conservative substitutions, thus the skilled person would know that they have no impact on protein stability.
This argument has been fully considered, but is not found persuasive. Applicant’s asserts that SEQ ID NOs: 8, 10 and 12 represent conservatively substituted variants that are also enabled, however, a comparison of the sequences shows that they only differ by a single substitution, whereas 10 amino acid residues represent about an 8% difference between the variants. The claims require the sCD83 induce hair growth or prevent hair loss. Small changes in protein structure can affect function. See Bhattacharya et al. and Fenton et al. (both of record), who teach even single substitutions can affect protein function (see also pages 8-9 of the Office action mailed 10/15/2025, hereby incorporated). The evidence in the specification is not commensurate with the scope of the claimed invention.
Written Description
The rejection of claims 17-23 and 25-35 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. In addition, new claims 37 and 38 are hereby included in this rejection.
Response to Arguments
Applicant argues at pages 12-13 of the Remarks filed 01/15/2025 that given the amendments to the claims, the skilled artisan would recognize that the encompassed variations have no impact on protein stability.
This argument has been fully considered, but is not found persuasive. The claims recite functional derivatives and fragments of the sCD83 polypeptides that may differ by having up to 10 amino acid residues conservatively substituted. The specification does not disclose how the sCD83 polypeptides can be mutated and still retain their ability to promote hair growth. A comparison of sequences set forth in SEQ ID NOs: 8, 10 and 12 shows that they only differ by a single substitution, whereas 10 amino acid residues represent about an 8% difference between the variants.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675