DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 7/31/2025 wherein claim 61 has been amended.
Claims 61-63, 68, 69 and 75 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 7/31/2025 overcome the rejection of claim 61 made by the Examiner under 35 USC 112(a). This rejection has been withdrawn.
Applicant’s amendments filed 7/31/2025 overcome the rejection of claims 61-63, 68, 69 and 75 made by the Examiner under 35 USC 102(a)(1) over Van’t Land et al. (WO 02/076456). This rejection has been overcome as the reference does not disclose concurrent or post administration of the COL17A1 expression activator.
New Rejections, Necessitated by Amendment
Claim Rejections - 35 USC § 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 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 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 61-63, 68, 69 and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van’t Land et al. (WO02/076456; of record).
Van’t Land teaches that dividing living tissues like epithelial cells (skin) are very sensitive to the influence of the stresses of chemotherapy and radiotherapy and that chemotherapy and radiotherapy destroy non-target cells such as the epithelial cells of the skin. The destruction of epithelial cells causes complications such as limiting the dose of drug to be administered during therapy as well as complications to the damaged tissues such as injury, infection and pain (see pages 1-3). However, chemotherapeutic drugs cause undesired epithelial cell death and that administration of therapeutic agents, such as apocynin (see claim 3) (Applicant’s elected species; see instant claims 61-63, 68 and 69), can be administered to inhibit apoptosis of critical cells, in particular stem cells, which are present in epithelial tissues, such as the skin, and are necessary in the process of replacing the differentiated cells that cannot themselves divide (see pages 1 and 2). Administration of apocynin in a prophylactic treatment suppresses apoptosis of stem cells which enables the stem cells to remain alive and maintain the health of the body’s skin by differentiating into epithelial cells. Van’t Land teaches that the apocynin may be administered as an oral, topical or subcutaneous formulation to a subject in need (see page 5). Oral, topical and subcutaneous formulations of apocynin are broadly understood as a ‘pharmaceutical composition’ as required by instant claim 75.
Regarding the instant limitation that the active ingredient is ‘a substance that induces or maintains the expression of COL17A1 in a cell’, this is a necessary outcome of administering the elected species, apocynin. See MPEP 2112.02(I).
Regarding the limitation that the anticancer agent is administered before or together with the COL17A1 expression activating agent (apocynin), it is noted that Van’t Land intends for the prophylactic administration of the apocynin. However, the administration of the apocynin concurrently with or after the administration of the anticancer agent would have been obvious as the selection of any order of performing process steps is considered obvious absent some new or unexpected results. See MPEP 2144.04(IV)(C). Thus, given that the administration of apocynin was known to improve skin health when administered before anticancer agents, it would be reasonably expected to perform that same function when provided together with or after the administration of an anticancer drug absent some evidence to the contrary.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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