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 .
Status of Claims
Claims 1, 5, 8, and 12-21 are pending in the instant application.
Claims 2-4, 6-7, and 9-11 have been canceled.
Information Disclosure Statement
Applicant has submitted no Information Disclosure Statement (IDS) with this application. Applicant is reminded per 37 CFR 1.56, “Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability …”
Withdrawn Objections/Rejections
Applicant has traversed the rejection of Claims 1-20 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The cancellation of Claims 2-4, 6-7, and 9-11 renders the rejection thereof moot.
The examiner finds Applicant’s traversal persuasive. In particular, Applicant notes at Page 5, Second Paragraph of the remarks filed April 27th, 2026 that YEL002 is a known compound with recognized radioprotective and anti-inflammatory properties and that a person having ordinary skill in the art would expect YEL002 to have beneficial effects on inflammatory skin conditions including psoriasis, eczema, and keratosis.
Further, Applicant establishes the disclosure does not require undue experimentation to use. At Page 6, Third Paragraph of the remarks filed April 27th, 2026, Applicant establishes that the instant disclosure requires only application of the disclosed composition to a recited condition followed by observation.
Taken together, in view of the prior art noted by the Applicant (US 9,045,474; cited in non-final rejection mailed January 27th, 206) and the arguments noted above, the examiner finds the arguments persuasive to overcome this rejection. This rejection is hereby withdrawn.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Schiestl et. al. (US 9,045,474 B2; cited in non-final rejection mailed January 27th, 2026; hereinafter referred to as Schiestl) is maintained.
Applicant traversed this rejection on the basis that Schiestl teaches mitigating radiation-induced tissue damage in proliferating tissue, but does not disclose treating non-radiation induced skin conditions.
The examiner does not find this argument persuasive.
Instant Claim 1 is drawn to a method of treating a skin condition including sunburn. Sunburn would be tissue damage that is a result of radiation.
At Column 4, Line 55, Schiestl teaches YEL002 as the compound having the formula IA. At Column 13, Line 63, Schiestl teaches that Formula IA is also described as Yel002 or Rad2.
At Column 2, Lines 21-25, Schiestl teaches a compound effective for mitigating tissue damage. At Column 5, Lines 30-31, Schiestl teaches the tissue damage can be induced by radiation of any kind.
At Column 17, Third Paragraph, Schiestl teaches the composition of various embodiments of the invention is suitable for formulation for topical administration.
At Claim 3, Schiestl teaches the method is suitable for mitigating tissue damage by radiation including ultraviolet radiation. The broadest reasonable interpretation of the instantly recited sunburn would include tissue damage due to ultraviolet radiation.
Taken together, Schiestl teaches a method of treating a sunburn, and therefore Claim 1 is anticipated.
Double Patenting
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.
The rejection of Claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,045,474 B2 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and U.S. Patent No. ‘474 are both drawn to the treatment of a skin condition comprising administration of Yel002.
Applicant has traversed this rejection on the basis that mitigating tissue damage is not the same as treating a skin condition.
The examiner does not find this persuasive.
Claim 1 of U.S. Patent No. ‘474 is drawn to administration of a compound of Formula IA as a method of mitigating tissue damage. As noted above, Formula IA in U.S. Patent ‘474 is YEL002 (see Column 13, Line 63 of U.s. Patent No. ‘474). Claim 2 of U.S. Patent No. ‘474 is drawn to administration of the compound in a pharmaceutical composition. As noted above, compositions taught by U.S. Patent No. ‘474 are suitable for formulation for topical administration (see Column 17, Third Paragraph of U.S> Patent No. ‘474).
The broadest reasonable interpretation of treating a sunburn, as instantly recited at instant Claim 1, would include mitigating tissue damage due to radiation. Therefore, instant Claim 1 and Claims 1-2 of U.S. Patent ‘474 are not patentably distinct.
The following rejections are necessitated by amendment:
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.
Claim 21 is 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.
Claim 21 contains the trademark/trade name Cosphaderm. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a cosmetic base and, accordingly, the identification/description is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 8, and 12-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 5, 8, and 12-20 each depend from Claim 1, which is drawn to the treatment of a skin condition wherein the skin condition is keratosis, psoriasis, eczema, inflammation of the skin, acne, precancerous skin lesions, sunburn, scarring, discolored skin patches, or itching from insect or tick bites. Claim 5 improperly expands the scope of Claim 1, as it is drawn to treatment of skin wrinkles. Claim 8 improperly expands the scope of Claim 1, as it is drawn to the treatment of sagging skin. Claim 12 improperly expands the scope of Claim 1, as it is drawn to the treatment of arthritis. Claim 13 improperly expands the scope of Claim 1, as it is drawn to the treatment of skin incisions during surgery. Claim 14 improperly expands the scope of Claim 1, as it is drawn to the treatment of whiplash syndrome. Claim 15 improperly expands the scope of Claim 1, as it is drawn to the treatment of abscess. Claim 16 improperly expands the scope of Claim 1, as it is drawn to the treatment of skin pain. Claim 17 improperly expands the scope of Claim 1, as it is drawn to the treatment of warts. Claim 18 improperly expands the scope of Claim 1, as it is drawn to the treatment of broken toes or fingers. Claim 19 improperly expands the scope of Claim 1, as it is drawn to treatment of burn blisters, burn inflammation, and pain caused by burns. Claim 20 improperly expands the scope of Claim 1, as it is drawn to the treatment of Hidradenitis Suppurativa.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 8, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schiestl et. al. (US 9,045,474; cited in non-final rejection mailed January 27th, 2026; hereinafter referred to as Schiestl).
At Column 4, Line 55, Schiestl teaches YEL002 as the compound having the formula IA. At Column 13, Line 63, Schiestl teaches that Formula IA is also described as Yel002 or Rad2.
At Column 22, Lines 22-27, Schiestl teaches the disclosed compositions have anti-inflammatory properties.
At Column 33, Lines 22-26, Schiestl states, “Mitigation effects of Yel001 and Yel002 on radiation-induced cancer of the proliferating hematopoietic cells are translatable into other radiation (or UV)-induced cancer models of proliferating tissues such as skin and intestinal lining.”
At Column 17, Third Paragraph, Schiestl teaches the composition of various embodiments of the invention is suitable for formulation for topical administration.
Taken together, Schiestl teaches Yel002 has recognized radioprotective and anti-inflammatory properties. In fact, Applicant states at Page 5, Second Paragraph of the remarks filed April 27th, 2026, “YEL002 is a known compound (see US 9,045,474) with recognized radioprotective and anti-inflammatory properties. One of skill in the art would reasonably expect YEL002 to have beneficial effects on inflammatory skin conditions such as psoriasis, eczema, and keratosis, which share underlying inflammatory pathways with radiation-induced damage. The prior art thus provides a reasonable expectation of success, not a need for undue experimentation.”
Taken together, applying KSR exemplary rationale E, a person having ordinary skill in the art would have found it obvious to try topical administration of YEL002 to attempt treatment of the instantly recited conditions with reasonable expectation of success. In fact, as noted above, the Applicant acknowledges such an application is obvious based on the teachings disclosed by Schiestl.
Conclusion
Claims 1, 5, 8, and 12-21 are rejected.
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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624
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