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 .
Claims Status
Claims 1-3 are pending and under current examination.
Applicants' remarks and amendment filed 03/09/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application
New rejections necessitated by claim amendment
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.
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(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (United States Patent 10696680) and Vyas et al. (Cutaneous manifestations associated with melanoma) as evidenced by Sun et al. (Ultraviolet Radiation and Melanomagenesis: From Mechanism to Immunotherapy-2020).
Chen et al. discloses a method of treating damage from UV exposure in a mammal by treating melanoma, see claims 1-9. The composition being administered comprises linoleic acid conjugated to perillyl alcohol, see claims 1 and 9. As evidenced by Sun et al. solar ultraviolet radiation is the main cause for melanoma. Melanoma is caused by UV radiation from sunlight that damages the epidermis, see Sun et al. Therefore, the treatment of melanoma as taught by Chen et al. inherently treats damage which has been caused by UV exposure. A composition comprising perillyl alcohol POH conjugated with linoleic acid is delivered for treatment of melanoma, thus occurs after UV exposure.
Regarding claim 2, Chen et al. discloses treatment of melanoma. As evidenced by Sun et al., solar ultraviolet radiation is considered the main factor for melanoma and is caused by UVB wherein UVB causes damages to the epidermis. Therefore, since the composition of Chen treats melanoma, the composition necessarily treats damage caused by UV-B exposure from the sun.
Regarding claim 3, Chen disclose wherein the composition is applied topically, see claims 6-7.
Chen does not expressly teach a condition including pigmentary change as the result of the UV radiation, see claim 1.
However, Vyas teaches that melanoma arises as a pigmented lesion where it is rare to have non pigmented lesions, see section 2.
Thus, it would have been prima facie obvious that in treating a genus of melanoma in Chen et al. that a pigmentary skin lesions is being treated since melanoma causes pigmented lesions and melanoma is caused by ultraviolet radiation. Therefore, the treatment of Chen et al. is inclusive of skin that has undergone a pigmentary change.
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.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of U.S. Patent No. 9522918 in view of Vyas et al. (Cutaneous manifestations associated with melanoma) as evidenced by Sun et al. (Ultraviolet Radiation and Melanomagenesis: From Mechanism to Immunotherapy-2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 918 recite topically administering POH conjugated to linoleic acid to treat melanoma (see claims 3-5 of Patent ‘918)
The difference between Patent ‘918 and the instant claims is that the POH conjugated to linoleic acid composition treats or prevents damage from UV exposure in a mammal including UV-B.
However, the instant claims of ‘Patent ‘918 are directed to treating cancers including melanoma. As evidenced by Sun et al. solar ultraviolet radiation is the main cause for melanoma. Melanoma is caused by UV radiation from sunlight that damages the epidermis., see Sun et al. Therefore, the treatment of melanoma claimed in Patent ‘918 necessarily treats damage which has been caused by UV exposure. A composition comprising perillyl alcohol POH conjugated with linoleic acid is delivered for treatment of melanoma, thus occurs after UV exposure. As evidenced by Sun et al., solar ultraviolet radiation is considered the main factor for melanoma and is caused by UVB wherein UVB causes damages to the epidermis. Therefore, since the composition of Patent ‘918 treats melanoma, the composition necessarily treats sun damage caused by UV-B exposure from the sun.
The difference between Patent ‘918 and the instant claims is that the POH conjugated to linoleic acid composition treats or prevents damage from UV exposure in a mammal including UV-B.
However, the claims of ‘693 are directed to treating cancers including melanoma (claim 12 and 17.) As evidenced by Sun et al. solar ultraviolet radiation is the main cause for melanoma. Melanoma is caused by UV radiation from sunlight that damages the epidermis, see Sun et al.
Patent ‘918 does not expressly teach a condition including pigmentary change as the result of the UV radiation, see claim 1.
However, Vyas teaches that melanoma arises as a pigmented lesion where it is rare to have non pigmented lesions, see section 2.
Thus, it would have been obvious that in treating a genus of melanoma that a pigmentary skin lesion is being treated since melanoma causes pigmented lesions. Therefore, the treatment of Patent ‘918 is inclusive of skin that has undergone a pigmentary change and treatment of melanoma claimed in Patent ‘918 necessarily treats damage which has been caused by UV exposure. A composition comprising perillyl alcohol POH conjugated with linoleic acid is delivered for treatment of melanoma, thus occurs after UV exposure. As evidenced by Sun et al., solar ultraviolet radiation is considered the main factor for melanoma and is caused by UVB wherein UVB causes damages to the epidermis. Therefore, since the composition of Patent ‘918 treats melanoma, the composition necessarily treats sun damage caused by UV-B exposure from the sun and pigmentary changes which are the result of melanoma.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Patent 9522918 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct invention.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10696680 in view of Vyas et al. (Cutaneous manifestations associated with melanoma) as evidenced by Sun et al. (Ultraviolet Radiation and Melanomagenesis: From Mechanism to Immunotherapy-2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 680 recite topically administering POH conjugated to linoleic acid to treat melanoma (see claims 1 and 9 Patent ‘680)
The difference between Patent ‘680 and the instant claims is that the POH conjugated to linoleic acid composition treats or prevents damage from UV exposure in a mammal including UV-B.
However, the instant claims of ‘Patent ‘680 are directed to treating cancers including melanoma. As evidenced by Sun et al. solar ultraviolet radiation is the main cause for melanoma. Melanoma is caused by UV radiation from sunlight that damages the epidermis, see Sun et al. Therefore, the treatment of melanoma claimed in Patent ‘680 necessarily treats damage which has been caused by UV exposure. A composition comprising perillyl alcohol POH conjugated with linoleic acid is delivered for treatment of melanoma, thus occurs after UV exposure. As evidenced by Sun et al., solar ultraviolet radiation is considered the main factor for melanoma and is caused by UVB wherein UVB causes damages to the epidermis. Therefore, since the composition of Patent ‘680 treats melanoma, the composition necessarily treats sun damage caused by UV-B exposure from the sun.
Patent ‘680 does not expressly teach a condition including pigmentary change as the result of the UV radiation, see claim 1.
However, Vyas teaches that melanoma arises as a pigmented lesion where it is rare to have non pigmented lesions, see section 2.
Thus, it would have been obvious that in treating a genus of melanoma that a pigmentary skin lesion is being treated since melanoma causes pigmented lesions. Therefore, the treatment of Patent ‘680 is inclusive of skin that has undergone a pigmentary change and treatment of melanoma claimed in Patent ‘680 necessarily treats damage which has been caused by UV exposure. A composition comprising perillyl alcohol POH conjugated with linoleic acid is delivered for treatment of melanoma, thus occurs after UV exposure. As evidenced by Sun et al., solar ultraviolet radiation is considered the main factor for melanoma and is caused by UVB wherein UVB causes damages to the epidermis. Therefore, since the composition of Patent ‘680 treats melanoma, the composition necessarily treats sun damage caused by UV-B exposure from the sun and pigmentary changes.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Patent 10696680 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct invention.
Response to remarks
Applicants argue that none of the rejections taught the newly amended limitation of claim 1 including where the damage is pigmentary changes.
However, the amendment to the claims necessitated the new rejections presented above. It is noted that the prior art teaches treatment of melanoma in which as evidenced by Sun is caused by ultraviolet radiations. The prior art teaches that melanoma causes pigmentary change with a non-pigmentary change being rarer. Therefore, in treating damage such as melanoma, this is inherently caused by ultraviolet damage and per the prior art would have been obvious that the skin exhibits a pigmentary change since a non-pigmentary change is rarer.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive and the amendment to the claims necessitated new grounds of rejections. 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).
Currently, all claims are rejected and no claims are allowed.
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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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