Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-24 are pending. Claims 1 and 6-8 are examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-8), the species polysorbate 80 in the reply filed on 3/20/2026 is acknowledged.
Claims 2-5 and 9-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/20/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/25/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1 and 6-8 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.
In Claim 1, lines 1-2, the method of treating is with “oral administration”, then in line 9, the administering is “to a dermal tissue of a subject”. Which is the formulation administration used for “oral” or “dermal tissue”? It is unclear how the acute oral toxicity LD50 is relevant to the dermal formulation. Please correct.
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 and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10-15, and 20-23 of U.S. Patent No. 8815220 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the same method of treating skin with Curcuma with solvents are taught. The same solvent polysorbate 80 is also known as TWEEN 80.
U.S. Patent No. 8815220 B2:
1. A method of treating a skin to inhibit exposure of the skin to UVA and UVB, the method comprising topically administering to a dermal tissue of a subject an effective amount of a composition consisting essentially of a purified liquid extract from the roots of a Curcuma longa L. plant, the purified liquid extract including curcumin, demethoxycurcumin, and bisdemethoxycurcumin; the administering inhibiting exposure of the skin to UVA and UVB.
2. The method of claim 1, further comprising oral administration of an effective amount of an oral dosage form of the composition to the subject in combination with the topical administration.
3. The method of claim 1, the composition comprising polyoxyethylene (20) sorbitan monooleate (TWEEN 80 HP), polyethylene glycol, isopropyl myristate, or a combination thereof.
4. The method of claim 1, the composition comprising a combination of TWEEN 80 HP and isopropyl myristate.
5. The method of claim 1, the composition comprising a ratio of TWEEN 80 HP:isopropyl myristate ranging from about 20:80 to about 50:50.
10. A method of treating a skin to inhibit exposure of the skin to UVA and UVB, the method comprising topically administering to a dermal tissue of a subject an effective amount of an emulsion consisting essentially of a purified liquid extract from the roots of a Curcuma longa L. plant, the emulsion comprising curcumin, demethoxycurcumin, bisdemethoxycurcumin, a pharmaceutically acceptable oil; and, an emulgent; the administering inhibiting exposure of the skin to UVA and UVB.
11. The method of claim 10, further comprising oral administration of an effective amount of an oral dosage form of the composition to the subject in combination with the topical administration.
12. The method of claim 10, wherein the emulsion is an aqueous emulsion.
13. The method of claim 10, the composition comprising polyoxyethylene (20) sorbitan monooleate (TWEEN 80 HP), polyethylene glycol, isopropyl myristate, or a combination thereof.
14. The method of claim 10, the composition comprising a combination of TWEEN 80 HP and isopropyl myristate.
15. The method of claim 10, the composition comprising a ratio of TWEEN 80 HP:isopropyl myristate ranging from about 20:80 to about 50:50.
20. A method of treating a skin to inhibit exposure of the skin to UVA and UVB, the method comprising obtaining a kit containing a composition consisting essentially of a purified liquid extract from the roots of a Curcuma longa L. plant, the purified liquid extract including curcumin, demethoxycurcumin, and bisdemethoxycurcumin; an oral dosage form having the purified liquid extract; and, instructions for administering the purified liquid extract topically administering to a dermal tissue of a subject an effective amount of the composition to inhibit exposure of the skin to UVA and UVB; and, orally administering an effective amount of the oral dosage form to the subject.
21. The method of claim 20, the composition comprising polyoxyethylene (20) sorbitan monooleate (TWEEN 80 HP), polyethylene glycol, isopropyl myristate, or a combination thereof.
22. The method of claim 20, the composition comprising a combination of TWEEN 80 HP and isopropyl myristate.
23. The method of claim 20, the composition comprising a ratio of TWEEN 80 HP:isopropyl myristate ranging from about 20:80 to about 50:50.
However, the method of treating wounded skin is not taught.
The UVA and UVB exposure can lead to wounding dermal tissue and leading to inflammation of the dermal tissue. Therefore, the method for treating wounded tissue would be obvious to use.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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