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 .
Detailed Action
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 April 2025, 7 July 2025, 12 December 2025 and 15 January 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a continuation of Application 17/680970 (now U.S. Patent No. 12,150,970) filed 25 February 2022. Claims 1-21 are cancelled. Claims 22-48 are currently pending and examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
3. Claims 33-39 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.
4. Claims 33-34 recite the limitation "the atopic dermatitis" in line 1. There is insufficient antecedent basis for this limitation in the claim.
5. Claims 33-39 are directed to “The method of claim”. However, claim 31 is directed to “A hydrogel formulation”. The claims are directed to two different inventions, a method and a product; thus the metes and bound cannot be determined. It is believed claims 33-34 should depend from claim 32, which would correct the issue with claims 35-39.
Double Patenting
6. 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.
7. Claims 22-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-56 of U.S. Patent No. 12,150,970.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant Application and U.S. Patent No. 12,150,970 are directed to hydrogels comprising filtered latex Croton lechleri, glycerin, methylparaben, propylparaben, water, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic, sodium hexametaphosphate, medium chain triglycerides, acrylamide, sodium acryloyldimethyl taurate copolymer, isohexadecane and polysorbate 80. The only difference lies in the fact that the instant application is directed to methods of treating and U.S. Patent No. 12,150,970 is directed to the composition and further includes the makeup of Croton lecheri, wherein Croton lechleri contains at least about 110 PPM of Gallocatechin, at least about 780 PPM of Epigallocatechin, at least about 1.6 PPM of Catechin, at least about 2 PPM of Epicatechin, at least about 45 PPM Taspine, and at least about 0.1 PPM of dimethylcedrusin. Thus, the invention of the patent is in effect a "species of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). In addition, U.S. Patent No. 12,150,970 also contains method of treating claims and the instant application contains composition claims. The dependent claims are included in this rejection for further describing the components of the composition and amounts thereof. Thus the two are not patentably distinct.
Conclusion
8. No claims are allowed at this time.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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