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 1-8, 15-20 and 27-30 filed September 15, 2025 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/15/2025 has been entered.
Status of Claims
As indicated in the Office Action of 06/06/2024, claims 1-8 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/08/2024.
Response to Amendment
Applicant’s amendments, filed 09/15/2025 are acknowledged. Applicant has amended the phrase “said alcohol” to amount of “the benzyl alcohol” and also amended the phrase “the hydrocarbon” to “the mineral oil”.
Withdrawn Rejection(s)
Applicant’s arguments, filed 09/15/2025 are acknowledged. Applicant’s arguments pertaining to the 35 U.S.C 103(a) rejection of record of claims 27-30 in view of the combination of Precopio (U.S. Patent 7,294,342 published 11/13/2007), Bowles (WO2006/076761 published 07/27/2006), Parker (US2004/0062785 published 04/01/2004) and Liu (W002012/096836 published 07/19/2012) and Shionogi et al are persuasive. As such, the pending 35 U.S.C 103 rejections of record are withdrawn.
In addition, the copending double patenting rejection of record with U.S. Patent 9,839,631 in view of Precopio (U.S. Patent 7,294,342 published 11/13/2007), Bowles (WO2006/076761 published 07/27/2006), Parker (US2004/0062785 published 04/01/2004) and Liu (W002012/096836 published 07/19/2012), U.S. Patent 8,212,038 in view of Precopio (U.S. Patent 7,294,342 published 11/13/2007), Bowles (WO2006/076761 published 07/27/2006), Parker (US2004/0062785 published 04/01/2004) and Liu (W002012/096836 published 07/19/2012) and U.S. Patent 7,812,163 in view of Precopio (U.S. Patent 7,294,342 published 11/13/2007), Bowles (WO2006/076761 published 07/27/2006), Parker (US2004/0062785 published 04/01/2004) and Liu (W002012/096836 published 07/19/2012) are also withdrawn for the same reasons as applied to the 35 U.S.C 103 rejections of record.
Applicant's arguments, filed 09/15/2025 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Double Patenting-Rejections Maintained
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 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10 of U.S. Patent No. 10,292,389.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claims 8-10 of U.S. Patent 10,292,389 are directed to the treatment of a lice infestation comprising topically applying to a host having a lice infestation an effective amount of a composition comprising: 0.5-1.0%wt. 5,5’-dimethyl-2,2’-dipyridyl; 1-3% wt. benzyl alcohol; 20%-30% wt. mineral oil; 60-90% wt. water; 0.1-0.5%wt. carbomer, 0.1-1% trolamine, 0.2-1.0% wt. butylated hydroxy toluene and 0.5% to 1.0% wt. polysorbate 20. The amounts of 5,5’-dimethy-2,2’-dipyridyl, benzyl alcohol, mineral oil, water, carbomer, trolamine, butylated hydroxy toluene and polysorbate 20 embraced within the topically applied composition of claims 8-10 of U.S. Patent 10,292,389 lie inside the topically applied composition embraced within instant claims 27-30.
Claims 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,510,410.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of U.S. Patent 11,510,410 are directed to the use of a composition comprising 0.5-1.0%wt. 5,5’-dimethyl-2,2’-dipyridyl; 1-3% wt. benzyl alcohol; 20%-30% wt. mineral oil; 60-90% wt. water; 0.1-0.5%wt. carbomer, 0.1-1% trolamine, 0.2-1.0% wt. butylated hydroxy toluene and 0.5% to 1.0% wt. polysorbate 20 for ovicidal and lousicidal purposes, which overlaps with the methodology and composition applied in instant claims 27-30. For double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010), See Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008) and Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). We held that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use." Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86.
In Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,563,165 ("′165 patent"), at col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n. 9; see U.S. Patent No. 5,760,068 ("′068 patent") col.97 l.49-col.108 l.29. After rejecting the patentee's objection to our consideration of the specification of the earlier patent, we determined that the later patent "merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent." Pfizer, 518 F.3d at 1363. As such, we concluded that the asserted claims of the later patent were not "patentably distinct" from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.
Thus, the holding of Geneva and Pfizer, that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use," extends to any and all such uses disclosed in the specification of the earlier patent. Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. In the present case, as disclosed in the patent of claims 1-13 of U.S. Patent 11,510,410 the composition comprising 0.5-1.0%wt. 5,5’-dimethyl-2,2’-dipyridyl; 1-3% wt. benzyl alcohol; 20%-30% wt. mineral oil; 60-90% wt. water; 0.1-0.5%wt. carbomer, 0.1-1% trolamine, 0.2-1.0% wt. butylated hydroxy toluene and 0.5% to 1.0% wt. polysorbate 20 is directed to the identical use of providing an ovicidal and lousicidal effect for treating a pest infestation, which overlaps with the methodology and composition applied in instant claims 27-30.
Applicant traverses. Applicant asserts that the pending claims recite methods comprising particular amounts of formulary components that function specifically to act as an activating solvent system for the 5,5'-dimethyl-2,2'-dipyridyl, which are features and functions that are not reasonably expected (i.e., non-obvious) based on the guidance provided by the references relied on in the pending rejections
Response to Arguments
Applicant’s arguments, filed 09/15/2025 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the pending claims recite methods comprising particular amounts of formulary components that function specifically to act as an activating solvent system for the 5,5'-dimethyl-2,2'-dipyridyl, which are features and functions that are not reasonably expected (i.e., non-obvious) based on the guidance provided by the references relied on in the pending rejections, this argument is unavailing.
The capacity of the claimed amounts of benzyl alcohol, mineral oil, trolamine, BHT and polysorbate 20 to act as an activating solvent system for 5,5’-dimethyl-2,2’-dipyridyl is merely a recognition of a latent property of the combined components embraced within the composition embodied claims 1-13 of U.S. Patent No. 11,510,410 and also embodied within the topical administration methodology of claims 8-10 of U.S. Patent 10,292,389.
Said latent property will naturally flow from the combination of benzyl alcohol, mineral oil, trolamine, BHT and polysorbate 20 5,5’-dimethyl-2,2’-dipyridyl as disclosed in the rejections of record above. See MPEP 2145. For this reason, the rejections of record are maintained.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GEORGE W KOSTURKO/Examiner, Art Unit 1621