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 .
This Office action is responsive to Applicant’s preliminary amendment and remarks, filed 14 July 2026, in which claims 1 and 17 are amended to change the change the scope and breadth of the claim, and claims 7-8 are canceled.
This application is a domestic application, filed 18 Dec 2023; claims benefit as a CON of PCT/US22/34685, filed 23 June 2022; and which claims benefit of provisional application 63/214,967, filed 25 June 2021.
Claims 1-6 and 9-20 are pending in the current application. Claims 17-20, drawn to non-elected inventions, are withdrawn. Claims 1-6 and 9-16 are examined on the merits herein.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-16, in the reply filed on 14 July 2026 is acknowledged. The traversal is on the ground(s) that there would be no serious burden to examine the claims together. This is not found persuasive because as detailed in the Requirement for Restriction mailed 19 May 2026, a serious search and/or examination burden is shown because the inventions have a different classification, showing that the inventions have attained recognition in the art as a separate subject for inventive effort, and they would require different field of search or search strategies.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 July 2026.
Claim Rejections - 35 USC § 112
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.
Claim 16 is 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. Amended claim 1 includes the limitation “at a feeding frequency selected from the group consisting of at least 3 times per week, substantially daily and daily.” Claim 16 depends from claim 1 and recites “wherein the oral administration includes a feeding frequency selected from the group consisting of at least 3 times per week, substantially daily and daily.” Claim 16 is substantially identical in scope with amended claim 1, therefore fails to further limit the subject matter of the claim upon which it depends. 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-6, 9, 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mertens et al. (US 2007/0049631, published 01 March 2007, provided by Applicant in IDS filed 07 Aug 2025) in view of US’237 (Snyder, US 6,664,237, issued 16 Dec 2003, provided by Applicant in IDS filed 11 Oct 2024) and US’076 (Snyder et al., US 2010/0286076, published 11 Nov 2010, provided by Applicant in IDS filed 27 May 2026).
Mertens et al. teaches a method for controlling an ectoparasite infestation by simultaneously or sequentially administering the active ingredients of an azole pesticide and spinosyns (abstract). Fleas are the most common ectoparasites of cats and dogs (page 1, paragraph 5). In general the formulation according to the current invention can be administered to all species of animals that have ectoparasite infestation. The recipient of the formulation may be a companion animal e.g. dog, cat, rabbit or horse (page 3, paragraph 48), where a companion animal cat is reasonably interpreted as a domestic cat. The formulations of the invention are preferably administered in an oral formulation. These formulations include animal feeds containing the active ingredients (page 3, paragraph 46) The animals may receive a monthly, weekly or daily dosage, optionally preceded by a higher loading dose (initial higher dose). The treatment can, for example, be continuing or seasonal (page 2, paragraph 42). Preferably the treatment is carried out so as to administer to the animal a dose from 0.1 to 100 and in particular from 1 to 40 mg/kg bodyweight of the azole pesticide of formula (I) and a dose from 0.1 to 100 and in particular 1 to 40 and most preferably less than 30 mg/kg bodyweight of the spinosyn compound(s) (page 2, paragraph 44), addressing limitations of claim 6 and 13. As far as the spinosyns used in the formulations according to the invention are concerned, particular preference is given to using Spinosad, which essentially consists of a mixture of spinosyn A and spinosyn D in a ratio of approximately 85:15 (page 2, paragraph 33), addressing limitations of claim 3. Mertens et al. teaches the working example 1 of weekly treatment of a dog to effectively control flea and tick infestation over 28 days (page 4).
Mertens et al. does not specifically disclose the method of controlling a flea infestation in a feline in need thereof, comprising orally administering to said feline an effective amount of a spinosyn for a specified effective time and feeding frequency (claim 1). Mertens et al. does not specifically disclose the method wherein the feed is a dry cat food or a wet cat food (claim 4).
US’237 teaches methods for controlling ectoparasite infestation on a companion animal for a prolonged time comprising orally administering a single dose of formulations comprising a spinosyn component, or a physiologically acceptable derivative or salt thereof, and a carrier in oral dosage (abstract). Especially useful methods of orally administering the spinosyn component are by administering it in chewable tablets or treats and animal feeds (column 5, lines 10-15). Animal feeds will typically contain from about 0.1 to about 10 percent of spinosyn component or components (by weight) in the feed (column 5, lines 50-55). US’237 teaches working example 4 in which the Spinosad is administered per os to cats for the treatment and control of fleas and a dose of 12.5 mg/kg to provide a therapeutic effect 8 hrs to 28 days post treatment. Each cat was fed a small amount of moist cat food just prior to and just after receiving their individual gelatin capsules containing Spinosad. As adverse reactions, one cat in the 25 mg/kg dose group and 2 cats in the 50 mg/kg dose group vomited a small amount of food ~1 hour post-treatment (column 8, line 50 to column 9, line 30).
US’076 teaches methods and formulations for systemically controlling ectoparasite infestations in animals using spinetoram or a pharmaceutically acceptable salt thereof (abstract). Spinetoram is the common name for a mixture of derivatives of spinosyns (page 1, paragraph 3). US’076 teaches no substantial difference in efficacy results whether a SID 60 mg/kg dose or TID 20 mg/kg doses are administered (page 4, paragraphs 31-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Mertens et al. in view of US’237 and US’076 in order to select the method of controlling a flea infestation in a feline in need thereof. One of ordinary skill in the art would have been motivated to combine Mertens et al. in view of US’237 and US’076 with a reasonable expectation of success because all of Mertens et al., US’237, and US’076 are drawn to methods of treating controlling ectoparasite infestations in animals such as cats by oral administration of a spinosyn, Mertens et al. teaches the method encompassing the method of controlling a flea infestation in a feline in need thereof comprising orally administering to said feline an effective amount of a spinosyn and an additional active agent where the composition is administered daily in order to be effective for at least 2 weeks as an animal feed, and US’237 teaches a reasonable expectation of success for selecting specifically treating a cat with an effective amount of the spinosyn and suggests the animal feed to be a moist cat food. Regarding claims 5-6 reciting the specific dosage or concentration of spinosyn in the feed, Mertens et al. teaches a dose from 0.1 to 100 and in particular 1 to 40 and most preferably less than 30 mg/kg bodyweight of the spinosyn compound(s), US’237 teaches animal feeds will typically contain from about 0.1 to about 10 percent of spinosyn component or components (by weight) in the feed and that adverse reactions occurred for higher doses of the spinosyn, and US’076 teaches a single total dose may be divided into smaller doses administered more frequently, suggesting one of ordinary skill in the art would have been motivated to divide a total dose into smaller doses with a reasonable expectation of success in order to reduce adverse reactions. See also MPEP 2144.05 at II.A. providing “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” In this case, as detailed above, the combined teachings of the prior art teach the general conditions of the dosage or concentration of spinosyn in the feed, and provide guidance suggesting it would been routine experimentation to determine the optimum ranges for these. Regarding claim 12, Mertens et al. in view of US’237 and US’076 teaches administration daily and treatment over the course of 28 days, suggesting administration of at least 28 days out of 30 days.
Claims 10-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mertens et al. (US 2007/0049631, published 01 March 2007, provided by Applicant in IDS filed 07 Aug 2025) in view of US’237 (Snyder, US 6,664,237, issued 16 Dec 2003, provided by Applicant in IDS filed 11 Oct 2024) and US’076 (Snyder et al., US 2010/0286076, published 11 Nov 2010, provided by Applicant in IDS filed 27 May 2026) as applied to claims 1-6, 9, 12-13, and 16 above, and further in view of Riggs et al. (US 9,220,719, issued 29 Dec 2015, cited in PTO-892).
Mertens et al. in view of US’237 and US’076 teaches as above. As detailed above, Mertens et al. teaches the animals may receive a monthly, weekly or daily dosage. The treatment can, for example, be continuing or seasonal (Mertens et al. page 2, paragraph 42).
Mertens et al. in view of US’237 and US’076 does not specifically teach the administration provides a therapeutically effective level of spinosyn in said feline's blood for a period of time of at least 45 days (claim 10). Mertens et al. in view of US’237 and US’076 does not specifically teach the administration provides a concentration of spinosyn of between 15 ng/mL and 383 ng/mL in said feline's blood for a time period of at least 30 days (claim 11). Mertens et al. in view of US’237 and US’076 does not specifically teach the method comprising discontinuing the administration of spinosyn for a number of days, wherein the feline's blood concentration of spinosyn is maintained at a therapeutically effective level (claim 14). Mertens et al. in view of US’237 and US’076 does not specifically teach the method comprising resuming the administration of spinosyn after the discontinuing of the administration of spinosyn (claim 15).
Riggs et al. teaches a single-dose oral formulation of spinosad for the extended control of a C. felis infestation on a cat at a predictable dose of spinosad that is suitable for administration once every 30 days (abstract). Riggs et al. teaches the plasma concentrations and resulting pharmacokinetics of spinosad tablets when administered orally to adult cats in the fed or fasted state can be evaluated and the values normalized to dose (example 2 at column 9, line 35 to column 10, line 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Mertens et al. in view of US’237 and US’076 further in view of Riggs et al. in order to select the optimal administration regimen in order to provide the effective dose of agents. One of ordinary skill in the art would have been motivated to combine Mertens et al. in view of US’237 and US’076 further in view of Riggs et al. with a reasonable expectation of success because all of Mertens et al., US’237, US’076, and Riggs et al. are drawn to methods of treating controlling ectoparasite infestations in animals such as cats by oral administration of a spinosyn, Mertens et al. suggests it would have been routine experimentation in order to determine the workable or optimal administration regimen, such as a monthly, weekly or daily dosage or that the treatment can be continuing or seasonal, US’237 teaches adverse reactions may occur from high doses of the spinosyn, and Riggs et al. teaches the plasma concentrations and resulting pharmacokinetics of spinosad when administered orally to adult cats can be determined and the values normalized to dose, suggesting it would have been routine optimization of the administration regimen based on the known determination of the plasma concentrations and pharmacokinetics of the Spinosad in the cat and that it would have been obvious to one of ordinary skill in the art to modify the administration regimen if adverse reactions occur.
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 1-6 and 9-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-15, and 17-20 of copending Application No. 18/464,082 (reference application) in view of Mertens et al. (US 2007/0049631, published 01 March 2007, provided by Applicant in IDS filed 07 Aug 2025), US’237 (Snyder, US 6,664,237, issued 16 Dec 2003, provided by Applicant in IDS filed 11 Oct 2024), and US’076 (Snyder et al., US 2010/0286076, published 11 Nov 2010, provided by Applicant in IDS filed 27 May 2026).
Reference claims 1-5, 8-15, and 17-20 of the reference application are drawn to a method of controlling a flea infestation in a canine in need thereof, comprising orally administering to said canine an effective amount of a spinosyn for a period of time consisting of at least one week and at least two weeks at a frequency of substantially daily. Reference claim 2 addresses limitations of claim 3. Reference claim 3 addresses limitations of claim 4. Reference claim 4-5 address limitations of claims 5-6. Reference claim 8 addresses limitations of claim 12. Reference claim 9 addresses limitations of claim 9. Reference claim 10 addresses limitations of claim 10. Reference claims 11-12 address limitations of claim 11. Reference claim 13 addresses limitations of claim 13. Reference claim 14-15 addresses limitations of claim 14-15. Reference claims 17-20 recite the feed composition formulated for substantially daily administration to a canine, and the specification, for example at the abstract, defines the patentable utility of the claimed composition as useful for controlling a flea infestation in a canine, making obvious its use according to its patentable utility.
Reference claims 1-5, 8-15, and 17-20 do not specifically recite the method for controlling a flea infestation in a feline in need thereof comprising orally administering to said feline an effective amount of a spinosyn (claim 1).
Mertens et al. teaches as above. Mertens et al. as above teaches the companion animal treated may be a dog or a cat.
US’237 teaches as above. US’237 further teaches working examples wherein the companion animal treated is a dog (examples 1-3 at columns 5-8) as well as a cat as detailed above.
US’076 teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the Reference claims in view of Mertens et al., US’237, and US’076 in order to treat a feline instead of a canine subject. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Mertens et al., US’237, and US’076 with a reasonable expectation of success because all of the cited references are drawn to methods of method of controlling a flea infestation in a companion animal comprising orally administering an effective amount of a spinosyn, and Mertens et al. and US’237 suggest it would have obvious to one of ordinary skill in the art with a reasonable expectation of success to treat a feline instead of a canine by orally administering an effective amount of a spinosyn in order to control a flea infestation in that companion animal, where US’237 teaches working examples of treatment of either a dog or a cat using the same orally administered spinosyn in order to control a flea infestation.
This is a provisional nonstatutory double patenting rejection.
The application under examination is deemed to have a later patent term filing date compared to the reference application. See MPEP 804 especially at I.B.1.(b). Further, the record shows a Notice of Allowance was mailed in copending Application No. 18/464,082 on 21 July 2026.
Claims 1-6 and 9-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 15-16, and 18-19 of copending Application No. 18/464,233 (reference application) in view of Mertens et al. (US 2007/0049631, published 01 March 2007, provided by Applicant in IDS filed 07 Aug 2025), US’237 (Snyder, US 6,664,237, issued 16 Dec 2003, provided by Applicant in IDS filed 11 Oct 2024), and US’076 (Snyder et al., US 2010/0286076, published 11 Nov 2010, provided by Applicant in IDS filed 27 May 2026).
Reference claims 1-9, 15-16, and 18-19 are drawn to a method of controlling a flea and/or tick infestation in a mammal in need thereof, comprising orally administering to said mammal an effective amount of an active material; continuing the oral administration substantially daily over a period of days to thereby increase the mammal's blood concentration of the active material to an amount effective to reduce the flea and/or tick infestation; after the mammal's blood concentration of the active material reaches the amount effective to reduce the flea or tick infestation, discontinuing the oral administration for a time period of at least one day, wherein the mammal's blood concentration of active material remains effective to control the flea and/or tick infestation over the time period, addressing limitations of claims 14-15. Reference claims 5-6, 16, and 19 recite the active material is a spinosyn such as Spinosad, addressing limitations of claims 1 and 3. Reference Claim 1 is drawn to a method of establishing such a regimen.
The Reference claims do not specifically recite the method of controlling a flea infestation in a feline in need thereof, comprising orally administering to said feline an effective amount of a spinosyn for a specified effective time and feeding frequency (claim 1).
Mertens et al. teaches as above.
US’237 teaches as above.
US’076 teaches as above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the Reference claims in view of Mertens et al., US’237, and US’076 in order select the mammal treated to be a feline. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Mertens et al., US’237, and US’076 with a reasonable expectation of success because all of the cited references are drawn to methods of method of controlling a flea infestation in a mammal comprising orally administering an effective amount of a spinosyn, and Mertens et al., US’237, and US’076 suggest it would have obvious to one of ordinary skill in the art with a reasonable expectation of success to treat a cat by orally administering an effective amount of a spinosyn in order to control a flea infestation in that companion animal for the reasons detailed above.
This is a provisional nonstatutory double patenting rejection.
The application under examination is deemed to have a later patent term filing date compared to the reference application. See MPEP 804 especially at I.B.1.(b).
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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