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
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to a method of controlling a flea infestation, classified in A61P 33/00.
II. Claims 17-20, drawn to a fee or chew for controlling fleas, classified in A61K 31/42.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method of controlling a flea infestation can be practiced with a materially different product such as a non-isoxazoline compound such as selamectin. .
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Inventorship
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Telephonic Restriction Response
During a telephone conversation with John Emanuele on 12 Feb 2026, a provisional election was made with traverse to prosecute the invention of Group II, claims 17-20. The traversal is on the ground that it is not more difficult and not a significant burden to search both groups. This is not found persuasive as the two groups are distinguished as a product and process where the process may be practices with a materially different compound and the groups have acquired a separate status in the art in view of their different classification.
Affirmation of this election must be made by applicant in replying to this Office action.
Claims 1-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 17-20 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 Oct 2024 and 07 Aug 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 has “isooxazoline” misspelled with two o’s. Appropriate correction is required.
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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gruet (WO 2020/201440, published 08 Oct 2020, listed on IDS filed 11 Oct 2024).
Gruet teaches low dose fluralaner or another isooxazoline derivative for administration to a pet such as a cat with efficacy against arthropods, especially fleas and ticks (page 2 lines 4-8, page 15 lines 9-25). Gruet teaches oral dosing such as with pet food and chews (page 3 lines 12-15). Gruet teaches fluralaner administered continuously or periodically, such as daily, weekly, or monthly (page 3 line 21) and teaches administration one, two, three, four or five days in a row (page 13 line 32) and teaches an embodiment of delivery for 90 days (page 11 line 6), rendering obvious “a frequency of at least four times per month.”
Gruet does not expressly teach selecting an isooxazoline compound such as fluralaner as part of a feed or chew with an effective amount of the compound for treating fleas in a frequency of at least four times per month with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a pet food or chew comprising an effective amount of an isoxazoline compound, such as fluralaner, when delivered daily such as four or five days in a row. One of ordinary skill in the art would have been motivated to do so as isooxazoline compounds such as fluralaner are taught by Gruet as suitable for treating pets such as cats against arthropods such as fleas. One of ordinary skill in the art would have a reasonable expectation of successfully forming a pet food or chew with an effective amount of an isooxazoline compound such as fluralaner, as taught by Gruet, since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Gruet.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gruet (WO 2020/201440, published 08 Oct 2020, listed on IDS filed 11 Oct 2024) as applied to claims 17 and 18 above and in view of An et al. (US 8,889,710, published 18 Nov 2014, listed on IDS filed 11 Oct 2024) as evidenced by the instant specification.
The teachings of Gruet are described supra.
Gruet further teaches dosages of fluralaner from 0.025 mg/kg and 12.5 mg/kg (page 2 lines 25-29). Gruet teaches that the target dosage may vary according to the targeted pest and its susceptibility to the active ingredient (page 11 lines 8-13) and that the dosage form may contain from about 0.5 mg to about 5 g of an active agent (page 11 line 17).
Gruet does not teach the compound mivorilaner. This deficiency is made up for in the teachings of An.
An teaches parasiticidal compounds for use on animals for combating an ectoparasiticidal infestation (col 2 lies 5-10) such as fleas (col 4 line 55) in an animal such as a cat (col 4 line 2). An teaches an effective amount of the compound as the amount sufficient to control and ectoparasite infestation and may range from 0.01 to 100 mg/kg of the animal’s body weight (col 5 lines 8-15). An teaches that the frequency of the administration is dependent upon several factors and a single dose may be administered once a day, once a week, or once a month (col 5 lines 15-20). An teaches oral administration (col 5 lines 39-40). An teaches administration of compounds of Formula (I) (col 2) including the structures of examples 244 and 245 (col 63 and 71) which is mivorilaner, as evidenced by the instant specification at [0018].
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed an animal feed composition comprising structure 244/245 of An (i.e. mivorlinaer) with an effective amount for daily delivery. The compounds of An and Gruet are known to be used for controlling fleas in animals such as pets and such compounds may be administered in pet food, as known from Gruet. The compositions of An may be administered orally, providing a reasonable expectation of success in forming a pet food composition comprising the structure 244/245, as the compounds of An and Gruet have similar uses of treating fleas in cats and may be administered orally. Regarding the dosing of claim 20, the compounds of An may be administered from 0.1 to 100 mg/kg of the animal’s body weight, rendering obvious the range of claim 20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Additionally, the dosing of the compounds for treating fleas is a result effective variable such that the dosing amount of the compound and the amount of the compound relative to the food (as in claims 19 and 20) is obvious as a matter of routine experimentation. "[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). As known from An, the effective amount sufficient to control and ectoparasite infestation is variable. Similarly, it is known from Gruet that the target dosage may vary according to the targeted pest and its susceptibility to the active ingredient and that a dosage form may contain from about 0.5 mg to about 5 g of an active agent. Thus, it is obvious that the dosing and the amount of active is variable and one of ordinary skill would optimize the amount of the active included for the specific pest targeted.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20 of copending Application No. 18/543,614 (reference application)
The ‘614 application recites a feed or chew for controlling ticks in a feline, where the feed/chew comprises an effective amount of an isooxazoline administered for an effective time at a frequency of at least four times per month (claim 16). The isooxazoline may be mivorilaner (claim 17) between about 0.0015 to about 0.6 percent by weight of the feed (claim 18) and in an amount between about 0.215 mg/kg and 5 mg/kg of body weight of said feline (claim 19).
The claims thus render obvious the instant claims. It is noted that the reference application claims are directed to controlling “ticks” whereas the instant claims are directed to controlling fleas, but the examiner notes that this limitation is an intended use of the composition that does not change the patentability of the product. The same product of isooxazoline compound in different dosages as in the instant claims is obvious from the reference claims.
This is a provisional nonstatutory double patenting rejection.
Claims 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-20 of copending Application No. 18/464,034 (reference application).
The ‘034 application recites a feed or chew for controlling fleas in a canine, where the feed/chew comprises an effective amount of an isooxazoline administered for an effective time at a frequency of at least four times per month (claim 14). The isoxazoline may be mivorilaner (claim 17) between about 0.0001 to about 0.08 percent by weight of the feed (claim 19) and in an amount between about 0.04 mg/kg and 3.33 mg/kg of body weight of said canine (claim 20).
The claims thus render obvious the instant claims. It is noted that the reference application claims are directed to treating a “canine” whereas the instant claims are directed to treating a feline, but the examiner notes that this limitation is an intended use of the composition that does not change the patentability of the product. The same product of isooxazoline compound in different dosages as in the instant claims is obvious from the reference claims.
This is a provisional nonstatutory double patenting rejection.
Claims 17-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-20 of copending Application No. 18/464,222 (reference application)
The ‘222 application recites a feed or chew for controlling ticks in a canine, where the feed/chew comprises an effective amount of an isooxazoline administered for an effective time at a frequency of at least four times per month (claim 14). The isooxazoline may be mivorilaner (claim 17) between about 0.001 to about 0.4 percent by weight of the feed (claim 19) and in an amount between about 0.21 mg/kg and 3.33 mg/kg of body weight of said feline (claim 20).
The claims thus render obvious the instant claims. It is noted that the reference application claims are directed to treating a “canine” whereas the instant claims are directed to treating a feline, but the examiner notes that this limitation is an intended use of the composition that does not change the patentability of the product. The same product of isooxazoline compound in different dosages as in the instant claims is obvious from the reference claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600