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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 16 Jun 2026 has been entered.
Claims 1-20 remain pending in the application.
Claims 17 and 18 are amended.
Claims 1-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 02 February 2023 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Maintained – in modified form
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), rendering obvious a “feed” as in claim 17. 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 that the configuration for administration of at least one week or at least two weeks at a substantially daily frequency.
Gruet does not expressly teach selecting an isooxazoline compound such as fluralaner as part of a feed an effective amount of the compound for controlling fleas in a frequency of substantially daily for at least one week or at least two weeks 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 comprising an effective amount of an isoxazoline compound, such as fluralaner, when delivered daily over a period of time such as 90 days. 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 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.
Response to Arguments
Applicant's arguments filed 16 Jun 2026 have been fully considered but they are not persuasive. Applicant states that the examples of Gruet teach administering fluralaner dissolved in DMSO and notes that Gruet teaches the examples had increased bioavailability to 5 times the expected level (pages 5-6 of remarks). Applicant notes that Gruet does teach other compounds can be combined with fluralaner but argues that Gruet does not provide any guidance on which of the compounds would increase the bioavailability of fluralaner as well as DMSO (page 6 of remarks). Applicant argues that Gruet fails to teach the fluralaner could be administered to a feline with an acceptable bioavailability in the absence of DMSO (page 6 of remarks). Applicant argues that a feed cannot include DMSO as it is recognized as having adverse health effects with continuing exposure (page 6 of remarks). Applicant notes that the AAFCO OP states that DMSO is not permissible for use in feeds (page 6 of remarks). Applicant argues that based on this knowledge and the teachings of Gruet that one would have been led away from the applicant’s invention of a feed configured to be administered for at least one substantially daily (page 6 of remarks).
The examiner does not find this to be persuasive. As a first matter the examiner notes that Gruet does not anywhere require that DMSO be used with fluralaner. Even though Gruet may demonstrate an improved bioavailability with particular formulations utilizing DMSO, this does not restrict the teachings of Gruet to thus require that DMSO be present. As noted by the applicant, Gruet teaches other compounds that might be combined with fluralaner (e.g. solvents on page 24) and there is no reason that one of ordinary skill would discount this teaching from Gruet. The examiner notes that that the rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Gruet may not provide a specific embodiment of the instantly claimed invention and an example without DMSO, this is not a requirement for the art to render the claims as obvious. Similarly with this, the examples that are embodied in the teachings of Gruet do not thereby render every other teaching presented as non-obvious. One of ordinary skill would be able to utilize the teachings of Gruet in order to form a suitable pet food as is taught by Gruet. It is not necessary for Gruet to embody every solvent in an example or to provide specific guidance related to bioavailability for different solvents to be considered obvious. In connection with this, the evidence presented by the applicant from AAFCO OP indicating DMSO as not permissible for feeds may be understood as evidence that one of ordinary skill would seek to use an alternative solvent to the DMSO used in the examples of Gruet. Thus, the evidence of AAFCO OP is not sufficient to overcome the prima facie case of obviousness and may alternatively be understood to provide evidence that one would utilize an alternative solvent than DMSO, thereby in keeping with the applicant’s arguments regarding what is required in the instant invention.
Further, the examiner notes that the claims are broad in that they don’t specifically require that DMSO is not present. Additionally, there is not a definition of “feed” provided that clearly distinguishes what is meant by the broad term “feed” such that it would necessarily exclude DMSO. For example, Gruet teaches a soft chewable veterinary pharmaceutical composition utilizing DMSO and that is delivered with a per day dosage (page 77 lines 22-26). Other than being edible, there is nothing that indicates that “feed” is intended to limit the composition by any particular amount or form and a soft chew given on a per day regimen is understood to render obvious a “feed” as claimed.
Thus, the claims are understood to remain obvious over the teachings of Gruet for the reasons provided above.
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. Similarly, the reference claims do not recite that the feed is configured for administration of substantially daily. The examine notes however, that the claims are directed to a composition and not to the method of administration and substantially daily administration does not distinguish the instantly claimed feed from the feed of 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 for controlling fleas in a canine, where the feed is formulated for substantially daily administration and comprises an effective amount of an isooxazoline where the effective amount is suboptimal when administered as a single dose once per month but over time results in efficacious control of flea infestations (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. Similarly, the reference claims do not recite that the feed is configured for administration of at least one week. The examine notes however, that the claims are directed to a composition and not to the method of administration and administration of at least one week does not distinguish the instantly claimed feed from the feed of 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 at least one week substantially daily (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 canine (claim 20).
The claims thus render obvious the instant claims. It is noted that the reference application claims are directed to treating a “ticks in a canine” whereas the instant claims are directed to treating fleas in 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 claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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
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