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 .
Summary
Claims 1 and 4-20 are pending in this office action. Claims 2-3 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on September 10, 2023. The current application is a continuation of a 371 of PCT/US2022/019889 filed on March 11, 2022, which in turn claims domestic priority to provisional patent application 63/159,760 filed on March 11, 2021.
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 non-obviousness.
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 10, 12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over An et al. (WO2012/155676A1) in view of Mertens et al. (WO2005/041950A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. An et al.
An et al. teach parasiticidal compounds, methods, and formulations (see title). Additionally, An et al. disclose that provided are dihydroisoxazole compounds useful for controlling parasites both in animals and agriculture. Further provided are methods for controlling parasite infestations of an animal by administering an effective amount of a compound as described above, or a pharmaceutically acceptable salt thereof, to an animal, as well as formulations for controlling parasite infestations using the compounds described above or an acceptable salt thereof, and an acceptable carrier. Also provided are compounds and processes useful for making the dihydroisoxazole compounds (see abstract).
2. Mertens et al.
Mertens et al. teach ectoparasiticidal formulations of spinosyns and azole pesticides (see title). Furthermore, Mertens et al. disclose that the present invention relates to formulations comprising a combination of an azote pesticide and spinosyns as active ingredients for the control of ectoparasites such as ticks or fleas, and to a method for the manufacture of a medicament for controlling an ectoparasite infestation by administering the active ingredients in combination, either simultaneously or sequentially (see abstract).
Combination of Mertens et al. and An et al.
Regarding instant claim 10, An et al. and Mertens et al. teach a method of controlling a tick infestation in a canine in need thereof, comprising orally administering to said canine an effective amount of mivorilaner for a period of time selected from the group consisting of at least one week and at least two weeks at a frequency of substantially daily. An et al. disclose the synthesis and use of the isoxazoline, mivorilaner (see Example 245 within An et al.). Furthermore, An et al. disclose where the parasite is a tick (see claim 20 within An et al.) and the companion animal is a dog (see claim 19 within An et al.). Mertens et al. disclose the daily administration of the formulation (see page 5, line 15 within Mertens et al.). A skilled artisan (POSITA; person of ordinary skill in the art) could select the administration of the drug to the canine over a period of one or two weeks under routine experimentation (based on the potency).
Regarding instant claim 18, An et al. and Mertens et al. teach a feed for controlling ticks in a canine, comprising an effective amount of mivorilaner or salt of mivorilaner when administered to said canine for a period of time selected from the group consisting of at least one week and at least two weeks at a frequency of substantially daily. Mertens et al. disclose that their formulation can comprise animal feeds (see page 5, line 40). All other instant claim limitations are addressed within instant claim 10.
Regarding instant claims 12 and 20, An et al. and Mertens et al. teach wherein said mivorilaner or salt thereof is administered to said canine in an amount selected from the group consisting of: between about 0.21 mg/kg and about 3.33 mg/kg of body weight of said canine and between about 0.33 mg/kg; and about 1.5 mg/kg of body weight of said canine. An et al. disclose ranges for a compound of formula I, or a salt thereof, in the methods include from 0.01 to 1000 mg/kg and more desirably, 0.1 to 100 mg/kg of the animal's body weight (overlapping region; see page 6, lines 27-29 within An et al.). [An et al. further disclose the animal may be a dog (see page 6, line 5 within An et al.)].
Analogous Art
The An et al. and Mertens et al. references are directed to the same field of endeavor as the instant claims, that is, a method of controlling a tick infestation in a canine in need thereof as disclosed within instant claims 10 and 18.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the parasiticidal compounds disclosed by An et al., using the teachings of Mertens et al. in order to arrive at the subject matter of the instant claims.
The An et al. and Mertens et al. references all have considerable overlap in the anti-ectoparasite arts. In this instance, An et al. supplies a method for controlling a tick infestation within a canine, while Mertens et al. supplies the daily administration of the formulation. All references are directed to the anti-ectoparasites arts and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the two references when seeking to develop an enhanced method for controlling a tick infestation within a canine.
Given these teachings, a POSITA would have been motivated to combine a method for controlling a tick infestation within a canine as disclosed by An et al. into the daily administration of the formulation supported by Mertens et al.
The modification constitutes a simple substitution of one known element for another to obtain a predictable results [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar device in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the method for controlling a tick infestation within a canine taught by An et al. along with the use of the necessary claim limitation taught by Mertens et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitation taught by Mertens et al. would have been viewed by a POSITA as a routine design optimization or known modification within the anti-ectoparasite arts. Implementing these features in An et al.’s method for controlling a tick infestation within a canine would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of An et al., supplemented by Mertens et al. provides all the elements of instant claims 10 and 18. The resulting enhanced method for controlling a tick infestation within a canine constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/464034 (reference application) in view of An et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘034 encompass controlling pest infestation in a canine.
The difference between the instant claims and that of Application ‘034 is the specific pest (tick vs. flea) to be controlled.
However, An et al. teach parasiticidal compounds, methods, and formulations (see title). Additionally, An et al. disclose that provided are dihydroisoxazole compounds useful for controlling parasites both in animals and agriculture. Further provided are methods for controlling parasite infestations of an animal by administering an effective amount of a compound as described above, or a pharmaceutically acceptable salt thereof, to an animal, as well as formulations for controlling parasite infestations using the compounds described above or an acceptable salt thereof, and an acceptable carrier. Also provided are compounds and processes useful for making the dihydroisoxazole compounds (see abstract).
It would have been prima facie obvious to provide the isoxazoline active agent within Application ‘034 to control tick infestation in canines. One of ordinary skill in the art would have been motivated to do so to expand the commercial applicability for the treatment from fleas to fleas and ticks. There would have been a reasonable expectation of success given that Application ‘034 discloses isoxazolines for controlling fleas, and An et al. teaches controlling ticks using a dihydroisoxazole compound.
Allowable Subject Matter
Claims 1, 4-9, and 14-17 are allowed.
Claims 11, 13, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The support for patentability came from both the instant claim 1 amendment (limiting dosage) and the arguments eliminating both the Altehheld et al. and Gruet references because of the co-administration with pamoic acid and DMSO, respectively, have negative health issues for canines according to the Association of American Feed Control Officials Official Publication (AAFCO OP). Motivation is lacking to add the new instant claim amendment to the closest prior art remaining on the record of An et al.
Response to Arguments
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive.
The drawings have been corrected and the 35 U.S.C. §112(b) rejection was addressed with the claim amendments. Furthermore, the claim amendments and arguments were sufficient to remove the 35 U.S.C. §102(a)(1) rejection. Therefore, they are all withdrawn from the Non-Final Rejection dated September 26, 2025.
The claim amendments did necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the Alteheld et al. and Gruet references fail to meet all the claim limitations within the instant application.
Examiner’s Rebuttal: The argument is now moot. The Applicant gave a convincing argument against both references within the Remark’s Section based on the claim amendments. Therefore, a significant portion of the instant claims fall within the allowable subject matter realm.
However, the Applicant failed to argue against the An et al. reference. The Examiner has added the Mertens et al. reference and combination of the two results in the 35 U.S.C. 103 rejection of instant claims 10, 12, 18, and 20.
Examiner’s Comment: The Double Patenting rejection has remained as stated within the Non-Final Rejection.
Therefore, the 35 U.S.C. §103 rejection for instant claims 10, 12, 18, and 20 is maintained.
Conclusion
Claims 1, 4-9, 14-17, and 19 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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