DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Application and Claims Status
Claims 30-51 were pending. In the amendment as filed on 5/13/2026, applicants have amended claims 40 and 44; withdrawn claims 30-39; cancelled no claims; and added no new claims. Therefore, claims 30-51 are currently pending and claims 40-51 presently under examination.
Election/Restrictions
Applicant’s election of Group II, encompassed by claims 40-51 in the reply filed on January 14, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). As a species of isoxazoline compound of Formula (1), Applicant elects fluralaner. As a species of a solid carrier, Applicant elects microcrystalline cellulose. As a species of solvent, Applicant elects 2-pyrrolidone or dimethyl acetamide.
Applicant has not pointed to any errors in the Examiner' s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112(b)
Claims 40-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for being dependent upon a withdrawn base claim, is withdrawn based on amendments.
Claims 40 and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for lack of antecedent basis, is withdrawn based on amendments.
Claims 40 and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being vague for its usage of “a chain”, is withdrawn based on amendments.
Claims 40 and 44 are still rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being vague and indefinite for reciting a broad range or limitation together with a narrow range of limitation for reciting “…especially a three or four membered chain”, in the definition of Y is maintained because the rejection was not addressed.
Double Patenting
The rejection of claims 40-43 on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 11,712,416 B2 is withdrawn based on the terminal disclaimer submitted.
The rejection of claims 44-45, 49-51 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,770,440 B2 is withdrawn based on the terminal disclaimer submitted.
New Objections/Rejections
Claim Objections
(Not Necessitated by Claim Amendment)
Claims 40 and 44 are objected to, in the limitation of Y, for the recitation “…or two adjacent radicals Y form together an alkyl chain, especially a three of four membered chain…”. How can two adjacent radicals (e.g. radicals on adjacent carbons) come together to form an alkyl chain? Two adjacent radicals could come together to possibly form a ring but not to form an alkyl chain, as far as the Examiner is aware.
Claim 45 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 42. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b)
(Not Necessitated by Claim Amendment)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 40 and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 40 and 44 are rejected as vague and indefinite over the recitation of the term “radical” in the limitations of T, Y, and Q. The specification does not provide a definition for the term “radical”, and a person of ordinary skill in the art would recognize a “radical” as an atom that has at least one unpaired electron. Radicals are highly reactive species and rarely isolable under normal conditions. Has Applicant prepared and isolated compounds containing radicals? Examiner recommends amending claims to properly convey the scope of their claimed subject matter.
Claim Rejections - 35 USC § 103
(Not Necessitated by Claim Amendment)
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
After further consideration by the Examiner, an art rejection is being applied in this Office Action.
Claim(s) 40-51 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Körber et al. (WO 2010/003923 A1, published January 14, 2010)(hereinafter, ‘Körber’) and Heckeroth et al. (US 2011/0059988 A1, published March 10, 2021, cited on IDS filed 9/18/2023)(hereinafter, ‘Heckeroth’).
Körber discloses at least one isooxazoline compound of Formula (I) (pages 1, lines 30-36, and page 2, lines 1-14) that read genus of instant claim 40 and 44 as well as the fluralaner species of instant claims 47 and 50.
Körber discloses (page 59, lines 24-26; ) that the invention relates to “compositions containing a parasiticidally effective amount of compounds of formula I or the enantiomers or veterinarily acceptable salts thereof and an acceptable carrier, for combating parasites in and on animals” as well as a method (page 85, claim 28) “for protecting animals against infestation or infection by parasites which comprises administering to the animals a parasitically effective amount of a mixture according to any of claims 1 to 20 to the animal in need thereof”.
Körber teaches (page 68, lines 8-11) that “other suitable auxiliaries are lubricants and glidants such as magnesium stearate, stearic acid, talc, bentonites…and dry binders such as microcrystalline cellulose” (emphasis added).
Körber teaches (page 64, lines 23-25) that “suitable solvents are physiologically tolerable solvents such as water, alkanols such as ethanol, butanol, benzyl alcohol, glycerol, propylene glycol, polyethylene glycols, N-methyl-pyrrolidone, 2-pyrrolidone, and mixtures thereof” (emphasis added).
Körber teaches (page 64, lines 15-17) that “solid preparations such as powders, premixes or concentrates, granules, pellets, tablets, boluses, capsules; aerosols and inhalants, and active compound-containing shaped articles” are suitable preparations.
Regarding claim 40 and 44, the claim language around “wherein the solvent is 2.0 – 35.0 % w/w of the composition…” is language around amounts and concentrations of reaction components since the instant claim is reciting a range of solvent percentages. In this instance, modifying concentrations or quantities (result effective variables) would be obvious based on routine optimization (In re Aller), unless there is evidence to the contrary. Furthermore, the specification does not show that modification of said variables is critical to the claimed invention. The selection of reaction conditions is more optimization by more modification of routine experimentation and within one skilled in the art. Change in temperature, concentration, or both is not patentable modification in the absence of unexpected results which is different in kind and not degree. Therefore, the determination of workable solvent ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the criticality of the claimed solvent ratio, the determination of the optimum or workable solvent ratio given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 U.S.P.Q. 33 (C.C.P.A. 1937). In re Russell, 439 F.2d 1228; 169 U.S.P.Q. 426 (C.C.P.A. 1971). Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."). Accordingly, this limitation is not given patentable weight.
Körber does not teach adsorbing the resulting solution on to a solid carrier excipient.
Heckeroth teaches compositions containing species that read on genus of Formula (I) of instant claim 40 and 44.
Heckeroth teaches (page 25, para 0238), that “solid dosage forms, for example, may be prepared by, for example, intimately and uniformly mixing the isooxazoline with fillers, binders, lubricants, glidants, disintegrants, flavoring agents (e.g., sweeteners), buffers, preservatives,
pharmaceutical-grade dyes or pigments, and controlled release agents” (emphasis added). Additionally, Heckeroth teaches (page 25, para 0232) that “when the composition is administered as a feed additive, it may be convenient to prepare a "premix" in which the composition is dispersed in a liquid or solid carrier. This "premix" is, in turn, dispersed in the animal's feed using, for example, a conventional mixer” (emphasis added).
Altogether, Heckeroth teaches preparation of an isoxazoline composition by dispersing it onto a solid carrier. Microcrystalline cellulose is both a binder (as taught by Körber) and a solid carrier. It matters not whether microcrystalline cellulose is used as a binder or a solid carrier as it inherently has both functionalities, and thus, Heckeroth, in combination with Körber, teach preparation of an isooxazoline composition by dispersing it onto microcrystalline cellulose.
Regarding claims 46 and 49: Heckeroth teaches (page 22, para 0203) the preparation of an “acid addition salt of a isooxazoline of Formula (I)”, and that examples of often suitable organic acids for making pharmaceutically acceptable salts include “embonic (pamoic)” acid.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art, at the time before the effective filing date of the claimed invention, to practice the disclosed preparation taught by Heckeroth with the compounds and conditions taught by Körber. A person of ordinary skill in the art would have been motivated to use the compounds, solvent, and use taught by Körber to prepare a composition taught by Heckeroth because Heckeroth and Körber teaches species that read on the genus of the instant application. Furthermore, Heckeroth teaches dispersion onto a “solid carrier”. While Heckeroth does not specify microcrystalline cellulose as the solid carrier, Körber teaches the addition of microcrystalline cellulose as a suitable “binder” and Heckeroth teaches solid dosage forms by mixing with a “binder”.
Thus, said claims are rendered obvious.
Conclusion
All claims are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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