DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election of Group II, encompassed by claims 40-45, and new claims 46-51 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.
Claims 40-51 are examined herein. Claims 30-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 14, 2026.
Priority
The instant application is a continuation of U.S. Application No. 17/189,939, filed March 2, 2021, which is a continuation of 16/508,758, filed July 11, 2019, which is a continuation of 15/386,100, filed December 21, 2016, which is a continuation of U.S. Application No. 14/390,052, filed on October 2, 2014, now US Patent No. US 9,770,440 issued on September 26, 2017, which is the national stage entry under 35 U.S.C. §371 of PCT/EP2013/056992, filed on April 3, 2013, which claims priority to US Provisional Application No. 61/782,028, filed on March 14, 2013, and EP Application No. 12163198.0, filed on April 4, 2012.
Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14/390/052, filed on October 2, 2014. Therefore, this application has an effective filing date of 04/04/2012.
Information Disclosure Statement
The information disclosure statement filed on September 18, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Documents marked with a strikethrough have not been considered for the following reasons: they have not been placed in the application contents, or image file wrapper, of the instant application.
Claim Interpretation
Claims 40-51 presently under examination are drawn to a method of preparing a composition comprising the compound of Formula (I); however, the claims fail to recite any structure of Formula (I). For examination purposes, the claims are being examined in view of the genus of Formula (I) set forth in withdrawn claims 30 and 35.
Specification - Drawings
Acknowledgement is made of the drawings received June 15, 2023. These drawings are acceptable.
Specification – Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Rejections - 35 USC § 112(b)
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 40-51 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 being dependent upon a withdrawn base claim, thereby rendering it indefinite. Any claim which is directly or indirectly dependent thereon should be rejected as incomplete. In the instant claims, claims 40 and 44 depend from and refer back to then genus species Formula (I) of withdrawn claims 30 and 35, respectively. For purposes of compact prosecution, claims 40 and 44 will be broadly interpreted to incorporate the limitations of a composition comprising a compound of Formula (I) of claim 30 into claim 40, however examiner recommends the Applicants amend the claims to incorporate the withdrawn claim 30 into claim 40 so that it no longer is dependent upon a withdrawn claim. As claims 41-43 and 45-51 depend on a rejected base claim, they are also rejected.
In Claim 40, the phrases “the composition”, “the isoxazoline compound”, “the solvent”, “the resulting solution”, and “the solid carrier excipient” all lack antecedent basis.
In claim 44, the phrases the phrases “the composition”, “the isooxazoline compound”, “the solvent”, “the resulting solution”, and “the solid carrier excipient” all lack antecedent basis.
Claims 40 and 44 recite a method of preparing the composition of withdrawn claims 30 and 35, respectively. Claims 30 and 35 recite a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim), and this is considered indefinite, since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by “such as” and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 30 recites the broad recitation of “Y = methyl, halomethyl, halogen, CN, NO2, NH2-C=S, or two adjacent radicals Y form together a chain”, and the claim also recites “especially a three or four membered chain” which is the narrower statement of the range/limitation. Accordingly, claim 40, claim 44, and their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claims 40 and 44 recite a method of preparing the composition of withdrawn claims 30 and 35, respectively. As cited above, claims 30 and 35 recite, in the limitation of Y, “or two adjacent radicals Y form together a chain”, and the claim also recites “especially a three or four membered chain””. The use of the word “chain” is vague and indefinite as “chain” is not an art-recognized standalone term, and the specification does not provide any further definition. If applicant intends to mean an “alkyl chain”, it should be explicitly stated.
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.
Claim 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 11,712,416 B2 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 40 is directed to a method of preparing a composition comprising an isoxazoline compound of Formula (I), a solid carrier, and a solvent, wherein the solvent is 2.0 – 3.5% w/w of the composition with solubility for the isooxazoline compound and wherein the solid carrier is microcrystalline cellulose. The method of preparing, as recited in instant claim 40, comprises dissolving the isoxazoline compound in the solvent and adsorbing the resulting solution on to the solid carrier. This method of preparing is recited in reference claim 5, which is directed to a method of preparing a composition comprising an isoxazoline compound of Formula (I) that reads on the same genus Formula (I) of instant application, a macrocyclic lactone selected from the group of ivermectin, milbemycin, and moxidectin, solid carrier, and a solvent, wherein the solvent is 2.0 – 3.5% w/w of the composition with solubility for the isooxazoline compound and wherein the solid carrier is microcrystalline cellulose. The method of preparing, as recited in reference claim 5, comprises dissolving the isoxazoline compound in the solvent and adsorbing the resulting solution on to the solid carrier, which is identical to the method of preparing of instant claim 40. Reference claim 5 recites a composition that is more specific than the composition of instant claim 40, in that refence claim 5 additionally includes a macrocyclic lactone. Therefore, reference claim 5 of ‘416 is, in essence, a “species” of the generic invention of application claim 40. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Similarly, dependent instant claims 41-43 recite further limitations that are recited in dependent reference claims 6-8, respectively.
Claim 44-45, 49-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,770,440 B2 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of reference patent is a product by process claim. The product composition of reference claim 1 reads on the composition of instant claim 44. Further, the solvent of reference claim 1 is selected from 2-pyrrolidone, dimethyl acetamide, or a mixture thereof, and the solvent of instant claim 44 is 2-pyrrolidone. Further, reference claim 1 ends with “…wherein the isoxazoline compound is dissolved in the solvent and then the resulting solution is adsorbed on to the solid carrier,” which reads on the method recited in instant claim 44.
Examiner Comments
Examiner notes that U.S. Patent No. 8,563,474 (herein, “Koerber”) discloses at least one isoxazoline compound of Formula (I) (col 1-2, and elsewhere) and solid preparations wherein the active compound is mixed with suitable solvents such as 2-pyrrolidinone (col 42, line 55) or dimethylacetamide (col 42, line 53) and suitable excipients, such as microcrystalline cellulose (col 44, lines 15-17, line 31-36). However, Koerber does not teach methods of preparing said composition, whereby the isoxazoline compound is dissolved in the solvent and then adsorbed on to the solid carrier excipient.
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
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624