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
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The application is a continuation of the national stage application PCT/US2022/019866, filed on 3/11/2022, which claims benefit to provisional application US 63/159622 filed on 3/11/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 1/24/2024 and 3/26/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objection
Claim 16 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. 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 § 706.03(k).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dick et al. (WO 2006/127322A2, PTO-892).
Dick et al. discloses a fish feed comprising 1-2500 mg/kg spinosad. (Claim 19)
With respect to the claimed limitations that the composition is for dogs and is administered to dogs at the claimed amount, it is noted that the prior art does not teach these limitations. However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-3, 7, 9, 10, 13, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snyder et al. (US 6,664,237 B1; 2003, PTO-892).
Snyder et al. discloses a method for treating a flea infestation in dogs by orally administering a composition comprising spinosad. (Examples 1-3) Snyder also discloses that:
The composition may be dosed at 10-100 mg spinosad/kg body weight, with a dosing schedule from once every 7 days to once a month (Claims 1-7);
The orally administered composition may be in the form of a chewable tablet or animal feed (Col. 5, Ln. 7-15), where the spinosyn is 1-75% by weight of the tablet or 0.1-10% by weight of the feed (Col. 5, Ln. 51-55);
The flea knockdown effectiveness was demonstrated after 8 hours up to 49 days (Examples 1-3); and
The spinosad composition may further include other anti-parasitic active agents. (Col. 4, Ln. 33-42)
With respect to claim 9 and the recitation regarding blood levels of spinosyn being therapeutically effective, this limitation is not accorded patentable weight because of the inseparable connection between an administered composition and the mechanism of action within the subject to which the composition is administered. The active method step in the instant claim is administering the spinosyn whereas the blood levels of spinosyn being therapeutically effective is an effect which will necessarily occur and does not delineate a manipulative difference between the instant method and the method of the prior art. Therefore, because the prior art teaches the same active step to administer the same composition resulting in therapeutic effectiveness against fleas, the properties applicant discloses and/or claims are necessarily present. Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993). See also MPEP § 2112.02.
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dick et al. (WO 2006/127322A2, PTO-892).
The disclosure of Dick is referenced as discussed above. Dick does not teach the specifically claimed ranges with respect to amount of spinosyn in the composition
The spinosad amount ranges of Dick overlap those instantly claimed. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 4, 5, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 6,664,237 B1; 2003, PTO-892).
The disclosure of Snyder is referenced as discussed above. Snyder does not teach the specifically claimed ranges with respect to amount of spinosyn in the composition or amount of spinosyn dosed to the dog.
The spinosad amount ranges of Snyder, for either the amount in the composition or the amount dosed to the dog, overlap those instantly claimed. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 6,664,237 B1; 2003, PTO-892), in view of White et al. (Vet. Parasit., 2017, PTO-892).
The disclosure of Snyder is referenced as discussed above. Snyder does not teach the blood levels of spinosyn in the treated dogs.
White discloses that spinosyns administered to treat flea infestation in dogs result in therapeutically effective flea control, for up to 5 weeks, at blood levels in the range of about 17 to about 60 ng/mL. (Table 3)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Snyder to optimize the amount of administered spinosad such that the blood levels of spinosad remain within the 17-60 ng/mL range because White teaches that this blood level range demonstrates flea control effectiveness for up to 5 weeks. The 17-60 ng/mL range overlaps that instantly claimed, which is prima facie obvious as per In Re Wertheim/Aller as discussed above.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 6, 8 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 6,664,237 B1; 2003, PTO-892), in view of Kritikou et al. (US 2012/0195961 A1, PTO-892).
The disclosure of Snyder is referenced as discussed above. Snyder does not teach daily administration nor discontinuing and restarting administration.
Kritikou discloses therapeutic treatment with spinosad where administration may be once-daily, twice-daily, three times daily, as an instant dose or by continuous infusion (i.e., 1 h or 2 h infusion), once-weekly or once-monthly or in any other dosage protocol. In addition, the administration can be continuous, i.e., every day, or intermittently. The term "intermittently" as used herein means stopping and starting at either regular or irregular intervals. For example, intermittent administration can be administration one to six days per week or it may mean administration in cycles ( e.g., daily administration for two to eight consecutive weeks, then a rest period with no administration for up to one week) or it may mean administration on alternate days. (¶0148)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Snyder to administer spinosad multiple times per day, daily, multiple times per week, weekly, multiple times per month, monthly, etc, as well as discontinue and restart administration, thereby arriving at the instant invention. The obviousness of this modification is provided by the teaching of Kritikou where it is taught that spinosad may be administered using a range of dosing protocols, including daily or multiple times per week, as well as including dosing rest periods of up to 7 days (i.e. discontinuing administration) followed by resuming administration.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 2, 4-10, 13-16 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9, 15, 16, 18 and 19 of copending application 18/464233. Although the conflicting claims are not identical, they are not patentably distinct from each other. The instant method recites controlling a flea infestation in a dog by administering a spinosyn, preferably spinosad. In comparison the method of ‘233 recites controlling a flea infestation in a mammal by administering a spinosyn, preferably spinosad, using the specific substeps (a) thru (d). It would be obvious based on the teaching of the prior art already cited that spinosad is effective to control flea infestations in dogs. By specifically selecting dog as a species of mammal in the method of ‘233, one arrives at a method which lies within the scope of the instant claims, such that the method of ‘233 and the instant method are obvious variants.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/DALE R MILLER/Primary Examiner, Art Unit 1693