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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 06/08/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of lotilaner as specific API for examination.
Claims 1, 6-20 are pending, claims 1, 6, 12-14 and 18-20 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/07/2026 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 fails to further limit the subject matter of the claim18 upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
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.
Claims 1, 6, 12-14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gruet (US20220168278) in view of Ueda et al. (EP2062574) and Watanabe et al. (EP1161940).
Additional API fluralaner is also examined for compact prosecution purpose.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Gruet teaches Low doses of fluralaner or another isoxazoline derivative are administered to an animal such as a pet, typically a dog or a cat, preferentially by administration of a repeated dose, at regular intervals or at varying intervals, each dose being of the same or different amount, which leads to efficacy against arthropods, especially fleas and tick (abstract). The isoxazoline derivative includes lotilaner (page 3, [0054-0055]). In one embodiment of the invention, the active agent is present in the formulation at a concentration of about 0.05 % to about 50 % weight / volume. In other embodiments, the active agent may be present in the formulation at a concentration of about 0.1 % to about 30 %, about 0.5 % to about 20 % (w /v) or about 1 % to about 10 % (w /v) (page 5, [0115]). The composition of the invention may be in a form suitable for oral use, for example, as baits, dietary supplements, troches, lozenges, chewable, tablets and chewable tablets. Tablets may contain the active ingredient in admixture with non-toxic, pharmaceutically acceptable excipients which are suitable for the manufacture of tablets. These excipients may be, for example, inert diluents, such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; granulating and disintegrating agents, for example, corn starch, or alginic acid; binding agents, for example starch, gelatin or acacia (page 9, [0194-0195]; page 17, [0280]).
Ueda et al. teaches composition as animal drug (abstract). The disintegrant is not subject to limitation; for example, starch, agar, calcium citrate, calcium carbonate, sodium hydrogen carbonate, dextrin, crystalline cellulose, carboxymethylcellulose, tragacanth, alginic acid and the like can be mentioned (page 5, [0021]). When the composition of the present invention is a solid, the content of excipient, disintegrant, lubricant, binder, anticoagulant, absorption promoter, solubilizing agent, stabilizer, fat and oil, surfactant, ethanol and water in the composition is not particularly limited. The total weight thereof relative to the whole weight of the composition is generally not less than about 1 wt%, preferably not less than about 3 wt%, more preferably not less than about 5 wt%, particularly preferably not less than about 10 wt%. While the upper limit is not particularly limited, it is generally not more than about 99 wt%, preferably not more than about 95 wt%, more preferably not more than about 90 wt%, particularly preferably not more than about 80 wt% (page 11, [0059]). In one embodiment, the chewable tablet (claims 1 and 23).
Watanabe et al. teaches A tablet obtainable by binding a powdered mixture including at least a principal agent, a saccharide with high wettability, and a disintegrant with a binder including a saccharide with high wettability to thereby obtain a granulated material and compressing the granulated material (abstract). The disintegrant particle 4 according to the present invention may be selected from the group consisting of Sodium alginate, carmellose, sodium carboxymethyl-cellulose, calcium carboxymethyl-cellulose, agar powder, gelatin, shellac, crystalline cellulose, calcium carbonate, sodium bicarbonate, starch such as corn starch and potato starch, sodium starch glycolate, tragacanth, methylcellulose (MC), pregelatinized starch (HPS), bentonite, sodium lauryl sulfate, calcium phosphate and povidone. The particle diameter of the disintegrant particle 4 is also greater than or equal to 10µm and less than or equal to 500µm, more preferably greater than or equal to 20µm and less than or equal to 300µm, still more preferably greater than or equal to 20µm and less than or equal to 200µm ([0104-0105]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Gruet is that Gruet do not expressly teach sodium bicarbonate and its amount and particle size. This deficiency in Gruet is cured by the teachings of Ueda et al. and Watanabe et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
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 invention of Gruet, as suggested by Ueda et al. and Watanabe et al., and produce the instant invention.
Gruet teaches a veterinary chewable tablet comprising fluralaner or lotilaner as active agent (about 0.05 % to about 50 % by weight/volume, which is about 0.05% to about 50% weight / weight when density is about 1g/ml, in the absence of evidence to the contrary) and disintegrating agent.
One of ordinary skill in the art would have been motivated to include sodium bicarbonate in the chewable tablets of Gruet because sodium bicarbonate is a suitable ingredient in chewable tablet. MPEP 2144.07. Under guidance from Gruet teaching disintegrating agent in the chewable tablet; Ueda et al. teaching sodium hydrogen carbonate (sodium bicarbonate) as suitable disintegrant in chewable tablet; Watanabe et al. teaching sodium bicarbonate as disintegrating agent; it is obvious for one of ordinary skill in the art to include sodium bicarbonate in the chewable tablets of Gruet and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include sodium bicarbonate with particle size 10-250um (30-150um or 40-100um) at 0.5% to 4% (because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Ueda et al. teaching excipient such as disintegrant from 1-80%, Watanabe et al. teaching disintegrant such as sodium bicarbonate with particle size from 20um to 200um; it is obvious for one of ordinary skill in the art to include sodium bicarbonate with particle size 10-250um (30-150um or 40-100um) at 0.5% to 4% (1.0-4.0%) and produce instant claimed invention with reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that each of prior art does not teach the claimed invention such as sodium bicarbonate and particle size, and all related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the above 103 rejection, Gruet is relied on for teaching a veterinary chewable tablet ([0280]) comprising fluralaner or lotilaner as active and disintegrating agent; Ueda et al. teaching sodium hydrogen carbonate (sodium bicarbonate) as suitable disintegrant at 1-80% in chewable tablet; Watanabe et al. is relied on for teaching disintegrant including sodium bicarbonate with particle size from 20um-200um in tablet; it is obvious for one of ordinary skill in the art to include sodium bicarbonate with particle size 10-250um (30-150um or 40-100um) at 0.5% to 4% as disintegrant and produce instant claimed invention with reasonable expectation of success. Therefore, the 103 rejection is still proper.
Applicants argue about unexpected results for sodium bicarbonate at 0.5% to 4.0% from the specification.
In response to this argument: this is not persuasive. MPEP 716.02(b), Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). MPEP 716.02(d), To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). In drug formulation, disintegrant including sodium bicarbonate functions to speed up drug release, and applicants need to demonstrate unexpected results by comparing sodium bicarbonate with other disintegrant, however applicants failed to compare with closet prior art teaching. Regarding the range of 0.5% to 4.0% of sodium bicarbonate, applicants failed to provide sufficient number of tests in and outside of claimed range to show criticality of claimed range. Thus, no unexpected results has been demonstrated, and the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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