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
Restriction/Election
Applicant's election with traverse of Group I, claims 1-9 in the reply filed on 01/05/26 is acknowledged. Applicant’s oral election of a specific active ingredient as spinosyn, claimed in instant claim 5 is also acknowledged. The oral election of the species was made on 03/20/26 with the attorney of record, Michael C. Bartol. The traversal is on the ground(s) that there would not be search burden on the office to search all the inventions. This is not found persuasive because the search of dosage regimen is not required by rest of the claims and search of method of controlling flea and/or tick would not yield results leading to dosage regimen or vice versa. Thereby causing search burden on the office. The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/Election, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/05/26.
Claim Rejections - 35 USC § 112, indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
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 1-9 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 pre-AIA the applicant regards as the invention. The term “less” and “reduced dosage” in claim 1 is a relative term which renders the claim indefinite. The term “less” or “reduced dosage” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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, 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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (WO 01/11963A1, presented in IDS) in view of Kritikou et al. (US PG Pub. 2012/0195961 A1).
Snyder et al. discloses a treatment of ectoparasite infestations in companion animals e.g. Cats, by oral administration of Spinosyns, which are active over long periods and have good safety profiles, see title. Snyder et al. teaches a single-dose oral formulation, for controlling an ectoparasite infestation on a companion animal, comprising (i) 0.1-75 wt.% of a spinosyn, or a salt or derivative of this, and (ii) a carrier wherein the formulation is in an oral dosage form suitable for administration once every 7 days, see claims 1-3. Snyder also provides methods for controlling such infestations comprising orally administering a single dose of these formulations to the animal, suitable for administration once every 7 days (see abstract, pages 21-22, claims 6 and 11; Examples 1-6). Snyder teaches from about 1 to about 100 mg/kg of the spinosyn (see page 10, penultimate paragraph]; test days of 6, 9 and 13 were taught at Example 3; effective amounts were taught (page 10, lines 9-20), as was systemic efficacy (see page 7, line 15 to page 8, line 5); the timing of doses was once every 30 days, or as sufficient to control the ectoparasite infestation for a period of several months (see page 4, lines 12-21). Snyder teaches from about 1 to about 100 mg/kg of the spinosyn; the timing of doses was once every 30 days, or as sufficient to control the ectoparasite infestation for a period of several months; or, once every 7 days (previously discussed). Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of spinosyn (Spinosad) to control tick infestations has been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum concentration of spinosyn via routine experimentation because the reference teaches the generic amount of spinosyn wherein the timing of the dosage administration can be as sufficient to control the ectoparasite infestation for a period of several months.
Snyder does not teach daily administration regimen of the active ingredient, spinosyn as claimed.
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, see ([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. Regarding the pharmacokinetics claimed in instant claim 9, since the references make obvious the claimed dosage regimen administration, it would appear reasonable to conclude that the maximum concentration in the mammal’s blood of the active ingredient would necessarily be similar to what is claimed as the property cannot be separated from the chemistry of the dosage administered.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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