DETAILED ACTION
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 .
Claim Rejections - 35 USC § 112
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 4-6, 9-14 and 18-20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claims 4 and 18 recite the broad recitation between 0.0015 to 0.6 %wt, and the claim also recites 0.003 to .36 %wt which is the narrower statement of the range/limitation.
Claim 5 and 19 recite the broad recitation between .315mg/kg and 5mg/kg, and the claim also recites between 0.495mg/kg and 2.25mg/kg which is the narrower statement of the range/limitation.
Claim 6 recites the broad recitation at least 30 days, and the claim also recites at least 365 days which is the narrower statement of the range/limitation.
Claim 9 recites the broad recitation “at least 3 times per week”, and the claim also recites “daily”, which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation “at least one week”, and the claim also recites “at least two weeks” which is the narrower statement of the range/limitation.
Claim 11 recites the broad recitation “one week”, and the claim also recites “two days” which is the narrower statement of the range/limitation.
Claim 12 and 20 recite the broad recitation “at least 30 days”, and the claim also recite “at least 365 days” which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation “at least 15 of 30 days”, and the claim also recites “at least 20 of 30 days”, which is the narrower statement of the range/limitation.
Claim 14 recites the broad recitation “at least 3 days”, and the claim also recites “at least 7 days”, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “substantially daily” in claim 9 renders the claim indefinite. The claim already comprises the term “daily”. The scope of the term “substantially daily” is unclear.
Claim 4 recites the limitation "of the feed" in line 3. There is insufficient antecedent basis for this limitation in the claim. Neither claim 1 or claim 3 from which claim 4 depends recite “a feed”.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 16, 17, 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freehauf et al (US 2017/0100377).
On page 13, Table 1, Freehauf discloses a chewable formulation comprising fluralaner. The formulation comprises fluralaner which is the sole recited component of claims 16, 17, 19 and 20. Since there is no difference between claimed composition and the one disclosed by Freehauf, the composition of Freehauf is effective in controlling tock infestation when administered to feline at the claimed frequency (claim 16). Limitation of claims 20 directed to pharmacokinetics following administration of the composition are inherently met because Freehauf discloses the claimed composition. Limitation of claim 19 directed amount of composition to be administered is treated as an intended use of the disclosed composition and is deemed as further limiting because the Freehauf discloses the claimed composition.
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
Claim(s) 1, 2 and 7, 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freehauf et al (US 2017/0100377).
Scope of prior art
With regards to claims 1 and 2, Freehauf teaches formulations comprising isoxazoline compound for treatment of ticks in dogs and cats (paragraph [0060]). The agent is delivered orally as a in the form of a soft chew (paragraph [0067]).
With regards to claim 7, Freehauf teaches fluralaner (paragraphs [0013], [0050], [0072]).
With regards to claim 9, 13-15, Freehauf teaches daily doses and weekly doses (paragraph [0106]). Weekly dose meets the limitation of claims 14 and 15 directed to 7-day break between treatment.
Regarding claims 10, directed to duration of treatment, Freehauf teaches seasonal administration which encompasses at least two weeks of treatment.
Regarding claims 11 and 12, directed to effective level of isoxazoline, Freehauf teaches that higher plasma levels achieved with the described formulation (paragraph [0040]) and the dose is adjusted based on the desired outcome (paragraph [0106]).
Ascertaining the difference
While Freehauf teaches treatment of dogs and cats, only treatment of dogs is exemplified,
Obviousness
A person of ordinary skill in the art, prior to the earliest filing date of the current application, would have found it obvious to treat tick infestation in cats by administering to a cat an oral formulation comprising fluralaner. Freehauf exemplifies administration of fluralaner formulation to dogs and the resulting efficacy against ticks (Example 9). While Freehauf does not exemplify administration to cats, a skilled artisan would have found it obvious to administer fluralaner formulation to cats because art teaches that both cats and dogs can be treated for tick infestation using described formulations (paragraph [0107]). As skilled artisan would have found it obvious to determine through routine experimentation the optimal frequency of administration and effective dose. In paragraph [0106], Freehauf teaches that it is within the skill level of the practitioner to determine such parameters. In determining the optimal dose and frequency a skilled artisan would inherently arrive at the currently claimed pharmacokinetic parameters recited in claims 11 and 12.
Claim(s) 1-7, 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freehauf et al (US 2017/0100377) as applied to claim 1 above, and further in view of An et al (US 8,648,081).
Ascertaining the difference
Freehauf teaches treatment of tick infestation in cats by administering an oral dose of isoxazoline compound in a form of a chew. Freehauf teaches compositions that provide improved bioavailability of the isooxazoline. Freehauf does not teach mivorilaner as the isoxazoline compound.
Secondary reference
An teaches mivorilaner in Example 245, column 71:
PNG
media_image1.png
264
350
media_image1.png
Greyscale
An also teaches controlling tick infestation in animals including cats (Col 3, line 54; Claims 22 and 23) by administering an effective amount encompassing currently claimed ranges and at frequency and duration as determined by a veterinarian (col 4, line64 – col 5, line 6).
Obviousness
A person of ordinary skill in the art would have found it obvious to formulate mivorilaner in a chew in an amount effective to treat tick infestation in a cat, and to orally administer the resulting formulation to a cat. Both Freehauf and An teach isoxazoline compounds and their utility in treatment of tick infestation in cats. One would have found it obvious to replace fluralaner which is taught by Freehauf, with mivorilaner which is taught by An for the same purpose. A skilled artisan would expect improved bioavailability of mivorilaner when formulated in a chew composition described by Freehauf. Fluralaner and mivorilaner are interchangeable because art describes both as agents for treatment of tick infestations. Both would therefore benefit from improved bioavailability as described by Freehauf.
With regards to therapeutically effective amount, frequency and duration of treatment:
Both Freehauf and An teach that effective amount and administration schedule can be determined by a skilled professional depending on needs of the subject. A skilled artisan would have found it obvious to determine the optimal effective amount and administration schedule via routine experimentation.
Claim(s) 1, 3 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freehauf et al (US 2017/0100377) as applied to claim 1 above, and further in view of Fixemclinic (www.fixemclinic.org/blog/medication; 10/17/2018)
Ascertaining the difference
Freehauf teaches formulating fluralaner into a chew, but does not teach adding fluralaner to cat food.
Secondary reference
Fixemclinic teaches placing the medicine inside cat food is a way to administer medicines to cats (see #1)
Obviousness
It would have been obvious to add fluralaner to cat food in order to administer the agent to a cat. Since Freehauf teaches oral administration, adding fluralaner to cat food would be expected to provide relief from a tick infestation.
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.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 10-15, 17, 18 and 20 of copending Application No. 18/464,233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claims of the ‘233 application are directed to a method of controlling tick infestation in a mammal comprising orally administering an effective amount of an isoxazoline (claims 1, 15, 18). Isoxazaline is selected from fluralaner and mivorilaner (claim 11). Monthly administration including discontinuing administration for a at least a day (claim 18). With regards to effective dose it would have been obvious to determine an effective dose via routine experimentation. While ‘233 does not specifically recite administration to cats, cats are within the scope of mammals in need of treatment for tick infestation. In claim 18, ‘233 claims administration as part of a feed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-20 are pending
Claims 1-20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YEVGENY VALENROD/Primary Examiner, Art Unit 1628