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
Response to Amendment
The amendment filed 5/22/2026 has been entered. Newly amended Claim 1 is pending in the application.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Regarding the rejection over Lehay et al., applicant refers to Para 167 of the specification describing pour-on solutions like those of Lehay which are topical and provided with instructions to avoid administering the solution to the eye. Lehay does not describe routes of administration which teach or would render obvious administration directly to the eye. Allen does teach generic parameters for forming ophthalmic compositions, but applicant notes “that ophthalmic solutions must be sterile; and that ophthalmic formulations require consideration of tonicity, pH/buffers, sterility, preservatives, antioxidants, viscosity enhancers, and compatibility between ingredients. Allen at pp. 399.” (Remarks: Page 2). Claim 1 however, is not specific with respect to particular formulations, excipients, pH, or any other factor that would distinguish the method from a combination of the teachings of Lehay and Allen. However, neither Lehay nor Allen suggest a particular amount of Lotilaner to be used in a “non-irritating” ophthalmic composition whereas the instant claim does teach a single % weight value. Therefore, one of skill in the art at the time the invention was effectively filed would not have found it obvious to form a non-irritating formulation from the teachings of Lehay, which teaches formulations that are suboptimal for administration to the eye at best, of the particular concentration claimed for ophthalmic use. Therefore, the rejection over Lehay is withdrawn.
Applicant’s terminal disclaimer is sufficient to overcome the nonstatutory nonprovisional double patenting rejections, all eight patents were approved in the disclaimer filed 5/22/2026.
The double patenting rejection over application no. 17620095 is moot following abandonment thereof.
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.
PROVISIONAL:
1. Claim 1 is provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 2-21 of copending Application No. 19000333 (hereinafter referred to as Tarsus).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating Demodex symptoms with similar compositions comprising comparable amounts of lotilaner.
Regarding sterility and irritation, Tarsus does not teach including non-sterile or irritating components, rendering obvious the two desirable properties. Further, essential oils are precluded by Tarsus (Claims 11-12).
Castor oil is a vehicle described in Tarsus (Claim 18).
Regarding the amounts of Tarsus, 0.15-0.40% (Claim 3), and the instant value 0.25%, 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). Further, 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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). One of skill in the art might select the mid-range value of 0.25% from the Tarsus range to avoid side effects from dosing too much and avoid ineffectiveness if not enough is administered.
Tarsus teaches treating erythema (redness) associated with Demodex whereas the instant teaches treating blepharitis (irritation, swelling, redness). One of skill in the art would find it obvious to employ the method of Tarsus to achieve the treatment of a condition encompassing the same symptoms associated with the same organism and expect success in doing so because both teach administering similar amounts effective for reducing Demodex symptoms like blepharitis which can induce erythema.
Since both applications teach methods of ophthalmic administration of comparable amounts of lotilaner with vehicle, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Tarsus.
This is a provisional nonstatutory double patenting rejection.
2. Claim 1 is provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 2-12 of copending Application No. 19242781 (hereinafter referred to as Tarsus).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to methods of treating Demodex symptoms with similar compositions comprising 0.25% by weight (Claim 4 in Tarsus) of lotilaner.
Regarding sterility and irritation, Tarsus does not teach including non-sterile or irritating components, rendering obvious the two desirable properties. Further, essential oils are precluded by Tarsus (Claim 6).
Castor oil is a vehicle described in Tarsus (Claim 8).
Regarding the amount of Tarsus Claim 5, 0.50%, and the instant value 0.25%, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, 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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). One of skill in the art might select 0.25% derived from the 0.5% teaching to avoid side effects from dosing at the high point of the range taught in Tarsus Claim 3 in a small, pediatric patient and/or a patient whose condition is not severe.
Tarsus teaches treating ocular rosacea (redness, irritation) associated with Demodex whereas the instant teaches treating blepharitis (irritation, swelling, redness). One of skill in the art would find it obvious to employ the method of Tarsus to achieve the treatment of a condition encompassing the same symptoms associated with the same organism and expect success in doing so because both teach administering the same amounts effective for reducing Demodex conditions like blepharitis and ocular rosacea.
Since both applications teach methods of ophthalmic administration of the same amount of lotilaner with vehicle, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Tarsus.
This is a provisional nonstatutory double patenting rejection.
3. Claim 1 is provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21 of copending Application No. 19440357 (hereinafter referred to as Tarsus).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating Demodex mites-associated blepharitis comprising administering an ophthalmic composition of 0.25% lotilaner with a vehicle.
Regarding sterility and irritation, Tarsus does not teach including non-sterile or irritating components, rendering obvious the two desirable properties. Further, essential oils are precluded by Tarsus (Claim 7).
Since both applications teach methods of administering compositions of the same compound in the same amount to treat the same associated condition, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Tarsus.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowable.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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