DETAILED ACTION
Claims 18-31, submitted on November 20, 2025, are pending in the application and are rejected for the reasons set forth below. No claim is allowed. This communication includes at least one new rejection that was not necessitated by amendment or information in an infor-mation disclosure statement, so this Office action is non-final. See MPEP1 706.07(a).
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Withdrawn Rejections
The rejection of claims 18-31 for double patenting over Patent No. 12,005,033 B2 is with-drawn in view of the terminal disclaimer submitted on November 20, 2025.
The provisional rejection of claims 18-31 for double patenting over copending Application No. 18/651,552 is likewise withdrawn.
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 possi-ble 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 provi-sions 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 accompa-nied 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 18-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,058,615 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘615 Patent is drawn to a “method of treating a disease or condition of a patient in need of such treatment, comprising administering an effective amount of a stable liquid composition, wherein the composition consists of a semifluorinated alkane of the formula F(CF2)n(CH2)mH, wherein n is an integer from 3 to 8 and m is an integer from 3 to 10, and optionally one or more excipients, wherein the composition is topically administered to an eye or ophthalmic tissue of the patient, and wherein the disease or condition is an inflammatory condition of the ophthalmic tissue or keratoconjunctivitis sicca (dry eye) and symptoms or conditions associated therewith.” Depend-ent claim 3 of the ‘615 Patent is drawn to F(CF2)6(CH2)8H, which meets the limitations of instant claims 19-20 and 24-25. Although the ‘615 Patent does not specifically state that the alkanes are “linear or branched” as recited in the instant claims, one of skill in the art would have appreciated that these are well known characteristics of alkanes. The examiner therefore concludes that one of skill in the art would have viewed the subject matter of the instant claims as being prima facie obvious over the claims of the ‘615 Patent.
Claims 18-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,369,117 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘117 Patent is drawn to a “method for treating Meibomian Gland Dysfunction, comprising administering, to a patient in need thereof, a composition comprising a liquid semifluorinated alkane to the surface of the cornea and/or conjunctiva; and wherein the semifluorinated alkane is F(CF2)6(CH2)8H; and wherein said composition is effective in spreading out over the corneal and conjunctival surface and penetrating the Meibomian gland and/or Meibomian gland ducts, and wherein said composition is effective solubilizing the abnormal Meibomian secretions of said patient.” As explained above, the “linear or branched” properties required by the instant claims would have been prima facie obvious to one of ordinary skill in the art.
Claims 18-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,449,164 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Note that the ‘164 Patent explains (see, e.g., col. 7, ll. 15-45) that the fluoroalkanes claimed in the Patent may be either branched or linear.
Claims 18-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,576,154 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Note that the ‘154 Patent discloses linear or branched alkanes (col. 7, ll. 35-65).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner 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.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
March 9, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]