DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 21 July 2026, in the matter of Application N° 19/540,268. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Track One status, granted 31 March 2026, remains in effect.
Newly submitted claims 1-28 and 30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 1-16 were originally presented and subject to a preliminary amendment on 13 February 2026. No requirement for restriction was issued.
The amendments filed on 13 May 2026 did not cancel any claims. However, the originally-filed composition claims (claims 1-14) and kit claims (15 and 16) were amended to a completely different statutory category: method of treating. The filed amendment also added new claims 17-30 directed to additional method of treating claims.
Applicants’ present submission has canceled claim 30 and added a new composition claim 31. Claims 1-28 and 30 continue to be directed to non-elected methods of treatment.
Since Applicants have received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1-28 and 30 remain withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should Applicants traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicants’ traversal of the election are acknowledged. Pursuant to the two aspects presented in the filed remarks, the Examiner submits that the process for using the product as claimed can be practiced with another materially different product. See MPEP §806.05(h). In the instant case, the Examiner submits that signs and symptoms of dry eye may be topically treated with other such compositions as Systane® (active ingredient PEG 400).
Regarding the second aspect, the Examiner submits that there would be added search and/or examination burden were Applicants be permitted to shift the elected invention to methods of treating. Empirically, the Examiner would need to re-search, reconsider, and likely apply additional copending applications and granted patents not previously relied upon, for rejection under nonstatutory double patenting.
The Examiner acknowledges Applicants’ request to switch elected invention. However, it is respectfully submitted that the request, as discussed above, is not considered to provide the same or reduced burden of examination, nor is it considered to simplify the issues of the instant case.
As stated in MPEP §819, “When claims are presented which the examiner finds are drawn to an invention other than the one elected, he or she should treat the claims as outlined in MPEP §821.03”.
The election is thus maintained.
Claims 1-28, 30, and 31 are pending, where claims 1-28 and 30 remain withdrawn from consideration.
Claim 29 has been canceled. Claim 31 is newly added and supported by the original disclosure. No new matter has been added.
Thus, claim 31 now represents all claims currently under consideration.
Information Disclosure Statement
Two new Information Disclosure Statements (IDS) filed 13 May 2026 and 21 July 2026 are acknowledged and have been considered.
Withdrawn Rejections
Applicants’ arguments with respect to the double patenting and remaining prior art rejections have been considered but are moot due to the claim amendments and the new rejection(s) applied as a result of the filed claim amendments.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8, and 10 of Haisser et al. (USPN 12,419,933 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the administered compositions disclosed by claims 8 and 10 of the reference is taught as consisting of cyclosporine (e.g., 0.1% w/v), 1-perfluorobutyl-pentane, and up to 1.0% (w/v) ethanol.
Were the reference available as prior art, claims 8 and 10 would anticipate the instantly claimed composition.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Leo et al. (USPN 11,413,323 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the administered composition disclosed by claim 1 of the reference is taught as comprising 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)-pentane, and up to about 1.0% (w/v) ethanol.
Were the reference available as prior art, claim 1 would anticipate the instantly claimed composition.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Leo et al. (USPN 12,059,449 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the administered composition disclosed by claim 1 of the reference is taught as comprising 0.1% (w/v) cyclosporine dissolved in 1-(perfluorobutyl)pentane, and up to about 1.0% (w/v) ethanol.
Were the reference available as prior art, claim 1 would anticipate the instantly claimed composition.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of Theisinger et al. (USPN 8,614,178 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the practiced composition disclosed by the reference is taught as comprising a therapeutically effective amount of an active ingredient (e.g., about 0.01 wt% to 0.5 wt%) cyclosporine, a liquid vehicle comprising a semifluorinated alkane (e.g., F4H5), and 1 wt% or less of ethanol.
Were the reference available as prior art, the instantly claimed composition at issue would be rendered prima facie obvious.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 17/613,832 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 discloses administering a composition that consists of about 0.5 mg/ml or 1.0 mg/ml (about 0.05-0.1 wt%) cyclosporine dissolved in 1-(perfluorobutyl)pentane and up to about 1% (w/w) ethanol.
Thus, were the copending ‘832 application available as prior art, it would immediately anticipate the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 21 of copending Application No. 18/784,569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claims 1 and 4 are directed to an ophthalmic composition comprising 0.1 wt% cyclosporine dissolved in 1-(perfluorobutyl)pentane. The limitations of claim 8 add the optional inclusion of ethanol, reciting that the composition may contain up to 1.0 wt% ethanol. This is read on by any disclosure where ethanol is not present (i.e., 0 wt%). Claim 9 recites that the ophthalmic composition consists of 0.1 wt% cyclosporine, 1-(perfluorobutyl)pentane, and up to about 1.0 % (w/w) ethanol (e.g., 0 wt% or optional). Claim 15 recites a “kit” comprising the composition of claim 1. Claim 16 recites that the kit comprises a container for the composition and a drop dispenser for administering the composition.
The method according to reference claim 21 discloses administering a composition comprising 0.1% (w/v) cyclosporine dissolved in 1-perfluorobutyl-pentane and up to about 1% (w/w) ethanol.
Thus, were the copending ‘569 application available as prior art, it would immediately anticipate the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22, and 23 of Graf et al. (US RE50,060 E). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 22 discloses a liquid composition is (i.e., consists of) an ophthalmic composition comprising 1 mg/mL (0.1 wt%) ciclosporine A and 1 wt% ethanol in 1-perfluorobutyl-pentane (F4H5). Claim 23 discloses the same formulation whereby it consists essentially of the foregoing composition.
Were the ‘060 patent available as prior art, it would immediately anticipate the instantly claimed composition.
Claim Rejections - 35 USC §102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 31 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Theisinger et al. (WO 2018/115097 A1; of record).
The limitations of instant claim 31 are directed to a composition comprising 0.1 wt% cyclosporine dissolved in 1-(perfluorobutyl)pentane and 1.0 wt% ethanol.
Theisinger discloses a pharmaceutical composition comprising about 0.05 to 0.1% (w/v) cyclosporine dissolved in 1-perfluorobutyl-pentane (see e.g., claim 1).
Claims 9 and 10 disclose that the composition may contain ethanol in an amount of about 1.0 % (w/w).
The reference is thus considered to meet each of the instantly recited compositional limitations.
Claim 31 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Theisinger et al. (USPN 8,614,178 B2; of record).
The limitations of the instantly claimed composition are discussed above.
Theisinger discloses a pharmaceutical composition comprising a therapeutically effective amount of a macrolide immunosuppressant, specifically, ciclosporin A (see e.g., claims 1-3). Claim 4 discloses that the amount of ciclosporin A present in the practiced composition ranges from about 0.01 wt% to about 0.5 wt%. More specific therapeutically useful concentrations of ciclosporin are disclosed as including 0.1 wt% (see col. 10, lines 50-52). This value and the three other cited values are interpreted as being preferred values.
Claims 1 and 5-7 also disclose that the liquid vehicle of the practiced composition comprises a semifluorinated alkane, which is used to produce the composition as a clear solution. Claim 7 discloses that the semifluorinated alkane is selected from such compounds as F4H5 (aka perfluorobutylpentane). Claim 13 specifically discloses it.
Claims 10 and 11 disclose the composition will contain ethanol at a concentration of about 1 wt% or less.
The reference is thus considered to anticipate the instantly claimed invention.
All claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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