DETAILED ACTION
Claims 1-28 are currently pending. Claims 1-3, 5-10, 13-18 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawn Rejections
The prior rejection of claims 13 and 17 under 112(b) is withdrawn in light of Applicant clearly referring back to previously named ingredients and correcting claim dependency, which the Examiner finds persuasive.
The prior rejection of claims 1-3, 7-8, 10 and 16 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 6,375,936 (IDS dated 02/10/2023) as evidenced by US 5,190,936 (Laugier) is withdrawn in light of Applicant narrowing the ammonium halide concentration of 0.005% to 0.02% that the ‘936 patent does not teach.
The prior rejection of claims 1-3, 6-8, 10, 16 and 18 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0043041 in view of Bell (Bell, Richard P. et al, American Journal of ophthalmology, Vol 34, Issue 9, (1951), pgs. 1321-1322) is withdrawn in light of Applicant narrowing the ammonium halide concentration of 0.005% to 0.02% that the ‘041 publication does not teach.
The prior rejection of claims 1-3, 5-10 and 13-18 under 35 U.S.C. 103(a) as being unpatentable over BAGUE (US 2006/0100288, filed Nov. 18, 2004; on IDS 2/10/2023) is withdrawn based on Applicant’s 1.132 Declaration. The instant claims distinguish over Bague by the choice and claimed amounts of cetalkonium chloride as the sole ammonium halide of the emulsion. Further, Applicants have demonstrated unexpected results (e.g. see declaration dated 09/04/2025) showing superior and unexpected results of cetalkonium chloride over benzalkonium chloride and related quaternary ammonium compound disclosed by Bague. The unexpected results are reasonably commensurate in scope with the instant claims.
Examiner’s Note
Applicant's amendments and arguments filed 09/04/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 09/04/2025, it is noted that claims 1, 13 and 17 are amended and no new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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 obviousness-type 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); and 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
U.S. Patent No. 7,973,081
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,973,081. The ‘081 patent and the instant claims are both directed to an oil in water emulsion comprising MCT, cetalkonium chloride, tyloxapol, poloxamer 188, glycerol and cyclosporin in overlapping amounts. The compositions are taught to have a positive zeta potential and droplet size range.
U.S. Patent No. 8,372,434
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-19 of U.S. Patent No. 8,372,434. Although the conflicting claims are not identical, they are not patentably distinct from each other because the scope of the '434 claims anticipates or renders obvious that of the instant claims. The ‘434 patent and the instant claims are directed mineral oil, cetalkonium chloride, tyloxapol, poloxamer in overlapping ranges in the form of an oil in water emulsion. The difference between the two claim sets is where the emulsion is described with functional properties that are not recited in the instant claims. However, as the claimed components are the same between the two emulsions, the functional properties recited in the instant claims are considered to be met by the emulsion taught by the ‘434 patent, absent evidence to the contrary.
U.S. Patent No. 9,220,694
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 9,220,694. Although the conflicting claims are not identical, they are not patentably distinct as they are both directed to oil in water emulsion comprising mineral oil or MCT, overlapping centration of cetalkonium chloride, overlapping surfactants and water and comprise glycerol as a tonicity agent wherein the ingredients are in overlapping concentrations and the oil in water emulsion has a positive zeta potential and overlapping droplet sizes.
U.S. Patent No. 9,956,289
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-17 of U.S. Patent No. 9,956,289. Although the conflicting claims are not identical, they are not patentably distinct as they are both directed to oil in water emulsion comprising mineral oil or MCT, overlapping centration of cetalkonium chloride, overlapping surfactants and water and comprise glycerol as a tonicity agent. The compositions are both taught to have a positive zeta potential and overlapping droplet size.
U.S. Patent No. 11,612,658
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 11,612,658. Although the conflicting claims are not identical, they are not patentably distinct as they are both directed to oil in water emulsion comprising mineral oil or MCT, overlapping centration of cetalkonium chloride, overlapping surfactants and water and comprise glycerol as a tonicity agent. The compositions are taught to both have a positive zeta potential and overlapping droplet sizes.
U.S. Patent No. 10,842,873
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-26 of U.S. Patent No. 11,612,658. Although the conflicting claims are not identical, they are not patentably distinct as they are both directed to oil in water emulsion comprising mineral oil or MCT, overlapping centration of cetalkonium chloride, overlapping surfactants and water and comprise glycerol as a tonicity agent. The compositions are taught to both have a positive zeta potential and overlapping droplet sizes.
U.S. Patent No. 8,524,779
Claims 1-3, 5-10 and 13-18 are non-provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1-19 of U.S. Patent No. 8,524,779. Although the conflicting claims are not identical, they are not patentably distinct as they are both directed to oil in water emulsion comprising mineral oil or MCT, overlapping centration of cetalkonium chloride, overlapping surfactants and water and comprise glycerol as a tonicity agent. The compositions are taught to both have a positive zeta potential and overlapping droplet sizes.
Response to Arguments:
Applicant’s arguments have been fully considered.
Double Patenting:
Applicant requests to hold the double patenting objections in abeyance until allowable subject matter has been identified.
In response, Applicant has presented no substantive arguments thus the rejections are maintained for reasons of record.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. 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.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
Prosecution Insights