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 .
Claims 12-16 are presented for examination.
Claims 1-11 and 17-20 are withdrawn from examination.
The remarks filed on 02/11/2026 have been received and entered.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santos et al. (US 20150224055) and as evidenced by Kwon et al. (submitted by the applicant).
Santos teaches pharmaceutical formulations comprising an anti-angiogenic compound such as a monoclonal antibody or fragment thereof Selected from, for example, ranibizumab, which is a vascular endothelial growth factor binder which inhibits the action of VEGF, and a delivery agent selected from a pharmaceutically acceptable liposome. The formulations are useful in the treatment of a variety of angiogenic disorders and diseases in animals and people, and, preferably, in ophthalmic disorders selected from age-related macular degeneration, diabetic macular edema and corneal neovascularize. See the abstract. the treatment of other forms of macular edema is taught in Para [0046]. Santo teaches that ophthalmic steroids that may be utilized in the liposomal formulation alone or in combination with any other active ingredient include dexamethasone, fluocinolone, loteprednol difluprednate, fluorometholone, prednisolone, medrysone, triamcinolone acetonide, rimexolone and the various salt forms thereof. See Para [0048]. Santos in table 2, Para [0056] teaches the use of triamcinolone acetonide in combination with glycerol dimyristate. The topical administration is taught in claim 4 and 13. The use of triamcinolone acetonide and topical administration is also taught in claims 36 and 39. To treat macular edema due branch retinal vein occlusion would have been obvious to a person skilled in the art, considering that Santo teaches the use of the claimed composition for the treatment diabetic macular edema and other types of macular edema. Furthermore, Kwon teaches the use of triamcinolone for the treatment of macular edema secondary to branch retinal vein occlusion.
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 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 10,548,841. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap.
The claims of the instant application are drawn to a method of treating a patient having macular edema secondary to branch retinal vein occlusion comprising topically administering a pharmaceutically effective amount of a triamcinolone acetonide- loaded liposomal formulation as primary therapy for said patient. The claims of the U.S. patent are drawn to a method of treating diabetic macular edema in a patient in need of treatment thereof comprising topically administering to the surface of the eye a pharmaceutically effective amount of a topical ophthalmic formulation comprising a thermodynamically stable self- forming liposome selected from the group consisting of PEG-12-GDM or PEG-12 GDO and triamcinolone acetonide wherein the liposome is a self-forming thermodynamically stable liposome present in a weight percentage of less than 20% wt./wt. based upon the total weight of the formulation. The claims of the instant application are within the scope of the claims of the U.S. Patent.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “The Santos disclosure teaches liposomal formulations and topical treatment of certain diseases or conditions using the liposomal formulation disclosed therein. Treatment of macular edema is disclosed. There is no teaching of treating macular edema secondary to branch vein retinal occlusion. The combination of references does not lead one of ordinary skill in the art to the treatment of any conditions which are secondary to occlusion of any sort, let alone branch vein retinal occlusion. The Santos disclosure focuses on primary diabetic macular edema, corneal neovascularization and AMD, without, again, suggesting or recognizing any efficacy in macular thickening, macular cysts or macular edema secondary to branch vein retinal occlusion (BRVO). In addition, there is clear evidence of unexpected results with respect to the data shown in, for example, Figure 4 of the present application for the treatment of subjects having macular edema secondary to branch vein retinal occlusion in CFT, BCVA and IOP during follow up of TA-LF therapy versus the treatment with placebo and versus the data shown in the Santos prior art (Santos, Figure 4) in subjects that were not subjects with macular edema secondary to branch vein retinal occlusion”. Applicant in his remarks further argues that “The results in the current application show a substantially greater reduction in central foveal thickness and superior visual recovery using equivalent dosing. This magnitude of improvement was clinically unexpected and indicates a distinct therapeutic mechanism or responsiveness in the BRVO-related group. The present application demonstrates surprising and unexpected results that would overcome any indicia of prima facie obviousness which, Applicant suggests, has not even been met”. It is the examiner’s position that comparing the use of the claimed composition in a patient having macular edema secondary to branch retinal vein occlusion with placebo shows that the claimed composition works on macular edema secondary to branch retinal vein occlusion. Santos clearly teaches the use of the triamcinolone for the treatment of macular edema due to many conditions. There is no evidence of record to show that such compound cannot be used for treating macular edema secondary to branch retinal vein occlusion. Furthermore, Kwon teaches the use of triamcinolone for the treatment of macular edema secondary to branch retinal vein occlusion by intravitreal injection. The topical liposomal administration triamcinolone acetonide is taught by santos et al. Furthermore, there is no side-by-side comparison commensurate with the claimed language to show the advantages of using topical triamcinolone acetonide in treating macular edema secondary to branch retinal vein occlusion and macular edema caused by other reasons. Additionally, since Santos uses the same composition as the claimed invention, the advantages applicant is claiming is the inherent property of Santos composition in the absence of evidence to the contrary.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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, Sue Liu can be reached at 571-272-5539. 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.
/ZOHREH A FAY/Primary Examiner, Art Unit 1617
Prosecution Insights