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 .
Status of Claims
Claims 112,122,125 and 205-221 are pending and under examination in this office action. Claims 205-221 are newly added.
The rejection of Claims 112, 114, 122 and 125 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph written description is withdrawn based on the amendment to the claims and argument.
The rejection of Claim(s) 112, 114, 122 and 125 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Varner et al. (US 2006/0257451) is withdrawn based on Applicant’s amendment to the claims.
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) 112,122,125 and 205-221 is/are rejected under 35 U.S.C. 103 as being unpatentable over Varner et al. (US 2006/0257451) in view of Jarrett et al. (US 2016/0331738) and Hussain. Et al. (Stargardt Macular Dystrophy and evolving therapies)
With regard to instant claim 112, Varner teaches treating eyes (see abstract) wherein the ocular disease is neovascularization; inflammation, retinal degenerations, specifically choiroidal vasculature, diabetic retinopathy (see 0003, 0009 and 0162 as required by instant claims 112 and 125) and the length of the implant is taught to be no greater than 5 mm, which reads on the length of less than 17 mm as claimed in instant claim 112) delivered via intravitreal (see 0011), subconjunctival (see 0232, as required by instant claim 122). Additionally Varner teaches the hydrogel comprises a polymer unit comprising polyethylene glycol (see 0106), comprising repeating polyethylene units ranging from 100 to 500 kilodalton (when converted falls within the recited range of claims 206-208, see 0094), wherein the implant is a fiber (see 0037, as required by instant claim 218).
However Verna fails to teach the sustained release biodegradable ocular implant comprising a hydrogel and avacincaptad pegol.
Jarrett et al. teach a sustained release biodegradable ocular implant comprising a hydrogel and an active agent a C5 agent, wherein the particles are dispersed within the hydrogel (see abstract) for treating eye disease (i.e., diabetic macular edema, see 0133, as required by instant claim 125) wherein hydrogels are formed by crosslinking to form network (see 0065) with a molecular weight ranging from 2,000 (as required by instant claim 208) and also can range from 5000-50,000 Dalton (as required by instant claims 209-211, see 0091) having multi-arms of polyethylene glycol units (see 0074) from 2-100 arms (see 0081, as required by instant claim 212-216) and administered via a needle (see 0064; 0137 as required by instant claim 219-220).
Hussain teaches avacincaptad pegol is a C5agent, therefore one of ordinary skill in the art would substitute the generic teaching of c5 agent taught by Jarrett with Hussain’s C5 agent avacincaptad pegol with a reasonable expectation of success.
With regards to instant claim 221, the combination using the C5 agent taught by Hussain would have resulted in the claimed matter of 221.
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Applicant’s argument have been considered and moot based on the rejections made.
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 112,122,125 and 205-221 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1, 112 159-226 of U.S. Patent Application No. 18033689 in view of the above 35 USC 103 above. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the instant refers to the method comprising administering to the patient a sustained release biodegradable ocular implant comprising a hydrogel and an active agent, wherein active agent particles are dispersed within the hydrogel, and wherein the implant in its dry state has a length of less than about 17 mm, wherein the active agent is not a tyrosine kinsase inhibitor and the copending claims are to a sustained release biodegradable ocular implant comprising a hydrogel and an active agent, wherein active agent particles are dispersed within the hydrogel, and wherein the implant in its dry state has a length of less than about 17 mm, wherein the active agent is not a tyrosine kinsase inhibitor..
· As to the copending application claims, it would have been obvious to one of ordinary skill in the art would have been used the composition claims of the copending in practicing the instant claims with a reasonable expectation of success, therefore are part of the obvious variation of the copending application claims compared to the current application claims.
In view of the foregoing, the copending application claims and the current application claims are obvious variations.
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 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. 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.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 3/3/26
Prosecution Insights