DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The instant application is a Continuation of application 17/381,320 filed 21 July 2021, now U.S. Patent 11,891,726, which is a Division of application 16/689,569 filed 20 November 2019, which is a Continuation of application 14/732,349 filed 30 March 2015, now U.S. Patent 10,538,864, which is a National Stage Entry of International Application PCT/EP2013/072274 filed 24 October 2013, which claims the benefit of Provisional U.S. application 61/717,806 filed 24 October 2012.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to European applications 13166874.1 filed 7 May 2013, and 12189803.5 filed 24 October 2012. The certified copies have been filed in parent Application No. 14/432,349, filed on 30 March 2015.
Status of the Claims
Claims 15-34 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to a method of treating ocular conditions by the intravitreal or subconjunctival injection of a fiber which combines a bioactive agent dispersed within a particular biodegradable polyesteramide defined according to what applicants refer to as “Formula (IV).” Dependent Claims 16-30 place further limitations on the identity of biodegradable polyesteramide. Claim 31 indicates that the bioactive agent is to be a prostaglandin. Claim 32 combines an additional biodegradable polymer with the biodegradable polyesteramide. Claim 33 specifies the dimensions of the fiber. Claim 34 indicates that the fiber is one which swells following implantation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 15-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Franken (WO2012/150255) as evidenced by “Syringe Needle Conversion Chart” (available at https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/374/803/syringes.pdf), in view of Mihov (WO2012/175746)(all of record).
The applied references have a common inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 103(a) might be overcome by: (1) a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor of this application and is thus not an invention “by another”; (2) a showing of a date of invention for the claimed subject matter of the application which corresponds to subject matter disclosed but not claimed in the reference, prior to the pre-AIA 35 U.S.C. 102(e) date of the reference under 37 CFR 1.131(a); or (3) an oath or declaration under 37 CFR 1.131(c) stating that the application and reference are currently owned by the same party and that the inventor or joint inventors (i.e., the inventive entity) named in the application is the prior inventor under pre-AIA 35 U.S.C. 104 as in effect on March 15, 2013, together with a terminal disclaimer in accordance with 37 CFR 1.321(c). This rejection might also be overcome by showing that the reference is disqualified under pre-AIA 35 U.S.C. 103(c) as prior art in a rejection under pre-AIA 35 U.S.C. 103(a). See MPEP §§ 2146 et seq.
Franken describes polyesteramide drug delivery device capable of being injected through a syringe bore of between 18-30 gauge, which the skilled artisan would understand possess an internal diameter of between 140-838 microns, defining a diameter overlapping and therefore rendering obvious those of instant claims 15, 32, and 34. (Pg.1, Pg.9, see also “Syringe Needle Conversion Chart”). Prostaglandins of Claims 29 and 30 are particularly recited as actives useful in such fibers. (Pg.7). The polyesteramides and actives are usefully combined with additional biodegradable polymers including, for example, poly (D, L-lactide) of Claim 31. (Pg.9). These fibers may be injected intravitreally or subconjuctivally, addressing limitations of Claim 15. (Pg.10).
Franken, describing a polyesteramide of “Formula I,” does not however address the polyesteramide of “Formula IV” encompassed by the instant claims as the PEAS for use as a drug delivery matrix.
This is cured by the teachings of Mihov, which describes a swellable polyesteramide useful for the sustained release of active agents combined therewith. (Pg.5-6). Prostaglandins are recited as active agents usefully included in these drug delivery devices. (Pg.12). Mihov appears to recite what applicants refer to as the instantly claimed PEA of “Structural Formula (IV)” as, oddly enough, “Structural Formula (IV).” (reproduced below).
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(Mihov, Pg.4-5).
It would have been prima facie obvious to have used the PEA Mihov recites as “Formula (IV) as the PEA in the method of implanting a fiber in the eye of a patient via intravitreal or subconjunctival implantation of a PEA/agent fiber of between 50-500 microns because Franken employs a functionally and structurally similar swellable biodegradable PEA polymer as a drug delivery construct. Because Mihov establishes the PEA of the instant claims are also useful as drug delivery carriers, the substitution of the Mihov PEA for the PEA of Franken appears to amount to little more than the substitution of one component for another, each of which is taught by the prior art to be useful for same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,538,864 in view of Franken as discussed in greater detail above.
The claims of the ‘864 patent encompass the polymer of “Formula (IV)” described by the Mihov reference discussed in greater detail above, having been formed into a fiber and active agent, either alone or in combination with, among others, a poly(D,L-lactide” copolymer as is set forth by Mihov. Its use in a method of delivering drug to the eye such as described by Franken is prima facie obvious for reasons similar to why the combination of Mihov and Franken, discussed in greater detail above, are obvious. Specifically, that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Claims 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,891,726 in view of Franken as discussed in greater detail above.
The claims of the ‘726 patent encompass the polymer of “Formula (IV)” described by the Mihov reference discussed in greater detail above, having been formed into a fiber and active agent, either alone or in combination with, among others, a poly(D,L-lactide” copolymer as is set forth by Mihov. Its use in a method of delivering drug to the eye such as described by Franken is prima facie obvious for reasons similar to why the combination of Mihov and Franken, discussed in greater detail above, are obvious. Specifically, that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614