DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of the composition of Claims 1-3, 5, 14, 17, 18, 22,-24, 26, 29, 46, and 49 in the reply filed on 9 June 2026 is acknowledged.
Status of the Claims
Claims 1-3, 5, 14, 17, 18, 22,-24, 26, 29, 46, and 49 are pending, presented for examination, and rejected as set forth in greater detail below.
Priority
The instant application is a National Stage entry of International application PCT/US2023/010319 filed 6 January 2023, which claims the benefit of Provisional U.S. application 63/297,776 filed 9 January 2022.
Claim Interpretation
Applicants Claims are directed to compositions which combine
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 14, 17, 22, 46, and 49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 3 recites a broad limitation of “up to about 2 weeks” while also claiming “or 1 month after administration. In a similar manner, Claim 14 identifies the comspotisoin as “essentially cylindrical” as well as “cylindrical,” while three overlapping ranges of dry state length are described. Claim 17 identifies the comspotisoin as “essentially cylindrical” as well as “cylindrical.” Claim 22 identifies the comspotisoin as “essentially cylindrical” as well as “cylindrical,” while three overlapping ranges of swollen length to diameter ratios are described. Claim 23 identifies three overlapping ranges of swollen length to diameter ratios as falling within the claims. Claim 46 recites multiple ranges corresponding to each of d90, d50, and d10 particle sizes. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 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.
Claims 1-3, 5, 14, 18, 22-24, 26, 29, 46, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Utkhede (WO2009/035562).
Utkhede describes implant bodies adapted for insertion into or adjacent to an eye of a patient which release active agents to the eye and surrounding tissues to treat diseases in patients to which they are administered. (Pg.2). Utkhede indicates that these implants may contain the active agent homogeneously dispersed throughout the matrix of the implant, and may form solid inclusions within the matrix. (Pg.3, 89, 120-21). Utkhede indicates that in certain embodiments, the entirety of the implant comprises a polymeric drug core matrix with the therapeutic agent dispersed therein. (Pg.5). Utkhede indicates that these implants are designed so that the drug core is to be exposed to tear liquid when implanted in or near the eye, (Pg.7), and in a particular embodiment the implant is designed to be placed within a punctum and swells from a first diameter to a second diameter when exposed to tear liquid. (Pg.20, 40). More specifically, Utkhede indicates these implants may be substantially cylindrical prior to swelling when placed in the lacrimal puncta. (Pg.88). Utkhede describes a particular embodiment where the diameter is to increase by about 50% of the first diameter of the implant, addressing the limitations of Claim 18. (Pg.40) This swelling is described by Utkhede as sufficient to retain the implant within a punctal canal of a patient. (Pg.21). Utkhede indicates that the cores may contain either solid or liquid inclusions of therapeutic agent, with the inclusions having an average diameter of less than about 10 microns, or between 5-50 microns, ranges overlapping and therefore rendering obvious the size limitations of Claim 46. (Pg.23, 38), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Utkhede indicates that in a preferred embodiment, the size distribution of the inclusions is monodisperse. (Pg.28). Suitable polymers described by Utkhede as useful as the matrix of the implants are hydrogels such as polyurethane hydrogel-forming polymers. (Pg.61-62, 86, 118-19). The nepafenac of the instant claims, in amounts of about 10-50 micrograms, (0.01-0.05mg) is identified as a particular therapeutic agent which may be included. (Pg.68). While outside the concentration of therapeutic agent recited by the claims, applicants are reminded that differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). Here, the difference between the claimed nepafenac dosage ranges and the amount of therapeutic agent described by the art is approximately 0.05mg. As these relate to dosages of therapeutic active agent, a skilled artisan would have the motivation to adjust and optimize the amount of active agent present in such a dosage form. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (indicating that every ordinary artisan in medicine performs "merely routine optimization of drug dosage to maximize therapeutic effect."). Indeed, Utkhede provide just such a motivation by indicating that dosages may be adjusted to accommodate the particulars of the agent to be included and the disease to be treated by its use. (Pg.112). Utkhede indicates that a wide variety of drug release times fall within the scope of the disclosure, from one week up to five years, or in an alternative between 1 week to 6 months, defining ranges overlapping and rendering obvious that of the instant claims. (Pg.72, 90, 113), See In re Peterson, supra. Utkhede indicates that while non-therapeutic agents may be incorporated into these drug-containing matrices, non are explicitly required, addressing the limitations of Claim 49. (Pg.119). Utkhede indicates that the drug matrices may have a weight of about 70 micrograms, addressing limitations of Claim 24. (Pg.122). An embodiment of a punctal plug according to Utkhede has a length of approximately 2mm, addressing limitations of Claim 14. (Pg.136-37). Utkhede describes an embodiment of drug cores having a dry diameter of about 0.32mm and length of 0.95mm (Pg.122), but also indicates that during manufacturing, drug cores can be cut to sections of suitable length for use as drug inserts, such as about 1mm. (Pg.157).
The specific combination of features claimed is disclosed within the broad teachings of the Utkhede reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific preservative-free biodegradable polymeric hydrogel cylinder having the dimensions, weight, and swellability recited by the claims which contains nepafenac particles of the size claimed which can fit the lacrimal puncta and enter the canaliculi to deliver nepafenac over a period of at least 5 days, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected a preservative-free biodegradable polymeric hydrogel cylinder having the dimensions, weight, and swellability recited by the claims which contains nepafenac particles of the size claimed which can fit the lacrimal puncta and enter the canaliculi to deliver nepafenac over a period of at least 5 days from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-3, 5, 14, 17, 18, 22-24, 26, 29, 46, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Utkhede as applied to Claims 1-3, 5, 14, 18, 22-24, 26, 29, 46, and 49above, and further in view of Sawhney (U.S. PGPub. 2010/0209478).
Utkhede, discussed in greater detail above, suggests a preservative-free biodegradable polymeric hydrogel cylinder having the dimensions, weight, and swellability recited by the claims which contains nepafenac particles of the size claimed which can fit the lacrimal puncta and enter the canaliculi to deliver nepafenac over a period of at least 5 days. Utkhede does not, however, describe a cylindrical rod-shaped lacrimal insert which swells when hydrated to increase the diameter of the rod, while decreasing the length of the rod.
This is cured by the teachings of Sawhney, which indicates that lacrimal canalicular implants designed for insertion through the lacrimal punctum can be designed to anisotropically swell, meaning swelling preferentially in one direction as opposed to another to conform to the canaliculus or punctum, having a dehydrated length of between 0.5-15mm and a diameter of between 0.1-1mm can be used with the expectation that it will swell by about 2x to provide for snug fit when placed in patients. [0102; 140]. Sawhney indicates that punctal lugs that have been stretched and which swell across their diameter while shrinking along their length find particular use as punctal plugs. [0224; Figs. 21A & 21B].
It would have been prima facie obvious to have employed a stretched hydrogel polymer per the teachings of Sawhney as the hydrogel polymer matrix of the punctal plugs of Utkhede. This is because Sawhney indicates that anisotropically swellable rod shaped implants that preferentially swell radially and shrink lengthwise possessing dimensions similar to those of Utkhede are known to be particularly useful as punctal plugs. This is because generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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.
At least Claims 1-3, 5, 26, 29, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 8,409,606 in view of Utkhede, discussed in greater detail above. The ‘606 claims recite a biodegradable sustained release hydrogel lacrimal canalicular implant containing active agent particles of sizes overlapping those of the present claims, but does not indicate that the active agent may be the nepafenac of the instant application. This is cured by the teachings of Utkhede which establish that nepafenac may be an active agent incorporated into lacrimal canalicular plugs for sustained delivery to the ocular environment.
At least Claims 1-3, 5, 26, 29, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 3, 6 and 10 of U.S. Patent No. 8,563,027 in view of Utkhede, discussed in greater detail above. The ‘027 claims disclose, in the context of a method of its making, a biodegradable sustained release hydrogel lacrimal canalicular implant containing active agent particles of sizes overlapping those of the present claims, but does not indicate that the active agent may be the nepafenac of the instant application. This is cured by the teachings of Utkhede which establish that nepafenac may be an active agent incorporated into lacrimal canalicular plugs for sustained delivery to the ocular environment.
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.
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, Ali Soroush can be reached at (571) 272-9925. 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.
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
Prosecution Insights