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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed July 5, 2024, is a reissue of U.S. Patent 10,307,408 (hereinafter the ‘408 patent), which issued from U.S. application Serial No. 15/956,931 (the ‘931 application) with claims 1-4 on June 4, 2019.
Reissue Declaration
The reissue declaration by assignee filed 07/05/2024 is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The reissue declaration is defective because it improperly lists Lee Nordan as a co-inventor. Lee Nordan is the person removed as a co-inventor from the ‘408 patent by the instant reissue application. As noted in MPEP 1414.01, a reissue declaration must identify the inventor. Non-inventor(s) cannot be listed on the reissue declaration.
A new reissue declaration identifying Gerald Horn as the sole inventor is required.
Claims 1-4 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the reissue declaration is set forth in the discussion above in this Office action.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2016/0018671 to Waite et al (hereinafter “Waite”) in combination with Romano, “Double-blind cross-over comparison of aceclidine and pilocarpine in open-angle glaucoma,” Brit. J. Ophthal., 1970, vol. 54, pp. 510-521 (hereinafter “Romano”)1.
With respect to claims 1-4, Waite teaches a contact lens that contains a fluidic module that contains a concentrated solution of a drug that is to be delivered to the eye in a sustained manner (see Abstract and ¶ 0009). The contact lens is a soft contact lens, e.g., a silicone-hydrogel contact lens (see ¶ 0065).
Waite teaches that the drug solution contains the ocular drug at a concentration in the range of 1-100 g/L or 0.001-0.3 moles/liter (see ¶ 0037). Waite teaches Timolol as an exemplary ocular drug, wherein the Timolol is delivered to the cornea for treatment of glaucoma (see ¶ 0039).
Waite further teaches that drugs delivered by eye drops can be rapidly washed away (see ¶ 0004). Waite’s contact lens provides for delivery of the drug in a sustained manner (see ¶ 0009).
Waite does not teach that the drug solution is a solution of aceclidine as the sole active agent.
Romano teaches aceclidine for the treatment of open-angle glaucoma (see pp. 510 and 520-521). As seen below in Romano’s Table I (p. 311), Romano’s aceclidine eye drops are a 2% solution, i.e., 20 g/liter or 0.097 moles/liter, of the aceclidine:
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438
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The aceclidine is the sole active agent since boric acid/sodium borate is a buffer (see, e.g., col. 25, lines 29-38 and Table 4 of the ‘408 patent).
Romano teaches that aceclidine provides the advantages of stability, penetration and long shelf-life (see p. 510). Romano concludes by teaching that aceclidine “would appear to deserve a place beside pilocarpine as a stable direct parasympathomimetic drug in the treatment of open-angle glaucoma, especially if pilocarpine is not tolerated, or if it is ineffective, or becomes so after a period of use.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Romano’s aceclidine solution as the ocular drug solution in Waite’s contact lens so as to treat open-angle glaucoma and take advantage of aceclidine’s stability, penetration and long shelf-life, as taught by Romano, and so as to provide for delivery of the drug in a sustained manner, as taught by Waite.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,179,327 (the ‘327 patent) in combination with Waite.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1-4, claims 1-15 of the ‘327 patent teach an ophthalmological composition for treatment of presbyopia, wherein the ophthalmological composition contains 0.225% to 1.85% w/v aceclidine as the only indicated active agent. Claims 1-15 of the ‘327 patent do not teach a contact lens comprising the ophthalmological composition.
Waite teaches a contact lens that contains a fluidic module that contains a concentrated solution of a drug that is to be delivered to the eye in a sustained manner (see Abstract and ¶ 0009). The contact lens is a soft contact lens, e.g., a silicone-hydrogel contact lens (see ¶ 0065).
Waite teaches that the drug solution contains the ocular drug at a concentration in the range of 1-100 g/L or 0.001-0.3 moles/liter (see ¶ 0037). Waite teaches Timolol as an exemplary ocular drug, wherein the Timolol is delivered to the cornea for treatment of glaucoma (see ¶ 0039).
Waite further teaches that drugs delivered by eye drops can be rapidly washed away (see ¶ 0004). Waite’s contact lens provides for delivery of the drug in a sustained manner (see ¶ 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the ophthalmological composition in claims 1-15 of the ‘327 patent in Waite’s contact lens so as to treat presbyopia with a delivery of the aceclidine in a sustained manner, as taught by Waite.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,959,990 (the ‘990 patent) in combination with Waite.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1-4, claims 1-12 of the ‘990 patent teach a composition for treatment of presbyopia, wherein the composition contains about 1.75% w/w aceclidine hydrochloride as the only indicated active agent. Claims 1-12 of the ‘990 patent do not teach a contact lens comprising the composition.
Waite is relied upon for the reasons stated above in Rejection No. 3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the composition in claims 1-12 of the ‘990 patent in Waite’s contact lens so as to treat presbyopia with a delivery of the aceclidine in a sustained manner, as taught by Waite.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,944,537 (the ‘537 patent) in combination with Waite.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1-4, claims 1-19 of the ‘537 patent teach an ophthalmological composition for treatment of presbyopia, wherein the ophthalmological composition contains about 0.25% to about 2.00% w/v aceclidine as the only indicated active agent. Claims 1-19 of the ‘537 patent do not teach a contact lens comprising the ophthalmological composition.
Waite is relied upon for the reasons stated above in Rejection No. 3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the ophthalmological composition in claims 1-19 of the ‘537 patent in Waite’s contact lens so as to treat presbyopia with a delivery of the aceclidine in a sustained manner, as taught by Waite.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,052,313 (the ‘313 patent) in combination with Waite.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 1-4, claims 1-18 of the ‘313 patent teach an ophthalmological composition for treatment of presbyopia, wherein the ophthalmological composition contains about 1.75% w/v aceclidine as the only indicated active agent. Claims 1-18 of the ‘313 patent do not teach a contact lens comprising the ophthalmological composition.
Waite is relied upon for the reasons stated above in Rejection No. 3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the ophthalmological composition in claims 1-18 of the ‘313 patent in Waite’s contact lens so as to treat presbyopia with a delivery of the aceclidine in a sustained manner, as taught by Waite.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 10,307,408 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
1 Waite and Romano are cited in the information disclosure statement filed 07/09/2024. Romano is also cited on the attached PTO-892 (Notice of References Cited) so that a copy of the reference is present in the instant reissue file.