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 .
Priority
The instant application is a DIV of 16/016,671 (filed 13 June 2018, now patent 11,938,058), which is a 371 of PCT US/2016/066957, filed 15 December 2016, which claims to provisional 62/267,794, filed 15 December 2015.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 1 May 2024 is acknowledged. Claims 13-20 were cancelled by Applicant. Claims 21-26 were added by Applicant. Claims 1-12 and 21-26 are examined herein on the merits.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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.
Claims 1, 2, 4, 5, 21, 22, 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 8,529,494 to Euteneuer et al in view of US 2003/0125351 to Azuma et al.
In the specification and figures, Euteneuer discloses the apparatus substantially as claimed by Applicant. With regard to claims 1, 2, 4, Euteneuer discloses an ocular implant for reducing intraocular pressure in a patient comprising an ocular implant 100 with a cannula 142 from the proximal end to distal end of the implant, a delivery tool 300 that may comprise a syringe 310, and a therapeutic material (see FIGS 1, 3 and accompanying text, column 9, lines 7-14).
Euteneuer doers not disclose a Rho kinase (ROCK) inhibitor. However, Azuma discloses a method of treating a patient with glaucoma to reduce intraocular pressure, using a ROCK inhibitor (see ¶0007-0011). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a ROCK inhibitor as disclosed by Azuma in conjunction with the ocular implant suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07. Furthermore, it is within the skill of a worker in the art to adjust the dosage of the ROCK inhibitor to achieve the desired pressure results.
With regard to claims 5, 24, Euteneuer discloses that the implant comprises a tubular body with a plurality of spines and frames that correspond to Applicant’s open areas and strut areas (see column 7, lines 29-42).
With regard to claims 21 and 22, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
Claims 6-10, 23, are rejected under 35 U.S.C. 103 as being unpatentable over US 8,529,494 to Euteneuer et al in view of US 2003/0125351 to Azuma et al, further in view of US 6,981,958 to Gharib et al.
In the specification and figures, the cited prior art suggests the method substantially as claimed by Applicant. With regard to claim 7, the prior art fails to disclose a pressure sensor as part of the implant. However, Gharib discloses an intraocular implant for glaucoma treatment comprising a pressure sensor on the implant (see column 11, lines 29-37). It would have been obvious to a person having ordinary skill in the art at the time of filing to add a pressure sensor as disclosed by Gharib to the implant in the method suggested by Euteneuer and Azuma in order to monitor intraocular pressure.
With regard to the particular claimed locations of the pressure sensor, it is within the skill of a person in the art to locate a pressure sensor where it would be most useful. Applicant’s Specification at ¶0117 discloses that the pressure sensor may be located at several locations, without disclosing any criticality of one location over another. Accordingly, the Specification teaches that the claimed locations are interchangeable, and not patentably distinct from the prior art.
Claims 11, 12, 25, 26, are rejected under 35 U.S.C. 103 as being unpatentable over US 8,529,494 to Euteneuer et al in view of US 2003/0125351 to Azuma et al, further in view of 2019/0076296 to Van Meter et al.
In the specification and figures, the cited prior art suggests the method substantially as claimed by Applicant. With regard to claim 11, the prior art fails to disclose a pressure sensor with a first substrate disposed on a second flexible substrate as part of the implant. However, Van Meter discloses an intraocular implant for glaucoma treatment comprising a pressure sensor on the implant with a first silicone substrate and a second flexible diaphragm 182 to determine pressure within the ocular cavity (see ¶0106, 0112). It would have been obvious to a person having ordinary skill in the art at the time of filing to add a pressure sensor as disclosed by Van Meter to the implant suggested by Euteneuer and Azuma in order to detect pressure within the ocular cavity.
With regard to claim 12, the cited prior art fails to disclose a delivery tool with an interlocking portion that interlocks with the implant. Van Meter discloses an intraocular cannula with a delivery tool that interlocks with a portion of the ocular implant to assist with implantation, allowing the delivery tool and the implant to move together during implantation (see ¶0016, 0146, 0166). It would have been obvious at the time of filing to add an interlocking portion as disclosed by Van Meter to the implant and delivery member suggested by the prior art in order to allow the delivery tool and implant to move together during implantation, as taught by Van Meter.
With regard to claims 25 and 26, the cited prior art fails to disclose the specific spine geometry claimed by Applicant. Van Meter discloses an intraocular cannula with spines and support frames, wherein the spines comprise a first major side, second major side, first minor side, and second minor side (see ¶0094). The spines also comprise a thickness between the first and second major sides and a width between the first and second minor sides, wherein a ratio of the width to the thickness is greater than about 2 (see ¶0095-0096).
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
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 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of U.S. Patent No. US 11,938,058 to Schieber et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 10-11 recite a method of inserting an implant as claimed by Applicant using a delivery tool, reciting the kit substantially as claimed by Applicant. Patented claim 12 (which was not originally presented in the claim set as restricted in the parent case) recites the use of as an eye dropper or a syringe as a therapeutic agent delivery device, anticipating the kit set forth in claims 3 and 4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached on Monday-Friday, 9am to 5:30pm.
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, Sarah Al-Hashimi can be reached on 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 8 May 2026
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