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.
Response to Amendments/Arguments
Applicant's amendments and arguments filed 11 August 2026 have been entered and fully considered, and are persuasive in part.
With regard to claims 1, 2, 4, 5, 21, 22, and 24, Applicant argues that the use of a ROCK inhibitor as disclosed by Azuma is not an obvious combination with Euteneuer because Azuma does not disclose the use of an ocular implant. The Examiner is relying on Euteneuer to teach the use of an ocular implant that may comprise therapeutic agents such as an anti-glaucoma drug (see col 9, ln 7-14). Euteneuer also teaches the use of a syringe to deliver a therapeutic fluid (see col 9, ln 15-27). Accordingly, Euteneuer teaches a “kit” for treating glaucoma comprising an ocular implant, a delivery tool, and a therapeutic agent that may be delivered by a syringe. Azuma discloses the use of a ROCK inhibitor to treat glaucoma. Taken together, the references reasonably suggest a kit with an ocular implant, a delivery tool, and a therapeutic agent comprising a ROCK inhibitor that may be delivered via a syringe.
Applicant further argues that the syringe disclosed by Euteneuer does not deliver a ROCK inhibitor. However, Applicant has claimed a system, and the system disclosed by Euteneuer comprises a syringe—the intended use of the syringe does not patentably distinguish from the structural elements disclosed by Euteneuer.
With regard to claims 6-10 and 23, Applicant argues that Gharib does not disclose a pressure sensor disposed on an inner surface of the tubular body. Applicant and Examiner agree that Gharib discloses an ocular implant with a pressure sensor.
Within the context of Applicant’s Specification, a pressure sensor is understood to be “disposed on” (claims 6, 8, 23), “disposed within” (claims 7, 10), or “disposed adjacent” (claim 9) to a surface of a cannula when the pressure sensor is “mounted” with respect to the surface. See Specification at ¶0117 (“While the pressure sensor 180 is illustrated as mounted to an inner surface 128 of the ocular implant 100 it is contemplated that the pressure sensor 180 may be mounted within one of the openings 124, 138, or on an outer surface of the ocular implant 100, as desired”). An analysis of obviousness does not require that the cited references teach each and every limitation of a claim. Rather, the test is based on what a person of ordinary skill in the art would contemplate based on the references before them. A skilled artisan would have contemplated from the combined teachings of Euteneuer, Azuma, and Gharib a configuration in which a pressure sensor is incorporated, and mounted, within an ocular implant. Accordingly, the claimed relationship of claims 6-10 and 23 of the pressure sensor to the cannula does not patentably distinguish those claims over the teachings of the prior art.
Applicant does not separately argue the rejections of claims 11, 12, 25, and 26.
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 apparatus 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 apparatus 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, suggesting that the claimed locations are interchangeable. Accordingly, the specific location of the sensor is not patentably distinguishable 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 apparatus 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.
Terminal Disclaimer
The terminal disclaimer filed on 11 August 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,938,085 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
Claim 3 is allowed.
The following is an examiner’s statement of reasons for allowance: The available prior art fails to teach the combination of an ocular implant with a cannula, delivery tool, and therapeutic agent comprising a ROCK inhibitor in combination with an eye dropper. The best prior art of record, US 11,938,085 is unavailable due to the Terminal Disclaimer filed 11 August 2026.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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 28 August 2026
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