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 .
Response to Amendment
The Amendment filed 04/14/26 has been entered. Claim 1 has been amended. Claims 1-20 are addressed in the following 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Walter et al. (US 2014/0142587), cited in previous office action, in view of Gulati et al. (US 2014/0316424).
Regarding claim 1, an invention relating corneal implant device, Walter discloses (Figs. 8A, 16, 20A-C, 22, 34-37) a donor corneal tissue storage and delivery device (10), comprising: a storage fluid (92; Par. 0153); a cannula (60) having a proximal end [i.e. end within element 10b] and a distal end (see annotated figure below); at least one fluid channel (150) with a proximal end [i.e. at the luer lock] and a distal end (see annotated figure below), the distal end disposed within the proximal end of the cannula (Par. 0125-0126); a flexible support (15) configured to receive a donor corneal tissue and retract into the cannula (Par. 0118); a retractor assembly (16) coupled to the flexible support (Par. 0092) and operable to retract the coupled flexible support thereby retracting the donor corneal tissue into the cannula (Par. 0121); a deployment assembly (65) coupled to the cannula (Par. 0118) and configured to retract the cannula and deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula (Par. 0121-0123); and a removable reservoir [i.e. cap] removably coupled to the deployment assembly and in fluid communication with the at least one fluid channel (Par. 0110), wherein the removable reservoir is configured to receive the storage fluid for hydrating the donor corneal tissue received by the flexible support while the flexible support is retracted into the cannula, wherein the at least one fluid channel, the cannula, and the removable reservoir are all filled with the storage fluid (Par. 0125-0126). However, Walter fails to disclose wherein the removable reservoir is a leakless chamber capable of holding one or more fluids.
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In the analogous art of IOL injector, Gulati discloses (Figs. 1-2) a removable reservoir (13 & 600) removably coupled to a deployment assembly (3, 200; Par. 0045), wherein the removable reservoir is configured to receive a storage fluid for hydrating a lens (400) retracted into the deployment assembly (Par. 0039 & 0047); wherein the removable reservoir is a leakless chamber capable of holding one or more fluids (Par. 0039).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walter to have wherein the removable reservoir is a leakless chamber capable of holding one or more fluids. Doing so would improve the ability to maintain fluid within the reservoir formed by flange and end cap, even when the injector assembly is sterilized using an autoclave (Par. 0040), as taught by Gulati.
Regarding claim 2, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter discloses (Fig. 20A) further comprising a housing (10b) having a proximal end (10p) and a distal end (see annotated figure below), wherein the cannula is disposed at and tapers towards the distal end of the housing (Par. 0117).
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Regarding claim 3, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 2. Walter further discloses wherein the cannula is slidably retractable relative to the housing (Par. 0117), and wherein the deployment assembly is configured to inhibit axial retraction of the cannula (Par. 0121).
Regarding claim 4, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 3. Walter discloses (Fig. 20A) further comprising a locking guard member (73) in communication with the deployment assembly and configured to inhibit axial retraction of the cannula (Par. 0121).
Regarding claim 5, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 4. Walter further discloses wherein the locking guard member is removable from the housing to allow the deployment assembly to retract the cannula into the housing, and wherein the at least one fluid channel remains stationary within the retracting cannula and acts to push the donor corneal tissue out of the cannula (Par. 0121-0123).
Regarding claim 6, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses (Figs. 8A & 20A) wherein the retractor assembly comprises a retractor shaft (16) coupled to the flexible support (15) and one or more loading members (72) coupled to the retractor shaft and operable to retract the retractor shaft and coupled flexible support thereby retracting the flexible support and donor corneal tissue into the cannula (Par. 0121).
Regarding claim 7, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 6. Walter discloses (Fig. 20A) further comprising a housing (10b) having a proximal end (10p) and a distal end (see annotated figure below), wherein the cannula is disposed at the distal end of the housing, and wherein the one or more loading members of the retractor assembly are held by the housing (Par. 0118 & 0121).
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Regarding claim 8, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses (Fig. 20A) wherein the deployment assembly comprises a deployment shaft (65) coupled to the cannula and one or more deployment members [i.e. slide control used to retract elements 60 and 65] coupled to the deployment shaft and operable to cause the deployment shaft to retract the cannula and to deliver the donor corneal tissue to an implantation site from the flexible support retracted into the cannula (Par. 0121-0123).
Regarding claim 9, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 8. Walther discloses (Fig. 20A) further comprising a housing (10b) having a proximal end (10p) and a distal end (see annotated figure below), wherein the cannula is disposed at the distal end of the housing, and wherein the deployment shaft of the deployment assembly is configured to retract into the distal end of the housing (Par. 0118 & 0121-0123).
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Regarding claim 10, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses wherein the at least one fluid channel is configured to receive irrigation fluid and direct the irrigation fluid to the cannula to provide irrigation to the donor corneal tissue and the implantation site and configured to help flowably deliver the donor corneal tissue when the deployment assembly is operated (Par. 0125-0126).
Regarding claim 11, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter discloses (Fig. 20A) further comprising a fluid channel connector (74) coupled to the proximal end of the at least one fluid channel and a fluid pressure source [i.e. syringe] configured to releasably engage the fluid channel connector to help deliver the donor corneal tissue into a small incision scleral access site (Par. 0126).
Regarding claims 12-13, Walter, as modified by Gulati, discloses wherein the removable reservoir contains the storage fluid, wherein the storage fluid comprises a biocompatible fluid [Claim 12]; wherein the biocompatible fluid is a cornea storage solution [Claim 13] (Par. 0125-0126) [i.e. saline solution, see Gulati paragraph 0067-0068].
Regarding claim 14, Walter, as modified by Gulati, further discloses wherein the removable reservoir comprises a reservoir base configured to removably couple the removable reservoir to a distal end of the deployment assembly, a reservoir body extending distally from the reservoir base, and a reservoir cap distal the reservoir base, the reservoir cap removably coupled to the reservoir body [i.e. reservoir base (600), reservoir body (101), reservoir cap (13), see Gulati paragraph 0041].
Regarding claim 15, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses wherein the flexible support and donor corneal tissue adopt a rolled shape when retracted into the cannula (Par. 0082 & 0085).
Regarding claim 16, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses wherein the removable reservoir encloses the flexible support and cannula when the removable reservoir is removably coupled to the deployment assembly (Par. 0126).
Regarding claim 17, Walter, as modified by Gulati, discloses further wherein the removable reservoir further comprises a fluid flow restrictor disposed therein [i.e. seal post (505), see Gulati paragraph 0040].
Regarding claim 18, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses wherein at least a portion of the cannula is visually transmissive (Par. 0124).
Regarding claim 19, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 1. Walter further discloses wherein a proximal portion of the deployment assembly is slidably engaged to the retractor assembly at a junction, the junction including a one-way valve or gasket that inhibits leakage of the storage fluid (Par. 0122-0123).
Regarding claim 20, Walter, as modified by Gulati, discloses the donor corneal tissue storage and delivery device according to claim 19. Walter further discloses (Fig. 8A) wherein the retractor assembly comprises a retractor shaft (16) coupled to the flexible support, and wherein the proximal portion of the deployment assembly is slidably engaged to the retractor shaft at the junction (Par. 0092).
Response to Arguments
Applicant’s arguments, see pages 1-3, filed 04/14/26, with respect to the rejections of claims under 35 USC § 102 & 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of newly cited art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 22, 2026
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