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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Walter et al. (US 2014/0142587) in view of Schneider et al. (US 2013/0023892).
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).
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In the alternative and the analogous art of corneal implant device, Schneider discloses (Fig. 1) a removable reservoir [i.e. cap (300)] removably coupled to a deployment assembly (310), wherein the removable reservoir is configured to receive a storage fluid for hydrating a donor corneal tissue (320) retracted into the deployment assembly (Par. 0040-0041).
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 a removable reservoir removably coupled to the deployment assembly and in fluid communication with the at least one fluid channel, 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, as taught by Schneider. Walter discloses a removable reservoir [i.e. cap] is desired (Par. 0110), thus Schneider’s removable reservoir would have provided Walter with a sufficient means for removably coupling to the deployment assembly and receiving a storage fluid for hydrating a donor corneal tissue retracted into the cannula.
Regarding claim 2, Walter, as modified by in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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. storage solution, see Schneider paragraph 0040-0041].
Regarding claim 14, Walter, as modified by in the alternative by Schneider, 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. inserter cap (300), see Schneider paragraph 0038-0041 & annotated figure below].
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Regarding claim 15, Walter, as modified by in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, discloses further wherein the removable reservoir further comprises a fluid flow restrictor disposed therein [i.e. inserter cap (300), see Schneider annotated figure below].
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Regarding claim 18, Walter, as modified by in the alternative by Schneider, 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 in the alternative by Schneider, 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 in the alternative by Schneider, 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).
Conclusion
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 January 11, 2026