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 .
Status of Claims
Claims 1-3, 5-6, 8-17, 23-26, 28-29, and 33 are pending and examined on the merits.
Claims 3, 6, 17, and 26 are currently amended.
Claims 4, 7, 18-22, 27, 30-32, and 34-35 are cancelled.
Information Disclosure Statement
The two information disclosure statements (IDS’s) submitted on 07/31/2025 and 06/10/2026 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-6, 8, 11-17, 23-26, 28-29, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz (U.S. Pre Grant Pub. No. 2024/0173169 A1).
Regarding claim 1, Shultz teaches: An implantable system for shunting fluid between a first body region and a second body region of a patient (see at least Abstract and para. [0002]), the system comprising:
a shunting element having a channel (see for example first channel 136a in Fig. 1B and para. [0024]) extending therethrough and a port (see first fluid inlet 124a in Fig. 1B and para. [0024]) in fluid communication with the channel (see at least para. [0024]);
a shape memory actuator (see actuator 130a in Fig. 1B and para. [0026]) configured to control flow of fluid through the port (see para. [0025]), the shape memory actuator comprising
an anchor element (see lowermost portion of the first actuator 130a in Fig. 1B; corresponding to end portion 234b in Figs. 2A-B);
a gating element (see 134a in Fig. 1B and para. [0025]) configured to moveably interface with the port (see para. [0025]),
a first actuation element (see 132a in Fig. 1B and para. [0026]) extending between the anchor element and the gating element (see Fig. 1B), and
a second actuation element (see 132a2 in Fig. 1B and para. [0026]) extending between the anchor element and the gating element (see Fig. 1B),
wherein the first actuation element, when actuated, is configured to pivot the gating element in a first direction relative to the port (see at least para. [0025-0026]), and
wherein the second actuation element, when actuated, is configured to pivot the gating element in a second direction relative to the port (see at least para. [0025-0026]), the second direction being opposite the first direction (Id.).
However, while the embodiment of Fig. 1B fails to explicitly teach an actuator priming element, as required by the claim, the embodiment of Figs. 3A-C teaches an actuator priming element (see outer perimeter 338 in Figs. 3A-C and para. [0049]) configured to receive the shape memory actuator (see Figs. 3A-C), wherein the actuator priming element extends between the anchor element and the gating element (as shown in Fig. 3A, the outer perimeter extends between anchor element 334b and gating element 334) and is shaped and sized to deform the shape memory actuator relative to its preferred geometry when the shape memory actuator is coupled thereto (see for example Figs. 3B-C and para. [0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schultz to combine the actuator priming element of the embodiment of Figs. 3A-B with the implantable shunting system of the embodiment of Fig. 1B at least because Shultz teaches that particular features of characteristics may be combined in any suitable manner in one or more embodiments (see para. [0017]).
Regarding claim 2, Shultz teaches the invention as discussed above in claim 1. Additionally, Shultz teaches wherein:
the actuator priming element includes a first end portion at the gating element (see portion adjacent gating element 334 in Fig. 3A) and a second end portion at the anchor element (see portion adjacent anchor element 334b in Fig. 3A); and
the gating element is configured to pivot about the first end portion of the actuator priming element when moving in the first direction and the second direction (para. [0049] teaches that first and second fingers 337a, 337b form pivot points that engage gating element 334).
Regarding claim 3, Shultz teaches the invention as discussed above in claim 1. Additionally, Shultz teaches wherein the actuator priming element has a tapered end portion (see frictional element 325 in Figs. 3A-C and para. [0050]), and wherein the gating element is configured to pivot about the tapered end portion of the actuator priming element when moving in the first direction and the second direction (see for example Figs. 3B-C and para. [0050]).
However, while the embodiments of Figs. 1B and 3A-C fail to explicitly teach wherein the gating element includes a recess and wherein the actuator priming element has a tapered end portion configured to extend into the recess, as required by the claim, in the embodiment of Fig. 5, Shultz teaches wherein the gating element includes a recess (para. [0060] teaches an aperture in the first end region 534a of gating element 534).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schultz to include a recess with the gating element at least because Shultz teaches that particular features of characteristics may be combined in any suitable manner in one or more embodiments (see para. [0017]). In addition, in the combined device of embodiments Figs. 1B, 3A-C, and 5, the tapered end portion of the actuator priming element is configured to extend into the recess of the gating element (see Figs. 1B, 3A-C, and 5).
Regarding claim 5, Shultz teaches the invention as discussed above in claim 3. Additionally, Shultz teaches wherein the tapered end portion of the actuator priming element contacts the gating element at a bottom of the recess (para. [0037] teaches that ledge 125b can form the floor of the first chamber 121a; para. [0042] teaches that frictional element 225 is similar to ledge 125; while para. [0050] teaches that frictional element 325 operates in a similar manner as frictional element 225; therefore, frictional element 325 can form the floor of actuator 330 which would enable the actuator priming element to contact the gating element at a bottom of the recess), and wherein sides of the tapered end portion are spaced apart from corresponding sides of the recess by a gap (as shown in Fig. 3A, the sides of the frictional element 325 are spaced apart from the first end portion 334a of gating element 334 by a gap).
Regarding claim 6, Shultz teaches the invention as discussed above in claim 1. Additionally, Shultz teaches wherein the gating element includes a projection (see for example first end portion 334a of gating element 334 in Fig. 3A and para. [0049]), wherein the actuator priming element has a recess configured to receive the projection (in Fig. 3A, see for example open space defined between first finger 337a, second finger 337b, and frictional element 325 which receives first end portion 334a), and wherein the projection element is configured to pivot relative to the recess as the gating element moves in the first direction and the second direction (see Figs. 3B-C).
Regarding claim 8, Shultz teaches the invention as discussed above in claim 6. Additionally, Shultz teaches wherein side walls of the projection are spaced apart from side walls of the recess (see Fig. 3A).
Regarding claim 11, Shultz teaches the invention as discussed above in claim 1. Additionally, Shultz teaches wherein the shape memory actuator is a single, unitary component (see at least Fig. 1B) composed of Nitinol (see at least para. [0026]).
Regarding claim 12, Shultz teaches the invention as discussed above in claim 1. Additionally, Shultz teaches wherein the shunting system is an intraocular shunting system configured to be implanted in an eye of the patient (see at least para. [0011 and 0020]).
Regarding claim 13, Shultz teaches A shape memory actuator for use with an implantable shunting system for treating a patient (see actuator 130a in Fig. 1B and para. [0026]; see also at least Abstract and para. [0002]), the shape memory actuator comprising:
a gating element (see 134a in Fig. 1B and para. [0025]) configured to moveably interface with a fluid port (see first fluid inlet 124a in Fig. 1B and para. [0024]) on the implantable shunting system (see para. [0025]) when the shape memory actuator is operably coupled to the implantable shunting system (see at least Fig. 1B);
a first actuation element coupled to the gating element (see 132a in Fig. 1B and para. [0026]),
wherein, when actuated the first actuation element is configured to pivot the gating element in a first direction (see at least para. [0025-0026]);
a second actuation element coupled to the gating element (see 132a2 in Fig. 1B and para. [0026]),
wherein, when actuated the second actuation element is configured to pivot the gating element in a second direction (see at least para. [0025-0026]).
However, while the embodiment of Fig. 1B fails to explicitly teach an elongated projection coupled to the gating element and extending between the first actuation element and the second actuation element, as required by the claim, the embodiment of Figs. 3A-C teaches an elongated projection (see outer perimeter 338 in Figs. 3A-C and para. [0049]) coupled to the gating element (as shown in Figs. 3B-C, the first and second fingers 337a, 337b are coupled to the gating element 334 when the gating element is pivoted between a first and second direction) and extending between the first actuation element and the second actuation element (see Fig. 3A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schultz to combine the elongated projection of Figs. 3A-B with the shape memory actuator of the embodiment of Fig. 1B at least because Shultz teaches that particular features of characteristics may be combined in any suitable manner in one or more embodiments (see para. [0017]).
Regarding claim 14, Shultz teaches the invention as discussed above in claim 13. Additionally, Shultz teaches wherein the elongated projection includes a thinned portion (see Fig. 3A).
Regarding claim 15, Shultz teaches the invention as discussed above in claim 13. Additionally, Shultz teaches further comprising an engagement element (see first and second fingers 337a, 337b) connected to the elongated structure at an end opposite of the gating element (as shown in Fig. 3A, the first and second fingers 337a, 337b are connected on opposite ends of the gating element 334), wherein the gating element and the elongated structure are configured to pivot about the engagement element (see for example Figs. 3B-C and para. [0049]).
Regarding claim 16, Shultz teaches the invention as discussed above in claim 15. Additionally, Shultz teaches further comprising an anchor portion (see lowermost portion of the first actuator 130a in Fig. 1B; corresponding to end portion 234b in Figs. 2A-B), wherein the first actuation element and the second actuation element extend between the anchor portion and the gating element (see at least Fig. 1B).
Regarding claim 17, Shultz teaches the invention as discussed above in claim 16. Additionally, Shultz teaches wherein:
the engagement element is moveable between a first position (see Fig. 3B) relative to the anchor portion and a second position (see Fig. 3C) relative to the anchor position different than the first position (para. [0049] teaches that the first and second fingers 337a, 337b for pivot points that engage an intermediate portion of the gating element 334; therefore, when gating element 334 pivots about the first and second fingers 337a, 337b, the first and second fingers 337a, 337b will necessarily move when the gating element 334 pivots); and
the shape memory actuator is configured such that moving the engagement element from the first position to the second position increases an amount of strain in the first actuation element and the second actuation element by compressing or stretching the first actuation element and the second actuation element (see at least para. [0048] and Figs. 3A-C).
Regarding claim 23, Shultz teaches An implantable shunting element (see at least Abstract and para. [0002]) having a channel (see for example first channel 136a in Fig. 1B and para. [0024]) extending therethrough for shunting fluid between a first body region and a second body region of a patient system (see at least Abstract and para. [0002]), the shunting element comprising:
an anchor element (see lowermost portion of the first actuator 130a in Fig. 1B; corresponding to end portion 234b in Figs. 2A-B);
a gating element (see 134a in Fig. 1B and para. [0025]) configured to moveably interface with the port (see para. [0025]) in fluid communication with the channel (see at least para. [0024]);
a first shape memory actuation element (see 132a in Fig. 1B and para. [0026]; see also Abstract) extending between the anchor element and the gating element (see Fig. 1B), wherein the first actuation element, when actuated, is configured to pivotably move the gating element in a first direction (see at least para. [0025-0026]); and
a second shape memory actuation element (see 132a2 in Fig. 1B and para. [0026]; see also Abstract) extending between the anchor element and the gating element (see Fig. 1B), wherein the second actuation element, when actuated, is configured to pivotably move the gating element in a second direction opposite the first direction (see at least para. [0025-0026]).
However, while the embodiment of Fig. 1B fails to explicitly teach an actuator priming element, as required by the claim, the embodiment of Figs. 3A-C teaches an actuator priming element (see outer perimeter 338 in Figs. 3A-C and para. [0049]) extending between the anchor element and the gating element (as shown in Fig. 3A, the outer perimeter extends between anchor element 334b and gating element 334), wherein the actuator priming element includes (a) a first end portion at the gating element (see at least Fig. 3A) and (b) a second portion at the anchor element (see at least Fig. 3A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schultz to combine the actuator priming element of the embodiment of Figs. 3A-B with the implantable shunting system of the embodiment of Fig. 1B at least because Shultz teaches that particular features of characteristics may be combined in any suitable manner in one or more embodiments (see para. [0017]).
Additionally, in the device of the combination of the embodiment of Fig. 1B and Figs. 3A-C, when moving in the first direction and the second direction, the gating element is configured to pivotably move about the first end portion of the actuator priming element (see para. [0049] teaching that first finger 337a and second finger 337b can form pivot points that engage an intermediate portion of the gating element 334).
Regarding claim 24, Shultz teaches the invention as discussed above in claim 23. Additionally, Shultz teaches wherein, when the actuator priming element is coupled between the anchor element and the gating element (such as shown in Figs. 3A-C), the actuator priming element is shaped and sized to deform both the first shape memory actuation element and the second shape memory actuation element relative to their preferred geometries (see for example Figs. 3B-C; see also para. [0049]).
Regarding claim 25, Shultz teaches the invention as discussed above in claim 23. Additionally, Shultz teaches wherein the gating element includes:
a blocking portion configured to moveably interface with the port (see for example the circled portion of the gating element 134a in Fig. 1B); and
a pivot region about which the blocking portion is configured to pivot upon actuation of the first actuation element or the second actuation element (see for example first finger 337a and second finger 337b in Figs. 3A-C and para. [0049]).
Regarding claim 26, Shultz teaches the invention as discussed above in claim 25. Additionally, Shultz teaches wherein an interface between the first end portion of the actuator priming element and the gating element defines the pivot region (see for example Figs. 3A-C and para. [0049]), and wherein the gating element is V-shaped (as broadly recited, and as shown in Fig. 1B, the gating element 134a is V-shaped).
Regarding claim 28, Shultz teaches the invention as discussed above in claim 25. Additionally, Shultz teaches wherein the blocking portion and the pivot region are spaced apart by less than about 100 microns (as shown in Figs. 3B-C and described in para. [0049], gating element 334 pivots around first finger 337a and second finger 337b; therefore, when the gating element 334 is pivoted about one of the first finger 337a or the second finger 337b, the space between the blocking portion and the pivot region is less than 100 microns at least since the gating element 334 touches one of the first finger 337a or the second finger 337b when it is pivoted).
Regarding claim 29, Shultz teaches the invention as discussed above in claim 23. Additionally, Shultz teaches wherein, in response to the first actuation element or the second actuation element being actuated:
the shunting element is configured to transition between (a) a first relatively low energy state in which the gating element occupies a first position (see para. [0055]) and (b) a second relatively low energy state in which the gating element occupies a second position different than the first position (see para. [0055]), and
the shunting element is configured to transition through one or more relatively higher energy states as it moves from the first relatively low energy state to the second relatively low energy state (see para. [0055]).
Regarding claim 33, Shultz teaches the invention as discussed above in claim 23. Additionally, Shultz teaches wherein the anchor element, the gating element, the first actuation element, and the second actuation element comprise a single, unitary structure (see for example Figs. 1B and 5).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schultz (U.S. Pre Grant Pub. No. 2024/0173169 A1) in view of Mazzocchi (U.S. Pre Grant Pub. No. 2013/0338767 A1).
Regarding claims 9-10, Shultz teaches the invention as discussed above in claim 1. However, Shultz fails to explicitly teach that the shape memory actuator has a width of less than about 100 microns and/or less than about 50 microns, as taught by the claims.
Mazzocchi teaches an analogous implantable ophthalmic device (see at least Abstract) comprising a shape-memory member that causes a first optical element to move relative to a second optical element (see para. [0008]). Mazzocchi further teaches that the shape-memory member can have a thickness of about 0.02 mm to about 0.10 mm (see para. [0009]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schultz to combine the teachings of Mazzocchi by making the shape memory actuator have a width of less than about 100 microns (as applied to claim 9) and/or less than about 50 microns (as applied to claim 10) since Applicant has not placed criticality over the claimed ranges and at least since it has been held that “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” See In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); See also MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lilly (U.S. Pre Grant Pub. No. 2022/0339035 A1) - ADJUSTABLE FLOW GLAUCOMA SHUNTS AND ASSOCIATED SYSTEMS AND METHODS
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
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