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 .
In light of the amendments to the claims filed 05/13/2026 in which claims 97-109 were cancelled, claims 1-13 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US2022/046604 which claims priority to U.S. Provisional Application no. 63/340,825 filed 05/11/2022 and 63/255,379 filed 10/13/2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994) The disclosure of the prior-filed application, U.S. Provisional Application no. 63/255,379, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application does not provide support for a third layer. Claims 6-11 are thus not supported from depending from an unsupported base claim. Accordingly, claims 6-11 do not receive priority of the application filed on 10/13/2021.
Claims 1-5 and 12-13 receive priority to the prior-filed application, filed on 10/13/2021.
Claims 6-11 receive priority to the prior-filed application, filed on 05/11/2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on 05/13/2026 is acknowledged. All claims directed to a non-elected group have been cancelled.
Election was made without traverse in the reply filed on 07/05/2023.
Specification
The abstract of the disclosure is objected to because the abstract comprises phrases which can be implied (“The present technology is generally directed to…”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites the limitation “wherein first layer” in ln. 1. This should read “wherein the first layer”.
Appropriate correction is required.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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Ex. Fig. 1 of Simon Fig. 1
Claims 1-5 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US/2006/0069340 A1 to Simon and WO/2020/150663 A1 to Argento.
Regarding claims 1, 3, and 12-13, Simon discloses
(Claim 1) a system for shunting fluid from a first body region to a second body region within a patient (Ex. Fig. 1, shunt 10; para. 0039-0040), the system comprising:
a first layer including a first fluid inlet and a second fluid inlet, wherein the first and second fluid inlets are each configured to receive fluid from the first body region (Ex. Fig. 1, first and second fluid inlets may be the outermost opening of any of the inlets 12 noted in the first layer; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”);
a second layer coupled to the first layer and including a first fluid outlet and a second fluid outlet, wherein the first and second fluid outlets are each configured to be positioned within the second body region, and wherein the first fluid outlet is fluidly coupled to the first fluid inlet via a first channel and the second fluid outlet is fluidly coupled to the second fluid inlet via a second channel (Ex. Fig. 1, first and second fluid outlets may be the outermost opening of any of the outlets 12 noted in the second layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”);
channels between first and second layer (Ex. Fig. 1, open channels 14); and
(Claim 3) wherein the first layer defines a chamber configured to receive fluid from the first body region (Ex. Fig. 1, chamber considered area defined between first and second layers other than walls creating open channels 14, walls creating closed channels 16, and internal support structures [denoted as 22 in Fig. 4]; para. 0039-0040).
Simon differs from the instantly claimed invention in that Simon fails to disclose
(Claim 1) an actuator positioned to selectively control the flow of fluid from the first fluid inlet of the first layer into the first channel of the second layer,
wherein, independent of a state of the actuator, the second channel is configured to receive fluid from the second fluid inlet; and
(Claim 3) wherein the actuator is positioned within the chamber and configured to adjust the flow of fluid within the chamber through the first fluid inlet;
(Claim 12) wherein, independent of a state of the actuator, the first channel is configured to receive fluid from the first fluid inlet; and
(Claim 13) wherein the actuator is configured to transition between (i) a first position in which the actuator allows fluid to flow between the first fluid inlet and the first fluid outlet at a first rate and (ii) a second position in which the actuator allows fluid to flow between the first fluid inlet and the first fluid outlet at a second rate less than the first rate.
Argento teaches
(Claim 1) a shunt comprising an actuator positioned to selectively control the flow of fluid from a first fluid inlet into a first channel, wherein, independent of a state of the actuator, a second channel is configured to receive fluid from a second fluid inlet (para. 0030-0031; Fig. 5A-5C, shunt 500, each individual actuator element 524 selectively controls flow through an inlet into each individual channel 522 such that each individual actuator element 524 is individually actuatable);
(Claim 3) wherein the actuator is positioned at least partially within the shunt and configured to adjust the flow of fluid within the chamber through the first fluid inlet (para. 0030-0031; Fig. 5B, actuator element 524 can be positioned partially within channel 522 of shunt 500);
(Claim 12) wherein, independent of a state of the actuator, the first channel is configured to receive fluid from the first fluid inlet (para. 0031, actuator element 524 can be transformed between an open position and a closed position in which flow to the channel 522 is blocked or attenuated);
(Claim 13) wherein the actuator is configured to transition between (i) a first position in which the actuator allows fluid to flow between the first fluid inlet and the first fluid outlet at a first rate and (ii) a second position in which the actuator allows fluid to flow between the first fluid inlet and the first fluid outlet at a second rate less than the first rate (para. 0030-0031, actuator element 524 can be transformed between an open position and a closed position in which flow to the channel 522 is blocked or attenuated); and
wherein the actuators allow for precise variable control of flow to or from the shunt (para. 0030-0031).
The shunt of Argento is considered to be functionally equivalent to the shunt of Simon in that Argento’s shunt comprises a mechanism for modifying the flow in the shunt post implantation (para. 0030-0031).
Further, it would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shunt of Simon to comprise actuators to modify the flow through the shunt as taught by Argento, because Argento teaches that this allows for more precise variable control of flow to or from the shunt (para. 0030-0031) without destroying or thinning the walls of the shunt such as taught in Simon (para. 0043).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Simon further discloses wherein the first fluid outlet and the second fluid outlet are positioned at a distal end of the second layer, and wherein the first fluid outlet is spaced apart and discrete from the second fluid outlet (Ex. Fig. 1, first and second fluid outlets may be the outermost opening of any of the outlets 12 noted in the second layer that are spaced apart and discrete from one another).
Regarding claim 4, the cited prior art suggests the invention of claim 1. Simon further discloses wherein the first layer includes (i) a third fluid outlet fluidly coupled to one or both of the first channel and the second channel (Ex. Fig. 1, third fluid outlet may be the outermost opening of any of the outlets 12 noted in the first layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”) and (ii) a fluid reservoir positioned downstream from the one or both of the first fluid inlet and the second fluid inlet and upstream from the third fluid outlet, and wherein the fluid reservoir is configured to substantially prevent fluid flow through the third fluid outlet until the fluid reservoir is at least partially filled with fluid received from one or both of the first channel and the second channel (Ex. Fig. 1, outlet fluid reservoir positioned entirely downstream from first and second fluid inlets and at least partially upstream from third fluid outlet; fluid reservoir must be at least partially filled to allow for fluid outflow).
Regarding claim 5, the cited prior art suggests the invention of claim 4. Simon further discloses wherein the third fluid outlet is fluidly coupled to the fluid reservoir by a third channel extending between the fluid reservoir and the third fluid outlet (Ex. Fig. 1, third fluid outlet on the outermost side of the first layer fluidly coupled to outlet fluid reservoir by a third channel 14 formed through the body of the first layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”).
Claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Simon and Argento as applied above, and further in view of US/2017/0367888 A1 to Brown.
Regarding claims 6-8, the cited prior art suggests the invention of claim 1.
Simon further discloses
(Claim 6) a third fluid outlet fluidly coupled to one or both of the first channel and the second channel (Ex. Fig. 1, third fluid outlet may be the outermost opening of any of the outlets 12 noted in the first layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”);
(Claim 7) wherein the first layer includes a first side and a second side opposite the first side, and wherein (i) the second layer is coupled to the first side (Ex. Fig. 1);
(Claim 8) wherein the first layer and the second layer are configured so that fluid at least partially flows (i) from the first layer to the second layer in a first direction perpendicular to a longitudinal axis of the system and (ii) from the second layer through the first layer in a second direction opposite the first direction and perpendicular to the longitudinal axis (Ex. Fig. 1, third fluid outlet may be the outermost opening of any of the outlets 12 noted in the first layer, open channels 14 fluidly couple all outlets and inlets; Ex. Fig. 1, one of multiple flow paths shown using arrows when proximal end is implanted in higher pressure area and distal end is implanted in lower pressure area; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose
(Claim 6) a third layer including a third fluid outlet fluidly coupled to one or both of the first channel and the second channel;
(Claim 7) wherein the first layer includes a first side and a second side opposite the first side, and wherein the third layer is coupled to the second side;
(Claim 8) wherein the first layer, the second layer, and the third layer are configured so that fluid flows (i) from the first layer to the second layer in a first direction perpendicular to a longitudinal axis of the system and (ii) from the second layer through the first layer to the third layer in a second direction opposite the first direction and perpendicular to the longitudinal axis.
Brown teaches a shunt comprising a body that can comprise an outer coating coupled to a portion of or all of the external surface which does not cover the channel openings, such that fluid may flow through it, and wherein the outer coating may enhance cellular ingrowth on the outside of the shunt (Fig. 2, shunt 1 comprising body 3 comprising channel 5; para. 0064-0065; para. 0174).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shunt of the cited prior art to comprise a third layer as taught by Brown coupled to a second outer side of at least the first layer, because Brown teaches that an outer coating may enhance cellular ingrowth on the outside of the shunt, increasing bio-integration (para. 0064-0065; para. 0174).
Regarding claim 9, the cited prior art suggests the invention of claim 6. Simon further discloses wherein the first layer includes a fluid reservoir configured to fluidly couple one or both of the first channel and the second channel to the third fluid outlet (Ex. Fig. 1, outlet fluid reservoir positioned entirely downstream from first and second fluid inlets and at least partially upstream from third fluid outlet; Ex. Fig. 1, third fluid outlet may be the outermost opening of any of the outlets 12 noted in the first layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”).
Regarding claim 10, the cited prior art suggests the invention of claim 9. Simon further discloses wherein the first layer includes a third channel configured to fluidly couple the fluid reservoir and the third fluid outlet (Ex. Fig. 1, third fluid outlet on the outermost side of the first layer fluidly coupled to outlet fluid reservoir by a third channel formed through the body of the first layer, open channels 14 fluidly couple all outlets and inlets; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”).
Regarding claim 11, the cited prior art suggests the invention of claim 10. Simon further discloses wherein at least a first portion of one or both of the first channel and the second channel are configured to direct fluid flow in a first direction, and wherein at least a second portion of the third channel is configured to direct fluid flow in a second direction opposite the first direction (Ex. Fig. 1, third fluid outlet on the outermost side of the first layer fluidly coupled to outlet fluid reservoir by a third channel formed through the body of the first layer, third channels direct fluid flow laterally, open channels 14 configured to direct fluid flow longitudinally; para. 0039-0040; para. 0043, “Fenestrations 12 may be formed prior to implantation or after implantation.”, “…all channels communicate with both the head and the foot of the shunt…”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent no. 10,335,030 B2 to Alhourani discloses a shunt comprising adjustable flow through the fluid outlets. WO/2011/034740 A1 to Rickard discloses a shunt comprising adjustable flow through the fluid inlets.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (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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/Linnae E. Raymond/Examiner, Art Unit 378
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
6 August 2026
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