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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/15/2024, , 07/25/2024, 10/03/2024, and 07/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Status of Claims
Claims 1-10 and 41-50 are pending and currently under consideration for patentability.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-10 and 41-45, and 47-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mixter (US 20200229977 A1).
Regarding Claim 1, Mixter teaches an actuation assembly (1322) for use with a shunting system for selectively controlling fluid flow in a patient ([0069] FIG. 12), the actuation assembly comprising:
a fluid inlet (362); and
an actuator (1218) configured to selectively control the flow of fluid through the fluid inlet ([0064] FIGS. 12A and 12B), wherein the actuator includes
a first body portion [0065],
a second body portion including a control element (1201) configured to sealingly engage the fluid inlet (1212)([0065]), and
an actuation element positioned between the first body portion and the second body portion,
wherein the actuation element is configured to transition the control element between (i) a first position in which the control element sealingly engages the fluid inlet and (ii) a second position in which the control element is spaced apart from the fluid inlet to allow fluid flow therethrough ([0065] [0076]).
Regarding Claim 4, Mixter the actuation assembly of claim 2. Mixter further teaches wherein the second body portion further includes a control element portion (1212), wherein the control element extends from the control element portion toward the fluid inlet ([0065]).
Regarding Claim 6 Mixter the actuation assembly of claim 1. Mixter further teaches: a chamber including a first chamber portion (left portion) and a second chamber portion (right portion), wherein the first body portion is configured to be received within the first chamber, the second body portion is configured to be received within the second chamber, the actuation element is a shape memory actuator having a preferred geometry (paragraph [0099]), and the shape memory actuator is deformed relative to the preferred geometry when the first body portion is received within the first chamber and the second body portion is received within the second chamber (figure 12A and 12B)
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Regarding Claim 7, Mixter the actuation assembly of claim 1. Mixter further teaches wherein, in the first position, at least a portion of the control element is positioned within the fluid inlet (Spring element can be replaced by actuator/control element [0039]).
Regarding Claim 8, Mixter the actuation assembly of claim 1. Mixter further teaches wherein the actuation element is further configured to transition the control element to a third position between the first position and the second position (paragraph [0065: first position is open, the second position is closed, and the third position is partial occlusion]).
Regarding Claim 9, Mixter the actuation assembly of claim 1. Mixter further teaches wherein the inlet is a first inlet and the control element is a first control element ([0065](fig. 12A and 12B),, and wherein the actuation assembly further comprises:
a second fluid inlet, wherein the second body portion further includes a second control element configured to sealingly engage the second fluid inlet ([0065-0066]), in the first position, the first control element sealingly engages the first fluid inlet and the second control element is spaced apart from the second fluid inlet to allow fluid flow therethrough ([0065](fig. 12A and 12B), and in the second position, the second control element sealingly engages the second fluid inlet and the first control element is spaced apart from the first fluid inlet to allow fluid flow therethrough ([0065](fig. 12A and 12B).
Regarding Claim 10, Mixter the actuation assembly of claim 1. Mixter further teaches further comprising a sealing element positioned between the control element and the fluid inlet and configured to sealingly engage the fluid inlet when the control element is in the first position ([0065] [0076]).
Regarding Claim 41, Mixer teaches a method for manufacturing an actuation assembly, the method comprising:
forming one or more actuators in a first configuration ([0069] FIG. 13D),, wherein in the first configuration each individual actuator of the one or more actuators is positioned in a corresponding well (figure 13A and 13B), each corresponding well including a first chamber (left portion) and a second chamber (right portion); and
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each individual actuator of the one or more actuators includes a first actuation element (1318), a second actuation element (1314), and an actuator body, the actuator body (Fig. 13A) having a distal end portion residing in the first chamber or the second chamber(figure 13A and 13B); and
moving the one or more of the actuators from the first configuration to a second, different configuration in which the distal end portion of the actuator body is residing in the other of the first chamber or the second chamber([0065] [0076]), wherein moving the one or more actuators from the first configuration to the second configuration deforms the first and/or second actuation elements relative to a preferred geometry([0065] [0076]).
Regarding Claim 42, Mixter teaches actuation assembly of claim 41. Mixter further teaches wherein: the distal end portion is positioned in the first chamber when the one or more actuators are in the first configuration ([0064-0065]);
moving the one or more actuators from the first configuration to the second configuration further includes moving the distal end portion from the first chamber to the second chamber [0065]); and
deforming the first and/or second actuation elements includes compressing the first and/or second actuation elements relative to the preferred geometry [0065] (fig. 12B).
Regarding Claim 43, Mixter teaches actuation assembly of claim 41. Mixter further teaches wherein: the distal end portion is positioned in the second chamber when the one or more actuators are in the first configuration[0064-0065] (fig. 12B).;
moving the one or more actuators from the first configuration to the second configuration further includes moving the distal end portion from the second chamber to the first chamber[0064-0065]; and
deforming the first and second actuation elements includes elongating the first and/or second actuation elements relative to the preferred geometry [0065] (fig. 12B).
Regarding Claim 44, Mixter teaches an actuation assembly (Fig. 12A) for use with an adjustable shunting system for selectively controlling fluid flow in a patient([0069] FIG. 12A-B),, the actuation assembly comprising:
a first body region([0065]),;
a second body region(1212)([0065]),;
an actuator extending between the first body region and the second body region, wherein the actuator includes a shape memory actuation element having an original geometry [0055]; and a pair of priming arms (variable fluid resistors, paragraph [0064]) extending between the first body region and the second body region, wherein the first body region, the second body region, and the pair of priming arms define a priming frame configured to deform the shape memory actuation element relative to the original geometry (paragraph [0064][0065]).
Regarding Claim 45, Mixter teaches actuation assembly of claim 44. Mixter further teaches wherein the pair of priming arms includes a first priming arm positioned on a first side of the actuator and a second priming arm positioned on a second side of the actuator opposite the first priming arm (paragraph [0064]).
Regarding Claim 47, Mixter teaches actuation assembly of claim 44. Mixter further teaches wherein individual ones of the pair of priming arms are configured to cause movement of the first body region relative to the second body region to transition the priming frame between a first state in which the shape memory actuation element has the original geometry, and a second state in which the shape memory actuation element is deformed relative to the original geometry [0064-0065].
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Regarding Claim 48, Mixter teaches actuation assembly of claim 47. Mixter further teaches wherein individual ones of the pair of priming arms are configured to at least partially prevent the priming frame from returning from the second state toward the first state [0064-0065].
Regarding Claim 49, Mixter teaches actuation assembly of claim 47. Mixter further teaches when the priming frame is in the second state, individual ones of the pair of priming arms are configured to at least partially prevent the first body region and the second body region from moving toward each other[0064-0065].
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.
Claim(s) 2, 3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mixter (US 20200229977 A1).
Regarding Claim 2, Mixter the actuation assembly of claim 1. An alternative embodiment of Mixter further teaches wherein the second body portion further includes a pivot feature, and wherein the actuation element is configured to transition the control element between the first position and the second position by moving the control element about the pivot feature [0074]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Mixter to include a pivot feature for the control element in order to create an adjustable pressure valve (Mixter, paragraph [0074]).
Regarding Claim 3, Mixter the actuation assembly of claim 2. Mixter further teaches wherein the actuation element is configured to transition the control element (1201) between the first position and the second position by rotating the control element about the pivot feature [0074]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Mixter to include a pivot feature for the control element in order to create an adjustable pressure valve (Mixter, paragraph [0074]).
Regarding Claim 5, Mixter the actuation assembly of claim 4. Mixter further teaches wherein the actuation element is configured to transition the control element between the first position and the second position by pivoting the control element portion about the pivot feature [0074]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Mixter to include a pivot feature for the control element in order to create an adjustable pressure valve (Mixter, paragraph [0074]).
Claim(s) 46 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mixter (US 20200229977 A1) in view of Park (US 20200008920 A1).
Regarding Claim 46, Mixter teaches actuation assembly of claim 44. Mixter fails to teach wherein individual ones of the pair of priming arms are configured to deflect inwardly toward the actuator to drive the first body region away from the second body region and deform the shape memory actuation element relative to the original geometry. Park teaches a device and method for delivering a synthetic mesh or graft for anatomical repair at a defect site wherein individual ones of the pair of priming arms are configured to deflect inwardly toward the actuator to drive the first body region away from the second body region and actuation element relative to the original geometry [0063]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuation assembly of Mixter so the actuator is driven by the priming arms.
Regarding Claim 50, Mixter teaches actuation assembly of claim 47. Mixter fails to teach in the first state, individual ones of the pair of priming arms have a first position; and in the second state, individual ones of the pair of priming arms have a second position that is deflected relative to the first position. Park teaches a device and method for delivering a synthetic mesh or graft for anatomical repair at a defect site wherein first state, individual ones of the pair of priming arms have a first position; and in the second state, individual ones of the pair of priming arms have a second position that is deflected relative to the first position [0063]. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuation assembly of Mixter so the actuator is driven by the priming arms.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20080125691 A1 and US 20130150773 A1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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