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
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.
Claims 1-4, 6-9, and 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nae et al. (WO 2021224736 A1), hereinafter referred to as “Nae”.
Regarding Claim 1, Nae teaches a shunt system (modified shunt 1100, see Figure 11A-B) comprising:
an anchoring frame (1100 and 1111) configured to be disposed within an opening between a first anatomical feature and a second anatomical feature (see Figure 11B) and expand from a collapsed state to an expanded state (the cylindrical shunt may be outside of the diabolo-shaped shunt. The cylindrical shunt may be formed of the malleable shape-memory material such that the cylindrical shunt radially constrains a dimension of the diabolo-shaped shunt at the neck region, and the diabolo-shaped shunt may self-expand at the neck region responsive to the malleable shape memory material expanding to a second cross-sectional area, see Paragraph [0043]), the anchoring frame including a self-expanding form (see Paragraph [0043]); and
an adjustable frame (second component or cylindrical shunt 1120) disposed around at least a portion of the anchoring frame and configured to adjust in size to set an amount of fluid that flows between the first and second anatomical features (the cylindrical shunt may be formed of the malleable shape-memory material such that the cylindrical shunt radially constrains a dimension of the diabolo-shaped shunt at the neck region, see Figure 11B; Paragraph [0043]).
Regarding Claim 2, Nae teaches wherein the anchoring frame includes one or more arms (leaves or petals 25 can be considered arms, see Figure 23B; embodiments may be used together, see Paragraph [0239]) configured to, in the expanded state, extend from a central portion of the anchoring frame to anchor the shunt system to a tissue wall (petals 25 extending from central portion 42, see Figure 23B).
Regarding Claim 3, Nae teaches wherein the adjustable frame comprises a permanently deformable form (the martensitic outer frame may be malleable and may be plastically deformed, see Paragraph [0164]).
Regarding Claim 4, Nae teaches wherein the anchoring frame includes a shape-memory material (nitinol material which is malleable shape memory material, see Paragraph [0164]).
Regarding Claim 6, Nae teaches wherein at least one of the anchoring frame or the adjustable frame includes a covering disposed between the anchoring frame and the adjustable frame (encapsulated frames, see last lines of Paragraph [0164]).
Regarding Claim 7, Nae teaches wherein the anchoring frame and the adjustable frame are independent frame structures that are coupled together with one or more attachment features (mechanically engaging, e.g., welding or mechanical interference, may be used to both directly and indirectly couple the present components to one another. see Paragraph [0139]).
Regarding Claim 8, Nae teaches wherein the adjustable frame includes a wire frame having a substantially cylindrical form (see Figures 11A-B).
Regarding Claim 9, Nae teaches wherein the anchoring frame includes a first anchoring arm (first flared region 702 having multiple arms, see Figure 7; embodiments may be used together, see Paragraph [0239]) configured to contact a first tissue wall within the first anatomical feature (see Paragraph [0150]) and a second anchoring arm (second flared region 706 having multiple arms) configured to contact a second tissue wall within the second anatomical feature (see Paragraph [0150]), the first anchoring arm being angularly offset from the second anchoring arm with respect to a longitudinal axis of the adjustable frame (the first and second flared arm portions are angular offset from each other, see Figure 7).
Regarding Claim 11, Nae teaches A method of providing blood flow between a first anatomical feature and a second anatomical feature (adjusting the flow of fluid within the human body, for example, through a passage between two body cavities, see Paragraph [0003]), the method comprising:
advancing a delivery catheter into an opening in a tissue wall between the first anatomical feature and the second anatomical feature (catheterization procedures, there is a benefit in moving from one cavity to another cavity by creating a passage; for example, such a passage may be formed between the right side of the heart and the left side of the heart, e.g., between the right atrium toward the left atrium, see Paragraph [0003]);
deploying, using the delivery catheter, a shunt within the opening (an interatrial shunt for placement at an atrial septum of a patient’s heart using the aforementioned catheterization methods, see Paragraph [0019]; modified shunt 1100, see Figure 11A-B), the shunt including an anchoring frame (1100 and 1111) configured to anchor the shunt to the tissue wall (see Figure 11B) and an adjustable frame (second component or cylindrical shunt 1120) disposed around at least a portion of the anchoring frame (the cylindrical shunt may be formed of the malleable shape-memory material such that the cylindrical shunt radially constrains a dimension of the diabolo-shaped shunt at the neck region, see Figure 11B; Paragraph [0043]), the anchoring frame being configured with at least one of shape memory or a super elasticity characteristic (formed from malleable shape-memory material, see Paragraph [0043]); and
dilating the adjustable frame to configure an amount of the blood flow between the first anatomical feature and the second anatomical feature (he martensitic outer frame may be malleable and may be plastically deformed, e.g., by incremental balloon dilatation which may expand its inner dimension by any desired amount, see Paragraph [0164]).
Regarding Claim 12, Nae further teaches
determining at least one of the amount of blood flow between the first and second features or pressure in the first anatomical feature or the second anatomical feature (determining pulmonary congestion or high blood pressure from blood in the heart, see Paragraph [0012]); and
adjusting the amount of blood flow by further dilating the adjustable frame (see Paragraph [068]).
Regarding Claim 13, Nae teaches wherein the deploying the shunt, the dilating the adjustable frame, the determining, and the adjusting the amount of blood flow occur during the same medical procedure (clinical procedures include, e.g., arrhythmia ablation procedures in the left atrium and mitral valve repair activities, see Paragraph [0003]).
Regarding Claim 14, Nae teaches wherein the deploying the shunt includes releasing a first arm of the anchoring frame to contact a first tissue wall within the first anatomical feature (first flared region 702 having multiple arms, see Figure 7, Paragraph [0150]); embodiments may be used together, see Paragraph [0239]) and releasing a second arm of the anchoring frame to contact a second tissue wall within the second anatomical feature (second flared region 706 having multiple arms, see Paragraph [0150]).
Regarding Claim 15, Nae teaches a shunt system (modified shunt 1100, see Figure 11A-B) comprising:
a first frame structure (1100 and 1111) configured to anchor the shunt system to an opening between a first anatomical feature and a second anatomical feature (see Figure 11B), the first frame structure being configured to implement a compressed form on a delivery system and to self-expand to an at least partially expanded form when released from the delivery system (the cylindrical shunt may be outside of the diabolo-shaped shunt. The cylindrical shunt may be formed of the malleable shape-memory material such that the cylindrical shunt radially constrains a dimension of the diabolo-shaped shunt at the neck region, and the diabolo-shaped shunt may self-expand at the neck region responsive to the malleable shape memory material expanding to a second cross-sectional area , se Paragraph [0043]); and
a second frame structure coupled to at least a portion of the first frame structure (second component or cylindrical shunt 1120 coupling by common encapsulant, see Paragraph [0164]), the second frame structure being configured to radially expand, based at least in part on a radial force from a dilator, to adjust an amount of fluid flow between the first and second features (the martensitic outer frame may be malleable and may be plastically deformed, e.g., by incremental balloon dilatation which may expand its inner dimension by any desired amount, see Paragraph [0164]).
Regarding Claim 16, Nae teaches wherein the anchoring frame includes a first anchoring arm (first flared region 702 having multiple arms, see Figure 7; embodiments may be used together, see Paragraph [0239]) configured to contact a first tissue wall within the first anatomical feature (see Paragraph [0150]) and a second anchoring arm (second flared region 706 having multiple arms) configured to contact a second tissue wall within the second anatomical feature (see Paragraph [0150]), the first anchoring arm being angularly offset from the second anchoring arm with respect to a longitudinal axis of the adjustable frame (the first and second flared arm portions are angularly offset from each other, see Figure 7).
Regarding Claim 17, Nae teaches wherein the second frame structure comprises a permanently deformable form (nitinol material which is malleable shape memory material, see Paragraph [0164]).
Regarding Claim 18, Nae teaches wherein at least one of the first frame structure or the second frame structure includes a covering disposed between the first frame structure and the second frame structure (encapsulated frames, see last lines of Paragraph [0164]).
Regarding Claim 19, Nae teaches wherein the first frame structure and the second frame structure are independent frame structures that are coupled together with one or more attachment features (mechanically engaging, e.g., welding or mechanical interference, may be used to both directly and indirectly couple the present components to one another. see Paragraph [0139]).
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.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nae (WO 2021224736 A1) in view of Sun et al. (CN 113367839 A, mapped by translated copy attached), hereinafter referred to as “Sun”.
Regarding Claim 5, Nae teaches all of the limitations as discussed above in Claim 1. However, Nae does not explicitly disclose wherein the adjustable frame includes at least one of stainless steel, cobalt chromium, or aluminum.
Sun teaches and adjustable frame (a atrial shunt implant bracket comprises a first bracket 1 and second bracket 2, see Figures 1-4; see Abstract) comprising: wherein the adjustable frame includes at least one of stainless steel, cobalt chromium, or aluminum (the material of the second bracket is cobalt-chromium alloy, see pg. 5 line 1).
Nae and Sun are analogous art because they both disclose an implantable shunt implant that is expandable.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the adjustable frame of Nae and further include wherein the adjustable frame includes cobalt chromium, as taught by Sun. Sun teaches it is beneficial to have cobalt chromium because the cobalt-chromium alloy has very good plastic deformation characteristic, so the second bracket 2 made of cobalt-chromium alloy after being expanded by the balloon, will not rebound (see pg. 5 lines 2-10).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nae (WO 2021224736 A1) in view of Brenneman et al. (US 20180116522 A1), hereinafter referred to as “Brenneman”.
Regarding Claim 10, Nae teaches all of the limitations as discussed above in Claim 9. However, Nae does not explicitly disclose wherein at least one of the first anchoring arm or the second anchoring arm includes a visual marker configured to provide imaging visualization.
Brenneman teaches a system for creating an arteriovenous flow pathway in a patient (see Abstract; Figures 7-10), comprising a stent having anchoring arms (a venous stent 195 having and opening 196 creating arms, see Figure 7), wherein at least one of the first anchoring arm or the second anchoring arm includes a visual marker configured to provide imaging visualization (radiopaque marker 197 positioned along at least a portion of the periphery of opening 196a, see Paragraph 0169]).
Nae and Brenneman are analogous art because both teach creating an arteriovenous flow pathway in a patient.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the shunt and catheterization system of Nae and further include wherein at least one of the first anchoring arm or the second anchoring arm includes a visual marker configured to provide imaging visualization, as taught by Brenneman. Brenneman teaches it beneficial to have a visual marker configured to provide imaging visualization to identify the cutaway portion of venous stent 195 or any opening along the length of stent 195 configured to accommodate blood flow through a flow pathway of the present inventive concepts (see Paragraph [0168]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nae (WO 2021224736 A1) in view of McNamara et al. (US 8157860 B2), hereinafter referred to as “McNamara”.
Regarding Claim 20, Nae teaches all of the limitations as discussed above in Claim 15. However, Nae does not explicitly disclose wherein the shunt system is sterilized.
McNamara teaches intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure (see Abstract), wherein the shunt system is sterilized (interatrial pressure vent 100 can be assembled using components that have been pre-sterilized, see Col. 26 lines 38-60).
Nae and McNamara are analogous art because both teach intracardiac shunt systems for treating heart failure.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the shunt and catheterization system of Nae and further include wherein the shunt system is sterilized, as taught by McNamara. McNamara teaches it is beneficial to have a sterilized shunt system so the final assembly may be accomplished in an aseptic manner to avoid contamination (see Col. 26 lines 58-60).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (6/30/2026)Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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