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 .
Response to Arguments
Even though the Applicant’s representative added the allowable subject matter in claim 108 to the independent claim 78. However, after a careful review of the application and the prior art, the Examiner found a reference having an anchor comprising a round surface and a different embodiment having a flat surface. Therefore, the Examiner believes that a USC 103 rejection is appropriate. See rejection below.
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 78, 83, 94, 106, 107 and 124 are rejected under 35 U.S.C. 103 as being unpatentable over Righini et al US Patent Pub. 2016/0346080A1 in view of Argento et al US patent Pub. 2024/0341951A1.
Righini et al discloses a device comprising: a valve prothesis (10) comprising a frame structure (16) and an anchor (36), wherein the anchor comprises a series of segments (37 and 38) operably coupled to one another and having a free end (e.g. 39 or 40), wherein the anchor has a delivery configuration and a deployed configuration, wherein the anchor is configured to secure the valve prosthesis to the diseased valve, wherein the anchor is configured to have a low compressive stiffness and low expansive stiffness in the delivery configuration (see Figs. 7 and 11B) and a high expansion stiffness after transition to the deployed configuration (see Fig. 11G). However, Righini et al does not disclose a flat annular shape.
Argento et al discloses an implant having an anchor made out of a single piece. The anchor as disclosed in Figs. 46 and 47 discloses an anchor made out of a cylindrical round cross-section. Additionally, Figs. 52-54 and 58-61 discloses an anchor having a flat annular shape (see paragraph 246)
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the anchor circular cross-section shape with the flat annular shape of the Argento et al reference because Applicant has not disclosed that by having a flat annular shape provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the circular shape of the Righini et al reference because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Righini reference to obtain the invention as specified in claim 78.
Regarding claim 83, see Fig. 7 disclosing element (39) as the slanted edge.
Regarding claim 94, see Fig. 14A showing the anchor inside the delivery system in the collapsed configuration.
Regarding claim 106, see element (39) as one free end and element (40) as the second end.
Regarding claim 107, the Examiner interpreted the “band of the component” as part of segment 37, the key as element (39) and the complementary lock as element (40).
Regarding claim 124, see Fig. 11; the coupling structure is element 39 and 40.
Claims 78, 94, 103, 115, 116, 118, 122 and 124 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al US Patent Pub. 2018/0177594A1 in view of Argento et al US patent Pub. 2024/0341951A1.
Patel et al discloses a device comprising: a valve prothesis (see Fig. 9) comprising a frame structure (40) and an anchor (1), wherein the anchor comprises a series of segments (each section divided by 216, see Fig. 12 and 11) operably coupled to one another and having a free end (222, see Fig. 12), wherein the anchor has a delivery configuration and a deployed configuration, wherein the anchor is configured to secure the valve prosthesis to the diseased valve, wherein the anchor is configured to have a low compressive stiffness and low expansive stiffness in the delivery configuration (see Fig. 6, inside the catheter) and a high expansion stiffness after transition to the deployed configuration (see Fig. 9). However, Patel et al does not disclose a flat annular shape.
Argento et al discloses an implant having an anchor made out of a single piece. The anchor as disclosed in Figs. 46 and 47 discloses an anchor made out of a cylindrical round cross-section. Additionally, Figs. 52-54 and 58-61 discloses an anchor having a flat annular shape (see paragraph 246)
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the anchor circular cross-section shape with the flat annular shape of the Argento et al reference because Applicant has not disclosed that by having a flat annular shape provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the circular shape of the Patel et al reference because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Patel et al reference to obtain the invention as specified in claim 78.
Regarding claim 94, see Fig. 6.
Regarding claim 103, see Figs. 6 and 7.
Regarding claim 115, see Figs. 3 and 4.
Regarding claim 116, see Fig. 12, the slits 216 inherently have an angled edge so element 200 can be able to curl up to the final spiral position.
Regarding claim 117, it would have been obvious to one ordinary skill in the art to have the edges of each selected segments at an angled between 5 to 85 degrees in order to allow the anchor take the shape of a spiral configuration.
Regarding claim 118, see Fig. 12.
Regarding claim 122, see Fig. 11, the Examiner interpreted element 212 as the material.
Regarding claim 124, see Fig. 11.
Allowable Subject Matter
Claims 123 and 125 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 12/11/25
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