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 .
Election/Restrictions
Applicant’s election without traverse of species 1b (there are two adjustable commissure support arms), and species 2b (the commissure support arms are rotationally coupled to the support base and arms are threadedly coupled to the base, seen in Figures 10a-b) in the reply filed on 04/21/26 is acknowledged.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/26.
Claim Objections
Claims 4-5 are objected to because of the following informalities:
Claim 4 is objected to for referring to the commissure support comprising “two adjustable arms” when claim 1, from which this claim depends, has already referenced two adjustable arms. It is unclear if this is an issue with antecedent basis, or whether there are more adjustable arms.
Claim 5 is objected to for referring to “two tabs of adjacent leaflets” with improper antecedent basis.
Further, the claim is objected to for referring to “the adjustable commissure support” when claim 1, from which this claim, has defined there being more than one commissure support, making it unclear which of the plurality is being referenced.
Appropriate correction is required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Maimon et al. (WO 2020102487 A1) hereinafter known as Maimon.
Regarding claim 1 Maimon discloses a prosthetic valve (Figure 1) comprising:
a frame (Figure 1 item 12) moveable between a radially compressed configuration and a radially expanded configuration ([097] mechanically-expandable valve),
a leaflet assembly mounted within the frame (Figure 1 item 14) and comprising a plurality of leaflets (Figure 1 item 20) configured to regulate flow through the valve (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Maimon discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example Figure 1 which shows leaflets which coapt, indicating they regulate flow therethrough), wherein each leaflet comprises a rounded cusp end portion defining a cusp edge (Figure 1 where the cusp is positioned adjacent the stent frame 12), a free edge opposite to the cusp edge (Figure 1 item 24), and a pair of opposite-directed tabs separating the cusp edge and the free edge (Figure 12 items 242, 246), and
a plurality of adjustable commissure supports (Figure 50a item 1100 (see also Figure 1 item 40)), each commissure comprising a support base attached to the frame (Figure 1 shows the supports connected to the frame), and at least two adjustable arms extending proximally from the support base (Figure 50a items 1102, 1104), wherein each adjustable arm comprises an engagement portion (Figure 50a items 1106, 1108),
wherein the tabs are attached to the adjustable arms ([0159] leaflets are inserted between the axial members 1102, 1104; [095] the commissure support elements attach to adjacent leaflets at tab portions),
the arms are configured to rotate when rotational force is applied to the engagement portions of the arms (this is also stated as a functional limitation of the arms (see the explanation above regarding “functional limitations” in the claims. The arms are considered capable of rotating if a rotational force is applied to the engagement portions 1106, 1108 of the arms (See [0159] which describes how the engagement portions rotate due to their flexible nature)), and
wherein rotation of the arms causes the tabs attached thereto, to wind around the adjustable arms (the Examiner notes that the direction of the rotation of the tabs (e.g. whether the tabs wind around the arms or unwind from the arms), depends entirely upon the direction the arms are rotated. Paragraph [0159] describes how the leaflets can be inserted between the axial arms 1102, 1104, and rotate/flex either inwardly or outwardly, indicating the tabs are capable of winding around the arms with the appropriate outwardly directed force).
Regarding claim 2 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the tabs are wrapped over the arms ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped therearound, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped over arms).
Regarding claim 4 Maimon discloses the valve of claim 1 substantially as is claimed,
wherein Maimon further discloses the arms are laterally spaced from each other and define a gap therebetween (Figure 50a item 1110).
Regarding claim 5 Maimon discloses the valve of claim 4 substantially as is claimed,
wherein Maimon further discloses the tabs are wrapped over the arms ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped therearound, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped over arms).
Regarding claim 6 Maimon discloses the valve of claim 5 substantially as is claimed,
wherein Maimon further discloses the tabs are wrapped over the arms in opposite directions with respect to each other ([0159] the leaflets are inserted between the axial members, to engage the arms 1102, 1104. Wrapping is understood when the tab portions of the arms twist when attached to the arms. The direction of their wrapping would depend upon the direction force is applied to each arm. Also, see Figure 12 which shows leaflet tabs 242, 246 inserted between axial arms and wrapped in opposite directions away from one another, Figure 13, Figure 24b-c, 45 which all show the tabs wrapped in opposite directions over arms).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maimon as is applied above.
Regarding claim 3 Maimon discloses the valve of claim 1 substantially as is claimed,
and further teaches wherein commissure support arms (Figures 2-3 item 44, 46) can includes a plurality of aperture (Figure 3 item 66). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of Maimon so that the arms included a plurality of apertures as is taught by Maimon in order to provide a mechanism to suture the leaflets to the arms for secure attachment ([0106]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/28/26
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