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 with traverse of invention 1 (claims 1-7), species 1c/d (protrusion embodiment of figures 8-10), 2a (there is a skirt covering the protrusions), 3b/c (there is a tether), 4b (there is a cover on only a portion of the outer surface of the valve), 5b (the protrusions are positioned closer to the proximal end on a proximal portion of the valve), 6a (upon expansion, the distal end of the valve is held in position as the valve body expands and the proximal end moves towards the distal end), 7a (an interior surface of the vasculature surrounds the valve outer body), and 8b (the protrusions rotate or move distally) in the reply filed on 09/26/25 is acknowledged. The traversal is on the ground(s) that some species refer to the same embodiment. This is not found persuasive because Applicant has elected the species that refer to both embodiments, and there are no arguments regarding the remainder of the restriction.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/26/25.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to for claiming the protrusions are configured to displace “one or more valve leaflets” outside the flow channel, but it is unclear if these are a part of the claimed prosthetic valve (and if so, whether they are different from the previously claimed “plurality of valve leaflets”), or not (and if so, it is unclear whether or not these leaflets are distinct from the ones previously claimed, or whether this is a part of the human body or not).
Further, the claim is unclear for claiming the protrusions are “configured to displace one or more valve leaflets positioned outside of the flow channel of the valve body in a distal direction” since it is unclear whether this intends the leaflets to be positioned in a distal direction or the displacement to occur in a distal direction.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 7 is indefinite for claiming that each of the tethers has a first end that is coupled “to the struts” which indicates that the one end is coupled to multiple struts. However, the Examiner is unclear as to how a single end can be coupled to multiple different elements which occupy different locations. The specification appears to indicate that the tether can be coupled to multiple struts, but it does not support the idea that a single end is coupled to multiple struts, but rather the tether appears to be coupled to struts along its length. Accordingly, the Examiner is unclear on how to interpret the meaning of this claim.
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Moriss et al. (US 9655722 B2) hereinafter known as Moriss.
Regarding claim 1 Moriss discloses a prosthetic valve (Abstract) comprising:
a valve body (Figure 63 item 900) with a proximal end (Figure 63 item 123), distal end (Figure 63 item 950), outer surface (Figure 63 , exterior of the device 900), and inner surface (Figure 63, inside of item 120) facing a flow channel (Figure 63, inside of the cylinder defined by items 950 and 123);
a plurality of valve leaflets positioned within the flow channel and extending inward from the inner surface of the valve body (Column 68 lines 30-33), and
one or more protrusions (Figure 63 item 972, 973) configured to extend outward from the outer surface of the valve body (Figure 63) and being configured to displace one or more valve leaflets positioned outside the flow channel of the valve body in a distal direction (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 Moriss 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 Figures 64a-d, and Column 68 lines 58-67 which explains how the lower ring 952 is moved towards the upper ring 950. The movement from the lower ring 952 to the upper ring 950 is understood to be in a “distal direction”, meaning as the native leaflets are crimped by the protrusions 972, 973, the native leaflets will be moved distally along with the lower ring 952. The Examiner notes further, that the precise direction of movement will depend entirely upon where the native leaflets lie in relation to the upper and lower ring when the leaflets are snagged, indicating that this limitation depends entirely upon a method of use of the device as opposed to structurally changing the device itself.).
Regarding claim 2 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the protrusion is configured to retain the leaflets in a space distal of the protrusion and outside the outer surface of the valve body (This is likewise a functional limitation (see the explanation regarding functional limitations above). See also Figures 64a-b which show how the leaflets remain outside the outer surface of the valve body 900).
Regarding claim 3 Moriss discloses the valve of claim 1 substantially as is claimed,
wherein Moriss further discloses the protrusion includes a first end coupled to the valve body (Figure 63 shows where element 972/973 engages the rings 950 or 952 of the valve body), and a second end (Figure 63 tip of element 972/973 ) having an atraumatic tip (Column 68 lines 65-67 the ends 972/973 can “engage or pierce” the annulus tissue; Column 48 lines 45-55 engagement can occur via an atraumatic tip).
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 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moriss as is applied above).
Regarding claim 4 Moriss discloses the valve of claim 3 substantially as is claimed,
wherein Moriss further teaches an atraumatic tissue-engaging element (Figure 68a item 1356) can include an end which is a flatted body (Figure 68a item 1356 shows a flat loop). 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 Moriss by having the protrusion’s second end include a flattened body as is taught by Moriss since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use of any known atraumatic end within the device of Moriss Figure 63 would have been considered obvious to substitute.
Allowable Subject Matter
Claims 5-7 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.
Claim 5 is not rejected with prior art, since while Moriss discloses the valve of claim 1 substantially as claimed, including a tether 974 which is configured to apply a force to the protrusion 972/973 to rotate the protrusion towards the distal direction (Figure 64a-b), this tether does not couple the valve body to the protrusion.
The prior art does not teach a tether which directly couples a valve body to a protrusion, while also acting to rotate the protrusion with force.
Regarding claim 6, Moriss discloses the valve body’s frame being expandable (Column 15 lines 4-5), and the tether being coupled to the frame (Figures 64a-d), but does not teach the expansion of the frame causing the tether to apply force to the protrusion. While prior art is known to teach the expansion of a valve frame to apply force to a protrusion (US 20210346153 A1 [0011]), there is no tether involved.
Regarding claim 7, Moriss also discloses the frame 900 can include struts (Figure 10a shows struts 124), separated by openings (Figure 10a shows openings between zig zag struts), Moriss fails to teach the tether having one end coupled to the struts and a second end coupled to the protrusion.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/06/25