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 .
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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 22-41, drawn to a prosthetic medical device, classified in A61F2/2445.
II. Claim 42, drawn to a method of implanting a prosthetic medical device, classified in A61F2/2442.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process for using the product as claimed can be practiced with another materially different product, as the process does not require the product to have a frame having an inflow end, an outflow end, and an opening through which blood can flow from the inflow end to the outflow end, wherein the frame comprises a plurality struts that define a plurality of petals that each extend at an angle relative to a longitudinal axis of the frame and define an outer wall of the frame that tapers from the inflow end toward the outflow end.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Group I require a search in at least A61F2/2445, along with a unique text search. Group II would not be searched as above and would instead require a search in at least A61F2/2442, along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Julia F. Kottmeier on 06/16/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 22-41. Affirmation of this election must be made by applicant in replying to this Office action. Claim 42 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
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 22-30, 32-35, and 38-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150119981 A1 (hereafter --Khairkhahan--).
Regarding Claim 22, Khairkhahan discloses a prosthetic medical device for improving competence of a native atrioventricular valve having native leaflets, the prosthetic medical device comprising: a frame having an inflow end, an outflow end, and an opening through which blood can flow from the inflow end to the outflow end (see annotated inflow end, outflow end, and opening in Figures 5A and 5B below, see also paragraphs [0016] and [0039]), wherein the frame comprises a plurality struts that define a plurality of petals that each extend at an angle relative to a longitudinal axis of the frame and define an outer wall of the frame that tapers from the inflow end toward the outflow end (see annotated struts, petals, outer wall, axis, and taper in Figures 5A and 5B below), wherein the frame is configured to be resiliently collapsed in a radial direction to a compressed state within a delivery catheter (see paragraph [0049]) for delivery to the native atrioventricular valve and expanded within an atrium of the heart (see paragraph [0057]) such that the frame is seated on an atrial side of the native atrioventricular valve (see Figure 14D below) and conforms to a wall of the atrium adjacent the native atrioventricular valve (see annotated atrium, wall, and atrioventricular valve in Figure 14D below); and a coaptation member coupled to the frame (see annotated coaptation member 82 in Figure 5A below), wherein the coaptation member comprises an atrial facing surface and a ventricular facing surface (see annotated atrial facing surface 86 and ventricular facing surface 84 in Figure 5A below, see also paragraph [0049]), wherein when the frame is implanted in the atrium (see Figure 14D below), the coaptation member is supported by the frame within an annulus of the native atrioventricular valve such that the native leaflets can coapt with the coaptation member (see paragraphs [0039], [0049], and [0053]).
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Regarding Claim 23, Khairkhahan discloses the prosthetic medical device of claim 22, wherein the frame is made of Nitinol (see paragraph [0089]).
Regarding Claim 24, Khairkhahan discloses the prosthetic medical device of claim 22, wherein the frame comprises one or more tissue anchors (see annotated tissue anchor 94 in Figure 5A below, see also paragraph [0050]).
Regarding Claim 25, Khairkhahan discloses the prosthetic medical device of claim 22, wherein the coaptation member is circular in shape (see annotated coaptation member 82 having a circular arc shape in Figure 5A below).
Regarding Claim 26, Khairkhahan discloses the prosthetic medical device of claim 25, wherein at least a portion of a perimeter region of the coaptation member is an attachment region (see annotated attachment region in Figure 5A below) having a plurality of sutures extending therethrough for attachment of the coaptation member to the frame (see paragraph [0052 denoting the coaptation member 82 can have tethers to facilitate attachment).
Regarding Claim 27, Khairkhahan discloses the prosthetic medical device of claim 22, wherein the coaptation member is coupled to the frame via a plurality of sutures (see paragraph [0052 denoting the coaptation member 82 can have tethers to facilitate attachment).
Regarding Claim 28, Khairkhahan discloses the prosthetic medical device of claim 22, the frame comprises a polymer outer layer defining a frame surface (see paragraph [0089] denoting the frame material can comprise of a polymer).
Regarding Claim 29, Khairkhahan discloses the prosthetic medical device of claim 22, wherein the frame is configured to be implanted entirely within an atrium adjacent the native atrioventricular valve (see Figure 14D above).
Regarding Claim 30, Khairkhahan discloses the prosthetic medical device of claim 22, the coaptation member comprises a laminate comprising one or more layers (see annotated coaptation member in Figure 5A above).
Regarding Claim 32, Khairkhahan discloses the prosthetic medical device of claim 22, wherein at least a portion of the coaptation member is coplanar with the outflow end of the frame (see coaptation member 82 with outflow end of frame in Figure 5A above).
Regarding Claim 33, Khairkhahan discloses a prosthetic medical device for improving competence of a native atrioventricular valve, the prosthetic medical device comprising: a frame having an inflow end portion and an outflow end portion (see annotated frame, inflow end, and outflow end in Figures 5A and 5B below), wherein the inflow end portion comprises a plurality of struts that define a plurality of petals that extend at an angle relative to a longitudinal axis of the frame (see annotated struts, petals, taper (angle), and axis in Figures 5A and 5B below) wherein the frame is configured to be implanted on an atrial side of the native atrioventricular valve (see Figure 14D below); and a coaptation member coupled to the outflow end portion of the frame (see annotated coaptation member in Figure 5A below), wherein the coaptation member has a circular shape and comprises one or more layers of material (see annotated coaptation member 82 having a circular arc shape in Figure 5A below).
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Regarding Claim 34, Khairkhahan discloses the prosthetic medical device of claim 33, wherein the one or more layers of material of the coaptation member comprise a first layer of material and a second layer of material (see annotated surfaces 86 and 84, 84 being the first layer and 86 being the second, see also paragraph [0049]).
Regarding Claim 35, Khairkhahan discloses the prosthetic medical device of claim 34, wherein the first layer (84) of material forms a ventricular facing surface of the support leaflet and the second layer of material (86) forms an atrial facing surface of the coaptation member (see annotated surfaces 86 and 84, 84 being the first layer and 86 being the second, see also paragraph [0049]).
Regarding Claim 38, Khairkhahan discloses the prosthetic medical device of claim 33, wherein at least a portion of the coaptation member is coplanar with the outflow end portion of the frame (see coaptation member 82 with outflow end of frame in Figure 5A above).
Regarding Claim 39, Khairkhahan discloses the prosthetic medical device of claim 33, wherein the frame is configured to be implanted entirely within an atrium adjacent the native atrioventricular valve (see Figure 14D above).
Regarding Claim 40, Khairkhahan discloses the prosthetic medical device of claim 33, wherein the inflow end portion has a tubular shape with a decreasing taper in a direction extending from a terminal end of the inflow end portion toward the outflow end portion (see annotated inflow end and taper in Figure 5A above).
Regarding Claim 41, Khairkhahan discloses the prosthetic medical device of claim 33, wherein the frame comprises one or more tissue anchors (see annotated tissue anchor 94 in Figure 5A below, see also paragraph [0050]).
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.
Claims 31, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150119981 A1 (hereafter --Khairkhahan--), in view of US 20170071729 A1 (hereafter --Wrobel--).
Regarding Claim 31, Khairkhahan discloses the prosthetic medical device of claim 30, wherein the laminate comprises a membrane (see annotated coaptation member in Figure 5A above, the “membrane being the top surface 86).
Khairkhahan fails to disclose the laminate comprising one or more reinforcements made of Nitinol.
Wrobel discloses a prosthetic heart valve (see Abstract) with prosthetic leaflet components that are made of multiple layers (see paragraph [0045]) and assist with coaptation in a native heart valve (see paragraph [0041]). Wrobel teaches in which said layers include two polymer layers surround a pre-stressed reinforcement layer made of metal, such as nitinol (see paragraph [0045], see also paragraph [0062] denoting it is also known to have multiple reinforcement layers).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the laminate to comprise one or more reinforcements made of Nitinol, as taught by Wrobel, as by doing so would increase the durability of the layered component by producing a compressive stress that balances the tensile stress that the polymer substrate would otherwise experience during use (see paragraph [0045]).
Regarding Claim 36, Khairkhahan discloses the prosthetic medical device of claim 35.
Khairkhahan fails to disclose further comprising a metallic reinforcement layer disposed between the first layer of material and the second layer of material.
Wrobel teaches comprising a metallic reinforcement layer disposed between the first layer of material and the second layer of material, in which the material could be nitinol (see paragraph [0045]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the device to further comprise of a metallic reinforcement layer disposed between the first layer of material and the second layer of material, as taught by Wrobel, as by doing so would increase the durability of the layered component by producing a compressive stress that balances the tensile stress that the polymer substrate would otherwise experience during use (see paragraph [0045]).
Regarding Claim 37, Khairkhahan as modified discloses the prosthetic medical device of claim 36.
Khairkhahan as modified fails to disclose wherein the metallic reinforcement layer comprises an open framework.
Wrobel teaches wherein the metallic reinforcement layer comprises an open framework (see paragraphs [0053], [0058], and [0059] denoting that the pre-stressed reinforcement elements can include a pre-stressed mesh composed of a plurality of fibers).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the metallic reinforcement layer comprise of an open framework, as taught by Wrobel, as by doing so would enable the reinforcement layer to include a mesh, screen, or fabric that has been pre-stressed in its entirety, or in select areas (see paragraph [0058]), thereby also allowing desired mechanical properties to be tailored, as desired, to appropriate locations of the heart leaflet (see paragraph [0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20050038508 A1: This reference contains a coaptation assistance device with a frame, configured to be implanted into a native atrioventricular valve .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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