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 Objections
Claim 5 is objected to because of the following informalities: lines 1-2 sets forth the limitation of “the implantable valve has a longitudinal axis”; however this limitation is found to be redundant since claim 5 depends from claim 1, which already sets forth “a longitudinal axis of the implantable valve” on the last line. Therefore, it is suggested the above mentioned limitation on lines 1-2 of claim 5 be deleted in order to avoid confusion and redundancy. 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.
Claims 1-13 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, lines 8-9 recite the limitation of “the primary crown segments”; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this issue, and keep claim terminology consistent, it is suggested the words “distal, downstream plurality of” be added between the words “the” and “primary”. Furthermore, line 7 sets forth the parameter of “a polymeric valvular body coupled with the stent in cured polymer”; however, this parameter is found to be confusing. Specifically, it is not clear if the valvular body is coupled to the stent with a cured polymer, or the valvular body is coupled to the stent which is encapsulated in a cured polymer, or something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as a polymeric valvular body coupled to the stent with a cured polymer.
Regarding claim 3, which indirectly depends from claim 1 which sets forth, on line 4, the parameter of “the stent is an alloy encapsuled in dipped polymer”; and claim 3 further sets forth that “the stent is encapsulated in the cured polymer”, however this parameter is found to be confusing. Specifically, it is not clear if the stent has two polymer layers, i.e. a dipped polymer layer and then a cured polymer layer, or if the dipped polymer is/comprises the cured polymer, or something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “the dipped polymer comprises the cured polymer”.
Regarding claim 9, which recites the limitation of “a plurality of cells”, on line 2; is this plurality of cells the same as the ones first set forth on line 3 of claim 1 (from which claim 9 indirectly depends) or are they completely different, distinct, cells. If they are the same cells, then it is suggested the limitation be amended to state “the plurality of cells”, in order to keep claim terminology consistent and avoid confusion. However, if they are different, distinct, cells from those of claim 1, then it is further found to be confusing as to what these cells are and/or how they relate to the final structure of the implantable valve.
Regarding claim 12, which sets forth the parameter of “the skirt is encapsulated in the dipped polymer”; however, this parameter is found to be confusing for multiple reasons. Specifically, it is not clear what exact final structure of the implantable valve would meet the above mentioned parameter. It is unclear if the skirt and stent are encapsulated/dipped in the polymer together, in which case the skirt would only be partially encapsulated, i.e. at the outer surface only and not on the surface/side coupled to the stent; or if the stent and skirt are individually dipped and coupled together after dipping, in which case both stent and skirt would be encapsulated, however such a parameter has not been mentioned or suggested in the originally filed disclosure; or if the skirt is made of a dipped polymer and therefore considered to be encapsulated. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US PG Pub. 2014/0012371), as disclosed in the IDS dated 09/05/2025, in view of Essinger et al. (US PG Pub. 2012/0271398), as disclosed in the IDS dated 09/05/2025, hereinafter Essinger.
Regarding claims 1-5, Li discloses an implantable valve, illustrated in Figure 5, comprising a leaflet support structure (20), illustrated in Figures 1, 2, 5 and 8, having a contoured surface and a non-uniform radius and comprised of a stent (20) formed from a lattice of a plurality of cells (28/50) each having an open space therein and formed from deflectable struts (26/34), wherein the stent (20) is an alloy encapsulated in dipped polymer and the lattice extends between a distal, downstream, plurality of primary crown segments (36/132) and an annular, upstream tertiary crown (proximal end of proximal portion 22), illustrated in Figure 8 ([0042] – to clarify, it is stated that the support structure need not be cylindrical in shape, and that it may have a narrow portion between flared sections; thereby teaching a contoured surface and non-uniform radius); a polymeric valvular body, comprising a plurality of artificial leaflets (78), composed of cured polymer, coupled with the stent (20) with the cured polymer, wherein adjacent leaflets (78) are located at the primary crown segments (36), wherein the stent (20) is encapsulated in the cured polymer (80), illustrated in Figures 5-7; wherein the implantable valve has a radial dimension and is transitionable between a contracted state and an expanded state, wherein the radial dimension is relatively smaller in the contracted state than in the expanded state and each strut (26/34) is encapsulated in the dipped polymer, wherein the implantable valve has a longitudinal axis, and when the implantable valve is in the expanded state, the plurality of deflectable strut (26/34) are oriented at an angle/transverse to the longitudinal axis, illustrated in Figure 5 ([0026]; [0027], Lines 1-12; [0032]; [0034]; [0035] & [0038] – [0042]); but does not specifically disclose a skirt extending over an exterior upstream portion of the stent.
However, Essinger teaches an implantable valve, in the same field of endeavor, comprising a stent (101), having an upstream portion (P), and a skirt (103) extending over an exterior of the upstream portion (P) of the stent, illustrated in Figures 1 and 9; the skirt (103) aiding to mitigate the risk of paravalvular leakage ([0081]; [0084], Lines 6-8 & [0098]).
In view of the teachings of Essinger, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implantable valve of Li to comprise a skirt, extending over an exterior upstream portion of the stent, in order to aid in mitigating the risk of paravalvular leakage, as taught by Essinger.
Regarding claim 6, Li in view of Essinger disclose the implantable valve of claim 5, wherein Li further teaches the implantable valve having a collapsed/contracted state (Li: [0032] & [0041], Lines 5-7); and though it is not specifically disclosed that the plurality of deflectable struts are parallel or substantially parallel to the longitudinal axis in the collapsed/contracted state, it would have been obvious and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to recognize that when a stent structure (such as the one taught by Li) is radially collapsed into a contracted state the plurality of struts would be parallel or substantially parallel to the longitudinal axis, since this is a well-known arrangement/positioning of struts in a collapsed/contracted state.
Regarding claim 13, Li in view of Essinger disclose the implantable valve of claim 1, wherein Essinger further teaches the skirt is not bonded to the exterior upstream portion of the stent (Essinger: [0081], Lines 9-11 – to clarify, Essinger states the skirt can be sutured, and suturing is not considered a form of bonding as described by the originally filed specification of the current application at hand).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Essinger as applied to claim 5 above, and further in view of Justino et al. (US PG Pub. 2017/0189175), as disclosed in the IDS dated 09/05/2025, hereinafter Justino.
Regarding claims 7 and 8, Li in view of Essinger disclose the implantable valve of claim 5, but do not teach a plurality of longitudinal struts positioned at a commissure between adjacent leaflets, wherein each of the plurality of longitudinal struts is parallel to a longitudinal axis of the implantable valve in the expanded and contracted configurations.
However, Justino teaches an implantable valve, in the same field of endeavor, comprising a stent (102) having deflectable struts oriented at an angle to a longitudinal axis of the stent, and a plurality of longitudinal struts (112b) positioned at a commissure between adjacent leaflets, wherein each of the plurality of longitudinal struts (112b) is parallel to a longitudinal axis of the implantable valve in the expanded and contracted configurations, illustrated in Figures 2 and 6; the longitudinal struts (112) provide mechanical support to the leaflets ([0080]; [0085], Line 1; [0088] & [0089], Lines 1-2).
In view of the teachings of Justino, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implantable valve of Li in view of Essinger to further comprise a plurality of longitudinal struts positioned at a commissure between adjacent leaflets, wherein each of the plurality of longitudinal struts is parallel to a longitudinal axis of the implantable valve in the expanded and contracted configurations, in order to provide mechanical support to the leaflets, as taught by Justino.
Regarding claim 9, Li in view Essinger and Justino disclose the implantable valve of claim 7 or 8, wherein Li further teaches the plurality of deflectable strut (26/34) cross and form the plurality of cells (28/50), illustrated in Figures 1, 2 and 5 (Li: [0026] & [0032], Lines 1-5).
Regarding claims 10 and 11, Li in view Essinger and Justino disclose the implantable valve of claim 9, wherein Li further teaches the stent comprises a first row of cells (50) located adjacent a downstream end (32) of the stent, and a second row of cells (28) located upstream of the first row (50) of cells, illustrated in Figures 1, 2 and 5 (Li: [0027], Lines 1-4 & [0032], Lines 1-5), and Justino teaches the plurality of longitudinal struts (112b) are located in a first row of cells (204) and no longitudinal struts are in a second row of cells located upstream of the first row of cells, illustrated in Figure 2. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the stent, of the implantable valve of Li in view Essinger and Justino, to comprise a first row of cells located adjacent a downstream end/leaflet attachment end of the stent, wherein the plurality of longitudinal struts are in the first row of cells, and the stent further having a second row of cells located upstream of the first row of cells, wherein no longitudinal struts are in the second row of cells, since the longitudinal struts provide mechanical support to the leaflets at the commissures, as taught by Justino.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774