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 .
Status of Claims
This office action is responsive to the amendment filed on 07/27/2026. As directed by the amendment: claims 1, 3, 5, 9, 12 and 13 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-13 are presently pending in this application, and currently examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the implantable valve comprising a support structure having a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position and comprising a distal, downstream plurality of primary crown segments, an annular upstream tertiary crown and having a secondary crown disposed therebetween, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position (claim 1), the implantable valve comprising a support structure having a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position and comprising a distal, downstream plurality of primary crown segments, an annular upstream tertiary crown and having a secondary crown disposed therebetween, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, and further comprising a plurality of longitudinal struts, each positioned at a commissure between adjacent leaflets, wherein each of the plurality of longitudinal struts is parallel to the longitudinal axis of the implantable valve in the expanded and contracted configurations (claims 7 and 8), the implantable valve comprising a support structure having a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position and comprising a distal, downstream plurality of primary crown segments, an annular upstream tertiary crown and having a secondary crown disposed therebetween, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, and further comprising a plurality of longitudinal struts, each positioned at a commissure between adjacent leaflets and are in a first row of cells located adjacent to a downstream end of the stent (claim 10), and the implantable valve comprising a support structure having a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position and comprising a distal, downstream plurality of primary crown segments, an annular upstream tertiary crown and having a secondary crown disposed therebetween, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, and further comprising a skirt located on the exterior surface of the upstream portion of the polymeric valvular body (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3 and 12 are objected to because of the following informalities: lines 8-9 of claim 1 states “each of the primary secondary and tertiary crowns…”; there should be a coma between the words “primary” and “secondary”. Furthermore, lines 2-3 of claim 3 sets forth the parameter of “and the stent and polymeric valvular body are coupled together with the cured polymer”; however, this parameter is found to be redundant since claim 3 depends from claim 2, and claim 2 depends from claim 1, and the above mentioned parameter is set forth in both claims 1 and 2. Therefore, it is suggested the above mentioned parameter on lines 2-3 of claim 3 be deleted in order to avoid confusion and redundancy. Additionally, claim 12 sets forth the parameter of “the skirt is located on the exterior surface of the upstream portion of the polymeric valvular body is comprised of an electrospun polymer” (emphasis added) however, this is found to be grammatically incorrect; it is suggested the word “and” be added between the words “body” and “is”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, which sets forth the parameter of “a non-uniform radius at a portion of the support structure providing support to a commissure position” (emphasis added), on lines 2-3; however, this parameter/such a structure was never mentioned, suggested or illustrated in the originally filed disclosure. Specifically, the originally filed specification never mentioned, nor did any of the figures show, a support structure/stent comprising “a non-uniform radius at a portion of the support structure providing support to a commissure position”. Furthermore, lines 8-10 set forth the parameter of “each of the primary secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position” (emphasis added); again, this parameter/such a structure was never mentioned, suggested or illustrated in the originally filed disclosure. Specifically, the originally filed specification never mentioned, nor did any of the figures show, a support structure/stent which had each of the primary secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position.
Regarding claim 12, which sets forth the parameter of “the skirt is located on the exterior surface of the upstream portion of the polymeric valvular body” (emphasis added); however, such a structure was never mentioned, suggested or illustrated in the originally filed disclosure. Specifically, the originally filed specification never mentioned, nor did any of the figures show, the skirt being located on the exterior surface of the upstream portion of the polymeric valvular body. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “the skirt is located on the exterior surface of the upstream portion of the stent”.
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, which sets forth the parameter of “a non-uniform radius at a portion of the support structure…” on lines 2-3, however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by a “non-uniform radius”; does a non-uniform radius mean the “radius” is of abnormal/non-circular shape, or does it mean the radius is different at a certain portion of the stent than at another portion(s) of the stent, or does it mean something else completely different. Additionally, lines 6-8 set forth the parameter of the support structure/stent having “a distal, downstream plurality of primary crown segments and an annular, upstream tertiary crown and having a secondary crown disposed therebetween” (emphasis added); however, this parameter is found to be confusing since it is not clear what location the secondary crown is located/what is meant by the term “therebetween”. Specifically, does “therebetween” mean the secondary crown is located between crowns of the tertiary crowns, or does it mean the secondary crown is located between the crowns of the primary crown segment, or does it mean the secondary crown is located between the primary and tertiary crowns, or does it mean something else completely different. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 13, which sets forth the parameter of “the skirt electrically insulates the stent”; however, this parameter is found to be confusing since it is not clear what exact structure, and/or chemical material/make-up, this parameter entails. Specifically, it is not clear what exactly would be needed, besides just have a skirt extending over an exterior of the stent (as set forth in claim 1, from which claim 13 depends), to meet the parameter set forth in claim 13; and the originally filed specification does not aid in clarify such a parameter. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The parameter disclosed in claim 2 can be found on lines 11-12 of independent claim 1, from which claim 2 depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 previously disclosed.
Regarding claims 1-5, Li an implantable valve, illustrated in Figure 5, comprising a support structure/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), the lattice extends between a distal, downstream, plurality of primary crown segments (36) and an annular, upstream tertiary crown (crowns at the proximal end of proximal portion 22), and having a secondary crown (29c) disposed therebetween, illustrated in Figure 2 ([0026]; [0027], Lines 1-12); wherein the stent (20) is an alloy and the entirety is encapsulated in dipped cured polymer; a polymeric valvular body coupled to the stent (20) with the cured polymer and comprising a plurality of artificial leaflets (78), wherein adjacent leaflets (78) are located at the distal, downstream plurality of primary crown segments (36), a skirt (80) extending over an exterior upstream portion (22) of the stent, 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 and oriented at an angle/transverse to a longitudinal axis (24) in the expanded state, illustrated in Figures 2 and 5 ([0032]; [0034]; [0035] & [0038] – [0041]); and though the embodiment of Figures 2 and 5 do not disclose the support structure (20) having a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, an embodiment, illustrated in Figure 8, teaches that the support structure doesn’t need to be cylindrical, instead having a contoured surface and a non-uniform radius/narrowed waist portion a portion of the support structure providing support to a commissure position, such that a portion proximal to the non-uniform radius/narrowed waist portion, i.e. the tertiary crowns, and a portion distal to the non-uniform radius/narrowed waist portion, i.e. the primary and secondary crowns, flare/extend outwardly from the non-uniform radius/narrowed waist portion; and that such a configuration of the support structure can be used to better secure the implantable valve in a native valve annulus ([0042] – it is to be noted that Li teaches the parameter of the non-uniform radius being at a portion of the support structure providing support to a commissure position to the same extent as disclosed/taught in the originally filed disclosure of the current application at hand). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the support structure, of the embodiment of Figures 2 and 5, to have a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, in order to better secure the implantable valve in a native valve annulus, as taught by Li.
Regarding claim 6, Li discloses the implantable valve of claim 5, wherein the implantable valve has a fully collapsed/contracted state ([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 fully 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 discloses the implantable valve of claim 1, wherein the skirt (80) electrically insulates the stent ([0038]; [0040] & [0047] – to clarify, the stent is metallic and the skirt is formed by dip coating the entire stent in polymeric material, which thereby acts as an insulator to the metallic stent; it is also to be noted that the originally filed specification of the current application at hand states that the skirt/polymeric material acts as an insulator to a metallic stent; thus, Li teaches this parameter to the same extent as taught in the originally filed specification of the current application).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 5 above, and in view of Justino et al. (US PG Pub. 2017/0189175), as previously disclosed, hereinafter Justino.
Regarding claims 7 and 8, Li discloses the implantable valve of claim 5, but does 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 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 of 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 2 and 5 (Li: [0026] & [0032], Lines 1-5).
Regarding claims 10 and 11, Li in view of 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 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 of Justino, to comprise the plurality of longitudinal struts in the first row of cells, and no longitudinal struts in the second row of cells, since the longitudinal struts provide mechanical support to the leaflets at the commissures, as taught by Justino.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Li as applied to claim 1 above, and in view of Vidlund et al. (US PG Pub. 2014/0214159), hereinafter Vidlund.
Regarding claim 12, Li discloses the implantable valve of claim 1, wherein the skirt (80) is located on the exterior surface of an upstream portion (22) of the stent (20), illustrated in Figure 5 ([0040]); but does not disclose the skirt is comprised of an electrospun polymer.
However, Vidlund teaches an implantable valve, in the same field of endeavor, comprising a stent having an outer/exterior skirt formed by an electrospun polymer; electrospinning allows the skirt to have controlled biological interactions, such as integration into the body by in-growth or cell attachment ([0283], Line 7-10 & [0284]).
In view of the teachings of Vidlund, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the skirt, of the implantable valve of Li, to comprise an electrospun polymer, since electrospinning allows the skirt to have controlled biological interactions such as integration into the body by in-growth or cell attachment, as taught by Vidlund.
Response to Arguments
Applicant's arguments filed 07/27/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 1 stating the newly added parameters are not taught by Li; Examiner respectfully disagrees with Applicant’s assertion. Firstly, it is to be noted that the originally filed disclosure, of the current application at hand, is completely silent (within the specification and figures) regarding the newly added parameter of the support structure having “a non-uniform radius at a portion of the support structure proving support to a commissure position”. The only time, in the entire originally filed specification of the current application at hand, a contoured stent with a non-uniform radius is mentioned is directed towards the embodiment of Figures 3A-3F; however, there is never any mentioning, suggestion and/or illustration of the non-uniform radius being at a portion of the support structure/stent which provides support to a commissure position. Instead, according to the originally filed disclosure of the current application at hand, it seems the non-uniform radius is at a waist portion (340) from which the primary, secondary and tertiary crowns extend radially outward. Thus, the rejection of independent claim 1, as being unpatentable over the prior art of Li, teaches the above mentioned newly added parameter to the same extent it is disclosed/taught by the disclosure of the current application at hand. Specifically, Li teaches, in the embodiment illustrated in Figures 2 and 5, all the structural limitations set forth in independent claim 1 (as detailed in the rejection section above), except that the support structure has a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position. However, the embodiment illustrated in Figure 8, of Li, teaches that the support structure doesn’t need to be cylindrical, instead having a contoured surface and a non-uniform radius/narrowed waist portion a portion of the support structure providing support to a commissure position, such that a portion proximal to the non-uniform radius/narrowed waist portion, i.e. the tertiary crowns, and a portion distal to the non-uniform radius/narrowed waist portion, i.e. the primary and secondary crowns, flare/extend outwardly from the non-uniform radius/narrowed waist portion; and that such a configuration of the support structure can be used to better secure the implantable valve in a native valve annulus (Li: [0042] – it is to be noted that Li teaches the parameter of the non-uniform radius being at a portion of the support structure providing support to a commissure position to the same extent as disclosed/taught in the originally filed disclosure of the current application at hand, as mentioned above). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the support structure, of the embodiment of Figures 2 and 5, to have a contoured surface and a non-uniform radius at a portion of the support structure providing support to a commissure position, wherein each of the primary, secondary and tertiary crowns extend outwardly from the non-uniform radius at the portion of the support structure providing support to a commissure position, in order to better secure the implantable valve in a native valve annulus, as taught by Li. Hence, the rejection of independent claim 1, as being unpatentable over the prior art of Li, is deemed to be proper since all the structural limitations set forth in the claim are taught by Li, to the same extend as they are disclosed/taught by the originally filed disclosure of the current application at hand; therefore the rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 08/11/2026
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