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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this 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 prosthetic valve comprising all the limitations set forth in claim 1, specifically: a lower region of the outer frame is coupled to a lower region of the inner frame; and the upper region of the outer frame extends generally perpendicular to an intermediate region of the outer frame to from a flange, when the outer frame is in an expanded configuration; and a plurality of anchors positioned radially outward from the outer frame, the anchors shaped to capture native leaflets; and a further anchoring mechanism on the expandable inner frame, for securing the inner frame to a portion of a heart wall (claim 1), the prosthetic valve comprising all the limitations set forth in claim 1 and wherein the anchors extend radially outward and upward for securing native leaflets in a gap between the anchors and an outer surface of the outer frame (claim 6), the prosthetic valve comprising all the limitations set forth in claim 1 and wherein the further anchoring mechanism, which is on the expandable inner frame for securing the inner frame to a portion of a heart wall, is adapted to secure the inner frame to a ventricular portion of the heart wall (claim 7), the prosthetic valve comprising all the limitations set forth in claim 1 and wherein the further anchoring mechanism, which is on the expandable inner frame for securing the inner frame to a portion of a heart wall, comprises a barb (claim 8), the prosthetic valve comprising all the limitations set forth in claim 1 and wherein the further anchoring mechanism, which is on the expandable inner frame for securing the inner frame to a portion of a heart wall, comprises a tether (claim 9), the prosthetic valve comprising all the limitations set forth in claim 10, specifically: a lower region of the outer frame is coupled to a lower region of the inner frame; and the upper region of the outer frame extends generally perpendicular to an intermediate region of the outer frame to from a flange, when the outer frame is in an expanded configuration; and a plurality of anchors positioned radially outward from the outer frame, shaped to grasp native leaflets (claim 10), the prosthetic valve comprising all the limitations set forth in claim 18, specifically: a lower region of the outer frame is coupled to a lower region of the inner frame; and the upper region of the outer frame extends radially outward to from a flange; and at least a portion of the outer frame has a D-Shape cross-section; and a plurality of anchors configured to grasp native leaflets; and a further anchoring mechanism configured to attach to a portion of the heart wall (claim 18), the prosthetic valve comprising all the limitations set forth in claim 18 and wherein the further anchoring mechanism, which is configured to attach to a portion of a heart wall, comprises a barb (claim 19), and the prosthetic valve comprising all the limitations set forth in claim 18 and wherein the further anchoring mechanism comprises a barb, which is configured to attach to a portion of a heart wall; and further comprising a tether configured to attach to a ventricular portion of the heart wall (claim 20) 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 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 4, 6 and 15 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 claims 4 and 15, which set forth the parameter of “the non-circular cross section has an ovoid shape” (emphasis added); however, this parameter is found to be confusing since the term “cross-section” applies to two-dimensional shapes, while an “ovoid” is a three-dimensional shape. Furthermore, if the intention of these claims was to claim the cross section is an oval shape, then it is further unclear how this limitation would differ from that set forth in claims 3 and 14. Therefore, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claim 6, which recites the limitation “the anchors”, on lines 1 and 2; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exactly these anchors are, and/or, how they relate to the final structure of the claimed invention; are they the same thing/structure as the “plurality of anchors” (as set forth on the 4th to last line of claim 1, from which claim 6 depends), or are they the same thing/structure as the “further anchoring mechanism” (as set forth on the 2nd to last line of claim 1, from which claim 6 depends), or are they completely separate and distinct structures/anchor. Furthermore, where exactly are these anchors “extending radially outward and upward” from; and how, structurally, can these anchors secure native leaflets “between the anchors and an outer surface of the outer frame”. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims 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 1-5, 8 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Raanani et al. (US PG Pub. 2015/0173897), as disclosed in the IDS dated 02/28/2025, hereinafter Raanani, in view of Morriss et al. (US PG Pub. 2015/0142100), as disclosed in the IDS dated 05/22/2025, hereinafter Morriss.
Regarding claims 1-4 and 8, Raanani discloses a prosthetic valve (10), illustrated in Figures 2-4B, for replacing the function of a native tricuspid valve ([0322]), comprising an expandable inner frame (35) having an upper region (33) and a lower region (30), wherein the expandable inner frame has a cylindrical shape and a circular cross-section when in an expanded configuration; an expandable outer frame (32) having an upper region (UR), an intermediate region (IR), and a lower region (36), wherein: the lower region (36) of the expandable outer frame (32) is coupled to the lower region (30) of the expandable inner frame (35), the upper and intermediate regions (UR & IR) of the expandable outer frame are larger in diameter than the lower region (36) of the expandable outer frame (32) when the expandable outer frame is in an expanded configuration, the upper region (UR) of the expandable outer frame extends generally perpendicular to the intermediate region (IR) of the expandable outer frame to form a flange when the expandable outer frame is in the expanded configuration, illustrated in Figures 3A-3D and modified figure 3C below, the upper and intermediate regions (UR & IR) of the expandable outer frame (32) are spaced radially outward from the expandable inner frame (35) when the expandable inner and outer frames (32 & 35) are in the expanded configurations, illustrated in Figures 4A, 4B and modified figure 4A below ([0192], Lines 1-3; [0195] & [0197]); a valve body (49) positioned within an interior of the expandable inner frame, the valve body comprising a plurality of leaflets that allow blood flow in a first direction and prevent blood flow in a second direction, the first direction extending from the upper region of the expandable inner frame toward the lower region of the expandable inner frame, and the second direction extending from the lower region of the expandable inner frame toward the upper region of the expandable inner frame, illustrated in Figures29A and 29B ([0136]; [0137]; [0180] & [0183]); a plurality of anchors (610), positioned radially outward from the expandable outer frame (32), shaped to capture native leaflets of the native tricuspid valve; and a further anchoring mechanism, comprising a barb (620), on the expandable inner frame (35) for securing the expandable inner frame to a portion of a heart wall, illustrated in Figures 22A-22C ([0306] – [0308]; [0311] & [0333]); but does not specifically disclose at least a portion of the expandable outer frame has a non-circular cross section, specifically a D-shape or oval/ovoid shape, when the expandable outer frame is in the expanded configuration, however it is disclosed the prosthetic valve/outer frame conforms to the shape of the natural valve once implanted/expanded ([0038] & [0314], Lines 1-6).
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However, Morriss teaches a prosthetic valve (100), for replacing a native tricuspid valve, comprising an inner frame (120) and an outer frame (110), wherein the outer frame (110) can have a non-circular cross section, specifically a D-shape or oval/ovoid shape cross section, in the expanded configuration to conform to the native valve anatomy, illustrated in Figure 15 ([0200], Lines 10-15).
In view of the teachings of Morriss, 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 determine an appropriate cross sectional shape for the outer frame, of the prosthetic valve of Raanani, in the expanded configuration, including being non-circular, specifically a D-shape or oval/ovoid shape cross section, in order to conform to native valve anatomy, as taught by Morris. Furthermore, doing so amounts to a mere change in the shape/form of a known component, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 5, Raanani in view of Morriss disclose the prosthetic valve of claim 1, wherein Raanani further teaches an outer skirt (48) on the expandable outer frame (32), and an inner skirt (47) on the expandable inner frame (32), illustrated in Figures 29A and 29B (Raanani: [0184] & [0186]).
Regarding claims 10-15, Raanani discloses a prosthetic valve (10), illustrated in Figures 2-4B, for implantation at a native valve, comprising an expandable inner frame (35) having an upper region (33) and a lower region (30), wherein the expandable inner frame has a cylindrical shape and a circular cross-section when in an expanded configuration; an expandable outer frame (32) having an upper region (UR), an intermediate region (IR), and a lower region (36), wherein: the lower region (36) of the expandable outer frame (32) is coupled to the lower region (30) of the expandable inner frame (35), the upper and intermediate regions (UR & IR) of the expandable outer frame are larger than the lower region (36) of the expandable outer frame (32) when the expandable outer frame is in an expanded configuration, the upper region (UR) of the expandable outer frame extends generally perpendicular to the intermediate region (IR) of the expandable outer frame to form a flange when the expandable outer frame is in the expanded configuration, illustrated in Figures 3A-3D and modified figure 3C above, the upper and intermediate regions (UR & IR) of the expandable outer frame (32) are positioned radially outward from the expandable inner frame (35) when the expandable inner and outer frames (32 & 35) are in the expanded configurations, illustrated in Figures 4A, 4B and modified figure 4A above ([0192], Lines 1-3; [0195] & [0197]); a valve body (49) positioned within an interior of the expandable inner frame, the valve body comprising a plurality of leaflets that allow blood flow in a first direction and prevent blood flow in a second direction, the first direction extending from the upper region of the expandable inner frame toward the lower region of the expandable inner frame, and the second direction extending from the lower region of the expandable inner frame toward the upper region of the expandable inner frame, illustrated in Figures29A and 29B ([0136]; [0137]; [0180] & [0183]); and a plurality of anchors (610), positioned radially outward from the expandable outer frame (32) and shaped to grasp native leaflets, illustrated in Figures 22A-22C ([0306] – [0308]; [0311] & [0333]); but does not specifically disclose at least a portion of the expandable outer frame has a non-circular cross section, specifically a D-shape or oval/ovoid shape, when the expandable outer frame is in the expanded configuration, however it is disclosed the prosthetic valve/outer frame conforms to the shape of the natural valve once implanted/expanded ([0038] & [0314], Lines 1-6).
However, Morriss teaches a prosthetic valve (100), for implantation at a native valve, comprising an inner frame (120) and an outer frame (110), wherein the outer frame (110) can have a non-circular cross section, specifically a D-shape or oval/ovoid shape cross section, in the expanded configuration to conform to the native valve anatomy, illustrated in Figure 15 ([0200], Lines 10-15).
In view of the teachings of Morriss, 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 determine an appropriate cross sectional shape for the outer frame, of the prosthetic valve of Raanani, in the expanded configuration, including being non-circular, specifically a D-shape or oval/ovoid shape cross section, in order to conform to native valve anatomy, as taught by Morris. Furthermore, doing so amounts to a mere change in the shape/form of a known component, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claims 16 and 17, Raanani in view of Morriss disclose the prosthetic valve of claim 10, wherein Raanani further teaches an outer skirt (48) on the expandable outer frame (32), and an inner skirt (47) on the expandable inner frame (32), illustrated in Figures 29A and 29B (Raanani: [0184] & [0186]).
Regarding claims 18 and 19, Raanani discloses a prosthetic valve (10), illustrated in Figures 2-4B, comprising an expandable inner frame (35); an outer frame (32), wherein a lower region (36) of the outer frame (32) is coupled to a lower region (30) of the inner frame (35), an upper region (UR) and an intermediate region (IR) of the outer frame (32) are larger in diameter than the lower region (36) of the outer frame (32), the upper and intermediate regions (UR & IR) of the expandable outer frame are spaced radially outward of the inner frame (35), the upper region (UR) of the outer frame extends (32) radially outward to form a flange, illustrated in Figures 3A-4B and modified figures 3C and 4A above ([0192], Lines 1-3; [0195] & [0197]); a valve body (49) positioned within an interior lumen of the inner frame, an outer skirt (48) on the outer frame (32) and an inner skirt (47) on the inner frame (32), illustrated in Figures29A and 29B ([0136] [0180]; [0183]; [0184] & [0186]); a plurality of anchors (610) configured to grasp native leaflets; a further anchoring mechanism, comprising a barb (620), configured to attach to a portion of a heart wall, illustrated in Figures 22A-22C ([0306] – [0308]; [0311] & [0333]); but does not specifically disclose at least a portion of the outer frame has a D-shape cross section, however it is disclosed the prosthetic valve/outer frame conforms to the shape of the natural valve once implanted/expanded ([0038] & [0314], Lines 1-6).
However, Morriss teaches a prosthetic valve (100), in the same field of endeavor, comprising an inner frame (120) and an outer frame (110), wherein the outer frame (110) has a D-shape cross section to conform to native valve anatomy, illustrated in Figure 15 ([0200], Lines 10-15).
In view of the teachings of Morriss, 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 determine an appropriate cross sectional shape for the outer frame, of the prosthetic valve of Raanani, including being a D-shape cross section, in order to conform to native valve anatomy, as taught by Morris. Furthermore, doing so amounts to a mere change in the shape/form of a known component, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Claims 7, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Raanani in view of Morriss as applied to claims 1 and 19 above, and further in view of Lutter et al. (US PG Pub. 2014/0364944), hereinafter Lutter.
Regarding claims 7 and 9, Raanani in view of Morriss disclose the prosthetic valve of claim 1, but do not specifically teach the further anchoring mechanism comprises a tether and is adapted to secure the expandable inner frame to a ventricular portion of the heart wall.
However, Lutter teaches a prosthetic valve (10), for replacing a native tricuspid valve, having an anchoring mechanism comprising a tether (40) adapted to secure the stent body (30) to a ventricular portion of the heart wall, illustrated in Figures 1 and 11, in order to have adjustability in positioning, and fixedly anchoring, the prosthetic valve ([0040]; [0043] & [0046]).
In view of the teachings of Lutter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the further anchoring mechanism, of the prosthetic valve of Raanani in view of Morriss, to comprise a tether and be adapted to secure the expandable inner frame to a ventricular portion of the heart wall, in order to have adjustability in positioning, and fixedly anchoring, the prosthetic valve, as taught by Lutter.
Regarding claim 20, Raanani in view of Morriss disclose the prosthetic valve of Claim 19, but do not specifically teach a tether configured to attach to a ventricular portion of the heart wall.
However, Lutter teaches a prosthetic valve (10), in the same field of endeavor, comprising a tether (40) configured to attach to a ventricular portion of the heart wall, illustrated in Figures 1, 7 and 11, in order to have adjustability in positioning, and fixedly anchoring, the prosthetic valve ([0036]; [0040]; [0043] & [0046]).
In view of the teachings of Lutter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the prosthetic valve, of Raanani in view of Morriss, to comprise a tether configured to attach to a ventricular portion of the heart wall, in order to have adjustability in positioning, and fixedly anchoring, the prosthetic valve, as taught by Lutter.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 07/23/2026
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