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 Species H in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground(s) that the species show a single inventive concept of a frame structure with specific features. This is not found persuasive as the frame structures cited by the Applicant have varying and incompatible elements that differentiate the listed embodiments. For example, the interior and exterior skirts of species H are applied to the atrial and the ventricular portions of frame and must accommodate both the foreshortening and non-foreshortening properties of these regions. The webbing of species E is only applied to the ventricular flared portion for an atraumatic engagement of the surrounding tissue (pgs. 6-7 of the specification). Claims 3 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/2/2026. The requirement is still deemed proper and is therefore made FINAL.
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 15 and its dependent claims 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. Claim 15 recites “every other vertex of the flared atrial portion comprises a paddle of the plurality of paddles extending therefrom.” It is unclear if these are intended to be the same elements as the vertices and paddles recited in claim 1, which describes a plurality of paddles, each of the paddles extending axially from a vertex of one of the plurality of expandable cells. Appropriate correction and/or clarification is required.
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.
Claim(s) 1, 4, and 6-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Argento et al. (Pub. No.: US 2022/0054261 A1; hereinafter “Argento”).
Argento discloses the following regarding claim 1: a device for treating a diseased native valve, the device comprising: a frame structure (12) (Figs. 4-12) having an unexpanded configuration and an expanded configuration (paras. 0011-0015, 0157), the frame structure in the expanded configuration having a flared atrial portion (157), a central annular portion (158), and a flared ventricular portion (146), further wherein the frame structure comprises a plurality of expandable cells (123) (para. 0155) and a plurality of paddles (146 and/or 159), each of the paddles extending axially from a vertex of one of the plurality of expandable cells (Fig. 8); a plurality of leaflets (16) coupled to the frame structure (Fig. 7; para. 0149); and a spiral anchor (15) configured to extend around the central annular portion (Figs. 4, 7, 9, 12).
Argento discloses the following regarding claim 4: the device of claim 1, wherein the each of the plurality of paddles (159) includes a linear extension and an eyelet (Figure A).
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Figure A.
Argento discloses the following regarding claim 6: the device of claim 1, wherein each of the paddles (146) is curved so as to extend radially away from the vertex and then to point axially in an atrial direction (Fig. 8).
Argento discloses the following regarding claim 7: the device of claim 1, wherein the expandable cells of the plurality of expandable cells are arranged in a plurality of annular rows (Fig. 8).
Argento discloses the following regarding claim 8: the device of claim 7, wherein the plurality of annular rows comprises three annular rows (Fig. 8).
Argento discloses the following regarding claim 9: the device of claim 1, wherein the frame structure has an axial length of less than 35mm in the expanded configuration (para. 0015).
Argento discloses the following regarding claim 10: the device of claim 1, wherein the spiral anchor is a flat spiral anchor (interpreted as having a smooth, even surface) (Fig. 9).
Argento discloses the following regarding claim 11: the device of claim 1, wherein the frame structure is configured to self-expand from the unexpanded configuration to the expanded configuration (paras. 0011-0015, 0157).
Argento discloses the following regarding claim 12: the device of claim 1, wherein the frame structure comprises nitinol (para. 0200).
Argento discloses the following regarding claim 13: the device of claim 1, wherein each of the expandable cells is substantially diamond shaped when the frame is in the expanded configuration (Fig. 8).
Argento discloses the following regarding claim 14: the device of claim 1, wherein the flared atrial portion is configured to extend further radially outwards than the flared ventricular portion (Figs. 4, 12).
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.
Claim(s) 2, 5, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento in view of Ratz et al. (Pub. No.: US 2014/0277427 A1; hereinafter “Ratz”).
Regarding claim 2, Argento discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite a skirt positioned around an external surface of the frame structure. Ratz teaches that it is well known in the art that a heart valve prosthesis comprises a skirt positioned around an external surface of the frame structure (220) (paras. 0059-0064), for the purpose preventing or inhibiting the backflow of fluids, such as blood, around the prosthesis. It would have been obvious to one having ordinary skill in the art to modify the device of Argento to comprise an exterior skirt, as taught by Ratz, in order to prevent or inhibit the backflow of fluids, such as blood, around the prosthesis. Such a modification would be made with a reasonable expectation of success.
Regarding claim 5, Argento discloses the limitations of the claimed invention, as described above. Argento further teaches the plurality of expandable cells foreshortening as the frame structure transitions from the unexpanded configuration to the expanded configuration (para. 0129). However, it does not explicitly recite the linear extension being non-foreshortening. Ratz teaches that it is well known in the art that a heart valve prosthesis comprises linear extensions (12) being non-foreshortening, and the plurality of expandable cells foreshortening as the frame structure transitions from the unexpanded configuration to the expanded configuration (paras. 0039-0041), for the purpose of providing the device with the desired dimensions needed to properly fit a particular implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Argento to have non-foreshortening linear extensions, as taught by Ratz, in order to provide the device with the desired dimensions needed to properly fit a particular implantation site. Such a modification would be made with a reasonable expectation of success.
As best interpreted, regarding claim 15, Argento discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite every other vertex of the expandable cells comprising a paddle of the plurality of paddles extending therefrom. Ratz teaches that it is well known in the art that a heart valve prosthesis comprises paddles (24) on every other vertex of the cells (Figs. 1A, 2A; paras. 0039-0041), for the purpose of providing the device with the appropriate anchor configuration needed to for a particular implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Argento to have paddles on every other cell vertex, as taught by Ratz, in order to provide the device with the appropriate anchor configuration needed to for a particular implantation site. Such a modification would be made with a reasonable expectation of success.
Regarding claim 20, Argento discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the plurality of expandable cells being smaller at an atrial end of the frame structure than at a ventricular end of the frame structure. Ratz teaches that it is well known in the art that a heart valve prosthesis comprises cells having different sizes (Fig. 5; paras. 0036-0038), for the purpose of providing the device with the dimensions and configurations needed to properly fit a particular implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the atrial end cells of Argento to be smaller than the ventricular end cells of, as taught by Ratz, in order to provide the device with the dimensions and configurations needed to properly fit a particular implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774