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 11 is objected to because of the following informalities: In claim 11, line 2, “the outlet region” should recite --the distal outlet region--. 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 1-14, 16-19, and 21 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, line 5 recites “defines a circumference with contours”. A “circumference” is traditionally understood to mean the perimeter of a circle. It appears that since the claim requires the contours to define a proximal inlet region and a distal outlet region (regions that each have their own circumferences) applicant may be using the term circumference in a different manner from the conventional definition. What does “a circumference with contours” mean? Does applicant mean for the term circumference to mean an outer surface? A tubular shape has “a circumference” at each longitudinal location of the tubular shape. Please clarify.
Claim 5, line 6 requires “the proximal inlet region is a linear cylindrical inlet region” and line 7 requires “the distal outlet region is a linear cylindrical outlet region”. When the stent structure is configured this way, it is unclear how two linear cylindrical regions that are directly connected could have different diameters. It appears at least one of the regions would be required to be conical/tapered or rounded and not cylindrical (cylinders are not tapered) in order for the regions to be directly connected to one another (required in claim 1) and have different diameters.
Claim 14 line 3 recites “0.10 = 0.24mm” which is unclear.
Regarding claim 14, the phrases "preferably", “more preferably”, and “most preferred” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 is unclear because line 3 recites an overall height of less than 35-50 mm but claim 1 requires an overall height is less than 45 mm. Claim 21 appears to broaden the maximum overall height recited in claim 1 which is unclear.
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.
Claims 2 and 16 are 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. Claims 2 and 16 recite features already recited in claim 1 and therefore do not further limit the subject matter of claim 1. 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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-14, 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Peterson et al. US 2021/0275298 (hereafter referred to as Peterson).
Regarding claims 1, 2, and 16, Peterson discloses a prosthetic heart valve (figs. 1, 2, 21, 27-28, 30-32 or 38A-E), comprising a stent structure (considered at least 102, 202, 2102, 2702, 3002 or 3802) configured to expand from a compressed state for transluminal delivery to a natural expanded state (par.2) and having an overall height, the stent structure comprising a mesh structure that has an essentially tubular shape and defines a circumference with contours (each stent structure is formed by struts forming a tubular mesh structure and the tubular shape has an outer surface with contours formed at least by the struts and the cylindrical shape), wherein the contours define a proximal inlet region 108, 208, 2018, 2708, 3008, 3808, and a distal outlet region (considered the upper regions above inlet regions), wherein the proximal inlet region and the distal outlet region are directly connected to one another, and wherein the mesh structure comprises a plurality of closed cells that in a longitudinal direction of the prosthetic heart valve have varying cell sizes and cell configurations to form a plurality of cell patterns that vary in size between the proximal inlet region and the distal outlet region (figs. 1, 2, 21, 27-28, 30-32 or 38A-E show the cells of the proximal inlet region have a smaller size and different shape than the cells of the distal outlet region), and a valve 132 arranged inside a lumen of the stent structure (fig.1A), wherein the stent structure comprises one or more connectors at the distal outlet region (the connectors can be considered the u-shaped underside of the apices at the distal end of the distal outlet region as shown in figs. 1, 2, and 21, or the extensions 2753, 3026, or 3826 as shown in figs. 27-28, 30-32 and 38A-E) and the overall height of the stent structure is less than 45 mm (each of at least pars. 9, 109, 112, 160, 190, and 213 disclose an overall height of less than 45 mm).
Regarding claim 3, see fig.1A for three leaflets.
Regarding claim 8, see fig.7 for 12 cells in a row of the proximal inlet region and figs.1 and 6A for at least rhombohedral/diamond shaped cells.
Regarding claim 9, see at least fig.5 for the proximal inlet region comprising 3 meander rows.
Regarding claims 10 and 11, see at least figs. 1 and 8 for the distal outlet region comprising one row of 6 closed cells.
Regarding claim 12, see at least figs.1 and 5 for the proximal inlet region consisting of 3 meander rows and the distal outlet region consisting of 1 meander row with the distal meander row being parallel to the distal most proximal inlet region meander row and connected with longitudinal struts.
Regarding claim 13, see at least fig.6 for commissure post 126A comprising curved material surrounding at least one hole (the material around the holes is curved).
Regarding claim 14, see pars. 154 and 171 for strut widths (Peterson refers to the distance as thickness but as shown in figs. 21A and 27A this can also be considered a strut width) greater than 0.25mm
Regarding claim 17, see at least figs. 27 and 32 for eyelets in connectors 2753 and 3026A.
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 1-11, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cerf et al. US 2012/0053685 (hereafter referred to as Cerf) in view of Alon et al. US 2010/0049313 (hereafter referred to as Alon).
Regarding claims 1, 2, and 16, Cerf discloses a prosthetic heart valve 10a, comprising a stent structure 64a configured to expand from a compressed state for transluminal delivery to a natural expanded state (par.45 discloses stent 64a is self-expanding) and having an overall height (fig.1), the stent structure comprising a mesh structure that has an essentially tubular shape and defines a circumference with contours (fig.2 shows contours of outer surface of the tubular shape), wherein the contours define a proximal inlet region (considered the bottom region comprising rows 82a, 74a, and 72a or rows 82a and 74a) and a distal outlet region (considered the upper region comprising row 70a or rows 70a and 72a), wherein the proximal inlet region and the distal outlet region are directly connected to one another (fig.1), and wherein the mesh structure comprises a plurality of closed cells that in a longitudinal direction of the prosthetic heart valve have varying cell sizes and cell configurations to form a plurality of cell patterns that vary in size between the proximal inlet region and the distal outlet region (fig.1 shows larger cells having longer proximal struts in the proximal inlet region), and a valve 66a arranged inside a lumen of the stent structure (fig.1; par.45), wherein the stent structure comprises one or more connectors 120a (par.52) at the distal outlet region (fig.1). While Cerf discloses the invention substantially as claimed, Cerf does not disclose that the overall height of the stent structure is less than 45 mm.
Alon teaches a prosthetic heart valve, in the same field of endeavor, wherein the overall height of the stent structure is about 20-24 mm (par.95) for the purpose of minimizing the overall length to minimize the extent to which the stent upper portion extends into non-diseased area of the aorta (par.94).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an overall length of about 20-24 mm for the stent structure of Cerf in order to provide an overall length which minimizes the extent to which the stent structure extends into non-diseased area of the aorta.
Regarding claim 3, see Cerf fig.1 for three valve leaflets.
Regarding claim 4, Cerf discloses a skirt and leaflets in par.10 but does not disclose wherein the valve comprises an inner skirt on the inside of the stent structure, wherein said valve is sutured or glued at least to the inner skirt and the inner skirt is itself sutured or glued to the stent structure.
Alon teaches a prosthetic heart valve, in the same field of endeavor, wherein a valve 14 comprises an inner skirt 42 on the inside of a stent structure, wherein the valve is sutured 44 at least to the inner skirt, and the inner skirt is itself sutured to the stent structure (par.97; figs. 1, 6, and 7) for the purpose of reinforcing attachment of the leaflets to the stent (par.98).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthetic valve of Cerf to include an inner skirt on the inside of the stent structure, wherein the valve is sutured at least to the inner skirt and the inner skirt is itself sutured to the stent structure as taught by Alon in order to reinforce attachment of the leaflets to the stent.
Regarding claims 5 and 6, see Cerf fig.2 for a conical-convex inlet region having the largest diameter, a linear cylindrical outlet region having a smaller diameter, and a central region having the smallest diameter.
Regarding claim 7, in Cerf fig. 1, fastening device 60a, holding devices 120a, and even the tips of the distal ends of the distal outlet region can be considered first and second connectors. They are each connected to apical nodes at the distal end of the distal outlet region. Note that 60a connects to an apex of row 72a which can be considered part of the distal outlet region. Struts of the first and second connectors have different lengths and the nodes which they are attached to are adjacent/near each other in a circumferential direction of the stent structure.
Regarding claim 8, see Cerf fig.1 for the proximal inlet region comprising a row of cells comprising at least 12 cells (fig.1; the claim does not limit the cells to 12, 15, or 18), wherein the cells are v-shaped.
Regarding claim 9, see Cerf fig.1 for at least 3 proximal meander rows.
Regarding claim 10, see Cerf fig.1 for the distal row comprising 15 cells which comprises at least 3 to 9 cells. The claim does not limit the row to 9 cells.
Regarding claim 11, see Cerf fig.1 for one or two meander rows in the distal outlet region.
Regarding claim 13, see Cerf fig.1 for commissure post 60a connected to a proximal end of the distal outlet region, wherein the commissure post comprises three holes 110a in a longitudinal direction.
Claims 1-3, 5-11, 16-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. CN 104758091 (hereafter referred to as Yang; refer to the attached translation for passages referenced herein) in view of Chau et al. US 2011/0137397 (hereafter referred to as Chau).
Regarding claims 1, 2, and 16, Yang discloses a prosthetic heart valve (figs. 1-5), comprising a stent structure 6 configured to expand from a compressed state for transluminal delivery to a natural expanded state (translation pg.2, 2nd to last paragraph) and having an overall height (fig.1), the stent structure comprising a mesh structure that has an essentially tubular shape and defines a circumference with contours (fig.1 shows contours of the outer surface), wherein the contours define a proximal inlet region (considered the bottom region) and a distal outlet region (consider the top region; translation pg.7, example 2 explains the inlet and outlet regions), wherein the proximal inlet region and the distal outlet region are directly connected to one another (fig.1), and wherein the mesh structure comprises a plurality of closed cells that in a longitudinal direction of the prosthetic heart valve have varying cell sizes and cell configurations to form a plurality of cell patterns that vary in size between the proximal inlet region and the distal outlet region (fig.1 shows larger, differently shaped cells at the proximal inlet region), and a valve 10 arranged inside a lumen of the stent structure (fig.5), wherein the stent structure comprises one or more connectors 1, 4 at the distal outlet region (fig.1). While Yang discloses the invention substantially as claimed, Yang does not disclose that the overall height of the stent structure is less than 45 mm.
Chau teaches a prosthetic heart valve, in the same field of endeavor, wherein the overall height of the stent structure is 30 mm (par.109) for the purpose of being sized to fit a mitral valve (par.6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an overall length of 30 mm for the stent structure of Yang in order to provide an overall length known to be ideal for use in the mitral valve as taught by Chau.
Regarding claim 3, see Yang fig.5 for three leaflets.
Regarding claims 5 and 6, see Yang fig.1 for wider conical-convex inlet region and narrower linear cylindrical outlet region. The translation of Yang at pg. 5, second to last paragraph further discloses that the middle part is smaller than both ends.
Regarding claim 7, see Yang fig.1 for first and second connectors 1 and 4 which are connected to adjacent apical nodes and have different strut lengths.
Regarding claim 8, see Yang fig.5 for a proximal row of cells comprising 12 cells. The cells in the proximal row of cells are shown in fig.1 of Yang to be honey-comb shaped.
Regarding claim 9, see Yang fig.1 for at least 3 proximal meander rows.
Regarding claim 10, see Yang fig.1 for the distal row comprising at least 6 cells which comprises at least 3 cells. The claim does not limit the row to a particular number of cells.
Regarding claim 11, see Yang fig.1 for one or two meander rows in the distal outlet region.
Regarding claim 17, see Yang fig.1 for eyelets in each of connectors 1 and 4.
Regarding claims 18 and 19, see fig.1 of Yang for the different lengths of the struts of connectors 1 and 4, wherein the length of the strut of 1 is higher than the length of 4.
Regarding claim 21, see the rejection of claim 1 above which discusses a maximum length of 30 mm which is more than 27 mm and less than 45 mm.
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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