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 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 10 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 10 recites “a first axially extending post” in line 2. It is unclear if this is the same first axially extending post recited in claim 9 line 2 or a separate and distinct first axially extending post. The Examiner understands these to be the same post and recommends amending claim 10 to read “the first axially extending post”.
Claim 10 recites “a second axially extending post” in lines 3-4. It is unclear if this is the same second axially extending post recited in claim 9 lines 3-4 or a separate and distinct second axially extending post. The Examiner understands these to be the same post and recommends amending claim 10 to read “the second axially extending post”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge (US 2013/0166017 A1) in view of Pintor (US 2010/0161036 A1).
Regarding claim 1, Cartledge teaches a prosthetic heart valve (13500, valve assembly fig. 135) comprising:
a radially expandable and compressible frame (figs. 135 & 137) comprising:
a plurality of groups of four outer struts and two axial struts forming a plurality of hexagonal outer cells arranged side-by-side in a circumferential direction of the frame (see annotated fig. 135, below), and
a plurality of groups of four inner struts forming a plurality of diamond-shaped inner cells (see annotated fig. 135, below), wherein each inner cell is located within a respective outer cell (fig. 135),
a valvular structure disposed within the frame (13540, valve, fig. 135)and configured to regulate the flow of blood through the frame in one direction. The phrase “a valvular structure and configured to regulate the flow of blood through the frame in one direction” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the valve is considered to be capable of regulating the flow of blood through the frame in one direction.
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Cartledge fails to teach the outer struts are shorter than the inner struts. However, Pintor teaches a stent that includes outer struts that are shorter than the inner struts (see annotated fig. 5A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the length of the struts of Cartledge to include the outer struts are shorter than the inner struts as taught by Pintor since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). Further, courts have found support for a conclusion of obviousness where the modification merely involves choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143). In the instant case the outer struts are either larger, smaller or the same as the inner struts.
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Regarding claim 2, Cartledge further teaches wherein the inner struts have a first uniform length (fig. 135).
Regarding claim 3, Cartledge as modified by Pintor discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the outer struts have a second uniform length less than the first uniform length (fig. 135, Cartledge).
Regarding claim 4, Cartledge further teaches the outer struts are curved (fig. 176).
Regarding claim 5, Cartledge further teaches
the frame comprises an inflow end (see annotated fig. 135, below) and an outflow end (see annotated fig. 135, below),
each outer cell comprises an inflow apex disposed towards the inflow end (see annotated fig. 135, below) and an outflow apex disposed towards the outflow end (see annotated fig. 135, below), and
for each outer cell, a first pair of two of the outer struts are connected to the inflow apex (see annotated fig. 135, below), and a second pair of two of the outer struts are connected to the outflow apex (see annotated fig. 135, below).
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Regarding claim 6, Cartledge further teaches for each outer cell, each outer strut of the first pair comprises a curved portion adjacent the inflow apex (see annotated fig. 176, below) and each outer strut of the second pair comprises a curved portion adjacent the outflow apex (see annotated fig. 176, below.
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Regarding claim 7, Cartledge further teaches each inner cell comprises an inflow apex disposed towards the inflow end (see annotated fig. 135, below) and an outflow apex disposed towards the outflow end (see annotated fig. 135, below), and
for each inner cell, a first pair of two of the inner struts are connected to the inflow apex of the inner cell (see annotated fig. 135, below), and a second pair of two of the inner struts are connected to the outflow apex of the inner cell (see annotated fig. 135, below).
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Regarding claim 8, Cartledge further teaches the frame comprises a plurality of pairs of first and second axially extending posts (see annotated, fig. 137, below), wherein the first and second posts of each pair are axially spaced from each other (fig. 137), and wherein each pair of first and second posts is positioned circumferentially between two of the axial struts (fig. 137).
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Regarding claim 9, Cartledge further teaches for each inner cell, the inner struts of the first pair of inner struts are connected to a first axially extending post of a pair of first and second posts (fig. 135), and the inner struts of the second pair of inner struts are connected to a second axially extending post of the pair of first and second posts (fig. 135).
Regarding claim 10, Cartledge further teaches for each outer cell, the outer struts of the first pair of outer struts are connected to a first axially extending post of a pair of first and second posts (fig. 135), and the outer struts of the second pair of outer struts are connected to a second axially extending post of the pair of first and second posts (fig. 135).
Regarding claim 11, Cartledge further teaches a plurality of actuator members (13520, jacks, fig. 135), each extending through a pair of first and second axially extending posts (fig. 135).
Regarding claim 12, Cartledge teaches a prosthetic heart valve (13500, valve assembly fig. 135) comprising:
a radially expandable and compressible frame (figs. 135 &137) comprising:
a plurality of circumferentially spaced axial struts (see annotated fig. 135, below);
a plurality of pairs of axial posts, wherein each pair of axial posts is positioned circumferentially between two axial struts (see annotated fig. 135, below);
a plurality of rows of angled struts, including at least a first row, a second row downstream of the first row, a third row downstream of the second row, and a fourth row downstream of the third row (see annotated fig. 135, below), wherein each angled strut is connected at one end to an axial strut and at another end to an axial post (fig. 135); and
a valvular structure disposed within the frame (13540, valve, fig. 135)and configured to regulate the flow of blood through the frame in one direction. The phrase “a valvular structure and configured to regulate the flow of blood through the frame in one direction” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the valve is considered to be capable of regulating the flow of blood through the frame in one direction.
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Cartledge fails to teach the struts of the first and fourth rows are shorter than the struts of the second and third rows. However, Pintor teaches a stent that includes outer struts that are shorter than the inner struts (see annotated fig. 5A, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the length of the struts of Cartledge to include the outer struts are shorter than the inner struts as taught by Pintor since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). Further, courts have found support for a conclusion of obviousness where the modification merely involves choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143). In the instant case the outer struts are either larger, smaller or the same as the inner struts.
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Regarding claim 13, Cartledge further teaches the valvular structure comprises a plurality of commissures (¶ [0371]), wherein each of the commissures is connected to one of the axial struts (fig. 135).
Regarding claim 14, Cartledge further teaches the second row of angled struts and the third row of angled struts form a plurality of diamond-shaped cells arranged in a circumferentially extending row of cells (see annotated fig. 135, below).
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Regarding claim 15, Cartledge further teaches the first row of angled struts, the fourth row of angled struts, and the axial struts form a plurality of hexagon-shaped cells (see annotated fig. 135, below) arranged in a circumferentially extending row of cells, wherein each diamond-shaped cell is disposed within a respective hexagon-shaped cell (fig. 135).
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Regarding claim 16, Cartledge teaches a prosthetic heart valve (13500, valve assembly fig. 135) comprising:
a radially expandable and compressible frame (figs. 135 & 137) comprising a plurality of cell columns arranged in a circumferentially extending row of cell columns (see annotated fig. 135, below), wherein each cell column comprises an outer cell (see annotated fig. 135, below) and an inner cell (see annotated fig. 135, below) disposed within the outer cell (fig. 135), wherein each inner cell comprises four angled inner struts (fig. 135) and each outer cell comprises four angled outer struts (fig. 135) and
a valvular structure disposed within the frame (13540, valve, fig. 135)and configured to regulate the flow of blood through the frame in one direction. The phrase “a valvular structure and configured to regulate the flow of blood through the frame in one direction” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the valve is considered to be capable of regulating the flow of blood through the frame in one direction.
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Cartledge fails to teach the outer struts are shorter than the inner struts. However, Pintor teaches a stent that includes outer struts that are shorter than the inner struts (figs. 5A-5B).Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the length of the struts of Cartledge to include the outer struts are shorter than the inner struts as taught by Pintor since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). Further, courts have found support for a conclusion of obviousness where the modification merely involves choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143). In the instant case the outer struts are either larger, smaller or the same as the inner struts.
Regarding claim 17, Cartledge further teaches
the frame comprises a plurality of circumferentially spaced axial struts (see annotated fig. 135, below) and a plurality of pairs of axial posts (see annotated fig. 135, below), wherein each pair of axial posts is positioned circumferentially between two axial struts (fig. 135); and
each angled outer strut is connected at one end to an axial strut and at another end to an axial post (fig. 135).
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Regarding claim 18, Cartledge further teaches each angled inner strut is connected at one end to an axial strut and at another end to an axial post (fig. 135).
Regarding claim 19, Cartledge further teaches each cell column extends an entire length of the frame from an inlet end of the frame to an outlet end of the frame (fig. 135).
Regarding claim 20, Cartledge further teaches the frame is cylindrical (fig. 135).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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