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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species C, FIG 5, corresponding to claims 1-3, 6-12, and 14-20 in the reply filed on 5/21/26 is acknowledged. Claims 4, 5, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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) 1-3, 7-12, 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson (20220061985).
Regarding claim 1, Peterson discloses an implantable medical device (100, FIG 1A-D) adapted to be implanted at an implantation site within the vasculature ([0145]), the implantable medical device capable of being implanted at the implantation site within the vasculature at more than one position relative to the implantation site (any valve is capable of being implanted in more than one position), the implantable medical device comprising: an expandable frame (102) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment (FIG 1A-D); and one or more radiopaque markers (160-170) disposed relative to the expandable frame such that fluoroscopic imaging of the implantable medical device during deployment provides an indication of a position of the implantable medical device relative to the implantation site (part of the function of radiopaque markers 160, 170).
Regarding claim 2, Peterson discloses the implantable medical device of claim 1, wherein at least some of the one or more radiopaque markers (160. 170) are positioned to provide an indication of an axial position of the implantable medical device relative to the implantation site via fluoroscopic imaging ([0142]).
Regarding claim 3, Peterson discloses the implantable medical device of claim 1, wherein at least some of the one or more radiopaque markers (160, 170) are positioned to provide an indication of a rotational position of the implantable medical device relative to the implantation site via fluoroscopic imaging ([0142]).
Regarding claim 7, Peterson discloses a replacement cardiac valve (100, FIG 1A-D) adapted to be implanted within a native cardiac valve annulus ([0145]), the replacement cardiac valve capable of being implanted in more than one position relative to the native cardiac valve annulus (any valve is capable of being implanted in more than one position), the replacement cardiac valve comprising: an expandable frame (102) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment (FIG 1A-D), the expandable frame (102) including an annular portion adapted to engage the native cardiac valve annulus when deployed (FIG 1A-D, [0182]); a plurality of commissural posts (126A) adapted to extend above the native cardiac valve annulus when deployed (FIG 1A); and a valve material secured relative to the plurality of commissural posts (FIG 1D, [0151]), with the valve material forming a valve cusp between each of the plurality of commissural posts (FIG 1D); and one or more radiopaque indicators (160, 170) disposed relative to the expandable frame (102) such that fluoroscopic imaging of the replacement cardiac valve during deployment provides an indication of a position of the replacement cardiac valve relative to the native cardiac valve annulus (part of the function of radiopaque markers 160, 170).
Regarding claim 8, Peterson discloses the replacement cardiac valve of claim 7, wherein at least some of the one or more radiopaque indicators (160, 170) are adapted to provide an indication of insertion depth of the replacement cardiac valve relative to the native cardiac valve annulus ([0170]).
Regarding claim 9, Peterson discloses the replacement cardiac valve of claim 8, wherein at least some of the one or more radiopaque indicators (160, 170) are secured relative to the annular portion of the expandable frame that is adapted to engage the native cardiac valve annulus when deployed (FIG 1C).
Regarding claim 10, Peterson discloses the replacement cardiac valve of claim 7, wherein at least some of the one or more radiopaque indicators (160, 170) are adapted to provide an indication of relative rotational position of the replacement cardiac valve relative to the native cardiac valve annulus ([0142]).
Regarding claim 11, Peterson discloses the replacement cardiac valve of claim 10, wherein at least some of the one or more radiopaque indicators (170) are secured relative to at least some of the plurality of commissural posts (FIG 1C).
Regarding claim 12, Peterson discloses the replacement cardiac valve of claim 7, wherein the expandable frame (102) comprises a plurality of struts (112), and one or more of the plurality of struts are adapted to accommodate at least some of the one or more radiopaque indicators ([0169]).
Regarding claim 15, Peterson discloses an aortic valve (100, FIG 1A-D) adapted to be implanted within a native aortic valve annulus ([0145]), the aortic valve capable of being implanted in more than one position relative to the native aortic valve annulus (any valve is capable of being implanted in more than one position), the aortic valve comprising: an expandable frame (102) that is adapted to expand from a collapsed configuration for delivery to an expanded configuration for deployment (FIG 1A-D), the expandable frame (102) including an annular portion adapted to engage the native aortic valve annulus when deployed (FIG 1A-D, [0182]); a plurality of commissural posts (126A) adapted to extend above the native cardiac valve annulus when deployed (FIG 1A); a plurality of stabilization arches (120A) adapted to extend above the plurality of commissural posts (FIG 1A); and a valve material secured relative to the plurality of commissural posts (FIG 1D, [0151]), with the valve material forming a valve cusp between each of the plurality of commissural posts (FIG 1D); and a plurality of radiopaque indicators (160, 170) disposed relative to the expandable frame (102) such that fluoroscopic imaging of the aortic valve during deployment provides an indication of a position of the aortic valve relative to the native aortic valve annulus (part of the function of radiopaque markers 160, 170).
Regarding claim 16, Peterson discloses the aortic valve of claim 15, wherein at least some of the plurality of radiopaque indicators (160, 170) are adapted to provide an indication of insertion depth of the aortic valve relative to the native aortic valve annulus ([0170]).
Regarding claim 17, Peterson discloses the aortic valve of claim 16, wherein at least some of the plurality of radiopaque indicators (160) are secured relative to the annular portion of the expandable frame that is adapted to engage the native aortic valve annulus when deployed (FIG 1C).
Regarding claim 18, Peterson discloses the aortic valve of claim 15, wherein at least some of the plurality of radiopaque indicators (160, 170) are adapted to provide an indication of relative rotational position of the aortic valve relative to the native aortic valve annulus ([0142]).
Regarding claim 19, Peterson discloses the aortic valve of claim 18, wherein at least some of the plurality of radiopaque indicators (170) are secured relative to at least some of the plurality of commissural posts (FIG 1C).
Regarding claim 20, Peterson discloses the aortic valve of claim 15, wherein at least some of the plurality of radiopaque indicators (160, 170) are adapted to provide an indication of insertion depth of the aortic valve relative to the native aortic valve annulus ([0170]) and at least some of the plurality of radiopaque indicators are adapted to provide an indication of relative rotational position of the aortic valve relative to the native aortic valve annulus ([0142]).
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.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (20220061985), as applied to claim 1 above, in view of Cohen-Tzemach (20200352710).
Regarding claim 6, Peterson discloses the implantable medical device of claim 1, but fails to disclose that at least some of the one or more radiopaque markers comprise radiopaque sutures sewn around a portion of the expandable frame.
Cohen-Tzemach discloses an implantable medical device (10) with an expandable frame (12) and radiopaque markers (206). Cohen-Tzemach teaches that at least some of the one or more radiopaque markers (206) comprise radiopaque sutures sewn around a portion of the expandable frame ([0062]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Peterson’s implantable medical device to include that at least some of the one or more radiopaque markers comprise radiopaque sutures sewn around a portion of the expandable frame, as taught by Cohen-Tzemach, in order to confirm correct orientation of the valve, and directly secure to the struts ([0062]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (20220061985), as applied to claim 7 above, in view of Cohen (20220331132).
Regarding claim 14, Peterson discloses the replacement cardiac valve of claim 7, but fails to disclose that the expandable frame comprises a plurality of loops, and one or more of the loops are adapted to accommodate one or more radiopaque indicators within at least some of the loops.
Cohen discloses a replacement cardiac device (120) with an expandable frame (126) and radiopaque markers (196). Cohen teaches that the expandable frame (126) comprises a plurality of loops (183), and one or more of the loops are adapted to accommodate one or more radiopaque indicators within at least some of the loops ([0196]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Peterson’s implantable medical device to include that the expandable frame comprises a plurality of loops, and one or more of the loops are adapted to accommodate one or more radiopaque indicators within at least some of the loops, as taught by Cohen, to provide real-time visibility ([0197]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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