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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "82" and "190" have both been used to designate upstream crown.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "86" and "192" have both been used to designate downstream crown.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "90" and "194" have both been used to designate upper crown.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "94" and "196" have both been used to designate lower crown.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 124, 190, 192, 194, 196, 213, 214 and D.
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. 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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 28 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other . See MPEP § 608.01(n). Accordingly, the claim 28 not been further treated on the merits.
Claim 45 objected to because of the following informalities: "markers, angle between" should read "markers, . 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.
Claim 27 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.
The term “substantially” in claim 27 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what substantially hemispherically shaped is. The specification offers no definition; thus, it is unclear what needs to be accomplished in order to be substantially hemispherically shaped. As best understood from the disclosure, the limitation of claim 27 is being interpreted, for the instant office action, as being spherical.
Claim Rejections - 35 USC § 102
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 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, 4-5, 17, 23-24, 28, 34, 37-38 and 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oba (US 2010/0249894 A1).
Regarding claim 1, Oba teaches a prosthetic device, comprising:
an anchoring member configured to engage an annulus of a heart valve of a heart (2, base stent, fig. 12C), wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus (fig. 12C);
a valve support mechanically supported by the anchoring member and surrounding the valve axis (8, coupling stent, fig. 12H), wherein the valve support is configured to define a flow path (¶ [0094]) from an inflow region of the valve support (14, inflow end portion, fig. 12C) to an outflow region of the valve support (12, outflow end portion, fig. 12C);
a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path; and
a plurality of imaging markers mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis (190, extending projections, figs. 25A and 28).
Regarding claim 4, Oba further teaches at least one imaging marker of the plurality of imaging markers extends from the defined perimeter in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region (fig. 25A).
Regarding claim 5, Oba further teaches at least one imaging marker of the plurality of imaging markers extends from the defined perimeter in a downstream direction of the prosthetic device, wherein the downstream direction is a direction from the inflow region toward the outflow region (fig. 25A).
Regarding claim 17, Oba further teaches the perimeter is a planar perimeter, and wherein the planar perimeter is substantially perpendicular to the valve axis (figs. 25A and 25B).
Regarding claim 23, Oba further teaches the anchoring member comprises a plurality of anchoring struts defining a plurality of upper crowns (10a, struts, fig. 5), wherein the plurality of upper crowns define at least a portion of the perimeter.
Regarding claim 24, Oba further teaches the valve support comprises a plurality of valve support struts defining a plurality of upstream crowns (112, peaks, fig. 19A), wherein the plurality of upstream crowns define at least a portion of the perimeter.
Regarding claim 28, Oba further teaches at least one imaging marker is configured to define a compressed state when constrained and an extended state when unconstrained (¶ [0017]), and further comprising increasing, by the at least one imaging marker, a displacement of the at least one imaging marker in a particular direction when the at least one imaging marker transitions from the compressed state to the extended state (the marker shifts from nearer the valve axis toward the valve annulus).
Regarding claim 34, Oba teaches A method, comprising:
delivering a prosthetic device to a heart of a patient in a radially compressed delivery configuration (¶ [0019]);
expanding the prosthetic device within the heart of the patient (¶ [0019]), the prosthetic device comprising:
an anchoring member configured to engage an annulus of a heart valve of a heart (2, base stent, fig. 12C), wherein the anchoring member is configured to cause a valve axis defined by the prosthetic device to pass through the annulus when the anchoring member engages the annulus (fig. 12C);
a valve support mechanically supported by the anchoring member and surrounding the valve axis (8, coupling stent, fig. 12H), wherein the valve support is configured to define a flow path (¶ [0094]) from an inflow region of the valve support (14, inflow end portion, fig. 12C) to an outflow region of the valve support (12, outflow end portion, fig. 12C);
a valve assembly mechanically supported by the valve support within the flow path, wherein the valve assembly is configured to allow a blood flow through the flow path; and
a plurality of imaging markers mechanically supported by the prosthetic device around a perimeter defined by the prosthetic device, wherein the perimeter surrounds the valve axis (190, extending projections, figs. 25A and 28); and
imaging the prosthetic device within the heart using an imaging system (¶ [0134]).
Regarding claim 37, Oba further teaches extending, by the prosthetic device, at least one imaging marker from the defined perimeter in an upstream direction of the prosthetic device, wherein the upstream direction is a direction from the outflow region toward the inflow region (fig. 25A).
Regarding claim 38, Oba further teaches extending, by the prosthetic device, at least one imaging marker from the defined perimeter in a downstream direction of the prosthetic device, wherein the downstream direction is a direction from the inflow region toward the outflow region (fig. 25A).
Regarding claim 47, Oba further teaches at least one imaging marker is configured to define a compressed state when constrained and an extended state when unconstrained (¶ [0017]), and further comprising increasing, by the at least one imaging marker, a displacement of the at least one imaging marker in a particular direction when the at least one imaging marker transitions from the compressed state to the extended state (the marker shifts from nearer the valve axis toward the valve annulus).
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) 6 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Rabito (US11,234,819 B2).
Regarding claims 6 and 39, Oba fails to teach at least a portion of at least one imaging marker of the plurality of imaging markers extends from the defined perimeter in a direction toward the valve axis. However, Rabito teaches a prosthetic heart valve that includes at least a portion of at least one imaging marker of the plurality of imaging markers extends from the defined perimeter in a direction toward the valve axis (306, retaining arms, fig. 14). 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 imaging marker of Oba to include extending from the defined perimeter in a direction toward the valve axis as taught by Rabito in order to form a releasable connection with the distal end of a delivery apparatus (col 14 lines 15-44, Rabito).
Claim(s) 25-26 and 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba.
Regarding claims 25 and 45, a first embodiment of Oba fails to teach a first and second portion of the imaging markers defining an angle. However, a second embodiment of Oba further teaches at least one imaging marker of the plurality of imaging markers includes a first portion (224, lower portion, fig. 29)and a second portion (226, upper portion, fig. 29) and defines an angle between the first portion and the second portion (fig. 29). 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 imaging marker of a first embodiment of Oba to include a first and second portion of the imaging markers defining an angle as taught by a second embodiment of Oba in order to contact the tissue above the annulus (¶ [0139], Oba).
Regarding claims 26 and 46, a first embodiment of Oba fails to teach the imaging marker defines a curved surface. However, a second embodiment of Oba further teaches at least one imaging marker of the plurality of imaging markers defines a curved surface (fig. 29). 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 imaging marker of a first embodiment of Oba to include the imaging marker defines a curved surface as taught by a second embodiment of Oba in order to contact the tissue above the annulus (¶ [0139], Oba).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Dugan (US 2007/0156230 A1).
Regarding claim 27, Oba fails to teach the imaging marker is hemispherically shaped. However, Dugan teaches a prosthetic stent that includes at least one imaging marker of the plurality of imaging markers is substantially hemispherically shaped (80, spherical marker, fig. 6, ¶ [0060]). 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 imaging marker of Oba to include a hemispherical shape as taught by Dugan in order to save time by not needing to orient the marker during placement (¶ [0051], Dugan).
Claim(s) 29 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Yang (US 2023/0263632 A1).
Regarding claim 29, Oba fails to teach at least one imaging marker defines a surface defining a dimension of from about 2 millimeters to about 5 millimeters. However, Yang teaches cardiac prosthetic that includes at least one imaging marker of the plurality of imaging markers defines a surface defining a dimension of from about 2 millimeters to about 5 millimeters (¶ [0054]). 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 imaging marker of Oba to include defining a surface defining a dimension of from about 2 millimeters to about 5 millimeters as taught by Yang in order to be long enough to provide easy detection via ultrasound imaging (¶ [0054], Yang).
Regarding claim 48, Oba fails to teach transmitting acoustic wave energy. However, Yang further teaches transmitting, using an ultrasound probe, acoustic wave energy to a heart when the prosthetic device is positioned within the heart (¶ [0055]); and defining, by at least one of the imaging markers, a surface defining a spatial dimension greater than a wavelength of the acoustic wave energy transmitted to the heart (¶ [0055]). 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 method of Oba to include transmitting acoustic wave energy as taught by Yang in order to confirm orientation of the anchor (¶ [0055], Yang).
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 - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C EDWARDS can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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