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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 22, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claims 1-6, 8, 9, 17, 18, 20-23, 25, 27-31, 34, 35, 156-158 are pending in the application. Claims 1 and 27, have been amended. Claims 1-6, 8, 9, 17, 18, 20-23, 25, 30, 31, 34, 35, 156-158 are rejected. Claims 27-29 are allowed.
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) 1-6, 8, 9, 17, 18, 20-23, 25, 30, 31, 34, 35, and 156-158 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (US PG Pub 2021/0283397).
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Regarding claim 1, Gross teaches a prosthetic cardiac valve (20), which is configured to be delivered to a patient in a constrained delivery configuration (See paragraphs [0019], [0024], and [0321]), and which comprises:
a frame (30), which defines a central longitudinal axis (see dotted line in Fig. 1A) when the prosthetic cardiac valve is in an expanded deployment configuration (See paragraphs [0017], [0019], Figs. 1A and 2), and which comprises interconnected stent struts (wires, such as 831) arranged so as to define interconnected stent cells (openings between wires, such as 833) that include upstream-most stent cells (end most row of cells near marker 50) and non-upstream-most stent cells (all other cells in the stent) (See paragraph [0351]);
a plurality of prosthetic leaflets (32) coupled to the frame so as to allow blood flow in a
downstream direction and inhibit blood flow in an upstream direction (See paragraph [0351]); and
first (34/57) and second (34/54) electrodes, which are disposed near1 respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively. (See annotated Fig. 1A).
Gross does not explicitly teach the first and second electrodes are not disposed at the upstream peaks of the upstream-most stent cells. Gross does teach the electrode may have other placement locations but is preferably “within a distance from inflow end, the distance equal to 10% of the axial length of frame (the distance is measured (a) along central longitudinal axis of frame when in the expanded fully-deployed configuration, and (b) between inflow end and an upstream-most point of the at least one electrode).” (See paragraph [0442]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Gross such that the electrode 34 is not disposed at upstream peaks of the upstream most-stent cells or whatever location was desired or expedient since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Additionally, it would have been obvious to one of ordinary skill in the art to try a variety of locations for the electrode since there are only a finite number of locations along the axial length of the stent and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Furthermore, applicant has not disclosed that having the electrode be not disposed at upstream peaks of the upstream-most cells solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. It is noted that applicant’s specification discloses having the electrode both at the upstream peaks of the upstream-most cells (See Fig. 3D) as well as set back slightly (Fig. 3E). It appears these locations for the electrode are known obvious variants of each other and work equally well.
Regarding claim 2, modified Gross teaches prosthetic cardiac valve as required by claim 1 above and further teaches the first and the second electrodes are disposed at a common axial position along the central longitudinal axis when the prosthetic cardiac valve is in the expanded deployment configuration. (See Fig. 2A of Dagan US PG Pub 2016/0278951 which is incorporated by reference at Gross paragraph [0128])
Regarding claim 3, modified Gross teaches prosthetic cardiac valve as required by claim 2 above and further teaches the frame is shaped such that when the prosthetic cardiac valve is in the expanded deployment configuration after deployment at a native cardiac valve, the first and the second electrodes are disposed at a height of an annulus of the native cardiac valve. (See paragraphs [0353], [0362], [0438], [0451])
Regarding claim 4, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches the first (34/57) and the second (34/54) electrodes are disposed at different respective axial positions along the central longitudinal axis (See Fig. 1A) when the prosthetic cardiac valve is in the expanded deployment configuration. (See Paragraphs [0428]-[0442]).
Regarding claim 5, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches the first (34/57) and the second (34/54) electrodes are disposed at a common angular location with respect to the central longitudinal axis when the prosthetic cardiac valve is in the expanded deployment configuration. (See Figs. 1A and 9)
Regarding claim 6, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches a third electrode (See Fig. 2A of Dagan US PG Pub 2016/0278951 which is incorporated by reference at Gross paragraph [0128]), which is disposed at or near an upstream peak of a third one of the non-upstream-most stent cells. (See also Figs. 1A and 9)
Regarding claim 8, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches wherein the first and the second non-upstream-most stent cells are located in an upstream half of the frame. (See Fig. 1A)
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Regarding claim 9, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches wherein the first (34/57) and the second (34/54) electrodes are disposed at respective axial positions along the central longitudinal axis when the prosthetic cardiac valve is in the expanded deployment configuration (See Fig. 1A), the axial positions the same (See Fig. 2A of Dagan US PG Pub 2016/0278951 which is incorporated by reference at Gross paragraph [0128]), or differing from one another (See Fig. 1A of Gross), and wherein each of the axial positions is at a downstream-end distance from a downstream end of the stent cells and is at an upstream-end distance from an upstream end of the stent cells wherein the downstream-end distance, the upstream-end distance, and the total axial length
of the stent cells are measured parallel to the central longitudinal axis. (See annotated Fig. 1A above).
Gross does not explicitly teach wherein the downstream-end distance equals at least 20% of a total axial length of the stent cells measured between the downstream end and the upstream end of the stent cells, wherein the upstream-end distance equals at least 20% of the total axial length of the stent cells.
As disclosed, the downstream-end distance and the upstream-end distance are result effective variables which assists with proper electrode positioning. It appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Gross to have the downstream-end distance equals at least 20% of a total axial length of the stent cells measured between the downstream end and the upstream end of the stent cells, wherein the upstream-end distance equals at least 20% of the total axial length of the stent cells, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, 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 upstream-end distance and downstream-end distance as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 17, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches the frame further comprises one or more delivery-tool-coupling tabs, which extend axially beyond the stent cells. (See Figs. 2A &3 and paragraph [0130] of Dagan US PG Pub 2016/0278951 which is incorporated by reference at Gross paragraph [0128]),
Regarding claim 18, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches the prosthetic cardiac valve further comprises: circuitry, which is configured to use the first electrode as an anode and the second electrode as a cathode; and first and second electrical leads, which electrically couple the first and the second electrodes, respectively, to the circuitry. (See paragraphs [0349]-[0353], [0369], [0372], [0374], [0376], and [0395])
Regarding claim 20, modified Gross teaches the prosthetic cardiac valve as required by claim 18 above and further teaches the circuitry is configured to apply pacing to a heart of the patient using the first electrode as the anode and the second electrode as the cathode. (See paragraphs [0395], [0486])
Regarding claim 21, modified Gross teaches the prosthetic cardiac valve as required by claim 18 above and further teaches the circuitry is configured to sense cardiac electrical activity of the patient using the first electrode as the anode and the second electrode as the cathode. (See paragraphs [0154], [0156], [0395], [0402], [0431], [0486])
Regarding claim 22 and 23, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches wherein the prosthetic cardiac valve further comprises an outer skirt (See paragraph [0354] which states skirt 49 is coupled to an external surface of the frame 30), wherein a portion of the stent cells is coupled to a radially inner surface of the outer skirt (See paragraph [0354]) so that the outer skirt covers a first axial portion of the stent cells and does not cover a second axial portion of the stent cells (See Figs. 1A, 4, and 6), and an edge of the outer skirt is disposed around a circumference of the stent cells axially at a border between the first and the second axial portions of the stent cells, (See Figs. 1A, 4, and 6; paragraphs [0351], and [0354]) wherein the first and the second electrodes are disposed at least partially on a radially outer surface of the outer skirt (See paragraph [0354]), when the prosthetic cardiac valve is in the expanded deployment configuration.
Gross does not explicitly teach the first and second electrodes are positioned within 8 mm or within 4 mm of the edge of the outer skirt.
As disclosed, the distance of the electrode to the edge of the outer skirt helps to stabilize the electrode with respect to the frame. It appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Gross to have the first and second electrodes be within 8mm or 4mm of the edge of the outer skirt as it only involves adjusting the dimension of a component already disclosed to be adjustable. Therefore, 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 distance of the electrode from the edge of the outer skirt as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 25, modified Gross teaches the prosthetic cardiac valve as required by claim 22 above and further teaches the first axial portion of the stent cells is downstream of the second axial portion of the stent cells. (See Fig. 1A above)
Regarding claim 30, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above and further teaches the prosthetic cardiac valve is a prosthetic aortic valve (See Title, Abstract, Figs. 4A & 4B)
Regarding claim 31, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above but does not explicitly state the prosthetic cardiac valve is a prosthetic atrioventricular valve. It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device as taught by Gross be a prosthetic atrioventricular valve since this is a recitation of intended use and it is within the ordinary level of skill in the art to deploy a prosthetic valve to the desired location. Additionally, the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 34, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above but does not explicitly state the prosthetic cardiac valve is a prosthetic pulmonary valve. It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device as taught by Gross be a prosthetic pulmonary valve since this is a recitation of intended use and it is within the ordinary level of skill in the art to deploy a prosthetic valve to the desired location. Additionally, the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 35, modified Gross teaches the prosthetic cardiac valve as required by claim 1 above but does not explicitly state the prosthetic cardiac valve is a prosthetic caval valve. It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the device as taught by Gross be a prosthetic caval valve since this is a recitation of intended use and it is within the ordinary level of skill in the art to deploy a prosthetic valve to the desired location. Additionally, the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 156, Gross teaches a prosthetic cardiac valve (20), which is configured to be delivered to a patient in a constrained delivery configuration (See paragraphs [0019], [0024], and [0321]), and which comprises:
a frame (30), which defines a central longitudinal axis (see dotted line in Fig. 1A) when the prosthetic cardiac valve is in an expanded deployment configuration (See paragraphs [0017], [0019], Figs. 1A and 2), and which comprises interconnected stent struts (wires, such as 831) arranged so as to define interconnected stent cells (openings between wires, such as 833) that include upstream-most stent cells (end most row of cells near marker 50) and non-upstream-most stent cells (all other cells in the stent) (See paragraph [0351]);
a plurality of prosthetic leaflets (32) coupled to the frame so as to allow blood flow in a
downstream direction and inhibit blood flow in an upstream direction (See paragraph [0351]); and
first (34/57) and second (34/54) electrodes, which are disposed near2 respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively. (See annotated Fig. 1A).
Gross does not explicitly teach the first and second electrodes are disposed at respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively. Gross does teach the electrode may have other placement locations but is preferably “within a distance from inflow end, the distance equal to 10% of the axial length of frame (the distance is measured (a) along central longitudinal axis of frame when in the expanded fully-deployed configuration, and (b) between inflow end and an upstream-most point of the at least one electrode).” (See paragraph [0442]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Gross such that the electrode 34 is disposed at respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively or whatever location was desired or expedient since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Additionally, it would have been obvious to one of ordinary skill in the art to try a variety of locations for the electrode since there are only a finite number of locations along the axial length of the stent and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Furthermore, applicant has not disclosed that having the electrode be at respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. It is noted that applicant’s specification discloses having the electrode both at the upstream peaks of the upstream-most cells (See Fig. 3D) as well as disposed at respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively (Fig. 3E). It appears these locations for the electrode are known obvious variants of each other and work equally well.
Regarding claim 157, modified Gross teaches prosthetic cardiac valve as required by claim 156 above and further teaches the first and the second electrodes are disposed at a common axial position along the central longitudinal axis when the prosthetic cardiac valve is in the expanded deployment configuration. (See Fig. 2A of Dagan US PG Pub 2016/0278951 which is incorporated by reference at Gross paragraph [0128])
Regarding claim 158, modified Gross teaches the prosthetic cardiac valve as required by claim 156 above and further teaches the prosthetic cardiac valve further comprises: circuitry, which is configured to use the first electrode as an anode and the second electrode as a cathode; and first and second electrical leads, which electrically couple the first and the second electrodes, respectively, to the circuitry. (See paragraphs [0349]-[0353], [0369], [0372], [0374], [0376], and [0395])
Allowable Subject Matter
Claims 27-29 are hereby allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The following is an examiner’s statement of reasons for allowance: the claims in the instant application have overcome the previous rejection(s). Specifically, the prior art of record does not teach or render obvious a prosthetic cardiac valve with a plurality of electrodes and further comprising circuitry and first and second electrical leads which electrically coupled the first and second electrodes respectively to the circuitry and where the leads are coupled to interconnected stent struts in the second axial portion of the stent cells but are NOT coupled to interconnected stent struts of the first axial portion of the stent cells in combination with the other elements as claimed. Additionally, no other references, or reasonable combination thereof, could be found which disclose or suggest these features in combination with other limitations in the claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments filed May 11, 2026, with respect to the anticipation rejection(s) of the claims under over Gross (US PG Pub 2021/0283397) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of obviousness rejection is made in view of over Gross (US PG Pub 2021/0283397).
Applicant argues Gross does not teach the first and second electrodes are not disposed at the upstream peaks of the upstream-most stent cells or teach that the first and second electrodes are disposed at respective upstream peaks of first and second ones of the non-upstream-most stent cells, respectively. This is true. However, Gross does teach the electrode may have other placement locations but is preferably “within a distance from inflow end, the distance equal to 10% of the axial length of frame (the distance is measured (a) along central longitudinal axis of frame when in the expanded fully-deployed configuration, and (b) between inflow end and an upstream-most point of the at least one electrode).” (See paragraph [0442]).
Furthermore, it is well within the ordinary skill in the art to alter the locations of the first and second electrodes since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Additionally, it would have been obvious to one of ordinary skill in the art to try a variety of locations for the electrode since there are only a finite number of locations along the axial length of the stent and one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “near” is defined by Merriam-Webster as “close to” and Cambridge Dictionary defines “near” as “not far away in distance”. As can be seen in annotated Fig. 1A, the second electrode (34/54) is not far away in distance to the peaks of several non-upstream-most cells. This is deemed sufficient to meet the limitation as presently claimed.
2 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “near” is defined by Merriam-Webster as “close to” and Cambridge Dictionary defines “near” as “not far away in distance”. As can be seen in annotated Fig. 1A, the second electrode (34/54) is not far away in distance to the peaks of several non-upstream-most cells. This is deemed sufficient to meet the limitation as presently claimed.
Prosecution Insights