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 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) 1-3 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0274618 A1 to Hou et al. (hereinafter “Hou”).
Regarding claim 1, Hou discloses (see abstract; Figs. 1-2A; and [0026]-[0061]) a delivery assembly for a prosthetic heart valve (see at least [0061]), comprising: a delivery apparatus ("TAVI device", [0061]), a guidewire (100, Fig. 1A, also 200, Fig. 2) extending through the delivery apparatus (see [0061]); a first pressure sensor (124) configured to be positioned near an inlet end of a prosthetic heart valve (see Fig. 1A and [0028]-[0030]); and a second pressure sensor (122) configured to be positioned near an outlet end of the prosthetic heart valve (see Fig. 1A and [0028]-[0030]), wherein the first pressure sensor and second pressure sensor are positioned on the guidewire (see Fig. 1A and [0028]-[0030]) and are configured to measure a pressure gradient across the prosthetic heart valve (see [0029]/[0030] & [0061]).
Hou further discloses (claim 2) wherein the first pressure sensor and the second pressure sensor are positioned on the guidewire (see Figs. 1A/2A); and (claim 3) wherein at least one of the first pressure sensor and the second pressure sensor are inset in the guidewire (see Figs. 1A/2A); (claim 16) wherein the delivery assembly further comprises one or more radiopaque markers (see [0037]).
Regarding claim 20, Hou discloses (see abstract; Figs. 1-2A; and [0026]-[0061]) a delivery assembly for a prosthetic heart valve (see at least [0061]), comprising: a guidewire (100, Fig. 1A); a first pressure sensor (124) configured to be positioned near an inlet end of a prosthetic heart valve (see Fig. 1A and [0028]-[0030]); and a second pressure sensor (122) configured to be positioned near an outlet end of the prosthetic heart valve (see Fig. 1A and [0028]-[0030]), wherein the first pressure sensor and second pressure sensor are positioned on the guidewire (see Fig. 1A and [0028]-[0030]) and are configured to measure a pressure gradient across the prosthetic heart valve (see [0029]/[0030] & [0061]).
Claim(s) 1, 4-5, 12-13, 15-17, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0390350 A1 to Glawdel et al. (hereinafter “Glawdel”).
Regarding claim 1, Glawdel discloses (see abstract; Figs. 13-15; and [0068]-[0126]) a delivery assembly (Fig. 15) for a prosthetic heart valve, comprising: a delivery apparatus (700 + 200 + 300, Fig. 15); a guidewire (200) extending through the delivery apparatus (see Fig. 15 and [0103]); a first pressure sensor (230, "P1", see Fig. 15 and [0103]) configured to be positioned near an inlet end of a prosthetic heart valve (see [0103]/[0022 and Fig. 15); and a second pressure sensor (330, "P2", see Fig. 15 and [103]) configured to be positioned near an outlet end of the prosthetic heart valve (see [0103] and Fig. 15), wherein the first pressure sensor and second pressure sensor are positioned on the delivery apparatus (P2 on 300) or the guidewire (P1 on 200) and are configured to measure a pressure gradient across the prosthetic heart valve (see Fig. 15 and [0103]).
Glawdel further discloses (claim 4) wherein the first pressure sensor is positioned on the guidewire, and wherein the second pressure sensor is positioned on the delivery apparatus (see Fig. 15 and [103]); (claim 5) wherein the first pressure sensor is positioned on the delivery apparatus, and wherein the second pressure sensor is positioned on the guidewire (note that the differentiation between the sensors is based on a functional relationship relative to the prosthetic heart valve and could be differentiated as desired); (claim 12) wherein the delivery assembly further comprises a fiberoptic cable (232) or an electrical wire for transmitting data from the first pressure sensor and the second pressure sensor (see [0076]); (claim 13) wherein the delivery assembly further comprises a wireless device for transmitting data from the first pressure sensor and the second pressure sensor and a wireless receiver to receive the transmitted data (see [0029]); (claim 15) wherein the first pressure sensor and the second pressure sensor are independently movable relative to each other (see Fig. 15); (claim 16) wherein the delivery assembly further comprises one or more radiopaque markers (see [0027]); (claim 17) wherein the delivery assembly further comprises a display apparatus configured to display measurements taken by at least the first pressure sensor and the second pressure sensor (see [0029]-[0031] and [0094]-[0097])
Regarding claim 18, Glawdel discloses (see abstract; Figs. 13-15; and [0068]-[0126]) a delivery assembly (Fig. 15) for a prosthetic heart valve, comprising: a delivery apparatus (700 + 200 + 300, Fig. 15); a first pressure sensor (230, "P1", see Fig. 15 and [0103]) configured to be positioned near an inlet end of a prosthetic heart valve (see [0103]/[0022 and Fig. 15); and a second pressure sensor (330, "P2", see Fig. 15 and [103]) configured to be positioned near an outlet end of the prosthetic heart valve (see [0103] and Fig. 15), wherein the first pressure sensor and second pressure sensor are positioned on the delivery apparatus and are configured to measure a pressure gradient across the prosthetic heart valve (see Fig. 15 and [0103]).
Glawdel further discloses (claim 19) wherein the delivery apparatus comprises a nosecone (701), a delivery sheath (indicated by #702, Fig. 15), and a nosecone shaft (indicated by #700, Fig. 15).
Claim(s) 1, 6-11, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/219459, first named inventor Becerra (hereinafter “Becerra”).
Regarding claim 1, Becerra discloses (see abstract; Figs. 1-2C, 6A & 21; and [0080]-[0117] & [0162]) a delivery assembly for a prosthetic heart valve, comprising: a delivery apparatus (10); a guidewire extending through the delivery apparatus (see [0092]/[0117]); a first pressure sensor (578) configured to be positioned near an inlet end of a prosthetic heart valve (see Fig. 21 and [0162]); and a second pressure sensor (578) configured to be positioned near an outlet end of the prosthetic heart valve (see Fig. 21 and [0162]), wherein the first pressure sensor and second pressure sensor are positioned on the delivery apparatus or the guidewire (see Fig. 21 and [0162]) and are configured to measure a pressure gradient across the prosthetic heart valve (see [0162]).
Becerra further discloses (claim 6) wherein the first pressure sensor and the second pressure sensor are positioned on the delivery apparatus (see Fig. 21 and [0162]); (claim 7) wherein the delivery apparatus further comprises an outer sheath (22), a nosecone (28), and a nosecone shaft (27) (see Figs. 1-2C & 6A); (claims 8-11) wherein the first pressure sensor can be positioned on the nosecone or nosecone shaft and wherein the second pressure sensor is positioned on the guidewire or nosecone shaft (see [0162], the disclosure states that pressure sensors may be positioned on the nose cone or capsule among other locations, and that in other embodiments, other positions of pressure sensors may be provided - it would be apparent that this disclosure encompasses embodiments where the pressure sensors can be loaded on various locations of the delivery apparatus and guidewire, so long as a first location is on a first side of the native and/or implanted valve and a second location is on an opposite, second side of the native and/or implanted valve to measure the pressure gradient across the valve, and thus these locations would include the nosecone or nosecone shaft for the first sensor as the nosecone and nosecone shaft are on a first side of the implanted valve and the second location is on the guidewire or nosecone shaft as these can be located on the second side of the implanted valve); (claim 14) wherein the delivery assembly comprises more than two pressure sensors (see [0162]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing pressure sensors in the context of heart valve delivery devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771