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 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”) (previously of record).
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]); an array of pressure sensors comprising three or more pressure sensors (see [0029]), a first pressure sensor (124) of the array of pressure sensors 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) of the array of pressure sensors 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 wherein the array of pressure sensors is configured to measure a pressure gradient across the prosthetic heart valve (see [0029]/[0030] & [0061]) and is fully capable of providing data for use in generating a three-dimensional pressure map (Hou’s pressure sensors are fully capable of generating data that could be used in a variety of data analysis techniques, including generating a three-dimensional pressure map, if one desired to do so - note that the limitations of this claim are merely functional limitations and do not affect the structure of the claimed invention as the claim does not positively recite structure which receives, calculates, and outputs the data as a three-dimensional pressure map - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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]).
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”) (previously of record).
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]); an array of pressure sensors comprising three or more pressure sensors (see [0162]), a first pressure sensor (578) of the array of pressure sensors configured to be positioned near an inlet end of a prosthetic heart valve (see Fig. 21 and [0162]); and a second pressure sensor (578) of the array of pressure sensors 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]) wherein the array of pressure sensors are configured to measure a pressure gradient across the prosthetic heart valve (see [0162]) and is fully capable of providing data for use in generating a three-dimensional pressure map (Becerra’s pressure sensors are fully capable of generating data that could be used in a variety of data analysis techniques, including generating a three-dimensional pressure map, if one desired to do so - note that the limitations of this claim are merely functional limitations and do not affect the structure of the claimed invention as the claim does not positively recite structure which receives, calculates, and outputs the data as a three-dimensional pressure map - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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]).
Claim(s) 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”) (previously of record).
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) comprising an array of pressure sensors (see [0103]), a first pressure sensor (230, "P1", see Fig. 15 and [0103]) of the array of pressure sensors 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]) of the array of pressure sensors configured to be positioned near an outlet end of the prosthetic heart valve (see [0103] and Fig. 15), wherein the array of pressure sensors is positioned on the delivery apparatus and is configured to measure a pressure gradient across the prosthetic heart valve (see Fig. 15 and [0103]) and is fully capable of providing data for use in generating a three-dimensional pressure map (Glawdel’s pressure sensors are fully capable of generating data that could be used in a variety of data analysis techniques, including generating a three-dimensional pressure map, if one desired to do so - note that the limitations of this claim are merely functional limitations and do not affect the structure of the claimed invention as the claim does not positively recite structure which receives, calculates, and outputs the data as a three-dimensional pressure map - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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 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) 1, 4-5, 12-13, and 15-17 is is/are rejected under 35 U.S.C. 103 as being unpatentable over 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]); an array of pressure sensors comprising two pressure sensors (see [0103]), a first pressure sensor (230, "P1", see Fig. 15 and [0103]) of the array of pressure sensors 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]) of the array of pressure sensors 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 wherein the array of pressure sensors are configured to measure a pressure gradient across the prosthetic heart valve (see Fig. 15 and [0103]) and is fully capable of providing data for use in generating a three-dimensional pressure map (Glawdel’s pressure sensors are fully capable of generating data that could be used in a variety of data analysis techniques, including generating a three-dimensional pressure map, if one desired to do so - note that the limitations of this claim are merely functional limitations and do not affect the structure of the claimed invention as the claim does not positively recite structure which receives, calculates, and outputs the data as a three-dimensional pressure map - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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])
With respect to claim 1, Glawdel fails to specifically disclose wherein the array of pressure sensors comprises three or more pressure sensors. However, 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 Gladwel to include at least three (such as four) pressure sensors since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) and MPEP 2144.04(VI)(B). The claim does not recite any use of the third+ sensors as it only refers to the first and second sensors, therefore there is no new or unexpected result produced. One of ordinary skill would have found it obvious to duplicate the sensors on Gladwel’s device (for example, to provide redundancy in case a particular sensor failed or was obstructed from obtaining a proper measurement) with no new or unexpected result.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becerra in view of US 2001/0001812 A1 to Valley et al. (hereinafter “Valley”).
Becerra discloses the invention substantially as claimed as discussed above, including wherein the delivery apparatus comprises a radially expandable balloon (see [0206]), however, with respect to claim 22, Becerra fails to specifically disclose wherein the pressure sensors are disposed on the balloon, although Becerra does disclose that the pressure sensors can be positioned as desired on the delivery apparatus (see [0162]). Valley discloses, in the same field of endeavor of cardiovascular surgery, the known use of pressure sensors on balloons in order to measure a pressure differential across the balloon which might move the balloon upstream/downstream (see [0036]/[0139]/[0142]/[0228]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of combining prior art elements according to known methods to yield predictable results (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of a pair of pressure sensors disposed on the balloon of Becerra, since Becerra discloses that pressure sensors can be positioned as desired on the delivery apparatus which contains a balloon, and Valley teaches that pressure sensors on a balloon are known in the art, and therefore one of ordinary skill could have modified Becerra to have the pressure sensors on the balloon by known methods with the pressure sensors performing the same pressure measurement when disposed on the balloon or disposed on any other part of the delivery apparatus.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are merely conclusory, and do not persuasively establish how the claims differentiate from the cited art. With respect to the limitation “provide data for use in generating a three-dimensional map”; as set forth in the rejections above, the cited references are fully capable of providing data for use in generating a three-dimensional pressure map (the references’ pressure sensors are fully capable of generating data that could be used in a variety of data analysis techniques, including generating a three-dimensional pressure map, if one desired to do so - note that the limitations of this claim are merely functional limitations and do not affect the structure of the claimed invention as the claim does not positively recite structure which receives, calculates, and outputs the data as a three-dimensional pressure map - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art). Accordingly, Applicant’s arguments are not persuasive.
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 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
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