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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 8 and 16, the claim limitation “a hypothetical transvalvular flow for a normal artic valve” in claims 1, 8 and 16 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification discloses transvalvular flow (see par. [0052], [0053]) of the Pg Pub. version of the specification), but does not explicitly disclose a hypothetical transvalvular flow.
Claims 2-7, 9-15 and 17-20 are rejected as they depend from rejected claims 1, 8 and 16.
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.
Claims 1-20 are 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.
Regarding claims 1, 8 and 16, the claim limitation “a hypothetical transvalvular flow” in the claim is indefinite because it is unclear what is meant by the a hypothetical transvalvular flow and how it is defined by a value. The specification does not disclose “a hypothetical transvalvular flow”, therefor it is unclear what is meant by a hypothetical transvalvular flow.
Furthermore, for claims 1, 8 and 16, the claims “(TVFAS/TVFnormal)” and “(Ao/LV)” are indefinite because these limitations are withing parenthesis and it is unclear if the limitations within the parenthesis are part of the claims and further limit the claims.
Claims 2-7, 9-15 and 17-20 are rejected as they depend from rejected claims 1, 8 and 16.
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.
Claims 1, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877).
Regarding claim 1, Burwash discloses a flow dependence of measured of aortic stenosis severity during exercise. Burwash shows a method for characterizing cardiac aortic valve function (see abstract): comprising: acquiring baseline measurements of cardiac activity (see right column on page 1343, and “results” on page 1344); increasing cardiac stress (see right column on page 1343); acquiring additional measurements of cardiac activity with increased cardiac stress (see right column on page 1343); and computing a stress aortic valve index value for an aortic valve (see right column on page 1343, and “results” on page 1344), wherein the SAVI quantifies transvalvular flow for the aortic valve (see “result” on page 1344).
As stated above that Burwash shows increasing cardiac stress using exercise stress test (see right column on page 1343), and typically an exercise stress test would increase cardiac contract force, but Burwash does not explicit state that the exercise stress test does increase cardiac contract force. Furthermore, Burwash fails to explicitly state that the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress.
Fortuin discloses an exercise stress testing and states that the exercise stress test does increase cardiac contract force (see “exercise physiology” on page 699).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of that the exercise stress test does increase cardiac contract force in the invention of Burwash, as taught by Fortuin, to be able determine whether the coronary circulation can increase oxygen delivery to the myocardium in the response to increase demands and assess exercise capacity.
But, Burwash and Fortuin fail to explicitly state that the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress.
Taylor discloses method and system for quantifying limitations of coronary artery blood flow during physical activity. As best understood of the indefinite language, Taylor teaches the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve (see fig. 9-11; par. [0172]) and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress (see fig. 9-11 and par. [0172]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to provide additional information to determine the severity of aortic stenosis.
Regarding claim 4, Burwash shows positioning a non-invasive imaging system for cardiac imaging (see “method” on page 1343, and “results” on page 1344); and acquiring the baseline measurements and the additional measurements using the non invasive imaging system (see “method” on page 1343, and “results” on page 1344).
Regarding claim 6, Burwash shows wherein increasing cardiac stress comprises administering exercise (see right column on page 1343).
Regarding claim 7, Burwash and Fortuin disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state that the stress aortic valve index value as a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress.
Taylor teaches a similar method of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress (see par. [0006], [0119], [0172], [0150]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to predict and diagnosis the patient and determine whether a lesion is functionally significant and whether to treat the lesion.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877) as applied to claim 1 above, and further in view of Hou et al. (US 2013/0274618; hereinafter Hou).
Regarding claim 2, Burwash, Fortuin and Taylor discloses the invention substantially as disclosed in the 103 rejection above, furthermore, Burwash shows acquiring the baseline measurement (see right column on page 1343, and “results” on page 1344) and the additional measurements (see right column on page 1343, and “results” on page 1344), but fails to explicitly state inserting a coronary pressure wire in a left ventricle; and acquiring measurements using the coronary pressure wire.
Hou discloses a guidewire system for use in transcatheter aortic valve implantation procedure. Hou teaches inserting a coronary pressure wire in a left ventricle (see par. [0073]; and acquiring measurements using the coronary pressure wire (see par. [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized inserting a coronary pressure wire in a left ventricle; and acquiring measurements using the coronary pressure wire in the invention of Burwash, Fortuin and Taylor, as taught by Hou, to be able to measure or determine the blood pressure gradient prior to performing a TAVI procedure.
Regarding claim 3, Burwash, Fortuin and Taylor disclose the invention substantially as disclosed in the 103 rejection above, furthermore, Burwash shows acquiring the baseline measurement (see right column on page 1343, and “results” on page 1344) and the additional measurements (see right column on page 1343, and “results” on page 1344), but fails to explicitly state inserting a coronary pressure wire in an ascending aorta.
Hou discloses a guidewire system for use in transcatheter aortic valve implantation procedure. Hou teaches inserting a coronary pressure wire in an ascending aorta (see par. [0073]; and acquiring measurements using the coronary pressure wire (see par. [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized inserting a coronary pressure wire in an ascending aorta; and acquiring measurements using the coronary pressure wire in the invention of Burwash, Fortuin and Taylor, as taught by Hou, to be able to measure or determine the blood pressure gradient prior to performing a TAVI procedure.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of in view of Taylor (US 2016/0070877) as applied to claim 1 above and further in view of Mansi et al. (US2016/0220311).
Regarding claim 5, Burwash, Fortuin and Taylor disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state transthoracic echocardiogram.
Mansi teaches using transthoracic echocardiogram. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of transthoracic echocardiogram in the invention of Burwash, Fortuin and Taylor, as taught by Mansi, to be able to provide a in depth 3D or 4D image of the heart.
Claims 8, 11, 13-15, 16-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877), in view of Ben-Dor et al. (“Coronary blood flow in patients with severe aortic stenosis before and after transcatheter aortic valve implantation”; the American Journal of Cardiology; volume 114; hereinafter Ben-Dor).
Regarding claim 8, Burwash discloses a flow dependence of measured of aortic stenosis severity during exercise. Burwash shows a method for characterizing cardiac aortic valve function (see abstract): comprising: acquiring baseline measurements of cardiac activity (see right column on page 1343, and “results” on page 1344); increasing cardiac stress (see right column on page 1343); acquiring additional measurements of cardiac activity with increased cardiac stress (see right column on page 1343); and computing a stress aortic valve index value for an aortic valve (see right column on page 1343, and “results” on page 1344), wherein the SAVI quantifies transvalvular flow for the aortic valve (see “results” on page 1344 ).
As stated above that Burwash shows increasing cardiac stress using exercise stress test (see right column on page 1343), and typically an exercise stress test would increase cardiac contract force, but Burwash does not explicit state that the exercise stress test does increase cardiac contract force, that the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress, and recommends implanting transcatheter aortic valve implantation and transcatheter aortic valve implantation.
Fortuin discloses an exercise stress testing and states that the exercise stress test does increase cardiac contract force (see “exercise physiology” on page 699).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of that the exercise stress test does increase cardiac contract force in the invention of Burwash, as taught by Fortuin, to be able determine whether the coronary circulation can increase oxygen delivery to the myocardium in the response to increase demands and assess exercise capacity.
But, Burwash and Fortuin fail to explicitly state that the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress, and recommends implanting transcatheter aortic valve implantation and transcatheter aortic valve implantation.
Taylor discloses method and system for quantifying limitations of coronary artery blood flow during physical activity. As best understood of the indefinite language, Taylor teaches the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve (see fig. 9-11; par. [0172]) and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress (see fig. 9-11 and par. [0172]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to provide additional information to determine the severity of aortic stenosis.
But, Burwash, Fortuin and Taylor fail to explicitly recommends implanting transcatheter aortic valve implantation and transcatheter aortic valve implantation.
Ben-Dor discloses coronary blood flow before and after transcatheter aortic valve implantation. Ben-Dor teaches recommending recommends implanting transcatheter aortic valve implantation (see abstract and discussion), transcatheter aortic valve implantation (see abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of transcatheter aortic valve implantation in the invention of Burwash, Fortuin and Taylor, as taught by Ben-Doe, to improve coronary blood flow.
Regarding claim 11, Burwash shows positioning a non-invasive imaging system for cardiac imaging (see “method” on page 1343, and “results” on page 1344); and acquiring the baseline measurements and the additional measurements using the non invasive imaging system (see “method” on page 1343, and “results” on page 1344).
Regarding claim 13, Burwash shows wherein increasing cardiac stress comprises administering exercise (see right column on page 1343).
Regarding claim 14, Burwash and Fortuin disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state that the stress aortic valve index value as a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress.
Taylor teaches a similar method of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress (see par. [0006], [0119], [0172], [0150]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to predict and diagnosis the patient and determine whether a lesion is functionally significant and whether to treat the lesion.
Regarding claim 15, Burwash, Fortuin, Taylor and Ben-Dor disclose the invention substantially as described in the 103 rejection, furthermore, combined invention of Burwash, Fortuin and Ben-Dor suggest transcatheter aortic valve implantation at sever stenosis, but furthermore Taylor teaches that the stress aortic valve index value is less than 0.7 ( see fig. 11). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of the stress aortic valve index value is less than 0.7 in the invention of Burwash and Fortuin, as taught by Taylor, to be able to provide additional information to determine the severity of aortic stenosis.
Regarding claim 16, Burwash discloses a flow dependence of measured of aortic stenosis severity during exercise. Burwash shows a method for characterizing cardiac aortic valve function (see abstract): comprising: acquiring baseline measurements of cardiac activity (see right column on page 1343, and “results” on page 1344); increasing cardiac stress (see right column on page 1343); acquiring additional measurements of cardiac activity with increased cardiac stress (see right column on page 1343); and computing a stress aortic valve index value (see right column on page 1343, and “results” on page 1344), wherein the SAVI quantifies a transvalvular flow for the aortic valve see “results” on page 1344).
As stated above that Burwash shows increasing cardiac stress using exercise stress test (see right column on page 1343), and typically an exercise stress test would increase cardiac contract force, but Burwash does not explicit state that the exercise stress test does increase cardiac contract force, the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, transcatheter aortic valve implantation, and comparing the computed stress aortic valve index value to a predetermined stress aortic valve index value to assess the effectiveness of the transcatheter aortic valve implantation.
Fortuin discloses an exercise stress testing and states that the exercise stress test does increase cardiac contract force (see “exercise physiology” on page 699).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of that the exercise stress test does increase cardiac contract force in the invention of Burwash, as taught by Fortuin, to be able determine whether the coronary circulation can increase oxygen delivery to the myocardium in the response to increase demands and assess exercise capacity.
Burwash and Fortuin fail to explicitly state that the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, transcatheter aortic valve implantation, and comparing the computed stress aortic valve index value to a predetermined stress aortic valve index value to assess the effectiveness of the transcatheter aortic valve implantation.
Taylor discloses method and system for quantifying limitations of coronary artery blood flow during physical activity. As best understood of the indefinite language, Taylor teaches the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve (see fig. 9-11; par. [0172]) and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress (see fig. 9-11 and par. [0172]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claim invention, to have utilized the teaching of the SAVI quantifies a relative reduction in between a measured transvalvular flow for the aortic valve and a hypothetical transvalvular flow for a normal aortic valve, and wherein the SAVI is calculated by aortic pressure and left ventricular pressure after increasing cardiac stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to provide additional information to determine the severity of aortic stenosis.
Burwash, Fortuin and Taylor fail to explicitly transcatheter aortic valve implantation, and comparing the computed stress aortic valve index value to a predetermined stress aortic valve index value to assess the effectiveness of the transcatheter aortic valve implantation.
Ben-Dor discloses coronary blood flow before and after transcatheter aortic valve implantation. Ben-Dor teaches transcatheter aortic valve implantation (see abstract), comparing the computed stress aortic valve index value to a predetermined stress aortic valve index value to assess the effectiveness of the transcatheter aortic valve implantation (see abstract; method, Fig. 1 and table 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of transcatheter aortic valve implantation, and comparing the computed stress aortic valve index value to a predetermined stress aortic valve index value to assess the effectiveness of the transcatheter aortic valve implantation in the invention of Burwash, Fortuin and Taylor, as taught by Ben-Doe, to improve coronary blood flow, and the verify the improvement of the blood flow after TAVI.
Regarding claim 17, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially as described in the 103 rejection above, furthermore Ben-Dor teaches the predetermined stress aortic valve index value comprises a stress aortic valve index value computed based on baseline measurements and additional measurements acquired prior to the transcatheter aortic valve implantation (see abstract; method, Fig. 1 and table 1).
Regarding claim 20, Burwash and Fortuin, disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state that the stress aortic valve index value as a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress.
Taylor teaches a similar method of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress based on baseline measurements and additional measurements (see par. [0006], [0119], [0172], [0150]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of a unitless mean ratio of aortic to left ventricular systolic ejection pressure during stress in the invention of Burwash and Fortuin, as taught by Taylor, to be able to predict and diagnosis the patient and determine whether a lesion is functionally significant and whether to treat the lesion.
Ben-Dor discloses coronary blood flow before and after transcatheter aortic valve implantation. Ben-Dor teaches computing a prosthetic resistance of the transcatheter aortic valve implant as a slope of a pressure loss versus flow curve computed based on baseline measurements and additional measurements (see page 1265-1267).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of computing a prosthetic resistance of the transcatheter aortic valve implant as a slope of a pressure loss versus flow curve computed based on baseline measurements and additional measurements in the invention of Burwash, Fortuin and Taylor, as taught by Ben-Doe, to improve coronary blood flow and verify the effeteness of transcatheter.
Claims 9, 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877), in view of Ben-Dor et al. (“Coronary blood flow in patients with severe aortic stenosis before and after transcatheter aortic valve implantation”; the American Journal of Cardiology; volume 114; hereinafter Ben-Dor) as applied to claims 8 and 16 above, and further in view of Hou et al. (US 2013/0274618; hereinafter Hou).
Regarding claim 9, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially as disclosed in the 103 rejection above, furthermore, Burwash shows acquiring the baseline measurement (see right column on page 1343, and “results” on page 1344) and the additional measurements (see right column on page 1343, and “results” on page 1344), but fails to explicitly state inserting a coronary pressure wire in a left ventricle; and acquiring measurements using the coronary pressure wire.
Hou discloses a guidewire system for use in transcatheter aortic valve implantation procedure. Hou teaches inserting a coronary pressure wire in a left ventricle (see par. [0073]; and acquiring measurements using the coronary pressure wire (see par. [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized inserting a coronary pressure wire in a left ventricle; and acquiring measurements using the coronary pressure wire in the invention of Burwash, Fortuin, Taylor, and Ben-Dor, as taught by Hou, to be able to measure or determine the blood pressure gradient prior to performing a TAVI procedure.
Regarding claim 10, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially as disclosed in the 103 rejection above, furthermore, Burwash shows acquiring the baseline measurement (see right column on page 1343, and “results” on page 1344) and the additional measurements (see right column on page 1343, and “results” on page 1344), but fails to explicitly state inserting a coronary pressure wire in an ascending aorta.
Hou discloses a guidewire system for use in transcatheter aortic valve implantation procedure. Hou teaches inserting a coronary pressure wire in an ascending aorta (see par. [0073]; and acquiring measurements using the coronary pressure wire (see par. [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized inserting a coronary pressure wire in an ascending aorta; and acquiring measurements using the coronary pressure wire in the invention of Burwash, Fortuin, Taylor, and Ben-Dor, as taught by Hou, to be able to measure or determine the blood pressure gradient prior to performing a TAVI procedure.
Regarding claim 18, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially as disclosed in the 103 rejection above, furthermore, Burwash shows acquiring the baseline measurement (see right column on page 1343, and “results” on page 1344) and the additional measurements (see right column on page 1343, and “results” on page 1344), fails to explicitly state inserting a coronary pressure wire in a left ventricle; and inserting second coronary pressure wire in an ascending aorta.
Hou discloses a guidewire system for use in transcatheter aortic valve implantation procedure. Hou teaches inserting a coronary pressure wire in a left ventricle (see par. [0073], inserting a second coronary pressure wire in an ascending aorta (see par. [0073], and acquiring measurements using the coronary pressure wire (see par. [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized inserting a coronary pressure wire in a left ventricle; inserting a second coronary pressure wire in an ascending aorta, and acquiring measurements using the coronary pressure wire in the invention of Burwash, Fortuin, Taylor, and Ben-Dor, as taught by Hou, to be able to measure or determine the blood pressure gradient prior to performing a TAVI procedure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877), in view of Ben-Dor et al. (“Coronary blood flow in patients with severe aortic stenosis before and after transcatheter aortic valve implantation”; the American Journal of Cardiology; volume 114; hereinafter Ben-Dor) as applied to claims 8 and 11 above, and further in view of Mansi et al. (US2016/0220311).
Regarding claim 12, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially described the 103 invention above, but fails to explicitly state transthoracic echocardiogram.
Mansi teaches using transthoracic echocardiogram. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of transthoracic echocardiogram in the invention of Burwash, Fortuin, Taylor, and Ben-Dor, as taught by Mansi, to be able to provide a in depth 3D or 4D image of the heart.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Burwash et al. (“Flow Dependence of Measures of Aortic Stenosis Severity During Exercise; JACC Vol. 24, NO. 5, November 1, 1994; hereinafter Burwash), in view of Fortuin et al. (“Exercise Stress Testing”; Circulation, Volume 56, No 5, November 1977; hereinafter Fortuin), in view of Taylor (US 2016/0070877), in view of Ben-Dor et al. (“Coronary blood flow in patients with severe aortic stenosis before and after transcatheter aortic valve implantation”; the American Journal of Cardiology; volume 114; hereinafter Ben-Dor) as applied to claims 16 above, and further in view of Mansi et al. (US2016/0220311).
Regarding claim 19, Burwash, Fortuin, Taylor, and Ben-Dor disclose the invention substantially described the 103 invention above, furthermore, Burwash shows positioning a non-invasive imaging system for cardiac imaging (see “method” on page 1343, and “results” on page 1344); and acquiring the baseline measurements and the additional measurements using the non invasive imaging system (see “method” on page 1343, and “results” on page 1344), but fails to explicitly state transthoracic echocardiogram.
Mansi teaches using transthoracic echocardiogram. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of transthoracic echocardiogram in the invention of Burwash, Fortuin, Taylor, and Ben-Dor, as taught by Mansi, to be able to provide a in depth 3D or 4D image of the heart.
Response to Arguments
The previous rejection under 35 USC 112 (a) to claims 1-20 has been withdrawn in view of amendments to the claims 1, 8 and 16.
Applicant’s arguments filed on 07/24/2025 with respect to prior art rejection have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior office action of record for any teaching or matter specifically challenged in the argument. The examiner has provided new prior art Taylor for independent claims 1, 8 and 16.
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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