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 .
Response to Amendment
Amendment filed 06/12/2025 has been entered. Claims 1, 9, and 18 have been amended. Claims 12-13 have been cancelled. Claims 21-22 have been added. Claims 1-11 and 14-22 are pending on the application.
Response to Arguments
Applicant's arguments filed 06/12/2025 have been fully considered but are not persuasive.
Applicant has amended the independent claims to specify that “the step of positioning the medical instrument to enter the vein occurring before entering the vein by moving the medical instrument including axially aligning the medical instrument to enter the vein”. Applicant argues that Olson (US 20190343578 A1) par [0074] which discloses “aligning a longitudinal axis of the ablation balloon with a second longitudinal axis of the pulmonary vein”, does not explicitly disclose aligning before entering the vein. However, Olson further discloses in Figs 2-3 and par [0044] that the catheter is oriented towards the ostium before entering the vein, and as such the step of alignment, even if accomplished by engaging with the ostium, occurs before entering the vein.
Applicant further argues that using a sum of squares minimization to find the best fit circle for determining the axis of a vein is nonobvious over the prior art of Otake (US 20190231291 A1). While Otake does not explicitly mention the mathematical expression used to calculate the best fit circle, sum of squares minimization is a common mathematical technique often used for vein and artery calculation (See for example, Raman (US 20050180621 A1) par [0024], Kinouchi (US 20060241427 A1) par [0041], and Silber (US 20090093703 A1) par [0090]). Furthermore, the instant Specification par [0027] discloses no criticality to the method of calculation, and suggests that any method of calculation may be used. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods disclosed by Otake to determine the axial alignment of the vein for proper positioning using the method disclosed by Olson, as this method of axial calculation for a blood vessel are known in the art to produce the expected result of finding a centerline of a tubular structure. Thus, applicant’s argument is not persuasive.
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.
Claims 1, 5-9, 13-16, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20190343578 A1) in view of Otake (US 20190231291 A1), and further in view of Hareland (US 20180064494 A1).
Regarding Claim 1, Olson discloses
A method for achieving an axial alignment of structural elements in an ablation procedure (Olson par [0009]), the method comprising:
a first structural element of a plurality of structural elements utilized in the procedure (Olson Fig 2 (214) par [0040]),
inserting a medical instrument into a patient (Olson Fig 1 par [0037]), the medical instrument including a shaft having a magnetic location sensor (Olson Fig 1 shaft (124) par [0034] magnetic location sensor);
a second structural element of the plurality of structural elements utilized in the procedure including a portion that is used to perform the ablation procedure (Olson Fig 2 (231) par [0042]),
positioning the medical instrument to enter the vein by moving the medical instrument, the step of positioning the medical instrument to enter the vein occurring before entering the vein by moving the medical instrument including axially aligning the medical instrument to enter the vein by aligning the determined axis of the first structural element with the determined axis of the second structural element (Olson Fig 2-3 show alignment then entering; par [0044] catheter is oriented towards ostium before entering the vein; par [0074] aligning a longitudinal axis of the ablation balloon with a second longitudinal axis of the pulmonary vein).
Olson fails to explicitly disclose
determining the axis of the first structural element by determining a plurality of best-fit circles of a plurality of cross-sections on a vein and connecting center points of each of the plurality of best-fit circles;
determining the axis of the second structural element by finding a vector connecting the magnetic location sensor at the shaft of the medical instrument and a center of the portion of the second structural element, the second structural element comprising the medical instrument.
However, Otake discloses a method of determining the axis of a blood vessel by determining a plurality of best-fit circles of a plurality of cross-sections and connecting center points of each of the plurality of best-fit circles (Otake par [0074] The center line of the blood vessel is derived by calculating center points of the blood cross sectional data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods disclosed by Otake to determine the axial alignment of the vein for proper positioning using the method disclosed by Olson, as this method of axial calculation for a blood vessel are known in the art to produce the expected result of finding a centerline of a tubular structure (Otake par [0074]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Furthermore, Hareland discloses a method of aligning the axis of a catheter and an ostium of interest (Hareland par [0007]) comprising determining the axis of the second structural element by finding a vector connecting the magnetic location sensor at the shaft of the medical instrument and a center of the portion of the second structural element, the second structural element comprising the medical instrument (Hareland, Fig 1 location sensor (38a) at shaft (22) used to find axis (24) which goes through center of treatment portion (34), the vector used to determine the axis from 40a to 40b must go through the center of the treatment portion 34 of the device, par [0039] location sensor may be magnetic).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods and the magnetic positioning of Hareland to determine the axial alignment of the medical instrument for proper positioning using the method disclosed by Olson in view of Otake, as these methods of axial calculation are known in the art to produce the expected result of finding an axis of the tool being used in a procedure using magnetic positioning sensors commonly used in the art (Hareland par [0039]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Regarding Claim 5, Olson in view of Otake and Hareland discloses the method of claim 1. Olson further discloses the first structural element comprising an ostium (Olson, Fig 2 ostium (214), par [0040]).
Regarding Claims 6-8, Olson in view of Otake and Hareland discloses the method of claim 1. Olson further discloses the second structural element comprising a surgical tool, a catheter, and a balloon catheter (Olson, Fig 2 balloon catheter (231), par [0040]).
Regarding Claim 9, Olson discloses
A method to assist in a robotic procedure for achieving an axial alignment between structural elements in an ablation procedure (Olson par [0009], par [0036] catheter may be robotically driven), the method comprising:
a first structural element of a plurality of structural elements utilized in the procedure (Olson Fig 2 (214) par [0040]),
inserting a second structural element of the plurality of structural elements into a patient (Olson Fig 1-2 par [0037]), the second structural element including a medical instrument having a shaft with a magnetic location sensor (Olson Fig 1 shaft (124) par [0034] magnetic location sensor);
and moving the medical instrument to enter the vein, the step of moving the medical instrument to enter the vein including axially aligning the medical instrument to the vein by aligning the determined axis of the first structural element with the determined axis of the second structural element by controlling the second structural element for automatic alignment of the determined axis of the first structural element and the determined axis of the second structural element (Olson par [0074] aligning a longitudinal axis of the ablation balloon with a second longitudinal axis of the pulmonary vein).
Olson fails to explicitly disclose
determining an axis of the first structural element by determining a plurality of best-fit circles of a plurality of cross-sections on a vein and connecting center points of each of the plurality of best-fit circles;
determining an axis of the second structural element by finding a vector connecting the magnetic location sensor at the shaft of the medical instrument and a center of the portion of the second structural element, the second structural element comprising the medical instrument.
However, Otake discloses a method of determining an axis of a blood vessel by determining a plurality of best-fit circles of a plurality of cross-sections and connecting center points of each of the plurality of best-fit circles (Otake par [0074] The center line of the blood vessel is derived by calculating center points of the blood cross sectional data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods disclosed by Otake to determine the axial alignment of the vein for proper positioning using the method disclosed by Olson, as this method of axial calculation for a blood vessel are known in the art to produce the expected result of finding a centerline of a tubular structure (Otake par [0074]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Furthermore, Hareland discloses a method of aligning the axis of a catheter and an ostium of interest (Hareland par [0007]) comprising determining the axis of the second structural element by finding a vector connecting the magnetic location sensor at the shaft of the medical instrument and a center of the portion of the second structural element, the second structural element comprising the medical instrument (Hareland, Fig 1 location sensor (38a) at shaft (22) used to find axis (24) which goes through center of treatment portion (34), the vector used to determine the axis from 40a to 40b must go through the center of the treatment portion 34 of the device, par [0039] location sensor may be magnetic).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods and the magnetic positioning of Hareland to determine the axial alignment of the medical instrument for proper positioning using the method disclosed by Olson in view of Otake, as these methods of axial calculation are known in the art to produce the expected result of finding an axis of the tool being used in a procedure using magnetic positioning sensors commonly used in the art (Hareland par [0039]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Regarding Claims 14-16, Olson in view of Otake and Hareland discloses the method of claim 9. Olson further discloses the second structural element comprising a surgical tool, a catheter, and a balloon catheter (Olson, Fig 2 balloon catheter (231), par [0040]).
Regarding Claim 18, Olson discloses
A method to assist in a robotic procedure for achieving a preferred alignment between structural elements in an ablation procedure (Olson par [0009], par [0036] catheter may be robotically driven), the method comprising:
a first structural element of a plurality of structural elements utilized in the procedure (Olson Fig 2 (214) par [0040]),
inserting a medical instrument into a patient (Olson Fig 1-2 par [0037]), the medical instrument including a shaft having a magnetic location sensor (Olson Fig 1 shaft (124) par [0034] magnetic location sensor) and a second structural element of the plurality of structural elements (Olson Fig 2 (231) par [0042]);
and controlling the medical instrument to position the medical instrument such that the determined axis of the first structural element is colinear with the determined axis of the second structural element (Olson par [0074] aligning a longitudinal axis of the ablation balloon with a second longitudinal axis of the pulmonary vein).
Olson fails to explicitly disclose
determining the axis of the first structural element by determining a plurality of best-fit circles of a plurality of cross-sections on a vein and connecting center points of each of the plurality of best-fit circles;
determining the axis of the second structural element of the plurality of structural elements utilized in the procedure including a portion that is used to perform the ablation procedure, the axis being determined by finding a vector connecting the magnetic location sensor at the shaft of the second structural element and a center of a best fit circle of the portion of the second structural element, the best fit circle being based on minimizing a sum of squares of distances between a section of the medical instrument to closest points of the best fit circle.
However, Otake discloses a method of determining the axis of a blood vessel by determining a plurality of best-fit circles of a plurality of cross-sections and connecting center points of each of the plurality of best-fit circles (Otake par [0074] The center line of the blood vessel is derived by calculating center points of the blood cross sectional data). While Otake does not explicitly mention the mathematical expression used to calculate the best fit circle, sum of squares minimization is a common mathematical technique often used for vein and artery calculation (See for example, Raman (US 20050180621 A1) par [0024], Kinouchi (US 20060241427 A1) par [0041], and Silber (US 20090093703 A1) par [0090]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used well-known calculation methods in addition to those disclosed by Otake to determine the axial alignment of the vein for proper positioning using the method disclosed by Olson, as this method of axial calculation for a blood vessel are known in the art to produce the expected result of finding a centerline of a tubular structure (Otake par [0074]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Furthermore, Hareland discloses a method of aligning the axis of a catheter and an ostium of interest (Hareland par [0007]) comprising determining the axis of the second structural element by finding a vector connecting the magnetic location sensor at the shaft of the medical instrument and a center of the portion of the second structural element, the second structural element comprising the medical instrument (Hareland, Fig 1 location sensor (38a) at shaft (22) used to find axis (24) which goes through center of treatment portion (34), the vector used to determine the axis from 40a to 40b must go through the center of the treatment portion 34 of the device, par [0039] location sensor may be magnetic).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the calculation methods and the magnetic positioning of Hareland to determine the axial alignment of the medical instrument for proper positioning using the method disclosed by Olson in view of Otake, as these methods of axial calculation are known in the art to produce the expected result of finding an axis of the tool being used in a procedure using magnetic positioning sensors commonly used in the art (Hareland par [0039]), and furthermore, Olson explicitly mentions that “During cardiac ablation therapy, it is desirable to align the centerline of ablation balloon 130 with a centerline of an antral and/or proximal ostia of a pulmonary vein in which the ablation therapy is to take place” (Olson par [0039]).
Regarding claim 22, Olson in view of Otake and Hareland discloses the method of claim 1. Olson does not explicitly disclose the step of moving the medical instrument to enter the vein further including optimizing the movement of the medical instrument to thereby minimize a number of maneuvers to enter the vein.
However, Olson does disclose that precise positioning is required for optimum results (Olson par [0029]). Furthermore, the instant Specification (par [0041-0042]) does not give detail on the manner of optimization of movement. Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to perform routine optimization of the movement of the disclosure of Olson, in order to find the optimal positioning and maneuvering required for alignment (See MPEP 2144.05).
Claims 2-4, 10-12, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20190343578 A1) in view of Otake (US 20190231291 A1), and Hareland (US 20180064494 A1), and further in view of Mintz (US 20190000576 A1).
Regarding claim 2, Olson in view of Otake and Hareland discloses the method of claim 1.
Olson in view of Otake and Hareland fails to explicitly disclose determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element.
However, Mintz discloses determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element (Mintz, par [0021] instrument driver (second structural element) and second instrument driver (third structural element) are aligned along the axis of the first structural element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the third structural element alignment of the disclosure of Mintz with the method of Olson in view of Otake and Hareland, as aligning a third structural element allows for improved control of minimally invasive procedures (Mintz, par [0065-0066]).
Regarding claims 3-4, Olson in view of Otake and Hareland and Mintz discloses the method of claim 2. Olson further discloses a sheath of a catheter (Olson par [0037]).
Regarding claim 10, Olson in view of Otake and Hareland discloses the method of claim 9.
Olson in view of Otake and Hareland fails to explicitly disclose determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element.
However, Mintz discloses determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element (Mintz, par [0021] instrument driver (second structural element) and second instrument driver (third structural element) are aligned along the axis of the first structural element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the third structural element alignment of the disclosure of Mintz with the method of Olson in view of Otake and Hareland, as aligning a third structural element allows for improved control of minimally invasive procedures (Mintz, par [0065-0066]).
Regarding claims 11-12, Olson in view of Otake and Hareland and Mintz discloses the method of claim 10. Olson further discloses a sheath of a catheter (Olson par [0037]).
Regarding claim 17, Olson in view of Otake and Hareland and Mintz discloses the method of claim 10. Olson further discloses a deflectable catheter and deflectable sheath (Olson Fig 1-2 par [0038] catheter and sheath both guided through peripheral vein, which is only possible if they are deflectable).
Regarding claim 19, Olson in view of Otake and Hareland discloses the method of claim 18.
Olson in view of Otake and Hareland and Viswanathan fails to explicitly disclose determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element.
However, Mintz discloses determining the axis of a third structural element of the plurality of elements utilized in the procedure and aligning the determined axis of the third structural element with the aligned axis of the first structural element and the aligned axis of the second structural element (Mintz, par [0021] instrument driver (second structural element) and second instrument driver (third structural element) are aligned along the axis of the first structural element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the third structural element alignment of the disclosure of Mintz with the method of Olson in view of Otake and Hareland and Viswanathan, as aligning a third structural element allows for improved control of minimally invasive procedures (Mintz, par [0065-0066]).
Regarding claim 20, Olson in view of Otake and Hareland and Mintz discloses the method of claim 19. Olson further discloses a deflectable catheter and deflectable sheath (Olson Fig 1-2 par [0038] catheter and sheath both guided through peripheral vein, which is only possible if they are deflectable).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Olson (US 20190343578 A1) in view of Otake (US 20190231291 A1), and Hareland (US 20180064494 A1), and further in view of Oezbek (US 20200085511 A1).
Regarding claim 21, Olson in view of Otake and Hareland discloses the method of claim 1. Olson fails to explicitly disclose presenting an angle between the axis of the first structural element and the axis of a second structural element onto a display.
However, Oezbek discloses a method of aligning a surgical instrument (Oezbek par [0028]) including displays an angle between structural elements (Oezbek Fig 5 (310) par [0060;0083] method of aligning includes displaying angle between elements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Olson to display an angle between the elements of interest, as display of such information allows for describing deviation from a target trajectory (Oezbek par [0083]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tegg (US 20200085483 A1) discloses similar methods of alignment for medical devices.
Barrish (US 20180263688 A1) discloses aligning a medical device with an opening of the heart (Barrish par [0147] Fig 36A-C).
Warren (US 10022069 B2) Displays an angle between elements (Fig 8 (67,68) displays angle between two elements, col 7 line 63-66)
Fredrickson (US 20200198147 A1) discloses methods of alignment for medical devices. Wiemker (US 20200320684 A1) discloses using successive weighted centroids to plot successive points along a capillary. Richter (US 20150119966 A1) discloses calculating the centroid path of veins. Konstorum (US 20150087907 A1) discloses a method for using center points for aligning a sheath with a catheter. Ditter (US 20160143689 A1) discloses methods for aligning a vein, a catheter, and a sheath. Li (US 20200357162 A1) discloses connecting center points of cross sections of a vein or artery.
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.
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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794