DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s Amendment filed March 20, 2026 (hereinafter “03/20/26 Amendment") has been entered, and fully considered. In the 03/20/26 Amendment, claims 1, 2, 7, 9-11, & 16 were amended, and claim 12 was cancelled. No claims were newly added. Therefore, claims 1-11 & 13-19 are now pending in the application.
3. The 03/20/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the Non-Final Office Action mailed 11/20/25 (“11/20/25 Action”).
4. The prior rejections under § 103 have been maintained.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Rejections - 35 USC § 103
6. 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.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
8. Claims 1-11 & 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0012307 to Harlev et al. ("Harlev") in view of U.S. Patent Application Publication No. 2019/0105466 to Schibli et al. ("Schibli").
9. Regarding claim 1, Harlev teaches a medical probe, comprising:
a hub [shaft (122) - ¶[0034]; FIG. 3A] comprising a distal end [coupler (367) - ¶[0040]; FIG. 3A] and a proximal end [proximal end of shaft (122) - FIG. 3A];
an expandable basket assembly [expandable portion (250) of tip section (124) - ¶¶ [0034], [0036]; FIGS. 3A, 13] comprising a proximal end [neck portion (357) - ¶[0040]], a distal end [distalmost portion (240) of tip section (124) - ¶[0036]; FIGS. 3A, 13], and extending along a longitudinal axis [longitudinal axis of deployment member (235) of tip section (124) - ¶[0036]; FIGS. 3A, 13], the expandable basket assembly [(250)/(124)] comprising:
a plurality of spines [broadly, an individual “spine” comprises an individual panel (750) which is formed by struts (751), (755), (757) as shown in FIG. 7A (reproduced below); see also ¶[0053]] connected to the distal end of the hub [¶[0056]] and extending along the longitudinal axis [FIG. 8D] and configured to bow radially outward [¶[0040]] from the longitudinal axis when the expandable basket assembly [(250)/(124)] is transitioned from a collapsed form [shown in FIG. 6A] to an expanded form [shown in FIG. 6B];
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FIG. 7A of HARLEV (Exemplary “Spine”)
a plurality of electrodes [sensors (826) - ¶¶ [0089], [0093] (“Each sensor 826 can act as an electrode (e.g., a surface electrode) to detect electrical activity of the heart in an area local to the sensor 826”); [0095], [0096]], each electrode [(826)] of the plurality of electrodes being respectively attached to a spine of the plurality of spines [see FIG. 8A & FIG. 8B (reproduced below) which shows a sensor (826) attached to a strut (751) of spline (750)];
one or more struts [(806)] respectively attached to at least one of the plurality of electrodes [NOTE: as broadly as claimed, and with reference to FIG. 8B and the excerpt of FIG. 13 of Harlev provided below, each electrode (826) is attached to a “lead” (806) in the form of a flexible printed circuit (see ¶[0091]) which can include, or form, a sensor (1326) to measure deformation (see also ¶[0113])]; and
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FIG. 8B OF HARLEV
EXCERPT OF FIG. 13 OF HARLEV
a… sensor [(1326)] attached to the distal end of the hub [shown in FIG. 13; see also ¶[0091]] and at least one of the plurality of struts [see ¶[0113] (“One or more of the electrical leads 806 illustrated in FIG. 13 include one or more additional sensors 1326 that are formed by and/or are positioned on the electrical leads 806…”)], the… sensor configured to detect deformation [¶[0113]].
“FORCE” SENSOR
As noted above, each strut (806) includes an associated sensor (1326) for detecting deformation thereof [see ¶[0113] (“the additional sensors 1326 can be used, for example, to form one or more electrograms and/or to measure electrical signals (e.g., voltage or impedance) to determine the shape (e.g., the extent of deployment, deformation, etc.) of the expandable portion 1150, etc”)].
Harlev does not, however, explicitly teach that the sensors (1326) comprise “force” sensors, and therefore fails to teach the following emphasized claim limitations:
a force sensor attached to the distal end of the hub and at least one of the one or more struts, the force sensor configured to detect a force applied to one or more electrodes of the plurality of electrodes via the one or more struts.
Schibli, in a similar field of endeavor, teaches that it was known in the art to use a strain gauge to measure strain on an object based on deformation of the object [see, e.g., ¶’s [0026], [0027]; note also that Applicant has defined a “strain gauge” as an example of a force sensor (see, e.g., claim 3 of the instant application)]. Schibli also teaches using one strain gauge for each electrode [see ¶[0027] (“The measured deformation or deflection can be used to detect a contact between the strain gauge and thereby the ring electrode and surrounding tissue and to calculate a contact force of the strain gauge and thereby the ring electrode when using the ring electrode for, for example, pulmonary vein ablation. This means, a contact or a contact force is not directly measured, but indirectly by means of a measurement of the deformation of the flexible catheter body caused by contact or contact pressure”)].
Given that Harlev already teaches that each strut (806) includes one or more sensors (1326) that are formed by and/or are positioned on the struts for detecting deformation [¶[0113]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harlev to utilize a known, art-recognized sensor for detecting deformation, such as a strain gauge force sensor, since such a modification amounts merely to the simple the substitution of one known deformation sensor for another, yielding only predictable results [measuring deformation] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). As modified, a strain gauge formed by and/or positioned on each strut (806) of Harlev would detect a force applied to its respective electrode (826) via deformation of the strut (806).
10. Regarding claim 2, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein each of the one or more struts [(806)] comprises a first width less than a second width of each of the plurality of spines [(750)] [compare the width of strut (806) in FIG. 13 to the overall width of spine (750) in FIG. 7A].
11. Regarding claim 3, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev was modified above (in the rejection of claim 1) to include the force sensor of Schibli, which comprises a strain gauge [Schibli, ¶[0026]].
12. Regarding claim 4, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein each spine [(750)] of the plurality of spines comprises nitinol [see ¶[0054]], cobalt chromium, stainless steel, titanium, or combinations thereof.
13. Regarding claim 5, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the plurality of spines is configured to form an approximately spherically-shaped basket assembly when in the expanded form [see, e.g., ¶[0040] (“the expandable portion 250 can have a different general shape (e.g., spherical, conical, cylindrical, hourglass, etc.)”)].
14. Regarding claim 6, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the plurality of spines is configured form an approximately oblate-spheroid basket assembly when in the expanded form [see, e.g., ¶[0040]; as broadly as claimed, a “spherical” shape is considered to be an approximately “oblate-spheroid” shape].
15. Regarding claim 7, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the hub [(122)] further comprises spray ports configured to deliver an irrigation fluid to the plurality of electrodes [deployment member (235), which extends through and from shaft (122), includes irrigation holes - see ¶’s [0046] & [0047] (“the deployment member 235 can include holes (not shown) spaced axially along and/or circumferentially about the deployment member 235 at the tip section 124 to deliver fluid to the treatment site from within the expandable portion 250”)].
16. Regarding claim 8, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches a plurality of electrically insulative jackets each disposed between a respective spine [(750)] of the plurality of spines and a respective electrode [(826)] of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines [see ¶¶ [0067]-[0069]].
17. Regarding claim 9, Harlev teaches a medical probe, comprising:
an expandable basket assembly [expandable portion (250) of tip section (124) - ¶¶ [0034], [0036]; FIGS. 3A, 13] comprising a proximal end [neck portion (357) - ¶[0040]], a distal end [distalmost portion (240) of tip section (124) - ¶[0036]; FIGS. 3A, 13], and extending along a longitudinal axis [longitudinal axis of deployment member (235) of tip section (124) - ¶[0036]; FIGS. 3A, 13], the expandable basket assembly [(250)/(124)] comprising:
a plurality of spines [broadly, an individual “spine” comprises an individual panel (750) which is formed by struts (751), (755), (757) as shown in FIG. 7A (reproduced below); see also ¶[0053]] extending along the longitudinal axis [FIG. 8D] and configured to bow radially outward [¶[0040]] from the longitudinal axis when the expandable basket assembly [(250)/(124)] is transitioned from a collapsed form [shown in FIG. 6A] to an expanded form [shown in FIG. 6B];
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FIG. 7A of HARLEV (Exemplary “Spine”)
a plurality of electrodes [sensors (826) - ¶¶ [0089], [0093] (“Each sensor 826 can act as an electrode (e.g., a surface electrode) to detect electrical activity of the heart in an area local to the sensor 826”); [0095], [0096]], each electrode [(826)] of the plurality of electrodes being respectively attached to a spine of the plurality of spines [see FIG. 8A & FIG. 8B (reproduced below) which shows a sensor (826) attached to a strut (751) of spline (750)];
one or more struts [(806)], each strut of the one or more struts being attached to a respective electrode of the plurality of electrodes [NOTE: as broadly as claimed, and with reference to FIG. 8B and the excerpt of FIG. 13 of Harlev provided below, each electrode (826) is attached to a “lead” (806) in the form of a flexible printed circuit (see ¶[0091]) which can include, or form, a sensor (1326) to measure deformation (see also ¶[0113])]; and
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FIG. 8B OF HARLEV
EXCERPT OF FIG. 13 OF HARLEV
one or more… sensors [(1326)] respectively attached to the one or more struts [(806)], each.. sensor [(1326)] configured to detect… deformation [see ¶[0113] (“One or more of the electrical leads 806 illustrated in FIG. 13 include one or more additional sensors 1326 that are formed by and/or are positioned on the electrical leads 806…”)], the… sensor configured to detect deformation [¶[0113]].
“FORCE” SENSOR
As noted above, each strut (806) includes an associated sensor (1326) for detecting deformation thereof [see ¶[0113] (“the additional sensors 1326 can be used, for example, to form one or more electrograms and/or to measure electrical signals (e.g., voltage or impedance) to determine the shape (e.g., the extent of deployment, deformation, etc.) of the expandable portion 1150, etc”)].
Harlev does not, however, explicitly teach that the sensors (1326) comprise “force” sensors, and therefore fails to teach the following emphasized claim limitations:
one or more force sensors respectively attached to the one or more struts, each force sensor configured to detect a force applied to the respective electrode attached thereto via the one or more struts.
Schibli, in a similar field of endeavor, teaches that it was known in the art to use a strain gauge to measure strain on an object based on deformation of the object [see, e.g., ¶’s [0026], [0027]; note also that Applicant has defined a “strain gauge” as an example of a force sensor (see, e.g., claim 10 of the instant application)]. Schibli also teaches using one strain gauge for each electrode [see ¶[0027] (“The measured deformation or deflection can be used to detect a contact between the strain gauge and thereby the ring electrode and surrounding tissue and to calculate a contact force of the strain gauge and thereby the ring electrode when using the ring electrode for, for example, pulmonary vein ablation. This means, a contact or a contact force is not directly measured, but indirectly by means of a measurement of the deformation of the flexible catheter body caused by contact or contact pressure”)].
Given that Harlev already teaches that each strut (806) includes one or more sensors (1326) that are formed by and/or are positioned on the struts for detecting deformation [¶[0113]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harlev to utilize a known, art-recognized sensor for detecting deformation, such as a strain gauge force sensor, since such a modification amounts merely to the simple the substitution of one known deformation sensor for another, yielding only predictable results [measuring deformation] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). As modified, a strain gauge formed by and/or positioned on each strut (806) of Harlev would detect a force applied to its respective electrode (826) via deformation of the strut (806).
18. Regarding claim 10, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev was modified above (in the rejection of claim 9) to include the force sensor of Schibli, which comprises a strain gauge [Schibli, ¶[0026]].
19. Regarding claim 11, the combination of Harlev and Schibli teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
The combination of Harlev and Schibli does not, however, teach:
wherein each strain gauge is attached to an inwardly-facing surface of its respective strut.
Harlev does, however, teach that the sensors (1326) that are formed by and/or are positioned on the struts (806) are done so such that the sensors (1326) remain within the interior of the expandable portion, and do not contact tissue when the expandable portion is in contact with tissue [see ¶[0113]].
In view of this teaching, it is the Examiner’s position that it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Harlev and Schibli to place each strain gauge [sensor (1326)] on whatever surface (inward or outward-facing) of the strut (806) was desired, since neither placement would interfere with any tissue contact given Harlev’s broader teaching that the sensors (1326) are positioned to remain within the interior of the expandable portion.
20. Regarding claim 13, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein each of the one or more struts comprise a biocompatible material selected from a group consisting essentially of nitinol [see ¶[0054]], cobalt chromium, stainless steel, titanium, or combinations thereof.
21. Regarding claim 14, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the plurality of spines is configured to form an approximately spherically-shaped basket assembly when in the expanded form [see, e.g., ¶[0040] (“the expandable portion 250 can have a different general shape (e.g., spherical, conical, cylindrical, hourglass, etc.)”)].
22. Regarding claim 15, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches wherein the plurality of spines is configured form an approximately oblate-spheroid basket assembly when in the expanded form [see, e.g., ¶[0040]; as broadly as claimed, a “spherical” shape is considered to be an approximately “oblate-spheroid” shape].
23. Regarding claim 16, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches a hub [shaft (122) - ¶[0034]; FIG. 3A] comprising spray ports configured to deliver an irrigation fluid to the plurality of electrodes [deployment member (235), which extends through and from shaft (122), includes irrigation holes - see ¶’s [0046] & [0047] (“the deployment member 235 can include holes (not shown) spaced axially along and/or circumferentially about the deployment member 235 at the tip section 124 to deliver fluid to the treatment site from within the expandable portion 250”)].
24. Regarding claim 17, the combination of Harlev and Schibli teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Harlev further teaches a plurality of electrically insulative jackets each disposed between a respective spine [(750)] of the plurality of spines and a respective electrode [(826)] of the plurality of electrodes, thereby electrically isolating the plurality of electrodes from the plurality of spines [see ¶¶ [0067]-[0069]].
25. Regarding claim 18, the combination of Harlev and Schibli teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action
Harlev further teaches:
a controller [interface unit (108), including processing unit (110) - ¶[0032]; FIG. 1] of a medical device, the controller configured to:
receive force data from one or more force sensors [(1326)] of the medical probe of claim 1 [see the rejection of claim 1 (above), which is incorporated herein, in which Harlev was modified to utilize the strain gauge force sensors of Schibli];
calculate a force applied to the one or more electrodes [(826)] based at least in part on the received force data [Schibli teaches calculating contact force - e.g., ¶’s [0027], [0030]]; and
output the calculated force to a connected display [graphical user interface (109) - ¶[0032]; NOTE that Harlev teaches displaying collected data, including data collected by the sensors on the struts (806) - see ¶’s [0032], [0110], [0147]].
26. Regarding claim 19, the combination of Harlev and Schibli teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Harlev (as modified) further teaches the controller configured to:
determine calculated force corresponds to tissue contact [Harlev, ¶’s [0095], [0098] (a force above the threshold)]; and
output a contact indication to the connected display when the controller determines the force corresponds to tissue contact [¶’s [0032], [0110], [0147]].
Response to Arguments
27. As noted above, the 03/20/26 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the 11/20/25 Action.
28. The prior rejections under § 103 based on the combination of Harlev and Schibli have been maintained.
29. The formulated rejection for each of independent claims 1 and 9 relies on lead (806) of Harlev, in the form of a flexible printed circuit (see ¶[0091]), as the claimed “strut.” In the Remarks, Applicant argues against the propriety of this interpretation as follows:
Harlev altogether fails to disclose "struts" and, therefore, cannot disclose a "force sensor configured to detect a force applied to one or more electrodes of the plurality of electrodes via the one or more struts" as required in Claim 1 (emphasis added). Rather, Harlev discloses "[t]he electrical leads 806 may comprise wires (e.g., insulated wires) or printed circuits (e.g., flexible printed circuits) or a combination thereof." See Harlev at paragraph [0091]. Harlev fails to disclose any mechanical properties of the electrical leads 806, which appear to be primarily for electrical communication and not force transmitting members which would be capable of transmitting a force applied to the one or more electrodes of the plurality of electrodes to be detected by a force sensor. Schibli discloses strain gauges which have "an electrical connection to the respective one of the ring electrodes 12 and are arranged in the proximity of the respective one of the ring electrodes 12." See Schibli at paragraph [0078].
03/20/26 Amendment, pg. 9, emphasis added.
30. Applicant’s argument is not persuasive. It is the Examiner’s position that the flexible printed circuit (806) of Harlev has at least some structural rigidity, and is therefore capable of providing at least some structural support, as broadly as currently claimed. It is additionally noted that Harlev explicitly teaches that the flexible printed circuit (806) itself may include, or form, a sensor (1326) to measure deformation [see ¶[0113], & the excerpt of FIG. 13 provided below].
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Excerpt of Fig. 13 Of Harlev highlighting lead (806) [flexible printed circuit]
including deformation sensor (1326)
The flexible printed circuit (806) of Harlev reads on Applicant’s “strut,” as broadly as currently claimed.
31. Next, concerning the modification of Harlev to utilize the strain gauge force sensor of Schibli, which is an example of a known, art-recognized sensor for detecting deformation, Applicant argues as follows:
Additionally, the Office Action neglects to note that if one of ordinary skill in the art was to substitute the strain gauge taught by Schibili (or any force sensor, for that matter) into Harlev one would replace the sensor 826, as Harlev provides a broad definition for its uses (see, Harlev at least at paragraph [0093]). However, the sensor 826 is identified in the Office Action as the claimed electrode and thus cannot be both elements at the same time, as the sensors 826 would be configured one way or the other.
03/20/26 Amendment, pg. 9.
32. This argument is without merit, as it ignores the formulated rejection. The rejection is not based on replacing the electrode (or sensor) (826) of Harlev with the strain gauge force sensor of Schibli, as Applicant contends. By contrast, the formulated rejection makes clear that the proposed modification is based on replacing the sensor (1326) on each strut [flexible printed circuit] (806) of Harlev that is used to measure deformation with a strain gauge - which Schibli establishes is a known, art-recognized sensor for measuring strain on an object based on deformation.
33. For the foregoing reasons, the combination of Harlev and Schibli renders independent claims 1 & 9 obvious under § 103. Applicant has failed to establish otherwise.
Conclusion
34. THIS ACTION IS MADE FINAL. 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 extension fee 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 date of this final action.
35. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
Prosecution Insights