DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. Applicant’s Amendment filed June 26, 2026 (“06/26/26 Amendment") has been entered, and fully considered. In the 06/26/26 Amendment, claims 1, 16, & 19 were amended. No claims were cancelled, or newly added. Therefore, claims 1-20 remain pending in the application.
3. The 06/26/26 Amendment has overcome the rejections under § 102 previously set forth in the Non-Final Office Action mailed 03/27/26 (“03/27/26 Action”), as well as the non-statutory double patenting rejections.
4. New rejections under § 102 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
6. Claims 1-20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by U.S. Patent Application Publication No. 2013/0006238 to Ditter et al. (“Ditter”) [made of record in Applicant’s 01/20/26 IDS].
7. Regarding claim 1, Ditter discloses a medical device comprising:
a handle assembly [control handle (16) - ¶[0050]; FIG. 1];
an elongate catheter body [catheter body (12) - ¶’s [0049], [0053]; FIG. 1] coupled to the handle assembly [(16)] and having a proximal portion, a distal portion [¶[0053] (“the catheter comprises an elongated catheter body 12 having proximal and distal ends”)] , and a longitudinal axis [see ¶[0049] (“catheter body 12 having a longitudinal axis”)]; and
a distal assembly [distal assembly (17) - ¶[0049]; FIG. 1] at the distal portion of the elongate catheter body [(12)], the distal assembly [(17)] having a plurality of electrodes [electrodes (19) (¶[0049]) which may comprise AR electrodes (¶[0075]); FIGS. 2; 4B] located on a single arm [the non-linear or curved distal portion on which electrodes (19) are provided - see ¶[0049] (“with ring electrodes 19 disposed along a nonlinear or curved distal portion”); FIGS. 2, 18, 19] and being transitionable between a substantially linear configuration [see ¶[0051] (“straightens for insertion into the guiding sheath”)] and a deployed configuration [see ¶[0051] - when “exposed and unconstrained”], the distal assembly [(17)] being wound in a substantially semi-circular configuration when the distal assembly is in the deployed configuration [NOTE: while primarily described as having a “helical” form, Ditter discloses that the distal assembly (17) can also have a semi-circular form - see, e.g., ¶[0099] (“the distal assembly 17 includes a curved portion that has a semi-circular form or a crescent shape 22'”); see FIGS. 18, 19], all of the plurality of electrodes [(19)] being coplanar in a plane that is substantially orthogonal to the longitudinal axis of the elongate catheter body [(12)] when the distal assembly [(17)] is in the deployed configuration [NOTE: with reference to annotated FIG. 18 of Ditter (provided below)], Ditter discloses that all of the electrodes (19) are coplanar in a plane (plane along annotated axis (B”)) that is substantially orthogonal to the longitudinal axis (annotated axis (“A”)) of the elongate catheter body (12); see also ¶[0049] (“The angle between the plane and the axis ranges between about 45 to 105 degrees, preferably between about 75 to 105 degrees, and more preferably about 90 degrees”); and FIG. 4B], a distal end of the single arm being free floating [the distal end of the single arm of distal assembly (17) is “untethered” - e.g., FIGS. 2, 4B, 18, 19].
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ANNOTATED EXCERPT OF FIG. 18 of DITTER
8. Regarding claim 2, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses a deflection actuator [control handle (16) - ¶[0050]] configured to control a deflection [Abstract, ¶[0057]] of the distal assembly [e.g., ¶[0052] (“a contraction wire manipulated via the control handle”); & ¶’s [0071], [0094]-[0097]].
9. Regarding claim 3, Ditter discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the handle assembly includes the deflection actuator [e.g., ¶’s [0091], [0094]-[0097]].
10. Regarding claim 4, Ditter discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the deflection includes bi-directional deflection [e.g., ¶[0049]].
11. Regarding claim 5, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the distal assembly defines a rounded distal tip [clearly shown in, e.g., FIGS. 2, 4B, 19].
12. Regarding claim 6, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the elongate catheter body [(12)] defines a lumen therethrough [e.g., ¶[0054] (“the catheter body 12 comprises an elongated tubular construction having a single, axial or central lumen 18”)].
13. Regarding claim 7, Ditter discloses all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the lumen [(18)] is configured to receive a wire [e.g., ¶[0055] (“the central lumen 18 can accommodate any desired wires, cables and/or tubes”)].
14. Regarding claim 8, Ditter discloses all of the limitations of claim 6 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein when the distal assembly is in the substantially linear configuration [see ¶[0051] (“straightens for insertion into the guiding sheath”)], at least a portion of the distal assembly is coaxial with the lumen [see ¶[0051]].
15. Regarding claim 9, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein in the deployed configuration [see ¶[0051] - when “exposed and unconstrained”], the distal assembly [(17)] is wound around the longitudinal axis of the elongate catheter body [e.g., FIGS. 2, 4B, 18, 19].
16. Regarding claim 10, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein in the deployed configuration [see ¶[0051] - when “exposed and unconstrained”], a radial center of the distal assembly is offset from the longitudinal axis of the elongate catheter body [see ¶[0062]].
17. Regarding claim 11, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the plurality of electrodes includes at least 6 electrodes [see ¶’s [0075], [0081] (“The number of AR electrodes on the distal assembly 17 can vary as desired. Preferably the number of AR electrodes ranges from about six to about twenty, more preferably from about eight to about twelve. In one embodiment, the distal assembly 17 carries ten AR electrodes. The electrodes can be approximately evenly spaced around the helical form 22, as shown in FIG. 7”)].
18. Regarding claim 12, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the plurality of electrodes includes less than or equal to 10 electrodes [¶[0081] (“In one embodiment, the distal assembly 17 carries ten AR electrodes. The electrodes can be approximately evenly spaced around the helical form 22, as shown in FIG. 7”)].
19. Regarding claim 13, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the plurality of electrodes are symmetrically mounted along the distal assembly [e.g., ¶[0081]].
20. Regarding claim 14, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the plurality of electrodes are separated from each other by a distance of at least 1 mm along the distal assembly [e.g., ¶[0089] (“In the illustrated embodiment, the distal assembly 17 carries 10 AR electrodes with a spacing of approximately 4.0 mm between adjacent AR electrodes”)].
21. Regarding claim 15, Ditter discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein in the deployed configuration, the distal assembly is configured for ablating a pulmonary vein from a location within a left atrium [e.g., ¶’s [0112]-[0113]; FIG. 22].
22. Regarding claim 16, Ditter discloses a medical device system comprising:
a wire [any wire of the respective pair of wires (40, 41) connected to each AR electrode - see ¶[0082]];
a handle assembly [control handle (16) - ¶[0050]; FIG. 1];
an elongate catheter body [catheter body (12) - ¶’s [0049], [0053]; FIG. 1] coupled to the handle assembly [(16)] and having a proximal portion, a distal portion [¶[0053] (“the catheter comprises an elongated catheter body 12 having proximal and distal ends”)], and a longitudinal axis [see ¶[0049] (“catheter body 12 having a longitudinal axis”)], the elongate catheter body [(12)] defining a wire lumen [central lumen (18)] therethrough configured to receive the wire [¶[0082] (“The wire pairs for each electrode extend from the control handle 16, through the central lumen 18 of the catheter body 12, the first lumen 33 of the intermediate section 14, the central lumen of the transitional section 20, and the second lumen 58 of the distal assembly 17. Ablation energy, e.g., RF energy, is delivered to the AR electrodes via the wire 40 of the wire pairs”)]; and
a distal assembly [distal assembly (17) - ¶[0049]; FIG. 1] at the distal portion of the elongate catheter body [(12)], the distal assembly [(17)] having a plurality of electrodes [electrodes (19) (¶[0049]) which may comprise AR electrodes (¶[0075]); FIGS. 2; 4B] located on a single arm [the non-linear or curved distal portion on which electrodes (19) are provided - see ¶[0049] (“with ring electrodes 19 disposed along a nonlinear or curved distal portion”); FIGS. 2, 18, 19] and being transitionable between a substantially linear configuration [see ¶[0051] (“straightens for insertion into the guiding sheath”)] and a deployed configuration [see ¶[0051] - when “exposed and unconstrained”], the distal assembly [(17)] being in a substantially semi-circular configuration when the distal assembly is in the deployed configuration [NOTE: while primarily described as having a “helical” form, Ditter discloses that the distal assembly (17) can also have a semi-circular form - see, e.g., ¶[0099] (“the distal assembly 17 includes a curved portion that has a semi-circular form or a crescent shape 22'”); see FIGS. 18, 19], all of the plurality of electrodes [(19)] being coplanar in a plane that is substantially orthogonal to the longitudinal axis of the elongate catheter body [(12)] when the distal assembly [(17)] is in the deployed configuration [NOTE: with reference to annotated FIG. 18 of Ditter (provided below)], Ditter discloses that all of the electrodes (19) are coplanar in a plane (plane along annotated axis (B”)) that is substantially orthogonal to the longitudinal axis (annotated axis (“A”)) of the elongate catheter body (12); see also ¶[0049] (“The angle between the plane and the axis ranges between about 45 to 105 degrees, preferably between about 75 to 105 degrees, and more preferably about 90 degrees”); and FIG. 4B], a distal end of the single arm being free floating [the distal end of the single arm of distal assembly (17) is “untethered” - e.g., FIGS. 2, 4B, 18, 19].
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ANNOTATED EXCERPT OF FIG. 18 of DITTER
23. Regarding claim 17, Ditter discloses all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses a deflection actuator [control handle (16) - ¶[0050]] configured to control a deflection [Abstract, ¶[0057]] of the distal assembly [e.g., ¶[0052] (“a contraction wire manipulated via the control handle”); & ¶’s [0071], [0094]-[0097]].
24. Regarding claim 18, Ditter discloses all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the plurality of electrodes includes at least 6 electrodes [see ¶’s [0075], [0081] (“The number of AR electrodes on the distal assembly 17 can vary as desired. Preferably the number of AR electrodes ranges from about six to about twenty, more preferably from about eight to about twelve. In one embodiment, the distal assembly 17 carries ten AR electrodes. The electrodes can be approximately evenly spaced around the helical form 22, as shown in FIG. 7”)].
25. Regarding claim 19, Ditter discloses a medical device comprising:
a handle assembly [control handle (16) - ¶[0050]; FIG. 1];
an elongate catheter body [catheter body (12) - ¶’s [0049], [0053]; FIG. 1] coupled to the handle assembly [(16)] and having a proximal portion, a distal portion [¶[0053] (“the catheter comprises an elongated catheter body 12 having proximal and distal ends”)] , and a longitudinal axis [see ¶[0049] (“catheter body 12 having a longitudinal axis”)]; and
a distal assembly [distal assembly (17) - ¶[0049]; FIG. 1] at the distal portion of the elongate catheter body [(12)], the distal assembly [(17)] having a plurality of electrodes [electrodes (19) (¶[0049]) which may comprise AR electrodes (¶[0075]); FIGS. 2; 4B] located on a single arm [the non-linear or curved distal portion on which electrodes (19) are provided - see ¶[0049] (“with ring electrodes 19 disposed along a nonlinear or curved distal portion”); FIGS. 2, 18, 19] and that are spaced apart along the distal assembly by a distance of at least 1 mm [e.g., ¶[0089] (“In the illustrated embodiment, the distal assembly 17 carries 10 AR electrodes with a spacing of approximately 4.0 mm between adjacent AR electrodes”)],
wherein the distal assembly is transitionable between a substantially linear configuration [see ¶[0051] (“straightens for insertion into the guiding sheath”)] and a deployed configuration [see ¶[0051] - when “exposed and unconstrained”],
all of the plurality of electrodes [(19)] being coplanar in a plane that is substantially orthogonal to the longitudinal axis of the elongate catheter body [(12)] when the distal assembly [(17)] is in the deployed configuration [NOTE: with reference to annotated FIG. 18 of Ditter (provided below)], Ditter discloses that all of the electrodes (19) are coplanar in a plane (plane along annotated axis (B”)) that is substantially orthogonal to the longitudinal axis (annotated axis (“A”)) of the elongate catheter body (12); see also ¶[0049] (“The angle between the plane and the axis ranges between about 45 to 105 degrees, preferably between about 75 to 105 degrees, and more preferably about 90 degrees”); and FIG. 4B, a distal end of the single arm being free floating [the distal end of the single arm of distal assembly (17) is “untethered” - e.g., FIGS. 2, 4B, 18, 19], and wherein the distal assembly is deflectable [¶’s [0050], [0052], [0057], [0091], [0094]-[0097]].
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ANNOTATED EXCERPT OF FIG. 18 of DITTER
26. Regarding claim 20, Ditter discloses all of the limitations of claim 19 for the reasons set forth in detail (above) in the Office Action.
Ditter further discloses wherein the handle assembly includes a deflection actuator [control handle (16) - ¶[0050]] configured to control deflection [Abstract, ¶[0057]] of the distal assembly [e.g., ¶[0052] (“a contraction wire manipulated via the control handle”); & ¶’s [0071], [0094]-[0097]].
Response to Arguments
27. As noted above, the 06/26/26 Amendment has overcome the rejections under § 102 previously set forth in the 03/27/26 Action, as well as the non-statutory double patenting rejections.
28. New rejections under § 102 are set forth herein, necessitated by Applicant’s Amendment.
Conclusion
29. 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 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.
30. 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, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Joanne M. Rodden, can be reached at telephone number 303-297-4276. 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
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