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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on October 9, 2025 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hillukka et al (WO/2020/194216).
Referring to claim 1, Hillukka et al teaches an irrigation hub for an ablation catheter (Figure 1), the irrigation hub comprising: a cylindrical member (801) extending along a longitudinal axis (Figures 8E and 8F), the cylindrical member comprising:
a proximal end (803) having a first outer diameter and a recess (839) extending inwardly along the longitudinal axis forming an interior portion (paragraph 00138; Figures 8E and 8F); a distal end (802) having a second outer diameter, the second outer diameter being less than the first outer diameter (measured either at the distal end where it curves or measured at reference number 834) (Figures 8E and 8F);
an irrigation inlet chamber (distal end of 839) disposed proximate the interior portion and configured to receive fluid from an irrigation supply (12, 27) (Figures 1, 8E and 8F);
a plurality of irrigation openings (8351-3) disposed generally transverse to the longitudinal axis from a distal portion of the irrigation inlet chamber (paragraph 00138; Figures 8E and 8F); and a flow diverter (893) extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid flow out of the plurality of irrigation openings in a direction generally transverse relative to the longitudinal axis (paragraphs 00138-00143; Figures 1, 8E and 8F).
Referring to claims 2-4, Hillukka et al teaches wherein the plurality of irrigation openings (8351-3) are disposed radially around the cylindrical member and are configured to direct the fluid toward electrodes of a basket catheter, wherein each irrigation opening of the plurality of irrigation openings comprises an aperture having an outlet area greater than an inlet area and wherein the flow diverter (893) comprises a conical member extending proximally along the longitudinal axis into the irrigation inlet chamber (paragraphs 00138-00143; Figures 1, 8E and 8F). It is noted that electrodes of a basket catheter are not positively recited.
Referring to claims 5-6, Hillukka et al teaches wherein at least a portion of each irrigation opening extends outwardly at an angle and wherein the angle of each irrigation opening relative to the longitudinal axis is approximately equal to an angle formed by an outer surface of the conical member relative to the longitudinal axis (paragraphs 00138-00143; Figures 1, 8E and 8F).
Referring to claim 7, Hillukka et al teaches wherein the proximal end comprises one or more attachment mechanisms (proximal end of Figure 8E and 8F) configured to releasably attach the proximal end to a catheter shaft (910) (paragraph 00148; best shown in Figure 9D).
Referring to claim 8, Hillukka et al teaches wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a force sensor (paragraphs 00087 and 00148; best shown in Figure 9D). It is noted that a force sensor is not positively required and since Hillukka et al teaches a sensor attached to the catheter shaft the claim language is met.
Referring to claim 11, Hillukka et al teaches wherein the distal end further comprises a sensor mount (833) configured to receive and support a sensor (paragraph 00135; Figure 8A).
Claims 1-8 and 10-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Govari et al (2021/0338319).
Referring to claims 1 and 14, Govari et al teaches a medical probe (Figure 1), comprising: a tubular shaft (22) extending along a longitudinal axis of the medical probe (paragraph 0039; Figure 1); a plurality of spines (55) configured to bow radially outward from the longitudinal axis (paragraphs 0051 and 0055; Figures 2-3); a plurality of electrodes (48), each electrode of the plurality of electrodes attached to a spine of the plurality of spines (paragraphs 0051 and 0055; Figures 2-3); and an irrigation hub (65) attached to the tubular shaft (22) and configured to receive and support the plurality of spines (paragraphs 0056-0057; Figures 1-6), the irrigation hub (65) comprising a cylindrical member extending along the longitudinal axis and comprising: a proximal end (end of 65 having the proximal connector 77 as shown in Figures 4 and 6) having a first outer diameter and a recess (83) extending inwardly along the longitudinal axis forming an interior portion (paragraphs 0061 and 0064; Figures 1-6); a distal end (end of 65 between the proximal connector 77 and distal connector in Figure 4) having a second outer diameter, the second outer diameter being less than the first outer diameter (Figures 4 and 5); an irrigation inlet chamber (79-2) disposed proximate the interior portion and configured to receive fluid from an irrigation supply line separate from the tubular shaft to prevent fluid immersion into the tubular shaft (paragraph 0064; Figures 1-6); a plurality of irrigation openings (67) disposed generally transverse to the longitudinal axis from a distal portion of the irrigation inlet chamber (79-2) (paragraphs 0056-0058); and a flow diverter (75) extending into the distal portion of the irrigation inlet chamber to block fluid flow and redirect fluid out of the plurality of irrigation openings in a direction generally transverse relative to the longitudinal axis (paragraphs 0059 and 0062; Figures 1-6).
Referring to claims 2-3 and 5, Govari et al teaches wherein the plurality of irrigation openings (67) are disposed radially around the cylindrical member and are configured to direct the fluid toward electrodes of a basket catheter; wherein each irrigation opening of the plurality of irrigation openings comprises an aperture having an outlet area greater than an inlet area and wherein at least a portion of each irrigation opening extends outwardly at an angle (paragraphs 0056-0058; Figures 1-6).
Referring to claim 4, Govari et al teaches wherein the flow diverter (75_ comprises a conical member extending proximally along the longitudinal axis into the irrigation inlet chamber (Figures 4-5).
Referring to claim 6, Govari et al teaches the angle of each irrigation opening relative to the longitudinal axis is approximately equal to an angle formed by an outer surface of the conical member relative to the longitudinal axis (paragraphs 0056-0058; Figures 1-6).
Referring to claims 7 and 8, Govari et al teaches wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a catheter shaft and wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to a force sensor (Figures 1-6). It is noted that no specific structure is claimed.
Referring to claim 10, Govari et al teaches wherein the proximal end further comprises a plurality of relief lands disposed radially around an outer surface of the proximal end, each relief land of the plurality of relief lands configured to receive a spine of a basket catheter (shown best in Figures 4 and 6).
Referring to claim 11, Govari et al teaches a sensor mount configured to received and support a sensor (81) (paragraph 0061; Figure 4). It is noted that no specific structure is claimed and therefore the distal end can be releasably attached. The sensors are also not positively required.
Referring to claims 12 and 13, Govari et al teaches wherein the sensor comprises a reference electrode or a position sensor (paragraph 0061; Figure 4).
Referring to claim 15, Govari et al teaches wherein the plurality of spines (55) are configured to transition between an expanded state and a collapsed state (paragraphs 0054-0055).
Referring to claim 16, Govari et al teaches wherein the plurality of irrigation openings are disposed radially around the cylindrical member and are configured to direct the fluid toward the plurality of electrodes (paragraphs 0056-0058; Figures 1-6).
Referring to claim 17, Govari et al teaches wherein each electrode (48) of the plurality of electrodes having a tissue-facing surface and an inwardly-facing surface, the plurality of irrigation openings configured to direct the fluid toward the inwardly-facing surface of each electrode of the plurality of electrodes (paragraphs 0047, 0051-0052, 0056-0058; Figures 1-6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hillukka et al (WO/2020/194216) as applied to claims 1 and 8 above, and further in view of Ramberg et al (2019/0350647).
Referring to claim 9, Hillukka et al fails to teach one or more bayonet mounts. Ramberg et al teaches an analogous surgical instrument with a detachable distal end wherein the one or more attachment mechanisms comprises one or more bayonet mounts (paragraph 0048). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end, as taught by Hillukka et al, to include a bayonet mount, as taught by Ramberg et al, in order to provide a releasable coupling mechanism that can easily remove it from the hand piece (paragraph 0048).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (2021/0338319) applied to claims 1 and 8 above, and further in view of Ramberg et al (2019/0350647).
Referring to claim 9, Govari et al fails to teach one or more bayonet mounts. Ramberg et al teaches an analogous surgical instrument with a detachable distal end wherein the one or more attachment mechanisms comprises one or more bayonet mounts (paragraph 0048). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end, as taught by Govari et al, to include a bayonet mount, as taught by Ramberg et al, in order to provide a releasable coupling mechanism that can easily remove it from the hand piece (paragraph 0048).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (2021/0338319) applied to claim 14 above, and further in view of Daniel et al (2020/0197082).
Referring to claim 18, Govari et al teaches a sensor (81) disposed between the irrigation hub (65) and the tubular shaft (22) (shown best in Figure 4), however fails to teaches that it is a force sensor. Daniel et al teaches an analogous medical probe comprising a force sensor (80) disposed between the irrigation hub (15) and the tubular shaft (14) (paragraphs 0068, 0074, 0094 and 0098; Figure 1B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor, as taught by Govari et al, to be a force sensor, as taught by Daniel et al, in order to measure the magnitude and direction of the force on distal end (paragraph 0074).
Referring to claim 19, the modified Govari reference teaches wherein the proximal end comprises one or more attachment mechanisms configured to releasably attach the proximal end to the force sensor (Figures 1-6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794