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 § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 and 10-13 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 10, Hillukka et al teaches wherein the proximal end further comprises a plurality of relief lands (832) disposed radially around an outer surface of the proximal end (paragraph 00135; Figure 8A), each relief land of the plurality of relief lands configured to receive a spine of a basket catheter. It is noted that the spine of the basket catheter is not claimed and that the term “relief lands” is broad.
Referring to claims 11-13, 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). Referring specifically to claims 12 and 13 the recited sensors are not positively required since claim 11 only requires a sensor mount.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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).
Response to Arguments
Applicant's arguments filed June 15, 2026, with regard to the Hillukka et al reference have been fully considered but they are not persuasive. The examiner maintains that Hillukka et al teaches a flow diverter (893) that extends into the distal portion of the irrigation inlet chamber (distal end of 839) as shown in the image below.
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Applicant’s representative labeled a gap between a deflection surface and central lumen 839, however the tip of the flow diverter (839) extends into the distal portion of the irrigation inlet chamber (839) as shown in the image above. The claim does not require that the entire flow diverter be within the irrigation inlet chamber. The examiner maintains that Hillukka et al teaches that the tip of the flow diverter (839) extends into the distal portion of the irrigation inlet chamber.
Applicant’s arguments filed June 15, 2026, with regard to the PG Pub 2021/0338319 have been considered persuasive and have been withdrawn.
Allowable Subject Matter
Claims 14-19 are allowed. The prior art of record fails to teach a flow diverter 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, in the context of the claim as a whole. WO/2020/194216 teaches a flow diverter 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, however fails to teach that the irrigation hub is part of a medical probe with a tubular shaft, a plurality of spines and a plurality of electrodes as recited in claim 14. US Patent Publication 2021/0338319 teaches a medical probe, comprising: a tubular shaft extending along a longitudinal axis of the medical probe; a plurality of spines configured to bow radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to a spine of the plurality of spines; and an irrigation hub attached to the tubular shaft and configured to receive and support the plurality of spines, the irrigation hub comprising a cylindrical member extending along the longitudinal axis and comprising: a proximal end having a first outer diameter and a recess extending inwardly along the longitudinal axis forming an interior portion; a distal end having a second outer diameter, the second outer diameter being less than the first outer diameter; an irrigation inlet chamber 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; a plurality of irrigation openings disposed generally transverse to the longitudinal axis from a distal portion of the irrigation inlet chamber, however fails to teach a flow diverter 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.
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
