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
Acknowledgment is made to the amendment received 12/31/2025.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim language previously read “one or more legs attached to the electrode body and configured to bend at least partially around or into a spine of a basket catheter”. Now, the claim language for claims 1 and 10 reads “one or more legs attached to the electrode body and configured to bend at least partially around a spine of a basket catheter”, which changes the scope of the claim language. Thus, previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Pate in view of Waldstreicher, and claim 10 was rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Pate in view of Embodiment B of Pate and Waldstreicher. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Litscher and claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Litscher in view of Pate.
Applicant's arguments filed 12/31/2025 with respect to claim 18 have been fully considered but they are not persuasive. Regarding claim 18, applicant argues that neither Pate nor Waldstreicher discloses the claim language “the one or more legs attached to the electrode body and configured to bend at least partially around the spine of the plurality of spines to attach the electrode body to the spine”. Applicant argues that proximal and distal ends 108 and 112 of Pate do not bend at least partially around a spine and distal end 112 is configured to slide within housing 102 and thus is not attached to the spine. However, there is no requirement that the legs bend at least partially around the exterior surface of the spine, which applicant appears to be arguing. The language “bend at least partially around the spine” is quite broad, specifically about the part of the spine that the legs bend around. As seen in Figures 2A-B, proximal and distal ends 108 and 112 of Pate bend around the interior portion of the spine, from lumen 120 to the side of opening 104 in the spine to outside the spine at opening 104. Thus, proximal and distal ends 108 and 112 do “bend at least partially around the spine”. Additionally, the claim language states that “the one or more legs … configured … to attach the electrode body to the spine”. There is no requirement that the legs fixedly attach the electrode body to the spine, which applicant appears to be arguing. Proximal end 108 is fixed relative to housing 102, as shown in Figures 2A-B and paragraph [0078] of Pate. Distal end 112 is allowed to slide within lumen 120, but only within this lumen, which is a part of housing 102. Thus, the shape and length of distal end 112 does attach the electrode body to the spine, as shown in Figures 2A-B and described in paragraph [0077] of Pate. If distal end 112 did not attach the electrode body to the spine, then one side of electrode 106 would be able to move in and out of opening 104. However, this is not the case. Distal end 112 does not move in and out of opening 104 and thus, distal end is attached to the spine, housing 102. Therefore, applicant’s arguments have been fully considered but they are not persuasive and the previous rejection of claim 18 stands.
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 1-2, 7-8, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Litscher et al., US 20150045788, herein referred to as “Litscher”.
Regarding claim 1, Litscher discloses an electrode for a medical probe (Figures 1-5: electrode panel 202), the electrode comprising: an electrode body configured to deliver electrical energy to biological tissues (Figure 2A: electrode 10 and [0040]: “The catheters may be constructed without welding the electrodes together. In particular, the catheter can be used in a procedure, such as, e.g., an energy delivery procedure, where energy may be transferred to target tissue (e.g., lung tissue) by the RF catheter electrode.”); and one or more legs attached to the electrode body (Figure 2A: distal portion 22 and proximal portion 24) and configured to bend at least partially around a spine of a basket catheter so as to be attached thereto (Figure 5: distal portion 22 and proximal portion 24 bend around activation element 104, which is a spine of a basket catheter).
Regarding claim 2, Litscher discloses the electrode of claim 1, the one or more legs extending from an edge of the electrode body (Figure 2A: distal portion 22 and proximal portion 24 extend from an edge of electrode 10) and configured to be bent such that the electrode is crimped to the spine (Figure 5).
Regarding claim 7, Litscher discloses the electrode of claim 1, the electrode body further comprising an undulating outer surface (Figure 5: electrode 10).
Regarding claim 8, Litscher discloses the electrode of claim 7, wherein the undulating outer surface is configured to permit the electrode body to bend (Figure 5: electrode 10).
Regarding claim 21, Litscher discloses the electrode of claim 1, the one or more legs dispersed evenly on opposite sides of the electrode body (Figure 1: distal portion and proximal portion 22).
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 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.
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.
Claims 3-4, 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Litscher in view of Pate et al., US 20210267675, herein referred to as “Pate”.
Regarding claim 3, Litscher discloses the electrode of claim 1, but does not explicitly disclose an electrode with the electrode body further comprising a proximal end having a first thickness and a distal end having a second thickness, the second thickness being greater than the first thickness.
However, Pate teaches an electrode with the electrode body (Figure 8: electrode 800) further comprising a proximal end having a first thickness (Figure 8: proximal end 802) and a distal end having a second thickness (Figure 8: intermediate portion 804), the second thickness being greater than the first thickness (Figure 8: the thickness of intermediate portion 804 is greater than the thickness of proximal end 802).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that it comprises a proximal end having a first thickness and a distal end having a second thickness, the second thickness being greater than the first thickness as taught by Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 4, Litscher in view of Pate discloses the electrode of claim 3, and Pate further discloses the electrode body tapering from the first thickness to the second thickness between the proximal end and the distal end (Figure 8: the thickness tapers from proximal end 802 to intermediate portion 804).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that the electrode body tapers from the first thickness to the second thickness between the proximal end and the distal end as taught by Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 10, Litscher discloses an electrode for a medical probe (Figures 1-5: electrode panel 202), the electrode comprising: an electrode body configured to deliver electrical energy to biological tissues (Figure 2A: electrode 10 and [0040]: “The catheters may be constructed without welding the electrodes together. In particular, the catheter can be used in a procedure, such as, e.g., an energy delivery procedure, where energy may be transferred to target tissue (e.g., lung tissue) by the RF catheter electrode.”); and one or more legs attached to the electrode body (Figure 2A: distal portion 22 and proximal portion 24) and configured to bend at least partially around a spine of a basket catheter so as to be attached thereto (Figure 5: distal portion 22 and proximal portion 24 bend around activation element 104, which is a spine of a basket catheter). Litscher does not explicitly disclose an electrode for a medical probe with the electrode body comprising: a proximal end having a first thickness; a distal end having a second thickness, the second thickness being greater than the first thickness; wherein the electrode body is attached to a spine of a basket catheter.
However, Pate teaches an electrode with the electrode body (Figure 8: electrode 800) further comprising a proximal end having a first thickness (Figure 8: proximal end 802) and a distal end having a second thickness (Figure 8: intermediate portion 804), the second thickness being greater than the first thickness (Figure 8: the thickness of intermediate portion 804 is greater than the thickness of proximal end 802 and [0124]: “It should be appreciated that any combination of electrode designs described herein may be used in the synergistic ablation systems contemplated herein”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that it comprises a proximal end having a first thickness and a distal end having a second thickness, the second thickness being greater than the first thickness as taught by Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 11, Litscher in view of Pate discloses the electrode of claim 10, and Pate further discloses the electrode body tapering from the first thickness to the second thickness between the proximal end and the distal end (Figure 8: the thickness tapers from proximal end 802 to intermediate portion 804).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that the electrode body tapers from the first thickness to the second thickness between the proximal end and the distal end as taught by Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 12, Litscher in view of Pate discloses the electrode of claim 10, and Pate further discloses an electrode wherein the first thickness and the second thickness are each measured in a height direction of the electrode body (Figure 21E: projection portion 2120 is the second thickness in a height direction and [0124]: “It should be appreciated that any combination of electrode designs described herein may be used in the synergistic ablation systems contemplated herein”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that the first thickness and the second thickness are each measured in a height direction of the electrode body as taught by Pate so that the electrode can have a suitable size and shape for a particular procedure (Pate [0124]).
Regarding claim 13, Litscher in view of Pate discloses the electrode of claim 10, and Pate further discloses an electrode wherein the first thickness and the second thickness are each measured in a width direction of the electrode body ([0099]: “ The electrode (800) may vary in width along its length where, for example, an intermediate portion (804) is wider than a proximal end (802) ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that the first thickness and the second thickness are each measured in a width direction of the electrode body as taught by Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 14, Litscher in view of Pate discloses the electrode of claim 10, and Litscher further discloses an electrode with the electrode body further comprising an undulating outer surface (Figure 5: electrode 10).
Regarding claim 15, Litscher in view of Pate discloses the electrode of claim 14, and Litscher further discloses an electrode wherein the undulating outer surface is configured to permit the electrode body to bend (Figure 5: electrode 10).
Regarding claim 16, Litscher in view of Pate discloses the electrode of claim 10, Litscher further discloses an electrode with the one or more legs comprising two or more legs attached to the electrode body (Figure 2A: distal portion 22 and proximal portion 24 are attached to electrode 10) and configured to bend at least partially around the spine of a basket catheter so as to be attached thereto (Figure 5).
Regarding claim 17, Litscher in view of Pate discloses the electrode of claim 16, and Litscher further discloses an electrode with the one or more legs extending from an edge of the electrode body (Figure 2A: distal portion 22 and proximal portion 24 extend from an edge of electrode 10) and configured to be bent such that the electrode is crimped to the spine (Figure 5).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Litscher in view of Waldstreicher et al., US 20210146126, herein referred to as “Waldstreicher”.
Regarding claim 9, Litscher discloses the electrode of claim 1, but does not explicitly disclose an electrode wherein the electrode is configured to deliver electrical pulses having a peak voltage of at least 900 volts (V).
However, Waldstreicher further discloses an electrode wherein the electrode is configured to deliver electrical pulses having a peak voltage of at least 900 volts (V) ([0332]: “ In some embodiments, each high voltage pulse is in range of approximately 1000 V to 2500 V ”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that the electrode is configured to deliver electrical pulses having a peak voltage of at least 900 volts as taught by Waldstreicher so as to treat or affect particular cells somewhat shallowly, such as epithethial cells (Waldstreicher [0332]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view of Pate.
Regarding claim 18, Waldstreicher discloses a medical probe (Figure 34), comprising: an insertion tube having a proximal end and a distal end (Figure 34: elongate shaft 106), the insertion tube extending along a longitudinal axis (Figure 34: elongate shaft 106); and an expandable basket assembly coupled to the distal end of the insertion tube (Figure 34: energy delivery body 108), the expandable basket assembly comprising: a plurality of spines extending along the longitudinal axis (Figure 34: protrusions 850) and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form (Figure 34: protrusions 850 bow radially outward and [0501]: “The protrusions 850 position said electrodes 107 against the tissue upon expansion, such as via a pull wire and mechanism within the handle.”); a plurality of electrodes (Figure 34: electrodes 107), each electrode of the plurality of electrodes attached to a spine of the plurality of spines (Figure 34: each electrode 107 is attached to a protrusion 850) and comprising: an electrode body configured to deliver electrical energy ([0501]: “Each electrode 107 has a conductive wire 860 connecting the electrode 107 to the generator 104. ”). Waldstreicher does not explicitly disclose a medical probe comprising a plurality of electrodes comprising one or more legs attached to the electrode body and configured to bend at least partially around the spine of the plurality of spines to attach the electrode body to the spine.
However, Pate teaches a medical probe (Figures 2A-B) comprising an electrode (Figures 2A-B: electrode 106) comprising one or more legs (Figure 2A: proximal end 108 and distal end 112) attached to the electrode body (Figure 2A: proximal end 108 and distal end 112 are attached to intermediate portion 110) and configured to bend at least partially around the spine to attach the electrode body to the spine (Figures 2A-B: catheter housing 102 and [0077]: "The proximal end (108) of the electrode (106) may be fixed relative to the housing (102) in order to fix an axial and/or rotational orientation of the distal end (112) of the electrode (106) relative to the housing (102). " and [0085]: " For example, as shown in most clearly in FIG. 4, the distal end (112) of the electrode (106) may comprise a shape, such as a bend and/or an upturned shape. "). In combination with Waldstreicher, each electrode 107 of Waldstreicher would be shaped like electrode 106 of Pate and would be attached to protrusions 850 by proximal ends 108 and distal end 112.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Waldstreicher so that the electrodes comprises one or more legs attached to the electrode body and configured to bend at least partially around the spine to attach the electrode body to the spine as taught by Pate so that the electrode maintains continuous contact with tissue (Pate [0082]).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Waldstreicher in view Embodiment A of Pate, further in view of Embodiment B of Pate.
Regarding claim 19, Waldstreicher in view of Embodiment A of Pate discloses the medical probe of claim 18, but does not explicitly disclose a medical probe with the electrode body further comprising a proximal end having a first thickness and a distal end having a second thickness, the second thickness being greater than the first thickness.
However, Embodiment B of Pate teaches a medical probe with the electrode body (Figure 8: electrode 800) further comprising a proximal end having a first thickness (Figure 8: proximal end 802) and a distal end having a second thickness (Figure 8: intermediate portion 804), the second thickness being greater than the first thickness (Figure 8: the thickness of intermediate portion 804 is greater than the thickness of proximal end 802 and [0124]: “It should be appreciated that any combination of electrode designs described herein may be used in the synergistic ablation systems contemplated herein”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical probe disclosed by Waldstreicher so that it comprises a proximal end having a first thickness and a distal end having a second thickness, the second thickness being greater than the first thickness as taught by Embodiment B of Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Regarding claim 20, Waldstreicher in view of Embodiment A of Pate and Embodiment B of Pate discloses the medical probe of claim 19, and Embodiment B of Pate further discloses a medical probe with the electrode body tapering from the first thickness to the second thickness between the proximal end and the distal end (Figure 8: the thickness tapers from proximal end 802 to intermediate portion 804 and [0124]: “It should be appreciated that any combination of electrode designs described herein may be used in the synergistic ablation systems contemplated herein”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the medical probe disclosed by Waldstreicher so that the electrode body tapers from the first thickness to the second thickness between the proximal end and the distal end as taught by Embodiment B of Pate to create a larger surface to contact and ablate tissue (Pate [0099]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Litscher in view of Harlev et al., US 20230012397, herein referred to as “Harlev”.
Regarding claim 22, Litscher discloses the electrode of claim 1, but does not explicitly disclose an electrode with a number of the one or more legs being different on either side of the electrode body so as to allow the one or more legs to avoid overlapping when crimped around the spine.
However, Harlev discloses an electrode (Figure 14A) with a number of the one or more legs being different on either side of the electrode body so as to allow the one or more legs to avoid overlapping when crimped around the spine (Figure 14C: strut 751 on the top left of the figure is considered on side, while the other three struts 751 are considered on the other side. As seen in Figure 14A, each strut has two legs around eyelet 758, so one side of the electrode has two legs, while the other has six).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the electrode disclosed by Litscher so that a number of the one or more legs are different on either side of the electrode body so as to allow the one or more legs to avoid overlapping when crimped around the spine as taught by Harlev to facilitate forming a robust mechanical connection (Harlev [0090]).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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