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
The Amendment filed December 30, 2025 has been entered. Currently claim 1 has been amended, and claims 1-6, 8-21 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-6, 8-9, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the cardiac chamber" in line 24. There is insufficient antecedent basis for this limitation in the claim. Claims 2, 5-6, 8-9, and 21 are also rejected because they are dependent on claim 1.
Claim 1 recites the limitation "the distal end" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claims 2, 5-6, 8-9, and 21 are also rejected because they are dependent on claim 1.
Claim 1 recites the limitation "the distal end" in line 4. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this distal end is different from the atraumatic distal end just previously cited in the claim, or if they are the same structure. For examination purposes, Examiner will interpret the distal end as the section of the catheter body that is furthest away from the user/doctor when in use, which includes the plurality of tines and the atraumatic distal end, and will interpret the atraumatic distal end only as the distalmost section of the catheter body. Henceforth, Examiner will refer to the atraumatic distal end/distalmost section as the “distalmost end”. Claims 2, 5-6, 8-9, and 21 are also rejected because they are dependent on claim 1.
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.
Claims 1-2, 5-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Young (U.S. Application No. 20050080409 A1), in view of He (U.S. Application No. 20170120048 A1), and further in view of Fernald (U.S. Application No. 20070250053 A1).
Regarding independent claim 1 and claim 9, Young discloses a catheter for ablation comprising:
a flexible catheter body (108) extending from a proximal end (112) to a distalmost end (114), the catheter body forming a lumen (116) extending from the proximal end to the distal end (i.e., distal section which includes the distalmost end of the catheter body and a plurality of tines), the catheter body defining a longitudinal axis (pa. 0040, 0042 & Figs. 5-7);
a plurality of tines (124) disposed at the distal end of the catheter body (at least tines (124(1)) is disposed at the distal end of the catheter body), the plurality of tines formed of an electrically conductive material and configured to deploy from the lumen at the distal end of the catheter body (pa. 0041-0042), each tine of the plurality of tines configured to self-bias from a linear configuration within the lumen to a curved configuration when deployed from the lumen (pa. 0043), each tine of the plurality of tines forming a curve extending from the distal end of the catheter body and away from the longitudinal axis in the curved configuration (pa. 0043), and each tine of the plurality of tines having a pointed tip configured to penetrate cardiac tissue (pa. 0041, 0045). Examiner is interpreting the claim limitation, “penetrate cardiac tissue”, as a functional recitation of the intended use of the device, specifically since the language does not result in a structural difference between the claimed invention and Young; therefore, the device of Young is capable of performing this function. Furthermore, Examiner is interpreting the “cardiac tissue” as only the specific sections of tissue immediately surrounding the pointed tips of the plurality of tines (124(1)) disposed at the distal end of the catheter body after the catheter body is disposed on/has been successfully introduced and the tines have been deployed (see annotated boxes in Fig. 6 below; note, certain original reference characters have been omitted by Examiner for simplicity purposes).
Young further discloses a flexible shaft (118) formed of an electrically conductive material, the shaft mechanically and electrically coupled to the plurality of tines and extending through the lumen from the proximal end of the catheter body (pa. 0050-0051), the shaft configured to deploy the tines from the lumen when the shaft is moved along the longitudinal axis with respect to the catheter body toward the distal end of the catheter body (pa. 0040, 0042); and
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a return electrode (124(2)) disposed on an outer surface of the catheter body (in the deployed configuration as seen in figure 6) and spaced from the distal end (pa. 0048, see annotated Fig. 6 below), the distalmost end of the catheter body is configured to contact the cardiac tissue without penetrating the cardiac tissue while the plurality of tines penetrate the cardiac tissue (the distalmost end of the catheter body is in direct contact with the plurality of tines, and the plurality of tines are in direct contact with the specific sections of the tissue which Examiner is interpreting as the cardiac tissue, therefore the claim limitation of the distal end contacting the cardiac tissue is met), the return electrode is configured to remain in blood within the cardiac chamber and spaced from the cardiac tissue (see annotated Fig. 6 below) while the plurality of tines are deployed into the cardiac tissue.
Young additionally discloses an electrical conductor (the conductive material that comprises the shaft (118) (pa. 0042) electrically coupled to the return electrode, the electrical conductor extending through the catheter body from the proximal end of the catheter body (pa. 0051).
Lastly, Young discloses how the distal end of the catheter body (108) may have a sharpened tip in order to introduce it to the target site, or it may be introduced through a sheath and sharpened obturator (stylet) assembly so that the distal end of the cannula advances from the sheath into the target site (pa. 0055).
However, Young does not explicitly disclose the catheter is configured for focal cardiac ablation by irreversible electroporation.
He, in the same field of endeavor, teaches a catheter configured for providing treatment including focal cardiac ablation by irreversible electroporation (IRE) or by radio frequency energy (pa. 0011, 0025-0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode catheter of Young to incorporate focal cardiac ablation by irreversible electroporation because the catheter of He describes it as being routine skill in the art to operate electrodes in either RF or IRE mode. Moreover, IRE is defined as a technology that uses DC current to induce cell death, and Young discloses emitting RF energy to create lesions and induce cellular death, or necrosis.
However, Young/He combination do not explicitly recite that the distal end of the flexible catheter body is an atraumatic distal end.
Fernald, in the same field of endeavor, teaches a tissue ablation system (10) comprising a probe shaft (18) further comprising a proximal end (20) and a distal end (22) (pa. 0032 & Figs. 1-2). The probe shaft may be ridged and include a sharp, tissue-penetrating tip distal end so that it may be more easily introduced through tissue, or in a second configuration, the probe shaft can be a flexible material with a blunt/atraumatic distal end and may be introduced through the tissue with the aid of a sharp cannula and trocar assembly (analogous to the sheath and obturator stylet assembly of Young) (pa. 0036, 0060).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal end of the catheter body of Young to have an atraumatic tip, as taught by Fernald, in the second configuration where the catheter body is introduced to the tissue using the sheath with the sharp distal end.
Regarding claim 2, Young/He/Fernald combination discloses the return electrode includes a ring extending around a circumference of the catheter body (Young, pa. 0084-0095 & Figs. 19-20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the return electrode from a deployable configuration as seen in the first embodiments of Figures 5-6 to a ring electrode configuration extending around the circumference of the catheter body as seen in a second embodiment of Figures 19-20, for the purpose of modifying the type/shape of lesion created during the ablation procedure (Young, pa. 0059).
Regarding claim 5, Young/He/Fernald combination discloses the catheter body includes a deployable array (124(2)) at the distal end of the catheter body, the return electrode includes a plurality of return electrodes (126) disposed on the deployable array, and the deployable array including a plurality of splines, each spline of the plurality of splines including at least one return electrode of the plurality of return electrodes (Young, pa. 0042 & Fig. 6).
Regarding claim 6, Young/He/Fernald combination discloses the plurality of splines are configured to transition between a retracted configuration (Young, pa. 0042), in which each spline of the plurality of splines is substantially parallel to the longitudinal axis and a deployed configuration in which each spline of the plurality of splines is bowed radially outward from the longitudinal axis. The modification of the linear arrangement of the splines as disclosed in Young into a bowed configuration, as disclosed in the tines of Young, would be an obvious modification because it would not change the way the device operates to provide ablation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Young, He, and Fernald as applied to claim 1 above, and further in view of Goble (U.S. Patent No. 6261286 B1).
Regarding claim 8, Young/He combination discloses the invention substantially as claimed in claim 1 and discussed above. Moreover, while Young contemplates that the various return electrodes of the device may have different spacings and patterns between various electrodes (Young, pa. 0043-0044).
However, the combination of Young/He/Fernald specifically fails to provide the return electrode is disposed between 1mm and 10mm from the distal end of the catheter body
Goble, in the same field of endeavor, teaches the return electrode is disposed between 1 mm and 10 mm from the distal end of the catheter body (Col. 8, lines 14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distance of the return electrode relative to the distal end of the catheter body in order to provide the proper amount of space of the electrode from the ablated tissue (Goble, Col. 8, lines 21-25).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Young, He, and Fernald as applied to claim 1 above, and further in view of Werneth (U.S. Patent No. 8486063 B2).
Regarding claim 21, Young/He/Fernald combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, they do not disclose that the flexible shaft is formed of a multifilar wire coil, wherein each filar of the multifilar wire coil is connected to a respective tine of the plurality of tines.
Werneth, in the same field of endeavor, teaches a catheter for performing targeted tissue ablation comprising multiple carrier assembly (120) with a plurality of electrodes (130) electrically connected to a coupler (140) and a control shaft (150) (Col. 7, lines 53-56; & Figs. 5-6). The control shaft extends from the proximal end to distal end (102) of catheter shaft (101) and is maneuvered in such a way that retracting it results in the carrier to be constrained in the lumen of the catheter shaft and advancing it allows the carrier assembly to be fully deployed (Col. 8, lines 48-58). Moreover, the control shaft is formed of an electrically conductive material (Col. 8, lines 4-15), consisting of a multifilar spring wire coil (Col. 8, lines 15-17; Co. 12, lines 24-27), wherein each filament is connected to a respective electrode of the plurality of electrodes via the coupler (Col. 9, lines 4-13; Col. 9, lines 64-66).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the structure of the flexible shaft of Young to incorporate the structure of Werneth for the purpose of allowing the shaft to be electrically connected to the plurality of tines.
Response to Arguments
Applicant's arguments, see pages 7-9, have been fully considered but they are not persuasive.
With regards to newly amended claim 1, Applicant argues that the combination of Young, He, and Fernald do not teach, “the atraumatic distal end of the catheter body is configured to contact the cardiac tissue without penetrating the cardiac tissue while the plurality of tines penetrate the cardiac tissue”, as claimed. Specifically, Applicant contends that Young discloses the cannula 108 having a sharpened tip to facilitate introduction to the treatment region or, alternatively, may be introduced using a sheath and sharpened obturator assembly, such as at Young, paragraph [0055]. Neither configuration teaches nor suggests an atraumatic distal end configured to contact cardiac tissue without penetrating it while tines penetrate the cardiac tissue, as recited by claim 1 as amended. However, Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As stated in the Applicant’s argument, the Young reference discloses two different configurations for introducing the catheter into the tissue, one where the distalmost end of the catheter body is sharpened and another one where an introductory sharpened sheath is utilized to penetrate the tissue; the second configuration being ambiguous about the state (i.e., sharpness/dullness) of the distalmost end of the catheter body. Examiner therefore introduced the Fernald reference to ameliorate the shortcomings of the Young reference. Fernald teaches the same two configurations for introducing a catheter body into targeted tissue but in much greater detail. Specifically, Fernald describes a probe shaft (18) with either a sharp, tissue-penetrating tip distal end (22) that easily penetrates tissue, or with a blunt/atraumatic distal end and therefore is introduced to the tissue with the aid of a sharp cannula and trocar assembly (analogous to the sheath of Young) (pa. 0036, 0060). Therefore, it would have been obvious to have modified the distal end of the catheter body of Young to have an atraumatic tip, as taught by Fernald, in the second configuration where the catheter body is introduced to the tissue using the sheath with the sharp distal end.
In regards to the claim limitation of the atraumatic distal end being configured to contact cardiac tissue without penetrating it while tines penetrate the cardiac tissue, Examiner is interpreting the “cardiac tissue” as only the specific sections of tissue immediately surrounding the pointed tips of the plurality of tines (124(1)) disposed at the distal end of the catheter body after the catheter body is disposed on/has been successfully introduced and the tines have been deployed. Therefore, since the distalmost end of the catheter body is in direct contact with the plurality of tines, and the plurality of tines are in direct contact with the specific section of tissue Examiner is interpreting as the cardiac tissue, the claim limitation of the distalmost end/atraumatic distal end contacting the cardiac tissue is met since the claim is still broad and does not specify that there must be direct contact between these two components. Therefore, the rejection is maintained.
With regards to newly amended claim 1, Applicant further argues that Young's return electrode array 124(2) comprises tissue-penetrating needle electrodes 126 that deploy out from ports 139 in the cannula wall, and therefore do not remain spaced from cardiac tissue in blood within a cardiac chamber. However, Examiner disagrees.
As specified in the action above, Examiner is interpreting the “cardiac tissue” as only the specific sections of tissue immediately surrounding the pointed tips of the plurality of tines (124(1)) disposed at the distal end of the catheter body after the catheter body is disposed on/has been successfully introduced and the tines have been deployed; thereby, explicitly excluding the sections of the cardiac tissue which come in contact with the return electrode (124(2)). This interpretation allows the Young reference to meet the claim language of the return electrode configured to remain in blood within the cardiac chamber and spaced from the cardiac tissue. The claim language of independent claim 1 is still broad and does not require the return electrodes to not penetrate the cardiac tissue, or to have atraumatic tips in the deployed configuration. Therefore, the rejection using Young is maintained.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794