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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/04/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/04/2025 was filed before the current action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
It is noted that the Applicant did not file any amendments to the claims. Claims 1, 3-4, 6, 11-12, 14, 20-21, and 24 are pending on the application. However, because no such amendment or argument was filed, the case is now seen as final as this is the same claim set rejected in the Final Action set-forth on 4/28/2025.
Response to Arguments
Applicant did not file any arguments against the substance of the previous Final Rejection of Record. Therefore the previous rejection is upheld.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “second catheter” of claim 1 line 8, the “second deflectable element” of claim 1 line 10, and the “pump configured to be connected to the…second catheter,” of claim 11 line 4-5, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3, and 11 objected to because of the following informalities:
Regarding Claim 1, the limitation “an expandable distal end assembly disposed at the distal end of the deflectable element” is recited in line 5-6 of the claim. This should instead be “an expandable distal end assembly disposed at the distal end of the first deflectable element”, for consistency and clarity.
Regarding claim 3, the limitation “wherein the at least one electrical connection configured to” in line 1-2 of the claim should instead be written as wherein the at least one electrical connection is configured to”.
Regarding Claim 11, the limitation “pump the irrigation fluid from the irrigation reservoir through the irrigation holes via the irrigation tube” is recited in line 5-6 of the claim. This should instead be “pump the irrigation fluid from the irrigation reservoir through the irrigation holes via the first irrigation tube”, for consistency and clarity.
Appropriate correction is required.
Claim Interpretation
Regarding claim 4, the “switching circuit” is assumed to be the same as the “switching circuitry” mentioned in page 23 line 9 of the Specification. The structure given is from page 9 of the Specification:
“In some embodiments, the electrical connection(s) 230 may be configured to selectively connect together the assembly electrodes 48 to act as the combined assembly electrode 232 and also allow the electrodes 48 to act as individual electrodes, for example, for sensing positions, electrical activations, and performing individual ablation. In such embodiments, the electrical connections 230 may include switching circuitry (not shown) which enables selectively connecting together two or more (and optionally all) of the assembly electrodes 48.”
Looking at Fig 10, it is interpreted that any electrical connection able to selectively connect electrodes may be regarded as a “switching circuit”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3-4, 6, 11-12, 14, 20-21, and 24 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “a second catheter configured to be inserted into a body part of a living subject, and including: a second deflectable element” is recited in line 8-10 of the claim. Applicant cites page 23 line 19-21 as support for a second catheter “indifferent electrode attached to the patient’s skin or on another catheter”, but makes no mention of a second deflectable element in this “another catheter”. Regarding the limitation “an ablation power generator configured to be connected to each of the first catheter and the second catheter” in line 21-22 of claim 1, the Specification does not explicitly disclose the second catheter being connected to an ablation power generator. These are considered as new matter, as there is no support in the original disclosure for these limitations. Claims 3-4, 6, 12, 14, and 20-21 similarly rejected for inheriting the deficiencies of claim 1.
Regarding Claim 11, the limitation “a pump configured to be connected to the irrigation reservoir and the second catheter” is recited in line 4-5 of the claim. There is no support in the Specification or Drawings that demonstrates a pump connected to a second catheter.
Regarding claim 24, the limitation “wherein the switching circuit is configured to switch between selectively forming the combined assembly electrode and sampling output from each of the assembly electrodes individually” is recited in line 1-3 of the claim. This is considered as new matter, as there is no support in the original disclosure for this limitation. The Specification recites that the electrical connections may be configured to “allow the electrodes 48 to act as individual electrodes, for example, for sensing positions, electrical activations, and performing individual ablation”. The Specification makes no mention of “sampling output from each of the assembly electrodes individually”. It is encouraged to the Applicant to ensure that claim language matches what is described in the Specification and original disclosure for clarity.
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.
Claims 1, 3-4, 6, 11-12, 14, 20-21, and 24 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.
Regarding claim 1, the limitations “a ring-shaped electrode extending circumferentially around the deflectable element” in line 11-13 of the claim; and “a first irrigation tube disposed in the deflectable element” in line 17 of the claim are all considered indefinite, as these are all unclear if they are claiming the first deflectable element of the first catheter or the second deflectable element of the second catheter. Claims 3-4, 6, 12, 14, and 20-21 similarly rejected for inheriting the deficiencies of claim 1.
Regarding Claim 11, the limitation “wherein the ring-shaped electrode and the deflectable element” recited in line 6-7 of the claim is considered indefinite, as this is unclear if it is claiming the first deflectable element of the first catheter or the second deflectable element of the second catheter.
Regarding Claim 14, the limitation “the axis of the deflectable element” recited in line 3 of the claim is considered indefinite, as this is unclear if it is claiming the first deflectable element of the first catheter or the second deflectable element of the second catheter.
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 (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 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, 3-4, 6, 11, 14, 20, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 20160331459 A1) in view of Ditter (US 20130006238 A1).
Regarding claim 1, Townley discloses
A medical system comprising:
a first catheter configured to be inserted into a body part of a living subject (Townley Fig 10 (1002) par [0102]), and including:
a first deflectable element having a proximal end and a distal end (Townley Fig 10 (1008) par [0102]);
an expandable distal end assembly disposed at the distal end of the deflectable element, and comprising a plurality of assembly electrodes (Townley Fig 10 (1044) par [0102]), and
configured to expand from a collapsed form to an expanded deployed form (Townley par [0068]);
a ring-shaped electrode extending circumferentially around the deflectable element (Townley Fig 10 ring-shaped electrode (1060) par [0102]),
at least one electrical connection (e.g., the generator 216 of FIG.2) configured to electrically connect (Paragraph [0073], “electrodes 1044 can be electrically coupled to an RF generator 216 via wires not shown that extend from electrodes 1044, through shaft 1008, and to the RF generator”) together at least two of the assembly electrodes to act as a combined assembly electrode (Paragraph [0073], “multiple electrodes can be controlled together and coupled to the same wire through the shaft”); and
an ablation power generator configured to be connected to the first catheter (Townley par [0045]), and apply an electrical signal between at least two of the plurality of assembly electrodes configured to act as a combined assembly electrode and the ring-shaped electrode, wherein only the assembly electrodes are configured for delivering ablative energy to surrounding tissue and the ring-shaped electrode is an indifferent electrode providing a return path for ablation energy delivered to the combined assembly for ablating tissue in the body part of the living subject (Townley Fig 10 proximal electrode (1060) par [0102] ring-shaped electrode is return electrode).
Townley further discloses a second catheter configured to be inserted into a body part of a living subject, and including: a second deflectable element (Townley par [0053] guide catheter may be used to introduce therapeutic device). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have a second catheter with a second deflectable element to serve as a guide for the first catheter (Townley par [0053]).
Townley fails to explicitly disclose wherein the ring-shaped electrode includes irrigation holes through which irrigation fluid is expelled wherein irrigation fluid expelled through the irrigation holes is configured to cool the ring-shaped electrode; and a first irrigation tube disposed in the deflectable element and configured to deliver the irrigation fluid to the ring-shaped electrode.
However, Ditter discloses a medical system comprising: a catheter configured to be inserted into a body part of a living subject for ablation of tissue (Ditter Fig 2 catheter (10) par [0047]), and including: a deflectable element (Ditter Fig 2 (22) par [0050]); and comprising a ring-shaped electrode extending circumferentially around the deflectable element (Ditter Fig 2 (19/AR) par [0049]);
wherein the ring-shaped electrode includes irrigation holes through which irrigation fluid is expelled wherein irrigation fluid expelled through the irrigation holes is configured to cool the ring-shaped electrode (Ditter Fig 13 (69) par [0078]); and
a first irrigation tube disposed in the deflectable element and configured to deliver the irrigation fluid to the ring-shaped electrode (Ditter Fig 14 (59) par [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Townley with an irrigated electrode and associated lumen such as disclosed by Ditter, as during ablation, heat is generated in the electrode or electrodes providing the ablation, as well as in the surrounding region, and such irrigation would be useful to control temperature and minimize charring (Ditter par [0011]).
Regarding claim 3, Townley in view of Ditter discloses the medical system of claim 1. Townley further discloses wherein the at least one electrical connection is configured to permanently electrically connect the at least two of the plurality of assembly electrodes (Townley, par [0073]). It should be noted that the term “permanently electrically connects” is being interpreted as having a permanent physical connection that provides for electrical connection.
Regarding claim 4, Townley in view of Ditter discloses the medical system of claim 1. Townley further discloses a switching circuit (Townley Fig 2 (204) par [0046]), wherein the switching circuit is configured to selectively electrically connect the at least two of the plurality of assembly electrodes to act as the combined assembly electrode (Townley, par [0072,0073] electrodes are independently selectable and thus can be selected together to act as a combined assembly electrode). As noted above under the Claim Interpretation heading, it is interpreted that any electrical connection able to selectively connect electrodes may be regarded as a “switching circuit”.
Regarding claim 6, Townley in view of Ditter discloses the medical system of claim 1. Townley further discloses wherein the expandable distal end assembly includes at least one of: an expandable basket comprising a plurality of splines, the assembly electrodes being disposed on the splines; or an inflatable balloon with the assembly electrodes disposed thereon (Townley Fig 10A expandable assembly (1042) electrodes (1044) par [0102]).
Regarding claim 11, Townley in view of Ditter discloses the system of claim 1. Ditter further discloses an irrigation reservoir configured to store the irrigation fluid (inherent); and a pump configured to be connected to the irrigation reservoir and the second catheter (Ditter par [0080]), and to pump the irrigation fluid from the irrigation reservoir through the irrigation holes via the irrigation tube (Ditter par [0080]), wherein the ring-shaped electrode and the deflectable element define an annular hollow therebetween and wherein the irrigation holes are disposed both radially around the ring-shaped electrode and longitudinally along the ring-shaped electrode (Ditter Fig 14 annular hollow (G) irrigation holes (69) par [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Townley with the irrigation reservoir and pump, and ring-electrode irrigation holes and annular hollow such as disclosed by Ditter, as during ablation, heat is generated in the electrode or electrodes providing the ablation, as well as in the surrounding region, and such features assist in irrigation which is useful to control temperature and minimize charring (Ditter par [0011]).
Regarding claim 14, Townley in view of Ditter discloses the system of claim 1. Ditter further discloses wherein the ring-shaped electrode has a maximum thickness measured perpendicular to the axis of the deflectable element of at least 0.05 mm and an inner diameter in the range of 2 mm to 6 mm (Ditter par [0075] inner diameter is 2.3 mm, outer diameter is 3.0 mm, so thickness is about 0.47 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Townley with the ring-electrode disclosed by Ditter, as during ablation, heat is generated in the electrode or electrodes providing the ablation, as well as in the surrounding region, and such irrigation features assist to control temperature and minimize charring (Ditter par [0011]).
Regarding claim 20, Townley in view of Ditter discloses the system of claim 1. Townley further discloses an embodiment wherein the expandable distal end is an inflatable balloon with the electrodes disposed thereon (Townley Fig 13 expandable assembly (1370) electrodes (1344) par [0116]),
and further comprising a second irrigation tube extending into the inflatable balloon and configured to deliver irrigation fluid into the inflatable balloon and out through irrigation holes (Townley Fig 13 irrigation tube (1374) par [0122] irrigation fluid expressed through irrigation holes in assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Townley with an irrigated balloon as disclosed in an embodiment of Townley (Townley par [0116] embodiment may include features of other embodiments), as such a configuration allows for the cooling of the assembly electrodes (Townley par [0122])
Townley fails to explicitly disclose wherein the plurality of assembly electrodes are formed with irrigation holes therethrough.
However, Ditter discloses electrodes formed with irrigation holes therethrough (Ditter Fig 13 (69) par [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the assembly electrodes of Townley to have irrigation apertures therein to allow for direct cooling of the electrodes to prevent charring during treatment (Ditter par [0011])
Regarding claim 24, Townley in view of Ditter discloses the system of claim 4. Townley further discloses wherein the switching circuit is configured to switch between selectively forming the combined assembly electrode and sampling output from each of the assembly electrodes individually (Townley, Fig 2 switching circuit (204), par [0046] electrodes may switch between energy delivery and detection modalities, par [0072,0073] electrodes are independently selectable and thus can be selected together to act as a combined assembly electrode). As noted above under the Claim Interpretation heading, it is interpreted that any electrical connection able to selectively connect electrodes may be regarded as a “switching circuit”.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 20160331459 A1) in view of Ditter (US 20130006238 A1), and further in view of Viswanathan (US 20200205892 A1).
Regarding claim 12, Townley in view of Ditter discloses the system of claim 1. Townley further discloses wherein the ablation power generator is configured to apply the electrical signal between the combined assembly electrode and the ring-shaped electrode to perform therapy of tissue of the body part.
Townley fails to explicitly disclose where the therapy is electroporation.
However, Viswanathan discloses a similar catheter (Viswanathan Fig 1-2) wherein the ablation power generator is configured to apply the electrical signal between the assembly electrode and a ring-shaped electrode to perform therapy of tissue of the body part (Viswanathan Fig 2 assembly electrode (240) ring-shaped electrode (220) par [0078] electrical signal between anode and cathode to effect electroporation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ablation generator of Townley to incorporate a multi-electrode electroporation interface system such as taught by Viswanathan to produce the predictable results of being able to perform electroporation treatment (Viswanathan par [0004]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 20160331459 A1) in view of Ditter (US 20130006238 A1), and further in view of Harlev (US 20170312024 A1).
Regarding claim 21, Townley in view of Ditter discloses the system of claim 1. Townley further discloses wherein the expandable distal end assembly is formed by a plurality of flexible Nitinol strips (Townley par [0070]).
Townley fails to explicitly disclose electrodes formed by Nitinol strips that are covered with insulating material at each of their distal and proximal ends and are selectively exposed in their central regions to provide electrically active regions.
However, Harlev discloses a catheter medical system (Harlev FIGS.2A-2C) comprising electrodes formed by Nitinol strips that are covered with insulating material at each of their distal and proximal ends and are selectively exposed in their central regions to provide electrically active regions (Harlev Fig 6 (144b) par [0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Townley with electrodes formed from partially insulated Nitinol, such as taught by Harlev, as this facilitates uniform energy delivery (Harlev par [0100]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Monday-Friday 9am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (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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/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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