DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 28, 2026 has been entered.
Currently, claims 56, 57, 59 and 61-77 are pending with claims 1-55, 58 and 60 cancelled, claims 69-77 newly added, and claims 56, 57, 66 and 67 amended. The following is a complete response to the July 28, 2026 communication.
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 Interpretation
The Examiner notes that the instant disclosure sets forth multiple special definitions for various terms and phrases utilized in the instant application. The Examiner further notes that the following listed paragraphs set forth the various terms/phrases and their respective definitions that will be utilized by the Examiner in the interpretation of the pending claims. Please see:
[0032] – “opposite to the distal portion relative to the phrenic nerve”;
[0042] – “phrenic nerve”;
[0042] – “vena cava”;
[0042] – “a patient”;
[0046] – “configured to be introduced in the vena cava of the patient so as to position the distal portion in the vena cava, in the right brachiocephalic vein, and/or in the right subclavian vein”;
[0046] – “simultaneously”;
[0052] – “intravascular electrode”;
[0053], [0068] – “ length” and “width”;
[0062] – “selective operation”;
[0064] – "operating the extracorporeal electrode patch in a bipolar mode with the one or more intravascular electrodes";
[0075] – “affixed to the patient”;
[0092] – “expandable portion”;
[0095] – “fit”;
[0096] – “circumferentially fit”;
[0098] – “in contact”;
[0099] – “positioned circumferentially”;
[0104] – “deflectable”;
[0107] – “helical/spiral configuration”;
[0110] – “loop configuration”;
[0111] – “lasso configuration”;
[0112] – “umbrella configuration”;
[0113] – “basket configuration”;
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.
Claims 56, 57, 59 and 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1), Coulombe (US Pat. Pub. 2015/0359487 A1) and Ward (US Pat. Pub. 2008/0009846 A1).
Regarding claims 56 and 59, Condie provides for a system capable of providing phrenic nerve stimulation, the system comprising a catheter including a plurality of intravascular electrodes (electrodes 34), the plurality of intravascular electrodes being (i) electrically connected together so as to form a single pole, or (ii) individual electrodes electrically disconnected one from the other and operable altogether as a single pole (the catheter with the electrodes 34 of Condie is functionally capable of operating as claimed in view of the disclosure in paragraph [0032] providing for “a plurality of output channels with each channel coupled to an individual electrode 34” and then for “energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57; such fails to structurally define the claimed catheter/electrodes over the prior art catheter/electrodes of Condie),
each intravascular electrode being arranged on an expandable portion of a distal portion of the catheter (the expandable portion at 36 as in figures 2 and 3), the catheter being configured to be introduced into a vein of a human patient so as to position the distal portion in the venin (the catheter 12 is disclosed as an intravascular catheter with such being structurally capable of being introduced as claimed), the expandable portion being configured to circumferentially fit the inner wall of the vein so as to remain in position during stimulation of adjacent tissue/nerves, thereby acting as an anchoring portion (the expandable portion 36 and the catheter at 16 is an intravascular device that would be capable of providing the claimed function when 36 is in an expanded position), and
an extracorporeal electrode configured to be affixed to the human patient opposite to the distal portion relative to the tissue within the body, (see [0032] with 57 being capable of placement on the skin as set forth in the claim), the extracorporeal electrode being operable in a bipolar mode with the plurality of intravascular electrodes when the plurality of intravascular electrodes forms a single pole or is operated altogether as a single pole, so as to stimulate tissue therebetween.
The Examiner preliminary notes that the claimed ‘bipolar mode’ is equivalent to the monopolar mode of Condie in view of the disclosure in paragraphs [0008], [0047], [0056] and [0062] of the filed Specification which provide that the claimed ‘bipolar’ energy delivery is between one or more electrodes internal to the body to a return electrode located on an external portion of the body. Accordingly, the Examiner is of the position that the disclosed capability in Condie of the monopolar energy delivery between multiple ones of the electrodes 34 to electrode 57 readily provide for the bipolar mode between the patch and the plurality of intravascular electrodes as claimed. The Examiner is further of the position that the plurality of intravascular electrodes would further function and/or operate together as a single pole given, again, that paragraph [0032] of Condie provides that for “a plurality of output channels with each channel coupled to an individual electrode 34” and then for “energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”.
While Condie provides that its expandable portion forms a helix or spiral having a coil-shape in the expanded configuration, Condie fails to provide that the number of coils is more than one (claim 56) or at most two (claim 59). Abboud discloses a similar device as that of Condie and specifically provides for a catheter with a plurality of intravascular electrodes (see figure 4A/B with catheter 34 and electrodes 90-97) wherein the distal end of the catheter is expandable to an expanded configuration with the expanded configuration to have more than one coil and at most two (see figures 4A/B with the expanded coil/spiral shape displayed having more than 1 coil, but less than 2 full coils). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the alternative number of spirals/coils for the expandable portion of Condie in view of the teaching of Abboud to provide for a known alternative manner of providing an expandable distal portion of a catheter capable of intravascular insertion of a plurality of electrodes. Condie already contemplates a helical/coiled arrangement with the alternative embodiment in Abboud functioning equally as well to deliver the electrodes within a lumen of the body and into contact with the lumen wall at a desired location.
While Condie contemplates the treatment within a vein/artery of the body and Abboud contemplates the placement its device to provide for treatment proximate the phrenic nerve (see at least claim 19), neither specifically set forth an exemplary circumferential fit (in light of the interpretation of the terms “fit” and “circumferentially fit” in respective paragraphs [0095] and [0096]) within the superior vena cava as claimed.
Coulombe provides for an exemplary catheter similar to that of Condie and Abboud and specifically provides for an expandable portion arranged on the distal portion of the catheter wherein the expandable portion is configured to circumferentially fit the inner wall of the superior vena cava so as to remain in position during phrenic nerve stimulation, thereby acting as an anchoring portion (see [0033] providing for the structural capability of the catheter of Coulombe to be inserted into the patient’s vasculature; [0044] and [0051] discuss the vena cava),
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have altered the size of the expandable portion of Condie in view of the teaching of the suitable size as in Coulombe to provide for an expandable portion of a catheter that would ‘circumferentially fit’ the vena cava of a patient as claimed. Coulombe readily teaches that it is known in the art to change size/diameter of an exemplary expandable member as in [0044] when the location of treatment is either in the pulmonary vein (the focus of Condie) or the SVC (the focus of Coulombe). The Examiner further notes that it is generally held that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
While Condie provides for the extracorporeal electrode (At 57), Condie fails to provide for such to specifically be an extracorporeal electrode patch. Abboud fails to cure this deficiency in Condie. Ward discloses an exemplary return electrode similar to that of Condie in the form of an extracorporeal electrode patch. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a patch electrode as in Ward for the extracorporeal electrode of Condie to achieve an externally located return/ground electrode that can safely and efficiently return energy delivered through one or more electrodes within the body. Ward further provides that its patch arrangement provides for a larger perimeter area with such having a reduction in the chance of burning at the electrode patch site.
Regarding claim 57, in view of the combination with Coulombe and Abboud in the rejection of claim 56 above, the combined arrangement of the expandable portion provides that, in the expanded configuration, the plurality of intravascular electrodes is positioned circumferentially on the expandable portion (via figure 2 of Condie providing for the electrodes 34 being placed circumferentially on 36, Abboud provides for a similar placement with electrodes 90-97 as in figures 4A-B).
Regarding claims 61 and 62, Condie provides that the catheter comprises a straight, non-expandable distal end after the expandable portion (see the straight, non-expandable end cap distal to the expandable portion s in figures 2/3).
Regarding claim 63, while Condie provides for the straight, non-expandable distal end after the expandable portion, Condie fails to specifically recite that the length of such is more than 1cm. The Examiner is of the position, however, that the end cap of Condie requires an inherent length and that the selection of such a value to be a length of greater than 1 cm (even such as 1.001 cm) would have been an obvious consideration to one of ordinary skill in the art when designing and manufacturing the device of Condie. It is well established the where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, the Examiner has found no criticality or unexpected results associated with a selection of a length at any length of the range set forth in claim 63 that would preclude the finding of obviousness as noted above.
Claims 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Coulombe (US Pat. Pub. 2015/0359487 A1) further in view of Condie et al. (US Pat. Pub. 2013/0296840 A1).
Regarding claim 66, Coulombe provides for a catheter including a distal portion (support device 20 with the distal assembly 36), an expandable portion arranged on the distal portion, the expandable portion being at least partially made of a shape memory material biasing the expandable portion into the expanded configuration (see figures 4A-7C with the expandable portion formed by the distal portion 58 as in [0039], a plurality of intravascular electrodes arranged at least partly on the expandable portion (at least two of the electrodes 16), the plurality of intravascular electrodes being capable of electrically connecting to a source of electrosurgical energy (see [0050]),
and a retractable sheath covering the expandable portion (sheath 24),
the catheter being configured to be introduced in the superior vena cava of a human patient so as to position the distal portion in the superior vena cava, in the right brachiocephalic vein, and/or in the right subclavian vein, the expandable portion being configured to circumferentially fit the inner wall of the superior vena cava, of the right brachiocephalic vein, and/or of the right subclavian vein, so as to remain in position during phrenic nerve stimulation, thereby acting as an anchoring portion (see [0033] providing for the structural capability of the catheter of Coulombe to be inserted into the patient’s vasculature; [0044] and [0051] discuss the vena cava),
the catheter being further configured such that retraction of the retractable sheath releases the biasing, thereby triggering automatic expansion of the expandable portion (retraction of 24 relative to 24/58 causing 58 to expand; see at least [0039]).
While Coulombe provides the connection of its electrodes 16 to the source of energy as in [0050], Coulombe is silent with respect to the explicit manner of electrically connecting the individual electrodes to either one another or to the source of energy so as to provide for one or both of the functional electrical connections set forth in “(i) electrically connected together so as to form a single pole, or (ii) individual electrodes electrically disconnected one from the other and operable altogether as a single pole”. Accordingly, while provided within a functional recitation of the intended use of the claimed catheter, it is unclear from the lack of description of the individual electrical connection of the electrodes 16 if the catheter of Coulombe is functionally capable of being operable to enable a bipolar mode between a single pole formed by the plurality of intravascular electrodes and an extracorporeal electrode patch affixed to the human patient opposite to the expandable portion relative to the right phrenic nerve, so as to stimulate the right phrenic nerve
Condie provides for a similar catheter as that of Coulombe that includes a plurality of intravascular electrodes (electrodes 34). Condie further provides for the electrodes of the catheter to have individual electrical connections such that the electrodes are electrically disconnected from one another (see [0032] providing for bipolar energy delivery with such requiring individual electrical connections through the catheter to provide for the bipolar energy delivery). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided individual electrical connections for each of the plurality of electrodes of the catheter of Coulombe in view of the teaching of Condie. Such would provide for a known manner of providing the requisite electrical connection for each of the electrodes of the catheter of Coulombe (as contemplated in its paragraph [0050]) and thereby allow for the selective delivery of energy to one or more of the electrodes of the catheter of Coulombe.
For the sake of completeness, the Examiner notes that instant claim 66 is directed towards a catheter in the preamble of the claim and not a system. The Examiner further notes that it is well established that a recitation of the intended use of the claimed invention, in the instant case the catheter being operable in the claimed bipolar mode of operation, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the claim is directed towards a catheter with a plurality of electrodes thereon, with the combined catheter of Coulombe and Condie readily providing for structure that is sufficiently capable of operating as claimed in conjunction with an extracorporeal patch electrode and a suitable source of energy.
Regarding claim 67, Coulombe provides that catheter comprises a non-expandable distal end distally located after the expandable portion and having a length higher than lcm (see figure 6 with the linear section 80 being distally located along the distal end of the device proximally after the expandable portion as the taken from a distal-to-proximal direction).
Regarding claim 68, Coulombe provides that the expanded configuration is a helical or a spiral configuration where the expandable portion forms a helix or a spiral (see figures 4A-7C with the spiral/helix arrangement), and the catheter is such that, when the retractable sheath is retracted and, at the same time, (ii) the helix or the spiral is stretched such that the catheter is in a straightened configuration, the distal portion consists of a single straight tube having a free distal end (tube formed by the structure of the distal portion 30).
Claims 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Coulombe (US Pat. Pub. 2015/0359487 A1) and Zirkle (EP-2664295-A1).
Regarding claims 69, Condie provides for an apparatus comprising a catheter (medical device 12 with the elongate body 16), the catheter including a free distal end (see figure 2 with the distal end being free), an expandable portion arranged on the distal portion (portion at 36 as in figure 2), the expandable portion having an expanded configuration being a helical configuration or a spiral configuration where the expandable portion forms a helix or a spiral that has a pitch/height (see figure 2 with the spiral/helical arrangement of 36)
a non-expandable distal end distally after the expandable portion and including the free distal end ((see the straight, non-expandable end cap distal to the expandable portion as in figure 2),
one or more intravascular electrodes arranged at least partly on the expandable portion (electrodes 34) and
either one of (i) a retractable inner straightening member inside a lumen of the catheter, or (ii) a retractable sheath covering the expandable portion (pullwire 48 as in [0030] with 48 being within the lumen 22),
the catheter being configured to be introduced into a vein of a human patient so as to position the distal portion in the venin (the catheter 12 is disclosed as an intravascular catheter with such being structurally capable of being introduced as claimed), the expandable portion being configured to circumferentially fit the inner wall of the vein so as to remain in position during stimulation of adjacent tissue/nerves, thereby acting as an anchoring portion (the expandable portion 36 and the catheter at 16 is an intravascular device that would be capable of providing the claimed function when 36 is in an expanded position),
the catheter being operable to enable a bipolar mode between a single pole formed by the one or more intravascular electrodes and an extracorporeal electrode patch affixed to the human patient opposite to the expandable portion relative to the right phrenic nerve, so as to stimulate the right phrenic nerve.
The Examiner preliminary notes that the claimed ‘bipolar mode’ is equivalent to the monopolar mode of Condie in view of the disclosure in paragraphs [0008], [0047], [0056] and [0062] of the filed Specification which provide that the claimed ‘bipolar’ energy delivery is between one or more electrodes internal to the body to a return electrode located on an external portion of the body. Accordingly, the Examiner is of the position that the disclosed capability in Condie of the monopolar energy delivery between multiple ones of the electrodes 34 to electrode 57 readily provide for the bipolar mode between the patch and the plurality of intravascular electrodes as claimed. The Examiner is further of the position that the plurality of intravascular electrodes would further function and/or operate together as a single pole given, again, that paragraph [0032] of Condie provides that for “a plurality of output channels with each channel coupled to an individual electrode 34” and then for “energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”.
While Condie contemplates the treatment within a vein/artery of the body Condie fails to specifically set forth an exemplary circumferential fit (in light of the interpretation of the terms “fit” and “circumferentially fit” in respective paragraphs [0095] and [0096]) within one of the listed locations as claimed such that the anchoring is “in a vena cava region vessel”.
Coulombe provides for an exemplary catheter similar to that of Condie and Abboud and specifically provides for an expandable portion arranged on the distal portion of the catheter wherein the expandable portion is configured to circumferentially fit the inner wall of the superior vena cava so as to remain in position during phrenic nerve stimulation, thereby acting as an anchoring portion (see [0033] providing for the structural capability of the catheter of Coulombe to be inserted into the patient’s vasculature; [0044] and [0051] discuss the vena cava),
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have altered the size of the expandable portion of Condie in view of the teaching of the suitable size as in Coulombe to provide for an expandable portion of a catheter that would ‘circumferentially fit’ the vena cava of a patient as claimed. Coulombe readily teaches that it is known in the art to change size/diameter of an exemplary expandable member as in [0044] when the location of treatment is either in the pulmonary vein (the focus of Condie) or the SVC (the focus of Coulombe). The Examiner further notes that it is generally held that a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
While Condie provides for the helical/spiral arrangement as in figure 2, Condie fails to specifically provide that such is at least partially made of a shape memory material biasing the expandable portion into an expanded configuration, the expanded configuration being the helical/spiral configuration wherein the helical configuration or the spiral configuration has a pitch or a height of one complete helical or spiral turn between 5mm and 15mm. Further, while Condie provides that the straightening member provides for the expansion of the expandable portion, Condie fails to specifically provide that the straightening member or the retractable sheath releases the biasing of the shape memory material so as to trigger automatic expansion of the expandable portion, the non-expandable distal end being straight and in an axis of the vena cava region vessel when the catheter expand. Coulombe fails to cure this deficiency.
Zirkle discloses a similar arrangement as that of Condie for providing an expandable helical/spiral arrangement at the distal end of the catheter. Zirkle, therein, provides for a catheter helical form constructed at least piratically of a shape-memory material (see paragraph [0057] discussing the helical form 22) wherein the helical confirmation includes one complete helical turn between 5mm and 15mm (see [0070] with the pitch of 0.5cm to 1.0cm). Zirkle then further teach a straightening member that releases the biasing of the shape memory material so as to trigger automatic expansion of the expandable portion, the non-expandable distal end being straight and in an axis of the vena cava region vessel when the catheter expands (via the use of the mandrel member 84 as in [0057]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the alternative helical member construction along with the associated straightening member of Zirkle in place of the single spiral arrangement as in figure 2 of Condie. Condie readily provides for various different structural arrangements of the distal structure 36 containing the electrodes thereon with Zirkle providing a known alternative arrangement that would function equally well as those arrangements in Zirkle to provide for the expanded configuration with electrode contact to tissue of a lumen.
Neither Condie nor Zirkle provide that the non-expandable distal end having a length higher than 1cm. The Examiner is of the position, however, that the end cap of Condie in figure 2 necessarily requires a length with the selection of a value to be greater than 1cm (even such as 1.001 cm) being an obvious consideration to one of ordinary skill in the art when designing and manufacturing the arrangement in the combination of Condie/Zirkle. The Examiner holds that it is well established that where the general conditions of a claim are discovered in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, the Examiner has found no criticality or unexpected results associated with a selection of a length at any length of the range set forth in claim 69 that would preclude the finding of obviousness as noted above.
Regarding claim 70, Condie further provides that the one or more intravascular electrodes comprise a plurality of intravascular electrodes arranged on the expandable portion, the plurality of intravascular electrodes being (i) electrically connected together so as to form a single pole, or (ii) individual electrodes electrically disconnected one from the other and operable altogether as a single pole (the catheter with the electrodes 34 of Condie is functionally capable of operating as claimed in view of the disclosure in paragraph [0032] providing for “a plurality of output channels with each channel coupled to an individual electrode 34” and then for “energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57; such fails to structurally define the claimed catheter/electrodes over the prior art catheter/electrodes of Condie).
Regarding claim 71, in view of the combination in the rejection of claim 69 above with Zirkle, the Examiner is of the position that Zirkle would either provide or render obvious an arrangement with five electrodes that are spaced above 4mm and below 18mm as claimed. In particular, Zirkle provides for a spacing (S) as in figures 25A and 25B of “approximately 4 millimeters” as in [0122]. Thus, the Examiner finds that such would either include a variance that would result in a value over 4mm, or that the general direction in Zirkle would render obvious the use of a value of above 4mm and below 18mm given that where the general conditions of a claim are discovered in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 72-77 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Coulombe (US Pat. Pub. 2015/0359487 A1) and Zirkle (EP-2664295-A1) as applied to claims 69 and 71 respectively above and further in view of Ward (US Pat. Pub. 2008/0009846 A1).
Regarding claims 72 and 75, while Condie provides for the extracorporeal electrode (At 57), Condie fails to provide for such to specifically be an extracorporeal electrode patch. Zirkle fails to cure this deficiency in Condie. Ward discloses an exemplary return electrode similar to that of Condie in the form of an extracorporeal electrode patch. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a patch electrode as in Ward for the extracorporeal electrode of Condie to achieve an externally located return/ground electrode that can safely and efficiently return energy delivered through one or more electrodes within the body. Ward further provides that its patch arrangement provides for a larger perimeter area with such having a reduction in the chance of burning at the electrode patch site.
Regarding claims 73 and 76, in view of the combination in the respective rejections of claims 72 and 75 above, the exemplary return electrode of would further provide for the higher length/width measurements required by the claim (see [0025]). Therefore, it is the Examiner's position that it would have been further obvious to one of ordinary skill in the art at the time of filing to have utilized a length/width measurement as in Ward for the combined electrode patch in the rejection of each of claims 72/75 above to achieve a patch that can safely and efficiently return energy delivered through one or more electrodes within the body. Ward further provides that its arrangement for providing the larger perimeter area provides the additional benefit of reduction in chances of burning at the electrode patch site.
Regarding claims 74 and 77, the Examiner is of the position that the combined catheter as set forth in the rejections of claim 70 above with the combined teachings of Condie and Coulombe would be configured to be introduced in the superior vena cava of the human patient so as to position the distal portion in the superior vena cava, the expandable portion being configured to circumferentially fit the inner wall of the superior vena cava when the expandable portion is in the expanded configuration, so as to remain in position during phrenic nerve stimulation, thereby acting as the anchoring portion, the expandable portion forming the helix or the spiral having more than one coil in the expanded configuration.
Terminal Disclaimer
The terminal disclaimer filed on January 22, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 11,553,963 has been reviewed and is accepted. The terminal disclaimer has been recorded. The acceptance of the terminal disclaimer has obviated the previously-filed obviousness-type double patenting rejection set forth in the October 22, 2025 Non-Final Office Action.
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered by the Examiner. The Examiner submits the following comments below in light of the new grounds of rejection set forth above and further in view of Applicant’s arguments in the Remarks with respect to the various reference still being relied upon by the Examiner in the Action.
As a preliminary matter, the Examiner notes that the rejection of claim 66 under 35 U.S.C. 102(a)(1) as anticipated by Coulombe has been withdrawn in the instant action. The Examiner has, instead, proffered a new grounds of rejection of claim 66 under 35 U.S.C. 103 as unpatentable over a combination of Coulombe and Condie.
For the sake of completeness, the Examiner notes that Applicant has submitted arguments in the second paragraph on page 11 and further highlights functional usage of the disclosed catheter at a desired location within the body in the third paragraph on page 11. Applicant then points to granted US Pat. No. 11,553,963 on pages 11-12, and specifically notes that the allowed method therein for performing phrenic nerve stimulation should be taken into consideration when considering non-obvious of instant claim 66 over the prior art.
The Examiner must highlight that the preamble of independent claim 66 is specifically directed towards a catheter and not an electrosurgical system. The remainder of the claim sets forth various structural features of the catheter including a distal portion, an expandable portion and a plurality of intravascular electrode, and then further sets forth various functional limitations related to these structural features. The Examiner notes, with respect to these highlighted functional limitations in claim 66, that it is well established that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See, at least, MPEP 2114.
Applicant has specifically argued that the catheter of Coulombe is not functionally capable of operating to provide for “a bipolar mode between a single pole formed by the intravascular electrodes and an extracorporeal electrode patch affixed to the patient opposite to the expandable portion relative to the right phrenic nerve, so as to stimulate the right phrenic nerve” (see lines 7-12 on page 12 of the Remarks) and alleges that the electrodes 16 of Coulombe are only suggested to have “an operation of a pair of electrode in a bipolar mode to create an electrical field between the two electrodes”. Applicant concludes that the capability of in operating the electrodes of the claimed catheter in manner set forth items (i) and (ii) in claim 66 is not contemplated by Coulombe. Applicant furthers this reasoning in highlights Coulombe’s inclusion of a switch to define pairs of electrode to operate in a desired bipolar mode, and that “it would never be possible to form a single pole with the plurality of electrodes 16” thereby preventing the catheter to operate as set forth in either of items (i) or (ii) in claim 66.
But these arguments are directed towards the functionality of the overall system of Coulombe and not to the structure and functional capability of the catheter itself. Said differently, while the Examiner recognizes that the overall system of Coulombe may not be explicitly set forth as functioning in the manner set forth in items (i) and (ii), the Examiner maintains the position that the catheter of Coulombe provides for structure that would indeed be readily capable of functioning as set forth in claim 66. MPEP 2114 establishes, which respect to functional recitations in an apparatus claim, that “the burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971)”. In the instant case, the Examiner fails to find Applicant’s arguments as persuasive in showing that the catheter of Coulombe as relied upon in the rejection of claim 66 above, does not possess the claimed functional capabilities as required by the claim. Thus, the Examiner must maintain that the rejection of claim 66 remains tenable given that the prior art structure is capable of performing the functional recitation of the intended use of the claim catheter.
The Examiner further notes that this capability is only further supported by the combination with the Condie reference with such providing the catheter with individual electrical connections to each of the electrodes thereby allowing the electrodes of the catheter to be selectively energized as desired if/when connected to a suitable source of energy.
The Examiner has further reviewed Applicant’s remarks on pages 14-15 of the Remarks with respect to the reliance on the disclosure of Condie to provide for the requirement in amended claim 56 of “the catheter being configured to be introduced in the superior vena cava … the expandable portion being configured to circumferentially fit the inner wall of the superior vena cava so as to remain in position …”and has found such to be persuasive given the noted differences in the relative sizes of the pulmonary vein and the superior vena cava. Further, the Examiner has interpreted the claim in light of the definitions of “fit” and “circumferentially fit” in paragraphs [0095] and [0096] of the filed Specification, with such requiring a specific dimension size relative to the wall of the vessel the expandable member is inserted into. Therefore, the prior rejection of claim 56 under 35 U.S.C. 103 based on the Condie reference have been withdrawn.
For the sake of the completeness, and in view of Condie still being relied upon in the rejection of claim 56 above, Applicant has argued with respect to the functionality of the system of Condie on pages 15-17 of the Remarks. Applicant alleges that Condie fails to provide for “the extracorporeal patch being operable in a bipolar mode with the plurality of intravascular electrodes when the plurality of intravascular electrodes forms a single pole or is operated altogether as a single pole”. Applicant provides a review of cited paragraph [0032] of Condie on page 16 in alleging that Condie contemplates three options for operation that ultimately result localized energy delivery with the monopolar option of Condie resulting in “the use of individual electrodes, for very local ablation energy delivery”. The Examiner fails to find these arguments as persuasive.
As a preliminary matter, the Examiner notes that the claim terminology of “” in claim 56 is specifically defined in paragraph [0064] of the filed Specification to mean:
By "operating the extracorporeal electrode patch in a bipolar mode with the one or more intravascular electrodes", it is meant that the extracorporeal electrode patch may form one pole and the (selected) intravascular electrode(s) may form another pole, thus creating an electric field between the two poles. For example, the extracorporeal electrode patch may form the cathode while the one or more intravascular electrodes may form the anode. Alternatively, the extracorporeal electrode patch may form the anode while the one or more intravascular electrodes may form the cathode. Optionally the stimulation system may be configured for alternating polarity of the extracorporeal electrode patch and of the one or more intravascular electrodes.
In light of this defining of what is meant by a “bipolar mode”, the Examiner maintains the position set forth in the Action above that the claimed bipolar mode is substantially similar, by definition, to the monopolar mode set forth in Condie.
Accordingly, the Examiner is of the position that the disclosed capability in Condie of the monopolar energy delivery between multiple ones of the electrodes 34 to electrode 57 readily provide for the bipolar mode between the patch and the plurality of intravascular electrodes as claimed. The Examiner is further of the position that the plurality of intravascular electrodes would be capable of functioning so as to operate together as a single pole given, again, that paragraph [0032] of Condie provides that for “a plurality of output channels with each channel coupled to an individual electrode 34” and then for “energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”.
While Applicant proffers three distinct operating modes in view of the disclosure in [0032] of Condie, Applicant is conflating the disclosed system of Condie (including its catheter, ground electrode, and generator) to the claimed system of set forth in claim 56. Said differently, the system of claim 56 only requires the catheter and the extracorporeal electrode patch. There is no claim language directed towards any manner of switch (as argued for being required in Condie to provide the three operating modes on page 16 of the Remarks) or any manner of electrosurgical generator for providing the claimed bipolar mode of operation of the system.
The Examiner, therefore, must maintain that the catheter and ground electrode of Condie are indeed capable of being operated in the bipolar mode as claimed given that the electrodes of Condie’s catheter are individually electrically connectable to a source of energy along with the ground electrode in view of the disclosure in [0032]. If Applicant desires a narrower interpretation of the claimed system, limitations that either structurally and/or functionally limit electrical interconnections within the system, or which add additional structural features such as the source of electrosurgical energy can be added to define the claimed system over the functional capability of the catheter and ground electrode of Condie.
The Examiner notes, in view of the various arguments in the response filed July 28, 2026, the following new grounds of rejection for the pending claims have been set forth in the action above:
Claims 56, 57, 59 and 61-63 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1), Coulombe (US Pat. Pub. 2015/0359487 A1) and Ward (US Pat. Pub. 2008/0009846 A1).
Claims 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Coulombe (US Pat. Pub. 2015/0359487 A1) further in view of Condie et al. (US Pat. Pub. 2013/0296840 A1).
Claims 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Coulombe (US Pat. Pub. 2015/0359487 A1) and Zirkle (EP-2664295-A1).
Claims 72-77 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) further in view of Coulombe (US Pat. Pub. 2015/0359487 A1) and Zirkle (EP-2664295-A1) as applied to claims 69 and 71 respectively above and further in view of Ward (US Pat. Pub. 2008/0009846 A1).
Conclusion
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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