DETAILED ACTION
Applicant’s amendments and remarks in the response filed January 22, 2026 are fully acknowledged by the Examiner. Currently, claims 47-51, 53-57, 59 and 61-68 are pending, with claims 1-46, 52, 58 and 60 cancelled, claims 67 and 68 newly added, and claims 47, 48, 53, 56, 57, 59, 63, 65 and 66 amended. Applicant’s amendments to claims 48 and 63 have obviated the respective rejections under one or more of 35 U.S.C. 112(b) or (d). The following is a complete response to the January 22, 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 .
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.
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 § 102
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.
Claims 66-68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coulombe (US Pat. Pub. 2015/0359487 A1).
Regarding claim 66, Coloumbe provides for a catheter including a distal portion (support device 20 with the distal assembly 36), an expandable portion arranged on the distance 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], one or more intravascular electrodes arranged at least partly on the expandable portion (electrodes 16), 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 Coloumbe 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]), and
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 patient opposite to the expandable portion relative to the right phrenic nerve, so as to stimulate the right phrenic nerve (the Examiner notes that the catheter of Coloumbe with its electrodes 16 are readily capable of operating as claimed). The Examiner notes that it is well established that a recitation of the intended use of the claimed invention (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 catheter of Coloumbe 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, Coloumbe provides that catheter comprises a non-expandable distal end after the expandable portion having a length higher than lcm (see figure 6 with the linear section 80 being proximally after the expandable portion as the taken from a distal-to-proximal direction).
Regarding claim 68, Coloumbe 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).
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) 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 (see [0032] providing for “monopolar or unipolar energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”),
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 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 catheter 12 is disclosed as an intravascular catheter with such being structurally capable of being introduced as claimed; it is well established that if the prior art structure is capable of performing the intended use, then it meets the claim), 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 (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 patient opposite to the distal portion relative to the right phrenic nerve, (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 one or more intravascular electrodes so as to stimulate the right phrenic nerve (via the disclosed capability in Condie of the monopolar energy delivery between multiple ones of the electrodes 34 to electrode 57; the Examiner is of the position that the claimed ‘bipolar mode’ is equivalent to the monopolar mode of Condie; see at least [0008], [0047], [0056] and [0062] of the filed Specification that provides 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).
While Condie provides that its expandable portion forms a helix or spiral having a coil-shape in the expanded configuration, Condie fails to provides 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 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 Abboud in the rejection of claim 56 above, the combined arrangement of the expandable portion provides that, in the expanded configuration, the one or more intravascular electrodes are 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.
Claim 47-51 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) as applied to claim 47 above, and further in view of Ward (US Pat. Pub. 2008/0009846 A1).
Regarding claim 47, Condie provides for a system for phrenic nerve stimulation, the system comprising: catheter including one or more intravascular electrodes wherein each of the electrodes are arranged on a distal portion of the catheter (electrodes 34) and forming a single pole (see [0032] providing for “monopolar or unipolar energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”), 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 catheter 12 is disclosed as an intravascular catheter with such being structurally capable of being introduced as claimed; it is well established that If the prior art structure is capable of performing the intended use, then it meets the claim), and
an extracorporeal electrode comprising a conductive surface and configured to be affixed to the patient opposite to the distal portion relative to the right phrenic nerve, such that the conductive surface of the extracorporeal electrode is located at least partly on a right half of a back of the patient and/or at least partly on a right side of an upper body of the patient, across the right phrenic nerve from the location of the distal portion (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 one or more intravascular electrodes so as to stimulate the right phrenic nerve (via the disclosed capability in Condie of the monopolar energy delivery between multiple ones of the electrodes 34 to electrode 57; the Examiner is of the position that the claimed ‘bipolar mode’ is equivalent to the monopolar mode of Condie; see at least [0008], [0047], [0056] and [0062] of the filed Specification that provides 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).
Condie further provides for an energy source configured to be in electrical communication with the one or more intravascular electrodes and with the extracorporeal electrode (power source 56, see [0032] and [0033]), and a processor and a memory coupled together (see [0035] providing for 14 to have controllers, processors and stored instructions/algorithms). Condie then contemplates that the memory has recorded, thereon, a computer program wherein the computer program comprises code instructions configured for, when executed by the processor, controlling the energy source so as to perform phrenic nerve stimulation by delivering electric pulses that create an electric field between the single pole formed by the one or more intravascular electrodes and a pole formed by the extracorporeal electrode, the electric field causing stimulation of the right phrenic nerve (via the instructions functioning to controller the power source 56 to apply energy pulses between the at least one electrode 34 placed within the body and the electrode 57).
The Examiner is of the position that recited code instruction to be executed by the processor to cause the creation of the electric field to cause stimulation of the right phrenic nerve are directed towards a functional recitation of each of the energy source and the processor. It is well established that for programmed devices (in this case a processor and associated memory with stored instructions), the claimed function can be met by the prior art if such discloses a programmed device that is capable of performing the same function.
In the instant case, the Examiner is of the position that the system of Condie is readily capable of performing this claimed function. The Examiner has previously taken the position in the rejection that the catheter 12 is disclosed as an intravascular catheter with such being structurally capable of being introduced into the superior vena cava so as to place the distal portion at one of the claimed site, and the ground electrode 57 is capable of placement on the skin as set forth in the claim.
The Examiner is of the position that the remaining function attributed to the energy source and the control of the energy source to perform the phrenic nerve stimulation by the process/memory/code instructions are a result of the placement of each of the one or more intravascular electrodes and the extracorporeal electrode at a desired location as claimed, and then the subsequent generation of electrical pulses therebetween to cause the claimed electric field. The Examiner maintains that the power source 56 is readily capable of being controlled by the processor and the memory set forth in paragraph [0035] so as to cause electric pulses to be supplied between the pole formed by the at least one intravascular electrode and the return electrode to thereby cause the claimed phrenic nerve stimulation dependent upon the location at which each of the electrodes is placed in/on the body.
While Condie provides for the extracorporeal electrode (At 57), Condie fails to provide for such to specifically be an extracorporeal electrode patch. 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 48, in view of the combination in the rejection of claim 47 above, the exemplary return electrode of would further provide for the higher length/width measurements required by claim 48 (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 claim 47 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 claim 49, in view of the combination in the rejection of claim 47 above, the exemplary return electrode of would further for the inclusion of a conductive layer made of a flexible and/or metallic material, and/or a conductive adhesive coating. Ward specifically provides for its electrode patch to include a flexible conductive layer (see [0027]). 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 provided the construction of the electrode patch including the flexible conductive layer as in Ward to provide for an exemplary manner of constructing an electrode patch for coupling to an external surface of the body.
Regarding claims 50 and 51, Condie, provides for a lumen within the catheter (lumen I through shaft 22) for introducing a retractable inner straightening member (pull wire 48 as in [0030]) and then specifically the inner straightening member to be inside the lumen (48 running through the lumen in 22 as in [0030]).
Regarding claim 54, Condie provides that the one or more intravascular electrodes comprise a plurality of electrodes electrically connected together so as to form the single pole, or a plurality of individual electrodes electrically disconnected one from the other and operable altogether as the single pole (electrodes 34; see [0032] providing for “monopolar or unipolar energy delivery to one or more electrodes 34 … within a patient’s body and through a patient return or ground electrodes 57”).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 52 above, and further in view of Sherman et al. (US Pat. Pub. 2008/0281322 A1).
Regarding claim 53, while Condie contemplates a source configured to deliver electric pulses with a voltage and a pulse duration, Condie fails to specifically provide that the voltage amplitude is between 1V and 50V and of a duration between 0.1ms and 20ms. Sherman provides for a similar catheter and electrode arrangement as that of Condie, and specifically provides for a source (generator 10) that controls features of the applied voltage including an amplitude between 1V and 50V (see [0060] providing for 20-200V RMS and [0151] providing for 40V in an monopolar mode between an electrode and a return pad). Sherman also provides for durations of between 10 and 500 milliseconds (see [0059] and [0062]). 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 the energy source of Condie with the output parameters of the voltage and the duration as in Sherman to provide for an exemplary manner of delivering voltage pulses between electrodes and an electrode patch attached to the body. Condie, itself, cites to the Sherman reference in [0033] as an exemplary manner of providing the power source 56, and the Examiner is of the position that such would provide an exemplary manner of arranging the power source 56 to provide an exemplary delivery of monopolar energy between the electrodes 34 and the return electrode 57.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 47 above, and further in view of Hoffer et al. (US Pat. Pub. 2016/0220822 A1).
Regarding claim 55, Condie fails to provide for a unit for monitoring a diaphragmatic response to phrenic nerve stimulation. Hoffer provides for an intravascular device/system for applying energy within the body. Hoffer further provides for a unit capable of monitoring a diaphragmatic response to phrenic nerve stimulation (unit 8 with sensor 12 as in [0063] and [0064]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill int eh art at the time of filing to have utilized the feedback arrangement of the unit 8 as in Hoffer to the system of Condie to provide for additional sensing of response to stimulation to the patient during treatment. Such can provide, for example, mapping of nerves within the body, neurovascular pacing, and other diagnostic/therapeutic applications (See [0025] of Hoffer).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1) and Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 56 above, and further in view of Werneth et al. (US Pat. Pub. 2008/0281312 A1).
Regarding claim 64, while Condie provides for the expandable portion as in figures 2-4, Condie fails to specifically provide that the expandable portion has a diameter between 10 mm and 35 mm in the expanded configuration. Abboud fails to provide details of the diameter of its expandable portion as relied upon in the rejection of claim 56 above. Werneth provides for a similar expandable portion of a catheter as that of Condie and further provides for exemplary diameters in the expanded configuration of 15mm to 35mm (see [0075]). 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 diameter of the expandable portion as in Werneth as the diameter of the expandable portion of Condie to provide for an expandable portion of a desired size to accommodate treatment within a desired anatomy. The Examiner further notes that Condie itself cites to Werneth as providing additional details of its own expandable portion in [0027].
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1) and Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 56 above, and further in view of Schuler et al. (US Pat. Pub. 2017/0189106 A1).
Regarding claim 65, both Condie and Abboud fail to provide for the features of claim 65. Schuler discloses a similar device as that of Condie where an expandable portion is at least particularly made of a shape memory material for the claimed biasing into the expanded configuration (see [0046] with the self-expanding nitinol array, see also [0165] and [0166] with the nitinol arrangement). 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 self-expanding configuration in the form of a shape memory material for the expandable portion of Condie in view of the teaching of Schuler. Schuler readily provides that such a manner of providing an expandable portion at the distal end of the catheter is a well-known configuration in the art would function with a reasonably expectation of success to provide for the expanding of the expandable portion when at a target site within the body.
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 January 22, 2026 with respect to independent claim 47 and the recite limitation of the “extracorporeal electrode patch” have been fully considered but they are persuasive.
Applicant argues with respect to the rejection of claim 47 under 35 U.S.C. 102 as unpatentable over Condie on pages 10-11 of the Remarks. Therein, Applicant contend that Condie “does not disclose an ‘extracorporeal electrode patch’” in that the disclosed electrode 57 of Condie “could be, for example, a clamp electrode and still be ‘on a patient’s skin’”. The Examiner, upon further review of the Condie reference, finds this argument as persuasive. The Examiner notes that similar reasoning is equally applicable to independent claim 56 and the requirement of “an extracorporeal electrode patch” set forth therein.
As such, the Examiner has proffered a plurality of new rejections in the action above. A full list of these rejections appears below.
For the sake of completeness, the Examiner notes that Applicant further argues with respect to the amended subject matter in claim 47 in that “it would not make any technical sense to incorporate the specific computer program recited by the claim into the system of Condie, as the catheter of Condie and its electrodes are intended for radiofrequency ablation, not phrenic nerve stimulation.” The Examiner respectfully disagrees that the amended requirement of the energy source, the processor and the memory having the computer program thereon render the system as recited in claim 47 as structurally different from the prior art system of Condie.
The Examiner reiterates the position set forth in the rejection of claim 47 above that claimed code instructions of the computer program to be executed by the processor to cause the creation of the electric field to cause stimulation of the right phrenic nerve are directed towards a functional recitation of each of the energy source and the processor. It is well established that for programmed devices (in this case a processor and associated memory with stored instructions), the claimed function can be met by the prior art if such discloses a programmed device that is capable of performing the same function. Accordingly, the Examiner has taken the position that the system of Condie is readily capable of performing this claimed functionality as set forth in the amended version of claim 47.
The Examiner has proffered in the rejection of claim 47 that the catheter 12, in being disclosed as an intravascular catheter, is structurally capable of being introduced into the superior vena cava so as to place the distal portion at one of the claimed site, and the ground electrode 57 is capable of placement on the skin as set forth in the claim. The Examiner further submits that the remaining function attributed to the energy source and the control of the energy source to perform the phrenic nerve stimulation by the process/memory/code instructions are a result of the placement of each of the one or more intravascular electrodes and the extracorporeal electrode patch at a desired location as claimed, and then the subsequent generation of electrical pulses therebetween to cause the claimed electric field. The Examiner maintains that the power source 56 is readily capable of being controlled by the processor and the memory set forth in paragraph [0035] so as to cause electric pulses to be supplied between the pole formed by the at least one intravascular electrode and the patch electrode to thereby cause the claimed phrenic nerve stimulation dependent upon the location at which each of the electrodes is placed in/on the body.
Thus, it is for at least the reasoning set forth in the rejection of claim 47 as well above Remarks that the Examiner fails to find Applicant’s arguments on page 10 with respect to the now-recited energy source, processor, memory, computer program and code instructions as persuasive.
Applicant’s arguments, see pages 11-12 of the Remark filed January 22, 2026 with respect to the rejection of claim 56 under 35 U.S.C. 102(a)(1) as anticipated by Condie have been fully considered and are persuasive. First, the Examiner finds Applicant’s remarks with respect to the “extracorporeal electrode patch” as persuasive for at least the reasoning noted above. Further, the Examiner finds that the Condie reference fails to provide for more than one coil for the helix/spiral of the expandable portion given that Condie discloses, at most, the helix/coil to have a single coil. Therefore, the prior rejection of clam 56 as anticipated by Condie under 35 U.S.C. 102(a)(1) has been withdrawn.
Further Applicant’s arguments, see pages 12-13 of the Remark filed January 22, 2026 with respect to the rejection of claim 66 under 35 U.S.C. 102(a)(1) as anticipated by Condie have been fully considered and are persuasive. The Examiner finds that the Condie reference fails to provide for each and every limitation set forth independent claim 66 including that the expandable portion is at least partially made of a shape memory material biasing the expandable portion into the expanded configuration and then for the specific inclusion of either the retractable inner straightening member or the retractable sheath, and associated functionality as recited. Therefore, the prior rejection of clam 66 as anticipated by Condie under 35 U.S.C. 102(a)(1) has been withdrawn.
Upon further consideration of the prior art, the following new grounds of rejection have been set forth in the action above:
Claims 66-68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coulombe (US Pat. Pub. 2015/0359487 A1).
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) and Ward (US Pat. Pub. 2008/0009846 A1).
Claim 47-51 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) as applied to claim 47 above, and further in view of Ward (US Pat. Pub. 2008/0009846 A1).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 52 above, and further in view of Sherman et al. (US Pat. Pub. 2008/0281322 A1).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 47 above, and further in view of Hoffer et al. (US Pat. Pub. 2016/0220822 A1).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1) and Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 56 above, and further in view of Werneth et al. (US Pat. Pub. 2008/0281312 A1).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Condie et al. (US Pat. Pub. 2013/0296840 A1) in view of Abboud et al. (US Pat. Pub. 2014/0180278 A1) and Ward (US Pat. Pub. 2008/0009846 A1) as applied to claim 56 above, and further in view of Schuler et al. (US Pat. Pub. 2017/0189106 A1).
It is the Examiner’s position that each of the newly proffered new grounds of rejection are tenable for at least the reasoning set forth in the action above.
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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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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