DETAILED ACTION
Applicant’s amendments and remarks, filed April 10, 2026, are fully acknowledged by the Examiner. Currently, claims 18, 20-26, 28-34 and 36-40 are pending with claims 38-40 newly added, claims 1-17, 19, 27 and 35 cancelled, and claims 18, 25, 30 and 33 amended. Applicant’s amendments to claim 25 have obviated the previously-filed rejection under 35 U.S.C. 112(b). The following is a complete response to the April 10, 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 .
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 a) “an internal stylet slidably disposed within the electrode lead” as in claims 18 and 25, and b) “a respective internal stylet slidably disposed within each of the first, second, and third electrode leads” as in claim 33, 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 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 18, 20-26, 28-34 and 36-40 are 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 claims 18, 25 and 33, claims 18 and 25 each recite the new limitation of “an internal stylet slidably disposed within the electrode lead”. Claim 33 recites a similar new limitation of “a respective internal stylet slidably disposed within each of the first, second, and third electrode leads”.
The Examiner has reviewed the instant disclosure, but has failed to find any recitation that clearly establishes either implicit or explicit support for the style to be “slidably disposed” with a stylet as claimed.
First, the Examiner notes that Applicant sets forth that support for the amendments made in the April 10, 2026 response can be figure in at least “FIG. 2 and [0047] of U.S. Publication No. 2024/0407822”. The Examiner has reviewed all of the filed figures included noted figure 2, but has failed to find any depiction in any of the drawings that display a) a stylet, b) an internal stylet or c) an internal stylet that is slidably disposed within a respective electrode lead. The Examiner notes that figure 2 provides for an electrode lead 130 and a needle 120, but fails to illustrate any manner of stylet or any manner of internal structure of the lead 130 to reasonable convey to one of ordinary skill in the art that the internal stylet was contemplated as being slidably disposed therein.
Turning to the Specification, the Examiner has reviewed the cited paragraph [0047] of the publication for support of the above-noted at-issue limitations. The disclosure, therein, provides for the inclusion of an internal stylet that functions to configure/steer the lead “in response to manipulation of an internal stylet”, with the internal style being “a rigid linear member”. Paragraph [0047] continues that “when the stylet is withdrawn, the electrode lead 130 can reconfigure to its natural, unconstrained shape” such that the control of the amount of the withdrawal of the style functions to steer and reconfigure the electrode lead. The Examiner is of the position, however, that this disclosure fails to either implicitly or explicitly support that the internal stylet is specifically arranged as being slidable within the electrode lead.
Said differently, while [0047] discusses withdrawing the stylet relative to the electrode lead, there is nothing to suggest that this withdrawing of the stylet is specifically the sliding of the stylet within the electrode lead. There are multiple other manners in which an internal stylet can be arrangement within the electrode lead to provide the disclosed manipulation/steering that are equally as plausible as the stylet being slidably disposed within the electrode lead as presented claimed. This, coupled with the lack of depiction in the figures of the structure of either of the a) internal structure of the electrode lead or b) the internal stylet itself, results in the Examiner finding that the disclosure in Applicant-cited paragraph [0047] fails 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
The Examiner has found additional disclosure of the stylet in [0007] (“a stylet-drive flexible lead that is configurable by an internal stylet …”), [0009] (“electrode lead may be a stylet-drive flexible lead that is configurable by an internal stylet”), [0011] (“first, second and third electrodes leads may each by stylet-driven flexible leads that are configurable by an internal stylet”, [0057] (“the electrode lead 230 is a stylet-driven flexible lead that is configurable (e.g., steerable) in response to manipulation of an internal stylet”), [0065] (“the electrode leads 330a-c are stylet-driven flexible leads that are configurable (e.g., steerable) in response to manipulation of internal stylets”), and [0089] (“each of the electrode branches can have a stylet therein by which the shape of the electrode branches can be controlled”).
These additional paragraphs, much like the disclosure in paragraph [0047], fail to clearly convey that the internal stylet (single electrode lead) or internal stylets (multiple electrode leads) were ever contemplated as being specifically configured to be slidably disposed within a respective one or more of the electrode leads.
Thus, it is the Examiner’s position, for at least the reasoning in the rejection above, that each of claims 18, 25 and 33 contain 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. Claims 20-14, 26, 28-32, 34 and 36-40 are rejected due to their respective dependency on claims 18, 25 and 33. Appropriate correction is required.
Regarding claims 38-40, each claim recites further limitations of the internal stylet (claims 38, 39) or each of the plurality of stylets (claim 40) therein. The Examiner notes that, while the various limitations set forth in each of claims 38-40 are supported by the disclosure in one or more of paragraphs [0007], [0009] , [0011], [0047], [0057], [0065], and [0089], the Examiner has failed to find support for the combination of limitations set forth in each of claims 38-40 wherein the stylet(s) is/are slidably disposed within a respective electrode lead. The Examiner points to the rationale set forth in the rejections of claims 18, 25 and 33 above to support this position. Appropriate correction is required.
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 18, 21-24 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Friedman et al. (US Pat. No. 9,144,431 B2), Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Regarding claim 18, Nishina provides for an endoscopic or endobronchial tumor treatment system (see figures 39, 40 and 55) comprising:
an ultrasound probe (EUS 2A1) comprising a shaft (insertion portion 21) and an ultrasonic transducer attached to a distal end of the shaft (30A), the shaft defining a working channel (a channel defined at 32),
a sheath defining a first lumen (sheath 53 defines a first lumen therethrough), the sheath being slidably disposable within the working channel and extendable from a distal end of the working channel (see at least [0102] providing for 53 to be insertable within the working channel and to extend from the opening at 32),
a needle slidably disposed within the first lumen, the needle defining a lumen (54), and
an electrode lead slidably disposed within a second lumen and configured to be an anode (see figure 55 with 3 extending from a second lumen 32a of the device).
While Nishina contemplates the limitations above and further provides for the inclusion of multiple lumens as well as multiple treatment devices, Nishina fails to specifically contemplate for the sheath to specifically define the second lumen or for the needle within the first lumen to be configured to be a cathode.
Friedman discloses an exemplary treatment device for use with an endoscopic system and specifically provides for a sheath that includes a first lumen and a second lumen (see figure 2B with the sheath at 110a with the lumens at 112a and 114a). Therefore, it is the Examiner’s position that it would have been obvious to utilize a sheath with a first and second lumen through the working channel 32 of Nishina to provide for an alternative manner of delivering both the needle and electrode lead to the target location within the body. Nishina readily contemplates the usage of various numbers of working channels as well as various iterations of the number and types of probes used. As such, the Examiner finds that the use of a single working channel with a dual-lumen sheath would have been an obvious consideration in light of the teaching of Friedman that would function equally as well and with a reasonable expectation of success to provide endoscopic delivery of the needle and electrode lead to the target location within the body.
Friedman fails to cure the deficiency in Nishina for the needle to be configured to function as a cathode. Grossman, however, provides for the use of a endoscopically placed needle as an electrode for delivering energy to another portion of the device (at least 32 in figure 2B is described as a needle capable of delivering RF energy). Thus, 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 needle of Nishina as an electrode per the teaching of Grossman. Such provides the user the ability to select a desired treatment location/area for applying energy by the device. Nishina itself contemplates utilizing two or more electrode leads itself, and the use of the needle as an electrode would result in both the ability to deliver fluid and markers to the location of treatment while also allowing for the delivery of energy.
While Nishina contemplates the selective direction of the a needle (figure 2, see 5/53/54 being steered by 33), and for the placement of an electrode at different locations relative to the distal end of the device (See figures 24, 31, 37, and 40-43), neither Nishina nor the above combination of references provide that the electrode lead is a stylet-driven flexible lead that comprised an unconstrained curved shape wherein, an internal style is slidably disposed within the electrode lead, the internal stylet configured to control the shape of the electrode lead, wherein the electrode lead assumed the unconstrained curved shape upon withdrawal of the internal stylet.
Ventura discloses an exemplary manner of steering the distal end of a probe within the body where the angle of the distal end of the probe is adjustable via the use of an internal stylet (see figures 43A and B with the stylet at 370 within the probe 320), wherein the probe is capable of assuming an unconstrained curved shape upon withdrawal of the internal stylet (see figure 43B with the right-most option have the stylet 370 withdrawn with 320/328 having an unconstrained curved shape).
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 an internal stylet as in Ventura to the electrode lead of Nishina to provide for an exemplary member of controlling the desired direction and angle of the tip of the electrode lead. Nishina already contemplates embodiments when the direction/angle a probe or electrode is changed with Ventura providing for an exemplary alternative manner of providing such with a probe inserted within the body itself.
Regarding claim 21, Nishina provides that the needle is configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 21).
Regarding claim 22, Nishina provides that the sheath is distally extendable from a distal end of the working channel (see at least [0102] providing for 53 to be insertable within the working channel and to extend from the opening at 32).
Regarding claim 23, in view of the combination in the rejection of claim 18 above, the combined needle capable of functioning as a cathode would further be configured to deliver a pulsed electrical field or electroporation energy to a target tissue. Such is a functional recitation of the intended use of the needle that would fail to structurally define the claimed needle from that of the prior art.
Regarding claim 24, Nishina provides that the ultrasound probe is configured to provide ultrasonic visualization for endoscopically or endobronchially treating tumors (the probe 2A1 is capable of providing such visualization via 3A functioning to provide for endoscopic imaging).
Regarding claim 38, in view of the combination with Ventura above, Ventura further provides for that the internal stylet is a rigid linear member (stylet 370 as in [0206] is a rigid member, with the figures showing at least one linear portion) wherein the combined arrangement results in an electrode lead that is configured to be steered by partially withdrawing the internal stylet to control an extent to which the electrode lead partially reconfigures to the unconstrained curved shape (in view of the rationale in the rejection of claim 18 above, and further as shown in figure 43B of Ventura with the partial withdrawing changing the shape)
Claims 25, 26, 29-32 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Regarding claim 25, Nishina provides for an endoscopic or endobronchial tumor treatment system (See figures 39, 40 and 55) comprising:
an ultrasound probe (probe at 2) comprising a shaft (insertion portion at 21) and an ultrasonic transducer attached to a distal end of the shaft (transducer at 30/30A), the shaft defining a working channel (the passageway through 21 operably coupled to the opening at 32),
a needle slidably disposed within the working channel, the needle defining a lumen (see figure 55 with the needle at 5A),
a collar adapter configured to attach to a shaft of an ultrasound probe and defining a lumen (the collar formed at the distal end of 21a1 as in figure 55; such defines a lumen at 32a), and
an electrode lead comprising one or more contact electrodes and being slidably disposed within the lumen of the collar adapter and configured to be an anode (ablation device 3 as in figure 55; 3 is slidably disposed within the lumen at 32a and through the remainder of the device).
While Nishina contemplates the limitations above, Nishina fails to specifically contemplate for the needle to be configured to be a cathode. Grossman, however, provides for the use of a endoscopically placed needle as an electrode for delivering energy to another portion of the device (at least 32 in figure 2B is described as a needle capable of delivering RF energy). Thus, 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 needle of Nishina as an electrode per the teaching of Grossman. Such provides the user the ability to select a desired treatment location/area for applying energy by the device. Nishina itself contemplates utilizing two or more electrode leads itself, and the use of the needle as an electrode would result in both the ability to deliver fluid and markers to the location of treatment while also allowing for the delivery of energy.
While Nishina contemplates the selective direction of the a needle (figure 2, see 5/53/54 being steered by 33), and for the placement of an electrode at different locations relative to the distal end of the device (See figures 24, 31, 37, and 40-43), neither Nishina nor the above combination of references provide that the electrode lead is a stylet-driven flexible lead that comprised an unconstrained curved shape wherein, an internal style is slidably disposed within the electrode lead, the internal stylet configured to control the shape of the electrode lead, wherein the electrode lead assumed the unconstrained curved shape upon withdrawal of the internal stylet.
Ventura discloses an exemplary manner of steering the distal end of a probe within the body where the angle of the distal end of the probe is adjustable via the use of an internal stylet (see figures 43A and B with the stylet at 370 within the probe 320), wherein the probe is capable of assuming an unconstrained curved shape upon withdrawal of the internal stylet (see figure 43B with the right-most option have the stylet 370 withdrawn with 320/328 having an unconstrained curved shape).
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 an internal stylet as in Ventura to the electrode lead of Nishina to provide for an exemplary member of controlling the desired direction and angle of the tip of the electrode lead. Nishina already contemplates embodiments when the direction/angle a probe or electrode is changed with Ventura providing for an exemplary alternative manner of providing such with a probe inserted within the body itself.
Regarding claim 26, in view of the combination with Grossman above, the combined needle provide for an outer insulative covering on the needle except for the distal end portion of the needle (see figures 2A/B with the insulation at 34 and the exposed tip at 32).
Regarding claim 29, Nishina provides that the needle is configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 25).
Regarding claim 30, Nishina further provides that the collar adapter is capable of being slidably attached to an outer diameter of the shaft of the ultrasound probe (the collar formed at the distal end of 21a1 as in figure 55 would be capable of being attached to an outer diameter of an endoscope shaft).
Regarding claim 31, in view of the combination in the rejection of claim 25, the combined system would provide that each of the electrode lead and the needle are positioned to contact tissue when configured in a deployed state (via each of 3 and 5A functioning to contact tissue in a deployed state).
Regarding claim 32, in view of the combination in the rejection of claim 25 above, the combined needle capable of functioning as a cathode would further be configured to deliver a pulsed electrical field or electroporation energy to a target tissue. Such is a functional recitation of the intended use of the needle that would fail to structurally define the claimed needle from that of the prior art.
Regarding claim 39, in view of the combination with Ventura above, Ventura further provides for that the internal stylet is a rigid linear member (stylet 370 as in [0206] is a rigid member, with the figures showing at least one linear portion) wherein the combined arrangement results in an electrode lead that is configured to be steered by partially withdrawing the internal stylet to control an extent to which the electrode lead partially reconfigures to the unconstrained curved shape (in view of the rationale in the rejection of claim 18 above, and further as shown in figure 43B of Ventura with the partial withdrawing changing the shape).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Friedman et al. (US Pat. No. 9,144,431 B2), Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 18 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 20, while Nishina provides that the electrode lead includes two contact electrodes (see [0100] with the electrodes 43A and 43B) fails to specifically recite that the electrode lead includes three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Nishina and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). 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 three or more contact electrodes as in Machell to the electrode lead of Nishina to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 25 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 28, while Nishina provides that the electrode lead includes two contact electrodes (see [0100] with the electrodes 43A and 43B) fails to specifically recite that the electrode lead includes three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Nishina and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). 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 three or more contact electrodes as in Machell to the electrode lead of Nishina to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Claims 33, 34, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1), and further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Regarding claim 33, Long provides for an endoscopic or endobronchial tumor treatment system (see figures 1 and 4A-B) comprising,
an imaging probe comprising a shaft (endoscope 12 having a shaft 32) and an imaging modality attached to a distal end of the shaft (see [0029] providing for the imaging via the distal end of the endoscope 12)
the shaft defining a working channel; a needle slidably disposed within the working channel, the needle defining a lumen and configured to be a cathode;
a collar adapter capable of being attached to a shaft of an endoscope (33 is capable of contacting an endoscope so as to be attached thereto) defining a first lumen, a second lumen, and a third lumen (see figures 2A-2D and 4A-4B where the embodiment in figures 4A and B with 33 having three lumens therein; see also [0049] and [0050]),
a first electrode lead slidably disposed within the first lumen of the collar adapter and configured to be an anode (124),
a second electrode lead slidably disposed within the second lumen of the collar adapter and configured to be an anode (125), and
a third electrode lead slidably disposed within the third lumen of the collar adapter and configured to be an anode (126).
Long fails to provide that the imaging probe is an ultrasound probe having an ultrasound transducer disposed at the distal end, and for a needle slidably disposed within the working channel, the needle defining a lumen and configured to be a cathode. Nishina provides for an exemplary imaging probe similar to that of Long and specifically provides that such is an ultrasound endoscope (see figures 2 and 9 with the endoscope 2 with the transducer 30). Nishina further provides for the inclusion of a needle slidably disposed within the working channel (see figures 2 and 9 with the probe 3 slidably disposed within the channel 32), the needle defining a lumen and configured to be a cathode (via 42 of 3 being a tube and configured to connect to a cathode of an electrical source).
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 ultrasound endoscope as in figures 2/9 of Nishina in place of the endoscope of that of Long to provide for an alternative manner of imaging and directing energy to tissue within the body. Nishina, like Long, contemplates the usage of an ultrasound endoscope with multiple electrodes (see figures 41A-42 providing for Nishina to utilize three electrode like that in Long), and would further provide the ability of the ultrasound endoscope to provide both visual imaging as well as ultrasound imaging to provide for targeting of desired tissue within the body.
While Long contemplates the selective direction of the a needle with the placement of needle at different locations relative to the distal end of the device (figures 2A-D with the steering of 25; see also figures 3-4 with the various arrangement of the probes 25, or 125/126), and for (See figures 24, 31, 37, and 40-43), neither Long nor the above combination of references provide that each of the first, second and third electrode leads are a stylet-driven flexible lead that each comprise an unconstrained curved shape wherein a respective internal style is slidably disposed within each electrode lead, the respective internal stylet configured to control the shape of the respective electrode lead, wherein the respective electrode lead assumes the unconstrained curved shape upon withdrawal of the respective internal stylet.
Ventura discloses an exemplary manner of steering the distal end of a probe within the body where the angle of the distal end of the probe is adjustable via the use of an internal stylet (see figures 43A and B with the stylet at 370 within the probe 320), wherein the probe is capable of assuming an unconstrained curved shape upon withdrawal of the internal stylet (see figure 43B with the right-most option have the stylet 370 withdrawn with 320/328 having an unconstrained curved shape).
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 an internal stylet as in Ventura to each electrode lead of Long to provide for an exemplary manner of controlling the desired direction and angle of the tip of the electrode lead. Long already contemplates embodiments when the direction/angle a probe or electrode is changed with Ventura providing for an exemplary alternative manner of providing such with a probe inserted within the body itself.
Regarding claim 34, the combination of Long and Nishina provides for an outer insulative covering on the needle except for on a distal end portion of the needle (see [0098] of Nishina providing that the needle would include an insulating portion at 42 with an exposed portion at 43).
Regarding claim 37, in view of the combination in the rejection of claim 33 above with the needle provided per Nishina, the combined system would include the needle to be configured to obtain a tumor tissue sample and to inject processed tissue or other immune enhancing substances into a tumor (the needle 5 has a passageway therethrough thereby providing for the functional capability set forth in claim 21).
Regarding claim 40, in view of the combination with Ventura above, Ventura further provides for that each internal stylet is a rigid linear member (stylet 370 as in [0206] is a rigid member, with the figures showing at least one linear portion) wherein the combined arrangement results in that each respective electrode lead is configured to be steered by partially withdrawing the internal stylet to control an extent to which the electrode lead partially reconfigures to the unconstrained curved shape (in view of the rationale in the rejection of claim 18 above, and further as shown in figure 43B of Ventura with the partial withdrawing changing the shape).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1) further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 33 above and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Regarding claim 36, Long fails to provide that the first, second, and third electrode leads each comprise three or more contact electrodes. Machell provides for a similar flexible electrode lead as that of Long and specifically contemplates the inclusion of three or more contact electrodes (see figure 2 with electrodes 20/22/24/26). 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 three or more contact electrodes as in Machell to each electrode lead of Long to provide for an alternative manner of providing bipolar treatment to a target location. Machell specifically provides that three or more electrode contacts provides the user the ability to select desired combinations of electrode contacts to achieve treatment of a desired area and/or volume of tissue along the electrode lead without needing to move/manipulate the electrode lead (See at least [0048] and [0060]).
Response to Arguments
Applicant’s arguments, see pages 6-8 of the Remarks filed April 10, 2026, with respect to the prior rejections of each of claims 18, 25 and 33 under 35 U.S.C. 103 for the various grounds set forth in the January 13, 2026 Non-Final Rejeciton have been fully considered and are persuasive. Specifically, Applicant has persuasively argued with respect to each of independent claims 18, 15 and 33 that each respective prior art combination under 35 U.S.C. 103 fails to provide for each and every limitation set forth therein. In particular, the prior teaching of Cosman was previously relied upon by the Examiner to teach an internal stylet, but Cosman fails to provide for the claimed internal stylet (claims 18 and 25) or respective stylets (claim 33) that is slidably disposed within the electrode lead such that an electrode lead can assume an unconstrained curved shape upon withdrawal of the internal stylet.
Accordingly, each of the prior rejections under 35 U.S.C. 103 have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 18, 21-24 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Friedman et al. (US Pat. No. 9,144,431 B2), Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Claims 25, 26, 29-32 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) and further in view of Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Friedman et al. (US Pat. No. 9,144,431 B2), Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 18 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Nishina et al. (US Pat. Pub. 2012/0078094 A1) in view of Grossman (US Pat. Pub. 2006/0189972 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 25 above, and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
Claims 33, 34, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1), and further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Long et al. (US Pat. Pub. 2011/0098704 A1) further in view of Nishina et al. (US Pat. Pub. 2012/0078094 A1) and Ventura et al. (US Pat. Pub. 2008/0015625 A1) as applied to claim 33 above and further in view of Machell (US Pat. Pub. 2008/0033426 A1).
It is the Examiner’s that the newly cited Ventura reference readily cures the above-noted deficiencies in the previous prior art combinations (including the specific deficiency in the teaching of the Cosman reference) for at least the reasoning set forth in the updated action.
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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