DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 03/03/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome each claim objection and the interpretation of the prior art rejection with respect to claim 2 previously set forth in the Non-Final Office Action mailed 12/04/2025, however has not overcome the interpretation of the prior art rejection with respect to claim 1. An alternate rejection to claim 2 is applied as outlined below.
Response to Arguments
Applicant’s arguments with respect to claims 2, 12, 13, 15, and 17 have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Applicant's arguments filed 03/03/2026 have been fully considered but they are not persuasive with respect to claims 1, 7-9, and 13.
Applicant argues on pages 9-10 that Viswanathan is not in the “field of endeavor of implanting leads” and that Viswanathan is directed to an ablation device used for providing electroporation ablation therapy. The Office respectfully disagrees. When linking the two prior arts, the Office stated that Viswanathan is in a similar field of endeavor of implanting leads. The definition of implant according to Merriam Webster is “to insert in living tissue.” The Office did not intend for the term implant to mean a permanent implant, as the Office was relating the Viswanathan art as art that discusses the delivery and insertion of leads. Therefore, the rejection is maintained.
Applicant argues on pages 10-11 that Viswanathan’s angular positioning are not used to identify an entry region into the second vessel from the first vessel and rather, the distal portions 2914/2924 are moved to be positioned relative to the target tissue for applying the ablation therapy. The Office respectfully disagrees. The entry into the second vessel from the first vessel is disclosed by Ni. Viswanathan teaches the angular positioning “at a plurality of positions” as taught in paragraph 146 of Viswanathan, as one of the positions will be that of Ni when entering the second vessel from the first vessel. Therefore, the rejection is maintained.
In response to applicant’s argument on pages 11-12 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine Ni in view of Viswanathan comes from the similar field of endeavor of implanting/delivering leads, as explained above.
In response to applicant's argument on page 12 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The knowledge being made which was within the level of ordinary skill at the time the claimed invention was made is the maneuverability and facilitation of Viswanathan’s elongate arm 2914/2924 as it can be angled as it traverses through the vasculature. This is to be used in combination with Ni’s elongate arm so that it may enter the first and second vessels. Therefore, the rejection is maintained.
Applicant argues on page 13 that Ni and/or Viswanathan do not teach or suggest identifying the surfaces includes using sensor signals from a sensor or sensor element since the feedback in the cited portions of Ni is associated with muscle response and not with surfaces associated with topographic structures. The Office respectfully disagrees. Paragraph 61 discloses “Accordingly, fine wire electrodes 308 (or similar) are connected in electrical communication with the nerve integrity monitor 190 and are used to continuously monitor the muscle activity in response to the stimulation patterns applied via electrode portion 156 during navigation of the lead 150. Using this arrangement, this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve.” Thus, the muscle response does play a role in the sensing of the real-time feedback of the position, and thus identifying the surfaces. Therefore, the rejection is maintained.
Applicant argues on page 13 that Ni and/or Viswanathan do not teach or suggest transitioning back to the first state in response to sensed pressure indicative of the elongate arm contacting a valve within the second vessel. The Office respectfully disagrees. Paragraph 61 of Ni discloses the real-time feedback of a position of the electrode leads to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve. Capturing the target nerve is interpreted to mean contacting the vessel. And as stated in Viswanathan’s paragraph 146, “a distal portion (2914) rotatable about a first hinge (2918) that may be configured to position the distal portion (2914) relative to the proximal portion (2912) at a plurality of positions,” and such positions are related to the elongate arm 156 of Ni contacting the vessels during the real-time feedback. Therefore, the rejection is maintained.
Applicant argues on pages 14-15 that there is no palpable contact of the elongate arm with the surfaces while the elongate arm is at a tilt angle relative to the distal elongate portion of the guide tool, and that Ni’s paragraph 61, which discloses the real-time feedback, does not disclose palpable contact of the elongate arm 156. The Office respectfully disagrees. Paragraph 61 discloses “Using this arrangement, this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve.” It can be interpreted that capturing the target nerve is palpable contact of the elongate arm, as it would not suggest otherwise. Additionally, the elongate arm is traversing through the transvenous pathway as real-time feedback is tracking the position of the elongate arm, so there is palpable contact of the elongate arm with the surfaces. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the position" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear which position the Applicant is intending as there are a plurality of positions in which the elongate arm can be under. For the purposes of examination, the Office will interpret the claim to mean “a position” meaning any position of the elongate arm will read on the claim language.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, 9-12, 14, 16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ni et al. (US PGPub 2011/0202119) in view of Viswanathan et al. (US PGPub 2019/0069950), hereinafter known as “Ni” and “Viswanathan,” respectively.
With regards to claim 1, Ni discloses (Figures 1-3B) a method, comprising:
establishing, via a guide tool 150 (paragraph 58), a stimulation element (electrodes on 156) in a first position within a first vessel 184 of a vasculature which is in communication with a second vessel 186/188 of the vasculature (paragraphs 51-52);
identifying, via positioning of an elongate arm 156 relative to a distal elongate portion (portion of the guide tool 150 that is proximal to the stimulation element 156, will be referred to as lead body 152) of the guide tool 150, an entry region into the second vessel 186/188 from the first vessel 186 (see annotated figure 3A below; paragraph 61 – “monitor 190 and one or more aspects of the response array 200 is used to evaluate the positioning of a lead within a vein relative to a potential stimulation site on a target nerve… this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve”); and
maneuvering the stimulation element (electrodes on 156) through the entry region and to a second position within the second vessel 186/188 (figure 3A) via the guide tool 150, the second position being adjacent to a target tissue 190 (paragraphs 51-52).
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Ni is silent to angularly positioning of the elongate arm relative to the distal elongate portion of the guide tool.
However, in a similar field of endeavor of implanting leads, Viswanathan teaches (Figures 29A-29D) angularly positioning (via 2918/2928) of the elongate arm 2914/2924 relative to the distal elongate portion 2912/2922 of the guide tool (paragraphs 143, 146 and 148-151).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni to include angularly positioning of the elongate arm relative to the distal elongate portion of the guide tool as taught by Viswanathan for the purpose of further facilitation and maneuverability of the elongate arm as it traverses through the vasculature.
With regards to claim 3, Ni/Viswanathan disclose further comprising angularly positioning the elongate arm (156 of Ni via the hinge 2918 of Viswanathan) relative to the distal elongate portion (Ni: 152) of the guide tool (Ni: 150) to at least one of:
a tilt angle relative to the distal elongate portion of the guide tool (the hinge 2918 of Viswanathan allows for a tilt angle to be achieved relative to the distal elongate portion 152 of Ni; paragraph 146 of Viswanathan – “where a distal portion of each catheter (2910, 2920) may rotate, twist, or bend about its corresponding hinge (2918, 2928) relative to a proximal portion of its corresponding catheter (2910, 2920)”)); or
a rotational angle relative to a longitudinal axis of the distal elongate portion (the hinge 2918 of Viswanathan allows for a rotational angle to be achieved relative to the distal elongate portion 152 of Ni; paragraph 146 of Viswanathan – “where a distal portion of each catheter (2910, 2920) may rotate, twist, or bend about its corresponding hinge (2918, 2928) relative to a proximal portion of its corresponding catheter (2910, 2920)”).
With regards to claim 4, Ni further discloses wherein maneuvering the stimulation element (electrodes of 156) comprises inserting the guide tool 150 along a pathway through the vasculature from the first vessel 184 to the second vessel 186/188, wherein the entry region includes a junction of the first vessel 184 and the second vessel 186/188 through which the stimulation element is inserted and advanced (see annotated figure 3A above; paragraphs 51-52).
With regards to claim 5, Ni further discloses wherein the second vessel 186/188 extends at a first angle relative to the first vessel 184, the first angle comprising: an obtuse angle (see annotated figure 3A below).
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With regards to claim 6, Ni/Viswanathan disclose wherein identifying the entry region into the second vessel (Ni: 186/188) and maneuvering the stimulation element (Ni: electrodes of 156) through the entry region and to the second position within the second vessel comprises advancing the distal elongate portion (Ni: 152) of the guide tool (Ni: 150) to the second position along a pathway through the vasculature by identifying surfaces within the vasculature via the angularly positioning (Viswanathan: hinge 2918) of the elongate arm (Ni: 156; paragraph 61 – “closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve”; identifying surfaces within the vasculature is achieved by obtaining real-time feedback of a position of the elongate arm 156).
With regards to claim 9, Ni further discloses wherein identifying the surfaces includes using sensor signals from a sensor element 308 associated with the elongate arm 156 (figures 3A-3B; paragraphs 60-61), wherein the sensor element 308 is selected from the group consisting of:
conductive filaments (paragraph 61 – fine wire electrodes are conductive filaments).
With regards to claim 10, Ni further discloses wherein maneuvering the stimulation element (electrodes of 156) through the entry region and to the second position within the second vessel 186/188 comprises:
advancing the distal elongate portion 152 of the guide tool 150 proximate to a target location within the second vessel 186/188 adjacent to the target tissue 190 via a pathway through the second vessel 186/188 (figure 3B; paragraphs 51-52); and
positioning the stimulation element (electrodes of 156) proximate to the target location via the guide tool 150 and without use of a contrast agent (figure 3B; paragraphs 51-52).
With regards to claim 11, Ni/Viswanathan disclose further comprising:
activating the angularly positioning (Viswanathan: hinge 2918) of the elongate arm (Ni: 156) in response to establishing the distal elongate portion (Ni: 152) of the guide tool (Ni: 150) at the first position within the first vessel (Ni: 184) by placing the elongate arm (Ni: 156) at a tilt angle (Viswanathan: via hinge 2918) relative to the distal elongate portion (Ni: 152) of the guide tool (Ni: 150; Viswanathan discloses in paragraph 146 that the hinge 2918 “may be configured to position the distal portion (2914) relative to the proximal portion (2912) at a plurality of positions,” and thus is used in combination with the closed loop feedback of Ni (paragraph 61) to obtain real-time feedback of a position of the elongate arm 156); and
angularly positioning the elongate arm (Ni: 156) of the guide tool (Ni: 150) by at least one of:
rotating about a rotational angle (Viswanathan: paragraph 146 – “where a distal portion of each catheter (2910, 2920) may rotate, twist, or bend about its corresponding hinge (2918, 2928) relative to a proximal portion of its corresponding catheter”) relative to a longitudinal axis of the distal elongate portion (Ni: 152), while the elongate arm (Ni: 156) is at the tilt angle, to identify at least one surface of the vasculature (Ni: paragraph 61 – “closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve”; identifying surfaces within the vasculature is achieved by obtaining real-time feedback of a position of the elongate arm 156).
With regards to claim 12, Ni/Viswanathan disclose wherein activating the angularly positioning of the elongate arm (Ni: 156 via hinge 2918 of Viswanathan) comprises:
at least one of mechanically (Viswanathan: paragraphs 149-150) causing the elongate arm (Ni: 156) to transition from a first state (state shown in Ni’s figure 3A where the elongate arm 156 are distal elongate portion 152 are coaligned) to a second state (state where the elongate arm 156 of Ni is angled relative to the distal elongate portion 152 via the hinge 2918 of Viswanathan) associated with an angular position of the elongate arm (Ni: 156); and
while in the second state, to move to the tilt angle relative to the distal elongate portion (Ni: 152) (as the distal elongate portion 152 of Ni navigates from the first position of the first vessel 184 to the entry region, a tilt angle is formed via the hinge 2918 of Viswanathan that “may be configured to position the distal portion relative to the proximal portion at a plurality of positions), wherein:
the first state comprises the elongate arm (Ni: 156) being axially aligned with and extending from the distal elongate portion (Ni: 152) such that the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152) are positioned generally straight with respect to one another (state shown in Ni’s figure 3A where the elongate arm 156 are distal elongate portion 152 are coaligned); and
the second state comprises the elongate arm (Ni: 156) being axially unaligned with and extending from the distal elongate portion (Ni: 152) such that the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152) are positioned at a tilt angle with respect to one another (state where the elongate arm 156 of Ni is angled, or axially unaligned, relative to the distal elongate portion 152 via the hinge 2918 of Viswanathan).
With regards to claim 14, Ni/Viswanathan disclose wherein angularly positioning the elongate arm comprises at least one of:
rotating the elongate arm (Ni: 156) to at least one degree position within a 360 degree range about the longitudinal axis of the distal elongate portion (Ni: 152), while the elongate arm (Ni: 156) is at the tilt angle with respect to the distal elongate portion (Ni: 152; see figures 29A-29D and paragraph 146 of Viswanathan where the distal portion of the catheter rotates about the hinge 2918 to at least one degree position within a 360 degree range about the longitudinal axis relative to the proximal portion of the catheter).
With regards to claim 16, Ni/Viswanathan disclose wherein the distal elongate portion (Ni: 156) of the guide tool (Ni: 150) further comprises a junction (Viswanathan: paragraph 146 - hinge 2918 between proximal and distal portions of the catheter, which is akin to being between the elongate arm 156 and distal elongate portion 152 of Ni) between the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152), the method further comprising:
controlling the angularly positioning of the elongate arm (Ni: 156) via the junction (Viswanathan: 2918), wherein the junction (Viswanathan: 2918) is selected from:
a hinge joint (Viswanathan: 2918) to permit tilting of the elongate arm;
wherein the elongate arm (Ni: 156) extends from the junction (Viswanathan: 2918) of the guide tool (NI: 150) and the elongate arm (Ni: 156) comprises at least one of:
a length that is less than a length of a body of the guide tool (Ni: 150) and the distal elongate portion (Ni: 152 – see figure 3B for the respective lengths of the elongate arm 156 and the rest of the guide tool 150).
With regards to claim 19, Ni further discloses wherein maneuvering the stimulation element (electrodes of 156) through the entry region and to the second position in the second vessel 186/188 comprises at least one of:
advancing the guide tool 150 into and through a subclavian vein 182, into and through a jugular vein 184, into and through a vein trunk 186, and into a vena comitante hypoglossi 190 (paragraph 52; figure 3B).
With regards to claim 20, Ni further discloses wherein:
the target tissue 190 comprises a hypoglossal nerve 190 and the second vessel 188 comprises a vena comitante hypoglossi (figure 3B, paragraph 52); and
maneuvering the stimulation element (electrodes of 156) through the entry region and to the second position in the second vessel 186/188 comprises:
advancing the distal elongate portion 156 of the guide tool 150 into the entry region of the vena comitante hypoglossi 190 and through at least one valve of the vena comitante hypoglossi 190 (paragraph 52 discloses the “vein comitans of the hypoglossal nerve”, and thus would include at least one valve of the vena comitante hypoglossi).
Claims 7-8, 13, 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over NI in view of Viswanathan, and further in view of Westlund et al. (US PGPub 2021/0046303), hereinafter known as “Westlund.”
With regards to claim 7, Ni/Viswanathan discloses the method as claimed in claim 6. The combination further discloses wherein the surfaces are associated with topographic structures including the entry region and the second vessel (Ni: 186/188), the surfaces being identified by:
identifying the surfaces within the vasculature via the angularly positioning (Viswanathan: via hinge 2918) of the elongate arm (Ni: 156) and palpable contact (paragraph 61 – “fine wire electrodes 308 (or similar) are connected in electrical communication with the nerve integrity monitor 190 and are used to continuously monitor the muscle activity in response to the stimulation patterns applied via electrode portion 156 during navigation of the lead 150. Using this arrangement, this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156” – thus palpable contact of the elongate arm 156 allows for real-time feedback of a position along the transvenous pathway of the electrode leads 156) of the elongate arm (Ni: 156) with the surfaces while the elongate arm (Ni: 156) is at a tilt angle relative to the distal elongate portion (Ni: 152) of the guide tool (Ni: 150); and
in response, maneuvering the guide tool (Ni: 150) along the pathway through the vasculature and to the second position within the second vessel (Ni: 186/188; paragraphs 51-52).
The combination is silent wherein the surfaces are associated with topographic structures including valves within the second vessel.
However, in a similar field of endeavor of delivering leads, Westlund teaches (Figures 1-3 and 6) maneuvering the guide tool 110 to surfaces are associated with topographic structures including valves within the second vessel (paragraphs 22-23, 25-26, and 28-29).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni/Viswanathan to include maneuvering the guide tool through at least one valve within the second vessel for the purpose of being able to smoothly pass through bends, valves, and other challenging pathways (paragraph 26 of Westlund).
With regards to claim 8, the combination discloses wherein the palpable contact of the elongate arm (Ni: 156) with the surfaces is transmitted from the elongate arm (Ni: 156) to a handle (Ni: 55) of the guide tool (Ni: 150; (paragraph 61 – “fine wire electrodes 308 (or similar) are connected in electrical communication with the nerve integrity monitor 190 and are used to continuously monitor the muscle activity in response to the stimulation patterns applied via electrode portion 156 during navigation of the lead 150. Using this arrangement, this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156” – thus palpable contact of the elongate arm 156 allows for real-time feedback of a position along the transvenous pathway of the electrode leads 156 as the electrode leads 156 deliver electrical stimulation via the handle 55).
With regards to claim 13, Ni/Viswanathan disclose the method as claimed in claim 12. The combination discloses further comprising transitioning back to the first state (state shown in Ni’s figure 3A where the elongate arm 156 are distal elongate portion 152 are coaligned, achievable via the hinge 2918 of Viswanathan that “may be configured to position the distal portion relative to the proximal portion at a plurality of positions) and locking the elongate arm (Ni: 156) in the position of the first state (Viswanathan: paragraph 150 – “control mechanism of the handle may include a lock to fix a position of the distal portion”) in response to sensed pressure indicative of the elongate arm (Ni: 156) contacting a valve within the second vessel (Ni: paragraph 61 – “closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve”); and
advancing the guide tool (Ni: 150) while the elongate arm (Ni: 156) is locked in the first state (locked via Viswanathan’s control mechanism in paragraph 150).
The combination is silent to advancing the guide tool through the valve.
However, in a similar field of endeavor of delivering leads, Westlund teaches (Figures 1-3 and 6) advancing the guide tool 110 through the valve (paragraphs 22-23, 25-26, and 28-29).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni/Viswanathan to include advancing the guide tool through the valve for the purpose of being able to smoothly pass through bends, valves, and other challenging pathways (paragraph 26 of Westlund).
With regards to claim 15, Ni/Viswanathan disclose the method as claimed in claim 1. Ni further discloses wherein maneuvering the stimulation element (electrodes of 156) through the entry region and to the second position within the second vessel 186/188 comprising advancing the elongate arm 156 through the entry region and the second vessel (paragraphs 51-52) by transitioning the guide tool (Ni: 150) between a first state and a second state, wherein:
the first state comprises the elongate arm (Ni: 156) being axially aligned with and extending from the distal elongate portion (Ni: 152) such that the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152) are positioned generally straight with respect to one another (state shown in Ni’s figure 3A where the elongate arm 156 are distal elongate portion 152 are coaligned); and
the second state comprises the elongate arm (Ni: 156) being axially unaligned with and extending from the distal elongate portion (Ni: 152) such that the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152) are positioned at a tilt angle with respect to one another (state where the elongate arm 156 of Ni is angled, or axially unaligned, relative to the distal elongate portion 152 via the hinge 2918 of Viswanathan);
wherein the guide tool (Ni: 150) is:
in the second state for identifying, via the angularly positioning of the elongate arm (Ni: 156) relative to the distal elongate portion (Ni: 152) of the guide tool (Ni: 150; via the hinge 2918 of Viswanathan), the entry region into the second vessel (Ni: 186/188) from the first vessel (Ni: 184); and
in the first state for advancing the guide tool (Ni: 150).
The combination is silent to advancing the elongate arm through at least one valve within the second vessel; and advancing the guide tool through the at least one valve.
However, in a similar field of endeavor of delivering leads, Westlund teaches (Figures 1-3 and 6) advancing the elongate arm 110 through at least one valve within the second vessel; and advancing the guide tool through the at least one valve (paragraphs 22-23, 25-26, and 28-29).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni/Viswanathan to include advancing the elongate arm/guide tool through at least one valve within the second vessel for the purpose of being able to smoothly pass through bends, valves, and other challenging pathways (paragraph 26 of Westlund).
With regards to claim 17, Ni/Viswanathan disclose the method as claimed in claim 1. Ni/Viswanathan further disclose wherein:
identifying the entry region into the second vessel (Ni: 186/188) comprises:
tilting the elongate arm (Ni: 156 via the hinge 2918 of Viswanathan) to a tilt angle with respect to the distal elongate portion (Ni: 152) of the guide tool (Ni: 150); and
while at the tilt angle, rotating the elongate arm (Ni: 156) at a rotational angle (Viswanathan: paragraph 146 – “where a distal portion of each catheter (2910, 2920) may rotate, twist, or bend about its corresponding hinge (2918, 2928) relative to a proximal portion of its corresponding catheter (2910, 2920) (e.g., FIGS. 29B-29D). For example, as best illustrated in FIGS. 29B-29C, the first catheter (2910) may include a distal portion (2914) rotatable about a first hinge (2918) that may be configured to position the distal portion (2914) relative to the proximal portion (2912) at a plurality of positions”) relative to a longitudinal axis of the distal elongate portion (Ni: 152) of the guide tool (Ni: 150) to identify the entry region via contact of the elongate arm (Ni: 156) with surfaces of the vasculature (Ni: paragraph 61 – “fine wire electrodes 308 (or similar) are connected in electrical communication with the nerve integrity monitor 190 and are used to continuously monitor the muscle activity in response to the stimulation patterns applied via electrode portion 156 during navigation of the lead 150. Using this arrangement, this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156”); and
in response to the identification, maneuvering the stimulation element (NI: electrodes of 156) through the entry region and to the second position in the second vessel (Ni: 186/188; paragraphs 51-52) comprises:
advancing the distal elongate portion (Ni: 152) of the guide tool through the entry region and into the second vessel (Ni: 186/188; figure 3B; paragraphs 51-52); and
advancing the distal elongate portion (Ni: 152) of the guide tool to a target location within the second vessel (Ni: 186/188) adjacent to the target tissue (Ni: 190; paragraphs 51-52) while the elongate arm (Ni: 156) is axially aligned with and extending from the distal elongate portion (Ni: 152) such that the elongate arm (Ni: 156) and the distal elongate portion (Ni: 152) are positioned generally straight with respect to one another (state shown in Ni’s figure 3A where the elongate arm 156 are distal elongate portion 152 are coaligned).
The combination is silent to advancing the distal elongate portion of the guide tool through at least one valve of the second vessel.
However, in a similar field of endeavor of delivering leads, Westlund teaches (Figures 1-3 and 6) advancing the distal elongate portion 110 of the guide tool through at least one valve of the second vessel (paragraphs 22-23, 25-26, and 28-29).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni/Viswanathan to include advancing the distal elongate portion of the guide tool through at least one valve of the second vessel for the purpose of being able to smoothly pass through bends, valves, and other challenging pathways (paragraph 26 of Westlund).
With regards to claim 18, the combination discloses wherein advancing the distal elongate portion (Ni: 152) of the guide tool (Ni: 150) through the at least one valve (Westlund: paragraphs 22-23) comprises:
opening the at least one valve and advancing the elongate arm (Ni: 156) through the at least one valve via pressure applied by the elongate arm (Ni: 156) to the at least one valve (Westlund: paragraph 26 – “tapered tip 112 smoothly transitions to diameter D3 from D4 over a length L of the tip 112 such that the lead 110 is able to smoothly pass through bends, valves, and other challenging pathways”, paragraph 28 – “to ensure that the lead 110 can pass through valves”) while the elongate arm (Ni: 156) is locked in the position (Viswanathan: paragraph 150 – “control mechanism of the handle may include a lock to fix a position of the distal portion”).
Alternate rejection to claims 1-2 with respect to Ni in view of Viswanathan:
With regards to claim 1-2, Ni discloses (Figures 1-3B) a method, comprising:
establishing a stimulation element (electrodes on 156) in a first position within a first vessel 184 of a vasculature which is in communication with a second vessel 186/188 of the vasculature (paragraphs 51-52);
identifying, via positioning of an elongate arm 156, an entry region into the second vessel 186/188 from the first vessel 186 (see annotated figure 3A below; paragraph 61 – “monitor 190 and one or more aspects of the response array 200 is used to evaluate the positioning of a lead within a vein relative to a potential stimulation site on a target nerve… this closed loop feedback will allow the physician to obtain real-time feedback of a position (along the transvenous pathway) of the electrode leads 156 and feedback regarding the ability of the electrode leads 156 to capture the target nerve at a particular position of the electrode leads 156 along the transvenous pathway adjacent the target nerve”); and
maneuvering the stimulation element (electrodes on 156) through the entry region and to a second position within the second vessel 186/188 (figure 3A) via the guide tool 150, the second position being adjacent to a target tissue 190 (paragraphs 51-52); and
further comprising transvascularly delivering stimulation to the target tissue 190 via the stimulation element (paragraph 61).
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Ni is silent to a guide tool, angularly positioning of the elongate arm relative to the distal elongate portion of the guide tool (claim 1); and wherein maneuvering the stimulation element comprises guiding a lead comprising the stimulation element through or over the guide tool (claim 2).
However, in a similar field of endeavor of implanting leads, Viswanathan teaches (Figures 29A-29D) a guide tool 2902 (paragraphs 143 and 146), angularly positioning (via 2918/2928) of the elongate arm 2914/2924 relative to the distal elongate portion 2912/2922 of the guide tool (paragraphs 143, 146 and 148-151); and wherein maneuvering the stimulation element 2916/2926 comprises guiding a lead 2910/2920 comprising the stimulation element 2916/2926 through or over the guide tool 2902 (figures 29A and 29D; paragraphs 143, 146 and 151).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni to include a guide tool, and wherein maneuvering the stimulation element comprises guiding a lead comprising the stimulation element through or over the guide tool as taught by Viswanathan for the purpose of further delivering and protecting the stimulation element as the stimulation element traverses through the vasculature.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ni to include angularly positioning of the elongate arm relative to the distal elongate portion of the guide tool as taught by Viswanathan for the purpose of further facilitation and maneuverability of the elongate arm as it traverses through the vasculature.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 05/26/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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