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
This office action is responsive to the amendment filed on 6/3/25. As directed by the amendment: no claims have been amended, claims 17 and 19 have been cancelled, and new claims 26 and 27 have been added. Thus, claims 1-16, 18, and 20-27 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15, 26, and 27) in the reply filed on 6/3/25 is acknowledged. Upon further review, restriction between Group I and Group II is hereby withdrawn, and applicant’s election of Group I will be interpreted to encompass claims 1-16, 18, 20, 21, 26, and 27. Claims 22-25 are withdrawn from further consideration.
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.
Claims 26 and27 are 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 26 is replete with limitations that appear to be reciting the same or similar limitation to those recited in parent claim 1, without utilizing either antecedent basis to provide clear continuity of meaning from parent claim 1 or utilizing distinguishing language to separately identify elements recited in claim 26 from those previously recited in claim 1. For example, it is not clear if either the first or second therapeutic element recited in claim 26 is the same as or different from the at least one therapeutic element recited in claim 1. Additionally, the manipulating step recited in claim 26 is not clear as to whether it is performed in addition to, or instead of, the manipulating step of claim 1; the same is true of the deploying and delivering steps. It is not clear if these limitations correctly align with the requirements of 35 U.S.C. 112(d). Claim 27 depends from claim 26 and inherits those deficiencies.
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.
Claim(s) 1-6, 9-11, 16, 18, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toth et al. (US 20150289929).
Regarding claim 1, Toth et al. discloses a method (specifically a neuromodulation method, see method illustrated in fig. 16 and described in par. 0336-0340, utilizing probe embodiment of fig. 4d, par. 0256, and agent embodiment for neuromodulation described in the abstract and par. 0020), comprising: positioning a distal portion of a neuromodulation catheter in a first renal vessel of a patient (distal end of 1610 placed in 63 in fig. 16; alternatively, positioned in 65 as described on par. 0339), wherein the distal portion of the neuromodulation catheter comprises a plurality of therapeutic elements 1614a-c arranged around a perimeter of the distal portion of the neuromodulation catheter (see fig. 16), and wherein, in a deployed configuration, the plurality of therapeutic elements are configured to extend at least partially through a wall of the first renal vessel (through wall of 63 in fig. 16; alternatively through wall of 65 as described in par. 0339); imaging the distal portion of the neuromodulation catheter to visualize positions of the plurality of therapeutic elements (par. 0336-0340); manipulating the distal portion of the neuromodulation catheter so that at least one therapeutic element of the plurality of therapeutic elements is oriented toward a second renal vessel adjacent the first renal vessel (positioned toward 64 and/or 65 in fig. 16; alternatively, positioned toward 64 from 65 as described in par. 0339); deploying the at least one therapeutic element to extend at least partially through the wall of the first renal vessel such that the at least therapeutic element extends toward the second renal vessel (positioned toward 64 and/or 65 in fig. 16; alternatively, positioned toward 64 from 65 as described in par. 0339); and delivering a chemical agent through the plurality of therapeutic elements to modulate activity of at least one renal nerve adjacent to the first renal vessel and at least one renal nerve adjacent to the second renal vessel (where probes 1614a-c utilize the probe embodiment as disclosed in fig. 4d, delivering a neuromodulating agent as disclosed in par. 0020).
Regarding claim 2, Toth et al. discloses positioning the distal portion of the neuromodulation catheter in renal vessel of the patient comprises positioning the distal portion of the neuromodulation catheter in a distal aspect of an accessory renal artery, wherein the second renal vessel is a main renal artery (positioning the catheter within 65 as illustrated by arrow 1622 in fig. 16 and described in par. 0339, while treating both 64 and 65 as described in par. 0339)
Regarding claim 3, Toth et al. discloses each therapeutic element is independently deployable from the neuromodulation catheter (par. 0117).
Regarding claim 4, Toth et al. discloses a deployment distance of each therapeutic element is independently controllable (par. 0117).
Regarding claim 5, Toth et al. discloses deploying the at least one therapeutic element comprises deploying the at least one therapeutic element to extend fully through the wall of the first renal vessel (see fig. 16).
Regarding claim 6, Toth et al. discloses deploying at least one other therapeutic element a shorter distance than the at least one therapeutic element (par. 0036 describes deploying individual probes to different target locations; par. 0117 describes mechanisms for independent probe control; fig. 14a-b illustrate an example of deploying probes to different depths).
Regarding claim 9, Toth et al. discloses the perimeter is a circumference, and wherein the plurality of therapeutic elements comprises three therapeutic elements, and wherein the three therapeutic elements are spaced substantially equally around the circumference of the neuromodulation catheter (par. 0189-0190).
Regarding claim 10, Toth et al. discloses each therapeutic element comprises a needle (see fig. 16 and probe embodiment of fig. 4d).
Regarding claim 11, Toth et al. discloses each therapeutic element further comprises a guide tube 476 (fig. 4h), and wherein the needle of each therapeutic element is configured to be moved relative to the corresponding guide tube (par. 0263).
Regarding claim 16, Toth et al. discloses Toth et al. discloses a method (specifically a neuromodulation method, see method illustrated in fig. 16 and described in par. 0336-0340, utilizing probe embodiment of fig. 4d, par. 0256, and agent embodiment for neuromodulation described in the abstract and par. 0020), comprising: positioning a distal portion of a neuromodulation catheter in a first renal vessel of a patient (distal end of 1610 placed in 63 in fig. 16; alternatively, positioned in 65 as described on par. 0339), wherein the distal portion of the neuromodulation catheter comprises a plurality of therapeutic elements 1614a-c arranged around a perimeter of the distal portion of the neuromodulation catheter (see fig. 16), and wherein, in a deployed configuration, the plurality of therapeutic elements are configured to extend at least partially through a wall of the first renal vessel (through wall of 63 in fig. 16; alternatively through wall of 65 as described in par. 0339); imaging the distal portion of the neuromodulation catheter to visualize positions of the plurality of therapeutic elements (par. 0336-0340); manipulating the distal portion of the neuromodulation catheter so that the first therapeutic element is oriented toward a second renal vessel adjacent the first renal vessel (1614b towards 64) and the second therapeutic element is oriented toward a third renal vessel adjacent the first renal vessel (1614a oriented toward 65); deploying the first therapeutic element to extend at least partially through the wall of the first renal vessel such that the first therapeutic element extends toward the second renal vessel (see fig. 16); deploying the second therapeutic element to extend at least partially through the wall of the first renal vessel such that the second therapeutic element extends toward the third renal vessel (see fig. 16), and delivering the chemical agent through the plurality of therapeutic elements to modulate activity of at least one renal nerve adjacent to the first renal vessel (via 1614c, see fig. 16), at least one renal nerve adjacent to the second renal vessel (via 1614b, see fig. 16), and at least one renal nerve adjacent to the third renal vessel (via 1614a, see fig. 16; where probes 1614a-c utilize the probe embodiment as disclosed in fig. 4d, delivering a neuromodulating agent as disclosed in par. 0020).
Regarding claim 18, Toth et al. discloses deploying at least one other therapeutic element a shorter distance than the at least one therapeutic element (par. 0036 describes deploying individual probes to different target locations; par. 0117 describes mechanisms for independent probe control; fig. 14a-b illustrate an example of deploying probes to different depths).
Regarding claim 26, as best understood, Toth et al. discloses the plurality of therapeutic elements comprises a first therapeutic element and a second therapeutic element (elements 1614a-c), wherein manipulating the distal portion of the neuromodulation catheter comprises manipulating the distal portion of the neuromodulation catheter so that the first therapeutic element is oriented toward a second renal vessel adjacent the first renal vessel (1614b towards 64) and the second therapeutic element is oriented toward a third renal vessel adjacent the first renal vessel (1614a oriented toward 65),wherein deploying the at least one therapeutic element comprises: deploying the first therapeutic element to extend at least partially through the wall of the first renal vessel such that the first therapeutic element extends toward the second renal vessel (see fig. 16); and deploying the second therapeutic element to extend at least partially through the wall of the first renal vessel such that the second therapeutic element extends toward the third renal vessel (see fig. 16), and wherein delivering the chemical agent through the plurality of therapeutic elements comprises delivering the chemical agent through the plurality of therapeutic elements to modulate activity of at least one renal nerve adjacent to the first renal vessel (via 1614c, see fig. 16), at least one renal nerve adjacent to the second renal vessel (via 1614b, see fig. 16), and at least one renal nerve adjacent to the third renal vessel (via 1614a, see fig. 16; where probes 1614a-c utilize the probe embodiment as disclosed in fig. 4d, delivering a neuromodulating agent as disclosed in par. 0020).
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.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. in view of Salahieh et al. (US 20110257622).
Regarding claims 7 and 8, Toth et al. discloses the method as claimed except for disclosing delivering the chemical agent through the at least one therapeutic element comprises independently controlling an amount of chemical agent delivered through each therapeutic element of the plurality of therapeutic elements, and delivering more chemical agent through the at least one therapeutic element than an amount of chemical agent delivered through at least one other therapeutic element. However, Salahieh et al. teaches delivering different amounts of flow through different delivery elements (delivery members referred to as “controls” in par. 0003, illustrated as 16 in fig. 1; claims 1-4; par. 0059 describes acting on renal nerve tissue). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Toth et al. to deliver different amounts of chemical agent through different probes, as taught by Salahieh et al., for the purpose of providing sufficient structure and methodology to delivery correct dosages to individual treatment regions.
Claim(s) 12, 13, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. in view of Hinchliffe et al. (US 20020143302).
Regarding claims 12, 13, and 20, Toth et al. discloses the method as claimed, including disclosing that the probes can be configured to deploy in a variety of directions relative to the elongate member, including radially, circumferentially, axially, combinations thereof, or other orientations (par. 0108) and when deployed, distal portions of the needles of the plurality of therapeutic elements are in tissue outside the first renal vessel (see fig. 16 and par. 0336-0340), except for specifically disclosing when deployed, the needles of the plurality of therapeutic elements are oriented in a generally distal direction with reference to the neuromodulation catheter, or the distal portions of the needles are substantially parallel to a longitudinal axis of the neuromodulation catheter. However, Hinchliffe et al. teaches positioning deployable needles so that they project generally distally and/or distal portions of the needles are substantially parallel to the longitudinal axis of the catheter (see fig. 16). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the orientation of some or all of the probes of Toth et al. to be oriented generally distally and/or have distal portions oriented substantially parallel to the longitudinal axis of the catheter, as taught by Hinchliffe et al., since Toth et al. envisions a variety of orientations in order to access various target tissue, since Hinchliffe et al. teaches this orientation as a viable alternative to orientations such as those specifically disclosed by Toth et al., and in order to provide sufficient structure to access a target tissue location positioned in relatively to the catheter that would require such an orientation.
Claim(s) 14, 15, 21, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. in view of Evans et al. (US 20110184337).
Regarding claims 14, 15, 21, and 27 (claim 27 as best understood), Toth et al. discloses deploying at least one expandable centering element 1620 to substantially center the neuromodulation catheter within the first renal vessel (fig. 16; par. 0336), except for specifically disclosing performing that step after manipulating the distal portion of the neuromodulation catheter so that the at least one therapeutic element of the plurality of therapeutic elements/the first therapeutic element is oriented toward the second renal vessel and before deploying the at least one therapeutic element. However, Evans et al. teaches a similar methodology for probe placement which involves first longitudinally and rotationally orienting the catheter relative to treatment zones, then expanding a centering mechanism, then placing the probes (par. 0079). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Toth et al. to deploy the expandable centering element after achieving correct orientation, but before deploying probes, as taught by Evans et al., to lock in the desired orientation so that the probes are placed correctly in target tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Deem et al. (US 8852163) discloses orienting a guide catheter with a centering mechanism in a renal vein, deploying a probe through the vein wall to act on a renal nerve associated with an adjacent renal artery (fig. 23A-C, associated description, and claims)
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783