DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
Currently, claims 1-11 are pending with claim 1 amended. Applicant’s amendments to claim 1 have obviated the previously-filed rejections under 35 U.S.C. 112(b). The following is a complete response to the January 7, 2026 communication.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 1, 2 and 4-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ku et al. (US Pat. Pub. 2012/0116382 A1) further in view of Kear (US Pat. Pub. 2004/0019358 A1).
Regarding claim 1, Ku provides for a system capable of treatment of nerves present in a wall of a human renal pelvis, the system comprising: a sheath having a distal opening and a length and outer diameter suitable for insertion through a human subject's urinary tract to position the distal opening in a renal pelvis of the human subject or in a ureter of the human subject at a position adjacent the renal pelvis (guide catheter 1290),
an effector for insertion through the sheath (treatment assembly 1221), the effector having a distal region with a pre-set shape and comprising a superelastic wire support with a plurality of discrete electrode elements distributed along the wire support (see [0238] providing for 1221 to allow for 1222 to deploy when removed from 1290/1291; the wire support is disclosed as being from a superelastic material as in [0127] and [0201]; 1221 includes the electrodes at 1224), wherein the distal region does not comprise an internal cooling conduit (the embodiment in figures 15A/B includes a single lumen which the Examiner characterizes as the guidewire/fluid lumen; this embodiment does not require cooling; see [0091], [0138], [0259]-[0264]) providing for the capability for passive cooling without the delivery of fluid),
each electrode having a rounded outer surface that protrudes beyond the surface of the wire support (see figures 15A/B with 1024 extending beyond the surface of 1023),
the distal region of the effector constrained from the pre-set shape to allow movement of the effector through the sheath (see [0238] providing for 1221 to allow for 1222 to deploy when removed from 1290/1291), and
the effector having one or more conductive wires accessible external to the human subject during treatment, for delivery of monopolar radiofrequency (RF) energy to the electrode elements (supply wires as discloses throughout such as element 25; see [0100], [0101], [0148], [0190], [0214] with the wire configured to couple to the generator 26; also capable of monopolar delivery as in [0101], [0106] and [0136]),
an RF generator configured to couple to at least a subset of the one or more conductive wires to deliver RF energy between each of the electrode elements and at least one second electrode separate from the distal region of the effector (generator 26 such is configured to couple to the elements 1024 as well as the return electrode forming the second electrode 38),
and a vacuum port connectable to a vacuum source that is capable of drawing a vacuum through the sheath of a magnitude sufficient to at least partially evacuate the renal pelvis while the RF generator is delivers RF energy to the electrode elements and while the effector is inserted through the sheath whereby, when the distal region of the effector protrudes from the distal opening of the sheath and expands towards its pre-set shape within the renal pelvis (port forming the opening for connection to the lumen 1029; such is capable of connecting to a source of vacuum; see at least [0232] providing that such lumens that are capable of conveying a fluid also functions as a guidewire lumen), and wherein, if applied through the port of Ku, the vacuum is capable of draw two opposing wall portions of the renal pelvis inwards and compressing the distal region of the effector from its pre-set shape such that the opposing renal pelvic wall portions each intimately engage at least one of the discrete electrode elements during the delivery of RF energy,
the system being further configured to create, at locations corresponding to the renal pelvic wall engagement with the electrode elements, a plurality of discrete lesions extending into the renal pelvic wall to ablate afferent nerves disposed within the wall of the renal pelvis (via generator 26 being capable of applying energy through the electrode at such a point).
While the vacuum port of Ku is capable of connecting to a vacuum source as noted above, Ku fails to specifically recite that the vacuum port of its system is “connected to a vacuum source” as claimed.
Kear discloses an system including an elongated sheath having a vacuum port connected thereto (elongated member 102 with the port at 104), the vacuum port for connected to a source of a vacuum source through a lumen of elongated sheath and for the amount of vacuum applied to the vacuum port and through the elongated sheath to be adjustable (see vacuum source 212 connected to passageway 110; see also [0048] providing for the source to have a regulator to vary suction as desired). Kear further provides that the elongated sheath of the device is for insertion through the ureter of a patient to a renal pelvis within the kidney (see the figures with the ability of the system to be placed within the renal pelvis of the kidney 208).
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 the system of Ku with a vacuum source connected to the vacuum port of Ku so as to provide for an exemplary manner of achieving a controllable amount of vacuum to be drawn through a guide sheath. The Examiner finds that such a modification of the system of Ku would be advantageous to provide the ability to deliver suction at a target location in the body to provide for a variety of effects (fluid removal, material removal, negative pressure within target location of body, etc.).
The Examiner further notes that the requirements prescribed to the vacuum source in the last paragraph of claim 1 are contained withing a functional recitation of the intended use of the vacuum port, vacuum source and the vacuum drawn through the sheath. It is well established that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See additionally MPEP 2173.05(g) and MPEP 2114. The Examiner is of the position that the claimed system including the “vacuum port connected to a vacuum source” and further requiring the various functional requirements of the vacuum drawn through the sheath at a time when the system is inserted into the renal pelvis fails to be structurally differentiated by the prior art combination of Ku in view of Kear, wherein the combination with Kear readily provides for an exemplary vacuum source capable of drawing a vacuum through a sheath placed within the same location within the kidney of the patient and further having an adjustable amount of vacuum being capable of being applied through the vacuum port and sheath.
Regarding claim 2, Ku provides that plurality of discrete electrode elements comprise between four and ten electrode elements (see the various embodiments having 4 or more electrodes; see also [0098] contemplating two or more of elements 24).
Regarding claim 4, Ku provides that the energy to at least two of the plurality of electrode elements are energizable independent of each other by the RF generator during treatment (See [0106]).
Regarding claim 5, in view of the combination of Ku and Kear in claim 1 above, the combination would provide that the drawn vacuum by the combined system is sufficient to substantially remove fluid from the renal pelvis. Please see at least [0048] of Kear providing for the adjustable amounts of vacuum capable of being provided by the source 212).
Regarding claim 6, Ku provides that the wire support is monofilament or braided (see [0125] contemplating a wire or braided cable, [0235] with a braid).
Regarding claim 7, Ku provides for circuitry to measure a first temperature proximate at least one location on the distal region during treatment (see [0101] and [0102] with the temperature sensors and associated circuity of the generator 26 to process the signals over the supply wires).
Regarding claim 8, Ku provides that the RF generator is configured to control delivery of RF energy between each of the plurality of electrode elements and the at least one second electrode during treatment to maintain the first temperature at or near a set temperature (via the generator functioning in the monopolar manner as in [0101], [0106] and [0136] to the dispersive electrode 38).
Regarding claim 9, Ku provides that the generator is configured to maintain a set temperature that approximately 60° C (see at least [0097] and [0315] providing for the capability to set the temperature at 60 °C).
Regarding claim 10, Ku provides that the RF generator is configured to control delivery of RF energy during treatment based on an impedance measured within the system (see at least [0101], [0255], [0257], and [0279]).
Regarding claim 11, Ku provides that the RF generator is configured to allow control of a depth of the lesions such that the lesions extend into the renal pelvic wall through a depth of 0.5mm to 1.2mm (see [0272] providing for treating through the claimed depth up to about 3mm, see also [0389] and [0132] defining the control of the depth of energy delivery).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ku et al. (US Pat. Pub. 2012/0116382 A1) in view of Kear (US Pat. Pub. 2004/0019358 A1) as applied to claim 1 above, and further in view of Jenson (US Pat. Pub. 2012/0130368 A1).
Regarding claim 3, while Ku contemplates that the electrode elements have a cylindrical shape with rounded ends (see [0113] and can comprise other shapes and sizes as needed (see [0143]), Ku fails to specifically contemplate the use of a spherical or an ovoid outer shape without electrical insulation. Kear fails to cure this deficiency in Ku. Jenson, however, contemplates a similar system for treating within a lumen of the body and specifically contemplates for its electrode elements to protrude from a supporting wire and to have a spherical or oval shape (see [0062]).
As such, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a spherical or ovoid shape as in Jenson for the shape of the electrode elements in Ku given that Jenson readily provides that such electrode shapes are known in the art for use in a substantially similar location within the body to effectively deliver electrosurgical energy to the walls of a bodily lumen, and further in view of Ku’s contemplation in [0143] that a wide-range of shapes would be suitable for use with its device.
Response to Arguments
Applicant's arguments filed January 7, 2026 have been fully considered but they are not persuasive.
Applicant argues on page 6 of the Remarks with respect to the prior rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Ku in view of Kear. Therein, Applicant argues that “claim 1, as amended, provides sufficient structural recitation relating to the ‘vacuum’ structural recitations to distinguish over the prior art.”
This is not persuasive.
The Examiner has updated the rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Ku in view of Kear to address the amendments in the claim that have positively set forth the functional requirements of the “vacuum port connected to a vacuum source”.
The Examiner notes that the at-issue functional recitations in claim 1 associated with the vacuum port and vacuum source are as follows:
configured to draw a vacuum through the sheath of a magnitude sufficient to at least partially evacuate the renal pelvis while the RF generator delivers RF energy to the electrode elements and while the effector is inserted through the sheath whereby, when the distal region of the effector protrudes from the distal opening of the sheath and expands towards its pre-set shape within the renal pelvis,
the vacuum is configured to draw two opposing wall portions of the renal pelvis inwards and compress the distal region of the effector from its pre-set shape such that the opposing renal pelvic wall portions each intimately engage at least one of the discrete electrode elements during the delivery of RF energy
The Examiner maintains that these requirements prescribed to the vacuum source in the last paragraph of claim 1 are indeed functional recitation of the intended use of the vacuum port, vacuum source and the vacuum drawn through the sheath.
The Examiner reiterates the rationale in the updated rejection of claim 1 that it is well established that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
While Applicant alleges that the claimed structure of the various vacuum structural features define over the prior art combination of Ku and Kear, the Examiner readily maintains the position that the claimed system including the “vacuum port connected to a vacuum source” and further requiring the various functional requirements of the vacuum drawn through the sheath at a time when the system is inserted into the renal pelvis fails to be structurally differentiated by the prior art combination of Ku in view of Kear. It is the Examiner’s position that the combination with Kear readily provides for an exemplary vacuum source capable of drawing a vacuum through a sheath placed within the same location within the kidney of the patient and further having an adjustable amount of vacuum being capable of being applied through the vacuum port and sheath.
To this end, the Examiner has looked to the guidance set forth in each of MPEP 2173.05(g) and MPEP 2114 regarding the manner in which functional limitations are to be considered and evaluated. MPEP 2114 notes that “[a] claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”.
The Examiner has provided explanation above that describes the manner in which the Examiner finds that the prior art structure in the combination of Ku in view of Kear readily meets the structural requirements of the claim. The Examiner further notes that, in considering these limitations in light of the instant disclosure, the instant Specification only substantially recites similar recitations as found in claim 1 with respect to the functional limitations of the vacuum source. The instant disclosure fails to define any manner of structure for the vacuum source and fails to provide any defined ranges of pressures for the vacuum drawn through the sheath considered sufficient to provide for the claimed functionality that would require the structure of the vacuum source to be structurally different than the prior art vacuum source of Kear. The Examiner takes this position further in view of the fact that the Kear is specifically directed for an intended use of placing a sheath through a ureter of the body and within the kidney, and for the application of vacuum within that location of the body.
Thus, the Examiner maintains that the rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Ku in view of Kear is tenable for at least the reasoning set forth in the rejections and Remarks above.
Applicant further argues that “it would not have been obvious to supplement Ku with Kear to add such ‘vacuum’ structural limitations for the reasons set forth in Applicant’s response of October 31, 2025 and declaration filed in support, namely, that a vacuum source would be avoided by those of ordinary skill in the art because of potential damage to the renal pelvis, and thus would not combine Ku and Kear.”
The Examiner notes that the November 19, 2025 Final Office Action has set forth remarks with respect to Applicant’s October 31, 2025 arguments and declarations. Applicant has not submitted any remarks in the instant response to contradict the Examiner’s prior remarks in the November 19, 2025 Final Office Action.
Accordingly, the Examiner maintains the prior position that the arguments in the October 31, 2025 Remarks and Declarations are persuasive in preempting the above proffered combination of Ku in view of Kear under 35 U.S.C. 103.
In particular, the Examiner reiterates that the cited declarations in the related US App. No. 18/412,240 are directed towards a method for treating hypertension and not a “system for treatment of nerves present in a wall of a human renal pelvis” as currently required in instant independent claim 1. Such rationale is equally applicable to the declarations filed in related US App. No. 17/097,387 and its focus on a method of delivering energy to a renal pelvis.
The Examiner fails to find that Applicant’s prior declarations preempt the combination of Kear with Ku to provide for the specific connection to a source of vacuum or the functional requirements of the vacuum source. These prior declarations and their focus on specific methods of treatment hypertension or the renal pelvis fails to address the specific fact pattern presented in the rejections above, and further fails to address a system claim that functionally recites in the preamble that such is “for treatment of nerves present in a wall of a human renal pelvis”. These declarations also do not address the specific manner in which functional limitations are interpreted in apparatus claims. Thus, the Examiner maintains that the proffered rejection of claim 1 under 35 U.S.C. 103 as unpatentable over the combination of Ku in view of Kear in the action remains tenable for at least the reasoning set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794