DETAILED ACTION
Response to Arguments
Applicant’s arguments, see pages 10-12, filed on 2/13/2026, with respect to the drawing objections have been fully considered and are persuasive. The previous drawing objections pertaining to reference characters “106”, “108”, “204”, “206”, “210A/B”, “214A/B”, “212A”, “216A”, and “50” have been withdrawn. The previous drawing objections due to reference characters “10” and “400” not being mentioned in the description have also been withdrawn.
Applicant’s arguments, see pages 12-13, filed on 2/13/2026, with respect to the previous 35 U.S.C. 112(f) interpretation of claim 21 have been fully considered and are persuasive. The previous 112(f) interpretation of claim 21 has been withdrawn.
Applicant’s arguments, see pages 13-14, filed on 2/13/2026, with respect to the previous 35 U.S.C. 112(a) rejection of claim 21 have been fully considered and are persuasive. The previous 112(a) rejection of claim 21 has been withdrawn.
Applicant’s arguments, see pages 14-17, filed on 2/13/2026, with respect to the previous 35 U.S.C. 112(b) rejections of claims 1-9, 11-12, 15-19, and 24 have been fully considered and are persuasive. The previous 112 rejections of claims 1-9, 11-12, 15-19, and 24 have been withdrawn.
Applicant's arguments filed on 2/13/2026 regarding the 35 U.S.C. 103 rejections have been fully considered, but they are not persuasive. The response is below.
Regarding the prior art rejections of claims 1-8, 13-19, 22, and 24 under Mishra in
view of Ahimsadasan and Sata, these rejections are not withdrawn. Applicant argues that
Mishra does not disclose delivering electrical stimulation to preganglionic dorsal root fibers of a patient to activate renal afferent nerves. The examiner notes that this claim language describes an intended use of said system.
In response to applicant's argument that stimulating preganglionic dorsal root fibers to activate renal afferent nerves is not disclosed in Mishra, 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.
Mishra teaches delivering electrical stimulation to the dorsal root, dorsal root ganglia, or other spinal cord tissue in order to provide electrical stimulation to nerves in a targeted tissue. Therefore, it would be understood by a person of ordinary skill in the art that the disclosed structure in Mishra is capable of performing the intended use of the instant claims to deliver electrical stimulation to preganglionic dorsal root fibers of a patient to activate renal afferent nerves. Therefore, the rejections of claims 1-8, 13-19, 22, and 24 are not withdrawn.
Regarding the prior art rejections of claims 9-10 under Mishra in view of
Ahimsadasan, Sata, and Lee, these rejections are not withdrawn. Applicant argues that claims 9-10 are patentable over the cited prior art due to the prior reasoning regarding the rejection of independent claim 1 from which each of claims 9-10 depends. Furthermore, Applicant argues that Lee does not teach or suggest to contain a cathodic current flow from the cathode to restrict stimulation of nerves other than the renal afferent nerves of the preganglionic dorsal root fiber. Because the rejection of claim 1 is upheld and the Examiner still ascertains that Lee teaches an electrical stimulation system that uses a cathode and anode to contain a cathodic current flow to minimize electrical stimulation of undesired nerves, the rejections of claims 9-10 are not withdrawn.
Regarding the prior art rejections of claims 11-12 under Mishra in view of
Ahimsadasan, Sata, and McLaughlin, these rejections are not withdrawn. Applicant argues that claims 11-12 are patentable over the cited prior art due to the prior reasoning regarding the rejection of independent claim 1 from which each of claims 11-12 depends. Because the rejection of claim 1 is upheld and no other argument is provided regarding claims 11-12, the rejections of claims 11-12 are not withdrawn.
Regarding the prior art rejections of claims 20-21 and 23 under Mishra in view of
Ahimsadasan, Sata, and Connor, these rejections are not withdrawn. Applicant argues that claims 20-21 and 23 are patentable over the cited prior art due to the prior reasoning regarding the rejection of independent claim 1 from which each of claims 20-21 and 23 depends. Because the rejection of claim 1 is upheld and no other argument is provided regarding claims 20-21 and 23, the rejections of claims 20-21 and 23 are not withdrawn.
Applicant's arguments filed 2/13/2026 regarding the double patenting rejections have been fully considered but they are not persuasive. Applicant respectfully traversed these rejections in view of the lack of indication of allowable subject matter. Because there is no indication of allowable subject matter in the present office action, the double patenting rejections of claims 1-2, 11-13, and 23 are not withdrawn.
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.
Claims 1-8, 13-19, 22 and 24 are rejected under 35 U.S.C. 103 as being
unpatentable over Mishra (U.S. PGPub No. 2024/0139517) in view of Neuroanatomy,
Dorsal Root Ganglion, 2022 (herein referred to as Ahimsadasan) and Role of the
Sympathetic Nervous System and Its Modulation in Renal Hypertension, 2018 (herein
referred to as Sata).
Regarding claim 1, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9)
comprising: at least one electrode (Paragraph 0070, lines 27-30) to deliver electrical
stimulation (Paragraph 0070, lines 24-25) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) of a patient (Paragraph 0061, lines 1-2) to activate nerves in a target tissue (Paragraph 0220, lines 18-26) innervating at least one kidney (Paragraph 0184, lines 25-26) of the patient; and a computing apparatus (Paragraph 0109, lines 3-8) comprising a processor (Paragraph 0109, line 8) and operably coupled to the at least one electrode, the computing apparatus is configured to control the electrical stimulation delivered using the at least one electrode to inhibit activation of nerves in non-targeted tissue (Paragraph 0220, lines 18-26).
Mishra does not disclose delivering electrical stimulation to preganglionic dorsal
root fibers. Ahimsadasan, however, teaches that dorsal root fibers traverse the length of
the dorsal column, which are located in the dorsal root (Structure Section).
Mishra also does not disclose activating renal afferent nerves and inhibiting
activation of renal efferent nerves to innervate at least one kidney of the patient to
promote diuresis. Sata, however, teaches that activating renal afferent nerves and
inhibiting renal efferent nerves results in increased urinary sodium excretion (Fig. 3),
which indicates innervation of a kidney and promotion of diuresis.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of both Ahimsadasan and Sata to deliver electrical stimulation to preganglionic dorsal root fibers, and to activate renal afferent nerves and inhibit activation of renal
efferent nerves. Doing so would innervate a kidney of a patient and promote increased
sodium excretion and diuresis, as recognized by Ahimsadasan and Sata.
Although Mishra does not explicitly disclose delivering electrical stimulation to preganglionic dorsal root fibers of a patient, Mishra does disclose delivering electrical stimulation to spinal cord tissue including the dorsal root and dorsal root ganglia (Paragraph 0081). Because this language would be an intended use of said system, and Mishra discloses all of the structural components of the instant claim, it would be well understood by a person of ordinary skill in the art that the system and electrode disclosed in Mishra would be capable of delivering electrical stimulation to preganglionic dorsal root fibers of a patient.
And although Mishra does not explicitly disclose delivering electrical stimulation to activate renal afferent nerves and inhibit activation of renal efferent nerves, Mishra does disclose delivering electrical stimulation to nerves in targeted tissues and minimizing stimulation of nerves in non-targeted tissues (Paragraph 0220). Because this language would be an intended use of said system, and Mishra discloses all of the structural components of the instant claim, it would be well understood by a person of ordinary skill in the art that the system disclosed in Mishra would be capable of delivering electrical stimulation to activate renal afferent nerves and inhibit activation of renal efferent nerves.
Regarding claim 2, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) as in claim 1, wherein controlling the electrical stimulation (Paragraph 0070,
lines 24-25) delivered using the at least one electrode (Paragraph 0070, lines 27-30) to
the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises adjusting one or more parameters (Paragraph 0121, lines 6-10) of the electrical stimulation delivered to the dorsal root, dorsal root ganglia, or other spinal cord tissue using the at least one electrode, wherein the one or more parameters comprises one or more of pulse width (Paragraph 0059, line 11), amplitude (Paragraph 0059, line 9), frequency (Paragraph 0059, line 10), on/off cycle timing (Paragraph 0059, lines 13-14), burst cycle timing (Paragraph 0059, lines 15-17), and pulse shape (Paragraph 0059, lines 12-13).
Regarding claim 3, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) as in claim 1, wherein the computing apparatus (Paragraph 0109, lines 3-8) is
further configured to execute receiving electromyographic (EMG) data (Paragraph 0127,
lines 9-11) from the at least one electrode (Paragraph 0070, lines 27-30), and wherein
controlling the electrical stimulation (Paragraph 0070, lines 24-25) delivered using the at
least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation delivered using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue based on the received EMG data.
Regarding claim 4, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein controlling the electrical stimulation (Paragraph 0070, lines
24-25) delivered using the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises adjusting one or more parameters (Paragraph 0121, lines 6-10) of the electrical stimulation delivered to the dorsal root, dorsal root ganglia, or other spinal cord tissue using the at least one electrode in response to one or more of side effect response data (Paragraph 0316, lines 4-5) and stimulation response data (Paragraph 0316, lines 4-5).
Regarding claim 5, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 4. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 4, wherein the computing apparatus (Paragraph 0109, lines 3-8) is
further configured to execute receiving evoked compound action potential (ECAP)
signals (Paragraph 0023, lines 1-4) from the at least one electrode (Paragraph 0070, lines
27-30) in response to the delivery of electrical stimulation (Paragraph 0070, lines 24-25)
using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8), and wherein adjusting one or more parameters (Paragraph 0121, lines 6-10) of the electrical stimulation delivered to the dorsal root, dorsal root ganglia, or other spinal cord tissue using the at least one electrode comprises adjusting the one or more parameters of the electrical stimulation based on the received ECAP signals.
Regarding claim 6, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 5. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 5, wherein receiving ECAP signals (Paragraph 0023, lines 1-4) from
the at least one electrode (Paragraph 0070, lines 27-30) in response to the delivery of
electrical stimulation (Paragraph 0070, lines 24-25) using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises receiving ECAP signals from at least one sensing electrode (Paragraph 0070, lines 27-30) in response to the delivery of electrical stimulation using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue.
Regarding claim 7, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 5. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 5, wherein receiving ECAP signals (Paragraph 0023, lines 1-4) from
the at least one electrode (Paragraph 0070, lines 27-30) in response to the delivery of
electrical stimulation (Paragraph 0070, lines 24-25) using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises measuring a latency of response (Fig. 2A, Paragraph 0310, lines 4-10) of the ECAP signals in response to the delivery of electrical stimulation using the at least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue.
Regarding claim 8, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein controlling the electrical stimulation (Paragraph 0070, lines
24-25) delivered using the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises adjusting a pulse width (Paragraph 0059, line 11) of the electrical stimulation delivered to the dorsal root, dorsal root ganglia, or other spinal cord tissue or an amplitude (Paragraph 0059, line 9) of the electrical stimulation delivered to the dorsal root, dorsal root ganglia, or other spinal cord tissue based on a strength-duration curve (Fig. 6) of the targeted-tissue nerves (Paragraph 0220, lines 18-26) of the dorsal root, dorsal root ganglia, or other spinal cord tissue.
Regarding claim 13, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein the at least one electrode (Paragraph 0070, lines 27-30)
comprises an implantable electrode (Paragraph 0087, lines 15-18) to be implanted in the
patient's body.
Regarding claim 14, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 13 that includes the implantable electrode (Paragraph 0087, lines 15-18). Mishra does not disclose that the implantable electrode is configured to be
implanted between 2 millimeters and 6 millimeters from the patient's spinal midline.
However, it is well known in the art that the distance between a preganglionic dorsal root
ganglia and the spinal midline varies by spinal level, but that the nerve fibers themselves are typically within 1-3 millimeters of the spinal midline.
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to modify Mishra to incorporate the known distance range between nerve fibers and the spinal midline. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try locating a stimulating electrode in the range of 2-6 millimeters from the patient’s spinal midline in order to stimulate preganglionic dorsal root fibers.
Regarding claim 15, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein the electrical stimulation (Paragraph 0070, lines 24-25)
delivered using the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal root,
dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation to be delivered according to a predetermined schedule (Paragraph 0121, lines 1-5) identifying one or more time periods (Paragraph 0287, lines 44-49) when to deliver the electrical stimulation.
Regarding claim 16, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein controlling the electrical stimulation (Paragraph 0070, lines
24-25) delivered using the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation to be delivered based on the patient's circadian rhythm (Paragraph 0127, lines 15-16).
Regarding claim 17, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein controlling the electrical stimulation (Paragraph 0070, lines
24-25) delivered by the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation to be delivered based on an activity sensor (Paragraph 0127, lines 1-20).
Regarding claim 18, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein controlling the electrical stimulation (Paragraph 0070, lines
24-25) delivered by the at least one electrode (Paragraph 0070, lines 27-30) to the dorsal
root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation to be delivered based on a sensed position of the patient's body (Paragraph 0127, line 14).
Regarding claim 19, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 1. Mishra further discloses a system (Fig. 1, Paragraph 0069,
lines 8-9) of claim 1, wherein the system further comprises at least one sensor (Paragraph
0185, lines 1-3) operably coupled to the computing apparatus (Paragraph 0109, lines 3-8)
to detect and the computing apparatus is further configured to execute detecting using at
least one sensor at least one physiological parameter (Paragraph 0089, lines 1-4) of the
patient (Paragraph 0061, lines 1-2), and monitoring the at least one physiological
parameter using the at least one sensor; and wherein controlling the electrical stimulation
(Paragraph 0070, lines 24-25) delivered by the at least one electrode (Paragraph 0070,
lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises controlling the electrical stimulation in response to the detected at least one physiological parameter.
Regarding claim 22, Mishra in view of Ahimsadasan and Sata discloses the
claimed invention of claim 19. Mishra further discloses a system (Fig. 1, Paragraph
0069, lines 8-9) of claim 19, wherein monitoring the at least one physiological parameter
(Paragraph 0089, lines 1-4) using the at least one sensor (Paragraph 0185, lines 1-3)
comprises monitoring a first physiological parameter (Paragraph 0089, lines 1-4) and a
second physiological parameter (Paragraph 0089, lines 1-4), wherein controlling the
electrical stimulation (Paragraph 0070, lines 24-25) in response to the detected at least
one physiological parameter comprises controlling the electrical stimulation in response
to the first physiological parameter and the second physiological parameter.
Regarding claim 24, Mishra discloses a method (Paragraph 0061, lines 1-2)
comprising: Delivering electrical stimulation (Paragraph 0070, lines 24-25) using at least
one electrode (Paragraph 0070, lines 27-30) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) of a patient (Paragraph 0061, lines 1-2) to activate nerves in a target tissue (Paragraph 0220, lines 18-26) innervating at least one kidney (Paragraph 0184, lines 25-26) of the patient; and controlling the electrical stimulation delivered using the at least one electrode to inhibit activation of nerves in non-targeted tissue (Paragraph 0220, lines 18-26).
Mishra does not disclose delivering electrical stimulation to preganglionic dorsal
root fibers. However, Ahimsadasan teaches that dorsal root fibers traverse the length of
the dorsal column, which are located in the dorsal root (Structure Section).
Mishra also does not disclose activating renal afferent nerves and inhibiting
activation of renal efferent nerves to innervate at least one kidney of the patient to
promote diuresis. However, Sata teaches that activating renal afferent nerves and
inhibiting renal efferent nerves results in increased urinary sodium excretion (Fig. 3),
which indicates innervation of a kidney and promotion of diuresis.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of both Ahimsadasan and Sata to deliver electrical stimulation to preganglionic
dorsal root fibers, and to activate renal afferent nerves and inhibit activation of renal
efferent nerves. Doing so would innervate a kidney of a patient and promote increased
sodium excretion and diuresis, as recognized by Ahimsadasan and Sata.
Although Mishra does not explicitly disclose delivering electrical stimulation to preganglionic dorsal root fibers of a patient, Mishra does disclose delivering electrical stimulation to spinal cord tissue including the dorsal root and dorsal root ganglia (Paragraph 0081). Because this language would be an intended use of said invention, and Mishra discloses all of the structural components of the instant claim, it would be well understood by a person of ordinary skill in the art that the electrode disclosed in Mishra would be capable of delivering electrical stimulation to preganglionic dorsal root fibers of a patient.
And although Mishra does not explicitly disclose delivering electrical stimulation to activate renal afferent nerves and inhibit activation of renal efferent nerves, Mishra does disclose delivering electrical stimulation to nerves in targeted tissues and minimizing stimulation of nerves in non-targeted tissues (Paragraph 0220). Because this language would be an intended use of said invention, and Mishra discloses all of the structural components of the instant claim, it would be well understood by a person of ordinary skill in the art that the system disclosed in Mishra would be capable of delivering electrical stimulation to activate renal afferent nerves and inhibit activation of renal efferent nerves.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra in view of Ahimsadasan and Sata as applied to claim 1 above, and further in view of Lee (U.S. Patent No. 9,095,712).
Regarding claim 9, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 1 that includes the at least one electrode (Paragraph 0070, lines 27-30), wherein
controlling the electrical stimulation (Paragraph 0070, lines 24-25) delivered using the at
least one electrode to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) comprises delivering electrical stimulation to restrict stimulation of nerves (Paragraph 0220, lines 18-26) other than the target tissue nerves.
Mishra does not disclose at least one electrode that comprises a cathode and an anode proximate to and spaced apart from the cathode. Mishra also does not disclose using the cathode and anode to contain a cathodic current flow. Lee, however, teaches an electrical stimulation system for modulation of sensory information around dorsal root ganglia that uses at least one electrode that comprises a cathode (Col. 6, lines 14-16) and an anode (Col. 6, lines 14-16) proximate to and spaced apart from the cathode (Col. 6, lines 33-36). Lee also teaches using the cathode and anode to contain a cathodic current flow (Col. 7, lines 51-53).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings of Lee to use at least one electrode that comprises a cathode and an anode that is proximate to and spaced apart from the cathode, which would enable cathodic current flow. Doing so would minimize electrical stimulation of undesired nerves and undesired side effects (Col. 2), as recognized by Lee.
Regarding claim 10, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-
9) of claim 1 that includes the at least one electrode (Paragraph 0070, lines 27-30). Mishra does not disclose that the at least one electrode comprises a multi-polar electrode configured as an unbalanced multi-polar electrode. Lee, however, teaches an electrical stimulation system for modulation of sensory information around dorsal root ganglia that uses at least one electrode that comprises a multi-polar electrode (Col. 6, lines 28-30),
which can be configured as an unbalanced multi-polar electrode (Col. 6, lines 38-41).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings of Lee to use at least one electrode that comprises a multi-polar electrode configured as an unbalanced multi-polar electrode. Doing so would minimize electrical stimulation of undesired nerves and undesired side effects (Col. 2), as recognized by Lee.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra in view of Ahimsadasan and Sata as applied to claim 1 above, and further in view of McLaughlin (U.S. PGPub No. 2018/0200505).
Regarding claim 11, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 1, wherein the at least one electrode (Paragraph 0070, lines 27-30) is configured to deliver stimulation (Paragraph 0070, lines 24-25) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) of at least one of the patient's T11 or T12 vertebrae (Paragraph 0087, lines 19-21).
Mishra does not disclose delivering stimulation to the preganglionic dorsal root
fibers of at least one of the left or right dorsal root. McLaughlin, however, teaches a spinal cord stimulation method that uses an electrode array to deliver electrical stimulation to the dorsal root fibers of at least one of the left or right dorsal root (Paragraph 0078, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of McLaughlin to deliver electrical stimulation to the preganglionic dorsal root fibers of at least one of the left or right dorsal root. Doing so would ensure that preganglionic
dorsal root fibers could be stimulated on either side of the spinal cord as needed (Paragraph 0084), as recognized by McLaughlin.
Regarding claim 12, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 1, wherein the at least one electrode (Paragraph 0070, lines 27-30) comprises at least two electrodes (Paragraph 0070, lines 27-30) to deliver electrical stimulation (Paragraph 0070, lines 24-25) to the dorsal root, dorsal root ganglia, or other spinal cord tissue (Paragraph 0081, lines 2-8) of at least one of the patient's T11 or T12 vertebrae (Paragraph 0087, lines 19-21).
Mishra does not disclose delivering stimulation to the preganglionic dorsal root
fibers of both the left or right dorsal root. McLaughlin, however, teaches a spinal cord
stimulation method that uses an electrode array to deliver electrical stimulation to the dorsal root fibers of both the left and right dorsal root (Paragraph 0078, lines 9-11).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of McLaughlin to deliver electrical stimulation to the preganglionic dorsal root fibers of
both the left and right dorsal root. Doing so would ensure that preganglionic dorsal root
fibers could be stimulated on both sides of the spinal cord as needed (Paragraph 0084), as recognized by McLaughlin.
Claims 20-21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra in view of Ahimsadasan and Sata as applied to claim 1 above, and further in view of Connor (U.S. PGPub No. 2024/0065550).
Regarding claim 20, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 19, wherein the at least one physiological parameter (Paragraph 0089, lines 1-4) of the patient (Paragraph 0061, lines 1-2) includes one or more of a respiration rate (Paragraph 0127, line 15), a heart rate (Paragraph 0127, line 4), a pulmonary arterial wedge pressure (Paragraph 0088, lines 10-11), and a capillary wedge pressure (Paragraph 0088, lines 10-11). Mishra does not disclose the at least one physiological parameter includes a creatine level, a urea nitrogen level, an electrolyte level, a blood urea nitrogen level, a heart rate variability, an abdominal fluid content, a thoracic fluid content, a thoracic fluid content shift, a thoracic impedance, an abdominal impedance, and an epidural impedance.
Connor, however, teaches an implantable medical device that records physiological parameters including creatine level (Paragraph 0395, line 20), urea nitrogen level (Paragraph 0396, line 16), electrolyte level (Paragraph 0396, line 7), a blood urea nitrogen level (Paragraph 0395, lines 8-9), a heart rate variability (Paragraph 0396, line 8), an abdominal fluid content (Paragraph 0250, lines 6), a thoracic fluid content (Paragraph 0250, lines 6), a thoracic fluid content shift (Paragraph 0250, lines 6), a thoracic impedance (Paragraph 0250, lines 6), an abdominal impedance (Paragraph 0250, lines 6), and an epidural impedance (Paragraph 0250, lines 6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of Connor to ensure that the at least one physiological parameter could include creatine
level, urea nitrogen level, electrolyte level, a blood urea nitrogen level, a heart rate
variability, an abdominal fluid content, a thoracic fluid content, a thoracic fluid content
shift, a thoracic impedance, an abdominal impedance, and an epidural impedance. Doing so would specify which physiological parameters are pertinent to the monitoring of electrical stimulation treatment for a patient to promote diuresis (Paragraphs 0250), as recognized by Connor.
Regarding claim 21, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) of claim 19 that includes the computing apparatus (Paragraph 0109, lines 3-8), wherein controlling the electrical stimulation (Paragraph 0070, lines 24-25) in response to the detected physiological parameter comprises controlling the electrical stimulation in response to the determined rate of change of the monitored at least one physiological parameter.
Mishra does not teach a computing apparatus further configured to determine a rate of change of the monitored at least one physiological parameter. Connor, however, teaches adjusting operating parameters of an implanted medical device based on the determined rate of change (Paragraph 0338, lines 1-7) of the monitored at least one physiological parameter.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings
of Connor to include a computing apparatus that can determine a rate of change of the
monitored at least one physiological parameter. Doing so would provide greater control
over the electrical stimulation that is provided to a patient (Paragraph 0338), as recognized by Connor.
Regarding claim 23, Mishra discloses a system (Fig. 1, Paragraph 0069, lines 8-9) as in claim 22 that monitors the first physiological parameter and the second physiological parameter (Paragraph 0089, lines 1-4). Mishra does not disclose that the first physiological parameter is blood urea nitrogen concentration and that the second physiological parameter is an abdominal impedance. Connor, however, teaches an implantable medical device that records physiological parameters using sensors, such as blood urea nitrogen concentration (Paragraph 0395, lines 8-9) and abdominal impedance (Paragraph 0250, lines 6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Mishra to incorporate the teachings of Connor to include that the first physiological parameter is blood urea nitrogen
concentration and that the second physiological parameter is an abdominal impedance.
Doing so would specify which physiological parameters are more pertinent to the
improvement of electrical stimulation treatment for a patient to promote diuresis (Paragraphs 0250), as recognized by Connor.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or
1.321(d) may be used to overcome an actual or provisional rejection based on
Non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP
§ 717.02 for applications subject to examination under the first inventor to file provisions
of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not
subject to examination under the first inventor to file provisions of the AIA . A terminal
disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a
nonstatutory double patenting (NSDP) rejection. A complete reply requires that the
terminal disclaimer be accompanied by a reply requesting reconsideration of the prior
Office action. Even where the NSDP rejection is provisional the reply must be complete.
See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR
1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for
reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for
consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be
used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the
application in which the form is filed determines what form (e.g., PTO/SB/25,
PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal
Disclaimer may be filled out completely online using web-screens. An eTerminal
Disclaimer that meets all requirements is auto-processed and approved immediately upon
submission. For more information about eTerminal Disclaimers, refer to
www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of non-statutory double patenting as
being unpatentable over claim 1 of copending Application No. 17/382,743 (Kornet) in view of Ahimsadasan (2022).
Claim 1 of Kornet '743 recites a system (Paragraph 0072, line 14) comprising: at least one electrode (Paragraph 0072, line 15) to deliver electrical stimulation (Paragraph 0072, line 15) to preganglionic dorsal root fibers of a patient to activate renal afferent nerves (Paragraph 0072, lines 16-17) innervating at least one kidney of the patient (Paragraph 0072, lines 17-18); and a computing apparatus (Paragraph 0072, line 19) comprising a processor (Paragraph 0072, line 19) and operably coupled to the at least one electrode, the computing apparatus is configured to control the electrical stimulation delivered using the at least one electrode to the preganglionic dorsal root fibers to inhibit activation of renal efferent nerves (Paragraph 0072, lines 22-23) innervating the at least
one kidney to promote diuresis (Paragraph 0072, line 24).
Claim 1 of Kornet '743 does not recite delivering electrical stimulation to
preganglionic dorsal root fibers of a patient. However, Ahimsadasan discloses that dorsal
root fibers traverse the length of the dorsal column, which are located in the dorsal root
(Structure Section). It would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified delivering electrical
stimulation to a dorsal root ganglion recited in claim 1 of Kornet '743 to include dorsal
root fibers, as taught by Ahimsadasan, as dorsal root fibers make up the dorsal root and
dorsal root ganglion.
This is a provisional non-statutory double patenting rejection.
Claim 2 is provisionally rejected on the ground of non-statutory double patenting as
being unpatentable over claim 22 of copending Application No. 17/382,743 in view of Ahimsadasan (2022) and Mishra (U.S. PGPub No. 2024/0139517).
Claim 22 of Kornet '743 recites a system (Paragraph 0072, line 118) as in claim 1,
wherein controlling the electrical stimulation (Paragraph 0072, line 120) delivered using
the at least one electrode (Paragraph 0072, line 121) to the preganglionic dorsal root fibers comprises adjusting one or more parameters (Paragraph 0072, line 119) of the electrical stimulation delivered to the preganglionic dorsal root fibers using the at least one electrode, wherein the one or more parameters (Paragraph 0072, line 121) comprises one or more of pulse width, amplitude, frequency, on/off cycle timing, burst cycle timing, and pulse shape (Paragraph 0072, lines 122-123).
Claim 22 of Kornet '743 does not recite delivering electrical stimulation to
preganglionic dorsal root fibers of a patient. However, Ahimsadasan discloses that dorsal
root fibers traverse the length of the dorsal column, which are located in the dorsal root
and dorsal root ganglion. Claim 22 of Kornet '743 does not recite parameters comprising
one or more of burst cycle timing and pulse shape. However, Mishra discloses adjusting
one or more parameters of the electrical stimulation including burst cycle timing
(Paragraph 0059, lines 15-17) and pulse shape (Paragraph 0059, lines 12-13).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified delivering electrical stimulation to a
dorsal root ganglion recited in claim 22 of Kornet '743 to include dorsal root fibers, as
taught by Ahimsadasan, as dorsal root fibers make up the dorsal root and a dorsal root
ganglion. It would have also been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified adjusting one or more
parameters of the electrical stimulation to also include burst cycle timing and pulse shape,
as taught by Misha, as this would provide more options for altering parameters of the
electrical stimulation.
This is a provisional non-statutory double patenting rejection.
Claim 11 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 3 of copending Application No. 17/382,743 in view of Ahimsadasan (2022).
Claim 3 of Kornet '743 recites a system (Paragraph 0072, line 30) of claim 1, wherein the at least one electrode (Paragraph 0072, line 31) is configured to deliver stimulation (Paragraph 0072, line 31) to the preganglionic dorsal root fibers of at least one of the left or right dorsal root (Paragraph 0072, line 32) of at least one of the patient's T11 or T12 vertebrae (Paragraph 0072, lines 32-33).
Claim 3 of Kornet '743 does not recite delivering stimulation to preganglionic
dorsal root fibers of a patient. However, Ahimsadasan discloses that dorsal root fibers
traverse the length of the dorsal column, which are located in the dorsal root and dorsal
root ganglion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified delivering electrical
stimulation to a dorsal root ganglion recited in claim 3 of Kornet '743 to include dorsal
root fibers, as taught by Ahimsadasan, as dorsal root fibers make up the dorsal root and
dorsal root ganglion.
This is a provisional nonstatutory double patenting rejection.
Claim 12 is provisionally rejected on the ground of nonstatutory double patenting
as being unpatentable over claim 5 of copending Application No. 17/382,743 in view of
Ahimsadasan (2022).
Claim 5 of Kornet '743 recites a system (Paragraph 0072, line 40) of claim 1,
wherein the at least one electrode comprises at least two electrodes (Paragraph 0072,
lines 40-41) to deliver electrical stimulation (Paragraph 0072, line 41) to the
preganglionic dorsal root fibers of both the left and right dorsal root (Paragraph 0072,
lines 41-42) of at least one of the patient's TII or T12 vertebrae (Paragraph 0072, line 42).
Claim 5 of Kornet '743 does not recite delivering stimulation to preganglionic
dorsal root fibers of a patient. However, Ahimsadasan discloses that dorsal root fibers
traverse the length of the dorsal column, which are located in the dorsal root and dorsal
root ganglion. It would have been obvious to one of ordinary skill in the art before the
effective filing date of the claimed invention to have modified delivering electrical
stimulation to a dorsal root ganglion recited in claim 5 of Kornet '743 to include dorsal
root fibers, as taught by Ahimsadasan, as dorsal root fibers make up the dorsal root and
dorsal root ganglion.
This is a provisional nonstatutory double patenting rejection.
Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of copending Application No. 17/382,743 (Kornet) in view of Ahimsadasan (2022).
Regarding claim 13, Kornet '743 in view of Ahimsadasan teaches a provisional nonstatutory double patenting rejection of claim 1 in which claim 13 depends. Furthermore, claim 13 is directed to the same invention as that of claim 8 of commonly
assigned copending Application No. 17/382,743. Under 35 U.S.C. 101, more than one
patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely
filed petition. The U.S. Patent and Trademark Office normally will not institute a
derivation proceeding between applications or a patent and an application having
common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims
such that the reference and the instant application no longer contain claims directed to the
same invention.
Claim 23 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 17/382,743 (Kornet) in view of Ahimsadasan (2022).
Regarding claim 23, Kornet '743 in view of Ahimsadasan teaches a provisional
nonstatutory double patenting rejection of claim 1 in which claim 23 depends. Furthermore, claim 23 is directed to the same invention as that of claim 21 of commonly
assigned copending Application No. 17/382,743. Under 35 U.S.C. 101, more than one
patent may not be issued on the same invention.
The USPTO may not institute a derivation proceeding in the absence of a timely
filed petition. The U.S. Patent and Trademark Office normally will not institute a
derivation proceeding between applications or a patent and an application having
common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims
such that the reference and the instant application no longer contain claims directed to the
same invention.
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.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796