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 .
Election/Restrictions
Applicant’s election without traverse of claims 7-20 in the reply filed on 5/13/26 is acknowledged. Applicant canceled claims 1-6.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/3/23 is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
electrode device in claims 7 and 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For electrode device in claims 7 and 14, the specification discloses “an electrode device that is a lead comprising at least two electrical contacts” (¶24). Therefore, the Examiner is interpreting an electrode device to be a lead comprising at least two electrical contacts, or any equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 9-12 and 17-20 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 9 recites the limitation "the plurality of stimulation pulses" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The use of “the plurality of stimulation pulses” in lines 6-7 of claim 9 is similarly rejected for the same deficiency. For the purpose of examination, the Examiner is interpreting “the plurality of stimulation pulses” in lines 3-4 as “a plurality of stimulation pulses.”
Claim 10 recites the limitation "the plurality of stimulation pulses" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting “the plurality of stimulation pulses” in line 3 as “a plurality of stimulation pulses.”
Claim 10 recites the limitation "the frequency" in lines 5 and 9-10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting “the frequency” in line 5 as “a frequency.”
In claim 10, the limitation of “an SAP signal” in lines 5-6 seems unclear. It remains unclear if this is the same or different than “an SAP signal” in line 2. For the purpose of examination, the Examiner is interpreting “an SAP signal” in lines 5-6 as “the SAP signal,” similar to claim 17.
In claim 10, the limitation of “an ECAP signal” in lines 6 and 10 seems unclear. It remains unclear if this is the same or different than “an ECAP signal” in lines 3-4. For the purpose of examination, the Examiner is interpreting “an ECAP signal” in lines 6 and 10 as “the ECAP signal,” similar to claim 17.
Claim 11 recites the limitation "the plurality of stimulation pulses" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The use of “the plurality of stimulation pulses” in line 8 of claim 11 is similarly rejected for the same deficiency. For the purpose of examination, the Examiner is interpreting “the plurality of stimulation pulses” in lines 3-4 as “a plurality of stimulation pulses.”
Claims 12 and 19 recite the limitation "the pterygopalatine fossa (PPF)" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting "the pterygopalatine fossa (PPF)" as "a pterygopalatine fossa (PPF)."
Claim 17 recites the limitation "the frequency" in lines 4 and 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting “the frequency” in line 4 as “a frequency.”
In claim 18, the limitation of “biometric data” in line 2 seems unclear. It remains unclear whether this is the same or different than “biometric data” in claim 14, line 8. For the purpose of examination, the Examiner is interpreting “biometric data” in claim 18, line 2 to be the same as “biometric data” in claim 14, line 8.
Claim 18 recites the limitation "the pattern" in lines 4, 7, and 9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting “the pattern” in line 4 to be “a pattern.”
Claim 18 recites the limitation "the level" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner is interpreting “the level” in line 5 to be “a level.”
Regarding claim 20, the phrase "a branch of any of the foregoing" in line 5 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "any of the foregoing"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For the purpose of examination, the Examiner is interpreting the dorsal nasal nerve structure to be at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a greater petrosal nerve (GPN), a lesser petrosal nerve, or a deep petrosal nerve (DPN). Applicant is encouraged to remove “a branch of any of the foregoing” in line 5 and have claim 20 be worded similarly to claim 13.
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 7-8, 12-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf (US 20150174406 filed on 1/2/15 as cited in the IDS) in view of Papay (US 20120209286 filed on 2/15/12 as cited in the IDS).
Regarding claim 7, Lamensdorf teaches a method comprising: inserting in the patient an electrode device sized and dimensioned to deliver a stimulation signal to a dorsal nasal nerve structure (¶91-an implantable neural stimulator, the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶190-192; ¶342; ¶394), the stimulation signal having stimulation parameters (¶95-the level of stimulation of the SPG is determined by receiving feedback directly from the SPG, or from other neural tissue in a vicinity of the SPG, i.e., by using at least a portion of the electrodes to directly measure a level of stimulation of the SPG or the other neural tissue at or in a vicinity of the site(s) of the stimulation by the electrodes; ¶98-determine parameters of the applied current; ¶377-stimulation parameters); sensing a physiological parameter (¶98-at least one physiological indicator of cerebral blood flow (CBF) is observed or measured), the physiological parameter including at least one of: tearing; impedance of tissue surrounding the dorsal nasal structure; an electrically evoked signal; or biometric data (¶98-at least one physiological indicator of cerebral blood flow (CBF) is observed or measured; ¶95-the level of stimulation of the SPG is determined by assessing an indirect physiological parameter of the subject related to the level of SPG stimulation, such as cerebral blood flow (CBF); ¶27; ¶28; ¶149-150; ¶170-171; ¶395), wherein said sensing is performed intra-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator so as to increase or decrease CBF, as appropriate. Alternatively or additionally, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF); automatically controlling, based on the sensed physiological parameter, at least one of placement of an electrode device adjacent to the dorsal nasal structure, or stimulation parameters delivered by the electrode device to the dorsal nasal structure (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator so as to increase or decrease CBF, as appropriate; ¶413; ¶426), wherein said automatically controlling is performed intra-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator); and delivering a stimulation signal via the electrode device to the dorsal nasal structure (¶99-apply excitatory electrical stimulation to at least one “modulation target site” (MTS), as defined hereinbelow, such as a sphenopalatine ganglion (SPG)).
While Lamensdorf teaches treatment of an adverse brain condition, such as an adverse cerebrovascular condition, e.g., an ischemic event (¶99) and headache (¶30-31), Lamensdorf does not explicitly teach to improve the patient's headache pain and a parameter associated with the headache pain.
Papay relates generally to generally to an apparatus and method for delivering therapy delivery devices to craniofacial locations, and more particularly to a surgical guide and method for delivering a therapy delivery device into the pterygopalatine fossa of a subject (¶2). Papay further teaches the invention using the following steps:
improve the patient's headache pain (¶79-treating a medical condition (e.g., headache) in a subject) and a parameter associated with the headache pain (¶93-electrical parameters may be automatically tailored in response to a sensed symptom or a related symptom indicative of a headache).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include improving the patient's headache pain and a parameter associated with the headache pain of Papay in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92).
Regarding claim 8, the combination of Lamensdorf and Papay teaches the method of claim 7, further comprising delivering a plurality of stimulation pulses to tissue adjacent to the dorsal nasal nerve structure before said sensing (Lamensdorf, ¶199-applying a current to the site capable of inducing a change in cerebral blood flow (CBF) of the subject; detecting an indication of the CBF; ¶95-the level of stimulation of the SPG is determined by assessing an indirect physiological parameter of the subject related to the level of SPG stimulation, such as cerebral blood flow (CBF)).
Regarding claim 12, the combination of Lamensdorf and Papay teaches the method of claim 7, wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatine fossa (PPF) (Papay, ¶6-a surgical guide to facilitate delivery of a therapy delivery device into the pterygopalatine fossa (PPF) of a subject; ¶63-the SPG 16 is located behind the maxilla 20 in the PPF 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatine fossa (PPF) of Papay in order to in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92). The SPG is located behind the maxilla in the PPF (Papay, ¶63).
Regarding claim 13, the combination of Lamensdorf and Papay teaches the method of claim 7, wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a vidian nerve (VN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), a nasopalatine nerve, a greater palatine nerve, an inferior posterior lateral nasal branch of the greater palatine nerve, a lesser palatine nerve, or a superior maxillary nerve (Lamensdorf, ¶91-the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶102-a nerve of the pterygoid canal (also called a vidian nerve) such as a greater superficial petrosal nerve (a preganglionic parasympathetic nerve) or a lesser deep petrosal nerve (a postganglionic sympathetic nerve), a greater palatine nerve, a lesser palatine nerve; ¶9-a nasopalatine nerve).
Regarding claim 14, Lamensdorf teaches a method comprising: inserting in the patient an electrode device sized and dimensioned to deliver a stimulation signal to a dorsal nasal nerve structure (¶91-an implantable neural stimulator, the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶190-192; ¶342; ¶394), the stimulation signal having stimulation parameters (¶95-the level of stimulation of the SPG is determined by receiving feedback directly from the SPG, or from other neural tissue in a vicinity of the SPG, i.e., by using at least a portion of the electrodes to directly measure a level of stimulation of the SPG or the other neural tissue at or in a vicinity of the site(s) of the stimulation by the electrodes; ¶98-determine parameters of the applied current; ¶377-stimulation parameters); sensing a physiological parameter (¶98-at least one physiological indicator of cerebral blood flow (CBF) is observed or measured), the physiological parameter being at least one of: tearing; impedance of tissue surrounding a dorsal nasal nerve structure; an evoked electrical signal; or biometric data (¶98-at least one physiological indicator of cerebral blood flow (CBF) is observed or measured; ¶95-the level of stimulation of the SPG is determined by assessing an indirect physiological parameter of the subject related to the level of SPG stimulation, such as cerebral blood flow (CBF); ¶27; ¶28; ¶149-150; ¶170-171; ¶395); and automatically controlling, based on the sensed physiological parameter, stimulation of the dorsal nasal nerve structure by at least one of initiating delivery of the stimulation signal, or adjusting the stimulation parameters of the stimulation signal (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF; ¶99-apply excitatory electrical stimulation to at least one “modulation target site” (MTS), as defined hereinbelow, such as a sphenopalatine ganglion (SPG); ¶101-adjust at least one parameter of the applied stimulation; ¶413-technique is used to verify the placement of electrodes 38 after implantation, and/or to select which combination of electrodes to use, such as by using the feedback algorithm; ¶426), wherein said sensing and said automatically controlling are performed post-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF; ¶413-technique is used to verify the placement of electrodes 38 after implantation, and/or to select which combination of electrodes to use, such as by using the feedback algorithm).
While Lamensdorf teaches treatment of an adverse brain condition, such as an adverse cerebrovascular condition, e.g., an ischemic event (¶99) and headache (¶30-31), Lamensdorf does not explicitly teach to improve the patient's headache pain and a parameter associated with the headache pain.
Papay teaches to improve the patient's headache pain (¶79-treating a medical condition (e.g., headache) in a subject) and a parameter associated with the headache pain (¶93-electrical parameters may be automatically tailored in response to a sensed symptom or a related symptom indicative of a headache).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include improving the patient's headache pain and a parameter associated with the headache pain of Papay in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92).
Regarding claim 19, the combination of Lamensdorf and Papay teaches the method of claim 14, wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatinefossa (PPF) (Papay, ¶6-a surgical guide to facilitate delivery of a therapy delivery device into the pterygopalatine fossa (PPF) of a subject; ¶63-the SPG 16 is located behind the maxilla 20 in the PPF 14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatinefossa (PPF) of Papay in order to in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92). The SPG is located behind the maxilla in the PPF (Papay, ¶63).
Regarding claim 20, the combination of Lamensdorf and Papay teaches the method of claim 14, wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), or a branch of any of the foregoing (Lamensdorf, ¶91-the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶102-a nerve of the pterygoid canal (also called a vidian nerve) such as a greater superficial petrosal nerve (a preganglionic parasympathetic nerve) or a lesser deep petrosal nerve (a postganglionic sympathetic nerve).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf in view of Papay as applied to claims 7 and 14 above, and further in view of Caparso (US 20180133478 filed on 12/22/17).
Regarding claim 9, the combination of Lamensdorf and Papay teaches the method of claim 7. However, the combination of Lamensdorf and Papay does not teach wherein the sensed parameter includes tearing, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient.
Caparso teaches wherein the sensed parameter includes tearing (¶84-tear production; ¶73), and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient (¶47-can be used to induce tear production via neuromodulation to treat or prevent dry eye disease; ¶73-in order to induce tear production, one or more devices (like implantable microstimulator 201, an example of which is shown in FIG. 7 that is configured for the induction of tear production) may be positioned within the nasolacrimal drainage system to prompt or stimulate the lacrimal gland 2; ¶84-the central lumen 116, in another example, may have a means of measuring the volume or velocity of tears flowing through the microstimulator); and said automatically controlling is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient (¶84-the volume or velocity of tear flow could be used as a close-loop system, in which the microstimulator alerts the user that the tear production is dropping and that would cause the user to apply the therapy; ¶85-if the impedance indicates that the patient's tear production is the lowest during the morning, the system can remind the patient to stimulate at certain times that are associated with the lowest amount of tear production).
Caparso relates generally to systems and methods for preventing, diagnosing, and/or treating one or more medical conditions via neuromodulation. The systems and methods of the present disclosure can be used, as an example, to use neuromodulation to induce tear production to treat or prevent the medical condition of dry eye disease (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed parameter includes tearing, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient of Caparso in order to treat a headache (Caparso, ¶49).
Regarding claim 15, the combination of Lamensdorf and Papay teaches the method of claim 14. However, the combination of Lamensdorf and Papay does not teach wherein the sensed physiological parameter includes tearing, and wherein: said sensing comprises determining whether the patient is tearing; and said automatically controlling comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal to decrease tearing in the patient.
Caparso teaches wherein the sensed physiological parameter includes tearing (¶84-tear production; ¶73), and wherein: said sensing comprises determining whether the patient is tearing (¶47-can be used to induce tear production via neuromodulation to treat or prevent dry eye disease; ¶73-in order to induce tear production, one or more devices (like implantable microstimulator 201, an example of which is shown in FIG. 7 that is configured for the induction of tear production) may be positioned within the nasolacrimal drainage system to prompt or stimulate the lacrimal gland 2; ¶84-the central lumen 116, in another example, may have a means of measuring the volume or velocity of tears flowing through the microstimulator); and said automatically controlling comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal to decrease tearing in the patient (¶50- the implantable microstimulator 201 can be configured to deliver the therapy signal to the anatomical structure; ¶85-if the impedance indicates that the patient's tear production is the lowest during the morning, the system can remind the patient to stimulate at certain times that are associated with the lowest amount of tear production; ¶51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed physiological parameter includes tearing, and wherein: said sensing comprises determining whether the patient is tearing; and said automatically controlling comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal to decrease tearing in the patient of Caparso in order to treat a headache (Caparso, ¶49).
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf in view of Papay as applied to claims 7 and 14 above, and further in view of Hou (US 20160158550 filed on 12/8/14).
Regarding claim 10, the combination of Lamensdorf and Papay teaches the method of claim 7. However, the combination of Lamensdorf and Papay does not teach wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses and wherein: said sensing comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal; and said automatically controlling is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value.
Hou teaches wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses (¶84-a group of composite SAP signals indicative of evoked compound action potentials (ECAP) collected during a sensing operation; ¶58-the method collects SAP signals, for a data collection window, indicative of the sensory action potential; Fig. 5) and wherein: said sensing comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal (¶45-controller 151 controls sensing signals at the at least one electrode on the lead, and analyzing the signals to identify a C-fiber sensory action potential (C-fiber SAP) component of the signals; ¶69-analyzes the slow conduction SAP data (in the time domain or frequency domain) for one or more features of interest; ¶84-the sensed ECAP signals are sensed between 0.8 ms to 3.0 ms. Each of the ECAP signals represents a composite SAP signal including action potential components conveyed along the A, B and Group C-fibers); and said automatically controlling is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value (¶60-the method determines whether the SAP activity level data determined at 312 satisfies one or more threshold criteria that are indicative of an acceptable pain relief efficacy; ¶60-when the SAP activity level data exceeds the upper threshold limit or the upper limit of the range, the method determines that the coupled tonic/burst therapy is not adequately suppressing a patient's pain; ¶45-the controller 151 further comprises comprising adjusting the tonic-burst delay based on the C-fiber SAP component of the signals; ¶68; ¶79).
Hou generally relates to neurostimulation (NS) systems, and more particularly to coupling burst and tonic stimulation signals in connection with pain relief (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses and wherein: said sensing comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal; and said automatically controlling is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value of Hou in order to treat the patient (Hou, ¶50) and afford desirable pain relief (Hou, ¶26).
Regarding claim 17, the combination of Lamensdorf and Papay teaches the method of claim 14. However, the combination of Lamensdorf and Papay does not teach wherein the sensed physiological parameter includes an evoked electrical potential that is a SAP signal or an ECAP signal, and wherein: said sensing comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers; and said automatically controlling comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal.
Hou teaches wherein the sensed physiological parameter includes an evoked electrical potential that is a SAP signal or an ECAP signal (¶84-a group of composite SAP signals indicative of evoked compound action potentials (ECAP) collected during a sensing operation; ¶58-the method collects SAP signals, for a data collection window, indicative of the sensory action potential; Fig. 5), and wherein: said sensing comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers (¶45-controller 151 controls sensing signals at the at least one electrode on the lead, and analyzing the signals to identify a C-fiber sensory action potential (C-fiber SAP) component of the signals; ¶69-analyzes the slow conduction SAP data (in the time domain or frequency domain) for one or more features of interest; ¶84-the sensed ECAP signals are sensed between 0.8 ms to 3.0 ms. Each of the ECAP signals represents a composite SAP signal including action potential components conveyed along the A, B and Group C-fibers); and said automatically controlling comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal (¶60-the method determines whether the SAP activity level data determined at 312 satisfies one or more threshold criteria that are indicative of an acceptable pain relief efficacy; ¶68-certain composite frequency components of the sensed composite SAP signal entirely or primarily are generated by slow conduction nerve fibers (e.g., C-fibers); ¶45-the controller 151 further comprises comprising adjusting the tonic-burst delay based on the C-fiber SAP component of the signals; ¶62-as the difference between the SAP activity level data and threshold decreases, the tonic-burst delay is changed by similarly/proportionally decreasing amounts; ¶68; ¶79).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed physiological parameter includes an evoked electrical potential that is a SAP signal or an ECAP signal, and wherein: said sensing comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers; and said automatically controlling comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal of Hou in order to treat the patient (Hou, ¶50) and afford desirable pain relief (Hou, ¶26).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf in view of Papay as applied to claims 7 and 14 above, and further in view of Townley (US 20160331459 filed on 5/12/16).
Regarding claim 11, the combination of Lamensdorf and Papay teaches the method of claim 7. However, the combination of Lamensdorf and Papay does not teach wherein the sensed parameter includes impedance of tissue surrounding the dorsal nasal nerve structure, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value.
Townley teaches wherein the sensed parameter includes impedance of tissue surrounding the dorsal nasal nerve structure (¶59-the system 200 and the therapeutic neuromodulation devices described herein can be used to apply therapeutically effective energy to arteries (e.g., the sphenopalatine artery and its branches) as they enter the nasal cavity (e.g., via the SPF, accessory foramen, etc.) to partially or completely coagulate or ligate the arteries; ¶44-the therapeutic assembly 212 can include one or more sensors (not shown), such as one or more temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, and/or other sensors), and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value (¶47-a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement; ¶80-once the impedance exceeds a threshold); and said automatically controlling is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value (¶80-limit the energy applied to tissue at the target site because once the impedance exceeds a threshold in one electrode pairing, the next electrode pairing will occur with a lower impedance).
Townley relates generally to devices, systems, and methods for therapeutically modulating nerves in or associated with a nasal region of a patient. In particular, various embodiments of the present technology are related to therapeutic neuromodulation systems and methods for the treating rhinitis and other indications (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed parameter includes impedance of tissue surrounding the dorsal nasal nerve structure, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value of Townley because the impedance measurements can then be used to identify the presence of neural fibers in the selected regions. If nerves are detected in one or more specific regions associated with an electrode pair, the same electrode pair can be used to apply RF energy to that region and therapeutically modulate the nerves in that region (Townley, ¶85).
Regarding claim 16, the combination of Lamensdorf and Papay teaches the method of claim 14. However, the combination of Lamensdorf and Papay does not teach wherein the sensed physiological parameter includes impedances and wherein: said sensing comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure; and said automatically controlling comprises determining if the impedance exceeds a pre-determined threshold value and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value.
Townley teaches wherein the sensed physiological parameter includes impedances and wherein: said sensing comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure (¶59-the system 200 and the therapeutic neuromodulation devices described herein can be used to apply therapeutically effective energy to arteries (e.g., the sphenopalatine artery and its branches) as they enter the nasal cavity (e.g., via the SPF, accessory foramen, etc.) to partially or completely coagulate or ligate the arteries; ¶44-the therapeutic assembly 212 can include one or more sensors (not shown), such as one or more temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, and/or other sensors); and said automatically controlling comprises determining if the impedance exceeds a pre-determined threshold value (¶47-a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement; ¶80-once the impedance exceeds a threshold) and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value (¶80-limit the energy applied to tissue at the target site because once the impedance exceeds a threshold in one electrode pairing, the next electrode pairing will occur with a lower impedance).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed physiological parameter includes impedances and wherein: said sensing comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure; and said automatically controlling comprises determining if the impedance exceeds a pre-determined threshold value and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value of Townley because the impedance measurements can then be used to identify the presence of neural fibers in the selected regions. If nerves are detected in one or more specific regions associated with an electrode pair, the same electrode pair can be used to apply RF energy to that region and therapeutically modulate the nerves in that region (Townley, ¶85).
27. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lamensdorf in view of Papay as applied to claim14 above, and further in view of Yoo (US 20150148878 filed on 11/25/14 as cited in the IDS).
Regarding claim 18, the combination of Lamensdorf and Papay teaches the method of claim 14. However, the combination of Lamensdorf and Papay does not teach wherein the sensed physiological parameter includes biometric data that is at least one of sleep or locomotor activity of the patient and wherein: said sensing comprises detecting the pattern of said at least one of sleep or the level of locomotor activity of the patient; and automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value.
Yoo teaches wherein the sensed physiological parameter includes biometric data that is at least one of sleep or locomotor activity of the patient (¶311-detect the onset or presence of a sleep apnea event (e.g., snoring can be detected by a microphone or a decrease in airflow can be detected via a flow sensor) or a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event)) and wherein: said sensing comprises detecting the pattern of said at least one of sleep or the level of locomotor activity of the patient (¶311-detect the onset or presence of a sleep apnea event (e.g., snoring can be detected by a microphone or a decrease in airflow can be detected via a flow sensor) or a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event)); and automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient (¶323-the at least one stimulator is provided 32 at a cutaneous location on the head, or within the nasal or oral openings and has a physical size that has been adjusted 32 to correspond to the size and location of the IPC 10; ¶302-the system and method can include at least one IPC implanted on, around, or proximate to, at least one of a vidian nerve (VN), a greater petrosal nerve (GPN), a deep petrosal nerve (DPN), or a branch thereof, of the person. At least one stimulator can be used to apply an electrical signal to a target near the IPC such as the VN, the GPN, the DPN, or a branch thereof; ¶311-a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event), where a particular change in EMG pattern that tends to precede an event aligns with differing than a pre-determined threshold value for the patient) and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value (¶311-the detection of such an event by the processing module 58 may require stimulation to occur; ¶324-apply an electrical signal in a targeted manner to the target; ¶101-patient measurement data can also be used to adjust stimulation protocol parameters and system components, used during therapy, according to individual patients).
Yoo relates to the field of modulating biological tissue (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lamensdorf to include wherein the sensed physiological parameter includes biometric data that is at least one of sleep or locomotor activity of the patient and wherein: said sensing comprises detecting the pattern of said at least one of sleep or the level of locomotor activity of the patient; and automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value of Yoo in order for treatment related to migraine and headache (Yoo, ¶33).
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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.
Claims 7-8, 13-14, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf (US 20150174406).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
7
1
Lamensdorf teaches the stimulation signal having stimulation parameters (¶95-the level of stimulation of the SPG is determined by receiving feedback directly from the SPG, or from other neural tissue in a vicinity of the SPG, i.e., by using at least a portion of the electrodes to directly measure a level of stimulation of the SPG or the other neural tissue at or in a vicinity of the site(s) of the stimulation by the electrodes; ¶98-determine parameters of the applied current; ¶377-stimulation parameters); wherein said sensing is performed intra-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator so as to increase or decrease CBF, as appropriate. Alternatively or additionally, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF); automatically controlling, based on the sensed physiological parameter, at least one of placement of an electrode device adjacent to the dorsal nasal structure, or stimulation parameters delivered by the electrode device to the dorsal nasal structure (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator so as to increase or decrease CBF, as appropriate; ¶413; ¶426), wherein said automatically controlling is performed intra-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, and generally simultaneously monitoring CBF while manipulating the placement of the stimulator); and delivering a stimulation signal via the electrode device to the dorsal nasal structure (¶99-apply excitatory electrical stimulation to at least one “modulation target site” (MTS), as defined hereinbelow, such as a sphenopalatine ganglion (SPG)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the stimulation signal having stimulation parameters; wherein said sensing is performed intra-operatively; , based on the sensed physiological parameter, at least one of placement of an electrode device adjacent to the dorsal nasal structure, or stimulation parameters delivered by the electrode device to the dorsal nasal structure, wherein said automatically controlling is performed intra-operatively; and delivering a stimulation signal via the electrode device to the dorsal nasal structure of Lamensdorf in order to provide treatment of an adverse brain condition (Lamensdorf, ¶30-31; ¶99).
8
1
Lamensdorf teaches delivering a plurality of stimulation pulses to tissue adjacent to the dorsal nasal nerve structure before said sensing (Lamensdorf, ¶199-applying a current to the site capable of inducing a change in cerebral blood flow (CBF) of the subject; detecting an indication of the CBF; ¶95-the level of stimulation of the SPG is determined by assessing an indirect physiological parameter of the subject related to the level of SPG stimulation, such as cerebral blood flow (CBF)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include delivering a plurality of stimulation pulses to tissue adjacent to the dorsal nasal nerve structure before said sensing of Lamensdorf in order to provide treatment of an adverse brain condition (Lamensdorf, ¶30-31; ¶99).
13
Lamensdorf teaches wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a vidian nerve (VN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), a nasopalatine nerve, a greater palatine nerve, an inferior posterior lateral nasal branch of the greater palatine nerve, a lesser palatine nerve, or a superior maxillary nerve (Lamensdorf, ¶91-the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶102-a nerve of the pterygoid canal (also called a vidian nerve) such as a greater superficial petrosal nerve (a preganglionic parasympathetic nerve) or a lesser deep petrosal nerve (a postganglionic sympathetic nerve), a greater palatine nerve, a lesser palatine nerve; ¶9-a nasopalatine nerve). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a vidian nerve (VN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), a nasopalatine nerve, a greater palatine nerve, an inferior posterior lateral nasal branch of the greater palatine nerve, a lesser palatine nerve, or a superior maxillary nerve of Lamensdorf in order to provide treatment of an adverse brain condition (Lamensdorf, ¶30-31; ¶99).
14
1
Lamensdorf teaches the stimulation signal having stimulation parameters (¶95-the level of stimulation of the SPG is determined by receiving feedback directly from the SPG, or from other neural tissue in a vicinity of the SPG, i.e., by using at least a portion of the electrodes to directly measure a level of stimulation of the SPG or the other neural tissue at or in a vicinity of the site(s) of the stimulation by the electrodes; ¶98-determine parameters of the applied current; ¶377-stimulation parameters); sensing a physiological parameter (¶98-at least one physiological indicator of cerebral blood flow (CBF) is observed or measured); and automatically controlling, based on the sensed physiological parameter, stimulation of the dorsal nasal nerve structure by at least one of initiating delivery of the stimulation signal, or adjusting the stimulation parameters of the stimulation signal (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF; ¶99-apply excitatory electrical stimulation to at least one “modulation target site” (MTS), as defined hereinbelow, such as a sphenopalatine ganglion (SPG); ¶101-adjust at least one parameter of the applied stimulation; ¶413-technique is used to verify the placement of electrodes 38 after implantation, and/or to select which combination of electrodes to use, such as by using the feedback algorithm; ¶426), wherein said sensing and said automatically controlling are performed post-operatively (¶98-optimization of placement of the stimulator onto the appropriate neural structure is performed by activating the stimulator, a similar optimization process is performed, either during or after implantation of the stimulator, to determine parameters of the applied current that achieve a desired effect, as indicated by CBF; ¶413-technique is used to verify the placement of electrodes 38 after implantation, and/or to select which combination of electrodes to use, such as by using the feedback algorithm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the stimulation signal having stimulation parameters; and automatically controlling, based on the sensed physiological parameter, stimulation of the dorsal nasal nerve structure by at least one of initiating delivery of the stimulation signal, or adjusting the stimulation parameters of the stimulation signal; wherein said sensing and said automatically controlling are performed post-operatively of Lamensdorf in order to provide treatment of an adverse brain condition (Lamensdorf, ¶30-31; ¶99).
20
Lamensdorf teaches wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), or a branch of any of the foregoing (Lamensdorf, ¶91-the stimulator is adapted to be passed through a greater palatine foramen of a palate of an oral cavity of a subject into a greater palatine canal, such that the electrodes are brought into a vicinity of a sphenopalatine ganglion (SPG); ¶102-a nerve of the pterygoid canal (also called a vidian nerve) such as a greater superficial petrosal nerve (a preganglionic parasympathetic nerve) or a lesser deep petrosal nerve (a postganglionic sympathetic nerve). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the dorsal nasal nerve structure is at least one of a sphenopalatine ganglion (SPG), a sphenopalatine nerve (SPN), a greater petrosal nerve (GPN), a lesser petrosal nerve, a deep petrosal nerve (DPN), or a branch of any of the foregoing of Lamensdorf in order to provide treatment of an adverse brain condition (Lamensdorf, ¶30-31; ¶99).
Claims 9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf and Caparso (US 20180133478).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf and Caparso as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
Secondary Reference Caparso (US 20180133478)
9
1, 2
Caparso teaches wherein the sensed parameter includes tearing (¶84-tear production; ¶73), and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient (¶47-can be used to induce tear production via neuromodulation to treat or prevent dry eye disease; ¶73-in order to induce tear production, one or more devices (like implantable microstimulator 201, an example of which is shown in FIG. 7 that is configured for the induction of tear production) may be positioned within the nasolacrimal drainage system to prompt or stimulate the lacrimal gland 2; ¶84-the central lumen 116, in another example, may have a means of measuring the volume or velocity of tears flowing through the microstimulator); and said automatically controlling is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient (¶84-the volume or velocity of tear flow could be used as a close-loop system, in which the microstimulator alerts the user that the tear production is dropping and that would cause the user to apply the therapy; ¶85-if the impedance indicates that the patient's tear production is the lowest during the morning, the system can remind the patient to stimulate at certain times that are associated with the lowest amount of tear production). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed parameter includes tearing, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses elicits tearing in the patient; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses elicits tearing in the patient of Caparso in order to treat a headache (Caparso, ¶49).
15
1, 2
Caparso teaches wherein the sensed physiological parameter includes tearing (¶84-tear production; ¶73), and wherein: said sensing comprises determining whether the patient is tearing (¶47-can be used to induce tear production via neuromodulation to treat or prevent dry eye disease; ¶73-in order to induce tear production, one or more devices (like implantable microstimulator 201, an example of which is shown in FIG. 7 that is configured for the induction of tear production) may be positioned within the nasolacrimal drainage system to prompt or stimulate the lacrimal gland 2; ¶84-the central lumen 116, in another example, may have a means of measuring the volume or velocity of tears flowing through the microstimulator); and said automatically controlling comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal to decrease tearing in the patient (¶50- the implantable microstimulator 201 can be configured to deliver the therapy signal to the anatomical structure; ¶85-if the impedance indicates that the patient's tear production is the lowest during the morning, the system can remind the patient to stimulate at certain times that are associated with the lowest amount of tear production; ¶51). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed physiological parameter includes tearing, and wherein: said sensing comprises determining whether the patient is tearing; and said automatically controlling comprises initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal to decrease tearing in the patient of Caparso in order to treat a headache (Caparso, ¶49).
Claims 10 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf and Hou (US 20160158550).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf and Hou as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
Secondary Reference Hou (US 20160158550)
10
Hou teaches wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses (¶84-a group of composite SAP signals indicative of evoked compound action potentials (ECAP) collected during a sensing operation; ¶58-the method collects SAP signals, for a data collection window, indicative of the sensory action potential; Fig. 5) and wherein: said sensing comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal (¶45-controller 151 controls sensing signals at the at least one electrode on the lead, and analyzing the signals to identify a C-fiber sensory action potential (C-fiber SAP) component of the signals; ¶69-analyzes the slow conduction SAP data (in the time domain or frequency domain) for one or more features of interest; ¶84-the sensed ECAP signals are sensed between 0.8 ms to 3.0 ms. Each of the ECAP signals represents a composite SAP signal including action potential components conveyed along the A, B and Group C-fibers); and said automatically controlling is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value (¶60-the method determines whether the SAP activity level data determined at 312 satisfies one or more threshold criteria that are indicative of an acceptable pain relief efficacy; ¶60-when the SAP activity level data exceeds the upper threshold limit or the upper limit of the range, the method determines that the coupled tonic/burst therapy is not adequately suppressing a patient's pain; ¶45-the controller 151 further comprises comprising adjusting the tonic-burst delay based on the C-fiber SAP component of the signals; ¶68; ¶79). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed parameter is an electrically evoked signal that is a sensory action potential (SAP) or an electrically evoked compound action potential (ECAP) in response to delivery of the plurality of stimulation pulses and wherein: said sensing comprises detecting the frequency of an SAP signal or an ECAP signal indicating activation of A-delta fibers and C fibers of the electrically evoked signal; and said automatically controlling is based on when the frequency of the SAP signal or an ECAP signal increases above a pre-determined threshold value of Hou in order to treat the patient (Hou, ¶50) and afford desirable pain relief (Hou, ¶26).
17
Hou teaches wherein the sensed physiological parameter includes an evoked electrical potential that is a SAP signal or an ECAP signal (¶84-a group of composite SAP signals indicative of evoked compound action potentials (ECAP) collected during a sensing operation; ¶58-the method collects SAP signals, for a data collection window, indicative of the sensory action potential; Fig. 5), and wherein: said sensing comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers (¶45-controller 151 controls sensing signals at the at least one electrode on the lead, and analyzing the signals to identify a C-fiber sensory action potential (C-fiber SAP) component of the signals; ¶69-analyzes the slow conduction SAP data (in the time domain or frequency domain) for one or more features of interest; ¶84-the sensed ECAP signals are sensed between 0.8 ms to 3.0 ms. Each of the ECAP signals represents a composite SAP signal including action potential components conveyed along the A, B and Group C-fibers); and said automatically controlling comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal (¶60-the method determines whether the SAP activity level data determined at 312 satisfies one or more threshold criteria that are indicative of an acceptable pain relief efficacy; ¶68-certain composite frequency components of the sensed composite SAP signal entirely or primarily are generated by slow conduction nerve fibers (e.g., C-fibers); ¶45-the controller 151 further comprises comprising adjusting the tonic-burst delay based on the C-fiber SAP component of the signals; ¶62-as the difference between the SAP activity level data and threshold decreases, the tonic-burst delay is changed by similarly/proportionally decreasing amounts; ¶68; ¶79). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed physiological parameter includes an evoked electrical potential that is a SAP signal or an ECAP signal, and wherein: said sensing comprises detecting the frequency of the SAP signal or the ECAP signal indicating activation of A-delta fibers and C fibers; and said automatically controlling comprises adjusting the stimulation parameters of the stimulation signal to decrease the frequency of the SAP signal or the ECAP signal of Hou in order to treat the patient (Hou, ¶50) and afford desirable pain relief (Hou, ¶26).
Claims 11 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf and Townley (US 20160331459).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf and Townley as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
Secondary Reference Townley (US 20160331459)
11
7
Townley teaches wherein the sensed parameter includes impedance of tissue surrounding the dorsal nasal nerve structure (¶59-the system 200 and the therapeutic neuromodulation devices described herein can be used to apply therapeutically effective energy to arteries (e.g., the sphenopalatine artery and its branches) as they enter the nasal cavity (e.g., via the SPF, accessory foramen, etc.) to partially or completely coagulate or ligate the arteries; ¶44-the therapeutic assembly 212 can include one or more sensors (not shown), such as one or more temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, and/or other sensors), and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value (¶47-a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement; ¶80-once the impedance exceeds a threshold); and said automatically controlling is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value (¶80-limit the energy applied to tissue at the target site because once the impedance exceeds a threshold in one electrode pairing, the next electrode pairing will occur with a lower impedance). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed parameter includes impedance of tissue surrounding the dorsal nasal nerve structure, and wherein: said sensing comprises detecting when at least one of the plurality of stimulation pulses increases the impedance of the tissue above a pre-determined threshold value; and said automatically controlling is based on when the at least one of the plurality of stimulation pulses increases the impedance of the tissue above the pre-determined threshold value of Townley because the impedance measurements can then be used to identify the presence of neural fibers in the selected regions. If nerves are detected in one or more specific regions associated with an electrode pair, the same electrode pair can be used to apply RF energy to that region and therapeutically modulate the nerves in that region (Townley, ¶85).
16
7
Townley teaches wherein the sensed physiological parameter includes impedances and wherein: said sensing comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure (¶59-the system 200 and the therapeutic neuromodulation devices described herein can be used to apply therapeutically effective energy to arteries (e.g., the sphenopalatine artery and its branches) as they enter the nasal cavity (e.g., via the SPF, accessory foramen, etc.) to partially or completely coagulate or ligate the arteries; ¶44-the therapeutic assembly 212 can include one or more sensors (not shown), such as one or more temperature sensors (e.g., thermocouples, thermistors, etc.), impedance sensors, and/or other sensors); and said automatically controlling comprises determining if the impedance exceeds a pre-determined threshold value (¶47-a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement; ¶80-once the impedance exceeds a threshold) and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value (¶80-limit the energy applied to tissue at the target site because once the impedance exceeds a threshold in one electrode pairing, the next electrode pairing will occur with a lower impedance). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed physiological parameter includes impedances and wherein: said sensing comprises measuring the impedance of the tissue surrounding the dorsal nasal nerve structure; and said automatically controlling comprises determining if the impedance exceeds a pre-determined threshold value and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the impedance exceeds the pre-determined threshold value of Townley because the impedance measurements can then be used to identify the presence of neural fibers in the selected regions. If nerves are detected in one or more specific regions associated with an electrode pair, the same electrode pair can be used to apply RF energy to that region and therapeutically modulate the nerves in that region (Townley, ¶85).
Claims 12 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf and Papay (US 20120209286).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf and Papay as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
Secondary Reference Papay (US 20120209286)
12
Papay teaches wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatine fossa (PPF) (Papay, ¶6-a surgical guide to facilitate delivery of a therapy delivery device into the pterygopalatine fossa (PPF) of a subject; ¶63-the SPG 16 is located behind the maxilla 20 in the PPF 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatine fossa (PPF) of Papay in order to in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92). The SPG is located behind the maxilla in the PPF (Papay, ¶63).
19
Papay teaches wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatinefossa (PPF) (Papay, ¶6-a surgical guide to facilitate delivery of a therapy delivery device into the pterygopalatine fossa (PPF) of a subject; ¶63-the SPG 16 is located behind the maxilla 20 in the PPF 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the dorsal nasal nerve structure is a structure at least partially within the pterygopalatinefossa (PPF) of Papay in order to in order to diminish the pain experienced by the subject (Papay, ¶92) and alter the electrical signal at the earliest onset of pain (Papay, ¶92). The SPG is located behind the maxilla in the PPF (Papay, ¶63).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11679263 in view of Lamensdorf and Yoo (US 20150148878).
This is a nonstatutory double patenting rejection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include the subject matter in Lamensdorf and Yoo as shown below.
Claims of the Present Application (18/311541)
Claims of US Patent No. 11679263
Secondary Reference Lamensdorf (US 20150174406)
Secondary Reference Yoo (US 20150148878)
18
Yoo teaches wherein the sensed physiological parameter includes biometric data that is at least one of sleep or locomotor activity of the patient (¶311-detect the onset or presence of a sleep apnea event (e.g., snoring can be detected by a microphone or a decrease in airflow can be detected via a flow sensor) or a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event)) and wherein: said sensing comprises detecting the pattern of said at least one of sleep or the level of locomotor activity of the patient (¶311-detect the onset or presence of a sleep apnea event (e.g., snoring can be detected by a microphone or a decrease in airflow can be detected via a flow sensor) or a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event)); and automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient (¶323-the at least one stimulator is provided 32 at a cutaneous location on the head, or within the nasal or oral openings and has a physical size that has been adjusted 32 to correspond to the size and location of the IPC 10; ¶302-the system and method can include at least one IPC implanted on, around, or proximate to, at least one of a vidian nerve (VN), a greater petrosal nerve (GPN), a deep petrosal nerve (DPN), or a branch thereof, of the person. At least one stimulator can be used to apply an electrical signal to a target near the IPC such as the VN, the GPN, the DPN, or a branch thereof; ¶311-a sleep apnea precursor (e.g., a particular change in EMG pattern that tends to precede an event), where a particular change in EMG pattern that tends to precede an event aligns with differing than a pre-determined threshold value for the patient) and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value (¶311-the detection of such an event by the processing module 58 may require stimulation to occur; ¶324-apply an electrical signal in a targeted manner to the target; ¶101-patient measurement data can also be used to adjust stimulation protocol parameters and system components, used during therapy, according to individual patients). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of the U.S. Patent to include wherein the sensed physiological parameter includes biometric data that is at least one of sleep or locomotor activity of the patient and wherein: said sensing comprises detecting the pattern of said at least one of sleep or the level of locomotor activity of the patient; and automatically controlling stimulation of the dorsal nasal nerve structure comprises determining if the pattern or level is different than a pre-determined threshold value for the patient and initiating delivery of the stimulation signal or adjusting the stimulation parameters of the stimulation signal if the pattern or level is different than the pre-determined threshold value of Yoo in order for treatment related to migraine and headache (Yoo, ¶33).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10286213: relates generally to systems, devices, and methods for using an implantable medical device to deliver therapy to a patient. More specifically, according to one aspect of the invention, systems, devices, and methods according to the invention are used to deliver electrical stimulation to a peripheral, central or autonomic neural structure. In one particular aspect, the invention relates to neurostimulator systems, devices, and methods for treating primary headaches, such as migraines, cluster headaches, trigeminal autonomic cephalalgias and/or many other neurological disorders, such as atypical facial pain and/or trigeminal neuralgias (col. 1 and lines 33-44).
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/LAURA HODGE/Examiner, Art Unit 3792
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