DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 18-33 are objected to because of the following informalities:
For consistency any recitation of ‘the first array’ or ‘the second array’ should read ‘the first array of electrodes’ and ‘the second array of electrodes’ respectively.
Appropriate correction is required.
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:
“control unit” in claims 26-33 with the functions of ‘cause application of a stimulus’, ‘obtain…a measurement’, ‘implementing closed-loop feedback control…by adjusting…’, ‘determine…a desired location’, ‘generate’, ‘optimize’, ‘provide’, ‘give’, ‘determine’. There does not appear to be any corresponding structure clearly linked to the ‘control unit’ in the disclosure.
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.
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 18-33 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 18 recites the limitation "the dorsal column" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the applied stimulus" in Line 11. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the stimulus’.
Claim 19 recites ‘a plurality of electrodes of the second array’ and is dependent back to claim 18 which recites ‘an electrode from the second array’ making it unclear if the electrode in claim 18 is part of the plurality in claim 19 or not. For examination purposes the electrode will be treated as part of the plurality.
The term “desired” in claim 19 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes it will be treated as if the term ‘a desired location’ merely reads ‘a location’.
Claim 19 recites the limitation "the stimuli" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the position" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the first electrode array" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the position" in Lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the first electrode array" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the spinal cord" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the suitability" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the stimuli" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites ‘a location’ and is dependent back to claim 19 which recites the same making it unclear if each recitation is referring to the same element or not. For examination purposes they will be treated as the same.
Claim 24 recites the limitation "the stimuli" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the ongoing measurements" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites ‘electrode(s)’ making it unclear exactly what is intended to be claimed. Is only one electrode being claimed or multiple?
Claim 26 recites the limitation "the dorsal column" in Lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the applied stimulus" in Line 14. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the stimulus’.
Claim 27 recites ‘a plurality of electrodes of the second array’ and is dependent back to claim 26 which recites ‘an electrode from the second array’ making it unclear if the electrode in claim 26 is part of the plurality in claim 27 or not. For examination purposes the electrode will be treated as part of the plurality.
The term “desired” in claim 27 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes it will be treated as if the term ‘a desired location’ merely reads ‘a location’.
Claim 27 recites the limitation "the measurements" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the stimuli" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the position" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the first electrode array" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the position" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the first electrode array" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the spinal cord" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the suitability" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the stimuli" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites ‘a location’ and is dependent back to claim 27 which recites the same making it unclear if each recitation is referring to the same element or not. For examination purposes they will be treated as the same.
Claim 32 recites the limitation "the stimuli" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the ongoing measurements" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites ‘electrode(s)’ making it unclear exactly what is intended to be claimed. Is only one electrode being claimed or multiple?
For claims 26-33: Claim limitation “control” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The appears to be no corresponding structure for the control unit. Nothing is clearly linked to ‘control unit’ and the specification never describes the ‘control unit’. It is unclear if it is a combination of hardware and software. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 18-19, 23-24, 26-27, and 31-32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliner et al. (US 2004/0158298) in view of Wacnik et al. (US 2011/0040348)
Regarding claim 18, Gliner teaches a method for applying a neural therapy (Abstract), the method comprising:
positioning a first array of electrodes (electrode array 110) proximal to neural tissue of a dorsal root ganglion (DRG) (Paragraph 0023; “It will be appreciated that many of the electrode arrays can be implanted at the spinal cord for spinal cord stimulation”; proximal is relative and thus implantation near the spinal cord can be considered proximal dorsal root ganglion);
positioning a second electrode (Paragraph 0026; “The sensing device 180 can be an electrode”) proximal to neural tissue of the dorsal column (Paragraph 0026; “The sensing device 180 can be an implantable electrode that can be implanted at a number of different locations according to the desired response of the stimulus applied to the therapy electrodes 114”; proximal is relative and thus implantation near the spinal cord can be considered proximal the dorsal column);
applying a stimulus from the first array according to a stimulation parameter (stimulating procedure 220; Figure 2; Paragraph 0032; stimulation parameters determined during setup procedure 210), wherein the stimulus evokes a neural compound action potential response in the neural tissue of the DRG proximate to the first array (Paragraph 0027; ‘ The pulse system 140 generates and sends a single pulse or pulse train to the active therapy electrodes in accordance with the command signals, and the sensing device 180 senses the neural responses, motor responses, or other types of responses to the stimulus.’);
obtaining, using an electrode from the second array, a measurement of the neural compound action potential response evoked by the stimulus (Paragraph 0033; Figure 2; sensing procedure 230); and
implementing closed-loop feedback control of the neural therapy by adjusting the stimulation parameter of the applied stimulus based on the measurement of the neural compound action potential response (Figures 2 or 5).
Gliner is silent on the sensing device specifically being a second array of electrodes;
Wacnik teaches a second array of electrodes (Paragraph 0044; “In examples in which lead 18 is configured to sense the signals evoked by the delivery of stimulation to a dorsal root and/or peripheral nerve, lead 18 may include an array of electrodes to sense the evoked signal at a plurality of locations on the dorsal columns to provide sensing at a plurality of locations along the dorsal columns.”)
positioning a second array of electrodes proximal to neural tissue of the dorsal column (Paragraphs 0005-0006 and 0107). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Wacnik because it would aid in identifying stimulation locations to help treat or manage pain experienced by the patient (Paragraphs 0004-0005 of Wacnik) and because modifying Gliner with Wacnik would only involve routine experimentation with reasonably expectation of yielding predictable results.
Regarding claim 19, Gliner is silent on the sensing device specifically being a second array of electrodes. Wacnik teaches further comprising: using a plurality of electrodes of the second array to simultaneously obtain a plurality of respective measurements of the neural compound action potential response; and determining, from the plurality of measurements of the neural compound action potential response, a desired location for applying the stimuli (Paragraphs 0031 and 0044; “In examples in which lead 18 is configured to sense the signals evoked by the delivery of stimulation to a dorsal root and/or peripheral nerve, lead 18 may include an array of electrodes to sense the evoked signal at a plurality of locations on the dorsal columns to provide sensing at a plurality of locations along the dorsal columns.”). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Wacnik because it would aid in identifying stimulation locations to help treat or manage pain experienced by the patient (Paragraphs 0004-0005 of Wacnik) and because modifying Gliner with Wacnik would only involve routine experimentation with reasonably expectation of yielding predictable results.
Regarding claim 23, Gliner teaches further comprising giving ongoing post-operative guidance as to the suitability of the location for applying the stimuli (Paragraph 0029).
Regarding claim 24, Gliner teaches further comprising determining when manual or automated re-fitting of a therapeutic device is required, to cause a location for applying the stimuli to be revised in response to the ongoing measurements (Paragraphs 0031-0038).
Regarding claim 26, Gliner teaches a system (Abstract) comprising:
a first array of electrodes (electrode array 110) configured to be implanted proximal to neural tissue of a dorsal root ganglion (Paragraph 0023; “It will be appreciated that many of the electrode arrays can be implanted at the spinal cord for spinal cord stimulation”; proximal is relative and thus implantation near the spinal cord can be considered proximal dorsal root ganglion);
a second electrode (Paragraph 0026; “The sensing device 180 can be an electrode”) configured to be implanted proximal to neural tissue of the dorsal column (Paragraph 0026; “The sensing device 180 can be an implantable electrode that can be implanted at a number of different locations according to the desired response of the stimulus applied to the therapy electrodes 114”; proximal is relative and thus implantation near the spinal cord can be considered proximal the dorsal column); and
a control unit (Figure 1; 140, 130, 150, 160) configured to:
cause application of a stimulus from the first array according to a stimulation parameter (stimulating procedure 220; Figure 2; Paragraph 0032; stimulation parameters determined during setup procedure 210), wherein the stimulus evokes a neural compound action potential response in the neural tissue of the DRG proximate to the first array of electrodes (Paragraph 0027; ‘ The pulse system 140 generates and sends a single pulse or pulse train to the active therapy electrodes in accordance with the command signals, and the sensing device 180 senses the neural responses, motor responses, or other types of responses to the stimulus.’);
obtain, using an electrode, a measurement of the neural compound action potential response evoked by the stimulus (Paragraph 0033; Figure 2; sensing procedure 230);
implementing closed-loop feedback control of the neural therapy by adjusting the stimulation parameter of the applied stimulus based on the measurement of the neural compound action potential response (Figures 2 or 5).
Gliner is silent on the sensing device specifically being a second array of electrodes;
Wacnik teaches a second array of electrodes (Paragraph 0044; “In examples in which lead 18 is configured to sense the signals evoked by the delivery of stimulation to a dorsal root and/or peripheral nerve, lead 18 may include an array of electrodes to sense the evoked signal at a plurality of locations on the dorsal columns to provide sensing at a plurality of locations along the dorsal columns.”) configured to be implanted proximal to neural tissue of the dorsal column (Paragraphs 0005-0006 and 0107). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Wacnik because it would aid in identifying stimulation locations to help treat or manage pain experienced by the patient (Paragraphs 0004-0005 of Wacnik) and because modifying Gliner with Wacnik would only involve routine experimentation with reasonably expectation of yielding predictable results.
Regarding claim 27, Gliner is silent on the sensing device specifically being a second array of electrodes. Wacnik teaches wherein the control unit is further configured to: obtain, using a plurality of electrodes of the second array, a plurality of respective to simultaneous measurements of the neural compound action potential response; and determine, from the measurements of the neural compound action potential response, a desired location for applying the stimuli (Paragraphs 0031 and 0044; “In examples in which lead 18 is configured to sense the signals evoked by the delivery of stimulation to a dorsal root and/or peripheral nerve, lead 18 may include an array of electrodes to sense the evoked signal at a plurality of locations on the dorsal columns to provide sensing at a plurality of locations along the dorsal columns.”). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Wacnik because it would aid in identifying stimulation locations to help treat or manage pain experienced by the patient (Paragraphs 0004-0005 of Wacnik) and because modifying Gliner with Wacnik would only involve routine experimentation with reasonably expectation of yielding predictable results.
Regarding claim 31, Gliner teaches wherein the control unit is further configured to give ongoing post-operative guidance as to the suitability of the location for applying the stimuli (Paragraph 0029).
Regarding claim 32, Gliner teaches wherein the control unit is further configured to determine when manual or automated re-fitting of a therapeutic device is required, to cause a location for applying the stimuli to be revised in response to the ongoing measurements (Paragraphs 0031-0038).
Claims 22 and 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gliner et al. (US 2004/0158298) in view of Wacnik et al. (US 2011/0040348) and in further view of Costantino (US 2009/0033486).
Regarding claim 22, Gliner is silent on the use of an amplitude meter. Costantino teaches further comprising providing intra-operative information representing the plurality of measurements of the neural compound action potential response to a surgeon using an amplitude meter (Paragraph 0009). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Costantino because it allows for monitoring of the activity of the surgeon and for the surgeon to monitor their own activity to prevent damage to a patient’s nerves (Paragraphs 0005-0006 of Costantino).
Regarding claim 30, Gliner is silent on the use of an amplitude meter. Costantino teaches wherein the control unit is further configured to provide intra-operative information representing the plurality of measurements of the neural compound action potential response to a surgeon using an amplitude meter (Paragraph 0009). It would have been obvious to one of ordinary skill in the art to have modified Gliner with Costantino because it allows for monitoring of the activity of the surgeon and for the surgeon to monitor their own activity to prevent damage to a patient’s nerves (Paragraphs 0005-0006 of Costantino).
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 18-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10568559 in view of Gliner et al. (US 2004/0158298) and Wacnik et al. (US 2011/0040348) and claims 1-17 of U.S. Patent No. 11819332 in view of Gliner et al. (US 2004/0158298) and Wacnik et al. (US 2011/0040348). As shown below the only differences in the instant application and the patents is the location of the arrays being proximate to a DRG and the dorsal column and then the closed-loop feedback using the measured neural compound action potential to adjust stimulation. Placing the arrays near the DRG and dorsal columns would be inherently taught by the patents given proximate/proximal is relative and the patents teach placing them near those locations. The closed-loop feedback is taught by Gliner et al. (US 2004/0158298) see at least Figures 2 and 5. It would have been obvious to one of ordinary skill in the art to have modified the Patents with Gliner so as to implement safer stimulation and allows for a more effective electrode configuration and stimulus parameters (Paragraph 0012).
Instant Application 18/467,578
US Patent No. 10568559
US Patent No. 11819332
18. (New) A method for applying a neural therapy, the method comprising:
positioning a first array of electrodes proximal to neural tissue of a dorsal root ganglion (DRG);
positioning a second array of electrodes proximal to neural tissue of the dorsal column;
applying a stimulus from the first array according to a stimulation parameter, wherein the stimulus evokes a neural compound action potential response in the neural tissue of the DRG proximate to the first array;
obtaining, using an electrode from the second array, a measurement of the neural compound action potential response evoked by the stimulus; and
implementing closed-loop feedback control of the neural therapy by adjusting the stimulation parameter of the applied stimulus based on the measurement of the neural compound action potential response.
1. A method for determining a desired location at which to apply a neural therapy, the method comprising:
implanting an array of electrodes mounted on a common paddle proximal to neural tissue, where a first plurality of electrodes in the array are configured to provide an electrical stimulus, and a second plurality of electrodes in the array are configured to internally measure neural compound action potential responses; applying a stimulus from the array which evokes a neural compound action potential response in the neural tissue proximal to the array using the first plurality of electrodes;
obtaining a plurality of simultaneous respective internal measurements of the neural compound action potential response evoked by applying the stimulus using the second plurality of electrodes, the plurality of simultaneous respective internal measurements being obtained from respective distinct measurement amplifiers each connected to respective distinct electrodes of the second plurality of electrodes; and determining from the plurality of internal measurements of the neural compound action potential response a neural sensitivity map of the area alongside the array and determining therefrom a desired location at which to apply a neural therapy.
1. A method for determining an indication of efficacy of a neural therapy, the method comprising:
applying, using a first plurality of electrodes from an array of electrodes implanted proximal to neural tissue, a first stimulus which evokes a neural compound action potential response in the neural tissue proximal to the array of electrodes;
obtaining, using a second plurality of electrodes from the array of electrodes, a plurality of simultaneous measurements of the neural compound action potential response evoked by the stimulus;
determining, from the plurality of simultaneous measurements of the neural compound action potential response, a neural sensitivity map of the neural tissue proximal to the array of electrodes; and
determining, from the neural activity map, the indication of efficacy of the neural therapy.
26. (New) A system comprising:
a first array of electrodes configured to be implanted proximal to neural tissue of a dorsal root ganglion;
a second array of electrodes configured to be implanted proximal to neural tissue of the dorsal column; and
a control unit configured to:
cause application of a stimulus from the first array according to a stimulation parameter, wherein the stimulus evokes a neural compound action potential response in the neural tissue of the DRG proximate to the first array of electrodes;
obtain, using an electrode from the second array of electrodes, a measurement of the neural compound action potential response evoked by the stimulus;
implementing closed-loop feedback control of the neural therapy by adjusting the stimulation parameter of the applied stimulus based on the measurement of the neural compound action potential response.
17. A system for determining a desired location at which to apply a neural therapy, the system comprising: an array of electrodes mounted on a common paddle implanted into a patient configured to be positioned proximal to neural tissue, the array comprising: a first plurality of electrodes configured to provide an electrical stimulus, and a second plurality of electrodes configured to measure neural compound action potential responses; a plurality of measurement amplifiers each connected to a respective electrode of the second plurality of electrodes;
a control unit configured to cause application of a stimulus from the array which evokes a neural compound action potential response in the neural tissue proximal to the array using the first plurality of electrodes, the control unit further configured to simultaneously obtain a plurality of respective internal measurements of the neural compound action potential response from a plurality of electrodes of the array using the second plurality of electrodes, the plurality of simultaneous respective internal measurements being obtained from the respective distinct measurement amplifiers each connected to respective distinct electrodes of the second plurality of electrodes, and
the control unit further configured to determine from the plurality of internal measurements of the neural compound action potential response a neural sensitivity map of the area alongside the array and to determine therefrom a desired location at which to apply a neural therapy.
13. A system for determining an indication of efficacy of a neural therapy, the system comprising:
an array of electrodes configured to be implanted proximal to neural tissue; and a control unit configured to: cause application of a first stimulus from the array which evokes a neural compound action potential response in the neural tissue proximal to the array of electrodes;
obtain, using a second plurality of electrodes from the array of electrodes, a plurality of simultaneous measurements of the neural compound action potential response evoked by the stimulus;
determine, from the plurality of simultaneous measurements of the neural compound action potential response, a neural sensitivity map of the neural tissue proximal to the array of electrodes; and
determine from the neural sensitivity map the indication of efficacy of the neural therapy.
Allowable Subject Matter
Claims 20-21, 25, 28-29, and 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and the Double Patenting Rejection set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. These claims correspond to the allowable subject matter in the parent applications (See the Patents provided in the Double Patenting Rejection) and the reasoning for indicating these claims as allowable in the instant application can be found in the parent applications.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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