DETAILED ACTION
Contents
I. Notice of Pre-AIA or AIA Status 4
II. Priority 4
III. Pertinent Prosecution History 5
IV. Claim Status 6
V. Reissue Requirements 6
VI. Reissue Oath/Declaration 8
VII. Specification Objections 8
VIII. Drawing Objections 10
IX. Claim Objections 12
X. Claim Interpretation 12
A. Lexicographic Definitions 13
B. 35 U.S.C. § 112 6th Paragraph 13
XI. Claim Rejections – 35 U.S.C. § 112 14
A. 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph 14
(1) Written Description 14
A. 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph 16
XII. Claim Rejections – 35 U.S.C. § 251 20
A. Oath/Declaration 20
B. Original Patent Requirement 20
XIII. Claim Rejections – 35 U.S.C. § 102/103 23
A. Claims 1-9, 21 and 22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”). 24
B. Claims 10-20, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) as applied to claims 1-9, 21 and 22 above, and further in view of De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”). 32
C. Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) and De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”) as applied to claims 10-20, 23 and 24 above, and further in view of Cholette (U.S. Publication No. 2008/0300655). 43
D. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) and De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”) as applied to claims 10-20, 23 and 24 above, and further in view of Gillbe (U.S. Publication No.2010/0152817). 45
XIV. Response to Arguments 49
A. Oath/Declaration Issue 49
B. Specification Objection(s) 49
C. Drawing Objection(s) 50
D. 35 U.S.C. § 251 Rejections 50
(1) Oath/Declaration Issue 50
(2) Original Patent Requirement Issue 50
E. 35 U.S.C. §§ 102/103 Rejections 52
(1) Claim 1 52
(2) Claim 12 56
XV. Conclusion 62
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant filed the instant reissue application 18/101,646 (“‘646 Reissue Application”) on 26 January 2023 for U.S. Application No. 16/398,945 (“‘945 Application”), filed 30 April 2019, now U.S. Patent No. 11,090,493 (“‘493 Patent”), issued 17 August 2021, which is a continuation of U.S. Application No. 15/944,606 (“‘606 Application”) filed on 03 April 2018, now U.S. Patent No. 10,272,250 (“‘250 Patent”), which is a continuation of U.S. Application No. 15/470,223 (“‘223 Application”) filed on 27 March 2017, now U.S. Patent No. 9,931,510 (“‘510 Patent”), and which is a continuation of U.S. Application No. 14/539,802 (“‘802 Application”) filed on 12 November 2014, now U.S. Patent No. 9,610,448 (“‘448 Patent”).
Thus, the Examiner concludes that for examination purposes the instant ‘646 Reissue Application has an effective filing data of 12 November 2014, which is the filing date of the ‘802 Application.
Pertinent Prosecution History
As set forth supra, Applicant filed the application for the instant ‘646 Reissue Application on 26 January 2023. The Examiner finds that the instant ‘646 Reissue Application included a preliminary amendment (“Jan 2023 Preliminary Amendment”) to the claims (“Jan 2023 Claim Amendment”). The Jan 2023 Claim Amendment includes an amendment: amending original claims 1 and 12; original claims 2-11 and 13-20; and adding new claims 21-24.
The Office issued a non-Final Office action on 04 August 2025 (“Aug 2025 Non-Final Office Action”). In particular, the Aug 2025 Non-Final Office Action provided rejections for claim 1-24 (“Rejected Claims”) under 35 U.S.C. §§ 102, 103, 112 and 251.1
On 04 November 2025, Applicant filed a Response to Non-Final Office Action (“Nov 2025 Response”). The Nov 2025 Response contained: “Remarks,” “Amendments to the Specification” (“Nov 2025 Spec Amendment”); “Amendments to the Drawings” (“Nov 2025 Drawings Amendment”); and “Amendments to the Claims” (“Nov 2025 Claim Amendment”) including: twice amended original2 claims 1 and 12; amended original3 claims 3, 7-9, 13-15, 17, 18 and 20; original claims 2, 4-6, 10, 11, 16 and 19; amended new4 claims 22 and 24; and new5 claims 21, 23 and 25.
Claim Status
The Examiner finds that the claim status in the instant ‘646 Reissue Application is as follows:
Claim(s) 1 and 12 (Original and twice amended)
Claim(s) 3, 7-9, 13-15, 17, 18 and 20 (Original and amended)
Claim(s) 2, 4-6, 10, 11, 16 and 19 (Original)
Claim(s) 22 and 24 (New and amended)
Claim(s) 21, 23 and 25 (New and amended)
Thus, the Examiner concludes that claims 1-25 are pending in the instant ‘646 Reissue Application. Claims 1-25 are examined (“Examined Claims”).
Reissue Requirements
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which the ‘493 Patent is or was involved. These proceedings would include interferences, reissues, reexaminations, post-grant proceedings and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
The Examiner notes that Amendment practice for Reissue Applications is NOT the same as for non-provisional applications. See MPEP §§ 1413 and 1453. Reissue application amendments must comply with 37 CFR 1.173, while non-provisional application amendments must comply with 37 CFR 1.121. Particularly,
Manner of making amendments under 37 CFR 1.173:
All markings (underlining and bracketing) are made relative to the original patent text, 37 CFR 1.173(g) (and not relative to the prior amendment).
For amendments to the abstract, specification and claims, the deleted matter must be enclosed in brackets, and the added matter must be underlined. See 37 CFR 1.173(d).
For amendments to the drawings, any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings. See 37 CFR 1.173(d)(3).
The Examiner further notes that all amendments to the instant ‘646 Reissue Application must comply with 37 CFR 1.173(b)-(g).
Reissue Oath/Declaration
The Examiner finds that the Oath/Declaration filed 07 March 2023 filed by Applicant (“Mar 2023 Oath/Declaration”) states,
The patentee claimed less than the patentee had a right to claim in the patent. This reissue is a broadening reissue, as patentee seeks to broaden independent claims 1 and 12.
(Mar 2023 Oath/Declaration). While the Mar 2023 Oath/Declaration states that the instant ‘646 Reissue Application is a broadening application and indicates claims intended to be broadened, the Mar 2023 Oath/Declaration is defective because the statement does not specify a particular error within the ‘493 Patent as a basis for the instant ‘646 Reissue Application. Specifically, a proper error statement must identify a single word, phrase, or expression in the specification or in an original claim in the underlying patent, i.e., the ‘493 Patent, and how it renders the original patent wholly or partly inoperative or invalid. (See MPEP §1414(II)).
Thus, Applicant is required to provide a new declaration with: (1) a statement of error with respect to ‘493 Patent identifying “a single word, phrase, or expression” from the ‘493 Patent that was not included therein that rendered the ‘493 Patent invalid or inoperative; and (2) identify a claim that the application seeks to broaden in the identification of the error. (See 37 CFR 1.175 and MPEP § 1414).
Specification Objections
The Examiner finds that the Nov 2025 Spec Amendment is non-compliant since it does not comply with 37 CFR 1.173(g). Specifically, the Nov 2025 Spec Amendment provides an entire copy of the ‘493 Patent’s specification with the markings relative to “paragraph” numbers and not to relative to the original patent text (i.e., “column and row”). In order to resolve the issue, Applicant must provide a Specification Amendment with the appropriate corrections in the paragraphs of the ‘493 Patent indicated by “column and row.” Applicant should not provide an entire copy of the ‘493 Patent specification unless Applicant is amending the entire specification.
Thus, the Specification Objections, as set forth in the Aug 2025 Non-Final Office Action, are still outstanding and asserted below.
The disclosure is objected to because of the following informalities:
In c.1, ll.35-37, the ‘493 Patent provides disclosure to “NS systems are device that generate electrical pulses and deliver the pulses to nervous tissue to treat a variety of disorders.” The ‘493 Patent further recites “the NS system/systems…” twenty-three (23) more times throughout the ‘493 Patent. In c.4, ll.21-22, the ‘493 Patent discloses “FIG. 1 illustrates a neurostimulation systems, according to an embodiment of the present disclosure.” The Examiner recommends that Applicant amend the first instance on “NS systems…” on c.3, ll.35-37 to instead read – Neurostimulation (NS) systems… – if that is what “NS” is designating. (Emphasis added).
In c.23, l.11; and c.24, ll.24, 29, 34, the ‘493 Patent provides disclosure to “the CNS system 110….” In c.5, ll.25-31, the ‘493 Patent discloses “[t]he nervous system is comprised of the central nervous system (CNS) and… that connects the CNS….” The Examiner queries Applicant to what exactly a “CNS” is outside of the central nervous system. (Emphasis added). Thus, the Examiner suggests that Applicant, at the first instant disclosure of “CNS,” provide the actual terms the acronym “CNS” is representing similar to what is suggested above for “NS.”.
In c.11, l.37, the disclosure to “… frequency content of the SAP signal fails below a threshold …” should instead read – … frequency content of the SAP signal falls below a threshold … – (emphasis added).
In c.19, ll.57-58, the disclosure to “[a]t 376, when it is determined the additional SAP samples should be collected, the process of FIG. 3C ends” should instead read – [a]t 376, when it is determined the additional SAP samples should not be collected, the process of FIG. BC ends – in order to be consistent with Figure 3C.
In c.3, ll.57-58, the disclosure to “[t]he analyzing operations obtain a collection of activity data associated with multiple therapy parameter set” should instead read – [t]he analyzing operations obtain a collection of activity data associated with a multiple therapy parameter set – in order to be consistent with the disclosure of the ‘493 Patent. (See discussion in § X.A, infra).
Appropriate correction is required.
Drawing Objections
The Examiner finds that the Nov 2025 Drawings Amendment is non-compliant since it does not comply with 37 CFR 1.173(b)(3). Specifically, the Nov 2025 Drawings Amendment provides every Figure of the ‘493 Patent (i.e., Figures 1-6) indicated as a Replacement Sheets when an amendment was only made to Figure 1. In addition, while Figure 1 is indicated as a “Replacement Sheet,” amended Figure 1 is not labeled as “amended,” as required. (See 37 CFR 1.173(b)(3); also see MPEP §§ 1413, 1453). In order to resolve the issue, Applicant must provide a Drawings Amendment with: (1) a detailed explanation, on a separate sheet accompanying the papers including the amendment to the drawings, detailing the changes; and (2) only Figure 1, labeled as “amended” and as a “Replacement Sheet,” with the appropriate amendment to overcome the objections set forth below,
Thus, the Drawing Objections, as set forth in the Aug 2025 Non-Final Office Action, are still outstanding and asserted below.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “158” has been used to designate both “housing or can” and “memory;”
reference character “110” has been used to designate both “lead/leads” and “CNS;” and
reference character “121” has been used to designate “stimulation electrode/electrodes,” “electrodes” and “one or more leads.”
Corrected drawing sheets in compliance with 37 CFR 1.173(b)(3), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.173(b)(1) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure of an amended drawing should be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be surrounded by brackets and identified as "Canceled," and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.173(b)(3). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
MPEP § 1453 states,
pursuant to 37 CFR 1.173(c), each claim amendment must be accompanied by an explanation of the support in the disclosure of the patent for the amendment (i.e., support for all changes made in the claim(s), whether insertions or deletions). The failure to submit an explanation will generally result in a notification to applicant that the amendment before final rejection is not completely responsive (see 37 CFR 1.135(c)).
(MPEP § 1453; emphasis added). The Examiner finds that Applicant has not provided sufficient explanation of support for at least the amendments to claims instantly provided in the Nov 2025 Claim Amendment, as set forth in 37 CFR 1.173(c). (Id.) While the Nov 2025 Response provides direction for the Examiner to find support for the claim amendments, the Examiner finds that the direction is not sufficient. Specifically, the Examiner finds that appropriate explanation of support in accordance with Rule 1.173(c) – with reference to particular passages and/or figures in the specification, and preferably on a claim-by-claim and limitation-by-limitation basis – is required.
Claim Interpretation
During examination, claims are given the broadest reasonable interpretation consistent with the specification and limitations in the specification are not read into the claims. See MPEP § 2111, MPEP § 2111.01 and In re Yamamoto et al., 222 USPQ 934 (Fed. Cir. 1984). Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01(I). It is further noted it is improper to import claim limitations from the specification, i.e., a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. See MPEP § 2111.01(II). Therefore, unless one of the exceptions applies below, Examiners will interpret the limitations of the pending and examined claims using the broadest reasonable interpretation.
Lexicographic Definitions
A first exception to the prohibition of reading limitations from the specification into the claims is when the Applicant for patent has provided a lexicographic definition for the term. (See MPEP § 2111.01(IV)). After careful review of the original specification, the prosecution history, and unless expressly noted otherwise by the Examiner, the Examiner finds that he is unable to locate any lexicographic definitions (either express or implied) with reasonable clarity, deliberateness, and precision. Because the Examiner is unable to locate any lexicographic definitions with reasonable clarity, deliberateness, and precision, the Examiner concludes that Applicant is not his/her own lexicographer. (Id.)
35 U.S.C. § 112 6th Paragraph
A second exception to giving words in the claims their ordinary and customary meaning is when a claimed phrase is interpreted in accordance with 35 U.S.C. § 112 6th paragraph. See MPEP § 2181 et seq.
The Examiner finds that because the Examined Claims do not recite “step,” “means” or a claim term used as a substitution for “means” (i.e. a generic placeholder for “means”), the Examined Claims fail Prong (A) as set forth in MPEP §2181. Because the twenty-four (24) Examined Claims fail Prong (A) as set forth in MPEP §2181 I., the Examiner concludes that all Examined Claims do not invoke 35 U.S.C. §112, 6th paragraph. See also Ex parte Miyazaki, 89 USPQ2d 1207, 1215-16 (B.P.A.I. 2008)(precedential).
Claim Rejections – 35 U.S.C. § 112
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to the limitations of claim 25, the recitation to
the method further comprises:
calculating and storing, for the patient, an individualized transfer function that maps high-frequency content of C-fiber and A-delta fiber SAP signals to the pain score that is received, wherein the transfer function is used to automatically adjust therapy parameters in subsequent closed-loop operation
is insufficiently described in the original specification. [Emphasis added]. The MPEP states,
[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases).
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.
(MPEP § 2161.01.(I); emphasis added). The Examiner finds that that the method of claim 25, and its preceding claim, is performed by a computer utilizing an algorithm. For a computer-implemented invention, the algorithm must be of sufficient detail that one of ordinary skill in the art would understand how the inventor intended the functions to be performed. Applicant’s disclosure, however, lacks the required detailed algorithm.
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Owner had possession of a method to treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system comprising “calculating and storing, for the patient, an individualized transfer function that maps high-frequency content of C-fiber and A-delta fiber SAP signals to the pain score that is received, wherein the transfer function is used to automatically adjust therapy parameters in subsequent closed-loop operation.”
35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph
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 1-24 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 pre-AIA the applicant regards as the invention.
Claims 1 and 12 recites the limitation “sensing SAP signal in response to the non-paresthesia waveform….” The Examiner finds it unclear and indefinite as to whether “the non-paresthesia waveform” is the same as “a non-paresthesia stimulation waveform” claim requirement. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements. The claims are examined as the – non-paresthesia stimulation waveform –. [Emphasis added].
Claims 2-11 and 13-24 are rejected in light of their dependency from at least independent claims 1 and 12.
Claims 1, 7, 8 and 13-15 recites the limitation “…, multiple ones of the TPS….” The Examiner finds it unclear and indefinite to exactly what multiple ones of a single entity (i.e., TPS being a single therapy parameter set) exactly is. The Examiner finds that the ‘493 Patent states,
The analyzing operations obtain a collection of activity data associated with [a] multiple therapy parameter set.
Optionally, the method further comprises selecting a candidate TPS from the multiple therapy parameter set, wherein the candidate TPS selected has corresponding activity data that meets a criteria of interest. Optionally, the method may include a selecting operation which includes optimizing the candidate TPS to a stimulation configuration that affords a result of interest without inducing paresthesia.
(‘493 Patent at c.3, ll.16-25). From this perspective, the “multiple therapy parameter set” is a set of therapy parameter sets (emphasis added to a singular set encompassing/consisting of a plurality sets). Thus, further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements in order to correlate to the disclosure of the ‘493 Patent. The Examiner suggests that Applicant amend “multiple ones of the TPS” to “a multiple therapy parameter set” and provide a further relationship to the original “therapy parameter set” recited previously as well as a “selected candidate TPS” recited further in claims 7-8 and 14-15.
Furthermore, in light of the disclosure of the ‘493 Patent above, it is unclear and indefinite to how “one or more parameters for the TPS” is selected from the collection of the SAP activity data and baseline signals when it is an entire TPS that is selected as a candidate TPS, not one or more parameters for the TPS. Thus, again, further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements in order to correlate to the disclosure of the ‘493 Patent.
Claims 2-11, 14, 15, 21, 22 and 25 are rejected in light of their dependency from at least independent claim 1 and dependent claim 13.
Claim 1 recites the limitation “iteratively repeating delivering the non-paresthesia stimulation waveform and sensing the SAP signals while changing at least one parameter from the TPS ….” The claim previously recites “delivering the non-paresthesia stimulation waveform …;” and “sensing the SAP signals. It is unclear and indefinite to whether the “delivering” and “sensing”” steps are the same or different from each other. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements. The Examiner suggest Applicant amend claim 1 with “iteratively repeating the delivering the non-paresthesia stimulation waveform and the sensing the SAP signals while changing at least one parameter from the TPS ….….”
Claim 8 recites the limitation “wherein selecting the candidate TPS includes….” The preceding claim recites “selecting the candidate TPS….”. It is unclear and indefinite to whether the “selecting” steps are the same or different from each other. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements. The Examiner suggest Applicant amend claim 8 with “wherein the selecting the candidate TPS includes….”
Claims 9 and 13 recites the limitation “wherein analyzing the SAP signals includes…;” and claims 1 and 17 recite the limitation “wherein analyzing the SAP signals to obtain the SAP activity data comprises ….” The preceding claim recites “analyzing the candidate TPS to obtain the SAP activity data….”. It is unclear and indefinite to whether the “analyzing” steps are the same or different from each other. Further clarification is required to either provide proper antecedent basis or further differentiate the claim requirements. The Examiner suggest Applicant amend claims 9, 13 and 17 with “wherein the analyzing the SAP signals to obtain the SAP activity data comprises/includes….”
Claim 11 recites the limitation “the therapy parameter sets” in line 2; and claim 20 recites the limitation “the one or more therapy parameters" in line 1. There is insufficient antecedent basis for these limitations in the claims.
The Examiner finds that because claims 1-25 are indefinite under 35 U.S.C. §112 second paragraph as outlined above, it is impossible to properly construe claim scope at this time. See e.g. Honeywell International Inc. v. ITC, 68 USPQ2d 1023, 1030 (Fed. Cir. 2003) (“Because the claims are indefinite, the claims, by definition, cannot be construed.”). However, in accordance with MPEP § 2173.06 and the USPTO’s policy of trying to advance prosecution by providing art rejections even though these claims are indefinite, the claims are construed and the art is applied as much as practically possible.
Claim Rejections – 35 U.S.C. § 251
Oath/Declaration
Claims 1-24 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action. (See § VI supra).
Original Patent Requirement
Claims 1-24 are rejected under 35 U.S.C. 251 as being in violation of the original patent requirement.
Section 251 requires that reissue is for “the invention disclosed in the original patent.” In order to satisfy the original patent requirement, “[i]t must appear from the face of the instrument that what is covered by the reissue was intended to have been covered and secured by the original.” U.S. Indus. Chems., Inc. v. Carbide & Carbon Chems. Corp., 315 U.S. 668, 676 (1942)(“Indus Chems”). Furthermore, “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.” Id. In other words, the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1362 (Fed. Cir. 2014) (“Antares”).
In the instant case, it does not appear from the face of the original patent that Applicant intended to cover a method to treat chronic pain in a patient without 1) controlling non-paresthesia stimulation of neural tissue of a dorsal root ganglion of the patient; 6 and 2) providing a lead having at least one electrode on the lead configured to be implanted at a target position proximate to neural tissue of the dorsal root ganglion of the patient. 7
The Technical Problem first makes clear that the invention is drawn to a system and method for determining non-paresthesia therapies to suppress or ameliorate pain related to A-delta and C-fibers. (‘493 Patent at Abstract; c.4, l. 64 – c.5, l.34). The Examiner finds that the problem is solved through “A-delta and C-fiber sensory action potentials (SAP) sensed from the [dorsal root ganglion] DRG or dorsal roots (DR)” in which “cell bodies of all primary afferent pain neurons from the body, face and head are located in.” (Id. at c.5, ll.4-7, c.6, ll.5-5-11). It is readily apparent that the entire point of the ‘493 Patent was to solve a problem of providing a system and method for treating chronic pain in a patient by sensing SAP in the DRG or DR to provide therapy parameter sets that provide relief from the pain sensed at A-delta and/or C-fibers. (Id. at Abstract; c.4, l. 64 – c.5, l.34). The claims as filed and during prosecution were always drawn to methods to treat chronic pain in a patient by controlling non-paresthesia stimulation of neural tissue of a dorsal root ganglion of the patient by, including: providing a lead having at least one electrode on the lead configured to be implanted at a target position proximate to neural tissue of the dorsal root ganglion of the patient in order to sense SAP and thereby, suppress or ameliorate pain related to A-delta and C-fibers. (Id. at c.5, ll.4-23; c.6, ll.5-11; c.7, ll.37-39, 44-47; c.8, ll.14-39; c.14, ll.3-24; also see claim 1 in the ‘945 Application, filed 30 April 2019).
This situation is also somewhat analogous to the Federal Circuit decision in Antares. In Antares, the original patent claims were drawn to various embodiments of a jet injection device that specify, for example, the exact depth the needle assist plunges to, the force at which the medicant is expelled, and the gauge of the needle. (Antares at 1356). In reissue, patentee broadened the claims to cover embodiments of injection devices with particular combinations of safety features. (Id.) The Federal Circuit determined that the new claims did not comply with the original patent requirement of section § 251 because the face of the patent (i.e., via the abstract, summary of invention, specification and all disclosed embodiments) provides “‘suggest[ions]’ or ‘indicat[ions]’ of alternative inventions [that] are not sufficient to satisfy the original patent requirement of § 251.” (Id. at 1363). The Court concluded that the specification did not clearly and unequivocally disclose the particular combinations of safety features claimed on reissue, separate from the jet injection invention, thus, the original patent requirement was violated by broadening the claims to the separate invention. (Id.) Similarly, the patent here does not clearly and unequivocally disclose any embodiment that includes a system and method to treat chronic pain in a patient without providing a lead having at least one electrode on the lead configured to be implanted at a target position proximate to neural tissue of the dorsal root ganglion of the patient to control non-paresthesia stimulation of neural tissue of a dorsal root ganglion of the patient. To support the Examiner’s position, while the ‘493 Patent does provide simple statements/disclosure to NS system being adapted to stimulate other tissues, including “any other suitable nervous tissue of interest (‘493 Patent at c.7, ll.59-65), the Examiner finds this statement is no more than mere suggestion and/or indication of a claimed invention and not a fully described invention, in order to satisfy the original patent requirement of § 251 (i.e., “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification;” Indus Chems at 676). Thus, to broaden the claims to permit such an embodiment runs afoul of the original patent requirement.
Claims 2-11 and 13-24 are similarly rejected based on their dependency from independent claims 1 and 12, respectively.
Claim Rejections – 35 U.S.C. § 102/103
35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 21 and 22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”).
With respect to the limitations of claim 1, and
[1] [a] method to treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, the method comprising:
In this regard, the Examiner finds that Su discloses a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation by a therapy system 10 comprising an implantable medical device (IMD) 16. (Su at Abstract; p.1, ll.9, 31-33; p.7, 20-23; see Figures 1, 4, 6). The Examiner finds that Su discloses the therapy system 10 having a programmer communicating to the IMD 16 which is coupled to leads 18, 20 and 28, each having electrodes thereon, to supply electrical stimulation to various target locations proximate to nervous tissue of interest. (Id. at p.2, ll.13-22; p.7, ll.20-23; p.7, l.30 – p.10, l.30; see Figures 1, 4).
To the degree a reviewing body finds that it is not inherent that Su teaches the method specifically “treating chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system,” the following alternative to this feature is provided as set forth below:
As set forth above, the Examiner finds that Su teaches a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation by a therapy system 10 comprising an implantable medical device (IMD) 16. (Su at Abstract; p.1, ll.9, 31-33; p.7, 20-23; see Figures 1, 4, 6). The Examiner finds that Su teaches the therapy system 10 having a programmer communicating to the IMD 16 which is coupled to leads 18, 20 and 28, each having electrodes thereon, to supply electrical stimulation to various target locations proximate to nervous tissue of interest. (Id. at p.2, ll.13-22; p.7, ll.20-23; p.7, l.30 – p.10, l.30; see Figures 1, 4).
The Examiner finds that that 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 method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system.
A person of ordinary skill in the art would be motivated to modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system, since it provides a mechanism to manage undesired pain in the pelvic area (Su at p.1, ll.31-33; p.7, l.30 – p.8, l.5; p.77, ll.18-21). In other words, such a modification would have provided a method for effectively managing undesired pelvic area pain, thereby increasing operational efficiency of the system. (Id.)
Furthermore, this combination of references/teachings also satisfies at least rationale E identified by the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007): “ ‘Obvious to try’ – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.” The elements of the Graham factual inquiry for supporting a finding of obviousness based on this rationale are provided below:
(1) A finding that at the time of the invention, there had been a recognized problem or need of controlling non-paresthesia stimulation of a patient by an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, as described by Su, in order to treat a patient.
(2) A finding that Su provides a finite number of identified, predictable potential solutions of treating a patient by controlling non-paresthesia stimulation of a patient by an implantable neurostimulation system, either to treat bladder dysfunction or pelvic pain.
(3) A finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Here, since Su explicitly teaches the utilization of an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, to provide treatment of a patient, Su teaches that one of ordinary skill in the art could have pursued the known potential solutions (i.e., modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system) with a reasonable expectation of success (i.e., Obvious to try).
From this perspective, the Examiner asserts choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious to one of ordinary skill in the art. That is, as set forth above, one of ordinary skill in the art could have pursued the known potential solutions (i.e., modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system”) with a reasonable expectation of success (i.e., Obvious to try).
Thus, the rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.
obtaining sensory action potential (SAP) baseline signals indicative of SAP experienced inherently by the nervous tissue of interest at the target position;
In this regard, the Examiner finds that Su discloses the therapy system 10 capturing baseline signals that are generated by the nervous tissue at the various target locations. (Su at p.26, ll.15-27; p.27, ll.3-15; p.42, ll.10-22; p.43, ll.18-19). The Examiner finds that Su discloses the baseline signals being based upon “nerve action potential” detected by the sensors (i.e., electrodes within the body). (Id. at p.21, ll.2-8; p.26, ll.6-12).
delivering a non-paresthesia stimulation waveform to the at least one electrode based on a therapy parameter set (TPS), the non-paresthesia stimulation waveform including a series of pulses configured to generate action potentials in at least one of A-delta fibers or C-fibers of the nervous tissue of interest;
In this regard, the Examiner finds that Su discloses delivering stimulation therapy, via electrical pulses/waveforms produced via electrodes, from stored stimulation therapy programs 66 in order to specifically generate action potentials in A-delta fibers or C-fibers of the nervous tissue of interest. (Su at p.2, ll.12-22; p.9, l.26 – p.10, l.8; p.37, l.19 – p.40, l.9; see Figure 4).
sensing SAP signals in response to the non-paresthesia waveform;
iteratively repeating delivering the non-paresthesia stimulation waveform and sensing the SAP signals while changing at least one parameter from the TPS;
analyzing the SAP signals to obtain SAP activity data associated with the TPS for at least one of an SAP C-fiber component or an SAP A-delta fiber component, wherein analyzing the SAP signals to obtain SAP activity data includes obtaining a collection of SAP activity data associated with multiple ones of the TPS;
selecting one or more parameters for the TPS based on the collection of the SAP activity data and the SAP baseline signals;
programming the implantable pulse generator to deliver stimulation to the nervous tissue of interest according to the TPS; and
activating the implantable pulse generator to deliver electrical stimulation to the patient according to the TPS.
In this regard, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that: (1) implements a closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy; (2) iteratively changes at least one parameter of the stimulation therapy selected set based upon the instantly determined “nerve action potential” and the “nerve action potential” of the baseline; (3) provides the changed stimulation therapy to the therapy delivery module 52; and (4) activates the therapy delivery module 52 to deliver the changed stimulation therapy to the patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
With respect to the limitations of claims 2, 3 and 4, Su teaches and/or renders obvious
[2] wherein the SAP baseline signals are indicative of sensory action potentials experienced at the target position when no external sensory stimulation is delivered;
[3] wherein the obtaining the SAP baseline signals comprises collecting the SAP baseline signals, over a single data collection window, wherein the SAP baseline signals are indicative of a baseline responsiveness of at least one of the SAP C-fiber component or the SAP A-delta fiber component; and
[4] wherein the baseline responsiveness corresponds to an absence of at least one of external pinch, pressure, temperature or other external input that would cause activity within at least one of the SAP C-fiber component or the SAP A-delta fiber component.
In this regard, the Examiner finds that Su discloses the “nerve action potential signals” sensed at a target position being based upon a time period (i.e., equivalent to a “single data collection window) prior to the delivery of any stimulation therapy. (Su. at p.21, ll.2-8; p.26, ll.6-8, 15-21). In addition, the Examiner finds that Su discloses no external pressure or input being provide for the baseline acquisition of the “nerve action potential signals” sensed at a target position. (Id. at p.26, ll.21-27).
With respect to the limitations of claim 5, Su teaches and/or renders obvious
[5] further comprising applying a reference input during an interval between successive burst waveforms of the non-paresthesia stimulation waveform, and sensing second SAP signals in response to the reference input.
In this regard, the Examiner finds that Su discloses delivering a first reference point stimulation therapy before the closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy. (Su at p.22, ll.16-29; p.27, ll.3-6; p.39, ll.16-36; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.43, l.18 – p.44, l.10;).
With respect to the limitations of claim 6, Su teaches and/or renders obvious
[6] further comprising applying a reference noxious input during an interval between successive burst waveforms, the reference noxious input creating the SAP signals sensed.
As set forth above, the Examiner finds that Su discloses delivering a first reference point stimulation therapy before the closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy. (Su at p.22, ll.16-29; p.27, ll.3-6; p.39, ll.16-36; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.43, l.18 – p.44, l.10). In addition, the Examiner finds that Su discloses delivering a first reference point stimulation therapy that can cause pain. (Id. at p.11, ll.29-31).
With respect to the limitations of claims 7-9, Su teaches and/or renders obvious
[7] further comprising selecting a candidate TPS from the multiple ones of the TPS, wherein the candidate TPS selected has corresponding SAP activity data that meets a criteria of interest;
[8] wherein the selecting the candidate TPS includes optimizing the candidate TPS to a stimulation configuration that affords a result of interest without inducing paresthesia; and
[9] wherein the analyzing the SAP signals includes identifying a high frequency content of at least one of the SAP C-fiber component or the A-delta fiber component within the SAP signals sensed.
In this regard, the Examiner finds that Su discloses the control module 50 comparing the sensed “nerve action potentials,” representing the frequency upon which the muscle is contracting, to a threshold and/or range around a threshold. (Su at p.76, l.13 – p.77, l.17; see Figure 11). The Examiner finds that Su discloses the therapy delivery module 52 delivering a stimulation therapy that correlates to the results of the control module 50 (i.e., the results corresponding to the sensed “nerve action potentials”). (Id.) As set forth above, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that implements a closed loop process that senses the “nerve action potential” after the delivery of the various stimulation therapies. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
With respect to the limitations of claim 21, Su teaches and/or renders obvious
[21] wherein the sensory action potential experienced at the target position represents an intrinsic sensory action potential of the nervous tissue of the patient when no external sensory stimulation is delivered;
In this regard, the Examiner finds that Su discloses the therapy system 10 capturing baseline signals that are generated by the nervous tissue at the various target locations when no external stimulation is provided. (Su. at p.26, ll.15-27; p.27, ll.3-15; p.42, ll.10-22; p.43, ll.18-19). The Examiner finds that Su discloses the baseline signals being based upon “nerve action potential” detected by the sensors (i.e., electrodes within the body). (Id. at p.21, ll.2-8; p.26, ll.6-12).
With respect to the limitations of claim 22, Su teaches and/or renders obvious
[22] wherein the nervous tissue of interest includes nervous tissue of a dorsal root ganglion or a spinal cord.
In this regard, the Examiner finds that Su discloses the nervous tissue of interest including many different nerves on or which in the “spinal nerve.” (Id. at p.2, ll.19-22; p.7, l.30 – p.8, l.5; claims 5, 17, 27, 40, 47) The Examiner finds that that the spinal nerve is known in the art to be part the dorsal root ganglion.
Claims 10-20, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) as applied to claims 1-9, 21 and 22 above, and further in view of De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”).
With respect to the limitations of claims 10 and 11, and
[10] further comprising obtaining a pain-SAP activity data relation defining a relation between high frequency content of at least one of the SAP C-fiber component or the A-delta fiber component and pain scores indicative of pain experienced by a patient; and
[11] further comprising receiving a pain score indicative of a level of pain experienced by the patient in connection with the therapy parameter sets; defining a relation between the SAP activity data and the pain scores; and saving the relation in memory
As set forth above, Su teaches sensing “nerve action potentials,” representing the frequency upon which the muscle is contracting, of the C-fiber component or the A-delta fiber component to detect a condition of a patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
Su discloses all the limitations, as previously set forth, except for specifically calling for obtaining a pain-SAP activity data relation defining a relation between high frequency content of at least one of the SAP C-fiber component or the A-delta fiber component and pain scores indicative of pain experienced by a patient; and receiving a pain score indicative of a level of pain experienced by the patient in connection with the therapy parameter sets; defining a relation between the SAP activity data and the pain scores; and saving the relation in memory.
However, a system and method for providing stimulation to treat pain including obtaining a pain-SAP activity data relation defining a relation between high frequency content of the detected simulation and indicative of pain scores; and receiving a pain score indicative of a level of pain experienced by the patient in connection with the therapy parameter sets; defining a relation between the SAP activity data and the pain scores; and saving the relation in memory is known in the art. The Examiner finds that Ridder, for example, teaches a system and method for providing stimulation to the spinal cord to treat pain comprising obtaining a pain measurement/score (e.g., Visual Analog Scale (VAS)) before any trial therapy simulations; implementing several cycles of intra-implantation trial therapy simulation and obtaining VAS scores for each trial; and modifying the stimulation parameters of each repetitive therapy simulation to attain the desired pain score. (Ridder at ¶¶ 0057-0062 for stimulation pulse generation; ¶¶ 0063-0066 for iterative comparison process). The Examiner finds that Ridder further teaches recording the data into a Table. (Id. at ¶¶ 0041).
The Examiner finds that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate obtaining a pain-SAP activity data relation defining a relation between high frequency content of the detected simulation and indicative of pain scores; and receiving a pain score indicative of a level of pain experienced by the patient in connection with the therapy parameter sets; defining a relation between the SAP activity data and the pain scores; and saving the relation in memory as described in Ridder in the method for treating chronic pain in a patient of Su.
A person of ordinary skill in the art would be motivated to incorporate obtaining a pain-SAP activity data relation defining a relation between high frequency content of the detected simulation and indicative of pain scores; and receiving a pain score indicative of a level of pain experienced by the patient in connection with the therapy parameter sets; defining a relation between the SAP activity data and the pain scores; and saving the relation in memory, since it provides a mechanism to effectively map what stimulation parameters and protocols resolve certain pain issues. (Id. at ¶ 0044). In other words, such a modification would optimize the development of pain treatment plans in patients, thereby inherently increasing the operational efficiency. (Id.)
With respect to the limitations of claim 12, and
[12] [a] method to treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, the method comprising:
In this regard, the Examiner finds that Su discloses a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation by a therapy system 10 comprising an implantable medical device (IMD) 16. (Su at Abstract; p.1, ll.9, 31-33; p.7, 20-23; see Figures 1, 4, 6). The Examiner finds that Su discloses the therapy system 10 having a programmer communicating to the IMD 16 which is coupled to leads 18, 20 and 28, each having electrodes thereon, to supply electrical stimulation to various target locations proximate to nervous tissue of interest. (Id. at p.2, ll.13-22; p.7, ll.20-23; p.7, l.30 – p.10, l.30; see Figures 1, 4).
To the degree a reviewing body finds that it is not inherent that Su teaches the method specifically “treating chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system,” the following alternative to this feature is provided as set forth below:
As set forth above, the Examiner finds that Su teaches a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation by a therapy system 10 comprising an implantable medical device (IMD) 16. (Su at Abstract; p.1, ll.9, 31-33; p.7, 20-23; see Figures 1, 4, 6). The Examiner finds that Su teaches the therapy system 10 having a programmer communicating to the IMD 16 which is coupled to leads 18, 20 and 28, each having electrodes thereon, to supply electrical stimulation to various target locations proximate to nervous tissue of interest. (Id. at p.2, ll.13-22; p.7, ll.20-23; p.7, l.30 – p.10, l.30; see Figures 1, 4).
The Examiner finds that that 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 method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system.
A person of ordinary skill in the art would be motivated to modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system, since it provides a mechanism to manage undesired pain in the pelvic area (Su at p.1, ll.31-33; p.7, l.30 – p.8, l.5; p.77, ll.18-21). In other words, such a modification would have provided a method for effectively managing undesired pelvic area pain, thereby increasing operational efficiency of the system. (Id.)
Furthermore, this combination of references/teachings also satisfies at least rationale E identified by the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007): “ ‘Obvious to try’ – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.” The elements of the Graham factual inquiry for supporting a finding of obviousness based on this rationale are provided below:
(1) A finding that at the time of the invention, there had been a recognized problem or need of controlling non-paresthesia stimulation of a patient by an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, as described by Su, in order to treat a patient.
(2) A finding that Su provides a finite number of identified, predictable potential solutions of treating a patient by controlling non-paresthesia stimulation of a patient by an implantable neurostimulation system, either to treat bladder dysfunction or pelvic pain.
(3) A finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Here, since Su explicitly teaches the utilization of an implantable neurostimulation system including an implantable pulse generator and at least one lead comprising at least one electrode implanted at a target position proximate to nervous tissue of interest, to provide treatment of a patient, Su teaches that one of ordinary skill in the art could have pursued the known potential solutions (i.e., modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system) with a reasonable expectation of success (i.e., Obvious to try).
From this perspective, the Examiner asserts choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious to one of ordinary skill in the art. That is, as set forth above, one of ordinary skill in the art could have pursued the known potential solutions (i.e., modify the method to specifically treat chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system”) with a reasonable expectation of success (i.e., Obvious to try).
Thus, the rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.
delivering a non-paresthesia stimulation waveform to the at least one electrode based on a therapy parameter set (TPS), the non-paresthesia stimulation waveform including a series of pulses configured to generate action potentials in at least one of A-delta fibers or C-fibers of the nervous tissue of interest;
In this regard, the Examiner finds that Su discloses delivering stimulation therapy, via electrical pulses/waveforms produced via electrodes, from stored stimulation therapy programs 66 in order to specifically generate action potentials in A-delta fibers or C-fibers of the nervous tissue of interest. (Su at p.2, ll.12-22; p.9, l.26 – p.10, l.8; p.37, l.19 – p.40, l.9; see Figure 4)
sensing SAP signals in response to the non-paresthesia waveform;
receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform;
iteratively repeating the delivering, sensing and receiving operations while changing at least one parameter from the TPS;
analyzing the SAP signals to obtain SAP activity data associated with the TPS for at least one of an SAP C-fiber component or an SAP A-delta fiber component;
defining a relation between the SAP activity data and the pain scores;
selecting one or more parameters for the TPS based on the SAP activity data and the relation;
programming the implantable pulse generator to deliver stimulation to the nervous tissue of interest according to the TPS.
In this regard, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that: (1) implements a closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy; (2) iteratively changes at least one parameter of the stimulation therapy selected set based upon the instantly determined “nerve action potential” and the “nerve action potential” of the baseline; (3) provides the changed stimulation therapy to the therapy delivery module 52; and (4) activates the therapy delivery module 52 to deliver the changed stimulation therapy to the patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
Su discloses all the limitations, as previously set forth, except for specifically calling for receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform; including the receiving step with the iteratively determining and sensing steps; defining a relation between the SAP activity data and the pain scores; and utilizing the relation along with the SAP activity to determine one or more parameters for the TPS.
However, a system and method for providing stimulation to treat pain including receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform; including the receiving step with the iteratively determining and sensing steps; defining a relation between the SAP activity data and the pain scores; and utilizing the relation along with the SAP activity to determine one or more parameters for the TPS is known in the art. The Examiner finds that Ridder, for example, teaches a system and method for providing stimulation to the spinal cord to treat pain comprising obtaining a pain measurement/score (e.g., Visual Analog Scale (VAS)) before any trial therapy simulations; implementing several cycles of intra-implantation trial therapy simulation and obtaining VAS scores for each trial; and modifying the stimulation parameters of each repetitive therapy simulation to attain the desired pain score. (Ridder at ¶¶ 0057-0062 for stimulation pulse generation; ¶¶ 0063-0066 for iterative comparison process). The Examiner finds that Ridder further teaches recording the data into a Table. (Id. at ¶¶ 0041).
The Examiner finds that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform; including the receiving step with the iteratively determining and sensing steps; defining a relation between the SAP activity data and the pain scores; and utilizing the relation along with the SAP activity to determine one or more parameters for the TPS as described in Ridder in the method for treating chronic pain in a patient of Su.
A person of ordinary skill in the art would be motivated to incorporate receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform; including the receiving step with the iteratively determining and sensing steps; defining a relation between the SAP activity data and the pain scores; and utilizing the relation along with the SAP activity to determine one or more parameters for the TPS, since it provides a mechanism to effectively map what stimulation parameters and protocols resolve certain pain issues. (Id. at ¶ 0044). In other words, such a modification would optimize the development of pain treatment plans in patients, thereby inherently increasing the operational efficiency. (Id.)
With respect to the limitations of claim 13, Su teaches and/or renders obvious
[13] wherein analyzing the SAP signals includes obtaining a collection of SAP activity data associated with multiple ones of the TPS.
In this regard, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that: (1) implements a closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy; (2) iteratively changes at least one parameter of the stimulation therapy selected set based upon the instantly determined “nerve action potential” and the “nerve action potential” of the baseline; (3) provides the changed stimulation therapy to the therapy delivery module 52; and (4) activates the therapy delivery module 52 to deliver the changed stimulation therapy to the patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
With respect to the limitations of claims 14, 15 and 17, Su and Ridder teaches and/or renders obvious
[14] further comprising selecting a candidate TPS from the multiple ones of the TPS, wherein the candidate TPS selected has corresponding SAP activity data that meets a criteria of interest;
[15] wherein the criteria of interest represents a number of peaks that occur in the SAP signal and the candidate TPS selected has a fewest number of peaks with respect to the multiple ones of the TPS that are analyzed; and
[17] wherein analyzing the SAP signals to obtain the SAP activity comprises analyzing a feature of interest from a morphology of the SAP signal over time, counting a number of occurrences of the feature of interest that occur within the SAP signal over a predetermined duration, and generating the SAP activity data based on the number of occurrences of the feature of interest.
In this regard, the Examiner finds that Su discloses the control module 50 comparing the sensed “nerve action potentials,” representing the frequency (i.e., the number of instances/peaks) upon which the muscle is contracting, to a threshold and/or range around a threshold. (Su at p.76, l.13 – p.77, l.17; see Figure 11). The Examiner finds that Su discloses the therapy delivery module 52 delivering a stimulation therapy that correlates to the results of the control module 50 (i.e., the results corresponding to the sensed “nerve action potentials”). (Id.) As set forth above, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that implements a closed loop process that senses the “nerve action potential” after the delivery of the various stimulation therapies. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
With respect to the limitations of claim 16, Su and Ridder teaches and/or renders obvious
[16] where the SAP signals include multiple SAP sample windows separated by therapy delivery windows, wherein, when a burst therapy is delivered during the therapy delivery windows, the SAP signal is not collected.
In this regard, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that: (1) implements a closed loop process that senses the “nerve action potential” after the delivery of a first stimulation therapy; (2) iteratively changes at least one parameter of the stimulation therapy selected set based upon the instantly determined “nerve action potential” and the “nerve action potential” of the baseline; (3) provides the changed stimulation therapy to the therapy delivery module 52; and (4) activates the therapy delivery module 52 to deliver the changed stimulation therapy to the patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27). The Examiner finds that the collection of “nerve action potential” data is done in a non-stimulation therapy windows. (Id.; also see Figures 10, 11).
With respect to the limitations of claims 18 and 19, Su teaches and/or renders obvious
[18] further comprising determining whether the SAP signal represents i) a signal that directly measures sensory action potential of the at least one of A- delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column, where the composite SAP signal includes SAP components associated with fast conducting fibers and SAP components associated with slow conducting fibers; and
[19] further comprising processing the composite SAP signal to identify the conduction SAP component and generating the at least one of an SAP C-fiber component or an SAP A-delta fiber component based thereon.
In this regard, the Examiner finds that Su discloses the therapy delivery module 52 delivering a stimulation therapy that correlates to the results of the control module 50 (i.e., the results corresponding to the sensed “nerve action potentials”). (Id.) As set forth above, the Examiner finds that Su discloses the IMD 16 comprising a control module 50 that implements a closed loop process that senses the “nerve action potential” after the delivery of the various stimulation therapies. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27). The Examiner finds that the delivery of the signal is provide to the A-beta, A-delta fibers and/or C-fibers of the nervous tissue of interest and thus the sensed “nerve action potentials” are based on at least from these fibers. (Su at p.2, ll.12-22; p.9, l.26 – p.10, l.8; p.37, l.19 – p.40, l.9; see Figure 4).
With respect to the limitations of claim 20, C and Ridder teaches and/or renders obvious
[20] wherein the one or more therapy parameters define at least one of a burst stimulation waveform or a high frequency stimulation waveform.
In this regard, the Examiner finds that Su discloses delivering stimulation therapy, via electrical pulses/waveforms produced via electrodes, from stored stimulation therapy programs 66 in order to specifically generate action potentials in A-delta fibers or C-fibers of the nervous tissue of interest. (Su at p.2, ll.12-22; p.9, l.26 – p.10, l.8; p.37, l.19 – p.40, l.9; see Figure 4)
With respect to the limitations of claim 23, Su and Ridder teaches and/or renders obvious
[23] wherein the sensory action potential experienced at the target position represents an intrinsic sensory action potential of the nervous tissue of the patient when no external sensory stimulation is delivered;
In this regard, the Examiner finds that Su discloses the therapy system 10 capturing baseline signals that are generated by the nervous tissue at the various target locations when no external stimulation is provided. (Su. at p.26, ll.15-27; p.27, ll.3-15; p.42, ll.10-22; p.43, ll.18-19). The Examiner finds that Su discloses the baseline signals being based upon “nerve action potential” detected by the sensors (i.e., electrodes within the body). (Id. at p.21, ll.2-8; p.26, ll.6-12).
With respect to the limitations of claim 24, Su and Ridder teaches and/or renders obvious
[24] wherein the nervous tissue of interest includes nervous tissue of a dorsal root ganglion or a spinal cord.
In this regard, the Examiner finds that Su discloses the nervous tissue of interest including many different nerves on or which in the “spinal nerve.” (Id. at p.2, ll.19-22; p.7, l.30 – p.8, l.5; claims 5, 17, 27, 40, 47) The Examiner finds that that the spinal nerve is known in the art to be part the dorsal root ganglion.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) and De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”) as applied to claims 10-20, 23 and 24 above, and further in view of Cholette (U.S. Publication No. 2008/0300655).
With respect to the limitations of claims 18 and 19, and
[18] further comprising determining whether the SAP signal represents i) a signal that directly measures sensory action potential of the at least one of A- delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column, where the composite SAP signal includes SAP components associated with fast conducting fibers and SAP components associated with slow conducting fibers; and
[19] further comprising processing the composite SAP signal to identify the conduction SAP component and generating the at least one of an SAP C-fiber component or an SAP A-delta fiber component based thereon.
As set forth above, Su teaches sensing “nerve action potentials,” representing the frequency upon which the muscle is contracting, of the C-fiber component or the A-delta fiber component to detect a condition of a patient. (Su at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
To the degree a reviewing body finds that it is not inherent that Su teaches the SAP signal representing i) a signal that directly measures sensory action potential of the at least one of A- delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column, the following alternative to this feature is provided as set forth below:
Su discloses the limitations, as previously set forth, except for specifically calling for the SAP signal representing i) a signal that directly measures sensory action potential of the at least one of A- delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column.
However, a system and method for providing nerve stimulation including the SAP signal representing i) a signal that directly measures sensory action potential of the at least one of A-delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column is known in the art. The Examiner finds that Cholette, for example, teaches a system and method for providing stimulation by implanting an electrode suited to acquire an evoked compound action potential (ECAP) electrical information from a nerve or nerve bundle that is measurement. (Cholette at ¶¶ 0049-0050; 0056-0061). The Examiner finds that the ECAP information includes neural information from A-beta, A-delta fibers and C-fibers. (Id.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the SAP signal representing i) a signal that directly measures sensory action potential of the at least one of A-delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal column as described in Cholette in the method for treating chronic pain in a patient of Su and Ridder.
A person of ordinary skill in the art would be motivated to incorporate the SAP signal representing i) a signal that directly measures sensory action potential of the at least one of A-delta fibers or C-fibers, or ii) a composite SAP signal from multiple types of fibers in the dorsal, since it provides a mechanism to deliver energy to a nerve at more than one frequency and/or at more than one strength to selectively activate different populations and/or types of nerve fibers. (Id. at ¶ 0061). In other words, such a modification would a more diverse indicator of neural transmissions, thereby inherently increasing the operational efficiency. (Id.)
stimulation to a nerve that includes at least one of Aβ (A-beta) afferent nerve fibers, Aδ (A-delta) afferent nerve fibers, and C-afferent nerve fibers. (Su at p.10, ll.6-9; also see p.11, ll.6-15).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Su et al. (International Publication No. WO 2012/024286 A2)(“Su”) and De Ridder (U.S. Publication No. 2012/0283797)(“Ridder”) as applied to claims 10-20, 23 and 24 above, and further in view of Gillbe (U.S. Publication No.2010/0152817).
With respect to the limitations of claim 25, and
[25] wherein receiving the pain score comprises receiving, within a threshold time period of a SAP sample window during which the SAP baseline signals are obtained, a subjective pain score from the patient, and storing the pain score together with the corresponding SAP sample as a time-stamped paired data-point; and the method further comprises:
calculating and storing, for the patient, an individualized transfer function that maps high-frequency content of C-fiber and A-delta fiber SAP signals to the pain score that is received, wherein the transfer function is used to automatically adjust therapy parameters in subsequent closed-loop operation
As set forth above, Su teaches receiving SAP baseline signal, based upon stimulation to a nerve that includes at least one of Aβ (A-beta) afferent nerve fibers, Aδ (A-delta) afferent nerve fibers, and C-afferent nerve fibers (Su at p.10, ll.6-9; also see p.11, ll.6-15), in a time period window (id. at p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27). Similarly, as set forth above, the Ridder teaches and or renders obvious incorporating receiving a pain score indicative of a level of pain experienced by the patient in connection with the delivering the non-paresthesia stimulation waveform; including the receiving step with the iteratively determining and sensing steps; defining a relation between the SAP activity data and the pain scores; and utilizing the relation along with the SAP activity to determine one or more parameters for the TPS. (See § XIII.B.(3).(b)-(h), supra).
Su and Ridder discloses the limitations, as previously set forth, except for specifically calling for the pain score to be sampled during the SAP window time period with the method further comprising calculating and storing an individualized transfer function that maps the SAP signals to the pain score received; and the transfer function being utilized to automatically adjust the therapy parameters.
However, sampling a pain score during the SAP window time period with the method further comprising calculating and storing an individualized transfer function that maps the SAP signals to the pain score received is known in the art. Gillbe, for example¸ teaches an electrical device that produces currents that affect the behaviour of nerves and other excitable tissues. [AltContent: textbox (Figure 4 of Gillbe)]
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(Gillbe at ¶ 0001). In examination of Figure 4 of Gillbe included below, Gillbe further teaches a function that correlates the onset of a sensation with the pulse width of current applied. (Id. at ¶¶ 0087, 0119). The Examiner finds that this relationship is for one subject of interest and will vary based upon subject, however, the general shape of the curve will remain the same. (Id. at ¶ 0119).
The Examiner finds that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate sampling a sensation/pain score during the SAP window time period with the method further comprising calculating and storing an individualized transfer function that maps the SAP signals to the sensation/pain score as described in Gillbe in the method for treating chronic pain in a patient of Su and Ridder.
A person of ordinary skill in the art would be motivated to incorporate sampling a sensation/pain score during the SAP window time period with the method further comprising calculating and storing an individualized transfer function that maps the SAP signals to the sensation/pain score, since it provides a mechanism to utilize a well-known characteristics of sensation to current to mathematically derive a model for the pain/sensation.
Similarly, the Examiner asserts that applying a known technique to a known device ready for improvement would yield predictable results. That is, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Gillbe to the method of Su and Ridder would have yielded predicable results and resulted in an improved method, namely, providing the method for treating/managing persistent pelvic pain utilizing sampling a pain/sensation score during the SAP window time period with the method further comprising calculating and storing an individualized transfer function that maps the SAP signals to the pain/sensation score, in Su and Ridder, to deliver a mechanism to utilize a well-known characteristics of sensation to current to mathematically derive a model of the pain/sensation.
In addition, the Examiner finds that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate utilizing the transfer function of pain/sensation to current as described in Gillbe to automatically adjust the therapy parameters in the method for treating chronic pain in a patient of Su and Ridder.
A person of ordinary skill in the art would be motivated to incorporate utilizing the transfer function of pain/sensation to current to automatically adjust the therapy parameters in the method for treating chronic pain in a patient, since it provides a mechanism to effectively map what stimulation parameters and protocols resolve certain pain issues, thereby optimizing the development of pain treatment plans for patients. (Ridder at ¶ 0044).
Response to Arguments
Oath/Declaration Issue
Without any explanation of support, Applicant contends that the Mar 2023 Oath/Declaration is compliant. (Nov 2025 Response at 10). However, in order to expedite prosecution, Applicant asserts that a new Oath/Declaration is trying to be obtained. (Id.)
With respect to the Reissue Oath/Declaration Objection, the Nov 2025 Response did not provide a new reissue oath/declaration to overcome the defective oath/declaration issue. Thus, the objection and rejection based upon a defective reissue declaration under 35 U.S.C. 251 is still present and maintained in the instant ‘646 Reissue Application. (See §§ VI, XII.A, supra).
Specification Objection(s)
Applicant contends that the Nov 2025 Spec Amendment has corrected the outstanding issues in the instant ‘646 Reissue Application, and thus, no Specification issues are present. (Nov 2025 Response at 10-11).
The Examiner respectfully disagrees. Based upon the Nov 2025 Spec Amendment, the Examiner finds that the instant ‘646 Reissue Application still has outstanding Specification Objection issues present. (See § VII, supra).
Drawing Objection(s)
Applicant contends that the Nov 2025 Drawings Amendment has corrected the outstanding issues in the instant ‘646 Reissue Application, and thus, no Drawing issues are present. (Nov 2025 Response at 11).
The Examiner respectfully disagrees. Based upon the Nov 2025 Drawings Amendment, the Examiner finds that the instant ‘646 Reissue Application still has outstanding Drawing Objection issues present. (See § VIII, supra).
35 U.S.C. § 251 Rejections
Oath/Declaration Issue
As asserted above, the Examiner finds that Applicant has not filed a new Oath/Declaration to overcome the oath/declaration issues in the Mar 2023 Oath/Declaration. (See § XIV.A, supra)),
Thus, the Examiner finds the Nov 2025 Response did not resolve the 35 U.S.C. § 251 Oath/Declaration issues. (Id.; also see §§ VI, XII.A, supra). Thus, the instant ‘646 Reissue Application still has an outstanding 35 U.S.C. § 251 defective reissue declaration rejection. (Id.)
Original Patent Requirement Issue
Since the ‘493 Patent briefly indicates that the invention may be directed to an embodiment of “controlling non-paresthesia stimulation nervous tissue of interest nervous tissue of interest,” Applicant contends that the ‘493 provides sufficient support to satisfy the Original; Patent Requirement. (Nov 2025 Response at 11-12).
The Examiner respectfully disagrees. The MPEP states,
To satisfy the original patent requirement where a new invention is sought by reissue, "… the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention." Antares Pharma, Inc., 771 F.3d at 1363, 112 USPQ2d at 1871. Accordingly, claims drawn to an invention comprising a newly claimed combination of features that were only disclosed in the original patent as suggested alternatives (and not as a single combination) or only as part of the original invention and not as an invention separate from the original invention would not satisfy the original patent requirement. See also Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346, 1352, 2019 USPQ2d 221227 (Fed. Cir. 2019) ("nowhere do the written description or drawings disclose that arbors are an optional feature of the invention. Even if a person of ordinary skill in the art would understand that the newly claimed, arbor-less invention would be possible, that is insufficient to comply with the standard set forth in Industrial Chemicals [315 U.S. 668 (1942)] and Antares."). "The ‘original patent’ standard and the written description requirement are not the same. Where the written description requirement is based on what the skilled artisan would have understood was within the possession of the inventor, recent Federal Circuit case law indicates that the original patent requirement under § 251 requires something more." See Ex parte Sandwick, Appeal No. 2018-008369, op. at 22 (PTAB July 23, 2019) (Rejection under 35 U.S.C. 251 was affirmed because the patent did not describe any fabrication method other than casting. While one of ordinary skill in the art would have understood that other fabrication methods, such as injection molding or 3D printing, were possible or conventional, the reissue claims that did not include casting did not comply with the original patent requirement.)
(MPEP § 1412.01.I). As set forth above, it is not enough to simply disclose “suggested alternatives” because “something more” is required to show the separate invention. (Id.) While the ‘493 Patent does provide simple statements/disclosure to NS system being adapted to stimulate other tissues, including “any other suitable nervous tissue of interest (‘493 Patent at c.7, ll.59-65), the Examiner finds this statement is no more than mere suggestion and/or indication of a claimed invention and not a fully described invention, in order to satisfy the original patent requirement of § 251 (i.e., “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification;” Indus Chems at 676).
Thus, the Examines concludes and maintains that claims 1-24 are in violation of the original patent requirement.
35 U.S.C. §§ 102/103 Rejections
Claim 1
Contention I
Applicant contends that Su never records or analyzes SAP originating from A-delta or C-fibers, nor does Su obtain SAP baseline signals indicative of SAP experienced by the nervous tissue of a patient. (Nov 2025 Response at 13).
The Examiner respectfully disagrees. While the one of ordinary skill in the art can recognize the disclosure of Su focuses on bladder issues, the Examiner finds that the invention of providing a stimulation therapy and monitoring it is equally applicable to pain, explicitly pelvic pain and other regions of the lower back. (Su at Abstract; p.1, l.9, 29-33; p.7, l.30 – p.8, l.7; p.8, ll.21-31). Moreover, the Examiner finds that the leads 19, 21 and 29 of the implantable medical device (IMD) 16 provide stimulation to a nerve that includes at least one of Aβ (A-beta) afferent nerve fibers, Aδ (A-delta) afferent nerve fibers, and C-afferent nerve fibers. (Id. at p.10, ll.6-9; also see p.11, ll.6-15). Thus, the stimulation provided to the nerve has a measurable effect on the Aβ, Aδ and C afferent nerve fibers. From this perspective, the Examiner finds that Su discloses multiple means to monitor the physiological response as well as determine a physiological threshold with one being an automatically “detected physiological response, such as a nerve action potential” by sensors within the patient. (Id. at p.21, ll.1-8). Specifically, Su discloses a sensor 22 including “one or more electrodes for sensing afferent nerve signals, the sense electrodes may be carried on one of leads 18, 20, or 28 or an additional lead coupled to IMD 16.” (Id. at p.26, ll.6-8). Furthermore, the Examiner finds that Su discloses the baseline signals being based upon “nerve action potential” detected by the sensors (i.e., electrodes within the body) (id. at p.21, ll.2-8; p.26, ll.6-12); and the IMD 16 “control[ling] at least one parameter of the stimulation therapy the based on input received from sensor 22.” (id. at p.26, ll.10-12).
Thus, the Examiner concludes and maintains that Su sufficiently teaches recording and analyzing SAP originating from A-delta or C-fibers, and does obtain SAP baseline signals indicative of SAP experienced by the nervous tissue of a patient.
Contention II
Applicant contends that Su does not obtain a collection of SAP activity data linked to multiple therapy parameters sets. (Nov 2025 Response at 13).
The Examiner respectfully disagrees. The claim requirement recites “wherein analyzing the SAP signals to obtain SAP activity data includes obtaining a collection of SAP activity data associated with multiple ones of the TPS” (i.e., a multiple therapy parameter set including a plurality of therapy parameter sets). The Examiner construes “associate” as “bring[ing] together or into relationship in any of various intangible ways. 8” From this perspective, the Examiner finds that Su discloses the control module 50 comparing the sensed “nerve action potentials,” representing the frequency upon which the muscle is contracting, to a threshold and/or range around a threshold. (Su at p.76, l.13 – p.77, l.17; see Figure 11). The Examiner finds that a frequency is the number of times an event occurs. In this light, the Examiner finds that comparing the real-time frequency of muscle contractions to the determined baseline frequency of muscle contractions would inherently involve a collection of real-time sensed nerve action potentials (i.e., a collection of SAP activity data). In addition, the Examiner finds that this collection of real-time sensed nerve action potentials (i.e., a collection of SAP activity data) is associated with the multiple therapy parameter set (i.e., the plurality of therapy parameter sets) via the parameters in the multiple therapy parameter set which are common to the multiple therapy parameter set.
Thus, the Examiner concludes and maintains that Su sufficiently teaches obtaining a collection of SAP activity data associated to the multiple therapy parameters set.
Contention III
Since Su does not teach forming a collection of SAP activity, Applicant contends that Su does teach selecting parameters for the TPS based on the collection of SAP activity. (Nov 2025 Response at 13).
The Examiner respectfully disagrees. As set forth above, the Examiner finds that Su does sufficiently teach forming a collection of SAP activity. (See § XIV.E.(1)(b), supra). Moreover, the Su discloses the IMD 16 “control[ling] at least one parameter of the stimulation therapy the based on input received from sensor 22.” (Su at p.26, ll.10-12). The Examiner finds that this “frequency” of real-time sensed nerve action potentials and providing stimulation therapy thereto is equally applicable to pain, explicitly pelvic pain and other regions of the lower back. (Id. at Abstract; p.1, l.9, 29-33; p.7, l.30 – p.8, l.7; p.8, ll.21-31). Accordingly, while the immediate physiological feedback signals are detected, Su discloses the control module 50 closed loop functionality determining the real-time frequency (i.e., the number of times an event occurs) of muscle contractions and comparing to an already determined baseline frequency of muscle contraction and changing the stimulation parameters of the TPS accordingly. (Id. at p.21, ll.2-8; p.22, ll.16-29; p.25, l. 1-4; p.27, ll.3-15; p.41, l.26 – p.42, l.32; p.43, l.18 – p.44, l.10; p.46, ll.18-27).
Thus, the Examiner concludes and maintains that Su sufficiently teaches selecting parameters for the TPS based on the collection of SAP activity.
Contention IV
Applicant contends that Su does teach providing a non-paresthesia stimulation waveform. (Nov 2025 Response at 13-14).
The Examiner respectfully disagrees. The Examiner finds that Su discloses the IMD 16, generating and delivering therapy to patient 14, may define a stimulation intensity which is less than, equal to, or greater than a threshold stimulation intensity. (Su at p.20, ll.15-18). Su further discloses the stimulation being provided may or may not be perceived by the patient and may instead be automatically “detected physiological response, such as a nerve action potential” by sensors within the patient. (Id. at p.20, ll.27-31; p.21, ll.1-8).
Thus, the Examiner concludes and maintains that Su sufficiently teaches providing a non-paresthesia stimulation waveform.
Claim 12
Contention I
While Su describes the application being for bladder dysfunction and/or pelvic pain, Applicant contends that Su does not describe the Application therapy being for chronic pain. (Nov 2025 Response at 14).
The Examiner respectfully disagrees. First, the claim does not specifically define what chronic pain is. One of ordinary skill in the art would recognize that pain is traditionally characterized as being from “1 to 10,” and is clearly dependent on pain thresholds of a particular patient. From this perspective, the Examiner finds pelvic pain, from patient to patient, can be categorized at many different levels with chronic pelvic pain for one patient for one patient as being pelvic pain for another patient. Thus, given its broadest reasonable interpretation, Su discloses pelvic pain broadly, which includes both chronic pelvic pain and non-chronic pelvic pain.
To the degree a reviewing body finds that it is not inherent that Su teaches the method specifically “treating chronic pain in a patient by controlling non-paresthesia stimulation of the patient by an implantable neurostimulation system,” the Examiner provided an obvious-type rejection for this claim requirement. (See § XIII.B.(3), supra).
Thus, the Examiner finds that Su sufficiently also teaches and/or renders obvious the Application therapy being for chronic pain.
Contention II
Applicant contends that Su does not describe or suggest sensing or analyzing SAP signals. (Nov 2025 Response at 15). Applicant further contends that Su does not describe extracting C-fiber or A-delta fiber component from the SAP signals. (Id.)
The Examiner respectfully disagrees. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., extracting C-fiber or A-delta fiber component from the SAP signals) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
From this perspective, the Examiner finds that the leads 19, 21 and 29 of the implantable medical device (IMD) 16 provide stimulation to a nerve that includes at least one of Aβ (A-beta) afferent nerve fibers, Aδ (A-delta) afferent nerve fibers, and C-afferent nerve fibers. (Su at p.10, ll.6-9; also see p.11, ll.6-15). Thus, the stimulation provided to the nerve has a measurable effect on the Aβ, Aδ and C afferent nerve fibers. From this perspective, the Examiner finds that Su discloses multiple means to monitor the physiological response as well as determine a physiological threshold with one being an automatically “detected physiological response, such as a nerve action potential” by sensors within the patient. (Id. at p.21, ll.1-8). Specifically, Su discloses a sensor 22 including “one or more electrodes for sensing afferent nerve signals, the sense electrodes may be carried on one of leads 18, 20, or 28 or an additional lead coupled to IMD 16.” (Id. at p.26, ll.6-8). Furthermore, the Examiner finds that Su discloses the baseline signals being based upon “nerve action potential” detected by the sensors (i.e., electrodes within the body) (id. at p.21, ll.2-8; p.26, ll.6-12); and the IMD 16 “control[ling] at least one parameter of the stimulation therapy the based on input received from sensor 22.” (id. at p.26, ll.10-12).
Thus, the Examiner concludes and maintains that Su sufficiently teaches sensing or analyzing SAP originating from A-delta or C-fibers, and does obtain SAP baseline signals indicative of SAP experienced by the nervous tissue of a patient.
Contention III
Applicant contends that Su does not describe or suggest defining or storing a relation between the SAP activity data and the pain scores (Nov 2025 Response at 15). Applicant further contends that Ridder does not describe or suggest defining a relation between the SAP activity data and the pain scores. (Id.)
The Examiner respectfully disagrees. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, the MPEP states,
“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396.
(MPEP at § 2141.II.C).
From this perspective, the Examiner finds that it is Su that is cited for a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation by a therapy system 10 comprising an implantable medical device (IMD) 16. (Su at Abstract; p.1, ll.9, 31-33; p.7, 20-23; see Figures 1, 4, 6). The Examiner finds that Su discloses the therapy system 10 having a programmer communicating to the IMD 16 which is coupled to leads 18, 20 and 28, each having electrodes thereon, to supply electrical stimulation to various target locations proximate to nervous tissue of interest. (Id. at p.2, ll.13-22; p.7, ll.20-23; p.7, l.30 – p.10, l.30; see Figures 1, 4). The Examier finds that Su discloses a memory 56 of the IMD 16 storing the stimulation therapy programs 66 and the determined baseline frequency of muscle contractions and defining a relationship therebetween. (Su at p.26, ll.15-19; p.36, ll.16-17, 24-25; p.37, ll.3-5; p.37, l.12 – p.38, l.6; p.42, ll.10-12). Accordingly, Su is concerned with providing the correct stimulation therapy based upon “[sensed/]detected physiological response, such as a nerve action potential” by sensors within the patient (id. at p.21, ll.1-8) from therapy programs by comparing an already determined baseline frequency of muscle contraction to a real-time frequency of muscle contractions and changing the stimulation parameters of the TPS accordingly. However, since Su is silent to utilizing any other data sensed during the delivery of the non-paresthesia stimulation waveform and combining it with the therapy programs, the Examiner finds that one of ordinary skill in the art would look to the teachings of generating a relationship of pain score data with delivered non-paresthesia stimulation waveforms based upon the combination pain score data with the information associated with delivery of the non-paresthesia stimulation waveform to improve the method for treating/managing persistent pelvic pain.
In this light, the Examiner finds that Ridder is concerned with monitoring the threshold of pain, and scoring it, relative to before/after therapy stimulations and utilizing the pain score/therapy stimulation relationship for patient treatment. Specifically, the Examiner finds that Ridder, for example, teaches a system and method for providing stimulation to the spinal cord to treat pain comprising obtaining a pain measurement/score (e.g., Visual Analog Scale (VAS)) before any trial therapy simulations; implementing several cycles of intra-implantation trial therapy simulation and obtaining VAS scores for each trial; and modifying the stimulation parameters of each repetitive therapy simulation to attain the desired pain score. (Ridder at ¶¶ 0057-0062 for stimulation pulse generation; ¶¶ 0063-0066 for iterative comparison process). The Examiner finds that Ridder further teaches recording the data into a Table. (Id. at ¶¶ 0041).
In conclusion, since Su explicitly discloses a method of treating/managing persistent pelvic pain by controlling the delivery of electrical stimulation, from therapy programs, by a therapy system comprising an implantable medical device (IMD) providing the correct stimulation therapy based upon sensed/detected physiological response (i.e., nerve action potential) by sensors within the patient by comparing an already determined baseline frequency of muscle contraction to a real-time frequency of muscle contractions and changing the stimulation parameters of the TPS and Ridder teaches monitoring the threshold of pain, and scoring it, relative to before/after therapy stimulations and utilizing the pain score/therapy stimulation relationship for patient treatment, the Examiner finds that one of ordinary skill in that art would look to improve the method for treating/managing persistent pelvic pain of Su with the utilization of the generating a relationship of pain score data with delivered non-paresthesia stimulation waveforms based upon the combination pain score data with the information associated with delivery of the non-paresthesia stimulation waveform since it provides a mechanism to effectively map what stimulation parameters and protocols resolve certain pain issues, thereby optimizing the development of pain treatment plans for patients. (Ridder at ¶ 0044).
Thus, the Examiner concludes and maintains that one of ordinary would look to the teachings of Ridder and combine them with Su. Thus, the Office has properly established a prima facie case of obviousness.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Because this application is now final, Applicant are reminded of the USPTO’s after final practice as discussed in MPEP §714.12 and §714.13 and that entry of amendments after final is not a matter of right. “The refusal of an examiner to enter an amendment after final rejection of claims is a matter of discretion.” In re Berger, 279 F.3d 975, 984, 61 USPQ2d 1523, 1529 (Fed. Cir. 2002) (citations omitted). Furthermore, suggestions or examples of claim language provided by the Examiner are just that—suggestions or examples—and do not constitute a formal requirement mandated by the Examiner. Unless stated otherwise by an express indication that a claim is “allowed,” exemplary claim language provided by the Examiner to overcome a particular rejection or to change claim interpretation has not been addressed with respect to other aspects of patentability (e.g. §101 patentable subject matter, §112, first paragraph written description and enablement, §112, second paragraph indefiniteness, and §102 and §103, prior art). Therefore, any claim amendment submitted under 37 C.F.R. §1.116 that incorporates an Examiner suggestion or example or simply changes claim interpretation will nevertheless require further consideration and/or search and a patentability determination as noted above.
Applicant is respectfully reminded that any suggestions or examples of claim language provided by the Examiner are just that—suggestions or examples—and do not constitute a formal requirement mandated by the Examiner. To be especially clear, any suggestion or example provided in this Office Action (or in any future office action) does not constitute a formal requirement mandated by the Examiner.
Should Applicant decide to amend the claims, Applicant is also reminded that—like always—no new matter is allowed. The Examiner therefore leaves it up to Applicant to choose the precise claim language of the amendment in order to ensure that the amended language complies with 35 U.S.C. § 112 1st paragraph.
Independent of the requirements under 35 U.S.C. § 112 1st paragraph, Applicant is also respectfully reminded that when amending a particular claim, all claim terms must have clear support or antecedent basis in the specification. See 37 C.F.R. § 1.75(d)(1) and MPEP § 608.01(o). Should Applicant amend the claims such that the claim language no longer has clear support or antecedent basis in the specification, an objection to the specification may result. Therefore, in these situations where the amended claim language does not have clear support or antecedent basis in the specification and to prevent a subsequent ‘Objection to the Specification’ in the next office action, Applicant is encouraged to either (1) re-evaluate the amendment and change the claim language so the claims do have clear support or antecedent basis or, (2) amend the specification to ensure that the claim language does have clear support or antecedent basis. See again MPEP § 608.01(o) (¶3). Should Applicant choose to amend the specification, Applicant is reminded that—like always—no new matter in the specification is allowed. See 35 U.S.C. § 132(a). If Applicant has any questions on this matter, Applicant is encouraged to contact the Examiner via the telephone number listed below.
Applicant is reminded of the obligation to apprise the Office of any prior or concurrent proceedings in which the ‘493 Patent is or was involved, such as interferences or trials before the Patent Trial and Appeal Board, other reissues, reexaminations, or litigations and the results of such proceedings.
Applicant is further reminded of the continuing obligation under 37 C.F.R. §1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN J RALIS whose telephone number is (571)272-6227. The examiner can normally be reached Monday-Friday 8:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hetul Patel can be reached on 571-272-4184. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Stephen J. Ralis/Primary Examiner, Art Unit 3992 Conferees:
/Luke S. Wassum/Primary Examiner, Art Unit 3992
/ANDREW J. FISCHER/Supervisory Patent Examiner, Art Unit 3992
SJR
11/20/2025
1 The Examiner notes that all of the Rejected Claims stood rejected under 103, 112(b) and 251; and claims 1-9, 21 and 22 stood rejected under 102(a)(1)/(a)(2).
2 Claims 1 and 12 amended in the instant Nov 2025 Claim Amendment.
3 Claims 3, 7-9, 13-15, 17, 18 and 20 amended in the instant Nov 2025 Claim Amendment.
4 Claims 22 and 24 amended in the instant Nov 2025 Claim Amendment.
5 Claims 21 and 23 added in the Jan 2023 Claim Amendment; and claim 25 added in the instant Nov 2025 Claim Amendment.
6 Independent claims 1 and 12.
7 Id.
8 Merriam Webster’s Collegiate Dictionary, Tenth Edition. 1996 at 70.
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