DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/30/2025 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Claim Objections
Applicant is advised that should claim 14 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the peak-to-peak action potential growth" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the pulse generator" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the motor threshold" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "a pulse generator of the neurostimulator" in line 14. It is unclear if this is the same or a different pulse generator as that previously recited in the claim.
Claim 1 recites the limitation "an electrode portion" in line 22. It is unclear if this is the same or a different electrode portion as that previously recited in the claim.
Claim 2 recites the limitation "the peak-to-peak action potential growth" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the motor threshold" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "a pulse generator of the neurostimulator" in line 14. It is unclear if this is the same or a different pulse generator as that previously recited in the claim.
The term “lowest” in claims 3 and 16 is a relative term which renders the claim indefinite. The term “lowest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims fail to include any comparison step or generation of multiple values and, thus, there is nothing by which a value is compared to be considered “lowest”.
The term “highest” in claims 4, 5, 17, and 18 is a relative term which renders the claim indefinite. The term “highest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims fail to include any comparison step or generation of multiple values and, thus, there is nothing by which a value is compared to be considered “highest”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-20 are directed to a system.
Step 2A, Prong One
Regarding claims 1 and 2, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitations of “receive measured data of the subject” (claims 1 and 2), “determines from the measured data real time guidance information for guiding a position and/or orientation of an electrode portion during implantation” (claim 1), and “determines from the measured data a set of operating parameters of the pulse generator” (claim 2) is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, these limitations are nothing more than receiving and analyzing data.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, claims 1 and 2 also recite a processor configured to receive data. The processor configured to receive data amounts to nothing more than the pre-solution activity of data gathering. The processor is recited at a high-level of generality and amounts to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the processor amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of electrical stimulation and physiological monitoring. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d). In this case, elements of general computer are being used to implement the abstract idea of receiving and analyzing data.
Regarding dependent claims 3-20, the limitations of claims 3-20 further defines the limitations already indicated as being directed to the abstract idea.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al. (U.S. 2016/0114167, cited by Applicant), herein Jiang. Regarding claim 1, Jian discloses a system for guiding implantation of an electrode portion of a lead of a neurostimulator (“In one aspect, the system utilizes EMG to improve the accuracy and resolution of neural localization with the foramen needle as well as to improve consistency and ease of performing each of neural localization and lead placement, as well as subsequent programming of the implanted neurostimulation system.”, paragraph [0091]) for treatment of a pelvic floor dysfunction and/or of a pelvic floor-related disorder of a subject (“The present invention has particular application to sacral nerve stimulation treatment systems configured to treat bladder and bowel related dysfunctions.”, paragraph [0008]), the system comprising a processor (“the CP 60 has a control unit which can include a microprocessor and specialized computer-code instructions for implementing methods and systems for use by a physician in deploying the treatment system and setting up treatment parameters.”, paragraph [0064]), wherein the processor is configured to: receive measured data of the subject comprising: pelvic floor muscle electromyography (PFM-EMG) data of the subject, wherein the PFM-EMG data comprises: a) action potential (AP) growth data, comprising one or more measurements of the peak-to-peak action potential growth (AP growth) of the subject, wherein the AP growth is an indication of an increase in contraction force per unit of stimulation delivered by the pulse generator (“the EMG signal is used to evaluate placement quality and programming quality based on stimulation amplitude to evoke a response. The EMG responses are measured based on one of several approaches for quantifying the compound muscle action potential (CMAP). Referring to the EMG waveform shown in FIG. 9E, the “peak” is the maximum value of the positive peak of the CMAP, “peak-to-peak” is the value from the maximum peak to the minimum peak of the CMAP”, paragraph [0094]); wherein the system determines from the measured data real time guidance information for guiding a position and/or orientation of an electrode portion during implantation (“ In one aspect, the system provides improved lead placement by determining lead position of a multi-electrode lead relative the target nerve with EMG using an electrode sweeping process.”, paragraph [0100]). It is respectfully submitted that the recitations “optionally b) motor threshold (MT) data comprising one or more measurements of the motor threshold of the subject, where the MT is an indication of a minimum stimulation amplitude delivered by a pulse generator of the neurostimulator that induces a measurable action potential in the pelvic floor of the subject as measured by the PFM-EMG; and optionally c) peak-to-peak amplitude of the action potential (PtP- AP) data comprising one or more measurements of the PtP-AP of the subject, wherein the PtP- AP is an indication of a contraction force of the pelvic floor as measured by the PFM-EMG during stimulation delivered by the pulse generator” fail to further define the claimed invention over that of the prior art because they are optional limitations that are not required by the claim.
Regarding claim 2, Jian discloses a system for adjusting and/or determining a set of operating parameters of a pulse generator of a neurostimulator (“In one aspect, the system utilizes EMG to improve the accuracy and resolution of neural localization with the foramen needle as well as to improve consistency and ease of performing each of neural localization and lead placement, as well as subsequent programming of the implanted neurostimulation system.”, paragraph [0091]) for treatment of a pelvic floor dysfunction and/or of a pelvic floor-related disorder of a subject (“The present invention has particular application to sacral nerve stimulation treatment systems configured to treat bladder and bowel related dysfunctions.”, paragraph [0008]), the system comprising a processor (“the CP 60 has a control unit which can include a microprocessor and specialized computer-code instructions for implementing methods and systems for use by a physician in deploying the treatment system and setting up treatment parameters.”, paragraph [0064]), wherein the processor is configured to: receive measured data of the subject comprising: pelvic floor muscle electromyography (PFM-EMG) data of the subject, wherein the PFM-EMG data comprises: a) action potential (AP) growth data, comprising one or more measurements of the peak-to-peak action potential growth (AP growth) of the subject, wherein the AP growth is an indication of an increase in contraction force per unit of stimulation delivered by the pulse generator (“the EMG signal is used to evaluate placement quality and programming quality based on stimulation amplitude to evoke a response. The EMG responses are measured based on one of several approaches for quantifying the compound muscle action potential (CMAP). Referring to the EMG waveform shown in FIG. 9E, the “peak” is the maximum value of the positive peak of the CMAP, “peak-to-peak” is the value from the maximum peak to the minimum peak of the CMAP”, paragraph [0094]); wherein the system determines from the measured data a set of operating parameters of the pulse generator (“aspects and embodiments of the present disclosure are directed to aiding and refining protocols for setting therapeutic treatment signal parameters for a stimulation program implemented through implanted neurostimulation electrodes.”, paragraph [0058]). It is respectfully submitted that the recitations “optionally b) motor threshold (MT) data comprising one or more measurements of the motor threshold of the subject, where the MT is an indication of a minimum stimulation amplitude delivered by a pulse generator of the neurostimulator that induces a measurable action potential in the pelvic floor of the subject as measured by the PFM-EMG; and optionally c) peak-to-peak amplitude of the action potential (PtP- AP) data comprising one or more measurements of the PtP-AP of the subject, wherein the PtP- AP is an indication of a contraction force of the pelvic floor as measured by the PFM-EMG during stimulation delivered by the pulse generator” fail to further define the claimed invention over that of the prior art because they are optional limitations that are not required by the claim.
Regarding claim 3, it is respectfully submitted that the recitation “an MT that is lowest is indicative of a therapeutically effective pose of the electrode portion” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed. Furthermore, it is further limiting an optional aspect of claim 1 and it is suggested that the optional aspect be positively recited in subsequent claim submissions.
Regarding claim 4, it is respectfully submitted that the recitation “a PtP-AP that is highest is indicative of a therapeutically effective pose of the electrode portion” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed. Furthermore, it is further limiting an optional aspect of claim 1 and it is suggested that the optional aspect be positively recited in subsequent claim submissions.
Regarding claim 5, it is respectfully submitted that the recitation “an AP growth that is highest is indicative of a therapeutically effective pose of the electrode portion” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed.
Regarding claim 6, Jian discloses that the measured data further comprises self-observation data of the subject, wherein the self- observation data comprises: d) sensory threshold (ST) data comprising one or more measurements of the ST of the subject, wherein the ST is an indication of a minimum stimulation amplitude delivered by the pulse generator that induces a physical sensation felt by the subject (see “User feedback” section in Tables 2 and 3); and e) location of sensation (LoS) data comprising one or measurements of the LoS of the subject data, wherein the LoS is an indication by the subject of a location of the feeling of the physical sensation in the body caused by stimulation delivered by the pulse generator (“EMG can be used to determine if the related muscle is activated, (i.e. whether the muscle fully contracts, partially contracts, or does not contract) in response to the stimulus”, paragraph [0060], where the determination of a particular muscle contracts is considered to satisfy the location of sensation measurement, as the contraction of the muscle is the location of the feeling of the physical sensation in the body caused by stimulation).
Regarding claim 7, it is respectfully submitted that the recitation “a MT:ST ratio indicating that ST is greater than MT is indicative of a therapeutically effective position and orientation of the electrode portion” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed.
Regarding claim 8, it is respectfully submitted that the recitation “a LoS contained within an anal region or perianal region or genital region of the subject is indicative of a therapeutically effective position and orientation of the electrode portion” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed.
Regarding claim 9, Jian discloses that the d) ST data and the e) LoS data are collected while the subject is conscious (the use of user feedback, as set forth in Tables 2 and 3, which requires a user interaction, requires that the subject is conscious).
Regarding claim 10, Jian discloses that the a) AP growth data, optionally the b) MT data and optionally the c) PtP-AP data are collected while the subject is conscious or unconscious (the use of user feedback, as set forth in Tables 2 and 3, which requires a user interaction, requires that the subject is conscious).
Regarding claim 11, Jian discloses that the measured data comprises a) the AP growth data, b) the MT data, c) the PtP-AP data, d) the ST and e) the LoS data (see paragraphs [0060] and [0094] and Tables 2 and 3).
Regarding claim 12, Jian discloses that the measured data is collected while the electrode portion of the lead is being positioned towards or is placed adjacent to a sacral or pudendal root of the subject (“Where the nerve targeted being targeted by the neurostimulation treatment is the sacral nerve”, paragraph [0010]).
Regarding claim 13, Jian discloses that the pelvic floor-related disorder is one or more of an overactive bladder, non- obstructive urinary retention, faecal incontinence, pain, and sexual dysfunction (“sacral nerve stimulation treatment systems configured to treat bladder dysfunctions, including overactive bladder (“OAB”), as well as fecal dysfunctions and relieve symptoms associated therewith”, paragraph [0043]).
Regarding claim 14, Jian discloses a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps recited in claim 1 (“the CP 60 has a control unit which can include a microprocessor and specialized computer-code instructions for implementing methods and systems for use by a physician in deploying the treatment system and setting up treatment parameters”, paragraph [0064]).
Regarding claim 15, Jian discloses a computer-readable medium comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps recited in claim 1 (“the CP 60 has a control unit which can include a microprocessor and specialized computer-code instructions for implementing methods and systems for use by a physician in deploying the treatment system and setting up treatment parameters”, paragraph [0064]).
Regarding claim 16, it is respectfully submitted that the recitation “an MT that is lowest is indicative of a therapeutically effective set of operating parameters” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed. Furthermore, it is further limiting an optional aspect of claim 2 and it is suggested that the optional aspect be positively recited in subsequent claim submissions.
Regarding claim 17, it is respectfully submitted that the recitation “a PtP-AP that is highest is indicative of a therapeutically effective set of operating parameters” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed. Furthermore, it is further limiting an optional aspect of claim 2 and it is suggested that the optional aspect be positively recited in subsequent claim submissions.
Regarding claim 18, it is respectfully submitted that the recitation “an AP growth that is highest is indicative of a therapeutically effective set of operating parameters” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed.
Regarding claim 19, Jian discloses that the measured data further comprises self- observation data of the subject, wherein the self-observation data comprises: d) sensory threshold (ST) data comprising one or more measurements of the ST of the subject, wherein the ST is an indication of a minimum stimulation amplitude delivered by the pulse generator that induces a physical sensation felt by the subject (see “User feedback” section in Tables 2 and 3); and e) location of sensation (LoS) data comprising one or measurements of the LoS of the subject data, wherein the LoS is an indication by the subject of a location of the feeling of the physical sensation in the body caused by stimulation delivered by the pulse generator (“EMG can be used to determine if the related muscle is activated, (i.e. whether the muscle fully contracts, partially contracts, or does not contract) in response to the stimulus”, paragraph [0060], where the determination of a particular muscle contracts is considered to satisfy the location of sensation measurement, as the contraction of the muscle is the location of the feeling of the physical sensation in the body caused by stimulation).
Regarding claim 20, it is respectfully submitted that the recitation “a MT:ST ratio indicating that ST is greater than MT is indicative of a therapeutically effective set of operating parameters” fails to further define the claimed invention over that of the prior art because it is recited as a result rather than further limiting any aspect of the system as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
