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 .
Status of Claims
Claims 1-34 are currently pending and under consideration.
Election/Restrictions
Applicant’s election of Species 1B: heart rate variability in the reply filed on August 11, 2026 is acknowledged.
Claims 3-8 and 20-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election is being assumed as made without traverse in the reply filed on August 11, 2026 as the applicant provided no arguments.
Applicant is advised to amend claims 2 and 19 to remove “brain wave”.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Oct. 17, 2024 and Aug. 18, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 9 abbreviated terms “FSBR”, “FSBRt”, and “FSBRs” should be defined at their first occurrences.
Claim 15 abbreviated term “SPI” should be defined at its first occurrence.
In claim 32, a colon should be added after “further comprising” in line 2.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“input unit configured to receive an electrical stimulation guideline…”, “a reference value setter configured to set a reference value…”, and “a stimulation value adjuster configured to adjust the electrical stimulation guideline” in claim 18; and
“initial stimulation value setter configured to derive initial stimulation values adjusting numerical values comprised in the electrical stimulation guideline” in claim 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For “input unit”, the specification fails to provide sufficient structure and will be interpreted as any component that is capable of the claimed function.
For “reference value setter”, the specification describes an ECG machine that measures HRV and other parameters, and any equivalents thereof (¶[67]).
For “stimulation value adjuster”, the specification describes an ECG machine that measures HRV to calculate parameters and can use all or some of the components of the reference value setter, and any equivalents thereof (¶[78]).
For “initial stimulation value setter”, the specification describes an input device that can receive age, sex; a BMI measurer, a thermometer, hygrometer, and any equivalents thereof (¶[57]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
FSBR is the ratio of power of high frequency to power of low frequency.
FSBRs is the standard deviation plus the mean of FSBR taken over a period of time.
FSBRt is the current FSBR measurement.
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.
Claim 18 limitation “input unit configured to receive an electrical stimulation guideline…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification does not describe any structure and only references the input unit as being a part of the electrical stimulation application apparatus. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 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 18-19, and 26-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract ideas of “receive an electrical stimulation guideline comprising numerical information about electrical stimulation”, “set a reference value for a biosignal of a user from the biosignal measured a plurality of times over predetermined intervals without electrical stimulation applied”, and “adjust the electrical stimulation guideline by comparing a value calculated by measuring the biosignal of the user with the reference value before applying electrical stimulation” without significantly more.
Step 1:
Claims 18-19 and 26-34 recite an apparatus. Therefore, the claim(s) fall within the statutory categories.
Step 2A, Prong 1:
Claim 18 recites limitations of receive an electrical stimulation guideline comprising numerical information about electrical stimulation, set a reference value for a biosignal of a user from the biosignal measured a plurality of times over predetermined intervals without electrical stimulation applied, and adjust the electrical stimulation guideline by comparing a value calculated by measuring the biosignal of the user with the reference value before applying electrical stimulation. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the claim 18 recitation of “an electrode configured to apply electrical stimulation in contact with the skin of a human body”, “an input unit”, “a reference value setter”, and “a stimulation value adjuster”. That is, other than reciting that the electrode, input unit, reference value setter, and stimulation value adjuster are performing these tasks, nothing in the claims precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitation of “electrode”, “input unit”, “reference value setter”, and “stimulation value adjuster” language, the claim encompasses the user looking at a plan for electrical stimulation, comparing previous biosignal measurements to a more recent measurement, and adjusting the plan based on the comparison. These limitations are a mental process.
Step 2A, Prong 2:
The claims recite “electrode”, “input unit”, “reference value setter”, and “stimulation value adjuster” to perform the abstract steps.
The reference value setter and stimulation value adjuster read on ECG devices and are used in combination with the electrode for stimulation. This is merely a pre-solution gathering activity.
The input unit reads on a computer implemented system and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component and provide a means for creating the plan, collecting data, and performing stimulation. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well- understood, routine, conventional activity in the field. The specification does not provide structure for the input unit and therefore, does not provide any indication that the computer and computer programming is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐ implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
The reference value setter and stimulation value adjuster read on ECG devices or other devices capable of obtaining heart rate variability and are used in combination with the electrode for stimulation. Lerman et al. states that many existing methods and systems for producing electrical fields, including ultrasonic pulses, for transcutaneous nerve stimulation may use physiological signals (e.g., heart rate variability) to trigger and/or adjust stimulation (¶[0021] US 20190030334 A1). Therefore, it is well-known to collect physiological signals related to heart rate variability and use it in combination with transcutaneous electrodes for stimulation.
Dependent claims 19, 26-31 further limit the process of receive an electrical stimulation guideline comprising numerical information about electrical stimulation, set a reference value for a biosignal of a user from the biosignal measured a plurality of times over predetermined intervals without electrical stimulation applied, and adjust the electrical stimulation guideline by comparing a value calculated by measuring the biosignal of the user with the reference value before applying electrical stimulation. Therefore, these claims further limit the abstract idea already indicated in independent claim 18 and they are ineligible for the same reasons provided for claim 18 above.
Dependent claim 32 further limits claim 18 and introduces the abstract ideas of “derive initial stimulation values adjusting numerical values comprised in the electrical stimulation guideline by applying an SPI calculated by applying one or more of demographic markers and environmental markers; wherein the SPI is an index quantifying sensitivity to electrical stimulation, the demographic markers are markers statistically reflecting sensitivity to electrical stimulation, and the environmental markers are markers reflecting environmental factors influencing sensitivity to electrical stimulation”. The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the claim 32 recitation of “initial stimulation value setter”. That is, other than reciting that the initial stimulation value setter is performing these tasks, nothing in the claims precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitation of “initial stimulation value setter” language, the claim encompasses the adjusting the plan using information based on the patient and the environment. The initial stimulation value setter is insignificant extra-solution activity and reads on a display where input of patient information can be added which is a part of a generic computer. Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2. Further dependent claims 33-34 further limit the abstract idea presented in claim 31 and are ineligible for the same reason.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 103
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 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 1-2 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lerman et al. (US 20190030334 A1, published Jan. 31, 2019, hereinafter referred to as “Lerman”) in view of Massoumi et al. (US 20160136429 A1, published May 19, 2016, hereinafter referred to as “Massoumi”).
Regarding claims 1 and 18, Lerman teaches an electrical stimulation application method and apparatus for pneumogastric nerves through an electrode that is in contact with the skin of a human body (“The exemplary embodiments disclosed in FIGS. 1 to 5 may disclose stimulating vagus nerve fibers transcutaneously” ¶[0072]; “FIG. 5 is an example block diagram showing a system 500 for selecting a pair of electrodes for electrical nerve stimulation” ¶[0113]), the electrical stimulation application method and apparatus comprising: a reference value setting step of setting a reference value for a biosignal of a user by measuring a biosignal a plurality of times over predetermined intervals without electrical stimulation applied (Fig. 3 “The flow diagram 300 begins when at least one baseline physiological signal may be received at block 310. Each of the at least one baseline physiological signal may be transmitted from at least one physiological sensor. Each of the at least one physiological sensor may measure at least one physiological property of a user. The baseline physiological signal may include a physiological signal captured prior to stimulation of at least a portion of a vagus nerve of the user. The physiological signal may be captured prior to recent stimulation or stimulation received within a predetermined historical timeframe.” ¶[0098]); an electrical stimulation guideline input step of inputting an electrical stimulation guideline comprising numerical values for electrical stimulation (Fig. 3 “an electric signal that stimulates at least a portion of a vagus nerve of the user transcutaneously may be produced at block 320. The electric signal may be based at least in part on at least some of a plurality of stimulation parameters.” ¶[0099]); a stimulation value adjustment step of adjusting the electrical stimulation guideline; an electrical stimulation step of applying electrical stimulation on the basis of the adjusted value (Fig. 3 “A value for at least one of the plurality of stimulation parameters may be selected at block 370. The value may be based at least in part on the difference. The value may be based at least in part on at least one of the at least one measured intermodulation distortion” ¶[0102]).
Lerman does not teach the adjustment step is done by comparing a value calculated by measuring the biosignal of the user with the reference value before applying electrical stimulation.
Massoumi’s invention relates to implantable electrical stimulation systems that include devices or methods for electrical stimulation which utilize one or more sensors to adjust stimulation parameters, as well as methods of making and using the electrical stimulation systems (¶[0002]). The external programming unit 106 or control module 102 receives the measurements from the sensor(s) 107 and includes an algorithm or other computer program that utilizes the sensor measurements and the current stimulation parameters and, optionally, other information regarding the patient, disease or disorder, and the like to determine adjustment to one or more of the stimulation parameters. In yet other embodiments, the sensor includes the algorithm or other computer program that determines adjustment to one or more of the stimulation parameters based on the sensor measurements (¶[0082]). In addition to the sensor measurements, the algorithm or computer program also receives the current stimulation parameters from, for example, the external programming unit or the control module or any other suitable source. The system can also incorporate one or more of medication information, demographics (for example, age, gender, ethnicity, height, weight, or the like), disease-specific details (for example, pain etiology(ies), number of prior back surgeries, relevant diagnoses, imaging findings, or the like) in the information used to determine adjustments to the stimulation parameters. The algorithm or computer program may determine adjustments based on patient-specific response to previous adjustments, based on population response to previous adjustments, based on patient activity or disease/disorder status determined from the sensor measurements, or any combination thereof. In at least some embodiments, the clinician may direct the patient to perform a particular activity (for example, finger tapping, drawing a spiral or other shape, walking, or the like) and the system uses the sensor measurements during this activity to evaluate and determine adjustments to the stimulation parameters (¶[0083]). The system may also determine a preferred set of stimulation parameters associated with patient activity, disease state, or sensor measurement value or range using the algorithmic techniques described above and may adjust the stimulation parameters to that preferred set upon detecting the patient activity, disease state, or sensor measurement value or range (¶[0086]). In Fig. 7 step 704, the biosignal is analyzed and an adjustment to one or more stimulation parameters is generated (¶[0093]). In step 706, the stimulation parameter(s) are automatically adjusted at the external programming unit 106 (¶[0094]). In step 708, the external programming unit 106 transmits the adjusted stimulation parameters to the control module 102. The control module 102 then proceeds to deliver electrical stimulation using the adjusted stimulation parameters (¶[0095]). Fig. 8 shows a similar method where in step 806, the stimulation parameters are automatically adjusted in the control module 102. The control module 102 then proceeds to deliver electrical stimulation using the adjusted stimulation parameters. This process may be particularly useful where the control module 102 receives the measurements or the adjustment to the stimulation parameters directly from the sensor 107 (¶[0099]). The measurements can be used in an automated or semi-automated manner to alter one or more stimulation parameters to enhance the treatment (¶[0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to adjust the stimulation parameters prior to stimulation based on the acquired biosignal as taught by Massoumi in the method and apparatus for pneumogastric nerve stimulation of Lerman in order to tailor and enhance the treatment to the patient.
Regarding claims 2 and 19, Lerman teaches wherein the biosignal of the user that is measured is a brain wave (brain wave not elected) or heart rate variability (“the at least one physiological sensor (e.g., 230) may include a heart rate sensor, at least one scalp electrode … The heart rate sensor may measure Heart Rate Variability (HRV).” ¶[0039]).
Claims 9-14 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Lerman in view of Massoumi (hereinafter referred to as “Modified Lerman”), as applied to claims 1 and 18, and in further view of Levine et al. (US 20170203103 A1, published July 20, 2017, hereinafter referred to as “Levine”).
Regarding claims 9 and 26, modified Lerman teaches the method and apparatus for pneumogastric nerve stimulation of claims 1 and 18. Lerman teaches wherein the biosignal of the user that is measured is heart rate variability (see claim 2).
Although Lerman discloses a ratio of low and high frequencies for HRV, modified Lerman does not disclose an FSBR is calculated for each of a plurality of times of measurement over the predetermined intervals and an FSBRS that is an FSBR reference value is set in the reference value setting step, an FSBRt calculated by measuring heart rate variability of the user is compared with the FSBRS in the stimulation value adjustment step, and the FSBR is an index reflecting a state of a symptom of the user and is calculated by dividing power of a high frequency band with a relatively high frequency by power of a low frequency band with a relatively low frequency in the measured heart rate variability.
Levine’s invention relates to neuromodulation of the vagus nerve for the treatment of inflammation (¶[0004]). Applying the second electrical stimulation to the subject's vagus nerve based on the first heart rate variability and the second heart rate variability may comprise determining a ratio of high frequency to low frequency components of heart rate variability. The method of claim 1, wherein the second electrical stimulation is applied after an off-period of between 30 minutes and 24 hours. The electrode may be in contact with the subject's vagus nerve in the patient's cervical region. The low frequency (LF) band (e.g., approximately 0.04-0.15 Hz) may be related to both sympathetic and parasympathetic modulation, and the high frequency (HF) band (e.g., approximately 0.15-0.40 Hz, or 0.18 to 0.4 Hz) may be governed almost exclusively by parasympathetic effects. The ratio of LF to HF power (inverse of FSBR) may be used as a metric of sympathetic/parasympathetic balance (index reflecting the state of the user) (¶[0044]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to calculate the FSBR for each of the measurements to show an index reflecting the state of the user as taught by Levine in the method and apparatus of modified Lerman in order to show the balance of parasympathetic/sympathetic as a metric value.
Regarding claims 10 and 27, Lerman teaches wherein the high frequency band is a range of 0.15Hz or more and 0.4Hz or less and the low frequency band is a range of 0.04Hz or more and less than 0.15Hz (“the low frequency (LF) may, for example, include a range of 0.04-0.15 Hz; and the high frequency (HF) may, for example, include a range of 0.15-0.4 Hz” ¶[0042]).
Regarding claims 11 and 28, wherein, in the reference value setting step, the FSBRS is obtained by adding standard deviation of FSBR values calculated by measuring heart rate variability a plurality of times to an average of the FSBR values.
It would have been obvious to a person having ordinary skill in the art at the time of filing to substitute the reference value with a value that is the standard deviation added to the average because the standard deviation is a mathematical function that tells you how spread the data is and creates a better picture of the overall data.
Regarding claims 12 and 29, Lerman teaches wherein, in the stimulation value adjustment step, when the FSBRt is larger than the FSBRS, electrical stimulation that is applied through the electrode is adjusted (Fig. 3 “A value for at least one of the plurality of stimulation parameters may be selected at block 370. The value may be based at least in part on the difference. The value may be based at least in part on at least one of the at least one measured intermodulation distortion” ¶[0102] Therefore, the electrical stimulation will be adjusted whenever there is a deviation from the baseline measurement).
Regarding claims 13 and 30, modified Lerman and Levine do not teach wherein when the FSBRt is larger than the FSBRS, a duty ratio of electrical stimulation is increased.
Lerman teaches that the at least one duty cycle of stimulation pulses may be adjustable from 50 percent to 10 percent (¶[0092]). Levine teaches that heart rate variability (HRV) may provide an indicator of therapy efficacy, as it may effect vagal tone. For example, HRV may change as therapy is applied, as shown in FIG. 13, showing changes in HRV measured in a Crohn's patient over a treatment (study) period, comparing changes in the ratio of LF/HF from baseline (e.g., week 0) over time, where LF refers to the low-frequency power and HF is a measure of the high-frequency power. LF/HF ratio may be considered an indicator of the autonomic balance for the patient (¶[0156]). Stimulation can be delayed or cancelled or aborted while in progress when the HR and/or HRV is above or below a predetermined threshold. In some embodiments, the predetermined thresholds can be determined based on a patient's normal resting HR and HRV, or a patient's sleeping HR and HRV if stimulation is applied when the patient is asleep. For example, the predetermined threshold can be about +/−10%, 20%, 30%, 40%, or 50% of the resting or sleeping HR and HRV. In some embodiments, the device and system can determine whether the stimulation is adversely affecting the patient's HR and/or HRV by comparing the HR and/or HRV from before, during, and after stimulation. If the stimulation is adversely affecting the HR and/or HRV, stimulation parameters can be adjusted, such as decreasing amplitude and/or duration and/or frequency of dosages, and/or the position of the implant on the vagus nerve can be adjusted (¶[0157]).
It would have been obvious to a person having ordinary skill in the art at the time of filing to increase the duty ratio of electrical stimulation when the recent measurement is larger than the baseline measurement because the ratio indicates the autonomic balance of the patient is different from baseline and there are a finite number of parameters to change the electrical stimulation based on the data input in order to tailor the electrical stimulation.
Regarding claims 14 and 31, modified Lerman and Levine do not teach wherein the duty ratio is increased in proportion to a difference between the FSBRt and the FSBRS.
It would have been obvious to a person having ordinary skill in the art at the time of filing to try to increase the duty ratio in proportion to the difference because there are a finite number of solutions for determining the stimulation parameters and the larger the calculated difference, the further from the baseline the patient is, so the more the stimulation parameter can change.
Claims 15-17 and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over modified Lerman, as applied to claims 1 and 18 above, and in further view of Hyde et al. (US 10039928 B2, published Aug. 7, 2018, hereinafter referred to as “Hyde”).
Regarding claims 15 and 32, Modified Lerman teaches the method and apparatus for pneumogastric nerve stimulation of claims 1 and 18. Lerman teaches wherein an initial stimulation value setting step of deriving initial stimulation values adjusting numerical values included in an electrical stimulation guideline by applying an SPI calculated by applying one or more of demographic markers; and the SPI is an index quantifying sensitivity to electrical stimulation, the demographic markers are markers statistically reflecting sensitivity to electrical stimulation, the stimulation value adjustment step adjusts the initial stimulation values (“The value for at least one of a plurality of stimulation parameters may be based at least in part on at least one physical attribute of the user. In the example, the at least one physical attribute may include gender, age, height, weight, wrist girth, at least one baseline autonomic tone, at least one baseline inflammation level, combinations thereof, and/or the like.” ¶[0093]).
Massoumi further teaches the system can also incorporate one or more of medication information, demographics (for example, age, gender, ethnicity, height, weight, or the like), disease-specific details (for example, pain etiology(ies), number of prior back surgeries, relevant diagnoses, imaging findings, or the like) in the information used to determine adjustments to the stimulation parameters. The algorithm or computer program may determine adjustments based on patient-specific response to previous adjustments (potentially discomfort level), based on population response to previous adjustments, based on patient activity or disease/disorder status determined from the sensor measurements, or any combination thereof. In at least some embodiments, the clinician may direct the patient to perform a particular activity (for example, finger tapping, drawing a spiral or other shape, walking, or the like) and the system uses the sensor measurements during this activity to evaluate and determine adjustments to the stimulation parameters (¶[0083]).
Modified Lerman does not disclose environmental markers is performed before the stimulation value adjustment step; and the environmental markers are markers reflecting environmental factors influencing sensitivity to electrical stimulation.
Hyde’s invention relates to a neural signal sensor adapted to sense a neural signal from a subject, the neural signal indicative of a physiological status of the subject, a neural stimulator adapted to produce a stimulus responsive to the sensed neural signal, the stimulus configured to activate at least one sensory nerve fiber innervating at least a portion of a pinna of the subject (Col. 1, ln. 46-52). In Fig. 7, secondary sensor 750 is an environmental sensor, for example a light sensor 782, which may be configured to sense light level 784 and or day length 786. Environmental sensor 750 may include a temperature sensor 788, or an acoustic sensor 790, e.g., configured to sense ambient noise level 792. Other types of sensors for providing information regarding the state of the subject and his or her environment may be used (Col. 14, ln. 2-9). Data drawn from one or more neural signals, physiological signals, environmental signals, or other secondary signals (e.g. obtained with secondary sensor 750 in FIG. 7) or secondary inputs (e.g. secondary signal input 800 in FIG. 7), as well as clock or timer information, can be correlated with a mental or emotional state of the subject, reported to a medical care provider or other party, and/or stored in the subject's medical or health records. In particular, values of any such parameters that are indicative of worsening mental or physical/physiological status of the subject can be reported to a medical care provider so that an appropriate intervention can be made, and/or used as a basis for modulating the delivery of neural stimulation (Col. 14 ln. 57- Col. 15 ln. 2). Method 2700 includes generating an update for the configuration of the neural stimulus. This may be done based on a response of the subject to a previous treatment regimen, based on an environmental factor, or based on motion or location of the subject. In an aspect, the update is generated automatically e.g., when it is determined that an update is needed (based on a subject response or sensed environmental factor). In another aspect, the update is generated based upon acceptance of a recommendation for the update by the subject (Col. 40, ln. 51-60).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include environmental factors in the stimulation adjustment step as taught by Hyde in the method and apparatus for pneumogastric nerve stimulation of modified Lerman in order to account for any factors that can affect the physiological status of the patient and update the delivery of neural stimulation accordingly.
Regarding claims 16 and 33, Lerman teaches wherein the demographic markers comprise one or more pieces of information of age, sex, BMI (“gender, age, height, weight” ¶[0093]).
Regarding claims 17 and 34, Hyde teaches wherein the environmental markers comprise one or more pieces of information of temperature (“temperature sensor 788” Col. 14).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Libbus et al. (US 20070260285 A1) – high and low frequency bands with claimed frequencies and reasoning; duty cycling parameter and other parameters for balancing responses between parasympathetic and sympathetic nervous system
Malchano et al. (US 20180133507 A1) – environmental feedback and sensing
Tyler et al. (US 20190046787 A1) – wearable stimulator with electrodes
Hamner et al. (WO 2020185601 A1) – benefit of measuring ratios of high and low frequency power
La Rovere et al. (US 20200345970 A1) – reasons to track heart rate variability
Offutt et al. (WO 2021211357 A1) – collect baseline, stimulate, adjustment
Hamner et al. (US 20210379374 A1) – transcutaneous electrode stimulation of vagus nerve, measure HRV and discuss the reason why along with noticing changes from the baseline value; potentially shows proportionate increases
Kim Won Ki (KR 20220041636 A) – figure 3 shows a process of adjusting based on signals
Song et al. (US 20240189591 A1) – dated within grace period
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/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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