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 the Claims
The office action is in response to the claims filed on March 3, 2025 for the application filed March 3, 2025 which claims priority to a provisional application filed on March 18, 2024. Claims 1-20 are currently pending and have been examined.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-14 are directed towards a method (i.e. a process), which is a statutory category. Claim 15 is directed towards one or more non-transitory computer0readable media (i.e. a manufacture), which is a statutory category. Claims 16-20 are directed towards a system (i.e. a machine), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1, 15 and 16 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the claim 1 and 16 is identified in representative claim 16 as:
A system, comprising:
a processing system configured for use to:
receive medication data associated with administration of medication from a patient in an absence of administering electrostimulation to the patient;
receive stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication;
compare the medication data to the stimulation data to provide a comparison; and
generate a medication schedule and an electrostimulation schedule based on the comparison to increase efficacy of therapy and minimize side effects.
The abstract idea (identified in bold) recited in the claim 15 is identified as:
One or more non-transitory computer-readable media storing instructions executable by processing circuitry to:
receive:
medication data associated with administration of medication from a patient prior to administering electrostimulation to the patient; and
stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication;
compare the medication data to the stimulation data; and
determine whether at least a first symptom associated with the medication data is equal to or greater than at least a second symptom associated with the stimulation data.
The identified limitations of the abstract idea of claims XXX fall within the subject matter grouping of certain methods of organizing human activity related and the sub grouping of managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions), commercial or legal interactions (including agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations) or fundamental economic principles or practices (including hedging, insurance, mitigating risk). Choose the subgrouping which best fits the method of organizing human activity and articulate why the claim corresponds to that subgrouping. See MPEP §2106.04(a)(2)(II).
The identified limitations fall within the subject matter grouping of mental processes. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. The limitations of comparing data to provide a comparison, generating a medication schedule and an electrostimulation schedule based on the comparison and determining whether at least a first symptom associated with the medication data is equal to or greater than at least a second symptom associated with the stimulation data can be performed in the human mind by observations, evaluations, judgments and opinions.
Accordingly, claims 1, 15 and 16 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 16 are identified in italics as:
A system, comprising:
a processing system configured for use to:
receive medication data associated with administration of medication from a patient in an absence of administering electrostimulation to the patient;
receive stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication;
compare the medication data to the stimulation data to provide a comparison; and
generate a medication schedule and an electrostimulation schedule based on the comparison to increase efficacy of therapy and minimize side effects.
The additional elements recited in claim 15 are identified in italics as:
One or more non-transitory computer-readable media storing instructions executable by processing circuitry to:
receive:
medication data associated with administration of medication from a patient prior to administering electrostimulation to the patient; and
stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication;
compare the medication data to the stimulation data; and
determine whether at least a first symptom associated with the medication data is equal to or greater than at least a second symptom associated with the stimulation data.
The additional limitations of “A system, comprising: a processing system configured for use to: and “One or more non-transitory computer-readable media storing instructions executable by processing circuitry to” are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f). The system and media are recited at a high level of generality and merely used to implement the abstract idea on a computer. Therefore, these additional elements amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
The additional limitations of “receive” medical data and stimulation data are determined to be no more than the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g).
Accordingly, claims 1, 15 and 16 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements 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 limitations are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f) and the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g). Evidence that mere necessary data gathering using a processing system/computer-readable media is well-understood, routine and conventional is provided by MPEP §2106.05(d), subsection II. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea as detailed below.
Regarding claims 2-3 and 17-19, the determinations are directed to a mental process.
Regarding claims 4-6 and 20, the comparing and medication and stimulation schedule details response to the comparing are directed to a mental process.
Regarding claim 7-11, acquiring medical data of a patient under certain conditions and sending inquiries to the patient to determine additional information is a method of organizing human activity, such as the activity of data collection between a patient and a doctor.
Regarding claims 12-14, merely defining what the received data comprises is still the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g).
Therefore, whether taken individually or as an ordered combination, 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 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.
Claims 1-4, 7-8, 12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenisek et al. (U.S. Pub. No. 2023/0012100).
Regarding claim 1, Zenisek discloses a method, comprising:
receiving medication data associated with administration of medication from a patient prior to administering electrostimulation to the patient (Paragraph [0027], leads may be implanted in a patient simply for sensing and determining when the patient is taking medication and whether the medication is effective, but never provide any electrical stimulation. Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. Paragraph [0006], the system may be configured monitor the dosing by the HCP denoting within the system, at what times the dosing should occur, and may look for the medication and/or LFP reaction that would indicate the medication was taken and/or if the medication/LFP reaction does not occur, remind the patient to take their medication. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values.);
receiving stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication (Paragraph [0051], the clinician may select one or more stimulation electrode combinations with which stimulation is delivered to brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by patient 112 or based on one or more physiological parameters of patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). Paragraph [0137], when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values.);
comparing the medication data to the stimulation data to provide a comparison (Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. In this example, when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment.); and
generating a medication schedule and an electrostimulation schedule based on the comparison to increase efficacy of therapy and minimize side effects (Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Given this information, system 100 could provide guidance of stimulation changes to help optimize the therapy and/or outcome.).
Regarding claim 2, Zenisek further discloses:
determining that the medication data is attributable to the administration of medication (Paragraph [0027], leads may be implanted in a patient simply for sensing and determining when the patient is taking medication and whether the medication is effective, but never provide any electrical stimulation. Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. Paragraph [0006], the system may be configured monitor the dosing by the HCP denoting within the system, at what times the dosing should occur, and may look for the medication and/or LFP reaction that would indicate the medication was taken and/or if the medication/LFP reaction does not occur, remind the patient to take their medication. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Also see fig. 8.); and
determining that the stimulation data is attributable to the administration of the electrostimulation (Paragraph [0051], the clinician may select one or more stimulation electrode combinations with which stimulation is delivered to brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by patient 112 or based on one or more physiological parameters of patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). Paragraph [0137], when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Also see fig. 9.).
Regarding claim 3, Zenisek further discloses determining an effect of the administration of medication and an effect of the administration of the electrostimulation therapy on symptoms experienced by the patient (Paragraph [0117], Using first LFP activity level 802 and second LFP activity level 804, system 100 may determine how well one or more of the stimulation, the medication, or both the stimulation and the medication is working as LFP reduction may equate to symptom reduction. Paragraph [0127], Using first LFP activity level 902 and second LFP activity level 904, system 100 may determine how well the first stimulation and the second stimulation is working as LFP reduction may equate to symptom reduction.).
Regarding claim 4, Zenisek further discloses comparing the medication data to the stimulation data by determining whether a first symptom parameter associated with the medication data is equal to or greater than a second symptom parameter associated with the stimulation data (Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. In this example, when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment. The is construed as the LFP activity level of the medication without stimulation as being greater than the LFP value of the stimulation with the medication. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Also see paragraphs [0117] and [0121].).
Regarding claim 7, Zenisek further discloses acquiring the medication data in response to dosing the patient and the patient being at a peak of medication dosage (Paragraph [0116], In the example of FIG. 8 , patient 122 may take the first medication at an initial time 820 (“T0”). Paragraph [0118], Programmer 104 may determine duration 812 of when the first medication is effective based on a time difference between when the first medication is effective for treatment of patient 102 (e.g., second time 822) and when the first medication is no longer effective for treatment of patient 102 (e.g., third time 824). Paragraph [0006], The system may be configured to reduce stimulation based on the efficacy of the drug when at peak, or other defined efficacy, determined by the system logic/algorithm. Also see figs 6-8.).
Regarding claim 8, Zenisek further discloses monitoring the patient to determine whether medication symptoms change (Paragraph [0005], This disclosure describes example techniques for using local field potential (LFP) activity to monitor medication supplementation, onset/duration, effectiveness, etc. to assist the Healthcare professionals (HCPs) to understand how compliant the patient is and the medication's effectiveness. A medical device may monitor disease progression in Parkinson's Disease (PD) patients, as one example, through LFP and medication supplementation. Paragraph [0006], The system may be configured to help determine if the efficacy of the stimulation and/or medication has changed over time possibly due to various issues such as, for example, dementia, forgetfulness, and disease progression. Also see figs 6-8. Paragraph [0117], Using first LFP activity level 802 and second LFP activity level 804, system 100 may determine how well one or more of the stimulation, the medication, or both the stimulation and the medication is working as LFP reduction may equate to symptom reduction..
Regarding claim 12, Zenisek further discloses wherein the medication data comprises at least one of rigidity, bradykinesia, tremors, or dyskinesia (Paragraph [0060], The medical device may monitor other bands such as, for example, a gamma band to determine if the medication(s) are causing dyskinesias (e.g., a side effect of too much medication).).
Regarding claim 14, Zenisek further discloses wherein the stimulation data comprises at least one of apathy, anxiety, depression, or compulsive disorders (Paragraph [0032], therapy system 100 may provide therapy to manage symptoms of other patient conditions, such as, but not limited to, seizure disorders (e.g., epilepsy) or mood (or psychological) disorders (e.g., major depressive disorder (MDD), bipolar disorder, anxiety disorders, post-traumatic stress disorder, dysthymic disorder, and obsessive-compulsive disorder (OCD)). Paragraph [0127], Using first LFP activity level 902 and second LFP activity level 904, system 100 may determine how well the first stimulation and the second stimulation is working as LFP reduction may equate to symptom reduction.).
Regarding claim 15, Zenisek discloses one or more non-transitory computer-readable media storing instructions executable by processing circuitry to (Paragraph [0063]):
receive:
medication data associated with administration of medication from a patient prior to administering electrostimulation to the patient (Paragraph [0027], leads may be implanted in a patient simply for sensing and determining when the patient is taking medication and whether the medication is effective, but never provide any electrical stimulation. Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. Paragraph [0006], the system may be configured monitor the dosing by the HCP denoting within the system, at what times the dosing should occur, and may look for the medication and/or LFP reaction that would indicate the medication was taken and/or if the medication/LFP reaction does not occur, remind the patient to take their medication. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values.); and
stimulation data associated with administration of electrostimulation therapy to the patient while the patient is not being administered medication (Paragraph [0051], the clinician may select one or more stimulation electrode combinations with which stimulation is delivered to brain 120. During the programming session, the clinician may evaluate the efficacy of the specific program being evaluated based on feedback provided by patient 112 or based on one or more physiological parameters of patient 112 (e.g., muscle activity, muscle tone, rigidity, tremor, etc.). Paragraph [0137], when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values.);
compare the medication data to the stimulation data (Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values. Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. In this example, when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment.); and
determine whether at least a first symptom associated with the medication data is equal to or greater than at least a second symptom associated with the stimulation data (Paragraph [0137], when patient 122 takes a first medication of the first stimulation and medication combination without stimulation, the LFP activity level of patient 102 reduces by 20% compared to no treatment. In this example, when system 100 applies a first stimulation of the first stimulation and medication combination to patient 122 without the first medication, the LFP activity level of patient 102 reduces by 30% compared to no treatment. This is construed as the LFP activity level of the medication without stimulation as being greater than the LFP value of the stimulation with the medication as less reduction equates to higher LFP values. Paragraph [0143], Knowing the effectiveness of the medications alone, stimulation alone, and/or both medication(s) and stimulation may help the user better titrate the medication, stimulation values, and/or threshold values.).
Regarding claims 16-20: all limitations as recited have been analyzed and rejected with respect to claims 1-4. Claims 16-20 pertain to a system, corresponding to the method of claims 1-4. Claims 16-20 do not teach or define any new limitations beyond claims 1-4 apart from the processing system disclosed by Zenisek in Fig. 2; therefore claims 16-20 are rejected under the same rationale.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Zenisek et al. (U.S. Pub. No. 2023/0012100) in view of Smyth et al. (WO 2025/177099 A1).
Regarding claim 5, Zenisek further discloses using effectiveness of the medications alone and stimulation alone using LFP activity levels to help the user better titrate the medication, stimulation values, and/or threshold values (Paragraphs [0137] and [0143]), if the LFP activity levels of medication alone is less than the LFP levels in stimulation alone, this would indicate medication alone provides better symptom reduction than stimulation alone. Smyth teaches that it was old and well known in the art of coordinating electrical and drug therapies to treat a condition of a recipient at the time of the filing that control of drug and stimulation therapies are based on trigger events, indicating the efficacy of the therapies to treat symptoms, and responsive to a remedy to improve/reduce the symptoms (Smyth, paragraph [0057]). If no triggering event is detects (e.g. stimulation of does adjustment would not improve/reduce symptoms), the drug therapy continues to be provided without making any changes (Smyth, paragraph [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art of coordinating electrical and drug therapies to treat a condition of a recipient at the time of the filing to modify the method of Zenisek to include maintaining a dosage level of the medication in response to the first symptom parameter being less than the second symptom parameter, as taught by Zenisek and Smyth, in order to effectively treat the condition while maintaining treatment effectiveness and avoiding causing potential side effects and/or other discomfort to the recipient (Smyth, paragraph [0024]).
Regarding claim 6, Zenisek further discloses using effectiveness of the medications alone and stimulation alone using LFP activity levels to help the user better titrate the medication, stimulation values, and/or threshold values (Paragraphs [0137] and [0143]), if the LFP activity levels of medication alone is greater than the LFP levels in stimulation alone, this would indicate medication alone equal or worse symptom reduction than stimulation alone. Smyth teaches that it was old and well known in the art of coordinating electrical and drug therapies to treat a condition of a recipient at the time of the filing that control of drug and stimulation therapies are based on trigger events, indicating the efficacy of the therapies to treat symptoms, and responsive to a remedy to improve/reduce the symptoms (Smyth, paragraph [0057]). Control of the drug and stimulation therapies include adjusting the drug therapy based on trigger events by changing the amount of a drug delivery, a concentration of a drug delivery, and/or a frequency of drug delivery and adjusting stimulation therapies based on the trigger events by adjusting a stimulation level, by adjusting a stimulation rate, by adjusting a stimulation location (Smyth, paragraphs [0061] and [0063]). Adjusting the therapies may include increasing or decreasing the dosage level of the drug therapy and increasing or decreasing the a stimulation level or a stimulation rate of the stimulation therapy (Smyth, paragraphs [0068]-[0069]) .
Therefore, it would have been obvious to one of ordinary skill in the art of coordinating electrical and drug therapies to treat a condition of a recipient at the time of the filing to modify the method of Zenisek to include in response to the first symptom parameter being equal to or greater than the second symptom parameter, decreasing a dosage level of the medication schedule and increase a stimulation parameter for the electrostimulation schedule, as taught by Zenisek and Smyth, in order to effectively treat the condition while maintaining treatment effectiveness and avoiding causing potential side effects and/or other discomfort to the recipient (Smyth, paragraph [0024]) and because decreasing a dosage level of a medication schedule and increasing a stimulation parameter for the electrostimulation schedule would have been obvious to trey. When faced with the problem using effectiveness of the medications and stimulation to titrate the medication and stimulation values to help optimize the therapy and/or outcome as identified in Zenisek, with the finite number of identified solutions to titrate the medication and stimulation values, including increasing or decreasing amount of a drug delivery, a concentration of a drug delivery, and/or a frequency of drug delivery, changing the drug, increasing or decreasing a stimulation level and/or a stimulation rate and adjusting the stimulation locations identified in Smyth, one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zenisek et al. (U.S. Pub. No. 2023/0012100) in view of Gerber et al. (U.S. Pub. No. 2007/0255322).
Regarding claim 9, Zenisek further discloses prompting a patient for information to determine symptoms (Paragraph [0146]). Zenisek does not appear to explicitly disclose, but Gerber teaches that it was old and well known in the art of electrical stimulation therapy at the time of the filing to include sending an inquiry to the patient on a specified schedule to determine (Gerber, paragraph [0089], a patient programmer 14 may be equipped to elicit and accept user input specifying efficacy ratings at scheduled intervals.):
whether additional symptoms have occurred since a last inquiry (Gerber, paragraph [0093], As shown in FIG. 8, the efficacy profiler user interface permits a user (patient and/or clinician) to select efficacy parameters from a list of parameters. For example, the user may click on a checkbox or radio button 90 to select individual parameters from the list of efficacy parameters. In some embodiments, a user may be required to select a minimum number of efficacy parameters. Also, in some embodiments, a user may be required to select no more than a maximum number of efficacy parameters. The process of FIGS. 8 and 9 may be generally referred to as efficacy profiling in that it permits the user to customize a list of efficacy parameters for a particular patient, thereby profiling the efficacy to the patient. Paragraph [0094], As an illustration, for a urinary incontinence application, the efficacy parameters may include incontinent episodes, urination frequency, nocturia, undesirable paresthesia, pain, retention, sexual dysfunction, and battery consumption rate. In some embodiments, the user may be permitted to add one or more efficacy parameters, beyond the list of parameters initially presented for selection. Also see paragraph [0038].); and
in response to additional symptoms occurring, a severity of the additional symptoms (Gerber, paragraph [0008], specify… severity index. Paragraph [0116], Presentation of efficacy parameter values as negative values relative to a baseline may be more intuitive to some users, e.g., indicating that the severity of a baseline condition is being reduced. Accordingly, the display of stimulation parameter values with a positive or negative orientation may be an option for the user.) so that efficacy and associated stimulation parameters can be customized to individual patient desires (Gerber, paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art of electrical stimulation therapy at the time of the filing to modify the method of Zenisek to include sending an inquiry to the patient on a specified schedule to determine: whether additional symptoms have occurred since a last inquiry; and in response to additional symptoms occurring, a severity of the additional symptoms, as taught by Gerber, in order to allow efficacy and associated stimulation parameters to be customized to individual patient desires.
Regarding claim 10, Zenisek does not appear to explicitly disclose, but Gerber teaches that it was old and well known in the art of electrical stimulation therapy at the time of the filing sending an inquiry to the patient to sort their experience of each of a plurality of symptoms experienced (Gerber, paragraph [0068], The efficacy input may take a variety of forms, including numeric values, rankings, symbolic selections, color selections, or the like. Paragraph [0007], , the patient may rank the importance of the parameters as (1) nocturia, (2) incontinent episodes, and (3) frequency.) so that efficacy and associated stimulation parameters can be customized to individual patient desires (Gerber, paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art of electrical stimulation therapy at the time of the filing to modify the method of Zenisek to include sending an inquiry to the patient to sort their experience of each of a plurality of symptoms experienced, as taught by Gerber, in order to allow efficacy and associated stimulation parameters to be customized to individual patient desires.
Regarding claim 11, Zenisek does not appear to explicitly disclose, but Gerber teaches that it was old and well known in the art of electrical stimulation therapy at the time of the filing wherein the inquiry sent to the patient comprises a request for a preference of which of the plurality of symptoms to alleviate to which degree (Gerber, paragraph [0007], the patient may rank the importance of the parameters as (1) nocturia, (2) incontinent episodes, and (3) frequency. Paragraph [0094], For each parameter, the user specifies a weighting value to indicate the relative importance of the efficacy parameter in the overall efficacy rating on a patient-individualized basis.) so that efficacy and associated stimulation parameters can be customized to individual patient desires (Gerber, paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art of electrical stimulation therapy at the time of the filing to modify the method of Zenisek such that the inquiry sent to the patient comprises a request for a preference of which of the plurality of symptoms to alleviate to which degree, as taught by Gerber, in order to allow efficacy and associated stimulation parameters to be customized to individual patient desires.
Claims 13 are rejected under 35 U.S.C. 103 as being unpatentable over Zenisek et al. (U.S. Pub. No. 2023/0012100)in view of Probst et al. (U.S. Pub. No. 2020/0251525).
Regarding claim 13, Zenisek does not appear to explicitly disclose, but Probst teaches that it was old and well known in the art of electrical stimulation therapy at the time of the filing wherein the stimulation data comprises at least one of hypodopaminergic syndrome, hypomania, psychosis (Probst, paragraph [0033], High excursions such as point 210 may be associated with motor or cognitive side-effects, such as dyskinesias, psychosis, changes in mood or mental state, or aggressive behavior, as well as a wide range of common systemic side effects including abnormal heart rhythm, difficult or painful urination, excessive nausea or vomiting, or hypotension.. Paragraph [0040], At point 220, monitoring of the patient's blood-drug concentration indicates that the patient's blood L-Dopa concentration is rising and an algorithm determines the concentration may exceed the upper limit 204 and cause the patient to experience side effects. In response, the closed loop system may automatically reduce the electrical stimulation setting to reduce the effect of the electrical stimulation, shifting the brain's tuning parameters to the drug concentration, and thereby increase upper limit 204 (see second area 222) or may recommend to a patient or provider to reduce the electrical stimulation setting.) to alleviate concerns related to high blood-drug concentration side-effect (Probst, paragraph [0038]).
Therefore, it would have been obvious to one of ordinary skill in the art of electrical stimulation therapy at the time of the filing to modify the method of Zenisek such that the stimulation data comprises at least one of hypodopaminergic syndrome, hypomania, psychosis, as taught by Probst, in order to alleviate concerns related to high blood-drug concentration side-effect.
Conclusion
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/DEVIN C HEIN/Examiner, Art Unit 3686
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