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 (IDS) filed on 3/5/2024 has been considered by examiner.
Drawings
The drawings are objected to because in Fig. 5 Calandar is misspelled in drawing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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 19 is 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.
Dependent claim 19 is understood to require both control circuitry and an implantable medical device. However, independent claim 11 requires only the control circuitry, and does not positively recite the implantable medical device as being provided as part of the method. The implantable medical device is recited only such that the instruction is intended “for an implantable medical device”. This claim is rendered indefinite because it does not clearly define the elements that are required by the limitation. Therefore, it is the inability to clearly determine the necessary elements which make it impossible to determine the metes and bounds.
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 non-statutory subject matter of abstract ideas under the mental processes grouping, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 1, 16, and 17 are directed to a system or a method, and thus, the claims all fall under one of the four patent eligible categories.
To Step 2(a) prong 1:
Independent claims 1, 11, and 20 recite:
“identify an instruction for the implantable medical device to set or adjust the
stimulation provided at the plurality of electrodes or an operational mode of the implantable medical device”
“determine whether the instruction complies with one or more instruction rules”
“execute the instruction to set or adjust the stimulation or the operational
mode when the control circuitry determines that the instruction is compliant with the one or more instruction rules”
Under the broadest reasonable interpretation, these limitations require identification of instructions or commands, validation of instructions or commands, and application of validated instructions or commands. These limitations are a process that can be practically performed in the mind through a series of observations, calculations, and/or judgements.
For example, a person may identify stimulation instructions through observations made from a user interface. That person may validate the identified stimulation instructions by mentally comparing them to rules or predefined threshold values. This person can then apply or execute these validated stimulation instructions through the user interface. Accordingly, claims 1, 11, and 20 are directed to a judicial exception including one or more abstract ideas under mental processes.
Dependent claims 2 and 12 recite additional limitations for rejecting instructions that are not compliant. This limitation is also directed to a judicial exception including one or more abstract ideas under mental processes.
Dependent claims 3, 4, 13, and 14 recite additional limitations for rejecting instructions that are not compliant with firewall rules and/or comprised of packet, stateful, or application rules. These limitations are also directed to a judicial exception including one or more abstract ideas under mental processes.
Dependent claims 5-8 and 15-18 recite additional limitations for specifying types of stimulation or operational mode settings or adjustments, percentage changes in stimulation amplitude and stimulation amplitude over time, and amount of change of a parameter of stimulation that are not allowable. These limitations are also directed to a judicial exception including one or more abstract ideas under mental processes.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 1, 9-11, and 20 recite additional elements of “implantable medical device comprising electrodes”, “control circuitry”, and “antenna” but they merely define the general field of use and/or cover performance of abstract mental processes using generic computer elements. These elements do not improve upon any technology, technical field, or effect a particular treatment.
Under its broadest reasonable interpretation, the control circuitry identifies instructions from data sent to the implantable medical device, validates these instructions for compliance, then executes valid instructions. The control circuitry is understood to act as an intermediary filter which allows or blocks the instructions or signals. Examiner does not interpret the control circuitry to directly set or adjust stimulation or operational modes but rather to block or allow transmission of the previously sent instructions.
Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). See MPEP 2106.04(a)(2)(III).
Furthermore, generic computer components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “implantable medical device comprising electrodes” and “control circuitry” amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.Under Step 2b: These 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 judicial exception into a practical application, these additional elements or any combination thereof do not improve technology or a technical field. The control circuitry is a generic computer that is used to perform and/or apply mental processes. The antenna is a generic computer element within the implantable medical deviceand merely receives instructions. Applicants do not provide any additional information in the written description regarding “implantable medical device” or “electrodes.” Applicants also recite the benefits of using well-known mobile devices such as cell phones and tablets as external controllers [0008] and “antenna” within the context of mobile devices [0033]. Therefore, these elements must be well-understood, routine, and conventional activity to enable one of ordinary skill to practice the claimed invention.
In addition, these elements in the field of electrostimulation are well-understood, routine, and conventional activities previously known in the industry as indicated in the following references:
US 2002/0022866 A1: See [0003] for implantable medical device comprising electrodes and antenna
US 2003/0153953 A1: See [0077] for control circuitry; “The processor 460 can be implemented as any suitable control device such as a microcontroller, a controller, a microprocessor, a central processing unit, a signal processor, a digital signal processor, a state machine, a control logic, discrete control circuitry, or any similar control circuitry… Usage of microprocessor-based control circuits for performing timing and data analysis functions are well known by those having ordinary skill in the art.”
US 2009/0024187 A1: See [0084] for well-known devices and wireless communication (antenna); “For example, external interface platform 140 of embodiments of the present invention comprise a personal digital assistant (PDA), such as a pocket PC operable under control of the WINDOWS CE operating system, as are well known in the art.”
US 2010/0222844 A1: See [0038] for antenna;
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.
(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.
Claim(s) 1-4, 11-14, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tahmasian et al (US Pre Grant Publication 2012/0215285).
Regarding claims 1, 11, and 20, Tahmasian teaches a system, comprising:
an implantable medical device (100) [Fig. 1, 3] comprising a plurality of
electrodes (106) selectable to provide stimulation to a patient’s tissue (Fig. 1, [0042]; “For example, upon selecting 930, the patient may change the electrodes 106 (FIG. 1A) through which stimulation is being delivered.”);
control circuitry (Bridge 300 at least Firewall 1000) [Fig. 10] configured to
identify an instruction for the implantable medical device to set or adjust
the stimulation provided at the plurality of electrodes or an
operational mode of the implantable medical device (Fig. 10,
[0055]; examines commands received),
determine whether the instruction complies with one or more instruction
rules (Fig. 10, [0055]; validates each command), and
execute the instruction to set or adjust the stimulation or the operational
mode when the control circuitry determines that the instruction is compliant with the one or more instruction rules (Fig. 10, [0055]; valid commands without unsafe conditions executed by IPG 100).
Regarding claims 2 and 12, Tahmasian teaches the system of claim 1, and further teaches that wherein the control circuitry is configured to reject the instruction if it is not compliant with the one or more instruction rules ([0055]; “Commands that would put the IPG 100 into an unsafe condition may be rejected or possibly modified to avoid the unsafe condition.”).
Regarding claims 3 and 13, Tahmasian teaches the system of claim 1, and teaches the system wherein the control circuitry is further configured to determine whether the instruction is compliant with one or more firewall rules [0052].
Regarding claims 4 and 14, Tahmasian teaches the system of claim 3, and further teaches a system wherein the one or more firewall rules comprise one or more packet, stateful, or application rules [0053-0055].
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 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.
Claim(s) 5, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tahmasian et al (US Pre Grant Publication 2012/0215285) in view of Kaula et al (US Pre Grant Publication 2014/0343628).
Regarding claim 5, Tahmasian teaches the system of claim 1 but fails to teach a type of stimulation setting or adjustment, or an operational mode setting or adjustment that is not allowable.
However, Kaula teaches a method and device for electrostimulation including a safety control feature that dynamically adjusts maximum stimulation current and electrode contact configuration based on factors such as number of contacts, pulse width, or frequency. These control limits prevent the user from adjusting parameters beyond a predefined maximum setting and necessarily specifies a range of values that are not allowed [0104]. In addition, Kaula teaches the display of a warning message when the electrode contact configuration violates lead control limits such as “Contact change would violate lead limits. Reduce program's amplitude or pulse limits or add contacts," further specifying settings and/or adjustments that are not allowed [0105].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Tahmasian with the safety control features to limit stimulation and operational mode settings and/or adjustments as taught by Kaula. One of ordinary skill in the art would have been motivated to make this modification to reduce the likelihood of causing inadvertent pain and discomfort for the patient (Kaula, [0104]).
Regarding claim 15, Tahmasian teaches the method of claim 11 but fails to teach a type of stimulation setting or adjustment, or an operational mode setting or adjustment that is not allowable.
However, Kaula teaches a method for electrostimulation including a safety control feature that dynamically adjusts maximum stimulation current and electrode contact configuration based on factors such as number of contacts, pulse width, or frequency. These control limits prevent the user from adjusting parameters beyond a predefined maximum setting and necessarily specifies a range of values that are not allowed [0104]. In addition, Kaula teaches the display of a warning message when the electrode contact configuration violates lead control limits such as “Contact change would violate lead limits. Reduce program's amplitude or pulse limits or add contacts," further specifying settings and/or adjustments that are not allowed [0105].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Tahmasian with the safety control features to limit stimulation and operational mode settings and/or adjustments as taught by Kaula. One of ordinary skill in the art would have been motivated to make this modification to reduce the likelihood of causing inadvertent pain and discomfort for the patient (Kaula, [0104]).
Claim(s) 6-8, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tahmasian et al (US Pre Grant Publication 2012/0215285) in view of Kaula et al (US Pre Grant Publication 2014/0343628), and further in view of Nolan et al (US Pre Grant Publication 2007/0213789).
Regarding claim 6-8, the method of Tahmasian modified by the method of Kaula, teaches the system of claim 5 but fails to teach at least one of the instruction rules that specify a percentage change in stimulation amplitude, stimulation amplitude in a period of time, and an amount of change of a parameter of the stimulation that is not allowable.
However, Nolan teaches a system and method for electrostimulation including global stimulation adjustments based on step values. Step values allow for equivalent percentage-based adjustments across multiple stimulation programs (Fig. 4B, [0057]). Global adjustments maintain the step values or percent change of various stimulation parameters or change of various stimulation parameters with respect to a range of parameter values or relative change across a plurality of programs wherein the values do not exceed or fall below a limit ([0030], [0053], [0061]). Nolan further teaches that global adjustments can be used with other stimulation parameters such as current amplitude, pulse width, pulse rate, or electrode configuration [0071].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the method of Tahmasian and Kaula with the global adjustments to limit stimulation amplitude and pulse rate by a percentage change and/or a parameter by an amount of change with respect to a range of values and/or relative change as taught by Nolan. These limits establish a threshold in which any amount of change or values outside of the threshold are not allowable. One of ordinary skill in the art would have been motivated to make this modification to reduce the number of steps and errors that could occur when a patient is adjusting a plurality of programs with varying parameter values (Nolan, [0024]). Furthermore, it has been held that, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Regarding claims 16-18, the method of Tahmasian modified by the method of Kaula, teaches the method of claim 15 but fails to teach at least one of the instruction rules that specify a percentage change in stimulation amplitude, stimulation amplitude in a period of time, and an amount of change of a parameter of the stimulation that is not allowable.
However, Nolan teaches a method for electrostimulation including global stimulation adjustments based on step values. Step values allow for equivalent percentage-based adjustments across multiple stimulation programs (Fig. 4B, [0057]). Global adjustments maintain the step values or percent change of various stimulation parameters and/or change of various stimulation parameters with respect to a range of parameter values or relative change across a plurality of programs wherein the values do not exceed or fall below a limit ([0030], [0053], [0061]). Nolan further teaches that global adjustments can be used with other stimulation parameters such as current amplitude, pulse width, pulse rate, or electrode configuration [0071].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the method of Tahmasian and Kaula with the global adjustments to limit stimulation amplitude and pulse rate by a percentage change and/or a parameter by an amount of change with respect to a range of values or relative change as taught by Nolan. These limits establish a threshold in which any amount of change or values outside of the threshold are not allowable. One of ordinary skill in the art would have been motivated to make this modification to reduce the number of steps and errors that could occur when a patient is adjusting a plurality of programs with varying parameter values (Nolan, [0024]). Furthermore, it has been held that, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tahmasian et al (US Pre Grant Publication 2012/0215285) in view of Osorio et al (US Pre Grant Publication 2004/0133119).
Regarding claim 9, Tahmasian teaches the system of claim 1 but fails to teach control circuitry within an implantable medical device.
However, Osorio teaches a fully implanted control system wherein the control system and the software methods of the control system are implemented within the implanted device [0147-0148].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Tahmasian with the implantable control system and software methods as taught by Osorio. One of ordinary skill in the art would have been motivated to make this modification to enhance the management and treatment of nervous system disorders through specific configurations of the medical device system (Osorio, [0042]).
Regarding claim 19, Tahmasian teaches the method of claim 11 but fails to teach control circuitry within an implantable medical device.
However, Osorio teaches a fully implanted control system wherein the control system and the software methods of the control system are implemented within the implanted device [0147-0148].
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the system of Tahmasian with the implantable control system and software methods as taught by Osorio. One of ordinary skill in the art would have been motivated to make this modification to enhance the management and treatment of nervous system disorders through specific configurations of the medical device system (Osorio, [0042]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11, and 20 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11925810. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader than the patent claims in at least one aspect.
Regarding claim 1, the following table compares application claim 1 to patent claim 1. The elements which are included in the application claim are underscored in the patent claim.
Instant Application 18596368
US Patent 11925810
Claim 1
Claim 1
A system, comprising: an implantable medical device comprising a plurality of electrodes selectable to provide stimulation to a patient’s tissue;
An implantable medical device, comprising: a plurality of electrodes selectable to provide stimulation to a patient's tissue
control circuitry configured to identify an instruction for the implantable medical device to set or adjust the stimulation provided at the plurality of electrodes or an operational mode of the implantable medical device,
control circuitry programmed with a filter, wherein the filter comprises: a firewall configured to: receive first data, allow the first data to pass as second data if the first data is compliant with one or more firewall rules; and an instruction analyzer configured to: identify an instruction for the implantable device in the second data, wherein the instruction is configured to set or adjust the stimulation provided at the plurality of electrodes or to set or adjust an operational mode of the implantable medical device
determine whether the instruction complies with one or more instruction rules, and execute the instruction to set or adjust the stimulation or the operational mode when the control circuitry determines that the instruction is compliant with the one or more instruction rules
determine whether the instruction complies with one or more instruction rules, wherein the control circuitry is configured to execute the instruction to set or adjust the stimulation or the operational mode when the instruction analyzer determines that the instruction is compliant with the one or more instruction rules
execute the instruction to set or adjust the stimulation or the operational mode when the control circuitry determines that the instruction is compliant with the one or more instruction rules.
wherein the control circuitry is configured to execute the instruction to set or adjust the stimulation or the operational mode when the instruction analyzer determines that the instruction is compliant with the one or more instruction rules.
Patent claim 1 further limits and/or includes additional elements which encompass application claim 1. Therefore, patent claim 1 anticipates application claim 1.
Following the rationale in In re Goodman, cited above, where applicant has been granted a patent containing a claim for the specific or narrower invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 11, the following table compares application claim 11 to patent claim 11. The elements which are included in the application claim are underscored in the patent claim.
Instant Application 18596368
US Patent 11925810
Claim 11
Claim 11
A method, comprising:
identifying using control circuitry an instruction for an implantable medical device to set or adjust a stimulation provided at one or more of a plurality of electrodes or an operational mode of the implantable medical device;
A method implemented in an implantable medical device comprising a plurality of electrodes selectable to provide stimulation to a patient's tissue, the method comprising:(a) receiving first data in the implantable medical device;
identifying an instruction for the implantable device in the second data, wherein the instruction is configured to set or adjust the stimulation provided at the plurality of electrodes or to set or adjust an operational mode of the implantable medical device;
determining using the control circuitry whether the instruction complies with one or more instruction rules; and
determining whether the instruction complies with one or more instruction rules;
executing the instruction to set or adjust the stimulation or the operational mode when instruction is compliant with the one or more instruction rules.
executing the instruction to set or adjust the stimulation or the operational mode when the instruction is compliant with the one or more instruction rules.
Patent claim 11 further limits and/or includes additional elements which encompass application claim 11. Patent claim 11 does not explicitly mention “control circuitry.” However, Examiner takes official notice that it is extremely well known in the field of electrostimulation as external and/or internal “controllers”, “processors”, or any other equivalent generic computer elements (Tahmasian, [0005], Claim 1), (Kaula, [0165]), (Nolan, [0027]) and would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to modify the method of patent claim 11 with an external and/or internal controller to program electrostimulation parameters.
Following the rationale in In re Goodman, cited above, where applicant has been granted a patent containing a claim for the specific or narrower invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Regarding claim 20, the following table compares application claim 20 to patent claim 20. The elements which are included in the application claim are underscored in the patent claim.
Instant Application 18596368
US Patent 11925810
Claim 20
Claim 20
A non-transitory computer readable medium containing programming instructions executable in control circuitry of an implantable medical device comprising a plurality of electrodes selectable to provide stimulation to a patient’s tissue, wherein the programming instruction when executed are configured to:
A non-transitory computer readable medium containing instructions executable in control circuitry of an implantable medical device comprising a plurality of electrodes selectable to provide stimulation to a patient's tissue, wherein the instruction when executed are configured to:(a) pass first data in the implantable medical device as second data if the first data is compliant with one or more firewall rules;
identify an implant instruction for an implantable medical device to set or adjust a stimulation provided at one or more of a plurality of electrodes or an operational mode of the implantable medical device;
identify an instruction for the implantable device in the second data, wherein the instruction is configured to set or adjust the stimulation provided at the plurality of electrodes or to set or adjust an operational mode of the implantable medical device;
determine whether the implant instruction complies with one or more instruction rules; and
determine whether the instruction complies with one or more instruction rules; and
executing the implant instruction to set or adjust the stimulation or the operational mode when implant instruction is compliant with the one or more instruction rules.
execute the instruction to set or adjust the stimulation or the operational mode when the instruction analyzer determines that the instruction is compliant with the one or more instruction rules.
Patent claim 20 further limits and/or includes additional elements which encompass application claim 20. Therefore, patent claim 20 anticipates application claims 20.
Following the rationale in In re Goodman, cited above, where applicant has been granted a patent containing a claim for the specific or narrower invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben 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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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792