DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 3/5/2024 has been considered by examiner.
Response to Arguments
Applicant’s arguments, see page 6; I line 1, filed 6/3/2026, with respect to Drawings Objections have been fully considered and are persuasive. The drawing objection of Fig. 5 has been withdrawn.
Applicant’s arguments, see page 6; II line 1, filed 6/3/2026, with respect to claim 19 have been fully considered and are persuasive. The 112(b) rejection of claim 19 has been withdrawn.
Applicant's arguments with respect to claims 1, 11, and 20 have been fully considered but they are not persuasive. Applicant argues that control circuitry is a component of the implantable medical device and, as a result, the claimed process cannot be performed in the mind. Examiner acknowledges that amendments to claims 1 and 11 require control circuitry in the implantable device to perform the claimed processes but respectfully disagrees that the claimed processes cannot be performed in the mind. The claimed processes performed by the control circuitry within the implantable medical device is not distinct from control circuitry configured to perform the claimed processes under 35 U.S.C. 101.
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").
In addition, with reference to MPEP 2106.04(d), the Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’).
With respect to claims 1 and 11, the additional element of control circuitry and step of “execute the instruction to set or adjust the stimulation or the operational mode” does not integrate into a practical application in light of Gottschalk v. Benson. Furthermore, execution of the instruction to set or adjust stimulation or operational modes does not preclude these steps from being performed by a human, mentally, or with pen and paper, in light of Intellectual Ventures I LLC v. Symantec Corp. Therefore, the 101 rejection for claims 1 and 11 is maintained.
With respect to claim 20, examiner acknowledges that the control circuitry is a component of the implantable medical device but respectfully disagrees that the claimed process cannot be performed in the mind. Claim 20 does not integrate into a practical application for at least the same reasons as claims 1 and 10. Therefore, the 101 rejection for claim 20 is maintained.
The terminal disclaimer filed on 6/3/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,925,810 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1 and 11 under 35 U.S.C 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C 103 in view of Polefko et al (US Pre Grant Publication 2013/0166642 A1). Polefko discloses a system and a method for transmitting and validating instructions for implantable medical devices ([0002], [0021]).
Applicant's arguments with respect to the rejection of claim 20 under 35 U.S.C 102 has been fully considered but is not persuasive. Applicant argues that the claimed process performed by the control circuitry within the implantable medical device is not anticipated by Tahmasian. Examiner acknowledges that Tahmasian does not anticipate the claimed process performed by control circuitry within the IMD but respectfully disagrees that this is a required limitation.
Under broadest reasonable interpretation, claim 20 only requires a device capable of executing programming instructions in the control circuitry of an implantable medical device. Tahmasian discloses IPG (200, Fig. 2) and various electronic components (220, Fig. 2) such as a microcontroller and integrated circuits [0006]. One of ordinary skill in the art would be reasonably apprised to determine IPG control circuitry (220) as capable of executing said programming instructions. The claim does not positively recite a processor or any structure for execution of the instructions and therefore does not preclude the use of the instructions being operable on a smartphone or other structure as taught by Tahmasian. Therefore, the rejection regarding claim 20 is maintained.
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 1-8, 10-18, and 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 device and 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polefko et al (US Pre Grant Publication 2013/0166642 A1).
Regarding claims 1, 11 Polefko teaches a system, comprising:
an implantable medical device (101, Fig. 1A) comprising a plurality of
electrodes (135, Fig. 1B) selectable to provide stimulation to a patient’s tissue (0023], Fig. 1B; “…to deliver the intended therapeutic effects of spinal cord electrical stimulation in a desired region of the spine 140.”);
control circuitry ([0021], Fig. 1A) within the implantable medical device (101, Fig.
1A) configured to
identify an instruction for the implantable medical device ([0003];
datablocks) to set or adjust the stimulation provided at the plurality of electrodes ([0021]; control parameters govern operation of implanted device) or an operational mode of the implantable medical device (optional),
determine whether the instruction complies with one or more instruction
rules ([0040], Fig. 4; checksum values (step 405) verified); and
execute the instruction to set or adjust the stimulation or the operational
mode (optional) when the control circuitry determines that the instruction is compliant with the one or more instruction rules ([0021]; IMD executes instructions stored in memory 105, [0042], Fig. 4; process message 419).
Regarding claims 2 and 12, Polefko 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 ([0040], Fig. 4; checksum values (step 405) not valid then error (step 407)).
Regarding claims 3 and 13, Polefko 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 ([0041], Fig. 4; step 409 determines if device ID recognized by IMD; equivalent function to firewall).
Regarding claims 4 and 14, Polefko teaches the system of claim 3, and further teaches a system wherein the one or more firewall rules comprise one or more packet ([0025], Fig. 4; data block equivalent function to data packets), stateful, or application rules.
Claim(s) 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 claim 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).
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 Polefko et al (US Pre Grant Publication 2013/0166642 A1), in view of Kaula et al (US Pre Grant Publication 2014/0343628).
Regarding claim 5, Polefko 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 Polefko 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, Polefko 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 Polefko 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 Polefko et al (US Pre Grant Publication 2013/0166642 A1) 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 Polefko 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 Polefko 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 Polefko 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 Polefko 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/William J Levicky/Primary Examiner, Art Unit 3796
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