DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 10/27/2025. Claims 1, 10, and 14-17 are currently amended. Claims 1-17 are currently pending.
3. 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.
3.1. Claims 1-17 are 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.
3.2. Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: remotely programming an implantable medical device and providing therapy to a patient. Claims are directed to a method of remotely programming an implantable medical device that provides therapy to a patient. The claims, however, do not appear to recite any limitations evidencing remotely programming an implantable medical device or providing therapy to a patient.
Claim Rejections - 35 USC § 101
4. 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.
4.1. Claims 1-17 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claim 1 and its’ respective dependent claims are directed, in part, to a method of programming an implantable medical device that provides therapy to a patient—the claims however, no longer recite any steps evidencing programming or provision of therapy.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mathematical concepts, mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1, as a whole, is directed to programming an implantable medical device that provides therapy to a patient by applying patient data to a trained neural network, calculating a probability of a correct classification operation for the patient, comparing the calculated probability to a minimum value, and displaying a patient value related to the classification operation based on part whether the calculated probability satisfies the minimum accuracy value which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper.
CLAIM 1:
A method of remotely programming an implantable medical device that provides therapy to a patient, comprising:
establishing a first communication between a patient controller (PC) device and the implantable medical device, wherein the implantable medical device provides therapy to the patient according to one or more programmable parameters, and the PC device comprises a video camera;
establishing a video connection between the PC device and a clinician programmer (CP) device of a clinician for a remote programming session in a second communication that includes an audio/video (A/V) session;
applying patient data, generated during the remote programming session, to a trained neural network;
calculating a probability of a correct classification of a classification operation for the patient according to the patient data;
comparing the calculated probability to a minimum value;
displaying, via the CP, a graphical user interface (GUI) display of a patient value related to the classification operation based at least in part on whether the calculated probability satisfies the minimum accuracy value.
CLAIM 2:
The method of claim 1 wherein the patient data includes video data of the patient.
CLAIM 3:
The method of claim 1 wherein the patient data includes physiological data sensed from the patient.
CLAIM 4:
The method of claim 1 wherein the patient data includes historical medical data of the patient.
CLAIM 5:
The method of claim 1 further comprising: superimposing one or more GUI elements over or surrounding bodily regions automatically analyzed for patient movement.
CLAIM 6:
The method of claim 5 wherein the one or more GUI elements are indicative of tremor of the patient.
CLAIM 7:
The method of claim 6 wherein the one or more GUI elements are indicative of rigidity of the patient.
CLAIM 8:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (AI) classification of patient movement.
CLAIM 9:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (AI) quantification of patient movement.
CLAIM 10:
The method of claim 1 further comprising: displaying calculated anatomical features that track patient movement over a display of the patient.
CLAIM 11:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow limb movement of the patient.
CLAIM 12:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow torso movement of the patient.
CLAIM 13:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow head movement of the patient.
CLAIM 14:
The method of claim 1 wherein the CP device is programmed to provide one or more pop-up windows to control types of patient movement for automatic analysis to generate a plurality of movement metrics.
CLAIM 15:
The method of claim 1 wherein the analyzing comprises processing sensor data from a wearable device of the patient.
CLAIM 16:
The method of claim 1 wherein the analyzing comprises processing sensor data from a smartwatch device of the patient.
CLAIM 17:
The method of claim 1 wherein the analyzing comprises processing sensor data from a device implanted within the patient.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
Furthermore, calculating a probability of a correct classification of a classification operation for the patient according to the patient data is considered a mathematical concept. As such, this claims can be also categorized under the abstract grouping of mathematical concepts.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., implantable medical device, a patient controller device, a trained neural network, GUI, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, while the claims are directed to a method of remotely programming an implantable medical device that provides therapy to a patient, the claims do not appear to recite any limitations that evidence active programming of the medical device or any active provision of therapy to the patient. Rather, the claims are not primarily directed to using a trained neural network to perform steps that could otherwise be performed by a human (i.e., calculating a probability, comparing the calculated probability to a minimum value, displaying a patient value, etc.). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0052]-[0053] of applicant's specification (US 2024/0382770) recites that the system/method is implemented using devices such as smartphones, tablets or phablets, laptops/desktops, handheld/palmtop computers, wearable devices such as smart glasses and smart watches, personal digital assistant (PDA) devices, smart digital assistant devices, etc., any of which may operate in association with one or more virtual assistants, smart home/office appliances, smart TVs, external/auxiliary AV equipment, virtual reality (VR), mixed reality (MR) or augmented reality (AR) devices, and the like, which are generally exemplified by wearable device(s) 106, smartphone(s) 108, tablet(s)/phablet(s) 110, computer(s) 112, and AV equipment 114 which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). 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 improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Double Patenting
5. 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.
5.1. Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,076,552. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim(s) is/are either anticipated by, or would have been obvious over, the reference claim(s) because all of the limitations of claims 1-17 of instant pending patent application 18/782572 correspond to limitations recited in claims 1-17 of U.S. Patent 12,076,552. Any claim limitation differences are not substantively significant and/or are obvious under a broad and reasonable interpretation, as detailed in the comparison chart below.
PENDING CLAIMS (18/782572)
US PATENT 12076552
CLAIM 1:
A method of remotely programming an implantable medical device that provides therapy to a patient, comprising:
establishing a first communication between a patient controller (PC) device and the implantable medical device, wherein the implantable medical device provides therapy to the patient according to one or more programmable parameters, and the PC device comprises a video camera;
establishing a video connection between the PC device and a clinician programmer (CP) device of a clinician for a remote programming session in a second communication that includes an audio/video (A/V) session;
applying patient data, generated during the remote programming session, to a trained neural network;
calculating a probability of a correct classification of a classification operation for the patient according to the patient data;
comparing the calculated probability to a minimum value;
displaying, via the CP, a graphical user interface (GUI) display of a patient value related to the classification operation based at least in part on whether the calculated probability satisfies the minimum accuracy value.
CLAIM 1:
A method of remotely programming an implantable medical device that provides therapy to a patient, comprising:
establishing a first communication between a patient controller (PC) device and the implantable medical device, wherein the implantable medical device provides therapy to the patient according to one or more programmable parameters, the PC device communicates signals to the implantable medical device to set or modify the one or more programmable parameters, and the PC device comprises a video camera;
establishing a video connection between the PC device and a clinician programmer (CP) device of a clinician for a remote programming session in a second communication that includes an audio/video (NV) session;
communicating a value for a respective programmable parameter of the implantable medical device from the CP device to the PC device during the remote programming session; and
modifying, by the PC device, the respective programming parameter of the implantable medical device according to the communicated value from the CP device during the remote programming session;
wherein the method further comprises:
automatically analyzing, by one or more processors, patient data generated during the remote programming session;
applying the patient data to a trained neural network to perform a classification operation;
calculating a probability of a correct classification of the classification operation for the patient according to the patient data;
comparing the calculated probability to a minimum accuracy value;
displaying, via the CP device during the remote programming session, a graphical user interface (GUI) display of a patient value related to the classification operation when the calculated probability satisfies the minimum accuracy value.
CLAIM 2:
The method of claim 1 wherein the patient data includes video data of the patient.
CLAIM 2:
The method of claim 1 wherein the patient data includes video data of the patient.
CLAIM 3:
The method of claim 1 wherein the patient data includes physiological data sensed from the patient.
CLAIM 3:
The method of claim 1 wherein the patient data includes physiological data sensed from the patient.
CLAIM 4:
The method of claim 1 wherein the patient data includes historical medical data of the patient.
CLAIM 4:
The method of claim 1 wherein the patient data includes historical medical data of the patient.
CLAIM 5:
The method of claim 1 further comprising: superimposing one or more GUI elements over or surrounding bodily regions automatically analyzed for patient movement.
CLAIM 5:
The method of claim 1 further comprising: superimposing one or more GUI elements over or surrounding bodily regions automatically analyzed for patient movement.
CLAIM 6:
The method of claim 5 wherein the one or more GUI elements are indicative of tremor of the patient.
CLAIM 6:
The method of claim 5 wherein the one or more GUI elements are indicative of tremor of the patient.
CLAIM 7:
The method of claim 6 wherein the one or more GUI elements are indicative of rigidity of the patient.
CLAIM 7:
The method of claim 6 wherein the one or more GUI elements are indicative of rigidity of the patient.
CLAIM 8:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (Al) classification of patient movement.
CLAIM 8:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (AI) classification of patient movement.
CLAIM 9:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (Al) quantification of patient movement.
CLAIM 9:
The method of claim 5 wherein the one or more GUI elements are modified according to an artificial intelligence (AI) quantification of patient movement.
CLAIM10:
The method of claim 1 further comprising: displaying calculated anatomical features that track patient movement over a display of the patient.
CLAIM 10:
The method of claim 1 further comprising: displaying calculated anatomical features that track patient movement over a display of the patient in a first mode of operation.
CLAIM 11:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow limb movement of the patient.
CLAIM 11:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow limb movement of the patient.
CLAIM 12:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow torso movement of the patient.
CLAIM 12:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow torso movement of the patient.
CLAIM 13:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow head movement of the patient.
CLAIM 13:
The method of claim 10 wherein the calculated anatomical features comprise one or more features that follow head movement of the patient.
CLAIM 14:
The method of claim 1 wherein the CP device is programmed to provide one or more pop-up windows to control types of patient movement for automatic analysis to generate a plurality of movement metrics.
CLAIM 14:
The method of claim 1 wherein the CP device is programmed to provide one or more pop-up windows to control types of patient movement for automatic analysis to generate a plurality of movement metrics.
CLAIM 15:
The method of claim 1 wherein the analyzing comprises processing sensor data from a wearable device of the patient.
CLAIM 15:
The method of claim 1 wherein the automatically analyzing comprises processing sensor data from a wearable device of the patient.
CLAIM 16:
The method of claim 1 wherein the analyzing comprises processing sensor data from a smartwatch device of the patient.
CLAIM 16:
The method of claim 1 wherein the automatically analyzing comprises processing sensor data from a smartwatch device of the patient.
CLAIM 17:
The method of claim 1 wherein the analyzing comprises processing sensor data from a device implanted within the patient.
CLAIM 17:
The method of claim 1 wherein the automatically analyzing comprises processing sensor data from a device implanted within the patient.
Conclusion
6. 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 Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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