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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on December 12, 2025 is acknowledged. The traversal is on the ground that it would not be a serious burden to examine all the claims 1-39. This is found persuasive. Therefore, the requirement for restriction has been withdrawn. Claims 1-39 are pending in the application, and claims 1-39 will be examined here within.
Specification
The use of the term “Wi-Fi”, “Bluetooth”, and “Zigbee”, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
in ¶[0116]: “Wi-Fi” should be “WI-FI®”;
in ¶[0116]: “Bluetooth” should be “BLUETOOTH®”; and
in ¶[0116]: “Zigbee” should be “ZIGBEE®”.
Appropriate correction is required.
Claim Objections
Claims 19, 24-25, and 32 are objected to because of the following informalities:
in claim 19, line 3: “via” should be inserted before “communication”;
in claim 24, line 3: “generated” should be inserted before “stimulus”;
in claim 25, line 1: “generated” should be inserted before “stimulus”; and
in claim 32, line 2: “the” should be inserted before “biometric”.
Appropriate correction is required.
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.
Claims 6-11, 17, 19-20, 29-36, and 39 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.
Claim 6 recites “an electronic device” in line 6, but it is not clear if this recitation is the same as, related to, or different from the recitation “an electronic device” in claim 1, lines 20-21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electronic device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 6 recites “a medical specialist” in lines 6-7, but it is not clear if this recitation is the same as, related to, or different from the recitation “a medical specialist” in claim 1, line 21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the medical specialist”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 7-8 are rejected by virtue of their dependence from claim 6.
Claim 9 recites “a medical specialist” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a medical specialist” in claim 1, line 21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the medical specialist”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 10 recites “a medical specialist” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a medical specialist” in claim 1, line 21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the medical specialist”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 11 recites “a medical specialist” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a medical specialist” in claim 1, line 21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the medical specialist”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 17 recites “a user terminal” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a user terminal” in claim 1, line 20. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the user terminal”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 19 recites “a user terminal” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “a user terminal” in claim 1, line 20. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the user terminal”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 20 is rejected by virtue of its dependence from claim 19.
Claim 19 recites “an electronic device” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “an electronic device” in claim 1, lines 20-21. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electronic device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 29 recites the limitation “the biometric information” in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. Deleting “the” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claims 30-34 are rejected by virtue of their dependence from claim 29.
Claim 30 recites “an electronic device” in line 6, but it is not clear if this recitation is the same as, related to, or different from the recitation “an electronic device” in claim 29, line 16. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electronic device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 32 recites “an electronic device” in line 4, but it is not clear if this recitation is the same as, related to, or different from the recitation “an electronic device” in claim 29, line 16. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the electronic device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claims 33-34 are rejected by virtue of their dependence from claim 32.
Claim 35 recites “a stimulus” in line 16, but it is not clear if this recitation is the same as, related to, or different from the recitation “a stimulus” in line 12. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the stimulus”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 35 recites “an internal device” in line 23, but it is not clear if this recitation is the same as, related to, or different from the recitation “an internal device” in line 8. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the internal device”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 36 is rejected by virtue of its dependence from claim 35.
Claim 39 recites “a user terminal” in line 21, but it is not clear if this recitation is the same as, related to, or different from the recitation “a user terminal” in line 2. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the user terminal”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
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 1-17, 21, 29-30, 32-34, and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification’s identification, the recitation “determining, based on the biometric information received, whether an urgent action is required to treat a disease or a symptom of the user” (see specification ¶[0085]) is being interpreted as observations, judgements and/or opinions. The recitation “generating, based on the received biometric information, of a stimulus information” (see specification ¶[0098]-[0100]) is being interpreted as observations, judgements and/or opinions.
Claim 29 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification’s identification, the recitation “generating control information in response to an input by a user or a medical specialist diagnosing the user” (see specification ¶[0098]-[0100]) is being interpreted as observations, judgements and/or opinions. The recitation “an urgent action being determined required in a determination” (see specification ¶[0085]) is being interpreted as observations, judgements and/or opinions.
Claim 39 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification’s identification, the recitation “generating control information in response to an input by a user or a medical specialist diagnosing the user” (see specification ¶[0098]-[0100]) is being interpreted as observations, judgements and/or opinions. The recitation “an urgent action being determined required in a determination” (see specification ¶[0085]) is being interpreted as observations, judgements and/or opinions.
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claims 1 and 29 recite a method, which is directed towards a process (a statutory category of invention). Claim 39 recites a system, which is directed towards a machine and/or a manufacture (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, observations, judgements and/or opinions for an urgent action determination and stimulus operation generation. Accordingly, the limitations as seen in claims 1, 29, and 39 recite judicial exceptions (abstract ideas that fall within the mental process grouping).
Claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a medical device method, the method comprising:
receiving biometric information of the user;
determining, based on the biometric information received, whether an urgent action is required to treat a disease or a symptom of the user;
selectively performing: a generating, based on the received biometric information, of a stimulus information; and
the stimulus information configured to specify a stimulus;
and wherein the selective performing of the generating of the stimulus information: in response to the urgent action being determined required as a result of the determining of whether the urgent action is required, selecting to perform the generating of the stimulus information; and
in response to the urgent action being determined not required as the result of the determining of whether the urgent action is required, selecting to not perform the generating of the stimulus information and transmitting,
wherein the generating of the stimulus information includes generating the stimulus information to include stimulus characteristics to be used to derive the stimulus.
Claim 29 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a medical device method, the method comprising:
generating control information in response to an input by a user or a medical specialist diagnosing the user,
the control information being configured to cause to derive and first stimulus information; and
wherein the generating of the control information includes deriving the control information based on the input by the user or the medical specialist,
wherein second stimulus information is generated in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device, of whether the urgent action is required to treat a disease or symptom of the user, and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted.
Claim 39 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
generating control information in response to an input by a user or a medical specialist diagnosing the user,
the control information being configured to cause to derive, and
wherein the generation of the control information includes a derivation of the control information based on the input by the user or the medical specialist,
wherein second stimulus information is generated in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device, of whether the urgent action is required to treat a disease or symptom of the user, and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claims 1, 29, and 39 recite an internal device and an external device; however, those elements are not positively recited in those claims. Claims 29 and 39 recite a user terminal; however, the user terminal is not positively recited in claim 29. Claims 1 and 29 recite no other element that may serve as integration into a practical application. The user terminal is positively recited in claim 39, but only includes a data transceiver and a controller, such components are, and as indicated in the specification, may be implemented as a generic computer (see specification ¶[0078]). Thus, the system merely uses a generic computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, the claims recite additional elements which are directed towards the gathering/input of data, and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. These elements/steps can be seen as well-understood, routine, and conventional individually and in combination. Claims 1, 29, and 39 recite an internal device and an external device; however, those elements are not positively recited in those claims. Claims 29 and 39 recite a user terminal; however, the user terminal is not positively recited in claim 29. Claims 1 and 29 recite no other element that may amount to significantly more than the recited exceptions. The user terminal is positively recited in claim 39, but only includes a data transceiver and a controller, such components are, and as indicated in the specification, may be implemented as a generic computer (see specification ¶[0078]). Thus, the user terminal (generic computer) does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well- understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Step 2B: NO.
Claims 1, 29, and 39 are NOT eligible.
Claims 2-17; and 30 and 32-24 depend from claims 1 and 29, respectively, and merely further define the abstract idea of claims 1 and 29. Claim 21 recites additional elements (i.e., the non-transitory computer-readable storage medium storing instructions and the processor) directed towards a generic computer and/or computer-readable medium. The claims recite no element that integrates the judicial exceptions into a practical application. The method/devices are merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea – see MPEP 2106.04(d) and MPEP 2106.05(f). The claims recite no element that adds an inventive concept to the claim and/or amounts to significantly more than the recited exception. The method/devices utilizing a generic computer do not qualify as significantly more because these limitations are simply appending well- understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
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, 3, 5-12, and 15-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,738,191 in view of Gilson et al. (US Patent 9,278,208 – cited by Applicant), hereinafter Gilson.
Regarding Claims 1, 3, 5-12, and 15-34, patented claims 1-4 teach every element of pending claims 1, 3, 5-12, and 15-34, except the urgent action determination and subsequent actions.
Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device method (see abstract; Figs. 5a-5b and 10-10b), the method comprising:
receiving biometric information (col. 6 ln. 27-35, the method includes recording and transmitting physiological data), by an external device external to a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), of the user from an internal device within the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13);
determining, based on the biometric information, whether an urgent action is required to treat a disease or a symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b);
selectively performing:
a generating, based on the received biometric information, of a stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
a wirelessly transmitting to the internal device (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes):
of the stimulus information configured to specify a stimulus (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes); and
power configured to drive the internal device (col 11 ln. 19-32, the batteries, which are wirelessly recharged); and
wherein the selective performing of the generating of the stimulus information and the wireless transmitting includes:
in response, selecting to perform the generating of the stimulus information and the wireless transmitting (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b); and
in response to the urgent action being determined not required as the result of the determining of whether the urgent action is required, selecting to not perform the generating of the stimulus information and the wireless transmitting and transmitting the biometric information to a user terminal controlled by the user and/or an electronic device controlled by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b),
wherein the generating of the stimulus information includes generating the stimulus information to include stimulus characteristics to be used by the internal device to derive the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s));
applying the generated stimulus to the body of the user through a plurality of electrodes arranged at different positions in the body of the user (see Gilson col. 6 ln. 36-57 and col. 10 ln. 4-50, the stimulation provided via electrodes 40-70, see also Fig. 10b, the electrodes 40-70 are at different positions);
the applying of the generated stimulus to the user through the plurality of electrodes arranged at the different positions in the body of the user comprises applying the stimulus through a number of electrode pairs including an anode electrode and a cathode electrode (col. 15 ln. 22-28 and 51-65, the electrodes are implemented as anodes and cathodes, the pairs (a cathode and an anode)), wherein the number of electrode pairs is equal to or greater than a number of channels of the stimulus (col. 15 ln. 22-28 and 51-65, the electrodes may be switched between sensing/transmitting, indicating the channels of stimulus corresponds to the number of electrode pairs);
the applying of the stimulus through the number of electrode pairs includes variably changing the anode electrode and the cathode electrode included in each of the electrode pairs based on the stimulus information (col. 15 ln. 22-28, the physician may control/adjust based on the monitoring, including switching electrodes between anodes and cathodes);
the internal device is located between a skull and a scalp of the user (col. 6 ln. 4-26 and col. 9 ln. 9-18, the hole cap 20 mounted as a cap on top of the skull; Figs. 5a-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the implanted device with urgent action determination and subsequent actions of Gilson with the patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) switching between the two modes would not overload the circuit components and maximizes power usage during operation (see Gilson col. 10 ln. 40-43).
Claims 2, 13-14, and 35-38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,738,191 in view of Gilson as applied to claim 1 above, respectively, and in view of Greenberg et al. (US Patent Application Publication 2015/0157862), hereinafter Greenberg.
Regarding Claims 2 and 13-14, the modified patented claims 1-4 teach every element of pending claims 2 and 13-14, except the continuous power supply through coils (i.e., the no battery embodiment).
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1). Greenberg further teaches that the implant may be RF powered, meaning that no battery would be needed in the implant device (see ¶[0140] and ¶[0153]-[0156]), in which the power is received via the coil (see ¶[0217]). In such an embodiment, as the power is delivered via the external device, power would need to be continuously supplied, otherwise, the implant would not have power, and would not be capable of stimulus or measurement.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize RF powering via coils, and no battery of Greenberg for the power of the modified patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the lack of the battery would reduce the size and the cost of the implant; and/or (3) no battery would mean that the implant has no end-of-life battery restrictions (see Greenberg ¶[0156]).
Regarding Claims 35-38, patented claims 1-4 teach every element of pending claims 35-38, except the urgent action determination and subsequent actions.
Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device system (see abstract; Figs. 5a-5b and 10-10b), the system comprising:
receiving biometric information (col. 6 ln. 27-35, the method includes recording and transmitting physiological data), by an external device external to a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), of the user from an internal device within the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13);
determining, based on the biometric information, whether an urgent action is required to treat a disease or a symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b);
selectively performing:
a generating, based on the received biometric information, of a stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
a wirelessly transmitting to the internal device (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes):
of the stimulus information configured to specify a stimulus (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes); and
power configured to drive the internal device (col 11 ln. 19-32, the batteries, which are wirelessly recharged); and
wherein the selective performing of the generating of the stimulus information and the wireless transmitting includes:
in response, selecting to perform the generating of the stimulus information and the wireless transmitting (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b); and
in response to the urgent action being determined not required as the result of the determining of whether the urgent action is required, selecting to not perform the generating of the stimulus information and the wireless transmitting and transmitting the biometric information to a user terminal controlled by the user and/or an electronic device controlled by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b),
wherein the generating of the stimulus information includes generating the stimulus information to include stimulus characteristics to be used by the internal device to derive the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s));
applying the generated stimulus to the body of the user through a plurality of electrodes arranged at different positions in the body of the user (see Gilson col. 6 ln. 36-57 and col. 10 ln. 4-50, the stimulation provided via electrodes 40-70, see also Fig. 10b, the electrodes 40-70 are at different positions);
the applying of the generated stimulus to the user through the plurality of electrodes arranged at the different positions in the body of the user comprises applying the stimulus through a number of electrode pairs including an anode electrode and a cathode electrode (col. 15 ln. 22-28 and 51-65, the electrodes are implemented as anodes and cathodes, the pairs (a cathode and an anode)), wherein the number of electrode pairs is equal to or greater than a number of channels of the stimulus (col. 15 ln. 22-28 and 51-65, the electrodes may be switched between sensing/transmitting, indicating the channels of stimulus corresponds to the number of electrode pairs);
the applying of the stimulus through the number of electrode pairs includes variably changing the anode electrode and the cathode electrode included in each of the electrode pairs based on the stimulus information (col. 15 ln. 22-28, the physician may control/adjust based on the monitoring, including switching electrodes between anodes and cathodes);
the internal device is located between a skull and a scalp of the user (col. 6 ln. 4-26 and col. 9 ln. 9-18, the hole cap 20 mounted as a cap on top of the skull; Figs. 5a-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the implanted device with urgent action determination and subsequent actions of Gilson with the patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) switching between the two modes would not overload the circuit components and maximizes power usage during operation (see Gilson col. 10 ln. 40-43).
The modified patented claims 1-4 does not specifically teach all the components of the internal and external devices.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1). Greenberg teaches that the external system/device comprises coils 2/3 connected to the external controller 4, including microprocessor and telemetry electronics (i.e., the controller and data transceiver (see ¶[0155] and ¶[0158]), and a power transmitter (see ¶[0140] and ¶[0153]-[0155], the telemetry circuitry is capable to transmit power to the implanted device).
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1). Greenberg teaches that the external system/device comprises coils 2/3 connected to the external controller 4, including microprocessor and telemetry electronics (i.e., the controller and data transceiver (see ¶[0155] and ¶[0158]), and a power transmitter (see ¶[0140] and ¶[0153]-[0155], the telemetry circuitry is capable to transmit power to the implanted device).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in the modified patented claims 1-4 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,738,191 in view of Gilson as applied to claim 1 above, and in view of Greenberg et al. (US Patent Application Publication 2007/0255319 – cited by Applicant), hereinafter Greenberg ‘319.
Regarding Claim 4, the modified patented claims 1-4 teach every element of pending claim 2 and 13-14, except that the selective performing of the generating of the stimulus information and the wireless transmitting further includes selecting to not perform the generating of the stimulus information and the wireless transmitting when the body of the user is determined damaged or when the internal device is determined to be malfunctioning based on the biometric information.
Greenberg ‘319 teaches systems and stimulation control mechanisms to prevent damage to neural tissue (see abstract and Figs. 7A-7B), including stimulation above safe threshold levels (see ¶[0044]-[0045]), and to halt stimulation if broken/damaged electrodes are detected, and log such electrode damage, by monitoring impedance (see ¶[0046], ¶[0051], and ¶[0055]; Figs. 7A-7B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode monitoring of Greenberg ‘319 with the electrodes in the modified patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) monitoring for damaged/broken electrodes and halting stimulation would help to prevent neural and further electrode damage (see Greenberg ‘319 abstract).
Claim 39 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,738,191 in view of Gilson, and in view of Dzirasa et al. (US Patent Application Publication 2019/0143119 – cited by Applicant), hereinafter Dzirasa.
Regarding Claim 39, patented claims 1-4 teach every element of pending claim 39, except the urgent action determination and subsequent actions.
Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device system (see abstract; Figs. 5a-5b and 10-10b), the system comprising:
receiving biometric information (col. 6 ln. 27-35, the method includes recording and transmitting physiological data), by an external device external to a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), of the user from an internal device within the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13);
determining, based on the biometric information, whether an urgent action is required to treat a disease or a symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b);
selectively performing:
a generating, based on the received biometric information, of a stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
a wirelessly transmitting to the internal device (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes):
of the stimulus information configured to specify a stimulus (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes); and
power configured to drive the internal device (col 11 ln. 19-32, the batteries, which are wirelessly recharged); and
wherein the selective performing of the generating of the stimulus information and the wireless transmitting includes:
in response, selecting to perform the generating of the stimulus information and the wireless transmitting (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b); and
in response to the urgent action being determined not required as the result of the determining of whether the urgent action is required, selecting to not perform the generating of the stimulus information and the wireless transmitting and transmitting the biometric information to a user terminal controlled by the user and/or an electronic device controlled by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b),
wherein the generating of the stimulus information includes generating the stimulus information to include stimulus characteristics to be used by the internal device to derive the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s));
applying the generated stimulus to the body of the user through a plurality of electrodes arranged at different positions in the body of the user (see Gilson col. 6 ln. 36-57 and col. 10 ln. 4-50, the stimulation provided via electrodes 40-70, see also Fig. 10b, the electrodes 40-70 are at different positions);
the applying of the generated stimulus to the user through the plurality of electrodes arranged at the different positions in the body of the user comprises applying the stimulus through a number of electrode pairs including an anode electrode and a cathode electrode (col. 15 ln. 22-28 and 51-65, the electrodes are implemented as anodes and cathodes, the pairs (a cathode and an anode)), wherein the number of electrode pairs is equal to or greater than a number of channels of the stimulus (col. 15 ln. 22-28 and 51-65, the electrodes may be switched between sensing/transmitting, indicating the channels of stimulus corresponds to the number of electrode pairs);
the applying of the stimulus through the number of electrode pairs includes variably changing the anode electrode and the cathode electrode included in each of the electrode pairs based on the stimulus information (col. 15 ln. 22-28, the physician may control/adjust based on the monitoring, including switching electrodes between anodes and cathodes);
the internal device is located between a skull and a scalp of the user (col. 6 ln. 4-26 and col. 9 ln. 9-18, the hole cap 20 mounted as a cap on top of the skull; Figs. 5a-6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the implanted device with urgent action determination and subsequent actions of Gilson with the patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) switching between the two modes would not overload the circuit components and maximizes power usage during operation (see Gilson col. 10 ln. 40-43).
The modified patented claims 1-4 does not specifically teach the components of the user terminal.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]) and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified patented claims 1-4 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 12-16, 18, 21, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US Patent 9,278,208 – cited by Applicant), hereinafter Gilson, and in view of Greenberg et al. (US Patent Application Publication 2015/0157862), hereinafter Greenberg.
Regarding Claim 1, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device method (see abstract; Figs. 5a-5b and 10-10b), the method comprising:
receiving biometric information (col. 6 ln. 27-35, the method includes recording and transmitting physiological data), by an external device external to a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), of the user from an internal device within the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13);
determining, based on the biometric information, whether an urgent action is required to treat a disease or a symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b);
selectively performing:
a generating, based on the received biometric information, of a stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
a wirelessly transmitting to the internal device (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes):
of the stimulus information configured to specify a stimulus (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes); and
power configured to drive the internal device (col 11 ln. 19-32, the batteries, which are wirelessly recharged); and
wherein the selective performing of the generating of the stimulus information and the wireless transmitting includes:
in response, selecting to perform the generating of the stimulus information and the wireless transmitting (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b); and
in response to the urgent action being determined not required as the result of the determining of whether the urgent action is required, selecting to not perform the generating of the stimulus information and the wireless transmitting and transmitting the biometric information to a user terminal controlled by the user and/or an electronic device controlled by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b),
wherein the generating of the stimulus information includes generating the stimulus information to include stimulus characteristics to be used by the internal device to derive the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device.
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
Regarding Claim 2, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson does not specifically teach that the wirelessly transmitting of power includes continuously wirelessly transmitting an amount of power required by the internal device, for generating the stimulus, in response to the transmitted stimulus information.
Greenberg further teaches that the implant may be RF powered, meaning that no battery would be needed in the implant device (see ¶[0140] and ¶[0153]-[0156]), in which the power is received via the coil (see ¶[0217]). In such an embodiment, as the power is delivered via the external device, power would need to be continuously supplied, otherwise, the implant would not have power, and would not be capable of stimulus or measurement.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize RF powering and no battery of Greenberg for the power of the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the lack of the battery would reduce the size and the cost of the implant; and/or (3) no battery would mean that the implant has no end-of-life battery restrictions (see Greenberg ¶[0156]).
Regarding Claim 3, Gilson in view of Greenberg teaches the method of claim 1 as stated above. Gilson further teaches the selective performing of the generating of the stimulus information and the wireless transmitting further includes selecting to perform the generating of the stimulus information and the wireless transmitting, for application of the stimulus to the user by the internal device, in response to a detection of an abnormal symptom of the user based on the biometric information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the trigger may be a number of impulses within a predetermined time (abnormal symptom); Figs. 9 and 10b).
Regarding Claim 12, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson further teaches the wirelessly transmitting of the stimulus information and the wirelessly transmitting of the power are respectively performed dependent on the external device being within at least a proximity to the internal device enabling power and stimulus information transfer from the external device to the internal device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the communication between the internal and external coils; Fig. 1). In this case, the transmitting would necessarily be dependent on the external device (including the external coils) being within at least a proximity to the internal device (including the internal coils), as otherwise, no data would be capable to transmit between the internal and external devices, which would cause the system to be inoperable.
Regarding Claim 13, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson further teaches the wirelessly transmitting of the stimulus information and the wirelessly transmitting of the power are respectively performed using a coil of the external device, the coil corresponding to a coil of the internal device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the communication between the internal and external coils; Fig. 1).
Regarding Claim 14, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson does not specifically teach that the receiving of the biometric information of the user comprises receiving the biometric information of the user from the internal device while the power for driving the internal device is transmitted to the internal device from the external device.
Greenberg further teaches that the implant may be RF powered, meaning that no battery would be needed in the implant device (see ¶[0140] and ¶[0153]-[0156]), in which the power is received via the coil (see ¶[0217]). In such an embodiment, as the power is delivered via the external device, power would need to be continuously supplied, otherwise, the implant would not have power, and would not be capable of transmitting the biometric data.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize RF powering and no battery of Greenberg for the power of the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the lack of the battery would reduce the size and the cost of the implant; and/or (3) no battery would mean that the implant has no end-of-life battery restrictions (see Greenberg ¶[0156]).
Regarding Claim 15, Gilson in view of Greenberg teaches the method of claim 1 as stated above. Gilson further teaches the stimulus information includes information on any one or any combination of an intensity, a duration, an interval, and a repetition count of a pulse applied to the user as respective stimulus characteristics (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)).
Regarding Claim 16, Gilson in view of Greenberg teaches the method of claim 1 as stated above. Gilson further teaches the biometric information includes information on any one or any combination of a contact impedance, a humidity, a temperature, and an electroencephalogram (EEG) signal of the user (col. 13 ln. 60 – col. 15 ln. 28 and col. 10 ln. 4-50, the measured neurological signal are recorded via electrodes implanted in the brain, which would be considered an EEG signal).
Regarding Claim 18, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson further teaches the method is an operating method of a medical device system that includes the internal device and the external device (see above claim 1 mapping),
and the method further comprises controlling the internal device to collect the biometric information (see Gilson col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b), and
controlling the internal device to apply the stimulus (see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b).
Regarding Claim 21, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson further teaches a non-transitory computer-readable storage medium storing instructions that, when executed by a processor, cause the processor to perform (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, which would necessarily have memory for running the program/analysis; Fig. 1) the method of claim 1 (see above claim 1 mapping).
Regarding Claim 35, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device system (see abstract; Figs. 5a-5b and 10-10b), the system comprising:
an external device located outside a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13),
determine, based on biometric information (col. 6 ln. 27-35, the method includes recording and transmitting physiological data) received from an internal device inserted in the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13),
whether an urgent action is required to treat a disease or symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b);
in response to the urgent action being determined required in the determining of whether the urgent action is required:
generate stimulus information, to specify a stimulus, based on the biometric information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
to transfer wirelessly (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes), the stimulus information (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes) and power (col 11 ln. 19-32, the batteries, which are wirelessly recharged)
to the internal device configured to drive the internal device and to apply a stimulus in response to the transmitted stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b); and
transmit, in response to the urgent action being determined not required in the determining of whether the urgent action is required, the biometric information to a user terminal controlled by the user and/or an electronic device controlled by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b),
wherein the generation of the stimulus information includes generation of the stimulus information to include stimulus characteristics to be used by an internal device to derive the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions; or any such components of the external device.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1). Greenberg teaches that the external system/device comprises coils 2/3 connected to the external controller 4, including microprocessor and telemetry electronics (i.e., the controller and data transceiver (see ¶[0155] and ¶[0158]), and a power transmitter (see ¶[0140] and ¶[0153]-[0155], the telemetry circuitry is capable to transmit power to the implanted device).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device.
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
Regarding Claim 36, Gilson in view of Greenberg teaches the system of claim 35 as stated above. Gilson further teaches further comprising the internal device (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gilson, and in view of Greenberg, and in view of Greenberg et al. (US Patent Application Publication 2007/0255319 – cited by Applicant), hereinafter Greenberg ‘319.
Regarding Claim 4, Gilson in view of Greenberg teaches the method of claim 1 as stated above. Gilson further teaches the generating of the stimulus information further includes generating an instruction to instruct the internal device to derive or apply the stimulus to the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, col. 11 ln. 33-42, the stimulation generator controller 120; Figs. 9 and 10b).
Greenberg teaches that the health of the electrodes/implant may be monitored via impedance (see ¶[0154]-[0155]); however, the modified Gilson does not specifically teach to not perform the generating of the stimulus information and the wireless transmitting when the body of the user is determined damaged or when the internal device is determined to be malfunctioning based on the biometric information.
Greenberg ‘319 teaches systems and stimulation control mechanisms to prevent damage to neural tissue (see abstract and Figs. 7A-7B), including stimulation above safe threshold levels (see ¶[0044]-[0045]), and to halt stimulation if broken/damaged electrodes are detected, and log such electrode damage, by monitoring impedance (see ¶[0046], ¶[0051], and ¶[0055]; Figs. 7A-7B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode monitoring of Greenberg ‘319 with the electrodes in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) monitoring for damaged/broken electrodes and halting stimulation would help to prevent neural and further electrode damage (see Greenberg ‘319 abstract).
Claims 5-11, 17, 22-34, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson, and in view of Greenberg, and in view of Dzirasa et al. (US Patent Application Publication 2019/0143119 – cited by Applicant), hereinafter Dzirasa.
Regarding Claim 5, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson does not specifically teach that receiving control information from the user terminal controlled by the user; and generating the stimulus information based on the control information.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]; Fig. 2), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]), and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]).
Regarding Claim 6, Gilson in view of Greenberg and Dzirasa teaches the method of claim 5 as stated above. The modified Gilson further teaches the control information includes at least one of:
first control information determined by a first feedback loop including the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user; Figs. 9, 10b, and Fig. 13), the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals; Fig. 1), and the user terminal (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, Fig. 2); and
second control information determined by a second feedback loop including the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user; Figs. 9, 10b, and Fig. 13), the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals; Fig. 1), the user terminal (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2), and an electronic device controlled by a medical specialist (see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 7, Gilson in view of Greenberg and Dzirasa teaches the method of claim 6 as stated above. The modified Gilson further teaches the first control information includes information indicating a stimulus pattern selected from at least one first stimulus pattern determined in association with the first feedback loop (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user, Figs. 9, 10b, and Fig. 13; see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, Fig. 2).
Regarding Claim 8, Gilson in view of Greenberg and Dzirasa teaches the method of claim 6 as stated above. The modified Gilson further teaches the second control information includes at least one of:
information indicating a stimulus pattern selected from at least one second stimulus pattern determined in association with the second feedback loop (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user, Figs. 9, 10b, and Fig. 13; see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data); and
information indicating a stimulus pattern generated in real time based on the biometric information (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user, Figs. 9, 10b, and Fig. 13; see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals, Fig. 1).
Regarding Claim 9, Gilson in view of Greenberg and Dzirasa teaches the method of claim 5 as stated above. The modified Gilson further teaches the control information is set by the user (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment; Fig. 2) or
a medical specialist diagnosing the user (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 10, Gilson in view of Greenberg and Dzirasa teaches the method of claim 5 as stated above. The modified Gilson further teaches the generating of the stimulus information based on the control information comprises resetting the stimulus information based on control information determined by a medical specialist diagnosing the user (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 11, Gilson in view of Greenberg and Dzirasa teaches the method of claim 5 as stated above. The modified Gilson further teaches the generating of the stimulus information based on the control information comprises resetting the stimulus information based on the control information determined by a medical specialist diagnosing the user in response to a current state of the user based on the biometric information (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 17, Gilson in view of Greenberg teaches the method of claim 1 as stated above. The modified Gilson does not specifically teach transmitting the received biometric information to a user terminal controlled by the user while the external device is connected to the user terminal.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays (including system information), outputs, or other elements of a user interface, and be controlled via such user interface (see ¶[0103]-[0104]; Fig. 2), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]), and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface, including the display, of the external controller, so as to provide user input and display, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Regarding Claim 19, Gilson in view of Greenberg teaches the method of claim 18 as stated above. Gilson further teaches determining control information set by a technician, respectively controlling the wirelessly transmitting of the stimulus and the wirelessly transmitting of the power to the internal device by the external device based on the determining and/or the control information as provided by the technician (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b).
The modified Gilson does not specifically teach that the medical device system further includes a user terminal, and the method further comprises determining control information set by the technician provided communication with the user terminal, and respectively controlling the wirelessly transmitting of the stimulus and the wirelessly transmitting of the power to the internal device by the external device based on the determining and/or the control information as provided by the user terminal.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays (including system information), outputs, or other elements of a user interface, and be controlled via such user interface (see ¶[0103]-[0104]; Fig. 2), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]), and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface, including the display, of the external controller, so as to provide user input and display, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Regarding Claim 20, Gilson in view of Greenberg and Dzirasa teaches the method of claim 19 as stated above. The modified Gilson further teaches the medical device system further includes an electronic device that includes a user interface to set the control information based on input by the technician to the user interface (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user, Figs. 9, 10b, and Fig. 13; see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 22, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device method (see abstract; Figs. 5a-5b and 10-10b), the method comprising:
wirelessly transmitting (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes),
from an internal device in a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13),
biometric information of the user (col. 6 ln. 27-35, the method includes recording and transmitting physiological data) to an external device located outside the body of the user and separate from the internal device (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13); and
wirelessly receiving (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes), by the internal device, from the external device:
stimulus information configured to specify a stimulus, the stimulus information being generated based on the biometric information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes); and
power (col 11 ln. 19-32, the batteries, which are wirelessly recharged) configured to drive the internal device and to apply the stimulus to the user in response to the received stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b);
deriving, by the internal device, the stimulus based on stimulus characteristics included in the stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)); and
applying, by the internal device, the derived stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b),
wherein the stimulus information is generated in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b),
of whether the urgent action is required to treat a disease or symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b), and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted to the user terminal and/or an electronic device configured for control by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device; and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
The modified Gilson does not specifically teach that the external controller includes a user interface, such that the stimulus characteristic included in the stimulus information describe the stimulus based on the biometric information transmitted from the internal device through the external device to a user terminal controlled by the user, or transmitting from the external device.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]), and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]).
Regarding Claim 23, Gilson in view of Greenberg and Dzirasa teaches the method of claim 22 as stated above. The modified Gilson further teaches generating the stimulus using the received power based on the stimulus information (see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, col 11 ln. 19-32, the batteries, which are wirelessly recharged, Figs. 9 and 10b; see Greenberg ¶[0154], the decoding of the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes); and
applying the generated stimulus to the body of the user through a plurality of electrodes arranged at different positions in the body of the user (see Gilson col. 6 ln. 36-57 and col. 10 ln. 4-50, the stimulation provided via electrodes 40-70, see also Fig. 10b, the electrodes 40-70 are at different positions).
Regarding Claim 24, Gilson in view of Greenberg and Dzirasa teaches the method of claim 23 as stated above. Gilson further teaches the applying of the generated stimulus to the user through the plurality of electrodes arranged at the different positions in the body of the user comprises applying the stimulus through a number of electrode pairs including an anode electrode and a cathode electrode (col. 15 ln. 22-28 and 51-65, the electrodes are implemented as anodes and cathodes, the pairs (a cathode and an anode)), wherein the number of electrode pairs is equal to or greater than a number of channels of the stimulus (col. 15 ln. 22-28 and 51-65, the electrodes may be switched between sensing/transmitting, indicating the channels of stimulus corresponds to the number of electrode pairs).
Regarding Claim 25, Gilson in view of Greenberg and Dzirasa teaches the method of claim 24 as stated above. Gilson further teaches the applying of the stimulus through the number of electrode pairs includes variably changing the anode electrode and the cathode electrode included in each of the electrode pairs based on the stimulus information (col. 15 ln. 22-28, the physician may control/adjust based on the monitoring, including switching electrodes between anodes and cathodes).
Regarding Claim 26, Gilson in view of Greenberg and Dzirasa teaches the method of claim 22 as stated above. Gilson further teaches the internal device is located between a skull and a scalp of the user (col. 6 ln. 4-26 and col. 9 ln. 9-18, the hole cap 20 mounted as a cap on top of the skull; Figs. 5a-6).
Regarding Claim 27, Gilson in view of Greenberg and Dzirasa teaches the method of claim 22 as stated above. The modified Gilson further teaches the method is an operating method of a medical device system that includes the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13) and the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals, Fig. 1), and
the method further comprises controlling the external device to respectively wirelessly transmit second stimulus information and the power to the internal device dependent on control information received by the external device (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, such as to start the stimulus; Fig. 2).
Regarding Claim 28, Gilson in view of Greenberg and Dzirasa teaches the method of claim 22 as stated above. The modified Gilson further teaches the medical device system further includes a user interface configured to set the control information based on user input and/or provide the control information to the external device (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, such as to start the stimulus; Fig. 2).
Regarding Claim 29, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device method (see abstract; Figs. 5a-5b and 10-10b), the method comprising:
generating, by a terminal, control information in response to an input by a user or a medical specialist diagnosing the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, via a programmer, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
the control information being configured to cause an external device that is located outside a body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13) to derive and wirelessly transmit (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes)
first stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes) and
wirelessly transmit power (col 11 ln. 19-32, the batteries, which are wirelessly recharged)
to an internal device inserted in the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13); and
wherein the generating of the control information includes deriving the control information based on the input by the user or the medical specialist (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
wherein second stimulus information is generated by the external device in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b),
of whether the urgent action is required to treat a disease or symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b), and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted to a user terminal and/or an electronic device configured for control by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions, or transmitting stimulus information.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device.
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
The modified Gilson does not specifically teach that control information is generated by a user terminal, associated with the external controller, including transmitting, such that the first stimulus information is transmitted to the internal device from the external device, in response to the external device receiving the control information.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]) and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Regarding Claim 30, Gilson in view of Greenberg and Dzirasa teaches the method of claim 29 as stated above. The modified Gilson further teaches the control information includes at least one of:
first control information determined by a first feedback loop including the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user; Figs. 9, 10b, and Fig. 13), the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals; Fig. 1), and the user terminal (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, Fig. 2); and
second control information determined by a second feedback loop including the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user; Figs. 9, 10b, and Fig. 13), the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals; Fig. 1), the user terminal (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2), and an electronic device controlled by the medical specialist (see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 31, Gilson in view of Greenberg and Dzirasa teaches the method of claim 29 as stated above. The modified Gilson further teaches the generating of the control information comprises generating control information configured to cause application of a predetermined stimulus to the user at a point in time desired by the user in response to a request input from the user (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user control/adjustment, including the therapy start command/control input by the user, which includes a point in time desired by the user; Fig. 2).
Regarding Claim 32, Gilson in view of Greenberg and Dzirasa teaches the method of claim 29 as stated above. The modified Gilson further teaches receiving, from the external device, biometric information of the user sensed by the internal device; and transmitting the received biometric information to an electronic device controlled by the medical specialist diagnosing the user (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; see Dzirasa ¶[0103]-[0104], the electronic device in communication with the controller, such as a computer or server in a physician’s office, ¶[0096] the information or other indications provided to the user).
Regarding Claim 33, Gilson in view of Greenberg and Dzirasa teaches the method of claim 32 as stated above. The modified Gilson further teaches the generating of the control information includes receiving from the electronic device the control information set by the medical specialist diagnosing the user in response to a current state of the user indicated by the biometric information (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 34, Gilson in view of Greenberg and Dzirasa teaches the method of claim 32 as stated above. The modified Gilson further teaches the method is an operating method of a medical device system that includes the internal device (see Gilson col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, the specific stimulation delivered to the user; Figs. 9, 10b, and Fig. 13), the external device (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4 for determination of the proper stimulation patterns in real-time from recorded neural signals; Fig. 1), the user terminal (see Greenberg ¶[0155], ¶[0158], and ¶[0202], the external controller 4, Fig. 1; see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2), and the electronic device (see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data), and
wherein the control information is set by the user or the medical specialist (see Dzirasa ¶[0103]-[0104] and ¶[0133], the user interface of the external controller, for user and/or clinician control/adjustment, Fig. 2; see Gilson col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes via the programmer, in the implanted device, based on the recorded physiological data).
Regarding Claim 37, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device system (see abstract; Figs. 5a-5b and 10-10b), the system comprising:
an internal device located inside a body of a user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), the internal device comprising:
a data transceiver (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes);
a power receiver (col 11 ln. 19-32, the batteries, which are wirelessly recharged);
a sensor configured to sense biometric information of the user (col. 6 ln. 27-35, the method includes recording and transmitting physiological data via the electrodes);
a stimulator (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data); and
a controller (col. 11 ln. 33-42, the stimulation generator controller 120; Fig. 10b) configured to cause the data transceiver to:
wirelessly transmit the biometric information to an external device located outside the body of the user and is separate from the internal device (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13);
wirelessly receive, from the external device using the data transceiver (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes), stimulus information configured to specify a stimulus, the stimulus information being generated based on the biometric information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data); and
wirelessly receive from the external device using the power receiver power configured to drive the sensor, stimulator, and controller (col 11 ln. 19-32, the batteries, which are wirelessly recharged),
wherein the controller causes the stimulator to apply the stimulus to the body of the user in response to the received stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off, col. 11 ln. 33-42, the stimulation generator controller 120; Figs. 9 and 10b),
wherein the stimulus information includes stimulus characteristics to indicate the stimulus (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
wherein the stimulus is derived by the internal device based on the stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s), it is inherent that the implanted device derives the stimulus, as otherwise the implanted device would not be capable to apply the stimulus),
wherein the stimulus information is generated in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device, of whether the urgent action is required to treat a disease or symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b), and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted to a user terminal and/or an electronic device configured for control by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions; or that the wireless transmission is implemented via a coil.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device; and/or (3) Gilson requires a modality to implement the wireless transmission and Greenberg teaches one such modality (i.e., the coils).
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
The modified Gilson does not specifically teach transmitting from the external device.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]) and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Regarding Claim 38, Gilson in view of Greenberg and Dzirasa teaches the system of claim 37 as stated above. Gilson further teaches further comprising the external device (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13).
Regarding Claim 39, Gilson teaches methods, systems, and devices for a deep brain stimulation (DBS) device (see abstract; Figs. 5a-5b and 10-10b). Gilson teaches a medical device system (see abstract; Figs. 5a-5b and 10-10b), the system comprising:
a terminal (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, via a programmer, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
generating control information in response to an input by a user or a medical specialist diagnosing the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, via a programmer, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
the control information being configured to cause an external device that is located outside a body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13) to derive and wirelessly transmit (col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes)
first stimulus information (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data and receiving the control signal, so as to control/tweak the electrodes) and
wirelessly transmit power (col 11 ln. 19-32, the batteries, which are wirelessly recharged)
to an internal device inserted in the body of the user (col. 13 ln. 34-48 and col. 14 ln. 7 – col. 15 ln. 7, the physiological data (including the visual data) transmitted over the internet to a physician via an interface and programmer from the implanted DBS device; Fig. 13), and
cause the terminal to transmit the control information to the internal device (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),
wherein the generation of the control information includes a derivation of the control information based on the input by the user or the medical specialist (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, such as by controlling/tweaking the amplitude, pulse width and/or frequency of the stimulation pulse(s)),),
wherein second stimulus information is generated by the external device in response to an urgent action being determined required in a determination, based on the biometric information received from the internal device (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, including the sensing and transmitting modes; Figs. 9 and 10b),
of whether the urgent action is required to treat a disease or symptom of the user (col. 13 ln. 60 – col. 15 ln. 28, when an event or tremor is sensed, pulses/stimulation may be delivered to the targeted area, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems), and the physician may control or tweak the stimulation information used by the one or more electrodes, in the implanted device, based on the recorded physiological data, col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the transmitting mode in which the stimulation is delivered to the user, the on/off trigger such that in the transmitting mode, the sensing is off; Figs. 9 and 10b), and
wherein, in response to the urgent action being determined not required in the determination of whether the urgent action is required, the biometric information is transmitted to a user terminal and/or an electronic device configured for control by a medical specialist (col. 6 ln. 36-57 and col. 10 ln. 4-50, the triggering instructions for activating a stimulator to generate at least one treatment pulse from the electrodes and record physiological data, the sensing mode in which the neurological signals are sensed, the on/off trigger such that in the sensing mode, the stimulation is off, col 5 ln. 20-24 and ln. 48-64, the interface, such as a wireless interface, for transmitting physiological data to the external computer (i.e., the electronic device), col. 13 ln. 60 – col. 15 ln. 28, the physician may monitor the physiological/visual data during the 48-hour recorded window (as opposed to after in prior art systems); Figs. 9 and 10b).
Gilson teaches that the stimulus information may be generated/tweaked in the device used by the physician, then transferred to the implanted device, but Gilson does not specifically teach that an external device performs the determining, such that in response to the urgent action being determined required/not-required, performing the subsequent actions, or transmitting stimulus information.
Greenberg teaches an implantable device that sends and receives data or signals, and optionally power, from an external system through at least one coil (see abstract), in which the implanted device records signals via the implanted electrodes 9, transmits the recorded signals via the coil 17 to an external coil 2, which is carried to an external controller 4 for analysis in real-time and determination of the proper stimulation patterns, the external controller 4 then sends the stimulation patterns to external coil 3 to be received by internal coil 16, which provides the data to the stimulation electronic circuit 14, which drives stimulation electrode array 11 (see ¶[0155], ¶[0158], and ¶[0202]; Fig. 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the external controller of Greenberg for the analysis of the data (triggering and real-time analysis) with the recorded data in Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the processing via the external controller as taught in Gilson would reduce the processing power required in the implant device, thus reducing the size, power requirements, and cost of the implanted device.
While the internal device deriving the stimulus from the stimulation information is inherent (as otherwise the implanted device would not be capable to apply the stimulus), such process is not explicitly taught by Gilson.
Alternatively and/or additionally, Greenberg further teaches that the implanted device may receive the modulated data from the external controller, before decoding the telemetry data, which includes the implant control commands that include electrode selection for each neural sensing channel, gain selection, sampling control and other safety, diagnostic commands, and supports CNS electrode stimulation commands for up to 60 electrodes (see ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal decoding of Greenberg for the decoding of the received data in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the modified Gilson requires decoding/deriving the received data, and Greenberg teaches one such modality of decoding/deriving.
The modified Gilson does not specifically teach that control information is generated by a user terminal, associated with the external controller, including transmitting, such that the first stimulus information is transmitted to the internal device from the external device, in response to the external device receiving the control information.
Dzirasa teaches treating various pathological behavioral and/or psychological states via stimulation applied to regions in the brain (see abstract; Figs. 2 and 5), in which the implanted elements (i.e., the implanted leads 230) and external elements (i.e., the coil 250a and the external cabling 235) are controlled via the controller 220, which may be non-implanted (i.e., external) (see ¶[0099]-[0102]; Fig. 2), in which the controller 220 may include one or more controls, displays, outputs, or other elements of a user interface, such as a smartphone or computer, and be controlled via such user interface (see ¶[0103]-[0104]), in which stimulation parameters (i.e., an amplitude, frequency, timing relative to a determined reference phase, or other properties of the provided stimulus) and commands (i.e., a command to being providing a therapy/stimulus) may be input by a user and/or clinician (see ¶[0133]) and information or other indications provided to the user (see ¶[0096]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the user interface of the external controller, so as to provide user input, of Dzirasa for with the external controller in the modified Gilson because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) it would allow the user to initiate their own therapy/stimulus, and adjust frequency/amplitude, such as with a user prone to anxiety attacks, to allow the user with more control over their treatment (see Dzirasa ¶[0104]); and/or (3) displaying the biometric data (information) would give the user and/or the clinician real-time understanding of the user’s present condition.
Conclusion
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791