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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: acquisition device in claims 16, 20, and 27.
Claims recites “acquisition device.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “device” and functional language “acquisition” without reciting sufficient structure to achieve the function.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claims 16, 20, and 27 regarding “acquisition device” cannot be interpreted because the specification fails to adequately disclose structure to perform the claimed function. Therefore, the examiner is interpreting the acquisition device as an element that acquires the physiological signals from the user.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16, 20 and 22-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 16, 20, and 27 recites “acquisition device,” but is not recited within the specification. Because of this, the examiner cannot determine whether “acquisition device” is a structural form (hardware) or a program/algorithm (software) within the device. Claims 22-26 are rejected due to their dependence on claim 16, and Claims 28-30 are rejected due to their dependence on claim 27.
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 16, 20 and 22-30 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 limitation “acquisition device” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of “acquisition device” as described in Claims 16, 20, and 27. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 16, 20, and 22-30 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.
In Claim 16 and 27, the claim limitation “acquisition of a physiological signal” and “related physiological signal” renders the claim indefinite because the limitation is unclear. It is unclear whether the same physiological signal is being references or not. For purposes of examination, the claim limitation is interpreted as referencing the same physiological signal.
In Claim 26, the claim limitation “electrical stimulation device” renders the claim indefinite because the limitation is unclear. It is unclear whether the “electrical stimulation device” and the “acquisition device,” as previously recited in claim 16, are the same or different. For purposes of examination, the claim limitation is interpreted as the same device.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16, 20, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 20170027812 A1) in view of Tyler et al. (US 20150174418 A1), and Simon et al. (US 20170177023 A1).
Regarding Claim 16, Hyde discloses a system for stimulation and automatic evaluation of cognition and consciousness of a subject through external stimulations (nerve stimulation system – element 4200), said system for stimulation comprising a micro-controller (wireless microcontroller – element 4280), a digital-to-analog converter (digital-to-analog converter (DAC) – element 4270) and at least one sensory stimulation device (nerve stimulation earpiece – element 4201),
wherein the system is configured to (Paragraph 0016):
receive an input comprising an information concerning a stimulation paradigm comprising at least one pattern of a sensory stimulation configured to induce a cognitive process in a stimulated subject (Paragraphs 0013, 0015);
generate, as output a corresponding stimulation digital output (Paragraph 0227, The digital stimulus signal generator 4020 may generate a digital stimulus signal based, at least in part, on the one or more stimulation parameters received from the personal computing device 4045) according to said stimulation paradigm and at least one synchronization signal (Paragraph 0110); and
transmit, through a cable (communication link – element 210; Paragraph 0091; first and second electrical connector 4240 and 4225; Paragraph 0241), said at least one synchronization signal determined by the stimulation paradigm (Paragraph 0110-0111), to an acquisition device for an acquisition of a physiological signal so as to synchronize said system for stimulation with the acquisition device for the acquisition of the physiological signal during the acquisition (Paragraph 0110-0111; [Examiner’s note, the acquisition device is the neural stimulation system.]); and
wherein the digital-to-analog converter (DAC – element 4270) is configured to receive the stimulation digital output and to generate the sensory stimulation comprising at least one stimulus according to the stimulation paradigm by means of the at least one sensory stimulation device (Paragraph 0245), and
wherein the physiological signal is at least one of an electrocardiographic signal (Paragraph 0243), an electroencephalographic signal, a respiratory rate, or a pupil diameter measurement [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Hyde is silent in teaching the system is a microcontroller, where the microcontroller comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation.
Tyler teaches a microcontroller comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). Hyde teaches the system and Tyler teaches the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde to incorporate the teachings of the microcontroller containing the functions of receiving, generating, and transmitting at least one stimulus of the sensory stimulation from Tyler because the microcontroller can then serve as a compact tool for real-time analysis of physiological data, which greatly improves feedback regarding targeted electrical stimulation within the brain (Tyler | Paragraphs 0019, 0022).
Though Hyde in view of Tyle teach of the microcontroller, it is silent in teaching the microcontroller without scheduling by an operating system; the at least one synchronization signal is a temporal tag configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal and based on a starting time of the at least one stimulus of the sensory stimulation, the at least one synchronization signal originates from the microcontroller as a digital output generated by the microcontroller and corresponding to the onset of the at least one stimulus as determined by the microcontroller according to the stimulation paradigm.
Simon teaches microcontroller without scheduling by an operating system (Simon | Paragraph 0016; [Examiner’s note, the microcontroller is receiving the data in real-time and synchronizing the data. Therefore, this citation from Simon teaches the microcontroller is operating without a schedule by an operating system.]); at least one synchronization signal is a temporal tag (Simon | reaction time – elements 640 and 648) configured to time-locking an onset of the at least one stimulus of the sensory stimulation with the related physiological signal (Simon | Paragraphs 0003, 0005, 0088) and based on the starting time of the at least one stimulus of the sensory stimulation (Simon | Figure 10; Paragraph 0088); the at least one synchronization signal originates from the microcontroller (Simon | Paragraph 0016) as a digital output generated by the microcontroller (Simon | Paragraph 0073) and corresponding to the onset of the at least one stimulus as determined by the microcontroller according to the stimulation paradigm (Simon | Paragraph 0073-0074).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde in view of Tyler to incorporate the teachings of synchronization signals with time-locking because doing so would allow analyzing the timing of the patient's response to a stimulus, which will offer their physician valuable insights for diagnostic evaluations. This performance data helps the physician make an accurate diagnosis and determine the appropriate treatment plan to assist the patient (Simon | Paragraphs 0003, 0040).
Regarding Claim 20, Hyde in view of Tyler and Simon teaches the system according to Claim 16, wherein the acquisition device (Hyde | nerve stimulation ear piece – element 3000; [Examiner’s note, the nerve stimulation ear piece is the acquisition device.]) for the acquisition of the physiological signal is an electroencephalogram device or an electrocardiogram device (Hyde | Paragraph 0213; [Examiner’s note, the acquisition device, nerve stimulation ear piece, comprises a physiological sensor that includes an electroencephalogram sensor or electrocardiograph sensor. Therefore, one skilled in the art can conclude that sensor allows the acquisition device to be an electroencephalogram device or an electrocardiogram device.]).
Regarding Claim 22, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the at least one sensory stimulation device is configured to provide auditory stimulation (Hyde | auditory stimulus source – element 828), visual stimulation (Hyde | visual stimulus source – element 834) and/or haptic stimulation (Hyde | haptic stimulator – element 838).
Regarding Claim 23, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the micro-controller is pre- programmed and programmable (Hyde | Paragraph 0091, personal computing device 208 can be an audio player, a mobile phone, a computer, or any of various other devices having computing capability (e.g., microprocessor based devices) and including application software and/or suitable hardware for controlling operation of wearable neural stimulation device 202; [Examiner’s note, the device is controlled by hardware and software. For the user to operate the device, it is preprogrammed and also programmable.]).
Regarding Claim 24, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the information concerning the stimulation paradigm comprises information concerning a type of stimulation paradigm (Hyde | treatment regimen information – element 2574) and at least one stimulation paradigm parameter (Hyde | Paragraph 0148, secondary input signal may be representative of a physiological parameter of the subject or an environmental parameter of the subject, and may include a signal sensed from a sensor on or associate with neural stimulation device 1314, or a sensor in the environment of the subject, and/or parameters or values derived from such sensed signals).
Regarding Claim 25, Hyde in view of Tyler and Simon teaches the system according to claim 16, further comprising a proprietary non-volatile memory (Hyde | Paragraph 0121, a data processing system generally includes one or more of a system unit housing, a video display, memory such as volatile or non-volatile memory) and a user interface (Hyde | user interface – element 867), notably a screen touch (Hyde | Paragraph 0118, user interface 894, which may include one or more input devices such as a keyboard, button, switch, computer mouse, or touchscreen), through which a user selects the stimulation paradigm to be generated (Hyde | Paragraphs 0015, 0021).
Regarding Claim 26, Hyde in view of Tyler and Simon teaches the system according to claim 16, wherein the stimulation digital output of the microcontroller (Hyde | wireless microcontroller – element 4280) is received by an external stimulation device (Hyde | nerve stimulation earpiece – element 4201), notably an electrical stimulation device configured to deliver somatosensory stimulation (Hyde | Paragraph 0013, a wearable neural stimulation device includes, but is not limited to, a vibratory mechanical stimulator adapted to produce a vibratory stimulus of sufficient frequency and amplitude to modulate the activity of at least one mechanoreceptor with a receptive field on at least a portion of a pinna of a subject, and a securing member configured to secure the vibratory mechanical stimulator to the pinna; [Examiner’s note, mechanical vibration is a form of somatosensory stimulation.]).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde in view of Tyler, Simon, and Maschino et al. (US 20070179557 A1).
Regarding Claim 27, Hyde discloses a method for the stimulation of a patient for cognitive evaluation comprising the steps of (Paragraph 0012):
receiving a clinical information concerning the patient (Paragraph 0111);
receiving a selection of at least one stimulation paradigm obtained on the basis of the clinical information concerning the patient (Paragraph 0110), the stimulation paradigm comprising at least one pattern of a sensory stimulation configured to induce a cognitive process in the patient (Paragraph 0013, 0015);
receiving an input comprising information concerning the selected stimulation paradigm (Paragraphs 0013, 0015) so as to generate the sensory stimulation comprising at least one stimulus according to said stimulation paradigm and at least one synchronization signal determined by the stimulation paradigm (Paragraph 0110); [Wingdings font/0xDF] Updated
transmitting (communication link – element 210; Paragraph 0091; first and second electrical connector 4240 and 4225; Paragraph 0241) the at least one synchronization signal (Paragraphs 0110-0111) to an acquisition device for an acquisition of a physiological signal of the patient during the generation of the sensory stimulation (Paragraphs 0110-0111; [Examiner’s note, the acquisition device is the neural stimulation system.]);
wherein the physiological signal is at least one of an electroencephalographic signal (Paragraph 0243), an electrocardiographic signal, a respiratory rate, or a pupil diameter measurement [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]; and
transferring the information concerning the selected stimulation paradigm (personal computing device – element 4290), the physiological signal acquired and the at least one synchronization signal (Paragraph 0016; [Examiner’s note, the stimulation paradigm is selected from the personal computing device and a signal is determined.]).
Hyde is silent in teaching receiving and transmitting by microcontroller;
Tyler teaches the receiving and transmitting by microcontroller (Tyler | Paragraphs 0086, 0088-0089, 0125). Hyde teaches the system and Tyler teaches the microcontroller which comprises receiving, generating, and transmitting at least one stimulus of the sensory stimulation (Tyler | Paragraphs 0086, 0088-0089, 0125). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde to incorporate the teachings of the microcontroller containing the functions of receiving, generating, and transmitting at least one stimulus of the sensory stimulation from Tyler because the microcontroller can then serve as a compact tool for real-time analysis of physiological data, which greatly improves feedback regarding targeted electrical stimulation within the brain (Tyler | Paragraphs 0019, 0022).
Hyde in view of Tyler is silent in teaching the at least one synchronization signal is a temporal tag configured to time-locking an onset of the at least one stimulus of the sensory stimulation with a related physiological signal and based on a starting time of the at least one stimulus of the sensory stimulation; the at least one synchronization originates from the microcontroller as a digital output generation by the microcontroller and corresponding to the onset of the at least one stimulus as determined by the microcontroller according to the stimulation paradigm;
Simon teaches at least one synchronization signal is a temporal tag (Simon | reaction time – elements 640 and 648) configured to time-locking an onset of the at least one stimulus of the sensory stimulation with a related physiological signal (Simon | Paragraphs 0003, 0005, 0088) and based on a starting time of the at least one stimulus of the sensory stimulation (Simon | Figure 10; Paragraph 0088); the at least one synchronization signal originates from the microcontroller (Simon | Paragraph 0016) as a digital output generated by the microcontroller (Simon | Paragraph 0074) and corresponding to the onset of the at least one stimulus as determined by the microcontroller according to the stimulation paradigm (Simon | Paragraph 0073-0074).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Hyde in view of Tyler to incorporate the teachings of synchronization signals with time-locking because doing so would allow analyzing the timing of the patient's response to a stimulus, which will offer their physician valuable insights for diagnostic evaluations. This performance data helps the physician make an accurate diagnosis and determine the appropriate treatment plan to assist the patient (Simon | Paragraphs 0003, 0040).
Lastly, Hyde in view of Tyler and Simon is silent in teaching the information, concerning the selected stimulation paradigm, is transferred to a database for storage. However, Maschino teaches a database for storage (database - element 240). One having ordinary skill in the art at the time the invention was filed would have found it obvious to modify the neural stimulation device of Hyde in view of Tyler and Simon to incorporating the teachings of the database from Maschino because Maschino teaches in Paragraph 0066, a stimulation parameter module 230 in FIG. 2, may be capable of accessing data from the database 240 based upon data received from the neuro-response analysis module 220. When data can be accessed from a database, then data can be stored within the same database.
Regarding Claim 28, Hyde in view of Tyler, Simon, and Maschino teaches the method according to claim 27, further comprises a step of analyzing the physiological signal acquired and the at least one synchronization signal (Hyde | Paragraph 0143).
Regarding Claim 29, Hyde in view of Tyler, Simon, and Maschino teaches the method in Claim 27. Hyde in view of Tyler and Simon is silent in teaching the clinical information is provided by either: the database, wherein the database is a clinical database, or a user, the clinical information being further saved in the clinical database;
Maschino teaches the clinical information is provided by either: the data base, wherein the database is a clinical database (database – element 240), or by a user, the clinical information being further saved in the clinical database [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
One having ordinary skill in the art at the time the invention was filed would have found it obvious to modify the neural stimulation system of Hyde in view of Tyler, Simon, and Maschino to incorporate the teaching of the database from Maschino because Maschino teaches in Paragraph 0066, the system 205 may also comprise a database 240 that may provide a tabulation of various patient characteristics to particular neuro-transmission parameters. Consultation into the database 240 may provide correlation between the types of internal stimulation that may be desirable based upon various physiological parameters of a particular patient. A stimulation parameter module 230 in FIG. 2, may be capable of accessing data from the database 240 based upon data received from the neuro-response analysis module 220. It would have been notoriously obvious to a skilled artisan to incorporate a database where clinical information can be provided by the user, through the medical device, or through the database. The clinical information would need to obviously be included, within the database, for the device to function. Thus, allowing for the clinic to provide support for the user’s needs.
Regarding Claim 30, Hyde in view of Tyler, Simon, and Maschino teaches the method according to claim 27, further comprising a step of generating a report (Hyde | report – element 2576) comprising a result of the analysis step and an information concerning the stimulation paradigm selected (Hyde | Paragraph 0184, report 2576 is generated by reporting circuitry 2578 and stored in data storage circuitry 2566 in addition to, or as an alternative to, providing report 2576 to a recipient).
Response to Arguments
Applicant’s arguments and amendments filed 10/29/2025 have been fully considered.
Regarding the 35 U.S.C. 112(f) Rejection, the applicant’s amendments have overcome this rejection.
Regarding the 35 U.S.C 112(b) Rejection, the applicant’s amendments have overcome most of the rejections made, but not all.
Regarding the 35 U.S.C 103 Rejection, the applicant’s amendments to the claims have required further search and consideration. Therefore, additional citation from references Hyde et al. (US 20170027812 A1) in view of Tyler et al. (US 20150174418 A1), Simon et al. (US 20170177023 A1), and Maschino et al. (US 20070179557 A1) are brought in to teach the synchronization signals are originated from the microcontroller (see citation from Simon above), the synchronization signal corresponds to the onset of the stimulus determined by the microcontroller (see citation from Simon above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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