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 .
Status of Claims
Claims 1-18 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 11, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on March 29, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 122 in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
element 402 points to two distinct features of Fig. 4;
element 508 is labelled as “during prediction” in Fig. 5;
it is unclear what “innovation” refers to in Fig. 5;
“x[n]” in Fig. 5 is a product of element 508 however the Fig. shows it stemming from a separate arrow and it is unclear if this is a separate function;
element 602 points to two distinct features of Fig. 6;
elements 1002, 1102, and 1104 point to the word “signal” in Fig.’s 10-12 however the disclosure refers to these elements as “artifact removal algorithm”;
element 1204 is not depicted in Fig. 10 (¶[0053]); and
element 400 does not appear in Fig. 13 (¶[0063]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
The disclosure is objected to because of the following informalities:
“cause the hardware processor perform a method” should be changed to “cause the hardware processor to perform a method” in ¶[0010];
“has been attributes” should be changed to “has attributes” in ¶[0050]; and
“electrophysiological recording 1204” should be changed to “electrophysiological recording 1004” in ¶[0053].
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities: “receiving” in line 5 should be changed to “receive”, “predicting” in line 7 should be changed to “predict”, “inserting” in line 10 should be changed to “insert”, “determining” in line 11 should be changed to “determine”, and “causing” in line 13 should be changed to “cause”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “determining” in line 3 and line 5 should be changed to “determine”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “predicting” in line 3 should be changed to “predict”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “cause the hardware processor perform a method, comprising” should be changed to “cause the hardware processor to perform a method comprising”. Appropriate correction is required.
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 1-18 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 3, and 5 of U.S. Patent No. 11,975,199 (hereinafter referred to as “’199”) in view of Anderson et al. (WO2020/163177 published August 13, 2020, hereinafter referred to as “Anderson”). For the Anderson reference, US 11,975,199 has been used as an equivalent document for WO2020/163177.
Regarding claims 1, 7, and 13, immediately below is a reproduction of claim 1 of the instant application on the left and claim 1 of ’199 on the right.
PNG
media_image1.png
328
747
media_image1.png
Greyscale
On the left, round-cornered boxes in the instant claim 1 (on the left) illustrate what is not found in claim 1 of the ‘199 (on the right).
Anderson discloses the control device may determine an artifact during the first time period associated with a prior brain stimulus, determine an artifact-removed brain activity for the first time period based on the artifact; and predict the brain activity for the second time period based on the artifact-removed brain activity (Col. 7 ln. 29-34). Anderson further discloses to reduce or eliminate the stimulus artifact from recordings, an optimized auto-regressive (AR) model (or another model) may be utilized for predicting the recorded signal during stimulation events. The predicted signal may be substituted for the stimulus artifact during active stimulation (Col. 10 ln. 23-28).
Therefore, it would have been obvious to a person having ordinary skill in the art before the filing date to have specified the brain activity as a stimulus artifact signal and predict the brain activity as a second time period without the stimulus artifact signal and insert the predicted activity into the second time period as taught by Anderson in the method of ‘199 in order to remove the effect of the stimulus and know when the apply future stimulants.
Claim 7 introduces the limitation of a device, comprising: one or more memories; and one or more processor communicatively coupled to the one of more memories. Anderson discloses a device may include one or more memories and one or more processors communicatively coupled to the one or more memories (Col. 1 ln. 39-41). Therefore, it would have been obvious to a person having ordinary skill in the art before the filing date to include one or more memories and one or more processors communicatively coupled to the one or more memories as taught by Anderson in order to carry out various method steps (Col. 6 ln. 11-20).
Claim 13 adds the limitation of a non-transitory computer readable medium comprising instructions that when executed by a hardware processor cause the hardware processor perform the method. Anderson discloses in Fig. 3 the device 300 may perform these processes based on processor 320 executing software instructions stored by a non-transitory computer-readable medium, such as memory 330 and/or storage component 340 (Col. 6 ln. 11-16). Therefore, it would have been obvious to a person having ordinary skill in the art before the filing date to use non-transitory computer readable medium comprising instructions of Anderson so that when executed by a hardware processor cause the hardware processor perform the method steps (Col. 6 ln. 11-20).
Regarding claim 2, 8, and 14, it is noted that they are recited in the square box illustrated in the screenshot of claim 1 of ‘199 above.
Claim 3-4, 9-10, and 15-16 corresponds to claim 2 of ‘199.
Claims 5 and 11 corresponds to claim 3 of ‘199.
Claims 6, 12, and 18 corresponds to claim 5 of ‘199.
Claim 17 adds the additional limitation of wherein the brain stimulus is caused to occur during a period of rhythmic brain activity to claim 3 of ‘199.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract ideas of “predicting, based on the information identifying the brain activity for the first time period, predicted brain activity without the stimulus artifact signal for a second time period that is to occur after the first time period”; “inserting the predicted brain activity into the information for a second time period”; and “determining, based on the predicted brain activity for the second time period, a brain stimulus for the second time period” without significantly more.
Step 1
Claims 1, 7, and 13 recite a method and devices, and therefore, they are a product and method, and fall within the statutory category.
Step 2A, Prong 1
Claims 1, 7, and 13 recite the limitations of predicting, based on the information identifying the brain activity for the first time period, predicted brain activity without the stimulus artifact signal for a second time period that is to occur after the first time period; inserting the predicted brain activity into the information for a second time period; and determining, based on the predicted brain activity for the second time period, a brain stimulus for the second time period. The limitations, as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of “receiving, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period”. Claim 7 additionally recites “one or more memories”, and “one or more processors”, which is a computer processor. Further, claim 13 additionally recites “a non-transitory computer readable medium comprising instructions that when executed by a hardware processor cause the hardware processor perform a method”.
That is, other than reciting “receiving, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period”, “one or more memories”, “one or more processors”, and “a non-transitory computer readable medium comprising instructions that when executed by a hardware processor cause the hardware processor perform a method”, nothing in the claim precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that 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. For example, aside from the “one or more electrodes”, “brain stimulus”, “one or more memories”, “one or more processors” and “non-transitory computer readable medium” language, the claims encompasses the user inspecting a brain signal output, identifying the brain activity for a first period of time, predicting what the next period of time will look like and determining when to activate another brain stimulus. For example, these limitations are nothing more than a person looking at a waveform, noting the first time period and mapping out a second time period, and deciding on a treatment plan. The limitation of “causing the brain stimulus to be applied the second time period” under BRI is nothing more than a treatment plan being developed mentally or being provided to a patient, which do not necessarily include the active treatment being given to a patient. This is a mental process.
Step 2A, Prong 2
The claims recites additional elements: “receiving, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period”, “causing the brain stimulus to be applied the second time period”, “one or more memories”, “one or more processors”, and “a non-transitory computer readable medium comprising instructions that when executed by a hardware processor cause the hardware processor perform a method” to perform the abstract steps.
The system for determining predicting brain activity consisting of the “memories”, “processor” and “non-transitory computer readable medium” read on a computer implemented system and are recited at a high level of generality, i.e., as a generic processor with memory, performing a generic computer function of processing and storing data and displaying that data. This generic limitation is no more than mere instructions to apply the exception using generic computer components (see ¶[0065], ¶[0066], ¶[0068]). Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The “receiving, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period” is recited at a high level of generality (i.e., claimed broadly encompassing “a measurement electrode… for sensing a phase, a frequency, and amplitude, cross-frequency coupling, and/or the like of brain activity… mounted onto a head, a measurement device surgically implanted into a head of the patient, or and/or the like” ¶[0041], and other options capable of this type of measurement) and amount to no more than pre-solution activity of data gathering by the system to analyze the brain activity.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component, pre solution activity and a post solution activity that is not directed by the abstract idea. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well- understood, routine, conventional activity in the field. The specification in ¶[0065], ¶[0066], and ¶[0068] does not provide any indication that the computer processor, memory, and non-transitory computer readable medium is anything other than a generic, off-the shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐ implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well- understood, routine, conventional activity is supported under Berkheimer Option 2.
As discussed with respect to Step 2A Prong Two, the “receiving, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period” is recited at a high level of generality (i.e., “a measurement electrode” ¶[0041]) which individually and in combination amount to no more than pre-solution activity of data gathering by the system to analyze brain activity. This pre- solution activity of obtaining brain activity using electrodes is well- understood, routine, and conventional technology in the field of neurology: “Intracranial EEG (iEEG) is the most effective method for functional localization of the [seizure onset zones]; invasive electrodes are implanted and monitored for several days” (Miller K. et al. “Chapter 7 Biomechanical Modelling of the Brain for Neuronavigation in Epilepsy Surgery”. Biomechanics of the Brain, Biological and Medical Physics. pg 166. 2019. https://doi.org/10.1007/978-3-030-04996-6_7 ). All uses of the recited abstract idea require the pre-solution of data gathering.
Dependent claims 2-6, 8-12, and 14-18 add additional abstract limitations or further limit the process of predicting, based on the information identifying the brain activity for the first time period, predicted brain activity without the stimulus artifact signal for a second time period that is to occur after the first time period; inserting the predicted brain activity into the information for a second time period; and determining, based on the predicted brain activity for the second time period, a brain stimulus for the second time period. Therefore, these claims further limit the abstract idea already indicated in independent claims 1, 7, and 13 and they are ineligible for the same reasons provided for claims 1, 7, and 13 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (WO 2020163177 A1, published August 13, 2020, hereinafter referred to as “Anderson”).
Regarding claims 1, 7, and 13, Anderson teaches a method and a device (Fig. 3 “device 300” in ¶[0024]), comprising: one or more memories (Fig. 3 “memory 330” in ¶[0024]); and one or more processors (Fig. 3 “processor 320” in ¶[0024]) communicatively coupled to the one or more memories (“a device may include one or more memories and one or more processors communicatively coupled to the one or more memories” in ¶[0033]), configured to: receive, from one or more electrodes, information identifying brain activity with a stimulus artifact signal for a first time period (“Fig. 4, process 400 may include receiving, from one or more electrodes, information identifying brain activity for a first time period (block 410)” in ¶[0033] and “the control device may determine an artifact during the first time period associated with a prior brain stimulus” in ¶[0038]); predict, based on the information identifying the brain activity for the first time period, predicted brain activity without the stimulus artifact signal for a second time period that is to occur after the first time period (“Fig. 4, process 400 may include predicting, based on the information identifying the brain activity for the first time period, predicted brain activity for a second time period that is to occur after the first time period (block 420)” in ¶[0034] and “determine an artifact-removed brain activity for the first time period based on the artifact; and predict the brain activity for the second time period based on the artifact-removed brain activity” in ¶[0038]); insert the predicted brain activity into the information for a second time period (Fig. 10A “to reduce or eliminate the stimulus artifact from recordings, an optimized auto-regressive (AR) model (or another model) may be utilized for predicting the recorded signal during stimulation events. The predicted signal may be substituted for the stimulus artifact during active stimulation” in ¶[0068]); determine, based on the predicted brain activity for the second time period, a brain stimulus for the second time period (“Fig. 4, process 400 may include determining, based on the predicted brain activity for the second time period, a brain stimulus for the second time period … (block 430)” in ¶[0035]); and cause the brain stimulus to be applied the second time period (“Fig. 4, process 400 may include causing the brain stimulus to be applied in accordance with the frequency and the phase during the second time period (block 440)” in ¶[0036]).
Anderson further teaches the claim 13 limitation a non-transitory computer readable medium comprising instructions that when executed by a hardware processor cause the hardware processor perform the method (Fig. 3 “Device 300 may perform these processes based on processor 320 executing software instructions stored by a non-transitory computer-readable medium, such as memory 330 and/or storage component 340” in ¶[0029]).
Regarding claims 2, 8, and 14, Anderson teaches wherein the brain stimulus is associated with a frequency and a phase determined based on the predicted brain activity for the second time period (“Fig. 4, process 400 … wherein the brain stimulus is associated with a frequency and a phase determined based on the predicted brain activity for the second time period (block 430)” in ¶[0035]).
Regarding claims 3, 9, and 15, Anderson teaches wherein the method and one or more processors communicatively coupled to the one or more memories are further configured to: determining the stimulus artifact signal during the first time period associated with a prior brain stimulus; and determining an artifact-removed brain activity for the first time period based on the artifact (“the control device may determine an artifact during the first time period associated with a prior brain stimulus; determine an artifact-removed brain activity for the first time period based on the artifact” in ¶[0038]).
Regarding claims 4, 10, and 16 Anderson teaches wherein predicting the brain activity for the second time period further comprises: predicting the brain activity for the second time period based on the artifact- removed brain activity (“predict the brain activity for the second time period based on the artifact-removed brain activity” in ¶[0038]).
Regarding claims 5, 11, and 17, Anderson teaches wherein the brain stimulus is caused to occur during a period of rhythmic brain activity (“the brain stimulus is caused to occur during a period of rhythmic brain activity in accordance with the frequency” in ¶[0040]).
Regarding claims 6, 12, and 18 Anderson teaches wherein predicting the brain activity for the second time period further comprises: predicting the brain activity using a parametric spectral estimation technique for modeling band limited oscillations (“the control device may predict the brain activity using a parametric spectral estimation technique for modeling band limited oscillations” in ¶[0042]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Echauz, J. (US 20080021342 A1 published Jan. 24, 2008) – additional reference for independent claims; see ¶[0021].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-F 8-4:30 ET.
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, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792