DETAILED ACTION
Claims 1-14 are hereby the present claims under consideration.
Examiner’s Note: all references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 20260020801 A1.
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 .
Specification
The amendment filed 12/16/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/KR2023/006528 and of the Korean patent application 10-2022-0074205 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 05/15/2023, see MPEP 1893.03(b). Therefore the specification amendment of 12/16/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
Examiner’s Note: Applicant may overcome this objection by removing the words “the disclosures of which are herein incorporated by reference in their entirety” from the specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters have been used to designate multiple components. 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. 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 particular, paragraphs 0060-0064 refer to EEG channel 105. Fig. 1A does not include a reference 105 and it would seem that reference 110 is used to designate the EEG channels. Reference 110 is also used to designate the storage unit in paragraph 0065 and Fig. 1B. Additionally, reference 120 is used in paragraph 0066 and Fig. 1B to designate a communication unit but also seemingly designated the patient in Fig. 1A.
Examiner’s Note: Claims 4 and 11 each recite the relative term “high” however the term is not used to describe the likelihood of postoperative delirium but is rather used as a label for when the MDF value satisfies the recited threshold. Thus the claim is interpreted as labelling likelihood of postoperative delirium as “high” when the recited threshold is met. The term high used in this context is not considered a relative term of degree since it is associated with explicit criteria being met.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-14 are directed to a method of processing EEG signals using a computational algorithm, which is an abstract idea. Claims 1-14 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] predicting a likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery
This elements [A1] of claim 1 are drawn to an abstract idea since it involves a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] receiving an electroencephalogram (EEG) signal obtained from an individual prior to surgery
[B2] a processor
This element [A2] of claim 1 does not integrate the exception into a practical application of the exception. In particular, element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Additionally, the element [B2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “receiving an electroencephalogram (EEG) signal obtained from an individual prior to surgery” does not qualify as significantly more because this limitation merely describes the nature of the received EEG data and does not incorporate the EEG electrodes as part of the claimed invention.
Furthermore, the element [B2] does 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)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). 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.
Claims 2-7 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 5: the EEG signal is obtained through only two channels;
Claim 6: the EEG channels are located on a prefrontal cortex; and
Each of these claim limitations do not integrate the exception into a practical application. In particular, the elements of claims 5-6 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the electrodes are nothing more than conventional EEG electrodes which are well known in the art. Additionally the use of only two electrodes and their particular placement are not considered to implement the abstract idea into a practical application. Such EEG electrodes are conventional as evidenced by:
U.S. Patent Application Publication No. US 2006/0173510 A1 (Besio) discloses that EEG electrodes are conventional (paragraph 0013 of Besio);
U.S. Patent No. US 3993046 A (Fernandez) discloses that EEG signals are conventionally derived from electrodes (Col 1 lines 31-56 of Fernandez);
US Patent Application Publication No. US 2015/0313498 A1 (Coleman) discloses that the number, size, location and/or placement of electrodes for EEG monitoring are all optimizable parameters (Paragraph 0074).
US Patent Number US 6052619 A (John) teaches a small preferably handheld device in communication with EEG electrodes. Depending upon the application the system may use between 1 and 16 electrodes which includes the use of two electrodes (Col 3 lines 16-44).
US Patent Number US 5999846 A (Pardey) which teaches a small self-contained portable unit to continually acquire and analyze EEG signals (Col 7 lines 1-5). The device includes EEG sensors which include two electrodes attached to the user’s head and an optional third electrode used as a reference (Col 7 lines 21-37).
US Patent Application Publication Number US 2011/0245702 A1 (Clark) teaches a hand-held EEG sensor probe comprising two sensors for acquiring electrical signals from the scalp (Paragraph 0066).
US Patent Application Publication Number US 2012/0065536 A1 (Causevic) teaches a patient sensor operatively coupled to a handheld base which processes brain electrical signals, wherein the sensor comprises at least on reference and at least one sensing electrode (Paragraph 0008) and that the electrodes may be attached to the patient’s forehead, or prefrontal cortex (Paragraph 0023).
US Patent Application Publication Number US 2016/0287125 A1 (Weinberg) teaches a smartphone mobile device in communication with and for processing the output of two EEG electrodes (Paragraph 0040).
US Patent Application Publication Number US 2018/0353094 A1 (Cromwell) teaches a handheld delirium predicting device for determining a likelihood of delirium that uses two electrodes on the patient’s forehead, or prefrontal cortex (Abstract; Paragraph 0045; Fig. 1)
Thus, the electrodes, their claimed number, and placement are each considered to be well-known, routine, and conventional in light of Besio, Fernandez, Coleman, John, Pardey, Clark, Causevic, Weinberg, and Cromwell.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). 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. 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.
Claim 8 recites substantially the same abstract idea as claim 1 and is rejected on the same basis as claim 1. An abridged analysis of claim 8 is presented below:
The analysis of claim 8 is as follows:
Step 1: Claim 8 is drawn to a machine.
Step 2A – Prong One: Claim 8 recites an abstract idea. In particular, claim 8 recites the same abstract idea as claim 1
Step 2A – Prong Two: Claim 8 recites the following limitations that are beyond the judicial exception and not already addressed in the above analysis of claim 1:
[A2] a communication unit
[B2] a processor connected to the communication unit
This elements [A2]-[B2] of claim 8 does not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 8 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the elements [A2]-[B2] 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)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). 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.
Claims 9-14 depend from claim 8, and recite the same abstract idea as claim 8. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 12: the EEG signal is obtained through only two channels;
Claim 13: the EEG channels are located on a prefrontal cortex
Each of these claim limitations do not integrate the exception into a practical application. In particular, the elements of claims 12-13 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). The elements do no amount to significantly more for the same reasons presented above with respect to claims 5 and 6.
Thus, the electrodes, their claimed number, and placement are each considered to be well-known, routine, and conventional in light of Besio, Fernandez, Coleman, John, Pardey, Clark, Causevic, Weinberg, and Cromwell.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). 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. 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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shim the machine English translation of International Patent Application Publication Number WO 2022149789 A1 hereinafter Shim.
Regarding claim 1, Shim discloses a delirium occurrence predicting method for predicting a likelihood of delirium occurrence prior to surgery (Abstract), implemented by a processor (Page 4: paragraph 6: the various devices for data processing), the method comprising the steps of:
receiving an electroencephalogram (EEG) signal obtained from an individual prior to surgery (Page 3: paragraph 6: collecting data before surgery; Page 4 paragraph 3: the preoperative EEG characteristics; Page 5 paragraph 7: the EEG measuring device measures EEG before surgery); and
predicting a likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery (Page 4 paragraphs 3 and 8: predicting postoperative delirium using pre-operative EEG characteristics; Page 5: paragraph 3: it may be predicted that the subject is more likely to develop delirium; Page 7 paragraphs 6-7: the algorithm may calculate a probability value for post-operative delirium).
Regarding claim 8, Shim discloses a delirium occurrence predicting device, comprising:
a communication unit configured to receive an EEG signal obtained from an individual prior to surgery (Page 3: paragraph 6: collecting data before surgery; Page 4 paragraphs 3 and 8: the preoperative EEG characteristics, receiving the EEG at the computer terminal, thus some form of communication unit which receives the EEG data is implicitly disclosed; Page 5 paragraph 7: the EEG measuring device measures EEG before surgery); and
a processor connected to the communication unit (Page 4: paragraphs 6 and 8: the various devices for data processing such as the computer terminal. The computer terminal received the EEG data and performs the analysis. Thus a processor of the computer terminal is implicitly disclosed and in communication with the communication unit.),
wherein the processor is configured to predict a likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery (Page 4 paragraphs 3 and 8: predicting postoperative delirium using pre-operative EEG characteristics; Page 5: paragraph 3: it may be predicted that the subject is more likely to develop delirium; Page 7 paragraphs 6-7: the algorithm may calculate a probability value for post-operative delirium).
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.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shim the machine English translation of International Patent Application Publication Number WO 2022149789 A1 hereinafter Shim
Regarding claims 2 and 9, Shim discloses the delirium occurrence predicting method and device of claims 1 and 8 respectively. Shim further discloses the method and device wherein the step of predicting the likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery, includes: a step of predicting the likelihood of postoperative delirium occurrence prior to the surgery based on a power value of a frequency range of in the EEG signal (Page 7: paragraphs 6-7: predicting the likelihood of delirium involves determining a power value for each frequency band; Page 3: paragraph 13: the various frequency bands).
Shim fails to explicitly disclose the frequency range of 5.5 to 13 Hz. Shim does disclose the evaluation of the theta and alpha band with respect to each other encompassing the range of 4-12Hz (Page 3: paragraph 13).
The specification discloses the appropriate ranges that apply to the claimed invention in paragraphs 0092-0094 as 4-15 Hz and more desirably, 5.5-13 Hz. However, the specification does not disclose that the specifically claimed range(s) of 5.5-13 Hz is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s). In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05. Since Shin teaches that post-operative delirium may be predicted using a comparison of a lower frequency band (delta or theta) to a higher frequency band (alpha or beta) (Page 3: paragraph 13 – Page 4: paragraph 2), the prior art therefore provides teaching that the frequency band utilized to predict post-operative delirium is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization. Because Applicants fail to disclose that the claimed range(s) of 5.5-13Hz provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that multiple frequency ranges may be used to predict post-operative delirium, absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 5.5-13 Hz by normal optimization procedures known in the delirium prediction arts.
Thus, Shin is considered to render the power value being in the frequency range of 5.5-13 Hz as obvious.
The above obviousness rationale for the specific frequency range is further applied to each claim directed towards the specific frequency range and will hereinafter be referred to as the frequency range obviousness rationale.
Claims 3-4 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shim the machine English translation of International Patent Application Publication Number WO 2022149789 A1 hereinafter Shim as applied to claims 1 and 8 above and further in view of Epelbaum US Patent Application publication Number US 20220079507 A1 hereinafter Epelbaum.
Regarding claims 3 and 10, Shim discloses the delirium occurrence predicting method and device of claims 1 and 8 respectively. Shim further discloses the method and device wherein the step of predicting the likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery, includes: a step of predicting the likelihood of postoperative delirium occurrence prior to the surgery (Page 4 paragraphs 3 and 8: predicting postoperative delirium using pre-operative EEG characteristics; Page 5: paragraph 3: it may be predicted that the subject is more likely to develop delirium; Page 7 paragraphs 6-7: the algorithm may calculate a probability value for post-operative delirium)
Shim fails to further disclose the method wherein the step of predicting the likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery, includes: a step of predicting the likelihood of postoperative delirium occurrence prior to the surgery based on a median dominant frequency (MDF) of power values of a frequency band of 5.5 to 13 Hz in the EEG signal.
Shim instead discloses the determination of a ratio including a ratio between the theta and alpha bands. Shim teaches that higher ratio values corresponding to higher power values in the slower frequency band (the theta band) and lower power values in the fast frequency band (the alpha band) recorded before surgery are indicative of increased likelihood of post-operative delirium (Page 3: paragraph 13 – Page 4: paragraph 3). Thus, Shim teaches that post-operative delirium is predicted before surgery by showing an increased proportion of power in lower frequency bands than higher frequency bands. The claimed frequency range is further considered to be obvious over Shim in light of the above presented frequency range rationale.
Shim fails to disclose the determination of a median dominant frequency (MDF) of power values of a frequency band of 5.5 to 13 Hz in the EEG signal.
Epelbaum teaches a system to measure and monitor neurodegeneration of a subject, which includes: an acquisition module configured to acquire electroencephalographic signals with multiple EEG channels from a subject perceptually isolated; a calculation module configured to extract at least one EEG metric representative of neurodegeneration; and an evaluation module configured to evaluate the at least one EEG metric and extract a neurodegeneration index (Abstract). Thus, Epelbaum is reasonably pertinent to the problem of EEG analysis at hand.
Epelbaum teaches that calculating the median spectral frequency as an EEG metric advantageously summarizes the relative distribution of power in the frequency spectrum and is particularly useful when comparing the powers of different frequency bands such as in Alzheimer’s evaluation (Paragraphs 0088-0089). The extracted EEG metric may then be compared to a particular threshold determined based on trends of the metric is known patient groups (Paragraphs 0095-0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of Shim to determine a median spectral frequency over the theta to alpha bands rather than a ratio between the two bands because Epelbaum teaches that the median spectral frequency advantageously summarizes the relative distribution of power in the frequency spectrum and may provide a more sensitive metric than the ratio determined by Shim. Additionally, as described in the frequency range rationale above, the median spectral frequency being determined for the claimed specific frequency range is considered to be obvious in light of the teachings of Shim. One of ordinary skill in the art would recognize that changing the ratio of Shim to the median frequency measure of Epelbaum would not render the method inoperable or require significant redesign of its mode of operation because the ratio of Shim is measuring the same metric as the median spectral frequency of Epelbaum, that is, the relative distribution of power between the frequency bands and/or in a given frequency range.
Regarding claims 4 and 11, Shim in view of Epelbaum teaches the delirium occurrence predicting method and device of claims 3 and 10 respectively. Modified Shim fails to further disclose the method or device wherein the step of predicting the likelihood of postoperative delirium occurrence based on the received EEG signal, prior to the surgery, includes: a step of predicting that the likelihood of postoperative delirium occurrence is high when the MDF value is 8.40 or lower.
Epelbaum teaches that calculating the median spectral frequency as an EEG metric advantageously summarizes the relative distribution of power in the frequency spectrum and is particularly useful when comparing the powers of different frequency bands such as in Alzheimer’s evaluation (Paragraphs 0088-0089). The extracted EEG metric may then be compared to a particular threshold determined based on trends of the metric is known patient groups (Paragraphs 0095-0096).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of Shim to utilize a threshold level of the median spectral frequency for determining the presence of a clinical condition as taught by Epelbaum because the threshold comparison provides a definitive cutoff for determining the presence of the condition or not and the difference from the threshold may provide insight into the severity or probability of the condition as taught by Epelbaum (Paragraphs 0097-0098: the deviation from the threshold and the EEG metric may be the neurodegenerative index or may represent the probability that the subject has AD).
Shim in view of Epelbaum fails to teach the threshold being 8.4 but does teach that lower values represent increased likelihood of post-operative delirium (Page 3: paragraph 13 – Page 4: paragraph 3).
The specification discloses the appropriate ranges that apply to the claimed invention in paragraph 0095 as 8.4 and that values of approximately 8.4 Hz or lower results in a delirium risk classification. However, the specification does not disclose that the specifically claimed value of 8.4 Hz is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Epelbaum teaches that threshold may be set based on trends in previously observed metrics (Paragraph 0096) the prior art therefore provides teaching that the specific threshold utilized to predict post-operative delirium is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization. Because Applicants fail to disclose that the claimed threshold of 8.4 Hz provides a criticality to the invention that separates it from other possible thresholds, and the prior art discloses that the threshold value is based on previously identified trends of patient data, absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable threshold of 8.4 Hz for the median spectral frequency by normal optimization procedures known in the delirium prediction arts.
Thus, Shin in view of Epelbaum is considered to render the threshold for predicting post-operative delirium as the median spectral frequency being 8.4 Hz or lower as obvious.
Claims 5-6 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Shim the machine English translation of International Patent Application Publication Number WO 2022149789 A1 hereinafter Shim as applied to claims 1 and 8 above and further in view of Cromwell US Patent Application publication Number US 20180353094 A1 hereinafter Cromwell.
Regarding claims 5-6 and 12-13, Shim discloses the delirium occurrence predicting method and device of claims 1 and 8 respectively. Modified Shim fails to further disclose the method or device wherein in the step of receiving an EEG signal obtained from an individual prior to surgery, the EEG signal is obtained through only two EEG channels, and wherein the two EEG channels are located on a prefrontal cortex of the individual.
Cromwell teaches apparatuses, systems and methods relate to predicting, screening, and monitoring for delirium (Abstract). Thus, Cromwell falls within the same field of endeavor as Applicant’s invention.
Cromwell teaches that EEG monitoring may be performed using only 2 electrodes attached to the patient’s forehead, or attached to the prefrontal cortex (Paragraphs 0045, 0087 and 0114-0115).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of Shim to utilize only 2 electrodes on the patient’s forehead, or on the patient’s prefrontal cortex, as taught by Cromwell because Cromwell teaches that such a configuration is suitable for recording EEG signals for use in the diagnosis of delirium (Cromwell: Paragraph 0045) and using only two electrodes significantly reduces the complexity of setting up the system.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Shim the machine English translation of International Patent Application Publication Number WO 2022149789 A1 hereinafter Shim as applied to claims 1 and 8 above and further in view of Prerau US Patent Application publication Number US 20160324446 A1 hereinafter Prerau.
Regarding claims 7 and 14, Shim discloses the delirium occurrence predicting method and device of claims 1 and 8 respectively. Modified Shim fails to further disclose the method or device wherein the surgery requires general anesthesia.
Prerau teaches systems and methods for identifying physiological states of a patient (Abstract). Thus Prerau is reasonably pertinent to the problem at hand.
Prerau teaches that patient’s undergo general anesthesia prior to surgery and that monitoring the patient under general anesthesia prior to surgery helps to ensure they are neither over or under anesthetized. Prerau further teaches that general anesthesia may cause delirium (Paragraph 0091).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method and device of Shim such that the surgery requires general anesthesia because Prerau teaches that surgery includes general anesthesia and general anesthesia can cause delirium (Paragraph 0091) and thus the delirium prediction of Shim is more applicable to surgeries which involve general anesthesia,
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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, Jason Sims can be reached on Monday-Friday from 9:00AM – 4:00PM at (571) 272 – 7540. 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.
/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
Prosecution Insights