DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 May 2026 has been entered.
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 21, 22, 24, 27, and 31-35 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.
Regarding claim 21, the originally filed specification fails to provide support for initiating an electrical stimulation based on the first result and/or the third result.
Further regarding claim 21, the originally filed specification fails to provide support for a method that comprises: (a) determining a second, “responsive status” result, and then issuing to a patient a second summon to start and take at least one of a complex or choice reaction time test; or (b) determining a fourth, “responsive status” result, and then issuing to a patient a third summon to start and take at least one of a complex or choice reaction time test.
Regarding claim 32, the originally filed disclosure fails to provide support for “determining a classification of [a] medical event based on at least one of the claimed first result, third result, or fifth result”.
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 21, 22, 24, 27, and 31-35 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.
Regarding claim 21, the claim makes it unclear what the method comprises if the result of the first summon is the second result (i.e., the patient is determined to be in a responsive status). If the patient is determined to be in a responsive status based on the first summon, how is a first estimated risk of injury determined based on the first result? The same is true if a result of the second summon is the claimed fourth result, and if the result of the third summon is the claimed sixth result. Further regarding claim 21, the recitation of “where the first issued summon, the second issued summon, and the third issued summon are initiated during this method” appears to be redundant; the claim already requires that the first summon, the second summon, and the third summon be issued.
Claim 22 recites logging into a memory a time interval from “an indication of triggering event occurrence”. The phrase “an indication of triggering event occurrence” renders the claim indefinite. Does Applicant intend for the claim to recite logging into a memory at least one of… “a time interval from receiving the indication of the triggering event to the change in the patient’s responsiveness”? Clarification is requested.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 21, 22, 24, 27, and 31-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 21 follows.
Regarding claim 21, the claim recites a series of steps or acts, including issuing prompts to a patient to take multiple tests, determining results of the tests, and determining that a patient is unresponsive based on some of the determined results. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of determining first through sixth results, determining first through third estimated risks of injury based on the determined results, and determining that a patient is unresponsive based on the determined results set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 21 recites issuing a warning and initiating electrical stimulation, which is merely adding insignificant extra-solution activities to the judicial exception (MPEP 2106.05(g)). While the step of initiating electrical stimulation can be interpreted as effecting a particular treatment or effecting a particular change based on the first, third, and/or fifth result, it is noted that this step is capable of being performed by hand. There is no structure recited in claim 21; every step recited in the claim is capable of being performed mentally and/or by hand.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of receiving an indication of a triggering event, issuing multiple summons to perform a reaction time test, issuing a warning, and initiating an electrical stimulation to the patient. The receiving and issuing multiple summons steps are each recited at a high level of generality such that they amount to insignificant presolution activity, e.g., mere data gathering steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. And, as noted above, each of the steps is capable of being performed mentally and/or by hand.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claim as they generally recite method steps pertaining to making determinations, wherein each of the steps recited in the dependent claims are also capable of being performed mentally and/or by hand. The receiving, issuing summons, determining, issuing a warning, and initiating an electrical stimulation steps recited in the independent claim maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 24, 27, and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over John et al.’600 (US Pub No. 2007/0213600 – previously cited) in view of Hickle’854 (US Pub No. 2003/0145854 – previously cited).
Regarding claim 21, John et al.’600 discloses a method for determining a degree of responsiveness of a patient having a brain state change, the method comprising: receiving an indication of a triggering event (section [0032]); in response to the triggering event, issuing to the patient a first summon to start and take at least one of a complex or a choice reaction time test (sections [0059-0064]); determining at least one of a first result of the first issued summon and a second result of the first issued summon, wherein the first result is a non-responsive status and the second result is a responsive status (sections [0059-0064]); determining a first estimated risk of injury based on the first result (section [0062]: degree of trauma); determining that the patient is unresponsive based on the first result (section [0064]: summary results and trend states are used to diagnose the patient); issuing a warning based on the first result (section [0064]: the summary results are a warning); and initiating an electrical stimulation to the patient based on the first result (sections [0025], [0042], and [0088-0089]).
John et al.’600 discloses all of the elements of the current invention, as discussed above, except for the method comprising issuing to the patient a second summon to start and take at least one of a complex or a choice reaction time test based on the first result, determining at least one of a third result (non-responsive status) and a fourth result (responsive status), determining a second estimated risk of injury based on the third result, issuing to the patient a third summon to start and take at least one of a complex or a choice reaction time test based on the third result, determining at least one of a fifth result (non-responsive status) and a sixth result (responsive status), and determining a third estimated risk of injury based on the fifth result. Hickle’854 teaches a method for assessing a patient’s responsiveness, wherein the method repeats an assessment/summon when a patient fails to respond. Hickle’854 teaches that repeated tests decrease the risk of a false unresponsive assessment (section [0040]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of John et al.’600 to include repeating the steps of issuing to the patient a summon to start and take at least one of the complex or the choice reaction time test based on a failed patient response (unresponsive status/first result and/or third result), determining a non-responsive/responsive status based on the summon, and determining an estimated risk of injury based on the status result, because as taught by Hickle’854, this would decrease the risk of a false unresponsiveness determination of the patient.
Regarding claim 24, John et al.’600 teaches determining and logging into a memory a test of an assessment of efficacy of the electrical stimulation (section [0089]).
Regarding claim 27, John et al.’600 discloses the method further comprises determining and logging into a memory a test of an assessment of efficacy of a therapeutic action (section [0089]).
Regarding claim 32, John et al.’600 discloses the method further comprises determining a classification of a medical event based on the first result (section [0064]: a diagnosis is a classification).
Claims 22, 31, 34, and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over John et al.’600 in view of Hickle’854, as applied to claim 21, further in view of Jung et al.’005 (US Pub No. 2008/0243005 – previously cited).
Regarding claims 22 and 35, John et al.’600 in view of Hickle’854 discloses all of the elements of the current invention, as discussed in paragraph 10 above, except for the method comprising determining and logging into memory at least one of: a time of an occurrence of a change in the patient’s responsiveness; a duration of a change in the patient’s responsiveness; and a time interval from receiving the indication of the triggering event to the change in the patient’s responsiveness. Jung et al.’005 teaches identifying a change in a patient’s responsiveness (section [0049] – “For example, the device 102 may obtain an indication of decreased alertness in a user 190 in the form of output from a reaction time test function.”, and sections [0067], [0073-0075], and [0082]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of John et al.'600 in view of Hickle’854 to include determining and logging into memory the occurrence of a change in the patient's responsiveness, as taught by Jung et al.'005, since it would provide an indication as to whether the patient was becoming more or less responsive based on reaction time tests. Official notice is being taken that it is well known in the art to mark the time of occurrence of an important event (see for example, section [0185] of Burton et al.'068 -- US Pub No. 2004/0193068 – previously cited). It would have been obvious to one of ordinary skill in the art at the time of the invention to have noted the time of occurrence of the change in the patient’s responsiveness in order to allow a medical professional to know at what time the patient’s responsiveness changed.
Regarding claim 31, one of ordinary skill in the art would have realized that in order to determine that a patient has become more or less responsive based on reaction time tests, a determination would need to be made of a change in the patient’s reaction time. The difference in reaction times is a magnitude of a change in responsiveness.
Regarding claim 34, the method of John et al.’600 in view of Hickle’854 further in view of Jung et al.’005 discloses a method that determines a type of a change in responsiveness (more or less responsive).
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over John et al.’600 in view of Hickle’854, as applied to claim 32, further in view of Almarsson et al.’581 (US Pub No. 2003/0166581 – previously cited).
John et al.’600 in view of Hickle’854 discloses all of the elements of the current invention, as discussed in paragraph 10 above, except for the classification of the medical event being a simple partial seizure, a complex partial seizure, or a generalized seizure. Almarsson et al.’581 teaches that each of a simple partial seizure, a complex partial seizure, and a generalized seizure exhibit unique symptoms (section [0008]). It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the method of John et al.’600 in view of Hickle’854 to include diagnosing (classifying) one of a simple partial seizure, a complex partial seizure, or a generalized seizure based on the first result and patient symptoms, as it would provide a more accurate diagnosis for the patient.
Response to Arguments
Applicant's arguments filed 20 May 2026 have been fully considered.
With regard to the rejection of the claims under 35 U.S.C. 101, as noted in paragraph 8 above, each step recited in claim 21 is capable of being performed mentally and/or by hand. Each of the steps recited in the remaining dependent claims is also capable of being performed mentally. As such, the method as a whole is drawn to an Abstract Mental Concept.
Applicant’s arguments regarding the rejections of claims under 35 U.S.C. 112 are not persuasive. No rejection was made based on there being “no description in the specification of issuing a third summon, determining at least one of a fifth result or a sixth result based on third summon, determining a third estimated risk of injury based on the fifth result, determining that the patient is unresponsive based on the fifth result.” Neither the amendments nor Applicant’s Remarks responds to the assertion that the originally filed specification fails to provide support for “initiating an electrical stimulation based on the first result and/or the third result” or “determining a classification of [a] medical event based on at least one of the claimed first result, third result, or fifth result”. Neither the amendments nor Applicant’s Remarks responds to the rejection of Claim 22 under 35 U.S.C. 112, second paragraph.
Regarding the rejections of claims under 35 U.S.C. 102(b), the amendments to the claims have overcome the rejections.
Regarding the rejections of the claims under 35 U.S.C. 103, Applicant’s arguments remain unpersuasive as Applicant has not particularly pointed out why John et al.’600 in view of Hickle’854 does not read on the claims. Applicant’s only argument is on page 15 of the Remarks: “Applicant respectfully submits that Jung, Hickle and/or Almarsson does not cure the deficiencies of John because the above-mentioned limitations are disclosed, taught, or suggested by Jung, Hickle and/or Almarsson.” This is not a persuasive argument, particularly because Applicant states that “the above-mentioned limitations are disclosed, taught, or suggested by Jung, Hickle and/or Almarsson” (emphasis added). Assuming that Applicant intended to argue that the above-limitations are not disclosed, taught, or suggested by Jung, Hickle and/or Almarsson, the argument is still not persuasive as it does not explain why the sections of Hickle relied upon to cure the deficiencies of John do not cure the deficiencies of John.
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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