DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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? If the patient is determined to be in a responsive status based on the first summon, how is a second summon issued based on the first result? In general, if the patient is determined to be in a responsive status based on the first summon, how are any of the remaining claimed steps performed? 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. Furthermore, the addition of “where the first issued summon, the second issued summon, and the third issued summon are initiated during this method” has added to the unclarity of the claim. Are the first, second, and third summons initiated regardless of the determined results? Or is the phrase meant to be read as “when the first issued summon, the second issued summon, and the third issued summon are initiated during this method” (which is itself a conditional statement)?
Claim 21 is being interpreted as a method that comprises conditional statements. Steps that are performed based on “the first result”, “the third result”, or “the fifth result” are all conditional steps that need only be performed if a first/third/fifth result is determined. The determination that the patient is unresponsive based on at least one of the first result, the third result, and the fifth result, therefore, is conditional on the first issued summon, the second issued summon, and the third issued summon all being initiated during the method. If after issuing the first summon the second result of “a responsive status” is determined, then neither the second nor third summons are issued, and the step of determining that the patient is unresponsive based on at least one of the first result, the third result, and the fifth result need not be performed.
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 § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 24, 27, 32, and 33 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by John et al.’600 (US Pub No. 2007/0213600 – 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]); and 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]). John et al.’600 further discloses initiating an electrical stimulation to the patient (sections [0025], [0042], and [0088-0089]). It is noted that with the wording of claim 21, if the determination after the first summon is that the patient is in a responsive status, no other steps recited in the claim pertaining to the first, third, or fifth result need to be performed.
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 claims 32 and 33, as the steps are conditional steps, they need not be performed, and John et al.’600 reads on both 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 22, 31, 34, and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over John et al.’600, as applied to claim 21, in view of Jung et al.’005 (US Pub No. 2008/0243005 – previously cited).
Regarding claims 22 and 35, John et al.’600 discloses all of the elements of the current invention, as discussed in paragraph 9 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 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). 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 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 Jung et al.’005 discloses a method that determines a type of a change in responsiveness (more or less responsive).
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 in view of Hickle’854 (US Pub No. 2003/0145854 – previously cited).
It is noted that while claim 21 could be interpreted such that the method only comprises (1) receiving an indication of a triggering event, (2) 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, and (3) determining a second result (a responsive status result), for the purposes of compact prosecution, the rejection of claim 21 below interprets claim 21 such that all recited steps must be performed.
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 12 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 12 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 12 December 2025 have been fully considered and they are not persuasive.
With regard to the rejection of the claims under 35 U.S.C. 101, as noted in paragraph 7 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.
While the amendments to the claims have overcome one of the previous rejections under 35 U.S.C. 112, first paragraph, as discussed in paragraph 3 above, 35 U.S.C. 112, first paragraph, issues remain. Neither the amendments nor Applicant’s Remarks respond to the originally filed specification failing 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”.
Regarding the previous rejections under 35 U.S.C. 112, second paragraph, neither the amendments nor the Remarks have addressed the indefiniteness issues within the claims. With specific regard to claim 22, clarification has not been provided with regard to what is meant by logging into a memory a time interval from “an indication of triggering event occurrence” to a change in a patient’s responsiveness.
Applicant’s arguments with respect to the prior art rejections of the claims have been considered and are not persuasive. As discussed in paragraph 5 above, claim 21 only requires the following steps to be performed: (1) receiving an indication of a triggering event, (2) 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, and (3) determining a second result (a responsive status result). As such, the previous rejection under 35 U.S.C. 102(b) in view of John et al.’600 is still applicable.
Even with the additional interpretation of claim 21 requiring all of the recited steps to be performed, Applicant’s arguments remain unpersuasive as Applicant did not respond to the rejection of the claims in view of John et al.’600 in view of Hickle’854. John et al.’600 in view of Hickle’854 was used to reject the interpretation of claim 21 that requires each of the first, second, and third summons to be initiated.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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