DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on April 7, 2026 were received and fully considered. Claims 1, 2, 8, 12, 18, 22, 23, and 40 were amended. Claim 10 was cancelled. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 12, 2026 has been considered by the examiner.
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 1-3, 5-8, 12, 15, 16, 18, 19, 22-24, 39, and 40 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 1 follows.
Regarding claim 1, the claim recites a method of assessing a subject. Thus, the claim is directed to a process/method, 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 following limitations set forth a judicial exception:
“A method of assessing a subject comprising…measuring by at least one sensor a plurality of respirations of said subject to identify presence or lack of a sniff response in response to said olfactory test; determining one or more respiration parameters from said plurality of respirations, said one or more respiration parameters comprising said presence or lack of a sniff response and at least one measured sniff volume; and determining, using said one or more respiration parameter, including said presence or lack of a sniff response and said measured sniff volume, one or more of: a state of consciousness of said subject; and a prognosis of said subject.”
These limitations describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper. The skilled artisan is also capable of performing the measuring step, e.g. medical professional can sense, via sight/touch/feel, whether a patient sniffs/exhales via said patient’s nostrils.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…performing an olfactory test on the subject by an actuator configured to present said olfactory test to the subject…”
These additional limitations do not integrate the judicial exception into a practical application as they pertain to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception fail to integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to widely-understood, routine, and conventional techniques in the art for assessing patient status. Further, the additional limitations are recited at a high level of generality such that they fail to recite significantly more.
Dependent claims 2, 3, 5-8, 12, 15, 16, 18, 19, 22-24, 39, and 40 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-3, 5-8, 12, 15, 16, 18, 19, 22-24, 39, and 40 are not patent eligible under 35 USC 101.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-8, 12, 15, 16, 18, 19, 22-24, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Sattin et al., Olfactory discrimination in disorders of consciousness: A new sniff protocol, Brain Behavior, pgs. 1-6, 2019 (hereinafter “Sattin”).
With respect to claim 1, Sattin teaches a method of assessing a subject comprising: performing an olfactory test on the subject Methods “two assessment techniques the new olfactory discrimination protocol (ODP)”); measuring by at least one sensor a plurality of respirations of said subject to identify presence or lack of a sniff response in response to said olfactory test (pgs. 2-3, 2.2 The ODP for patients with DOC “four odors selected… each nostril was tested… mirror under the nose of each patient to test the presence of airflow from the nose”; Note: Sattin’s mirror that tests for the presence of airflow from the nose equates to the claimed sensor when taking into consideration broadest reasonable interpretation); determining one or more respiration parameters from said plurality of respirations, said one or more respiration parameters comprising said presence or lack of a sniff response (see pg. 3, Table 1, which shows ODP indicator values, of which ODP = 1 equates to presence of behavior response to odor stimulus) Discussion “ODP for patients with DOC showed substantial test-retest reliability and an almost perfect agreement with… fMRI indicator”).
Although Sattin does not explicitly teach performing an olfactory test by an actuator and determining at least one measured sniff volume, further modification to incorporate these features would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Sattin discloses performing an olfactory discrimination protocol and presenting DOC patients with various odors (see pg. 1, abstract). As such, further modifying Sattin to incorporate an actuator (in place of manually presenting DOC patients with various scents/odors) would only involve routine skill in the art1. Additionally, Sattin suggests opportunities for future research that could include volume of air exhaled through the nostrils (see pg. 5, first sentence of last paragraph). Therefore, PHOSITA would have had predictable success when the invention was filed modifying Sattin to determine sniff volume (volume of air exhaled through the nostrils) in order to consider correlation between ODP results and the quantitative analysis of the nasal airflow, as suggested by Sattin.
With respect to claims 2, 3, 5-8, 12, 15, 16, 18, 19, 22-24, 39, and 40, and while Sattin does not explicitly teach these features, Examiner argues that they pertain to modifications involving mere routine skill that would be prima facie obvious to PHOSITA when the invention was filed.
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were fully considered and were persuasive in view of applicant’s amendment and/or accompanying remarks. Therefore, these rejections are withdrawn.
Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action were fully considered, but they were not persuasive. Examiner maintains that the claims, when considered as an ordered combination, recite a mental process that (1) is not integrated into a practical application; and (2) does not recite additional limitations that amount to significantly more. Regarding the mental process, Examiner argues that a skilled artisan would be able to perform the steps corresponding to an abstract idea mentally, or using simple pen/paper. Examiner also argues that the measuring step could also be carried out by the skilled artisan, via sense of sight, sound, or touch. For example, a medical practitioner could hold a scented strip of paper to the patient’s nostril and sense/feel for the presence/absence of an olfactory reaction thereafter. For at least these reasons, the 35 USC 101 rejections are maintained. Please see corresponding rejection heading above for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see prior art section above for more detail, updated citations (new Sattin reference), and updated obviousness rationale.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
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