Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The reply filed 9/23/25 is acknowledged. Claims 1-15, 21-23 remain pending. Claims 23 are new. Claims 1-5, 9-13 have been amended.
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.
Claim 1-15, 21-23 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) generate, responsive to receiving the traumatic brain injury parameter sensor data from the patient monitoring sensor, a traumatic brain injury indicator derived from a monitoring, by the patient monitoring device of the received traumatic brain injury parameter sensor data relative to a traumatic brain injury parameter. The abstract idea is part of the Mathematical Concepts and/or Mental Process group(s) identified in the Ninth Edition, Revision 10.2019 (revised June 2020) of the Manual of Patent Examination Procedure (MPEP). This judicial exception is not integrated into a practical application because they amount to simply implementing the abstract idea on a computer; data-gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity; there is no improvement to a computer or other technology; does not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition; does not apply the abstract idea with, or by use of, a particular machine. The additional elements are identified as follows: patient monitoring sensor, patient monitoring device, a patient data monitor module, a traumatic brain injury monitor module. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, when considered both individually and as a whole, do not amount to significantly more than the abstract idea. The additional computer and data-gathering elements, which are recited at a high level of generality, provide conventional computer and data-gathering functions that do not add meaningful limitations to practicing the abstract idea.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by Martini, et al. (Targeting Brain Tissue Oxygenation in Traumatic Brain Injury). Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
When considered in combination, the additional elements (generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. The Federal Circuit has held that combining additional elements for data-gathering with abstract ideas does not make a claim patent-eligible. Looking at the claim limitations 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 or improves any other technology. Their collective functions merely provide conventional computer implementation.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data gathering that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known data-gathering equipment/functions is not significantly more than the abstract idea.
Response to Arguments
Regarding 35 U.S.C. § 101 rejections, Applicant argues that the Examiner fails to examiner the claims as a whole. Examiner respectfully disagrees. Examiner has identified from the claims as a whole – any limitations reciting an abstract idea, any limitations reciting additional elements and any limitations that may integrate the claims into a practical application.
Applicant argues that the human mind cannot generate sensor data or graphically display data. Examiner notes that those limitations are not abstract ideas, and were never identified as abstract ideas.
Applicant argues that the claims are not directed to an abstract idea. Applicant argues that the claims, similar to Examples 38 and 39, do not recite does not expressly recite any mathematical relationships formulas, equations or calculations. Examiner respectfully disagrees. Examiner notes that the claims themselves are directed to a mathematical concept and mental process abstract idea of indicating traumatic brain injury by comparing parameter data to guideline data. It is clear from the Specification that this “comparing” step is a comparison between two values – a parameter and a threshold which is a mathematical concept and a mental process as it can be performed in the human mind.
Applicant further argues that the claims recite a practical application of graphically displaying the indicator. Examiner disagrees. Displaying results is considered mere post solution activity that is well known and conventional in the art and does not amount to a practical application. Examiner further notes that the limitation “enabling the medical practitioner to manage…” is not positively recited, represents intended use and lacks patentable weight.
Applicant further argues that new claim 23 recites a particular treatment. Examiner respectfully disagrees. Examiner notes that the treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). Merely “managing” ventilation or hemodynamics is not “particular”.
For these reasons, the 101 Rejection is maintained.
Conclusion
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 JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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