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 amendment filed 9/4/25 is acknowledged. Claims 1-19, 22, 41, 43-44 are pending. Claim 20, 21, 23-40, 42 are canceled. Claim 1, 3, 13, 18, 22, 43 are amended. Claims 2, 4-12, 15-17, 19 are withdrawn from consideration.
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, 13, 14, 18, 21-22, 41-43 are 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) determining, by the one or more processors, one or more dynamical properties and a Poincare Map of the biophysical signal data set; and
determining, by the one or more processors, an alpha shape object of the Poincare map; determining, by the one or more processors, one or more geometric properties of the alpha shape object; determining, by the one or more processors, one or more estimated values for the presence, non-presence, localization, and/or severity of a disease or condition based on the determined one or more dynamical properties and the one or more determined geometric properties of the alpha shape object, wherein the plurality of geometric properties includes at least one property selected from the group consisting of: a density value of the alpha shape object, a convex surface area value of the alpha shape object, a perimeter value of the alpha shape object, a porosity value of the alpha shape object, and a void area value of the alpha shape object. The abstract idea is part of the Mathematical Concepts 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: surface sensors and a processor (claim 1) and display (claim 18). 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 non-patent literature of record in the application (Galiatsatos et al. Usefulness of a Noninvasive Device to Identify Elevated Left Ventricular Filling Pressure Using Finger Photoplethysmography During a Valsalva Maneuver; 2017 – cited by Applicant). 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 Amendment
Regarding 101 Rejections, Applicant argues the claims should be found eligible at Step 2A Prong 2. Examiner respectfully disagrees.
Applicant refers to Thales, Examiner notes that Thales recited inertial sensors used in a non-conventional approach. This is not the case in the instant application. In fact, the claims merely amount to collecting data, processing it and displaying the results. Examiner notes that “Gathering and analyzing information using conventional techniques and displaying the result” is not an improvement in technology. MPEP 2015.06(A)(II)(iii). Examiner notes that “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” MPEP 2106.05(a). The rejection is maintained
Applicant further argues that the amended claims now applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. Examiner respectfully disagrees. First, Examiner notes that the limitation “wherein the one or more estimated values are used in a diagnosis of the disease state or condition or to direct treatment of the disease state or condition” does not positively recite any particular treatment. Per MPEP 2106.04(d)(2) “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)”. Further, Examiner notes that any claimed treatment is “optional” and not required in the claimed invention.
Applicant further argues that Claim 1 does not recite any of "mathematical relationships, mathematical formulas or equations, and mathematical calculations". Examiner respectfully disagrees. Determining dynamic properties, Poincare maps, and geometrical properties are mathematical relationships. The rejection stands.
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