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 6/18/26 is acknowledged. Claims 1-3, 9, and 39-62 are pending. Claims 1, 2, 46, 47 are 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 1-3,6 and 39-62 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 a corrected measurement and determining a ketosis score by comparing the calibrated breath-acetone measurement value, or a transformed value generated from the calibrated breath-acetone measurement value, to one or more predetermined thresholds corresponding to calibrated breath-acetone measurement values and associated with levels of ketosis. The abstract idea is part of the Mathematical Concepts and/or Mental Process Activity group(s) identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. 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: acetone detector including a sensor and memory; an electronic device including display and memory and programs. 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. 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 101 Rejections, Applicant argues that the claims are not a mental process or mathematical concept. For example, Applicant points to limitations related to “generate sensor signals” and generating measurements via “analog to digital conversion”. Applicant further notes that the claims require per-device calibration to calibrate corrected breath measurements. Finally Applicant notes that a ketosis level is determined by comparing measurements to a predetermined threshold. Examiner notes that sensor reading based on A/D conversion is well-known and conventional data processing; merely obtaining device-specific calibration values to calibrate measurement data is an abstract idea; and comparing values to a threshold is an abstract idea. The amendments merely amount to obtaining/collecting data, performing calculations and displaying the results. The rejection is maintained.
Applicant further argues that baseline correction and device calibration are improvements in technology. Examiner respectfully disagrees. While baseline correction and signal calibration are well known data processing steps in the art, there are also an abstract idea related to mathematical concepts. Per the MPEP, it is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology and that gathering and analyzing information using conventional techniques and displaying the result is not an improvement in technology (MPEP 2106.05(a) II). The 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791