DETAILED ACTION
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 .
Response to Amendment
The preliminary amendment filed on 5 June 2025 has been accepted and entered. Claims 1-61 are canceled. Claims 62-81 are pending.
Claim Rejections - 35 USC § 112
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 62-81 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
With respect to claim 62, the omitted steps involve any and all actual processing steps. The claim sets forth simply receiving data, processing said data using “at least one machine learning algorithm”, and desired result quality. The claim does not specify what type of processing is performed, what steps are involved, or how the results are determined to be within the claimed criteria.
With respect to dependent claims 63-81, these claims define the nature of the sample and/or data, the type of machine learning algorithm that is used, or specifics of the desired results. None of these claims appear to provide any additional guidance as to how this processing is performed, what steps are involved, or how the results are determined to be within the claimed criteria.
Allowable Subject Matter
Claims 62-81 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Nye et al. (US 2020/0160574 A1) discloses methods for determining a disease state (par. [0022] comprising gathering x-ray scattering data (par. [0002]), processing said data using a machine learning algorithm to determine a disease state (par. [0061]).
With respect to claim 62, Nye does not specify that the x-ray scattering data is derived from an in vitro sample of the subject, nor does Nye specify the claimed accuracy, sensitivity, or specificity of at least about 90%.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK R GAWORECKI whose telephone number is (571)272-8540. The examiner can normally be reached Monday-Friday 8 AM-6 PM.
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/MARK R GAWORECKI/Primary Examiner, Art Unit 2884 7 October 2026
