DETAILED ACTION
This action is filed in response to the amendments filed on 1/07/2026.
Response to Arguments
Applicant’s amendments, filed 1/07/2026, with respect to the double patenting rejection of claims 1-5, 7-12, 14-16, and 19-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of indefinite language in new claim 21.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claim 21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 21, the claim discloses wherein the LP-X methyl proton signal is well resolved from the LP-Z methyl proton signal within the zone. Examiner notes the phrase “well-resolved” is indefinite as it is a subjective measurement of clarity and furthermore, the specification offers no definition for what “well-resolved” means in the context of this invention. Therefore the meets and bounds of this embodiment are unclear, and the claim is considered indefinite.
Allowable Subject Matter
Claims 1-5, 7-12, 14-16, 19-20, and 22-23 are allowed. The following is a statement of reasons for indication of allowable subject matter:
Regarding Claim 1, Examiner notes the closest prior art to be Otvos(US8013602B2), Reeve (US7243030B2), and Otvos (US20170003269A1).
None of the prior art discloses or renders obvious the method as claimed comprising, “acquiring an NMR spectrum of a biosample obtained from the subject, wherein the NMR spectrum includes a zone from 0.75 ppm to 1.0 ppm; and programmatically determining the presence of at least one of LP-X or LP-Z in the biosample based on the NMR spectrum of the biosample, wherein the determining comprises application of a first deconvolution model that includes lipoproteins that are present in the zone for a typical human sample but excludes LP-X and LP-Z.”
Claims 2-5, 7-11, and 22 are allowed based on their dependence on Claim 1.
Regarding Claim 14, Examiner notes the closest prior art to be Otvos(US8013602B2), Reeve (US7243030B2), and Otvos (US20170003269A1).
None of the prior art discloses or renders obvious the system as claimed comprising, “an NMR spectrometer for acquiring a measured lipid signal lineshape of an NMR spectrum of a biosample, wherein the NMR spectrum includes a zone from 0.75 ppm to 1.0 ppm; a computer program means for storing the measured lineshape of the sample… and a computer program means for comparing the measured lipid signal lineshape and the calculated lineshape to determine the degree of correlation between the calculated lineshape and the measured lipid signal lineshape.”
Claims 15-16 and 23 are allowed based on their dependence on Claim 14.
Regarding Claim 19, Examiner notes the closest prior art to be Otvos(US8013602B2), Reeve (US7243030B2), and Otvos (US20170003269A1).
None of the prior art discloses or renders obvious the non-transitory computer readable medium as claimed comprising, “a computer readable program code that obtains NMR signal spectra that includes a zone from 0.75 ppm to 1.0 ppm, wherein the zone comprises an LP-X methyl proton signal at a first region, an LP-Y methyl proton signal at a second region, and an LP-Z methyl proton signal at a third region; and a computer readable program code that determines the concentration of LP-X in the biosample.
Claim 20 is allowed based on its dependence on Claim 19.
Conclusion
Applicant's amendment necessitated the new ground 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 NYLA GAVIA whose telephone number is (703)756-1592. The examiner can normally be reached M-F 8:30-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached at 571-270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NYLA GAVIA/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2857