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 .
Election/Restrictions
Applicant's election with traverse of claims 1-12 in the reply filed on July 6, 2026 is acknowledged. The traversal is on the ground that Otvos does not teach the special technical feature shared by independent claims 1, 13 and 25, specifically an NMR spectra comprising a signal from a choline head group of an SPC. The argument is not persuasive because Otvos explicitly discloses an NMR spectra comprising a signal from a choline head group of an SPC (see Fig. 1 illustrating spectra showing signals in the region between 3.20 and 3.30 ppm, which encompass the claimed SPC signal). It should be noted that the common technical feature shared by the inventions is an NMR spectra of a blood plasma/serum sample. Even though the claimed SPC signal is not relevant to Otvos, Otvos nevertheless discloses an NMR spectra that includes the claimed SPC signal.
For the foregoing reason, the requirement is still deemed proper and is therefore made FINAL. Claims 13-32 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 13, 2023 and March 27, 2026 are being considered by the examiner.
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 7, 9, 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are use claims, which do not fall within at least one of the four categories of patent eligible subject matter. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 7, 9, 11 and 12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7, 9, 11 and 12 are indefinite because they are use claims. A method is defined by its step(s). Consequently, a use claim that does not set forth any step(s) of how the use is achieved renders the claim indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otvos et al. (“Otvos”) (US 2017/0003269 A1).
With respect to claim 1, Otvos teaches a 1H-NMR spectroscopic molecular marker for identifying a medical risk (see abstract), wherein the marker comprises a combination of NMR intensity signals having magnitudes that are significantly different from NMR intensity levels of a healthy patient (see Fig. 1), the marker including a Glyc signal from at least one N-acetyl (-NCOCH3) glycoprotein (Glyc A and Glyc B, see Fig. 1) and an SPC signal from a choline head group (+N-(CH3)3) of a supramolecular phospholipids cluster (SPC) present in HDL and LDL lipoprotein subfractions (see signals in regions 3.20 ppm to 3.30 ppm).
With respect to claims 2-4, the spectra spans chemical shift regions from 5.3 ppm to 1.3 ppm (see Fig. 1), which encompasses all of the claimed regions and subregions.
With respect to claim 5, the spectra further exhibits a ratio of NMR peak intensities of Glyc to NMR peak intensities of SPC (see Fig. 1).
With respect to claims 7, 9, 11 and 12, as discussed above, the claims are indefinite and they do not fall within one of the four categories of patent eligible subject matter. Consequently, the subject matter of the claims is deemed to be encompassed by the marker of claim 1. Because the marker of claim 1 is taught by Otvos, the claims are deemed to be anticipated by Otvos.
With respect to claims 8 and 10, the NMR spectra is derived from a patient suffering from acute inflammation or cardiovascular disease (see abstract and [0085]), meaning the spectra can be used to identify the claimed risks.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimhofer et al. (“Kimhofer”) “Integrative Modeling of Quantitative Plasma Lipoprotein, Metabolic, and Amino Acid Data Reveals a Multiorgan Pathological Signature of SARS-CoV-2 Infection”(see IDS).
With respect to claim 1, Kimhofer teaches a 1H-NMR spectra of blood plasma (see left column, p. 4444) for identifying a medical risk (SARS-CoV-2, see abstract), wherein the marker comprises a combination of NMR intensity signals having magnitudes that are significantly different from NMR intensity levels of a healthy patient (see left column, p. 4444), the marker including a Glyc signal from at least one N-acetyl (-NCOCH3) glycoprotein (Glyc A and Glyc B, see right column, p. 4444) and signals corresponding to lipoproteins (see right column, p. 4444), which must include signals corresponding to a choline head group (+N-(CH3)3) of a supramolecular phospholipids cluster (SPC) present in HDL and LDL lipoprotein subfractions.
With respect to claims 2-4, based on the disclosure that NMR spectroscopy was performed on a sample of blood plasma containing glycoproteins and lipoproteins, it is evident that the NMR spectra includes all of the claimed regions and subregions.
With respect to claim 5, it is also evident that the spectra exhibits a ratio of NMR peak intensities of Glyc to NMR peak intensities of SPC.
With respect to claims 6, 8 and 10, the NMR spectra is derived from a patient suffering from SARS-Cov-2 (see abstract), which also encompasses acute inflammation and is considered a cardiovascular risk condition.
With respect to claims 7, 9, 11 and 12, as discussed above, the claims are indefinite and they do not fall within one of the four categories of patent eligible subject matter. Consequently, the subject matter of the claims is deemed to be encompassed by the marker of claim 1. Because the marker of claim 1 is taught by Kimhofer, the claims are deemed to be anticipated by Kimhofer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/ Primary Examiner, Art Unit 1796
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