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 the Claims
Claims 3-6, 9-12, 18-24, 27, 29-31, 33, and 35-39 are cancelled.
Claims 1, 2, 7, 8, 13-17, 25, 32, and 34 are withdrawn.
Claims 26, 28, and 40 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group VII in the reply filed on 27 July 2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 2, 7, 8, 13-17, 25, 32, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 July 2026.
Drawings
The drawings are objected to because figures 1-10B are blurry. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The term “severe” in claim 26 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is nothing in the prior art that definitively defines what “severe COVID-19” is or at point a subject would pass from COVID-19 to “severe COVID-19”.
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 26, 28, and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon and an abstract idea) without significantly more. The claim(s) recite(s) a method for predicting the likelihood of a subject infected with SARS-CoV-2 to progressing to sever COVID-19. This judicial exception is not integrated into a practical application based on the reasoning below:
The unpatentability of laws of nature and abstract ideas was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S., (2010) (slip op., at 5). “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are directed to methods.
Step 2A, prong 1. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, where the claims recite a step of predicting if a subject will progress to severe COVID-19 from expression levels of specific genes, they encompass the mental comparison of data and the correlation of data and information to reach a conclusion. Further, the prediction is based on a law of nature or natural phenomenon because it is based on a level of a gene already occurring in the subject.
Step 2A, prong 2. Does the claim recite additional elements that integrate the exception into a practical application? No, the judicial exceptions to which the claims are directed are not integrated into a practical application because the rejected claims do not require any particular practical steps related to determining the presence of a SNP or an expression level and predicting severe COVID-19. The claims recite using a computer executable program, however reciting a generic computer does not overcome an eligibility rejection. The claims do not recite anything other than a trained classifier which is a computer executable program (claim 28).
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims only recite predicting severe COVID-19.
For these reasons, the claims are rejected under USC 35 section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 26, 28, and 40 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Daamen et al. (US 2023/0220470 A1, priority date of 11 May 2020).
Daamen et al. teach the active method steps of claims 26 and 28.
Regarding claim 26, Daamen et al. teach a method for determining a COVID-19 disease state of a subject comprising assaying a biological sample obtained from the subject to produce a gene expression data set. (claim 1). Daamen et al. teach determining gene expression measurements from the data set. (claim 1). Daamen et al. teach electronically outputting a report after computer processing the data to indicate the disease state of the subject. (claim 1).
Daamen et al. teach the use of a machine learning classifier to analyze the data set. (claim 19).
Regarding the genes in claim 26 and 40, Daamen et al. recite in claim 1 that genes in Table 6 are used for the analysis. Table 6 recites ADAM9, MCEMP1, MS4A4A, RAB10, EPHX2, RORA, GCLM, ARL4C, and ACSS1.
Daamen et al. define diagnose or diagnosis to include progression. [0118]. It is also noted that there is nothing in the claim to indicate what expression values or SNP absence or presence is associated with what outcome. Further, Daamen et al. state that some subjects are at an elevated risk of developing severe complications. [claim 40, 0038].
Regarding claim 28, Daamen et al. teach the use of a LASSO model, a ridge regression, a support vector machine, or a random forest classifier. [0069].
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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, Anne Gussow can be reached at (571) 272-6047. 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.
/MINDY G BROWN/ Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights