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 .
Applicant's response to the previous Office action, dated August 18, 2026, and supplemental response, dated September 7, 2026, have been received. By way of these submissions, Applicant has amended claims 1, 3-5, 12-15, 17, and 19, cancelled claims 2, 6, and 16, and introduced new claims 20-23.
Claims 1, 3-5, 7-15, and 17-23 are pending in the application. Newly submitted claims 20-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features because even though the inventions of these groups require the technical feature of determining the amount of 2-thiomethyl,6-threonylcarbamoyl adenosine (ms2t6A) in a sample derived from the subject, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of He (J Am Soc Mass Spectrom. 2019 Jun;30(6):987-1000).
He teaches a method of quantification of nucleosides and nucleotides from biological samples such as human plasma or urine by mass spectrometry (abstract and page 988, right column, third paragraph). He further teaches that the nucleosides and nucleotides to be quantified include 2-Methylthio-N6-threonylcarbamoyladenosine (ms2t6a), and adenosine (Table 1).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1, 3-5, 7-15, and 17-19 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 18, 2026.
Claim Interpretation
The claims as amended recite the limitation of "determining that the mammalian subject is at risk of suffering or is suffering from COVID-19 if the amount of t6A or ms2t6A in the sample is a set multiple of the amount of adenosine in the sample". While the specification does not recite the limitation of a "set multiple" in haec verba, page 16 of the specification recites that "if the amount of t6A in the blood sample exceeds at least 3 times, preferably 5 times, more preferably 10 times the serum adenosine, it can be determined the subject from which the blood sample is derived suffers or is at risk of suffering from COVID-19. If the amount of ms2t6A in the blood sample exceeds at least 2 times, preferably 3 times, more preferably 5 times the serum adenosine, it can be determined the subject from which the blood sample is derived suffers from or is at risk of suffering from COVID-19."
Under the broadest reasonable interpretation of the term "set multiple", if the amount of t6A in the blood sample exceeds at least 3 times the amount of adenosine in the sample, or if the amount of ms2t6A in the blood sample exceeds at least 2 times the amount of adenosine in the sample, then the subject suffers from or is at risk of suffering from COVID-19.
Response to Arguments
Applicant argues that the claims as amended add further detail regarding the steps in the claimed methods, and that the present methods are not directed to laws of nature; specifically, obtaining a sample and performing detections and comparisons cannot be done entirely within the human mind, and the step of treating a subject in claims 13 and 14 adds meaningful limitations to the claimed method. Applicant further argues that the claimed methods are not based solely on any law of nature. Applicant further argues that the obtaining a sample and detecting steps in each independent claim are not presently known.
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated previously, the law of nature recited in the claims is the correlation between levels of t6A and/or ms2t6A and COVID-19 disease. The claims do not integrate this judicial exception into a practical law of nature, as the step of detecting an amount of a modified nucleoside in a sample is well-understood, routine, conventional activity in the field. For example, He (J Am Soc Mass Spectrom. 2019 Jun;30(6):987-1000) teaches a method of quantification of nucleosides and nucleotides from biological samples such as human plasma or urine by mass spectrometry (abstract and page 988, right column, third paragraph). He further teaches that the nucleosides and nucleotides to be quantified include 2-Methylthio-N6-threonylcarbamoyladenosine (ms2t6a), and adenosine (Table 1). Using known methods disclosed in the specification such as mass spectrometry to detect a modified nucleoside in a sample would have been a routine, conventional choice, and as such does not offer significantly more than the exception itself. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, does not add "significantly more" to a judicial exception. MPEP 2106.05(I)(A).
Likewise, the steps of comparing and determining rely solely upon critical thinking, which the courts have determined to represent abstract ideas. University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014). This includes performing clinical tests on individuals to obtain input for an equation, as such a step is considered to be mere data gathering. In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989).
The step of correcting relies upon applying a mathematical formula, which is also a judicial exception. MPEP 2106.04(a)(2)(I).
The steps of treating the subject for COVID-19 also do not integrate the judicial exception into a practical application in Step 2A Prong Two or recite significantly more than a judicial exception in Step 2B, as the treating step is recited at a high level of generality. This does nothing more than instruct the practitioner to "apply" the judicial exception. The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). MPEP 2106.04(d)(2)(a).
Applicant's amendments to the claims do not integrate the judicial exception of correlation between levels of t6A and/or ms2t6A and COVID-19 disease into a practical application, for all of the above reasons. As such, the claims do not offer significantly more than the judicial exception itself, and are not patent eligible.
The rejection under 35 U.S.C. 101 of claims 1, 3-5, 7-15, and 17-19 is therefore maintained.
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 1, 3-5, 7-15, and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a law of nature, a natural phenomenon, or an abstract idea. This judicial exception is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981); see also Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010). "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, 70, 175 USPQ 673, 676 (1972). The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it." See, e.g., Gottschalk at 71–72. Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, the neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious [pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978); see also Bilski: "[T]he prohibition against patenting abstract ideas 'cannot be circumvented by' . . . adding 'insignificant post-solution activity'" (quoting Diehr, at 191-192).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
The first step under this guidance is determining if the claim is directed to one of the four statutory categories (process, machine, manufacture, or composition of matter). In this case, the claims are a method (process). The second step is determining if the claims recite or involve judicial exception(s), such as laws of nature, natural phenomena, natural products, or an abstract idea. In this case, the claims are drawn to methods for determining a treatment policy of a subject suffering from or predicted to be suffering from COVID-19, comprising detecting an amount of a modified nucleoside which is 6-threonylcarbamoyl adenosine (t6A) and/or 2-thiomethyl,6-threonylcarbamoyl adenosine (ms2t6A) in a sample derived from the subject. This is a natural correlation/observation of a natural phenomenon, the correlation between levels of t6A and/or ms2t6A and COVID-19 disease, which is a judicial exception.
Furthermore, the judicial exceptions are not integrated into a practical application, as the claims do not rely on or use the exceptions in a further step. See MPEP 2106.04(d). Thus, it must be determined if the claim as a whole recites something significantly more than the judicial exceptions.
The methods recite a step of detecting an amount of a modified nucleoside in a sample. This is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality), as evidenced by Applicant's specification at para. 0024 and 0034. See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). Furthermore, He (J Am Soc Mass Spectrom. 2019 Jun;30(6):987-1000) teaches a method of quantification of nucleosides and nucleotides from biological samples such as human plasma or urine by mass spectrometry (abstract and page 988, right column, third paragraph). He further teaches that the nucleosides and nucleotides to be quantified include 2-Methylthio-N6-threonylcarbamoyladenosine (ms2t6a), and adenosine (Table 1). Using known methods disclosed in the specification such as mass spectrometry to detect a modified nucleoside in a sample would have been a routine, conventional choice, and as such does not offer significantly more than the exception itself. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, does not add "significantly more" to a judicial exception. MPEP 2106.05(I)(A).
The steps of comparing and determining rely solely upon critical thinking, which the courts have determined to represent abstract ideas. University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014). This includes performing clinical tests on individuals to obtain input for an equation, as such a step is considered to be mere data gathering. In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989).
The step of correcting relies upon applying a mathematical formula, which is also a judicial exception. MPEP 2106.04(a)(2)(I).
The steps of treating the subject for COVID-19 also do not integrate the judicial exception into a practical application in Step 2A Prong Two or recite significantly more than a judicial exception in Step 2B, as the treating step is recited at a high level of generality. This does nothing more than instruct the practitioner to "apply" the judicial exception. The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). MPEP 2106.04(d)(2)(a).
The remaining claims further characterize the exception itself, e.g., additional details for the sample or patient, and do not add significantly more.
Therefore, claims 1, 3-5, 7-15, and 17-19 are patent ineligible.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1644
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