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 preliminary amendment, dated September 8, 2023, has been received. By way of this submission, Applicant has amended claims 1, 5-7, and 14-15, and introduced new claims 16-19.
Claims 1-19 are currently pending in the application and under examination before the Office.
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 1-19 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.
The claims additionally recite determining steps that are broad enough and simple enough that they can be done entirely within the human mind, which is another judicial exception. MPEP 2106.04(a)(2)(III).
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). Using known methods disclosed in the specification such as mass spectrometry or ELISA 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.
The claimed method does not affect any treatment step, or any steps at all beyond abstract ideas and observation of a natural phenomenon, and well-known, conventional methods to perform said observation.
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 1-19 are patent ineligible.
Conclusion
No claim is allowed.
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, 7:00 to 3:00.
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, Samira Jean-Louis can be reached at (571) 270-3503. 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.
/PETER JOHANSEN/Examiner, Art Unit 1644