Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 20 January, 2023. Claims 1-20 are pending in the instant application.
37 C.F.R. § 1.98
The information disclosure statements filed 20 January, 2023, and 10 May, 2023, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 20 January, 2023, have been reviewed and are acceptable.
35 U.S.C. § 112(a)
The following is a quotation 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.
Scope of Enablement
Claims 1-18 are rejected under 35 U.S.C. § 112(a), because the specification does not reasonably enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The claims are directed toward a method for detecting one or more of SARS-CoV-2 virus omicron, alpha, beta, delta and/or gamma in a sample, the method comprising:
(i) sequencing a nucleic acid comprising a nucleic acid having at least 80% identity to a nucleic acid corresponding to positions 76 to 645 of the nucleic acid as set forth in SEQ ID NO. 1, wherein the sequenced nucleic acid has a length of at most 1500 nucleotides; and wherein the nucleic acid has been derived from the sample; and
(ii) identifying from the sequenced nucleic acid (iia) one or more nucleotide replacement(s) at positions corresponding to positions 76, 77, 78, 238, 239, 240, 412, 413, 414, 424, 425, 426, 466, 467, 468, 568, 569, 570, 643, 644, and 645 of the nucleic acid as set forth in SEQ ID NO. 1; and/or (iib) one or more nucleotide deletion(s) in the sequenced nucleic acid at positions corresponding to positions 205, 206, 207, 208, 209, 210, 430, 431, 432, 469, 470, 471, 472, 473 and 474 of the nucleic acid as set forth in SEQ ID NO. 1; and
(iii) correlating the one or more nucleotide replacement(s) and/or one or more nucleotide deletion(s) with the presence of one or more of SARS-CoV-2 virus omicron, alpha, beta, delta and/or gamma.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
The claims recite a large number of nucleotide substitutions (e.g., 76, 77, 78, 238, 239, 240, 412, 413, 414, 424, 425, 426, 466, 467, 468, 568, 569, 570, 643, 644, and 645) within the SARS-CoV-2 S gene or a large number of deletions (e.g., 205, 206, 207, 208, 209, 210, 430, 431, 432, 469, 470, 471, 472, 473 and 474) within the S gene. However, the disclosure fails to clearly set forth how any given combination of nucleotide substitutions and deletions correlates with the genotype of the virus (e.g., omicron, alpha, beta, delta, or gamma). For example, looking at Fig. 2, the different viruses appear to display overlapping genotypes. Some share similar changes and some don’t share any common alteratons. Thus, simply measuring a single nucleotide alteration would be unlikely to accurately detect the genotypic and phenotypic properties of the virus.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that undue experimentation would be required to practice the claimed invention in a manner commensurate in scope with the claims.
Joint Inventors, Common Ownership Presumed
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Ko et al. (2022). The claims are directed toward a kit comprising components that are capable of amplifying the SARS-CoV-2 spike gene. Ko et al. (2022) provide primers for the amplification of spike gene fragments that can be subjected to sequence. This process enabled the accurate detection of various viral genotypes. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these primers in a kit for rapid distribution. It would also have been prima facie obvious to design various primer sets, including those set forth in SEQ ID NOS.: 28 and 29, for amplification purposes. Absent evidence to the contrary, the generation of primers is routine and conventional in the art.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Janet L. Andres, Ph.D., can be reached at (571) 272-0867. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 30 September, 2025