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 without traverse of Group I (claim 1) in the reply filed on 7/9/2026 is acknowledged.
Applicant's election with traverse of species primer set (ii) in the reply filed on 7/9/2026 is acknowledged. The traversal is on the ground(s) that there is no search or examination burden. This is not found persuasive because search and/or examination burden are not considered for Lack of Unity restrictions.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 7-10, 19-20, 23-26 and 34-41 have been withdrawn as being directed to a non-elected invention. Claim 1 is under examination at this time.
Specification
The disclosure is objected to because of the following informalities: Figures 2D and 5A contain nucleotide sequences without the appropriate sequence identifier (e.g., SEQ ID NO: X). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a primer that is at least 22 amino acids long and having at least 85% identity with SEQ ID NO:14 and a primer that is at least 21 amino acids long and having at least 85% identity with SEQ ID NO:15, does not reasonably provide enablement for a primer that is at least 15 amino acids long and having at least 85% identity with either SEQ ID NO:14 or 15. The specification does not 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 claim is directed to a composition for amplifying a SARS-COV-2 nucleic acid, the composition comprising, inter alia, a primer set comprising a first nucleic acid at least 15 nucleotides in length and having at least 85% sequence identity to SEQ ID NO: 14, and a second nucleic acid at least 15 nucleotides in length and having at least 85% sequence identity to SEQ ID NO:15.
However, one of ordinary skill in the art cannot make a primer that is, for example, 15 nt long and has 85% identity to either of SEQ ID NO: 14 or 15. Each of SEQ ID NOs: 14 and 15 are longer than 15 nt. For example, a primer that is 15 nt long cannot have at least 85% identity with SEQ ID NO: 14 [(15nt / 26nt) * 100 = 57.7%].
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim is directed to, a composition for amplifying a SARS-COV-2 nucleic acid, the composition comprising, inter alia, a primer set comprising a first nucleic acid at least 15 nucleotides in length and having at least 85% sequence identity to SEQ ID NO: 14, and a second nucleic acid at least 15 nucleotides in length and having at least 85% sequence identity to SEQ ID NO:15.
The written description rejection is made because the claim is interpreted as being drawn to a composition comprising a genus of first and second nucleic acids recited as having “at least 85% sequence identity” with instant SEQ ID NOs: 14 and 15. The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). While one would be able to construct variants of SEQ ID NOs: 14 and 15 and test them for their ability to function as a primer in an amplification assay, this process of guesswork does not put one in possession of the genus of first and second nucleic acids recited as having “at least 85% sequence identity” with instant SEQ ID NOs: 14 and 15. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the disclosure is the structure of the nucleic acids (i.e., SEQ ID NOs: 14 and 15) and the function of that structure (i.e., ability to function as a primer in an amplification assay). There is no disclosure of any particular portion of the structure that must be conserved or that can be altered in order to have “at least 85% sequence identity” to SEQ ID NOs: 14 and 15 and retain the ability to function as a primer in an amplification assay.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. A definition by function alone does not suffice to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is. EliLily, 119 F.3 at 1568, 43 USPQ2d at 1406.
The specification discloses at page 20 that in various embodiments, “the nucleic acid primer is complementary to a portion of the S144 allele and comprises a nucleic acid sequence having at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, at least 99%, or 100% identity to SEQ ID NO: 14 or 15.” However, the specification does not indicate which portions of SEQ ID NOs: 14 and 15 are essential to retain the ability to function as a primer in an amplification assay or which portions of SEQ ID NOs: 14 and 15 can be modified or altered and still retain the ability to function as a primer in an amplification assay.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of first and second nucleic acids recited as having “at least 85% sequence identity” with instant SEQ ID NOs: 14 and 15. Given that the specification has only described the structure and function of SEQ ID NOs: 14 and 15, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Allowable Subject Matter
A composition comprising a primer set comprising a first nucleic acid at least 26 nucleotides in length and having at least 85% sequence identity to SEQ ID NO: 14 and a second nucleic acid at least 24 nucleotides in length and having at least 85% sequence identity to SEQ ID NO:15 is free of the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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, Thomas Visone can be reached at 571-270-0684. 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.
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
Prosecution Insights