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 12 March, 2026. Claims 1-44 are pending in the instant application. Applicant’s election of Group I (claims 1-7) without traverse is noted. Claims 8-44 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 20 June, 2023, 26 June, 2023 (2), 17 August, 2023, 06 November, 2023, 10 January, 2024, 18 October, 2024, 12 December, 2024, 07 January, 2025, 12 March, 2025, 02 May, 2025, 21 May, 2025, and 12 March, 2026, 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 14 April, 2023, have been reviewed and are acceptable.
Claim Objections
Claims 1-7 are objected to because of the following informalities: claim 1 references a nucleic acid encoding “the nucleic acid molecule encodes amino acids 19 to 1276 of SEQ ID NO: 1 the nucleic acid molecule encodes the amino acid sequence f SEQ ID NO: 1” which should read “the nucleic acid molecule encodes amino acids 19 to 1276 of SEQ ID NO: 1; the nucleic acid molecule encodes the amino acid sequence f SEQ ID NO: 1”. Appropriate correction is required.
35 U.S.C. § 112(b)
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.
Claims 3-7 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
The claims reference an immunogenic composition comprising an expression vector containing nucleic acids encoding a SARS-CoV-2 spike antigen. The term immunogenic references the ability of an immunogen (e.g., protein, polysaccharide, etc.) to provoke an immune response. Immunizing references the process of inducing immunity in a subject following the administration of a suitable vaccine composition. The composition comprising the expression vector containing the spike-encoding nucleic acid would not normally be immunogenic. Immunity would be induced by the expressed immunogen (spike protein). Amendment of the claim language to reference an “immunizing” composition comprising the expression vector would be acceptable.
Allowable Subject Matter
The modified SARS-CoV-2 spike protein (SEQ ID NO.: 1) appears to be free of the prior art and is allowable.
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, Michael Allen, Ph.D., can be reached at (571) 270-3497. 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 03 April, 2026
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