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 22 December, 2025. Claims 1-16 are pending in the instant application. Applicants’ election of Group I (claims 1-11) with traverse is noted. It was argued that an undue examination burden was not present because the groups could all be searched concomitantly. Applicants’ arguments have been carefully considered but are not deemed to be persuasive for the reasons of record clearly set forth in the last Office action.
35 U.S.C. § 119
Acknowledgment is hereby made of Applicants’ claim for foreign priority based on AR P2020/0103102, filed 09 November, 2020. While a certified copy of the application has been received, Applicants failed to provide an English translation of this application as required by 35 U.S.C. § 119(b)(3). Accordingly, the foreign priority claim has NOT been entered.
37 C.F.R. § 1.98
The information disclosure statement filed 07 December, 20203, has been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 09 May, 2023, have been reviewed and are acceptable.
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 1-11 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.
Claim 1 references a DNA construct comprising a nucleotide sequence encoding a 3C protease and modified translation start codon. This claim is vague and indefinite because the nature of the modification is not readily apparent. Accordingly the metes and bounds of the patent protection desired cannot be readily ascertained.
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 1-11 are rejected under 35 U.S.C. § 103 as being unpatentable over Mignaqui et al. (2020), in view of Mignaqui et al. (2019) and Pöyry et al. (2011). The claims are directed toward a DNA construct capable of producing foot-and-mouth disease virus (FMDV) empty capsids, wherein the construct contains a nucleotide sequence encoding a P1 polyprotein, a nucleotide sequence encoding a 3C protease, a promoter, and a modified translation start codon in the 3C protease coding portion. Additional limitations are directed toward the construct sequence and promoter requirements.
Mignaqui et al. (2020) provides a DNA construct capable of producing FMDV empty capsids comprising a P1 coding region, 3C protease coding region, and promoter (see MATERIALS AND METHODS, Plasmids and Production of Recombinant VLPs, p. 3). This teaching does not disclose a modified 3C protease translation initiation codon. However, Mignaqui et al. (2019) teaches that overexpression of the 3C protease can have deleterious effects on eukaryotic cells. Moreover, Pöyry et al. (2011) teach that modification of the translation initiation codon provides much weaker translation. 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 modify the DNA construct of Mignaqui et al. (2020), to include a modified translation initiation codon for the 3C protease as suggested by Mignaqui et al. (2019) and Pöyry et al. (2011). Modification of this initiation codon would have reasonably been expected to produce a DNA construct with improved properties and FMDV VLP production.
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.
Information regarding the status of an application may be obtained from the Patent Center. Status information for published applications may be obtained from the Patent Center. Status information for unpublished applications is available through the Patent Center for authorized users only. Should you have questions about access to Patent Center, 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.
Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 04 April, 2026
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