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 May, 2026. Claims 1-19 are pending in the instant application. Applicants’ election of Group IV (claims 1-6, 18, and 19) with traverse is noted. Applicant argued the claims are share a special technical feature. These arguments are not persuasive for the reasons of record previously set forth and in view of the art rejection set forth in this Office action. Claims 7-17 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.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 11 May, 2023, 10 June, 2024, and 05 May, 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 11 May, 2023, have been reviewed and are acceptable.
Claim Objections
Claims 1-6, 18, and 19 are objected to because of the following informalities: the term “FHV Antigen” should read “FHV antigen.” 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 18 and 19 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 18 references an “FHV Antigen encoding sequence encodes equal or less than 1400 amino acids” which is vague and indefinite because the precise metes and bounds of the patent protection desired cannot be readily ascertained.
Claim 19 references an “FHV Antigen encoding sequence is one FHV Antigen encoding sequence” which is vague and indefinite because the precise metes and bounds of the patent protection desired cannot be readily ascertained.
Appropriate clarification and correction are required.
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 1-6, 18, and 19 are rejected under 35 U.S.C. § 112(a), because the specification does not reasonably provide enablement for generic equine herpesviruses (EHV) comprising any given feline herpesvirus (FHV) antigen. 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 claims are enabled for EHV-1 viruses comprising FHV gD or gB antigens inserted into the specific regions noted.
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 claim breadth encompasses a large family of equine herpesviruses with different genotypic and phenotypic properties. Many of these viruses display considerable genetic diversity and attendant physical properties. The term EHV encompasses nine herpesviruses so far, of which EHV-1 (equine abortion virus), EHV-3 (equine coital exanthema virus), EHV-4 (equine rhinopneumonitis virus), EHV-6 (asinine herpesvirus 1), EHV-8 (asinine herpesvirus 3) and EHV-9 (gazelle herpesvirus 1) belong to the genus Varicellovirus of the subfamily Alphaherpesvirinae. The other three viruses, EHV-2, EHV-5 and EHV-7 (asinine herpesvirus 2), belong to the Gammaherpesvirinae subfamily. The horse is the natural host to EHV-1, -2, -3, -4 and -5 while the donkey is the host to EHV-6, -7 and -8. EHV-9 is a neurotropic virus that was originally isolated from gazelle (Ma et al., 2013; Ata et al., 2018; Bryant et al., 2018; Liu et al., 2025).
However, the specification only provides a limited number of working embodiments involving EHV-1 encoding two FHV antigens, gD and gB. These glycoproteins were inserted into the ORF70 region. The specification fails to identify any other EHV-1 variants or other FHV antigens.
Moreover, the disclosure fails to provide adequate guidance with respect to the utilization and identification of other suitable EHVs that will provide suitable feline vaccine delivery vehicles. The EHVs are genotypically and phenotypically distinct viruses with different pathogenicities. For example, these viruses are responsible for respiratory, urogenital, and neurological disorders in equids. Thus, it is not readily manifest which additional EHVs would prove useful as feline vaccine delivery vehicles.
Accordingly, when all the aforementioned factors are considered in toto, the skilled artisan would reasonably conclude that undue experimentation would be required to make and/or use the invention commensurate in scope with these claims.
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 29 July, 2026
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