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 .
35 U.S.C. § 119
Acknowledgment is hereby made of Applicant’s claim for foreign priority based on KR 10-2022-0114175, filed 08 September, 2022, and KR 10-2022-0048696, filed 20 April, 2022. Copies of the foreign priority documents submitted under 35 U.S.C. § 119(a)-(d), have been received and placed of record in the file.
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 21 May, 2024. Claims 1-8 and 13-16 are pending in the instant application.
37 C.F.R. § 1.98
The information disclosure statement filed 21 May, 2024, 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 21 May, 2024, 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 1-8 and 13-15 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 simply references “High titer Japanese encephalitis virus genotype 5 K15P38-KNIH.” This claim language is vague and indefinite since it fails to set forth the salient characteristics of the virus. Is this virus present in a container or vial? Has this virus been isolated and purified or is it present in an infected cell line? Appropriate correction is required. Amendment of the claim language to reference an “isolated” and/or “purified” JEV K15P38-KNIH would be remedial.
Claims 1-8 all recite a “high titer” genotype 5 K15P38-KNIH JEV. However, the reference to a high titer is also vague and indefinite because this is a relative term which renders the claims indefinite. The term “high titer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While claim 4 recites an actual titer, this value is also vague and indefinite because the claim fails to recite any relevant identifying characteristics. For example, was this titer measured using a specific cell line or was murine cerebral tissue employed?
Claims 5-8 are additionally directed toward a method for producing a high titer JEV genotype 5 K15P38-KNIH virus comprising inoculating the cerebrum of a mouse and obtaining virus from it. However, the claims fail to set forth the original amount of inoculating virus, length of incubation in the mouse cerebrum, and any particular steps for assessing the titer of the KNIH virus after isolation. Accordingly, it is not readily manifest what constitutes a high titer in this setting.
Claims 13-16 reference a vaccine composition comprising JEV genotype 5 K15P38-KNIH. However, the salient characteristics of the vaccine composition are not readily manifest. Does the composition contain live-attenuated virus, inactivated virus, a subunit of the virus, or is the virus encoded by a viral vector? Appropriate clarification is required.
Claims 15 and 16 simply reference a vaccination method wherein a vaccine composition comprising JEV genotype 5 K15P38-KNIH is administered to a non-human animal. However, the method steps appear to be incomplete. In order to assess vaccine efficacy, the skilled artisan would typically need to examine certain parameters (e.g., the generation of a neutralizing antibody response or antiviral CTL response) in order to ascertain if the administration was effective at generating the requisite immune response. Appropriate clarification and correction are required.
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 26 June, 2026
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