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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 26 June 2024, in which applicant claims 1-16. Therefore, claims 1-16 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 9-15 drawn to a method to treat a disease comprising a composition comprising a transgenic hookworm configured to release at least one therapeutic agent in the reply filed on 16 September 2026 is acknowledged.
Claims 1-8 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 9-15 are under current examination.
Priority
This application was filed 06/26/2024, which claims benefit to the Provisional Application 63510315 filed on 06/26/2023. Thus, the earliest possible priority for the instant application is 06/26/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawdon et al., (US20190069528A1; cited in IDS filed 06/05/2025; hereinafter “Hawdon”).
With respect to claims 9-14, Hawdon discloses a composition for the treatment or prevention of viral infection (limitation of instant claim 14, [0132]) in a patient in need (Abstract),
the composition comprising a transgenic hookworm configured to release at least one therapeutic agent (e.g., therapeutic polypeptides, [0004], [0010], [0124]), the transgenic hookworm comprising a hookworm genome with a configurable chassis inserted ([0020], [0147]), the configurable chassis comprising
at least one transgenic DNA sequence encoding at least one therapeutic agent, wherein the at least one transgenic DNA sequence encodes the at least one therapeutic agent (e.g., nucleic acid sequence encodes a vaccine antigen and/or a therapeutic polypeptide, [0008]).
at least one promoter DNA sequence operatively linked to the at least one transgenic DNA sequence ([0008]), the at least one promoter DNA sequence encoding at least one promotor configured to drive expression of the at least one transgenic DNA sequence (i.e., EFT-3. [00418], [0026], claim 15 and 36; limitation of instant claims 10-11); and
at least one regulatory DNA sequence operatively linked to the at least one transgenic DNA sequence ([0008]; [0012]), the at least one regulatory DNA sequence encoding signaling peptide ASP-1 ([0018], [0161], limitation of instant claims 12-13) configured to enhance production of the at least one therapeutic agent [0051].
administering the transgenic hookworm to the gut of the subject ([0087], [0124]).
With respect to claim 15, Hawdon discloses that the transgenic hookworm is administered by oral administration of transgenic hookworm larvae ([0006], [0021], [0105], [0109], claim 40, )
Accordingly, Hawdon anticipates the instant claims 9-15.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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, Christopher Babic, can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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