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 .
The Notice of Allowability mailed on September 10, 2025 has been vacated and the Application has been withdrawn from issue. The prosecution is hereby reopened in order to make the following rejections. Claims 1-8 are pending and under examination in this Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are drawn to A chemical compound, comprising:
a protein conjugated to a virus particle,
wherein when the chemical compound is placed in an unrefrigerated environment at a storage temperature for a time period, a potency of the chemical compound at the end of the time period is at least 90% of an initial potency of the chemical compound, wherein the time period is at least 42 days after a release date of the chemical compound.
The claims are drawn to a large genus of proteins and virus particles that form the claimed chemical compound. The claims are rejected because Applicant’s specification does not provide sufficient written description support for the claimed genus of compounds and because the claims lack structure and function correlation, as further discussed below.
Applicant’s specification describes one representative species of the claimed compound, the influenza virus protein H7 and HA conjugated with the TMV virus particle. The Specification contemplates multiple other compounds comprising various virus particles and various antigens, Specification paragraph [0017].
The claims require that the potency of the claimed compound is maintained at least 42 days after a release date of the chemical compound. Thus, the claims require a certain property/function without providing a sufficient structure and function correlation.
Specification paragraph [0016] With regard to viruses, through the practice of some embodiments of an inventive virus purification platform described herein, purification of rod-shaped plant viruses (such as tobacco mosaic virus, i.e., “TMV”) and icosahedral plant viruses (such as red clover mosaic virus) has been achieved. According to multiple embodiments herein, purification of TMV and red clover mosaic virus was achieved, representing two structurally diverse viruses in terms of size and structure. For example, a smaller icosahedral virus like red clover mosaic virus has T=3 symmetry, dimensions of approximately 31-34 nm, and approximately 180 capsid proteins. Conversely, TMV is approximately 18 nm in diameter, 300 nm in length and contains 2160 capsid proteins.
Specification paragraph [0017] Based upon the successful purification of red clover mosaic virus and TMV, it is expected that the virus purification platform according to multiple embodiments and alternatives can successfully purify a wide array of virus particles including: viruses comprising a range of genetic materials (e.g. double- and single-stranded DNA viruses, and RNA viruses), geometries (e.g. rod-shaped, flexious rods, and icosahedral), and families (Caulimoviridae, Geminiviridae, Bromoviridae, Closteroviridae, Comoviridae, Potyviridae, Sequiviridae, Tombusviridae).
Specification paragraph [0025] With regard to antigens, through the practice of some embodiments of an inventive antigen purification platform described herein, the recombinant antigens H5 recombinant influenza hemagglutinin (rHA), H7 rHA, domain III of West Nile virus (WNV rDIII), and lassa fever virus recombinant protein 1/2 (LFV rGP1/2), H1N1 (Influenza A/Michigan), H1N1 (Influenza A/Brisbane), H3N2 (Influenza A/Singapore), H3N2 (Influenza A/Kansas), B/Colorado and B/Phuket have been produced and purified. Antigens for various embodiments herein can be from many sources, and may be produced using traditional recombinant protein manufacturing strategies, including bacterial, yeast, insect, mammalian or plant-based expression approaches.
Example 2 in Applicant’s specification describes the purification of rod-shaped TMV. Examples 3, 4 and 5 describe the production of recombinant antigen-virus conjugates and the conjugation of influenza virus protein H7 and HA to TMV.
The specification fails to provide a sufficient number of representative species to justify the present claim to the large genus of the claimed compounds comprising thousands of possible viruses like particles conjugated with thousands of possible antigens.
The art by Petukhova et al., (Viruses, 2014, p. 1789-1800 in IDS on July 12, 2024) disclose a viral particle of the tobacco mosaic virus conjugated to the M2e epitope of the influenza virus (see the entire document, particularly, Results and Figures 1-4). Petukhova et al. disclose M2e epitope of the influenza virus cloned cloned into the coat protein of the TMV virus.
Mallajosyula et al. (Human Vaccines, 2014, p. 586-595 in IDS on July 12, 2024) teaches a composition comprising Tobacco Mosaic Virus (TMV) antigen conjugated to influenza hemagglutinin antigen (HA) and a method for conjugating a protein and a virus comprising activating the virus particle and mixing the virus and the protein to form a conjugate (see the entire document, particularly Materials and Methods and Results on pages 587-593, Figure 2).
Based on the scientific publications, alone, the skilled artisan would have not been able to design various viral particle and antigen conjugates to satisfy the claimed genus.
The specification fails to provide a sufficient of the species of the claimed compounds to sufficiently represent the claimed genus. For these reasons the present claims are rejected for lack of written description support.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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