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 .
Claims 1-20 are pending and examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 or 35 U.S.C. 119(e) as follows: none of 16/959867, 62/672,080, 62/671,680 or 62/613,658 provide a written description of an Fc fusion comprising a first Mxra8 region and a second Mxra8 region, wherein the first Mxra8 region and the second Mxra8 region are not the same. Accordingly, the instant claims are not given benefit of priority to 16/959867, 62/672,080, 62/671,680 or 62/613,658, but are considered to have the priority date of 9/22/2023.
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
(a)overall configuration
The instant clams are reliant on a genus of fusion proteins comprising a first and second Mxra8 region and an Fc. The claims do not limit the fusion protein to a monomeric Fc or dimeric Fc, or to attachment to the Fc from the carboxyl terminus of the Mxra8 to the amino terminus of the Fc attachment of the amino terminus of the Mxra8 to the carboxyl terminus of the Fc. The claims do not limit the order in which the second Mxra8regions occurs relative to the first Mxra8 region. The claims do not specify if the first and second Mxra8 region are attached to the same Fc. The specification discloses the fusion protein of SEQ ID NO:18 wherein the amino terminus of the Fc region is attached to the carboxyl terminus of the Mxra8 ectodomain. This fail to adequate describe the genus of multiple configurations of the Fc, first Mxra8 and second Mxra8 because the genus is highly varied encompassing structures unlike that of SEQ ID NO:18 in terms of order of the various components and the presence or absence of an Fc dimer.
(b)”Mxra8 region” and “D2” region.
When given the broadest reasonable interpretation, an MxRa8 region can be any portion of the Mxra8 protein. Claims 5 encompasses a genus of fusion proteins wherein the first Mxra8 region comprises a “D2” mammalian or mouse Mxra8 region as the “second” Mxra8 region. The specification fails to provide a written description of the mammalian or mouse D2 region, or the second Mxra8 region. The art teaches that the Mxra8 region, D1, is directly targeted by the Mxra8 virus, the sequence of D1 being species specific,, but that the Mxra8 region, D2, on the cell membrane interacts with the virus surface glycoproteins to stabilize the host-virus binding. The specification provides a written description of SEQ ID NO: 141-162 as Mxra8 D1 sequences. The specification teaches that the fusion protein comprises the ectodomain and a D1 region of SEQ ID NO: 141-162. The specification states that the fusion protein can also comprise the D2 mammalian region, including mouse D2, but this region is not described in terms of sequence. The prior art does not describe a mammalian D2 region or mouse D2 region for the arithrogenic alpha virus.
The specification describes the D2 regions in reference to the binding of the Mxra8 of the virus to the host cell observed using Cryo EM:
[0054] FIG. 36A-FIG. 36D is an exemplary embodiment showing cryo-EM reconstruction of duck MXRA8 bound to WEEV in accordance with the present disclosure. FIG. 36A is a cryo-EM density map of WEEV-VLP bound to duck MXRA8 at 4.74 Å resolution. WEEV-E1, WEEV-E2, and MXRA8 are colored as light-blue, dark-blue, and violet, respectively. Rotational symmetries along the 2-fold, 3-fold, and 5-fold axes are displayed with white numbers. FIG. 36B is a map of WEEV-VLP bound to duck MXRA8. Asymmetric unit contains the entire quasi 3-fold spike (q3), and a single icosahedral spike (i3) E1-E2 heterodimer. Shown are two views of the asymmetric unit, a side view (left, parallel with the viral membrane) and a top-down view (right, perpendicular with the viral membrane). Local resolution of map is colored from blue (4.25 Å) to white (5.25 Å) to red (6.25 Å). Density maps are viewed at contour level=0.26 (0.966). FIG. 36C is a surface diagram of MXRA8 at site 3, detailing the three unique viral E1-E2 heterodimer contacts, wrapped (light gray), intraspike (gray), and interspike (dark gray). FIG. 36D is a surface diagram of MXRA8 at site 3 and interacting E1-E2 heterodimers, termed: E1-E2-wrapped, E1-E2-intraspike, or E1-E2-interspike. MXRA8 D1: light magenta; MXRA8 D2: dark magenta; E1 domain I: light gray; E1 domain II: medium-gray; E1 domain III: dark-gray; E1-TM (black); E2 Å domain: light-cyan; E2 β-linker: medium-cyan; E2 B domain: dark-cyan; E2 C domain: medium-blue; E2-TM: dark-blue. See also FIG. 45A-FIG. 45D, FIG. 46, and TABLE 7-TABLE 9.
It is noted that Tables 8 and 9 provide contact residues between D2 regions and Mxra8. However, none of the cartoon diagrmas or lists of contact residues provide an adequate description of what a D2 region actually is in terms of a contiguous sequence that could be included in the claimed fusion protein. One of skill in the art would reasonably assume that applicant was not in possession of the genus of fusion protein at the time of filing.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 1-3, 9, 10, 12, 14, 15, 16, 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diamond et al (WO2019/136,316).
Diamond et al disclose the Mxra8 ectodomain fused to mouse Fc, wherein the molecule is a dimer (Figure 14a), thus meeting the limitations of a first and second Mxra8 region in the fusion protein of claims 1, 9 and 16, wherein the first and second regions are the same. Diamond et al disclose that fusion is a mouse Fc is IgG2b fused to the Mxra8 ectodomain (page 2, lines 9-11) which meets the limitation of claim 2, 3, 10 and 17. Diamond et al disclose that the dimer binds to the surface displayed E2 protein in virus infected cells (page 13, lines 2-10) which meets the limitation of claim 16. Diamond et al disclose that the subject is selected from the group consisting of: a mammal, such as a horse, dog, cat, sheep, pig, mouse, rat, monkey, hamster, guinea pig, chicken, and human., which meets the limitations of claim 14 and a chicken in claim 15. Diamond et al disclose that the administration of the fusion protein in a method of treating Mxra8-assoicated alpha virus (claims 6, 9 and 10 of ‘316) which reduces or prevents infection by the arthritogenic alphavirus (claim 11 of ‘316) and meets that limitation in instant claim 9. Diamond eet al disclose that the alphavirus is chikungunya, Ross River, Mayaro, and O’nyong nyong (ONNV) viruses (page 20, lines 9-11) which meets the limitations of claims 12 and 19.
All claims are rejected.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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