18DETAILED 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 .
Preliminary Amendment
The preliminary amendment dated 10/25/2023 has been entered. Claims 1-14 and 24-31 are pending and under examination.
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. The earliest possible effective filing date for the instant claims is September 15, 2020 based on the filing date of the provisional application 63/078,614.
Objections
Drawings
The drawings are objected to because 37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."” In the current case, the view numbers for Figures 1-20 are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Objections
Specifications
The specification discloses in [0029]: Fig. 5C shows E1/E2 heterohexamer (PDB ID: 3J2W). Ca spheres indicate positions of escape mutations for DC2.M108 (cyan), DC2.M357 (magenta), as well as CHK-265 escape mutations against RRV (silver). E1 is colored gray. However, Fig. 5C is a black and white drawing and there is no indication of where these colors are.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention
Claim 31 recites the limitation "….biological sample comprising: - a first portion comprising a first plurality of anti-alphavirus antibodies of claim 1, wherein the antibodies are each attached….”. However, claim 1 only recites one antibody and not a plurality of antibodies.
Appropriate correction is required.
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 13-14 and 29-31 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention
1. Claims 13-14 and 29-30 are rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for the antibody of claims 1 and 2 to bind or cross-react typically with Chikungunya virus (CHIKV), Mayaro virus (MAYV) and O'nyong-nyong virus (ONNV), it does not reasonably provide enablement for (1) a method for treating any alphavirus infection in a subject (claim 13), (2) a method of inhibiting any alphavirus infection (claim 14), (3) reducing the activity of any alphavirus in a subject (claim 29), or (4) treating a disease, disorder, or condition mediated by, or related to increased activity of any alphavirus in a subject (claim 30). The specification also discloses in Fig. 15A the phylogenetic tree based on the structural polyprotein amino acid sequences of some alphaviruses (percent of identity): MAYV_guyane (60.2%), MAYV_TRVL4675 (60%), MAYV_BeH407 (60.0%), SFV_T88/11 (62%), RRV_T48 (61%), ONNV_SG650 (84.7%) and CHKV_LR2006OPY (97.4%) in comparison with CHKV_AF15661 (100%) showing how different these sequences can be. The potency and efficacy of the antibody will depend on the specific virus. Therefore, there is no nexus between the antibody recited in claims 1 and 2 and (1) the ability to treat any alphavirus infection (2) the ability of that one antibody to inhibit any Alphavirus infection or (3) reducing the activity of any Alphavirus or (4) treating a disease caused by any Alphavirus based on the information disclosed in the specification. Thus, 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 use the invention commensurate in scope with these claims.
Since the instant claims are not limited to these examples, the claims exceeds the scope described in the specification.
MPEP 2164.03 states that
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention.
MPEP 2164.03 further states that
The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. …
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
MPEP 2164.08(b) states that
The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).
Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable. A disclosure of a large number of operable embodiments and the identification of a single inoperative embodiment did not render a claim broader than the enabled scope because undue experimentation was not involved in determining those embodiments that were operable. In re Angstadt, 537 F.2d 498, 502-503, 190 USPQ 214, 218 (CCPA 1976). However, claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.
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 use the invention commensurate in scope with these claims.
2. Claim 31 is rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for an assay to detect an alphavirus in a biological sample comprising: (a) a first portion comprising the anti-alphavirus antibody of claims 1 and 2, it does not reasonably provide enablement for a second portion comprising a second plurality of anti-alphavirus antibodies. Since these antibodies have not been defined in the claims and the specification does not provide any further information about this second plurality of antibodies, 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 use the invention commensurate in scope with these claims.
Since the instant claims are not limited to by any examples, the claims exceeds the scope described in the specification. See the MPEP sections described above. 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 use the invention commensurate in scope with these claims.
Allowable Subject Matter
The following sequences are free of art:
(a) An alphavirus antibody or alphavirus binding fragment thereof comprising a heavy chain variable domain (SEQ ID NO: 199 and a light chain variable domain (SEQ ID NO: 200), wherein: the VH comprises a VH-CDR1 sequence, a VHl-CDR2 sequence, and a VH-CDR3 sequence and the VL comprises a VL-CDR1 sequence, a VL-CDR2 sequence, and a VL-CDR3 sequence:
(i) VH CDRs: SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3 respectively, and VL CDRs: SEQ ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6, respectively.
Conclusion
Claims 1-12 and 24-28 are allowed.
Claims 13-14 and 29-31 are rejected.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671