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 .
DETAILED ACTION
1. Claims 11, 14, 23 are amended. New claims 31-34 are added. Claims 10, 16, 22, 24-30 are canceled. Claims 1-9, 11-15, 17-21, 23, 31-34 are under consideration.
Declaration Submission
2. The Declaration under 37 CFR 1.130 filed 6/8/2026 is sufficient to overcome the rejection of claims 1, 2, 4, 5, 8, 9 based upon Laing et al. in view of Doyle et al. as set forth in the last Office action for the reasons as indicated below.
Specification
3. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claim 23 was rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing immune response and risk reduction, does not reasonably provide enablement for treating or preventing henipavirus infection.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
5. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 8, 9 were rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. ("Rescue and characterization of recombinant cedar virus, a non-pathogenic Henipavirus species," Virology Journal, Vol. 15: 56 (1-12))(2018))(cited in applicant's IDS submitted 6/25/2024) in view of Doyle et al. ("Functional cooperativity mediated by rationally selected combinations of human monoclonal antibodies targeting the henipavirus receptor binding protein," bioRxiv: 1-46 (2021))(cited in applicant's IDS submitted 6/25/2024).
Applicant contends: Doyle et al. is subject to disqualification as prior art under 35 U.S.C. 102(b)(1)(A); Rule 130 Declaration has been submitted.
In view of the submission and consideration of the Declaration, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claims 3, 6, 7, 18, 19, 23 were rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. in view of Doyle et al. as applied to claims 1, 2, 4, 5, 8, 9 above, and further in view of Stewart-Jones et al. (WO2020028902A1; previously cited).
In view of the withdrawal of the rejection over Laing et al. in view of Doyle et al. on which the instant rejection depends, the instant rejection is also withdrawn.
7. (previous rejection, withdrawn) Claims 20, 21 were rejected under 35 U.S.C. 103 as being unpatentable over Laing et al. in view of Doyle et al. and further in view of Stewart Jones et al. as applied to claims 3, 6, 7, 18, 19, 23 above, and further in view of Elhay et al. (WO2012158643A1; previously cited).
In view of the withdrawal of the rejection over Laing et al. in view of Doyle et al. on which the instant rejection depends, the instant rejection is also withdrawn.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. (previous rejection, maintained as to claims 11-13; new, necessitated by amendment as to claims 31, 32) Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tripodi et al. (US20210115472; previously cited) in view of Wang et al. (WO2014008263A2; previously cited), Stewart-Jones et al. (WO2020028902A1)(cited above), and Elhay et al. (WO2012158643A1)(cited above).
See claims 11-13 as submitted 6/8/2026.
Applicant contends: Tripodi et al. is focused on rabies virus vectors and does not provide any teachings, suggestions, or guidance that could have enabled a person of ordinary skill in the art to prepare chimera as claimed; the passing reference to Cedar virus in Table 1 would not have been sufficient to teach chimeras as claimed; those of ordinary skill in the art would not have found disclosure pertaining to rabies-based vectors to provide sufficient guidance to suggest or enable construction of chimeras as claimed; they have fundamentally different genomic organization, biology, envelope protein usage and assembly requirements; Stewart-Jones is focused on protein immunogens of henipavirus; nor does Stewart-Jones suggest or provide an expectation of success; Elhay et al. is also focused on protein immunogens; the disclosure in Elhay et al. does not suggest or provide an expectation of success; none of these references address or solve the problem of engineering CedV as claimed; it is only by using improper hindsight that the Office is able to arrive at the claimed subject matter; the cited references provide no such motivation and no expectation of success; in the context of a live virus, the encoded F/G envelope glycoproteins are not merely immunogens; those skilled in the art would have appreciated that the replication-competent virus chimeras cannot be constructed by “plug and play” techniques; the claimed chimeras make an important contribution; the chimeras can be readily propagated and used repeatedly.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
As to the new claims 31 and 32, respectively, it is noted that Tripodi et al. teaches carrier [0112]; as well as administration [0238].
Response to Arguments
Turning to applicant’s arguments, first, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is maintained that in view of the instant claim language, one of ordinary skill in the art would have had a motivation and reasonable expectation of success to arrive at the instant claims in view of Tripodi et al. in view of Wang et al., Stewart-Jones et al., and Elhay et al. (See MPEP 2143: Examples of Basic Requirements of a Prima Facie Case of Obviousness: I. EXEMPLARY RATIONALES: Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.).
With respect to the teachings or suggestions of Tripodi et al., Tripodi et al. is not so limited as applicant contends. While applicant contends that the reference is focused on rabies vector, on the contrary Tripodi et al. teaches or suggests: any mononegavirus may be used as the basis for a vector as described [0039](See MPEP 2121: I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). … See also MPEP 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012). … See also MPEP 2121.01: II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART: “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instrumentsv.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991)).
Further, Tripodi et al. teaches: the vector genome may comprise one or more heterologous genes [0055]; thus the heterologous gene(s) may encode any expression product (whether RNA or protein) which it is desired to express in the target cell [0055]. As previously indicated, Stewart-Jones et al. teaches: Nipah virus immunogens (abstract); nucleic acids encoding the immunogens (abstract); including F ectodomain trimers; G ectodomains (abstract); including from Malaysian strains and Bangladeshi strains (p. 16); wherein F protein is envelope glycoprotein of NiV (p. 16); wherein G glycoprotein is an envelope glycoprotein (p. 16); wherein henipavirus is also Hendra virus (p. 30); formulated with carrier (p. 47); administering to subject as part of vaccination (p. 45). Elhay et al. also teaches: immunogenic compositions comprising G glycoprotein from Hendra virus and/or Nipah virus (p. 1).
Applicant has not appeared to present evidence to the contrary, rather attorney argument (See MPEP 716.01(c): The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
Further, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, as indicated above and previously, Tripodi et al. in view of Wang et al., Stewart-Jones et al., and Elhay et al. not only teaches wherein any mononegavirus may be used as the basis for a vector as described, as well as use of one or more heterologous genes as taught more specifically by Stewart-Jones et al., and Elhay et al.
With respect to a reasonable expectation of success, in view of the instant claim language and absent unexpected results or evidence to the contrary, there would have been a reasonable expectation of success given the underlying materials (vectors and heterologous genes as taught by Tripodi et al. and coding sequences as taught by Stewart-Jones et al., and Elhay et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art. (See MPEP 2143.02, part II (requiring only at least some degree of predictability, not complete confidence in a desired outcome). To reiterate as indicated above, applicant has not appeared to present evidence to the contrary, rather attorney argument (See MPEP 716.01(c): The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
The rejection is maintained and extended for reasons of record.
9. (previous rejection, maintained as to claims 14, 15, 17; new, necessitated by amendment as to claims 33, 34) Claims 14, 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tripodi et al. (US20210115472)(cited above) in view of Wang et al. (WO2014008263 A2)(cited. above) and Stewart-Jones et al. (WO2020028902A1)(cited above).
See claims 14, 15, 17 as submitted 6/8/2026.
It is noted that applicant has not addressed the instant rejection separately, rather in combination with the rejection above regarding the instant references.
As indicated above with respect to the instant references, applicant’s arguments are considered but found unpersuasive.
See the rejection in the previous Office Action. As to the new claims 33 and 34, respectively, it is noted that Tripodi et a. teaches carrier [0112]; as well as administration [0238].
See the response above with respect to the instant references Tripodi et al., Wang et al. and Stewart Jones et al.
The rejection is maintained and extended for reasons of record.
Conclusion
10. Claims 1-9, 18, 19, 20, 21, 23 are allowed.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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