DETAILED CORRESPONDENCE
Application Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s amendment to the claims filed on 01/15/2026 in response to the Non-Final Rejection mailed on 09/15/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
3. Claims 1-15 are pending.
4. Claims 13-15 stand withdrawn pursuant to 37 CFR 1.142(b).
5. Applicant’s remarks and declaration under 1.130 filed on 01/15/2026 in response to the Non-Final Rejection mailed on 09/15/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
6. The IDS filed on 03/12/2026 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Claim Rejections - 35 USC § 112(b)
7. The rejection of claims 1-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for indefiniteness is maintained for the reasons of record and the reasons set forth below.
Regarding claims 1 (claims 3-5, 7-12 dependent therefrom), 2, and 6, the recitation of limitations within parentheses is indefinite because it is unclear whether or not the limitations are intended to be a part of the claimed invention. Accordingly, the metes and bounds of the invention cannot be ascertained. In the interest of compact prosecution, the limitations within the parentheses will be interpreted as not required in the claim. It is suggested that applicants clarify the meaning of the claims.
RESPONSE TO REMARKS: Beginning on p. 4 of applicants’ remarks, applicants in summary contend that the claim has been amended to delete “optionally” and the rejection should be withdrawn.
This argument is found to be not persuasive because the indefiniteness arises from the parentheses recited in the claim. As stated in the rejection above, it is unclear whether or not the limitations in the parentheses are intended to be a part of the claimed invention.
Claim Rejections - 35 USC § 103
8. The rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Wressnigg et al. (Vaccine, 2009; cited on IDS filed on 08/02/2024) in view of of Zhou et al. (Nature, 02/03/2020; cited on IDS filed on 08/02/2024) is withdrawn in view of applicants’ amendment to claim 6 to require each of the point mutations recited in the claims.
9. The rejection of claims 1-12 under 35 U.S.C. 103 as being unpatentable over Wang et al. (Therapeutics and Prevention, published 09/17/2019; cited on IDS filed on 12/11/2023) in view of Zhou et al. (Nature, 02/03/2020; cited on IDS filed on 08/02/2024) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to address applicants’ amendment to the claims.
9. As amended, claims 1-9 are drawn to a live attenuated chimeric virus comprising (a) an influenza B virus genome, wherein the influenza B virus genome comprises a deletion of a virulence factor activity (DELNS1-B), and a mutation to a parent virus genome, of M(A281G) and one or more mutations selected from the group consisting of PA (T210C), NA T(1424C), and NP(C182T), and (b) an insertion of one or more genes encoding one or more Sars-CoV-2 antigens (CoV2Ag).
Claims 10-12 are drawn to a pharmaceutical composition comprising an effective amount of the live attenuated chimeric virus of claim 1.
10. With respect to claim 1, Wang et al. teach a live attenuated chimeric virus comprising an influenza B virus genome comprising a deletion of the DELNS1-B that can used to enhance specific anti-influenza immunity through expression of additional antigens from the deleted-NS1 site and two adaptive mutation located in the NP and NEP genes [see Abstract; p. 3, bottom]. Wang et al. teach adaptive mutations located in the NP gene, PA segment, NA gene and M [see Figure 5] which is interpreted as reading on the limitations in view of the indefiniteness of the parentheses (see 112(b) rejection above).
With respect to claim 2, Wang et al. teach the live attenuated chimeric virus wherein the virus genome is from influenza B [see Abstract; p. 2-3].
With respect to claim 3, Wang et al. teach the live attenuated chimeric virus wherein the influenza B virus is not able to replicate in interferon-competent cells [see p. 5, bottom].
With respect to claim 4, Wang et al. teach the live attenuated chimeric virus wherein the deletion of virulence factory activity comprises deletion of at least part of a virulence factor gene [see Abstract; p. 2-3].
With respect to claim 5, Wang et al. teach the live attenuated chimeric virus wherein the deletion comprises a complete deletion of NS1 [see Abstract; Figure 1; p. 2-3].
With respect to claim 6, Wang et al. teach a live attenuated chimeric virus comprising an influenza B virus genome comprising a deletion of the DELNS1-B that can used to enhance specific anti-influenza immunity through expression of additional antigens from the deleted-NS1 site and two adaptive mutation located in the NP and NEP genes [see Abstract; p. 3, bottom]. Wang et al. does teach adaptive mutations located in the NP gene, which is interpreted as reading on the optional limitations in view of the indefiniteness of the parentheses (see 112(b) rejection above).
With respect to claim 7, Wang et al. teach the live attenuated chimeric virus wherein the virus replicates poorly in MDCK cells at 37oC, when compared to replication at 33oC in the MDCK cells [see Figure 1; p. 3, bottom].
With respect to claim 9, Wang et al. teach the live attenuated chimeric virus wherein the chimeric virus is DELNS1-B8038 [see p. 9].
With respect to claim 10, Wang et al. teach a pharmaceutical composition comprising an effective amount of the live attenuated chimeric virus [see p. 17].
With respect to claim 11, Wang et al. teach the composition further comprising an adjuvant [see p. 6; p. 17].
With respect to claim 12, Wang et al. teach the composition suitable for nasal administration [see p. 6; p. 17].
However, Wang et al. does not teach the inserted antigen is a Sars-CoV-2 antigen of claim 1 and wherein the one or more CoV2Ag is the Sar-CoV-2 receptor binding domain (RBD).
Zhou et al. teach the SARS-CoV-2 outbreak and the identification of the RBD of the spike protein as a route of infection via the ACE2 receptor on human cells [see abstract and p. 271, column 2].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Wang et al. and Zhou et al. to insert a SARS-CoV-2 RBD antigen of Zhou et al. into the live attenuated chimeric influenza B vaccine of Wang et al. because Wang et al. teach live attenuated influenza viruses as vectors for antigens against pathogenic viruses. Zhou et al. teach that SARS-CoV-2 was an epidemic causing acute respiratory syndrome. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Wang et al. and Zhou et al. because Zhou et al. acknowledges that SARS-CoV-2 was an emerging epidemic and one would desire to do so in order to get the epidemic under control. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 4 of applicants’ remarks and declaration, applicants contend that Wang is disqualified as prior art to the claims because two of the authors Honglin Chen and Pui Wang are co-inventors and the publication is one year or less before the effective filing date of the claimed invention.
This argument is found to be not persuasive because MPEP 2155.01 states a grace period disclosure shall not be prior art to a claimed invention under AIA 35 U.S.C. 102(a)(1) if the disclosure was made by the inventor or a joint inventor. An applicant may show that a disclosure was made by the inventor or a joint inventor by way of an affidavit or declaration under 37 CFR 1.130(a) (an affidavit or declaration of attribution). See In re Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA 1982) and MPEP § 717.01(a)(1). Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982). When any claim of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate affidavit or declaration to except a disclosure as prior art by establishing that the disclosure was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. However, an affidavit or declaration under 37 CFR 1.130(a) that is only a naked assertion of inventorship and that fails to provide any context, explanation or evidence to support that assertion is insufficient. See EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 123 USPQ2d 1146 (Fed. Cir. 2017). See also Ex parte Kroger, 219 USPQ 370 (Bd. App. 1982) (affirming rejection notwithstanding declarations by the alleged actual inventors as to their inventorship in view of a nonapplicant author submitting a letter declaring the nonapplicant author's inventorship). This is similar to the process for disqualifying a publication as not being by "others" discussed in MPEP § 2132.01, except that AIA 35 U.S.C. 102(b)(1)(A) requires only that the disclosure be by the inventor or a joint inventor. In the instant case, the declaration provides no reasonable explanation of the presence of additional authors in the Wang disclosure and is therefore insufficient to establish a prior art exception.
11. The rejection of claims 1-5, 7-8 and 10-12 under 35 U.S.C. 103 as being unpatentable over Wressnigg et al. (Vaccine, 2009; cited on IDS filed on 08/02/2024) in view of of Zhou et al. (Nature, 02/03/2020; cited on IDS filed on 08/02/2024) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to address applicants’ amendment to the claims.
12. With respect to claim 1, Wressnigg et al. teach a live attenuated chimeric virus comprising an influenza B virus genome comprising a deletion of the DELNS1-B that can used to enhance specific anti-influenza immunity through expression of additional antigens from the deleted-NS1 site and two adaptive mutation located in the NA and M genes [see Abstract; p. p. 2852]. Wressnigg et al. does teach adaptive mutations located in the NA and M gene, which is interpreted as reading on the limitations in view of the indefiniteness of the parentheses (see 112(b) rejection above).
With respect to claim 2, Wressnigg et al. teach the live attenuated chimeric virus wherein the virus genome is from influenza B [see Abstract; p. 2852].
With respect to claim 3, Wressnigg et al. teach the live attenuated chimeric virus wherein the influenza B virus is not able to replicate in interferon-competent cells [see p. 2854].
With respect to claim 4, Wressnigg et al. teach the live attenuated chimeric virus wherein the deletion of virulence factory activity comprises deletion of at least part of a virulence factor gene [see Abstract; p. 2852].
With respect to claim 5, Wressnigg et al. teach the live attenuated chimeric virus wherein the deletion comprises a complete deletion of NS1 [see Abstract; p. 2852].
With respect to claim 7, although Wressnigg et al. does not teach the live attenuated chimeric virus wherein the virus replicates poorly in MDCK cells at 37oC, when compared to replication at 33oC in the MDCK cells, Wressnigg et al. teach an attenuated influenza B virus that is structurally identical to what is claimed. Accordingly, it is the examiner’s position that this feature would be inherent to the attenuated influenza B virus of Wressnigg et al. Since the Office does not have the facilities for examining and comparing applicants’ virus with the virus of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the virus of the prior art does not possess the same material structural and functional characteristics of the claimed virus). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claim 10, Wressnigg et al. teach a pharmaceutical composition comprising an effective amount of the live attenuated chimeric virus [see p. 2852, column 2].
With respect to claim 11, Wressnigg et al. teach the composition further comprising an adjuvant [see p. 2852, column 2].
With respect to claim 12, Wressnigg et al. teach the composition suitable for nasal administration [see Abstract; p. 2852, column 2].
However, Wressnigg et al. does not teach the inserted antigen is a Sars-CoV-2 antigen of claim 1 and wherein the one or more CoV2Ag is the Sar-CoV-2 receptor binding domain (RBD).
Zhou et al. teach the SARS-CoV-2 outbreak and the identification of the RBD of the spike protein as a route of infection via the ACE2 receptor on human cells [see abstract and p. 271, column 2].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Wressnigg et al. and Zhou et al. to insert a SARS-CoV-2 RBD antigen of Zhou et al. into the live attenuated chimeric influenza B vaccine of Wressnigg et al. because Wressnigg et al. teach live attenuated influenza viruses as vectors for antigens against pathogenic viruses. Zhou et al. teach that SARS-CoV-2 was an epidemic causing acute respiratory syndrome. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would have been motivated to combine the teachings of Wressnigg et al. and Zhou et al. because Zhou et al. acknowledges that SARS-CoV-2 was an emerging epidemic and one would desire to do so in order to get the epidemic under control. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 6 of applicants’ remarks, applicants in summary contend that Wressnigg or Zhou fail to teach the limitations of the claims as amended.
This argument is found to be not persuasive in view of the modified rejection set forth above.
Conclusion
13. Status of the claims:
Claims 1-15 are pending.
Claims 13-15 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-12 are rejected.
No claims are in condition for an allowance.
THIS ACTION IS MADE FINAL. 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 PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656