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 .
Response to Amendment
The Amendment filed 01/13/2026, has been entered. No claims were amended, Claims 10-23 were previously withdrawn. Claims 2-4 and 7 were previously canceled.
Claims 1, 5-6, 8-9, and 24 are currently under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10/08/2025 and 01/06/2026 after the Nonfinal Office Action mailed on 10/14/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Previous rejection, maintained as to claims 1, 5, 6, 8 and 24) Claims 1, 5, 6, 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al., in view of Lan et al. (prior art of record).
See claims 1, 5, 6, 8 and 24 as submitted on 01/13/2026.
Regarding claims 1 and 24, it is noted that claims 1 and 24 do not recite any amendments nor new limitations. As previously explained, Rao et al. teach an engineered system for editing a bacteriophage genome using the CRISPR-Cas9 system (Abstract, ¶ 0007) comprising the following features:
A T4 bacterial phage (Abstract, ¶¶ [0007], [0039])
An E.coli host cell, wherein the T4 bacterial phage can infect the host cell, and the wherein the E. coli host cell comprises the following (¶ [0007], [0103]):
a CRISPR plasmid (one altered plasmid, as recited in claim 24); wherein the CRISPR plasmid comprises a gene encoding a Cas protein (one endonuclease, as recited in claim 1) that can be expressed within the host cell and is capable of generating a double-strand DNA break in the genomic DNA of the bacterial phage (Abstract, ¶¶ [0007], [0010]).
a donor plasmid; wherein the donor plasmid comprises a donor DNA sequence (at least one DNA segment, as recited in claim 1) that can be inserted into the genome of the bacterial phage at the cut created by the Cas protein encoded in the CRISPR plasmid (Abstract, ¶¶ [0007], [0010]). Rao et al. further teach a donor DNA may include a DNA sequence to generate a recombinant phage that could be used in various therapy applications (¶ [0099]).
Wherein the endonuclease is a Cas9 endonuclease for the CRISPR system (¶ [0008]).
and wherein the genome of the bacterial phage comprising at least one inserted DNA segment from the donor plasmid can be packaged and released from the host cell (Abstract, ¶¶ [0007], [0010], [0011]).
at least one protein is displayed on the surface of the at least one bacterial phage (Example 1, ¶¶ [0039], [0147]-[0151]).
Rao et al. do not teach wherein at least one DNA segment in the donor plasmid encodes at least one component of SARS-CoV-2 that is selected from the group consisting of spike trimer, ectodomain of the spike trimer, the receptor binding domain (RBD) of the spike trimer, envelope (E) protein and nucleocapsid protein (NP)
However, Lan et al. teach a SARS-CoV-2 spike protein comprising a receptor binding domain (RBD), wherein the SARS-CoV-2 spike protein is capable of inducing a humoral immune response in an animal (Abstract, pages 1, 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to have included the teachings of Lan et al. to the engineered system for editing a bacteriophage genome taught by Rao et al., with all of the elements recited above given that Rao et al. further teach a donor DNA may include a viral DNA sequence to generate a recombinant phage that could be used in various therapy applications (¶¶ [0039], [0099]). One of ordinary skill in the art would have been motivated to combine the teaching of Rao et al. and Lan et al. for the benefit of formulating a recombinant phage expressing a SARS-CoV-2 spike protein with potential in therapeutic applications specifically for SARS-CoV-2. Further motivation derives from the clinical need for a SARS-CoV-2 vaccine before the effective filing date of the claimed invention. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had a reasonable expectation of success for including the spike protein of SARS-CoV-2 into the engineered system for editing a bacteriophage genome taught by Rao et al. given that the methods of generating a recombinant T4 phages are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding amended claim 5, it is noted that no amendments were introduced to claim 5 in the amendment filed on 01/13/2026. As previously explained, Rao et al. further teach the CRISPR plasmid further comprising a spacer sequence, wherein the spacer sequence determines the location of the double-strand DNA break created by the Cas9 endonuclease (¶¶ [0010], [0051]).
Regarding claim 6, it is noted that no amendments were introduced to claim 6 in the amendment filed on 01/13/2026. As previously explained, Rao et al. further teach that the donor DNA may include a DNA sequence to generate a recombinant phage that could be used in various phage therapy applications (¶ [0099]), and Lan et al. teach a SARS-CoV-2 spike protein comprising a receptor binding domain (RBD), wherein the SARS-CoV-2 spike protein is capable of inducing a humoral immune response in an animal (is immunogenic, as recited in claim 6) (Abstract, pages 1, 4).
As to claim 8, it is noted that no amendments were introduced to claim 8 in the amendment filed on 01/13/2026. As previously explained, Rao et al. further teach a DNA fragment fused to the Hoc gene of the T4 bacteriophage at nucleotide 639 (Example 1, ¶ [0147]), wherein the expression of the DNA fragment fused to the Hoc gene was successfully expressed at the capsid surface of the T4 phages (Example 1, ¶¶ [0039], [0147]-[0151]), and Lan et al. teach a SARS-CoV-2 spike protein comprising a receptor binding domain (RBD), wherein the SARS-CoV-2 spike protein is capable of inducing a humoral immune response in an animal (is immunogenic, as recited in claim 6) (Abstract, pages 1, 4).
Accordingly, claims 1, 5, 6, 8 and 24 of the claimed invention were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
(Previous rejection, maintained as to claim 9) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rao et al., in view of Lan, J. et al. as applied to claims 1, 5, 6, 8 and 24 above, further in view of Mullaney et al. (prior art or record).
See claim 9 submitted on 01/13/2026.
Regarding amended claim 9, it is noted that no amendments were introduced to claim 9 in the amendment filed on 01/13/2026. As previously explained, Rao et al. further teach expression of the DNA fragment fused to the Hoc gene at the capsid surface of the T4 phages (Example 1, ¶¶ [0039], [0147]-[0151]). Rao et al. further teach that antigens fused to Soc or Hoc, may be displayed on the hoc-soc T4 capsid with high affinity and specificity (¶ [0089]). As indicated above, Lan et al. teach a SARS-CoV-2 spike protein sequence comprising a receptor binding domain (RBD).
Neither Rao et al. nor Lan et al. teach a capsid targeting sequence (CTS).
However, Mullaney et al. teach a capsid targeting sequence (CTS) fused at the N-terminal of a foreign gene (luciferase) that permits effective processing and packaging of a recombinant T4 phage. (Abstract, page 1-4).
It would have been prima facie obvious to a person of ordinary skill in the art at the time of filing to have included the teachings of Mullaney et al. to the engineered system for editing a bacteriophage genome taught by Rao et al., in view of Lan et al. such that a CTS sequence is added to the N-terminal of the SARS-CoV-2 spike protein for the benefit of including a CTS sequence that permits effective processing and packaging of a recombinant T4 phage as taught by Mullaney et al.
One of ordinary skill in the art would have had a reasonable expectation of success for including the CTS sequence at the N-terminal of the SARS-CoV-2 spike protein of the engineered system for editing a bacteriophage genome taught by Rao et al., in view of Lan et al. given that the methods of generating recombinant T4 phages are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, claim 9 of the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Previous rejection, withdrawn as to claims 1, 5, 24) Claims 1, 5, 24 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13, 14, 17, and 44 of copending Application No. 16/355932 filed on 03/18/2019.
The previous rejections of claims 1, 5, 24 are moot in view of the abandonment of copending Application No. 16/355932 mailed on 03/25/2026.
(Previous rejection, withdrawn as to claims 6 and 8) Claims 6 and 8 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13, 14, 17, and 44 of copending Application No. 16/355932 filed on 03/18/2019, as applied to claims 1, 5 and 24 above, in view of Lan et al. (previously cited).
The previous rejections of claims 6 and 8 are moot in view of the abandonment of copending Application No. 16/355932 mailed on 03/25/2026.
(Previous rejection, withdrawn as to claim 9) Claim 9 was provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 13, 14, 17, and 44 of copending Application No. 16/355932 filed on 03/18/2019, as applied to claims 1, 5 and 24 above, in view of Lan et al., and further in view of Mullaney et al. (previously cited).
The previous rejections of claim 9 is moot in view of the abandonment of copending Application No. 16/355932 mailed on 03/25/2026.
Response to Arguments
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive.
Applicant contends on page 10 of the Remarks submitted on 01/13/2026:
“Applicant respectfully disagrees with the conclusion of the Office Action with respect to Claims 1, 5, 6, 8 and 24. The Applicant reiterates, as submitted in response to the Final Rejection dated July 16, 2025, that there is no motivation or reasonable expectation of success6 for a person of ordinary skill in the art to combine Rao with Lan J. to arrive at the claimed invention.”
In response:
As previously explained, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated and had a reasonable expectation of success to have included the teachings of Lan et al. about a SARS-CoV-2 sequence into the engineered system for editing a bacteriophage genome taught by Rao et al., with all of the elements recited above for the benefit of formulating a recombinant phage expressing a SARS-CoV-2 spike protein with potential in therapeutic applications specifically for SARS-CoV-2. Further motivation derives from the clinical need for a SARS-CoV-2 vaccine before the effective filing date of the claimed invention. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Therefore, on the contrary, a person of ordinary skill in the art would have been motivated and would have had reasonable expectation of success for combining the teachings of Rao et al. and Lan et al. Accordingly, it is maintained that the claimed invention represents an obvious embodiment of the teachings of the cited prior art.
Applicant contends on page 15 of the Remarks submitted on 01/13/2026:
“In summary, contrary to the assertions in the Office Action, there is no reasonable expectation of success and no motivation for a skilled person to combine Rao and Lan to arrive at the claimed universal vaccine design platform of the instant Application. It would require unexpected insights into the relationship between antigen presentation and immunogenicity that are not suggested20 by the purported prior art combination made by the Office Action.”
In response:
Applicant’s argument that a person of ordinary skill in the art would not have reasonable expectation of success and no motivation to arrive at the claimed invention is not persuasive because as explained above and previously in detail Rao et al. and Lan et al. teach the exact claimed universal vaccine deign platform with all of the limitations as recited by instant claims. Accordingly, it is maintained that it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to have included the teachings of Lan et al. to the engineered system for editing a bacteriophage genome taught by Rao et al., with all of the elements recited above with reasonable expectation of success for the benefit of formulating a recombinant phage expressing a SARS-CoV-2 spike protein with potential in therapeutic applications specifically for SARS-CoV-2.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
Prosecution Insights