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
Acknowledgement is hereby made of receipt and entry of the communication filed on July 22, 2026. Claims 1-2, 4-20 are pending and are currently examined.
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.
(Previous rejection-withdrawn) Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
This rejection is withdrawn in view of the amendments and arguments filed on 07/22/2026.
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.
(previous rejection-withdrawn) Claims 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.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.
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
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.
(previous rejection-withdrawn) Claim 15 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 to show the PLA-SARS-COV 2 with AP205 can induce neutralizing antibodies produced in macaques immunized with PLA-SARS-CoV2 vaccine and reduce the viral load in a viral challenge experiment (See examples 8-10) for preventing a disease, does not reasonably provide enablement for a method for preventing a disease associated with influenza virus, African swine fever virus or autoantigen myelin oligodendrocyte glycoprotein MOG in any subject with any viral capsid.
This rejection is withdrawn in view of the arguments filed on 07/22/2026.
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.
(Previous rejection-withdrawn) Claims 1-4, 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over He et al. (WO2022005503A1, published on Jan. 06, 2022, international Filling date: Oct. 01, 2020, hereinafter, “He”) as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) and in view of Brune et al. (Sci Rep. 2016 Jan 19;6:19234).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. (WO2022005503A1, published on Jan. 06, 2022, international Filling date: Oct. 01, 2020, hereinafter, “He”) as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) in view of Brune et al. (Sci Rep. 2016 Jan 19;6:19234) as applied to claims 1-4, 12-13 and 15 above and further in view of Aebi et al. (EP3650044 A1, published May 13, 2020).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) in view of Brune et al. as applied to claims 1-4, 12-13 and 15 above and further in view of Franklin et al. (WO2019228995A1, published on May 12, 2019).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) in view of Brune et al. as applied to claims 1-4, 12-13 and 15 above and further in view of Frederik et al. (WO2016112921A1, published July 21, 2016).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) in view of Brune and Pedersen as applied to claims 1-2, 4, 12-13 and 15 above and further in view of Franklin et al. and Frederik et al.
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over He et al. as evidenced by Forrer et al. (J Mol Biol. 2004 Nov 12;344(1):179-93) in view of Brune et al. as applied to claims 1-4, 12-13 and 15 above and further in view of Paavola et al. (US 2006/0084792 A1, published on Apr. 20, 2006).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(Previous rejection-withdrawn) Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over He et al. as evidenced by Forrer et al. in view of Brune and Pedersen as applied to claims 1-4, 12-13 and 15 above and further in view of Yenkoidiok-Douti et al. (Sci Rep. 2019 Nov 14;9(1):16833) as evidenced by Li et al. (J Mol Biol. 2014 Jan 23;426(2):309-17).
This rejection is withdrawn in view of the amendments filed on 07/22/2026.
(New Rejection-necessitated by amendment) Claims 1-2 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (WO 2016/112921 A1, published on July 21, 2016, hereinafter, “Pedersen”) as evidenced by Brune et al. (Sci Rep. 2016 Jan 19;6:19234) in view of Keeble et al. (Methods Enzymol. 2019;617:443-461).
Regarding the amended base claim 1, Pedersen teaches self-assembly VLP-based vaccine (See page 16, lines 26-30) being capable of efficiently displaying epitopes and are thus able to induce long-term protective immunity in a subject (See page 3, lines 29-34), which comprising a peptide tag fused to the C-terminus of AP205 capsid protein (See page 19, lines 6-8) that teaches the base claim 1-(1) because the first Tag is Spytag and viral capsid protein is AP205 and they form as “ AP205-SpyTag “ (See page 19, lines 11-15), and also comprising a second fusion protein where the SpyCatcher is fused to the antigen in the N-terminal, C-terminal, and/or is fused to the antigen into the coding sequence of the antigen (See page 54, lines 19-23) that teaches the base claim 1-(2) because SpyCatcher can be at the N-terminus of the second fusion protein when it is fused to the N-terminal of the antigen. Pedersen also teaches that the viral capsid protein is from Escherichia coli phage AP205 (See page 20, lines 34-35), and mice are immunized with the VLP-displayed antigen (SpyTagVLP-SpyC-antigen) that indicates the complex is soluble (See Figure 17 and Page 11, lines 13-19).
As for the “covalently connected through the SpyCatcher and the SpyTag” as claimed, Pedersen teaches the SpyTag and SpyCatcher interact via a spontaneous isopeptide bond formation. This is a covalent interaction between the SpyTag and SpyCatcher linked antigen. The flexibility of the isopeptide bond is limited by the conformation of the co-joined SpyTag-SpyCatcher polypeptide ensuring consistent orientation of the antigens thus displayed on the VLP (See page 4, lines 20-25).
As for the claimed “ virus-like particle encapsulates nucleic acid inside it”, Pedersen teaches the same structure of capsid protein of AP205 to be fused to the SpyTag as claimed, it should inherit the function of “encapsulates nucleic acid inside it”. Also, this can be evidenced by Brune’s study. Brune teaches that AP205 VLPs have been previously shown to encapsulate various RNAs from their expression host (See page 7, paragraph 2).
As for the first and second linker peptide used for fusing viral capsid protein to SpyTag and for fusing SpyCatcher to an antigen, Pedersen teaches that SpyCatcher is fused to the N-terminus of the AP205 capsid protein optionally via a linker (See e.g., page 5, paragraph 2). Although Pedersen does not explicitly point out if there are linkers for the fusion protein between AP205 and SpyTag and between SpyCatcher and antigen, one of skilled in the art can add a linker in the fusion protein because adding linker is a routine and standard technique in the art to reduce steric hindrances, etc.
Nevertheless, Keeble teaches that they always insert a linker between SpyTag or SpyCatcher and the protein of interest. Gly/Ser linkers show a good balance of flexibility, solubility, and protease resistance. The linker increases the accessibility of SpyTag/SpyCatcher for faster and higher yielding reactions. The linker also reduces the chance of interference in the structure or function of the fused protein (See bridging pages 452 and 453).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the linker of Keeble into Pedersen’s fusion construction of SpyTag and SpyCatcher to arrive at an invention as claimed. One of skill in the art would have been motivated to do so based on the benefit the linker provided. There would be a reasonable expectation of success to add the linker to the constructs of AP205-SpyTag and SpyCatcher-antigen of Pedersen.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim 2, Pedersen teaches that the host cell comprising bacteria, yeast, fungi, plant, mammalian and/or insect cells (See page 61, lines 27-32) and the VLP-based vaccine comprise an AP205 capsid protein comprising a SpyTag polypeptide insertion such that the capsid protein can self-assemble into a VLP that displays the SpyTag in a context that it binds to SpyCatcher, and an antigen fused to SpyCatcher (See page 6, lines 8-14). The nucleic acid which is encapsulated by the virus-like particle can be shown in Figure 1 (See below) which teaches that general aspect of the present invention. Pedersen also teaches AP205 VLP is formed by recombinant expression of the AP205 capsid protein in the bacteria host (See birding pages 20-21; page 61, lines 28-32).
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Regarding claims 11,14,18 and 20, Pedersen teaches the ratio of AP205 capsid protein:SpyTag and/or KTag:SpyCatcher/antigen fusion is 1: 1:1 (See page 53, lines 29-30). Figure 16 of Pedersen teaches immunizing mice with SpyTag-AP205-SpyT coupled with SpyCatcher-antigen indicates the mixture is soluble at this ratio (See page 11, lines 5-11). Pedersen also teaches that they immunized groups of mice (n=5) with either VLP-coupled or non-coupled soluble antigen (control group) formulated with or without extrinsic adjuvant (See page 81, lines 1-11). Here the 1:1 ratio between SpyCatcher and SpyTag on the virus-like teaches the required ratio in claims 11, 14, 18 and 20 and the immunization indicates they are soluble pathogen-like antigen complex as claimed.
Regarding claims 12 and 15, Pedersen teaches mice are immunized by the VLP-displayed SpyCatcher-antigen (See page 82, lines 14-18) and the vaccine of the invention may be administered concurrently, simultaneously, or together with a pharmaceutically acceptable carrier or diluent (See page 69, lines 24-27). Here the antigen can be hemagglutinin (HA) antigen from the influenza virus (See 42, lines 1-2), thus, the VLP-based vaccine is for in the prophylaxis and/or treatment influenza infection (See page 42, lines 9-22).
Regarding claims 13 and 19, Pedersen teaches purifying VLP at pH 7.2 (See page 76, lines 8-9).
Regarding claim 16, Pedersen teaches that the antigen and AP205 capsid protein are linked via the interaction between the Spytag and the SpyCatcher to form a VLP (See page 5, lines 25-27), and Brune teaches that AP205 VLPs have been previously shown to encapsulate various RNAs from their expression host (See page 7, paragraph 2). Accordingly, Pedersen in view of Brune teaches that the nucleic acid is RNA as claimed.
Regarding claim 17, Pedersen teaches the capsid protein is from the AP205 phage and the host of the phage AP205 is Escherichia coli (See Pedersen, page 20, lines 35).
(New Rejection-necessitated by amendment) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen as evidenced by Brune in view of Keeble as applied to the claims 1-2 and 11-20 above and further in view of He et al. (WO2022005503A1, published on Jan. 06, 2022, international Filling date: Oct. 01, 2020, hereinafter, “He”)
Claim 4 requires that the antigen is selected from RBD sequence of S protein of SARS-CoV2 virus, African swine fever virus antigen eP22, influenza virus antigen M2E and autoantigen myelin oligodendrocyte glycoprotein MOG.
Pedersen teaches an antigen fused to SpyCatcher, however, it is silent on the antigen as claimed.
He teaches soluble coronavirus S protein derived immunogens that are stabilized via specific modifications in the wildtype soluble S sequences. Also provided in their invention are nanoparticle vaccines that contain the redesigned soluble S immunogens displayed on self-assembling nanoparticles (See Abstract), and the nanoparticles presenting stabilized S trimers and RBDs can be used as VLP-type coronavirus vaccines (See [0028]), where the S immunogens is a protein or a portion that is from the highly pathogenic SRAS-COV-2 (See [0026]), and the VLP can be SpyTag/SpyCatcher protein superglue system to create RBD presenting nanoparticles or VLP (See [0026]). Here the invention provides methods for preventing or treating a coronavirus infection in a subject (See e.g., [0017]).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the RBD sequence of S protein of SARS-CoV2 virus into Pedersen’s VLP and arrive at an invention as claimed. One of skill in the art would have been motivated to do so because the SpyTag/SpyCatcher (or simply SPY) system can be used to conjugate RBD to SApNPs to create multivalent RBD vaccines capable of eliciting a more potent NAb response (See [00159]). There would be a reasonable expectation of success to construct such soluble pathogen-like antigen complex as claimed.
(New Rejection-necessitated by amendment) Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen as evidenced by Brune in view of Keeble as applied to the claims 1-2 and 11-20 above and further in view of Frederik et al. (WO2016112921A1, published July 21, 2016).
Claim 7 requires that the sequence of the SpyCatcher consist of SEQ ID NO: 4.
Based on the description above, Pedersen teaches a virus-like particle (VLP), where one of the constructs comprising an antigen and SpyCatcher. However, it is silent on the sequence of the SpyCatcher consist of SEQ ID NO: 4.
Frederik teaches establishing a system to produce antigens fused to a SpyCatcher and/or a SpyTag polypeptide, which ensures control of the orientation of the coupled antigen (See page 4, lines 1-10), and the SpyCatcher comprises the amino acid sequence of SEQ ID NO: 60 (See page 53, lines 22-23), where the SEQ ID NO: 60 is identical to the claimed SEQ ID NO: 4 (See Table C below). Frederik also teaches that VLP generated in their system can be used to induce antibodies with increased avidity compared to the corresponding soluble protein vaccines.
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NO: 60 of Frederik into Pederson’s invention. One of skill in the art would be motivated to substitute one SpyCatcher for another (See MPEP 2144.06: Substituting equivalents known for the same purpose) because SpyCatcher-based VLP vaccine can induce a strong and long-lasting immune response to pathogens (See page 3, lines 20-23). There would be a reasonable expectation of success to develop such a soluble pathogen-like antigen complex with a specific SpyCatcher as claimed.
(New Rejection-necessitated by amendment) Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pedersen as evidenced by Brune in view of Keeble as applied to the claims 1-2 and 11-20 above and further in view of Paavola et al. (US 2006/0084792 A1, published on Apr. 20, 2006).
Claim 10 is directed to a soluble pathogen-like antigen complex according to claim 1, wherein the sequence of the second linker peptide consists of SEQ ID NO: 6.
Based on the description above, Pedersen teaches a virus-like particle (VLP) complex comprising an antigen fused to SpyCatcher. However, it is silent on a specific second linker consisting of SEQ ID NO: 6.
Paavola teaches a chaperonin EYFP fusion protein which is modified at position 267 comprises an additional linker comprising the sequence Gly-Ser-Gly-Gly-Ser-Gly (SEQ ID NO:83) which joins the yellow fluorescent protein to the chaperonin protein (FIG. 26B), where the linker sequence of SEQ ID NO: 83 is identical the SEQ ID NO: 6 as claimed (See Table D below).
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NO: 83 of Paavola into Pedersen’s invention. This intervening linker does not interfere with the ability of the modified chaperonin polypeptide to fold and assemble into double-ringed chaperonin structures and maintain the same or similar spatial organization or distance as that found in a folded wild type chaperonin polypeptide (See [0100]). Thus, one of skill in the art would be motivated to substitute one linker for another (See MPEP 2144.06: Substituting equivalents known for the same purpose). There would be a reasonable expectation of success to develop such a soluble pathogen-like antigen complex as claimed.
Allowable Subject Matter
The SEQ ID NOs: 1, 3, 5 are free of prior art.
The sequence having at least 99% sequence identity with SEQ ID NO: 1 is free of prior art.
Accordingly, claims 5, 6, 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
(previous rejection-withdrawn) Claims 1-7, 9-12 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9--14 of co-pending Application No. 18267355 (reference application).
This rejection is withdrawn in view of the amendments and arguments filed on 07/22/2026.
Responses to Applicant’s Remarks
Applicant’s arguments filed on July 22, 2026, have been received and fully considered.
1). Applicant’s amendment and argument regarding rejections under 35 U.S.C. § 112(b) is considered. The rejection is withdrawn.
2). Applicant’s amendment and argument regarding rejections under 35 U.S.C. § 112(a) (including the Scope of Enablement) are considered. The rejections are withdrawn.
3). Applicant’s argument regarding Nonstatutory Obviousness-Type Double Patenting is considered. The rejection is withdrawn.
4). Applicant’s amendment and argument regarding rejection under 35 U.S.C. § 103 are not found persuasive.
(i). Based on the amendment, a new primary art is applied to the current office action, thus, all arguments related to Hu are withdrawn and moot.
(ii). Applicant allegedly argued that "only the fusion protein formed by constructing Spy Tag at the C-terminus of the AP205 sequence can be assembled normally”. However, the new applied prior art reference, Pedersen et al., discloses a comparison of different engineered AP205 and Phage fr coat proteins with regard to recombinant expression yield, ability to assemble into a virus-like particle (VLP) and their capacity for antigen display (See page 77, lines 5-7 and Table 4, also see below). Based on Table 4 of Pederson, constructing Spy Tag at the C-terminus of the AP205 sequence has better yields and antigen coupling capacity. Thus, Pederson teaches the results argued.
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Conclusion
No claims are allowed.
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 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.
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/RUIXUE WANG/ Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672
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