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 .
Claims 32-34, 41, 45, 54, 55-66 are pending in the application. Claim 45 is withdrawn. Claims 32-34, 41, 54-66 are currently under examination.
This office action is in response to the amendment filed on 1/17/2026.
All previous rejection not reiterated in this office action are withdrawn.
Response to Amendment
The amendment to the claims filed on 1/17/2026 does not comply with the requirements of 37 CFR 1.121(c) because newly added claims does not have claim 63. Claim 64 directly follows claim 62, and the status of claim 63 is unclear. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Since the reply filed on appears to be bona fide, applicant is given a TIME PERIOD same as the response period for this office action for correction.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 32-34, 41, 54, 55, 61-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2023/0090422), in view of Georges (US 11,382,968). This rejection is rewritten to address the amendment.
Amended claim 32 is drawn to a nucleic acid encoding fusion protein consisting essentially of: (a) a polypeptide consisting essentially of an amino acid sequences at least 70% to amino acid sequence SEQ ID NO: 10; and (b) a multimerization domain comprising sequence having at least 70% identity with SEQ ID NO: 24. The instant specification does not set forth what is the scope for a fusion protein “consisting essentially” a polypeptide that consisting essentially of an amino acid sequence at least 70% identical to the amino acid sequence of SEQ ID NO: 10. In other words, the specification does not clearly define what is excluded from the fusion protein and/or the polypeptide when use the transitional word “consisting essentially of” in the context of a fusion protein, or an amino acid having 70% sequence identity with SEQ ID NO: 10. Therefore, “consisting essentially of” in the context of the amino acid sequences is interpreted as “comprising.”
Zhang teaches a novel coronavirus S protein double region subunit nano-vaccine based on a bacterial complex, wherein a receptor binding domain (RBD) and a fusion peptide are connected to a bacterial complex to form a fusion protein, so as to achieve antigen multimerization (abstract). Zhang teaches that the bacterial complex is Lumazine Synthase (LS) or PF-Ferritin (paragraph [0007]), wherein LS has amino acid sequence 100% identical to SEQ ID NO: 24 of present application (page 13, SEQ ID NO: 8). Zhang teaches a preferred embodiment of the antigen is the SARS-CoV2 surface spike protein RBD (paragraph [0023]). Zhang teaches that multimerization of the RBD monomer overcomes the defect of insufficient immunogenicity of an RBD monomer, and the obtained vaccine can significantly increase the level of a neutralization antibody against a virus in a host, and the resulting antibody has the capability of strongly blocking a virus from invading a target cell (abstract, last 8 lines).
However, Zhang does not give an example of coronavirus S protein amino acid sequence.
Georges teaches immunogenic compositions for preventing or treating COVID-19 related diseases caused by SARS-CoV-2, wherein the composition comprises SARS-CoV-2 spike protein receptor binding domain of S1 domain with conservative substitutions, wherein the sequence comprise SEQ ID NO: 16 (col.3, lines 30-40, and col.6, lines 4-7). SEQ ID NO: 16 of Georges has 100% sequence homology with currently claimed SEQ ID NO: 10 (see attached alignment).
It would have been obvious to an ordinary skilled in the art that multimerization of a RBD monomer by fusion with a multimerization domain comprising SEQ ID NO: 24 would significantly increase immunogenicity of said monomer based on the teaching from Zhang. Although Zhang does not teach the CoVID19 S protein amino acid sequence comprising SEQ ID NO: 10, this sequence is disclosed by Georges, and used as immunogenic composition for treating or preventing diseases related to CoVID19. The ordinary skilled in the art would be motivated to use this sequence and link it to a multimerization domain comprising SEQ ID NO: 24 to improve immunogenicity as demonstrated by Zhang. Combining prior art known elements to achieve its intended purpose would have been within the capability of an ordinary skilled in the art. Therefore, the claimed invention of claims 32, 54, 61-62 and 64-66 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claims 33 and 34, Zhang teaches recombinant vector and cell line that comprise nucleic acid sequence encoding the fusion (paragraph [0061]). Zhang also teaches cloning the nucleic acid sequence into an eukaryotic expression vector, which inherently comprises suitable control sequence.
Regarding claim 41, Zhang teaches the fusion protein diluted with physiological saline for immunization (paragraph [0123]), which meets the limitation of pharmaceutical composition that has a pharmaceutically acceptable carrier.
Regarding claim 55, Georges teaches that the immunogenic composition may comprise RNA immunogenic or vaccine composition that comprises a modified mRNA, a unmodified mRNA or a self-amplifying mRNA formulated in liposomes or lipid particles (col.87, lines 18-22).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Georges, as applied to claims 32 and 55 above, and further in view of the sequence having accession number BEJ16689 (WO2017167910, SEQ ID NO:40).
The teaching from Zhang and Georges have been discussed above. However, neither teaches a 5’ UTR comprises SEQ ID NO: 33.
BEJ16689 is a novel untranslated region that for producing mRNA for treatment of diseases (see attached alignment and disclosure), which has 100% sequence identity with SEQ ID NO: 33.
It would have been obvious to an ordinary skilled in the art that 5’ UTR is a necessary component in producing mRNA for therapeutic use. Using prior art known sequence for this purposes would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 59 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Georges, as applied to claims 32 and 55 above, and further in view of the sequence having accession number CHPHBB3CH (Martin, 1993).
The teaching from Zhang and Georges have been discussed above. However, neither teaches a 3’ UTR of beta globin mRNA comprising SEQ ID NO: 26.
CHPHBB3CH is beta globin mRNA 3’ untranslated region that is required for producing mRNA for treatment of diseases (see attached alignment and disclosure), which has 100% sequence identity with SEQ ID NO: 26.
It would have been obvious to an ordinary skilled in the art that 3’ UTR is a necessary component in producing mRNA for therapeutic use. Using prior art known sequence for this purposes would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 56 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Georges, as applied to claims 32 and 55 above, and further in view of Fotin-Mleczek (US 10,918,740).
The teaching from Zhang and Georges have been discussed above. However, neither reference teaches mRNA vaccine comprises 5’cap and polyA tail between 50-120 contiguous adenosine residues.
Fotin-Mleczek teaches RNA pharmaceutical compositions for treating diseases (abstract). Fotin-Mleczek teaches the RNA composition comprises 5’ and 3’ UTR, 5’-CAP structure; a polyA sequence (col.137, lines 1-5). Fotin-Mleczek teaches polyA tail preferably comprises 50-250 adenosine nucleotides (col.145, lines 59-60), which overlaps with claimed range of claim 57.
It would have been obvious to an ordinary skilled in the art that mRNA pharmaceutical composition requires 5’cap and polyA tail for its function as taught by Fotin-Mleczek. The ordinary skilled in the art would include said components when making a mRNA composition rendered obvious by Zhang and Georges based on such teaching. Therefore, the claimed invention of claims 56 and 57 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Response to Arguments
In response to the rejection, Applicant states that claim 32 has been amended to recite a RBD “consisting essentially of” the recited polypeptide sequence, and “wherein the RBD does not bind to angiotensin converting enzyme 2 (ACE2) receptor.” Applicant argues that the combined teaching from Zhang and Georges does not render the claim obvious.
The above argument has been considered but deemed unpersuasive because amended claim 32 does not recite any “RBD,” nor does it recite “wherein the RBD does not bind to angiotensin converting enzyme 2 receptor” as stated by Applicant. Since the remaining arguments are based on the amendment, they are not persuasive because such amendment does not exist. Applicant indicate that this limitation is described in paragraph [0084]. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, for reasons discussed in above rejection and set forth above, this rejection is still considered proper and thus maintained.
Conclusion
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 CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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/CELINE X QIAN/ Primary Examiner, Art Unit 1637