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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 8/20/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 11-14 and 18-20 are withdraw from consideration for being directed to non-elected subject matter. Claims 1-10 and 15-17 are currently under examination.
Specification
The use of the term” Histrap, Siperose and Glowmax,” which are trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
Claims 1-10 and 15-17 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.
Regarding claim 1, the recitation of “Helicobacter pylori multimeric protein (Helicobacter pylori_Ferritin, Ferritin(HP))” renders the claim indefinite because it is unclear whether the recitation in the parenthesis is part of the claim limitation.
Regarding claim 3, the term “novel coronavirus SARS-CoV-2 antigen” renders the claim indefinite because it is unclear what version of coronavirus SARS-CoV-2 antigen it is comparing to. In other words, it is unclear what structure and/or function of the SARS-CoV-2 antigen must have to meet the “novel” limitation.
Regarding claim 5, the recitation of “wherein a sequence of the receptor binding domain RBD of the novel coronavirus SARS-CoV-2 is shown in SEQ ID NO: 1, an amino acid sequence of the Ferritin (HP) is shown in SEQ ID NO: 2…an amino acid sequence of the resulting fusion protein RBD-HP_Ferritin is shown in SEQ ID NO: 3” renders the claim indefinite because it is unclear which part of the sequence (i.e. size and location) shown in SEQ ID NO: 1, 2 and 3 is being claimed. Moreover, the word “preferably” also renders the claim indefinite because it is unclear whether the limitation following this word is part of the claim limitation.
Regarding claim 6, the word “preferably” (3 times) renders the claim indefinite because it is unclear whether the limitation following this word is part of the claim limitation. The recitation of “an amino acid sequence of fusion of the SP, the His-tag…is as shown in SEQ ID NO: 4” renders the claim indefinite because it is unclear which part of the sequence (i.e. size and location) shown in SEQ ID NO: 4 is being claimed.
Regarding claim 8, the recitation of “Use of the coronavirus antigen in claim 7 in preparation of anti-coronavirus medicament” renders the claim indefinite because the claim merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Regarding claim 10, it depends on claim 8 but does not remedy the indefiniteness of claim 8. Further, the recitation of “the use is for preparation of a kit, the kit contains the antigen…bacterium expressing the antigen” also renders the claim indefinite because it is unclear whether the claim is directed to the use of an antigen, or a kit containing said antigen.
Dependent claims that depend on the above claims (claim 1) are rejected for same reason because they do not remedy the infiniteness.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10, 15-17 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Zhang et al. (US 2023/0080694).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 is drawn to a method for improving antigen immunogenicity comprising a single step of combining a receptor binding domain (RBD) of a virus with Helicobacter pylori multimeric protein to form RBD-HP_Ferritin.
Zhang et al. teach a method that taken RBD and combining it with Helicobacter pylori multimeric protein Ferritin (paragraph [0007]). The disclosure from Zhang thus anticipates the present invention of claim 1.
Regarding claims 2-4 and 15, Zhang et al. teaches the RBD is from SARS-CoV-2 spike protein (paragraph [0007]).
Regarding claims 5 and 16, Zhang et al. teaches the RBD that is same as SEQ ID NO: 1 (page 6, SEQ ID NO:1), and the Ferritin sequence SEQ ID NO: 4, that has 100% homology with SEQ ID NO: 2 (page 7, SEQ ID NO: 4).
Regarding claims 6 and 17, Zhang teaches adding a signal peptide and a purification tag, and express said antigen using a plasmid transfection eukaryotic cell expression system (paragraph [0007]).
Regarding claim 7, Zhang teaches a fusion protein RBD-HP-Ferritin (paragraph [0016], Figure 1 and legend).
Regarding claim 8-9, Zhang teaches anti-SARS-CoV-2 vaccine can be prepared by to combine the coronavirus antigen with a SAS adjuvant (paragraph [0040]).
Regarding claim 10, Zhang teaches use of the antigen to prepare for a kit (paragraph [0041]).
Claim(s) 1, 2, 6-10 and 17 is/are rejected under 35 U.S.C. 102(a1) (a2) as being anticipated by Graham (WO 2018/081318).
Graham teaches recombinant coronavirus S ectodomain trimer, including MERS-CoV S ectodomain or a SARS-CoV ectodomain trimer can be linked to a ferritin subunit to construct a ferritin nanoparticle (page 51, lines 17-19). Graham teaches the ferritin subunit may be from Helicobacter pylori ferritin (page 52, line 4). Graham teaches that the S1 ectodomain contains the receptor -binding domain (RBD) that mediates virus attachment to its host receptor (page 9, lines 31-32). Therefore, the teaching from Graham anticipates the claimed invention of claims 1, 2 and 7.
Regarding claims 6 and 17, Graham teaches adding signal peptide, and streptavidin tag and expressing said fusion in cells and purification of said antigen (page 69, lines 5-8).
Regarding claim 8, Graham teaches the coronavirus antigen may be used to provide prophylactic or therapeutic purpose (page 61, lines 34-36).
Regarding claim 9, Graham teaches the immunogenic composition can further comprise an adjuvant.
Regarding claim 10, since it is unclear how “use of antigen” for preparing a kit would impart a structural difference between the claimed antigen and the antigen disclosed by Graham, the antigen disclosed Graham is considered to meet all claim limitation.
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.
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graham, in view of Georges et al (US 11,382,968) and alignment.
Claim 3 is drawn to a method comprising combining a RBD of SARS-CoV2 antigen with HP Ferritin.
The teaching from Graham has been discussed above. The only difference is that Graham does not teach the antigen is SARS-CoV2 RBD.
Georges teach coronavirus immunogenic composition from SARS-CoV-2 (abstract). Georges teaches said immunogenic composition is epitopes from S protein RBD (col.3, lines 7-12). Georges teaches SARS-CoV-2 surface glycoprotein that comprise a full sequence share 100% sequence homology with SEQ ID NO: 1 (col.513, SEQ ID NO: 446, see alignment).
It would have been obvious to an ordinary skilled in the art to generate a fusion of SARS-CoV-2 antigen linked to HP Ferritin as claimed to induce multimerization and improve immunity when design an immunogenic composition based on combined teaching from Graham and Georges. The ordinary skilled in the art would be motivated to do so because Graham teaches designing a number of viruses in the coronavirus family to increase immunogenicity by combining with HP-Ferritin. The ordinary skilled in the art would have reasonable expectation of success to replace the RBD antigen from one member of coronavirus family with another member when the sequence encoding said RBD is disclosed by Georges. Therefore, the claimed invention of claims 3 and 4 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graham and Georges, as applied to claims 3 and 4 above, and further in view of Nabel et al (WO2013044203, see sequence alignment).
The teaching from Graham and Georges has been discussed above. However, neither teaches HP-Ferritin having full length SEQ ID NO: 2).
Nabel et al. teaches nanoparticles useful for producing vaccine against influenza virus that comprises ferritin subunit to form trimers, wherein the ferritin comprises SEQ ID NO: 5, which shares 100% sequence homology with SEQ ID NO: 2 claimed in claim 5 (see alignment).
It would have been obvious to an ordinary skilled in the art to use prior art known HP-Ferritin sequence to form immunogenic composition for preparation of vaccine based on teaching from Graham. The ordinary skilled in the art designing an immunogenic composition comprising RBD of SARS-CoV-2 would be motivated to use prior art known HP-Ferritin as taught by Nabel because Nabel has disclosed the entire sequence and demonstrated the design for making a viral vaccine. Combining prior art known elements to reach the fusion antigen, with each element performs its predictable function would have been routine experimentation rather than method of innovation. Therefore, the claimed invention of claim 5 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
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.
Claims 1-10 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-14 of copending Application No. 17801797 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of ‘797 application anticipates claim 1 or present application.
Regarding claim 2, claim 3 of ‘797 application recites same limitation as claim 2 of present application.
Regarding claim 3-5, claims 4-7 of ‘797 application recites same limitation as claims 3-5 of present application.
Regarding claim 6, claim 8 of ‘797 application recites same limitation directed to having signal peptide and tag to express and purify said fusion protein.
Regarding claim 7-10 and 15-17, claims 10-14 of ‘797’ application recites same coronavirus antigen and use thereof as currently claimed antigen in claims 7-10 and 15-17 of present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7, 12, 13 and 15-18 of copending Application No. 17/908,916(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of improving antigen immunogenicity of claim 1 of ‘916 application anticipates claim 1 of present application.
Regarding claim 2, claim 2 of ‘916 application recites same limitation as claim 2 of present application.
Regarding claim 3-5, claims 3-6 of ‘916 application recites same limitation as claims 3-5 of present application.
Regarding claim 6, claim 7 of ‘916 application recites same limitation directed to having signal peptide and tag to express and purify said fusion protein.
Regarding claim 7-10 and 15-17, claims 12-13 and 15-18 of ‘916 application recites same coronavirus antigen and use thereof as currently claimed antigen in claims 7-10 and 15-17 of present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claims are allowed.
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