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 03/03/2026 in which claims 1, 4, 7, 9, 10, 15, 16, were amended, new claims 46-51 were added, and claims 3, 33, 35, 40 and 43 were canceled, has been entered. Claims 17, 23, 43, 33 and 40 were previously withdrawn.
In reference to new claims 48-50, Applicant's election of the species of SEQ ID NO: 85 in the reply submitted on 09/11/2025, is acknowledged.
Claims 1, 4-10, 14-16, 34 and 46-51 are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional applications No. 63/038,600 filed on 06/12/2020 and 62/986,522 filed on 03/06/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/986,522 filed on 03/06/2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 48-50. Therefore, claims 48-50 do not receive domestic benefit to the provisional application No. 62/986,522 filed on 03/06/2020 because it does not disclose a sequence or mention of a SARS-CoV-2 spike (S-2P), as required by claims 48-50. For purposes of applying prior art, the filing date for claims 48-50 is 06/12/2020.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 03/03/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
(Previous objection, withdrawn) The previous objection to the Drawings is herein withdrawn.
(New objection, necessitated by amendment) The amended drawings were received on 03/03/2026. The drawings are objected to because nucleotide and/or amino acid sequences appearing in the drawings, Figs. 1-3, 11, 52, 54, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the Drawings or in the Brief Description of the Drawings.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 03/03/2026 have overcome the previous objection.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, maintained) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 03/03/2026 have not overcome the previous objection. As noted above, Figs. 1-3, 11, 52, 54, are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the Drawings or in the Brief Description of the Drawings.
Claim Objections
(Previous objections, withdrawn as to claims 4, 7). Applicant’s amendments to claims 4, 7 have overcome previous objections to those claims.
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 as to claim 9, 10 and 15) Claims 9, 10 and 15 were 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.
Applicant’s amendment to the instant claims filed on 03/03/2026 has overcome the previous rejections to claims 9, 10 and 15.
Claim Rejections - 35 USC § 112 - Written Description
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 as to claims 3 and 35, maintained and modified as to claims 1, 4-10, 14-16, 34, expanded as to new claims 46-51) Claims 1, 4-10, 14-16, 34, 46-51 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.
See claims 1, 4-10, 14-16, 34, 46-51 as submitted on 03/03/2026.
The previous rejections of claims 3, 35 are moot in view of Applicant’s cancelation of these claims.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
The amended claims require a nanoparticle comprising a fusion protein comprising two elements. First, a nanoparticle-forming peptide having an amino acid sequence with deletions or truncations of one or more amino acids in the amino acid sequences recited in claim 4 (Applicant elected species b which refers to a Helicobacter pylori ferritin [Hpf] in SEQ ID NO: 2), and having nanoparticle-forming ability. The instant claims alternatively require a peptide having a sequence identity to the amino acid sequence recited in claim 4 (Applicant elected Hpf in SEQ ID NO: 2) or a fragment thereof, and having nanoparticle-forming ability. Second, a at least one antigenic coronavirus peptide having an amino acid sequence with deletions of 1-15 amino acid residues or a variant of any thereof having 1-15 substitutions in the coronavirus amino acid sequences recited in claim 1 (for example a coronavirus spike S-2P protein) and having the ability to elicit an immune response (i.e., antigenic properties). The instant claims alternatively require at least one antigenic coronavirus peptide having a sequence identity to the amino acid sequences recited in claim 1 or a fragment or variant thereof, and having the ability to elicit an immune response.
However, the Specification has failed to sufficiently describe the structural features that must be retained by members of the claimed genera so as to establish a structure-function relationship with respect to nanoparticle-forming ability (as to the Hpf sequences) and the ability to elicit an immune response (as to coronavirus peptide sequences).
The Hpf in SEQ ID NO: 2, e.g., is 165 amino acids long. The instant claims encompass anywhere from 1 to 15 deletions, in any combination along any length of SEQ ID NO: 2, or a variant of any of those sequences having 1-15 substitutions. Thus, an enormous genus comprising trillions of sequences with respect to SEQ ID NO: 2 alone is encompassed by the tremendously broad scope of the claims.
With respect to the coronavirus peptide, for example the coronavirus spike protein (Specification, page 24) SEQ ID NO: 18, e.g., is 1273 amino acids long. The instant claims encompass anywhere from 1 to 15 deletions, in any combination along any length of SEQ ID NO: 18, or a variant of any of those sequences having 1-15 substitutions. Thus, an enormous genus comprising trillions upon trillions of sequences with respect to SEQ ID NO: 18 alone is encompassed by the tremendously broad scope of the claims.
However, while the claims are drawn to a genus that comprises innumerable
sequences, the Specification has only adequately described and successfully reduced to practice the full-length of Hpf and SARS-CoV-2 (SARS-CoV-2-Ferritin, Specification pages 55-58). This is not representative of the extremely large genus of sequences claimed, since no variants, fragments, etc. of for example SEQ ID NO: 2, and coronavirus peptides are demonstrated to have nanoparticle-forming ability and the ability to elicit an immune response, respectively.
At best, the Specification contemplates the use of BLAST to identify functional homologs based on sequence homology. However, this is not sufficient to describe members of the claimed genera because such methods access online databases that are continually being updated as sequencing technology improves. As a result, they are not a static source of information. Thus, one of skill in the art would readily appreciate that relying on a non-patent source that is continuously subject to change as a means to identify members of the claimed genera does not sufficiently meet the written description requirement.
Moreover, Friedberg (“Automated protein function prediction--the genomic challenge”. Brief Bioinform. 2006;7(3):225-242.) teaches that homology-based transfer is not reliable for functional annotation even with high alignment percentages (page 227, second column). Friedberg also teaches that identification of functionally significant sub-regions is critical to functional annotation, and that often addition, deletion, or re-shuffling of domains can lead to errors in annotation (page 227, second column; page 228, first paragraph). Furthermore, Friedberg teaches that sequence-based tools are just not sensitive enough to identify functional protein similarity as databases get larger, and diversity of sequences gets larger (page 228, first full paragraph).
Thorton (“Structural genomics takes off.” Trends Biochem Sci. 2001;26(2):88-89.) teaches that the same protein structure is often seen in apparently different homologous families with different functions. Thorton further describes examples of little correlation between specific binding function and overall protein structure (page 992, right column, at lines 2-10). Thus, when taken with the teachings of Friedberg and Thorton, one of skill in the art would readily appreciate that sequence homology alone cannot serve as the basis to describe members of the genus that have the recited function.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case nanoparticle-forming ability and the ability to elicit an immune response. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with respect to nanoparticle-forming ability and the ability to elicit an immune response.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
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.
(Previous rejection, withdrawn as to claims 3 and 35, maintained and modified as to claims 1, 4-10, 14-16, 34, expanded as to new claim 46, 47, and 51) Claims 1, 3-10, 14-16, 34 and 51 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PGPub 2018/0244756 A1 to Graham et al. published 08/30/2018. Prior art of record. It is noted that Graham et al. shares a co-inventor with instant application, but it is outside the 102(b)(1) exception grace period, thus qualifies as a 102(a)(1) reference.
See claims 1, 4-10, 14-16, 34, 46, 47, and 51 as submitted on 03/03/2026.
The previous rejections of claims 3, 35 are moot in view of Applicant’s cancelation of these claims.
Regarding claim 1, the amended claims recite narrower language in reference to the antigenic coronavirus peptide which is a stabilized extracellular S-2P domain, an spike domain, or an S-timer domain or a fragment of any of those, wherein the fragment bears 1-15 deletions relative thereto, or a variant of any of those having 1-15 substitutions relative thereto. However, these limitations are already taught by Graham et al. As explained previously, Graham et al. disclose methods of inducing an immune response and immunogens comprising a coronavirus (MERS-CoV) amino acid sequence (Abstract, ¶¶ [0004]-[0008]). Graham et al. further disclose one embodiment of the immunogens comprising a nanoparticle, wherein the nanoparticle comprises a) a ferritin polypeptide capable of self-assembly and b) a MERS-CoV peptide comprising the spike protein of MERS-CoV or a fragment thereof, for example the spike protein or fragment thereof is a extracellular domain in its stable prefusion conformation (Abstract, ¶¶ [0006], [0322]-[0327], [0441]). Graham et al. further disclose one embodiment wherein the nanoparticle comprises a peptide capable of self-assembly comprising Helicobacter pylori ferritin (Hpf) (¶¶ [0322]-[0327]).
Regarding claim 4, as noted previously Graham et al. further disclose one embodiment wherein the nanoparticle comprises a peptide capable of self-assembly comprising Helicobacter pylori ferritin (Hpf) (¶¶ [0322]-[0327]). Graham et al. further disclose a sequence (SEQ ID NO: 23) which shares 99.2% sequence identity with species b in claim 4 (instant SEQ ID NO:2). Here, under BRI, the claim is interpreted as comprising any amino acid sequence of any length that matches a portion of SEQ ID NO: 2 (elected species). See alignment below (Qy is instant SEQ ID NO: 2; Db is Graham et al.’s SEQ ID NO: 23).
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Regarding claim 5, Graham et al. further disclose the nanoparticle possesses a 4-fold axis or a 3-fold axis (¶¶ [0322]-[0327])
Regarding claims 6 and 7, Graham et al. further disclose wherein the antigenic coronavirus peptide is connected to the nanoparticle-forming peptide (ferritin) via a linker, such as a Ser-Gly linker (¶ [0337]). Two examples of such a linker sequence are an SGG linker (¶ [0341]) and a GGGGS linker (SEQ ID NO: 155, page 138).
Regarding claims 8 and 9, Graham et al. further disclose wherein the fusion protein comprises two or more MERS-CoV spike proteins or immunogenic fragments thereof joined together, wherein the two or more MERS-CoV spike proteins or fragments are from at least two different strains of MERS-CoV (¶¶ [0323], [0341]).
Regarding claim 10, Graham et al. further disclose wherein the at least one antigenic coronavirus peptide further comprises an RBD of MERS-CoV, and the RBD of MERS-CoV is linked to an Hpf protein via a peptide linker (¶¶ [0326], [0323], [0341]).
Regarding claims 14 and 15, Graham et al. further disclose a vaccine formulation comprising the nanoparticle of claim 1 and an aluminum hydroxide gel adjuvant such as ALHYDROGEL® (¶¶ [0343], [0406]).
Regarding claims 16 and 34 Graham et al. further disclose nucleic acid molecules encoding the nanoparticle in claim 1 comprising the RBD of MERS-CoV, wherein the nucleic acid molecules are an mRNA molecule and a DNA molecule (¶¶ [0382], [0393]).
Regarding claims 46 and 47, as noted above Graham et al. disclose a ferritin polypeptide capable of self-assembly connected via a peptide linker to a MERS-CoV peptide comprising the spike protein of MERS-CoV or a fragment thereof, for example the spike protein or fragment thereof is a extracellular domain in its stable prefusion conformation or an S-trimer protein (Abstract, ¶¶ [0006], [0233], [0322]-[0327], [0331], [0441]). It is noted that the term ‘S-2P domain’ refers to an extracellular spike protein stabilized in its prefusion conformation (Specification, page 29).
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.
(New rejection, necessitated by the addition of claims 48-50) Claims 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Graham et al. (previously cited) as applied to claims 1, 3-10, 14-16, 34, 46, 47 above, in view of Wrapp, et al. “Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation.” Science (New York, N.Y.) vol. 367,6483 (2020): 1260-1263. Published 02/19/2020. See PTO-892: Notice of References Cited.
Regarding claims 48-50, it is noted that Graham et al. disclose the nanoparticle of claim 1. Elected species of SEQ ID NO: 85 comprises the sequences of a SARS-CoV-2 spike protein in its prefusion conformation (termed S-2P), a linker and a sequence for a Helicobacter pylori ferritin (Hpf). As explained above in detail, Graham et al. already teach the sequence for Helicobacter pylori ferritin (Hpf) (see rejection of claim 4) and a linker (see rejection of claim 7).
Graham et al. do not teach a sequence for the SARS-CoV-2 spike protein in its prefusion conformation (termed S-2P).
However, Wrapp et al. teach a sequence for a SARS-CoV-2 spike protein in its prefusion conformation which binds to the human ACE2 receptor to mediate cell entry (page 1). The SARS-CoV-2 spike protein of Wrapp et al. is applicable for the development and evaluation of medical counter measurements against SARS-CoV-2 (Abstract, page 1). It is noted that SEQ ID NO: 85 residues 1-1130 comprise a sequence identical to the sequence taught by Wrapp et al. See alignment of the first 300 residues below (Qy is instant SEQ ID NO: 85 residues 1-1131; Db is Wrapp et al.’s RBD sequence). Here, under BRI, the claim is interpreted as comprising any amino acid sequence of any length that matches a portion of SEQ ID NO: 85.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the SARS-CoV-2 spike protein as taught by Wrapp et al. into the nanoparticle of Graham et al. for the benefit of formulating a nanoparticle comprising the SARS-CoV-2 spike protein in its prefusion conformation for the development and evaluation of medical counter measurements against SARS-CoV-2. 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). It is further noted that the spike protein of Wrapp et al. and the spike protein of MERS-CoV taught by Graham et al., both have the same function of mediating cell entry. As such, both proteins as well as any other viral glycoprotein involved in cell entry, are considered obvious targets to include in the nanoparticle as taught by Graham et al.
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the SARS-CoV-2 spike protein of Wrapp et al. into the nanoparticle as taught by Graham et al. given that the methods of formulating nanoparticles comprising an antigenic peptide are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, such a sequence comprising instant SEQ ID NO: 85 was an obvious embodiment to one of ordinary skill in the art before the effective filing date in view of the teachings of the cited prior, especially in the absence of evidence to the contrary.
(New rejection, necessitated by the addition of claim 51) Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Graham et al. (previously cited) as applied to claims 1, 3-10, 14-16, 34, 46, 47, above, in view of WO 2015183969 A1 to Mascola et al. Filed on 05/27/2015. See PTO-892: Notice of References Cited.
As explained above Graham et al. disclose the nanoparticle of claim 1. Graham et al. do not teach amino acid sequence of SEQ ID NO: 2.
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However, Mascola et al. teach monomeric ferritin subunit sequences which are capable to directing self-assembly of monomeric ferritin subunits into the globular form of the protein. These proteins can be use to construct nanoparticles displaying viral antigens such as an influenza HA protein on their surface (Abstract, page 37). One such sequence taught by Mascola et al. shares 100% sequence identity to instant SEQ ID NO: 2. See alignment below (Qy is instant SEQ ID NO: 2; Db is Mascola et al.’s SEQ ID NO: 2)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the ferritin sequence protein as taught by Mascola et al. into the nanoparticle of Graham et al. for the benefit of formulating a nanoparticle comprising monomeric ferritin subunit sequences which are capable to directing self-assembly of monomeric ferritin subunits into the globular form of the protein and display a viral protein on their surface. 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 reasonable expectation of success in incorporating the ferritin subunit sequence into the nanoparticle of Graham et al. given that the methods of formulating nanoparticles comprising an antigenic peptide are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
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, maintained and modified as to claims 1, 5, 8, 9, 14-16, 34), Claims 1, 5, 8, 9, 14-16, 34, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 20, 25 of US patent No. 10,961,283 B2 to Kwong et al. dated 03/30/2021. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a nanoparticle comprising a fusion protein comprising a nanoparticle-forming peptide and at least one antigenic coronavirus peptide.
See claims 1, 5, 8, 9, 14-16, 34, as submitted on 03/03/2026.
As to claims 1, 5, 8, 9, 14-16, 34, of instant application, the patented claims are directed to a nanoparticle comprising a fusion protein in an N- to C-terminal direction comprising a self-assembled insect ferritin peptide and eight antigenic coronavirus peptides (relevant to instant claims 1 and 8), wherein the recombinant insect ferritin nanoparticle comprises a shape having a tetrahedral symmetry (relevant in instant claim 5). The patented claims further recite a coronavirus spike protein ectodomains from two different strains of MERS or SARS coronavirus while instant claims are broader, as they encompass any coronavirus extracellular spike protein and do not require MERS or SARS sequences specifically (relevant to instant claims 1 and 9). The patented claims further recite an isolated nucleic acid molecule encoding: the recombinant insect ferritin light chain fusion protein and/or the recombinant insect ferritin heavy chain fusion protein (relevant to instant claims 16, 34 and 35). The patented claims further recite an immunogenic composition comprising an effective amount of the recombinant insect ferritin nanoparticle, and a pharmaceutically acceptable carrier (relevant to instant claims 14 and 15).
(Previous rejection, maintained and modified as to claims 1, 3, 6, 9, 14-16, 34) Claims 1, 3, 6, 9, 14-16, 34, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 10, 13, 15, 18 of US patent No. 10,960,070 B2 to Graham et al. dated 03/30/2021. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a nanoparticle comprising a fusion protein comprising a nanoparticle-forming peptide and at least one antigenic coronavirus peptide.
See claims 1, 3, 6, 9, 14-16, 34, as submitted on 03/03/2026.
As to claims 1, 3, 6, 9, 14-16, 34, of instant application, the patented claims are directed to an immunogen, comprising: a recombinant coronavirus S ectodomain trimer comprising protomers comprising one or two praline substitutions at a junction between a heptad repeat 1 (HR1) and 5 a central helix that stabilize the S ectodomain trimer in a prefusion conformation, wherein a C-terminal residue of the S2 ectodomain is linked to a ferritin protein nanoparticle subunit by a peptide linker, or is directly linked to the protein nanoparticle subunit (relevant to instant claims 1, 3, 6). The patented claims further encompass wherein the coronavirus is one of MERS-CoV, SARS-CoV, NL63-CoV, 229E-CoV, OC43-CoV, HKUl-CoV, WIVl-CoV, MHV, HKU9-CoV, PEDV-CoV, or SDCV (relevant to instant claim 9). The patented claims further encompass an isolated nucleic acid molecule encoding the fusion protein comprising a ferritin protein nanoparticle and a coronavirus peptide (relevant to instant claims 16, 34, 35); and an immunogenic composition comprising the fusion protein comprising a ferritin protein nanoparticle and a coronavirus peptide and a pharmaceutically acceptable carrier (relevant to instant claims 14 and 15).
(Previous rejection, maintained and modified as to claims 1, 6, 9, 14-16, 34) Claims 1, 6, 9, 14-16, 34, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 18, 20, 24 of copending application No. 17798021. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a nanoparticle comprising a fusion protein comprising a nanoparticle-forming peptide and at least one antigenic coronavirus peptide. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See claims 1, 6, 9, 14-16, 34, as submitted on 03/03/2026.
As to claims 1, 6, 9, 14-16, 34, of instant application, the copending claims are directed to an immunogen, comprising promoters comprising a recombinant coronavirus S ectodomain trimer comprising protomers, wherein a C-terminal residue of the promoters is linked to a protein nanoparticle subunit by a peptide linker, or is directly linked to the protein nanoparticle subunit (relevant to instant claims 1, 6). The copending claims further encompass SARS-CoV sequences (relevant to instant claim 9). The copending claims further encompass an isolated nucleic acid molecule encoding the promoter comprising the recombinant SARS-CoV-S ectodomain trimer (relevant to instant claims 16, 34, 35); and an immunogenic composition comprising the fusion protein comprising a ferritin protein nanoparticle and a coronavirus peptide and a pharmaceutically acceptable carrier (relevant to instant claims 14 and 15).
Response to Arguments
Applicant's arguments filed 03/03/2026 have been fully considered but they are not persuasive.
Applicant contends on page 10 of the Remarks submitted on 03/03/2026:
“With regard to nanoparticle-forming peptides, the claims now recite specific embodiments of Hpf proteins and specific fragments and variants thereof discussed in paragraphs [0109]-[0111] of the specification as filed. In this regard, Applicant notes that SEQ ID NO:2 and SEQ ID NO:3 are specific embodiments of variant fragments of SEQ ID NO: 1. With regard to antigenic coronavirus peptides, the claims now recite specific embodiments of such peptides and fragments and variants thereof discussed in paragraphs [0120]-[0131]. In this regard, Applicant notes that Table 2 discloses examples of specific substitutions that may be present in a recited RBD variant; paragraph [0130] discloses examples of specific substitutions that may be present in a recited S-2P variant, and the constructs in Table 18 embody many other variants and fragments within the scope of the claims…”
In response:
The instant rejection is in view of instant claim language. 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). It is noted that the instant claims merely recite an “a nanoparticle-forming peptide having an amino acid sequence with deletions or truncations of one or more amino acids in the amino acid sequences” (claim 4) and an “antigenic coronavirus peptide” or an antigenic coronavirus peptide having an amino acid sequence with deletions of 1-15 amino acid residues or a variant of any thereof having 1-15 substitutions in the coronavirus amino acid sequences. Further, the instant claims recite “comprising” and are interpreted in an open-ended fashion and do not even exclude additional components (See MPEP 2111). It is maintained that in view of the language, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Applicant contends on page 14 of the Remarks submitted on 03/03/2026:
“Claims 1, 5, 8, 9, 14-16, 34, 35 were rejected on the ground of nonstatutory double patenting as allegedly unpatentable over (i) claims 1, 10, 20, and 25 of U.S. Patent No. 10,961,283 and (ii) claims 1, 3, 9, 10, 13, 15, 18 of U.S. Patent No. 10,960,070; and were provisionally rejected over (iii) claims 1, 17, 18, 20, 24 of copending U.S. Patent Application No. 17/798,021. With regard to rejection (i), without acquiescing to the merits of the rejection of the claims as previously pending, Applicants believe the pending claims are directed to patentably distinct subject matter from the claim of the '283 patent. Applicants therefore respectfully request reconsideration and withdrawal of that rejection. With regard to rejections (ii) and (iii), Applicants respectfully defer addressing these rejections until the claims are otherwise in condition for allowance.”
In response:
To reiterate, the instant rejection is in view of instant claim language. 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). A detailed explanation of how the instant claims and the patented or copending claims are not patentably distinct is provided above. The rejection will not be held in abeyance and is maintained for reasons of record.
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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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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