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 without traverse of Group I, claims 1, 3-10, 14-16, 34 and 35 drawn to a nanoparticle, in the reply filed on 09/11/2025 is acknowledged. In addition, Applicant’s election of the following species in the reply filed on 09/11/2025 is acknowledged:
Species b in claim 4
The traversal is on the grounds that: the disclosure of Wu et al. (prior art of record) does not destroy unity of invention for the claimed subject matter as a whole, and further that the Office Action mailed on 06/11/2025 does not explain how Wu et al. destroys unity of invention for a nanoparticle comprising a fusion protein comprising a nanoparticle-forming peptide and at least one antigenic coronavirus peptide.
This is not found persuasive because: as indicated in the Restriction Action more completely, the common technical feature is a DNA molecule, comprising a sequence encoding a receptor receptor-binding domain (RBD) of a coronavirus, or a fragment or variant thereof. Wu et al. teach the full genomic DNA sequence of SARS-CoV-2 including a spike protein and a receptor binding domain (Abstract, pages 265-267). Therefore, no special technical feature exists for Groups I-IV as defined by PCT Rule 13.2 because it does not define a contribution over the prior art. Because the technical feature of Groups I-IV is not a special technical feature, unity of invention is lacking.
Given that the reasoning for the Restriction Action was provided and that Applicant has not appeared to provide persuasive arguments as to how the cited prior art does not destroy unity of invention for the claimed subject matter as a whole; the requirement is still deemed proper and is therefore made FINAL.
Claims 17, 23, 43, 33 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/11/2025.
Claims 1, 3-10, 14-16, 34 and 35 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.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 12/30/2022, 10/10/2023, 09/13/2024 and 09/11/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 09/02/2022. The drawings are objected to because figs. 1-3, 6-12, 15-16, 23-26, 33, 38, 44-45, 53, 54 contain text that is illegible. Further, fig. 31 is missing labels to indicate which panels are shown as described in the Specification. Further, in certain figures, for example figs. 2, 3, 6C, 7A-C, the resolution is so low as to render the drawing illegible. Note that figs. 2, 3, 6C, 7A-C are merely examples and all illegible drawings should be identified by Applicant and properly addressed.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, for example in page 48. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term ‘Strep-Tactin’ on page 48, which is a 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.
Note that ‘Strep-Tactin’ is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (for example 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.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, the amino acid sequences appearing on, for example, pages 2-3 of the Specification lack corresponding SEQ ID NOs. Sequence compliance rules require that SEQ ID NOs are provided for amino acid sequences with 4 or more residues and nucleotide sequences with 10 or more bases.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers or deleting the noncompliant sequences, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 4, 7 are objected to because of the following informalities:
Claims 4 and 7 are objected to because they contain sequence disclosures that are encompassed by the definitions for amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2) and they fail to make reference to the amino acid sequences by use of sequence identifiers (“SEQ ID NO:” or the like) in accordance to 37 CFR § 1.823(a)(5). See MPEP 2422. Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The instant claims recite the term “or a fragment or variant thereof” in the context of amino acid and/or nucleotide sequences. The term “variant” is not defined in the Specification. For the purposes of compact prosecution and applying prior art, the term “variant” was broadly interpreted herein consistent with its plain meaning to read on any sequence modification ranging from single amino acid residues alterations or single nucleotide alterations to larger modifications amounting to structural changes.
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 9, 10 and 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.
On claim 9 the recitation of “the antigenic coronavirus peptide is isolated or derived from a coronavirus” is not clear because it does not define the scope of a claim in relation to the coronavirus. See MPEP 2111.03. Further, it is unclear what the term “derived” means because the Specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim is indefinite. For the purposes of compact prosecution and applying prior art, claim 9 was interpreted herein as reciting the open-ended language of comprising a coronavirus peptide.
Claim 10 recites “any fusion protein disclosed in Table 3 and any fusion protein disclosed in Table 18”. MPEP 2173.05 (s) states that “Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim”. In the instant case, the tables referred to on the claim list fusion proteins. Fusion proteins can be incorporated in a claim. For purposes of compact prosecution and applying prior art, claim 10 was interpreted herein consistent with Applicant’s elected species as referring to a fusion protein comprising the nanoparticle-forming peptide of claim 4 species b.
Claim 15 contains the trademark/trade name “Alhydrogel”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an adjuvant and, accordingly, the identification/description is indefinite.
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.
Claims 1, 3-10, 14-16, 34 and 35 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, 3-10, 14-16, 34 and 35 as submitted on 04/06/2023.
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 instant claims require a nanoparticle comprising a fusion protein comprising a nanoparticle-forming peptide having an amino acid sequence with substitutions, additions, insertions, or deletions 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, or alternatively SEQ ID NOs: 1 or 3), 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 alternatively SEQ ID NOs: 1 or 3) or a fragment or variant thereof, and having nanoparticle-forming ability (See also Claim Interpretation above).
Further, the instant claims require a nanoparticle comprising a fusion protein comprising at least one antigenic coronavirus peptide having an amino acid sequence with substitutions, additions, insertions, or deletions of one or more amino acid residues in the coronavirus amino acid sequences recited in claim 1 (for example a coronavirus spike 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 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 165 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 2. Thus, an enormous genus (20165 = 4.7 x 10214) comprising trillions upon 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 1273 substitutions, deletions, or additions in any combination along any length of SEQ ID NO: 18. Thus, an enormous genus (201273 = 1.47 x 101666) 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.
Claims 1, 3-10, 14-16, 34 and 35 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. See PTO-892: Notice of References Cited. 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, 3-10, 14-16, 34 and 35 as submitted on 04/06/2023.
Regarding claim 1, 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 in its stable prefusion conformation (Abstract, ¶¶ [0006], [0322]-[0327], [0441]).
Regarding claims 3 and 4, 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. 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 fusion protein comprises wherein the nanoparticle comprises an Hpf protein connected via a peptide linker to an RBD of MERS-CoV (¶¶ [0326], [0323], [0341]).
Regarding claims 14 and 15, Graham et al. further disclose a vaccine formulation comprising the nanoparticle of claim 1 and an adjuvant such as ALHYDROGEL® (¶¶ [0343], [0406]).
Regarding claims 16, 34, and 35 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]).
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, 5, 8, 9, 14-16, 34, 35 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, 35 as submitted on 04/06/2023.
As to claims 1, 5, 8, 9, 14-16, 34, 35 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).
Claims 1, 3, 6, 9, 14-16, 34, 35 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, 35 as submitted on 04/06/2023.
As to claims 1, 3, 6, 9, 14-16, 34, 35 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).
Claims 1, 6, 9, 14-16, 34, 35 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, 35 as submitted on 04/06/2023.
As to claims 1, 6, 9, 14-16, 34, 35 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).
Conclusion
No claims are allowed.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672