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 .
Restriction/Election of Species
The previous Examiner required a Restriction in the Office Action mailed out on 08 October 2025. Examiner identified four groups: Group 1, claims 1, 9-21, and 32, drawn to a coronavirus vaccine composition; Group 2, claims 22-27, drawn to a method for treating or preventing; Group 3, claim 28, drawn to a method of making; Group 4, claims 29-31, drawn to a diagnostic assay.
In their Response filed on 08 December 2025, Applicant elected Group 1 with traverse, despite their assertion otherwise, due to the presence of arguments against the previous Examiner breaking unity of invention of the instant application.
The previous Examiner also required an Election of Species in the Office Action mailed out on 08 October 2025. Examiner required further election if Group 1 was elected, specifically one or more discrete hotspot regions from those indicated in Figures 13-18 (claim 13); Figures 15-16 (claim 14); and Figures 17-18 (claim 15).
In their Response filed on 08 December 2025, Applicant elected the following species, with traverse, despite their assertion otherwise, due to the presence of arguments against the previous Examiner breaking unity of invention of the instant application: the ORF3a 10-150 hotspot in Figure 13; the ORF3a 10-150 hotspot in Figure 16; and the ORF3a 10-150 hotspot in Figure 17.
Claims 1 and 9-32 are currently pending, with Claims 22-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction and species election requirement in the reply filed on 08 December 2025.
Response to Arguments
Applicant's election with traverse of the restriction and species election requirement in the reply filed on 08 December 2025 is acknowledged. The traversal is on the grounds that “Fast does not disclose any vaccine compositions comprising immunogenic portions of a coronavirus comprising ‘the polypeptide sequence identified herein as ORF3a: 100-150, or a portion thereof having at least 5 epitopes within said sequence’” and alleges that the “Examiner has mischaracterized the teachings of Fast, which are primarily concerned with the SARS-COV2 spike protein as a source of antigenic epitopes” (see Page 1 of Remarks, Paragraph 5). Applicant also argues that “Fast makes only a passing reference to ORF3a in describing an initial MHC presentation hotspot analysis of SARS-COV2 genes shown in Figure 2” and that “the search was narrowed ‘to S protein since it is the most likely target of human neutralizing antibodies’”. This is not found persuasive because the open-ended language of the claim (i.e., “comprising”) means that polypeptides other than those from ORF3a can be present and that other regions of ORF3a other than 100-150 can be present in the claimed vaccine composition. Also, the lack of a reference sequence for the instantly claimed ORF3a region 100-150 means that it reads on any prior art references which teach the use of any ORF3a epitopes.
Additionally, simply because Fast et al. focuses on a particular embodiment, such as epitopes from the Spike protein, does not mean that any alternative embodiments contemplated, epitopes from ORF3a, for example, are rendered irrelevant. Applicant is reminded that preferred embodiments are not the only teaching of a reference.
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
MPEP 2123.
As such, the restriction requirement is still deemed proper and is therefore made FINAL.
Disposition of Claims
Accordingly, Claims 1, 9-21, and 32 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2024/0408193 A1, Published 12 December 2024. Applicant’s amended Specifications as presented on 10 September 2025, 23 March 2023, and 19 October 2022 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statement filed 19 May 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because Foreign Patent Document A2, WO 2004/110349, is duplicate of Foreign Patent Document A1, WO 2004/110349 A. This reference has only been considered once. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement (IDS) submitted on 19 May 2025 has been considered by the examiner. Any individual references with strikethrough, however, have not been considered.
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/PatentLegalFramework), 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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Specifically, Figures 1-10 display full amino acid sequences for multiple SARS-CoV-2 proteins (see Paragraphs 0019-0028). 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.
Specification
The abstract of the disclosure is objected to because of minor informalities. It is suggested that it say “…through the analysis of large-scale epitope mapping”. There should be a hyphen between “large” and “scale”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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://, www., and/or other browser-executable code. The hyperlinks in question are www.iedb.org/ (Paragraph 0069); www.cbs.dtu.dk/services/NetMHC/ (Paragraph 0069); and www.cbs.dtu.dk/services/NetChop/ (Paragraph 0069). See MPEP § 608.01.
The disclosure is objected to because of the following informalities: in Paragraph 0006, it should say “an S-protein-centered approach” instead of “an S-protein-centred approach”.
In Paragraphs 0219 and 0229, it should say “IFN-γ” instead of “IFNg”.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 16-17 are objected to because of the following informalities: in Claim 1, it is suggested that it say “comprising an immunogenic portion of a coronavirus”.
In Claims 16-18, it is suggested that it say “The vaccine composition according to claim 1”.
Appropriate correction is required.
Applicant is advised that should claim 16 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112(b); Second Paragraph
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, and dependent claims 9-21 and 32 thereof, 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, it recites the limitation “said immunogenic portion comprising the polypeptide sequence identified herein as ORF3a: 100-150, or a portion thereof having at least 5 epitopes within said sequence or a polynucleotide encoding said sequence”. Claim 1 is rejected for claiming the limitation of amino acid positions within a protein sequence without providing an appropriate frame of reference for said sequence. Said frame of reference can be provided by referencing a sequence disclosed within the application (i.e., a sequence with a SEQ ID NO: identifier) or by referencing a start position for said sequence (i.e., “…wherein said amino acid is at position X from the starting methionine of the protein…”). As such, it is unclear which region corresponds to “100-150”. This region would differ if the full-length sequence is being used or if a truncated sequence is being used or if a tagged version of the sequence is being used. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended by providing a reference sequence for the claimed sequence, as long as said amendment does not introduce new matter, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 1 is rejected on the grounds of being indefinite. Claims 9-21 and 32 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
Claims 13-15 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.
These claims are rejected for referencing figures within the claim set.
In the instant case, Claim 13 references Figures 13-18, Claim 14 references Figures 15-16, and Claim 15 references Figures 17-18.
MPEP § 2173.05(s) discloses that where possible, claims are to be complete in themselves. 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. Incorporation by reference is a necessity doctrine, not for applicant's convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 32 is 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 32, it recites the limitation “The vaccine composition according to claim 1, wherein the composition is formulated as a therapeutic or prophylactic composition”. It is unclear how the claimed vaccine composition can be formulated as a therapeutic versus a prophylactic composition. It is also unclear how one of ordinary skill in the art would know the difference between the two. As such, what is and what is not encompassed by this claim limitation is not clear, rendering the claim indefinite. It is suggested that the claim be amended to clarify the metes and bounds of the claim limitation, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 32 is rejected on the grounds of being indefinite.
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.
For the purposes of examining the claims on their merits, due to the lack of a reference sequence for “ORF3a: 100-150”, this claim limitation in Claim 1 will be interpreted such that any prior art reference which teaches epitopes from ORF3a will read on the instant claims. Also, the phrase “domains thereof” in Claim 20 will be interpreted to read upon any fragment of the Spike protein, as Applicant has not provided a special definition for the term “domain” in the instant Specification.
Claim Rejections - 35 USC § 112(a); First Paragraph
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, 9-21, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an immunogenic composition comprising an immunogenic portion of a coronavirus, said immunogenic portion comprising the polypeptide sequence identified herein as ORF3a: 100-150, or a portion thereof having at least 5 epitopes within said sequence or a polynucleotide encoding said sequence, does not reasonably provide enablement for a vaccine composition comprising an immunogenic portion of a coronavirus, said immunogenic portion comprising the polypeptide sequence identified herein as ORF3a: 100-150, or a portion thereof having at least 5 epitopes within said sequence or a polynucleotide encoding said sequence. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. The claims are drawn to a vaccine composition, comprising an immunogenic portion of coronavirus, said immunogenic portion comprising the polypeptide sequence identified herein as ORF3a: 100-150, or a portion thereof having at least 5 epitopes within said sequence or a polynucleotide encoding said sequence. Paragraph 0053 of the instant Specification states, in part, that the “term vaccine composition, or vaccine, which from herein may be referred to interchangeably as the ‘composition’, relates to a biological preparation that provides active acquired immunity to a particular infectious disease, in this case a coronavirus infection”. Paragraph 0058 of the instant Specification states, in part, that the “term ‘epitope’ as used herein refers to any part of an antigen that is recognised by any antibodies, B cell, or T cells”.
State of the prior art/Predictability of the art. Reasonable guidance with respect to preventing any viral infection relies on quantitative analysis from defined populations that have been successfully pre-screened and are predisposed to particular types of viruses. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical infection and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. Further, a preventive administration also must assume that the therapeutic will be safe and tolerable for anyone susceptible to the disease. Therefore, Applicant may provide data showing prevention in vivo.
As stated in Cross v. Iizuka, 753 F.2d 1040, 1050, 224 USPQ 739, 747 (Fed. Cir. 1985): [B]ased upon the relevant evidence as a whole, there is a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence. (Citations omitted.) Therefore, in the absence of the in vivo data above, Applicant may also provide evidence of pharmacological activity that would reasonably correlate with prevention of infection.
In the case of virus vaccines, a reasonable nexus exists between neutralizing antibody generation and prevention of infection. Thus, a showing that an antigen within the recited immunogen scope can produce such antibodies would support enablement for use of said antigen in a vaccine and/or methods of preventing infection therewith of the virus comprising said antigen.
Burton (Nature Reviews Immunology, Vol. 2, Pg. 706-713, 2002) teaches neutralizing antibodies are crucial for vaccine-mediated protection against viral diseases (Abstract). Figure 1 divides antiviral activities of antibodies into two groups: activities against free virus and activities against infected cells. Actual block of infection (prevention of infection) is taught to be the role of neutralizing antibodies (Figure 1). Nonneutralizing antibodies thus cannot prevent infection, only treat an infection.
Adding to the unpredictability is the fact that not just any epitope of a target antigen/virus will lead to antibody generation, let alone that of neutralizing antibodies. Riddell (Journal of Virology, Vol. 74, No. 17, Pg. 8011-8017, 2000) at the abstract teaches patient sera reacts with some but not all B-cell epitopes on ORF7.1 protein. Thus, not just any epitope/antigen/immunogen will contribute to patient immunity against a virus. Sugiyama (Journal of Virology, Vol. 76, No. 4, Pg. 1691-1696, 2002) supports this by teaching in their abstract that even amongst known epitopes that lead to neutralizing antibodies in some species, another subject’s immune reaction will not necessarily generate antibodies against all said epitopes.
Burton (PNAS, Vol. 108, No. 27, Pg. 11181-11186, 2011) teaches three anti-HIV antibodies. Antibodies b12 and b6 bind CD4 binding sites while F240 binds gp41 (Abstract). All were tested for prevention of SHIV transmission to macaques (Abstract). While the two anti-gp120 antibodies have similar binding properties, b12 is strongly neutralizing and b6 is not (Abstract). F240 is nonneutralizing (Abstract). Compared to controls, the protection by b12 achieved statistical significance while no such protection was seen for either b6 or F240 (Abstract). Thus, the work of Burton supports the conclusion that neutralizing antibodies are required for prevention and so a functional vaccine should produce such. It also supports the idea that not just any peptide on protein may generate neutralizing antibodies that protect as evidenced by b12 and b6 performance above. Data are clearly required to calm the concerns of the prior art and make methods of viral infection prevention and vaccine products predictable.
Taken together, it is clear from the prior art that a PHOSITA cannot predict the preventative power of any immunogen. They must be shown data that supports such a conclusion. Without demonstration of neutralizing antibody production, for example, in the target population with the specific immunogen, no practitioner in this art would see any given immunogen as a functional, predictable prophylactic agent.
Working examples. No working example of a vaccine composition is disclosed in the specification. All examples of a vaccine composition for prophylaxis or prevention of a coronavirus infection are hypothetical or prophetic in nature.
Guidance in the specification. The specification provides guidance towards immunogenic epitopes which stimulate an immune response in samples obtained from patients who tested positive for COVID-19 and who had recovered from the disease (see Paragraphs 0218-0236, 0244-0253; Table 3). No evidence is provided that said immunogenic epitopes can generate neutralizing antibodies which could prevent infection.
Amount of experimentation necessary. Since the art teaches that it is unpredictable whether or not any immunogen can generate neutralizing antibodies, and the specification does nothing to ameliorate these concerns, one would be burdened with undue experimentation to use the claimed products.
Claims 1, 9-21, and 32 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.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirements for a generic claim covering several distinct inventions:
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 applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
Claims 1, 9-21, and 32 are rejected as lacking adequate descriptive support for epitopes derived from ORF3a which are preventative or prophylactic in nature.
In support of the claimed genus (epitopes derived from ORF3a which are preventative or prophylactic in nature), the application discloses zero (0) examples in which an epitope derived from ORF3a exhibits the ability to prevent infection with SARS-CoV-2 as part of a vaccine. Thus, the application fails to provide examples of any species within the claimed genus.
“[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 contributions to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle and Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient details that one skilled in the art can reasonably conclude that the invention had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
MPEP § 2163 states that 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, 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 applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. However, one of skill in this art cannot envision the structure of any peptide with the required structure and corresponding function of the claimed genus. Therefore, and since no species are provided to represent the genus, the claims encompassing the same clearly fail the written description requirement.
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014).
Overall, at the time the invention was made, the level of skill for preparing peptides which meet the desired structural and functional threshold was high. However, even if a selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identity peptides which meet the desired structural and functional threshold, the written description provision of 35 U.S.C. 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010). Absent the conserved structure provided by a core peptide, the skilled artisan would not be able to visualize or otherwise predict, a priori, what any peptide which meets the recited functional threshold would look like structurally.
Applicant has failed to describe any species within the genera recited, it is unknown how large the genus is, and the peptides encompassed by said genus cannot be visualized from the prior art or instant disclosure. One of skill in this art cannot determine the peptide structures encompassed by the claimed/recited genus. Any future peptides may or may not be encompassed, and if they are, they would not have been represented in Applicant’s disclosed species, particularly given that Applicant did not disclose any species. Thus, the lack of any described species obviously cannot be considered representative of the entire recited genera of peptides. E.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Therefore, the claims are rejected here.
As such, it does not appear Applicant was in possession of the full scope of the claimed invention at the time of filing and thus Claims 1, 9-21, and 32 do not meet the written description requirement.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 32, it recites the limitation “The vaccine composition according to claim 1, wherein the composition is formulated as a therapeutic or prophylactic composition”. Claim 32 does not further limit Claim 1, upon which it depends. Every single embodiment of Claim 32 is already present in independent Claim 1 as the composition of Claim 1 is either therapeutic or prophylactic. Claim 32 is simply redundant as there is no special definition of “vaccine” provided in the instant Specification which would differentiate Claim 1 from Claim 32.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections – Improper Markush Grouping
Claims 13-15 are rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives.
See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial structural feature and a common use that flows from the substantial structural feature for the following reasons:
MPEP 803.02 provides guidance on the analysis of a proper Markush group. Members of a proper Markush group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property. The MPEP further provides that in the members of a proper Markush group there should be (1) a common utility, and (2) a substantial structural feature essential to that utility.
In the instant case, the Markush grouping of the claimed immunogenic epitopes is improper because the alternative defined by the Markush grouping do not share both a structural similarity and a common use because the viral epitopes all have different sequences.
In response to this rejection, Applicant should either amend the claims to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 9-15, 20-21, and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature or natural phenomena without significantly more. Therefore, the claimed invention is a composition of matter (Step 1 is Yes) and since it is a product of nature or natural phenomena, which is a judicial exception, the answer for Step 2A is also Yes. The claims recite, Claim 1 in particular, a vaccine composition, comprising an immunogenic portion of a coronavirus, said immunogenic portion thereof having at least 5 epitopes within said sequence or a polynucleotide encoding said sequence. Claim 1 is ineligible because it recites amino acid sequences and the corresponding nucleic acid sequence that are naturally-occurring sequences which are not markedly different from their naturally-occurring counterparts because they convey the same genetic information and there are no additional required components of the claimed composition which would distinguish the claimed protein from its naturally-occurring counterpart. For example, GenBank Accession YP_009724391 provides an amino acid sequence of Orf3a protein isolated from a SARS-CoV-2 strain isolated from a human in China in 2019. Claims 9-15 are also ineligible because they simply recite naturally-occurring amino acid sequences which are not markedly different from their naturally-occurring counterparts because they convey the same genetic information and there are no additional required components of the claimed composition which would distinguish the claimed protein from its naturally-occurring counterpart. Claim 20 is ineligible because it recites the naturally-occurring SARS-CoV-2 spike protein without markedly distinguishing it from its naturally-occurring counterpart and there are no additional required components of the claimed composition which would distinguish the claimed protein from its naturally-occurring counterpart. While Paragraph 0100 of the instant Specification attempts to define “recombinant” by stating, in part, that “It is envisaged that such an immunogenic portion for use in the composition of the present invention would be recombinant in nature, wherein recombinant refers to the artificial and/or modified characteristic of said immunogenic portion, which may be produced through genetic recombination means”, this information does not materially alter the claimed protein or domains thereof. Claim 21 is ineligible because, as described in Paragraph 0122 of the instant Specification, the term “pharmaceutically acceptable carrier” includes any and all solvents, which encompasses a substance such as water. This substance does not impart a marked effect upon the naturally-occurring viral protein. While Claim 21 also recites an adjuvant, this is not a required element of the claim, due to the presence of “and/or”. Claim 32 is ineligible because it simply reiterates the limitations of instant Claim 1, without adding any required additional elements which would distinguish the claimed protein or portion thereof from its naturally-occurring counterpart.
This judicial exception is not integrated into a practical application because the claimed invention, as currently written, is not used to provide a particular treatment or prophylaxis for a disease or medical condition. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention, as currently written, simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Therefore, when considering Step 2B, the answer is No. It is suggested that the claims be amended to recite sequences that are not naturally occurring by incorporating non-natural amino acids, heterologous sequence elements, or tags, for example, or by requiring the presence or inclusion of components in the composition that markedly change the virus from its natural form, such as adjuvants. Applicant is free to amend the claim as they deem necessary, as long as said amendments do not introduce new matter, or persuasively argue that the claims are patent eligible. MPEP 2106, specifically 2106.04(b), provides further guidance on the analysis provided above.
Claim Rejections - 35 USC § 102
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, 9-21, and 32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by De Groot and Martin (US 2023/0151061 A1, earliest Priority Date 14 February 2020).
De Groot and Martin teach epitope-based compositions comprising immunogenic polypeptides which are predicted to be ligands of HLA class I and/or HLA class II MHC molecules as well as epitopes that are predicted to be recognized by T-cells in the context of MHC class I and/or class II molecules, wherein the epitopes are derived from SARS-CoV-2 proteins, including ORF3a and the Spike protein (see Abstract; Paragraph 0080), which reads on instant Claims 1 and 20. De Groot and Martin also teach wherein said compositions comprise 5 or more epitopes wherein the epitopes can be up to 25 amino acids in length (see Paragraphs 0012, 0129), which reads on instant Claims 1, 9-10, and 12. Additionally, De Groot and Martin teach epitopes which are predicted to be ligands of HLA class I and/or HLA class II MHC molecules as well as epitopes that are predicted to be recognized by T-cells in the context of MHC class I and/or class II molecules which are capable of stimulating a humoral immune response against SARS-CoV-2 (see Abstract; Paragraphs 0051, 0054, 0100, 0120), wherein the epitopes are derived from SARS-CoV-2 proteins, including the envelope, membrane, spike, nucleocapsid, ORF3a, ORF6, ORF7a, ORF8, ORF10, ORF1ab, and non-structural proteins (NSPs) 2-10 (see Paragraph 0080), which reads on instant Claims 11 and 13-15. Furthermore, De Groot and Martin teach wherein the epitopes comprised within the immunogenic composition are in the form of peptides (see Paragraphs 0009-0013, 0080), wherein the immunogenic peptides or polypeptides are expressed from DNA, RNA, or mRNA from expression cassettes (see Paragraphs 0009, 0017-0018), which reads on instant Claims 16-19. Finally, De Groot and Martin teach an immunogenic composition comprising said epitopes and further comprising a pharmaceutically acceptable carrier, excipient, diluent, and/or adjuvant, wherein said composition is used for treating a SARS-CoV-2 infection (see Paragraphs 0009, 0018, 0044, 0068), which reads on instant Claims 21 and 32.
For at least these reasons, De Groot and Martin teach the limitations of instant Claims 1, 9-21, and 32 and anticipate the invention encompassed by said claims.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Yu and Vyas (US 2022/0213175 A1, earliest Priority Date 20 March 2020)
Yu and Vyas teach peptides derived from the coronavirus envelope protein and compositions comprising said peptides for the detection and treatment of a coronavirus infection in human subjects. This reference has not been utilized, as rejection would be redundant to those set forth above.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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