DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-18 are pending. Claims 4-6, 8-12 and 16 are withdrawn. Claims 1-3, 7, 13-15, 17 and 18 are under examination.
Election/Restrictions
Applicants’ election of the species SEQ ID NO: 1 (Cda2-Pep1) in the reply filed on 07/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-6, 8-12 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/07/2026.
Information Disclosure Statement
The information disclosure statement filed 10/15/2024 has been considered and an initialed copy is enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings. See figure 2A and 3A.
Required response – Applicant must provide:
Amended 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 (i.e., “SEQ ID NO:X” or the like) 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.
Claim Rejections - 35 USC § 112
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, 7, 13-15 and 17-18 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. This is a written description rejection.
Claim 1 is drawn to a vaccine for cryptococcosis, comprising: 1) an antigenic peptide or an antigenic protein and 2) an adjuvant, wherein the antigenic peptide or antigenic protein is derived from Cda2 protein.
Claim 2 is drawn to the vaccine of claim 1 comprising an antigenic peptide, wherein the antigenic peptide comprises a sequence that is at least 80% identical to an amino acid sequence of SEQ ID NOs: 1.
SEQ ID NO: 1 is a 32 amino acid sequence fragment of Cda2 named Cda2-pep1.
Claim 13 is drawn to a method of protecting a subject against cryptococcosis infection, the method comprising: administering to a subject in need thereof the vaccine of claim 1 for protection against, or treatment of cryptococcosis infection in the subject.
Claim 14 is drawn to a method of protecting a subject against cryptococcosis infection, the method comprising: 1) generating an antibody using a composition comprising a) an antigenic protein or antigenic peptide derived from Cda2 protein and b) an adjuvant and 2) administering the generated antibody to the subject in need thereof for protection against, or treatment of cryptococcosis infection in the subject.
The claims require that an antigenic peptide or antigenic protein derived from Cda2 protein, and the claim requires an antigenic peptide comprising a sequence that is at least 80% identical to “an amino acid sequence of” SEQ ID NO: 1.
The scope of the claims encompasses a genus of antigenic proteins and antigenic peptides derived Cda1; the claims encompass a genus of antigenic peptides which vary by up to 20% from SEQ ID NO: 1; and the claims encompass a genus of antigenic peptides which vary by up to 20% from a fragment of SEQ ID NO: 1 wherein the fragment corresponds to “an amino acid sequence of” SEQ ID NO: 1.
The genus of adjuvant encompasses species of different adjuvants that function differently.
Each genus comprises a large number of structurally variant species and the species have the function as a vaccine for cryptococcosis, for protection against or treatment of cryptococcosis infection and for generating antibodies that can protect a subject against or treatment of cryptococcosis infection in a subject.
The disclosure fails to describe the common attributes or structural characteristics that identify members of said genus and because the genus is highly variant, the recitation of “derived from Cda2” and at least 80% amino acid sequence identity to “an amino acid sequence of SEQ ID NO: 1” is insufficient to describe the genus of protein and/or peptide variants that induces the cross protective immunity against cryptococcosis infection and/or cryptococcosis disease; that can treat cryptococcosis infection and can produce antibodies that can be administered to a subject in need thereof to treat and protect against cryptococcosis infection.
The genus of Cda2 variants and the genus of Cda2-pep1 is large and highly variant. For example, any antigenic peptide or protein derived from Cda2 and up to 20% of SEQ ID NO: 1 (Cda2-pep1) can vary and variants constitute deletion(s), substitution(s), addition(s) and combinations thereof). The general knowledge and level of skill in the art does not supplement the omitted description of such variants that induces protective immunity against infection and/or disease and that can produce antibodies that can be used to immunize subject to protect and treat cryptococcosis infection.
The specification discloses that use of full-length recombinant proteins in T cell vaccine studies has the advantage that all epitopes are included in the antigen and identifying and defining the protective peptides contained within vaccine antigens could be beneficial and identifying immunodominant peptide regions of the protein allows elimination of regions of the protein that could drive non-essential, antagonistic, immune suppressive, or autoimmune responses. See p. 21 example 1.
The specification teaches that an immunoinformatic analysis of Cda2 protein was performed with the goal of defining CD4+T cell epitopes for use in a Cryptococcus vaccine and peptides within Cda2 were selected based on their predicted binding to the MHC II alleles of BALB/c and C57BL/6 mice. See p. 22 first paragraph.
The specification reduces to practice administering to mice glucan particle adjuvant with full length Cda2 protein and that GP-Cda2 vaccine protected BALB/c mice more robustly than C57BL/6 mice and that differences in MHCII molecules in the different mice might explain the disparities in how well the GP-Cda2 vaccine protected in the different mice strains. See p. 25 first paragraph.
The specification discloses that other peptides (see table 1) based on Cda2 protein adjuvanted with glucan particle (GP) protected mice against otherwise lethal pulmonary challenge with C. neoformans and that there were differences in protection based on the different mice strains. See page 27.
The specification does not disclose the common structure of the genus of peptide sequences that vary by at least 20% from the sequence of the 32-mer peptide SEQ ID NO: 1 that correlates with protection form protection or treatment of cryptococcus infection. Variant sequences generated by mutating amino acids in SEQ ID NO: 1 together with GP adjuvant result in diminished but not eliminated vaccine mediated protection. See figure 2A-2D, p. 26 first and second paragraph. Thus, apart from Cda2-pep1, Cda2-Pep1-M1 and Cda2-Pep1-M2, variants of SEQ ID NO: 1 that vary by at least 20% are not correlated with protection against or treatment of cryptococcus infection.
Regarding adjuvant, the specification discloses that alum, Adjuplex.UM-1007, UM1502 afforded no protection with the Cda2 antigen but Cda2 and CAF01 as adjuvant afforded significant protection. See page 34.
While one of ordinary skill in the art using bioinformatics can identify other compositions comprising variants of Cda2 protein and variants of Cda2-Pep1 (SEQ ID NO: 1) that vary by up to 20% from SEQ ID NO: 1 together with an adjuvant and screen for those that can protect against or treat cryptococcosis infection and can produce antibodies that can be administered as passive immunization against or treat cryptococcosis infection, to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention as of the effective filing date. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895. The written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115. Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention”. “Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement”. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The disclosure of the compositions comprising Cda2-Pep1, Cda2-Pep1-M1 and Cda2-Pep1-M2 antigens or Cda2-Pep2, Cda2-Pep3, Cda2-Pep4, Cda2-Pep5,with glucan particle adjuvant or CAF01 adjuvant is not a "representative number of species" of the genus of variants of Cda2 and the genus of SEQ ID NO: 1 administered together adjuvant with the recited function. In addition, the disclosure of compositions comprising Cda2 antigen or homologs Cda1, Cda1-Pep1, Cda3, Cda3-Pep1, Fpd1 and Fpd1-Pep1 with glucan particles or CAF01 adjuvant is not a "representative number of species" of the genus of variants of Cda2 protein or the genus of variants of Cda2-Pep1 administered with adjuvant having the recited function. 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).
In the conclusion, Applicants as of the effective filing date was not in possession of the genus of composition comprising Cda2 protein or variants thereof and adjuvant and genus of composition comprising Cda2-Pep1 or variants thereof and adjuvant that can protect against and treat Cryptococcosis infection and can produce antibodies that can be used in passive immunization to protect against and treat Cryptococcosis infection.
Claims 1-3, 7, 13-15 and 17-18 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 Cda2 protein i.e. SEQ ID NO: 14 or SEQ ID NO: 15 and glucan particle (GP) or CAF01 and enabling for an immunogenic composition comprising: any one of Cda2-Pep1-Pep5 (SEQ ID NO: 1-5) and GP or CAF01, Cda2-Pep1-M1 protein (SEQ ID NO: ?) and GP or CAF01, Cda2-Pep1-M2 protein (SEQ ID NO: ?) and GP or CAF01 for increasing the survival of C57Bl/6 or BALB/c mice; does not reasonably provide enablement for a vaccine, does not provide enablement for said compositions comprising other adjuvants, does not provide enablement for protecting against cryptococcosis in humans or koalas, does not provide enablement for other variants of Cda2 protein or other variants of Cda2-Pep1 and does not provide enablement for a method of protecting a subject against cryptococcosis infection, the
method comprising: 1) generating an antibody using a composition comprising a) an antigenic protein or antigenic peptide derived from a protein listed in Table 1 and b) an adjuvant and 2) administering the generated antibody to the subject in need thereof for protection against, or treatment of cryptococcosis infection in the subject.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention
Claim 1 is drawn to a vaccine for cryptococcosis, comprising: 1) an antigenic peptide or an antigenic protein and 2) an adjuvant, wherein the antigenic peptide or antigenic protein is derived from Cda2.
Claim 2 is drawn to the vaccine of claim 1 comprising an antigenic peptide, wherein the antigenic peptide comprises a sequence that is at least 80% identical to an amino acid sequence of SEQ ID NOs: 1.
SEQ ID NO: 1 is the 32 amino acid sequence fragment of Cda2 named Cda2-pep1. SEQ ID NO: 14 and SEQ ID NO: 15 are the amino acid sequences for Cda2 protein/
Claim 13 is drawn to a method of protecting a subject against cryptococcosis infection, the method comprising: administering to a subject in need thereof the vaccine of claim 1 for protection against, or treatment of cryptococcosis infection in the subject.
Claim 14 is drawn to a method of protecting a subject against cryptococcosis infection, the method comprising: 1) generating an antibody using a composition comprising a) an antigenic protein or antigenic peptide derived from Cda2 protein and b) an adjuvant and 2) administering the generated antibody to the subject in need thereof for protection against, or treatment of cryptococcosis infection in the subject.
Breadth of the Claims
The claims require any antigenic peptide or antigenic protein derived from Cda2 protein and the claims requires an antigenic peptide comprising a sequence that is at least 80% identical to “an amino acid sequence of” SEQ ID NO: 1. “An amino acid sequence of” SEQ ID NO: 1 encompasses fragments of SEQ ID NO: 1 which is a 32mer peptide. The breadth of adjuvant is very large and encompasses different adjuvants that function differently.
Guidance in the Specification/The Existence of Working Examples
The specification discloses that of full-length recombinant proteins in T cell vaccine studies has the advantage that all epitopes are included in the antigen and identifying and defining the protective peptides contained within vaccine antigens could be beneficial and identifying immunodominant peptide regions of the protein allows elimination of regions of the protein that could drive non-essential, antagonistic, immune suppressive, or autoimmune responses. See p. 21 example 1.
The specification teaches that an immunoinformatic analysis of Cda2 protein was performed with the goal of defining CD4+T cell epitopes for used in a Cryptococcosis vaccine and peptides within Cda1 were selected based on their predicted binding to the MHC II alleles of BALB/c and C57BL/6 mice. See p. 22 first paragraph.
The specification reduces to practice administering to mice glucan particle adjuvant with full length Cda2 protein and that GP-Cda2 vaccine protected BALB/c mice more robustly than C57BL/6 mice and that differences in MHCII molecules in the different mice might explain the disparities in how well the GP-Cda2 vaccine protected in the different mice strains. See p. 25 first paragraph.
The specification discloses that other peptides (see table 1) based on Cda2 protein adjuvanted with glucan particle (GP) protected mice against otherwise lethal pulmonary challenge with C. neoformans and that there were differences in protection based on the different mice strains.
Eight 31-35 amino acid peptides based on sequences in Cda2 (Table 2), loaded into GPs, were tested in BALB/c and C57BL/6 mouse models of cryptococcosis. See FIGS. 4A-4D. The eight peptides were chosen to overlap with Cda2-Pep1 or based on
regions in Cda2 predicted to contain good CD4⁺ T cell epitopes based on predicted binding to the H2-1Ad allele in BALB/c. Regarding the GP-peptide vaccines, compared with unvaccinated mice, in BALB/c mice, significant protection was seen in five of the eight vaccines. In contrast, of the eight peptide-based vaccines, only Cda2-Pep5 significantly protected C57BL/6 mice (FIG. 4D). Cda2-Pep5 includes what was
predicted to be the strongest H2-IAb in the Cda2 recombinant protein (FIG. 4C).
See page 27of the specification.
The specification does not provide guidance as to any immune response generated by sequences that vary by at least 20% from the sequence of the 32-mer peptide SEQ ID NO: 1 that correlates with protection form protection or treatment of cryptococcus infection. None of the peptides in table 2 are at least 80% identical to SEQ ID NO: 1.
Variant sequences generated by mutating amino acids in SEQ ID NO: 1 together with GP adjuvant result in diminished but not eliminated vaccine mediated protection. See figure 2A-2D, p. 26 first and second paragraph. None of those variant sequences Cda2-Pep1-M1 and Cda2-Pep1-M2 are at least 80% identical to the 32-mer peptide Cda2-Pep1 (SEQ ID NO: 1) or the fragments thereof.
Regarding adjuvant, the specification discloses that alum, Adjuplex,UM-1007, UM1502 afforded no protection with the Cda2 antigen but Cda2 and CAF01 as adjuvant afforded significant protection. See page 34.
The specification only teaches immune correlates in C57BL/6 and BALB/c mice and that there were differences in protection based on the different mice strains. The specification does not disclose protective immunity elicited by the subunit and adjuvant composition in humans or koala or whether antibodies to the subunit antigen protects against cryptococcus in humans or koalas.
More guidance and working example is needed to vaccinate against cryptococcosis in humans and koalas. Systemic cryptococcosis kills 180,000 of the 225,000 infected people each year, even with the use of antifungal therapies there is no vaccine to prevent cryptococcosis. See Lin et al abstract. mBio. January/February 2022, Volume 13 Issue 1 e02785-21, 15 pages.
State of the Art and Predictability of the Art and Amount of Experimentation Necessary
Development of a cryptococcosis vaccine is complex. Even though in animal studies, protection against all the major medically important mycoses, there is still no vaccines for humans (Lin et al at abstract and Oliviera et al. p. 6 under conclusions). One reason for the complexity is due to the fact that although closely related the species complex of C. neoformans and C. gattii causing cryptococcosis cause infection with distinct clinical manifestations. The species elicit divergent immune responses and differ in terms of the proteome expressed during infection and ideally candidate vaccines able to protect against both species should be prioritized for advancement to human testing. See Oliveira et al at page 5 under Cryptococcus sp. NPJ Vaccines (2021) 6:33 ( 8 pages).
For these reasons, it is unpredictable that the Cda2 derived antigenic protein or antigenic peptide or Cda2-Pep1 (SEQ ID NO:1) together with adjuvant will protect against cryptococcosis in humans and koala. In addition, it is unpredictable that the passive immunization with antibodies generated against Cda2 derived antigenic protein or antigenic peptide or Cda2-Pep1 (SEQ ID NO:1) together with adjuvant can protect agent or treatment of cryptococcosis infection in any subject. The art is silent regarding passive immunization as a strategy against cryptococcosis and to protect or treat cryptococcosis. Applicant assumes a certain burden in establishing that inventions involving physiological activity are enabled. The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. However, in cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See MPEP 2164.03.
For these reasons, the specification is only enabling for an immunogenic composition comprising Cda2 protein i.e. SEQ ID NO: 14 or SEQ ID NO: 15 and glucan particle or CAF01 and enabling for an immunogenic composition comprising: any one of Cda2-Pep1-5 protein (SEQ ID NO: 1-5) and GP or CAF01, Cda2-Pep1-M1 protein and GP or CAF01, Cda2-Pep1-M2 protein and GP or CAF01 for increasing the survival of C57Bl/6 or BALB/c mice.
The specification does not reasonably provide enablement for a vaccine, does not provide enablement for adjuvants, does not provide enablement for protecting against cryptococcosis in humans or koalas, does not provide enablement for other variants of Cda2 protein or variants of SEQ ID NO: 1 (Cda2-Pep1) that are at least 80% identical and does not provide enablement for a method of protecting a subject against cryptococcosis infection, the method comprising: 1) generating an antibody using a composition comprising a) an antigenic protein or antigenic peptide derived from a protein listed in Table 1 and b) an adjuvant and 2) administering the generated antibody to the subject in need thereof for protection against, or treatment of cryptococcosis infection in the subject including where the subject is a human or koala.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7, 13-15, 17 and 18 are ejected 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.
The claims refer to table I in the specification.
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).
The antigenic peptides or antigenic proteins in table I can be listed in the claims. Appropriate correction is requested.
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.
Claim(s) 1-3, 7, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Specht et al. mBio. 2017 Nov 28;8(6):e01872-17, 14 pages, cited in IDS.
Claim 1: Specht et al disclose a vaccine for cryptococcosis, comprising: 1) an antigenic peptide or an antigenic protein and 2) an adjuvant, wherein the antigenic peptide or antigenic protein is derived from Cda2 protein and wherein the adjuvant is a glucan particle. See abstract.
SEQ ID NO: 1 (Cda2-pep1)
Claim 2: Specht et al disclose the vaccine of claim 1 comprising an antigenic peptide, wherein the antigenic peptide comprises a sequence that is 100% identical to an amino acid sequence of SEQ ID NOs: 1. See sequence alignment in Appendix A.
Claim 3: Specht et al disclose the vaccine of claim 2, wherein the antigenic peptide has an amino acid sequence of SEQ ID NO: 1. See sequence alignment in Appendix A.
Claim 7: Specht et al disclose the vaccine of a claim 2, wherein the adjuvant is glucan particles. See title abstract.
Claim 13: Specht et al disclose a method of protecting a subject against cryptococcosis infection, the method comprising: administering to a subject in need thereof the vaccine of claim 1 for protection against, or treatment of cryptococcosis infection in the subject. See title, abstract and importance on page 1-2 and p. 4 figure 2, p. 5 figure 3 and p. 12 under vaccination and challenge studies.
Status of Claims
Claims 4-6, 8-12 and 16 are withdrawn. Claims 1-3, 7, 13-15, 17 and 18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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