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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug. 22, 2023. Claims 1-11, 13 and 16-20 are pending and are currently examined.
Claim Objection
The base claim 10 is objected to because the SEQ ID NOs: 54-55 are not present in specification, drawings and the sequencing listing in a CRF.
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 13 is 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.
Claim 13 is directed to a vaccine composition comprising an isolated polypeptide according to the base claim 1.
The written description rejection is made because the claims are interpreted as being drawn to an isolated polypeptides or a vaccine composition including the SEQ ID NOs: 1-53, recited as being “at least 40% identity” or “at least 90% identity” to the instant claimed SEQ ID NOs 1-53 or SEQ ID NOs: 1-4, respectively. This means that up to 60% or 10% amino acids sequences of the isolated polypeptide that can be used for vaccination can vary. The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
The instant specification discloses that the isolated polypeptide has an amino acid sequence having at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, optionally at least 95%, optionally at least 99% identity to the amino acid sequence defined in any one of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:3, and SEQ ID NO: 1, or a fragment (See [0017]), the fragment has an amino acid sequence having at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, optionally at least 95%, optionally at least 99% identity to the amino acid sequence defined in any of SEQ ID NO:5-SEQ ID NO:19, SEQ ID NO:20-SEQ ID NO:33, SEQ ID NO:34-SEQ ID NO:39 and SEQ ID NO:41-SEQ ID NO:53. ) See [0024], [0026], [0028] and [0030]). The instant specification also discloses that the immunogenic composition is a vaccine composition that comprises the polypeptide and /or fragment (See [0032] to [0037]). At the same time, the instant specification discloses the identifications of B-Cell Epitopes (See instant specification, Table 1 and Example 2) and T-Cell Epitopes (See instant specification, Table 2 and Example 3) for peptide-based vaccine development and designs (See [0140), where the claimed SEQ ID NOs can be one of the epitopes, for example, the SEQ ID NO: 1 is the epitope 1 in Table 1 and SEQ ID NO: 17 is the epitope 42 in Table 2. However, the specification does not indicate which portions of the claimed SEQ ID NOs are essential to retain the ability to be a functional vaccine composition that can induce B-cell or T-cell responses or which portions of the SEQ ID NOs can be modified or altered up to 10% and 60% and still retain an ability to become a vaccine candidate.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.).
As discussed above, the skilled artisan cannot envision the detailed sequence structure of the encompassed genus of the polypeptides or fragment that are "at least 90% or 40% identical” to SEQ ID NOs. therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 112 (Enablement)
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 16-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claims 16-20 contain subject matter which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Enablement is considered in view of the Wands factors (MPEP 2164.01(a)) (1) the nature of the invention, (2) the state of the prior art, 3) the breadth of the claims, (4) the amount of guidance in the specification, (5) the presence or absence of working examples, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and 8) and the quantity of experimentation necessary.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Claims 16-20 are directed to a method for generating an immune response or against viral infection in a subject comprising administering the isolated polypeptide according to claim 1 to a subject, or for vaccinating a subject comprising administering the isolated polypeptide according to claim 1 to a subject.
The instant specification discloses identifying B-cell or T-cell epitopes for vaccine development (See the Table 1, Table 2 and Table 5 in Examples 2-3 and 6), where the identified epitopes contain the claimed SEQ ID NOs such as SEQ ID NOs: 1, 3, 5, 6, 17, 20, 34 and 41. However, the instant specification does not provide evidence to support a method for inducing immune responses in a subject or as a vaccine to against viral infection in a subject by administrating the composition including the claimed epitopes to the subject. Although most of these epitopes are from a specific domain of SARS-COV-2 spike protein (Tables 1-2) or a SARS Spike Glycoprotein sequence (Table 5), however, there is no experimental support for these epitopes including the claimed SEQ ID NOs can induce immune responses in a subject through vaccination or administration, and furthermore, there’s no evidence to demonstrate that the SARS-COV-2 specific epitopes can against all viral infection as claimed in claim 19. For example, the instant specification discloses that “a high degree of protein sequence similarity has been found between SARS-CoV-2 and SARS-CoV, but not between SARSCoV-2 and MER. Therefore, MERS spike glycoprotein sequences were excluded from this analysis. Multiple Sequence Aligmnent (MSA) of 144 non-redundant SARS spike glycoprotein sequences was performed with EMBLEBI' s Clustal Omega server (See instant specification, [0150]), which indicates the epitopes cannot against all viral infection as claimed. Therefore, the instant specification does not provide evidence to support a method for inducing immune responses to a target/virus in a subject as claimed.
Accordingly, when all the aforementioned factors are considered in total, it would require undue experimentation for one skilled in the art to practice the full scope of claimed invention as defined by instant claims. Therefore, claims 16-20 were rejected under 35 USC § 112 (Enablement).
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 1-2, 6-11, 13 and 16-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cheng et al. (WO2022031790A1, published on Feb. 22, 2022, priority data: May, 08, 2020).
The base claim 1 is directed to an isolated polypeptide having the amino acid sequence defined in any one of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:3, and SEQ ID NO:1 or an amino acid sequence having at least 40% identity thereto, or a fragment each thereof.
Chen et al. teaches a composition comprising polypeptides comprising a plurality of epitopes from the spike glycoprotein of SARS-Co V-2, systems, and methods of using thereof for the treatment of viral infections (e.g., coronavirus disease 2019 (COVID-19)) (See Abstract), where the plurality of epitopes comprises at least one of each of: a linear B lymphocyte (LBL) epitope comprising an amino acid sequence selected from the group consisting of: SEQ ID NOs: 1-5 and 24-446 (See page 32, claims 1 and 5). Among the SEQ ID NOs: 1-5 and 24-446, SEQ ID NO: 168 is identical to the SEQ ID NO: 4 as claimed (See Table A below). Here the description also teaches the claim 2 at the isolated polypeptide/fragment has an amino acid sequence having at least 90% identity to the amino acid sequence defined in any one of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:3, and SEQ ID NO:1 (claim 2).
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Regarding claims 6-7, they require the fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in any of SEQ ID NO:20 - SEQ ID NO:33 (claim 6), and the fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in either or both of SEQ ID NO:20 and SEQ ID NO:28 (claim 7), respectively. Cheng et al. teaches that in some embodiments, the LBL epitopes may each comprise an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-5 (See [046]), where the SEQ ID NO: 5 is identical to the claimed SEQ ID NO: 20 (See Table B below).
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Regarding claims 8-9, they require a fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in any of SEQ ID NO:34-SEQ ID NO:39 (claim 8) and a fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in either or both of SEQ ID NO:34 and SEQ ID NO:37 (claim 9), respectively. Cheng et al. teaches that each LBL epitope comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 1-5 and 24-446 (See page 32, clam 5), where the SEQ ID NO: 145 is identical the SEQ ID NO: 34 as claimed (See Table C below).
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Regarding claim 10-11, they require a fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in any of SEQ ID NO:41- SEQ ID NO:55, or an amino acid sequence having at least 40% identity to the amino acid sequence defined in either or both of SEQ ID NO:41 and SEQ ID NO:50, respectively. Cheng et al. teaches that each LBL epitope comprises an amino acid sequence selected from the group consisting of: SEQ ID NOs: 1-5 and 24-446 (See page 32, clam 5), where the SEQ ID NO: 378 is identical the SEQ ID NO: 41 as claimed (See Table D below).
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Regarding claim 13, it requires a vaccine composition comprising an isolated polypeptide according to any of Claims 1. Cheng et al. teaches that the one or more polypeptides comprise an adjuvant, an additional adjuvant may or may not be included in the composition or vaccine.
Regarding claims 16-20, Cheng et al. teaches that methods for reducing or preventing a viral infection in a subject in need thereof or inducing an immune response in a subject. The methods comprise administering to the subject an effective amount of the composition disclosed herein (claim 16). The administration may comprise an initial immunization and at least one subsequent immunization (claim 18). In some embodiments, the viral infection comprises a coronavirus infection. In some embodiments, the coronavirus is severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (claim 20). Cheng et al. also teaches that the route and regimen of administration will vary depending upon the population and the indication for vaccination and is to be determined by the skilled practitioner (See [065]) and the vaccine includes epitopes effective against the SARS-CoV-2 spike glycoprotein in both its unglycosylated and fully glycosylated states (See [105] that teach claim 19 at the subject is vaccinated against a viral infection as claimed.
As for claim 17, it requires the immune response is a humoral and cell-mediated immune response by depending on claim 16. Claim 16 teaches administering the isolated polypeptide into a subject. Therefore, all that is required to induce a humoral and cell-mediated immune response is to administer the polypeptide of claim 1. Claim 17 does not add additional steps or limitations to claim 16. Thus, Cheng et al. teaches claim 16 as well as claim 17.
Accordingly, claims 1-2, 6-11, 13 and 16-20 are anticipated by Cheng et al.
Claims 1 and 3-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (US 11,112,412 B1, date of patented: Sep. 07, 2021, Filed date Jul. 27, 2020).
The base claim 1 is directed to an isolated polypeptide having the amino acid sequence defined in any one of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:3, and SEQ ID NO:1 or an amino acid sequence having at least 40% identity thereto, or a fragment each thereof.
Regarding claim 3, it requires the isolated polypeptide has the amino acid sequence defined in SEQ ID NO:2 or an amino acid sequence having at least 40% identity thereto, or a fragment each thereof.
Regarding claims 4-5, they require that the fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in any of SEQ ID NO:5-SEQ ID NO:19 (claim 4) and the fragment has an amino acid sequence having at least 40% identity to the amino acid sequence defined in either or both of SEQ ID NO: 1 and SEQ ID NO: 17 (claim 5).
Wang et al. teaches that their inventor has addressed the challenge of COVID-19 serology with a new approach that enables the detection of NAbs in an easy, safe, rapid and inexpensive manner with enhanced specificity and sensitivity. The data indicate that their performance is generally well correlated. Its application can cover many aspects ofCOVID-19 investigation from contact tracing, sero-prevalence survey, reservoir/intermediate animal tracking to assessment of herd immunity, longevity of protective immunity and efficacy of different vaccine candidates (See column 36, lines 1-10). The SEQ ID NO: 5 discloses in the sequence table (See column 36) comprises a sequence that is identical to the instant SEQ ID NO: 2 as claimed (See Table E below), where SEQ ID NO: 5 is the SARS-COV-2 spike protein. The SEQ ID NO: 12 disclosed in the sequence table comprises a sequence that is identical to the SEQ ID NO: 17 as claimed (See Table F below) where the S1 subunit of the spike protein of SARS-CoV-2 have the amino acid sequence shown in SEQ ID NOs: 12 or 27 (See e.g., column 12, lines 16-21).
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Accordingly, claims 1 and 3-5 are anticipated by Wang et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached on (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUIXUE WANG/ Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672