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 1-3 and 10-41 are pending and are under examination.
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:
The name of the ASCII text file should be in bytes instead of kb. See paragraph 3 of the specification.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 2, 12, 24, 35, 36 and 39 are objected to because of the following informalities:
The claims recite respectively “epitope has a SEQ ID NO: 3” or “epitope has a SEQ ID NO: 4”. While it is interpreted that the epitope comprises the sequence set forth in SEQ ID NO: 3 or 4, technically the epitope doesn’t comprise a sequence identification number (SEQ ID NO). The objection can be obviated by reciting “epitope comprises the amino acid sequence set forth in SEQ ID NO: 3” and “epitope comprises the amino acid sequence set forth in SEQ ID NO: 3”.
Appropriate correction is required.
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, 10-11, 13-23, 25-34, 37-38 and 40-41 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 claims are drawn to:
A recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B- p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof,
A method of therapeutically or prophylactically immunizing a subject comprising administering to the subject a vaccine formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof.
A pharmaceutical composition for therapeutically or prophylactically immunizing a subject comprising a recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B- p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof, together with one or more pharmaceutically acceptable carriers, diluents, or excipients.
The claims require that the recombinant adenovirus vector encoding the substantially homologous fragment infect dendritic cells and upregulate the transcriptome of genes regulating antigen processing, used as a vaccine for therapeutically and prophylactically immunizing a subject include for protection from infection by any microorganism including fungi, bacteria including M. tuberculosis and viruses.
The genus of substantially homologous functional fragment is large and comprised of species which are highly variant. The claims require the fragment to be functional.
The specification does not disclosure the common structure of said genus that correlates with the required functions cited above.
The specification discloses a gene cassette of the Ag85B-p25 epitope of Mycobacterium tuberculosis without or with the autophagy-inducing peptide C5 (AIP-C5). The gene cassette was cloned into replication defective bovine adenovirus vector and replication defective human adenovirus vector. See Figure 1A and paragraph 9.
The specification teaches that replication defective bovine adenovirus vector expressing the 85B epitope and the AIP-C5 (BAdv85C5) and human adenovirus vector expressing the 85B epitope and the AIP-C5 (HAdv85C5) induces transcription of genes in mouse dendritic cells. See paragraph 10 and 80.
The specification disclose BAdv85C5 better upregulated the expression of CTSB, CTSA, CTSS, CTSK, CTSZ in dendritic cells compared to HAdv85C5. BAdv85C5 and HAdv85C5 also upregulated the expression of H2D1, B2M, HSPA9A, CD68, Gabarap, SQSTM1 RAB7 and L-gals-3 albeit at different levels.
The specification teaches that BAdv85C5 and BAdv85 induced immune responses that reduced the M. tuberculosis microbial counts in different organs such as the spleen, lungs in an M. tuberculosis. See Figure 6C.
The specification does not correlate immune response generated by a recombinant adenovirus vector encoding a substantially homologous fragment with treating or prophylactically immunizing as an effective vaccine protection from any microorganism or for upregulating the transcriptome of genes regulating antigen presenting in dendritic cells.
The specification does not identify any substantially homologous functional fragment that functions the same way as BAdv85C5 and BAdv85.
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. 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)
("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004).
In the instant case, no substantially homologous fragment having the required functions set forth above has been described.
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989).
To satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). MPEP 2163.02.
Even though one of ordinary skill in the art could screen for the substantially homologous fragments such that when encoded by the adenovirus vector that have the required functions set forth above, possession may not be shown by merely describing how to obtain possession of 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.
In view of the above, considerations, the claims do not comply with the written description requirement and therefore, Applicants as of the effective filing date were not in possession of the full genus recombinant adenovirus vector encoding a substantially homologous functional fragment thereof.
Claims 11-34 and 36-41 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:
for a method of therapeutically immunizing a subject comprising administering to the subject a formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1) or mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2) and enabled for the recombinant adenovirus vector encoding Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2) in infecting dendritic cells and upregulating the transcriptome of genes regulating antigen processing such as CTSA, CTSB, CTSK, CTSL, CTSS, CTSZ, Gabarap, Lgals-3, Lgals-8, LAMP1, Rab7, SQSTM1. B2M, CD53, CD63, CD68, Clec4e, H2D1, Hsp9a, LILRB4, and LAMP2;
does not reasonably provide enablement for:
a method of prophylactically immunizing a subject comprising administering to the subject a vaccine formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof;
for a vaccine
For a vaccine for protection from infections by a microorganism
For a vaccine for protection from a fungus, a virus, a bacteria
For a vaccine for protection from Mycobacterium tuberculosis
An effective mucosal vaccine
An effective vaccine delivered nasally
An effective vaccine for tuberculosis
An effective vaccine for infecting dendritic cells (DC) and thereby upregulating a transcriptome of genes regulating antigen processing
An effective vaccine for infecting dendritic cells (DC) and thereby upregulating a transcriptome of genes regulating antigen processing, wherein the genes are CTSA, CTSB, CTSK, CTSL, CTSS, CTSZ, Gabarap, Lgals-3, Lgals-8, LAMP1, Rab7, SQSTM1. B2M, CD53, CD63, CD68, Clec4e, H2D1, Hsp9a, LILRB4, and LAMP2.
the replication defective bovine or human adenoviral vector encoding Ag85B-p25 epitope without the autophagy inducing peptide
upregulating transcriptome of genes regulating antigen processing in dendritic cells
not enabled for a recombinant adenovirus vector encoding substantially homologous fragment thereof for use as a vaccine including therapeutic or prophylactic vaccine including vaccine for protection from infection by any microorganism and for ug-regulating transcriptome of genes regulating antigen processing in dendritic cells.
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.
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
The claims are drawn to:
A method of therapeutically or prophylactically immunizing a subject comprising administering to the subject a vaccine formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof.
A pharmaceutical composition for therapeutically or prophylactically immunizing a subject comprising a recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B- p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof, together with one or more pharmaceutically acceptable carriers, diluents, or excipients.
The claims require the vaccine formulation or pharmaceutical composition comprising the recombinant adenovirus recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof to prevent infections from fungi, bacteria, virus and also upregulate genes in DC cells. See (1)-(11) listed above.
Breadth of the Claims
The invention as claimed is very broad in scope. This is because the claims require the vaccine or pharmaceutical composition to prevent/protect from infection caused by any microorganism including fungi, bacteria and virus. The claims also require that the any substantially homologous functional fragment thereof of SEQ ID NO: 1 or SEQ ID NO: 2 encoded by the recombinant adenoviral vector has the function of prevent/protect from infection caused by any microorganism including fungi, bacteria and virus and other functions as listed in (1)-(11) including in dendritic cells upregulating transcriptome of genes regulating antigen processing.
Guidance in the Specification/The Existence of Working Examples
The specification discloses a gene cassette of the Ag85B-p25 epitope of Mycobacterium tuberculosis without or with the autophagy-inducing peptide C5 (AIP-C5). The gene cassette was cloned into replication defective bovine adenovirus vector and replication defective human adenovirus vector. See Figure 1A and paragraph 9.
The specification teaches that replication defective bovine adenovirus vector expressing the 85B epitope and the AIP-C5 (BAdv85C5) and human adenovirus vector expressing the 85B epitope and the AIP-C5 (HAdv85C5) induces transcription of genes in mouse dendritic cells. See paragraph 10 and 80.
The specification disclose BAdv85C5 better upregulated the expression of CTSB, CTSA, CTSS, CTSK, CTSZ in dendritic cells compared to HAdv85C5. BAdv85C5 and HAdv85C5 also upregulated the expression of H2D1, B2M, HSPA9A, CD68, Gabarap, SQSTM1 RAB7 and L-gals-3 albeit at different levels.
It is not clear from the specification whether the replication defective bovine or human adenoviral vector encoding Ag85B-p25 epitope without the autophagy inducing peptide also upregulated the expression of these genes in dendritic cells.
The specification teaches that BAdv85C5 and BAdv85 induced immune responses that reduced the M. tuberculosis microbial counts in different organs such as the spleen, lungs in an M. tuberculosis. See Figure 6C.
The specification does not correlate immune response generated by a recombinant adenovirus vector encoding Ag85B-p25 fusion or encoding Ag85B-p25-autophagy-inducing peptide-C5 fusion with treating or prophylactically immunizing as an effective vaccine protection from any other microorganism.
There is no evidence that the recombinant adenovirus vector encoding M. tuberculosis antigens is a universal vaccine protecting against infections by any microorganism including other bacteria, fungus and viruses.
Regarding, recombinant adenovirus vector encoding a substantially homologous functional fragment, the specification does not disclose what the substantially homologous functional fragments are and a correlation as a vaccine for therapeutic or prophylactic vaccine including to protect from infection from any microorganism and whether the recombinant adenovirus vector encoding a substantially homologous functional fragment can infect dendritic cells thereby upregulating transcriptome of genes regulating antigen processing.
Thus, it can be concluded that the recombinant adenovirus vector encoding M. tuberculosis antigens reduced M. tuberculosis infection in lung and spleen in a M. tuberculosis challenge model.
The specification does provide any evidence for a universal vaccine against the breadth of microorganisms very different from M. tuberculosis.
State of the Art and Predictability of the Art and Amount of experimentation Necessary
There are uncountable microorganisms and the type of immune responses required to treat or prevent infection from one microorganism may not apply to another microorganism. The state of the vaccine art is very complicated.
Using HBV virus as an example to demonstrate the complexity of developing vaccines, the art teaches that HBV therapeutic vaccines clear HBV infection but do not prevent the infection of a person. For example, Chuai et al (PLOS One, 8 (1): e54126, 2013) disclose that the currently used commercially available HBV vaccine combined with alum adjuvant, does not stimulate robust Th1 immunity or enhance the CTL responses that are critical to virus clearance during acute or chronic HBV infection. See p. 2 second column last paragraph to p. 2 first column and first paragraph. Prophylactic vaccines only need to provoke neutralizing antibodies directed against the HBV envelop proteins, whereas therapeutic vaccines are most likely needed to induce a comprehensive T cell response and thus, should include other HBV antigens, such as HBV core and polymerase. See abstract of Mahmood et al. Vaccines (Basel) 2023 Dec 18;11(12):1862.
There is no evidence that the claimed recombinant adenovirus vector encoding M. tuberculosis antigens can generate the immune responses required for a therapeutic or prophylactic vaccine for a virus such as HBV or any other virus, fungi and any other bacteria.
The prevention of M. tuberculosis infection and tuberculosis disease is complex.
The sole licensed TB vaccine to date is Bacille Calmette-Guérin (BCG), which was first developed in 1921 and is still widely used throughout the world. BCG provides significant protection against disseminated and meningeal TB when administered soon after birth, and protection lasts for up to 10 years. However, BCG’s efficacy against pulmonary TB in adults and adolescents varies greatly and has proven variable in its ability to reduce the incidence of pulmonary TB. Most subunit TB vaccines target certain proteins from M. tuberculosis and as such the breadth of immune response is generally much narrower, which makes the choice of antigenic target particularly important. viruses (i.e., the vector) are engineered to encode genes for M. tuberculosis proteins.
After immunization with the viral particles, virally infected cells are turned into factories to produce the M. tuberculosis proteins and induce a robust immune response without the need of an exogenous adjuvant. This approach leverages decades of experience using attenuated viruses as vaccines (e.g., poliovirus, vaccinia, measles) and takes advantage of the immune system’s strong innate and adaptive immune responses to viruses. One major downside to the use of viral vectors is the existence of pre-existing immunity to the virus. If a person has preexisting immunity to the vector at the time of vaccination, immune responses to the vector will be boosted, leading to premature clearing of the virus and dampening of the M. tuberculosis-specific response. To circumvent this potential problem, vaccine developers are using rare human serotypes (e.g., AdHu35) or viruses from other species (e.g., ChAd68Ag85A and ChAdOx1.85A). See Lai et al. pj Vaccines 8, 158 (2023). https://doi.org/10.1038/s41541-023-00750-7.
The nature of the instant invention is broad and complex for at least the reasons stated above and it would require “undue experimentation” to therapeutically or prophylactically immunize a subject against all microorganisms using the claimed recombinant adenovirus vector.
The instant specification has not taught how to use the instant invention commensurate with the scope of the claims.
The ability of the claimed recombinant adenovirus vector encoding M. tuberculosis antigens in treating and preventing infection from any microorganism is unpredictable especially because of the differences in the pathogenicity of each microorganism and the differences in the immune responses needed to treat or prevent infection from each microorganism.
"The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." "The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling". Physiological activity can be considered inherently unpredictable. Thus, Applicant assumes a certain burden in establishing that inventions involving physiological activity are enabled. See MPEP 2164.03.
It is determined that the specification is does not reasonably provide enablement for:
a method of prophylactically immunizing a subject comprising administering to the subject a vaccine formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1), mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2), or a substantially homologous functional fragment thereof;
a vaccine
a vaccine for treating and protection from infections by all microorganism;
a vaccine for protection from infection by any fungus, a virus, a bacteria;
a vaccine for preventing infection from Mycobacterium tuberculosis;
an effective mucosal vaccine
an effective vaccine delivered nasally
an effective vaccine for tuberculosis
an effective vaccine for infecting dendritic cells (DC) and thereby upregulating a transcriptome of genes regulating antigen processing
an effective vaccine for infecting dendritic cells (DC) and thereby upregulating a transcriptome of genes regulating antigen processing, wherein the genes are CTSA, CTSB, CTSK, CTSL, CTSS, CTSZ, Gabarap, Lgals-3, Lgals-8, LAMP1, Rab7, SQSTM1. B2M, CD53, CD63, CD68, Clec4e, H2D1, Hsp9a, LILRB4, and LAMP2;
not enabled for the replication defective bovine or human adenoviral vector encoding Ag85B-p25 epitope without the autophagy inducing peptide upregulating transcriptome of genes regulating antigen processing in dendritic cells; and
not enabled recombinant adenovirus vector encoding substantially homologous fragment thereof for as a vaccine including therapeutic or prophylactic vaccine including vaccine for protection from infection by any microorganism and for ug-regulating transcriptome of genes regulating antigen processing in dendritic cells.
The specification is enabling for a method of therapeutically immunizing a subject comprising administering to the subject a formulation of recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1) or mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2) and enabled for the recombinant adenovirus vector encoding Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2) in infecting dendritic cells and upregulating the transcriptome of genes regulating antigen processing such as CTSA, CTSB, CTSK, CTSL, CTSS, CTSZ, Gabarap, Lgals-3, Lgals-8, LAMP1, Rab7, SQSTM1. B2M, CD53, CD63, CD68, Clec4e, H2D1, Hsp9a, LILRB4, and LAMP2.
The specification is not enabled for a vaccine comprising recombinant adenovirus vector having a heterologous DNA segment encoding mycobacterial Ag85B-p25 epitope (SEQ ID NO: 1) or mycobacterial Ag85B-p25 epitope fusion of autophagy-inducing peptide-C5 (SEQ ID NO: 2) and including for therapeutic or prophylactic (preventing infection) immunization to protect from infection from all microorganisms.
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 10, 21 and 33 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 claims , the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 14-20, 22-23 and 26-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dijk et al. US 2020/0040358 2/6/2020.
Dijk et al disclose a recombinant adenoviral vector comprising a heterologous DNA segment encoding a substantially homologous functional fragment of SEQ ID NO: 2. See paragraph 35, 38, 64, 65, 232, 241 and 247.
See sequence alignment with SEQ ID NO: 2:
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Claim 11: Dijk et al disclose a method of therapeutically or prophylactically immunizing a subject comprising administering a vaccine formulation comprising said recombinant adenoviral vector. See paragraph 71 and 182.
Claims 14-20 (claim interpretation: these are not active method steps because the claims are drawn to the usefulness (intended use) of the vaccine formulation or merely stating what the vaccine formulation is i.e. “an effective vaccine for tuberculosis): Dijk et al discloses the vaccine formulation as claimed and thus would also be useful as an effective vaccine for protection from infections by a microorganism, wherein the microorganism is a fungus, virus, or a bacteria, wherein the microorganism is Mycobacterium tuberculosis, useful as an effective mucosal vaccine, useful as an effective vaccine delivered nasally, the vaccine formulation is an effective vaccine for tuberculosis and the vaccine formulation is useful as an effective vaccine by way of infecting dendritic cells (DCs) and thereby upregulating transcriptome of genes regulating antigen processing.
Claim 22: the subject is a human being or animal. See paragraph 117.
Claim 23: Dijk et al disclose a pharmaceutical composition for therapeutically or prophylactically immunizing a recombinant adenoviral vector comprising a heterologous DNA segment encoding a substantially homologous functional fragment of SEQ ID NO: 2 and a pharmaceutically acceptable carrier. See abstract, paragraphs 5, 35, 38, 64, 65, 67, 71, 72, 205, 206, 232, 241 and 247.
Claims 26-32 (claim interpretation: these are not active method steps because the claims are drawn to the usefulness (intended use) of the vaccine formulation or merely stating what the vaccine formulation is i.e. “an effective vaccine for tuberculosis): Dijk et al discloses the vaccine formulation as claimed and thus would also be useful as an effective vaccine for protection from infections by a microorganism, wherein the microorganism is a fungus, virus, or a bacteria, wherein the microorganism is Mycobacterium tuberculosis, useful as an effective mucosal vaccine, useful as an effective vaccine delivered nasally, the vaccine formulation is an effective vaccine for tuberculosis and the vaccine formulation is useful as an effective vaccine by way of infecting dendritic cells (DCs) and thereby upregulating transcriptome of genes regulating antigen processing.
Claim 34: the subject is a human being or animal. See paragraph 117.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 11, 13, 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dijk et al. US 2020/0040358 2/6/2020 in view of Khan et al. The Journal of Immunology, Volume 200, Issue Supplement_1, May 1 2018.
Dijk et al is set forth above but does not disclose that the adenovirus vector is a replication defective human adenovirus vector or bovine adenovirus vector.
Sadoff et al disclose different types of adenoviral vectors which includes human adenoviral vector and bovine adenoviral vectors and discloses that the adenoviral vectors are deficient in at least one essential gene function required for viral replication making them replication defective. See p. 10 lines 10-34 and p. 11-14.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used any of the replication defective adenovirus vectors known in the art for recombinant expression such as replication defective human or replication defective bovine adenoviral vector, as taught by Sadoff et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Dijk et al requires adenoviral vectors for administering to a subject and Sadoff et al disclose that human and bovine replication defective adenoviruses can used for delivering antigen into a subject.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Khan et al. The Journal of Immunology, Volume 200, Issue Supplement_1 May 2018.
Khan et al disclose a recombinant bovine adenovirus vector encoding M. tuberculosis antigen Ag85B and a TLR2 activating peptide or encoding M. tuberculosis antigen Ag85B.
Status of Claims
Claims 1, 3, 10-34 and 36-41 are rejected. Claim 2, 12, 24, 35, 36 and 39 are objected to.
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