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 .
Claim Status
Claims 1-24 are pending.
Claims 10-15 and 19-24 were withdrawn from further consideration (see below).
Claims 1-9 and 16-18 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 3/4/2026 is acknowledged.
Claim(s) 10-15 and 19-24 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/4/2025.
Specification
The disclosure is objected to because they depict nucleic acid and/or amino acid sequences, which is not identified by sequence identification numbers. Instant specification disclosed “SNSS” and “SNKE” without SEQ ID NO in the second from the last line at page 5; “SNKE” and “RKKR” without SEQ ID NO in the line 3-4 and 10 of page 6. Amino acid sequences with 4 or more residues must be identified by sequence identification numbers. Applicant must provide appropriate amendments to the specification inserting the required sequence identifiers.
Appropriate action correcting this deficiency is required. If any sequences are not in the current sequence listing, Applicant must submit paper and computer-readable copies of a substitute sequence listing, together with an amendment directing its entry into the specification and a statement that the content of both copies are the same and, where applicable, include no new matter.
Sequences appearing in the specification and/or drawings must be identified by a sequence identifier in accordance with 37 C.F.R. 1.821(d); sequence identifiers for sequences appearing in the drawings may appear in the drawings or in the brief description of the drawings.
Appropriate correction is required.
Drawings
Drawings are objected to because instant Figures 4, 6 and 7 have color drawings.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peachman et al (Clinical and Vaccine Immunology, January 2012, Vol. 19, Number 1, page 11-16).
Regarding claim 1-3, Peachman teaches anthrax vaccine antigen-adjuvant formulation (title). Peachman teaches “In an effort to develop an improved anthrax vaccine that shows high potency, five different anthrax protective antigen (PA)-adjuvant vaccine formulations that were previously found to be efficacious in a nonhuman primate model were evaluated for their efficacy in a rabbit pulmonary challenge model using Bacillus anthracis Ames strain spores. The vaccine formulations include PA adsorbed to Alhydrogel, PA encapsulated in liposomes containing monophosphoryl lipid A (corresponds to composition comprising both B. anthracis rPA and liposome-embedded MPLA of claim 1), stable liposomal PA oil-in-water emulsion, PA displayed on bacteriophage T4 by the intramuscular route, and PA mixed with Escherichia coli heat-labile enterotoxin administered by the needle-free transcutaneous route” (abstract). Peachman teaches vaccine formulation comprising PA + MPLA (Table 1 at page 12). Peachman teaches “For all of the formulations except the phage T4 nanoparticles, purified recombinant PA produced in Bacillus anthracis strain BH445 was used” (page 12, right column, first paragraph). Peachman teaches “All of the rabbits that were immunized by the intramuscular route received 10 mcg of PA. Rabbits immunized with L(PA_MPLA) and PA-emulsion also received 100 mcg of MPLA. Rabbits immunized by the transcutaneous route received 20 mcg of PA and various doses of HLT (10 to 80 mcg)” (page 12, right column, second paragraph).
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.
Claims 1-5 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Peachman et al (Clinical and Vaccine Immunology, January 2012, Vol. 19, Number 1, page 11-16) in view of Blake et al (WO 2009/126355; IDS).
Regarding claims 1-3, teachings of Peachman were discussed above in 102 section.
The difference between prior art and the instant invention is that Peachman does not teach mrPA with specific sequence of SEQ ID NO: 2.
Regarding claims 4-5 and 16-17, Blake teaches “PA protein can be used to develop an effective acellular recombinant vaccine against anthrax.” [0004]. Blake teaches “The recombinant proteins produced according to the methods of the invention retain the immunogenic properties of their wild-type counterparts, and thus may be used in immunogenic compositions (e.g., vaccines) for the treatment or prevention of B. anthracis infection and/or symptoms thereof” [0177]. Blake teaches “A modified B. anthracis Protective Antigen (PA) polypeptide or antigenic fragment thereof comprising one or more amino acid modifications relative to the wild type PA, wherein said one or more modifications is at one or more residues corresponding to position 1, 164, 165, 167, 266, 285, 308, 313, or 314 of SEQ ID NO:2.” (claim 1). Blake teaches “The modified PA polypeptide according to claim 1, wherein said polypeptide comprises SEQ ID NO:6” (claim 5). SEQ ID NO: 6 of Blake is 100% identical to instant SEQ ID NO: 2 (SCV; result 1 of 2.rag).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted rPA of PA+MPLA system of Peachman (see Table 1 of Peachman) with modified rPA of Blake because Blake teaches that modified rPA with specific sequence of SEQ ID NO: 6 effectively functions as an immunogenic composition. One of ordinary skill in the art would be motivated to make an alternative vaccine comprising modified rPA in place of wild type PA in PA+MPLA system of Peachman and see which one can be more effective in inducing immune response against B. anthracis. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Blake teaches that modified rPA with specific sequence of SEQ ID NO: 6 effectively functions as an immunogenic composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 6, 8-9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blake et al (WO2009/126355; IDS) in view of Ivins et al (Infection and Immunity, 1992, p.662-668; PTO-892).
Regarding claim 6, 9 and 18, Blake teaches “PA protein can be used to develop an effective acellular recombinant vaccine against anthrax.” [0004]. Blake teaches “The recombinant proteins produced according to the methods of the invention retain the immunogenic properties of their wild-type counterparts, and thus may be used in immunogenic compositions (e.g., vaccines) for the treatment or prevention of B. anthracis infection and/or symptoms thereof” [0177]. Blake teaches “A modified B. anthracis Protective Antigen (PA) polypeptide or antigenic fragment thereof comprising one or more amino acid modifications relative to the wild type PA, wherein said one or more modifications is at one or more residues corresponding to position 1, 164, 165, 167, 266, 285, 308, 313, or 314 of SEQ ID NO:2.” (claim 1). Blake teaches “The modified PA polypeptide according to claim 1, wherein said polypeptide comprises SEQ ID NO:6” (claim 5). SEQ ID NO: 6 of Blake is 100% identical to instant SEQ ID NO: 2 (SCV; result 1 of 2.rag). Blake teaches “The vaccine composition of the invention may also include suitable diluents, preservatives, solubilizers, emulsifiers, adjuvants (e.g., aluminum phosphate, hydroxide, or sulphate) and/or carriers.” [0167]. Therefore, the composition of Blake may or may not include adjuvant. Thus, Blake teaches both composition with adjuvant and composition without adjuvant. The composition without adjuvant of Blake anticipates instant claim 6.
The difference between prior art and the instant invention is that Blake does not teach specific concentration of mrPA protein.
Regarding claims 6 and 8, Ivins teaches immunization against anthrax with Bacillus anthracis protective antigen (title). Ivins teaches “Indeed, we have recently demonstrated that a single dose of PA (70 ug)-MPL (125 ug)-TDM (125 ug) completely protected guinea pigs from an i.m. challenge of 7,000 B. anthracis Ames spores 8 weeks after immunization” (page 664; right column; line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tested 70 ug of mrPA to use the vaccine composition of Blake because Ivins teaches that 70 ug of PA can be safely and effectively used as vaccine composition. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Ivins teaches that 70 ug of PA can be safely and effectively used as vaccine composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 6-9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blake et al (WO2009/126355; IDS) in view of Ivins et al (Infection and Immunity, 1992, p.662-668; PTO-892) as applied to claims 6, 8-9 and 18 above, and further in view of Kopecko et al (WO2005/026203; PTO-892).
Regarding claims 6, 8-9 and 18, teachings of Blake and Ivins were discussed above.
Regarding claim 7, Blake teaches “Vaccine compositions in accordance with the invention may further include various additional materials, such as a pharmaceutically acceptable carrier. Suitable carriers include any of the standard pharmaceutically accepted carriers, such as phosphate buffered saline solution, water, emulsions such as an oil/water emulsion or a triglyceride emulsion, various types of wetting agents, tablets, coated tablets and capsules” [0166]. Blake teaches “Such compositions may be in the form of liquid or lyophilized or otherwise dried formulations and may include diluents of various buffer content (e.g., Tris- HCl, acetate, phosphate)” [0167]. Blake teaches “Common suitable pharmaceutical excipients include starch, glucose, lactose, sucrose, gelatin, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, dried skim milk, glycerol, propylene, glycol, water, ethanol and the like.” [0163]. Therefore, although Blake does not specifically teach the phosphate-buffered sucrose, Blake suggests phosphate buffer and sucrose as a protein stabilizer.
However, Blake does not teach specific buffer comprising the phosphate-buffered sucrose
Regarding claim 7, Kopecko teaches “The stability of influenza virus vaccine stabilized in a conventional sucrose-phosphate-glutamate (SPG) buffer is shown in Table 5.” Therefore, Kopecko teaches buffer system comprising phosphate and sucrose as a conventional vaccine stabilizing buffer. Furthermore, it is well known in the art that many protein pharmaceuticals are store in phosphate buffer and that sucrose is well-known protein stabilizer for protein therapeutics.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tested phosphate buffer and sucrose to see whether B. anthrax mrPA protein is stable in the buffer because Blake suggests phosphate buffer and sucrose as a protein stabilizer and Kopecko teaches buffer system comprising phosphate and sucrose as a conventional vaccine stabilizing buffer. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Blake suggests phosphate buffer and sucrose as a protein stabilizer and Kopecko teaches buffer system comprising phosphate and sucrose as a conventional vaccine stabilizing buffer. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/ Examiner, Art Unit 1645
/MISOOK YU/ Supervisory Patent Examiner, Art Unit 1641
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