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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 1/12/2026 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 1-33 are pending. Claims 19-20 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-18, 21-23, and 27-33 are currently under examination.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10 contains a grammatical error in line 2 in the phrase “an a Shigella”. Appropriate correction is required.
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 11-18 and 30 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 pre-AIA the applicant regards as the invention. Claims not specifically mentioned are rejected because they include the issue of the parent claim.
Claim 11 is indefinite because it refers to “at least” 15% and to “greater than” 15%. These phrases mean the same thing. Therefore, it is not clear what applicant intends.
Claim 13 recites the limitations “the recombinant protein” and "the antigen" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitations “the recombinant protein” and "the antigen" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the antigen" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the antigen" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the antigen" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the AT expression vector" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giacalone et al (US Patent Application Publication 2012/0207754).
The instant claims are drawn to bacterial minicells that are genome reduced.
Giacalone et al disclose bacterial minicells with heterologous antigens displayed on the surface of the minicell (see paragraph 0010). The minicells are achromosomal and would therefore have reduced expression of at least 2.4% of their genes (see paragraph 0066). The cells can have a mutation in MinCDE (see paragraph 0127). With regard to claims 5 and 7-8, these cells meet all of the structural requirements recited in the claims. Therefore, absent evidence to the contrary, they would have the same functional features, including enhanced immune response and recombinant protein production. The minicells can be derived from Enterobacteriaceae, including Salmonella (see paragraph 0081). The antigen is expressed by the minicell on the surface (see paragraph 0010). The minicells include a monomeric autotransporter (see paragraph 0146). The heterologous protein can be an antigen from an infectious bacteria or a tumor (see paragraphs 0012 and 0015). The minicells are in a vaccine composition with an adjuvant and pharmaceutical carrier and can be administered in several ways, including oral administration (see paragraph 0091 and 0110). The minicells would necessarily contain a nucleic acid sequence that encodes the above protein features.
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.
Claims 1-18, 21-23, and 27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Giacalone et al (US Patent Application Publication 2012/0207754) in view of Elena et al (Frontiers in Microbiol., 5:1-8, 2014).
The instant claims are drawn to bacterial minicells that are genome reduced.
Giacalone et al disclose bacterial minicells with heterologous antigens displayed on the surface of the minicell (see paragraph 0010). The minicells are achromosomal and would therefore have reduced expression of at least 2.4% of their genes (see paragraph 0066). The cells can have a mutation in MinCDE (see paragraph 0127). With regard to claims 5 and 7-8, these cells meet all of the structural requirements recited in the claims. Therefore, absent evidence to the contrary, they would have the same functional features, including enhanced immune response and recombinant protein production. The minicells can be derived from Enterobacteriaceae, including Salmonella (see paragraph 0081). The antigen is expressed by the minicell on the surface (see paragraph 0010). The minicells include a monomeric autotransporter (see paragraph 0146). The heterologous protein can be an antigen from an infectious bacteria or a tumor (see paragraphs 0012 and 0015). The minicells are in a vaccine composition with an adjuvant and pharmaceutical carrier and can be administered in several ways, including oral administration (see paragraph 0091 and 0110). The minicells would necessarily contain a nucleic acid sequence that encodes the above protein features.
Giacalone et al differs from the instant invention in that they do not disclose that the nucleic acid sequence encoding the antigen is codon optimized.
Elena et al disclose the use of codon optimization for efficient production of functional proteins in heterologous hosts (see abstract). They show that codon replacement has a significant impact on expression levels and protein folding (see abstract). They state that variation in codon usage is one of the major factors affection protein expression levels since the presence of rare codons can reduce translation rates and induce translational errors with a significant impact (see page 1). The benefits of using codon optimized genes in industrial biotechnology have been extensively demonstrated during the past decade (see page 5).
It would have been obvious to one of ordinary skill in the art, at the time of invention, to use codon optimization in the heterologous protein of the minicells disclosed by Giacalone because it has a significant impact on expression levels and protein folding. One would have had a reasonable expectation of success because codon optimization has been widely used and the benefits have been extensively demonstrated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN GANGLE/Primary Examiner, Art Unit 1645