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 .
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:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). The claims and specification do not use the required “SEQ ID NO:” but rather use “sequence number 1”.
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 sequence identifiers, 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-7 and 12-15 is/are directed to peptides, proteins, and vectors, comprising a bacterial signal sequence (e.g. SEQ ID NO: 1) and thus are not markedly different from the same biomolecules found in nature (see the 35 USC 102 rejections below). The claimed signal peptides are intrinsically and naturally found fused to proteins, of which they direct the extracellular secretion. These sequences are encoded by and expressed from the bacterial genome, considered a polynucleotide vector, and operably linked to a promoter because they are expressed. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited peptides, proteins, and vectors are no different in their biological properties than those found in the organism from which they were derived, i.e. the recited peptides, proteins, and vectors perform the same biological function (secrete proteins, encode signal peptides) with the same structure (amino acids or nucleotides) as the biomolecules found in nature. As such, the claimed peptides, proteins, and vectors cannot be considered to comprise “significantly more” than the same molecules found in nature.
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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al (Science, 2003, of record) as evidenced by the corresponding Genbank entry (Genbank AAO78847.1, of record, also citing to Xu et al 2003).
Xu et al teach Bacteroides thetaiotaomicron gene BT3742 protein sequence that comprises instant SEQ ID NO: 1 in the first 25 amino acid residues, and fused to a longer protein sequence for a total of 505 amino acid residues. Inducing extracellular secretion is an inherent property of signal sequences. The B. thetaiotaomicron genome is considered to be a vector and to comprise a promoter operably linked to the BT3742 sequence for expression. Xu et al teach B. thetaiotaomicron to be viable in the intestine (p. 2074, right col.).
Claim(s) 4-9, 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falb et al (US 20190336544 A1, of record as WO 2018/129404).
Falb et al teach vectors, and E. coli Nissle microorganisms transformed with such, for secretion of antibodies or IL-12/IL-15 proteins fused to PelB secretion signals and expressed by promoters. See Examples 22, 36 and 37. Instant SEQ ID NO: 4, a PelB secretion signal, is found in the first 22 residues of SEQ ID NOs 1179 (Table 44) and 1202 (Table 47) of Falb et al. Promoters for intestinal expression include low oxygen promoters (¶’s [0855], [0987]). The E. coli Nissle may be E. coli Nissle 1917 (¶ [0007]). Cryoprotectants can be included with the compositions (¶ [1238]) and the compositions may be functional food products (¶ [1229]).
Claim Rejections - 35 USC § 103
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 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.
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) 4-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Falb et al (US 20190336544 A1, of record as WO 2018/129404) in view of Voigt et al (US 20180073031 A1).
The teachings of Falb et al are as above and applied as before. Falb et al do not teach the PBT1311 promoter. In addition, Falb et al teach that constitutive promoters may be used in their invention (¶ [0028]).
Voigt et al teach the use of the B. thetaiotaomicron BT1311 promoter to drive constitutive expression of heterologous bacterial genes. See Fig. 2B and ¶ [0032].
The claimed vectors are essentially disclosed by Falb et al with the exception of the BT1311 promoter limitation. The ordinary skilled artisan, seeking to express the fusion proteins of Falb et al, would have been motivated to use the BT1311 promoter of Voigt et al because Falb et al teaches such constitutive promoters to be desirable for their system, and Voigt et al teach the predictable use of the promoter to express heterologous proteins. It would have been obvious for the skilled artisan to do this because of the known benefit of expressing secreted fusion proteins from bacteria as taught by Falb and Voigt et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 13 merely recites a composition comprising the recombinant microorganism of 11, which is itself a composition. Thus, the claims do not differ in scope in any significant way.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638