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 10/2/2025 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 1-17, 19, and 23-25 are pending. Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-17 and 23-25 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 9/15/2023, 11/8/2023, and 7/10/2025 have been considered. Signed copies are enclosed.
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 1-17 and 23-25 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.
Claim 1 is rendered indefinite by the phrase “wherein administration of the bacterium to the host”. It is not clear if this is an indication of the capability of the bacterium if it were administered or if this is a required method step. A claim cannot be drawn to both a product and a method. Furthermore, claim 1 recites the limitation "the host" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 is rendered indefinite by the phrase “of claim 3 4”. It is not clear if applicant lined through the “4” in order to delete it in the previous amendment. If applicant intended to delete the 4, applicant should use double brackets so the deletion can be seen. If the 4 was not intended to be deleted, then “3 4” does not make sense.
Claim 17 is rendered indefinite by the use of “sp.” and “spp.”. In biological nomenclature, “sp.” refers to a single, unspecified species within a genus and “spp.” refers to multiple, unspecified species within the genus. If applicant intended to use “sp.”, it is not clear what species is encompassed by the claim. If applicant instead intended to use “spp.”, then, with regard to Clostridium, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation Clostridium, and the claim also recites various Clostridium species which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 23 is rendered indefinite by the phrase “wherein administration of the bacterium to a host”. It is not clear if this is an indication of the capability of the bacterium if it were administered or if this is a required method step. A claim cannot be drawn to both a product and a method.
Claim 24 is rendered indefinite by the phrase “wherein administration of the composition to a host”. It is not clear if this is an indication of the capability of the bacterium if it were administered or if this is a required method step. A claim cannot be drawn to both a product and a method.
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 1-3, 6-11, 16, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubensky et al (US Patent Application Publication 2005/0249748; IDS filed 9/15/2023).
The instant claims are drawn to recombinant commensal bacteria engineered to express a fusion protein comprising a non-native protein and a signal sequence, wherein administration of the bacteria to a host results in colonization of a host niched and generation of an adaptive immune response against the non-native protein.
Dubensky et al disclose recombinant Listeria monocytogenese (which are commensal) that are engineered to express a fusion protein comprising a signal sequence and an antigen (see paragraph 0099). The antigen can be a tumor associated antigen or an antigen associated with an infectious disease (see paragraph 0099). The signal sequence can be tat or sec (see paragraph 0105). The bacteria serve as a vaccine which induces an immune response to the antigen (see paragraph 0099). The signal sequence allows secretion of the fusion protein from the bacterium (see paragraph 0136). The bacterial vector induces an MHCII response, thus indicating the fusion protein contains a targeting moiety for MHCII (see paragraph 0389). The live bacteria produce the antigen after administration to the host, indicating that at least transient colonization occurs at the site of administration (see paragraph 0384 and 0410). The bacteria induce an immune response distal to the colonization site as evidenced by reduction of lung metastases after IV administration (see paragraphs 0608-0609). The bacteria are formulated for various type of administration and none of these preclude administration in combination with a high-complexity defined microbial community. The bacteria include two antigens as part of the fusion protein and the immune response includes induction of both CD4 and CD8 responses (see paragraph 0398 and claim 81).
Claims 1-4, 7-9, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott et al (US Patent Application Publication 2016/0304567).
The instant claims are drawn to recombinant commensal bacteria engineered to express a fusion protein comprising a non-native protein and a signal sequence, wherein administration of the bacteria to a host results in colonization of a host niched and generation of an adaptive immune response against the non-native protein.
Scott et al disclose recombinant bacteria that have a fusion protein comprising an antigen attached to a pilus with a cell wall sorting signal, useful for immunizing a subject (see abstract). The signal sequence includes sec signals and a sortase derived from an S. aureus housekeeping sortase, which is involved in S. aureus Protein A secretion (see paragraph 0054 and 0110). The antigens include heterologous antigens including infectious disease antigens (see paragraphs 0124 and 0132). The bacteria include commensal bacteria including Lactococcus lactis and Clostridium spp. (see paragraph 0049 and 0134). The signal sequence directs attachment to the cell wall (see paragraph 0116). Administration sites include IV, intradermal, oral, nasal, transmucosal, and vaginal routes (see paragraph 00135). The immune response would be systemic, which means that it would be distal from the site of administration. The live bacteria produce the antigen after administration to the host, indicating that at least transient colonization occurs at the site of administration (see paragraph 0134). The bacteria are formulated for various type of administration and none of these preclude administration in combination with a high-complexity defined microbial community.
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 1-3, 6-11, 16, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dubensky et al (US Patent Application Publication 2005/0249748; IDS filed 9/15/2023).
The instant claims are drawn to recombinant commensal bacteria engineered to express a fusion protein comprising a non-native protein and a signal sequence, wherein administration of the bacteria to a host results in colonization of a host niched and generation of an adaptive immune response against the non-native protein.
Dubensky et al disclose recombinant Listeria monocytogenese (which are commensal) that are engineered to express a fusion protein comprising a signal sequence and an antigen (see paragraph 0099). The antigen can be a tumor associated antigen or an antigen associated with an infectious disease (see paragraph 0099). The signal sequence can be tat or sec (see paragraph 0105). The bacteria serve as a vaccine which induces an immune response to the antigen (see paragraph 0099). The signal sequence allows secretion of the fusion protein from the bacterium (see paragraph 0136). The bacterial vector induces an MHCII response, thus indicating the fusion protein contains a targeting moiety for MHCII (see paragraph 0389). The live bacteria produce the antigen after administration to the host, indicating that at least transient colonization occurs at the site of administration (see paragraph 0384 and 0410). The bacteria induce an immune response distal to the colonization site as evidenced by reduction of lung metastases after IV administration (see paragraphs 0608-0609). The bacteria are formulated for various type of administration and none of these preclude administration in combination with a high-complexity defined microbial community. The bacteria include two antigens as part of the fusion protein and the immune response includes induction of both CD4 and CD8 responses (see paragraph 0398 and claim 81).
Dubensky et al differs from the instant invention in that they do not disclose a composition comprising two recombinant bacteria where one has a first antigen and the other has a second antigen.
It would have been obvious to use multiple bacteria with different antigens using the strains disclosed by Dubensky et al because combining prior art elements according to known methods to yield predictable results is obvious. Dubensky et al disclose multiple recombinant strains with multiple different antigens. The difference between the reference and the art is combining different strains into a single composition. One of ordinary skill in the art could have combined these strains and each would have performed the same function as it would have singly. There is no reason to think that the results of such a combination would have been unpredictable.
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.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645