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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 1/2/26. Claims 1-15 and 21-25 are pending. No Claims are withdrawn. Claims 1-15 and 21-25 are considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 1-20 were rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. (US 11,684,643 with prior publication March, 5, 2020 and Priority Date February, 17, 2017) in light of support of USPTO Sequence Search for SEQ ID NO. 4.The following Double Patenting rejections are withdrawn:
[insert rejections]
The following 35 U.S.C. 112 rejections are withdrawn:
Claim 11 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite.
The Applicant’s amendments necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Claim Objections
Claims 21-25 are objected to for having the wrong status identifier. These claims are marked ‘original’, but were not part of the initial set of claims filed 5/25/23. While they cover the same scope of cancelled claims 16-20, they are not considered original claims.
Claim Interpretation
The Specification defines biologic:
As used herein, "biologic" refers to any biologically active product capable
of being expressed from a gene. The biologic can be biologically active in
vivo in any prokaryote or eukaryote or in vitro in any in vitro biochemical
system. The biologic can have any activity, whether enzymatic, binding,
structural, etc. (Specification page 15, lines 5-10).
In light of this, the recombinant proteins expressed by the claimed microorganism meet this definition since they are express by a gene and are biologically active in a prokaryote. The claims do not limit the biologic must differ from those listed in the SEQ ID No’s in the Specification.
Claim Interpretation
Claims 8 and 15 a wherein clause that limits the “ recombinant microorganism exhibits a growth rate during exponential phase of growth no less than 90% of a growth rate exhibited by the corresponding microorganism during exponential phase of growth”. This change in growth rate reads as an intended result of the modifications of claim 1 and 14 without adding any additional structural changes to the microbe. MPEP 2111.04 state:
“Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure"
Therefore these limitations are not afforded significant patentable weight and art reading on the structural limitations in claims 1 and 14 will also read on the intended results since the same structure should obviously yield the same results. However if these results are an unexpected improvement, then this should be pointed out by the Applicant and the claims made commensurate in scope with the results shown. Applicant is encouraged to contact the Examiner if any questions about this arise.
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, 4-9, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensen et al. (Microbiology 2014 in IDS 1/2/26).
Jensen et al. teach L. reuteri with mutations to SrtA (sortase A), and five sortase-dependent proteins (SDPs) including mucus-binding protein A (cmbA), 10146, 11993, 10802, 10154 (see Table 1). The Applicant’s Specification lists cmbA as a SDP (Specification, pg. 64, lines 5-10). They teach that mutations to srtA, cmbA and 10802 significantly reduce L. reuteri adhesion mucus from pig small intestine (Fig 1. B).
Therefore the invention as a whole is anticipated by the reference.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1-10, and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Jensen et al. (Microbiology 2014) in light of support by NCBI Blast of SEQ ID No: 2. While Jensen et al. was submitted in an IDS, a copy is provided with this action since this rejection requires information in the supplemental contents attached to this article.
As detailed below, Jensen et al. teach a product that appears substantially identical in structure to the claimed composition but does not explicitly state all the functional limitations such as the sequence of srtA in their article matches srtA of SEQ ID NO: 2 of the Specification. Therefore a dual rejection under 102/103 is made since the composition of Jensen et al. either inherently meets the claims (M.P.E.P 2112 III and V) or is prima facie obvious since the compositions are structurally similar and share a similar utility and therefore are expected to have similar properties (MPEP 2144.09).
Jensen et al. teach L. reuteri with mutations to srtA (sortase A), and five sortase-dependent proteins (SDPs) including mucus-binding protein A (cmbA), 10146, 11993, 10802, 10154 (see Table 1). The Applicant’s specification lists cmbA as a SDP (Specification, pg. 64, lines 5-10). They teach that mutations to srtA, cmbA and 10802 significantly reduce L. reuteri adhesion mucus from pig small intestine (Fig 1. B).
Jensen et al. does not provide their sequence for srtA to compare to the srtA of SEQ ID NO: 2 in the Specification. However an NCBI BLAST search of SEQ ID NO: 2 shows it is a 100% match for srtA of L. reuteri (see BLAST search results). Therefore it appears that the L. reuteri srtA by Jensen et al. is identical or nearly identical to SEQ ID NO:2. Jensen et al. teaches that their srtA mutation is for 1 amino acid (Table S1, 10255, srtA). Therefore the single amino acid mutation of srtA by Jensen et al. overlaps in scope with SEQ ID NO: 2, since a single amino acid substitution to srtA would have at least 95% similarity since the total srtA is ~230 amino acids in length.
Therefore the invention as a whole is either anticipated or obvious by the reference.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (Microbiology 2014) in light of support by NCBI Blast of SEQ ID No: 2.
Jensen et al. teach L. reuteri with mutations to srtA (sortase A), and five sortase-dependent proteins (SDPs) including mucus-binding protein A (cmbA), 10146, 11993, 10802, 10154 (see Table 1). The Applicant’s specification lists cmbA as a SDP (Specification, pg. 64, lines 5-10). They teach that mutations to srtA, cmbA and 10802 significantly reduce L. reuteri adhesion mucus from pig small intestine (Fig 1. B).
Jensen et al. does not provide their sequence for srtA to compare to the srtA of SEQ ID NO: 2 in the Specification. However an NCBI BLAST search of SEQ ID NO: 2 shows it is a 100% match for srtA of L. reuteri (see BLAST search results). Therefore it appears that the L. reuteri srtA by Jensen et al. is identical or nearly identical to SEQ ID NO:2. Jensen et al. teaches that their srtA mutation is for 1 amino acid (Table S1, 10255, srtA). Therefore the single amino acid mutation of srtA by Jensen et al. overlaps in scope with SEQ ID NO: 2, since a single amino acid substitution to srtA would have at least 95% similarity since the total srtA is ~230 amino acids in length.
While Jensen et al. does not teach three or more mutations in a single cell of L. reuteri, this would be an obvious combination since mutations to srtA, cmbA and 10802 reduce mucus adhesion (see Fig 1b). Therefore it would be obvious in include all three mutations into a single L. reuteri to further reduce mucus adhesion (see MPEP 2144.06 I).
Claim(s) 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al. (Microbiology 2014) in light of support by NCBI Blast of SEQ ID No: 2 as applied to claims 1-15 above, and further in view of Mu et al. (Frontiers in Microbiology, 2018).
Jensen et al. teach a L. reuteri with mutations srtA (sortase), cmbA (a SDP), or 10802 (a SDP). While Jensen et al. teach their L. reuteri is marketed as a probiotic (Jensen, Abstract), and tests their adhesive properties in vitro, they do not teach administering the their L. reuteri orally to a subject. However this would be an obvious next step to determine the adhesive properties in vivo and determine how adhesion effect the therapeutic benefits of a probiotic. Mu et al. teach L. reuteri is administered orally for several therapeutic benefits (pg. 4, Histamine, pg. 5, Gut Microbiota). Therefore it would be obvious to apply the L. reuteri of Jensen et al. orally to a subject to obtained in vivo adhesive results, determine the therapeutic effects of the mutated L. reuteri, and because Mu et al. teaches that orally administration is common for this probiotic.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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