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 3/26/26. Claims 70-75, 78, 80-83, 86, 87, and 89-93 are pending. Claim 87 is withdrawn. Claims 70-75, 78, 80-83, 86, and 89-93 are considered on the merits.
Election/Restriction Requirement
Applicant’s election of Group I, claims 70-75, 78, 80-83 and 86 with new claims 89-93 in the reply filed on 3/26/26 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)). The Applicant elected the mutations are a combination of EutE and EutN.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 70-73, 81-86, and 89-93 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 70 limits a modified bacterium with a mutation in the eutE gene and eutN gene that can degrade oxalate. The Applicant has not provided sufficient description for which mutations predictably make a bacteria to degrade oxalate. In the description of in Fig. 2C state:
Repeated mutations suggest an evolved interaction between oxalate and a dehydrogenase - out of 33 total mutations, 15 mutations were identified in EutE (a microcompartment-enclosed aldehyde dehydrogenase ), EutN ( a selectively permeable component of the microcompartment shell enclosing EutE) and AdhE (a cytosolic alcoholaldehyde dehydrogenase).
This passage is interpreted that less than half of the mutations attempted resulting in bacteria that degrades oxalate. The Applicant does not provide specific regions of these genes that can be mutated or the types of mutations what will predictably result in oxalate-degrading bacteria. Fig 2B provides several combinations of 11 unique mutations to produce oxalate-degrading bacteria, but there is no clear pattern provided that shows what regions of the genes can be mutated and how specific the mutation will continue to produce a oxalate-degrading bacteria. For example, one of ordinary skill in the art could not predict that a eutE mutation of P421A or P421G and/or a eutN mutation of T51S or T51V will produce an oxalate-degrading bacteria.
It appears the Applicant has selected certain regions in AdhE (AA 541-840 in SEQ ID NO: 1), eutE (AA 6-14 of SEQ ID NO: 2) and eutN (AA 54-81 of SEQ ID NO: 3) to produce oxalate-degrading bacteria. Amendments to these regions will likely remove this rejection.
While the Applicant has shown several point mutations can produce an oxalate-degrading bacteria, they have not shown deletion of a portion of these genes will predictably produce a bacteria with this activity. Nor have they shown that more than one conservative and/or radical substitutions will successfully produce oxalate-degrading bacteria.
This rejection applies to icd, sthA, pka, aceK, nadR, iclR, rpoB, mg, tosA, and rpoS genes as well, where the Applicant has not provide sufficient information on what mutations or deletions will continue to produce an oxalate-degrading bacteria.
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 89-93 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. These claims limit the mutations to SEQ ID NO: 2 and 3, but do not clearly link these sequences to EutE and EutN in claim 70. It is unclear if these claims limit EutE and EutN mutated in the bacterium or if they are describing different genes or even a duplicate gene inserted into the bacterium.
Closest Prior Art
US 10934521 and WO 2011017458 are the closet prior art. However they do not teach a oxalate-degrading bacteria with comprising a mutation in both EutE and EutN. The mutation to EutN appears altern the permeability of the bacteria microcompartments (BMC). This decrease permeability enables trapped EutE (acetaldehyde dehydrogenase) to migrate to the cytosol and allow the bacteria to degrade oxalate (Specification, pg. 28, lines 15-30).
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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