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 .
Claim Status
The amended claim set filed 2 Dec 2025 is acknowledged. Claims 1, 5-7, 9-13 and 15-16 are currently pending. Of those, claims 1, 5, 9, and 15 are currently amended, and no claims are new. Claims 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 July 2025. Claims 2-4, 8, 14, and 17-19 are cancelled. Claims 1, 5-7, 9-10, and 15-16 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 2 Dec 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 3 Sep 2025 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The objections to the specification (NFOA par. 6-9) are all withdrawn in view of the amendments to the specification and abstract, and arguments.
The objections to the claims (NFOA par. 10-13) are all withdrawn in view of the amendments to the claims and arguments.
The rejections under 35 U.S.C. 112(b) (NFOA par. 15-23) are all withdrawn in view of the amendments to the claims and arguments, but see the new rejection of claim 9 below that is similar to the previous rejection of claim 9 (NFOA par. 21).
The rejections under 35 U.S.C. 112(a) (enablement and written description, NFOA par. 24-52) are both withdrawn in view of the amendments to the claims and arguments.
The rejection of claims 14-18 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Papoutsaki et al. (NFOA par. 53-57) is withdrawn in view of the amendments to the claims and arguments.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities: typographical error, claim 1 part (v) and claim 15 each read “ribose-5-phoshate” but should read “ribose-5-phosphate”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the microbial genus names in claim 6 should be italicized to be consistent with the conventions in the field. Appropriate correction is required.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
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, 5-7, 9 and 15-16 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.
Regarding claim 1, the claim has been amended to contain a list of proteins the SM should express, listed as (i)-(vii), but there is not an “and” or “or” before the final protein in the list. Therefore, one of ordinary skill would not be able to determine whether the claim requires that all genes be expressed (and), or only that at least one gene be expressed (or). Correction is required. This grounds of rejection also applies to dependent claims 5-7 and 9 because they depend from claim 1 and do not obviate the grounds of rejection.
Regarding claim 9, the claim has been amended to recite “The SM of claim 1, having the … fermentation profile of ATCC deposit accession number PTA- 126783, when grown on methanol.” The specification does not define the term “fermentation profile”, and this term does not have a generally accepted definition in the field at the time of filing. Accordingly, one of ordinary skill in the art would not be able to determine whether only the chemical identities must match or also the amounts produced, how much variation (if any) is permitted within the same “fermentation profile”, whether all possible chemical products are considered or only some (for example, only methanol utilization products), etc. The “fermentation profile” of ATCC deposit accession number PTA-126783 is also not defined in the specification and is not generally known in the field at the time of filing. The arguments point to Figure 7G and related text (Remarks pg. 9), but Figure 7G only provides the amounts of formate and acetate produced and the specification does not define anywhere that the fermentation profile is limited to those chemicals rather than other, undisclosed chemicals produced by fermentation. Figure 7G also does not indicate how to determine whether another strain has the same fermentation profile as the graph, must the strain’s fermentation match the graph exactly? The related text at [0019] and [0177] do not clarify this issue. Therefore, one of ordinary skill would not be able to clearly determine whether a potential SM has the same “product profile” as the deposited strain, and the claim boundaries are unclear.
Regarding claim 15, the claim has been amended to read “A recombinant microorganism that ... comprises a plurality of enzymes selected from the group consisting of methanol dehydrogenase (Medh), hexulose-6-phosphate synthaseps,6-phospho-3-hexulose isomerase (Phi), glucose phosphate isomerase (Pgi), ribose-5-phoshate isomerase (RpiA), transketolase (Tkt), transaldolase (Tal) and a reduction or knockout of 6-phosphofructokinase 1 (pfkA), glyceraldehyde-3- phosphate dehydrogenase A (qapA), S-(hydroxymethyl) glutathione dehydrogenase (frmA), phosphocarrier protein (hPr or ptsH), and regulator Q (proQ).” As in claim 1, it appears that the claim does not have a “and” or “or” before Tal, the final protein that must be comprised in the recombinant microorganism. Therefore, one of ordinary skill would not be able to determine whether the claim requires that all genes be expressed (and), or only that at least one gene be expressed (or). Additionally, the ambiguity is increased due to the formatting not clearly separating the list of “plurality of enzymes” from the list of “reduction or knockout” genes like in claim 1, for example, by placing the two lists onto separate lines or using different labels for the two lists. Correction is required. This grounds of rejection also applies to dependent claim 16 because it depends from claim 15 and does not obviate the grounds of rejection.
Allowable Subject Matter
Claim 10 is allowed. The following is a statement of reasons for the indication of allowable subject matter: The specific deposited strain is novel and the collection of mutations in this strain would not have been obvious in view of the art. Also, this claim would have been rejected as not enabled under 35 U.S.C. 112(a) but for the information about the deposit and the statement in the specification that “This deposit will be maintained at an authorized depository and replaced in the event of mutation, nonviability or destruction for a period of at least five years after the most recent request for release of a sample was received by the depository, for a period of at least thirty years after the date of the deposit, or during the enforceable life of the related patent, whichever period is longest. All restrictions on the availability to the public of these cell lines will be irrevocably removed upon the issuance of a patent from the application.” [0122].
Conclusion
Other than claim 10, no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645
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