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
The preliminary claim amendment filed 10/21/2023 is entered. Claim 10 is new. Claims 1-10 are pending and under consideration in this action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The instant claims are entitled to an effective filing date of 12/05/2022.
Specification
Abstract: Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract filed 10/21/2021 recites the following:
“The present invention discloses” in line 1, which is an implied phrase that should be avoided;
“an ω-transaminase mutant based on ancestral sequence reconstruction” in line 1, which is a repeat of the invention title; and
“said” in line 3, which is legal phraseology that should be avoided.
Disclosure: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Page 3 line 7 includes the browser-executable code: https://loschmidt.chemi.muni.cz/fireprotasr/.
The disclosure is objected to because of the following informalities:
The specification recites “T130S-R130K”, which should be replaced with “T130S-R131K” in the following places: page 3 line 22, page 6 line 24, and page 12 line 3.
Appropriate correction is required.
Examiner Comment
Instant SEQ ID NOs: 4 and 6 are synthetic ω-transaminase sequences. Compared to the wild-type sequence from Aspergillus terreus (SEQ ID NO: 2, 326aa), SEQ ID NO: 4 (330aa) and SEQ ID NO: 6 (328aa) include the following mutations: D5E, A12Q, I17V, S20A, T21S, E22A, T23S, A42H, I77L, T78S, R90K, D96E, Q97E, E104D, T130S, R131K, I135L, an insert of N after residue 138, V143I, D153E, V157T, V162I, V163I, A195S, H210N, Q236E, N245D, A246V, E248R, F250N, F258V, R266Q, T284S, M288K, G292D, Q294K, I295V, A313P, N322E, E323S, R324A, and N325S. SEQ ID NO: 4 further includes: T85S, L87M, D134E, A174S, I175M, V188T, and an insert of KKSG after residue 325. SEQ ID NO: 6 further includes T85A, M154V, L263M, and an insert of KS after residue 325. See page 6 line 17 to page 7 line 2 of the instant specification.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claims 1 and 4 recite “sequence as shown in SEQ”, which should be replaced with “sequence of SEQ” to be more concise.
Claims 2-10 recite “as claimed in claim”, which is redundant and should be replaced with “of claim”.
Appropriate correction is required.
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 2, 4-5, and 8 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.
Claims 2, 5, and 8 recite “[a] method” in line 1, but they do not recite any active method steps. MPEP 2173.05(q) states that “attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness”. Claim 2 requires utilizing the ω-transaminase mutant, claim 5 requires utilizing the gene encoding the ω-transaminase mutant, and claim 8 requires utilizing the genetically engineered bacterium comprising the gene encoding the ω-transaminase mutant. However, claims 2, 5 and 8 do not set forth any steps involved in such utilization processes.
Claim 4 recites “a gene sequence shown in SEQ ID NO. 3 or SEQ ID NO. 5”, which is indefinite because it is unclear whether the claim intends to encompass only the full-length gene, or both the full-length gene and fragments thereof. That is, “a gene sequence shown in SEQ ID NO. 3 or SEQ ID NO. 5” could reasonably be interpreted as encompassing gene fragments. However, claim 4 depends from claim 1, which is clearly limited to the full-length sequence of SEQ ID NO: 4 or 6. As such, claim 4 may also reasonably be interpreted as being limited to the full-length gene sequence of SEQ ID NO. 3 or SEQ ID NO. 5 because SEQ ID NOs: 3 and 5 encode SEQ ID NOs: 4 and 6 respectively. To obviate this rejection, claim 4 can be amended to replace “a gene sequence shown in SEQ ID NO. 3 or SEQ ID NO. 5” with the limitation of “the gene sequence of SEQ ID NO. 3 or SEQ ID NO. 5”.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1 and 9 require the ω-transaminase mutant having SEQ ID NO: 4 (330aa) or SEQ ID NO: 6 (328aa); claims 3, 6-7 and 10 require a gene encoding the ω-transaminase mutant thereof. SEQ ID NOs: 4 and 6 and their corresponding full-length genes are free of the prior art. The prior art reference disclosing the closest similarity is Huang (CN112481230, published 03/12/2021) as cited in the IDS filed 10/21/2023; the English translation of Huang is provided herein. Huang teaches a mutant ω-transaminase having an amino acid sequence shown in SEQ ID NO: 1 (321aa), wherein the mutation sites include H210N-N245D-E253A-G292D substitutions. See claim 1 of Huang. This mutant of Huang is 88% identical to the instant SEQ ID NO: 4 and 89.2% identical to the instant SEQ ID NO: 6. See the office action appendix for the alignment. Huang also teaches additional relevant mutations: I77L, Q97E, and I295V. See claim 1 of Huang. However, it would not have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify SEQ ID NO: 1 of Huang to arrive at the instantly claimed ω-transaminase mutant having SEQ ID NO: 4 or 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657