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 instant application is a US national phase of PCT/US20/48324, filed August 28, 2020. Applicant’s amendment filed July 20, 2026 is acknowledged. Claims 2-5, 7, 9-10, 18-20, 22-24, 27, and 29-31 are canceled, and claims 1 and 33 are amended. Currently claims 1, 6, 8, 11-17, 21, 25-26, 28, and 32-35 are pending, wherein claims 11-17, 21, 25-26, and 28 are withdrawn. Claims 1, 6, 8, and 32-35 are under examination.
Specification
The amendment filed July 20, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Applicant added to the specification in para [0018] “∆11-14= nucleotides 82-85 of SEQ ID NO: 125, ∆11-12= nucleotides 82-83 of SEQ ID NO: 125, ∆13-14= nucleotides 84-85 of SEQ ID NO: 125, ∆11 nucleotide 82 of SEQ ID NO: 125, ∆12 nucleotide 83 of SEQ ID NO: 125, ∆13 nucleotide 84 of SEQ ID NO: 125, ∆14 nucleotide 84 of SEQ ID NO: 125.”. These descriptions were not presented in the original disclosure as filed, thus constitute new matter. The original disclosure only supports cbiMCbl riboswitch SEQ ID NO:125 and 3 deletions of SL1, SL2 and SL3, respectively, in the original description of Figure 5E, 5G, and 6A-C. The specific point deletions annotated in the new matter were not originally disclosed as they relate to SEQ ID NO: 125, only indicated as position deletions according to the stem loops. In the instant case, information added in [0018] was not present in any one of the specification, claims or drawings of the application as filed.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 1, 6, 8, and 32-35 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.
Amended claims 1, 6, and 32, and 33 recite the mutated riboswitch is encoded by positions 27-166 of SEQ ID NO: 125 and has a deletion of nucleotides at positions recited in: (a)-(j). The limitations of deletions at positions (b)-(h) in claims 1 and 33 constitute new matter.
The specification does not adequately demonstrate applicant had possession of the claimed nucleic acid sequences comprising the specific deletions recited in the claim, only alleging support from Fig. 5E and Table 2 describing primers used to construct mutants according to specific SEQ ID NO’s. Fig. 5E and G and Fig. 6C, and Tables 1-2, however, do not provide structural support of the position numbers in the deleted nucleotides limitations according to (b)-(h) in claims 1 and 33.
While the figures include annotated sequences with bars suggesting certain deletions, the specification does not explicitly identify the deletions or the nucleotide positions corresponding to the claimed deletions. The annotated drawings of the stem loops and nucleic acid positions are unclear as to the positions recited in the claims. A person of ordinary skill in the art would be required to infer the positions from the figure alone, which does not provide sufficient guidance to establish that the inventors had possession of the claimed sequences. Accordingly, the specification as originally filed lacks adequate written description support for the claimed deletions.
To obviate this new matter rejection, the Examiner suggests amending claim 1 to only include deletions of the nucleotides corresponding to SL1, SL2, and SL3 as depicted originally in FIG. 6A-6C, such as the following:
A Propionibacterium freudenreichii strain UF1 bacterium comprising a mutated switch that is encoded by positions 27-166 of SEQ ID NO:125 and having a deletion of nucleotides at positions:
72-85;
86-103; or
106-137.
Response to Arguments
Applicant's arguments filed July 20, 2026 have been fully considered but they are not persuasive.
Regarding remarks directed to the 112(a) new matter rejection, Applicant argues the entire sequence of SEQ ID NO: 125 is included and annotated in Fig. 6C to identify the gene encoding the cbiMCbl riboswitch, and are clearly marked as being encoded by positions 27-166. The locations of stem loop 1 (SL1), stem loop 2 (SL2), and stem loop 3 (SL3) are also clearly marked within the numbered sequence of SEQ ID NO: 125 in Fig. 6C. Fig. 5E and 5G identify specific mutations identified by SL1 and SL3 the VB12 production of the various deletion mutants. Applicant argues with this knowledge in mind, the position number of the nucleotide within the stem loop with the corresponding the position number within SEQ ID NO: 125 based on the annotation of SEQ ID NO: 125 as found in Fig. 6C was aligned, resulting in the specific positions being recited in the claims (and reproduced in the tables below for convenience). Applicant argues since the correlation between stem loop positions and SEQ ID NO: 125 positions were derivable from the application as originally filed (as shown in the tables on pages 7-10), and the specific annotations are now explicitly stated in the specification, the claims reciting these positions are also supported by the application as filed.
Although the Examiner agrees that the original disclosure shows deletion of stem loop 1, and SL1 and SL3 mutant constructs in the Figures, and VB12 production resulting from the particular mutations in the stem loop, the Examiner disagrees that the specific point deletions in (b)-(h) recited in claims 1 and 33 are sufficiently supported by the original disclosure as outlined above in the 112(a) rejection. A person of ordinary skill in the art would be required to infer the claimed deletion from the figures and Table 2 primers. For example, Fig. 5A and 5E-H, describe specific deletion positions according to a stem loop, but do not reference if the positions are according to SEQ ID NO: 125 or 126 (or according to the 5’ or 3’ end of the sequence). The Examiner suggests amending claims 1 and 33 to only include deletions of the nucleotides corresponding to SL1, SL2, and SL3 to obviate this maintained rejection.
Conclusion
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 JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
Prosecution Insights