DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Election/Restrictions
Claims 29-30 and 32 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/21/2025.
Claims Status
Claims 1-25 and 31 is/are cancelled. Claims 26-30 and 32-38 is/are currently pending with claims 29-30 and 32 is/are withdrawn. Claims 26-28 and 33-38 is/are under examination.
Claim Rejections - 35 USC § 112
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 26-27, 33, 35, 37-38 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. This is a new grounds of rejection.
Claim 26 recites the limitation "a nucleic acid comprising at least one region complementary to the catB gene of sequence SEQ ID NO: 18 within the genome of the bacterium that hybridizes to at least 15 nucleotides of the sequence SEQ ID NO: 18" in lines 4-7. There is insufficient antecedent basis for this limitation in the claim. “that” could refer to the nucleic acid, the genome of the bacterium, or the bacterium. This limitation can be clarified by one of the following suggested amendments:
“a nucleic acid comprising at least one region complementary to and capable of hybridizing to at least 15 nucleotides of the catB gene of SEQ ID NO:18 within the genome of the bacterium.”
“a nucleic acid comprising at least one region complementary to at least 15 consecutive nucleotides of the catB gene of SEQ ID NO:18 within the genome of the bacterium.”
“a nucleic acid comprising at least one region complementary to the catB gene of SEQ ID NO:18 within the genome of the bacterium, wherein the nucleic acid hybridizes to at least 15 nucleotides of SEQ ID NO:18.”
Claims 27, 33, 35, 37-38 depend on claim 26 but do not clarify this indefiniteness, and so are rendered indefinite.
112(a):
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 26-27, 33-35, 37-38 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. This is a new grounds of rejection for claims 26-27, 33, 35, and 37-38, and a maintained rejection of claim 34.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
Written Description, Claims 26-27, 33-35, 37-38:
Claim 26 recites the limitation “a nucleic acid comprising at least one region complementary to the catB gene of sequence SEQ ID NO:18 within the genome of the bacterium that hybridizes to at least 15 nucleotides of the sequence SEQ ID NO:18” (lines 4-5). As described above, it is unclear if the nucleic acid must hybridize to at least 15 nucleotides of SEQ ID NO:18, or if the genome must hybridize to at least 15 nucleotides of SEQ ID NO:18. The former implies that the nucleic acid comprises at least 15 nucleotides.
Amended claim 34 recites that the nucleic acid comprises a gRNA or a “nucleic acid sequence allowing elimination or modification of the catB gene of sequence SEQ ID NO:18”, but the disclosure does not adequately define the entire genus of nucleic acid structural characteristics which provide the function of “allowing elimination or modification of the catB gene of sequence SEQ ID NO:18”; the disclosure only provides specific species of nucleic acids having the function of “allowing elimination or modification of the catB gene”, wherein these species are donor templates which comprise homology arms homologous to sequences in SEQ ID NO:18 and which are introduced into the cell genome through homologous recombination (otherwise referred to as “repair templates”), and guide RNAs (pages 15-16). As such, the disclosure does not sufficiently describe the structures of a number of nucleic acid species representative of the full scope of the genus of nucleic acids having the function of “allowing elimination or modification of the catB gene of sequence SEQ ID NO:18”.
The nucleic acid of claim 26 is interpreted as broadly encompassing the structures of claim 34 which lack sufficient written description. As such, the nucleic acid molecule of claim 26 lacks sufficient description, and dependent claims 27, 33, 35, and 37-38 do not sufficiently further limit the structure of the nucleic acid such that it is sufficiently described.
Amendment of claim 26 to recite that the nucleic acid comprises a guide RNA or a repair template (whose structure is described sufficiently in the specification) which comprises a region complementary to and able to hybridize to at least 15 nucleotides of the catB gene of SEQ ID NO:18 within the genome of the bacterium would be sufficient to overcome this rejection.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive (see pages 6-7 for arguments regarding the written description rejection of claim 34). Applicant’s amendment has overcome the issue of new matter in claim 34, which rejection has been withdrawn. However, the specification merely presents a repair template as an example of a nucleic acid which has the function of allowing elimination or modification of a gene. As such, this is not a limiting definition, and a repair template is not representative of the full scope of the genus of nucleic acids having the function of allowing elimination or modification of a gene. However, the specification does describe a repair template as having this function, and does describe the structural elements of a repair template such that an artisan would be able to determine that the applicants were in possession of a nucleic acid comprising a repair template.
Allowable Subject Matter
Claim 28 is allowed.
Claim 36 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 28, a C. beijerinckii DSM 6423 ΔcatB bacterium was not known prior to the effective filing date. Furthermore, with the amendment made, claim 28 properly identifies the required deposit of the biological material.
Regarding claim 36, methods of gene editing using the plasmids of SEQ ID NOs:21 and 38 were not taught in the art, nor using any plasmids with their component sequences (see Figs. 2 and 16). The limitations of claim 36 also overcome the specific indefiniteness and written description issues of claim 26, described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM 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, Ram Shukla can be reached on (571) 272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
To facilitate processing of the internet communication authorization or withdraw of authorization, the Office strongly encourages use of Form PTO/SB/439, available at www.uspto.gov/patent/patents-forms. The form may be filed via EFS-Web using the document description Internet Communications Authorized or Internet Communications Authorization Withdrawn to facilitate processing. See MPEP 502.03(II).
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.
/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636