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 .
Applicant’s response filed 10/28/2025 has been received and considered entered. This is a response to amendments and arguments filed 10/28/2025, and arguments filed 05/22/2025 regarding the restriction requirement mailed 03/24/2025.
Election/Restrictions
Applicant’s election with traverse of the method of Group II, claims 5-8, as defined in the restriction requirement mailed 03/24/2025, in the reply filed on 05/22/2025 is acknowledged. Claim 14 depends on claim 1, and thus is considered part of Group I as defined in the restriction requirement. In the non-final office action mailed 07/28/2025, Applicant’s election was mistakenly noted as without traversal. Applicant’s timely arguments for traversal are acknowledged and addressed below.
The traversal is on the grounds that Bjerre “does not disclose the genetically engineered bacterial strain defined in claim 1 of the present application obtained by using the ywkB gene from B. subtilis to modify e. coli” (page 8 of arguments filed 05/22/2025). This is not found persuasive because as originally filed, and as presented at the time of the mailing of the restriction requirement, claim 1 only required the following: “[a] genetically engineered bacterial strain for producing L-tryptophan, wherein a bacterial host strain is modified with ywkB gene, and the obtained genetically engineered bacterial strain has the activity of producing a higher yield of L-tryptophan than the bacterial host strain.” It is unclear what structure or mechanism “modified with ywkB gene” entails, and can be broadly interpreted to encompass bacteria which are modified and are “with” (or “comprise”) a ywkB gene. The claim further recites that “for example, the ywkB gene is from Bacillus subtilis”. B. subtilis strains with enhanced L-tryptophan production are taught by Bjerre, and as the claims indicate that B. subtilis naturally comprises a ywkB gene, the B. subtilis of Bjerre is interpreted to be a genetically modified bacterial strain that is modified and is “with” (or “comprises”) a ywkB gene. The restriction requirement is thus held to be proper and is made FINAL.
Claims 1-4 and 9-14 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/22/2025.
Claims Status
Claims 1-15 is/are currently pending with claims 1-4 and 9-14 withdrawn. Claims 5-8 and 15 is/are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
The amendment to the claims filed on 10/28/2025 does not comply with the requirements of 37 CFR 1.121(c) because claims 1-4 and 9-14 have incorrect claim status identifiers. Withdrawn claims 1-4 and 9-14 must be amended such that their respective claim status identifiers are “(Withdrawn)” (claims 1-4, 9-14) or “(Withdrawn—Currently Amended)” (claims 2, 13). Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Claim Rejections - 35 USC § 112
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.
Written description:
Claim 15 is 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 rejection is maintained.
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”).
Claim 15 recites the use of “bacterial host strain…E. coli TRP 03”; claim 15 as initially filed 05/22/2025 describes E. coli strain TRP 03 as a genetically-modified E. coli strain W3110. However, E. coli strain TRP 03 is not described in the disclosure, and the specific modifications made to strain W3110 in order to produce TRP 03 are not disclosed in the claims or specification. Furthermore, E. coli strain TRP 03 is not commercially or publicly available, and the applicant has not provided a biological deposit as per 37 C.F.R. 1.802 and MPEP § 2404. As such, the E. coli strain TRP 03 is not sufficiently defined such that an artisan would be able to determine that the applicant was in possession of the bacterial strain.
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
The bacterial strain recited by claim 15 is not sufficiently described, and the disclosure fails to provide representative numbers of species of these genera. As such, claim 15 is rejected as failing to provide sufficient written description.
Enablement:
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This rejection is maintained.
It is apparent that the biological material L-tryptophan-producing E. coli strain TRP 03 is required to practice the claimed invention (see claim 15, “the bacterial host strain is E. coli TRP 03”). As such, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 USC 112, first paragraph, may be satisfied by a deposit of the L-tryptophan-producing E. coli strain TRP 03.
The specification does not provide any process for making the E. coli strain TRP 03. The only description of the process by which E. coli strain TRP 03 is produced is recited in claim 15, requiring an undisclosed genetic modification of E. coli strain W3110. As such, it is impossible for a person of ordinary skill in the art to produce the E. coli strain TRP 03 required by the claimed methods. It is not clear that the invention will work with commonly-available material, and it is not apparent if the biological materials considered necessary to make and use the invention are both known and readily available to the public. Therefore, claim 15 fails to comply with the enablement requirement put forth in 35 USC 112(a), and a deposit of the biological material is required, per the guidelines and requirements provided in MPEP § 2404-2404.03, 37 CFR 1.802, 37 CFR 1.806, and 37 CFR 1.808.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
Applicant’s arguments did not address the availability of E. coli strain TRP 03, required for claim 15, and addressed in the above maintained written description and enablement rejections. Because this biological material (strain TRP 03) is required for the use of the claimed method, the biological material must be known and readily available, or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. As noted in the enablement rejection above, Applicant may view the biological deposit requirements in MPEP § 2404-2404.03, 37 CFR 1.802, 37 CFR 1.806, and 37 CFR 1.808.
Allowable Subject Matter
Claims 5-8 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: searches of the prior art regarding the utility of the ywkB gene from B. subtilis in the enhancement of L-tryptophan production in any bacterial species did not yield art which would anticipate or render obvious the pending claims. The most recent description of the B. subtilis ywkB gene found in this search was Charbonnier (2017, provided herein), which describes the ywkB gene as having an “unknown function” (page 10). Without knowing the function of the ywkB gene, or a function of the ywkB gene which was known or could be assumed to promote L-tryptophan production, an artisan would have no reason to introduce the B. subtilis ywkB gene into a tryptophan-producing E. coli strain for any purpose, including for increasing L-tryptophan production.
Conclusion
THIS ACTION IS MADE FINAL. 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 AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636