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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 4/29/2026 in response to the Non-Final Rejection mailed 11/6/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 23, 27-31, 33, 36-40, 42-44 are pending.
Claims 1-22, 24-26, 32, 34=35, 41 are cancelled.
Applicant’s remarks filed on 4/29/2026 in response to the Non-Final Rejection mailed on 11/6/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/15/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The rejection of claim 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicants cancellation of claim 24.
The scope of enablement rejection of claims 23-33, 36-44 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s amendment of claim 23 to incorporate the limitations of cancelled claim 26 ‘a disruption of a gene encoding a transporter that imports 6-aminocaproic acid into the microbial organism,’ and cancellation of claims 24-26, 32, 41.
The rejection of claims 24, 32, 37, 41 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) are withdrawn in view of Applicant’s cancellation of claims 24, 32, 37, 41.
The rejection of claims 24, 26, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Burgard et al (US 2009/0305364 A1, Date Published: Dec. 10, 2009, cited on PTO-892 dated 11/6/2025) {herein Burgard} as evidenced by Plaitakis et al (2017, biology review, cited on PTO-892 dated 11/6/2025).
New Claim Objections
Claim 23 is objected to because of the following informalities: the recitation of ‘wherein and an exogenous.’ There is redundancy of this phrase. It is recommended that Applicant amend the claim language to recite ‘wherein an exogenous.’ Appropriate correction is suggested.
New Claim Rejections - 35 USC § 112
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.
The rejection of claims 23, 27-31, 33, 36-40, 42-44 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 pre-AIA the applicant regards as the invention is maintained. The rejection has been modified in view of Applicant’s amendment of claim 23 to add the UniprotKB, UniParc ID, GenBank accession numbers from tables 16 and 17 of the instant application specification.
Claims 23 (claims 27-31, 33, 36-40, 42-44 dependent thereof), 31 (claim 33 dependent thereof), 37, 42-43 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The new rejection is necessitated by Applicant’s amendment of claims 23, 31, 37, 42-43 to add UniprotKB, UniParc ID, GenBank accession numbers. Claim 23 recites, ‘…wherein the exogenous nucleic acid encodes a transporter selected from the group consisting of UniprotKB Accession numbers P75826, A0A447V4H2, AOA085HLU7, AOA085AG20, AOA3S6EWD1, AOA3ROJPG3, AOA2X5EV87, AOA2X2DZ65, AOAlB9PQG6, AOAOQ9CPY2, AOAOB6FGQ0, AOAOT9KE32, AOA2DOJQA6, AOA2N5KTP3, AOA2U3BBA9, AOA3SOAXG7, AOA085HLU7, AOA198FET8, AOA1C5WGHO, AOAlI7IZI6, AOAlQSTYKI, AOAlQ5U965, AOA3E4Z618, A0A855M686, AOAOB6XA16, AOAOG3CKY0, AOAOH5M125, AOAOJ5FX48, AOA2DOIU27, AOA3A3ZES2, AOA2N4W2H6, AOA4R2XZM7, AOA1O1K111, AOA443UFD0, AOA2Z3F3X0, AOAOT9TQ60,AOAOT9T4V6, AOA3X9TWR2, AOA356QXL1, W3V0I2, AOA455VNE7, AOAOQ4NI65, and UniParc ID UPI00045BA014…’; claim 31 recites, ‘…GenBank Accession numbers AAF15393, BAA77715, or UniProtKB Accession numbers A3MUY9, P94316, Q18CSO, A0A095X4D3, AOAOM9CG05, C7RFH9, AOA2S7L1V8, AOAlF9IMB6, AOA229GSK5, W5WWS1, AOA367ZGM1, AOA1V4WK45, K9Z203, AOA134BPC5, AOA2M8ERW4, AOA3M1CG83, or AAA25611.’; claim 33 recites ‘…UniProtKB Accession numbers P94316, A0A095X4D3, AOA1F9IMB6, AOA2S7L1V8, C7RFH9, W5WWS1, AOA367ZGM1, AOA1V4WK45, AOA3M1CG83, or AAA25611.’; claim 37 recites, ‘…UniprotKB Accession numbers P75826, A0A447V4H2, AOA085HLU7, AOA085AG20, AOA3S6EWD1, AOA3ROJPG3, AOA2X5EV87, AOA2X2DZ65, AOA1B9PQG6, AOAOQ9CPY2, AOAOB6FGQ0, AOAOT9KE32, AOA2DOJQA6, AOA2N5KTP3, AOA2U3BBA9, AOA3SOAXG7, AOA085HLU7, AOA198FET8, AOA1C5WGHO, AOAlI7IZI6, AOAlQ5TYK1, AOAlQ5U965, AOA3E4Z618, A0A855M686, AOAOB6XA16, AOAOG3CKY0, A0A0H5M125, AOAOJ5FX48, AOA2DOIU27, AOA3A3ZES2, AOA2N4W2H6, AOA4R2XZM7, A0A101K111, AOA443UFD0, AOA2Z3F3X0, AOAOT9TQ60,AOAOT9T4V6, AOA3X9TWR2, AOA356QXL1, W3V0I2, AOA455VNE7, AOAOQ4NI65, K8WCQ8, A0A359G454, AOA331LGJ2, A0A168P3C4, A0A090T2I6, AOAOA2XQ71, AOA1TOAXW6, AOA3S6EWD1, AOAOM3EX80, AOAlI3WDG2, AOA8B3UA18, A0A411IV75, and UniParc ID UPI00045BA014, UPI0009A8BEF6, UPI0000683E9E.’; claim 42 recites, ‘…GenBank Accession numbers AAF15393, BAA77715, or UniProtKB Accession numbers A3MUY9, P94316, Q18CSO, A0A095X4D3, AOAOM9CG05, C7RFH9, AOA2S7L1V8, AOAlF9IMB6, AOA229GSK5, W5WWS1, AOA367ZGM1, AOA1V4WK45, K9Z203, AOA134BPC5, AOA2M8ERW4, AOA3M1CG83, or AAA25611.’; claim 43 recites, ‘…UniProtKB Accession numbers P94316, A0A095X4D3, AOA1F9IMB6, AOA2S7L1V8, C7RFH9, W5WWS1, AOA367ZGM1, AOA1V4WK45, AOA3M1CG83, or AAA25611.’
It is noted that identification of the respective transporters by a UniprotKB, UniParc ID, GenBank accession numbers renders the claim indefinite because, notably, the particular rules and regulations governing UniprotKB, UniParc ID, GenBank deposits allows for changes to the deposited sequences to be made at any time. There can be multiple updates and changes made to the same sequence, however, that sequence will still have the same accession number. Thus, one skilled in the art is not apprised as to which particular “version” of the sequences Applicants is claiming which renders the claims indefinite. Identification of the particular sequences used in the methods by specific SEQ ID NOs: overcomes any of these issues.
Regarding claims 23 (claims 27-31, 33, 36-40, 42-44 dependent thereof) 27, 40, the recitation of the phrase ‘the gene’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the ‘a gene’ in the instant application claim 23 and ‘the gene’ in the instant application claims 27, 40 are intended to encompass. It is unclear from the claims and specification what the ‘the gene’ is referring to structurally as a gene encompasses a polypeptides and polynucleotides. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant amend the claim to recite ‘a polypeptide’ or ‘a polynucleotide’ to overcome the rejection.
Regarding claim 39 (claims 42-44 dependent thereof), the phrase ‘The method of claim 26…’ is indefinite for depending upon canceled claim 26. To practice compact prosecution, examiner will interpret claim 39 to depend upon claim 23. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
RESPONSE TO REMARKS: Applicant's arguments filed 4/29/2026 with regard to the amendments made to claim 23 have been fully considered but they are not persuasive. Examiner contends that identification of the respective transporters by a UniprotKB, UniParc ID, GenBank accession numbers renders the claims indefinite because, notably, the particular rules and regulations governing UniprotKB, UniParc ID, GenBank deposits allows for changes to the deposited sequences to be made at any time. Additionally, the recitation of the phrase ‘the gene’ in claims 23 (claims 27-31, 33, 36-40, 42-44 dependent thereof) 27, 40 is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. Furthermore, the phrase ‘The method of claim 26…’ is indefinite for depending upon canceled claim 26. As such, the 112b rejection applied to the non-final office action dated 11/6/2025 is maintained.
Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection of claims 23-24, 26, 28, 30, 36, 39, 41 under 35 U.S.C. 103 as being unpatentable over Burgard et al (US 2009/0305364 A1, Date Published: Dec. 10, 2009, cited on PTO-892 dated 11/6/2025) {herein Burgard} as evidenced by Plaitakis et al (2017, biology review, cited on PTO-892 dated 11/6/2025) is maintained.
Claims 23-24, 26, 28, 30, 36, 39, 41 are drawn a method for making a 6-aminocaproic acid, comprising the steps of: providing a non-naturally occurring microbial organism comprising a disruption of a gene encoding a transporter that imports 6-aminocaproic acid into the microbial organism, a pathway for making a 6-aminocaproic acid, wherein and an exogenous nucleic acid encoding a transporter for the 6-aminocaproic acid, wherein the exogenous nucleic acid encodes a transporter selected from the group consisting of UniprotKB Accession numbers P75826, A0A447V4H2, AOA085HLU7, AOA085AG20, AOA3S6EWD1, AOA3ROJPG3, AOA2X5EV87, AOA2X2DZ65, AOAlB9PQG6, AOAOQ9CPY2, AOAOB6FGQ0, AOAOT9KE32, AOA2DOJQA6, AOA2N5KTP3, AOA2U3BBA9, AOA3SOAXG7, AOA085HLU7, AOA198FET8, AOA1C5WGHO, AOAlI7IZI6, AOAlQSTYKI, AOAlQ5U965, AOA3E4Z618, A0A855M686, AOAOB6XA16, AOAOG3CKY0, AOAOH5M125, AOAOJ5FX48, AOA2DOIU27, AOA3A3ZES2, AOA2N4W2H6, AOA4R2XZM7, AOA1O1K111, AOA443UFD0, AOA2Z3F3X0, AOAOT9TQ60,AOAOT9T4V6, AOA3X9TWR2, AOA356QXL1, W3V0I2, AOA455VNE7, AOAOQ4NI65, and UniParc ID UPI00045BA014, wherein the exogenous transporter exports the 6-aminocaproic acid from the cell; and culturing the non-naturally occurring microbial organism in a medium under conditions where the 6-aminocaproic acid is produced.
With respect to claims 23-24, 26-27, 31, 33, 36-37, 42-43, Burgard teaches a method wherein a non-naturally occurring organism comprises a pathway for making 6-aminocaproic acid (abstract). The non-naturally occurring microbial organism comprises at least one exogenous nucleic acid encoding a transaminase enzyme that reacts with adipate semialdehyde to form 6-aminocaproic acid (6ACA) (para 0041). Said exogenous nucleic acid is transformed into host cell MG1655 E. coli (para 0032, 0187). The methods include culturing the non-naturally occurring microbial organisms in medium under conditions and for a sufficient period of time to produce 6-aminocaproic acid (Burgard: claim 49). The production of 6-aminocaproic acid is increased through exogenous expression of the endogenous gene or genes, or through exogenous expression of the heterologous gene or genes (para 0056).
With respect to claims 28, 30, 39, 41, Burgard teaches a method wherein a transaminase transfers an amino acid from glutamate to the terminal aldehyde of succinyl semialdehyde for the synthesis of 6-aminocaproic acid (para 0179). As such, it would be obvious to one of ordinary skill in the art to add an exogenous nucleic acid encoding a glutamate dehydrogenase as said construct would result in an ample supply of glutamate for the synthesis of 6-aminocaproic acid.
However, Burgard does not teach the method of claim 23 of disruption of a gene encoding a transporter that imports 6-aminocaproic acid into the microbial organism; an exogenous nucleic acid encoding a transporter for the 6- aminocaproic acid; transporting the 6-aminocaproic acid from the microbial organism into the medium (claim 23).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method for making a 6-aminocaproic acid, taught by Burgards, by including an exogenous nucleic acid encoding a transporter for the 6- aminocaproic acid (instant application claim 23) because it would allow for better control of the export of 6-aminocaproic acid out of the cell thereby making purification of the molecule easier and subsequently reducing the costs associated with manufacturing high volumes of said molecule. Absent evidence otherwise, it is the Examiner’s opinion that the step of ‘transporting the 6-aminocaproic acid from the microbial organism into the medium’ (claim 24) would be inherent in the presence of an exporter for 6-aminocaproic acid. Furthermore, it would be obvious to one of ordinary skill in the art to modify the method of making 6-aminocaproic acid, taught by Burgard, by disrupting an importer of 6-aminocaproic acid (claim 23) as if said genes remained active, it would likely reduce the yield of 6-aminocaproic acid in medium, thereby requiring a step of lysing the host cells in order to purify 6-aminocaproic acid from cells. Said lysing could result in the accumulation of cellular artifacts in the resulting yield of 6-aminocaproic acid in medium resulting in the need for further purification. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would be motivated to add an exogenous nucleic acid encoding a transporter to a non-naturally occurring microorganism comprising a pathway for making 6-aminocaproic acid because doing so would increase the extracellular yield of 6-aminocaproic acid and would allow for its ease in purification for the production of pharmaceuticals to treat cancers. Furthermore, one of ordinary skill in the art would be motivated to disrupt a gene encoding a transporter that imports 6-aminocaproic acid into the microbial organism as doing so would increase the extracellular yield of 6-aminocaproic acid by inhibiting or limiting its importation from medium into the cell. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
It is noted that the identification of the respective transporters by UniprotKB, UniParc ID, GenBank accession numbers renders the claim indefinite because, notably, the particular rules and regulations governing UniprotKB, UniParc ID, GenBank deposits allows for changes to the deposited sequences to be made at any time. There can be multiple updates and changes made to the same sequence, however, that sequence will still have the same accession number. Thus, one skilled in the art is not apprised as to which particular “version” of the sequences Applicants is claiming which renders the claims indefinite. As such, the reference of Burgard is encompassed by the claims.
RESPONSE TO REMARKS: Applicant's arguments filed 4/29/2026 have been fully considered but they are not persuasive. Beginning on p. 9 of Applicants’ remarks, Applicants in summary contends that the amendment to the claims overcome the present obviousness rejections, and so, Applicants respectfully request that these rejections be withdrawn.
These arguments are found to be not persuasive. Examiner contends that amending claim 23 to incorporate the limitations of canceled claim 26 (a disruption of a gene encoding a transporter that imports 6-aminocaproic acid into the microbial organism) and tables 16 and 17 do not overcome the 103 rejection. Examiner contends that the incorporation of UniprotKB , UniParcID and GenBank Accession numbers into the instant application claims 23, 31, 33, 37, 42, 43 renders the claim indefinite because, notably, the particular rules and regulations governing UniprotKB, UniParc ID, GenBank deposits allows for changes to the deposited sequences to be made at any time. There can be multiple updates and changes made to the same sequence, however, that sequence will still have the same accession number. Thus, one skilled in the art is not apprised as to which particular “version” of the sequences Applicants is claiming which renders the claims indefinite. As such, the 103 rejection over claims 23-24, 26, 28, 30, 36, 39, 41 of the instant application are taught by the reference Burgard.
Conclusion
Status of Claims
Claims 23, 27-31, 33, 36-40, 42-44 are pending.
Claims 1-22, 24-26, 32, 34=35, 41 are cancelled.
Claims 23, 27-31, 33, 36-40, 42-44 are rejected.
No claims are in condition for allowance.
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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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