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 .
Claim Status
The amended claim set filed 31 Aug 2026 is acknowledged. Claims 1, 6, 10, 12, 14-22, 28, 30-31, and 37-40 are currently pending. Of those, claims 1 and 12 are currently amended, and claim 40 is new. Claims 12, 14-22, 28, and 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4 Mar 2026. Claims 2-5, 7-9, 11, 13, 23-27, 29, 32-36 are cancelled. Claims 1, 6, 10, and 37-39 will be examined on the merits herein.
Response to Arguments
The Applicants’ arguments filed 31 Aug 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 29 Apr 2026 will be referred to as “NFOA.”
Objection(s) and Rejection(s) Withdrawn
The following rejections are withdrawn in view of the amendment of claim 1 to include the limitation of claim 11 and associated applicant arguments:
Rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by APPLICANT ADMITTED ART.
Rejection of claims 1 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Ficht et al. (US-20140248354-A1; hereafter Ficht; PTO-892).
Rejection of claims 1 and 6 on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent Nos. US 9248176 B2, US 10220084 B2, US 10940193 B2, and US 11975060 B2.
Drawings
The drawings filed 31 Aug 2026 remain objected to because:
In Figures 1, 2A, 4C, and 9F, the black-and-white images cannot be interpreted because the color spectrum used gets darker at both high and low values.
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Examiner’s view of Figure 1.
In Figure 9C, the legend cannot be interpreted because the colors (if present) and shapes (if present) that differentiate the lines cannot be distinguished from each other.
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Examiner’s view of Figure 9C (partial figure).
In Figure 1 the text is pixelated to the point that it cannot be read.
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Examiner’s view of Figure 1.
As the drawings appear to have been originally created using colors, it is noted that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Rejection(s) Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
Claims 1, 6, 10 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Figueiredo et al. (May 2021; hereafter de Figueiredo; made of record in IDS filed 26 Jan 2024). This reference may be eligible for a 102(b)(1)(A) exception.
De Figueiredo teaches “we engineered an attenuated brucellosis vaccine (Brucella melitensis ΔvjbR Tna) to produce indole”, and that the indole-producing live attenuated bacteria were administered to a collagen induced arthritis (CIA) murine model (Abstract). For claim 37, the claimed tryptophanase “tnaA” is presumed to be the same as the disclosed “Tna”, absent evidence to the contrary, due to the very similar name and same function of producing indole.
Response to Arguments
Applicant argues (Remarks pg. 8) that “the de Figueiredo reference was published less than 1 year before the effective filing date of the claimed invention. As shown on page 1 of the de Figueiredo reference, Inventors de Figueiredo, Song, Ficht, and Alaniz are authors of de Figueiredo. Applicant respectfully asserts that the de Figueiredo reference was made by the inventors of the captioned application (i.e., de Figueiredo, Song, Ficht, and Alaniz) and that the other co-authors (i.e., Guo, Das, Ding, and Jayaraman) obtained the subject matter disclosed from the inventors. Accordingly, the de Figueiredo reference meets the definition under § 102(b)(1)(A) of a prior art exception for § 102(a)(1).”
This argument has been carefully considered but does not meet the requirements for claiming the prior art exception. See MPEP 2155.01 (emphasis added): “An applicant may show that a disclosure was made by the inventor or a joint inventor by way of an affidavit or declaration under 37 CFR 1.130(a) (an affidavit or declaration of attribution). See In re Katz, 687 F.2d 450, 455, 215 USPQ 14, 18 (CCPA 1982) and MPEP § 717.01(a)(1) . Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an unequivocal statement from the inventor or a joint inventor that the inventor or joint inventor (or some combination of named inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982). When any claim of an application or a patent under reexamination is rejected, the applicant or patent owner may submit an appropriate affidavit or declaration to except a disclosure as prior art by establishing that the disclosure was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. However, an affidavit or declaration under 37 CFR 1.130(a) that is only a naked assertion of inventorship and that fails to provide any context, explanation or evidence to support that assertion is insufficient. See EmeraChem Holdings, LLC v. Volkswagen Grp. of Am., Inc., 859 F.3d 1341, 123 USPQ2d 1146 (Fed. Cir. 2017).” Applicant has only argued that the inventors are authors on the reference, but does not provide a declaration or affidavit that the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor or provide a reasonable explanation of the presence of additional authors. MPEP 716.01(c): “Arguments presented by the applicant cannot take the place of evidence in the record.”
Claim Rejections - 35 USC § 103
Claims 1, 6, 10 and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over de Figueiredo et al. (May 2021; hereafter de Figueiredo; made of record in IDS filed 26 Jan 2024) in view of Mani et al. (US-20150258151-A1; hereafter Mani; PTO-892 mailed 29 Apr 2026).
De Figueiredo teaches “we engineered an attenuated brucellosis vaccine (Brucella melitensis ΔvjbR Tna) to produce indole”, and that the indole-producing live attenuated bacteria were administered to a collagen induced arthritis (CIA) murine model (Abstract). For claim 37, the claimed tryptophanase “tnaA” is presumed to be the same as the disclosed “Tna”, absent evidence to the contrary, due to the very similar name and same function of producing indole.
De Figueiredo does not teach that the tnaA is expressed under the control of a constitutive promoter, as in claim 38, and does not teach that the tryptophanase (tnaA) comprises E. coli tnaA, as in claim 39.
Mani teaches bacteria that produce an indole [Abstract]. Mani teaches “In an embodiment, the bacterium is a recombinant bacterium genetically engineered to constitutively-express an indole-producing enzyme. … In a preferred embodiment, the tryptophanase is an E. Coli tryptophanase.” [0031].
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the De Figueiredo indole-producing bacteria by choosing promoters and genes that are preferred for making indole producing bacteria as taught in Mani, thereby arriving at the claimed invention, because de Figueiredo is silent on the methodological details that would be needed to replicate their work, and Mani teaches the details that were preferred by one of ordinary skill in the art at the time of filing. Therefore the combination would be desirable because using art-recognized promoters and genes may make it easier to produce a disclosed indole-producing bacteria. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (de Figueiredo) teaches a product that only differs from the claimed invention by the substitution of a single component (i.e. choice of the promoter or gene used based on the generic disclosure, for claims 38-39, respectively); the substituted element (i.e. the constitutive promoter and E. coli tnaA) was already known and already shown to function as a promoter/gene that can be used in an indole-producing bacteria, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one promoter/gene for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
Applicant argues (Remarks pg. 9-10) that the de Figueiredo reference meets the definition under § 102(b)(1)(A) of a prior art exception for § 102(a)(1).
This argument has been carefully considered but does not meet the requirements for claiming the prior art exception, as discussed in the 102 rejection using this reference above.
Conclusion
No claims are allowed.
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 AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
