DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election
1) Applicant’s election filed 04/17/26 in response to the restriction and the species election requirement mailed 02/19/26 is acknowledged. Applicant has elected, with traverse, invention I, and the Pseudomonas fluorescence complex of species, the luxCDABE reporter gene species, the IH404_01620 promoter species, and the SEQ ID NO: 13 nucleic acid species within the elected invention I. Applicant states that marR is the generic name with the official gene identification being IH404_01620. Applicant’s traversal is on the basis that a search and examination of the elected invention I would overlap or encompass the search field of the non-elected claims of inventions II-IV.
Applicant’s argument has been carefully considered, but is deemed non-persuasive. The instant application is the national stage application filed under 35 U.S.C § 371, wherein lack of unity applies. As set forth previously, inventions I-IV do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons. The special technical feature of invention I, claim 1 for example, is a biosensor for detecting naphthenic acids in an environment comprising a modified Pseudomonas sps. However, such a product does not define over the prior art of record as evidenced by the art rejection(s) set forth in this Office Action. Thus, the special technical feature is not a unifying feature. Technically, the absence of a special technical feature permits the separation of method of using or making the product from the product itself. Therefore, the lack of unity held in the instant application is proper and is hereby made FINAL. Applicants should note the Notice of Possible Rejoinder set forth at paragraph 6 of the written lack of unity mailed 02/19/26.
Status of Claims
2) Claims 1-23 are pending.
Claims 7-19 are withdrawn from consideration as being directed to a non-elected inventions. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-6 are examined on the merits.
Sequence Listing
3) Acknowledgment is made of Applicant’s Sequence Listing which has been entered on 04/30/24.
Drawings
4) Acknowledgment is made of Applicant’s drawings filed 03/13/24.
Priority
5) The instant AIA application, filed 03/13/2024, is the national stage filed under 35 U.S.C. § 371 of application PCT/EP2021/085499 filed 09/16/2022, which claims priority to the U.S. provisional application 63245435 filed 09/17/2021.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
6) 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.
7) Claims 1-6 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 1 ambiguous and indefinite for having an antecedence issue with regard to the limitation “naphthenic acids”. See the last line. For proper antecedence, it is suggested that Applicant insert the limitation –the-- prior to the above-identified limitation.
(b) Analogous rejection applies to claim 6 with regard to the limitation “a promoter responsive to ......”. Since claim 6 depends from claim 1 which already includes this limitation,
for proper antecedence, it is suggested that Applicant insert the limitation –the-- prior to the above-identified limitation.
(c) Claims 4, 5, 7-12, 16, 17, 20 and 21, which depend directly or indirectly from claim 1, are also rejected as being indefinite because of the indefiniteness identified above in the base claim.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection would be the same under either status.
Rejection(s) under 35 U.S.C § 102
8) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
9) Claims 1-3 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by WO 9927351 A1.
WO 9927351 A1 disclosed a bioluminescent bioreporter or biosensor Pseudomonas species such as Pseudomonas fluorescens comprising integrated circuits or a recombinant vector comprising the luxCDABE reporter gene or luxCDABE gene cassette operatively linked to a promoter that is responsive to an environmental factor such as naphthenic acid in an environment. The biosensor is used for the detection of naphthalene concentrations in an environment. The luxCDABE cassette is chromosomally inserted. See Examples 3, 4, 12; TABLE 14; pages 41, 42, 70, 78, 91, 140; and sections 5.2.1.1; 5.4.1.1; and 5.12;
Claims 1-3 are anticipated by WO 9927351 A1.
10) Claims 1-3 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Xu et al. (Adv. Biochem. Engineer/Biotechnol. 144: 111-151, 2014 - Applicant’s IDS).
Xu et al. disclosed biosensors for detecting the presence of naphthalene in an environment comprising a modified Pseudomonas species carrying a plasmid, or chromosomally encoding a genetic circuit comprising a reporter gene fused with a promoter responsive to the presence of naphthenic acids, the genetic circuit being expressed in the presence of naphthenic acids in the environment. Xu et al. disclosed the use of Pseudomonas fluorescens species comprising the reporter construct luxCDABE. Xu et al. taught the use of said biosensor in detecting the presence of naphthalene in the environment. See the entire reference including pages 116, 117, 120 and 121; and Table 1.
Claims 1-3 are anticipated by Xu et al.
11) Claims 1-6 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by Shideler SM (Biosensors for the Detection of Naphthenic Acids in Wastewater from Oil Sands Operations. University of Calgary: PRISM: University of Calgary's Digital Repository, pages 1-118, 19 September 2019 - Applicant’s IDS).
Shideler SM taught disclosed biosensors for detecting the presence of naphthenic acids in an environment comprising a modified Pseudomonas species such as a Pseudomonas synxantha strain carrying a plasmid, or chromosomally encoding a genetic circuit comprising a reporter gene fused with the SIGNA_4 (i.e., marR IH404_01620) promoter responsive to the presence of naphthenic acids and a transcriptional repressor controlling the promoter, the genetic circuit being expressed in the presence of naphthenic acids in the environment. Said biosensor comprises the constructed genetic circuit and a promoter-lux construct inserted into the strain. Shideler SM disclosed the use of Pseudomonas fluorescens complex species with the luxCDABE gene. Shideler SM taught Pseudomonas synxantha 1909 expressing the plasmid-based biosensor; and the biosensor was exposed to OSPW naphthenic acids. The SIGNA_4 (i.e., marR IH404_01620) promoter sequence is upstream of a MarR regulator. The promoter-lux construct SIGNA_4 is taught. Shideler SM identified OSPW isolates belonging to the Pseudomonas fluorescens group with 99% homology to their 16S rRNA genes. Shideler SM further taught the use of said biosensors in detecting the presence of naphthenic acids in the environment. See the entire reference including pages 1, 9, 16-18, 20, 23, 24, 30, 31, 40, 74, 86 and 101; the last full sentence on page 16. Since the prior art Pseudomonas species comprises every structural element of the claimed biosensor, it is expected to necessarily comprise a nucleotide sequence having at least 80% sequence identity to SEQ ID NO: 13 absent evidence to the contrary. Since the Office does not have the facilities for examining and comparing Applicants’ modified Pseudomonas species comprising genetic circuit as claimed with that of the prior art, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed product and the prior art product. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594. Note that as long as there is evidence establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function, or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Claims 1-6 are anticipated by Shideler SM.
Conclusion
12) No claims are allowed.
Correspondence
13) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, her Supervisor Jeffrey Stucker, can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
14) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
June, 2026
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