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 preliminary amendment filed 3/17/2025 is acknowledged. Claims 5-9, 12-16, 18-20, 22-26 and 28 have been canceled. Claims 1-4, 10- 11, 17, 21 and 27 have been amended and are pending.
The amendment to the specification filed 8/8/2024 is acknowledged and has been entered.
Priority
This application is a 371 of PCT/GB2023/050275 filed 02/08/2023.
Drawings
The drawings were received on 8/8/2024. These drawings are found acceptable by the Examiner.
Substitute Specification
The substitute specification filed 3/17/2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: The specification is not accompanied by a statement that it contains no new matter and the substitute specification is not submitted with a “Mark-up” copy with clear markings showing all changes relative to the immediate or original prior version of the specification of record.
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.
Claims 4, 11 and 17 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.
(a) Clams 1-2, 4, 10-11, 17, 21 and 27 are indefinite in the claims 1 and 2 at the recitation of
(b) Claim 4 is confusing at the recitation of “a) at least conditions: (i) and (ii); (i) and (iii); (i) and (iv); (i) and (v); (ii) and (iii); (ii) and (iv);(ii) and (v); (iii) and (iv); (iii) and (v); or (iv) and (v); b) at least conditions: (i), (ii) and (iii); (i), (ii) and (iv); (i), (ii) and (v); (i), (iii) and (iv); (i), (iii) and (v); (i), (iv) and (v); (ii), (iii) and (iv); (ii), (iv) and (v); (ii), (iv) and (v); or (iii), (iv) and (v); c) at least conditions: (i), (ii), (iii) and (iv); (i), (ii), (iii) and (v); (i), (ii), (iv) and (v); (i), (iii), (iv) and (v); or (ii), (iii), (iv) and (v); or d) all of conditions (i), (ii), (iii), (iv) and (v)” because the metes and bounds of the limitation are unclear as currently written. It is unclear if application is suggesting options in (a), (b) or (c) or if applicant is suggesting all the conditions in (a) versus (b) or (c) or any one of the options in (a), (b) or (c). A clear interpretation cannot be ascertained.
(c) Claims 11 and 17 are indefinite at the recitation of “preferably” because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(d) Claim 11 is indefinite at the recitation of (T01-Biotin) in parentheses because “T01-Biotin is not another name for or definition of Thiazole orange and this it is unclear if the limitation is part of the claimed invention or a separate entity.
Claim Interpretation
The claims 1-4, 10-11, 17, 21 and 27 are directed to method and kit comprising of numerous “optional” or “contingent” limitations. MPEP 2111 notes “During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005)”. MPEP states with regards to contingent limitations, the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
The claim 3 is directed to a kit comprising of “intended use limitations” in the recitation of “for detecting a target nuclei8c acid sequence…”, “for amplifying the target…”, “for detecting the target nucleic acid sequence…” and “is used at a temperature…”. MPEP instructs us that intended use limitations refers to claim language describing what an invention is for, rather than its structure and it generally carries less weight during examination. MPEP states that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2173.05(g) and MPEP 2111).
The recited claims also recited a fixed temperature of between 30 and 40 degrees Celsius, MPEP 2144.04 states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. MPEP further states Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
In light of the teachings of MPEP, for the purpose of application of prior art, the claims are being given the broadest reasonable interpretation by the Examiner.
Claim Rejections - 35 USC § 102
9. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
10. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) and/or alternately 35 U.S.C. 102(a)(2) as being anticipated by Kent et al (WO 2020068983, April 2020). Regarding claim 3, Kent teaches a kit comprising reagents for amplifying a target, one or more primer wherein the primers may comprise of fluorescent change primers, polymerases, DNTPs and means for detecting the target nucleic acid, wherein a fluorescent signal indicates the presence of the target nucleic acid sequences in the sample (see page 37 and page 44). Even though the claim recites intended use limitations which do not particularly carry patentable weight, Kent also meets these limitations. Kent teaches wherein reagents in the kit may be used in amplification-based assay to detect a desired target sequence, wherein the assay may comprise of NASBA in a single mixture at one temperature consisting of 41 degrees Celsius (see pages 37, 40 and 41). Thus, Kent meets the limitations of the claim recited above.
Claim Rejections - 35 USC § 103
12. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
13. 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.
14. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
15. Claim(s) 1-2, 4, 10-11, 17, 21 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abdolahzadeh et al { Abdolahzadeh, used interchangeably herein} (RNA (2019) 25: 1806-1813).
Regarding claims 11-2, 4, 10-11, 17, 21 and 27, Abdolahzadeh teaches a detection and/or diagnosis method comprising the following: NASBA primers (IDT) were designed to target RNA amplification to the E. coli or P. fluorescens ClpB mRNA templates generated above (shown as “ClpB short target E. coli” and “ClpB short target P. fluorescens,” respectively, Table 1; Supplemental Fig. S6). Reactions were carried out using NASBA buffer mix, nucleotide mix, 250 nM of each primer described in the text, 480 nM TO1-Biotin, and NASBA enzyme mix mixed to a final volume of 14 µL. NASBA reactions were mixed excluding the enzyme mix and RNA target. RNA template was heated for 2 min to 65°C and brought down for 5 min to 41°C in a MJ research PTC-100 thermocycler before adding 1 µL of the template to each reaction mix (final template concentrations of either 0, 25 aM, 25 fM, 25 pM). To initiate the reaction, 5 µL of enzyme mix was added to the reactions and mixed. Reaction tubes were then sealed and incubated at 41°C in eight-tube strips (on-pot system) with optical caps on a StepOne Real-Time PCR System (Applied Biosystems). This instrument was set to read SYBR Green reagent in the following program: (i) Ramp to 41°C, read; (ii) hold for 30 sec at 41°C, read; and (iii) repeat step 2 until 480 cycles complete. Abdolahzadeh teaches that Experiments were carried out with primer P2C as shown in Table 1 using the WT Mango III that did not carry the A10U mutation. This mutation is known to make Mango III 14% brighter (see page 1811 section “Materials and Methods, col. 1)
With regards to lack of extraction step, Abdolahzadeh teaches ClpB DNA template was first generated by colony PCR reactions performed by picking either E. coli (strain DH5α) or P. fluorescens (strain ATCC 13525) colonies directly into PCR reactions consisting of Taq (NEB, 1 U/10 µL final), 0.2 mM each dNTP, 10 mM TRIS buffer pH 8.3, 50 mM KCl, 1.5 mM MgCl2, and 0.01% gelatin and the relevant primers (IDT) from Table 1 (see page 1811, section “Materials and Methods, col. 1)
With regards to the fixed temperature between 30 and 40°C, Abdolahzadeh teaches a temperature of 41°C, MPEP 2144.04 states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. MPEP further states Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (see page 1811, section “Materials and Methods, col. 1).
With regards to toe presence of fluorogenic aptamer, Abdolahzadeh teaches wherein the use of a fluorogenic mango aptamer in the presence of T01-Biotin (see page 1811, section Nested Mango NASBA, col. 2). With regards to the use of multiple primers in the NASBA
While Abdolahzadeh teaches both NASBA using nucleic acid from sample that has been added directly without extraction and nucleic acid that has been extracted, it would have been prima obvious to one of ordinary skill in the art at the time of the effective filing date that such modifications are within the ordinary artisan’s capability and would merely require routine optimization of known parameters and conditions based on the practitioner’s desired results. Accordingly, the teachings of Abdolahzadeh provides a prima facie case of obviousness over the instant invention.
Conclusion
16. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
Prosecution Insights