-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
Currently, claims 1-10, 12-14, 17-18 are pending in the instant application. Claims 11 and 15 have been canceled. This action is written in response to applicant’s correspondence submitted 01/26/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant’s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/051271 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. ‘271 does not provide support for any RNA polymerase other than T7 RNA polymerase. ‘’271 does not provide support for an engineered T7 polymerase. 271 ‘271 does not describe or provide support for any isolation methods, quantifying steps, nuclease free water or a lyophilized tablet. As such the effective filing date of claims 1-10, 12-14, 17-18 is 07/13/2021.
Withdrawn Rejections
The rejection of claims 10 and 17 under 35 USC 112(b) is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 5, 10-16 under35 USC 102(a)(1) as anticipated by Lorinez is withdrawn in view of the amendment to the claim.
Specification
The amendment filed 01/26/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “an engineered T7 polymerase” is new matter. While the specification disclosed Hi-T7 RNA polymerase, the specification did not disclose or encompass the genus of engineered T7 polymerases.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
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.
Claim 10 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.
The amendment to claim 10 recites “an engineered T7 RNA polymerase” this amendment to he claims is not supported by the instant disclosure and raises the issue of new matter. The specification disclose Hi-T7 RNA polymerase which is considered to be an engineered T7 polymerase but the specification does not disclose any other engineered T7 polymerases and does not disclose or contemplate using an engineered T7 polymerase. The recitation of engineered T7 polymerase broadens the scope of the claim and is not supported by the disclosure. As such the amendment to the claims are rejected as raises the issue of new matter.
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.
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.
Claims 1-10, 12-15, are rejected under 35 U.S.C. 103 as being unpatentable over Lorinez (US 6136535) in view of Shi et al. (CN110218778A, The pages cites are to the translated document)
Lorinez teaches continuous amplification reactions that produces RNA transcripts. Lorinez teaches RNA polymerase reactions. Lorinez teaches one or more suitable RNase inhibitors, dNTPs, template, primer and T7 polymerase added and incubated at 37 °C (see column 24, lines 30-35). Lorinez teaches RNA was detected by denaturing formaldehyde gel. Lorinez teaches synthesis of RNA transcripts are carried out in the presence of a ribonuclease inhibitor vanadyl-ribonucleoside complex (see column 11, lines 64-67). Lorinez does not teach concentration of RNAse inhibitor or quantifying transcribed RNA by real time monitoring.
However it was known in the art to vary the concentration of ribonuclease inhibitors in PCR reactions and it was known in the art to quantify transcribed RNA by real time monitoring.
Shi teaches amplification using real time amplification. Shi teaches reverse transcription PCR using a ribonuclease inhibitor which allows for direct PCR using a nucleic acid sample that is not extracted or purified and directly detected reverse transcription by fluorescence quantitative PCR on the RNA in the nucleic acid sample and avoids sample degradation (see pg. 9). Shi teaches using ribonuclease inhibitor to inhibit degradation of RNA when using RNA as a template. Shi teaches vanadyl riboside complexes and teaches 10 to 5000U/ml (.1 to 10mM concentration VRC) (see pg. 9). Shi teaches a one step RT-PCR reaction that comprises dNTPs, RNA polymerase, RNase inhibitor, primers and template.
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to apply the well-known ribonuclease inhibitor to RNA transcription reactions including using vanadyl riboside complexes at varying concentrations as taught by Shi in the method of Lorinez for the expected benefit of inhibiting degradation of RNA and using a one step RT-PCR reaction without the need for extracted or purified nucleic acid samples. Additionally the ordinary artisan would have been applied using real-time monitoring of the reaction to allow for real time detection and quantitative, which was well known in the art and taught by Shi to allow for the expected benefit of real time monitoring of RNA production in a one step reaction in the method of Lorinez.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lorinez (US 6136535) in view of in view of Shi et al. (CN110218778A, The pages cites are to the translated document) and further in view of Shieh (PLOS ONE, 13(3): e0194393, pp. 1-14).
Lorinez in view of Shi teaches continuous amplification reactions that produces RNA transcripts. Lorinez in view of Shi teaches RNA polymerase reactions. Lorinez in view of Shi teaches one or more suitable RNase inhibitors, dNTPs, template, primer and T7 polymerase added and incubated at 37 °C (see column 24, lines 30-35). Lorinez in view of Shi teaches RNA was detected by denaturing formaldehyde gel. Lorinez in view of Shi teaches synthesis of RNA transcripts are carried out in the presence of a ribonuclease inhibitor vanadyl-ribonucleoside complex (see column 11, lines 64-67). Lorinez in view of Shi does not teach a nuclease free water.
However it was known in the art to use nuclease free buffer when using RVC. Shieh teaches using RVS in nuclease free buffer. The nuclease free buffer comprises nuclease free water. (see preparation of preservative solution)
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use nuclease free water in the kit composition of Lorinez in view of Shi to reduce contamination of RNases from a water source to reduce RNase activity in water, preserve RNA and delay RNA degradation. The ordinary artisan would have been motivated to use nuclease free water in the kit of Lorinez in view of Shi for the expected benefit of preventing contamination of RNase activity from water and buffer solutions.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lorinez (US 6136535) in view of in view of Shi et al. (CN110218778A, The pages cites are to the translated document) and further in view of Udugama (J Am Chem Soc, 2017, 139, 17341-17349).
Lorinez in view of Shi teaches continuous amplification reactions that produces RNA transcripts. Lorinez in view of Shi teaches RNA polymerase reactions. Lorinez in view of Shi teaches one or more suitable RNase inhibitors, dNTPs, template, primer and T7 polymerase added and incubated at 37 °C (see column 24, lines 30-35). Lorinez in view of Shi teaches RNA was detected by denaturing formaldehyde gel. Lorinez in view of Shi teaches synthesis of RNA transcripts are carried out in the presence of a ribonuclease inhibitor vanadyl-ribonucleoside complex (see column 11, lines 64-67). Lorinez in view of Shi does not teach a lyophilized tablet
However it was known in the art to simplify assays by using lyophilized tablets. Udugama teaches use of tablets in diagnostic assays. Udugama teaches premeasured quantitates of reagents can be prepackaged into tablets to improve reproducibility of assays. Udugama teaches tables are easy to handle, easy to use and provide thermal stability (see pg. 17341). Udugama teaches polymerase and other reagents into tablet form (see pg. 17346).
Therefore it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to lyophilize the kit components of Lorinez in view of Shi in tablet form as taught by Udugama to allow for a thermally stable and easy to handle reagents. The ordinary artisan would have been motivated to provide the reagents of the kit of Lorinez in view of Shi in lyophilized tablet form to allow for easy to handle, premeasured quantities of reagents without the need for additional packaging consumables and allow for reduced user intervention when conducting multistep assays.
Response to Arguments
The response traverses the rejection of claims under 35 USC 102 and 35 USC 103 together on pages 2-3. The response asserts the claims have been amended and asserts that the claims are not anticipated or rendered unpatentable by the refences cited within the office action (pg. 2 of the remarks). The response asserts the skilled artisan would find claims 1 and 14 patentable because VRC provides an unexpected benefit when transcribing RNA via a T7 polymerase when in a transcription reaction at about 10mM or less. The response asserts VRC is an inhibitor of RNAase and also RNA polymerases and inhibition of VRC is portrayed in Fig 1B in which 1mM and 10mM VRC inhibited RNA transcription by SP6 polymerase. The resp9onse asserts that unexpectedly T7 RNA polymerase increased RNA production and points to fig 1A and fig 2. The response asserts that Lorinez does not provide description or appreciation of the ability of VRC to increase T7 polymerase output.
This response has been thoroughly reviewed but not found persuasive. Lorinez teaches carrying out the synthesis of RNA transcripts in the presence of a ribonuclease inhibitor, vanadyl-ribonucleoside complex in order to avoid possible degradation of transcripts (see X). Lorinez teaches the ability of VRC to increase RNA transcription and thus T7 polymerase output. By using a ribonuclease inhibitor the output of transcripts, and thus T7 polymerase output will be increased as taught by Lorinez (see column 11, lines 64-67 cont’d to column 12, lines 1-10). As such Lorinez in view of Shi render obvious the claimed invention with expected results. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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