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 .
Status of Claims
Claims 1-5 have been amended and are examined.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Pierson et al. (WO2018/057647, Pub Date: 03/29/2018) in view of Mcewen et al. (WO 2018/200872, Pub Date: 11/01/2018).
Regarding claim 1, Pierson teaches throughout the application a device, comprising:
a sample-receiving module (paragraphs 006 and 0197, sample introduction area);
an amplification module, the amplification module comprising: a plurality of isothermal amplification reagents (paragraphs 0005-0007 and 0019, sealed chamber with amplification constituents; amplification process can comprise isothermal amplification); and
a detection zone, the detection zone comprising; a sensor module comprising a sensor configured to detect a nucleic acid (paragraph 0005, sensing electrode; and for example, paragraph 0322).
However, Pierson fails to teach that the sensor module such as a sensing electrode is a functionalized nanowire.
Mcewen teaches throughout the publication methods and devices for diagnostics for sensing and/or identifying pathogen or biomarkers (abstract). More specifically, Mcewen teaches that one or more electrodes can be included or alternatively to the electrodes, flexible electrodes such as nanowires can be used. Furthermore, Mcewen teaches that the cover including the electrodes or nanowires can be modified to support movement, adhesion, or may be conditioned to have covalently bound molecules (paragraph 0096).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the electrode in the device of Pierson, functionalized nanowires as taught by Mcewen. One having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent sensor component) and since the same expected detection of molecules would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired device configuration and dimensions.
Regarding claim 2, Pierson teaches throughout the publication a method for detecting a target nucleic acid (paragraph 0060), the method comprising:
providing a sample comprising the target nucleic acid (paragraph 0199);
heating the target nucleic to a temperature (paragraphs 0005 and 0068);
exposing the target nucleic acid to a plurality of isothermal amplification reagents (paragraphs 0005-0007 and 0019);
amplifying the target nucleic acid to produce a plurality of amplified target nucleic acids (paragraph 0060);
exposing at least a portion of the plurality of amplified target nucleic acids to a sensor configured to detect the amplified target nucleic acid (paragraph 0060); and
detecting the target nucleic acid by a change in conductance (paragraphs 0072, 0105 and 0170).
However, Pierson fails to teach that the sensor module such as a sensing electrode is a functionalized nanowire.
Mcewen teaches throughout the publication methods and devices for diagnostics for sensing and/or identifying pathogen or biomarkers (abstract). More specifically, Mcewen teaches that one or more electrodes can be included or alternatively to the electrodes, flexible electrodes such as nanowires can be used. Furthermore, Mcewen teaches that the cover including the electrodes or nanowires can be modified to support movement, adhesion, or may be conditioned to have covalently bound molecules (paragraph 0096).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute for the electrode in the device of Pierson, functionalized nanowires as taught by Mcewen. One having ordinary skill in the art would have been motivated to make such a change as a mere alternative and functionally equivalent sensor component) and since the same expected detection of molecules would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired device configuration and dimensions.
Regarding claim 3, Pierson teaches the device wherein the target nucleic acid comprises coronavirus DNA and/or RNA (paragraphs 0004 and 0107-0109).
Regarding claim 4, Pierson teaches the device wherein the plurality of isothermal amplification reagents comprises isothermal primers (for example, paragraphs 0240, 0401 and 0416).
Regarding claim 5, although Pierson does not specifically teach the device wherein the amplified target nucleic acid comprises a portion of a nucleotide sequence that is neither identical nor complementary to the target nucleic acid, such limitation is drawn to intended use of the device and therefore the prior art only needs to be capable of performing the recited intended use (although it is unclear which specific component of the device is responsible for the amplified target nucleic acid as this limitation lacks antecedent basis – as described above). So long as the device of Pierson is capable of amplifying nucleic acids, it reads on the claims. Pierson teaches the same structural limitations as recited in the claims, therefore it is considered capable of performing the same intended use.
Response to Arguments
Applicant’s arguments filed 01/15/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. While Pierson does not teach functionalized nanowires, Mcewen teaches the functional equivalence of sensing electrodes and functionalized nanowires, as described above. Therefore, the claims remain unpatentable based on the teachings of Pierson in view of Mcewen.
Conclusion
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 REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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