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
Request for Information under 37 CFR 1.105
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Claim Interpretation
The recited “test display…to display a test result identifying a presence of at least one of…” as in claim 1 is construed as an element for visualization element, such as in a window or optically transmissive opening as is conventional in the art and coincident with that provided by the present disclosure.
‘Strep’ herein is treated as streptococcus.
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.
Claim 5 is 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.
The metes and bounds of claim 5 are indefinitely understood for the functionality provided to the test display.
A test display is conventionally understood as a visualization element, and as likewise seen in claim 1 wherein the test display is recited with the functionality “to display…”
A test display itself is not construed as an analytical element that affords identification, and of such with respect to COVID-19 and ‘strep.’
It is noted that the claims, as well as the specification, do not recite particular sensing chemistry (i.e. specific binding for antigen-antibody in correlation to one or both of COVID-19 and streptococcus, ‘strep’ herein) and indicator therewith (i.e. colorimetric indicator or otherwise transduction element providing detectable signal), to provide a visual indication of COVID-19 and/or ‘strep’ and a control line.
Furthermore thereto as it pertains to the present recitation of the display identifies, it is noted that the disclosure also indefinitely provides for such functionality as in addition to lacking a baseline sensor element (i.e. a test strip/lateral flow strip as discussed above), the specification lacks discussion to transduction/processing of signals/responses therefrom the test strip/lateral flow strip that provide for the test display itself identifying COVID-19 and ‘strep.’ Further, the specification is absent discussion to a processor or particular electronics for transducing and converting a signal(s) from a test strip to digitized results to particular assays as in COVID-19 and ‘strep.’ The drawings also show a window/transmissive portion at 110 for the test display provided to a general center body.
For purposes of Examination, “identifies” in the recitation of claim 5 will be construed with respect to the display (as in window/optically transmissive portion) that provides visualization of that portion of the center body where the display is disposed.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Tamir (US 2020/0261906).
With regard to claim 1, Tamir discloses a pathogen test device comprising a center body (casing 10 acting as a handle for gripping, see par.[0029], fig. 3) to facilitate gripping thereof, a swab tip 2 connected to at least a portion of a first end of the center body to absorb at least one fluid therein in response to contract with the at least one fluid, a testing container 4 detachably connected to at least a portion of a second end of the center body to store a testing liquid therein (testing liquid not positively recited, however, Tamir discloses an extraction reagent 5 thereto), and a test display 11 disposed on at least on a portion of the center body 10 (at the capture zone 7, in which the positive or negative result is displayed; see abstract, par.[0006] to ‘capture portion’) that is fully capable to display a test result identifying at least one of COVID-19, strep, and control as recited in claim 1, wherein Tamir provides a commensurate test display as claimed (abstract, pars.[0003,0007,0029,0061], fig. 3, for example).
With regard to claims 2 and 3, Tamir discloses the device further comprising a rod (stem of the swab) disposed on the first end of the center body to connect the swab to the center body (the stem is connected to the swab tip and connects the swab to the center body at the test strip’s sample pad 8; par.[0061], fig. 3, for example). Further, as in cl. 3, the rod/stem absorbs and transfers the at least one fluid on the swab toward the center body while the swab is inserted within the testing container, wherein the rod/stem provides for such functionality as the rod/stem is disclosed to be porous to provide capillary flow from the swab tip 2 therethrough the rod/stem and to the test strip 8; pars.[0008,0043,0061], fig. 3, for example).
With regard to claim 4, the test display 11 indicates the test result after predetermined time, in which the test display 11 of Tamir is fully capable thereof wherein Examiner notes that the recitation remains drawn to the display/visualization element. And wherein such test display 11 may provide indication of a result concordant with a predetermined time taken for the capillary wicking and reacting in going from the sample pad 8 to analyte-specific reagent zone 9, and ultimately to the capture zone 7 where the test display 11, as disclosed in Tamir, is located for indicating the test result after such a predetermined wicking and reaction time. Examiner further notes that the claims themselves are absent any test strip let alone particular antigen(s), antibody(ies), reagent, or indicator affording the ability to determine presence/absence of an analytes as in COVID-19, ‘strep’, and a control line therefor; wherein such recitation herein remains as a visualization element such as a window or opening affording viewing of a prospective indicator.
With regard to claim 5, and as similarly discussed above with respect to claim 4 and concordant with the above discussion under 35 USC 112 b/2nd, it remains that the claim is drawn to a test display, which is commensurately disclosed in Tamir and fully capable of displaying thereof wherein such window allows for reading of test results and being indicative of “COVID-19 and ‘strep’” in as much as claimed and recited herein. Examiner asserts that there are no active or positively provided structure(s)/provisions to carrying out specific binding assays for COVID-19 and ‘strep,’ let alone further delineations to transduction/processing of signals/responses therefrom within a test strip/lateral flow strip that provide for the test display itself identifying COVID-19 and ‘strep.’
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798