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 .
Response to Arguments
Applicants arguments dated 04/06/2026 fail to discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them. A simple statement that all concerns have been addressed is not a satisfactory response.
Additionally, not all concerns under 35 USC 112 have been addressed and remain as rejections as below with additional concerns due to claim 1 amendments.
The rejections are maintained with respect to the amended claims.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 17, 23, and 50 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.
With respect to claim 17, the limitation “reference narrative aperture” was not described in the original disclosure as “adapted to align with an optical character recognition (OCR) image area for decoding printed indicia on said assay”. The reference narrative aperture is described in the specification as providing a viewing area of a reference narrative, however a “reference narrative” is never described, even more so, not described as aligning with an OCR image area for decoding printed indicia. Correction is required.
With respect to claim 23, the limitation “wherein said clearance channel providing a manipulation gap for insertion, removal, or repositioning of said assay within said optics module” is not described in the original disclosure. The clearance channel is not defined and the new definition amended into the claim is not found prior to the amendment. Describing the clearance channel as “a manipulation gap” is new matter. Correction is required.
With respect to claim 50, the specification fails to disclose “a monitor” but rather discloses any other number of elements (imaging device, apparatus, sensor, dual analog converter, etc.) that “monitor” something or other. There is no indication of a separate structure called “a monitor” and no guidance if the monitor is actually a previously disclosed structure. Correction is required.
Claims 1-3, 8, 9, 13, 17, 23, 32, 35, 36, 38, 42, 43, 46, 48, 50, 76, and 100 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 1, the limitations “for positioning said assay in a testing position” and “while said assay is positioned within said non-planar optics module” is indefinite. These limitations are confusing as to where the assay is located and how the testing position relates to the optics module. It raises the issue of whether the claims require the assay to be moved to satisfy the apparatus claim. Clarification is required.
With respect to claim 1, the limitation “wherein said lighting assembly modulates said plurality of light sources” is unclear if the claim is infringed upon when the step of modulating the light sources is performed or if only the structure to be able to do so is considered the bound of the limitation. This is an apparatus claim, however this limitation is worded as a step to be performed. Clarification is required.
With respect to claim 9, the “aperture carrier heat block” is not structurally related to any of the claimed limitations. It is unclear how it is connected to any of the previously disclosed limitations. Clarification is required. Additionally, the phrase “aperture carrier heat block” is not a well-known phrase in the art nor is it defined in the specification. If applicant wishes to act as their own lexicographer, each phrase must be clearly defined to avoid being indefinite.
With respect to claim 17, the limitation “a reference narrative aperture” is not a known phrase and contains no definition nor description in the specification such that one of ordinary skill in the art can understand the metes and bounds of the limitation.
With respect to claim 36, the limitation “minimal specular reflection” is term of degree and one of ordinary skill in the art would not be able to ascertain to which degree “minimal specular reflection” satisfies the claimed limitation. Clarification is required.
With respect to claim 38, 42 and 43, “an edge of a dispersion angle” is unclear. The phrase is not known in the art and it is unclear structurally what it means with respect to the light source and assay. An edge of a dispersion angle is known in the art at the spot at which the most extreme wavelength emerges from a prism, the dispersion boundary. However, it is unclear what the dispersion is emitted from and how the light source causes the edge to be outside of a section of the assay. Clarification is required.
With respect to claim 43, the limitation discloses “free of specular reflection.” It is unclear what this phrase refers to, whether it refers to an assay free of specular reflection, a light source, an outside section of the assay free of specular reflection, or the edge of a dispersion angle being free of specular reflection. Clarification is required.
With respect to claim 50, the “monitor” is not disclosed in the specification so it is unclear what it actually is. There is no structure for a “monitor” but rather several elements in the specification are said to monitor parameters. The phrase “monitor” is indefinite since a monitor can be defined as any number of different structures and it wouldn’t be apparent to one of ordinary skill in the art which one this limitation refers to lacking guidance from the specification.
With respect to claim 76, the claim contains the limitation “positioned about said non-planar optics module” and “providing illumination about at least a portion of said assay”. These limitations are indefinite since they use terms of degree “about.” The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
With respect to claim 100, the limitation “during transit conditions present in said transit environment” is indefinite. It is unclear if this is a method step, moving the assay within a transit environment, or what “transit conditions” mean. The specification provides several examples of possible situations such as “bulk collections logistics to a truck collection” or “batch food supply collection”. However, it is unclear how this relates to the claim and structurally what additional limitations it provides.
All claims dependent on the claims specifically noted above also fail to cure the deficiencies described and are likewise rejected.
Claim Rejections - 35 USC § 102
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, 2, 3, 8, 9, 13, 35, 36, 46, 48, 50, 76, and 100 are rejected under 35 U.S.C. 103 as unpatentable over Graham et al. WO2021046164 (with citations below to the national stage filing U.S. Publication 2022/0291133).
With respect to claim 1, Graham et al. discloses a test device comprising:
A non-planar optics module including a substantially planar proximate portion and an opposing non-planar distal portion defining a non-planar flow path for positioning said assay in a testing position and including at least one optical window aligned with said assay in said testing position (P.0128, P.0130, P.0045, wherein aperture = window and optical window = window, P.0047, non-planar flow path = offset side frame 512, P.0010)
An incubator adapted to incubate said assay while said assay is positioned within said non-planar optics module (P.0126)
An imaging device in an optical alignment with said non-planar optics module and adapted to image said assay in said offset position (P.0126, P.0130)
A direct, dynamically controlled lighting assembly aligned about said non-planar optics module, said lighting assembly including a plurality of light sources positioned relative to said non-planar optics module directing light toward said assay to at least one angle relative to a surface of said assay such that specular reflection across said assay is reduced and wherein said plurality of light sources are independently controllable and wherein said lighting assembly modulates said plurality of light sources to control illumination intensity across assay (P.0136, light bars aligned along an angled pitch of the device, P.0129, wherein optics are aligned with aperture carrier 510, inherent that since the structure is the same as the prior art, the result “free of specular reflection” is also true, P.0045, control illumination = desired light emission pattern)
However, Graham fails to disclose the light sources are aligned along an angled imaging bracket.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use an angled imaging bracket for aligning and holding the light sources in place with respect to each other and the measuring surface which is angled. An imaging bracket provides reproducible and expected placements for the plurality of light sources allowing a more accurate, repeatable measurement.
With respect to claims 2, 3, 8, 9, 13, and 50, Graham discloses all of the limitations as applied to claim 1 above. In addition, Graham discloses:
2-Said optics module includes an overhang lip adapted to align a proximate portion of said assay protruding about said optics module in an operating position (P.0128)
3- said optics module includes a substantially planar proximate portion and an opposing substantially non-planar distal portion, wherein proximate and distal portion defining a non-planer flow path adapted for sample migration (P.0130, Figure 5, P.0010)
8- said optics module includes a bend aligned between said upper portion and said lower portion (P.0130)
9- an aperture carrier heat block, wherein said heat block configured to provide both optical alignment and controlled incubation of said assay (P.0011, P.0129, wherein the aperture carrier aligns optics and heat block by definition allows controlled incubation)
13- said aperture carrier heat block comprising a reference coding aperture, wherein said reference coding aperture adapted to expose a barcode, color code, or RFID positioned on said assay for decoding prior to imaging (P.0158, inherent that the reference coding can be viewed through some sort of aperture so that it is able to be read while inside the system, “adapted to expose…” only requires the ability to perform, the barcode, color code, or RFID are not components in the apparatus and cannot distinguish over prior art, “for decoding prior to imaging” is an intended use that conveys no structural limitations on the apparatus)
32- said optics module includes a proximity switch to trigger at least one condition chosen from the group consisting of an incubation, a detection of a transmission of light about said assay, and an imaging on said assay (P.0011)
50- a monitor for monitoring a voltage proportional to a light intensity of at least one of said plurality of light sources (P.0056)
With respect to claim 100, Graham et al. discloses a test device method comprising:
Applying a sample on said assay, and inserting said assay into an offset frame having an upper tier platform angled offset about a lower tier platform, and wherein said assay is positioned in a non-coplanar alignment for optical testing (P.0131, P.0010)
Securing a stabilizer about said assay in said offset frame with a spring loaded cover configured to exert consistent compressive force on said assay during testing in said transit environment (“a stabilizer” is being interpreted as a cover per description, P.0016, P.0129, spring loaded cover = consistent compressive force)
Generating said test result from said assay while said assay remains in said non-coplanar alignment and mechanically stabilized within said offset frame during transit conditions present in said transit environment (P.0019, P.0129, covered and held during test with spring loaded supports, “minimize impact of in-line sample delivery…during mobile phase traversing along the assay” P.0150)
It should be noted that the phrase “in transit environment” fails to limit the method since it doesn’t imply any particular steps or limitations on the method.
With respect to claims 35, 36, 46, and 48, Graham discloses all of the limitations as applied to claim 1 and 35 above. In addition, Graham discloses:
A light level detector with feedback to lighting to detect internal lighting levels and maintaining consistent lighting about the assay with an output of voltage, current or digital (P.0166-168)
However, Graham fails to disclose a dual digital-to-analog converter and aligned to provide uniform illumination across a multi-line assay strip with minimal specular reflection.
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a digital-to-analog converter and to use it to maintain a constant current and align the lights to provide uniform illumination across the assay strip since these components are well known for electronic measuring equipment and allows different types of signals to be passed through processing with accuracy and repeatability. Maintaining a constant current and uniform illumination is essential for accurate measurements and well-known in the art.
With respect to claim 76, Graham discloses all of the limitations as applied to claims 1 and 35 above.
Conclusion
THIS ACTION IS MADE FINAL. 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 CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/Primary Examiner, Art Unit 2877
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