Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Claims 42-60 are the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Election/Restrictions
The elections are withdrawn. All claims are examined.
Claim Rejection - 35 USC § 112 – Written Description
The following is a quotation 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.
Claims 42-60 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the full scope of the claimed invention.
The specification fails to demonstrate possession of “a normalizer plate configured to calibrate the plurality of detector pairs in the detector head, the normalizer plate comprising an optically-transparent material mixed with a chromophore or fluorophore.” In fact, the specification never actually performs this, much less provides any proof-of-principle. Instead, the specification merely wishes or plans to do so. At best, the specification has one paragraph describing this normalizer plate:
FIG. 4C provides a bottom plan view of the optical module 502. Shown in FIG. 4C is the aperture plate 540 and a normalizer plate 546 attached to the bottom of the 506 of the optical module 502. The normalizer plate may be used to calibrate the light source-photodetector pairs of the detector head. The normalizer plate 546 preferably comprises a one or more components having known, standardized optical characteristics, and is configured to calibrate, standardize, or confirm proper operation of the detector head 700 and associated circuitry. The normalizer plate 546 may extend into the optical module and the detector head 700 may be positioned over the normalizer plate. In some embodiments, prior to the start of cartridge optical measurements the detector head 700 is calibrated using the known properties of the normalizer plate 546. If the detector head 700 is not working properly, corrective action may be taken, such as including an offset in the measurements or notifying the user of the error. In some embodiments, the normalizer plate may be made of optically-transparent material such as polycarbonate mixed with a highly fluorescent dye, or other standardized chromophore or fluorophore. In one embodiment, the normalizer plate includes a standardized chromophore or fluorophore for each channel or color in the detector head 700.
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(para. 0090; Fig. 4C, annotated). However, this paragraph merely repeats the generic claim language of “normalizer plate may be made of optically-transparent material . . . mixed with a highly fluorescent dye, or other standardized chromophore or fluorophore.” The specification is completely silent about these “fluorescent dye, or other standardized chromophore or fluorophore.” Zero species are disclosed. The above only provides one example of “normalizer plate may be made of optically-transparent material,” which is “polycarbonate,” yet no specific composition is disclosed. Moreover, the specification lacks any details as to polycarbonate-dye/chromophore/fluorophore mixtures and amounts or ratios; how the normalizer plate is made; what other plate materials can be used; how the normalization/calibration is performed so that a skilled artisan can determine what materials and configurations of the “optical module” components are required; or any other critical features bearing on the normalizer plate.
The prior art fails to help here, either. At best, the prior art teaches calibration wells (US 20110312841, Figs. 140, 275 & 301), but not the claimed normalizer plate.
In sum, the specification reads as a wish or a plan to later experiment with how to make and use a normalizer plate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/ Primary Examiner, Art Unit 1681