DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/19/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 12/19/2025 with respect to claims 1-3, 6-11 and 13-23 have been considered but are moot in view of the current amendments. Thus, an updated rejection follows below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the sample container must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-3, 6-11 and 13-23 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.
Claim 1 recites the limitation “the receptacle which a sample container with the second longitudinal axis can be inserted to be held therein…wherein the reflector has an opening through which the sample container can be inserted to a position where the sample container is held in the receptacle, and wherein the receptacle is arranged such that, when the sample container with the sample is held in the receptacle, the sample is surrounded by the reflecting portion…” in the claim. While the sample container can be used to hold a sample during the inspection, a symbol container does not appear to be positively recited and thus claimed as part of the apparatus. Therefore, it is unclear if the claim actually recites the inclusion of the sample container.
Claims 2-3, 6-11 and 13-23 depend on independent claim 1 and are therefore, rejected for the same reason.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-3, 6-11 and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea et al. (hereinafter Bolea) US 2018/0113076.
Regarding claim 1, Bolea discloses a device (light detection device 10) for imaging a bioluminescence reaction of a sample, comprising: a reflector (reflector 50) having a reflecting portion (reflective surface 51) with a parametric form and extending about a first longitudinal axis (reflector axis 53) defining a light cavity [44] as discussed in at least paragraphs 53, 61 and 62; and shown in Figs. 2 and 4, a receptacle (receptacle 30) into which a sample container with a second longitudinal axis (optical axis 31) can be inserted to be held therein as discussed in at least paragraph 37, and a photo sensor (detector 40) with a photosensitive portion as discussed in at least paragraph 49, wherein the reflector has an opening (input aperture 56) through which the sample container (sampling apparatus 80) can be inserted to a position where the sample container is held in the receptacle as discussed in at least paragraphs 37, 46, 53-54, 87 and 88; and shown in Figs. 2-4 and 6, and wherein the receptacle is arranged such that, when the sample container with the sample is held in the receptacle, the sample is surrounded by the reflecting portion so that the light emitted from the sample due to the bioluminescence reaction is reflected by the reflecting portion onto the photosensitive portion of the photo sensor as discussed in at least paragraphs 37, 46, 53-54, 87 and 88. Also see whole document.
Bolea discloses a shield or mask (shutter 37), but does not explicitly disclose that shield or mask (shutter 37) is disposed within the light cavity between the sample container and the photo sensor when the sample container is disposed within the receptacle such that light emitted from the sample due to the bioluminescence reaction is prevented from directly reaching the photosensitive portion of the photo sensor.
However, Bolea does disclose that the shutter 37 can be disposed in any suitable location within the receptacle body 32… The shutter 37 can include any suitable mechanism that is adapted to prevent light from being directed along the receptacle body 32 and into the detector 40…The shutter 37 can be attached to the receptacle body 32 using any suitable technique or combination of techniques… as discussed in at least paragraphs 46-47 and shown Fig. 3. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to arrange the shutter at the second end of the receptacle within the light cavity between the sample container and the photo sensor (see Fig. 2) when the sample container is disposed within the receptacle such that light emitted from the sample due to the bioluminescence reaction is prevented from directly reaching the photosensitive portion of the photo sensor since, it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Regarding claim 2, Bolea discloses wherein the reflecting portion(reflective surface 51) is formed to be rotationally symmetrical about the first longitudinal axis (reflector axis 53) as discussed in at least paragraph 53; and shown in Fig. 5.
Regarding claim 3, in the interest of compact prosecution, the examiner has interpreted the phrase “fictive apex” as meaning an “assumed apex” and not that of an imaginary apex.
Bolea discloses wherein the opening (input aperture 56) is located at a fictive apex of the parametric form of the reflecting portion and the first longitudinal axis (reflector axis 53) is parallel to an insertion direction of the sample container as discussed in at least paragraph 53 and shown in Figs. 4 and 5.
Regarding claim 6, Bolea discloses wherein the receptacle (receptacle 30) is arranged such that the second longitudinal axis (along optical axis 31) of the sample container (sampling apparatus 80), when held in the receptacle, is disposed in an orientation parallel to the first longitudinal axis (reflector axis 53) of the reflecting portion as discussed in at least paragraphs 37, 46 and 53; and shown in Figs. 3, 4, 5 and 6.
Regarding claim 7, Bolea discloses wherein the receptacle (receptacle 30) is arranged such that the second longitudinal axis of the sample container (sampling apparatus 80), when held in the receptacle, is disposed in an orientation inclined to the first longitudinal axis (reflector axis 53) of the reflecting portion as discussed in at least paragraphs 37, 46 and 53; and shown in Figs. 3, 4, 5 and 6.
Regarding claim 8, Bolea discloses wherein the reflecting portion of the reflector is structured as discussed in at least paragraphs 63-65.
Regarding claim 9, Bolea discloses wherein the photo sensor is a photodiode or a photomultiplier tube as discussed in at least paragraph 49.
Regarding claim 10, Bolea discloses a light source (light source 70) arranged such that light emitted by the light source can be received by the photo sensor as discussed in at least paragraphs 76-77.
Regarding claim 11, Bolea discloses including a function for calibrating the photo sensor by the light emitted from the light source (In one or more embodiments, the light source 70 can be utilized as a reference source that can help determine an analog counting level of the detector 40… In one or more embodiments, the device 10 can include a feedback loop that can be utilized to control the light source 70 based upon the output of the detector 40 in response to the light source.) as discussed in at least paragraph 75.
Regarding claim 15, Bolea discloses a chamber (housing 12) that accommodates the reflecting portion of the reflector, at least a part of the sample container when it is held in the receptacle, and the photosensitive portion of the photo sensor, wherein the chamber is arranged such that these elements are shielded from ambient light (the housing 12 can also include a door 11 that is adapted to cover the port 20 to prevent ambient light from entering the housing.) as discussed in at least paragraphs 31-33; and shown in at least Figs. 1 and 2.
Regarding claim 16, Bolea discloses a hand-held analyzing and measuring apparatus for measuring ATP content of a sample as discussed in at least paragraph 30, comprising a device for imaging a bioluminescence reaction as discussed above in the rejection of claim 1.
Regarding claim 17, Bolea discloses wherein the photo sensor is a multi-pixel photon counter (detection device 10) as discussed in at least paragraph 89.
Regarding claims 18 and 19, Bolea does not explicitly disclose wherein the photo sensor is a silicon photomultiplier or a charge coupled device. However, Bolea does disclose that The detector 40 can include any suitable detection device or combination of devices, e.g., photomultiplier tube, avalanche detector, photodiode, etc. See paragraph 49. Therefore, it would have been obvious to one of ordinary in the art to make a simple substitution of one known element for another motivated by an expectation of success.
Regarding claim 20, Bolea discloses wherein the photo sensor (13) is a photomultiplier tube as discussed in at least paragraph 49.
Regarding claim 21, Bolea does not explicitly disclose a reflection portion of the reflector has a sectional form defined by the equation as recited.
As interpreted by the examiner, the claimed equation describes the shape of the reflecting portion.
While Bolea does not disclose the exact shape as recited in the instant claim, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed reflecting portion was significant. See MPEP §2144.04 (IV)(B).
Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent reflecting portion shape and since the same expected detection would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration.
Regarding claim 22, fig. 3 of Bolea shows wherein the receptacle [30] has a bottom (second end 36) and opposite end (first end 34) as discussed in at least paragraph 37. While Bolea does not explicitly state that the shield or mask is disposed on, within, or around the receptacle proximate to the bottom end of the receptacle also discloses, Bolea does disclose that the shutter 37 can be disposed in any suitable location within the receptacle body 32… In one or more embodiments, the shutter 37 is disposed between the first end 34 and the second end 36 of the receptacle body 32. The shutter 37 can include any suitable mechanism that is adapted to prevent light from being directed along the receptacle body 32 and into the detector 40… as discussed in at least paragraph 46 and shown Fig. 3. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to provide the shield or mask on, within, or around the receptacle proximate to the bottom end of the receptacle since, it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Regarding claim 23, Bolea discloses wherein the sample container has a proximal end (cuvette portion 100) and an opposite distal (handling portion 82) as discussed in at least paragraphs 77 and 79; and shown Fig. 6. While Bolea does not explicitly state that the shield or mask is disposed within or on the sample container proximal to the proximal end of the sample container, Bolea does disclose that the shutter 37 can be disposed in any suitable location within the receptacle body 32…The shutter 37 can include any suitable mechanism that is adapted to prevent light from being directed along the receptacle body 32 and into the detector 40… as discussed in at least paragraph 46 and shown Fig. 3.
Absent unexpected results, it would have been prima facie obvious to one of ordinary skill in the art to provide the shield or mask disposed within or on the sample container proximal to the proximal end of the sample container since, it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea US 2018/0113076 as applied above to claims 1-3, 6-11 and 15-23; and further in view of Cargill et al. (hereinafter Cargill) US 2015/0203922.
Regarding claims 13 and 14, Bolea does not explicitly disclose a temperature sensor for measuring the temperature of the sample and or of the sample container when the sample container with the sample is held in the receptacle.
Cargill also discloses a temperature sensor (temperature sensor 15) for measuring the temperature of the sample and or of the sample container (sample module 46) discussed in at least paragraphs 49.
Cargill also discloses that the temperature sensor is a contactless sensor (temperature sensor 15) as shown in Fig. 21 and discussed in at least paragraphs 49.
It would have been obvious to one of ordinary skill in the art to modify the detection system of Bolea with a temperature sensor as taught by Cargill in order to control the sample temperature when the sample is held in the receptacle to ensure the accuracy of the detector, because it is well known in the art that luminescence lifetimes depend on temperature.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796