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 .
Response to Arguments
Applicant’s arguments filed 04/10/2026 with respect to claims 1-3, 6-11 and 13-23 have been fully considered but they are not persuasive.
As to applicant’s argument regarding the objection to the drawings, the examiner acknowledges applicant’s admission that the “sample container”, while recited in the claims, is not a feature of the invention. Since the “sample container” is not required by the instant claim(s), the “sample container” will not been treated on the merits.
As to applicant’s argument regarding the 35 U.S.C. §112(b) rejection of claims 1-3, 6-11 and 13-23, the previous rejection has been withdrawn in light of applicant’s arguments. However, in view of applicant’s arguments regarding the sample container, a new rejection follows.
As to applicant’s argument regarding the Bolea reference, it appears the applicant has provided a narrow interpretation of Bolea in order to allege that the Bolea reference fails to disclose, teach, or suggest all of the features of amended independent claim 1. More specifically, applicant respectfiully [sic] submits that a person of ordinary skill in the art would, therefore, be deterred from arranging the shutter 37 at the second end 36 of the receptacle body or in the light cavity because doing so would prevent the shutter 37 from operating as intended in Bolea, the examiner disagrees. Bolea discloses a number of example embodiments, i.e., 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. For example, the shutter 37 can include an electrical, a mechanical, or an electromechanical shutter; and The receptacle body 32 can include an inset portion 35 that accommodates the shutter 37 when in the open position, e.g., when a sampling apparatus is disposed within the receptacle body [0046-0047]. In other words, Bolea is not limited to the application of a mechanical shutter and an inset portion 35 that accommodates the shutter. Although Bolea discloses that a mechanical shutter can be used in some instances, one of ordinary skill would have recognized that mechanical shutters are inherently characterized by certain advantages and certain disadvantages, and would have been capable of balancing competing benefits to arrive at a desired shutter configuration. Further, Bolea could also comprise an electrical shutter at the second end of the receptacle within the light cavity between the sample container and the photo sensor, which lacks moving parts, ensuring high-speed operation without mechanical degradation. Thus, the sampling apparatus could easily be inserted into the transmissive region 38 of the body 32 without a physical obstruction, while ensuring that ambient light is prevented from entering detector 40.
The examiner maintains that 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, the shield or mask is disposed between the sample container and the photo sensor an is configured to prevent light emitted from the sample due to the bioluminescence reaction 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).
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 shield or mask 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 contains conditional language i.e., when a sample container is disposed within the receptacle, the shield or mask is disposed between the sample container and the photo sensor and is configured to prevent such that light emitted from the sample due to the bioluminescence reaction from directly reaching the photosensitive portion of the photo sensor, that renders the claims indefinite, since it is not clear whether or not the necessary condition has actually been met.
If the sample container is not disposed within the receptacle, then the intended use/configuration of the device of claim 1 does not occur and is effectively void.
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) configured to receive and hold therein a sample container with a second longitudinal axis (optical axis 31), 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) configured to enable the sample container to 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 expressly state wherein the shield or mask (shutter 37) is disposed within the light cavity such that, when a sample container is disposed within the receptacle, the shield or mask is disposed between the sample container and the photo sensor and is configured to prevent such that light emitted from the sample due to the bioluminescence reaction 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… Bolea also discloses a number of example embodiments, i.e., 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. For example, the shutter 37 can include an electrical, a mechanical, or an electromechanical shutter; and The receptacle body 32 can include an inset portion 35 that accommodates the shutter 37 when in the open position, e.g., when a sampling apparatus is disposed within the receptacle body [0046-0047]. In other words, Bolea is not limited to the application of a mechanical shutter and an inset portion 35 that accommodates the shutter. Although Bolea discloses that a mechanical shutter can be used in some instances, one of ordinary skill would have recognized that mechanical shutters are inherently characterized by certain advantages and certain disadvantages, and would have been capable of balancing competing benefits to arrive at a desired shutter configuration. Alternatively, Bolea may comprise an electrical shutter at the second end of the receptacle within the light cavity between the sample container and the photo sensor, which lacks moving parts, ensuring high-speed operation without mechanical degradation. Thus, the sampling apparatus could easily be inserted into the transmissive region 38 of the body 32 without a physical obstruction, while ensuring that ambient light is prevented from entering detector 40.
Absent unexpected results, 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, the shield or mask is disposed between the sample container and the photo sensor an is configured to prevent light emitted from the sample due to the bioluminescence reaction 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
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 extension fee 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 LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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