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 .
Election/Restrictions
Applicant's election with traverse of a real-time thermocycler (Group I) in the reply filed on July 17, 2025 is acknowledged. The traversal is on the ground(s) that Werner does not teach the common special technical feature of “a controller configured to adjust the excitation intensity based on information about the sample and the target, such that the fluorescence signal is within the working range of the detector.”
This is not found persuasive based on a few reasons. Although the specifications mention a controller the present specifications does not teach a method or a computer readable medium with use of a controller as the new amended claims mention. In addition, Group 1 claims a controller for controlling the excitation unit intensity such that the fluorescence signal is in a working range of the detection unit. Amended Group II and III teaches wherein the second excitation intensity is chosen differently by a controller from the first excitation intensity such that a fluorescence signal of the second sample is in a working range of a detection unit. This is not a common technical feature among all three groups as Group I claims the controller for controlling such that the fluorescence signal is in a working range of the detection unit and Groups II and III claim first excitation and second excitation is chosen differently by a controller and the fluorescence signal of the second sample is in a working range of a detection unit. The requirement is still deemed proper and is therefore made FINAL.
Claims 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a method and non-transitory computer-readable storage medium (Group II and Group III), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 17, 2025.
Allowable Subject Matter
Claim 5 is are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach, or fairly suggest the controller, as claimed, configured to determine an adjustment of the intensity of the excitation of a current sample based on a previously detected fluorescence signal from a previous sample comprising a same type of target as the current sample.
Claim Interpretation
In claim 1, without “configured to” or “programmed to” recited language between the control device and the claimed operation, the limitations “a controller for controlling the excitation unit to adjust an intensity of the excitation of the sample based on information about the target, such that the fluorescence signal is in a working range of the detection unit” and “to adjust the excitation based on information about a type of the target obtained from a database” have been given their broadest reasonable interpretation and thus interpreted as an intended use of the control device.
Although claims are interpreted in light of the specification, it is improper to import claim limitations from the specification (see MPEP 2111). The current claim limitations do not require the control device to actually operate in accordance with the recited functions. Thus, a prior art controller need only be capable of operating in the claimed manner (see MPEP 2114(IV)).
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 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Stedtfeld et. al. (US 20140211204 A1).
Regarding claim 1, Stedtfeld teaches “A real-time thermocycler, comprising:”(Abstract, hand-held nucleic acid amplification device); “a well” (Abstract, sample wells, each sample well having a novel optical arrangement that includes a light-emitting diode (LED) and a single light capturing element (e.g. a photodiode) for quickly measuring light emissions from biological samples such as nucleic acid amplification reactions.).
The recitation “for storing a sample comprising a target and fluorescence molecules,” is capability of the well however taught within the Abstract above and (Para [0008], at least one of the wells containing a fluorescent molecule).
Stedtfeld further teaches “a thermal unit for adjusting a temperature of the sample,” (Para [0008], In some embodiments, the holder further comprises a heater capable of heating the sample wells in contact with the heater.); “an excitation unit for exciting the fluorescence molecules of the sample via radiation,” (Para [0032] and [0040], [0219], As used herein, "light source" in reference to an illuminating (illumination) light source refers to an excitation light source for exciting electrons in a fluorescent molecule. As used herein, "optical signal" refers to any energy (e.g., photo-detectable energy) emitted from a sample (e.g., produced from a microarray that has one or more optically excited [i.e., by electromagnetic radiation] molecules bound to its surface. A small, lightweight, economical and safe light source can be used such as a Light Emitting Diode, where one LED is used for each microfluidic well, and each LED is excited to provide excitation light to one sample well so the resulting emitted fluorescence can be detected or read using a single photodiode. The excitation by the LEDs can be done in a time staggered manner (sequentially)); “a detection unit for detecting a fluorescence signal from the sample,” (Paras [0003], and [0256], a compact and inexpensive fluorescence detector,); “and - a controller for controlling the excitation unit” (Paras [0022], [0312] [0563], [0562], and [0554], One PCB has 64 LEDs, 64 drivers to equally power each LED, and 4 different multiplexors to allow communication of 64 LEDs using 8 digital output lines from the microcontroller) The device of any of statements 1-49, further comprising a processor, computer, microprocessor, touch screen computational phone, tablet, PDA, music player with wireless capabilities, or smart device operably linked to the device. 51. The device of any of statements 1-50, further comprising a processor, computer, microprocessor, touch screen computational phone, tablet, PDA, music player with wireless capabilities, or smart device that can receive optical energy from the second end of an optical fiber via a light detector, a microcontroller, wireless transmission, or a combination thereof. 52.As used herein, the term "processor" refers to a device that performs a set of steps according to a program (e.g., a digital computer). Processors, for example, include Central Processing Units ("CPUs"), small CPUs such as microcontrollers, electronic devices, and systems for receiving, transmitting, storing and/or manipulating digital data under programmed control.). Therefore the LED’s are part of the excitation unit and the microcontrollers are the part of the central processing units which are the controller.
The recitation “to adjust an intensity of the excitation of the sample based on information about the target, such that the fluorescence signal is in a working range of the detection unit.” is capability of the controller as the “configured to” or “programmed to” is not between the controller and the claimed function. The current claim limitations do not require the controller to actually operate in accordance with the recited functions. Thus, a prior art controller need only be capable of operating in the claimed manner (see MPEP 2114(IV)). Stedtfeld discloses the positively claimed structural elements of the controller, such controller is said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 4, Stedtfeld teaches all of claim 1 as above in addition to “wherein the excitation unit comprises at least two emitters, in particular at least two light-emitting diodes.” (Abstract and Para [0008], sample wells, each sample well having a novel optical arrangement that includes a light-emitting diode (LED) and a single light capturing element (e.g. a photodiode) for quickly measuring light emissions from biological samples such as nucleic acid amplification reactions. A device, comprising: a) a plurality of sample wells, at least one of the wells containing a fluorescent molecule.)
Claim Rejections - 35 USC § 103
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stedtfeld et. al. (US 20140211204 A1) as applied to claim 1 and in further in view Chu et. al. (KR20170134359A).
Regarding claim 2, Stedtfeld teaches all of claim 1 as above but does not explicitly teach the configuration within the recitation “wherein the controller is configured to adjust the excitation based on information about a type of the target obtained from a database.”.
Chu teaches an apparatus includes an optical system capable of imaging fluorescence emission in addition to “wherein the controller is configured to adjust the excitation based on information about a type of the target obtained from a database.” (Page 6, The emission filter 308 may be selected to image the object of interest 310 according to various implementations. TH emission filter 308may be modified to image the fluorescent light emitted from the object of interest 301 in other embodiments. The optical system 300 may use the reflected light source 312 to image the object of interest 310. The light from the light source 312 is transmitted by the beam splitter 320 to the object of interest 310, A filter 314, a focuser / diverger 316, and an excitation filter 318. The optical system 300 may also include a field lens 322. Depending on the object of interest, the excitation filter 318 may be selected or changed to image the object of interest 310 according to various implementations. 4 is a block diagram illustrating a computer system 400 that may be employed to implement processing functionality, in accordance with various implementations. The equipment for performing the experiments may be coupled to the exemplary computing system 400. Computing system 400 may include one or more processors, such as processor 404. The processor 404 may be implemented using a general purpose or special purpose processing engine, such as, for example, a microprocessor, controller, or other control logic. In this example, processor 404 is coupled to bus 402 or other communication medium.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stedtfeld to incorporate the teachings of Chu wherein the controller is configured to adjust the excitation based on information about a type of the target obtained from a database in order to detect different targets of interest increasing the versatility of the device.
Claim 3 is additional rejected under 35 U.S.C. 103 as being unpatentable over Stedtfeld et. al. (US 20140211204 A1) in further view of Chu et. al. (KR20170134359A) as applied to claim 2 and in further in view of Chu et. al. (US 20160231246 A1).
Regarding claim 3, Modified Stedfeld teaches all of claim 2 but does not explicitly teach “further comprising a graphical user interface for entering information about the type of the target in the well in the database.”.
Chu teaches an optical system capable of imaging florescence emission from a plurality of reaction site using an emission filter which adjusts based on the object of interest within paras [0051] and [0052] in addition to “further comprising a graphical user interface for entering information about the type of the target in the well in the database.” (Para [0062] Computing system 400 may be coupled via bus 402 to a display 412, such as a cathode ray tube (CRT) or liquid crystal display (LCD), for displaying information to a computer user. An input device 414, including alphanumeric and other keys, is coupled to bus 402 for communicating information and command selections to processor 404, for example. An input device may also be a display, such as an LCD display, configured with touchscreen input capabilities.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stedtfeld to incorporate the teachings of Chu to further include a graphical user interface for entering information about the type of the target in the well in the database in order to easily display and identify information to a user as taught within Chu.
Claim 6 is additional rejected under 35 U.S.C. 103 as being unpatentable over Stedtfeld et. al. (US 20140211204 A1) in further view of Piron et. al. (WO 2014139018 A1)
Regarding claim 6, Stedtfeld teaches all of claim 1 but does not teach “wherein the excitation unit and/or the detection unit are mounted on a moveable arm that is configured to move the excitation unit and/or the detection unit between a plurality of wells.”.
Piron teaches a imaging optics assembly 260 within a optical system in addition to “wherein the excitation unit and/or the detection unit are mounted on a moveable arm” within (Pages 10, 14, 15, and 17, Optical system 250 may be supported by robotic arm 105. The example automated system includes an automated robotic arm 105, which supports an optical video scope 110 (and associated illumination), video display 115 for displaying a video image from optical video scope 1 10, navigation display 116 for providing a navigation user interface, a tracking device 120 for tracking various medical instruments within the surgical field, and a control and processing unit 400 for controlling various devices (such as the robotic arm 105) and providing surgical navigation. Examples of different types of illumination include a monochromatic or narrow band light source or laser source, a broadband source (such as a white light source) optionally having a spectrally selective element such as an optical filter, a projector type source (which may optionally be employed for surgical guidance or for projecting customized light patterns onto the surgical field), a polarized light source implemented by polarizing filters, structured light projectors, photo- acoustic excitation lasers. laser light delivered by an optical device supported by the automated arm may be employed for the alignment and/or excitation of photo-reactive therapeutics. Any or all of the optical imaging modes employed by a given system embodiment may be accommodated by a fiber-optic delivery and receiving bundle that is attached to the turret of robotic arm 105. Alternatively, or in addition, various ports or light guides may be used to co- align the light delivery or reception.). Therefore the optical system which has the illumination which includes the excitation lasers are mounted on the robotic arm teach to the excitation unit being on a movable arm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stedtfeld to incorporate the teachings of Piron wherein the excitation unit is mounted on a moveable arm in order to allow for easy navigation between the wells of Stedfeld’s device as taught by Piron.
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/JYOTI Mutreja/Primary Examiner, Art Unit 1798
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