DETAILED ACTION
Notice of AIA Status
The present application, filed on 5/25/23, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-11 and 20 are pending.
Claims 12-19 are withdrawn.
Claims 1-11 and 20 are rejected.
Claims 3, 4 and 5 are objected to.
Response to Arguments
The applicant’s arguments, filed 8/27/26, with respect to the interpretation under 35 USC 112(f), were considered and are persuasive. Therefore, interpretation under 35 USC 112(f) is no longer invoked.
In addition, the applicant’s arguments, filed 8/27/26, with respect to the objection to the claims, were considered and are persuasive. Therefore, the previous objections are withdrawn. However, claims 3, 4 and 5 are objected to in the present office action with minor clarity suggestions.
In addition, the applicant’s arguments, filed 8/27/26, with respect to the rejection of claim 10 under 35 USC 112(b), were considered and are persuasive in light of the amendment dated 8/27/26. Therefore, the rejection under 35 USC 112(b) is hereby withdrawn.
In addition, the applicant’s arguments, filed 8/27/26, with respect to the rejection of claim 1 over Miakov and claims dependent thereon and with respect to claim 20 over Miakov in view of Simon were considered and are persuasive in light of the amendment dated 8/27/26. However, upon further consideration, a new ground of rejection is made over Yager (US20020041827) regarding independent claim 1 necessitated by the amendment dated 8/27/26 and a new ground of rejection is made over Simon (US20090298129) in view of Yager (US20020041827) regarding independent claim 20 necessitated by the amendment dated 8/27/26.
Claim Interpretation
No interpretation under 35 USC 112(f) is invoked.
Claim Objections
Claims 3, 4, 5 are objected to because of the following informalities:
Claim 3 recites “the plurality of segments include”. Consider rephrasing the phrase to ‘the plurality of segments includes’.
Claim 4 recites “the plurality of segments include”. Consider rephrasing the phrase to ‘the plurality of segments includes’.
Claim 5 recites “the plurality of segments include”. Consider rephrasing the phrase to ‘the plurality of segments includes’.
Claim Rejections - 35 USC § 112
Claim 10 was rejected under 35 U.S.C. 112(b) in the previous office action dated 6/10/26. The rejection under 35 USC 112(b) is hereby withdrawn in light of the amendments dated 8/27/26.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yager (US20020041827).
With respect to claim 1, Yager (US20020041827) teaches a sensing chamber (diffusion-based sensor in [0053]) for a bioprocessing system (see [0034], which recites “biotechnological process samples”), the sensing chamber (diffusion-based sensor) comprising:
a front plate (transparent cover plate 15 in [0053]);
a back plate (substrate plate 10 in [0053]);
at least one fluidic channel (channel 20 in [0053]) intermediate the front plate (transparent cover plate 15) and the back plate (substrate plate 10) (see Fig. 1A), the front plate (transparent cover plate 15) and the back plate (substrate plate 10) forming the at least one fluidic channel (channel 20) (see [0053], which recites “Flow channels and inlets and outlets are formed in substrate plate 10, covered by transparent cover plate 15”) (see also [0036], which recites “the channel cell is generally formed by two plates with abutting surfaces. The channels may be formed in both plates, or one plate can contain the channels and the other can be a flat cover plate”);
a first port (sample inlet 30 in [0058]) in fluid communication with the at least one fluidic channel (channel 20) and permitting a flow of fluid (sample) into the at least one fluidic channel (channel 20) (see [0058], which recites “sample inlet 30 passes through substrate plate 10 into channel 20”); and
a second port (outlet 60 in [0059]) in fluid communication with the at least one fluidic channel (channel 20) and permitting a flow of fluid out of the at least one fluidic channel (channel 20) (see [0059], which recites “all fluid streams exit through outlet 60”) (see also [0068], which recites “means for applying pressure to the flow of the feed fluids through the device can also be provided. Such means can be provided at the feed inlets and/or the outlet”);
wherein the at least one fluidic channel (channel 20) includes a plurality of segments (spatially distinct portions of channel 20 corresponding to serially positioned detection locations) (see [0018] and [0028] and [0038]) permitting sensing of a plurality of parameters of the fluid (presence and concentration of multiple analytes) (see [0002] and [0028]) (see also [0037], which recites “for optical detection, such as absorption, luminescence or fluorescence detection, at least a portion of the channel in the analyte detection area is transparent … analyte detection area as used herein refers to that portion of a flow channel where a detectable change in the analyte or reagent particles is measured’) (see also [0038], which recites “for electrochemical detection, one or more electrodes is positioned in the detection area”) with a first sensing device (electrochemical detector in [0018]) and a second sensing device (optical detector in [0018], which recites “multiple detectors positioned with respect to the channel to detect interaction of components of the sample stream with the reagents. When optical detectors are used, at least a portion of the channel should be formed in a transparent material, i.e. the channel should be visible in its entirety or through windows in the channel walls. For electrochemical detection, an electrode or electrodes may be positioned in the channel or in communication with the channel. Electrodes can be coated on the channel walls. Detectors may be positioned in parallel or in series”);
wherein the first sensing device (electrochemical detector) is configured to sense at least one parameter of the fluid (presence and concentration of multiple analytes in [0002])(see also [0002] and [0032]-[0033]) using a first sensing technique (electrochemical analysis in [0031]) and the second sensing device (optical detector) is configured to sense at least one parameter of the fluid (analyte concentration in [0028]) using a second sensing technique (optical analysis in [0037]) (see also [0031]);
wherein the first sensing technique (electrochemical analysis) is different from the second sensing technique (optical analysis) (see [0031], which recites “the channel cell system of this invention can be used with external detecting means for detecting changes in reagent particles as a result of contact with analyte particles. Detection is done by optical, electrical, chemical, electrochemical, radioactive or calorimetric analysis, or any other technique in the analytical art. More than one detection technique can be used in the same system. The preferred embodiments use optical analysis or a combination of electrochemical and optical analysis. In optical detection, the product stream can be analyzed by luminescence, fluorescence or absorbance”).
With respect to claim 2, Yager teaches the sensing chamber of claim 1, wherein:
the first sensing technique (electrochemical analysis) is an electrochemical sensing process (electrochemical detection) and the second sensing technique (optical analysis) is an optical sensing process (optical detection).
With respect to claim 3, Yager teaches the chamber of claim 1, wherein:
the plurality of segments include a first segment (a first portion of channel 20 constituting the fluorescence analyte detection area) permitting interrogation of the fluid with at least one fluorescence sensor (optical detector in [0018]) (see also [0031], which recites “In optical detection, the product stream can be analyzed by …fluorescence”) (see also [0037]).
With respect to claim 7, Yager teaches sensing chamber of claim 3, wherein:
the at least one fluorescence sensor (optical detector) is configured to measure at least one of dissolved oxygen, pH, carbon dioxide and an analyte in the fluid (Yager teaches a fluorescent sensor configured to measure dissolved oxygen, see [0034], which recites “examples of analyte particles are … dissolved oxygen) (see also [0031], which recites “The channel cell system of this invention can be used with external detecting means for detecting changes in reagent particles as a result of contact with analyte particles. Detection is done by optical … analysis”) (see also [0056], which recites “the fluorescence of analyte particles can change in response to the analyte, in which case the fluorescence can be monitored. “)
With respect to claim 9, Yager teaches the sensing chamber of claim 1, further comprising:
a plurality of electrodes (multiple electrodes in [0038]) configured to contact the fluid within the at least one fluidic channel (channel 20), the plurality of electrodes permitting electrochemical monitoring of the fluid within the at least one fluidic channel (channel 20) (see [0038], which recites “one or more electrodes is positioned in the detection area. For turgid sample fluids, the electrodes are preferably placed on the carrier fluid side to prevent fouling of the electrodes. For multiple analytes, multiple electrodes are placed in parallel. To measure the detection gradient for each analyte, multiple electrodes can be positioned in series. The position of the electrodes can be used to distinguish between analytes having similar redox potentials but different diffusion coefficients. The electrodes can be deposited on the channel surface, on either or both plates.”).
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.
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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Yager (US20020041827) in view of Yang (US20070207061).
With respect to claim 4, Yager teaches the sensing chamber of claim 3, wherein:
a light transmissive region of the at least one fluidic channel (windows in the channel walls in [0018]) permitting interrogation of the fluid with a transmitted or backscattered light instrument (light source in [0056] and camera in [0056])) (see [0018], which recites “When optical detectors are used, at least a portion of the channel should be formed in a transparent material, i.e. the channel should be visible in its entirety or through windows in the channel walls”).
Yager fails to explicitly teach that the plurality of segments include a second segment defining the light transmissive region.
In the analogous art of analytical devices, Yang teaches a second segment (a portion of fluid channel 22 corresponding to one or more light transmissive regions 14 in [0058]) defining a light transmissive region (one of the light transmissive regions 14) see [0059], which recites “the body 16 may define or include the fluid channel 22”) (see [0061], which recites “the light transmissive regions 14 in the body 16”) (see [0061], which recites “the light transmissive regions 14 form a diagonal line, which extends from one lateral side of the fluid channel 22 to the other lateral side of the fluid channel 22. In other embodiments, the light transmissive regions 14 can be in the form of an array or a one-dimensional line that extends perpendicular to the direction of flow within the fluid channel 22”) permitting interrogation of fluid with a transmitted or backscattered light instrument (illumination source 12 in [0062] and optical detector 18 in [0063], which recites “an optical detector 18 is on the other side of the surface 16(a). The optical detector 18 may include a charge coupled device, and may include an array of discrete light detecting elements that respectively correspond to the light transmissive regions 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Yager such that the plurality of segments include a second segment defining the light transmissive region as disclosed by Yang, with a reasonable expectation of success for the benefit of enabling high resolution transmitted light imaging and detection of biological targets flowing through the channel using small sample volumes with a device inexpensive to fabricate (see [0074] of Yang) The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, A.).
With respect to claim 5, Yager in view of Yang teaches the sensing chamber of claim 4, wherein:
the plurality of segments include a third segment (a portion of fluid channel 22 corresponding to reflective segments 174/176 of reflective line 178, see [0161] of Yang, which recites “transmissive or reflective line 178 across the body of the optofluidic microscope device. The reflected or transmitted signal is imaged in a similar fashion onto a CCD or other detector. Different segments 174, 176 of the line 178 may correspond to discrete light detecting elements in a detector that may be under the surface 16(a) forming the fluid channel 22) defining a light reflective region (reflective line 178 in [0161] of Yang) of the at least one fluidic channel (fluid channel 22) permitting interrogation of the fluid with a reflected light instrument (CCD or other detector, see [0161]) (CCD stands for charge coupled device).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yager (US20020041827) in view of Yang (US20070207061) in view of Frese (US20090161108).
With respect to claim 6, Yager in view of Yang teaches the sensing chamber of claim 5.
Yager in view of Yang fails to teach a mirror positioned behind the third segment of the fluidic channel for reflection of light generated by the reflected light instrument.
In the analogous art of analytical devices, Frese teaches a mirror (mirror surface 6 in [0038]) positioned behind a third segment of the fluidic channel (measurement cell 3 in [0041]) (see Fig. 2B) for reflection of light generated by the reflected light instrument (light source 11 in [0038], which recites “FIG. 1 shows a diagrammatic view of a measurement chip 1 according to the invention from above with a base plate 2 of a transparent polymer material. Fluid passages 4 and 4′ for the feed and discharge of fluid are formed in the base plate 2. The fluid flow direction is indicated by black arrows. Disposed between the fluid passages 4, 4′ is an elongate measurement cell 3 which, as can be seen from FIG. 2 a), is of a substantially square cross-section…. the beam path of the excitation light is shown by open arrows in the Figures. As can be seen from the cross-sectional view of FIG. 2 b) excitation light is introduced from a light source 11”) (see also [0042], which recites “FIG. 2 a) further shows a diagrammatic view of a detector 13 which is provided in an operator unit and which receives the light which is emitted by a fluid sample in the measurement cell 3 and which is coupled out of the base plate downwardly”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Yager in view of Yang by incorporating the mirror disclosed by Frese with a reasonable expectation of success for the benefit of effectively redirecting light from the light source to the fluid sample. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, A.).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yager (US20020041827) in view of Yang (US20070207061) in view of Mathuis (US20150248109).
With respect to claim 8, Yager in view of Yang teaches the sensing chamber of claim 5.
Yager in view of Yang fails to teach that the reflected light instrument is configured to determine a parameter of the fluid via at least one of optical density sensing, turbidimetry, digital holographic microscopy, light dynamic scattering and optical interferometry.
In the analogous art of analytical devices, Mathuis teaches a reflected light instrument (a digital holographic microscope (DHM) in [0023]) is configured to determine a parameter of the fluid via digital holographic microscopy (see [0024], which recites “a digital holographic microscope (DHM) capable of obtaining phase information of a fluid sample ..whereby preferably at least one fluidic system comprises one or more tubes which may come in direct contact with fluid from said reactor; characterized in that preferably at least one tube comprises a part which is at least partially transparent for the illumination means of said DHM for obtaining holographic information of said fluid sample”) (see also [0030], which recites “said tube comprises at least one transparent side and whereby said DHM is capable of working in reflection mode”) (see also [0005], which recites “With digital holographic imaging (DHI), real-time observations can be achieved by using a charged coupled device (CCD) camera as recording device and by performing a numerical reconstruction of the hologram”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Yager in view of Yang by configuring the reflected light instrument such that the reflected light instrument is configured to determine a parameter of the fluid via digital holographic microscopy as disclosed by Mathuis with a reasonable expectation of success for the benefit of effectively enabling real time monitoring and analysis of biological samples including 3-D reconstruction (see [0077], which recites “DHM offers directly digitalized phase information which allows 3D imaging … the present invention leads to a faster, more accurate and more reliable analyzing and/or monitoring of reactors by using DHM as an observation, analysis and/or monitoring apparatus or mechanism. DHM is also more apt than other microscopy system for analyzing fluid, more preferably liquid, samples, especially for obtaining 3D information, because it is faster and more accurate than e.g. CT techniques”) . The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, A.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yager (US20020041827) in view of Lee (US20100003666).
With respect to claim 10, Yager teaches the sensing chamber of claim 9.
Yager fails to teach that the electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and polarography.
In the analogous art of analytical devices, Lee teaches electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and polarography (see [0076], which recites “the detection module can incorporate both electrical sensing and optical illumination to enable a scheme where the label probes or cells include multiple detection moieties”) (see [0077], which recites “the detection modules of the invention comprise electrodes”) (see [0079], which recites “electronic detection is used, including amperommetry, … time-dependent electrochemical analyses (chronoamperometry, chronopotentiometry, cyclic chronopotentiometry and amperometry, … chronogalvametry, …) …. AC impedance measurement”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Yager by incorporating the electrochemical monitoring disclosed by Lee for the benefit of providing time-dependent electrochemical analysis of the analyte. In addition, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., (see MPEP § 2143, A.).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yager (US20020041827) in view of Welter (US20070042490).
With respect to claim 11, Yager teaches the sensing chamber of claim 1, wherein:
the front plate and the back plate are formed from a transparent (see [0056], which recites “Plates 10 and 15 are made of an optically transparent material such as glass”).
Yager fails to teach that the front plate and back plate are from a biocompatible material.
In the analogous art of analytical devices, Welter teaches the front plate and the back plate are formed from a transparent and biocompatible material (polycarbonate in [0026], which recites “Irradiation chamber 700 (FIG. 2) is formed by joining two plates, a front and a back plate … of a material ideally transparent”) (polycarbonate is transparent and biocompatible) (see also [0036], which recites “irradiation chamber of the present invention can be made from a biocompatible material”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Yager such that the front plate and the back plate are formed from a biocompatible material as disclosed by Welter for the benefit of holding biological fluid or components thereof such as blood or blood products to facilitate their exposure to electromagnetic radiation such as UV light (see [0001] of Welter).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Simon (US20090298129) in view of Yager (US20020041827).
With respect to claim 20, Simon (US20090298129) teaches a disposable kit (kit 2500 in [0203]) for a bioprocessing system (system 10 in [0109], which recites “the system 10 is used to process biological samples”), comprising:
a tray (tray 14 in [0203]);
a bioprocessing vessel received (“vessel that may be heated” in [0132]) within the tray (tray 14) (see [0132], which recites “the tray 14 can be substantially rigid and includes a number of features and/or stations 242 which may be molded, formed, attached or otherwise integrated with tray to accommodate. Some or all of the following components are examples of features that may be integrated into the tray 14: … a thermal cycler PCR plate 610 and/or other substrate or vessel that may be heated”); and
a sensing chamber (spectrophotometer cuvettes 660 in [0132]) mounted to the tray (tray 14).
Simon fails to teach that the sensing chamber is a flow-through sensing chamber having a front plate and a back plate, a fluidic channel intermediate the front plate and the back plate, the front plate and the back plate forming the fluidic channel, a first port in fluid communication with the fluidic channel and permitting a flow of fluid into the fluidic channel, and a second port in fluid communication with the fluidic channel and permitting a flow of fluid out of the fluidic channel.
In the analogous art of providing analytical devices, Yager teaches a flow through sensing chamber (diffusion-based sensor) comprising:
a front plate (transparent cover plate 15 in [0053]);
a back plate (substrate plate 10 in [0053]);
at least one fluidic channel (channel 20 in [0053]) intermediate the front plate (transparent cover plate 15) and the back plate (substrate plate 10) (see Fig. 1A), the front plate (transparent cover plate 15) and the back plate (substrate plate 10) forming the at least one fluidic channel (channel 20) (see [0053], which recites “Flow channels and inlets and outlets are formed in substrate plate 10, covered by transparent cover plate 15”) (see also [0036], which recites “the channel cell is generally formed by two plates with abutting surfaces. The channels may be formed in both plates, or one plate can contain the channels and the other can be a flat cover plate”);
a first port (sample inlet 30 in [0058]) in fluid communication with the at least one fluidic channel (channel 20) and permitting a flow of fluid (sample) into the at least one fluidic channel (channel 20) (see [0058], which recites “sample inlet 30 passes through substrate plate 10 into channel 20”); and
a second port (outlet 60 in [0059]) in fluid communication with the at least one fluidic channel (channel 20) and permitting a flow of fluid out of the at least one fluidic channel (channel 20) (see [0059], which recites “all fluid streams exit through outlet 60”) (see also [0068], which recites “means for applying pressure to the flow of the feed fluids through the device can also be provided. Such means can be provided at the feed inlets and/or the outlet”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing chamber disclosed by Simon such that the sensing chamber is a flow-through sensing chamber having a front plate and a back plate, a fluidic channel intermediate the front plate and the back plate, the front plate and the back plate forming the fluidic channel, a first port in fluid communication with the fluidic channel and permitting a flow of fluid into the fluidic channel, and a second port in fluid communication with the fluidic channel and permitting a flow of fluid out of the fluidic channel as disclosed by Yager for the benefit of enabling continuous measurement of fluid in a high throughput and automated manner.
Conclusion
The applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, this action is made final. See MPEP § 706.07(a). The applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 case, 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 JONATHAN BORTOLI whose telephone number is (571)270-3179. The examiner can normally be reached 9 AM till 6 PM EST Monday through Thursday.
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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