DETAILED ACTION
In application filed on 06/12/2023, Claims 56-75 are pending. The claim set submitted on 02/03/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 56-65 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/06/2023, 07/21/2023, 02/04/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 02/03/2026 is acknowledged. Claims 70-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/03/2026.
Group I, Claims 56-65 are considered on the merits below.
Claim Rejections - 35 USC § 112
Claim 58 is 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 58 recites the limitation "the second fluorescence swatch is separated from the first fluorescence swatch by one or more additional fluorescence swatches of the plurality of fluorescence swatches positioned between the first fluorescence swatch and the second fluorescence swatch".
It is not clear how the first fluorescence swatch and the second fluorescence swatch are separated by one or more additional fluorescence swatches.
Are the first fluorescence swatch and the second fluorescence swatch sequential in positioning?
Applicant should provide clarification.
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.
Claim 56-58 and 60-64 are rejected under 35 U.S.C. 103 as being unpatentable over by Holcomb et al. (US20030105195A1, submitted in IDS on 02/06/2023) in view of Krauss et al. (US20150377859A1, submitted in IDS on 02/06/2023) and further in view of Wendlandt (US20100210906A1, submitted in IDS on 02/06/2023).
Regarding Claim 56, Holcomb teaches a fluorescence evaluation apparatus comprising:
a substrate (referred to as a substrate [Para 0022]); and
a plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) of a fluorescence imaging agent (referred to as one or more fluorescent agents [Para 0025]), each fluorescence swatch (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) being arranged on the substrate (See Para 0025…one or more fluorescent agents, as will be described below, which are bound to the probes or binding agents associated with the surface of the substrate) and having a different concentration of the fluorescence imaging agent (See Para 0045…The concentration of the fluorescent agent (i.e., the concentration of each fluorescent agent if there is more than one) may vary depending on the particular scanning detector to be calibrated, thereby teaching “different concentration”).
Holcomb does not teach that “a substrate configured to be inserted into a body through a channel having an inside diameter.
In the analogous art of an analysis cartridge the includes a main body portion and a filter assembly, Krauss teach “a substrate (referred to as substrate [Para 0057]) configured to be inserted into a body (referred to as filter assembly [Para 0057]) through a channel (referred to as substrate space [Para 0057; Fig. 2, ref. 27]) having an inside diameter (See Para 0057; Fig. 2, ref. 27, the substrate space has an inner diameter).
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 Holcomb to have “a substrate configured to be inserted into a body through a channel having an inside diameter, as taught by Krauss for the benefit of disposing the substrate into the substrate space (Krauss, Para 0057), wherein the substrate is pre-loaded with the PD derivative (referred to herein as PD substrate) (Krauss, Para 0151), allowing for the detection and quantitation, and in particular the detection and quantitation of the concentration of carbonyl containing moieties in biological samples (Krauss, Para 0002).
The combination of Holcomb and Krauss does not explicitly teach a channel having an inside diameter between about 5 millimeters (mm) and about 30 mm.
In the analogous art of a catheter introducer system for endoscopy, Wendlandt teaches that a channel (referred to as working channel [Para 0045]) having an inside diameter between about 5 millimeters (mm) and about 30 mm (See Para 0045… the working channel can have a diameter of about 14 mm, resulting in an outer diameter of the device of about 20 mm).
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 Holcomb and Krauss to have a channel having an inside diameter between about 5 millimeters (mm) and about 30 mm, as taught by Wendlandt for the benefit of maintaining a constant size so that the binding of the tools inserted in the working channel is prevented (Wendlandt, Para 0045), allowing for the provision of an improved type of endoscope with a introducer system that obviates some of the drawbacks of currently known endoscopes (Wendlandt, Para 0009).
Regarding Claim 57, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb further teaches that the plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) are arranged on the substrate (See Para 0025…one or more fluorescent agents, as will be described below, which are bound to the probes or binding agents associated with the surface of the substrate) in an order of increasing concentration of the fluorescence imaging agent (See Para 0045…The concentration of the fluorescent agent (i.e., the concentration of each fluorescent agent if there is more than one) may vary depending on the particular scanning detector to be calibrated…However, typically, the final concentration of fluorescent agent will range from about 1 ppm to 5000 ppm, usually from about 100 to 500 ppm and more usually from about 150 to 200 ppm, thereby teaching “order of increasing concentration”).
Regarding Claim 58, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb further teaches a first fluorescence swatch (referred to as one of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3) of the plurality of fluorescence swatches(referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) has a first concentration of the fluorescence imaging agent (See Para 0044… all fluorescent agents employed will be distributed substantially uniformly throughout the polymer. Specifically, any variation in fluorescent agent distribution that is present typically does not exceed from about 1 ppm to 5000 ppm, usually does not exceed from about 100 ppm to 800 ppm and more usually does not exceed from about 150 ppm to 180 ppm);
a second fluorescence swatch (referred to as a second of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3) of the plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) has the first concentration of the fluorescence imaging agent (See Claim 9…at least one fluorescent agent is present in said polymer in a final concentration ranging from about 1 ppm to about 5000 ppm; Examiner interprets “at least one” as “one or more”); and
the second fluorescence swatch referred to as a second of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3) is separated from the first fluorescence swatch(referred to as one of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3)) by one or more additional fluorescence swatches(See Annotated Fig. 3) of the plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) the first fluorescence swatch (referred to as one of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3) and the second fluorescence swatch referred to as a second of the at least one fluorescent layer of the polymer layer [Fig. 3; Claim 35]); fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]; See Annotated Fig. 3).
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Annotated Fig. 3, Holcomb
Regarding Claim 60, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb further teaches that the fluorescence imaging agent (referred to as one or more fluorescent agents [Para 0025]) is configured to be excited by fluorescence excitation illumination having a wavelength between about 620 nm and about 780 nm (See Para 0025… a second laser capable of emitting light in the wavelength from about 780 to 620 nm).
While the combination of Holcomb, Krauss and Wendlandt does not teach that the fluorescence imaging agent is configured to be excited by fluorescence excitation illumination having a wavelength between about 750 nm and about 810 nm, Holcomb teaches this limitation by using an overlapping range disclosure where fluorescence excitation illumination having a wavelength between about 750 nm and about 810 nm (See Para 0025… fluorescence excitation illumination having a wavelength between about 750 nm and about 810 nm).
As a result, since the claimed limitation overlap the range disclosed by the prior art, a prima facie case of obviousness exists. Please see MPEP 2144.05 (I) and In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976) for further details.
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 the combination of Holcomb, Krauss and Wendlandt to incorporate that the fluorescence imaging agent is configured to be excited by fluorescence excitation illumination having a wavelength between about 750 nm and about 810 nm, as taught by Holcomb, for the benefit of illuminating the substrate surface is illuminated by light over a range of wavelengths, where the wavelengths correspond to the fluorescence excitation wavelengths of one or more fluorescent agents (Holcomb, Para 0025), allowing for the provision of calibration devices for optical scanners, including biopolymeric array optical scanners. Also provided are kits for use in verifying and calibrating optical scanners (Holcomb, Para 0010).
The combination of Holcomb, Krauss and Wendlandt does not teach that the fluorescence imaging agent is configured to emit, in response to excitation by the fluorescence excitation illumination, fluorescence having a peak intensity at a wavelength between about 800 nm to about 850 nm.
In the analogous art of medical imaging devices including rigid imaging tips and their methods of use for identifying abnormal tissue within a surgical bed, Lee teaches that the fluorescence imaging agent (referred to as the particular imaging agent [Para 0073]) is configured to emit, in response to excitation by the fluorescence excitation illumination, fluorescence having a peak intensity at a wavelength between about 800 nm to about 850 nm (See Para 0073… the various components of the medical imaging device may also be constructed and arranged to collect emission wavelengths from an imaging agent that are about 300 nm to 1,000 nm, …or any other appropriate range of wavelengths.).
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 the combination of Holcomb, Krauss and Wendlandt to incorporate that the fluorescence imaging agent is configured to emit, in response to excitation by the fluorescence excitation illumination, fluorescence having a peak intensity at a wavelength between about 800 nm to about 850 nm, as taught by Lee for the benefit of having the various components of the medical imaging device to be also be constructed and arranged to collect a specific emission wavelengths from an imaging agent (Lee, Para 0073), allowing for the provision of a hand-held device and related technology for performing such in situ observation of residual cancer cells in a tumor resection bed (Lee, Para 0007).
Regarding Claim 61, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb teaches that the substrate (referred to as a substrate [Para 0022, 0035]) is substantially transparent to near-infrared light (See Para 0035… The substrates may be fabricated from a variety of materials. In many situations, a suitable substrate material will be transparent to visible and/or UV and/or infrared light.).
Regarding Claim 62, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb teaches that each fluorescence swatch (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) of the plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) comprises surface irregularities (See Para 0052-0054… he polymeric layer having at least one fluorescent agent or moiety dispersed therethrough and having minimal local and global nonuniformities, thereby teaching “surface irregularities”).
Regarding Claim 63, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb teaches that each fluorescence swatch (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) of the plurality of fluorescence swatches (referred to as fluorescently-infused polymer layer; polymer layer having at least one fluorescent layer [Para 0050;0053; Fig. 3]) comprises an optical dust from an optical filter material (See Para 0085…particles, thereby teaching “optical dust from an optical filter material”; Examiner submits that the “optical dust” has the same structure as the “optical filter material” Therefore, the condition has been inherently met. Please see MPEP 2112.01 for further details.) and the fluorescence imaging agent (referred to as one or more fluorescent agents [Para 0025]).
The combination of Holcomb and Wendlandt does not teach “light having a wavelength that is shorter than a peak wavelength of fluorescence emitted by the fluorescence imaging agent”.
In the analogous art of an analysis cartridge the includes a main body portion and a filter assembly, Krauss teach “light (‘excitation’) having a wavelength that is shorter than a peak wavelength (See Para 0174…The excitation is at 405 nm and the emission is at 575-585 nm…increase wavelength discrimination afforded by the largeStokes shift between excitation and emission) of fluorescence emitted by the fluorescence imaging agent (referred to as mPDA-orange [Para 0174])
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 the combination of Holcomb and Wendlandt to incorporate “light having a wavelength that is shorter than a peak wavelength of fluorescence emitted by the fluorescence imaging agent”, as taught by Krauss for the benefit of detecting aldehydes including without limitation 1-hexanal. (Krauss, Para 0170), allowing for the detection and quantitation, and in particular the detection and quantitation of the concentration of carbonyl containing moieties in biological samples (Krauss, Para 0002).
Regarding Claim 64, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
Holcomb teaches further comprising distance scale markers (referred to as the spots of distinct polymers present on the array surface are generally present as a pattern, where the pattern may be in the form of organized rows and columns of spots, e.g. a grid of spots, across the substrate surface…The density of spots present on the array surface may vary, but will generally be at least about 10 and usually at least about 100 spots/cm 2, where the density may be as high as 106 or higher, but will generally not exceed about 105 spots/cm2. [Para 0094]) arranged on the substrate (referred to as a substrate [Para 0022]), wherein the distance scale markers (referred to as the spots of distinct polymers present on the array surface are generally present as a pattern, where the pattern may be in the form of organized rows and columns of spots, e.g. a grid of spots, across the substrate surface… [Para 0094]) comprise the fluorescence imaging agent (referred to as one or more fluorescent agents [Para 0025]; Also see Para 0093… an array is provided and a hybridization assay is performed to bind certain analytes or agents of interest, i.e., labeled analytes or agents (fluorescently labeled), to the array, or more specifically to certain polymeric binding agents or probes which make up an array).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over by Holcomb et al. (US20030105195A1, submitted in IDS on 02/06/2023) in view of Krauss et al. (US20150377859A1, submitted in IDS on 02/06/2023) and further in view of Wendlandt (US20100210906A1, submitted in IDS on 02/06/2023) as applied to claim 56 above, and further in view of Hasegawa et al. (US20140303496A1).
Regarding Claim 59, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
The combination of Holcomb, Krauss and Wendlandt does not teach that the fluorescence imaging agent comprises one or more of indocyanine green (ICG), IR- 125, or quantum dots.
In the analogous art of a fluorescent light phantom device and a fluorescent light imaging method, Hasegawa teaches that the fluorescence imaging agent (‘the fluorescent coloring matter’) comprises one or more of indocyanine green (ICG), IR- 125, or quantum dots (See Para 0020… the fluorescent coloring matter may be ICG).
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 the combination of Holcomb, Krauss and Wendlandt to have the fluorescence imaging agent which comprises one or more of indocyanine green (ICG), IR- 125, or quantum dots, as taught by Hasegawa for the benefit of measuring an object in a living body (Hasegawa, Para 0017, 0020), allowing for the provision of a fluorescent light phantom device and a fluorescent light imaging method, which make it possible to evaluate quantitatively the concentration of a fluorescent coloring matter in an object to be measured (Hasegawa, Para 0005).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over by Holcomb et al. (US20030105195A1, submitted in IDS on 02/06/2023) in view of Krauss et al. (US20150377859A1, submitted in IDS on 02/06/2023) and further in view of Wendlandt (US20100210906A1, submitted in IDS on 02/06/2023) as applied to claim 56 above, and further in view of Jang et al. (US20160370285A1).
Regarding Claim 65, the fluorescence evaluation apparatus of claim 56 is obvious over Holcomb in view of Krauss and further in view of Wendlandt.
The combination of Holcomb, Krauss and Wendlandt does not teach a near-infrared (NIR) light swatch arranged on the substrate and comprising an up- converting fluorescence imaging agent configured to emit visible light when excited by NIR light.
In the analogous art of biophotonic phantoms that can accurately mimic the optical properties of living tissue and their use, for example, to calibrate and test instrumentation for detecting (such as sensing and imaging) optical properties of a sample, Jang teaches a near-infrared (NIR) light swatch (referred to as biophotonic phantom [Claim 27]; Also see solid tissue-simulating phantoms [Para 0033]) arranged on the substrate (See Para 0033…silicone polymers such as PDMS) and comprising an up- converting fluorescence imaging agent (referred to as dyes [0033]) configured to emit visible light (See Para 0098…fluorescence typically involves dyes, …that absorb and emit at long visible …wavelengths) when excited by NIR light (See Claim 27…directing …near-infrared wavelengths of light to the biophotonic phantom).
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 the combination of Holcomb, Krauss and Wendlandt to incorporate “a near-infrared (NIR) light swatch arranged on the substrate and comprising an up- converting fluorescence imaging agent configured to emit visible light when excited by NIR light”, as taught by Jang for the benefit of using a phantom that simulates the optical properties of a tissue or organ, for example, to calibrate or test the performance of the detection system (Jang, Para 0089), allowing for the provision of biophotonic phantoms that can accurately mimic the optical properties of living tissue and their use, for example, to calibrate and test instrumentation for detecting (such as sensing and imaging) optical properties of a sample (Jang, Para 0002).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797