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 .
Claims status: amended claim: 1, 14; canceled claims: 11; the rest is unchanged.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
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 1-10, 12 -16 are 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.
Claims 1 & 14 recite “for any wavelength within the detection range of the imaging device an emission intensity of at least one of the first and second dyes is: i) 1% or less of an emission intensity at the peak emission wavelength of the respective dye; ii) 30% or less of the emission intensity at the peak emission wavelength of the respective dye; iii) up to 100% of the emission intensity at the peak emission wavelength of the respective dye; or iv) in the range between 30%-100% of the emission intensity at the peak emission wavelength of the respective dye”. According to the limitation it is possible for the emission intensity to equal zero. If the emission equals zero it will impossible to do any analysis of the sample because an analysis of the sample depends on the emission intensity. Which will render the claims indefinite.
Claims 2-10, 12-13, 15-16 are rejected on the same basis as independent claims 1 & 14 for dependency reasons.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive. Applicant argues in 1st para. of pg.10 of the remarks that Ness et al. do not teach a two-dimensional array focal array, not spatial image capability, and no in vivo biological imaging. The examiner respectfully disagrees because para. [0047] of Ness et al. teach the detectors are CMOS detectors. CMOS are built from an array of pixels. Fig.15 shows detectors 596 & 598 placed in different positions. None of claims claim an in vivo biological sample. Additionally, applicant asserts in 2nd para. of pg.10 of the remarks that Ness et al do not teach the emission of at least one dye lies outside the detection range. Para. [0082] teaches light emission is exclusively detected by one detector. Regarding the multi-pixel argument made in para. before last of pg.11 of the remarks, a new reference is currently being used to teach that limitation. In response to the argument made in 1st para. of pg.12 that Ness et al. do not teach a spatially resolved image of the sample. Fig.15 shows that detectors 596 & 598 are in different locations and para. [0082] teaches detectors that respond to a specific emission. Regarding the argument made in 2nd & 3rd para. of pg.12 of the remarks, Ness et al. teach in para. [0082] changing from one configuration to another where a detector from the two detectors is configured to be sensitive to one only light pulse source. Regarding the Gargir et al. reference, the reference is not used in the current rejection.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The limitation “an imaging device” recited in L5 of claim 14 invokes 35U.S.C 112(f) means (device) + function (for imaging). A review of the specification reveals that the corresponding structure is InGaAs detectors (e.g., 900 - 1700nm), HgCdTe or MCT detectors (e.g., 700 - 2500nm), Germanium, bolometers, superconducting nanowires, pyroelectric detectors etc as described in para. [0052], [0085]. Therefore, the limitation is interpreted as requiring InGaAs detectors (e.g., 900 - 1700nm), HgCdTe or MCT detectors (e.g., 700 - 2500nm), Germanium, bolometers, superconducting nanowires, pyroelectric detectors etc. or its equivalent.
The limitation “control unit” recited in L6 of claim 14 invokes 35U.S.C 112(f) means (device) + function (for imaging). A review of the specification reveals that the corresponding structure is a data acquisition unit (DAU), electronic processors (Processor), electronic memory unit (Memory), electronic input-output modules (1/O), display units (Display) as describe in para. [0055]. Therefore, the limitation is interpreted as requiring a data acquisition unit (DAU), electronic processors (Processor), electronic memory unit (Memory), electronic input-output modules (1/O), display units (Display) or its equivalent.
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.
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.
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.
Claims 1-10, 12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ness et al. (US 2012/0194805 A1; pub. Aug. 2, 2012) in view of Bayandorian et al. (US 8,318,094 B1; pub. Nov. 27, 2012) and further in view of Chiu et al. (US 2022/0025111 A1; pub. Jan. 27, 2022).
Regarding claim 1, Ness et al. disclose in a first method: a method for multiplexed and multicolor imaging of a biological sample location (para. [0046], [0062]), said method comprising:
i) illuminating or exciting a first dye by exposing a portion of said sample location to a first excitation light pulse, wherein said first excitation light pulse (para. [0028]) comprises:
pulse having (para. [0073]):
(a) a first state; or
(b) a first wavelength (para. [0073]);
wherein a first component, chemical composition, surface and/or region in the portion of said sample location comprises the first dye, and wherein the first dye exhibits a first peak emission wavelength and a first off- peak emission signal upon excitation by the first excitation light pulse (para. [0070], [0073], [0108], [0121]);
ii) illuminating or exciting a second dye by exposing the portion of said sample location to at least a second excitation light pulse having (para. [0070], [0073], [0121]):
(c) a second state, which is different from the first state of (a) (para. [0070], [0073], [0121]); or
(d) a second wavelength, which is different from the first wavelength of (b);
wherein a second component, chemical composition, surface and/or region in the portion of said sample location; comprises the second dye, wherein the second dye exhibits a second peak emission wavelength and a second off-peak emission signal upon excitation by the second excitation light pulse (para. [0070], [0073], [0121]) wherein said second component, chemical composition, surface and/or region is different from said first component, chemical composition, surface and/or region; the second dye is different from the first dye, and the first and second off-peak signals are not identical; (para. [0070], [0073], [0121]) wherein the first excitation light pulse and the second excitation light pulse are provided sequentially (para. [0073]);
iii) detecting light reflected or emitted by the first and the second dye, in the portion of said sample location by an imaging device (para. [0055]-[0056]).
In the first method Ness et al. are silent about:
iii) detecting light reflected or emitted by the first and the second dyes in the portion of said sample location by an imaging device comprising a multi-pixel detector array configured to capture a first multi-pixel image of the sample location in a first configuration and a second multi-pixel image of the sample location in a second configuration aa) switching the imaging device, in a sequential manner, between a first configuration during which the imaging device is responsive to a first electromagnetic radiation wavelength emitted by the first dye in response to excitation by the first excitation light pulse and a second configuration during which the imaging device is responsive to a second electromagnetic radiation wavelength emitted by the second dye in response to excitation by the second excitation light pulse, wherein said first and second electromagnetic radiations are not identical; wherein the peak emission wavelength of at least one of the first and second dyes lies outside of the detection range of the imaging device during the detection process,
wherein for any wavelength within the detection range of the imaging device an emission intensity of at least one of the first and second dyes is: i) 1% or less of an emission intensity at the peak emission wavelength of the respective dye; ii) 30% or less of the emission intensity at the peak emission wavelength of the respective dye; iii) up to 100% of the emission intensity at the peak emission wavelength of the respective dye; or iv) in the range between 30%-100% of the emission intensity at the peak emission wavelength of the respective dye;
wherein the switching between the first configuration and the second configuration is triggered by the provision of the first excitation light pulse and the second excitation light pulse such that the first excitation light pulse is synchronized with the first configuration and the second excitation light pulse is synchronized with the second configuration.
In a further method, Ness et al. disclose: aa) switching the imaging device, in a sequential manner, between a first configuration during which the imaging device is responsive to a first electromagnetic radiation wavelength emitted by the first dye in response to excitation by the first excitation light pulse and a second configuration during which the imaging device is responsive to a second electromagnetic radiation wavelength emitted by the second dye in response to excitation by the second excitation light pulse, wherein said first and second electromagnetic radiations are not identical; wherein the peak emission wavelength of at least one of the first and second dyes lies outside of the detection range of the imaging device during the detection process (para. [0080], “Also, the pulse lengths for illumination with each source may be the same or different from each other”, “For example, one light source may emit a pulse of light each time the other light source pauses, and vice versa”, para. [0082] teaches that the detectors are synchronized with the light pulses, para. [0088] teaches synchronizing one detector at the time with a illumination pulse), wherein the switching between the first configuration and the second configuration is triggered by the provision of the first excitation light pulse and the second excitation light pulse such that the first excitation light pulse is synchronized with the first configuration and the second excitation light pulse is synchronized with the second configuration (para. [0080], “Also, the pulse lengths for illumination with each source may be the same or different from each other”, “For example, one light source may emit a pulse of light each time the other light source pauses, and vice versa”, para. [0082] teaches that the detectors are synchronized with the light pulses, para. [0088] teaches synchronizing one detector at the time with a illumination pulse) motivated by the benefits for faster testing.
In light of the benefits for faster testing, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the two methods of Ness et al.
In a similar field of endeavor Bayandorian et al. disclose: a multi-pixel detector array configured to capture a first multi-pixel image of the sample (col.54 L56-64, col.56 L48-62) motivated by the benefits for a scalable detector array (Bayandorian et al. col.56 L48-62).
In light of the benefits for improved detection accuracy, 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 method of Ness et al. with teachings of Bayandorian et al.
Bayandorian et al. are silent about: for any wavelength within the detection range of the imaging device an emission intensity of at least one of the first and second dyes is: i) 1% or less of an emission intensity at the peak emission wavelength of the respective dye; ii) 30% or less of the emission intensity at the peak emission wavelength of the respective dye; iii) up to 100% of the emission intensity at the peak emission wavelength of the respective dye; or iv) in the range between 30%-100% of the emission intensity at the peak emission wavelength of the respective dye.
In a similar field of endeavor Chiu et al. disclose: for any wavelength within the detection range of the imaging device an emission intensity of at least one of the first and second dyes is: i) 1% or less of an emission intensity at the peak emission wavelength of the respective dye; ii) 30% or less of the emission intensity at the peak emission wavelength of the respective dye; iii) up to 100% of the emission intensity at the peak emission wavelength of the respective dye; or iv) in the range between 30%-100% of the emission intensity at the peak emission wavelength of the respective dye (para. [0297], [0308]) motivated by the benefits for efficient fluorescence measurement (Chiu et al. para. [0199]).
In light of the benefits for efficient fluorescence measurement as taught by Chiu et al., 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 method of Ness et al. and Bayandorian et al. with teachings of Chiu et al.
Regarding claim 2, Ness et al. disclose: providing an optical filter in the optical path between the portion of said sample location and the imaging device, the optical filter being configured to block the first excitation light and the second excitation light (para. [0077]-[0078]).
Regarding claim 3, Ness et al. disclose: the optical filter is configured as a longpass or bandpass filter with a cut-on wavelength in the micrometer range (para. [0056], [0077]-[0078]).
Regarding claim 4, Ness et al. disclose: the detection range of the imaging device lies in the micrometer range, optionally in the short-wave infrared (SWIR) range (para. [0056]).
Regarding claim 5, Ness et al. disclose: the first and the second excitation light pulses are provided at the same rate or at the different rate (para. [0073]).
Regarding claim 6, Ness et al. disclose: the pulse length of the first and second excitation light pulses is different (para. [0070], [0073]). Ness et al. are silent about: the pulse length of the first and second excitation light pulses is: 1) 10 ms or shorter; ii) up to several seconds; or ili) up to several minutes. However, [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, Ness et al. disclose: the pulse length of the first and second excitation light pulses is different (para. [0070], [0073]), varying lasers time cycles ((para. [0070], [0073])). Scott et al. disclose: the light sources have picosecond pulsed excitation (para. [0200]). Ness et al. are silent about: the duty cycle of the first and second pulses is: i) 1% or less; or ii) up to 100%. However, [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Ness et al. disclose: the first excitation light pulse/s and the second excitation light pulse/s impinge on the portion of said sample location from the same spatial direction (fig.2 items 82 & 84).
Regarding claim 9, Ness et al. disclose: the first excitation light pulse/s and the second excitation light pulse/s impinge on the portion of said sample location from different spatial directions (fig.14).
Regarding claim 10, Ness et al. disclose: the peak emission wavelength of at least one of the dyes lies below the cut-on wavelength of the longpass filter (para. [0056], [0077]-[0078]).
Regarding claim 12, Ness et al. disclose: the pulse length of the first and second excitation light pulses is different (para. [0070], [0073]), varying lasers time cycles (para. [0070], [0073]). Scott et al. disclose: the light sources have picosecond pulsed excitation (para. [0200]). The combined references are silent about: the switching of the device into the first configuration is triggered by the provision of the light pulse/s such that the imaging device is switched into the first configuration simultaneously with or within 2 microseconds after the emission of any one of the first and second excitation light pulse/s. However, [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Ness et al., Bayandorian et al. and Chiu et al. disclose: A system for multiplexed and multicolor imaging of a biological sample location, said system comprising:
i) a first light source configured to illuminate the sample location with a first excitation light pulse at a first excitation wavelength corresponding to an excitation wavelength of a first dye, wherein the first dye exhibits a first peak emission wavelength and a first off-peak emission signal upon excitation by the first excitation light pulse;
ii) at least a second light source configured to illuminate the sample location with a second excitation light pulse at a second excitation wavelength corresponding to an excitation wavelength of a second dye, wherein the second dye exhibits a second peak emission wavelength and a second off-peak emission signal upon excitation by the second excitation light pulse, wherein the first and second off-peak signals are not identical;
iii) an imaging device comprising a multi-pixel detector array configured to capture detect at the sample location a first multi-pixel image, wherein the multi-pixel detector array is responsive in a first configuration to a first electromagnetic radiation corresponding to a first emission wavelength of the first dye in response to the first excitation light pulse and a second multi-pixel image, wherein the multi-pixel detector array is responsive in a second configuration to a second electromagnetic radiation corresponding to a second emission wavelength of the second dye in response to the second excitation light pulse, wherein said first and second electromagnetic radiations are not identical;
iv) a control unit coupled to the first light source, the second light source and the imaging device, wherein the control unit is configured to control the first light source to provide the first excitation light pulse and to control the second light source to provide the second excitation light pulse in sequential manner; wherein the control unit is further configured to switch the imaging device in a sequential manner, between the first configuration during which the imaging device is responsive to the first electromagnetic radiation and the second configuration during which the imaging device is responsive to the second electromagnetic radiation;
wherein the system is configured such that the switching of the imaging device between the first configuration and the second configuration is triggered by the provision of the first excitation light pulse and the second excitation light pulse such that the first excitation light pulse is synchronized with the first configuration and the second excitation light pulse is synchronized with the second configuration, and wherein the system further comprises an optical filter in the optical path between the portion of said sample location and the imaging device, the optical filter being a longpass filter configured to block the first excitation wavelength and the second excitation wavelength, wherein the peak emission wavelength of at least one of the dyes lies below the cut-on wavelength of the longpass filter such that the peak emission wavelength of the at least one of the dyes lies outside of the detection range of the imaging device, and
wherein for any wavelength within the detection range of the imaging device an emission intensity of at least one of the dyes is configured to amount: i) 1% or less of an emission intensity at the peak emission wavelength of the respective dye; ii) 30% or less of the emission intensity at the peak emission wavelength of the respective dye; iii) up to 100% of the emission intensity at the peak emission wavelength of the respective dye; or iv) in the range between 30%-100% of the emission intensity at the peak emission wavelength of the respective dye (the claim contains the same substantive limitations as claim 1, therefore the claim is rejected on the same basis as claim 1, additionally see para. [0056], [0061], [0077]-[0078] of Ness et al.).
Claims 13, 16 are rejected under 35 U.S.C. 103 as being unpatentable Ness et al. (US 2012/0194805 A1; pub. Aug. 2, 2012) in view of Bayandorian et al. (US 8,318,094 B1; pub. Nov. 27, 2012) in view of Chiu et al. (US 2022/0025111 A1; pub. Jan. 27, 2022) and further in view of White et al. (US 2014/0171759 A1; pub. Jun. 19, 2014).
Regarding claim 13, the combined references are about: said method: i) does not comprise a moving and/or switching an optical filter or an array of optical filters; or ii) comprising providing only one optical filter; and/or iii) is a method for reduction of melanin absorption in the SWIR and/or a method for a non- invasive imaging of tissues and/or organisms in the presence of melanin.
In a similar field of endeavor White et al. disclose: said method: i) does not comprise a moving and/or switching an optical filter or an array of optical filters; or ii) comprising providing only one optical filter; and/or iii) is a method for reduction of melanin absorption in the SWIR and/or a method for a non- invasive imaging of tissues and/or organisms in the presence of melanin (para. [0375]) motivated by the benefits for high SNR (White et al. para. [0214]).
In light of the benefits for high SNR as taught by White et al., 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 method of Ness et al., Bayandorian et al. and Chiu et al. with teachings of White et al.
Regarding claim 16, the combined references are about: said system: i) does not comprise a movable optical filter or a movable array of optical filters; or ii) comprises only one optical filter; and/or iii) said system is for reduction of melanin absorption and/or for a non-invasive imaging of tissues and/or organisms in the presence of melanin.
In a similar field of endeavor, White et al. disclose: said system: i) does not comprise a movable optical filter or a movable array of optical filters; or ii) comprises only one optical filter; and/or iii) said system is for reduction of melanin absorption and/or for a non-invasive imaging of tissues and/or organisms in the presence of melanin (para. [0375]) motivated by the benefits for high SNR (White et al. para. [0214]).
In light of the benefits for high SNR as taught by White et al., 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 apparatus of Ness et al., Bayandorian et al. and Chiu et al. with teachings of White et al.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ness et al. (US 2012/0194805 A1; pub. Aug. 2, 2012) in view of Bayandorian et al. (US 8,318,094 B1; pub. Nov. 27, 2012) in view of Chiu et al. (US 2022/0025111 A1; pub. Jan. 27, 2022) and further in view of Luong et al. (US 8,802,424 B2; pub. Aug. 12, 2014).
Regarding claim 15, the combined references are about: said system comprises two or more light sources, preferably said light sources are configured to be operated simultaneously during pulses.
In a similar field of endeavor, Luong et al. disclose: said system comprises two or more light sources, preferably said light sources are configured to be operated simultaneously during pulses (claim 18) motivated by the benefits for improved analysis of biological information (Luong et al. col.1 L53-59).
In light of the benefits for improved analysis of biological information as taught by Luong et al., 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 apparatus of Ness et al., Bayandorian et al. and Chiu et al. with teachings of Luong et al.
Conclusion
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/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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