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.
Response to Arguments
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive. Applicant argues in 2nd para. of pg.10 of the remarks that Ness et al. do not teach “a system in which the peak emission wavelength of at least one of the first and second dyes lies outside of the detection range of the imaging device”. The examiner respectfully disagrees. In para. [0057], Ness et al. teach “two or more detection configurations, each detection configuration may have different sensitivities to dyes present in droplets”. Para. [0108] teaches “Individual droplet regions 414 (e.g., peaks or valleys) of the combined signal representing droplets may be identified, as indicated in graph 384 “, “droplet identification algorithms may be based on one or more predefined conditions corresponding to an acceptable range for the height (or depth), width, smoothness, and/or monotonicity of a peak 415 (or valley) formed by the combined signal”. Additionally, applicant asserts in last para. of pg.11 of the remarks that Ness et al. do not sequentially switching the imaging device. Ness et al. do teach sequentially switching the imaging device, para. [0080] teaches sequentially switching the light sources & para. [0082] teaches synchronizing the light detectors with light pulses. The imaging device is therefore sequentially switched with the light sources. Regarding the Gargir et al. reference applicant argues in pg.12 of the remarks that there is no Prima facie Obviousness to modify the method of Ness et al. with the teachings of Gargir et al. In response to applicant's argument that there is no Prima facie Obviousness to modify the method of Ness et al. with the teachings of Gargir et al., the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The rejection is therefore maintained and made final.
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 § 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.
Claim 1 recites the limitation "said first light pulse" in L4. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-10, 12-13 are rejected on the same basis as claim 1 for dependency reasons.
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 Gargir et al. (US 2015/0102234 A1; pub. Apr. 16, 2015).
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 light
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:
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 to combine the two methods of Ness et al.
In a similar field of endeavor, Gargir 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. [0023]) motivated by the benefits for improved detection accuracy.
In light of the benefits for improved detection accuracy, it would have been obvious to one of ordinary skill in the art to modify the method of Ness et al. with teachings of Gargir 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. and Gargir 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 configured to detect at the sample location 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 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 second excitation light pulse/s in sequential manner; wherein the control unit is further configured to switch the imaging device in a sequential manner, between a first configuration during which the imaging device is responsive to the first electromagnetic radiation and a second figuration 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 Gargir et al. (US 2015/0102234 A1; pub. Apr. 16, 2015) and further in view of White et al. (US 2014/0171759 A1; pub. Jun. 19, 2014).
Regarding claim 13, Ness et al. and Gargir et al. silent 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 to modify the method of Ness et al. and Gargir et al. with teachings of White et al.
Regarding claim 16, Ness et al. and Gargir et al. are silent 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 to modify the apparatus of Ness et al. and Gargir 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 Gargir et al. (US 2015/0102234 A1; pub. Apr. 16, 2015) and further in view of Luong et al. (US 8,802,424 B2; pub. Aug. 12, 2014).
Regarding claim 15, Ness et al. and Gargir et al. are silent 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 to modify the apparatus of Ness et al. and Gargir et al. with teachings of Luong et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAMADOU FAYE whose telephone number is (571)270-0371. The examiner can normally be reached Mon – Fri 9AM-6PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MAMADOU FAYE/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884