CTNF 18/455,470 CTNF 90066 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Priority The present application is filed as a Divisional of application 16/798,038, filed 02/21/2020 (US Patent No. 11,788,965). Application 16/798,038 claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/808,442, filed 02/21/2019. Status of the Claims Claims 1-30 are canceled; claims 31-34 are pending and examined below. Drawings 06-24-01 AIA Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted . Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “data acquisition system configured to receive the acoustic signals from the ultrasound transducer and the images from the camera to reconstruct and display a photoacoustic image of the sample” in claim 1. The originally filed specification describes the “data acquisition system” as 34 of figure 1A (see para [0034]), which is shown at figure 1A to include a computer and a built-in field programmable gate array (FPGA) (para [0037]). See paras [0042]-[0043], FPGA programmed for custom triggering and synchronization of the imaging system. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 31- 34 are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien et al., US PG Pub No. 2012/0064566A1 (hereinafter referred to as O’Brien et al.) in view of Nedosekin et al., Photoacoustic flow cytometry for nanomaterial research, Photoacoustics, 6, (2017), p. 16-25, Juratli et al., Real-time monitoring of circulating tumor cell release during tumor manipulation using in vivo photoacoustic and fluorescent flow cytometry, Head Neck, 36(8), (2014), 23 pages, Nedosekin et al., In vivo ultra-fast photoacoustic flow cytometry of circulating human melanoma cells using near-infrared high pulse rate lasers, Cytometry Part A, Journal of International Society for Advancement of Cytometry, 79A, (2011), p. 825-833 (hereinafter referred to as Nedosekin et al. (2011)), Li et al., US PG Pub No. 2020/0218882A1 (filing date of 07/27/2016) and Käs et al., US Patent No. 6,067,859, and as evidenced by O’Brien et al., Capture of circulating tumor cells using photoacoustic flowmetry and two phase flow, Journal of Biomedical Optics, 17(6), (2012), 10 pages (hereinafter referred to as O’Brien et al. (2012)) . O’Brien et al. teach a photoacoustic flow system (Figures 1 and 4, para [0026]), the system comprising a flow chamber 33 (Figure 4, reads on capillary tube) supported by a detection chamber 36 (Figure 4, reads on the claimed flow chamber configured to support a capillary tube), the system of O’Brien comprising a pump system coupled to the capillary tube (see Figure 1, a thin diameter tube), the pump system including a first syringe pump filled with separator fluid such as air, gas and/or oil for creating discrete compartments of the second fluid and a second syringe pump containing a sample (see Figure 1), wherein the first pump injects its contents into the capillary tube, and the second pump injects the sample into the capillary tube to produce two-phase flow with alternating air and sample through the capillary tube (see para [0025]). O’Brien’s system includes a detector having a laser and a transducer (see para [0018]). O’Brien teach the laser configured to transmit light to excite the sample in the capillary tube (Figure 1, 34, para [0026]); an ultrasound transducer coupled to the flow chamber (Example 1, paras [0035] describes the transducer provided in the detection chamber), wherein the ultrasound transducer detects acoustic signals generated by excitation of the sample. O’Brien further teaches their system comprising a data acquisition system configured to receive the acoustic signals from the ultrasound transducer (see para [0028], via connection 50 to computer display or other output device) to display a photoacoustic image of the sample. O’Brien et al. does teach at para [0026], that although 34 at Figure 1 is depicted in one embodiment to be a photoacoustic detector, it may include a variety of excitation devices and/or mechanisms for converting energy into something that can be further processed to obtain information, including fluorescence detection. See at Figure 1, transducer is coupled to the flow chamber (paras [0035]-[0036]), and further see referring to figure 1, the chamber of O’Brien is shown with and opening (slot) for providing access to the capillary tube system (providing external components access, for example, the photoacoustic source). However, O’Brien fails to teach their photoacoustic system coupled/the flow chamber supported on the stage of an inverted fluorescence microscope, the flow chamber having a slot (fails to teach camera aligned with the slot in the flow chamber for imaging sample as it passes through the capillary tube). The flow chamber of O’Brien is not described as having a window (the transducer coupled to the window). Further O’Brien fails to teach the data acquisition system receiving the images from the camera (FPGA coupled to the computer, see as discussed above under claim interpretation, 35 U.S.C. 112(f)). O’Brien’s system is further described in more detail at O’Brien (2012), O’Brien 2012 show the transducer aligned with a window of the flow chamber (see e.g., figure 1 and figure 4). Nedosekin et al. teach a photoacoustic fluorescence flow cytometry platform (abstract), see for example page 17, end of col. 1 and Figure 2, Nedosekin describes their flow through system positioned on an xy stage of an upright microscope, Nedosekin describe the laser source focused inside the capillary, collecting fluorescence through the objective, the system measuring the intensity of collected fluorescent light, while PA signals from the transducer were amplified and digitized (see col. 1, para 1). Nedosekin teach that conventional flow cytometry is a versatile tool for drug research and cell characterization, however, it is poorly suited for quantification of non-fluorescent proteins and artificial nanomaterials without the use of additional labeling; that advanced novel photoacoustic fluorescence flow cytometry integrates nanoparticle quantification and photoacoustic detection with conventional sample characterization using fluorescence labeling (abstract). Nedosekin teach the integrated system extends the range of application of conventional flow cytometry, allowing highly sensitivity absorbance quantification and single nanoparticle detection sensitivity, that photoacoustic detection serves as an additional source of data for complete cell characterization without compromising conventional fluorescence and light scattering detection of various cell biomarkers (see page 17, end of col. 1). Nedosekin report that high speed photoacoustic detection can be easily incorporated into existing flow cytometry schematics for label-free quantification of non-fluorescent nanoparticles, as well as light absorbing proteins and dye molecules, that PA detection is proposed as an additional modality to expand the range of applications for conventional flow cytometry (see page 22, Conclusions). Juratli et al. also teach a system for photoacoustic and fluorescent flow cytometry (title and abstract), Juratli et al. teach providing their system on the platform of an inverted fluorescence microscope (see page 3, Schematic of multimodal flow cytometry), Juratli teach laser-induced acoustic waves were detected by an ultrasound transducer. See also page 6, Juratli et al. teach regarding Data Collection, photoacoustic signals and fluorescence signal traces were displaced online and recorded for offline processing, Juratli using a two channel detection system to simultaneously monitor both signals. See the setup at page 13, Juratli et al. differs from claimed system in that they are monitoring flow through an ear vessel rather than an in vitro flow through system. Regarding the inverted microscope setup, Juralti collect the emitted fluorescence from below the stage (through an opening, see Figure 2), the photoacoustic waves collected by way of transducer positioned above the microscope stage (see also Figure 2). See also another configuration demonstrated by Nedosekin (2011), which shows a CCD camera positioned to be aligned with the stage containing the specimen (Figure 1B, scheme of experimental setup). Li et al. teach regarding flow cytometry for counting and classifying cells, providing a system inclusive of imaging (abstract, para [0001], [0081]). Li et al. teach recording fluorescent signal, signal correlated with holographic image as an additional feature of recognition and classification (para [0081]); Li teaching use of an FPGA, recording fluorescent signa, turning off laser, turning on imaging laser beam and triggering to capture holographic images by CMOS camera (para [0081]), FPGA used to control exact timing of those events. Li et al. describe camera positioned to view the flow of cells (see para [0072], view of the microfluidic chip, see para [0079]). See also Käs et al. at col. 3, lines 52-64, optical fibers are recognized as a favorable alternative to series of optical elements to direct light, the use of optical fibers allow user to avoid the need for additional optical elements and their alignment, Käs suggesting fiber optics as easier and cheaper. Regarding the limitation that the flow chamber has a window, although O’Brien (cited as primary reference is not described as having a window, see further O’Brien’s system is further described and shown in more detail at O’Brien (2012), O’Brien 2012 show the transducer aligned with a window of the flow chamber (see e.g., figure 1 and figure 4). As such, O’Brien (2012) is cited as evidence to support the system comprises a window as claimed, transducer coupled below the window. It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the two-phased photoacoustic detection system of O’Brien et al. with a fluorescence microscope in order to provide a photoacoustic fluorescence flow cytometry system, as in Nedosekin et al. and Juratli et al., specifically to have provided the chamber containing capillary at the stage of a fluorescence microscope, one motivated to make the modification to convert the photoacoustic system into a photoacoustic fluorescence flow cytometry system, because of the prior art recognized advantages of such an integrated system as taught by Nedosekin et al. In particular, as cited above Nedosekin teach that conventional flow cytometry is a versatile tool for drug research and cell characterization, however, it is poorly suited for quantification of non-fluorescent proteins and artificial nanomaterials without the use of additional labeling; that advanced novel photoacoustic fluorescence flow cytometry integrates nanoparticle quantification and photoacoustic detection with conventional sample characterization using fluorescence labeling (abstract). One having ordinary skill would have been motivated to integrate because Nedosekin teach the integrated system extends the range of application of conventional flow cytometry, allowing highly sensitivity absorbance quantification and single nanoparticle detection sensitivity, that photoacoustic detection serves as an additional source of data for complete cell characterization without compromising conventional fluorescence and light scattering detection of various cell biomarkers (see page 17, end of col. 1). Further motivation (as well as leading one to a reasonable expectation of success) Nedosekin teach that high speed photoacoustic detection can be easily incorporated into existing flow cytometry schematics for label-free quantification of non-fluorescent nanoparticles, as well as light absorbing proteins and dye molecules, that PA detection is proposed as an additional modality to expand the range of applications for conventional flow cytometry (see page 22, Conclusions). Also, O’Brien et al. does teach that although their embodiment 34 at Figure 1 is depicted to be a photoacoustic detector, it may include a variety of excitation devices and/or mechanisms for converting energy into something that can be further processed to obtain information, including fluorescence detection, thereby further attributing to a reasonable expectation of success integrating fluorescence capabilities. Although Nedoskin et al. teach an upright fluorescence microscope, it would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system such to utilize an inverted fluorescence microscope as a simple substitution of one art recognized fluorescent microscope for another, see specifically both of Nedosekin as well as Juralti teaching either microscope suitable for photoacoustic fluorescent flow cytometry. Given that either is demonstrated in the prior art as usable for such integrated system, one having ordinary skill in the art would have had a reasonable expectation of success. It would have been further prima facie obvious to have modified the system as taught by the combination of O’Brien, Nedosekin et al. and Juralti et al., to have provided the camera for obtaining images aligned with the capillary tube with an opening in the chamber (i.e., slot as shown in O’Brien for photoacoustic source), the acquisition system including an FPGA programmed to trigger and capture images consistent with the fluorescent signal obtained. Specifically, one having ordinary skill would have been motivated to have provided the camera aligned with the flow of target (i.e., the tube inside the Chamber of O’Brien) because capturing images that correlate with signal captured improves detection by contributing to recognition and classification (Li et al.). As understood from Li et al., in order to capture the image to correlate with signal it would be necessary to align the camera with the targeted analyte being detected, and it would be obvious to provide the alignment by way of a slot in the chamber because O’Brien demonstrate a slot (opening) to introduce other structures necessary for excitation/detection, as such providing a slot for the camera would be an obvious matter of applying a known technique for access through to the tube with flowing sample, O’Brien specifically teaching a structure where the tube with flowing sample is housed with the a chamber, O’Brien teaching openings to accommodate access to that tube with flowing sample. One having ordinary skill in the art would have a reasonable expectation of success given that O’Brien already demonstrate the ability to provide such access by way of an opening shown for the photoacoustic signal system. It would have been prima facie obvious to one having ordinary skill in the art to have modified the optical setup of O’Brien et al. and the cited prior art to substitute in an optical fiber in order to direct the excitation source light as an obvious matter of a simple substitution of one known way of delivering the excitation light for another, one further motivated because optical fibers were recognized as a substitute that avoids the need for optical elements and alignment, and is considered a cheap and easy alternative (Käs). One having ordinary skill would have a reasonable expectation of success using optical fiber given that this is an art recognized suitable alternative for delivering excitation from a laser source, one would expect the same outcome (providing excitation). Regarding claim 32, O’Brien et al. and the cited prior art teach a system comprising a transducer described as comprising an ultrasound pulser/receiver configured to receive an amplify the acoustic signals (see described at para [0026], referring to Figure 1, any piezoelectric material or other non-piezoelectric sound sensor). Regarding claim 33, the combination of the cited art addresses a system wherein the window and slot are arranged such to provide alignment of the system components, including the ultrasound transducer and the light from the optical fiber (necessarily have access to the flowing sample). Regarding claim 34, see O’Brien and the cited part, particularly evidence by O’Brien et al. (2012), the window giving access such that it is in a position perpendicular to the longitudinal (length) axis of the capillary tube . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 31 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,788,965. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘965 recites a method which uses the system as presently claimed, see at claim 1, the photoacoustic flow system comprising a flow chamber configured to support a capillary tube, the flow chamber including a window and a slot; a pump system coupled to the capillary tube, the pump system including a first syringe pump filled with air and a second syringe pump containing the test sample, wherein the first pump injects the air into the capillary tube, and the second pump injects the test sample into the capillary tube to produce two-phase flow with alternating air and test sample through the capillary tube; an optical fiber coupled to a laser and configured to transmit the laser light sample in the capillary tube; an ultrasound transducer coupled to the window of the flow chamber, wherein the ultrasound transducer detects the photoacoustic signals generated by the excited nanoparticles; an inverted fluorescence microscope including a stage for supporting the flow chamber and a camera aligned with the slot of the flow chamber for obtaining images of the test sample as it passes through the capillary tube; and a data acquisition system configured to receive the photoacoustic signals from the ultrasound transducer and the images from the camera to reconstruct and display the photoacoustic image. Regarding claim 33, it would have been further obvious, based on the citation of claim 1 of ‘965, that the window and slot be oriented/positioned in the flow chamber to provide alignment of the transducer and light from the optical fiber, specifically because claim 1 recites “transducer coupled to the window” the because the flow chamber supports the capillary tube. It would necessarily follow that the window must be positioned to provide alignment. This is similarly the case regarding the slot, as it would be necessary that the light be capable of striking the capillary containing the targeted analyte. 08-36 AIA Claim s 32 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-24 of U.S. Patent No. 11,788,965, as applied to claim 31 above, and further in view of O’Brien et al. US PG Pub No. 2012/0064566A1 . ‘965 teach a system substantially as claimed, however ‘965 fails to recite further comprising an ultrasound pulser/receiver coupled to the transducer and configured to receive and amplify the acoustic signal. However, see O’Brien et al., cited in detail previously above, O’Brien et al. and the cited prior art teach a system comprising a transducer described as comprising an ultrasound pulser/receiver configured to receive an amplify the acoustic signals (see described at para [0026], referring to Figure 1, any piezoelectric material or other non-piezoelectric sound sensor). Although ‘965 is silent as to this feature, it would have been prima facie obvious to have provided the transducer comprising an ultrasound pulser/receiver in order to accommodate detection of the photoacoustic waves to be detected at the transducer (see as in O’Brien et al.). One having ordinary skill in the art would have a reasonable expectation of success because like ‘965, O’Brien is teaching a transducer provided as part of a photoacoustic detection system to achieve photoacoustic detection of target. Regarding claim 34, see O’Brien et al. as evidenced by O’Brien et al., showing the tube with flow of sample placed longitudinally across the chamber (both cited previously above). It would have been prima facie obvious that the window be positioned perpendicular to the longitudinal axis defined by the tube because this is a position that would allow access to the tube by the transducer (as shown by O’Brien et al., as evidenced by O’Brien et al.). One having ordinary skill in the art would have a reasonable expectation of success because this would allow the transducer access to the tube in order to receive the necessary acoustic waves. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm. 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, Bao-Thuy Nguyen can be reached at 571-272-0824. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677 Application/Control Number: 18/455,470 Page 2 Art Unit: 1677 Application/Control Number: 18/455,470 Page 3 Art Unit: 1677 Application/Control Number: 18/455,470 Page 4 Art Unit: 1677 Application/Control Number: 18/455,470 Page 5 Art Unit: 1677 Application/Control Number: 18/455,470 Page 6 Art Unit: 1677 Application/Control Number: 18/455,470 Page 7 Art Unit: 1677 Application/Control Number: 18/455,470 Page 8 Art Unit: 1677 Application/Control Number: 18/455,470 Page 9 Art Unit: 1677 Application/Control Number: 18/455,470 Page 10 Art Unit: 1677 Application/Control Number: 18/455,470 Page 11 Art Unit: 1677 Application/Control Number: 18/455,470 Page 12 Art Unit: 1677 Application/Control Number: 18/455,470 Page 13 Art Unit: 1677 Application/Control Number: 18/455,470 Page 14 Art Unit: 1677