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 .
Applicant’s amendments and remarks filed on 01/12/2026 have been fully considered.
Claims 1-20 are pending for examination.
Claim Rejections - 35 USC § 103
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.
Claims 1-7 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Switz et al., “Low-Cost Mobile Phone Microscopy with a Reversed Mobile Phone Camera Lens,” PLoS One 9(5), e95330 (2014) - cited in previous action, and further in view of Mullani (USPN 7,167,244 – applicant cited). In regard to claim 1, Switz discloses a system (Figs. 1-4 and associated descriptions) comprising: an image capture device (mobile phone with camera, Figs. 1-4 and associated descriptions; iPhone 4S with camera, page 2); a capillaroscope attachable to the image capture device (microscope attachment with LED, Figs. 1-4 and associated descriptions), the capillaroscope comprising: a light source (LED, Figs. 3-4 and associated descriptions) provides light to a sample such that the sample-transmitted light captured by the capillaroscope has entered a focal plane of the capillaroscope (Figs. 2A, 3A and 4A and associated descriptions); a reverse lens through which the sample-transmitted light passes therethrough (reverse lens, Figs. 1-4 and associated descriptions); and one or more telescopic lenses (lens elements, Fig. 2 and associated descriptions) through which the illumination passes therethrough to a lens of the image capture device after passing through the reverse lens (any lens element(s) in the phone camera, Fig. 2 and associated descriptions).
Switz does not specifically discloses the light source configured to provide offset light at an angle and location offset from a horizontal optical axis of the capillaroscope such that remitted light captured by the capillaroscope has entered the focal plane of the capillaroscope at a net oblique angle remitted light.
Mullani teaches a dermoscopy device (Figs. 1-11 and associated descriptions) comprises a light source (at least one of elements 46, Fig. 9 and associated descriptions) provides offset light at an angle and location offset from a horizontal optical axis of the dermoscopy to a target (elements 46 and a horizontal optical axis at the normal of element 32, Fig. 9 and associated descriptions; skin, abstract and Col 9 lines 11-28) such that remitted light for the skin has entered a lens of the dermoscopy at a net oblique angle (lens, Figs. 9 and 11 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the light transmission configuration (Switz) with the light reflection configurations and associated elements/functions as taught by Mullani to yield predictable results, since both devices are microscopy systems and one of ordinary skill in the art would have recognized that reflection configuration is an alternative equivalent configuration in microscopy/ imaging. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claims 2-4, Switz as modified by Mullani discloses the image capture device is a portable device or a mobile phone or a handheld phone (mobile phone with camera, Figs. 1-4 and associated descriptions; iPhone 4S with camera, page 2 of Switz).
In regard to claim 5, Switz as modified by Mullani discloses all the claimed limitation except the capillaroscope further comprises a beam splitter configured to direct light from the light source to provide the offset light. However, one of ordinary skill in the in art would have recognized that a beam splitter facilitates changing the light emission angle and allowing the light source being arranged at different locations of a imaging device (e.g. Fymat et al., USPGPUB 2008/0086057 – cited in previous action, and Fletcher et al., USPGPUB 2011/0009163 – cited in previous action).
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 light source of the system to incorporate a beam splitter in order to change the light emission angle with respect to the configuration/ orientation of the light source.
In regard to claim 6, Switz as modified by Mullani discloses the light source is angled towards a patient site and circumvents the reverse lens (Figs. 9 and 11 and associated descriptions; skin, abstract and Col 9 lines 11-28 of Mullani).
In regard to claim 7, Switz as modified by Mullani discloses the capillaroscope further comprises one or more beam conditioning components to receive light from the light source or the remitted light (one or more lens elements in the reverse lens attachment, Fig. 2 and associated descriptions of Switz).
In regard to claim 15, Switz as modified by Mullani discloses the image capture device is configured to acquire data in a burst mode (imaging function(s) of iPhone 4S, page 2 of Switz) to allow short windows of high-speed video to be captured (the function(s) recited after “allow” is considered as intended uses which have insufficient patentable weights; imaging function(s) of iPhone 4S, page 2 of Switz).
In regard to claim 16, Switz as modified by Mullani discloses a cap that is positioned around the outside of the reverse lens, wherein the cap is disposable or cleanable between uses (elements 28 and 32, Figs. 9 and 11 and associated descriptions of Mullani).
In regard to claim 17, Switz as modified by Mullani discloses the cap provides a suction to stabilize the capillaroscope during use (glass faceplate 32, Figs. 9 and 11 and associated descriptions; glass faceplate and oil emersion, Col 9 lines 11-28 of Mullani).
Claims 8-12, 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Switz and Mullani as applied to claims 1-7 and 15-17 above, and further in view of Demirci et al. (USPGPUB 2019/0197294 – cited in previous action). In regard to claims 8-12 and 19, Switz as modified by Mullani discloses zoomed image of a blood smear with blood cells (Fig. 4E and associated descriptions of Switz) and provides feedback to a user as to a best position of the capillaroscope to acquire accurate measurements (iPhone camera and real-time display function of unfocused and focused image, iPhone 4S with camera, page 2 of Switz) but does not specifically disclose a processor that outputs an operational blood count data as input to a diagnostic workflow to execute the diagnostic workflow based on the remitted light that passes through the lens of the image capture device; the diagnostic workflow is executed using a trained neural network; the trained neural network is trained using supervised, unsupervised, or semi-supervised training; the diagnostic workflow includes at least one of: cellular volume determination to determine complete blood count; sickle cell analysis; blood cell concentration determination; hematocrit determination; or hemoglobin concentration determination; the operational blood count includes at least one of: complete blood count (CBC) data; blood cell masks; viscosity of blood cells; rolling/stickiness of blood cells; blood cell distribution width for sepsis; or temporal trends of blood cell behavior; the image capture device comprises an application that produces a user interface that shows images captured by the capillaroscope, provides feedback to a user as to a best position of the capillaroscope to acquire accurate measurements, and display results produced by the diagnostic workflow.
Demirci teaches a smartphone camera based imaging/ diagnostic system (Figs. 7-9 and associated descriptions) comprises a processor that outputs an operational blood count data as input to a diagnostic workflow to execute the diagnostic workflow based on the light that passes through a lens of an image capture device (processor, [0008]; software application, [0009]; [0011]; [0013]; complete blood count, a red blood cell count, a white blood cell count, a platelet count, or any combination thereof, [0011]; [0013]; lens and imaging capture device, Fig. 7 and associated descriptions); the diagnostic workflow is executed using a trained neural network (neural network, [0011], [0013] and [0130-0131]; the trained neural network is trained using supervised, unsupervised, or semi-supervised training ([0011] and [0013]); the diagnostic workflow includes at least one of: cellular volume determination to determine complete blood count; sickle cell analysis; blood cell concentration determination; hematocrit determination; or hemoglobin concentration determination ([0011] and [0013]); the operational blood count includes at least one of: complete blood count (CBC) data; blood cell masks; viscosity of blood cells; rolling/stickiness of blood cells; blood cell distribution width for sepsis; or temporal trends of blood cell behavior ([0011] and [0013]); the image capture device comprises an application (application, [0011] and [0013]) that produces a user interface that shows images captured by the capillaroscope (display result images, [0144]; Figs. 23A-B and 25 and associated descriptions), and display results produced by the diagnostic workflow (display results, [0144]; Figs. 23A-B and 25 and associated descriptions).
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 system (Switz as modified by Mullani) to incorporate the above mentioned features of the smartphone as taught by Demirci, since both systems are smartphone-based imaging devices and one of ordinary skill in the art would have recognized that the features as taught by Demirci improves the imaging/ diagnostic functions of the smartphone. The rationale would have been to improve the imaging/ diagnostic functions and to obtain more tissue information form the target.
In regard to claim 19, Switz as modified by Mullani and Demirci discloses a system (referring to claim 1 above) comprising: a capillaroscope attachable to an image capture device (referring to claim 1 above), the capillaroscope comprising: a light source configured to provide offset light at an angle and location offset from a horizontal optical axis of the capillaroscope such that remitted light captured by the capillaroscope has entered the focal plane of the capillaroscope at a net oblique angle (rejected as best understood, see the 35 USC 112(b) rejection above; referring to claim 1 above); a reverse lens through which the remitted light passes therethrough (referring to claim 1 above); one or more telescopic lenses through which the remitted light passes therethrough to a lens of the image capture device after passing through the reverse lens (referring to claim 1 above); and a processor that outputs an operational blood count data as input to a diagnostic workflow to execute the diagnostic workflow based on the remitted light that passes through the lens of the image capture device (referring to claims 1 and 8 above).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Switz and Mullani as applied to claims 1-7 and 15-17 above, and further in view of Liu et al. (CN 104224135 – applicant cited). In regard to claim 13, Switz as modified by Mullani discloses all the claimed limitations except a light guide that couples output light from the light source to a patient site and a relay lens system that couples reflected light from the patient site to the reverse lens.
Liu teaches a microcirculation imaging device (Figs. 1-2 and associated descriptions) comprises a light guide that couples output light from the light source to a patient site (elements 204/205, Fig. 2 and associated descriptions) and a relay lens system (element 209, Fig. 2 and associated descriptions) that couples reflected light from the patient site to a detection system (elements 211/212, Fig. 2 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the light source configuration (Switz as modified by Mullani) with the light guide(s) and relay lens configurations as taught by Liu to yield predictable results, since both systems are tissue imaging devices and the light guide(s) and relay lens configurations are alternative equivalent optical imaging components for directing light and collect reflected light (see Liu). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claim 20, Switz as modified by Mullani and Liu discloses a system (referring to claim 1 above) comprising: an image capture device (referring to claim 1 above) comprising a light source (referring to claim 1 above); a light guide that provides light from the light source to a patient site (referring to claim 13 above); a capillaroscope attachable to the image capture device (referring to claim 1 above), the capillaroscope comprising: a reverse lens through which remitted light from the patient site passes therethrough (referring to claim 1 above); and one or more telescopic lenses (referring to claim 1 above) through which oblique illumination passes therethrough to a lens of the image capture device after passing through the reverse lens (referring to claim 1 above; Figs. 1-4 and associated descriptions of Switz; in the reflection configuration, the skin surface reflects and scatters the illumination light at all directions and passing through the lens, Fig. 9 and associated descriptions of Mullani).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Switz and Mullani and Demirci as applied to claims 8-12, 14 and 19 above, and further in view of Toofan (USPGPUB 2009/0018414 – cited in previous action). In regard to claim 18, Switz as modified by Mullani and Demirci discloses the image capture device is configured to acquire images at different focal planes/ depths during use (iPhone 4S and associated imaging functions, page 2 of Switz; Figs. 7-9 and associated descriptions of Demirci) and a diagnostic workflow for analyzing cells for diagnosis (referring to claim 8 above) but does not specifically discloses produce three-dimensional data that is used by a diagnostic workflow for analyzing 3D cells.
Toofan teaches an imaging device (Figs. 1-2 and associated descriptions) comprises an image capture device (element 8, Figs. 1-2 and associated descriptions) is configured to acquire images at different depths during use and produce three-dimensional data that is used by a diagnostic workflow for analyzing 3D information ([0042]).
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 system (Switz as modified by Mullani and Demirci) to incorporate the 3D imaging generation/ reconstruction function(s) as taught by Toofan, since both systems are tissue imaging devices and one of ordinary skill in the art would have recognized that 3D image can be obtained by slices of images at different focal depths (see Toofan). The rationale would have been to obtain 3D information of the tissue site.
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed on 01/12/2026, with respect to claims 1-20 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-20 have been withdrawn.
Applicant's arguments filed on 01/12/2026 have been fully considered but they are not persuasive. In regard to claims 1, 19 and 20, applicant alleged that Switz does not teach or suggest the amened features. In response, the combination of Switz and Mullani discloses the limitations of the amended claims 1, 19 and 20 (see above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ntziachristos et al. (USPGPUB 2020/0355604) teaches a microscopy system (Figs. 1 and 2 and [0074]) and indicates that the reflection configuration with angled illumination is an alternative equivalent configuration as compared to transmission configuration in microscopy (Figs. 1-2 and [0074] ).
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 CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791