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 .
Response to Arguments
Applicant’s arguments filed 04/22/2026 with respect to claims 17-21, 25, 28-29, 31, 38-40 have been considered but are moot in view of new grounds of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-21, 25, 28-29, 31, 38-40 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 recites “wherein said arrangement being effective to reduce motion artifacts caused by rotational motions of the handheld laser-based perfusion imaging apparatus induced by a user manually holding the apparatus” This is new matter with respect to the original disclosure. According to the original disclosure (for e.g. see spec pages 4-5), positioning of the center of a spherical wavefront, at or near a pivot point, is required to achieve a sensitivity to the rotational motion. However, instant claim recites that the “said arrangement” i.e., mere arrangement of light source and imaging device, on same side, and generating coherent spherical wavefront, will achieve this result. This is not recited in original disclosure, and hence is new matter. Examiner suggests clearly reciting features as in psec. Pages 4-5, to overcome this particular rejection. For prior art rejection purposes, examiner interprets that the “said arrangement” achieves the claimed effect. The prior art rejections are in view of this interpretation.
Claims 18-21, 25, 28-29, 31, 38-40 recite or encompass this limitation and are rejected for same reasons as above.
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 17-18, 25, 29, 38-39 rejected under 35 U.S.C. 103 as being unpatentable over Munoz [US 20160157725 A1].
As per claim 17, Munoz teaches a handheld laser-based perfusion imaging apparatus (Munoz Fig 10, abstract “Disclosed herein are portable handheld devices”)
comprising a light source (Munoz Fig 10 lasers 120, 130, ¶0132 “laser comprises a VSCEL array or discrete VSCELs”) and
an imaging device (Munoz Fig 10, ¶0132 “IR camera 140 takes a laser speckle image of the region of interest’)
which are arranged in a fixed orientation to each other in said apparatus (Munoz Fig 10, fixed orientation since it is assembled in phone),
wherein the light source is configured for projecting a beam of coherent light onto a measurement field at a distance spaced apart from the apparatus (Munoz Fig 10, ¶0112 “VSCELs provide a substantially coherent light’, ¶0113 “device/system is located in a range of 0 cm to about 20 cm from the region of interest”), and
the imaging device is configured for recording intensity maps of the measurement field (Munoz ¶0120-¶0121 “acquiring raw laser speckle images, … processing the raw laser speckle image/data, thermal image/data, and/or a digital picture to provide a microvascular analysis (e.g., a three dimensional reconstruction of the microvascular) of the region of interest,” speckle data and patterns includes intensity information for reconstruction),
wherein the light source and the imaging device are arranged facing the same side of the measurement field (Munoz Fig 10, implied arrangement),
wherein the light source comprises one or more optical components arranged for configuring the beam of coherent light (Munoz ¶0112)
Munoz does not expressly teach a spherical wavefront at the measurement field, wherein the wavefront is convex towards the measurement field, and wherein said arrangement being effective to reduce motion artifacts caused by rotational motions of the handheld laser-based perfusion imaging apparatus induced by a user manually holding the apparatus.
However, Munoz teach a spherical wavefront at the measurement field, wherein the wavefront is convex towards the measurement field (Munoz ¶0076, ¶0113 discloses variations for the invention, using a diffuser lens with a divergence angle between source and ROI. This output divergent beam will have a spherical wavefront, with convex wavefront shape as described by the applicant all throughout the spec. For e.g. see discussion with respect to Figs 2 and 3)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus sin Munoz Fig 10 by utilizing a diffuser lens so as to provide a uniform coherent light to the region of interest (Munoz ¶0113).
Munoz does not expressly recite wherein said arrangement being effective to reduce motion artifacts caused by rotational motions of the handheld laser-based perfusion imaging apparatus induced by a user manually holding the apparatus. However, since the arrangement as claimed would have been obvious as discussed above, any effect / effectiveness that results in the arrangement would be obvious also. In this case, the arrangement using a diffuser with the setup of Fig 10 in Munoz would provide same result of reduce motion artifacts as claimed.
As per claim 18, Munoz further teaches wherein the one or more optical components are configured to position a center of the spherical wavefront at or near a pivot point of said handheld laser-based perfusion imaging apparatus and/or a pivot point of a user of said handheld laser-based perfusion imaging apparatus (Munoz Figs 9-10, any wave emanating from the laser 120/130 of the handheld device 200 will be near a pivot point when user holds the device, since the hands are placed on the device for holding ).
As per claims 25, 29 have limitations similar to claim 17 and are rejected for same reasons as above. Munoz further teaches LSCI (Munoz ¶0017, ¶0084).
As per claim 38, Munoz further teaches wherein further comprising a grip or a handle for holding the apparatus, wherein the pivot point is arranged near the grip or handle in a manner effective to reduce motion artifacts caused by rotational movement of the apparatus around the pivot point (Munoz Fig 1 sidewall 230 of cradle 210 is a grip. The pivot point will be near the cradle when the handheld device is held).
As per claim 39, Munoz further teaches wherein the one or more optical components are configured to position a center of the spherical wavefront at or near a wrist joint, and elbow joint, and a shoulder joint of a user holding the apparatus (Munoz Fig 9, laser source approximate to handheld device and hence wavefront will be near the wrist).
Claims 19 rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claim 17 above and further in view of Villeneuve [US 5825792 A].
As per claim 19, Munoz does not expressly teach wherein the one or more optical components comprises a single mode optical fibre, which is configured for emitting a diverging light beam.
Villeneuve, in a general field of laser emission and control teaches wherein the one or more optical components comprises a single mode optical fibre, which is configured for emitting a diverging light beam (Villeneuve Col 5 lines 22-27 “The assembly comprises a divergent source 12 of laser emission, that is, a semiconductor laser facet 14 of a DFB laser, as shown, or alternatively an output facet of a single mode fibre (SMF).”).
As per MPEP section 2143.1, example of rationales that may support a conclusion of obviousness include (B) simple substitution of one known element for another to obtain predictable results. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Wang, by substituting an SMF, for generating a divergent beam, in Munoz. The substituted elements would have functioned in similar way to obtain the predictable results of generating divergent or spherical waves.
Claim 20 rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claim 17 above, and further in view of AAPA [Applicant Admitted Prior Art, Spec. page 6 lines 5-10].
As per claim 20, Munoz does not expressly teach wherein the one or more optical components comprises a focussing lens and a pinhole aperture arranged at a position where the focussing lens focusses the beam of coherent light.
AAPA teaches a focussing lens and a pinhole aperture arranged at a position where the focussing lens focusses the beam of coherent light (AAPA page 6 lines 5-10 “assemblies comprising a focussing lens and a pinhole aperture, are known in the art.”).
As per MPEP section 2143.1, example of rationales that may support a conclusion of obviousness include (B) simple substitution of one known element for another to obtain predictable results. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Wang, by substituting a focusing lens / pinhole arrangement, as in AAPA, for generating a divergent beam, in Munoz. The substituted elements would have functioned in similar way to obtain the predictable results of generating divergent or spherical waves.
Claim 21 rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claim 17 above, and further in view of Bass [US 20020015218 A1]
As per claim 21, Munoz does not expressly teach wherein the light source is configured to provide a collimated light beam and wherein the one or more optical components comprises a lens, for converting the substantially collimated light beam in a diverging light beam with a spherical wavefront at the measuring field.
Bass, in a related field of illumination systems, teaches wherein the light source is configured to provide a collimated light beam and wherein the one or more optical components comprises a lens, for converting the substantially collimated light beam in a diverging light beam with a spherical wavefront at the measuring field (Bass Fig 1, ¶0029).
As per MPEP section 2143.1, example of rationales that may support a conclusion of obviousness include (B) simple substitution of one known element for another to obtain predictable results. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Munoz, by substituting lens arrangement as in Bass. The substituted elements would have functioned in similar way to obtain the predictable results of generating divergent or spherical waves.
Claim 28, rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claims 25, above, and further in view of Mannoh [US 20220007997 A1].
As per claim 28, Munoz does not expressly teach wherein the apparatus comprises one or more targeting light sources which are configured to project one or more targeting light beams onto the measurement field.
Mannoh in a related filed of laser speckle contrast imaging teaches wherein the apparatus comprises one or more targeting light sources which are configured to project one or more targeting light beams onto the measurement field (Mannoh Fig 2G item 170, ¶0075).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Munoz by integrating laser 170 as in Mannoh so as to guide a surgeon in positioning the imaging head so that the target of interest in roughly in the center of the field of view (Mannoh ¶0075).
Claim 31 rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claim 17 above, and further in view of Chen [US 20180020932 A1]
As per claim 31, it has limitations similar to claim 17 and rejected for same reasons as above. Munoz does not expressly teach a method for measuring a perfusion in a tissue using a handheld Laser Doppler Perfusion Imaging (LDPI).
Chen teaches handheld device for LDPI (Chen Fig 23, ¶0038, ¶0060)
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Munoz to include algorithms and components for LDPI, so as to provide multispectral imaging system for accurately providing perfusion and blood speed or velocity data where the target is moving (Chen ¶003-¶0005).
Claim 40, rejected under 35 U.S.C. 103 as being unpatentable over Munoz as applied to claims 25, above, and further in view of Ni [US 20210379406 A1]
As per claim 40, Munoz in view of Mannoh does not expressly teach wherein the one or more targeting light sources comprise two cross line laser modules which are configured to illuminate the boundaries of the measurement field.
Ni, in a related medical field of radiotherapy, teaches wherein the one or more targeting light sources comprise two cross line laser modules which are configured to illuminate the boundaries of the measurement field (Ni ¶0004 “horizontal line is marked on the patient's skin near the midline of the body through a laser cross-line on both sides of the CT, and the laser cross-line at the ceiling is provided for marking a vertical line on the skin at the center of the patient's body”).
As per MPEP 2413.I., example of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results. In the instant case the claim is merely directed to include cross lasers as in Ni so as to provide marking on target area. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to make this modification, by adding targeting lasers to handheld device so as to provide predictable result of markings in target area.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797
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