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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rotating table”, “excitation source”, “region of interest”, “fluorescence detector” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both collimator and beam expander in FIG. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because FIGS. 1-2 and 6 contain multiple unidentified structures that are not labeled or identified in some way, and the omitted information is necessary for a proper understanding of the invention. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Please amend the first paragraph of page 28 with to recite:
--In certain embodiments, the sample table or stage is operable to rotate (e.g. about an axis passing through its center), as indicated by right facing-arrow ”
Please replace the paragraph beginning on line 23 of page 28with the following rewritten paragraph:
--Turning to FIG. 3, a series of transillumination images 302, 304, 306, 308, and 310, each corresponding to an angular projection measurement associated with a different illumination angle are shown. The subject under study is a nu/nu mouse, and as seen in image 306, an illuminated region of interest corresponds to a thoracic cavity of the mouse…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-10, 12-13, and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yared (US20070238957).
Regarding claim 1, Yared teaches a method of creating an optical tomographic image of a region of interest of a subject (see abstract, processing method), the method comprising:
(a) directing illumination radiation into the region of interest of the subject at a plurality of illumination angles*, thereby illuminating the region of interest ([0100] the gantry rotates around the subject to provide multiple light beams at multiple positions);
(a) a sample stage configured for mounting the subject (see 236 in FIG. 2);
(b) for each of the plurality of illumination angles, detecting radiation transmitted through the region of interest at a corresponding detection angle, thereby obtaining a plurality of angular projection measurements ([0100] detecting at each angular position images which correspond to multiple source locations positioned at multiple angles in order to produce multiple images depicting multiple angular projections);
(b) a first source (see 122 in FIG. 2) configured to output illumination radiation (see 123 in FIG. 2) into the region of interest of the subject (see 132 in FIG. 2);
(c) determining, by a processor of a computing device (see [0029] a processor for executing the set of instructions stored in the memory), a representation corresponding to a tomographic reconstruction of an optical absorption map of the region of interest ([0031]-[0033] system provides measurement/determination of a tomographic reconstruction of the 3D optical absorption map [0103] processors 154, 156 in FIG. 1 provide data to a solution in the form of a 3D optical absorption map) using data corresponding to the obtained plurality of angular projection measurements ([0031]-[0033] the 3D surface model of the subject provides optical tomography algorithm with the target volume /region of interest [0103] processors 154, 156 in FIG. 1 provide data to a solution in the form of a 3D optical absorption map).
*For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to be inclusive of the plurality of illumination angles with reference to any axial position, whereas the plurality of illumination angles may be made with reference to having any desired origin and/or axial orientation with respect to the subject and may pass through any point within or around or relating to the subject, as known in the tomographic arts.
Regarding claim 2, Yared teaches wherein:
step (a) comprises directing illumination radiation from a first source (see 122 in FIG. 2) and step (b) comprises detecting radiation transmitted through the region of interest at a first detector (see 132 in FIG. 2),
the first source and the first detector are mounted on a rotating gantry operable to rotate about the subject ([0100], FIG. 2, the light source is mounted on a fixed surface away from the rotating gantry, see arrow indicating rotation direction of gantry in FIG. 2), and
wherein the method comprises, for each of a plurality of positions of the rotating gantry, illuminating the region of interest of the subject at a given illumination angle ([0100] the gantry rotates around the subject to provide multiple light beams at multiple positions) and detecting radiation transmitted through the region of interest at the corresponding detection angle, thereby obtaining the plurality of angular projection measurements ([0100] detecting at each angular position images which correspond to multiple source locations positioned at multiple angles in order to produce multiple images depicting multiple angular projections).
Regarding claim 4, Yared teaches wherein step (c) comprises inverting a projection model of radiation transmission from a first source, through the region of interest of the subject, to a first detector at each of the plurality of illumination angles and corresponding detection angles ([0130] the time-dependent fluctuation of the average intensity U at any point in space can be obtained as the Green function that models light propagation within the medium from a point source to a corresponding point detector is known).
Regarding claim 5, Yared teaches wherein inverting the projection model comprises applying an inverse operator of the projection model ([0128], [0130] the inverse problem is solved in which the optical wave-transmitting propagation through the medium are updated to minimize the errors observed between the predicted and measured field) to a plurality of observation values determined using the data corresponding to the plurality of angular projection measurements ([0130] the time-dependent fluctuation of the average intensity U at any point in space can be obtained as the Green function that models light propagation within the medium from a point source to a corresponding point detector is known), thereby determining the optical absorption map of the region of interest ([0108], [0130] electrical signals provided by the data processor 128 can correspond to measured optical data associated with the light 123, 127 which has propagated though the diffusive volume V/region of interest delimited by surface S on the subject 132). Additionally ([0114] the optical absorption map is used in Diffuse Optical Tomography (DOT) to construct a forward problem that is then through direct or iterative techniques used to solve the inverse problem), thereby determining the optical absorption map of the region of interest ([0091]-[0092] a three-dimensional map of a given volume includes a dataset of values of a given quantity of an average optical absorption coefficient and an average optical scattering coefficient for the object being imaged at the wavelengths of imaging that varies in three spatial dimensions throughout the volume).
Regarding claim 6, Yared teaches wherein the projection model is a discretized model that relates (0149]-[0150] as determined by tomography modes including any surface-bounded inversion operators of tissues, the infinite space Green function g is defined above, ΔS(rp) is defined as the discretized surface area at point), for each of the plurality of angular measurements ([0100] the one or multiple images acquired corresponding to one or multiple source locations in raster-scan fashion so that each angular position of the different gantry positions correspond to the multiple angular projections, (i) a value corresponding to an intensity of the detected radiation at the angular measurement ([0150] defined as the average intensity at each surface point of the angular measurements) to (ii) a plurality of optical absorption coefficients ([0033] a collection of absorption coefficients and [0155] μa is the value of each absorption coefficient), each representing optical absorption at a specific point within the region of interest ([0033] a each of the plurality of absorption coefficients corresponding to each of the plurality of segmented regions of the target volume/region of interest in the three-dimensional optical absorption map).
Regarding claim 7, Yared discloses comprising applying a discretized version of the inverse operator of the projection model, wherein the discretized inverse operator of the projection model relates ([0149]-[0150] as determined by tomography modes including any surface-bounded inversion operators of tissues, the infinite space Green function g is defined above, ΔS(rp) is defined as the discretized surface area at point), for each of a plurality of discretized locations representing physical locations in the region of interest ([0150] defined as the average intensity at the surface point), a corresponding value of the optical absorption coefficient ([0155] μa is the corresponding absorption coefficient value), a value of an optical absorption coefficient at the location to at least a portion of the plurality of observation values determined using the data corresponding to the angular projection measurements ([0150] defined as the average intensity at the surface location), thereby determining, for each of the plurality of discretized locations, a corresponding value of the optical absorption coefficient, thereby determining the optical absorption map of the region of interest ([0100] the plurality of observation/images acquired corresponding to one or multiple source locations in raster-scan fashion so that each angular position of the different gantry positions correspond to the multiple angular projections).
Regarding claim 8, Yared teaches wherein step (c) comprises determining the optical absorption map of the region of interest using the data corresponding to the plurality of angular projection measurements ([0100] the one or multiple images acquired for the optical absorption map correspond to the multiple angular projections that are in correspondence with one or multiple source locations in raster-scan fashion so that each angular position of the different gantry positions) and calibration data in order to determine the optical absorption map of the region of interest ([0112], [0114] the measurements corresponding to the excitation light transmitted through the object, or intrinsic light determined in step 910 in FIG. 9 are used to correct/calibrate captured fluorescent measurements such as in the optical absorption map), wherein the optical absorption map is quantitative ([0050], [0052] the optical absorption map visually indicate a spatial distribution of a quantity (e.g., concentration) of at least one of the one or more fluorophores within the target volume/region of interest in the subject).
Regarding claim 9, Yared teaches wherein the calibration data comprises* at least one member selected from the group consisting of:
data corresponding to a power of the source ([0150] the flux detected is defined as the power flowing through a surface S within an interval of time t and has units of power per area per second in the time-domain).
*The limitation has been interpreted in the alternative, requiring only the calibration data comprises only data corresponding to a power of the source; or requiring only the calibration data comprises only data corresponding to measurement(s) of a radiometric configuration of the system; or requiring only the calibration data comprises only data corresponding to an intensity response of the detector.
Regarding claim 10, Yared teaches comprising obtaining a measurement of one or more boundaries representing a surface of the subject about the region of interest ([0093] a three-dimensional surface model of the object is generated to provide the optical tomography algorithm with the boundary conditions necessary for its computation), wherein step (c) comprises determining the optical absorption map of the region of interest using the measurement of the one or more boundaries ([0115] using the boundaries detected so that different parts of the tissue under examination may be delineated for the creation of the optical absorption map).
Regarding claim 12, Yared teaches wherein the optical absorption map is a three dimensional (3-D) map ([0103], [0108], [0127] the anatomical image processor 156 provides the anatomical data in the form of three-dimensional optical absorption map).
Regarding claim 13, Yared teaches wherein the region of interest comprises one or more anatomical organs ([0108] an animal or human subject 132 has internal structures/organs and is not internally homogeneous) and the method comprises processing the absorption map to automatically localize the one or more anatomical organs in the optical absorption map ([0103], [0108], [0127] the anatomical image processor 156 provides the anatomical data in the form of three-dimensional optical absorption map to the solution processor 154 which [automatically] solves for the unknown distribution inside internal structures of subject 132 in order to establish physical positions and characteristics of the internal structures of the object 132 in a specific volume [region of interest] of the three-dimensional optical absorption map).
Regarding claim 16, Yared discloses teaches comprising using the determined optical absorption map to obtain a tomographic representation of a distribution* of a fluorescent emitter within the region of the subject ([0052] the tomographic image(s) visually indicates a spatial distribution of a quantity (e.g., concentration) of at least one of the one or more fluorophores within the target volume of the object).
*The limitation has been interpreted in the alternative, requiring a tomographic representation of a distribution of a fluorescent emitter within the region of the subject; or a tomographic representation of a distribution of a bioluminescent emitter within the region of the subject.
Regarding claim 17, Yared teaches comprising:
(d) illuminating, by an excitation source (122 in FIG. 2), he region of interest with excitation light ([0031] excitation light is directed into the subject), the excitation light having a wavelength corresponding to an excitation wavelength of a fluorescent emitter present in the region of interest ([0023] fluorescent light emitted from the fluorophore(s) inside the subject, [0100] the representative values of the excitation wavelength of the narrow-band light sources 122 corresponding to multiple molecular probes designed for the excitation wavelengths); and
(e) detecting, by a fluorescence detector ([0040] the light detector is or includes a CCD camera and/or a time-gated intensified CCD camera, e.g., an iCCD camera), fluorescent light emitted from the plurality of fluorescent emitters in the region of interest ([0112] fluorescent light emitted by a fluorophore inside the subject are detected), the fluorescence detector responsive to light having a wavelength corresponding to an emission wavelength of the fluorescent emitter present in the region of interest ([0045] the detected fluorescent light is different than the peak wavelength of the excitation light, for example, to facilitate discrimination between the narrow bandwidth excitation and emission light at multiple locations/regions of interest in the subject); and
(f) determining, by the processor, a tomographic representation of the distribution of the fluorescent emitter in the region of interest using data corresponding to the detected fluorescent light and the determined optical absorption map ([0050], [0052] optical absorption map includes absorption coefficients corresponding to a plurality of segmented regions of the target volume/ region of interest of the subject to visually indicate a corresponding spatial distribution map of a quantity (e.g., concentration) of at least one of the one or more fluorophores within the target volume/region of interest of the subject, [0115] the distribution of (μa) absorption coefficients throughout the cavity being imaged is used in the forward model of photon propagation, yielding a more accurate solution to the problem of fluorescence distribution and see a tomographic representation generated in FIG. 9 step 928 which is generated as a result of the output of steps 902-926).
Regarding claim 18, Yared teaches wherein step (d) comprises illuminating the region of interest with excitation light using a plurality of different excitation source positions ([0024], [0100] excitation light beams are directed into the object at multiple/plurality of different positions, e.g., at multiple angles).
Regarding claim 19, Yared teaches wherein step (e) comprises detecting emitted fluorescent light using at a plurality of different fluorescent detector positons ([0094], [0096] each of the one or more light sources 122 projects light 123 toward the subject 132. Portions 127 of the light 123 which pass through the subject 132 are received by one or more light detectors 124, which are adapted to receive fluorescent light generated by fluorophores internal to the subject 132).
Regarding claim 20, Yared teaches wherein step (e) comprises inverting a forward model ([0114] after solving the forward model in the first step, the second step is solved using direct inversion, χ2-based fits, and algebraic reconstruction techniques) that describes (i) excitation light propagation from a point corresponding to an excitation source position to a point corresponding to a position of a fluorescent emitter in the region of interest ([0115] in the forward model of photon/light propagation, yielding a more accurate solution to the problem of fluorescence distribution) and (ii) emission light propagation from the position of the fluorescent emitter to a point corresponding to a fluorescence detector position (see 127 in FIG. 2 ).
Regarding claim 21, Yared teaches comprising using the determined optical absorption map in the forward model ([0114]-[0115] instruction step 924 provides boundary conditions and the optical absorption map provides parameters used in application of DOT principles to construct the forward model).
Regarding claim 22, Yared teaches comprising determining, by the processor, a map of the quantity of the fluorescent emitter in the region of interest using data corresponding to the detected fluorescent light and the determined optical absorption map ([0050], [0052] optical absorption map includes absorption coefficients corresponding to a plurality of segmented regions of the target volume/ region of interest of the subject to visually indicate a corresponding spatial distribution map of a quantity (e.g., concentration) of at least one of the one or more fluorophores within the target volume/region of interest of the subject).
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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yared, in view of Goertzen et al. (Simultaneous molecular and anatomical imaging of the mouse in vivo, hereafter “Goertzen”).
Regarding claim 3, Yared discloses wherein:
step (a) comprises directing illumination radiation from a first source and step (b) comprises detecting radiation transmitted through the region of interest at a first detector [0100] the light source is mounted on a fixed surface away from the rotating gantry),
the subject is mounted on an adjustable table operable to adjust about an axis passing through its center ([0098]-[0099]. FIG. 2, the subject is positioned on the support/table 236 positioned at the isocenter of the rotating gantry configured to move in a linear motion along an axis),
the first source and first detector are mounted in a fixed position about the subject ([0100] the light source is mounted on a fixed surface away from the rotating gantry), and
the method comprises, for each of a plurality of positions of the adjustable table, illuminating the region of interest of the subject at a given illumination angle and detecting radiation transmitted through the region of interest at the corresponding detection angle, thereby obtaining the plurality of angular projection measurements ([0100] the one or multiple images acquired corresponding to one or multiple source locations in raster-scan fashion so that each angular position of the different gantry positions correspond to the multiple angular projections).
The adjustable table configured for mounting the subject as disclosed by Yared is not explicitly disclosed as being a rotating table operable to rotate about an axis passing through its center and configured for mounting the subject.
However, in the same field of endeavor, Goertzen teaches a rotating table operable to rotate about an axis passing through its center and configured for mounting the subject (page 4319, fourth paragraph, FIG. 3, see rotation stage with mouse bed. The central rotating stage is used to rotate the animal in front of the detectors to acquire tomographic information).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Yared with the rotating table configured for mounting the subject to be operable to rotate about an axis passing through its center as taught by in order to acquire data is simultaneously for both the CT and PET systems in a step-and-shoot mode by rotating the object to the appropriate angle for acquiring data (page 4319, fifth paragraph of Goertzen).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yared.
Regarding claim 11, Yared teaches in an alternative embodiment comprising applying one or more denoising filters to the data corresponding to the plurality of angular projection measurements ([0146] using a convergence criterion at iterative steps limits/filters limits are put on the relative change in a value of a function after each plurality of angular projection measurements and limits on new contributions of the new plurality of an angular projection measurement to the overall value of the intensity by selecting a threshold value which can be about twice the value of noise).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the embodiments of modified Yared with the features of an alternate embodiment where applying one or more denoising filters to the data corresponding to the plurality of angular projection measurements provides an adaptive adjustment can be achieved by monitoring the relative change in value of the calculated intensity added by each iteration step and stopping the number of iterations based on a convergence criterion ([0146] of Yared).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yared, in view of Darne et al. (US20160038029, hereafter “Darne”).
Regarding claim 14, Yared substantially discloses all the limitations of the claimed invention, specifically, Yared discloses comprising:
recording at each of a plurality of time points, a corresponding set of a plurality of angular projection measurements ([0024] multiple positions (e.g., at multiple angles)/projection measurements are each acquired by one beam at one point in time); and
for each of the plurality of time points, determining, by the processor, a corresponding optical absorption map of the region of interest using data corresponding to the corresponding set of the plurality of angular projection measurements ([0100] the one or multiple images acquired for the optical absorption map correspond to the multiple angular projections that are in correspondence with one or multiple source locations in raster-scan fashion so that each angular position of the different gantry positions), thereby determining an optical absorption map representing optical absorption in the region of interest at each of the plurality of different time points ([0159] resolves the distribution of times that the detected photons travel into the medium for each of the multiple source-detector pairs is determined), but does not explicitly disclose a plurality of optical absorption maps.
However, in the same field of endeavor of infrared fluorescence imaging, Darne a plurality of optical absorption maps ([0068] the plurality of 2D slices show logarithmic intensity/absorption maps of the fluorophore along with the artifacts generated internal to the reconstructed volume).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Yared with the inclusion of the plurality of optical absorption maps taught by Darne to provide the 2D absorption maps indicate the actual position of the fluorophore ([0068] of Darne) and provide intensity attenuation and phase-shift measurements at multiple-frequencies that can image intrinsic absorption and scattering, and also fluorophore concentration ([0159] of Yared).
Regarding claim 15, modified Yared discloses wherein a temporal separation between each of the plurality of time points is sufficiently small so as to provide video rate images of optical absorption in the region of the subject ([0098] improved scan speed and temporal resolution/small temporal separation, [0102] the detectors are capable of imaging rates are 5-30 frames per second [indicating a rate of high-definition video] at low read-out noise and dynamic range of 2000-4000 or higher).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798