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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-12, directed to portable multispectral imaging device, classified in (A61B5/0077).cpc.
Claims 13-18, directed to method for positioning a portable multispectral imaging device, classified in (G01S17/08 or A61B2090/061).cpc.
Claims 19-20, directed to method for calibrating a light source unit of a portable multispectral imaging device, classified in (A61B2560/0223).cpc.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case process as claimed can be practiced by another and materially different apparatus or by hand (hence, as process does not require the particulars of the apparatus e.g., a light source unit comprising an array of LEDs radially disposed around the light sensor for illuminating the ROI of the tissue surface during image capture, etc.).
Inventions I and III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case process as claimed can be practiced by another and materially different apparatus or by hand (hence, as process does not require the particulars of the apparatus e.g., a light source unit comprising an array of LEDs radially disposed around the light sensor for illuminating the ROI of the tissue surface during image capture, etc.).
Inventions II and III are related as subcombinations disclosed as usable together in a single combination. The subcombinations are distinct if they do not overlap in scope and are not obvious variants, and if it is shown that at least one subcombination is separately usable. In the instant case, subcombination III has separate utility such as system calibration. See MPEP § 806.05(d).
The examiner has required restriction between subcombinations usable together. Where applicant elects a subcombination and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Toni Orsi on 1/12/2026 a provisional election was made without traverse to prosecute the invention of Invention II, claims 13-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-12 and 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Interpretation
Claims recite the newly amended limitation of “determining whether the distance is within the target distance range” which in an interpretation it may be construed as a conditional limitation where the limitations followed by the conditional limitations may not be given a full weight in light of the below decisions as for considering the other case scenario of “the distance” not being “within the target distance range”.
Claim 16 also recites similar conditional limitation.
In the recent Ex parte Gopalan decision, the PTAB addressed a claim where all of the features were recited in a conditional manner. A first step of “identifying … an outlier” was performed if “traffic is outside of a prediction interval.” A second step of “identifying” was performed “only when a count of outliers … is greater than or equal to two, and exceeds an anomaly threshold.” These were the only two elements of the independent claim. Thus, if the traffic is never outside Gopalan’s prediction interval, then the steps of the method are never performed.
However, the PTAB distinguished Schulhauser and noted that this construction “would render the entire claim meaningless.” Gopalan at p. 5. The Board went on to state, “Although each of these steps is conditional, they are integrated into one method or path and do not cause the claim to diverge into two methods or paths, as in Schulhauser. Thus, we conclude that the broadest reasonable interpretation of claim 1 requires the performance of both steps…” Id. at p. 6.”
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 13-14 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta et al (US20200364862A1) in view of Dacosta ‘671 (US20220061671A1).
Regarding claim 13, Dacosta teaches method for positioning a portable multispectral imaging device within a target distance range relative to a surface for imaging a region of interest (ROI) of the surface (“fluoresce with a unique spectral signature when subjected to excitation light with a known wavelength or range of wavelengths” abst; “methods and analyses described could be used to analyze other colors or spectral wavelengths of fluorescence to identify bacterial load or other parameters associated with a given fluorescence wavelength” [0068]), wherein the method comprises:
determining a distance between the portable multispectral imaging device and the ROI of the surface (“device may include a system or device 8 such as a rangefinder or other means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10” [0041]);
determining whether the distance is within the target distance range (“a range finder LED system 205 indicating an optimal distance from the wound being targeted or imaged” [0045]);
generating a signal indicating to a user that the portable multispectral imaging device (“a rangefinder or other means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10. For example, the device may use two light sources, such as two laser diodes, as part of a triangulation apparatus to maintain a constant distance between the device and the object 10. …structure 9 (e.g., a pivot) to permit the manipulation and orientation of the excitation light sources 5, 8 so as to position these sources 5,8 to change the illumination angle of the light striking the object 10 for varying distances.” [0041]; “a range finder LED system 205 indicating an optimal distance from the wound being targeted or imaged, an ambient light status LED 206 for indicating an optimal lighting environment for fluorescence mode imaging” [0044]); and
triggering an image capturing sequence when the portable multispectral imaging device is within the target distance range (“device 200 further includes LEDs 212 that have specific wavelengths or ranges of wavelengths for illuminating targets when in fluorescence imaging mode, as well as a camera lens 213 enabling image and video capture, a range finder sensor 214 for detecting an optimal distance from a wound or surrounding skin, and an ambient light sensor 215 for detecting optimal lighting conditions for the fluorescence imaging mode.” [0045]).
Dacosta does not point out the specifics of if device is not within the target distance range and providing instructions to the user to guide that the user for repositioning the device.
However, in the same field of endeavor, Dacosta ‘671 teaches device for illuminating a subject with light of a calibrated intensity and for capturing closeup fluorescence digital images including an optical rangefinder that the rangefinder value is presented to the user via the display screen where the user may set the intensity of the light on the subject by adjusting the height of the device from the subject according to the rangefinder value on the screen and capture an image [0144].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with if device is not within the target distance range and providing instructions to the user to guide that the user for repositioning the device as taught by Dacosta ‘671 because it would be desirable if such cells could be monitored in a minimally-invasive or non-invasive way ([0009] Dacosta ‘671).
Regarding claim 14, Dacosta teaches wherein determining the distance between the portable multispectral imaging device and the ROI of the surface comprises:
obtaining, from a distance sensor, at least one measurement of the distance between the portable multispectral imaging device and the surface (“a range finder sensor 214 for detecting an optimal distance from a wound or surrounding skin,” [0045]).
Regarding claim 17, Dacosta teaches wherein generating the signal indicating that the portable multispectral imaging device is not within the target distance range from the tissue region comprises generating one of: a signal indicating that the device is too close to the tissue region or a signal indicating that the device is too far from the tissue region (“a range finder LED system 205 indicating an optimal distance from the wound being targeted or imaged” [0044]; “ device 8 such as a rangefinder or other means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10. For example, the device may use two light sources, such as two laser diodes, as part of a triangulation apparatus to maintain a constant distance between the device and the object 10. Other light sources may be possible. The device may also use ultrasound, or a physical measure, such as a ruler, to determine a constant distance to maintain. The device may also include a structure 9 (e.g., a pivot) to permit the manipulation and orientation of the excitation light sources 5, 8 so as to position these sources 5,8 to change the illumination angle of the light striking the object 10 for varying distances.” [0041]).
Further, Dacosta ‘671 also teaches the rangefinder value is presented to the user via the display screen … adjusting the height of the device from the subject according to the rangefinder value on the screen… [0144].
Regarding claim 18, Dacosta teaches wherein the method further comprises generating and displaying a distance indicator that is shown on a display to aid the user in positioning the portable multispectral imaging device (“a range finder LED system 205 indicating an optimal distance from the wound being targeted or imaged” [0044]; “ device 8 such as a rangefinder or other means (e.g., use of compact miniature laser diodes that emit a collimated light beam) to measure and determine the distance between the imaging device and the object 10. For example, the device may use two light sources, such as two laser diodes, as part of a triangulation apparatus to maintain a constant distance between the device and the object 10. Other light sources may be possible. The device may also use ultrasound, or a physical measure, such as a ruler, to determine a constant distance to maintain. The device may also include a structure 9 (e.g., a pivot) to permit the manipulation and orientation of the excitation light sources 5, 8 so as to position these sources 5,8 to change the illumination angle of the light striking the object 10 for varying distances.” [0041]).
Further, Dacosta ‘671 also teaches the rangefinder value is presented to the user via the display screen … adjusting the height of the device from the subject according to the rangefinder value on the screen… [0144].
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta in view of Dacosta ‘671 and further in view of Tan et al (US 20230384433)
Regarding claim 15, the above noted combination teaches all the claimed limitations except for wherein the distance sensor is a light detection and ranging (LIDAR) sensor.
However, in the same field of endeavor, Tan teaches an optical range finding device and an optical range finding method (abst). Light detection and ranging, lidar, has been proposed as a range finding mechanism [0003].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with LIDAR as taught by Tan because it helps to overcome the complex and expensive entangled photon pair source, with associated multiple points-of-failure of the existing technology ([0003] of Tan).
Regarding claim 16, the above noted combination teaches all the claimed limitation.
Specifically, Dacosta teaches device 200 further includes LEDs 212 that have specific wavelengths or ranges of wavelengths for illuminating targets when in fluorescence imaging mode, as well as a camera lens 213 enabling image and video capture, a range finder sensor 214 for detecting an optimal distance from a wound or surrounding skin, and an ambient light sensor 215 for detecting optimal lighting conditions for the fluorescence imaging mode [0045]. Spatio-temporal co-registration may be performed to correlate a plurality of images to provide more detailed analyses for a specific wound, characteristic, or patient, such as tracking a change or growth of specific characteristics [0076].
Further, in the same field of endeavor, Tan also teaches an optical range finding device and an optical range finding method (abst). Light detection and ranging, lidar, has been proposed as a range finding mechanism [0003]. [0039] The timing position of the peak signal in this histogram, i.e. the two-photoevent coincidence distribution, corresponds to the time-of-flight of the probe beam to and from the target 108, from which the distance, d, can then be determined. In other words, this histogram will show a peak associated with the same (to within the measurement uncertainty) time difference between the correlated photon pairs (within the filtered band) as a result of the specific delay caused by the additional (2*distance, d) travelled by the photons in the reflected probe beam 122. This step corresponds roughly to the peak finding process when using a traditional lidar scheme when modulating the light source with a pseudorandom pattern [0039].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with temporal filter to obtain a filtered distance measurement and wherein determining whether the distance is within the target distance range as taught by Tan because it helps to overcome the complex and expensive entangled photon pair source, with associated multiple points-of-failure of the existing technology ([0003] of Tan).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Farooq et al (US 20190104980).
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797