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 12/12/2025 have been fully considered but they are not persuasive.
The Applicant argues “The fluorescent strip of Dacosta does not contain volumetric portions for each fluorescent ink color. The strip of Dacosta contains four spots having no volume. It is essentially two-dimensional and quite small such that it can be arranged adjacent a wound.” The Examiner disagrees and respectfully submits the following the portions for each fluorescent ink color are indeed “volumetric” and exist in more than a 2D plane, because Dacosta sets forth at paragraph [0100] that the strip may be “impregnated” with fluorescent ink color. DaCosta discloses at paragraph [0100] that the substrate is a “standard strip” that acts as the main body. To impregnate this main body means to diffuse into and fill the interstices of the main body. This is quite clearly a 3D process, and not just a 2D coating. When the ink impregnates the substrate, it travels into the depth of the main body, therefore, the ink does not sit just on the main body, it resides within a defined volume of the body.
It would have been obvious to a person of ordinary skill in the art that a test strip “impregnated” with ink, as disclosed in Dacosta, comprises “volumetric portions”. A skilled artisan would have recognized that test strip substrates are physical objects with a defined thickness/depth are not dimensionless surfaces. Therefore, the process of impregnation of ink into the test strip, which necessitates both ink on the surface for viewing, and additional ink being absorbed and/or impregnated into the test strip would occupy a specific three-dimensional space define by the area of application and depth of penetration. Consequently, an impregnated section is a “volumetric portion” of the main body.
The Applicant argues that Davis is non-analogous art and provides no reasons to modify Dacosta’s calibration strip to include the claimed translucent forth sector. The Examiner disagrees and submits that Davis is analogous art under BRI because both references address the same general problem: providing repeatable optical access to regions on/within a strip while mainlining physical protection and stable conditions. Under BRI, a transparent protective layer, backing, or window is a translucent material arranged in a main body when incorporated as part of the calibration strip assembly. Davis explains that the transparent backing lies between the test strip and the viewing apertures and can “act as a seal against the ingress of moisture”, and further notes transparent inserts can increase security against ingress. Dacosta’s strip is expressly used in the field during imaging for calibration, so a skilled artisan would have been motivated to incorporate Davis’s transparent protective structure to improve durability, handling, and repeatability of the calibration target using in clinical imaging. Therefore, the Applicant’s “non-analogous/no motivation” arguments are not persuasive because Davis expressly teaches translucent structural regions used to enable viewing while protecting the strip, and Dacosta expressly teaches a strip used for optical calibration in a field of view.
The Applicant argues that a person of ordinary skill in the art would not use Zhang as a modifying reference because Zhang is drawn to a “microscopic” bead structure. The Examiner disagrees and respectfully submits that both Davis and Zhang reside within the same field of calibration targets for fluorescent optical system and a skilled artisan designing a calibration target for would look to all fluorescence calibration standards to identify effective geometric patterns. Finding that concentric rings (as taught by Zhang) are effective for calibrating cameras (see Zhang col. 1, lines 10-15), and a skilled artisan would have found it obvious to provide such a calibration standard. The pattern is the teaching, not the size. Furthermore, it is noted that the Applicant’s arguments are not commensurate in scope with the claimed invention, because the claimed invention is completely silent regarding any size, whether it be macro, micro, or somewhere in between.
The Applicant argues that Zhang’s “rings” are “3D internal shells” inside a sphere and do not “extend parallel to the front surface” as claimed. The Examiner disagrees and respectfully submits that when a spherical shell is viewed or imaged from the “front”, the equatorial slice or the projected shell effectively forms a layer/ring that extends parallel to the focal plane. Even if the bead is spherical, when viewed or imaged from the front, the perspective would be a planar configuration. A skilled artisan would have recognized that such a pattern could be used on the planar target of Dacosta for the motivational purpose of calibrating cameras.
The Applicant argues that the choices of green and red dyes in Zhang is merely chemical and does not suggest a specific spatial arrangement. The Examiner disagrees and respectfully submits that Zhang teaches that green and red are standard, distinct channels used in fluorescence calibration to check for chromatic aberration (color shift). Furthermore, it is noted that Dacosta discloses the device (calibration strip), Davis teaches that structure (sectors) and Zhang was introduced to teach optimization (i.e., using concentric red/green zones to calibrate alignment and aberration). It would have been obvious to a skilled artisan to arrange the fluorescent materials of Dacosta in view of Davis in the concentric red/green pattern of Zhang to a achieve the predictable benefit of simultaneous multi-channel calibration and alignment verification, which Zhang teaches is the purpose of such patterns.
The rejections are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4 and 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20110117025 A1 to Dacosta et al. (hereinafter, Dacosta).
Regrading Claim 1, Dacosta discloses a calibration unit for the calibration of a macroscopic medical imaging device, comprising inter alia:
a main body having a front surface being configured for being optically oriented towards the imaging device (paragraph [0100] “…a disposable simple fluorescent standard `strip` may be placed into the field of view during wound imaging…”), wherein
a fluorescent material of a first type is arranged in a first sector of the main body, the first section being a volumetric portion of the main body (paragraph [0100] “…strip may be impregnated with one or several different fluorescent dyes of varying concentrations which may produce pre-determined and calibrated fluorescence intensities when illuminated by the excitation light source…”), and
a. wherein a fluorescent material of a second type is arranged in a second sector of the main body, the second sector being a volumetric portion of the main body (paragraph [0100] “…strip may be impregnated with one or several different fluorescent dyes of varying concentrations which may produce pre-determined and calibrated fluorescence intensities when illuminated by the excitation light source…”), the first sector and the second sector being separate from one another and the fluorescent material of the first type being different from the fluorescent material of the second type sector (paragraph [0100] “ The disposable strip may also have the four spots as described above (e.g., each of different diameters or sizes and each of a different fluorescent ink color with a unique black dot placed next to it) from separate indelible fluorescent ink pens.”) and/or
(Optional limitation based on “or” limitation: b. wherein an opaque, non-fluorescent material is arranged in a third sector of the main body, the third sector being separate from each of the first sector and the second sector, the third sector being a volumetric portion of the main body ([0100] “The disposable strip may also have the four spots as described above (e.g., each of different diameters or sizes and each of a different fluorescent ink color with a unique black dot placed next to it)”).
(Claim 4) wherein the main body comprises at least one supplementary sector, wherein the fluorescent material of the first type, the fluorescent material of the second type or the opaque, non-fluorescent material is arranged in the supplementary sector (especially as broadly claimed, the fluorescent material of the first type, the fluorescent material of the second type or the opaque non-fluorescent material may be interpreted as being located on the supplementary sector).
It would have been obvious to a person of ordinary skill in the art that a test strip “impregnated” with ink, as disclosed in Dacosta, comprises “volumetric portions”. A skilled artisan would have recognized that test strip substrates are physical objects with a defined thickness/depth are not dimensionless surfaces. Therefore, the process of impregnation of ink into the test strip, which necessitates both ink on the surface for viewing, and additional ink being absorbed and/or impregnated into the test strip would occupy a specific three-dimensional space define by the area of application and depth of penetration. Consequently, an impregnated section is a “volumetric portion” of the main body.
Regarding Claim 12, Dacosta teaches the calibration unit (28) according to claim 1, wherein at least one of the first sector, the second sector, the third sector, the fourth sector and the supplementary sector comprises a dental restoration material (Dacosta: the device especially as broadly claimed, including respect sensors are a dental restoration material, because the device can be under intraorally in a manner to diagnose and resolve dental issues such an gum disease).
Regarding Claim 13, Dacosta teaches a macroscopic medical imaging calibration system, comprising at least one imaging device, at least one calibration unit according to claim 1, and at least one excitation device, wherein the at least one excitation device is configured to excite fluorescence of the fluorescent material of the first type, and wherein the imaging device is configured to capture excitation emissions of the fluorescent material of the first type (Dacosta: paragraphs [0100], [0127]).
Regarding Claim 14, Dacosta teaches the macroscopic medical imaging calibration device according to claim 13, wherein the imaging device is one of an intra-oral camera, an extra-oral camera and an intra-oral scanner (Dacosta: paragraph [0100] “…a disposable simple fluorescent standard `strip` may be placed into the field of view during wound imaging…”) (Dacosta: types of cameras described in paragraph [0071] which are capable of being used for intra-oral and/or extra-oral camera/scanner applications).
Regarding Claim 15, Dacosta teaches a method of using the calibration unit according to claim 1 for the calibration of a macroscopic medical imaging device, comprising calibrating the macroscopic medical imaging device (Dacosta: paragraph [0100] “… multiple fluorescence emission wavelengths or wavelength bands for image intensity calibration.”).
Regarding Claim 16, Dacosta teaches the calibration unit according to claim 1, wherein the macroscopic medical imaging device is a macroscopic dental imaging device (Dacosta: paragraph [0100] “…a disposable simple fluorescent standard `strip` may be placed into the field of view during wound imaging…”) (Dacosta: types of cameras described in paragraph [0071] are capable of detection of the fluorescent images from the strip, and therefore are especially as broadly claimed, macroscopic dental imaging devices).
Regarding Claim 17, Dacosta teaches the macroscopic medical imaging calibration system according to claim 13, wherein the macroscopic medical imaging calibration system is a macroscopic dental imaging calibration system (Dacosta: paragraph [0100] “…a disposable simple fluorescent standard `strip` may be placed into the field of view during wound imaging…”) (Dacosta: types of cameras described in paragraph [0071] are capable of detection of the fluorescent images from the strip for calibration, and therefore are especially as broadly claimed, macroscopic dental imaging devices).
Regarding Claim 18, Dacosta teaches the method according to claim 15, wherein the macroscopic medical imaging device is a macroscopic dental imaging device (Dacosta: types of cameras described in paragraph [0071] are capable of detection of the fluorescent images from the strip, and therefore are especially as broadly claimed, macroscopic dental imaging devices).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta in view of US 6352862 B1 to Davis et al. (hereinafter, Davis).
Dacosta discloses the calibration unit according to claim 1, including where the fourth sector being separate from each of the first sector, the second sector, and the third sector (paragraph [0100] “The disposable strip may also have the four spots as described above (e.g., each of different diameters or sizes and each of a different fluorescent ink color with a unique black dot placed next to it) from separate indelible fluorescent ink pens.”).
Dacosta does not expressly disclose wherein a translucent material is arranged in a fourth sector.
However, Davis teaches a test strip which is fully enclosed within a housing having a transparent window (col. 5, lines 50-53). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the test strip of Dacosta with the translucent material of Davis, as Davis teaches at col. 5, lines 24-27 that the housing would have protected the strip before use.
Claim(s) 3, 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta in view Davis, and further in view of US 5786219 A to Zhang et al. (hereinafter, Zhang).
Dacosta in view of Davis discloses the calibration unit (28) according to claim 2 including where wherein the front surface coincides with an end surface/face of at least one of the first sector, the second sector, the third sector, and the supplementary sector (the front surface provides the first, second and third sector a substrate to apply the fluorescent material, and the outer boundaries of the front surface including the end surface for the respective sectors, the end surface/face being particular distances to each of the sectors. Dacosta in view of Davis do not expressly disclose wherein at least one of the first sector, the second sector and the third sector is at least partially surrounded by the fourth sector and extend parallel to the front surface, where one of the sectors is cylinder shaped and where the fluorescent material is green and red fluorescent material. However, Zhang teaches multiple fluorescent rings, including green and red (col. 18, lines 16-20) embedded one within another in a cylinder shape (col. 3, lines 11-25) on top of therefore generally parallel to a front surface for the purpose of camera calibration (col. 3, lines 26-32). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the first, second and third sections which contain the first, second and third fluorescent material, as Zhang teaches at col. 1, lines 10-15 that such arrangement of fluorescent rings would have been helpful in calibration of cameras.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791