DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 (i.e., changing from AIA to pre-AIA ) 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 6-8, 12-14, 18-20, 24, 26-27 and 29-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benaron et al. (US Patent No. 5,769,791) in view of Salb (US Patent No. 5,408,996) and Brooker (US Pub No. 2008/0116392).
With regards to claims 1, 12-13 and 24, Benaron et al. disclose a medical imaging system comprising:
an imaging device (i.e. “camera”/CCD) including a plurality of pixels (column 27, lines 11-24, referring to a camera capturing an image of the field which is stored as pixels in a memory array; column 13, lines 14-22, referring to the detector (47), which can be a CCD; Figures 1, 4);
an imaging lens optically coupled to the imaging device (column 25, lines 50-53, referring to lenses being used to couple light to a light detector, and thus the lenses would be “optically coupled” to the imaging device/light detector; column 13, lines 11-29, referring to the optical elements for emitting and detecting light including “glass” optical windows (45) and (46), which thus may serve as an imaging lens; Figure 4);
an excitation light source configured to emit an excitation light towards an object in substantially a whole field of view of the imaging device, wherein the plurality of pixels of the imaging device simultaneously collect light fluoresced from the object from substantially the whole field of view (i.e. “entire surgical field”) of the imaging device, and wherein the imaging device is configured to analyze the collected light fluoresced from the object (column 9, lines 22-32, referring to the light source which emits light and is launched into the tissue; column 14, line 67-column 15, line 3, referring to some of the irradiating light is fluorescence; column 4, line 67-column 5, line 3, referring to sensing a wavelength emitted from the tissue in response to the emitted light, e.g., fluorescent wavelength; column 25, line 30-36, referring to fluorescent applications; column 27, lines 11-24, referring to “the entire surgical field is illuminated…A camera captures an image of the field [i.e. “the entire surgical field”] which is stored as pixels in a memory array…The paged memory can be analyzed by a computer to yield colorimetric information about each pixel of the image”, and thus the plurality of pixels of the camera/imaging device can simultaneously collect light fluoresced from the object form substantially the whole field of view/”entire surgical field”, wherein the collected data is further analyzed); and
an image processor (“computer”) in communication with the imaging device, wherein the image processor analyzes an image from the imaging device to determine a cell state and location of pixels having light intensities greater than or equal to a predetermined threshold light intensity (column 27, lines 10-28, referring to a camera capturing an image of the field which is stored as pixels in a memory array, wherein the paged memory can be analyzed by a computer yielding colorimetric information about each pixel of the image, wherein the colorimetric information can be further analyzed for spectral fingerprints of various tissue qualities and wherein pixels which match the spectral fingerprint would be highlighted on a video system, and thus a location of pixels having light intensities (i.e. spectral intensities) equal to a predetermined threshold light intensity (i.e. intensity associated with the “spectral fingerprint”) is determined; column 28, lines 16-34, referring to the colorimetry technique being used to identify endometriosis, wherein the spectral characteristics can be used to decide whether the tissue being interrogated is normal or abnormal (i.e. cell state) distinguishing normal tissue from abnormal tissue and a pathological tissue classification being used to distinguish cancerous tissue from noncancerous and other types of healthy tissue; column 11, lines 20-32; Figures 1, 4);
wherein the medical imaging system is configured: (i) to be hand-held (ii) for in vivo imaging: and (iii) such that an instrument head (40) of the medical imaging system is configured to contact a tissue of the object during at least one operating mode of the imaging device (column 1, lines 25-29, referring to the sensors of the invention being for in vivo measurements of body tissues; column 10, lines 28-46, referring to the tool including a handle (32), wherein the handle (32) also includes the usual electronics, imaging equipment, signal paths, circuits and/or logic for operating the tool to perform its intended functions, and thus the medical imaging system is configured to be hand-held via the handle; column 4, lines 32-37, referring to the instrument having a probe member for contacting tissue and a plurality of optical components disposed on the member for non-destructive interrogation of tissue proximate to the member; Figures 1, 4).
However, though Benaron et al. do disclose using fluorescent tags (column 7, lines 53-62), Benaron et al. do not specifically disclose that the excitation light is in a wavelength range of 625 nm to 680 nm or is configured to excite specifically a “Cy5” fluorophore.
Further, Benaron et al. do not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system.
Salb discloses a system for practical and accurate detection and localization of malignant tissue during medical procedures, wherein an image is acquired and analyzed by having the image/frame data mapped into a lookup table (LUT), wherein the LUT can be configured as a threshold-level scale, with all tissue brightness values between zero and a user-selected threshold (i.e. threshold light intensity) represented by one color and all tissue brightness values above the threshold and below full-scale represented by a second color (Abstract; column 6, line 50-column 7, line 11). The color-coded or threshold-level-coded frame is displayed and emphasizes hypermetabolic areas (i.e. malignant tissue; cell state including a cell being cancerous) in the field of view (Abstract; column 7, lines 11-17). Further, a glucose analog may be coupled to a fluorophore in a manner that allows transport of the imaging agent across the cell membrane and facilitates attachment of the agent to the substrate binding site of the hexokinase enzyme within the cell, wherein quantification of the enzyme is a useful method for the detection of hypermetabolic tissue such as malignant tissue (column 4, lines 1-9). The metabolic imaging agent may be a glucose analog coupled to a fluorophore such as CY5, wherein the absorption wavelength maximum for CY5 is 652 nm with a useful range of 580nm-670nm and the emission wavelength maximum for CY5 is 667 nm with a useful range of 650nm-685nm (column 4, lines 13-24).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to substitute the fluorophore of Benaron et al. with the fluorophore comprising of Cy5 [and therefore have the excitation light source of Salb be configured to emit at an excitation wavelength of, for example, 652 nm [with a useful range of 580nm-670nm] (i.e. which is in the claimed wavelength range of 625 nm-680 nm) to excite the Cy5 fluorophore), as taught by Salb as the substitution of one known fluorophore for another yields predictable results (i.e. providing effective excitation of a fluorophore to analyze biological tissue) to one of ordinary skill in the art and further to effectively detect hypermetabolic tissue such as malignant tissue. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Alternatively, if it is viewed that Benaron et al. do not specifically disclose that the image processor analyzes the image from the imaging device to “determine a cell state”, Salb discloses a system for practical and accurate detection and localization of malignant tissue during medical procedures, wherein an image is acquired and analyzed by having the image/frame data mapped into a lookup table (LUT), wherein the LUT can be configured as a threshold-level scale, with all tissue brightness values between zero and a user-selected threshold (i.e. threshold light intensity) represented by one color and all tissue brightness values above the threshold and below full-scale represented by a second color (Abstract; column 6, line 50-column 7, line 11). The color-coded or threshold-level-coded frame is displayed and emphasizes hypermetabolic areas (i.e. malignant tissue; cell state including a cell being cancerous) in the field of view (Abstract; column 7, lines 11-17). Further, a glucose analog may be coupled to a fluorophore in a manner that allows transport of the imaging agent across the cell membrane and facilitates attachment of the agent to the substrate binding site of the hexokinase enzyme within the cell, wherein quantification of the enzyme is a useful method for the detection of hypermetabolic tissue such as malignant tissue (column 4, lines 1-9). The metabolic imaging agent may be a glucose analog coupled to a fluorophore such as CY5, wherein the absorption wavelength maximum for CY5 is 652 nm with a useful range of 580nm-670nm and the emission wavelength maximum for CY5 is 667 nm with a useful range of 650nm-685nm (column 4, lines 13-24).
Therefore, in the alternative, at the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the image processor of Benaron et al. to analyze the image from the imaging device to determine a cell state, as taught by Salb, in order to provide practical and accurate detection and localization of malignant tissue during medical procedures (Abstract).
However, the above combined references do not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system.
Brooker discloses an optical imaging system that includes a dichroic mirror (30; “dichromatic filter including a dichromatic mirror”), wherein the dichroic mirror (30) reflects a certain wavelength range and passes a different wavelength range (paragraphs [0028], [0036], [0037]). As seen in Figure 1, the dichroic mirror (30) reflects the longer wavelength excitation light and passes the shorter wavelength emission light, wherein at least a portion of the excitation light and at least a portion of the collected emission light has an overlapping optical path within a body of the system (paragraph [0037]).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object of the above combined references have an overlapping optical path within a body of the system, as taught by Brooker, in order to provide the ability to efficiently reflect a certain wavelength range and pass a different wavelength range along the same path, thereby providing a more compact imaging system (paragraphs [0036]-[0037]).
With regards to claims 2 and 14, Benaron et al. disclose that the imaging lens is configured to remain stationary (column 25, lines 50-53, column 13, lines 11-29, referring to the lenses (i.e. “lenses” and/or the optical elements for emitting and detecting light including “glass” optical windows (45) and (46), which thus may serve as an imaging lens) which are not disclosed as moving and thus are configured to remain stationary, at least when performing the detection of light).
With regards to claims 6 and 18, Benaron et al. disclose that the cell state includes a cell being diseased (column 28, lines 15-34, referring to deciding whether the tissue being interrogated is normal or abnormal (i.e. diseased) and a pathological tissue classification being used to distinguish cancerous tissue from noncancerous and other types of healthy tissue).
With regards to claims 7 and 19, Benaron et al. disclose that the light collected by the imaging device is not magnified (column 25, line 42-column 26, line 7, referring to a detector for detecting light, but no structure for magnification disclosed).
With regards to claims 8 and 20, Benaron et al. disclose that the imaging device has a field of view substantially greater than about a diameter of a human cancer cell (column 5, lines 1-17, referring to the tool being used to identify the “tissue” being interrogated, for example, as presenting one or more of blood vessels, ureter, bladder, etc., wherein the field of view to identify such tissue would inherently be required to be substantially greater than about a diameter of a human cancer cell; column 27, lines 11-15, referring to “the entire surgical field” being illuminated with the camera capturing an image of the field, and thus would cover a FOV greater than a diameter of a human cancer cell).
With regards to claims 26-27 and 29-30, as discussed above, the above combined references meet the limitations of claims 1 and 13. However, the above combined references do not specifically disclose that the system further comprises a dichroic mirror disposed within the body of the system and the dichroic mirror is configured to reflect the excitation light to direct the excitation light toward the object and configured to allow the collected light fluoresced from the object to pass therethrough toward the imaging device.
Brooker discloses an optical imaging system that includes a dichroic mirror (30; “dichromatic filter including a dichromatic mirror”), wherein the dichroic mirror (30) reflects a certain wavelength range and passes a different wavelength range (paragraphs [0028], [0036], [0037]). As seen in Figure 1, the dichroic mirror (30) reflects the longer wavelength excitation light and passes the shorter wavelength emission light, wherein at least a portion of the excitation light and at least a portion of the collected emission light has an overlapping optical path within a body of the system (paragraph [0037]).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the system of the above combined references further comprise a dichroic mirror disposed within the body of the system and the dichroic mirror is configured to reflect the excitation light to direct the excitation light toward the object and configured to allow the collected light fluoresced from the object to pass therethrough toward the imaging device, as taught by Brooker, in order to provide the ability to efficiently reflect a certain wavelength range and pass a different wavelength range along the same path, thereby providing a more compact imaging system (paragraphs [0036]-[0037]).
Claims 3-4 and 15-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benaron et al. in view of Salb and Brooker as applied to claims 1 and 13 above, and further in view of Hillman et al. (WO 2009/005748). Note that, with regards to the Hillman et al. reference, for convenience Examiner refers to the equivalent specification in corresponding US Pub No. 2010/0168586).
With regards to claim 3 and 15, as discussed above, the above combined references meet the limitations of claims 1 and 13. However, they do not specifically disclose that the instrument head further comprises a spacer configured to maintain a fixed distance between a portion of the spacer configured to contact the tissue of the object and the imaging lens.
Hillman et al. disclose a medical imaging system comprising: an imaging device (i.e. optical light detector, such as a photomultiplier array (148) or CCD) including a plurality of pixels (paragraphs [0096], [0101]-[0102]; Figures 1-2); an imaging lens (208, 128, 140) optically coupled to the imaging device (paragraphs [0093], [0100]; Figures 1-2); and a spacer (210) configured to maintain a fixed distance between a portion of the spacer constructed to contact tissue and the imaging lens, wherein, in at least one operating mode, the imaging device is focused on and images tissue (204, 206) in contact with the portion of the spacer (paragraphs [0023], [0100]; Figure 2). Hillman et al. further disclose that the spacer assembly includes a disposable tip (paragraph [0100]). The spacer allows the device to maintain a specified distance between the lens and a target region (paragraph [0023]).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the instrument head of the above combined references further comprise a spacer configured to maintain a fixed distance between a portion of the spacer configured to contact the tissue of the object and the imaging lens, as taught by Hillman et al., in order to ensure and maintain a specified distance between the lens and a target region for in-vivo optical imaging (paragraph [0023]).
With regards to claims 4 and 16, Hillman et al. disclose that during the at least one operating mode of the imaging device, the imaging device is configured to be focused on and image the tissue of the object (204, 206) in contact with the portion of the spacer (210) (paragraphs [0023], [0100]; Figure 2).
Claims 5 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benaron et al. in view of Salb, Brooker and Hillman et al. as applied to claims 3 and 15 above, and further in view of Alfano et al. (US 6,587,711).
With regards to claims 5 and 17, as discussed above, the above combined references meet the limitations of claims 3 and 15. However, they do not specifically disclose that the portion of the spacer configured to contact the tissue of the object includes a planar surface that extends across a distal end of the spacer.
Alfano et al. disclose an imaging apparatus suitable for examining an object, such as skin, for detecting cancer and precancerous conditions (Abstract). The apparatus includes a gun-shaped housing having a handle portion and a barrel portion (107), wherein the front end of the barrel portion is open and a glass cover (109) is mounted therein (Abstract; column 7, lines 44-48, 56-60; Figure 4, note that the glass cover (109) forms a planar surface that extends across a distal end of the spacer (107)).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to substitute the spacer of the above combined references with a spacer that has the portion of the spacer configured to contact the tissue of the object include a planar surface that extends across a distal end of the spacer, as taught by Alfano et al., as the substitution of one known spacer for another yields predictable results (i.e. effectively providing a distance between the spacer and imaging lens and the tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Claims 9 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benaron et al. in view of Salb and Brooker as applied to claims 8 and 20 above, and further in view of Wolfe (US Patent No. 6,256,530).
With regards to claims 9 and 21, as discussed above, the above combined references meet the limitations of claims 8 and 20. However, they do not specifically disclose that the imaging device has an analysis resolution less than or equal to about the diameter of the human cancer cell.
Wolfe discloses instrumentation for in-vivo detection of cancerous cells using fluorescence excitation in tissue that is optically accessible for examination, wherein the optical system is designed such that each pixel corresponds approximately to the size of a tissue cell in order to maximize the contrast between normal and malignant tissue (column 1, lines 7-13, column 8, lines 26-29, note that a tissue cell is known to be smaller than a human cancer cell, and thus the analysis resolution (defined by a pixel size) is less than to about the diameter of the human cancer cell).
At the time of the invention, it would have been obvious to one of ordinary skill in the art to have the imaging device of the above combined references have an analysis resolution less than or equal to about the diameter of the human cancer cell, as taught by Wolfe, in order to maximize the contrast between normal and malignant tissue (column 8, lines 26-29).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6, 9, 13, 15, 18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 16 and 18 of U.S. Patent No. 8,983,581 in view of Montagu et al and Brooker et al..
With regards to claims 1 and 13, claims 1-2 of the Patent meet most of the limitations of claims 1 and 13 (i.e. an imaging device/image detector including a plurality of pixels [see claims 1 and 2], an imaging lens/optical receptor; an excitation source, and an image processor/feedback system). However, the Patent does not specifically disclose that the emitted light is in a wavelength range of 625nm to 680nm or is configured to excite a Cy5 fluorophore. Further, the Patent does not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system. Montagu et al. disclose a CCD-based imaging system for examination of biological material, wherein the system includes light sources (12) that direct light to the substrate having the embedded optical features selected to emit light of wavelengths capable of exciting selected fluorophores associated with, e.g., tagged to, the biological material to be examined (Abstract; paragraphs [0085]-[0087]; Figure 2). The excitation light may excite various types of fluorophores, including Cy5, which excites at 650 nm (paragraphs [0086]-[0087]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to substitute excitation wavelength range of the Patent with the excitation wavelength range for exciting Cy5 [and therefore have the excitation light source of the Patent be configured to emit at an excitation wavelength of 650nm (i.e. which is in the claimed wavelength range of 625 nm-680 nm), as taught by Montagu et al., as the substitution of one known excitation range for another yields predictable results (i.e. providing effective excitation of a fluorophore to analyze biological tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable. However, the modified Patent does not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system. Brooker discloses an optical imaging system that includes a dichroic mirror (30; “dichromatic filter including a dichromatic mirror”), wherein the dichroic mirror (30) reflects a certain wavelength range and passes a different wavelength range (paragraphs [0028], [0036], [0037]). As seen in Figure 1, the dichroic mirror (30) reflects the longer wavelength excitation light and passes the shorter wavelength emission light, wherein at least a portion of the excitation light and at least a portion of the collected emission light has an overlapping optical path within a body of the system (paragraph [0037]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object of the above combined references have an overlapping optical path within a body of the system, as taught by Brooker, in order to provide the ability to efficiently reflect a certain wavelength range and pass a different wavelength range along the same path, thereby providing a more compact imaging system (paragraphs [0036]-[0037]).
Claim 6 of the patent meets the limitations of claims 3 and 15 of the copending application.
Claim 16 of the patent meets the limitations of claims 6 and 18 of the copending application.
Claim 18 of the patent meets the limitations of claims 9 and 21 of the copending application.
Claims 1, 3-4, 6, 7-8, 10, 13, 15-16, 18-19, 20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, 26, 28, 29, 48 and 65 of U.S. Patent No. 11,266,313 in view of Montagu et al. and Brooker et al..
With regards to claims 1 and 13, claims 1 and 48 of the Patent meets most of the limitations of claims 1 and 13 (i.e. an imaging device/in-vivo imaging device including a plurality of pixels, an imaging lens/optical receptor; an excitation source, and an image processor). However, the Patent does not specifically disclose that the emitted light is in a wavelength range of 625nm to 680nm or is configured to excite a Cy5 fluorophore. Further, the Patent does not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system. Montagu et al. disclose a CCD-based imaging system for examination of biological material, wherein the system includes light sources (12) that direct light to the substrate having the embedded optical features selected to emit light of wavelengths capable of exciting selected fluorophores associated with, e.g., tagged to, the biological material to be examined (Abstract; paragraphs [0085]-[0087]; Figure 2). The excitation light may excite various types of fluorophores, including Cy5, which excites at 650 nm (paragraphs [0086]-[0087]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to substitute excitation wavelength range of the Patent with the excitation wavelength range for exciting Cy5 [and therefore have the excitation light source of the Patent be configured to emit at an excitation wavelength of 650nm (i.e. which is in the claimed wavelength range of 625 nm-680 nm), as taught by Montagu et al., as the substitution of one known excitation range for another yields predictable results (i.e. providing effective excitation of a fluorophore to analyze biological tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable. However, the modified Patent does not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system. Brooker discloses an optical imaging system that includes a dichroic mirror (30; “dichromatic filter including a dichromatic mirror”), wherein the dichroic mirror (30) reflects a certain wavelength range and passes a different wavelength range (paragraphs [0028], [0036], [0037]). As seen in Figure 1, the dichroic mirror (30) reflects the longer wavelength excitation light and passes the shorter wavelength emission light, wherein at least a portion of the excitation light and at least a portion of the collected emission light has an overlapping optical path within a body of the system (paragraph [0037]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object of the above combined references have an overlapping optical path within a body of the system, as taught by Brooker, in order to provide the ability to efficiently reflect a certain wavelength range and pass a different wavelength range along the same path, thereby providing a more compact imaging system (paragraphs [0036]-[0037]).
Claims 1 and 48 of the patent meets the limitations of claims 3 and 15 of the copending application.
Claim 18 of the patent meets the limitations of claims 8 and 20 of the copending application.
Claim 26 of the patent meets the limitations of claims 4 and 16 of the copending application.
Claim 28 of the patent meets the limitations of claims 10 and 22 of the copending application.
Claim 29 of the patent meets the limitations of claims 8 and 20 of the copending application.
Claim 65 of the patent meets the limitations of claims 6 and 18 of the copending application.
Claim 7 of the patent meets the limitations of claims 7 and 19 of the copending application.
Claims 1, 3, 6, 10, 11, 13, 15, 18, 22 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 11 and 15 of U.S. Patent No. 11,730,371 in view of Montagu et al. in view of Brooker et al.
With regards to claims 1 and 13, claim 1 of the Patent meets most of the limitations of claims 1 and 13 (i.e. an imaging device/in-vivo imaging device including a plurality of pixels, an imaging lens/optical receptor; an excitation source, and an image processor). However, the Patent does not specifically disclose that the emitted light is in a wavelength range of 625nm to 680nm or is configured to excite a Cy5 fluorophore. Montagu et al. disclose a CCD-based imaging system for examination of biological material, wherein the system includes light sources (12) that direct light to the substrate having the embedded optical features selected to emit light of wavelengths capable of exciting selected fluorophores associated with, e.g., tagged to, the biological material to be examined (Abstract; paragraphs [0085]-[0087]; Figure 2). The excitation light may excite various types of fluorophores, including Cy5, which excites at 650 nm (paragraphs [0086]-[0087]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to substitute excitation wavelength range of the Patent with the excitation wavelength range for exciting Cy5 [and therefore have the excitation light source of the Patent be configured to emit at an excitation wavelength of 650nm (i.e. which is in the claimed wavelength range of 625 nm-680 nm), as taught by Montagu et al., as the substitution of one known excitation range for another yields predictable results (i.e. providing effective excitation of a fluorophore to analyze biological tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable. However, the modified Patent does not specifically disclose that at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object have an overlapping optical path within a body of the system. Brooker discloses an optical imaging system that includes a dichroic mirror (30; “dichromatic filter including a dichromatic mirror”), wherein the dichroic mirror (30) reflects a certain wavelength range and passes a different wavelength range (paragraphs [0028], [0036], [0037]). As seen in Figure 1, the dichroic mirror (30) reflects the longer wavelength excitation light and passes the shorter wavelength emission light, wherein at least a portion of the excitation light and at least a portion of the collected emission light has an overlapping optical path within a body of the system (paragraph [0037]). At the time of the invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object of the above combined references have an overlapping optical path within a body of the system, as taught by Brooker, in order to provide the ability to efficiently reflect a certain wavelength range and pass a different wavelength range along the same path, thereby providing a more compact imaging system (paragraphs [0036]-[0037]).
Claim 1 of the patent meets the limitations of claims 3 and 15 of the copending application.
Claim 2 of the patent meets the limitations of claims 6 and 18 of the copending application.
Claim 11 of the patent meets the limitations of claims 10 and 22 of the copending application.
Claim 15 of the patent meets the limitations of claims 11 and 23 of the copending application.
Response to Arguments
Applicant's arguments filed October 16, 2025 have been fully considered but they are not persuasive.
With regards to claim 1, Applicant argues that there is no motivation or reasonable expectation of success to combine Benaron and Salb with Brooker to meet the limitation of having at least a portion of the excitation light and at least a portion of the collected light fluoresced from the object having an overlapping optical path within a body of the system, at least because there is no structure in Benaron capable of being modified to have the claimed arrangement. Specifically, Applicant argues that one of ordinary skill in the art would readily recognize that Benaron fails to recite any structure capable of being modified to have overlapping excitation and emission optical paths at least because separate optical windows on the tissue contacting surface in Benaron are associated with the light source and the detector having parallel optical axes, and therefore there would be no motivation or reasonable expectation of success for a person of ordinary skill to modify Benaron as suggested in the Office Action at least because it would not have been possible to modify the arrangement of Benaron to have an overlapping excitation and emission optical path.
Examiner respectfully disagrees and notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Benaron discloses various variations of the arrangement of the optical elements for emitting and detecting light, including an alternative embodiment as depicted in Figure 4C wherein the light source 43 is included in analyzer 20, e.g., as part of controller 22, and the light detector 47 is included in analyzer 20, e.g., as part of spectrometer 24, wherein the analyzer is external/separate from the surgical tool (30) body/shaft (34) which defines the majority of the linear optical path for the excitation light and the collected light and an alternative embodiment as depicted in Figure 4B/4C, wherein the light detector (47) and the light source (43) are located in the tool (30) and depicted as aligned with the surgical tool (30) body/shaft (34) (column 13, lines 11-14; column 13, lines 46-48; column 13, line 65-column 14, line 5; Figures 4A-C). Benaron further discloses that their invention is not limited to the disclosed optical element arrangements (column 13, lines 43-45, referring to “Other variations are believed apparent to those skilled in the art, subject to space and cost considerations in constructing tip 40”; column 14, lines 6-8, referring to “Of course, it should be understood that variations of the foregoing embodiments are deemed within the scope of the present invention”). In view of this, it would have been reasonable to one of ordinary skill in the art to expect success in the above modification and recognize that it is possible to modify the arrangement of Benaron to have an overlapping excitation and emission optical path, as taught by Brooker et al., as Benaron is open to different variations of the optical arrangement and further discloses different embodiments wherein the arrangement of the detector and light source share similar relative positions to the main body which is aligned with the majority of the optical path to that of the arrangement of Brooker, such that it would be reasonable to modify Benaron to assume the optical arrangement of Brooker, thus resulting in at least a portion of the excitation light and at least a portion of the collected light to have an overlapping optical path within a body of the system (i.e. see the embodiments (Figures 4A-C) of Benaron which depicts that the light source may be offset with the shaft body and that alternatively the detector may be aligned with the shaft body, which defines the majority of the optical path, and Brooker (Figure 1) similarly discloses that at least the detector (90) is aligned with the linear main body of the instrument and that at least the light source (10) is external/offset to the linear main body of the instrument, which defines the majority of the optical path).
Applicant further argues that modifying the combination of Benaron/Salb with Brooker as suggested would change the principle of operation of Benaron by eliminating its ability to compare differences between illumination light passed through tissue and detected light representing tissue altered transmission spectra, thereby rendering Benaron unsuitable for its intended purpose of determining different types of tissue, specifically pointing to column 20, lines 42-46.
Examiner respectfully disagrees and notes that column 20, lines 42-46 of Benaron discloses that “It should be understood that the light emitting window element and the light detecting window element may be arranged in any configuration on the tip so that, in response to the light intensity launched by the light emitting window, the light detector produces a signal that corresponds to the spectral characteristics of the tissue being interrogated.”. It is not clear how arranging the optical elements of Benaron to assume an arrangement as taught by Brooker that results in at least a portion of the excitation light and at least a portion of the collected light to have an overlapping optical path within a body of the system would impede the light detector of Benaron from producing a signal that corresponds to the spectral characteristics of the tissue being interrogated as Brooker discloses that the detector in an arrangement which provides an overlapping optical path still has the ability to collect light in response to emitted light. As such, modifying the combination of Benaron/Salb with Brooker would not change the principle of operation of Benaron.
The claims therefore remain rejected under the previously applied prior art.
Conclusion
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.
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798