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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Independent claims 1 and 15 each recite “a medical device for imaging fluorescence from tissue” in the preamble. The claims further recite that the medical device comprises: a housing; a power source; a light source; a camera system; a control circuit; and a display. The specification, as originally filed, discloses that the device (100) comprises: a housing (102); a power source (702); a light source (706); a camera system (CamF1 and/or CamF2); and a control circuit (710) (see par. [0028] of the published application). However, the specification, as originally filed, discloses “[d]evice 100 communicates with an outside display 108 and an outside user interface 110 via a link 112 that can be a cable or a wireless link” (see par. [0027] of the published application). As is clear, the device (100) itself neither includes the display (108) nor the user interface (110). It is not clear how the display and the user interface are components of the device when it is disclosed that they are components outside of the device with which the device communicates. It is not clear whether Applicant intends to claim the device or the system. Accordingly, the claims are rendered indefinite.
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 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.
Claim(s) 1, 7-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth (US 2016/0045757 A1) in view of Han et al. (US 2022/0134125 A1) in view of Irion (US 2004/0249245 A1).
Regarding claim 1, Groseth discloses a medical device (Figs. 5-11) for imaging fluorescence from tissue at or adjacent a patient's cervix treated with photodynamic therapy, comprising: a housing (2/4; par. [0134]; Fig. 5) that has an open, cup-shaped distal portion (4; par. [0135]; Fig. 6) configured for insertion to a treatment position in the patient's vagina to cover an external opening of the cervix and secure itself in place by contact with at least one of the patient's vagina and cervix for photodynamic therapy of patient's tissue (abstract and par. [0135]); a power source (41; par. [0136]; Fig. 6), a light source (22; par. [0136]; Fig. 6), and a control circuit (24/40; par. [0136] and [0144]-[0148]; Fig. 6) integrated in said housing (2/4; Fig. 6); wherein: said power source (41) is configured to power said light source (22; par. [0144]) and control circuit (24/40; par. [0144]); said light source (22) is configured to selectively illuminate tissue for photodynamic treatment and to cause fluorescence from portions thereof when the housing is at said treatment position relative to the cervix and the light source is energized (par. [0062]); and said control circuit (24/40) is configured to selectively cause said power source (41) to power said light source during one or more treatment time intervals (par. [0063], [0072] and [0145]-[0146]).
However, Groseth does not specifically disclose its device comprising a camera system; said power source configured to power said camera system; said camera system comprises a camera CamF1 configured to selectively image said fluorescence from selected tissue from a first viewpoint and provide first image data; said control circuit is configured to cause said camera system to image said selected tissue and to transmit said first image data at selected times; and a display operatively coupled with the camera CamF1 and configured to receive said first image data and display a first fluorescence image derived from said first image data. Irion teaches an analogous device (10) for imaging fluorescence from tissue treated with photodynamic therapy (par. [0071] and [0096]-[0097]) that includes a camera system (20/18; par. [0078]-[0079]; Fig. 1), a power source (30; par. [0085]) to power said camera system; said camera system (20/18) comprises a camera CamF1 (20; par. [0079]) configured to selectively image said fluorescence from selected tissue from a first viewpoint and provide first image data; and a display (par. [0081] – display unit or screen) operatively coupled with the camera CamF1 (20) and configured to receive said first image data and display a first fluorescence image derived from said first image data (par. [0081] and par. [0090]-[0094]). Irion teaches using a camera to capture images provides the advantage of allowing the operator to visualize the target area (par. [0026]). Han teaches using a camera system (43a/50; par. [0080], [0081] and [0083]; Fig. 5B) for imaging fluorescence when providing photodynamic therapy to tissue adjacent a patient’s cervix (abstract; par. [0090] and [0092]). It would have been obvious to one having ordinary skill in the art to include a camera system and display in the device of Groseth in order to allow the operator to visualize the target area for photodynamic diagnosis and therapy, as taught by Irion, and image fluorescence from the cervix treated with photodynamic therapy, as taught by Han.
Regarding claim 9, Groseth in view of Irion in view of Han disclose the medical device of claim 1, further including a wireless link (Irion: 24/26; par. [0081]) between said control circuit (24/40; Irion: 28) and said display (Irion: par. [0081]) configured to selectively transmit wirelessly said first image data to said display (Irion: par. [0081]).
Regarding claim 11, Groseth in view of Irion in view of Han disclose the medical device of claim 1, in which said control circuit is configured to energize said light source only intermittently, at selected times while the housing is in said treatment position (par. [0063] and [0072]).
Regarding claim 12, Groseth in view of Irion in view of Han disclose the medical device of claim 1. Han teaches in which said control circuit (80/87; par. [0111]) is configured to energize said light source (22) at respective different intensities at selected times while the device is in said treatment position (par. [0112]-[0113]). Han teaches that by varying the intensity of the light sources, irradiation of normal tissues near the target area is minimized (par. [0112]). It would have been obvious to one having ordinary skill in the art to modify the intensity of the light source of Groseth in order to minimize irradiation of and damage to normal tissue near the target region, as taught by Han, while the housing is in the treatment position.
Regarding claim 13, Groseth in view of Irion in view of Han disclose the medical device of claim 1. Irion teaches in which said control circuit (28) is configured to energize said light source (16/32) to illuminate said tissue with light at respective different wavelength ranges (par. [0073], [0080], [0096] and [0098) at different selected times (par. [0082]-[0083]). It would have been obvious to one having ordinary skill in the art to use different wavelength ranges of light sources while the housing is in said treatment position in the device of Groseth in order to provide light that can both properly image and treat the target area.
Regarding claim 14, Groseth in view of Irion in view of Han disclose the medical device of claim 1, Irion teaches in which said control circuit (28) is configured to energize said light source (16/32) to illuminate said tissue with light at respective different wavelength ranges (par. [0073], [0080], [0096] and [0098]) at selected time intervals (par. [0082]-[0083]), wherein said selected time intervals include time intervals of illumination with white light or time intervals of illumination with light in wavelength ranges narrower that the white light range (par. [0073], [0080], [0082]-[0083]; [0096] and [0098]). It would have been obvious to one having ordinary skill in the art to use different wavelength ranges of light sources while the housing is in said treatment position in the device of Groseth in order to provide light that can both properly image and treat the target area.
Regarding claim 15, Groseth discloses a medical device (Figs. 5-11) for imaging fluorescence from a patient's tissue treated with photodynamic therapy, comprising: a housing (2/4; par. [0134]; Fig. 5) configured for insertion to a treatment position in the patient to cover selected internal tissue of the patient and remain in place during a photodynamic therapy period exceeding an hour (abstract); a power source (41; par. [0136]; Fig. 6), a light source (22; par. [0136]; Fig. 6), and a control circuit (24/40; par. [0136] and [0144]-[0148]; Fig. 6) integrated in said housing (2/4; Fig. 6); wherein: said power source (41) is configured to power said light source (22; par. [0144]) and control circuit (24/40; par. [0144]); said light source (22) is configured to selectively illuminate said selected internal tissue for photodynamic treatment and to cause fluorescence from portions thereof when the housing is at said treatment position and the light source is energized (par. [0062]); and said control circuit (24/40) is configured to selectively cause said power source (41) to power said light source at selected time intervals during said treatment period (par. [0063], [0072] and [0145]-[0146]).
However, Groseth does not specifically disclose its device comprising a camera system; said power source configured to power said camera system; said camera system comprises a camera CamF1 configured to selectively image said fluorescence from said tissue from a first viewpoint and provide first image data; said control circuit is configured to cause said camera system to image said tissue and to transmit said first image data; and a display operatively coupled with the camera CamF1 and configured to receive said first image data and display a first fluorescence image derived from said first image data. Irion teaches an analogous device (10) for imaging fluorescence from tissue treated with photodynamic therapy (par. [0071] and [0096]-[0097]) that includes a camera system (20/18; par. [0078]-[0079]; Fig. 1), a power source (30; par. [0085]) to power said camera system; said camera system (20/18) comprises a camera CamF1 (20; par. [0079]) configured to selectively image said fluorescence from selected tissue from a first viewpoint and provide first image data; and a display (par. [0081] – display unit or screen) operatively coupled with the camera CamF1 (20) and configured to receive said first image data and display a first fluorescence image derived from said first image data (par. [0081] and par. [0090]-[0094]). Irion teaches using a camera to capture images provides the advantage of allowing the operator to visualize the target area (par. [0026]). Han teaches using a camera system (43a/50; par. [0080], [0081] and [0083]; Fig. 5B) for imaging fluorescence when providing photodynamic therapy to tissue adjacent a patient’s cervix (abstract; par. [0090] and [0092]). It would have been obvious to one having ordinary skill in the art to include a camera system and display in the device of Groseth in order to allow the operator to visualize the target area for photodynamic diagnosis and therapy, as taught by Irion, and image fluorescence from the selected internal tissue treated with photodynamic therapy, as taught by Han.
Regarding claim 16, Groseth in view of Irion in view of Han disclose the medical device of claim 15, in which the selected internal tissue is at the entrance of the patient's cervix (abstract) and the housing (2/4) has an open, cup-shaped portion (4; par. [0135]; Fig. 6) configured to conform to and cover tissue at the cervix entrance (abstract; par. [0135]).
Regarding claim 18, Groseth discloses a method of photodynamic therapy of internal tissue of a patient medicated to fluoresce when illuminated with selected light, comprising: inserting a housing (2/4; par. [0134]; Fig. 5) of a treatment device at a treatment position adjacent said internal tissue of the patient and maintaining the housing in the treatment position for treatment period of an hour or more (par. [0152]); Illuminating said internal tissue with light from a light source (22; par. [0136]; Fig. 6) in said housing (2/4) while said housing is in said treatment position to cause at least selected portions of the tissue to fluoresce (par. [0152] – photosensitizer and light), and controlling at least one of said illuminating (par. [0063] and [0065]) and imaging with at least one of a control circuit (par. [0063] and [0065]) integrated in said housing and an interface device that is outside the patient.
However, Groseth does not specifically disclose imaging said fluorescence from a first viewpoint with a camera CamF1 integrated in said housing of the treatment device while the housing is in said treatment position in the patient to provide first image data; transmitting said first image data to a display outside the patient and displaying the first image data at said display. Irion teaches an analogous device (10) and method for imaging fluorescence from tissue treated with photodynamic therapy (par. [0071] and [0096]-[0097]) that includes a camera system (20/18; par. [0078]-[0079]; Fig. 1), a power source (30; par. [0085]) to power said camera system; said camera system (20/18) comprises a camera CamF1 (20; par. [0079]) configured to selectively image said fluorescence from selected tissue from a first viewpoint and provide first image data; transmitting said first image data to a display (par. [0081]) outside the patient and displaying the first image data at said display (par. [0081] and par. [0090]-[0094]). Irion teaches using a camera to capture images provides the advantage of allowing the operator to visualize the target area (par. [0026]). Han teaches using a camera system (43a/50; par. [0080], [0081] and [0083]; Fig. 5B) for imaging fluorescence when providing photodynamic therapy to tissue adjacent a patient’s cervix (abstract; par. [0090] and [0092]). It would have been obvious to one having ordinary skill in the art to include a camera system and display in the device of Groseth in order to allow the operator to visualize the target area for photodynamic diagnosis and therapy, as taught by Irion, and image fluorescence from the internal tissue treated with photodynamic therapy, as taught by Han.
Claim(s) 2, 5, 17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han as applied to the claims above, and further in view of Ouyang (US 2019/0216325 A1).
Regarding claim 2, Groseth in view of Irion in view of Han disclose the medical device for imaging fluorescence from a patient's cervix of claim 1, but does not specifically disclose wherein said camera system further comprises a camera CamF2 also integrated in said housing and configured to image said fluorescence from a second viewpoint and provide second image data, wherein said display is configured to receive said second image and to display a second fluorescence image derived from the second image data. Ouyang teaches fluorescence imaging of bodily tissue (abstract) using a device that comprises two separate cameras (810 and 812; Fig. 8; par. [0079]) and different viewpoints (Fig. 8). Ouyang teaches that one camera is a white camera module (810) and the second camera is a blue camera module (812; par. [0079]). Ouyang teaches that simultaneously acquiring a visible light image and a fluorescent image, and overlaying the fluorescent image over the visible light image provides contrast of the surgical area to a surgeon (par. [0024]). Ouyang teaches a display (par. [0029]) receives and displays both images. They are typically shown composited, in geometric registration, so that the position of selected tissue can be visualized relative to surrounding anatomy (par. [0067]). It would have been obvious to one having ordinary skill in the art to provide a second camera to the housing of the device of Groseth, such that the simultaneous captured and displayed images allow the operator to see the position of the selected tissue relative to the surrounding anatomy, as taught by Ouyang.
Regarding claim 5, Groseth in view of Irion in view of Han in view of Ouyang disclose the medical device of claim 2, further including a wireless link (Irion: 24/26; par. [0081]) between said control circuit (24/40; Irion: 28) and said display (Irion: par. [0081]) configured to selectively transmit wirelessly said first and second image data to said display (Irion: par. [0081]).
Regarding claim 17, Groseth in view of Irion in view of Han disclose the medical device of claim 16, but does not specifically disclose wherein said camera system further comprises a camera CamF2 also integrated in said housing and configured to image said fluorescence from a second viewpoint and provide second image data, wherein said display is configured to receive said second image and to display a second fluorescence image derived from the second image data. Ouyang teaches fluorescence imaging of bodily tissue (abstract) using a device that comprises two separate cameras (810 and 812; Fig. 8; par. [0079]) and different viewpoints (Fig. 8). Ouyang teaches that one camera is a white camera module (810) and the second camera is a blue camera module (812; par. [0079]). Ouyang teaches that simultaneously acquiring a visible light image and a fluorescent image, and overlaying the fluorescent image over the visible light image provides contrast of the surgical area to a surgeon (par. [0024]). Ouyang teaches a display (par. [0029]) receives and displays both images. They are typically shown composited, in geometric registration, so that the position of selected tissue can be visualized relative to surrounding anatomy (par. [0067]). It would have been obvious to one having ordinary skill in the art to provide a second camera to the housing of the device of Groseth, such that the simultaneous captured and displayed images allow the operator to see the position of the selected tissue relative to the surrounding anatomy, as taught by Ouyang.
Regarding claim 19, Groseth in view of Irion in view of Han disclose the method of claim 18, but does not specifically disclose further comprising imaging said fluorescence from a second viewpoint with a camera CamF2 integrated in said housing of the treatment device while the housing is in said treatment position in the patient to provide second image data and transmitting the said second image data to said display and displaying the second image data at said display. Ouyang teaches fluorescence imaging of bodily tissue (abstract) using a device that comprises two separate cameras (810 and 812; Fig. 8; par. [0079]) and different viewpoints (Fig. 8). Ouyang teaches that one camera is a white camera module (810) and the second camera is a blue camera module (812; par. [0079]). Ouyang teaches that simultaneously acquiring a visible light image and a fluorescent image, and overlaying the fluorescent image over the visible light image provides contrast of the surgical area to a surgeon (par. [0024]). Ouyang teaches a display (par. [0029]) receives and displays both images. They are typically shown composited, in geometric registration, so that the position of selected tissue can be visualized relative to surrounding anatomy (par. [0067]). It would have been obvious to one having ordinary skill in the art to provide a second camera to the housing of the device of Groseth, such that the simultaneous captured and displayed images allow the operator to see the position of the selected tissue relative to the surrounding anatomy, as taught by Ouyang.
Regarding claim 20, Groseth in view of Irion in view of Han in view of Ouyang disclose the method of claim 19, in which at least one of said transmitting and said controlling is via a wireless link (Irion: 24/26; par. [0081]) between said control circuit (24/40; Irion: 28) and an external interface (Irion: 26; par. [0081]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han in view of Ouyang as applied to claim 2 above, and further in view of Yanagisawa (US 2020/0237183 A1).
Regarding claim 3, Groseth in view of Irion in view of Han in view of Ouyang disclose the medical device of claim 2, further including a contact (par. [0069] – input port) at said housing operatively coupled with said control circuit (par. [0068]-[0069]) and a cable (par. [0069]) configured to releasably couple operatively with said contact (par. [0069]-[0070]). However, Groseth does not specifically disclose that the cable is for conveying said first and second image data to said display and Irion teaches wirelessly transmitting the images to the display (Irion: par. [0081]). It is generally known in the art that endoscopic images can be transmitted by wired/cabled connection or wirelessly. Yanagisawa is cited as one of several references which teach such wired or wireless transmission of image signals to the display (par. [0132]). It would have been obvious to one having ordinary skill in the art to use the cable to transmit images to the display, as is generally known in the art, and evidenced by Yanagisawa.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han in view of Ouyang in view of Yanagisawa as applied to claim 3 above, and further in view of Bettesh (US 2008/0193139 A1).
Regarding claim 4, Groseth in view of Irion in view of Han in view of Ouyang in view of Yanagisawa disclose the medical device of claim 3, but does not specifically disclose it further including an outside user interface operatively coupled with said control circuit to control operation of one or more of said cameras CamF1 and CamF2 and said light source by operator commands. Bettesh teaches a medical device wherein an outside user interface (par. [0032] – input device) operatively coupled with said control circuit (47; par. [0032]) to control operation of one or more of said cameras CamF1 and CamF2 and said light source by operator commands (par. [0032]). It would have been obvious to one having ordinary skill in the art to include an outside user interface that allows an operator to remotely control the operation of the imager, light source, and other components of the device as determined by the operator, as taught by Bettesh.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han in view of Ouyang as applied to claim 5 above, and further in view of Bettesh (US 2008/0193139 A1).
Regarding claim 6, Groseth in view of Irion in view of Han in view of Ouyang in disclose the medical device of claim 5, but does not specifically disclose it further including an outside user interface operatively coupled through said wireless link with said control circuit to control operation of one or more of said cameras and said light source by operator commands. Bettesh teaches a medical device wherein an outside user interface (par. [0032] – input device) operatively coupled through said wireless link (13/39; par. [0032]) with said control circuit (47; par. [0032]) to control operation of one or more of said cameras and said light source by operator commands (par. [0032]). It would have been obvious to one having ordinary skill in the art to include an outside user interface that allows an operator to remotely control the operation of the imager, light source, and other components of the device as determined by the operator, as taught by Bettesh.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han as applied to claim 1 above, and further in view of Yanagisawa (US 2020/0237183 A1).
Regarding claim 7, Groseth in view of Irion in view of Han disclose the medical device of claim 1, further including a contact (par. [0069] – input port) at said housing operatively coupled with said control circuit (par. [0068]-[0069]) and a cable (par. [0069]) configured to releasably couple operatively with said contact (par. [0069]-[0070]). However, Groseth does not specifically disclose that the cable is for conveying said first image data to said display and Irion teaches wirelessly transmitting the images to the display (Irion: par. [0081]). It is generally known in the art that endoscopic images can be transmitted by wired/cabled connection or wirelessly. Yanagisawa is cited as one of several references which teach such wired or wireless transmission of image signals to the display (par. [0132]). It would have been obvious to one having ordinary skill in the art to use the cable to transmit images to the display, as is generally known in the art, and evidenced by Yanagisawa.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han in view of Yanagisawa as applied to claim 7 above, and further in view of Bettesh (US 2008/0193139 A1).
Regarding claim 8, Groseth in view of Irion in view of Han in view of Yanagisawa disclose the medical device of claim 7, but does not specifically disclose it further including an outside user interface operatively coupled with said control circuit to control operation of one or more of said camera CamF1 and said light source by operator commands. Bettesh teaches a medical device wherein an outside user interface (par. [0032] – input device) operatively coupled with said control circuit (47; par. [0032]) to control operation of one or more of said camera CamF1 and said light source by operator commands (par. [0032]). It would have been obvious to one having ordinary skill in the art to include an outside user interface that allows an operator to remotely control the operation of the imager, light source, and other components of the device as determined by the operator, as taught by Bettesh.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groseth in view of Irion in view of Han as applied to claim 9 above, and further in view of Bettesh (US 2008/0193139 A1).
Regarding claim 10, Groseth in view of Irion in view of Han in view of Yanagisawa disclose the medical device of claim 9, but does not specifically disclose it further including an outside user interface operatively coupled through said wireless link with said control circuit to control operation of one or more of said camera CamF1 and said light source by operator commands. Bettesh teaches a medical device wherein an outside user interface (par. [0032] – input device) operatively coupled through said wireless link (13/39; par. [0032]) with said control circuit (47; par. [0032]) to control operation of one or more of said camera CamF1 and said light source by operator commands (par. [0032]). It would have been obvious to one having ordinary skill in the art to include an outside user interface that allows an operator to remotely control the operation of the imager, light source, and other components of the device as determined by the operator, as taught by Bettesh.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2021/0007591 A1 Weber et al. Medical Endoscopic Instrument
US 2021/0220665 A1 Ruiz et al. System and Method for Quantitative…
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
8/25/25
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