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
1. Applicant's arguments filed 09/29/2025 have been fully considered but they are not persuasive. The Applicant argues that the art of Rubinstenn does not teach actually using an EMR system to ablate the tissue, but rather that Rubinstenn is merely an imaging device. The Examiner agrees and notes that producing/controlling an EMR beam is not what Rubinsten is used to teach in this action. The art of Merlin teaches controlling an EMR system to direct the beam; however, they do not teach comparing images to generate comparison data. Rubinstenn is then used to show that it is common in the art to have an imaging device for imaging skin conditions or marks on the skin where there are two sets of imaging data taken in and analyzed/compared and used to generate treatment recommendations, for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses. The claim is being rejected by a combination of these references. Per the MPEP, 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.
The Applicant also argues that none of the applied references teach the first and second targeted points of tissue not overlapping. The Examiner respectfully disagrees and points to Fig 4a, b, and c of Manstein which show the pattern having multiple points/lines that do not overlap. This portion of the rejection still stands.
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.
2. Claim(s) 1-3, 5-7, 10, 12-18, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein (US 20050222555 A1) in view of Rastegar (US 20080033410 A1) and in further view of Rubinstenn (US 20030065278 A1).
In regards to claim 1, Manstein discloses a system (Fig. 5) comprising:
an electromagnetic radiation (EMR) system configured to generate an EMR beam (Par. 0019) having a wavelength that is absorbable by the tissue (Par. 0059 discloses using wavelengths that are absorbable); and
a controller (Par. 0074) configured to control the EMR system to fractionally direct the EMR beam to impact a surface of the tissue to ablate at least a first and second portion of the surface of a tissue containing the target, wherein the first and second portions do not overlap (Par. 0056 and 0059 teach a fractional resurfacing apparatus 500 for conducting various dermatological treatments using EMR and generating a pattern of micro-lines of skin damage over a target region of skin. Fig 4a, b, and c show the pattern having multiple points/lines that do not overlap).
Manstein does not discloses the system comprising a digital detector configured to acquire a plurality of images of a tissue over the course of a treatment, wherein an image recognition system configured to identify a target within the tissue based on an initial image of the plurality of images or a digital storage device configured to store the plurality of images.
However, in the same field of endeavor, Rastegar, teaches a system for treating the tissue of a patient with a laser to remove tattoos (Abstract and Par. 0016) wherein the system employs real-time, continuous imaging of the tissue to identify the target (Par. 0043-0050; the Examiner is interpreting this portion of the claims to mean that the system performs continuous/real-time feedback (in form of imaging) throughout the procedure to monitor the progress of the treatment, i.e. what portion of the tattoo needs to be ablated/treated. The claims, as currently written, do not preclude additional images (after the initial) from also being used to identify the target. In order to know the location/position relative to the target being ablated, the target must inherently be identified in the image) in order to precisely target the tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and modified them by having the system determine the target based on an initial image, as taught and suggested by Rastegar, in order to precisely target the tissue.
The combined teachings of Manstein in view of Rastegar disclose the system, except for wherein: the controller is further configured to (i) compare one or more subsequent images of the plurality of images and the initial image to generate comparison data, (ii) determining a remaining portion of the target based on the comparison data, and (iii) control the EMR system to fractionally direct the EMR beam to impact the surface of the tissue to ablate at least the surface of the tissue containing the remaining portion of the target
Manstein does teach controlling the EMR system to direct the beam, they do not teach comparing images to generate comparison data. However, in the same field of endeavor, Rubinstenn discloses an imaging device for imaging skin conditions or marks on the skin (Abstract and Par. 0005) wherein there are two sets of imaging data taken in and analyzed/compared and used to generate treatment recommendations (Par. 0052-0053 and Figs 1-2) for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and Rastegar and modified them by comparing a first and second set of imaging data, as taught and suggested by Rubinstenn, for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
In regards to claim 2, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 discloses the system of claim 1, wherein the wavelength of the EMR beam is within a set of ranges which are at least one of (i) 1300 - 3500nm, or (iii) 9 - 11µm (Par. 0059 of Manstein teaches using a wavelengths of 1200-2300 nm).
In regards to claim 3, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 discloses the system of claim 1, wherein the one or more targets comprise at least one of (i) a sebaceous gland, (ii) a eccrine gland, (iii) a hair follicle, or (iv) a tattoo (Par. 0037 of Manstein discloses this system is used to target a tattoo for removal).
In regards to claim 5, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1, do not teach wherein the image recognition system further comprises at least one of a neural network, an artificial intelligence, a clinical decision support system, or a machine vision system.
However, Rubinstenn does go on to teach using artificial intelligence for the image recognition system (Par. 0045) in order to streamline the imaging process. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 and further modified them by using artificial intelligence, as taught and suggested by Rubinstenn, in order to streamline the imaging process.
In regards to claim 6, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1, do not teach wherein the detector is configured to facilitate a time period to elapse between acquiring the initial image and the one or more subsequent images which is longer than 12 hours.
However, Rubinstenn does go on to teach waiting 6 months between imaging data (Par. 0069) in order to have more accurate data over a longer period of time. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 and further modified them by having 6 months between imaging data, as taught and suggested by Rubinstenn, in order to have more accurate data over a longer period of time.
In regards to claim 7, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 discloses the system of claim 1, except for wherein the digital storage device comprises at least one of a network storage device, a flash drive, a USB drive, a hard disk drive, or a memory device, and wherein the digital storage device is configured to store an electronic health record.
However, Rastegar does go on to teach the system comprising a storge means/device (Par. 0058) in order to store important data for later use. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 and further modified them by having the device comprise storage, as taught and suggested by Rastegar in order to store important data for later use.
In regards to claim 10, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 discloses the system of claim 1, except for wherein the digital detector comprises at least one of a camera, an ultrasound transducer, a photoacoustic imaging system, an optical coherence tomography system, an optical coherence elastography system, a coherent anti-stokes Raman spectroscopy imaging system, a two-photon imaging system, second harmonic generation imaging system, a phase conjugate imaging system, a hyperspectral imaging system, a low-power carbon-dioxide laser imaging system, X-ray backscatter imaging system, a millimeter wave imaging system, a magnetic resonance imaging system, a high-frequency ultrasound imaging system, a photodiode, an ultrasound transducer array, a fluoroscope, a surface profilometer, an infrared imaging system, or a confocal microscope.
However, Rastegar does go on to teach the system using a camera (Par. 0059) in order to provide imaging to the system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 and further modified them by using a camera, as taught and suggested by Rastegar, in order to provide imaging to the system.
In regards to claim 12, Manstein discloses a method comprising:
generating, using an electromagnetic radiation (EMR) system (Par. 0019), an EMR beam having a wavelength that is absorbable by the tissue (Par. 0059 discloses using wavelengths that are absorbable); and
controlling, by a controller (Par. 0074), EMR system to fractionally direct the EMR beam to impact a surface of the at least one portion of the tissue containing the one or more targets to ablate at least the surface of the at least one portion of the tissue containing the one or more targets, not overlapping (Par. 0056 and 0059 teach a fractional resurfacing apparatus 500 for conducting various dermatological treatments using EMR and generating a pattern of micro-lines of skin damage over a target region of skin. Fig 4a, b, and c).
Manstein does not discloses the system comprising a digital detector configured to acquire a plurality of images of a tissue over the course of a treatment, wherein an image recognition system configured to identify a target within the tissue based on an initial image of the plurality of images or a digital storage device configured to store the plurality of images
However, in the same field of endeavor, Rastegar, teaches a system for treating the tissue of a patient with a laser to remove tattoos (Abstract and Par. 0016) wherein the system employs real-time, continuous imaging of the tissue to identify the target (Par. 0043-0050; the Examiner is interpreting this portion of the claims to mean that the system performs continuous/real-time feedback (in form of imaging) throughout the procedure to monitor the progress of the treatment, i.e. what portion of the tattoo needs to be ablated/treated. The claims, as currently written do not preclude additional images (after the initial) from also being used to identify the target. In order to know the location/position relative to the target being ablated, the target must inherently be identified in the image) in order to precisely target the tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and modified them by having the system determine the target based on an initial image, as taught and suggested by Rastegar, in order to precisely target the tissue.
The combined teachings of Manstein in view of Rastegar disclose the system, except for wherein: the controller is further configured to (i) compare one or more subsequent images of the plurality of images and the initial image to generate comparison data, (ii) determining a remaining portion of the target based on the comparison data, and (iii) control the EMR system to fractionally direct the EMR beam to impact the surface of the tissue to ablate at least the surface of the tissue containing the remaining portion of the target
Manstein does teach controlling the EMR system to direct the beam, they do not teach comparing images to generate comparison data. However, in the same field of endeavor, Rubinstenn discloses an imaging device for imaging skin conditions or marks on the skin (Abstract and Par. 0005) wherein there are two sets of imaging data taken in and analyzed/compared and used to generate treatment recommendations (Par. 0052-0053 and Figs 1-2) for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and Rastegar and modified them by comparing a first and second set of imaging data, as taught and suggested by Rubinstenn, for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
In regards to claim 13, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 discloses the method of claim 12, wherein the wavelength of the EMR beam is within a set of ranges which are at least one of (i) 1300 - 3500nm, or (iii) 9 - 11µm (Par. 0059 of Manstein teaches using a wavelengths of 1200-2300 nm).
In regards to claim 14, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 discloses the method of claim 12, wherein the one or more targets comprise at least one of (i) a sebaceous gland, (ii) a eccrine gland, (iii) a hair follicle, or (iv) a tattoo (Par. 0037 of Manstein discloses this system is used to target a tattoo for removal).
In regards to claim 15, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 discloses the method of claim 12, further comprising: comparing, by the controller, the one or more images and the one or more subsequent images to generate comparison data, and based on the comparison, determining at least one of a suggested course of therapy, a probable diagnosis, a characteristic related to treatment progression, or a characteristic of the tissue (Par. 0052-0053 and Figs 1-2 of Rubinstenn).
In regards to claim 16 the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12, do not teach wherein the image recognition system further comprises at least one of a neural network, an artificial intelligence, a clinical decision support system, or a machine vision system.
However, Rubinstenn does go on to teach using artificial intelligence for the image recognition system (Par. 0045) in order to streamline the imaging process. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 and further modified them by using artificial intelligence, as taught and suggested by Rubinstenn, in order to streamline the imaging process.
In regards to claim 17, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claims 12, do not teach wherein the detector is configured to facilitate a time period to elapse between acquiring the initial image and the one or more subsequent images which is longer than 12 hours.
However, Rubinstenn does go on to teach waiting 6 months between imaging data (Par. 0069) in order to have more accurate data over a longer period of time. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 and further modified them by having 6 months between imaging data, as taught and suggested by Rubinstenn, in order to have more accurate data over a longer period of time.
In regards to claim 18, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 discloses the method of claim 12, except for wherein the digital storage device comprises at least one of a network storage device, a flash drive, a USB drive, a hard disk drive, or a memory device, and wherein the digital storage device is configured to store an electronic health record.
However, Rastegar does go on to teach the system comprising a storge means/device (Par. 0058) in order to store important data for later use. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 and further modified them by having the device comprise storage, as taught and suggested by Rastegar in order to store important data for later use.
In regards to claim 21, the combined teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 12 discloses the method of claim 12, except for wherein the detector comprises at least one of a camera, an ultrasound transducer, a photoacoustic imaging system, an optical coherence tomography system, a photodiode, an optical coherence elastography system, a coherent anti-stokes Raman spectroscopy imaging system, a two-photon imaging system, second harmonic generation imaging system, a phase conjugate imaging system, a hyperspectral imaging system, a low- power carbon-dioxide laser imaging system, X-ray backscatter imaging system, a millimeter wave imaging system, a magnetic resonance imaging system, a high-frequency ultrasound imaging system, a photodiode, an ultrasound transducer array, a fluoroscope, a surface profilometer, an infrared imaging system, or a confocal microscope.
However, Rastegar does go on to teach the system using a camera (Par. 0059) in order to provide imaging to the system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn as applied to claim 1 and further modified them by using a camera, as taught and suggested by Rastegar, in order to provide imaging to the system.
In regards to claim 23, Manstein discloses a computer-accessible medium having computer software thereon, wherein, when the computer software is executed by a computer processor, the computer processor is configured to perform procedures (Par. 0074) comprising:
controlling an electromagnetic radiation (EMR) system to generate an EMR beam having a wavelength absorbable by the tissue (Par. 0056 and 0059 teach a fractional resurfacing apparatus 500 for conducting various dermatological treatments using EMR and generating a pattern of micro-lines of skin damage over a target region of skin).
identifying one or more targets (Par. 0050); and
controlling, by a controller, EMR system to fractionally direct the EMR beam to impact a surface of the at least one portion of the tissue containing the one or more targets to ablate at least the surface of the at least one portion of the tissue containing the one ore more targets (Par. 0056 and 0059 teach a fractional resurfacing apparatus 500 for conducting various dermatological treatments using EMR and generating a pattern of micro-lines of skin damage over a target region of skin).
Manstein does not discloses the system comprising a digital detector configured to acquire a plurality of images of a tissue over the course of a treatment, wherein an image recognition system configured to identify a target within the tissue based on an initial image of the plurality of images or a digital storage device configured to store the plurality of images
However, in the same field of endeavor, Rastegar, teaches a system for treating the tissue of a patient with a laser to remove tattoos (Abstract and Par. 0016) wherein the system employs real-time, continuous imaging of the tissue to identify the target (Par. 0043-0050; the Examiner is interpreting this portion of the claims to mean that the system performs continuous/real-time feedback (in form of imaging) throughout the procedure to monitor the progress of the treatment, i.e. what portion of the tattoo needs to be ablated/treated. The claims, as currently written do not preclude additional images (after the initial) from also being used to identify the target. In order to know the location/position relative to the target being ablated, the target must inherently be identified in the image) in order to precisely target the tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and modified them by having the system determine the target based on an initial image, as taught and suggested by Rastegar, in order to precisely target the tissue.
The combined teachings of Manstein in view of Rastegar disclose the system, except for wherein: the controller is further configured to (i) compare one or more subsequent images of the plurality of images and the initial image to generate comparison data, (ii) determining a remaining portion of the target based on the comparison data, and (iii) control the EMR system to fractionally direct the EMR beam to impact the surface of the tissue to ablate at least the surface of the tissue containing the remaining portion of the target
Manstein does teach controlling the EMR system to direct the beam, they do not teach comparing images to generate comparison data. However, in the same field of endeavor, Rubinstenn discloses an imaging device for imaging skin conditions or marks on the skin (Abstract and Par. 0005) wherein there are two sets of imaging data taken in and analyzed/compared and used to generate treatment recommendations (Par. 0052-0053 and Figs 1-2) for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein and Rastegar and modified them by comparing a first and second set of imaging data, as taught and suggested by Rubinstenn, for the purpose of comparing the effectiveness of a prior treatment and giving more accurate recommendations for future treatments/diagnoses.
3. Claim(s) 9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein, Rubinstenn, and Rastegar in view of Li (US 20160307057 A1).
In regards to claims 9 and 20, the combined teachings of Manstein, Rastegar, and Rubinstenn discloses the system of claim 8 and 19, except for wherein the image recognition system comprises at least one of an edge detection module, a corner detection module, or a blob detection module.
However, in the same field of endeavor, Li discloses a tattoo imaging system (Abstract) wherein the image recognition comprises edge detection (Par. 0005 and 0031) for the purpose of providing more accurate and reliable biometric image identification.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn and modified them by using edge detection, as taught and suggested by Li, for the purpose of providing more accurate and reliable biometric image identification.
4. Claim(s) 11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manstein, Rastegar, and Rubinstenn in view of Sneyders (US 20140111621 A1)
In regards to claims 11 and 22, he combined teachings of Manstein, Rastegar, and Rubinstenn discloses the system of claim 1 and 12, except for the system further comprising a structured light source, wherein the detector comprises at least one of a fringe projection profilometry configuration, a structure light profilometry configuration, a laser triangulation profilometry configuration, or a stereovision measurement configuration.
However, in the same field of endeavor, Sneyders discloses a measurement/imaging system for recognizing marks (Abstract and Par. 0021) wherein the system comprises a structured light source (Par. 0005) wherein the system comprises a stereovision measurement configuration (Par. 0018) for the purpose of obtaining 3D measurements of target objects for more detained image observation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Manstein, Rastegar, and Rubinstenn and modified them by having a structured light source and a stereovision measurement configuration, as taught and suggested by Sneyders, for the purpose of obtaining 3D measurements of target objects for more detained image observation.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792