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 .
DETAILED ACTION
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.
Claim(s) 1-14, 16, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madar et al. US2004/0092825 and further in view of Wang US2008/0091249.
Madar discloses for claim 1,
“A system comprising:
an intraluminal device (300; fig 3A; 0124) comprising:
at least one light delivery device (320; fig 3A; 0127) configured to provide photobiomodulation to biological tissue as a treatment, wherein the photobiomodulation comprises one or more wavelengths of light that produce at least one therapeutic effect on the biological tissue when applied (0064);
at least one photodetector device (330; fig 3A; 0125 describes the detector within the system, 0140 describes the specific functions);
Madar does not disclose at least one photodetector device (330; fig 3A; 0125 describes the detector within the system, 0140 describes the specific functions) configured to measure a magnitude or intensity of reflected light from the biological tissue based on the photobiomodulation delivered to the biological tissue and output a reflectance signal. Wang teaches in the same field of endeavor, monitoring the efficacy of photobiomodulation therapy by directly measuring the radiation emitted using a photodetector (0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Madar in order to configure the system e.g. as claimed because it provides real-time direct monitoring of a result of phototherapy.
Modified Madar further discloses “a processor (340; fig 3A; 0125, 0153) configured to receive the reflectance signal (Wang: 0024 photobiomodulation signal) from the at least one photodetector device process the reflectance signal (0151, and 0153 describes detailed functions, including the diagnosis and therapy decisions which are based on the detected illumination signals as described at 0064, 0115), and monitor effects of the photobiomodulation (Wang: 0024); and
a wireless transceiver (350; fig 3A; 0177 describes wireless two-way communications) coupled to the processor to transmit at least a portion of the processed reflectance signal (0008 and 0165 describes the transmission of the relevant data to an external device/monitoring unit 250); and
an external device (250; fig 2; 0118 and 0154 describes the exchange of data) comprising a wireless transceiver (252; fig 2) configured to receive at least the portion of the processed reflectance signal (0153 describes data communicated to the external monitoring unit)”.
Madar discloses for claim 2, “The system of claim 1, wherein the intraluminal device is configured to travel through at least a portion of a patient's gastrointestinal tract and the external device is configured to be outside the patient's body (0059; fig 2 shows the external device/monitoring unit 250 outside the patient 290)”.
Madar discloses for claim 3, “The system of claim 1, wherein at least the processor and the wireless transceiver are encased in a biocompatible housing (0125).
Madar discloses for claim 4, “The system of claim 1, wherein the intraluminal device further comprises one or more sensors configured to provide data regarding an environment of the intraluminal device (0140 describes an array of sensors each sensor used to detect a different portion of the environment)”.
Madar discloses for claim 5, “The system of claim 1, wherein the wireless transceiver of the external device is configured to send configuration information and/or parameters for the photobiomodulation to the wireless transceiver of the processor (0153 describes the diagnosis and therapy decisions can be shared by either the internal processor 340 or the external monitoring unit 250 and 0165 describes the transmission of commands)”.
Madar discloses for claim 6, “The system of claim 5, wherein the processor is configured to communicate the configuration information and/or parameters to the at least one light delivery device (0151 describes the processor control of the light sources)”.
Madar discloses for claim 7, “The system of claim 1, wherein the processor is configured to control delivery of the photobiomodulation provided by the at least one light delivery device based on the processed reflectance signal (step 170 in fig 1 describes determining diagnosis or therapy based on the measured fluorescent signal)”.
Madar discloses for claim 8, “The system of claim 1, wherein the processor is configured to receive signals (Wang: 0024) from one or more sensors of the intraluminal device that are used by one or more signal processing algorithms to create the processed reflectance signal (0152 describes the processor receiving imaging signals and processing them to generate the processed signal)”.
Madar discloses for claim 9, “The system of claim 1, wherein the external device is configured to display a graphical, tactile, or audio representation of the at least the portion of the processed reflectance signal (0119 describes displaying the data or results to a use)”.
Madar discloses for claim 10, “The system of claim 1, wherein the at least one light delivery device comprises at least four light delivery devices (0053 describes a broad band white light source and one or more narrowband light sources, where 0023 describes the a particular wavelength of light is used to determine efficacy of treatment by exciting a particular fluorescent signal), wherein at least two of the at least four light delivery devices are configured to provide light having different wavelengths from one another (0149 describes providing three different wavelengths for three different fluorophores used in different protocols and pathologies, totaling the four lights)”.
Madar discloses for claim 11, “The system of claim 1, wherein the at least one light delivery device comprises a light emitting diode or a laser diode (0127).
Madar discloses for claim 12, “The system of claim 1, wherein the at least one photodetector device comprises at least one of a photosensor, a photodiode, a photoresistor, and a phototransistor (0140 describes the detector as a light/photo sensor)”.
Madar discloses for claim 13, “An intraluminal device comprising a biocompatible casing (fig 3A) configured to encase at least a portion of:
at least one light delivery device (320; fig 3A; 0127) configured to provide photobiomodulation to biological tissue as a treatment, wherein the photobiomodulation comprises one or more wavelengths of light that produces at least one therapeutic effect on the biological tissue when applied (0064);
at least one photodetector device (330; fig 3A; 0125 describes the detector within the system, 0140 describes the specific functions);
Madar does not disclose at least one photodetector device (330; fig 3A; 0125 describes the detector within the system, 0140 describes the specific functions) configured to measure a magnitude or intensity of reflected light from the biological tissue based on the photobiomodulation delivered to the biological tissue and output a reflectance signal. Wang teaches in the same field of endeavor, monitoring the efficacy of photobiomodulation therapy by directly measuring the radiation emitted using a photodetector (0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Madar in order to configure the system e.g. as claimed because it provides real-time direct monitoring of a result of phototherapy.
Modified Madar further discloses “a processor (340; fig 3A; 0125) configured to receive the reflectance signal (Wang: 0024 photobiomodulation signal) from the at least one photodetector device, process the reflectance signal (0151, and 0153 describes detailed functions), and monitor effects of the photobiomodulation (0024); and
a wireless transceiver (350; fig 3A; 0177 describes wireless two-way communications) coupled to the processor to transmit at least a portion of the processed reflectance signal”.
Madar discloses for claim 14, “The intraluminal device of claim 13, wherein at least a portion of the biocompatible casing is opaque (fig 3A shows elements on the shell which are not transparent, i.e. electrode 380a-d. Additionally, there are transparent section of the shell such as optical window 312)”.
Madar discloses for claim 16, “The intraluminal device of claim 13, wherein the at least one light delivery device and/or the at least one photodetector device is encased within a transparent portion of the biocompatible casing (fig 3A shows the transparent optical window which is encasing the inner space where the light and photodetector are located)”.
Madar discloses for claim 19, “A method comprising:
delivering photobiomodulation therapy to biological tissue of a lumen of a portion of a patient's GI tract by at least one light delivery device (320; fig 3A; 0127), wherein the photobiomodulation comprises one or more wavelengths of light that produces at least one therapeutic effect on the biological tissue when applied (0064);
determining, by a signal processing device, whether the photobiomodulation therapy is sufficient to treat the portion of the patient's GI tract based on a signal detected by at least one photodetector (step 170 in fig 1 describes determining diagnosis or therapy based on the measured fluorescent signal); and
at least one of:
reconfiguring the photobiomodulation therapy (step 170 in fig 1 describes determining diagnosis or therapy based on the measured fluorescent signal); or
expelling the at least one light delivery device, the at least one photodetector, and the signal processor from the GI tract by defecation (0109 describes the capsule as swallowed and traversing the GI tract, where without any other intervention is then defecated)”.
Madar does not disclose determining, by a signal processing device, whether the photobiomodulation therapy is sufficient to treat the portion of the patient's GI tract based on a “magnitude or intensity of reflected light from the biological tissue based on the photobiomodulation”. Wang teaches in the same field of endeavor, monitoring the efficacy of photobiomodulation therapy by directly measuring the radiation emitted using a photodetector (0024). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Wang into the invention of Madar in order to configure the system e.g. as claimed because it provides real-time direct monitoring of a result of phototherapy.
Madar discloses for claim 20, “The method of claim 19, wherein the photo biomodulation therapy is configured based on one or more parameters, wherein the one or more parameters comprise at least one of wavelength, timing for delivery, frequency, on time and off time (0060 - 0064 describes specific wavelengths for excitation, where the selection of the wavelength is the parameterization of the therapy and the therapy is determined by a property of the fluorescent signal of the target molecule)”.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madar and Wang as applied to claim 13 above, and further in view of Montalbo et al. US7,044,908.
Madar does not disclose for claim 15, “The intraluminal device of claim 13, wherein a portion of the at least one light delivery device and/or the at least one photodetector device are arranged on an outer surface of the biocompatible casing”. Montalbo teaches in the same field of endeavor, providing an illumination source and a sensor (fig 2, 3a; 4:22-27, 4:55 photodiodes, CCD, CMOS and other light sensitive optical detectors). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Montalbo into the invention of Madar in order to configure the intraluminal device e.g. as claimed because it allows illumination and imaging that is less impeded by the capsule components such as windows which may distort the transmission of light and also potentially reduce the field of view.
Claim(s) 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madar and Wang as applied to claim 13 above, and further in view of Gat US2013/0053928.
Madar does not disclose for claim 17, “The intraluminal device of claim 13, wherein the at least one light delivery device comprises four light delivery devices arranged in a round configuration on a circuit board and the at least one photodetector is at the center of the round configuration on the circuit board”. Gat teaches in the same field of endeavor, providing multiple light sources on a circuit board circumferentially around a capsule (0015; fig 1A, 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Gat into the invention of Madar in order to configure the device e.g. as claimed, using any number of light sources, including four because it provides a direct light source without the use of reflecting elements, thereby reducing the number of components and complexity.
Modified Madar discloses for claim 18, “The intraluminal device of claim 17, wherein the photodetector is optically isolated from the surrounding four light delivery devices to reduce light contamination (Gat: fig 2)”.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, e.g. Wang.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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/Jae Woo/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
9/19/25