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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “512” is used to refer to the longitudinal axis of each of: the flexible elongate member 422 of the embodiment depicted in Figs. 5A-B [Applicant’s Specification p. 20:33-21:1 properly references longitudinal axis “512”], the flexible elongate member 422 of the embodiment depicted in Figs. 6A-B [Applicant’s Specification p. 21:25-30 properly references longitudinal axis “512”], the flexible elongate member 422 of the embodiment depicted in Figs. 8A-B [Applicant’s Specification p. 23:13-18 references longitudinal axis “712”].
The drawings are objected to because reference character “908b” is partially obscured in Fig. 9B.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “heart 300” [Applicant’s Specification p. 12:23-28].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 15 October 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [“This application is the U.S. National Phase application under 35 U.S.C. §371 of International Application No. PCT/EP2023/059794, filed on April 14, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63/332,722, filed April 20, 2-022 and European Patent Application No. 22171131.0, filed on May 2, 2022. These applications are hereby incorporated by reference herein.”]. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Objections
Claim(s) 4 is/are objected to because of the following informalities:
Claim 4 should read “670[[-]] nanometers” [lines 2-3].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 4 is/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.
Claim 4 recites the limitation “approximately 670- nanometers” [line 2-3]. The term “approximately” in claim 4 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention [In some instances, the light directed into and/or around the target tissue area may have a wavelength configured to stimulate the release of nitric oxide (NO), including without limitation light having a wavelength of approximately 670 nm (Applicant’s Specification p. 15:3-5)].
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-9, 11, 13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehrenreich (US-20140188035-A1, cited by Applicant).
Regarding claim 1, Ehrenreich teaches
An apparatus, comprising:
a flexible elongate member configured to be positioned within a body lumen of a patient [catheter 1 (Ehrenreich Fig. 1); A guide wire 11 is used to guide the catheter 1 to a treatment area that includes the target tissue. In an alternative embodiment, catheter 1 may be a fixed-wire type catheter that does not require guide wire 11 for guidance through a patient anatomy (Ehrenreich ¶0041)];
at least one light emitter positioned within the flexible elongate member, the at least one light emitter configured to emit light into tissue of the patient [Referring to FIG. 1, the catheter 1 includes arrays of light emitters (e.g., light emitter 28) and light detectors (e.g., light detector 26) disposed on substrates 30. These light emitters and detectors are used to selectively photo-activate agents in tissue (Ehrenreich ¶0044, Fig. 1); As was just recently mentioned, each LED may be paired with a photodiode as in, e.g., LED-photodiode pairs 22a, 22b, and 22c (LEDs are distinguished from photodiodes in the drawings by hash-marks over photodiodes). The pair may be designed to operate as follows. The LED portion emits light towards adjacent tissue. Light reflected, emitted or scattered from the tissue is detected by the adjacent photodiode. The amplitude of this light energy is then communicated to the controller 34 from the photodiode by an electrical signal that is proportional to the magnitude of the detected light energy (Ehrenreich ¶0048)]; and
at least one light detector positioned within the flexible elongate member, the at least one light detector configured to receive light from the tissue of the patient [Ehrenreich ¶¶0044, 0048, Fig. 1].
Regarding claim 2, Ehrenreich teaches
The apparatus of claim 1, wherein the received light from the tissue is indicative of an absorption of the light within the tissue [Ehrenreich ¶¶0044, 0048, Fig. 1, wherein a level of reflected light is considered to be equivalent to an absorption of light within the tissue; When on-board control begins, a determination is made as to which LEDs are positioned opposite healthy tissue and/or which LEDs are positioned opposite abnormal tissue, e.g., lipid-rich tissue such as atheroma which tends to absorb and scatter more light than healthy tissue (Ehrenreich ¶0059)].
Regarding claim 5, Ehrenreich teaches
The apparatus of claim 1, wherein:
the at least one light emitter is positioned within a distal portion of the flexible elongate member [Ehrenreich ¶¶0044, 0048, Fig. 1];
the at least one light detector is positioned within the distal portion of the flexible elongate member [Ehrenreich ¶¶0044, 0048, Fig. 1]; and
the distal portion of the flexible elongate member is configured to be positioned in contact with the tissue of the patient [Next, the catheter 1 is delivered to the treatment area, e.g., percutaneously. The balloon 7 is then inflated and pressed against the tissue. This provides a light path from/to the light detectors and emitters (Ehrenreich ¶0058, Figs. 3A-B)].
Regarding claim 6, Ehrenreich teaches
The apparatus of claim 1, wherein the at least one light emitter includes a plurality of light emitters arranged in a linear array [Ehrenreich ¶¶0044, 0048, Fig. 1].
Regarding claim 7, Ehrenreich teaches
The apparatus of claim 1, wherein the at least one light detector includes a plurality of light detectors arranged in a linear array [Ehrenreich ¶¶0044, 0048, Fig. 1].
Regarding claim 8, Ehrenreich teaches
The apparatus of claim 1, wherein the at least one light emitter includes a plurality of light emitters arranged in a matrix array and/or the at least one light detector includes a plurality of light detectors arranged in a matrix array [Ehrenreich ¶¶0044, 0048, Fig. 1, wherein the Examiner notes that a [1,x] arrangement is considered to define a matrix].
Regarding claim 9, Ehrenreich teaches
The apparatus of claim 1,
wherein the at least one light detector is a plurality of light detectors [Ehrenreich ¶¶0044, 0048, Fig. 1], and
wherein one or more of the plurality of light detectors are offset from the at least one light emitter in a direction along or parallel to a longitudinal axis of the flexible elongate member [Ehrenreich ¶¶0044, 0048, Fig. 1].
Regarding claim 11, Ehrenreich teaches
The apparatus of claim 4,
wherein the at least one light emitter is a plurality of light emitters [Ehrenreich ¶¶0044, 0048, Fig. 1], and
wherein one or more of the plurality of light emitters are offset from the at least one light detector in a direction along or parallel to a longitudinal axis of the flexible elongate member [Ehrenreich ¶¶0044, 0048, Fig. 1].
Regarding claim 13, Ehrenreich teaches
A system comprising the apparatus of claim 1, further comprising:
a processing system configured to be in communication with the at least one light emitter and the at least one light detector [The catheter 1 may include a power cord 38 that provides power to a controller 34 and circuitry associated with LED and photodiode chips (Ehrenreich ¶0046)],
wherein the processing system is configured to:
control a timing of emission of the light from the at least one light emitter [The amplitude of this light energy is then communicated to the controller 34 from the photodiode by an electrical signal that is proportional to the magnitude of the detected light energy. The controller 34 may then be programmed to turn the LED "on" or "off" based on the magnitude of electrical signal received from the photodiode (Ehrenreich ¶0048); "On/off" signal commands to LEDs may be produced by the controller 34 by opening/closing switches, and the photodiode signals communicated to the controller 34 in order to decide which LEDs should be turned on or off (Ehrenreich ¶0050)]; and
control a timing of detection of light by the at least one light detector, indicative of the absorption of the light within the tissue [Ehrenreich ¶¶0048, 0050].
Regarding claim 15, Ehrenreich teaches
A method, comprising:
introducing a flexible elongate member into a body lumen of a patient, wherein the flexible elongate member includes at least one optical fiber [catheter 1 (Ehrenreich Fig. 1); A guide wire 11 is used to guide the catheter 1 to a treatment area that includes the target tissue. In an alternative embodiment, catheter 1 may be a fixed-wire type catheter that does not require guide wire 11 for guidance through a patient anatomy (Ehrenreich ¶0041); The light source may correspond to an LED array (as described earlier) or fiber optics. In the later case, a fiber optic bundle may be configured to transmit light originating at the proximal portion 14 of the catheter to a location near end 6b, e.g., by passing the fiber optic bundle through the inflation lumen. From this point, the body 2b may be configured to transmit light from its outer surface (Ehrenreich ¶0065)];
emitting, by at least one light emitter positioned within the flexible elongate member, light into tissue of the patient [Referring to FIG. 1, the catheter 1 includes arrays of light emitters (e.g., light emitter 28) and light detectors (e.g., light detector 26) disposed on substrates 30. These light emitters and detectors are used to selectively photo-activate agents in tissue (Ehrenreich ¶0044, Fig. 1); As was just recently mentioned, each LED may be paired with a photodiode as in, e.g., LED-photodiode pairs 22a, 22b, and 22c (LEDs are distinguished from photodiodes in the drawings by hash-marks over photodiodes). The pair may be designed to operate as follows. The LED portion emits light towards adjacent tissue. Light reflected, emitted or scattered from the tissue is detected by the adjacent photodiode. The amplitude of this light energy is then communicated to the controller 34 from the photodiode by an electrical signal that is proportional to the magnitude of the detected light energy (Ehrenreich ¶0048)]; and
monitoring, by at least one light detector positioned within the flexible elongate member, light received from the tissue of the patient, indicative of an absorption of the light within the tissue [Ehrenreich ¶¶0044, 0048, Fig. 1, wherein a level of reflected light is considered to be equivalent to an absorption of light within the tissue; When on-board control begins, a determination is made as to which LEDs are positioned opposite healthy tissue and/or which LEDs are positioned opposite abnormal tissue, e.g., lipid-rich tissue such as atheroma which tends to absorb and scatter more light than healthy tissue (Ehrenreich ¶0059)].
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenreich, as applied to claims 1-2 above, in view of Scharf (US-20160151639-A1).
Regarding claim 3, Ehrenreich teaches
The apparatus of claim 2.
However, Ehrenreich fails to explicitly disclose wherein the absorption of the light within the tissue of the patient is indicative of a level of oxygenation of the tissue.
Scharf discloses systems comprising a flexible elongate member comprising at least one light emitters and at least one light detectors disposed thereon, wherein an absorption of light within tissue of a patient measured by the at least one light detectors is indicative of a level of oxygenation of the tissue [sensor 619 can comprise one or more optical fibers (e.g. one or more optical fibers 651), which collect infrared light (e.g. from their distal end). In these embodiments, sensor measurement assembly 200 comprises an infrared sensor… Measurement assembly 200 can include a microprocessor and/or other electronic circuitry to receive one or more signals from sensor 619… In some embodiments, sensor 619 comprises an oxygen sensor, such as an oxygen saturation sensor used to titrate the effect of oxygen unloading. In these embodiments, sensor 619 can comprise a sensor constructed and arranged to determine the difference in absorption spectrum red (650 nm to 750 nm) for dexoy-Hb and infrared 860-1000 nm for oxy-Hb (Scharf ¶0264)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Ehrenreich to employ wherein the absorption of the light within the tissue of the patient is indicative of a level of oxygenation of the tissue, as modifying the apparatus of Ehrenreich to measure a level of oxygenation of the tissue is considered to amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable correlation of measured light indicative of light absorption to physiological parameters] [MPEP § 2143(I)(D)].
Regarding claim 4, Ehrenreich teaches
The apparatus of claim 1.
However, Ehrenreich fails to explicitly disclose wherein the at least one light emitter is configured to emit the light having a wavelength of approximately 670- nanometers.
Scharf discloses systems comprising a flexible elongate member comprising at least one light emitters and at least one light detectors disposed thereon, wherein the at least one light emitter is configured to emit the light having a wavelength of approximately 670- nanometers [Scharf ¶0264].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Ehrenreich to employ wherein the absorption of the light within the tissue of the patient is indicative of a level of oxygenation of the tissue, as this modification is considered to amount to merely applying a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable correlation of measured light indicative of light absorption to physiological parameters] [MPEP § 2143(I)(D)].
Claim(s) 10, 12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenreich, as applied to claims 1, 4, and 13 above, in view of Eslami (US-20220192502-A1, effective filing date of 17 April 2020).
Regarding claim 10, Ehrenreich teaches
The apparatus of claim 1,
wherein the at least one light detector is a plurality of light detectors [Ehrenreich ¶¶0044, 0048, Fig. 1].
However, Ehrenreich fails to explicitly disclose wherein one or more of the plurality of light detectors are offset from the at least one light emitter in a direction perpendicular to a longitudinal axis of the flexible elongate member.
Eslami discloses a flexible elongate member configured to be positioned within a body lumen of a patient and an array of one or more light emitters and one or more light detectors positioned on the elongate member such that one or more of the plurality of light detectors are offset from one or more light emitters in a direction perpendicular to a longitudinal axis of the flexible elongate member [FIG. 4 shows an exemplary orifice detection device 200. In the illustrated example of FIG. 4, the device 200 contains a two-dimensional array 202 of sensors and emitters. Each element of the array 202 comprises a sensor and an emitter such as emitter 210 and sensor 212 shown in FIG. 4. The emitters can emit infrared light (or in some examples, light at other wavelengths as described above), and the sensors can detect reflected or transmitted light emitted by the emitters. In the example of FIG. 4, the array 202 contains seven rows and four columns of sensor/emitter elements. In other examples, the array 202 can contain additional sensor/emitter elements (Eslami ¶0042, Figs. 5-6, 8)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Ehrenreich to employ wherein one or more of the plurality of light detectors are offset from the at least one light emitter in a direction perpendicular to a longitudinal axis of the flexible elongate member, as this modification would amount to mere simple substitution of one known element for another with similar expected results [an arrangement of light emitters and light detectors for emitting light and receiving reflected light, respectively, to measure an intensity of reflected light] [MPEP § 2143(I)(B)].
Regarding claim 12, Ehrenreich teaches
The apparatus of claim 4,
wherein the at least one light emitter is a plurality of light emitters [Ehrenreich ¶¶0044, 0048, Fig. 1].
However, Ehrenreich fails to explicitly disclose wherein one or more of the plurality of light emitters are offset from the at least one light detector in a direction perpendicular to a longitudinal axis of the flexible elongate member.
Eslami discloses a flexible elongate member configured to be positioned within a body lumen of a patient and an array of one or more light emitters and one or more light detectors positioned on the elongate member such that one or more of the plurality of light detectors are offset from one or more light emitters in a direction perpendicular to a longitudinal axis of the flexible elongate member [FIG. 4 shows an exemplary orifice detection device 200. In the illustrated example of FIG. 4, the device 200 contains a two-dimensional array 202 of sensors and emitters. Each element of the array 202 comprises a sensor and an emitter such as emitter 210 and sensor 212 shown in FIG. 4. The emitters can emit infrared light (or in some examples, light at other wavelengths as described above), and the sensors can detect reflected or transmitted light emitted by the emitters. In the example of FIG. 4, the array 202 contains seven rows and four columns of sensor/emitter elements. In other examples, the array 202 can contain additional sensor/emitter elements (Eslami ¶0042, Figs. 5-6, 8)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Ehrenreich to employ wherein one or more of the plurality of light emitters are offset from the at least one light detector in a direction perpendicular to a longitudinal axis of the flexible elongate member, as this modification would amount to mere simple substitution of one known element for another with similar expected results [an arrangement of light emitters and light detectors for emitting light and receiving reflected light, respectively, to measure an intensity of reflected light] [MPEP § 2143(I)(B)].
Regarding claim 14, Ehrenreich teaches
The system of claim 13.
However, Ehrenreich fails to explicitly disclose further comprising: a display in communication with the processing system, wherein the processing system is configured to output a visual representation of the absorption of the light within the tissue via the display.
Eslami discloses systems comprising a processing system for communicating with an apparatus comprising one or more light emitters and one or more light detectors [Eslami ¶0042], wherein Eslami further discloses a display in communication with the processing system, wherein the processing system is configured to output a visual representation of absorption of detected light within tissue via the display [An image can be generated by the light detector of the device based on the light received from the emitter 304 through the wall of the stent graft. Such an image can be generated by an external device electrically or optically coupled to the device 312. In such an image, certain colors can represent higher intensity light reception, whereas other colors can represent lower intensity light reception (Eslami ¶0050), wherein an external device for generating an image for visualization is considered to read on the broadest reasonable interpretation of a display].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ehrenreich to employ further comprising: a display in communication with the processing system, wherein the processing system is configured to output a visual representation of the absorption of the light within the tissue via the display, so as to facilitate visualization of measured data, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [use of a display to visualize data] [MPEP § 2143(I)(D)].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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