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 21-24 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 21 recites the limitation "the electromagnetic radiation from the first electromagnetic radiation source" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the electromagnetic radiation from the first electromagnetic radiation source” is being interpreted as “a first electromagnetic radiation from the first electromagnetic radiation source.”
Claim 21 recites the limitation "the electromagnetic radiation from the second electromagnetic radiation source" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the electromagnetic radiation from the second electromagnetic radiation source” is being interpreted as “a second electromagnetic radiation from the second electromagnetic radiation source.”
Claim 22 recites “electromagnetic radiation” in line 4. It is unclear if applicant is referring to the “the [first] electromagnetic radiation from the first electromagnetic radiation source” previously recited in lines 2-3 of Claim 21, “the [second] electromagnetic radiation from the second electromagnetic radiation source” previously recited in lines 3-4 of Claim 21, or separate, different electromagnetic radiation. For the purposes of examination, “electromagnetic radiation” is being interpreted as “the first electromagnetic radiation and the second electromagnetic radiation, respectively.”
Claim 23 recites “electromagnetic radiation” in line 4. It is unclear if applicant is referring to the “the [first] electromagnetic radiation from the first electromagnetic radiation source” previously recited in lines 2-3 of Claim 21, “the [second] electromagnetic radiation from the second electromagnetic radiation source” previously recited in lines 3-4 of Claim 21, or separate, different electromagnetic radiation. For the purposes of examination, “electromagnetic radiation” is being interpreted as “either the first electromagnetic radiation or the second electromagnetic radiation, respectively.”
Claim 24 recites “electromagnetic radiation” in lines 4-5. It is unclear if applicant is referring to the “the [first] electromagnetic radiation from the first electromagnetic radiation source” previously recited in lines 2-3 of Claim 21, “the [second] electromagnetic radiation from the second electromagnetic radiation source” previously recited in lines 3-4 of Claim 21, or separate, different electromagnetic radiation. For the purposes of examination, “electromagnetic radiation” is being interpreted as “the first electromagnetic radiation.”
Claim 24 recites “electromagnetic radiation” in lines 6-7. It is unclear if applicant is referring to the “the [first] electromagnetic radiation from the first electromagnetic radiation source” previously recited in lines 2-3 of Claim 21, “the [second] electromagnetic radiation from the second electromagnetic radiation source” previously recited in lines 3-4 of Claim 21, or separate, different electromagnetic radiation. For the purposes of examination, “electromagnetic radiation” is being interpreted as “the second electromagnetic radiation.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-7, 9-13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2020/0196873 A1 to Ntziachristos et al. (“Ntziachristos”) in view of U.S. Patent Appl. Publ. No. 2011/0004058 A1 to Oneda et al. (“Oneda”).
Regarding claim 1, Ntziachristos discloses a system (device 1 for endoscopic optoacoustic imaging; Fig. 1-2, paragraph 0076) for performing retrograde tethered capsule endomicroscopy (to improve diagnostic accuracy, a class of imaging technologies capable of providing optical biopsies in living patients without excising any tissue has been provided. Among them are confocal laser endomicroscopy and optical coherence tomography (OCT); paragraph 0003), comprising:
a capsule (the position stabilizing structure 3 preferably comprises a rigid or elastic shell with an outer face 3a that is at least optically and/or acoustically transparent and forms a cavity with an interior 3b. Thus, the interior 3b can be filled with a coupling medium … during assembly the capsule can be filled with coupling medium, for example by submersion of the position stabilizing structure 3 in a reservoir filled with the coupling medium; Fig. 2, paragraphs 0089-0090);
a drive shaft (the connecting element 9 preferably comprises a further transmitting nuit 14, for example a drive shaft; Figs. 1-2, paragraph 0105) coupled to the capsule (the position stabilizing structure 3 is arranged at the imaging unit 2, in particular at the distal end of the connecting element 9; Fig. 1-2, paragraph 0079); and
an optical system disposed within the capsule (the imaging unit 2 is disposed in the) interior 3b, for example at the center, of the position stabilizing structure 3 such that the imaging unit 2 is surrounded by the position stabilizing structure 3; Fig. 2, paragraph 0079) and configured to obtain circumferential imaging information (by rotating or translating the optoacoustic imaging head around or along the longitudinal axis 24, respectively, using the transmitting unit 14, two-dimensional images are acquired. By combining both rotation and translation of the optoacoustic imaging head, volumetric scans, i.e. three-dimensional images, are acquired without moving the connecting element 9; Figs. 1-3, paragraph 0108)(this allows for a stable 360° rotational scan of the imaging unit 2 which is not disturbed; paragraph 0151).
However, Ntziachristos fails to explicitly disclose a capsule comprising at least one outwardly-facing helical thread and a drive shaft configured to rotate the capsule.
Oneda teaches a system (colonscope 600; Fig. 9, paragraph 0099), comprising:
a capsule (imaging capsule 600; Fig. 9, paragraph 0099) comprising at least one outwardly-facing helical thread (an outer surface of imaging capsule 610 is optionally covered by a threading 614, which causes the imaging capsule to advance or retract along the colon (or other internal body channel) when imaging capsule 610 is rotated. Optionally, threading 614 has a helical form; Fig. 9, paragraph 0099);
a drive shaft (internal shaft 606; Fig. 9, paragraph 0099) coupled to the capsule and configured to rotate the capsule (an internal shaft 606 connects capsule 610 to a motor 612, such that rotation force from motor 612 rotates internal shaft 606, which rotates capsule 610; Fig. 9, paragraph 0099); and
an optical system disposed within the capsule and configured to obtain circumferential imaging information (capsule 610 optionally includes on its distal end, a camera 620; Fig. 9, paragraph 0100). Oneda teaches that the outwardly-facing helical thread on the outer surface of the capsule helps to allow the capsule to advance or retract along the intestinal tract (paragraph 0099).
Oneda is considered to be analogous to the claimed invention because it is in the same field of endoscopes. 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 Ntziachristos to incorporate the teachings of Oneda by adding at least outwardly-facing helical thread to the capsule and configuring the drive shaft to rotate the capsule. Doing so helps allow the capsule to advance and retract along the intestinal tract, as recognized by Oneda.
Regarding claim 2, Ntziachristos, as previously modified by Oneda, discloses the system according to claim 1. Ntziachristos further discloses comprising an optical waveguide disposed within the drive shaft (a transmitting unit 11, preferably comprising an optical fiber 11a … is located inside the transmitting unit; Fig. 4, paragraph 0122), and
wherein the optical system comprises a lens (beam shaping element 6a; Fig. 4, paragraph 0123) optically coupled to the optical waveguide and disposed within the capsule (electromagnetic radiation emanating from the distal end of the optical fiber 11a passes through a beam shaping element 6a, e.g., a lens; Fig. 4, paragraph 0123).
Regarding claim 3, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-2. Ntziachristos further discloses wherein the optical system further comprises an angled reflector aligned with the lens (electromagnetic radiation emanating from the distal end of the optical fiber 11a passes through a beam shaping element 6a, e.g., a lens, and is reflected by a reflection element 6b. Preferably, the reflection element 6b is arranged in a 45° angle with respect to a longitudinal axis 24 of the position stabilizing structure 3, such that the electromagnetic radiation is guided through an opening of the detection unit 8; Fig. 4, paragraph 0123), and
wherein the angled reflector is configured to rotate to direct a beam of electromagnetic radiation emitted from the lens in a circumferential pattern around the capsule (rotation of the carrier unit 16; Fig. 4, paragraph 0126).
Regarding claim 4, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-3. Ntziachristos further discloses wherein the capsule further comprises a circumferential imaging window aligned with the angled reflector (the imaging window 3c’ is preferably located in a region of a circumference of the position stabilizing structure 3. The imaging window 3c’ is preferably optically and acoustically transparent, and its thickness can be designed to decrease its influence on the imaging properties; Fig. 2 and 4, paragraphs 0090 and 0092).
Regarding claim 5, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-4. Oneda further teaches wherein the at least one outwardly-facing helical thread is absent in a region of the circumferential imaging window (Fig. 9 shows a viewing window for the camera 620 to image that is not blocked by the outwardly-facing helical thread; Fig. 9).
Regarding claim 6, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-5. Ntziachristos further discloses wherein the capsule comprises a rigid inner capsule body (supporting structures 3e; Fig. 2, paragraph 0091) and a resilient outer portion (proximal end portion 3c and distal end portion 3d; Fig. 2)(the position stabilizing structure 3 can be made of rigid or soft biomedical grade material or a combination of both. For example, the proximal end 3c and the distal end 3d can be fabrication of PMMA, polycarbonate, polyethylene, polyurethane, polyimide, Pebax, or metal, e.g. stainless steel or titanium; Fig. 3, paragraph 0091).
However, Ntziachristos does not explicitly disclose wherein the resilient outer portion comprises the at least one outwardly-facing helical thread.
Oneda teaches wherein the outer portion comprises the at least one outwardly-facing helical thread (an outer surface of imaging capsule 610 is optionally covered by a threading 614, which causes the imaging capsule to advance or retract along the colon (or other internal body channel) when imaging capsule 610 is rotated. Optionally, threading 614 has a helical form; Fig. 9, paragraph 0099).
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 Ntziachristos to incorporate the teachings of Oneda by adding at least outwardly-facing helical thread to the outer portion of the capsule. Doing so helps allow the capsule to advance and retract along the intestinal tract, as recognized by Oneda.
Regarding claim 7, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-6. Ntziachristos further discloses wherein the resilient outer portion comprises a proximal layer (proximal end 3c; Fig. 2, paragraph 0091) and a distal layer (distal end 3d; Fig. 2, paragraph 0091) attached to the rigid inner capsule body (supporting structures 3e; Fig. 2, paragraph 0091),
wherein the circumferential imaging window is between the proximal layer and the distal layer (the imaging window 3c’ is between the proximal end 3c and the distal end 3d; Fig. 2, paragraph 0092).
Regarding claim 9, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-5. Ntziachristos further discloses comprising an imaging system (carrier unit 16; Fig. 2, paragraph 0105-0106),
wherein the imaging system (carrier unit 16; Fig. 2) is coupled to the optical system (imaging unit 2; Fig. 2) using the optical waveguide (optical fiber 11a; Fig. 2),
wherein the imaging system comprises an interferometric imaging system (the at least one ultrasound transducer is preferably configured as a piezoelectric transducer, a micromachined transducer (CMUT) or an optical transducer using interferometric techniques for ultrasound wave detection; Fig. 2, paragraph 0101), and
wherein the circumferential imaging information is obtained using the interferometric imaging system (the at least one ultrasound transducer is preferably configured as a piezoelectric transducer, a micromachined transducer (CMUT) or an optical transducer using interferometric techniques for ultrasound wave detection; Fig. 2, paragraph 0101).
Regarding claim 11, Ntziachristos, as previously modified by Oneda, discloses the system according to claim 1. Ntziachristos further discloses comprising a drive system coupled to the drive shaft (the imaging unit 2 can be moved, in particular rotated and/or translated, by transmitting mechanical energy, i.e. forces or torques, from a drive unit 13 disposed at a proximal end of the connecting unit 9 to a carrier nuit 16, on which the irradiation unit 6 and the detection unit 8 are mounted; Fig. 2, paragraph 0105).
Regarding claim 12, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1 and 11. Ntziachristos further discloses wherein the drive shaft comprises a semirigid drive shaft (the connecting unit 9 is designed as a flexible tube, which is preferably configured to minimize stretching. Alternatively or additionally, the connecting unit 9 is designed to be resistant to rotational deformation; Fig. 2, paragraph 0087)(the connecting element 9 preferably comprises a further transmitting unit 14, for example a driveshaft, in particular a torque coil; Fig. 2, paragraph 0105), and
However, Ntziachristos does not explicitly disclose wherein the drive system is configured to rotate the semirigid drive shaft to rotate the capsule in a first rotational direction and a second rotational direction opposite the first rotational direction.
Oneda teaches wherein the drive system (motor 612; Fig. 9, paragraph 0099) is configured to rotate the semirigid drive shaft to rotate the capsule in a first rotational direction and a second rotational direction opposite the first rotational direction (Fig. 9 shows the internal shaft 606 in a bent position, making it semi rigid, where the motor 612 capsule 610 to advance [first rotational direction] and retract [second, opposite direction]; Fig. 9).
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 Ntziachristos to incorporate the teachings of Oneda by rotate the capsule in a first rotational direction and a second rotational direction opposite the first rotational direction. Doing so allows the capsule to advance or retract within a lumen based on the direction of rotation, as recognized by Oneda.
Regarding claim 13, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1 and 11-12. Ntziachristos further discloses wherein the drive system is coupled to the semirigid drive shaft using a catheter cap (the drive unit 13, for example an electric motor, can provide the torque for rotation and the pull/pish force for translation or the imaging unit 2 via rotary junction 15. The connecting element 9, in particular the transmitting units 11, 14 can be attached to the rotary junction 15 for example with hybrid connector; Fig. 2, paragraph 0111),
wherein the catheter cap provides at least one of optical or electrical connections to the capsule (such rotary junction 11 allows to a couple light and/or electrical signals from the rotating part to the stationary part with minimal losses; Fig. 2, paragraph 0111).
Regarding claim 17, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-5 and 9. However, Ntziachristos fails to explicitly disclose comprising a balloon surrounding the drive shaft adjacent to the capsule, wherein the balloon is configured to be inflated during operation of the imaging system.
Oneda teaches comprising a balloon (balloon 364; Fig. 7A-B) surrounding the drive shaft adjacent to the capsule (it is noted that a balloon may be mounted on any of the imaging units described above, including on imaging capsule 110; paragraph 0095), wherein the balloon is configured to be inflated during operation of the imaging system (outer tube 352 carries a balloon 364 which may be inflated through the interior of the tube 352 or a channel passing therethrough. The inflating of balloon 364 may be used to anchor imaging unit 350 within the patient; Fig. 7A-B, paragraph 0094).
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 Ntziachristos to incorporate the teachings of Oneda by comprising a balloon surrounding the drive shaft adjacent to the capsule. Doing so can help anchor the imaging device within a patient, as recognized by Oneda.
Regarding claim 19, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-4. However, Ntziachristos fails to explicitly disclose further comprising an infusion tube configured to deliver fluid to the imaging window to remove debris.
Oneda teaches further comprising an infusion tube configured to deliver fluid to the imaging window to remove debris (in order to clean a viewing window of imaging capsule 110, a physician retracts the imaging capsule into slot 106 and a fluid (e.g., water) is caused to flow through distal channels 112 and outlets 108 at imaging capsule 110; Fig. 1, paragraph 0059).
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 Ntziachristos to incorporate the teachings of Oneda by further comprising an infusion tube. Doing so allows the viewing window of the imaging capsule to be cleaned, as recognized by Oneda, thereby improving visualization.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ntziachristos, as modified by Oneda, as applied to claims 1 and 11-13 above, and further in view of U.S. Patent Appl. Publ. No. 2008/0255422 A1 to Kondoh et al. (“Kondoh”).
Regarding claim 14, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1 and 11-13. However, Ntziachristos, as modified by Oneda, does not explicitly disclose wherein the catheter cap comprises an inner cap disposed within an outer cap with a bearing therebetween, wherein the inner cap rotates within the outer cap via the bearing to rotate the semirigid drive shaft.
Kondoh teaches wherein the catheter cap (manipulating part 105; Fig. 47) comprises an inner cap (expanded diameter portion adjacent the drive shaft 122; Fig. 47) disposed within an outer cap (cover 125; Fig. 47) with a bearing (bearing 123; Fig. 47) therebetween, wherein the inner cap rotates within the outer cap via the bearing to rotate the semirigid drive shaft (the cover 125 is attached to the handle 120 such that the cover 125 and the handle 120 rotate together. The bearing 123 is fixed to the other portion of the manipulating part so as not to rotate; Fig. 47, paragraphs 0130-0131).
Kondoh is considered to be analogous to the claimed invention because it is in the same field of endoscopic systems with a capsule device. 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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Kondoh by including the outer cap, inner cap, and bearing. Doing so would provide a bearing assembly for the drive shaft (paragraphs 0130-0131), as recognized by Kondoh, thereby reducing the friction associated with the driveshaft rotating.
Claims 15 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ntziachristos, as modified by Oneda, as applied to claims 1-3 above, and further in view of U.S. Patent Appl. Publ. No. 2018/0070932 A1 to Tearney et al. (“Tearney”).
Regarding claim 15, Ntziachristos, as previously modified by Oneda, discloses the system according to claims 1-3. However, Ntziachristos, as modified by Oneda, does not explicitly disclose wherein the angled reflector is rotated using a micro-motor, wherein power is provided to the micro-motor via wires in the drive shaft, and wherein the lens comprises at least one of a ball lens or a prism configured to direct light from the optical waveguide toward the angled reflector.
Tearney teaches wherein the angled reflector is rotated using a micro-motor (a distal motor (1020) that is affixed inside the capsule through a holder (1019) can be used to rotate the reflective surface (1021) and/or perform the circumferential scan; Fig. 10B, paragraph 0103), wherein power is provided to the micro-motor via wires in the drive shaft (the distal motor 1020 must be powered in order to be operational; therefore, wiring of some manner must be provide through the drive shaft to provide power to the motor), and wherein the lens comprises at least one of a ball lens or a prism configured to direct light from the optical waveguide toward the angled reflector (focusing optics (2404), which focus light beam, can include, but is not limited to, lens, GRIN lens, ball lens, etc’ Fig. 24, paragraph 0116).
Tearney is considered to be analogous to the claimed invention because it is in the same field of endoscopic systems with a capsule device. 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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Tearney by rotating the angled reflection using a micro-motor. Doing so helps allow the capsule to perform the circumferential scan, as recognized by Tearney.
Regarding claim 20, Ntziachristos, as previously modified by Oneda, discloses the system according to claim 1. Ntziachristos further discloses comprising a first electromagnetic radiation source for imaging (radiation source 10; Fig, 2, paragraph 0094), wherein the first electromagnetic radiation source is optically coupled to the optical system (the radiation source 10, e.g. a pulsed or amplitude modulated tunable or single wavelength laser, a LED, a SLD or a laser diode, is optically coupled into the connecting element 9 at a proximal end of the connecting element 9; Fig. 2, paragraph 0094), and wherein the first electromagnetic radiation source is configured to obtain the circumferential imaging information of a sample (this allows for a stable full 360 degrees rotational scan of imaging nuit 2 which is not disturbed; Fig. 2, paragraphs 0098 and 0151).
However, Ntziachristos, as modified by Oneda, does not explicitly disclose a second electromagnetic radiation source for ablation, wherein the second electromagnetic radiation source is optically coupled to the optical system, and wherein the second electromagnetic radiation source is configured to ablate the sample.
Tearney teaches comprising a first electromagnetic radiation source for imaging (an imaging light 302; Fig. 3, paragraph 0091) and a second electromagnetic radiation source for ablation (a tissue altering light 304; Fig. 3, paragraph 0091), wherein each of the first electromagnetic radiation source and the second electromagnetic radiation source are optically coupled to the optical system (the imaging light, capture light, and/or tissue altering light (1003) can be delivered into the capsule (1001) using, e.g., a relay optics (1004), which can be or include, but is not limited to, optical fiber, grin lens, reflector, prism, mirror or fiber bundle; Fig. 10A, paragraph 0101), wherein the first electromagnetic radiation source is configured to obtain the circumferential imaging information of a sample (such device can be a swallowable capsule that can be attached to a tether that contains an optical fiber or additionally a driveshaft that rotates the optical fiber and the optics within the capsule; Fig. 10A, paragraph 0101), and wherein the second electromagnetic radiation source is configured to ablate the sample (the tissue alteration light, where the characteristics of tissue altering include, breakage of tight junctions, ablation, cutting, marking, separation from another tissue type, or the like can be switched on; Fig. 10A, paragraph 0096). Tearney teaches that ablating tissue helps to enhance the tissue collection (paragraph 0096).
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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Tearney by including a second electromagnetic radiation source configured to ablate the sample. Doing so helps to enhance tissue collection, as recognized by Tearney.
Regarding claim 21, Ntziachristos, as previously modified by Oneda and Tearney, discloses the system according to claims 1 and 20. Ntziachristos further discloses wherein the optical system comprises a lens (beam shaping element 6a, e.g., a lens; Fig. 4, paragraph 0123) configured to at least one of focus the electromagnetic radiation from the first electromagnetic radiation source or collimate the electromagnetic radiation from the second electromagnetic radiation source (electromagnetic radiation emanating from the distal end of the optical fiber 11a passes through a beam shaping element 6a, e.g. a lens, and is reflected by a reflection element 6b. Preferably, the reflection element 6b is arranged in a 45° angle with respect to a longitudinal axis 24 of the position stabilizing structure 3, such that the electromagnetic radiation is guided through an opening of the detection unit 8; Fig. 4, paragraph 0123).
Regarding claim 22, Ntziachristos, as previously modified by Oneda and Tearney, discloses the system according to claims 1 and 20-21. Ntziachristos further discloses comprising an optical waveguide disposed within the drive shaft (a transmitting unit 11, preferably comprising an optical fiber 11a … is located inside the transmitting unit; Fig. 4, paragraph 0122), and wherein the first electromagnetic radiation source deliver electromagnetic radiation to the optical system using the optical waveguide (electromagnetic radiation emanating from the distal end of the optical fiber 11a passes through a beam shaping element 6a, e.g., a lens; Fig. 4, paragraph 0123).
However, Ntziachristos, as previously modified by Oneda, does not explicitly disclose wherein the second electromagnetic radiation source deliver electromagnetic radiation to the optical system using the optical waveguide.
Tearney teaches wherein the second electromagnetic radiation source deliver electromagnetic radiation to the optical system using the optical waveguide (the imaging light, capture light, and/or tissue altering light (1003) can be delivered into the capsule (1001) using, e.g., a relay optics (1004), which can be or include, but is not limited to, optical fiber, grin lens, reflector, prism, mirror or fiber bundle; Fig. 10A, paragraph 0101). Tearney teaches that ablating tissue helps to enhance the tissue collection (paragraph 0096).
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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Tearney by including a second electromagnetic radiation delivering electromagnetic radiation to the optical system using the optical waveguide. Doing so helps to enhance tissue collection, as recognized by Tearney.
Regarding claim 23, Ntziachristos, as previously modified by Oneda and Tearney, discloses the system according to claims 1 and 20-22. Ntziachristos, as previously modified by Oneda, does not explicitly disclose wherein the lens comprises a tunable lens, and wherein the tunable lens is configured to change a focusing power based on whether the first electromagnetic radiation source or the second electromagnetic radiation source is delivering electromagnetic radiation to the optical system.
Tearney teaches wherein the lens comprises a tunable lens (the focusing optics (1005) can be or include, but is not limited to, lens, gradiant refractive (GRIN) lens, call lens, lens assembly, etc, focus light onto a capturing fil, (1005) or tissue (1006, 1007); Fig. 10A, paragraph 0101), and wherein the tunable lens is configured to change a focusing power based on whether the first electromagnetic radiation source or the second electromagnetic radiation source is delivering electromagnetic radiation to the optical system (based on the property of capture material (307), the capture light (301) and the tissue altering light (304) can be used independently and/or together for a beneficial tissue capturing; paragraph 0091).
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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Tearney by including a tunable lens. Doing so allows the energy to be accurately delivered to the area of interest in the desired amounts for different energy types, as recognized by Tearney (paragraphs 0013, 0017, and 0101).
Regarding claim 24, Ntziachristos, as previously modified by Oneda and Tearney, discloses the system according to claims 1 and 20-21. Ntziachristos further discloses a first optical waveguide disposed within the drive shaft (a transmitting unit 11, preferably comprising an optical fiber 11a … is located inside the transmitting unit; Fig. 4, paragraph 0122), and wherein the first electromagnetic radiation source delivers electromagnetic radiation to the optical system using the first optical waveguide (electromagnetic radiation emanating from the distal end of the optical fiber 11a passes through a beam shaping element 6a, e.g., a lens; Fig. 4, paragraph 0123).
However, Ntziachristos, as previously modified by Oneda, does not explicitly disclose comprising a second optical waveguide disposed within the drive shaft, wherein the second electromagnetic radiation source delivers electromagnetic radiation to the optical system using the second optical waveguide.
Tearney teaches wherein the second electromagnetic radiation source deliver electromagnetic radiation to the optical system using an optical waveguide (the imaging light, capture light, and/or tissue altering light (1003) can be delivered into the capsule (1001) using, e.g., a relay optics (1004), which can be or include, but is not limited to, optical fiber, grin lens, reflector, prism, mirror or fiber bundle; Fig. 10A, paragraph 0101). Tearney teaches that ablating tissue helps to enhance the tissue collection (paragraph 0096).
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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Tearney by including a second electromagnetic radiation delivering electromagnetic radiation to the optical system using a second optical waveguide. Doing so helps to enhance tissue collection, as recognized by Tearney.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ntziachristos, as modified by Oneda, as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2012/0245445 A1 to Black et al. (“Black”).
Regarding claim 25, Ntziachristos, as previously modified by Oneda, discloses the system according to claim 1. However, Ntziachristos, as modified by Oneda, does not explicitly disclose wherein the capsule is pretreated with plasma to reduce fouling during use.
Black teaches wherein the capsule is pretreated with plasma to reduce fouling during use (using a O2/CF4 plasma to etch the surfaces of a medical device to reducing fouling can be applied to any PMMA-based medical devices; paragraphs 0059, 0132, and 0296).
Black is considered to be analogous to the claimed invention because it is in the same field of body fluid sampling and delivery devices. 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 Ntziachristos, as modified by Oneda, to incorporate the teachings of Black by pretreating the capsule with plasma to reduce fouling during use. Doing so helps provide a suitable surface for the medical device that fits the device’s intended application, as recognized by Black (paragraph 0296).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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