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 2, 7, 8, 10, 12, 15,1 6, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, lines 4, 7, 12, 14 and 16 recite the term “about” is a relative term which renders the claim indefinite. The term “about” 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. For examination purposes, the term “about” shall not be considered.
Further, the claim recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, line 14-16 recites the broad recitation “one minute to two minutes”, and the claim also recites two minutes, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest recitation shall be considered.
Regarding claim 7, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 19-25 recites “the 10% or more than 10% of the excitation laser or light being sent to the clad so that a ratio value for the amount of the excitation laser or light being sent to the core is 90% or less than 90%; 50% or about 50% of the excitation laser or light sent to the clad and 50% or about 50% or more of the excitation laser or light sent to the core;47% to the clad and 53% to the core; and/or 50%-x% to the clad and 50%+x% to the core where x% is a value equal to a difference between 50% and the percentage value going to the clad” which recites broad and then more narrow limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest recitation shall be considered.
Further the claim recites “50%-x% to the clad and 50%+x% to the where x% is a value equal to a difference between 50% and the percentage value going to the clad” which renders the claim indefinite, as it fails to clearly define the bounds of x or the relationship between the recited percentages. The value of x is defined in terms of another variable that is itself not independently defined, resulting in ambiguity as the scope of the claim. For examination purposes, the value of x shall be any value.
Regarding claim 8, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 12-15 recites the broad recitation of at least .1 mW, and the claim also recites two (2) times or more higher than the nominal intensity, which is at least 0.2 mW or at least 0.5 mW; ten (10) times or more higher than the nominal intensity, which is at least 1 mW; and/or a hundred (100) times or more higher than the nominal intensity, which is at least 10 mW which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest range shall be considered.
Regarding claim 10, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 2-3 recites the broad recitation 400nm-900nm, and the claim also recites 635nm which is the narrower statement of the range/limitation. Further, lines 5-7 recites the broad recitation twenty-four hours or more and also recites thirty (30) minutes, thirty (30) minutes or more, in a range of thirty (30) minutes to twenty-four (24) hours, twenty-four (24) hours which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 12, lines 3, 6, 11, 15, and 19 recite the term “about” is a relative term which renders the claim indefinite. The term “about” 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. For examination purposes, the term “about” shall not be considered.
Further, the claim recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, line 22-24 recites the broad recitation “one minute to two minutes”, and the claim also recites two minutes, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 15, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 4-5 recites the broad recitation 400nm-900nm, and the claim also recites 635nm which is the narrower statement of the range/limitation. Further, lines 17-19 recites the broad recitation twenty-four hours or more and also recites thirty (30) minutes, thirty (30) minutes or more, in a range of thirty (30) minutes to twenty-four (24) hours, twenty-four (24) hours which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 16, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 19-25 recites “the 10% or more than 10% of the excitation laser or light being sent to the clad so that a ratio value for the amount of the excitation laser or light being sent to the core is 90% or less than 90%; 50% or about 50% of the excitation laser or light sent to the clad and 50% or about 50% or more of the excitation laser or light sent to the core;47% to the clad and 53% to the core; and/or 50%-x% to the clad and 50%+x% to the core where x% is a value equal to a difference between 50% and the percentage value going to the clad” which recites broad and then more narrow limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest recitation shall be considered.
Further the claim recites “50%-x% to the clad and 50%+x% to the where x% is a value equal to a difference between 50% and the percentage value going to the clad” which renders the claim indefinite, as it fails to clearly define the bounds of x or the relationship between the recited percentages. The value of x is defined in terms of another variable that is itself not independently defined, resulting in ambiguity as the scope of the claim. For examination purposes, the value of x shall be any value.
Regarding claim 17, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, lines 11-14 recites the broad recitation of at least .1 mW, and the claim also recites two (2) times or more higher than the nominal intensity, which is at least 0.2 mW or at least 0.5 mW; ten (10) times or more higher than the nominal intensity, which is at least 1 mW; and/or a hundred (100) times or more higher than the nominal intensity, which is at least 10 mW which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest range shall be considered.
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.
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.
Claims 1-4, 6-13, 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Selya et al., (US20220338721A1) in view of Lundquist et al., (US20100167413A1).
Regarding claim 1, Selya teaches an imaging apparatus comprising: a catheter having an optical probe having one or more optical fibers that operate to deliver and receive light (fig. 1 optical imaging device 318 is a catheter with an imaging core, the core comprising a double clad fiber that is used for optical scanning procedures such as transmitting and collecting light [0042]).
However, Selya fails to explicitly disclose a photo-bleached imaging apparatus comprising: wherein the optical probe or one or more components of the optical probe is/are photo-bleached.
In the same fluorescent field of endeavor, Lundquist teaches a photo-bleached imaging apparatus comprising ([0011] an optical system to illuminate and collect fluorescent signals; [0098] the optical system may have some of its optical components photobleached): wherein the optical probe or one or more components of the optical probe is/are photo-bleached ([0098] the optical system may have some of its optical components photobleached).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the optical system of Selya with the process of photobleaching the optical components of Lundquist, as this would reduce amount of autofluorescence background noise generated by the system components (see Lundquist [0098]).
Regarding claim 2, modified Selya teaches the apparatus of claim 1, wherein Selya further teaches the optical probe includes a double clad fiber ([0035] the optical device has a double clad fiber inside the catheter).
Regarding claim 3, modified Selya teaches the apparatus of claim 1, wherein Selya further teaches the one or more processors that operate to perform a pullback of the optical probe within a catheter ([0042] the pullback unit 314 of the optical imaging device 318 scans while the unit is moving linearly backwards).
Regarding claim 4, modified Selya teaches the apparatus of claim 3, wherein Selya further teaches the one or more imaging modalities includes optical coherence tomography (OCT) (fig. 1 the medical imaging system performs OCT [0034]; [0038] oct light source 300).
Regarding claim 6, modified Selya teaches the apparatus of claim 1, wherein Selya further teaches one or more of the following: a light source that operates to produce the light (fig. 1 light source 200).
Regarding claim 7, modified Selya teaches the apparatus of claim 1, wherein Selya further teaches wherein, in a case where the optical probe or the one or more components of the optical probe include or are attached to a double clad fiber, one or more of the following exists ([0035] the imaging device 318 includes a catheter with a double clad fiber): (i) the imaging apparatus further comprises one or more processors that operate to perform a pullback of the optical probe within a catheter ([0042] the pullback unit 314 of the optical imaging device 318 scans while the unit is moving linearly backwards).
Regarding claim 8, modified Selya teaches the apparatus of claim 1, wherein Selya further teaches a lens unit that operate to filter a light of a light source (fig. 1 first and second dichroic filter used to separate and direct the OCT light [0042]) and pass through the emission to the optical probe (fig. 1 the light source 200 directs light into the imaging device 318 [0036]), wherein the one or more components of the optical probe comprise a double clad fiber ([0035] catheter includes a double clad fiber).
Regarding claim 9, Selya teaches the a method of an imaging apparatus, the method comprising: using an excitation light with a wavelength of a predetermined value on the optical probe ([0036] light source 200 has a wavelength of 635nm), the optical probe for use in a catheter (fig. 1 optical imaging device 318 is a catheter with an imaging core, the core comprising a double clad fiber that is used for optical scanning procedures such as transmitting and collecting light [0042]).
However, Selya fails to explicitly disclose a method for photo-bleaching one or more components of an optical device of an imaging apparatus, the method comprising a set amount of time to perform the photo-bleaching such that lower and stabilized background emission noise is achieved for the optical device.
In the same fluorescent field of endeavor, Lundquist teaches a method for photo-bleaching one or more components of an optical device of an imaging apparatus, the method comprising ([0098] the optical components are photobleached) a set amount of time to perform the photo-bleaching such that lower and stabilized background emission noise is achieved for the one or more components of the optical probe ([0019] the optical component in the optical train is photobleached to reduce a level autofluorescence; [0098] the photobleaching may be done for greater than 10 minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the optical system of Selya with the process of photobleaching the optical components of Lundquist, as this would reduce amount of autofluorescence background noise generated by the system components (see Lundquist [0098]).
Regarding claim 10, modified Selya teaches the method of claim 9, wherein Selya further teaches the predetermined value is 635 nm ([0094] the excitation light source delivers a 635 nm laser diode) but is silent regarding the set amount of time is one or more of the following: thirty (30) minutes or more.
In the same fluorescent field of endeavor, Lundquist teaches the set amount of time is one or more of the following: thirty (30) minutes or more ([0098] the bleaching can be greater than 50 minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the optical system of Selya with the process of photobleaching the optical components of Lundquist, as this would reduce amount of autofluorescence background noise generated by the system components (see Lundquist [0098]).
Regarding claim 11, Selya teaches the method of claim 9, but fails to explicitly disclose one or more of the following: coupling an optical power of the excitation light on the one or more components of the optical probe for the predetermined amount of time to achieve the lower and stabilized background emission.
In the same fluorescent field of endeavor, Lundquist teaches coupling an optical power of the excitation light in the one or more components of the optical probe for the predetermined amount of time to achieve the lower and stabilized background emission ([0098] the one or more optical components may be photobleached by the illumination sources, and those sources would have to be coupled to a power source in order to function, and this photobleaching would decrease the autofluorescence background noise.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the optical system of Selya with the process of photobleaching the optical components of Lundquist, as this would reduce amount of autofluorescence background noise generated by the system components (see Lundquist [0098]).
Regarding claim 12, Selya teaches the method of claim 9, wherein Selya further teaches (v) the method further comprises using the optical probe while including a double clad fiber ([0035] the catheter includes a double clad fiber).
Regarding claim 13, modified Selya teaches the method of claim 9, wherein Selya further teaches performing a pullback of the optical probe within a catheter ([0042] the pullback unit 314 of the optical imaging device 318 scans while the unit is moving linearly backwards), wherein one or more of the following: the one or more imaging modalities include one or more of the following : Optical Coherence Tomography (fig. 1 OCT light source 300).
Regarding claim 15, modified Selya teaches the method of claim 9, wherein Selya further teaches one or more of the following: using a light source that operates to produce the light (fig. 1 light source 200 sends the light to the imaging device 318).
Regarding claim 16, modified Selya teaches the method of claim 9, wherein Selya further teaches wherein, in a case where the optical probe or the one or more components of the optical probe include or are attached to a double clad fiber, one or more of the following exists ([0035] the imaging device 318 includes a catheter with a double clad fiber): (i) the imaging apparatus further comprises one or more processors that operate to perform a pullback of the optical probe within a catheter ([0042] the pullback unit 314 of the optical imaging device 318 scans while the unit is moving linearly backwards).
Regarding claim 17, modified Selya teaches the method of claim 9, wherein Selya further teaches using a lens unit that operate to filter a light of a light source (fig. 1 first and second dichroic filter used to separate and direct the OCT light [0042]) and pass through the emission to the optical probe (fig. 1 the light source 200 directs light into the imaging device 318 [0036]), wherein the one or more components of the optical probe comprise a double clad fiber ([0035] catheter includes a double clad fiber).
Regarding claim 18, Selya teaches a computer-readable storage medium storing at least one program that operates to cause one or more processors to execute a method of an imaging apparatus, the method comprising: using an excitation light with a wavelength of a predetermined value on the optical probe ([0036] light source 200 has a wavelength of 635nm), the optical probe for use in a catheter (fig. 1 optical imaging device 318 is a catheter with an imaging core, the core comprising a double clad fiber that is used for optical scanning procedures such as transmitting and collecting light [0042]).
However, Selya fails to explicitly disclose a method for photo-bleaching one or more components of an optical device of an imaging apparatus, the method comprising a set amount of time to perform the photo-bleaching such that lower and stabilized background emission noise is achieved for the optical device.
In the same fluorescent field of endeavor, Lundquist teaches a method for photo-bleaching one or more components of an optical device of an imaging apparatus, the method comprising ([0098] the optical components are photobleached) a set amount of time to perform the photo-bleaching such that lower and stabilized background emission noise is achieved for the one or more components of the optical probe ([0019] the optical component in the optical train is photobleached to reduce a level autofluorescence; [0098] the photobleaching may be done for greater than 10 minutes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the optical system of Selya with the process of photobleaching the optical components of Lundquist, as this would reduce amount of autofluorescence background noise generated by the system components (see Lundquist [0098]).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Selya in view of Lundquist as applied to claims 3 and 13,respectively above, and further in view of Garcia-Garcia et al., (US20250182270A1).
Regarding claim 5, modified Selya teaches the apparatus of claim 3, where Selya further teaches wherein the one or more processors further operate to display the one or more images on a display (fig. 1 display 500 provides the images) but fails to explicitly disclose the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of acquire or receive image data during the pullback operation of the optical probe within the catheter.
In the same catheter field of endeavor, Garcia-Garcia teaches the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of acquire image data during the pullback operation of the optical probe within the catheter ([0031] during a pullback procedure, the images can be captured, and are provided to a convolutional neural network).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of modified Selya with the CNN of Garcia-Garcia, as this would result in a fast, accurate, and precise assessment of lumen areas (see Garcia-Garcia [0029]).
Regarding claim 14, modified Selya teaches the method of claim 13, where Selya further teaches wherein the one or more processors further operate to display the one or more images on a display (fig. 1 display 500 provides the images) but fails to explicitly disclose the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of acquire or receive image data during the pullback operation of the optical probe within the catheter.
In the same catheter field of endeavor, Garcia-Garcia teaches the one or more processors further operate to use one or more neural networks or convolutional neural networks to one or more of acquire image data during the pullback operation of the optical probe within the catheter ([0031] during a pullback procedure, the images can be captured, and are provided to a convolutional neural network).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Selya with the CNN of Garcia-Garcia, as this would result in a fast, accurate, and precise assessment of lumen areas (see Garcia-Garcia [0029]).
Conclusion
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798