DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicants reply filed 07/02/2026 has been entered. Currently claims 1-18 are pending.
Claim Objections
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 10. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-18 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 1, lines 4-7 recite “the optical probe or one or more components of the optical probe is/are photo-bleached by using an excitation laser or light with a wavelength of a predetermined range or value on or in the optical probe and/or in one or more components of the optical probe for a predetermined or set amount of time or more”. Due to the repeated use of “or” and “and/or” and the placement of the modifying phrases, it is unclear which alternatives are intended to be included and which terms the phrases “with a wavelength of a predetermined range or value”, “on or in the optical probe and/or in one or more components”, and “for a predetermined or set amount of time or more” modify. For examination purposes, the claim shall be considered as the optical probe or one or more components of the optical probe is/are photo-bleached (by using an excitation laser or light with a wavelength of a predetermined range or value) (on or in the optical probe and/or in one of more components of the optical probe) for
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]), using an excitation light with a wavelength of a predetermined value on the optical probe ([0036] light source 200 has a wavelength of 635nm), wherein one or more of the following: the method further comprises using the optical probe while including a double clad fiber ([0035] catheter has a double clad fiber).
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) by using one or more components of the optical probe for a set amount of time to perform the photo-bleaching ([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 2, modified Selya teaches the apparatus of claim 1, but is silent regarding wherein the predetermined range is one of the following (400 nm – 900 nm); and the predetermined amount of time is one of the following twenty-four (24) hours or more.
In the same fluorescence field of endeavor, Lundquist teaches wherein the predetermined range is one of the following (400 nm – 900 nm); and the predetermined amount of time is one of the following twenty-four (24) hours or more ([0098] a 162 mW laser at 488 nm from 1000 to 4600 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 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]), wherein in one or more of the following: (v) the method further comprises using the optical probe while including a double clad fiber ([0035] catheter includes a double clad fiber).
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, 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 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]), wherein in one or more of the following: (v) the method further comprises using the optical probe while including a double clad fiber ([0035] catheter includes a double clad fiber).
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]).
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 35 U.S.C. 103 rejections, Applicant has argued several points.
First, Applicant has argued that that the Lundquist fails to cure the deficiencies of the Selya reference for a plurality of reasons, such as not motivation to make the combination, and no prima facie case of obviousness has been presented because one skilled in the art would not be motivated and would be discouraged from making the combination because the combination would change a principle of operation of the Selya reference and would render the device of Selya inoperable for its intended purpose.
Examiner disagrees. Applicant has treated the techniques of Selya and Lundquist as mutually exclusive when the references do not indicate that as such. Selya identifies autofluorescence originating from components of the imaging devices, such as the optical fiber, lens, and sheath, as one of the unwanted background fluorescence. Selya further disclose an imaging core comprising a double clad fiber and distal optical components through which excitation light is transmitted. Lundquist teaches photobleaching an overall optical system or one or more optic al components through which the illumination passes to reduce autofluorescence generated by those components. Thus Selya identifies the particular problem of component generated autofluorescence, and Lundquist provides a known treatment directed to reducing that same for of autofluorescence.
Even though Lundquist describes substrate based applications, it does not negate or restrict its teachings of photo bleaching optical components through which excitation illumination passes. Lundquist states that its discussion of planar, single molecule arrays are provided for ease of discussion and that the disclosed techniques have broader applicability. Moreover, the rejection does not incorporate Lundquist’s substrate or multiplex array structure into Selya. Instead, the rejection relies upon Lundquist teaching of photobleaching optical components to reduce component generated autofluorescence.
The references also provide sufficient reasons for making the proposed modifications. It would have been obvious to one of ordinary skill in the art to photo-bleach the optical components of Selya, since Selya states that the components are sources of unwanted fluorescence, and Lundquist teaches the photobleaching as a way of reducing that background fluorescence. Thus, there the motivation provides a technical reason having a rational underpinning for combination the two references. Further, Selya explains that instrument background originates primarily from the double clad fibers and distal optical components, and then states that even after the instrument background has been factored, the raw NIRAF data still contains sample noises originated from residual blood, imaging media, and other sources. Selya’s single background fluorescence threshold is proposed to remove that remaining sample related background from the pullback signal.
As such, photobleaching Selya’s optical components as taught by Lundquist would reduce upstream instrument generated autofluorescence while Selya’s central tendency processing would remain available to remove downstream sample generated background fluorescence.
Applicant has further argued that photobleaching Selya’s optical components would change Selya’s principle of operation.
Examiner disagrees. The proposed modification does not alter, remove, or prevent any of Selya’s operations. Photobleaching merely treats the existing optical components before or apart from the actual imaging procedure, so that those components generate less autofluorescence when excitation light passes through them. Nothing in Lundquist’s treatment prevents Selya’s processor form calculating or applying its background threshold.
In addition, Selya does not state that it’s optical components must generate a particular amount of autofluorescence for its processing method to operate. Nor does Selya state that reducing one source of background fluorescence would interfere with the image generation operations.
The principle of operation doctrine does not prohibit or prevent every modification that improves a primary reference. It applies when the proposed modification would alter the basic manner in which the primary reference is intended to function. Here Selya would continue operating in the same manner and for the same purpose even after the photo bleaching. Therefore, the modification would not change Selya’s principle of operation.
Further, Applicant argues that the proposed modification would render Selya inoperable for its intended purpose because, after photobleaching, Selya’s back removal process would become unnecessary. Applicant also argues Selya teaches away from a hardware solution by relying upon real time mathematical filtering.
Examiner disagrees. Reducing the autofluorescence generated by the instrument does not make Selya incapable of performing its operations. The catheter would remain capable of generating raw NIRAF data, and would remain capable of determining a background threshold, and the detected values would remain capable of being adjusted based on the threshold. The reduction of the magnitude of a source of the autofluorescence noise does not constitute inoperability.
Selya states that the sample related noise remains after instrument background noise has been factored. That remaining noise originates from blood, imaging media, and other sample related sources, and is the background to which Selya applies its threshold. Therefore, Selya would still be operable for its intended purposes even with a reduced fluorescence from the optical components.
In addition, even if the modification reduced the amount of work required by Selya, the increased efficiency or partial redundancy would not render the apparatus inoperable. An apparatus does not become inoperable merely because an additional known technique reduces the severity of the problem addressed by another component or process.
Further, Selya does not teach away from photobleaching or from physical treatment of the optical components, as Selya discusses multiple approaches to the background fluorescence removal, and doesn’t state that photobleaching teaches away from its primary function. A reference does not teach away merely because it describes or prefers one solution or another. As such the Applicant has not disclosed or identified anything in Selya that would have discouraged one or ordinary skill in the art from reducing autofluorescence with photobleaching the optical components as taught by Lundquist while keeping Selya’s processing of background Fluorescence.
Applicant further argues that the rejection improperly unsolves a problem already solved by Selya in order to solve the problem using Lundquist. Applicant argues that because Selya already removes background fluorescence using a calculated threshold, there would have been no need to consult Lundquist.
Examiner disagrees. The rejection does not remove Selya’s solution or recreate a previously solved problem. Instead, the proposed combination retains Selya’s solution while also using Lundquist’s known photobleaching treatment to reduce a separate upstream contributor to the total background signal. The existence of Selya’s threshold based correction does not establish that all of those sources have been eliminated or that reducing the amount of noise would be detrimental to the system. Instead, Selya recognizes that weak fluoresce signals are signal-to-noise or background limited and that improved background removal remains desirable. The fact that the a primary reference addresses a problem does not preclude improving the primary reference using another known and compatible technique. In this case, the modification would predictably reduce the amount of instrument generated autofluorescence entering the detector while retaining the ability to correct residual background fluorescence computationally. Lundquist explicitly discloses that its preventative and remedial approaches may be combined.
As such, the rejection does not “unsolved” Selya’s problem. It applies a known technique to improve Selya’s existing system in a manner consistent with the teachings of both references.
Applicant has further argued that the rejection relies on impermissible hindsight because the prior art provides no motivation to make the proposed modification and the Applicant’s disclosure is the only source of the claimed invention.
Examiner disagrees, as the reason for the combination is obtained directly from the prior art and does not require the Applicant’s disclosure. Selya teaches the autofluorescence from the fibers, lens, sheath, etc., as a source of unwanted background fluorescence. Selya transmits excitation light through those optical components. Lundquist teaches photobleaching optical components through which excitation light passes, and that such treatment would substantially reduce autofluorescence generated by the optical components.
A conclusion of obvious is not improper hindsight when it rests upon knowledge and explicit disclosure supplied by the prior art, and thus the Examiner has not used impermissible hindsight.
Applicant has further argued that Garcia-Garcia do not cure the deficiencies of Selya and Lundquist to teach claims 1, 9, and 18. However, Garcia-Garcia is not needed to teach claims 1, 9, and 18, as Selya and Lundquist are sufficient.
Lastly, Applicant has further argued that Selya and Lundquist do not teach the now amended claim 1 (previously now canceled claim 2).
Examiner disagrees, as the way the Applicant has written the claims, as Selya teaches the excitation laser with a wavelength of a predetermined value in the probe and a double clad fiber, and Lundquist teaches the optical components photobleached for a predetermined amount of time.
For the reasons above, claims 1-18 remain rejected under 35 U.S.C. 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
