DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Response to Arguments
Applicant argues that the prior art does not teach how to transform the laboratory-based system taught by Zhu so that the system can operate in a more demanding endoscopic environment. Specifically, Applicant writes.
FIG. I of Zhu shows the outputs from two optical combs are propagated from component to component in an environment that must preserve coherence of the light (or the outputs will not produce the essential interference effects that allow the system to measure distance) and must have optical path lengths that are controlled or stabilized to within a fraction of a wavelength (or the measured distance may be inaccurate). The environment of the optical combs themselves must be tightly controlled to ensure good performance of the combs. Such control is difficult and expensive; a typical (single) optical comb system can cost tens of thousands of dollars. The dual comb ranging system of FIG. I of Zhu is more than twice the cost of a single comb, as it additionally includes the
other elements shown in FIG. I of Zhu.
In contrast, the claimed system works in an endoscopic environment that creates major
technical challenges Zhu never considers. For example, the claimed system delivers dual-comb light through an optical fiber extending from the endoscope tip. To ensure that the claimed system functions properly, the dual-comb light must retain its optical properties (e.g., optical alignment, coherence) as it traverses the optical fiber in both directions to and from the target. During use of the endoscope, the optical fiber may bend and/or twist as a practitioner torques or otherwise positions the endoscope to bring the tip of the optical fiber close to the target. Further, the measurement target is biological tissue like kidney stones, which scatters, absorbs, and reflects light in complex, unpredictable ways Zhu does not consider or explain. Zhu fails to explain how dualcomb ranging would even work when aimed at irregular, highly scattering biological tissue. In addition, endoscopic procedures happen in fluid environments filled with blood and irrigation solutions that may complicate or otherwise interfere with optical measurements. Because the environment in which Zhu operates is so tightly controlled for stability and accuracy, one of ordinary skill in the art would not tum to Zhu for teachings regarding an endoscopic device.
Given these substantial environmental differences, one of ordinary skill in the art would not have had a reasonable expectation that Zhu's laboratory-based dual-comb ranging technique could be successfully adapted to function in the demanding endoscopic environment of Kang. The challenges include maintaining coherence and phase stability of the dual-comb system through meters of flexible optical fiber, achieving sufficient signal-to-noise ratio when measuring from irregular biological targets in fluid, and operating reliably in the potential presence of motion, vibration, and variable biological conditions as a practitioner positions the endoscope. As noted in MPEP § 2143.02, "obviousness does not require absolute predictability, but at least some degree of predictability is required." Here, the substantial differences between the controlled environment of Zhu and the claimed endoscopic environment render the success of such a combination highly unpredictable.
See Remarks at 13-14.
Applicant’s argument has been fully considered but it is not persuasive.
In their argument, Applicant highlights several technical challenges that precludes the use of Zhu’s dual-comb technology in the more demanding endoscopic environment, including:
“To ensure that the claimed system functions properly, the dual-comb light must retain its optical properties (e.g., optical alignment, coherence) as it traverses the optical fiber in both directions to and from the target.”
“During use of the endoscope, the optical fiber may bend and/or twist as a practitioner torques or otherwise positions the endoscope to bring the tip of the optical fiber close to the target.”
“Further, the measurement target is biological tissue like kidney stones, which scatters, absorbs, and reflects light in complex, unpredictable ways Zhu does not consider or explain.”
“Zhu fails to explain how dualcomb ranging would even work when aimed at irregular, highly scattering biological tissue.
In addition, endoscopic procedures happen in fluid environments filled with blood and irrigation solutions that may complicate or otherwise interfere with optical measurements.”
“The challenges include maintaining coherence and phase stability of the dual-comb system through meters of flexible optical fiber, achieving sufficient signal-to-noise ratio when measuring from irregular biological targets in fluid, and operating reliably in the potential presence of motion, vibration, and variable biological conditions as a practitioner positions the endoscope.”
Applicant is encouraged to point out from the instant Specification the exact teachings and explanations (that, according to Applicant, are seemingly lacking in Zhu) concerning how to overcome these technical challenges. Applicant is also encouraged to point out the limitations recited in the claims that incorporate these elements that are essential to the claimed invention. Note that these six enumerated technical challenges are to be understood as conjunctive—in the sense that any one technical challenge can preclude enablement of the claimed invention.
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.
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.
Claims 1 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US 20140039261 A1, 2014-02-06) (hereinafter “Kang”) in view of (Zhu, Zebin, and Guanhao Wu. "Dual-comb ranging." Engineering 4.6 (2018): 772-778) (hereinafter “Zhu”).
Regarding claims 1 and 13-15, Kang teaches an endoscopic system (and method of use), comprising: an optical fiber having a distal end extending from a distal end of an endoscope and configured to direct light to and from a target (104); an interferometer (102), and an optical detector (108). See also Fig. 1 and associated text.
Kang does not teach use of dual-comb ranging. Zhu teaches dual-comb ranging. See Sect. 2-4.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Zhu with the invention taught by Kang such that the invention further comprises receive first light pulses from a first frequency comb having a first repetition rate; form reference arm light pulses and measurement arm light pulses from the first light pulses; direct the measurement arm light pulses to and from the target via the optical fiber to form return light pulses and interfere the return light pulses with the reference arm light pulses to form interferometer output pulses; a beamsplitter configured to interfere the interferometer output pulses with second light pulses from a second frequency comb having a second repetition rate different from the first repetition rate to form system output pulses; an optical detector configured to sense the system output pulses; and processor circuitry configured to: determine, from a time duration between consecutive system output pulses, a spacing between the distal end of the optical fiber and the target; and generate a spacing data signal representing the determined spacing (as recited in claim 1); wherein:the interferometer is a Michelson interferometer (construed as OCT as a particular implementation); the reference arm light pulses have the first repetition rate; and the measurement arm light pulses are temporally offset from the corresponding reference arm light pulses by a time interval that varies as a function of the spacing between the distal end of the optical fiber and the target (as recited in claim 13); wherein the optical fiber is configured such that the measurement arm light pulses enter the optical fiber, propagate to the distal end of the optical fiber, emerge from the distal end of the optical fiber, reflect from the target, enter the distal end of the optical fiber, propagate away from the distal end of the optical fiber, and exit the optical fiber to form the return light pulses (as recited in claim 14); a method for operating an endoscopic system including an optical fiber having a distal end extending from a distal end of an endoscope, the method comprising: receiving, with an interferometer, first light pulses from a first frequency comb having a first repetition rate; forming, with the interferometer, reference arm light pulses and measurement arm light pulses from the first light pulses; directing the measurement arm light pulses to and from a target via the optical fiber to form return light pulses; interfering the return light pulses with the reference arm light pulses to form interferometer output pulses; interfering, with a beamsplitter, the interferometer output pulses with second light pulses from a second frequency comb having a second repetition rate different from the first repetition rate to form system output pulses; sensing, with an optical detector, the system output pulses; determining, with processor circuitry, from a time duration between consecutive system output pulses, a spacing between the distal end of the optical fiber and the target; and generating, with the processor circuitry, a spacing data signal representing the determined spacing (as recited in claim 15) in order to improve the accuracy of the treatment.
Claims 2, 4-7, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Zhu, as applied to claim 1, and further in view of Goodman et al. (US 5460182 A, 1995-10-24) (hereinafter “Goodman”).
Regarding claims 2, 4-7, and 16-18, as discussed above, Kang teaches an endoscopic system (and method of use), except comprising the various limitations recited in the claims at issue. Goodman teaches time multiplexing of different wavelengths. See, e.g., 4:40-65 (“This permits using a single optical fiber, having a very small diameter, as the light emitting element”). Goodman also teaches use of various filters for signal conditioning. See, e.g., 5, 8, 13, 16 and associated text.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Goodman with the invention taught by Kang (in view of Zhu) such that the invention further comprises wherein the optical fiber is time-multiplexed to deliver the measurement arm light pulses to and from the target at first times and deliver therapeutic light pulses at second times different from the first times, the therapeutic light pulses being configured to ablate the target, the therapeutic light pulses being spectrally separated from the first light pulses (as recited in claim 2); further comprising: the first frequency comb and the second frequency comb, wherein the first frequency comb and the second frequency comb are spaced apart from the endoscope; and wherein the first light pulses and the second light pulses are spectrally separated from the therapeutic light pulses (as recited in claim 4); further comprising: a therapeutic laser light source spaced apart from the endoscope and configured to generate the therapeutic light pulses at the second times (as recited in claim 5); wherein the processor circuitry is further configured to vary at least one operational parameter of the therapeutic laser light source in response to the determined spacing represented by the spacing data signal (as recited in claims 6 and 17); wherein the processor circuitry is further configured to automatically switch off the therapeutic laser light source when the determined spacing represented by the spacing data signal is less than a specified threshold spacing (as recited in claims 7 and 18); wherein the optical fiber is time-multiplexed to deliver the measurement arm light pulses to and from the target at first times and deliver therapeutic light pulses at second times different from the first times, the therapeutic light pulses being configured to ablate the target, the therapeutic light pulses being spectrally separated from the first light pulses; and the endoscopic system further includes a therapeutic laser light source spaced apart from the endoscope and configured to generate the therapeutic light pulses at the second time (as recited in claim 16) in order to simplify and improve the usability of the invention.
Claims 8-9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Zhu, as applied to claim 1, and further in view of Speeg et al. (US 20050203497 A1, 2005-09-15) (hereinafter “Speeg”).
Regarding claims 8-9 and 19, as discussed above, Kang teaches an endoscopic system, except comprising an actuator configured to advance the optical fiber distally and retract the optical fiber proximally with respect to the endoscope. Speeg teaches an actuator configured to advance the optical fiber distally and retract the optical fiber proximally with respect to the endoscope. See, e.g., [0042] and Fig. 7 (depicting wheels or rollers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Speeg with the invention taught by Kang (in view of Zhu) such that the invention further comprises an actuator configured to advance the optical fiber distally and retract the optical fiber proximally with respect to the endoscope, wherein the processor circuitry is further configured to: compare the determined spacing to a specified threshold; and cause the actuator to automatically reduce a difference between the determined spacing and the specified threshold (as recited in claim 8); wherein the actuator comprises a wheel; the wheel has a center that is fixed in position with respect to the endoscope; the wheel has a circumferential surface that contacts the optical fiber; and the wheel is rotatable from a rotary actuator (as recited in claim 9); wherein the endoscopic system further includes an actuator configured to advance the optical fiber distally and retract the optical fiber proximally with respect to the endoscope; and the method further comprises using the processor circuitry to: compare the determined spacing to a specified threshold; and cause the actuator to automatically reduce a difference between the determined spacing and the specified threshold (as recited in claim 19) in order to improve the usability of the invention.
Claims 3, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Zhu, as applied to claim 1, and further in view of Goodman, as applied to claim 2, and further in view of Xuan et al. (US 20150230864 A1, 2015-08-20) (hereinafter “Xuan”).
Regarding claims 3, 10, and 11, as discussed above, Kang teaches an endoscopic system, except comprising a spectrometer, filters, and other signal processing components.
Xuan teaches use of filters (e.g., [0042], [0059]) and spectrometer to analyze the the return therapeutic light pulses (e.g., [0067). Official Notice is given that filters and analog-digital converters are widely used in the signal processing art.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Xuan with the invention taught by Kang (in view of Zhu and Goodman) such that the invention further comprises wherein :the optical fiber is further configured to: collect, as collected therapeutic light pulses, at least some of the therapeutic light pulses that are reflected from the target; and direct, as return therapeutic light pulses, at least some of the collected therapeutic light pulses along the optical fiber away from the distal end of the optical fiber; and the endoscopic system further comprises a spectrometer configured to analyze the return therapeutic light pulses (as recited in claim 3); an optical bandpass filter configured to reduce an optical spectrum of the system output pulses (as recited in claim 10); wherein: the optical detector is configured to generate an unfiltered electrical signal in response to the sensed system output pulses; the endoscopic system further comprises a low-pass filter configured to reduce high frequency content of the unfiltered electrical signal to form a filtered electrical signal; the endoscopic system further comprises an analog-to-digital converter configured to receive the filtered electrical signal and, in response, generate a digital detector signal; and the processor circuitry is configured to analyze the digital detector signal to determine the time duration between consecutive system output pulses (as recited in claim 11) in order to improve the accuracy and effectiveness of the invention.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kang in view of Zhu, as applied to claim 1, and further in view of Brown et al. (US 20090177094 A1, 2009-07-09) (hereinafter “Brown”).
Regarding claims 12 and 20, as discussed above, Kang teaches an endoscopic system, except comprising an illumination light source, a camera, and a video display. Brown teaches an illumination light source (e.g., [0093]), a camera (e.g., [0129]), and video display (e.g., [0129]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Brown with the invention taught by Kang (in view of Zhu) such that the invention further comprises an illumination light source disposed at the distal end of the endoscope and configured to illuminate the target with visible illumination light; a camera disposed at the distal end of the endoscope and configured to generate a video image of the illuminated target; and a display coupled to the processor circuitry and configured to display the video image of the illuminated target and a visual representation of the determined spacing represented by the spacing data signal (as recited in claim 11); an endoscopic system, comprising: an endoscope; a therapeutic laser light source spaced apart from the endoscope and configured to generate therapeutic light pulses at first times; a first frequency comb spaced apart from the endoscope and configured to generate first light pulses that repeat at a first repetition rate; a Michelson interferometer configured to split the first light pulses between a reference arm and a measurement arm to form respective reference arm light pulses that repeat at the first repetition rate and measurement arm light pulses that repeat at the first repetition rate; an optical fiber including a distal end extending from the endoscope, the optical fiber configured to: receive the therapeutic light pulses at the first times; receive the measurement arm light pulses at second times different from the first times; direct the therapeutic light pulses and the measurement arm light pulses along the optical fiber to emerge from the distal end of the optical fiber toward a target; collect, as collected light pulses, at least some of the measurement arm light pulses that are reflected from the target; and direct, as return light pulses, at least some of the collected light pulses along the optical fiber away from the distal end of the optical fiber, the Michelson interferometer further configured to interfere the return light pulses with the reference arm light pulses to form interferometer output pulses; a second frequency comb spaced apart from the endoscope and configured to generate second light pulses at a second repetition rate different from the first repetition rate; a beamsplitter configured to interfere the interferometer output pulses with the second light pulses to form system output pulses; an optical detector configured to sense the system output pulses; processor circuitry configured to: determine, from a time duration between consecutive system output pulses, a spacing between the distal end of the optical fiber and the target; and generate a spacing data signal representing the determined spacing; an illumination light source disposed at a distal end of the endoscope and configured to illuminate the target with visible illumination light; a camera disposed at the distal end of the endoscope and configured to generate a video image of the illuminated target; and a display coupled to the processor circuitry and configured to display the video image of the illuminated target and a visual representation of the determined spacing represented by the spacing data signal (as recited in claim 20) in order to improve the usability of the invention.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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