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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/7/2026 has been entered.
Response to Arguments
Applicant’s argument has been fully considered but it is moot in light of a new ground of rejection. See discussion below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In the prosecution history, Applicant has admitted to various technical challenges that preclude a straightforward application of the prior art reference. However, Applicant has not explained how the instant invention overcome those technical challenges.
In their Remarks (2/23/2026), 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.
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.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
Prosecution Insights