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 .
Status of Claims
Applicant’s amendments filed 09/23/2026 have been entered. Claims 1-5 are pending and currently under consideration for patentability under 37 CFR 1.104. Response to arguments found below.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2026 has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a flexible cannula constructed of polyamide intertwined with 316L stainless steel wires (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the trapezoidal shaped camera (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP 2161.01 I. 6th para states:
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. (emphasis added)
Claim 3 recites, “the temperature sensor (204) alerts the operator in real-time when detected temperatures approach the upper limit of its calibrated range during ureteroscopic laser lithotripsy procedures.” The specification does not provide any disclosure as to the specific steps/procedure needed to perform the temperature feedback function. Therefore claim 3 is rejected for insufficient written description.
Claim 4 recites, “wherein the pressure sensor (202) provides an immediate feedback mechanism for the surgeon by alerting of any abnormal intrarenal pressure conditions.” The specification does not provide any disclosure as to the specific steps/procedure needed to perform the pressure feedback function. Therefore claim 4 is rejected for insufficient written description.
The term “rapid communication” in claim 5 is a relative term which renders the claim indefinite. The term “rapid” 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.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. (U.S. 2022/0053998) in view of Liu et al. (U.S. 2018/0140177).
With respect to claim 1, Ghani et al. teaches a ureteroscope for ureteroscopic laser lithotripsy, wherein the ureteroscope, comprises:
a handle (2) portion designed for ergonomic single-handed operation;
a flexible cannula (10):
a trapezoidal shaped camera (50) specifically tailored for a 7.5Fr endoscope with a resolution of 1920x1080 pixels;
a distal tip (13);
an LED module arrangement (51) comprising a plurality of LEDs, each precisely situated around the camera to eliminate the requirement for a fibre optics cable;
a temperature sensor (410, para [0150]) situated at the distal tip (122), calibrated to detect a temperature range from 25"C to 50"C to monitor cellular damage risk during ureteroscopic laser lithotripsy;
a pressure sensor (410, para [0150]) located at the distal tip.
However, Ghani et al. does not teach the flexible cannula is disposable.
With respect to claim 1, Liu et al. teaches a ureteroscope for ureteroscopic laser lithotripsy, wherein the ureteroscope, comprises:
a handle (7) portion designed for ergonomic single-handed operation;
a disposable portion (3) made of a flexible cannula (110) constructed of polymer intertwined with wires (FIG. 7) with a specific diameter of 2.5 mm (para [0026]);
a trapezoidal shaped camera (1-1) specifically tailored for a 7.5Fr endoscope with a resolution of 1920x1080 pixels;
a distal tip (2); and
an LED module arrangement (1-2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the ureteroscope of Ghani et al. to have a removable disposable cannula in the manner taught by Liu et al. in order to reduce the cost and time associated with sterilizing, reprocessing, or repairing the cannula (para [0004] of Liu et al.).
While Ghani et al. in view of Liu et al. does not explicitly teach the disposable portion constructed of polyamide intertwined with 316L stainless steel wires, such materials were well known in the art at the time of invention. One of ordinary skill in the art could have substituted the material disclosed in Liu et al. for polyamide intertwined with 316L stainless steel wires, and the results of the substitution would have been predictable.
With respect to claim 2, Ghani et al. teaches the LED module arrangement and the camera operate synergistically to provide illumination and real-time visualization without reliance on an external light source (FIG. 7B for example).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. (U.S. 2022/0053998) in view of Liu et al. (U.S. 2018/0140177) as applied to claim 1 above and further in view of Sorensen (US 2021/0068642).
Ghani et al. in view of Liu et al. teaches a ureteroscope as set forth above. However, Ghani et al. in view of Liu et al. does not teach dual PCBs.
With respect to claim 5, Sorensen teaches an analogous endoscope incorporating a data transfer system consisting of dual PCBs (para [0055]) to ensure rapid communication (intended use).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the uteroscope of Ghani et al. in view of Liu et al. to utilize dual PCBs in the manner taught by Sorensen because Sorensen teaches it is a simple substitution of one known configuration for another and the results would have been predictable (para [0055] of Sorensen).
Response to Arguments
Applicant's arguments filed 09/23/2026 have been fully considered but they are not persuasive.
On page 4 Applicant argues a cannula is shown in the originally filed drawings. This is not persuasive at least because FIG. 1 does not show polyamide intertwined with 316L stainless steel wires. Therefore the drawing objection is maintained.
On page 4 Applicant argues the trapezoidal shaped camera is shown in the originally filed drawings. This is not persuasive because 206 in FIG. 2a is clearly a square, not a trapezoid. Therefore the drawing objection is maintained.
On page 7 Applicant argues that paragraphs [0010], [0028], and [0034]-[0035] provide sufficient written description for the subject matter of claim 3. Applicant further argues claim 3 does not require a particular audible alarm, tactile alarm, specific graphical symbol, comparator circuit, or software algorithm. Examiner respectfully disagrees. Claim 3 specifically requires alerting the operator in real-time when detected temperatures approach the upper limit of its calibrated range during ureteroscopic laser lithotripsy procedures (emphasis added). Therefore the claim does in fact require some sort of comparison between the detected temperature and the upper limit of its calibrated range in order to produce the real-time alert. None of paragraphs [0010], [0028], and [0034]-[0035] provide support for this limitation. Therefore the rejection is maintained.
On page 8 Applicant argues paragraphs [0010], [0026],[0028], and [0034]-[0035] provide sufficient written description for the subject matter of claim 4. Examiner respectfully disagrees. Claim 4 specifically requires “alerting of any abnormal intrarenal pressure conditions.” None of the paragraphs cited by Applicant discuss the means by which the pressure sensor determines what parameters constitute “abnormal intrarenal pressure conditions” nor how the device compares the current pressure to these parameters in order to produce an alert. Therefore the rejection is maintained.
In response to applicant's argument that Ghani does not teach the claimed polyamide and 316L stainless steel wire cannula construction, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant argues Ghani does not teach the claimed trapezoidal camera. This is not persuasive at least because the camera of Ghani is the same shape as the camera shown in Applicant’s figures which Applicant asserts is trapezoidal.
Applicant argues Ghani does not teach the claimed plurality of LEDs circumferential arrangement. This is not persuasive at least because the claim does not recite or require a “circumferential” arrangement. It is also noted that the LEDs of Ghani match the configuration shown in Applicant’s figures.
Applicant argues Ghani does not teach a temperature sensor calibrated from 25°C to 50°C. This is not persuasive at least because the calibration of the temperature sensor is intended use.
Applicant argues Ghani does not teach the claimed integration of the camera, plurality of LEDs, temperature sensor, and pressure at the distal tip. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to applicant's argument that Liu does not teach the claimed polyamide and 316L stainless steel wire cannula construction, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to Applicant’s argument that Liu does not teach the claimed trapezoidal camera, this is not persuasive at least because the camera of Liu is the same shape as the camera shown in Applicant’s figures which Applicant asserts is trapezoidal.
In response to Applicant’s argument that Liu does not teach the claimed plurality of LEDs in a circumferential arrangement, this is not persuasive at least because the claim does not recite or require a “circumferential” arrangement. It is also noted that the configuration in Liu matches Applicant’s figures.
On page 19 Applicant argues that even if Liu’s disposable catheter were incorporated into Ghani, the resulting device would still fail to teach or suggest the claimed polyamide and 316L stainless-steel wire construction. This is not persuasive at least because Examiner clearly stated above and in the previous office action that while Ghani et al. in view of Liu et al. does not explicitly teach the disposable portion constructed of polyamide intertwined with 316L stainless steel wires, such materials were well known in the art at the time of invention. One of ordinary skill in the art could have substituted the material disclosed in Liu et al. for polyamide intertwined with 316L stainless steel wires, and the results of the substitution would have been predictable.
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 Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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 (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALEXANDRA L. SURGAN
Primary Examiner
Art Unit 3795
/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
