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
Claims 1-7 are pending and currently under consideration for patentability under 37 CFR 1.104
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 03/21/2025 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 with a specific diameter of 2.5 mm (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.
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 four LEDs (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 Video Processing Unit (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 data transfer system (claim 5) 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 built-in mechanism for quick detachment and attachment, facilitating efficient replacement between procedures (claim 7) 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a built-in mechanism for quick detachment and attachment, facilitating efficient replacement between procedures in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3-6 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.
Claim 5 recites, “incorporating a data transfer system consisting of dual PCBs to ensure rapid communication between the sensors and the VPU.” The specification does not provide any disclosure as to the specific steps/procedure needed to perform the rapid communicaiton function. Therefore claim 5 is rejected for insufficient written description.
Claim 6 recites, “wherein the VPU utilizes a proprietary algorithm to process and enhance raw imagery from the camera (206), ensuring clarity and sharpness of the displayed visual data.” The specification does not provide any disclosure as to the specific steps/procedure needed to perform the function of “ensuring clarity and sharpness of the displayed visual data.” Therefore claim 6 is rejected for insufficient written description.
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.
Claim 6 is 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.
Claim 6 recites, “wherein the VPU utilizes a proprietary algorithm to process and enhance raw imagery from the camera (206), ensuring clarity and sharpness of the displayed visual data.” Applicant does not provide any disclosure regarding the proprietary algorithm. As such it is not possible to ascertain the scope of the processing unit—i.e. what types of algorithm would read on the claim and what types would not.
Claim limitation “built-in mechanism for quick detachment and attachment, facilitating efficient replacement between procedures” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 2 and 7 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) having a combined output of 600 lumens 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 with a sensitivity range of 0 to 40 mmHg for regulating intrarenal pressure; and
a Video Processing Unit (1B) with a processing speed of 2.5 GHz, configured to receive and process data from the sensors and the camera, and to display said data on a monitor (17) with a minimum latency of 10 milliseconds.
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);
an LED module arrangement (1-2) composed of four LEDs, each precisely situated at a 90-degree interval around the camera (206), having a combined output of 600 lumens to eliminate the requirement for a fibre optics cable.
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 does not explicitly teach four LEDs, duplication of parts is considered within the level of one of ordinary skill in the art. Further, 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 substitute 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 he 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).
With respect to claim 7, Liu et al. teaches the disposable portion features a built-in mechanism for quick detachment and attachment (4), facilitating efficient replacement between procedures.
Conclusion
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.
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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 NEWTON/ Primary Examiner, Art Unit 3799
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