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 .
Election/Restrictions
Applicant’s election without traverse of Species G, Figs. 27-36, readable on claims 1-14 in the reply filed on 2/19/2026 is acknowledged.
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 rotation drive system” in Claims 1 and 2
“a deflection control system” in Claims 1 and 2
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 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 1-14 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.
Claim 1 recites the limitation "the housing" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the cannula is sufficiently long and flexible to reach a kidney of an adult patient when inserted through a urethra, bladder and ureter” in Lines 15-17, wherein it’s not clear how the cannula can be inserted through a urethra, bladder and ureter in the same procedure. It appears the claim may have inadvertently used “and” instead of –or--. Appropriate correction is required.
Claim 2 recites the limitation "the housing" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the housing body" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the portion of the cap that is over the switch” in Line 2, wherein a portion of the cap has not been previously defined nor has the cap covering the switch been previously defined. Therefore, the claim is ambiguous as to which portion of the cap the claim is referring to. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2022/0079418, hereinafter Ouyang) in view of King et al. (US Patent Application Publication No. 2014/0275763, hereinafter King).
In regard to claim 1, Ouyang discloses a ureteroscope (100,Fig. 1B) comprising:
a single-use portion (102,104) including:
a housing assembly (140,168,172) having a body and a pistol-grip handle (140) that extends away from the body and has a proximal part that is integral with the housing (Fig. 1B), the housing assembly body includes a plurality of ports (132,134);
a hub assembly (174) extending distally along a cannula axis from the body (Fig. 1B);
a cannula (120) that extends distally from the hub assembly along the cannula axis and has an imaging module at a distal part (Fig. 1B, Par. 83), wherein the hub assembly and the cannula are mounted for rotation about the cannula axis relative to the housing assembly body (Fig. 1B, Par. 84) and the cannula is sufficiently long and flexible to reach a kidney of an adult patient when inserted through a urethra, bladder and ureter (Par. 84, wherein the cannula is capable of reaching a kidney of a patient);
an internal channel (830, Fig. 8A) that has a proximal part at the ports and extends therefrom to a distal port at a distal part of the cannula and is configured to provide a path for one or more surgical implements through at least one of the ports to and distally out of the distal part (Par. 92);
a rotation drive system (170) located at the housing assembly and operatively coupled with the hub assembly (172) to rotate the hub assembly and the cannula about the cannula axis relative to the housing assembly (Fig. 1B, Par. 84); and
a deflection control system (146) located at the housing assembly and interactive with the distal part of the cannula, such that when the deflection control system is activated the distal part of the cannula deflects in a positive direction between a first position and a second position along a deflection plane or in a negative direction between the first position and a third position along the deflection plane (Par. 86, Figs. 3A-3C).
Ouyang teaches of the handle having a rechargable battery, a PCB and electronic modules, but does not expressly teach the housing assembly having an open distal part, a reusable portion including: a housing having a proximal part and a distal part and configured for insertion in the open distal part of the handle; at least one electrical contact at the proximal part of the housing and accessible from an exterior of the reusable portion housing, the at least one electrical contact is configured to mate with one or more electrical contacts within the handle when the proximal part of the housing is inserted in the handle; and a cap configured to releasably mate with the open distal part of the handle so that when the reusable portion is inserted in the open distal part of the handle the cap covers the open distal part of the handle and encloses the distal part of the reusable portion housing.
King teaches an analogous endoscope (100) comprising a handle (102) which includes a removable control module (112) that provides power and camera control features. The removable control module can be removably inserted within an open end of the handle such that contacts on the proximal end of the control module mate with contacts within the handle. The control module is further retained within the handle via a hinged end cap (114) providing a module design for easy removal and/or replacement of the control module.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the battery, PCB and electronic modules of Ouyang to be incorporated within a removable control module (112) and sealed by cap (114) as taught by King thereby providing a modular design in which the control module is reusable as well as enabling simple replacement of the control module if a malfunction were to occur with the battery or circuitry instead of discarding the endoscope.
In regard to claim 2, Ouyang disclose a ureteroscope (100,Fig. 1B) comprising:
a single-use portion (102,104) including:
a housing assembly (140,168,172) having a body and a handle extending away from the housing body, the housing assembly body includes at least one port (132,134), and the handle has a proximal part that is integral with the housing (Fig. 1B);
a hub assembly (174) extending distally along a cannula axis from the body, the hub assembly having a body (Fig. 1B);
a cannula (120) that extends distally from the hub assembly along the cannula axis and has an imaging module at a distal part (Fig. 1B, Par. 83), wherein the hub assembly and the cannula are mounted for rotation about the cannula axis relative to the housing assembly body (Fig. 1B, Par. 84), the cannula having at least one channel (830) in communication with the at least one port and extending from a proximal part of the cannula to the distal part of the cannula (Fig. 8A, Par. 92);
a rotation drive system (170) located within the housing assembly and operatively coupled with the hub assembly (174) to rotate the hub assembly and the cannula about the cannula axis (Fig. 1B, Par. 84); and
a deflection control system (146) located within the housing assembly and interactive with the distal part of the cannula, such that when the deflection control system is activated the distal part of the cannula can deflect in a positive direction between a first position and a second position along a deflection plane, or the distal part of the cannula can deflect in a negative direction between the first position and a third position along the deflection plane (Par. 86, Figs. 3A-3C).
Ouyang teaches of the handle having a rechargable battery, a PCB and electronic modules, but does not expressly teach the handle has an open distal part and also does not teach a reusable portion including: a housing having a proximal part and a distal part and configured for insertion in the open distal part of the handle; at least one electrical contact at the proximal part of the housing and accessible from an exterior of the reusable portion housing, the at least one electrical contact is configured to mate with one or more electrical contacts within the handle when the proximal part of the housing is inserted in the handle; and a cap configured to releasably mate with the open distal part of the handle so that when the reusable portion is inserted in the open distal part of the handle the cap covers the open distal part of the handle and encloses the distal part of the reusable portion housing.
King teaches an analogous endoscope (100) comprising a handle (102) which includes a removable control module (112) that provides power and camera control features. The removable control module can be removably inserted within an open end of the handle such that contacts on the proximal end of the control module mate with contacts within the handle. The control module is further retained within the handle via a hinged end cap (114) providing a module design for easy removal and/or replacement of the control module.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the battery, PCB and electronic modules of Ouyang to be incorporated within a removable control module (112) and sealed by cap (114) as taught by King thereby providing a modular design in which the control module is reusable as well as enabling simple replacement of the control module if a malfunction were to occur with the battery or circuitry instead of discarding the endoscope.
In regard to claim 3, Ouyang teaches wherein the rotation drive system comprises a powered rotation drive system to rotate the hub assembly and the cannula about the cannula axis (Par. 101).
In regard to claim 4, Ouyang teaches wherein the powered rotation drive system comprises at least one selectively activated motor to rotate the hub assembly and the cannula about the cannula axis (Par. 101).
In regard to claim 5, Ouyang teaches wherein the rotation drive system comprises a manual rotation drive system to rotate the hub assembly and the cannula about the cannula axis (Par. 84).
In regard to claim 6, Ouyang teaches wherein the manual rotation drive system comprises at least one thumbwheel (170) to rotate the hub assembly and the cannula about the cannula axis (Par. 84).
In regard to claim 7, Ouyang teaches wherein the deflection control system comprises a manually operated deflection control system (146) interactive with the distal part of the cannula (Fig. 1B, Par. 83).
In regard to claim 8, Ouyang teaches wherein the manually operated deflection control system comprises a lever (146) positioned on an exterior of the housing assembly and at least one push-pull cable (via steering wire (520), Fig. 5) operatively connected to the lever and the cannula such that motion of the lever in a first direction causes the distal part of the cannula to deflect in the positive direction between the first position and the second position, and motion of the lever in a second direction causes the distal part of the cannula to deflect in the negative direction between the first position and the third position (Figs. 3A-3C illustrates the lever (146) causes corresponding deflection of the distal tip via at least one cable (2006), Par. 116,144).
In regard to claim 9, Ouyang teaches wherein the manually operated deflection control system comprises at least one deflection member (146) positioned on an exterior of the housing assembly and at least one push-pull cable (via steering wire (520), Fig. 5) operatively connected to the deflection member and the cannula such that motion of the deflection member in a first direction causes the distal part of the cannula to deflect in the positive direction between the first position and the second position, and motion of the deflection member in a second direction causes the distal part of the cannula to deflect in the negative direction between the first position and the third position (Figs. 3A-3C illustrates the lever (146) causes corresponding deflection of the distal tip via at least one cable (2006), Par. 116,144).
In regard to claim 10, King teaches wherein the reusable portion includes a battery and control and processing electronics configured to control the imaging module to take images in a field of view and to receive image data from the imaging module (Par. 65).
In regard to claim 11, King teaches wherein the reusable portion includes a facility to convey image data from the endoscope to an external processing/display unit (Par. 126-127) .
In regard to claim 12, King teaches wherein the facility is configured to convey image data by wireless transmission using a Point-to-Point Wi-Fi protocol (Par. 126-27, wifi transmission to external devices, wherein the reusable portion would be capable of transmitting using Point-to-Point Wi-Fi protocol).
In regard to claim 13, King teaches in which said facility in the reusable portion is configured to convert received image data into display images and convey display images to an external unit for display (Image and/or video data is transmitted to computer (188) and displayed on the display (190) via the control module (112), Fig. 18).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US Patent Application Publication No. 2022/0079418, hereinafter Ouyang) in view of King et al. (US Patent Application Publication No. 2014/0275763, hereinafter King), as applied to claim 1, Sanders et al. (US Patent Application Publication No. 2010/0030020, hereinafter Sanders).
In regard to Claim 14, Ouyang and King are silent with respect to further comprising a manual switch at the distal part of the reusable portion, wherein at least the portion of the cap that is over the switch is sufficiently flexible for manual operation of the switch through the cap.
Sanders teaches an analogous endoscope (100) with a pistol-grip handle (104) and an elongate shaft (102). A battery cartridge (210) is removably inserted within an opening of the pistol-grip handle and closed via a lid (120, Fig. 2b). The battery cartridge (210) has a switch (323, Fig. 3b) at a distal end thereof allowing a physician to actuate the switch to turn the cartridge on/off through a lid-switch cover (443, Fig. 4b) of the lid (120).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the control module and cap of Ouyang and King with the switch and lid configuration of Sanders thereby providing easy access to the physician for controlling powering on / off the control module. There being no unexpected results in modifying the control module and cap of Ouyang and King with the switch and lid configuration of Sanders.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/ Primary Examiner, Art Unit 3795 April 18, 2026
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