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 .
Response to Amendment
No amendments to the claims in the response filed on 07/08/2026 are acknowledged.
Claims 1-7 and 21-22 remain pending in the application
Claims 8-20 are cancelled.
Claims1-7 and 21-22 are examined.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
Regarding claim 1…
Applicant argues that Oskin fails to teach that the cited guidewire is inserted into a lumen of the tubular member 16. Applicant argues that 32 is separate and unconnected from 38.
The examiner respectfully disagrees. Claim 1 states “inserting a guidewire into a working lumen the flexible ureteroscope”. Oskin cites that in paragraph 39 that“ a guidewire…may be inserted distally through… lower lumen 38”. Lumen 38 is a working lumen of ureteroscope 16. Fig 3 clearly shows that 32 is connected to 38 (see examienr’s annotated Fig. 3 below). Therefore, Oskin does teach the limitations as recited in alim 1.
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Applicant argues that it is unclear how Oskin’s inner sheath 8 may be pushed distally over the guidewire. In response to applicant's argument that the references fail to show certain features of applicant's invention, it is noted that the features upon which applicant relies (i.e. the sheath must be pushed distally over the guidewire) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim recites an “access sheath”, which Oskin teaches as sheath 4. Therefore, Oskin teaches the limitations as recited in claim 1.
Regarding claim 3 (and similarly claims 3 and 22) …
Applicant argues that Baldwin does no teach the limitation that is acknowledged to missing from Oskin because there is no reason to combine to modify the method of Oskin to place a ureteral sten.
The examiner disagrees. Examiner points out it has been held that a prior art reference must either be in the field of Applicant's endeavor or, if not, then be reasonably pertinent to the particular problem with which the appellant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the Oskin ([0003]) and Baldwin ([0007]) are both directed toward a ureteroscope for removing kidney stones. They are in fact in the same field of endeavor. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Oskin, that teaches a ureteroscope for removing kidney stones with the device of Baldwin that teaches a ureteroscopy procedure using a stent. Therefore, Oksin, in view of Baldwin, does teach the limitations as recited in claim 3.
Regarding claim 5…
Applicant argues that Miller does not teach or suggest the method steps missing from Oskin because it teaches an entirely different anatomical structure accessed in a different manner.
The examiner respectfully disagrees. Examiner points out it has been held that a prior art reference must either be in the field of Applicant's endeavor or, if not, then be reasonably pertinent to the particular problem with which the appellant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Oksin and Miller are both directed toward medical devices. Therefore they are in fact in the same field of endeavor.
Regarding claim 21…
Applicant argues that is unclear what Oskin teaches.
The examiner notes that Oskin teaches the sheath (4), side port (32), lumen (38), bridge (outside of channel 34), and the at least one lumen (34). Oskin discloses that 34 is in communication with 38 (see [0033]). Therefore, Oskin teaches the limitations as recited in claim 21. Levine is used in combination to teach the two channels being in fluid communication with each other, which is seen in Fig. 10A and described in paragraph [0044]. The examiner notes that it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin, that teaches two channels in communication with each other, with the teachings of Levine, that teach two channels in fluid communication with each other. It would have been advantageous to make the combination for the purpose of directly providing an irrigating fluid, as recited in paragraph [0050]. Therefore, Oskin, in view of Levine, does teach the limitations as recited in claim 21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2016/0095510 to Oskin et al. (hereinafter “Oskin”).
Regarding claim 1, Oskin discloses a method of treating a kidney of a patient, comprising: advancing an access sheath through a urethra into a bladder of the patient (12, Fig. 1, [026]); disposing a flexible ureteroscope (16, Fig. 1, [0027]) within a lumen of the access sheath (4, Fig. 1, [0026]); visually locating a ureteric orifice within the bladder using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029]); inserting a guidewire into a working lumen the flexible ureteroscope ([0039], Fig. 5A); advancing the guidewire from the working lumen into the ureteric orifice while the flexible ureteroscope is disposed within the lumen of the access sheath ([0039]); advancing the flexible ureteroscope through the ureteric orifice and into the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath ([0039]); and performing a procedure within the kidney using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath ([0039]).
Regarding claim 2, Oskin disclose the method of claim 1, further comprising: removing the flexible ureteroscope from the lumen of the access sheath while maintaining a distal end of the guidewire within the kidney ([0039]); and advancing a deflectable distal tip of the flexible ureteroscope through the lumen of the access sheath alongside the guidewire and into the kidney ([0039]).
Regarding claim 6, Oskin discloses the method of claim 1, further comprising: disposing an access sheath over the guidewire; and advancing the access sheath into the ureteric orifice while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029]-[0041]).
Regarding claim 7, Oskin discloses the method of claim 6, wherein disposing an access sheath over the guidewire includes disposing the access sheath over an elongate shaft of the flexible ureteroscope ([0039]); and wherein advancing the access sheath into the ureteric orifice while the flexible ureteroscope is disposed within the lumen of the access sheath includes advancing the access sheath over the elongate shaft of the flexible ureteroscope into the ureteric orifice after advancing the flexible ureteroscope through the ureteric orifice and into the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029]-[0041]).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0095510 to Oskin et al. (hereinafter “Oskin”) and further in view of U.S. Publication No. 2019/0125398 to Baldwin et al. (hereinafter: “Baldwin”).
Regarding claim 3, Oskin discloses the method of claim 2.
Oskin fails to expressly teach further comprising: advancing a stent over the guidewire while the flexible ureteroscope is disposed within the lumen of the access sheath; and positioning a distal end of the stent within the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath.
However, Baldwin teaches of an analogous method including advancing a stent over the guidewire while the flexible ureteroscope is disposed within the lumen of the access sheath; and positioning a distal end of the stent within the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath (Baldwin: [0140]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin, to include advancing a stent in the manner taught by Baldwin. It would have been advantageous to make the combination for the purpose of inserting the stent into the body ([0140] of Baldwin).
Claim(s) 4 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oskin and further in view of U.S. Publication No. 2019/0125398 to Baldwin et al. (hereinafter: “Baldwin”) and U.S. Publication No. 2021/0401536 to Scott et al. (hereinafter “Scott”).
Regarding claim 4, Oskin, in view of Baldwin, teaches the method of claim 3.
Oskin, in view of Baldwin, fails to expressly teach further comprising: visually confirming placement of the stent using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath.
However, Scott teaches of an analogous method further comprising: visually confirming placement of the stent using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath (Scott: claim 1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin, in view of Baldwin to include visually confirming placement in the manner taught by Scott. It would have been advantageous to make the combination for the purpose of providing visual confirmation of the device (Scott: claim 1).
Regarding claim 22, Oskin discloses a method of treating a kidney of a patient, comprising: advancing an access sheath through a urethra into a bladder of the patient (12, Fig. 1, [026]); disposing a flexible ureteroscope(16, Fig. 1, [0027]) within a lumen of the access sheath(4, Fig. 1, [0026]); visually locating a ureteric orifice within the bladder using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029]); thereafter, advancing the flexible ureteroscope through the ureteric orifice and into the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath [029).
Oskin fails to expressly teach positioning a stent within the kidney using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath.
However, Baldwin teaches of an analogous method including positioning a stent within the kidney using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath (Baldwin: [0140]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin, to include positioning a stent in the manner taught by Baldwin. It would have been advantageous to make the combination for the purpose of inserting the stent into the body ([0140] of Baldwin).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oskin and further in view of U.S. Publication No. 2008/0312609 to Miller et al. (hereinafter “Miller”).
Regarding claim 5, Oskin discloses the method of claim 1.
Oskin fails to expressly teach wherein disposing a flexible ureteroscope within a lumen of the access sheath includes aligning at least one crosshair marking on an elongate shaft of the flexible ureteroscope with a corresponding crosshair marking on the access sheath and locking an orientation of the flexible ureteroscope relative to the access sheath.
However, Miller teaches of an analogous method wherein disposing a flexible ureteroscope within a lumen of the access sheath includes aligning at least one crosshair marking on an elongate shaft of the flexible ureteroscope with a corresponding crosshair marking on the access sheath and locking an orientation of the flexible ureteroscope relative to the access sheath (Miller: [0090]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin to include the crosshair markings in the manner as taught by Miller. It would have been advantageous to make the combination for the purpose of providing the location ([0090] of Miller).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oskin and further in view of U.S. Publication No. 2002/0188175 to Levine et al. (hereinafter “Levine”).
Regarding claim 21, Oskin discloses a method of providing irrigation and aspiration during an endoscopic procedure, comprising: advancing an access sheath (4, Fig. 1, [026]) having a lumen and at least one side port in communication with the lumen through a urethra into a bladder of a patient securing a bridge to a proximal end of the access sheath(12, Fig. 1, [026]), wherein the bridge includes at least one lumen extending therethrough in communication with the lumen of the access sheath (16, Fig. 1, [0027]); disposing a flexible ureteroscope within the lumen of the access sheath ([0029])visually locating a ureteric orifice within the bladder using the flexible ureteroscope while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029])and advancing the flexible ureteroscope through the ureteric orifice and into the kidney while the flexible ureteroscope is disposed within the lumen of the access sheath ([0029]).
Oskin fails to expressly teach having a lumen and at least one side port in fluid communication with the lumen, wherein the bridge includes at least one lumen extending therethrough in fluid communication with the lumen of the access sheath; providing irrigation fluid through the at least one side port of the access sheath during the endoscopic procedure.
However, Levine teaches of an analogous method including having a lumen and at least one side port in fluid communication with the lumen, wherein the bridge includes at least one lumen extending therethrough in fluid communication with the lumen of the access sheath; providing irrigation fluid through the at least one side port of the access sheath during the endoscopic procedure (Levine: [0044]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Oskin to include fluid communication in the manner as taught by Levine. It would have been advantageous to make the combination for the purpose of providing irrigating fluid ([0040] of Levine).
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 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 CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike 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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/C.A.S./Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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