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 .
Notice of Amendment
The Amendment filed 9/11/2026 has been entered. Claims 24-28, 30-46 are pending in the application with claims 24, 26, 28, 30, 31, 35, 36, 39, 41 amended, claims 41-46 withdrawn, claims 1-23, 29 cancelled.
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.
Claim 30 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 30 recites the limitation "the elongate tubular member" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 24-26, 31, 35, 36 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iyama (JP 2012-205717 A).
In regard to claim 24, Iyama discloses an endoscopy system (10,60, Fig. 1) for accessing anatomy inferior to a pylorus of a stomach of a patient (the system of capable of accessing the intended body cavity), the system comprising:
a cholangioscope (10) including a proximal portion (14), an elongate member (12), and a distal tip (44), wherein the distal tip is user-rotatable about a longitudinal axis of the cholangioscope and user-articulatable via separate user controls at the proximal portion of the cholangioscope (the distal tip is articulatable via control knobs (35, Fig. 1) and rotatable via gripping the housing of the proximal portion and manually rotating the housing); and
an endoscopic overtube (60), sized and shaped for insertion into a patient esophagus towards a patient duodenum (Par. 41), the overtube including a proximal portion and a distal portion, and an access lumen (66) extending therebetween, the access lumen providing an inner diameter to receive and pass a cholangioscope (10) therethrough (Fig. 4);
wherein:
the distal portion of the overtube includes a side port (68) sized and shaped to permit lateral exit of a distal portion of the cholangioscope (Fig. 7); and
the overtube includes a ramp (70) arranged to re-direct the distal portion of the cholangioscope from a longitudinal direction in the access lumen toward the lateral exit of the side port (Figs. 5-7), the ramp formed of a material (72) permitting visualization therethrough by optics of the cholangioscope (Par. 47).
In regard to claim 25, Iyama teaches further comprising a stabilizer (96) disposed about an exterior of a distal portion of the overtube, the stabilizer configured to stabilize the distal portion of the overtube with respect to the duodenum (Figs. 5-7).
In regard to claim 26, Iyama teaches wherein the stabilizer is configured to be expanded at the distal portion of the overtube (Figs. 5-7).
In regard to claim 31, Iyama teaches wherein, for a particular user-rotation, adjusting user-articulation of the distal tip of the cholangioscope, when extended out from the side port of the overtube, restricts angular travel of the distal tip to a particular longitudinal plane tangent to a distal end of the elongate tubular member (angular travel is restricted during rotation of the cholangioscope due to the angle at which the cholangioscope exits the side port of the overtube).
In regard to claim 35, Iyama teaches wherein the overtube is configured to provide a substantially unbent access route through the access lumen for the cholangioscope to traverse a patient duodenum within a portion of the overtube extending a distance between the pylorus and an ampulla of Vater of the patient (the overtube is capable of functioning in the claimed manner).
In regard to claim 36, Iyama teaches further comprising an expandable stabilizer includes an inflatable balloon configured to stabilize the overtube with respect to the patient anatomy, wherein the overtube extends through a central lumen defined by the balloon and is attached thereto (Figs. 5-7).
In regard to claim 39, Iyama discloses an endoscopy system (10,60, Fig. 1) for accessing anatomy inferior to a pylorus of a stomach of a patient (the system of capable of accessing the intended body cavity), the system comprising:
an endoscopic overtube (60), sized and shaped for insertion into a patient esophagus toward a patient duodenum (Par. 41), the overtube including a proximal portion and a distal portion (Fig. 1), and
an access lumen (66) extending therebetween, the access lumen providing an inner diameter to receive and pass a cholangioscope (10) therethrough (Figs. 5-7);
wherein:
the distal portion of the overtube includes a side port (68) sized and shaped to permit lateral exit of a distal portion of the cholangioscope (Figs. 5-7);
the overtube includes a ramp (70) arranged to re-direct the distal portion of the cholangioscope from a longitudinal direction in the access lumen toward the lateral exit of the side port (Figs. 5-7); and
an expandable stabilizer (96) is included about an exterior of a distal portion of the overtube, the stabilizer configured to be expanded to stabilize the distal portion of the overtube with respect to the duodenum (Figs. 5-7).
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 27 is rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Hutchins et al. (US Patent Application Publication No. 2015/0073391, hereinafter Hutchins).
In regard to claim 27, Iyama does not expressly teach wherein the system includes a guidewire to facilitate the overtube and the cholangioscope to a target anatomy/ pancreaticobiliary anatomy.
Hutchins teaches an analogous endoscope system comprising an endoscope (302), sphincterotome (300) and guidewire (210). The guidewire is inserted through the endoscope and sphincterotome in order to provide improved access to the biliary tree.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the endoscope system of Iyama with the guidewire of Hutchins as a matter of design choice for providing improved access to the biliary tree. There being no unexpected results in using the guidewire of Hutchins with the endoscope system of Iyama.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Takahashi et al. (US Patent Application Publication No. 2020/0170489, hereinafter Takahashi).
In regard to claim 28, Iyama does not expressly teach wherein the overtube is more rigid than the cholangioscope.
Takahashi teaches an analogous endoscope system (100) in which an endoscope (10) is inserted through an overtube (60) for navigation to a duodenum of a patient. Takahashi teaches the overtube having a larger rigidity than the endoscope inserted therein, specifically the rigidity of the flexural rigidity varying portion (36B) of the endoscope is more than half the rigidity of the overtube (Par. 55-56, Par. 9A-9B).
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to modify the overtube of Iyama to have a larger rigidity than the endoscope as taught by Takahashi thereby optimizing insertion of the overtube and endoscope through the mouth of the patient into the small intestine and duodeunom of a patient. Takahashi teaches that if the rigidity of the insertion portion of the endoscope is too high insertion becomes difficult and a large load is placed on the patient.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Levasseur et al. (US Patent Application Publication No. 2017/0020548, hereinafter Levasseur).
In regard to claim 30, Iyama does not expressly teach wherein the elongate tubular member has an outer diameter greater than 4.5mm (Par. 50 teaches the lumen of the overtube is sized as large as 9.5mm to allow imaging instrument to be inserted therethrough).
Levasseur teaches an analogous guide catheter (308) for insertion through a duodenum of a patient. The guide catheter having a side exit port enabling an elevator (320) to redirect an imaging device (350) towards a papilla. The guide catheter (308) has an expandable balloon (310) configured for inflation within a range of 10-20 mm (Par. 40). Levasseur further teaches lumen of the guide catheter is sized to receive medical instruments, such as imaging devices, with the lumen being sized with a range of 3.5 mm to 9.5 mm (Par. 50).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the access lumen of Iyama to have a diameter up to approximately 9.5 mm as taught by Levasseur as a matter of design choice enabling the access lumen to receive medical instruments, such as imaging devices, up to approximately 9.5 mm in size for delivery to the duodenum of a patient. Iyama teaches that the endoscope diameter is sized to be slightly less than the diameter of the lumen.
Claims 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Fujitani (US Patent Application Publication No. 2013/0150672).
In regard to claim 32, Iyama teaches wherein the cholangioscope includes a working channel lumen (Iyama teaches a lumen connected to the insertion port (46)) extending through the elongate tubular member (Iyama, Fig. 1). Iyama does not expressly teach wherein user-rotation of the distal tip is actuated via a rotary user control mechanism including or connected to a drive to rotate at least a portion of the elongate tubular member around a longitudinal axis of the elongate tubular member.
Fujitani teaches an analogous endoscope (1) comprising an operation unit (3) and an insertion shaft (2). A rotary dial (15) is disposed between the operation unit (3) and insertion shaft (2) such that rotation of the rotary dial (15) enable corresponding circumferential rotation of the insertion shaft (2) with respect to the operation unit (3).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the endoscope of Iyama with the rotary dial (15) of Fujitani thereby enabling the insertion shaft to circumferentially rotate relative to the operation unit in order to adjust an rotational angle of the imaging means, apply rotational torque to the tip to navigate through body lumens or adjust and adjust positioning of the operation unit with respect to the insertion shaft. There being no unexpected results in modifying the endoscope of Iyama with a rotational shaft as taught by Fujitani.
In regard to claim 34, Iyama teaches wherein the working channel lumen has a large enough diameter to accommodate one or more accessory device including an ablation catheter, a TTS dilation balloon, a TTS stent, a TTS cytology brush, biopsy forceps, or a lithotripsy probe or filter (the lumen is capable of receiving at least one of the aforementioned accessory devices).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Fujitani (US Patent Application Publication No. 2013/0150672), as applied to claim 29 and further in view of Lewinsky et al. (US Patent Application Publication No. 2014/0024894, hereinafter Lewinsky).
In regard to claim 33, Iyama and Levasseur do not expressly teach wherein the working channel lumen of the endoscope has a diameter greater than 2mm along a length of the channel.
Lewinksy teaches of an analogous endoscope system comprising a duodenoscope (470), a baby scope (480) and a fiber (410). Lewinsky teaches the working channel of the baby scope (480) allows for insertion of a fiber (410) having a diameter of 2mm, which is larger than a diameter of the working channel (see Claim 7).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the working channel of the endoscope of Iyama and Levasseur to have a diameter of greater than 2 mm as taught by Lewinsky enabling the insertion of medical instruments, such as a lithotripsy fiber, through the working channel to a papilla of a patient. There being no unexpected results in modifying the working channel of Iyama and Levasseur to have a diameter of greater than 2 mm as taught by Lewinsky.
Claims 37, 38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Iyama (JP 2012-205717 A) in view of Levasseur et al. (US Patent Application Publication No. 2017/0020548, hereinafter Levasseur).
In regard to claims 37 and 38, Iyama does not expressly teach wherein the balloon is inflatable to a burst pressure above at least 6 mm, wherein the balloon, in an inflated state, has an outer diameter between 15 mm and 40 mm.
Levasseur teaches an analogous guide catheter (308) for insertion through a duodenum of a patient. The guide catheter having a side exit port enabling an elevator (320) to redirect an imaging device (350) towards a papilla. The guide catheter (308) has an expandable balloon (310) configured for inflation within a range of 10-20 mm (Par. 40).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the balloon of Iyama to be inflated to a diameter of between 10-20 mm as taught by Levasseur as a matter of design choice since the overtube / guide catheter of Iyama and Levasseur are both configured for advancement within the small intestine and deliver imaging devices to the papilla. There being no unexpected results in modifying the balloon of Iyama to inflate to a diameter of between 10-20 mm as taught by Levasseur.
In regard to claim 40, Iyama does not expressly teach wherein an inner diameter of the endoscopic overtube is greater than 4mm.
Levasseur teaches an analogous overtube (408) having a working channel (412) with a side exit port for introducing surgical tools and/or imaging devices within a body cavity. Levassuer teaches the size of the working channel is between 3.5 and 9.5 mm (Par. 50).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the size of the working channel of Iyama to be greater than 4mm as taught by Levasseur as a matter of design choice allowing the working channel to have sufficient size to deliver various surgical tools to the biliary system of a patient.
Response to Arguments
Applicant's arguments filed 9/11/2026 have been fully considered but they are not persuasive.
Applicant argues:
“Applicant's rotary-articulating architecture, as claimed in claim 1 and described in [0010], [0037], and [0047] of the Application As-Filed, facilitates independent rotation of a cholangioscope's articulation plane, such as to enable precise steering and navigation in difficult patient anatomy (e.g., a human duodenum) after the distal tip has exited the overtube's side port.
The Office Action relies on Iyama, which discusses an endoscope 10 with a bending portion 42 that is remotely controlled by bending operation knobs 36 (Iyama, [0020]; FIG. 1). But Iyama provides no teaching or suggestion of any "user-rotatable" distal tip or elongate member controlled via a separate user control at the proximal portion. Iyama's endoscope 10 instead is a conventional steerable endoscope, requiring that hand operation unit 14 and insertion portion 12 be manually rotated by the operator as a single unit. There is no discussion of any integrated mechanism for rotating the insertion shaft relative to a stationary handle portion, let alone separate controls for this function.
Moreover, the claimed system enables a unique kinematic action not contemplated by Iyama. Applicant's architecture, with its separate rotary control, allows the user to change the radial orientation of the plane of articulation of the distal tip after it has exited the overtube's side port, all while the proximal handle remains stationary. This can facilitate, e.g., a sweeping motion of the articulated tip within a defined space opposite the side port to precisely cannulate target anatomy (Application As-Filed, [0010]; FIGS. 1B-1D). Iyama's device, which requires rotation of the entire endoscope body, provides no mechanism for such controlled, independent rotation of the articulation plane relative to the handle and overtube.”
The examiner disagrees since the handle of Iyama can be used as a control by the user rotating the entire handle to thereby rotate the distal tip of the endoscope. The examiner suggests including language that distinguishing the control from merely being considered rotation of the handle.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 September 26, 2026
