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 5/22/2026 has been entered. Claims 1-24 are pending in the application with claims 1-5, 8, 9, 14-16 amended, claims 17-22 withdrawn.
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 1-16, 23 and 24 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 “wherein the distal end of the hollow shaft comprises an adjustable ramp extending distally from the distal end of the lumen of the hollow shaft” in Lines 7-9, wherein it’s unclear how the lumen can extend to a distal end of the hollow shaft while also having the adjustable ramp, which is a component of the hollow shaft, extending distally of the distal end of the hollow shaft and lumen. The examiner suggests defining the defining hollow shaft as comprising a hollow tubular body and an adjustable ramp extending distally from the hollow tubular body with the lumen extending to a distal end of the hollow tubular body to remove indefiniteness as to the structure of the hollow body. 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 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 1-4, 6, 8, 9, 11-14, 16, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US Patent Application Publication No. 2005/0090709, hereinafter Okada) in view of Kawahara (US Patent No. 3,913,565).
In regard to claim 1, Okada discloses an apparatus (1, Fig. 1) for accessing a body lumen or a body cavity, the apparatus comprising:
a hollow shaft (3, Fig. 1) formed from a single piece of flexible material (Fig. 6), the hollow shaft comprising a proximal end, a distal end and a lumen (47) extending from the proximal end to the distal end (Figs. 4,6), wherein the lumen of the hollow shaft is configured to receive an endoscope (2, Fig. 6), and further wherein the distal end of the hollow shaft comprises an adjustable ramp (13,14,15) extending distally from the distal end of the lumen of the hollow shaft (Figs. 1,5), wherein the adjustable ramp comprises a fixed portion (13, the fixed portion is fixed to a distal end of the pivotable portion) and a pivotable portion (14,15, the pivotable portions can be actively pivoted via control cables), wherein the pivotable portion (14,15) which is configured to be articulated between (i) a straight configuration in which the pivotable portion is parallel to a longitudinal axis of the hollow shaft (Fig. 1), and (ii) a pivoted configuration in which the pivotable portion is disposed at an angle relative to the longitudinal axis of the hollow shaft (Figs. 5,6), whereby to bend the endoscope disposed within the lumen of the hollow shaft (Figs. 5,6).
Okada does not expressly teach a sleeve having a proximal end, a distal end and a lumen extending from the proximal end to the distal end, wherein the lumen of the sleeve is configured to receive the hollow shaft and the endoscope disposed therein; and a balloon mounted to the sleeve.
Kawahara teaches an analogous endoscope system comprising a guide tube (7) for advancing an endoscope (5) through a stomach of a patient. The guide tube (7) includes a balloon (16) for anchoring the guide tube to the duodenal cap (4) to fix a position of the guide tube within the body cavity and provide a lumen through which the endoscope can be inserted.
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 system (1) of Okada with the guide tube (7) of Kawahara to alleviate forceful insertion of the endoscope through the stomach and into the duodenum and removing difficulty and time to for the endoscope to reach the duodenum (Col. 4, Lines 47-63).
In regard to claim 2, Okada teaches wherein the proximal end of the hollow shaft comprises an actuator (36,37) for articulating the adjustable ramp between the straight configuration and the pivoted configuration (Fig. 4, Par. 73).
In regard to claim 3, Okada teaches wherein the proximal end of the hollow shaft comprises a handle (11), and further wherein the actuator comprises two cables extending from the pivotable portion to the handle (via cables extending from pulleys (36,37) to the pivotable portion (14,15), Par. 73).
In regard to claim 4, Okada teaches wherein each of the two cables comprise a proximal end mounted to the actuator and a distal end mounted to the pivotable portion (Par. 73).
In regard to claim 6, Kawahara teaches wherein the distal end of the hollow shaft is configured to be longitudinally movable relative to the distal end of the sleeve (Figs. 6-7).
In regard to claim 8, Okada teaches wherein the lumen of the hollow shaft is sized to be larger than an outer diameter of an endoscope such that when the endoscope is disposed within the lumen of the hollow shaft, a gap large enough to pass an instrument therethrough exists between the inner wall of the lumen of the hollow shaft and the exterior surface of the endoscope (an instrument is capable of being inserted between an outer diameter of the endoscope and an inner diameter of the lumen of the hollow shaft).
In regard to claim 9, Okada and Kawahara teaches wherein the lumen of the sleeve is sized to be larger than an outer diameter of the hollow shaft such that when the hollow shaft is disposed within the lumen of the sleeve, a gap large enough to pass an instrument therethrough exists between the inner wall of the lumen of the sleeve and the exterior surface of the hollow shaft (an instrument is capable of being advanced within a gap formed between the sleeve and hollow shaft, such as a protective or hygenic sheath mounted to the endoscope).
In regard to claim 11, Okada and Kawahara teach wherein the hollow shaft is configured to pivot relative to the distal end of the sleeve (the hollow shaft of Okada is configured to extend beyond a distal end of the guide tube (7) of Kawahara, wherein the hollow shaft comprises actuators (35a,35b,36,37) for articulating the hollow shaft).
In regard to claim 12, Okada and Kawahara teaches wherein the hollow shaft is steerable relative to the distal end of the sleeve (the hollow shaft of Okada is configured to extend beyond a distal end of the guide tube (7) of Kawahara, wherein the hollow shaft comprises actuators (35a,35b,36,37) for articulating the hollow shaft).
In regard to claim 13, Motai teaches wherein the hollow shaft is configured to be steered by articulating an endoscope disposed within the lumen of the hollow shaft (the hollow shaft is capable of being steered via joint pieces (24) being articulated via wire (32) within the endoscope (2)).
In regard to claim 14, Okada teaches wherein the hollow shaft is configured to be steered by moving the two cables secured to the pivotable portion (Par. 73).
In regard to claim 16, Okada teaches wherein the pivotable portion comprises a distal end, a proximal end, and a plurality of pivot points disposed therebetween (via pivot points within steering sections (14, 15)).
In regard to claim 23, Kawahara teaches wherein the sleeve further comprises at least one instrument lumen (via lumen to receive the hollow shaft (123), Figs. 27-28).
In regard to claim 24, Kawahara teaches wherein the distal end of the sleeve comprises an atraumatic tip (via flexible section (12) at the end of the guide tube)).
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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US Patent Application Publication No. 2005/0090709, hereinafter Okada) in view of Kawahara (US Patent No. 3,913,565), as applied to claim 1, and further in view of Hoshino (US 2012/0277535).
In regard to claim 5, Okada does not teach wherein the handle comprises a locking mechanism for locking the pivotable portion at a desired angle.
Hoshino teaches an analogous endoscope (1, Figs. 1,2) comprising a handle (3) including operation knobs (4, 6) for articulating a bending section (2w). The handle further includes fixing levers (5, 7) that can be actuated for fixing pivoting positions of the operation knobs (4, 6) thereby retaining a bent state of the bending section (2w, Par. 30-31).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the operation knobs (36,37) of Okada to include fixing levers (5,7) enabling a bent state of the pivotable portion to be maintained upon actuation of the fixing levers thereby freeing up hands of a surgeon for performing other aspects of the surgical procedure.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US Patent Application Publication No. 2005/0090709, hereinafter Okada) in view of Kawahara (US Patent No. 3,913,565), as applied to claim 1, and further in view of Takahashi et al. (US Patent Application Publication No. 2020/0170489, hereinafter Takahashi).
In regard to claim 7, Okada does not expressly teach wherein the hollow shaft comprises at least one visual marker for indicating how far the distal end of the hollow shaft extends beyond the distal end of the sleeve.
Takahashi teaches an analogous endoscope system (100) comprising a guide tube (50) and endoscope (10) in which the endoscope is inserted through and beyond the guide tube within a body cavity. The endoscope includes a scale on an exterior of the insertion portion indicating a distance of the markings from a distal end of the endoscope thereby providing a visual indication for how far the endoscope is advanced beyond the guide tube.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the insertion portion (10) of Okada with the scale of Takahashi providing a visual indication for the distance of each marking to a distal end of the endoscope providing a surgeon with a gauge of how far the insertion portion has been inserted within a body cavity or beyond the guide tube.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US Patent Application Publication No. 2005/0090709, hereinafter Okada) in view of Kawahara (US Patent No. 3,913,565), as applied to claim 1, and further in view of Boulais (US Patent Application Publication No. 2012/0245418).
In regard to claim 10, Okada does not expressly teach wherein the hollow shaft comprises a plurality of slits formed in the flexible material.
Boulais teaches an analogous endoscope (20, Fig. 2) comprising an insertion portion formed of an articulation joint body (300). The articulation joint body is formed of a tubular body (302) having a plurality of notches (310) cutout from the tube connected by hinge points enabling the articulation joint body to be articulating in the left/right and up/down directions via pullwires inserted through the tubular body.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to replace the joint pieces of Okada with the articulation joint body (300) of Boulais thereby providing a low-cost alternative construction of a bending joint for an endoscope (Par. 6).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US Patent Application Publication No. 2005/0090709, hereinafter Okada) in view of Kawahara (US Patent No. 3,913,565), as applied to claim 1, and further in view of Cruz et al. (US Patent Application Publication No. 2018/0035872, hereinafter Cruz).
In regard to claim 15, Okada and Kawahara does not expressly teach wherein the at least one balloon comprises at least one radiopaque marker.
Cruz teaches an analogous endoscope assembly (5) comprising a sleeve (15) and endoscope (10). The sleeve (15) comprises a balloon (20) for engaging a body lumen, wherein the balloon (20) has a radiopaque marker so that a physician can ascertain a position of the balloon within the surgical site (Par. 131).
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 Kawahara with a radiopaque marker as taught by Cruz enabling a physician to ascertain the position of the balloon within the surgical site (Par. 131).
Response to Arguments
Applicant’s arguments with respect to claims 1-16, 23 and 24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 June 9, 2026
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