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 Group I, claims 1-16, in the reply filed on January 20, 2026 is acknowledged.
Claims 17-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 20, 2026.
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) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (US 2021/0378740, hereinafter “Chu”).
Referring to claim 1, Chu discloses a sheath device comprising:
a sheath shaft 102 (FIGS. 1-4B; para. [0058] or 9A-9B and 11A) defining a lumen, the sheath shaft configured to be inserted into a body of a patient; and
a valve assembly (inlet body 130 and outlet body 137 as shown in FIGS. 4A-4B) coupled to a proximal end portion of the sheath shaft, the valve assembly including a connector (inlet body 130 and outlet body 137 as shown in FIGS. 4A-4B) and an elastic member (cap 148 as shown in FIG. 4A; para. [0066]. FIG. 9A shows valve 590; para. [0092]. Examiner notes that Chu inherently discloses valve 590 is made from elastic material to provide sealing between the valve and the scope), the elastic member being coupled to the connector, the connector including an arm portion (145, para. [0065] or 132, para. [0063]) that extends from a sidewall of the connector, the elastic member configured to operate as a valve, the elastic member 148 defining a lumen.
Referring to claim 2, Chu discloses the sheath device of claim 1, wherein sheath shaft includes a distal end portion, the distal end portion including a laser-resistant material (para. [0069]: “In some embodiments, the distal end 225 of the sheath 202 may be internally lined with a polytetrafluoroethylene (PTFE) or expanded PTFE, which is a highly lubricious, flexible, and laser resistant material.”).
Referring to claim 3, Chu discloses the sheath device of claim 1, further comprising: an elongated member configured to be inserted to the lumen of the sheath shaft (para. [0056]: “A scope 107 may extend through the first lumen 104, the scope 107 including a laser 108 (e.g., a laser fiber) extending through a working channel 109 thereof.”).
Referring to claim 4, Chu discloses the sheath device of claim 3, wherein the elongated member includes a dilator, a spacer, a biasing member, or a medical device, the medical device including a retrieval device or a pressure and temperature sensor (para. [0057]: “In some embodiments, the device 100 may include a sensor 112 (e.g., pressure sensor or a guide wire sensor) to control inlet and outlet flow via an automated fluid management system (FMS), e.g., to avoid over and under pressurizing the kidney.” FIG. 9A shows sensor lead 580 extends through the sheath shaft 502; para. [0091]: “Also extending through the body 532 is a sensor lead 580 and connector 581, which may be used to measure and communicate pressure, temperature, force, etc.”).
Referring to claim 5, Chu discloses the sheath device of claim 1, wherein the lumen of the elastic member (cap 148) is configured to receive a shaft of an insertion device (para. [0066]: “As further shown in FIG. 4A, a proximal end 147 of the outlet body 137 may include an elastomeric cap 148 including a funnel 149 and a central hole 150 that may be smaller than the OD of the scope (not shown) to seal against the exterior surface of the scope to prevent suction force from being lost.”).
Referring to claim 6, Chu discloses the sheath device of claim 1, wherein the arm portion is a first arm portion (145, para. [0065] or 132, para. [0063]), the connector including a second arm portion (132, para. [0063] or 145, para. [0065]) that extends from the sidewall of the connector.
Claim(s) 1, 3, 5, and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevens (US 5,591,137, hereinafter “Stevens”).
Referring to claim 1, Stevens discloses a sheath device comprising:
a sheath shaft 12 (FIGS. 1-5B; col. 5, ln. 29-40. FIGS. 4-5 are reproduced below) defining a lumen, the sheath shaft configured to be inserted into a body of a patient; and
a valve assembly 26 (adapter 16 as shown in FIGS. 1-2; col. 5, ln. 42-55) coupled to a proximal end portion of the sheath shaft 12, the valve assembly including a connector (cylindrical body 18 as shown in FIG. 2) and an elastic member (52 as shown in FIGS. 2-3; col. 6, ln. 15-16 and ln. 60-61; and col. 9, ln. 14-21: “Seal 52 is preferably made from a deformable, resilient material which allows seal 52 to compress and either independently seal or seal around a member positioned therethrough.”), the elastic member being coupled to the connector, the connector including an arm portion 30 (FIG. 2) that extends from a sidewall of the connector, the elastic member 52 configured to operate as a valve, the elastic member 52 defining a lumen (FIG. 4 shows cap 48 is moved in the distal direction to close valve 52. FIG. 5 shows cap 48 is moved in the proximal direction to open valve 52).
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Referring to claim 3, Stevens discloses the sheath device of claim 1, further comprising: an elongated member 28 configured to be inserted to the lumen of the sheath shaft (FIG. 5A; “In an alternative use, as shown in FIG. 5A, an elongated member 28, such as a catheter or guidewire, can be longitudinally disposed through passage 56 for insertion within the cardiovascular system of a patient, as discussed with regard to FIG. 1.” (col. 8, ln. 66 to col. 9, ln 13)).
Referring to claim 5, Stevens discloses the sheath device of claim 1, wherein the lumen of the elastic member 52 is configured to receive a shaft 28 of an insertion device (FIG. 5A; “In an alternative use, as shown in FIG. 5A, an elongated member 28, such as a catheter or guidewire, can be longitudinally disposed through passage 56 for insertion within the cardiovascular system of a patient, as discussed with regard to FIG. 1.” (col. 8, ln. 66 to col. 9, ln 13)).
Referring to claim 8, Stevens discloses the sheath device of claim 1, wherein the valve assembly includes a cap member 48, the cap member configured to move with respect to the connector 18 to open or close the lumen of the elastic member 52. (FIG. 4 shows cap 48 is moved in the distal direction to close valve 52. FIG. 5 shows cap 48 is moved in the proximal direction to open valve 52 (col. 8, ln. 49-65)).
Referring to claim 9, Stevens discloses the sheath device of claim 8, wherein the cap member 48 includes a cylindrical portion, the cylindrical portion including a plunger 136 (FIG. 3; col. 8, ln. 49-65 ) defining a lumen, the plunger configured to contact the elastic member.
Referring to claim 10, Stevens disclose the sheath device of claim 8, wherein the connector 18 includes a snap ramp 55 (FIG. 3), and the cap member 48 includes a snap hook 137 (FIG. 3) configured to be engaged with the snap ramp (FIGS. 4-5; “As shaft 136 is advanced within compression chamber 58, first compression lip 55 having an outer diameter slightly larger than the inner diameter of second compression lip 137 becomes biased against second compression lip 137. As additional force is applied, second compression lip 137 and distal end 124 radially outwardly expand to allow first compression lip 55 to pass through second compression lip 137.” (col. 8, ln. 18-25)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Gordon (US 2018/0264236, hereinafter “Gordon”).
Referring to claim 7, Chu discloses the sheath device of claim 6, wherein both of the arms 132 and 145 are straight. Chu fails to disclose one of the arm is straight and the second arm portion is curved.
Referring again to claim 7, however, in the same field of endeavor, which is a catheter system, Gordon discloses a support sheath 400 includes a tube 410 and a side arm 420 (FIGS. 4-5). Gordon further discloses that side arm 420 defines a central lumen for aspiration of air and blood and the side arm is flexible and curved without kinking or substantially blocking the central lumen of the side arm (para. [0052]). In view of Gordon’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified arm 145, which is utilize as a suction port (Chu: para. [0065]: “The outlet body 137 may further include a suction port 145 and a control aperture 146 to aid with suction control. A lumen 161 of the suction port 145 may be sealed or otherwise air-tight such that a suction force within the device 100 is not lost as the suction travels from the proximal end to the distal end.”), to include flexible and curved tubing as suggested by Gordon to provide flexibility and prevent kinking during evacuation of debris from the surgical site.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Russo (US 5,730,727, hereinafter “Russo”).
Referring to claim 11, Chu discloses the sheath device of claim 1, and a governing hole wherein the arm portion includes a governing hole (control aperture 146 as shown in FIG. 4A) to allow the user to control the vacuum pressure (para. [0065]). Chu fails to disclose the control aperture 146 is located in the side wall of arm 145.
Referring again to claim 11, however, Russo discloses the control aperture can be located on the side wall of a suction tube (FIGS. 1 and 6-7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have rearranged the control aperture 146 to the side wall of arm 145. One of ordinary skill in the art would motivate to make this modification because shifting the location of control aperture 146 is matter of design choice and shifting the location of control aperture 146 would not have modified the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975)).
Claim(s) 12-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (US 2021/0378740, hereinafter “Chu”) in view of Stevens (US 5,591,137, hereinafter “Stevens”).
Referring to claim 12, Chu discloses a sheath device comprising:
a sheath shaft 1207 (FIGS. 20A-20B; paras. [0115]-[0118]) defining a lumen, the sheath shaft configured to be inserted into a body of a patient;
a biasing member 1208 (FIGS. 20A-20B. FIG. 20B shows laser 1208 also acts as a biasing member because the laser member 1208 push sheath 1227 away from the center lumen) having a first portion disposed within the sheath shaft 1207; and a valve assembly 1230 (FIG. 20C; para. [0115]) coupled to a proximal end portion of the sheath shaft, the valve assembly including a connector and a valve member (para. [0115]: “In some embodiments, the Y-connector may include a Tuohy Borst adapter 1233 positioned in a first leg 1236 to prevent the backflow of fluid around the laser 1208. A self-closing seal 1240 may be provided in a second leg 1242 of the Y-connector, the sheath 1211 extending through the self-closing seal 1240. In various embodiments, the laser 1208 and the sheath 1211 can be inserted independently and manually by the user's hand.”), the valve member being coupled to the connector, the connector including an arm portion 1236 that extends from a sidewall of the connector, a second portion of the biasing member 1208 being disposed within the arm portion 1236, the valve member configured to operate as a valve, the valve member defining a lumen configured to receive a shaft of an insertion device.
In paragraph [0115] Chu discloses a self-closing seal 1240 is provided in arm 1242 to prevent leakage of fluid around sheath 1211. Chu also discloses a Tuohy Borst adapter 1233 at the proximal end of arm 1236 to prevent the backflow of fluid around the laser 1208. Examiner notes that in order for the Tuohy Borst adapter 1233 at the proximal end of arm 1236 to prevent the backflow of fluid around the laser 1208 the adapter must include a valve. Chu discloses the invention substantially as claimed except for disclosing the valve in the Tuohy Borst adapter 1233 and the self-closing seal 1240 is made from resilient material.
In the same field of endeavor, Stevens discloses a valve assembly 26 (adapter 16 as shown in FIGS. 1-2; col. 5, ln. 42-55) coupled to a proximal end portion of the sheath shaft 12, the valve assembly including a connector (cylindrical body 18 as shown in FIG. 2) and an elastic member 52, wherein the elastic member acts as a valve to compress and either independently seal or seal around a member positioned therethrough (52 as shown in FIGS. 2-3; col. 6, ln. 15-16 and ln. 60-61; and col. 9, ln. 14-21: “Seal 52 is preferably made from a deformable, resilient material which allows seal 52 to compress and either independently seal or seal around a member positioned therethrough.”). In view of Stevens’ teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the proximal end of arms 1236 and 1242 according to Stevens’ teaching to receive the valve 52, slip ring 50 and cap 48 to allow a large passageway without increasing the risk of blood leakage and prevent the risk of jamming or blocking the introduction of instrument (Stevens: col. 3, ln. 12-33).
Referring to claim 13, Chu/Stevens discloses the sheath device of claim 12, wherein the sheath shaft includes a distal end portion, the distal end portion including a laser-resistant material. (In paragraph [0069] Chu discloses “In some embodiments, the distal end 225 of the sheath 202 may be internally lined with a polytetrafluoroethylene (PTFE) or expanded PTFE, which is a highly lubricious, flexible, and laser resistant material.” It would have been obvious to one or ordinary skill in the art, before the effective filing date of the application, to have made the distal end of sheath shaft 1207 and 1211 from a laser resistant material to provide safety to the device and to the patient).
Referring to claim 14, Chu/Stevens discloses the sheath device of claim 12, wherein the sheath shaft 1207 includes a distal end portion, the distal end portion including a transparent portion (In paragraph [0132] Chu discloses “It can be appreciated that, in some examples, each of the first connection tube 1326 and the second connection tube 1328 may be transparent or translucent, thereby permitting a clinician to visualize the distal end of the laser fiber 1336 or the distal end of the retrieval device 1338 located therein when withdrawn from the working channel of the elongate shaft 1320 to permit the other device to occupy the working channel of the elongate shaft 1320.” It would have been obvious to one or ordinary skill in the art, before the effective filing date of the application, to have made the distal end of sheath shaft 1207 and 1211 from a laser resistant and transparent material to provide safety to the device and to the patient and to allow the user to view the position of the laser shaft 1208 with respect to the stone).
Referring to claim 16, Chu/Stevens discloses the sheath device of claim 12, wherein the arm portion is a first arm portion, the connector 1230 including a second arm portion (FIG. 20C shows the connector 1230 includes arm 1236, which is for receiving laser 1208, and arm 1242, which is for receiving sheath shaft 1211).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. in view of Stevens as applied to claim 12 above and further in view of Coambs et al. (US 2008/0197626, hereinafter “Coambs”).
Referring to claim 15, Chu/Stevens discloses the sheath device of claim 12 bur fails to disclose an indicator marking disposed on the connector, the indicator marking including an arrow.
Referring again to claim 15, Coambs discloses a coupling device 108 (FIG. 5) for medical lines. The coupling device 108 includes arrow marker 70 to help the user to align the marker 70 with alignment marking 78, 80, 82 based on the axial force (para. [0060]). Attention is directed to FIGS. 4-5B of Stevens reference. The figures show that as the cap 48 is tightened, the pressure exerted by valve 52 on shaft 28 increases. Based on Coambs’ teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided markers 70, 80, 82 and arrow 70 as suggested by Coambs to the arms 1236 and 1242 and the caps of the valve assembly of Chu/Stevens to notify the user about the location of the cap, which is correlated to the amount of pressure of valve 52 applied to the shaft 28.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771