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
This Office Action is a response to applicant’s arguments and amendment filed 04/10/2026. Claims 1-20 are cancelled. Claims 21-32 are new. Claims 21-32 are currently pending.
The rejection of claims 4-5 and 16-20 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/10/2026, with respect to the rejection(s) of claim(s) 1-5 and 12-13 under 35 U.S.C. 102(a)(1) as being anticipated by Wan; claims 6, 8-11 and 15-20 under 35 U.S.C. 103 as being unpatentable over Wan in view of De Leon; claims 7 and 14 under 35 U.S.C. 103 as being unpatentable over Wan in view of De Leon and Hart, have been fully considered but are not persuasive. The rejection has been modified with respect to new claims 21-32, necessitated by applicant’s amendments to the claims.
1) Applicant argues Wan does not disclose or suggest installing a pressure regulating mechanism 110 on the sheath 20 itself, rather than a tube emanating from the body portion (Remarks, pg. 2).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not preclude side arms from being formed in the hollow body portion, as the claimed structure of the hollow body portion is a structure with an inner and outer surface and ports formed in the body portion. The claim language does not provide any further detail as to the direction the hollow body portion extends or any other structure that would preclude side arm 50 from being a component of the hollow body portion. Therefore, as depicted in annotated fig. 13 below, the side arm 50 is considered to be a component of the hollow body portion, such that the claim limitation is met.
2) Applicant further argues De Leon does not teach a flat sealing washer, because the structure illustrated in figure 9 is different from the claim language, such that the flexible insert disclosed by De Leon is not a washer and buckles inwardly when compressed as opposed to axial compression (Remarks, pgs. 3-4).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. The instant specification does not provide any further structure to the washer itself, and appears to operate differently from a conventional washer in that it seals via compression or moving between a compressed and uncompressed state. Therefore, based on the disclosure, the flat sealing washer is interpreted as a seal with a flat structure. Further, the claim language does not define the type of compression the seal experiences. The claim language only describes that the sealing washer is compressed, but does not describe how the seal is compressed via axial elongation or contraction as described in the Remarks. Therefore, since De Leon discloses a sealing structure compressed when a screw cap is engaged, the claim limitation is considered to be met.
Claim Objections
Claims 21 and 29 are objected to because of the following informalities:
In claim 21, it is suggested to put a colon after “a negative pressure joint including” or similar punctuation to specifically identify the hollow body portion as a component of the negative pressure joint.
In claim 29, line 3, the phrase “the cavities” should read “the plurality of cavities”, to remain consistent in referring to the plurality of cavities previously introduced.
Appropriate correction is required.
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 21-30 and 32 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.
Regarding claim 21, the claim recites “the pressure adjusting port” in line 2. There is insufficient antecedent basis for this limitation in the claim, since a pressure adjusting port has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the pressure regulating port previously introduced.
Regarding claim 23, the claim recites “the pressure adjusting port” in line 2. There is insufficient antecedent basis for this limitation in the claim, since a pressure adjusting port has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the pressure regulating port previously introduced.
Regarding claim 32, the claim recites “the sealing member” in line 3. There is insufficient antecedent basis for this limitation in the claim, since a sealing member has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the sealing washer previously introduced.
Claims 22 and 24-30 are indefinite due to their dependency on indefinite base claim 21.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wan (US 2021/0015509 A1) (previously of record) in view of Graham (US 2010/0082016 A1).
Regarding claim 21, Wan discloses (abstract; paras. [0057]-[0115]; figs. 1-28c) a negative pressure suction sheath (fig. 1) comprising:
a negative pressure joint (includes sheath 30 and side arm 50, paras. [0074] and [0093]; figs. 11-15 and annotated fig. 13, see box in annotated fig. 13) including
a hollow body portion (includes hollow body of sheath 30 and side arm 50, annotated fig. 13) with an inner surface and an outer surface (inner and outer surfaces of sheath 30 and side arm 50), a side channel port (annotated fig. 13) and a pressure regulating port (annotated fig. 13) formed in the body portion (formed in body portions of sheath 30 and side arm 50, see fig. 13) and each extending between the inner surface and the outer surface of the body portion (fig. 13),
a negative pressure suction tube (accessory side arm 60, which may be used as an additional channel for stone or foreign body evacuation, paras. [0087] and [0093]) which extends outwards from the body portion of the negative pressure joint (fig. 13) and fluidly communicates with an interior of the body portion through the side channel port (para. [0093]; annotated fig. 13), and
a push-pull closure for opening and closing the pressure regulating port (para. [0088]);
a hollow sheath (distal sheath 40, para. [0060]) for insertion into a human body and having a proximal end secured to the body portion (figs. 12-13); and
an elongated member (90, para. [0058]; figs. 12-13) selected from a dilator and a surgical device (obturator considered to function as a dilator and surgical device) extending through the body portion of the negative pressure joint and into the sheath (extends into sheath 40, para. [0106]).
However, Wan fails to specifically disclose a slidable closure slidably mounted on the outer surface of the body portion atop the pressure regulating port for opening and closing the pressure regulating port by sliding along the outer surface of the body portion towards or away from a distal end of the body portion by a thumb of a user holding the body portion.
Graham teaches (paras. [0026]-[0040]; figs. 1-4a), in the analogous art of the claimed invention, a valve assembly comprising a slidable closure (130, para. [0027]; fig. 2a) slidably mounted on an outer surface of a body portion (110) atop a pressure regulating port (port of valve member 120) for opening and closing the pressure regulating port by sliding along the outer surface of the body portion towards or away from a distal end of the body portion by a thumb of a user holding the body portion (para. [0033]; see figs. 3-4a), for the purpose of actuating the valve between open and closed positions (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the push-pull mechanism of Wan to be a slidable closure slidably mounted on the pressure regulating mechanism 110 of Wan as claimed, in order to provide an actuator for opening and closing the control vent that the user can utilize to modify the amount of negative pressure being applied to the device when desired, based on the suggestions and teachings of Graham (para. [0033]).
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Annotated Figure 13 of Wan
Regarding claim 22, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21. Wan further discloses wherein the side channel port and the pressure adjusting port are spaced from each other by 180 degrees around the longitudinal axis of the body portion (see figs. 12-15 and annotated fig. 13, depicting port of 60 and port on side arm 50 spaced at least 180 degrees around the longitudinal axis of 30).
Regarding claim 23, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21. Wan further discloses wherein the side channel port and the pressure adjusting port are spaced from each other by 90 degrees around the longitudinal axis of the body portion (side channel port considered to extend along the longitudinal axis, and pressure regulating port positioned on side arm 50 is considered to extend along the axis of side arm 50, which may form a 90 degree angle with sheath 30, such that the pressure adjusting port is considered to be spaced from the side channel port by 90 degrees, para. [0088]).
Regarding claim 24, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21. Wan further discloses wherein a distal end of the sheath is flexible (para. [0095]).
Regarding claim 25, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21. Wan further discloses wherein the sheath is a single layer tube (formed as a tube, Wan is silent to multiple layers of the tube and therefore considered to be formed of a single layer, para. [0099]) made of a polymer (formed of polyethylene, para. [0099]).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wan in view of Graham as applied to claim 21 above, and further in view of Jones (US 2024/0198048 A1).
Regarding claim 26, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21.
However, Wan (as modified) fails to teach wherein the sheath is a three-layer reinforced tube having an exterior layer made of a thermoplastic material, a middle layer having a structure selected from a coiled spring structure and a metal braided wire structure, and an inner layer comprising a polymer tube with a low coefficient of friction.
Jones teaches (paras. [0059]-[0060]; fig. 6), in the same field of endeavor, a negative pressure suction sheath (abstract), wherein the sheath is a three-layer reinforced tube (includes layers 13, 15 and 17) having an exterior layer (17) made of a thermoplastic material (made of nylon, considered to be a thermoplastic material, see para. [0065] of the instant spec.), a middle layer (15) having a structure selected from a coiled spring structure (coil wire reinforcement), and an inner layer (13) comprising a polymer tube (para. [0060]) with a low coefficient of friction (para. [0060]), for the purpose of mitigating kinking during the removal of the dilator or buckling during insertion of the access sheath (para. [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Wan (as modified) to be a three-layer reinforced tube as claimed, in order to mitigate kinking or buckling of the sheath during use, based on the teachings of Jones (para. [0059]).
Claim(s) 27-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Wan in view of Graham as applied to claim 21 above, and further in view of De Leon (US 2022/0361901 A1) (previously of record).
Regarding claim 27, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 21.
Wan further discloses a flexible cap constructed to fit the proximal end of sheath 20 and including a center opening that is self-sealing (para. [0103]), and a screw-on connector engaging obturator 90 with sheath 20 (para. [0101]).
However, Wan (as modified) fails to teach further comprising: a flat sealing washer disposed at a proximal end of the body portion of the negative pressure joint and having a through hole which sealingly contacts an outer surface of the elongated member; and a threaded retainer which threadingly engages the proximal end of the body portion of the negative pressure joint, the sealing washer being disposed between a surface of the body portion and an opposing surface of the threaded retainer, whereby the sealing washer can be compressed between the opposing surfaces of the body portion of the negative pressure joint and the threaded retainer by tightening the threaded retainer with respect to the body portion of the negative pressure joint.
De Leon teaches (paras. [0021], [0045] and [0071]-[0072]; fig. 9), in the same field of endeavor, a negative pressure suction sheath (suction catheter) comprising a flat sealing washer (rubber material, considered to include a flat component, para. [0072]; fig. 9) disposed at a proximal end of the catheter (fig. 9) and having a through hole (considered to have through hole for receiving objects, para. [0021]; fig. 9) which sealingly contacts an outer surface of a surgical device (para. [0021]); and a threaded retainer (screw cap, para. [0021]) which threadingly engages the proximal end of the catheter (engages cannula), the sealing washer being disposed between a surface of the catheter and an opposing surface of the threaded retainer (depicted in fig. 9), whereby the sealing washer can be compressed between the opposing surfaces of the catheter and the threaded retainer by tightening the threaded retainer with respect to the catheter (para. [0021]), for the purpose of preventing air from getting into the system during aspiration (paras. [0021] and [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Wan (as modified) to include a flat sealing washer having a through-hole that compresses around the obturator via the screw-on connection, in order to prevent air from getting into the system during aspiration when desired, directing the negative pressure to the control vents as opposed to surrounding obturator 90 within the main lumen, based on the teachings of De Leon (paras. [0021] and [0072]).
Regarding claim 28, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 27. Wan further discloses wherein when the sealing washer is in an uncompressed state, a diameter of the through hole is larger than an outer diameter of the elongated member (combination considered to further teach diameter of seal larger than inserted instruments prior to compression, fig. 1 of Wan, fig. 9 of De Leon), and when the sealing member is compressed between the threaded retainer and the proximal end of the body portion, the diameter of the through hole is reduced relative to the diameter in an uncompressed state to seal the through hole to an outer periphery of the elongated member (combination considered to further teach compression of seal around inserted instruments encompassing a decreased size of the through-hole, paras. [0021] and [0072] of De Leon).
Regarding claim 30, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 27. Wan further discloses wherein the surgical device comprises an endoscope (abstract; paras. [0067]-[0070]).
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wan in view of Graham and De Leon as applied to claim 27 above, and further in view of Hart (US 5569205) (previously of record).
Regarding claim 29, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 27.
Wan further discloses wherein the sheath contains a plurality of cavities (cavities of barrels 25, para. [0113]; figs. 21a-c).
However, Wan (as modified) fails to teach the sealing washer contains a plurality of holes each corresponding to one of the cavities in the sheath.
Hart teaches (col. 5 line 36-col. 8 line 43; figs. 1-9), in the same field of endeavor, an access device (abstract) comprising a seal (valve sets 52-56) containing a plurality of holes (lumens of each valve, figs. 1-2), for the purpose of accommodating instruments of various sizes and diameters within a single multiport device (col. 5 lines 24-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing washer of Wan (as modified) to include a plurality of holes each corresponding with a barrel of the sheath of Wan, in order to provide a sealing structure that accommodates instruments of various sizes and diameters within a single device, based on the suggestions and teachings of Hart (col. 5 lines 24-35).
Claim(s) 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wan in view of De Leon.
Regarding claim 31, Wan discloses (abstract; paras. [0057]-[0115]; figs. 1-28c) a negative pressure suction sheath (fig. 1) comprising:
a negative pressure joint (includes sheath 30 and side arm 50, paras. [0074] and [0093]; figs. 11-15 and annotated fig. 13, see box in annotated fig. 13) including a hollow body portion (includes hollow body of sheath 30 and side arm 50, annotated fig. 13) with an inner surface and an outer surface (inner and outer surfaces of sheath 30 and side arm 50), a side channel port (annotated fig. 13) and a pressure regulating port (annotated fig. 13) formed in the body portion (formed in body portions of sheath 30 and side arm 50, see fig. 13) and each extending between the inner surface and the outer surface of the body portion (fig. 13), and a negative pressure suction tube (accessory side arm 60, which may be used as an additional channel for stone or foreign body evacuation, paras. [0087] and [0093]) which extends outwards from the body portion of the negative pressure joint (fig. 13) and fluidly communicates with an interior of the body portion through the side channel port (para. [0093]; annotated fig. 13);
a hollow sheath (distal sheath 40, para. [0060]) for insertion into a human body and having a proximal end secured to the body portion (figs. 12-13);
an elongated member (90, para. [0058]; figs. 12-13) selected from a dilator and a surgical device (obturator considered to function as a dilator and surgical device) extending through the body portion of the negative pressure joint and into the sheath (extends into sheath 40, para. [0106]).
Wan further discloses a flexible cap constructed to fit the proximal end of sheath 20 and including a center opening that is self-sealing (para. [0103]), and a screw-on connector engaging obturator 90 with sheath 20 (para. [0101]).
However, Wan fails to disclose a flat sealing washer disposed at a proximal end of the body portion of the negative pressure joint and having a through hole which sealingly contacts an outer surface of the elongated member; and a threaded retainer which threadingly engages the proximal end of the body portion of the negative pressure joint, the sealing washer being disposed between a surface of the body portion and an opposing surface of the threaded retainer, whereby the sealing washer can be compressed between the opposing surfaces of the body portion of the negative pressure joint and the threaded retainer by tightening the threaded retainer with respect to the body portion of the negative pressure joint.
De Leon teaches (paras. [0021], [0045] and [0071]-[0072]; fig. 9), in the same field of endeavor, a negative pressure suction sheath (suction catheter) comprising a flat sealing washer (rubber material, considered to include a flat component, para. [0072]; fig. 9) disposed at a proximal end of the catheter (fig. 9) and having a through hole (considered to have through hole for receiving objects, para. [0021]; fig. 9) which sealingly contacts an outer surface of a surgical device (para. [0021]); and a threaded retainer (screw cap, para. [0021]) which threadingly engages the proximal end of the catheter (engages cannula), the sealing washer being disposed between a surface of the catheter and an opposing surface of the threaded retainer (depicted in fig. 9), whereby the sealing washer can be compressed between the opposing surfaces of the catheter and the threaded retainer by tightening the threaded retainer with respect to the catheter (para. [0021]), for the purpose of preventing air from getting into the system during aspiration (paras. [0021] and [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Wan to include a flat sealing washer having a through-hole that compresses around the obturator via the screw-on connection, in order to prevent air from getting into the system during aspiration when desired, directing the negative pressure to the control vents as opposed to surrounding obturator 90 within the main lumen, based on the teachings of De Leon (paras. [0021] and [0072]).
Regarding claim 32, Wan (as modified) teaches a negative pressure suction sheath as claimed in claim 31. Wan (as modified) further teaches wherein when the sealing washer is in an uncompressed state, a diameter of the through hole is larger than an outer diameter of the elongated member (combination considered to further teach diameter of seal larger than inserted instruments prior to compression, fig. 1 of Wan, fig. 9 of De Leon), and when the sealing member is compressed between the threaded retainer and the proximal end of the body portion, the diameter of the through hole is reduced relative to the diameter in an uncompressed state to seal the through hole to an outer periphery of the elongated member (combination considered to further teach compression of seal around inserted instruments encompassing a decreased size of the through-hole, paras. [0021] and [0072] of De Leon).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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