DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 09/18/2025.
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 .
Status of Claims
Claims 1 and 3-10 are pending in the application.
Claims 1 and 3-10 are examined on the merits.
Response to Arguments
Applicant’s arguments/remarks filed on 09/18/2025 have been fully considered but are moot because the independent claim has been amended and the new ground of rejection does not rely on the same combination references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727) are applied to address the newly added/argued limitations.
With respect to the claim objection(s), applicant’s amendment(s) to the claim(s) has/have overcome the objection(s).
With respect to the claim rejection(s) under 35 U.S.C. § 112(b) of claims 6-7 and 9, applicant's amendment(s) to the claim(s) has/have overcome the claim rejection(s).
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.
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) 1 and 4 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727).
Schryver discloses a bifurcated surgical tubing device (a bifurcated or Y tubing 20: Abstract and Fig. 2), comprising:
a first tube having a proximal end and a distal end (a tube 21b having a proximal end and a distal end: Col. 3, lines 35-42; and Fig. 2), said proximal end being configured to couple to an inlet port of a suction canister (since the bifurcated or Y tubing 20 is commonly found on medical devices such as drain tubing, vacuum manifolds and the like, the bifurcated or Y tubing 20 is capable of connecting to a suction canister: Col. 1, lines 10-15; thus, the proximal end of the tube 21b is capable of coupling to an inlet port of a suction canister);
a bifurcated, Y-shaped connector (a bifurcated connector 23: Col. 3, lines 27-35 and Fig. 2), having a trunk portion coupled to the distal end (Fig. 2), a first branch portion, and a second branch portion (Fig. 2), wherein the trunk portion is coupled to the distal end (Fig. 2);
a second tube having a first end coupled to the first branch portion (a tube 21a having a first end coupled to the first branch portion: Col. 3, lines 35-42; and Fig. 2) and a second end configured to couple to a first surgical suction device (since the bifurcated or Y tubing 20 is commonly found on medical devices such as drain tubing, vacuum manifolds and the like, the bifurcated or Y tubing 20 is capable of connecting to a suction canister: Col. 1, lines 10-15; thus, the second end of the tube 21a is capable of coupling to a first surgical suction device); and
a third tube having a first end coupled to the second branch portion (a tube 21a’ having a first end coupled to the second branch portion: Col. 3, lines 35-42; and Fig. 2) and a second end configured to couple to a second surgical suction device (since the bifurcated or Y tubing 20 is commonly found on medical devices such as drain tubing, vacuum manifolds and the like, the bifurcated or Y tubing 20 is capable of connecting to a suction canister: Col. 1, lines 10-15); thus, the second end of the tube 21a is capable of coupling to a first surgical suction device) wherein the first tube, the bifurcated, Y-shaped connector, the second tube, and the third tube are formed as a unitary article (Abstract and Col. 1, lines 10-33; and Fig. 2).
Schryver does not disclose the first tube, the bifurcated, Y-shaped connector, the second tube, and the third tube are made of polyvinyl chloride.
In the same field of endeavor, multi-lumen connector and tubing, Heaton discloses a Y-shaped connector 100 with separable parts 80/81 attached to a respective tubing section (¶0033 and Figs. 7a-b). Heaton further discloses/suggests suitable materials for manufacturing tubing and connector comprising PVC (¶0030).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver in view of Heaton by using PVC as materials for the tubes and connector, in order to provide suitable materials for manufacturing tubes and connectors, as suggested in ¶0030 of Heaton and as it has been held that the substitution of a known material/element for another exchangeable material/element supports a prima facie obviousness determination (See MPEP § 2143 (I) (B)).
Regarding claim 4, Schryver further discloses the second tube and the third tube are symmetrical (tube 21a and 21a’ are symmetrical: Fig. 2).
Claim(s) 3 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727), as applied to claim 1 above, and further in view of Tsukamoto (US PGPUB 20170120038).
Regarding claim 3, Schryver/Heaton does not disclose a first flow control clamp mounted to the second tube and a second flow control clamp mounted to the third tube.
In an analogous art for being directed to solve the same problem, providing a clamp device for clamping a medical tube and blocking flow of fluid therethrough, Tsukamoto discloses a clamp device 1 (Figs. 1-13) for the benefits of clamping a medical tube, blocking flow of fluid therethrough, and preventing leakage of fluid (¶0006 and 0041).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of Tsukamoto by incorporating a first flow control clamp for the second tube and a second flow control clamp for the third tube, in order to clamp a medical tube, block flow of fluid therethrough, and prevent leakage of fluid, as suggested in ¶0006 and 0041 of Tsukamoto.
Claim(s) 5 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727), as applied to claim 1 above, and further in view of Wallis (US PAT 5236417).
Regarding claim 5, Schryver/Heaton does not disclose the second tube is longer than the third tube.
In an analogous art for being directed to solve the same problem, providing a bifurcated connector for accommodating coupling of different medical tubes, Wallis discloses a catheter 12 comprising a bifurcated connector 20 having two tubings 26 and 27 (Col. 5, lines 16-20, Col. 6, lines 3-10, and Fig. 1). Wallis further teaches to have the tubing 26 is shorter than the tubing 27 (Col. 6, lines 25-37) for the benefit of providing a system for enabling a medical technician to distinguish between the two tubings (Col. 6, lines 32-37).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of Wallis by having/making the second tube longer than the third tube, in order to provide a system for enabling a medical technician to distinguish between the two tubings, as suggested in Col. 6, lines 32-37 of Wallis.
Claim(s) 6-7 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727), as applied to claim 1 above, and further in view of McGhee (US PGPUB 20220090690).
Regarding claim 6, Schryver/Heaton does not disclose the trunk portion is positioned at an angle of 120° to 150° from the first branch portion and the second branch portion.
In the same field of endeavor, connectors, McGhee discloses a connector 1 comprising a trunk portion (a first passageway 14: ¶0058 and Fig. 1) and four branch portions (four inlet conduits 16a-d: ¶0058 and Fig. 1). McGhee further teaches an angle 22 between the trunk portion and each of the four branch portions is from 120 to 150 degree (¶0013 and Fig. 2; wherein the taught angle range is within the claimed angle range) for the benefits of reducing fluid turbulence through the bend but at the same time having the inlet conduits sufficiently offset radially from the longitudinal axis of the first passageway such that the inlet conduits are not crowded too close together (¶0013).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of McGhee by having/making the trunk portion positioned at an angle of 120° to 150° from the first branch portion and the second branch portion, in order to reduce fluid turbulence through the bend but at the same time having the branch portions sufficiently offset radially from the longitudinal axis of the trunk portion such that the branch portions are not crowded too close together, as suggested in ¶0013 of McGhee and as it has been that a prima facie case of obviousness exists when the claimed ranges lie inside ranges disclosed by the prior art (See MPEP § 2144.05 (I)). Further, Applicant places no criticality on the angle claimed, indicating simply that the trunk portion is positioned at an angle of 120° to 150° from the two branch portions (¶0016).
Regarding claim 7, Schryver/Heaton does not disclose the first branch portion is positioned at an angle of 60° to 120° from the second branch portion.
McGhee further implicitly discloses an angle 24 between a first branch portion 16a and a rotational axis 18a is 30 degrees when the angle 22 is 120 degrees (¶0059: 180° - 120° = 30°) and an angle between a second branch portion 16c and the rotational axis 18a is also 30 degrees when an angle between the trunk portion and the second branch portion 16c is 120 degrees (¶0059 and see annotated Fig. 2 below: 180° - 120° = 30°). Thus, McGhee implicitly teaches an angle between the first branch portion 16a and the second branch portion 16c is 60 degrees (30° + 30° = 60°: see annotated Fig. 2 below; the taught angle range is within the claimed angle range).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of McGhee by having/making the first branch portion positioned at an angle as claimed from the second branch portion, in order to reduce fluid turbulence through the bend but at the same time having the branch portions sufficiently offset radially from the longitudinal axis of the trunk portion such that the branch portions are not crowded too close together, as suggested in ¶0013 of McGhee and as it has been that a prima facie case of obviousness exists when the claimed ranges lie inside ranges disclosed by the prior art (See MPEP § 2144.05 (I)). Further, Applicant places no criticality on the angle claimed, indicating simply that the branch portions may be positioned with an angle of about 60° to about 120° therebetween (¶0016).
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Claim(s) 8 and 10 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727), as applied to claim 1 above, and further in view of Itou (US PGPUB 20060011501).
Regarding claim 8, Schryver/Heaton does not disclose the first tube, the bifurcated Y-shaped connector, the second tube, and the third tube are pre-packaged for use in surgeries.
In an analogous art for being directed to solve the same problem, providing sterile sealed package for medical tubes, Itou discloses a package for medical tubes which are used for a surgical procedure (Abstract and Fig. 6). Itou further teaches the medical tubes are aseptically wrapped by a cover/seal 60 for the benefit of providing aseptic package (¶0041). Itou also discloses the package is opened when the aseptic seal of the package is broken (¶0038).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of Itou by having a sterile sealed package for the first tube, the bifurcated Y-shaped connector, the second tube, and the third tube, in order to provide aseptic package for medical tubes which are used for a surgical procedure, as suggested in ¶0041 of Itou.
Regarding claim 10, Schryver/Heaton does not disclose a surgical suction supply kit comprising a sterile sealed package containing the bifurcated surgical tubing device of claim 1 and a plurality of flow control valves.
Itou further teaches a surgical suction supply kit comprising a sterile sealed package containing medical tubes (Abstract, ¶0041, and Fig. 6) for the benefit of providing aseptic package (¶0041) and a plurality of flow control valves (a plurality of three-way stopcocks 46: ¶0036 and Fig. 4) for the benefit of permitting a change in the flow path (¶0036).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of Itou by having a sterile sealed package for the bifurcated surgical tubing device and incorporating a plurality of flow control valves inside a sterile sealed package for the device, in order to provide aseptic package for medical tubes which are used for a surgical procedure and permit a change in the flow path, as suggested in ¶0036 and 0041 of Itou.
Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Schryver (US PAT 5945052) in view of Heaton (US PGPUB 20090312727), as applied to claim 1 above, and further in view of Espino (US PGPUB 20190255312).
Regarding claim 9, Schryver/Heaton does not disclose a first adaptor coupled to the proximal end of the first tube, a second adaptor coupled to the second end of the second tube, and a third adaptor coupled to the second end of the third tube.
In the same field of endeavor, dropper or syringe device, Espino discloses a system for applying suction during a surgical procedure that requires simultaneous application of suction to at least two surgical instruments or devices utilizes Y-configured suction hose arrangements that each includes a single body tube connected to a pair of extremities tubes by a Y-connector (Abstract and Fig. 1). Espino further discloses a first adaptor coupled to the proximal end of the first tube (a female connector 2: ¶0019 and Fig. 1) for connecting tube 1 to a suction system (¶0019), a second adaptor coupled to the second end of the second tube, and a third adaptor coupled to the second end of the third tube (two female connectors 5: ¶0019 and Fig. 1) for connecting tubes 4 to suction-utilizing surgical instruments or devices (¶0019).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Schryver/Heaton in view of Espino by incorporating first, second, and third adaptors as claimed, in order to assisting in coupling tubes to suction system and suction-utilizing surgical instruments or devices, as suggested in ¶0019 of Espino.
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 NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781