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
Applicant’s amendments filed on 01/05/2025 have been fully considered. Claims 1-10 are pending in this application. Claims 1, 4-7 are amended.
Response to Arguments
The amendment of claim 1 overcomes the claim objection of record. The claim objection of claim 1 is withdrawn.
Applicant’s arguments with respect to amended independent claim(s) 1 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.
Though some of the same prior art reference is re-used herein, amended claim 1 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection. In particular, the claim limitations “when the flow valve is oriented with the upstream end higher than the downstream end and when there is insufficient liquid backpressure, the heavy bob will abut the downstream end of the chamber in a non-sealing manner, and the liquid will flow into the upstream end, through the chamber, and out of the downstream end; and when the flow valve is oriented with the upstream end higher than the downstream end and when there is sufficient liquid backpressure, the heavy bob will abut the downstream end of the chamber in an on-sealing manner, and the light bob will float in the liquid up to abut the upstream end of the chamber in a sealing manner that inhibits the liquid from backflowing out of the chamber at the upstream end” further narrows the scope of the claimed invention.
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) 1-2, 4, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (Patent No. US 8,025,651 B1) in view of Alan (Publication No. US 2014/0276348 A1), and Marchaix et al. (Patent No. US 4,176,678 A).
Regarding claim 1, Hart teaches an apparatus comprising a one-way flow valve for a liquid having a liquid density (device 1 is a valve that prevents backflow of urine, having a liquid density; Abstract; Figure 1-2; Column 2, lines 14-16), the flow valve comprising: a chamber (housing 3; Figures 1-2; Column 2, lines 16-20) having an upstream end for receiving the liquid (upstream 3A for receiving a liquid; Figures 1-2; Column 2, lines 16-20) and a downstream end for dispensing the liquid (downstream 3B for dispensing a liquid; Figures 1-2; Column 2, lines 16-20); a heavy bob located within the chamber (flow ball 5 within housing 3; Figures 1-2; Column 2, lines 20-33); and a light bob located within the chamber (stopper ball 4 within housing 3; Figures 1-2; Column 2, lines 20-33), wherein: the heavy bob is located between the light bob and the downstream end of the chamber (flow ball 5 between stopper ball 4 and downstream 3B; Figures 1-2; Column 2, lines 20-33). Hart does not teach the heavy bob having a density greater than the liquid density, the light bob having a density smaller than the liquid density.
However, Alan teaches a heavy bob having a density greater than the liquid density and a light bob having a density smaller than the heavy bob (second ball 46 is made of tantalum metal and heavier than first ball 44 and first ball 44 is made of ruby which is lighter and less dense than metal; Paragraph 0029; Figure 3A).
Hart and Alan are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart to incorporate the teachings of Alan and have the heavy bob/flow ball and light bob/stopper ball of Hart, be made of metal and ruby, as taught by Alan. This allows for the valve to remain closed with the influence of gravitational pull (Alan; Paragraph 0029).
The combination of Hart in view of Alan does not teach the light bob having a density smaller than the liquid density.
However, Marchaix teaches the light bob having a density smaller than the liquid density (float 15 of a circular section made of hollow propylene to float 15 and displace the steel ball 14 of the valve 13 – float has lighter density than liquid density; Figure 5; Column 3, lines 58-68).
Hart in view of Alan and Marchaix are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Alan to incorporate the teachings of Marchaix and have the lighter bob of Hart in view of Alan to be made of hollow propylene, as taught by Marchaix. This allows for the ball valve to be displaced when liquid is present in the valve (Marchaix; Column 3, lines 58-68).
The combination of Hart in view of Alan and Marchaix further teaches when the flow valve is oriented with the upstream end higher than the downstream end and when there is insufficient liquid backpressure, the heavy bob will abut the downstream end of the chamber in a non-sealing manner, and the liquid will flow into the upstream end, through the chamber, and out of the downstream end (Hart; heavy flow ball 5 will allow for fluid to travel from upstream end 3A to downstream end 3B while flow ball 5 abuts the downstream end 3B in a non-sealing manner; Figure 1; Column 2, lines 53-61); and when the flow valve is oriented with the upstream end higher than the downstream end and when there is sufficient liquid backpressure, the heavy bob will abut the downstream end of the chamber in a non-sealing manner, and the light bob will float in the liquid up to abut the upstream end of the chamber in a sealing manner that inhibits the liquid from backflowing out of the chamber at the upstream end (Hart; obvious that at a given liquid backpressure, the light bob with a smaller density than liquid would float the light bob back up to abut the upstream 3A while the heavy bob remains to abut the downstream 3B; Figure 1; see combination above); and when the flow valve is oriented with the downstream end higher than the upstream end, the heavy bob forces the light bob to abut the upstream end of the chamber in the sealing manner that inhibits the liquid from backflowing out of chamber at the upstream end (Hart; when downstream 3B is higher than upstream 3A, the heavy bob 5 will force the light bob 4 to abut the upstream 3A to seal the upstream end 3A and prevent backflow; Figure 2; Column 2, line 61 to Column 3, line 7).
Regarding claim 2, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. Hart further teaches wherein the heavy and light bobs have spherical shapes (flow ball 5 and stopper ball 4 are spherical; Figures 1-2; Column 2, lines 14-33).
Regarding claim 4, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. Hart further teaches wherein: the diameters of the heavy and light bobs are smaller than the inner diameter of the chamber (diameters of stopper ball 4 and flow ball 5 are smaller than the inner diameter of housing 3; Figures 1-2); the chamber has interior guide rails that guide the heavy and light bobs along a longitudinal direction within the chamber (tapered end of upstream 3A and flow ball retainer 7 guide flow ball 5 and stopper ball 4 along the longitudinal direction within the housing 3; Figures 1-2; Column 2, lines 14-33); and the chamber and the guiderails are designed to enable the liquid to flow within the chamber around the heavy and light bobs (housing 3, tapered end of upstream 3A, and flow ball retainer 7 allows for fluid to travel around the flow ball 5 and stopper ball 4; Column 2, lines 14-33; Figures 1-2).
Regarding claim 8, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. Hart further teaches wherein the apparatus is any device in which liquid is transferred (device 1 is connected to a urinary catheter; Abstract; Column 2, lines 46-52; Figure 1-2).
Regarding claim 9, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. Hart further teaches wherein the apparatus is a urinary catheter (device 1 is connected to a urinary catheter; Abstract; Column 2, lines 46-52; Figure 1-2).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (Patent No. US 8,025,651 B1) in view of Alan (Publication No. US 2014/0276348 A1), and Marchaix et al. (Patent No. US 4,176,678 A), as applied to claim 2 above, and further in view of Sklar (Publication No. US 2021/0244922 A1).
Regarding claim 3, Hart in view of Alan and Marchaix teaches the apparatus of claim 2. The combination of Hart in view of Alan and Marchaix further teaches the light bob is a hollow polypropylene ball bearing (Marchaix; float 15 of a circular section made of hollow propylene; Figure 5; Column 3, lines 58-68; see rejection of claim 1 above). The combination of Hart in view of Alan and Marchaix does not teach wherein: the heavy bob is a stainless steel ball bearing.
However, Sklar teaches wherein: the heavy bob is a stainless steel ball bearing (ball 64 is made of stainless steel; Paragraph 0041).
Hart in view of Alan and Marchaix and Sklar are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Alan and Marchaix to incorporate the teachings of Sklar and have the heavier bob of Hart in view of Alan and Marchaix to be made of stainless steel, as taught by Sklar. This allows for the ball valve to be easily assessed by ultrasound applied on the body of the user (Sklar; Paragraph 0041).
Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (Patent No. US 8,025,651 B1) in view of Alan (Publication No. US 2014/0276348 A1), and Marchaix et al. (Patent No. US 4,176,678 A), as applied to claim 1 above, and further in view of Chavan et al. (Publication No. US 2022/0218973 A1).
Regarding claim 5, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. Hart further teaches wherein: the downstream end of the chamber has stops that receive the heavy bob in the non-sealing manner (retainer ring 7 is the stops that receive the flow ball in a non-sealing manner; Figures 1-2; Column 2, lines 26-45). The combination of Hart in view of Alan and Marchaix does not teach the upstream end of the chamber has a sealing element that receives the light bob in the sealing manner.
However, Chavan teaches the upstream end of the chamber has a sealing element that receives the light bob in the sealing manner (ball bearing 350 abuts the beveled distal end 314 of the connector body with a sealing connection with the O-ring 360; Paragraph 0073-0074; Figure 19).
Hart in view of Alan and Marchaix and Chavan are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Alan and Marchaix to incorporate the teachings of Chavan and have the lighter bob of Hart in view of Alan and Marchaix to have a sealing connection when abutting the upstream end of the valve of Hart in view of Alan and Marchaix, by including an O-ring and the beveled distal edge of Chavan on the side wall in the upstream end of Hart in view of Alan and Marchaix. This allows for the ball valve to completely seal the end of the connector body and prevent backflow in the distal direction (Chavan; Paragraph 0073-0074).
Regarding claim 6, Hart in view of Alan, Marchaix, and Chavan teaches the apparatus of claim 5. The combination of Hart in view of Alan, Marchaix, and Chavan further teaches wherein the upstream end has structure that limits the deformation of the sealing member when the light bob is forced into the sealing element by either (i) liquid backflow or (ii) the heavy bob forcing the light bob onto the sealing element (Chavan; ball bearing 350 abuts the beveled distal end 314/structure of the connector body with a sealing connection with the O-ring 360/sealing element; Paragraph 0073-0074; Figure 19 – obvious that the O-ring will not deform when the light and heavy bob are applied to the O-ring since the structure of the beveled distal end 314 will fix the O-ring in place and prevent movement; see rejection of claim 5 above).
Regarding claim 7, Hart in view of Alan, Marchaix, and Chavan teaches the apparatus of claim 5. The combination of Hart in view of Alan, Marchaix, and Chavan further teaches wherein: the stops are part of interior guide rails that guide the heavy and light bobs within the chamber (Hart; retainer ring 7 is the stops that receive the flow ball in a non-sealing manner; Figures 1-2; Column 2, lines 26-45); and the sealing element is a silicone O ring (Chavan; O-ring 360/sealing element; Paragraph 0073-0074; Figure 19; see rejection of claim 5 above).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hart (Patent No. US 8,025,651 B1) in view of Alan (Publication No. US 2014/0276348 A1), and Marchaix et al. (Patent No. US 4,176,678 A), as applied to claim 1 above, and further in view of Sklar (Publication No. US 2021/0244922 A1) and Chavan et al. (Publication No. US 2022/0218973 A1).
Regarding claim 10, Hart in view of Alan and Marchaix teaches the apparatus of claim 1. The combination of Hart in view of Alan and Marchaix further teaches wherein: the light bob is a hollow polypropylene ball bearing (Marchaix; float 15 of a circular section made of hollow propylene; Figure 5; Column 3, lines 58-68; see rejection of claim 1 above); the diameters of the heavy and light bobs are smaller than the inner diameter of the chamber (Hart; diameters of stopper ball 4 and flow ball 5 are smaller than the inner diameter of housing 3; Figures 1-2); the chamber has interior guide rails that guide the heavy and light bobs along a longitudinal direction within the chamber (Hart; tapered end of upstream 3A and flow ball retainer 7 guide flow ball 5 and stopper ball 4 along the longitudinal direction within the housing 3; Figures 1-2; Column 2, lines 14-33); the chamber and the guiderails are designed to enable the liquid to flow within the chamber around the heavy and light bobs (Hart; housing 3, tapered end of upstream 3A, and flow ball retainer 7 allows for fluid to travel around the flow ball 5 and stopper ball 4; Column 2, lines 14-33; Figures 1-2); the downstream end of the chamber has rigid stops that receive the heavy bob in the non-sealing manner (Hart; retainer ring 7 is the stops that receive the flow ball in a non-sealing manner; Figures 1-2; Column 2, lines 26-45the rigid stops are part of interior guide rails that guide the heavy and light bobs within the chamber (Hart; retainer ring 7 is the stops that receive the flow ball in a non-sealing manner; Figures 1-2; Column 2, lines 26-45); and the apparatus is a urinary catheter (Hart; device 1 is connected to a urinary catheter; Abstract; Column 2, lines 46-52; Figure 1-2). The combination of Hart in view of Alan and Marchaix does not teach the heavy bob is a stainless steel ball bearing.
However, Sklar teaches the heavy bob is a stainless steel ball bearing (ball 64 is made of stainless steel; Paragraph 0041).
Hart in view of Alan and Marchaix and Sklar are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Alan and Marchaix to incorporate the teachings of Sklar and have the heavier bob of Hart in view of Alan and Marchaix to be made of stainless steel, as taught by Sklar. This allows for the ball valve to be easily assessed by ultrasound applied on the body of the user (Sklar; Paragraph 0041).
The combination of Hart in view of Alan, Marchaix, and Sklar does not teach the upstream end of the chamber has a resilient sealing element that receives the light bob in the sealing manner; the upstream end has structure that limits the deformation of the resilient sealing member when the light bob is forced into the sealing element by either (i) liquid backflow or (ii) the heavy bob forcing the light bob onto the sealing element; the sealing element is a silicone O ring.
However, Chavan teaches the upstream end of the chamber has a resilient sealing element that receives the light bob in the sealing manner (ball bearing 350 abuts the beveled distal end 314 of the connector body with a sealing connection with the O-ring 360; Paragraph 0073-0074; Figure 19).
Hart in view of Alan, Marchaix, and Sklar and Chavan are considered to be analogous to the claimed invention because they are in the same field of ball-valve flow connectors. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Alan, Marchaix, and Sklar to incorporate the teachings of Chavan and have the lighter bob of Hart in view of Alan, Marchaix, and Sklar to have a sealing connection when abutting the upstream end of the valve of Hart in view of Alan, Marchaix, and Sklar, by including an O-ring and the beveled distal edge of Chavan on the side wall in the upstream end of Hart in view of Alan, Marchaix, and Sklar. This allows for the ball valve to completely seal the end of the connector body and prevent backflow in the distal direction (Chavan; Paragraph 0073-0074).
The combination of Hart in view of Alan, Marchaix, Sklar, and Chavan further teaches the upstream end has structure that limits the deformation of the resilient sealing member when the light bob is forced into the sealing element by either (i) liquid backflow or (ii) the heavy bob forcing the light bob onto the sealing element (Chavan; ball bearing 350 abuts the beveled distal end 314/structure of the connector body with a sealing connection with the O-ring 360/sealing element; Paragraph 0073-0074; Figure 19 – obvious that the O-ring will not deform when the light and heavy bob are applied to the O-ring since the structure of the beveled distal end 314 will fix the O-ring in place and prevent movement; see combination above); the sealing element is a silicone O ring (Chavan; O-ring 360/sealing element; Paragraph 0073-0074; Figure 19; see combination above).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781