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 .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Claims 18-20 that were previously recited seem to have been cancelled but no status indicator for these claims is presented in the most recent claim set.
Claim Rejections - 35 USC § 103
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(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shmulewitz et al. (US 6,569,145 B1) in view of Truitt et al. (US 2006/0089603 A1) and in further view Slater et al. (US 2005/0113798 A1).
With regard to claim 15, Shmulewitz discloses A system for dispensing a flowable viscous fluid comprising: a hollow tube (Fig. 6a-6c, element 70) having an outer wall that extends from a proximal end to a distal end of said hollow tube; at least one air vent (73a-c) formed in said outer wall of said hollow tube adjacent the distal end of said hollow tube; a valve (72a-c) comprising at least one flexible flap (duckbill valves 72a-c, have a flexible lips that seal and therefore these lips are considered a flexible flap) disposed inside said hollow tube, wherein said at least one flexible flap is moveable between a first position for unsealing said at least one vent and a second position for sealing said at least one air vent (Col 7, lines 45-84, the valves 72a-c are opened due to pressure and allow fluid to flow through it and out the vent 73a-c), and wherein said at least one flexible flap is biased into the first position for unsealing said at least one vent (Col 7, lines 45-84, flexible flap is considered biased into the first position for unsealing said at least one vent due to the pressure of fluid which opens the duckbill valve to allow fluid to flow through, claims may need to recite a resting position when no pressure is applied and in the resting position the vent is open, in order to overcome the rejection interpretation).
However, Shmulewitz does not disclose a syringe.
Truitt teaches a tubing for delivery fluid similar to the tubing in Shmulewitz (Fig. 2b, element 103). Truitt further teaches a syringe (100) for supplying the fluid, including a syringe barrel ([0003], standard syringe inherently includes a barrel and plunger), a syringe plunger (inherent to a standard syringe, [0003]) that is disposed inside said syringe barrel; a syringe connector (2a) having a proximal end (400) coupled with a distal end of said syringe barrel (see Fig. 2b) and a distal end (at 164 in Fig. 2b) coupled with said end of hollow tube ( at 72), wherein said syringe connector has a fluid conduit that extends from said proximal end to said distal end of said syringe connector to define a fluid flow path between said syringe and said hollow tube (Fig. 2b).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shmulewitz with the syringe connector as taught by Truitt for the purpose of providing a safe and efficient way to repeatedly inject fluid into and/or withdraw fluid from intravenous systems ([0003]).
However, Shmulewitz/Truitt teach the claimed invention except for a viscous fluid.
Slater teaches a similar system (Fig. 1,) having a syringe (21) connected at a proximal end of a catheter (10) for delivering a flowable viscous fluid disposed within said syringe barrel [0267], a viscous fluid can be delivered through the catheter causing a higher or viscous pressure drop before opening the valves covering openings for delivery of the viscous fluid ([0267]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Shmulewitz/Truitt with the viscous fluid because a substation of one delivery agent for another is well-known in the art and does not affect the overall function of the device ([0267]).
With regard to claim 16, Shmulewitz discloses wherein said at least one flexible flap comprises: a first flexible flap (72a) that is configured for sealing and unsealing a first air vent (73a) of said four air vents; a second flexible flap (72b) that is configured for sealing and unsealing a second air vent (73b) of said four air vents; a third flexible flap (72c) that is configured for sealing and unsealing a third air vent (73c) of said four air vents;
However, Shmulewitz does not disclose four air vents with a fourth flexible flap.
However, it would be prima facie for one of ordinary skill in the art to merely duplicate the parts to include a fourth air vent and fourth flexible flap as this would not affect the overall function of the invention (Col 7, lines 45-84).
Allowable Subject Matter
Claims 1-14 are allowed. With the amended claims now reciting the flap seals the air vent upon a flowable hemostatic material flowing in the tube past the valve, in combination with the other structural limitations that the air vent is through an outer wall of a hollow tube and that the valve is located inside the hollow tube, overcomes the closest prior art.
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Shmulewitz teaches vents and flexible flaps for opening and closing the vents. However, the particular structure of the valve ring with four flexible flaps that are hingedly connected specifically to the distal edge of the valve ring, overcomes the closest prior art. Some other prior art were found that had tubes with flexible flaps for covering over vent holes but these flaps were spaced individually around the tube or sheath and did not have specifically four flaps all hingendly located on an edge of the ring/tube.
Response to Arguments
Applicant’s arguments and amendments to claims 1-14 are persuasive and the claims are found allowable.
Applicant has not provided any specific remarks regarding claim 15 and claim 15 does not recite the allowable subject matter found in claim 1, therefore the rejection is being maintained unless further remarks are presented.
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.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783