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 .
Status of the Claims
The amendment filed 03/10/2026 has been entered. Claims 1-6 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 line 6 recites “spring” which should read “a spring”
Appropriate correction is required.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tessari (US 20020077589 A1) in view of Melsheimer (US 20110144568 A1), Wright et al (US 20070003489 A1), Grabenkort et al (US 5566729 A) and Throne et al (US 20090198211 A1).
Regarding claim 1, Tessari substantially teaches a method of making and providing a therapeutic foam ([0041]-[0051] and figures 1-6, method of making injectable foam using valve 30, two syringes 10 and 20) comprising:
providing (i) a syringe (figure 1, syringe 20) and (ii) a mixing device (figure 1, valve 30 + syringe 10); the syringe having a barrel (figure 3, barrel of syringe 20), a plunger (figure 3 and [0044] plunger of syringe 20), a tip (figure 3 and [0041], nozzle of syringe 20), and a foamable therapeutic disposed in the barrel (figure 3 and [0045] liquid sclerosant 80 is disposed barrel of syringe 20); the mixing device having (A) a syringe body (figure 2, body of syringe 10) and a mixing tip (figure 1 [0041], nozzle of syringe 10) fluidly coupled to an interior of the syringe body (figure 1, the nozzle fluidly connected to an interior of syringe 10), and a plunger (figure 1 and [0047], plunger of syringe 10); (B) a mixing channel (figure 1, port 32a), a supply channel (figure 1, port 32c) and a delivery channel (figure 1, port 32b); wherein one end of the mixing channel (annotated figure 1, end of mixing channel) is coupled to the mixing tip (figure 3, the end of mixing channel being coupled to nozzle of syringe 10) and one end of the supply channel (annotated figure 1, end of supply channel) includes a connector ([0041]-[0042] the end of port 32c includes thread projection that allows luer tip of syringe 20 removably coupled) for removably coupling to the syringe; (C) a three-way valve (figure 1 and [0042] rotatable cylindrical valve member 37 comprising bores 37a and 37b) that is configured to selectively couple an opposite end of the mixing channel (annotated figure 1, opposite end of the mixing channel), an opposite end of the supply channel (annotated figure 1, opposite end of the supply channel) and the delivery channel to one or more of the others (annotated figure 1, figures 3 and 4 and [0043] the valve 37 is configured to selectively couples the opposite end of the mixing channel to the opposite end of the supply channel in position B1, as shown in figure 4, or couples the opposite end of the supply channel to the delivery channel in position A as shown in figure 3); and
coupling the syringe to the connector ([0042], [0045] coupling syringe 20 to the threaded port 32c);
actuating the three-way valve to couple the supply channel to the mixing channel, but not to the delivery channel (figures 4, [0043] and [0046], rotating valve 37 into position B1 as shown figure 4 fluidly couples the port 32c to port 32a, but not to port 32b);
plunging the plunger of the syringe to force foamable therapeutic through the supply channel, mixing channel and into the mixing device (figure 4 and [0047] depressing plunger of syringe 20 forces sclerosant into syringe 10).
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Tessari does not teach the method comprising a spring disposed within the syringe body of the mixing device;
plunging the plunger of the syringe to force foamable therapeutic through the supply channel, mixing channel and mixing element and into the mixing device, thereby causing the spring to be compressed;
releasing force on the plunger of the syringe to allow the spring to force the foamable therapeutic back through the mixing channel, mixing element and supply channel and into the syringe, thereby creating a foamed therapeutic
actuating the three-way valve to couple the supply channel to the delivery channel, but not to the mixing channel; and
plunging the plunger to dispense the foamed therapeutic
In the same field of endeavor, namely an apparatus and method for preparing foam, Melsheimer teaches the method comprising a spring (figure 2, biasing member 56) disposed within the syringe body of the mixing device (figure 2, spring disposed within second housing 16);
plunging the plunger of the syringe to force foamable therapeutic through the supply channel, mixing channel and mixing element and into the mixing device, thereby causing the spring to be compressed (figure 3c [0023]-[0025] actuating handle 22 drives the movable member 34 toward the first end portion 44 of the first chamber 15, thereby forcing the fluid contained in the first chamber into the second chamber 17, which in turns compresses the biasing member 56);
releasing force on the plunger of the syringe to allow the spring to force the foamable therapeutic back through the mixing channel, mixing element and supply channel and into the syringe, thereby creating a foamed therapeutic ([0023]-[0026] releasing handle 22 allows the biasing member force the fluid in the second chamber flow back into the first chamber 15 and thereby generating foam)
actuating the three-way valve (figure 3d and [0027]-[0028] rotating valve 18 to position 76 as shown figure 3d fluidly couples the outlet 42 to outlet 29 but not to outlet 62) to couple the supply channel (figure 3d, outlet 42) to the delivery channel (figure 3d, outlet 29), but not to the mixing channel (figure 3d, outlet 62); and
plunging the plunger to dispense the foamed therapeutic ([0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari to incorporate the teachings of Melsheimer and provides the method as claimed for the purpose of generating foam by singe-hand operation thereby avoiding operator fatigue, as taught by Melsheimer ([0004] and [0024]).
The combination does not teach the mixing device comprising (d) a mixing element disposed in the mixing channel.
In the same field of endeavor, namely a method of generating therapeutic foam, Wright teaches a mixing device (figure 5, barrel 1) comprising a mixing element (figure 5, [0191]-[0198] and [0220], foaming unit 50 comprising mesh element) disposed in the mixing channel (figure 5, foaming unit 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, to incorporate the teachings of Wright and provide the mixing element as claimed for the purpose of create foam with desired bubble size, i.e., finer foam, as taught by Wright ([0221]).
The combination does not teach (E) removable seals comprising a supply channel seal and a delivery channel seal; and
removing the supply channel seal and the delivery channel seal.
In the same field of endeavor, namely a drug reconstitution and administration system, Grabenkort teaches a mixing adapter assembly (figures 1-2, 14) comprising (E) removable seals (figure 2, removable peel-seals 62 and 64) comprising a supply channel seal and a delivery channel seal; and
removing the supply channel seal and the delivery channel seal (col 4 line 50 – col 5 line 26, removing seals prior to interconnection of containers with the adapter assembly).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer and Wright, to incorporate the teachings of Grabenkort and provides the removable seals and method as claimed for the purpose of maintain the sterility of the interior of the mixing device as taught by Grabenkort (col 5 lines 5-9).
The combination is still silent as to wherein a longitudinal axis of the syringe is parallel to a longitudinal axis of the mixing device to facilitate one-handed operation by a user; and
plunging, by the user and with one hand, the plunger of the syringe
In the same field of endeavor, namely a convenient kit for use in measuring, filling and dispensing medication, Thorne teaches wherein a longitudinal axis of the syringe is parallel to a longitudinal axis of the mixing device to facilitate one-handed operation by a user ([0036] an figure 1, syringes 30 arranged parallel relative to syringe 20 facilitating one-hand operation); and
plunging, by the user and with one hand, the plunger of the syringe ([0044, 0112, 0126 0157] permitting plunging syringe 20 with one hand).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, Wright, Grabenkort, to incorporate the teachings of Throne and provide the claimed syringe and the mixing device orientation and claimed method for the purpose of permitting singe hand operation as taught by Thorne ([0056, 0126-0127]).
Regarding claim 2, Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, teaches the method of claim 1.
The combination further teaches comprising repeating the plunging and releasing steps one or more times (Tessari; [0011])
Regarding Claim 3, Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, teaches the method of claim 1.
The combination further teaches wherein the mixing element comprises a mesh screen (Wright; figures 11 and 12 and [0240]-[0243] foaming unit comprises mesh screen 52).
The combination does not teach the mesh screen characterized by apertures of between about 100 um and 500 um;
though Wright teaches the mesh screen characterized by apertures of between 0.1 and 100 micron ([0191]-[0198]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, and provides the mesh screen as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0041] and [0095]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding Claim 4, Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, teaches the method of claim 1.
The combination further teaches wherein the mixing element comprises a mesh screen (Wright; figures 11 and 12 and [0240]-[0243] foaming unit comprises mesh screen 52).
The combination does not teach the mesh screen characterized by apertures of between about 10 um and 25 um;
though Wright teaches the mesh screen characterized by apertures of between 0.1 and 100 micron ([0191]-[0198]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, and provides the mesh screen as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0041] and [0095]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding Claim 5, Tessari, as modified by Melsheimer, Wright, Grabenkort and Throne, teaches the method of claim 1.
The combination further teaches wherein the mixing element comprises a sintered or porous material (Wright; [0198] holes of the mesh screen provided by sinter).
Regarding claim 6, Tessari teaches a kit ([0033] and figure 1, a kit comprising syringes 10, 20 and valve 30) comprising:
a syringe (figure 1, syringe 20); and
a mixing device (figure 1, valve 30 + syringe 10);
the syringe having a barrel (figure 3, barrel of syringe 20), a plunger (figure 3 and [0044] plunger of syringe 20), a tip (figure 3 and [0041] nozzle of syringe 20), and a foamable therapeutic disposed in the barrel (figure 3 and [0045] barrel of syringe 20 contains liquid sclerosant 80); and the mixing device having (A) a syringe body (figure 1, body of syringe 10) and a mixing tip (figure 1 and [0041] nozzle of syringe 10 fluidly couples to interior of the syringe body 10) fluidly coupled to an interior of the syringe body, and a plunger (figure 1and [0047] plunger of syringe 10); (B) a mixing channel (figure 1, port 32a), a supply channel (figure 1, port 32c) and a delivery channel (figure 1, port 32b); wherein one end of the mixing channel (annotated figure 1, end of mixing channel coupled to nozzle of syringe 10) is coupled to the mixing tip and one end of the supply channel (annotated figure 1 and [[0041]-[0042], end of supply channel includes thread projection that allows luer tip of syringe 20 removably coupled) includes a connector for removably coupling to the syringe; (C) a three-way valve (figure 1 and [0042] rotatable cylindrical valve member 37) that is configured to selectively couple an opposite end of the mixing channel (annotated figure 1, opposite end of mixing channel), an opposite end of the supply channel (annotated figure 1, opposite end of the supply channel) and the delivery channel to one or more of the other (annotated figure 1, figures 3 and 4 and [0043] the valve 37 is configured to selectively couples the opposite end of the mixing channel to the opposite end of the supply channel in position B1 as shown in figure 4, or couples the opposite end of the supply channel to the delivery channel in position A as shown in figure 3); and
wherein the kit is configured to allow (x) the syringe to be removably coupled to the connector (figure 1, [0042] and [0045] port 32c comprises a threaded that allows the syringe 20 to be removably coupled); (y) the three-way valve to be actuated to couple the supply channel to the mixing channel, but not to the delivery channel (figure 4, [0043] and [0046] rotating valve 37 into position B1, as shown figure 4, fluidly couples to port 32c and port 32a, but not to port 32b); (z) the plunger to be plunged to force foamable therapeutic through the supply channel, mixing channel into the mixing device (figure 4 and [0047] pressing plunger of syringe 20 forces sclerosant into syringe 10 through port 32c and port 32b).
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Tessari does not teach the mixing device having a spring disposed within the syringe body;
plunging the plunger causing the spring to be compressed;
(aa) the plunger to be released, to allow the spring to force the foamable therapeutic back through the mixing channel, mixing element and supply channel and into the syringe, thereby creating a foamed therapeutic; (bb) the three-way valve to be actuated to couple the supply channel to the delivery channel, but not to the mixing channel; and (cc) the plunger to be plunged to dispense the foamed therapeutic.
In the same field of endeavor, namely an apparats and method for preparing foam, Melsheimer teaches a mixing device (figure 2, second housing 16) having a spring (figure 2, biasing member 56 disposed within the second housing 16) disposed within the syringe body;
plunging the plunger causing the spring to be compressed (figure 3c [0023]-[0025] actuating handle 22 drives the movable member 34 toward the first end portion 44 of the first chamber 15, thereby forcing the fluid contained in the first chamber into the second chamber 17, which in turns compresses the biasing member 56);
(aa) the plunger to be released (figure 3b and [0023]-[0026] releasing handle 22 allows the biasing member force the fluid in the second chamber flow back into the first chamber 15 and generating foam), to allow the spring to force the foamable therapeutic back through the mixing channel, mixing element and supply channel and into the syringe, thereby creating a foamed therapeutic; (bb) the three-way valve to be actuated to couple the supply channel to the delivery channel (figure 3d and [0027]-[0028] rotating valve 18 to position 76 as shown figure 3d fluidly couples the outlet 42 to outlet 29 but not to outlet 62), but not to the mixing channel; and (cc) the plunger to be plunged to dispense the foamed therapeutic ([0029]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari to incorporate the teachings of Melsheimer and provides the device as claimed for the purpose of generating foam by singe-hand operation thereby avoiding operator fatigue, as taught by Melsheimer ([0004] and [0024]).
The combination is still silent as to the mixing device comprising (D) a mixing element disposed in the mixing channel;
In the same field of endeavor, namely a method of generating therapeutic foam, Wright teaches a mixing device (figure 5, barrel 1) comprising a mixing element (figure 5, [0191]-[0198] and [0220], foaming unit 50 comprising mesh element) disposed in the mixing channel (figure 5, foaming unit 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, to incorporate the teachings of Wright and provide the mixing element as claimed for the purpose of create foam with desired bubble size as taught by Wright ([0221]).
Tessari, as modified by Melsheimer and Wright, does not teach (E) removable seals comprising a supply channel seal and a delivery channel seal;
Wherein the kit is configured to allow (w) the supply channel seal and the delivery channel seal to be removed
In the same field of endeavor, namely a drug reconstitution and administration system, Grabenkort teaches a mixing adapter assembly (figures 1-2, 14) comprising (E) removable seals (figure 2, removable peel-seals 62 and 64) comprising a supply channel seal and a delivery channel seal;
Wherein the kit is configured to allow (w) the supply channel seal and the delivery channel seal to be removed (col 4 line 50 – col 5 line 26, removable seals)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer and Wright, to incorporate the teachings of Grabenkort and provides the removable seals as claimed for the purpose of maintain the sterility of the interior of the mixing device as taught by Grabenkort (col 5 lines 5-9).
The combination is still silent as to (x) the syringe coupled to the connector in a manner that aligns a longitudinal axis of the syringe parallel to a longitudinal axis of the mixing device.
In the same field of endeavor, namely a convenient kit for use in measuring, filling and dispensing medication, Thorne teaches (x) the syringe coupled to the connector in a manner that aligns a longitudinal axis of the syringe parallel to a longitudinal axis of the mixing device ([0036] an figure 1, syringes 30 arranged parallel relative to syringe 20).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tessari, as modified by Melsheimer, Wright, Grabenkort, to incorporate the teachings of Throne and provide the claimed syringe and the mixing device orientation for the purpose of permitting singe hand operation as taught by Thorne ([0056, 0126-0127]).
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (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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/S.H./Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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