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 responsive to the amendment filed on 12/2/2025. As directed by the amendment: no claims have been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-19 are presently pending in this application.
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.
Claims 1, 4, 12-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Blank et al. (US 5630800 A) in view of Ty (US 4437858 A).
Regarding claim 1, Blank discloses a syringe assembly (Figs. 1-2) comprising:
a barrel (1) for containing one or more medicaments (Fig. 1), the barrel having a front outlet (3) for allowing the expulsion of said one or more medicaments from said barrel through said outlet (Col 7, lines 15-30);
a first stopper (16) disposed in the barrel and axially moveable therein (Fig. 1, Col 6, line 22), the first stopper having a two way valve (16);
a second stopper (8) disposed in the barrel axially rearward of the first stopper and axially moveable therein (Figs. 1-2), the second stopper providing a fluid tight seal to the barrel (Col 5, lines 41-42); and
a first plunger rod (20) connected to the first stopper and extending axially rearwardly through the second stopper (Fig. 1), the second stopper sealingly engaging with the first plunger rod but permitting axial sliding of the first plunger rod therethrough (Figs. 1-2);
wherein the first plunger rod is axially moveable in the barrel so as to axially move the first stopper from an initial position (When the syringe is being filled, the first plunger rod will assume an initial position) to a subsequent position (Fig. 1), wherein in the subsequent position a first volume (30) is defined in the barrel axially forwards of the first stopper (Fig. 1) and a second volume (32) is defined in the barrel axially rearwards of the first stopper (Fig. 1), and the first stopper is configured to be movable such that either of the first volume or second volume is a substantially zero volume (When 16 is pulled upwards towards 9, 32 would be substantially zero volume),
wherein the two-way valve is configured to permit the first stopper to repeatedly move successively axially forward and axially reward within the barrel relative to the second stopper to encourage mixing of the fluid of the first volume and the fluid of the second volume (Col 6, lines 22-32).
Blank is silent regarding
the two way valve being moveable between a sealing configuration and an open configuration;
wherein axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume.
In analogous prior art, Ty teaches a syringe assembly (Fig. 1) comprising a first stopper (25) disposed in a barrel (10, Fig. 1), the first stopper having a two way valve (25) that is moveable between a sealing configuration (Fig. 1) and an open configuration (Col 6, lines 29-44).
The substitution of one known material (disc as taught in Ty) for another (mixing piston as taught in Blank) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since Ty teaches that mixing two components and the substitution of the disc as taught in Ty would have yielded predictable results, namely, a mixing structure of Blank that would allow for both components to mix with one another. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The modification of Blank in view of Ty would teach wherein axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume (Blank teaches that the first stopper/mixing piston 16 moves to and fro to mix the substances, see Col 6, lines 2-25. Ty teaches that a portion of the disc having the lower friction with respect to the bore unseats and allows mixing between both chambers and is axially movable (after mixing has occurred), see Col 6, lines 29-50). One of ordinary skill in the art would recognize that the substitution of the mixing piston of 16 of Blank with the disc 25 of Ty would still operate in a manner in which the disc 25 would be able to move to and fro (thus allowing the substances to go past the area with lower friction) to mix the substances in the chambers, therefore teaching axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume).
Regarding claim 4, Blank in view of Ty disclose the syringe assembly according to claim 1, further comprising a second plunger rod (5, Blank) connected to the second stopper (Fig. 1, Blank), wherein axial movement of the second plunger rod causes axial movement of the second stopper (Figs. 1-2, Blank).
Regarding claim 12, Blank in view of Ty disclose the syringe assembly according to claim 1, wherein the two way valve comprises a resilient seal (37a/37b, Ty) that deforms under a predetermined fluid pressure (Col 6, lines 29-44, Ty).
Regarding claim 13, Blank in view of Ty disclose the syringe assembly according to claim 12, wherein the resilient seal includes a plurality of flexible flaps (37a/37b, Ty).
Regarding claim 14, Blank in view of Ty disclose the syringe assembly according to claim 12, wherein the resilient seal extends along an arc around the first stopper, wherein the angular extent of the arc is less than 360° (Figs. 1-2, Ty).
Regarding claim 16, Blank in view of Ty disclose the syringe assembly according to claim 1, wherein the fluid tight seal provided by the second stopper is a sterile seal (8, Blank).
Regarding claim 17, Blank in view of Ty disclose the syringe assembly according to claim 1, wherein the fluid tight seal provided by the second stopper is a microbiological seal (8, Blank).
Regarding claim 18, Blank in view of Ty disclose the syringe assembly according to claim 1, further comprising a medicament (Abstract, Col 6, lines 11-32, Blank), wherein when the first stopper is in the initial position the medicament is contained only in the one of the first volume and the second volume that is not the substantially zero volume (When the syringe is being filled, the mixing piston 16/disc 25 will assume an initial position, at which one either of the first volume or second volume will contain the medicament and the other of the first volume or second volume will be substantially zero volume).
Regarding claim 19, Blank discloses a method of using a syringe assembly (Figs. 1-2) that comprises:
a barrel (1) for containing one or more medicaments (Fig. 1), the barrel having a front outlet (3) for allowing the expulsion of said one or more medicaments from said barrel through said outlet (Col 7, lines 15-30);
a first stopper (16) disposed in the barrel and axially moveable therein (Fig. 1, Col 6, line 22), the first stopper having a two way valve (16);
a second stopper (8) disposed in the barrel axially rearward of the first stopper and axially moveable therein (Figs. 1-2), the second stopper providing a fluid tight seal to the barrel (Col 5, lines 41-42); and
a first plunger rod (20) connected to the first stopper and extending axially rearwardly through the second stopper (Fig. 1), the second stopper sealingly engaging with the first plunger rod but permitting axial sliding of the first plunger rod therethrough (Figs. 1-2);
the method comprising axially moving the first plunger rod in the barrel so as to axially move the first stopper from an initial position (When the syringe is being filled, the first plunger rod will assume an initial position, Col 6, lines 11-12) to a subsequent position (Fig. 1), wherein in the subsequent position a first volume (30) is defined in the barrel axially forwards of the first stopper (Fig. 1) and a second volume (32) is defined in the barrel axially rearwards of the first stopper (Fig. 1), and in the initial position either of the first volume or second volume is a substantially zero volume and the other of the first volume and the second volume contains the one or more medicaments (When the syringe is being filled, the mixing piston 16 will assume an initial position, Col 6, lines 11-12, at which one either of the first volume or second volume will contain the medicament and the other of the first volume or second volume will be substantially zero volume).
Blank is silent regarding
the two way valve being moveable between a sealing configuration and an open configuration;
wherein axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume.
In analogous prior art, Ty teaches a syringe assembly (Fig. 1) comprising a first stopper (25) disposed in a barrel (10, Fig. 1), the first stopper having a two way valve (25) that is moveable between a sealing configuration (Fig. 1) and an open configuration (Col 6, lines 29-44).
The substitution of one known material (disc as taught in Ty) for another (mixing piston as taught in Blank) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since Ty teaches that mixing two components and the substitution of the disc as taught in Ty would have yielded predictable results, namely, a mixing structure of Blank that would allow for both components to mix with one another. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
The modification of Blank in view of Ty would teach wherein axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume (Blank teaches that the first stopper/mixing piston 16 moves to and fro to mix the substances, see Col 6, lines 2-25. Ty teaches that a portion of the disc having the lower friction with respect to the bore unseats and allows mixing between both chambers and is axially movable (after mixing has occurred), see Col 6, lines 29-50). One of ordinary skill in the art would recognize that the substitution of the mixing piston of 16 of Blank with the disc 25 of Ty would still operate in a manner in which the disc 25 would be able to move to and fro (thus allowing the substances to go past the area with lower friction) to mix the substances in the chambers, therefore teaching axial movement of the first stopper in the barrel pressurises either of the first volume and second volume causing the two way valve to move into the open configuration and fluidly connect the first volume and the second volume).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Blank et al. (US 5630800 A) Ty (US 4437858 A) further in view of Haining (US 5453093 A).
Regarding claim 3, Blank in view of Ty disclose the syringe assembly according to claim 1, but are silent regarding wherein the first plunger rod includes one or more finger loops for facilitating handling of the first plunger rod.
In analogous art, Haining teaches a syringe assembly (Fig. 1) comprising a first plunger rod (20) includes one or more finger loops (22) for facilitating handling of the first plunger rod (Col 2, lines 21-23).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the first plunger rod of Blank to incorporate the teachings of Haining to incorporate one or more finger loops for facilitating handling of the first plunger rod in order to more easily manipulate the syringe (Col 2, lines 21-23).
Response to Arguments
Applicant's arguments filed 12/2/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments, on page 7, that “the mixing piston 16 is not required to maintain the solvent and solute in separate, sealed parts of the syringe prior to use, thus negating the need to provide a means of sealing the opening..." is not persuasive. As a first matter, this argument only focuses on a minor disclosure with respect to the embodiment of Fig. 2 that the syringe may be supplied containing only the solute with the solvent drawn up only immediately prior to use. This argument does not consider that the embodiment of Fig. 1 is directed to the solute and solvent being separated by the mixing piston 16. Secondly, even in the case that the syringe is supplied with only the solute for the solvent to be drawn up immediately prior to use, substituting the mixing piston with the two-way valve of Ty would still allow for this and may provide the additional benefit of allowing the user the option to not immediately have the solute and solvent unintentionally mix.
In response to applicant’s arguments, on pages 7-8, with respect to the embodiment shown in Figs. 3-4 are not persuasive because the rejection does not rely on these embodiments. The rejection only cites to the embodiment of Figs. 1-2.
In response to applicant’s arguments, on page 8, that the substitution of Ty's disc for the mixing piston of Blank is based on impermissible hindsight is not persuasive because any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant’s arguments, on page 9, that Ty fails to provide motivation to replace the mixing piston of Blank with its separator disc and that the office action allegedly fails to explain why one would substitute Blank's mixing piston for Ty's disc is not persuasive. Ty is not required to provide a motivation under the simple substitution rationale. the simple substitution rationale requires (1) a finding that the prior art contained a device which differed from the claimed device by the substitution of some components with other components (which is articulated in the office action finding that Blank teaches the claimed device except for the two way valve); (2) a finding that the substituted components and their functions were known in the art (which is articulated in the office action citing to Ty's disc); (3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable (which is articulated in the office action explaining the substitution of one known material for another). Since the rejection articulated each of the findings required by the simple substitution rationale, the rejection is proper.
In response to applicant’s arguments, on page 9, that "if anything, the disc 25 of Ty may be considered analogous to the second stopper 40 of Blank" is not persuasive, just because a different substitution can be made does not negate the substitution made in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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