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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 21 recites “the planar engagement surface” there is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to the support surface or a different surface. For purposes of the rejection, it is considered as the support surface. Similarly, claim 31 recites “the planar engagement surface” there is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to the engagement surface or a different surface. For purposes of the rejection, it is considered as the engagement surface.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhinehart et al. (WO 2015/066506) in view of Pananen (US 2017/0266373 A1), and Renz (US 6,616,000 B1).
With regard to claim 21, Rhinehart et al. teach a syringe, comprising: a syringe body having a proximal end and a distal end spaced apart from the proximal end along a longitudinal axis of the syringe body (Fig. 2C member 120); a cone portion and a nozzle extending distally from the distal end of the syringe body (Fig. 2C nozzle 112, cone portion between cylindrical body and nozzle generally where 100 is indicated), wherein the proximal end of the syringe body is configured to interact with a bottom plate of the fluid injector to align the syringe in a receiving space of the fluid injector ([0002], [0003], [0063], the syringe connects to a power injector and would be capable of interacting with such a plate).
In the embodiment of Figs. 2 a stabilizing element is not shown. However, in Figs. 1 lock member 18/118 are shown to lock with the pressure jacket 200 ([0059], [0063], [0064]), which is also shown in Figs. 2. This is also shown in Figs 9A-9C. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a stabilizing element in the embodiment of Figs. 2/9 as Rhinehart et al. teach such is beneficial for retaining the syringe within the pressure jacket. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. As combined the stabilizing member would be placed at the transition between the cone and the syringe body as is shown in Fig. 1D to be formed on the cone and extend from the cone. This is at the base of the slope of the cone as illustrated in Reference Figure 1 below. The stabilizing member is formed as one integral piece with the syringe, further this is a product by process limitation (The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.). Rhinehart et al. teach 18/118 to be a bayonet connection which would have a surface that extends substantially perpendicular but does not specifically disclose a ring. However, Pananen teaches equivalently retaining a syringe/cartridge within a housing portion using various equivalent connections (Fig. 2 at 220) which include bayonet, threads, or snap fit connections ([0056]). Further, Renz teaches equivalently using threaded connections or an annular ring and groove which mate in a snap fit connection (Col. 4 lines 17-30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an annular snap ring which mates with an annular groove in Rhinehart et al. as Pananen and Renz teach this to be equivalent to a bayonet connection and would yield the same predictable result. This provides a continuous ring around the entire circumferential surface. There would be a point along the upper surface of the ring that is planer and perpendicular relative to the longitudinal axis. The distal end of the pressure jacket provides a top plate, the stabilizing element stabilizes the syringe with the pressure jacket when attached to a power injector which would have a piston for engaging with 128 (Fig. 1C plunger element 128 of the syringe connects with a piston necessarily provided by the power injector [0063]). The ring would be placed in the area in Rhinehart et al. as shown by the bayonet 18/118 this is along the slope at the proximal end of the cone as the tapering of the cone ends in this area and would necessarily have an extent in the distal direction (Fig. 1C), this is extending from the cone portion, the stabilizing member has greater outer diameter than the syringe also as exemplified by Fig. 1C of Rhinehart et al. which would be necessary for the connection between the syringe and the injector. As placed the sloped surface transitions directly to the support surface provided by Pananen and Renz. Further, one of ordinary skill in the art would be able to place the stabilizer along the cone in a position as necessary for connection. Additionally, Applicant has not disclosed that such a placement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with the stabilizing member as combined as it provides an art effective connection between components.
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Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rhinehart et al. (WO 2015/066506) in view of Pananen (US 2017/0266373 A1), Renz (US 6,616,000 B1), and Stokes Jr et al. (US 2012/0123257 A1).
With regard to claim 31, Rhinehart et al. teach multi-use disposable set (MUDS) comprising: a syringe having a syringe body, a proximal end, a distal end spaced apart from the proximal end along a longitudinal axis of the syringe body (Fig. 2C member 120), a cone portion and a nozzle extending distally from the distal end of the syringe body (Fig. 2C nozzle 112, cone portion between cylindrical body and nozzle generally where 100 is indicated).
Rhinehart et al. teach such a syringe is used in contrast injection power syringes ([0002]-[0003]) but does not specifically disclose a plurality of syringes. However, Stokes Jr. et al. teach using two syringes in a contrast system to deliver both contrast and saline which are needed for imaging and providing a manifold in communication with the syringes (Fig. 1 manifold 200, [0006], [0141]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of syringes in Rhinehart et al. as Stokes Jr. et al. teach such is necessary in imaging procedures to provides flushing with saline and contrast. In the embodiment of Figs. 2 a stabilizing element is not shown. However, in Figs. 1 lock member 18/118 are shown to lock with the pressure jacket 200 ([0059], [0063], [0064]), which is also shown in Figs. 2. This is also shown in Figs 9A-9C. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a stabilizing element in the embodiment of Figs. 2/9 as Rhinehart et al. teach such is beneficial for retaining the syringe within the pressure jacket. Further, it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. As combined the stabilizing member would be placed at the transition between the cone and the syringe body as is shown in Fig. 1D to be formed on the cone and extend from the cone. This is at the base of the slope of the cone as illustrated in Reference Figure 1 above. The stabilizing member is formed as one integral piece with the syringe, further this is a product by process limitation (The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.). Rhinehart et al. teach 18/118 to be a bayonet connection which would have a surface that extends substantially perpendicular but does not specifically disclose a ring. However, Pananen teaches equivalently retaining a syringe/cartridge within a housing portion using various equivalent connections (Fig. 2 at 220) which include bayonet, threads, or snap fit connections ([0056]). Further, Renz teaches equivalently using threaded connections or an annular ring and groove which mate in a snap fit connection (Col. 4 lines 17-30). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an annular snap ring which mates with an annular groove in Rhinehart et al. as Pananen and Renz teach this to be equivalent to a bayonet connection and would yield the same predictable result. This provides a continuous ring around the entire circumferential surface. There would be a point along the upper surface of the ring that is planer and perpendicular relative to the longitudinal axis. The distal end of the pressure jacket provides a top plate, the stabilizing element stabilizes the syringe with the pressure jacket when attached to a power injector which would have a piston for engaging with 128 (Fig. 1C plunger element 128 of the syringe connects with a piston necessarily provided by the power injector [0063]). The ring would be placed in the area in Rhinehart et al. as shown by the bayonet 18/118 this is along the slope at the proximal end of the cone as the tapering of the cone ends in this area and would necessarily have an extent in the distal direction (Fig. 1C), this is extending from the cone portion, the stabilizing member has greater outer diameter than the syringe also as exemplified by Fig. 1C of Rhinehart et al. which would be necessary for the connection between the syringe and the injector. As placed the sloped surface transitions directly to the engagement surface provided by Pananen and Renz. Further, one of ordinary skill in the art would be able to place the stabilizer along the cone in a position as necessary for connection. Additionally, Applicant has not disclosed that such a placement provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the Applicant's invention to perform equally well with the stabilizing member as combined as it provides an art effective connection between components. The opening of the pressure jacket is taken as a syringe slot as it retains the syringe, the distal end of the pressure jacket provides a top plate, the stabilizing elements stabilizes the syringe with the pressure jacket when the pressure jacket is moved into the closed position which is taken as the position when it is attached to the syringe. Rhinehart et al. do not disclose a frame and manifold. Stokes et al. further teaches a frame and a manifold (Figs. 1 and 12 frame 102 for interacting with guide 26, [0100], manifold 200 in Figs. 17 and 20). Alternatively, if Rhinehart et al. is not found to specifically show how the syringe is configured to interact with a top plate of a fluid injector system, Stokes Jr. et al. teach a powered fluid injector in which the syringes are held within pressure jackets which are attached to the overall injector via a top plate which has slots which engage the syringes when moved into the closed position which ensures the syringes are aligned with the fluid delivery elements (Figs. 1 and 11, pressure jacket 136, syringe 1120, slot 122, plate 112, [0009]-[0017]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the syringe of Rhinehart et al. with an injector system as in Stokes Jr. et al. as Rhinehart teach the syringe is used with a pressure jacket and a fluid injector system as in Stokes Jr. et al. aligns the syringe with the injection components to utilized powered injection. As combined the stabilizing element retains/stabilizes the syringe in the pressure jacket when the syringe is moved into place with the top plate in conjunction with the frame and manifold.
Response to Arguments
Applicant's arguments filed June 5, 2026 have been fully considered but they are not persuasive. Applicant argues the lock of Rhinehart extends from a vertical side surface and not the cone. The Examiner finds that as combined the ring, which is substituted for the bayonet connection, would be placed as indicated in the Reference Figure. At this location there is nothing between the slope and the stabilizing element. The slope of the cone transitions directly to the stabilizing element.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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