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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 25, 2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 and 31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 21 and 31 recite the support surface is formed on and extends from a sloped surface of the cone portion. The specification at the time of filing discloses “The stabilizing element may include a ring provided on an outer circumferential surface of the distal end of the syringe body ([0009]) and “The stabilizing element 180 may be a ring that is formed integrally with the syringe body 138 ([0040]).” The ring is shown in Fig. 6A, there is no cross-section shown which shows exactly how the ring may be formed on the cone. The cone is not shown to extend proximally of the ring. The specification does not specifically distinguish that the stabilizing element and even more specifically the support surface is formed on the sloped surface of the cone portions as opposed to the syringe body. At best the ring appears to be at an intersection of the slope of the cone and the remainder of the syringe body.
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. 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.
PNG
media_image1.png
321
520
media_image1.png
Greyscale
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. 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 November 25, 2025 have been fully considered but they are not persuasive. As noted in the rejection under 35 U.S.C. 112 above, it is not distinguishable in Applicant’s originally filed disclosure how the stabilizing element support/engagement surface is formed on and extending from a sloped surface of the cone portion in a way that is distinguishable from Rhinehart. The Examiner maintains the stabilizing member is formed on the cone portion as illustrated in the provided Reference Figure.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783