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
The Amendment filed 10/1/2025 has been entered. Claims 21-45 remain pending in the application. Applicant’s amendments to the Specification, Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 7/7/2025.
The specification was received on 10/1/2025. This specification is acceptable.
The drawings were received on 10/1/2025. These drawings are acceptable.
Election/Restrictions
Newly submitted claim 45 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 45 is drawn to a single-use subassembly which was never presented before and is different from elected injection apparatus.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 45 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 28, 38 and 43 are objected to because of the following informalities:
Regarding claim 28, line 7, the recitation “second valve” appears to be amended to recite “the second valve” in order to refer to “a second valve” recited in claim 28, line 3.
Regarding claim 38, lines 4-5, the recitation “first fluid” appears to be amended to recite “the first fluid” in order to refer to “a first fluid” recited in claim 28.
Regarding claim 38, last line the recitation “fitting connector” appears to be amended to recite “the fitting connector” in order to refer to “a fitting connector” recited in claim 28, line 6.
Regarding claim 43, last line the recitation “fitting connector” appears to be amended to recite “the fitting connector” in order to refer to “a fitting connector” recited in claim 28, line 6.
Regarding claim 43, lines 4-5, the recitation “first fluid” appears to be amended to recite “the first fluid” in order to refer to “a first fluid” recited in claim 28.
Appropriate correction is required.
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.
Claim 33 is 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.
Regarding claim 33, lines 1 and 2, the recitation “a supply of the first fluid” and “a supply of the second fluid” renders the claim indefinite because the claim is unclear if “a supply” is referring to a physical structure such as a container or a reservoir or an access/provision of accessing the first and second fluid. Furthermore, if applicant intended to refer to “a supply” as a physical structure such as “a container” or “a reservoir”, then the claim is further unclear if “a supply” would be different or same as “a first container” and “a second container” recited in claim 28. For examination purposes, examiner construes “a supply” as a container/reservoir separate from a first container and a second container recited in claim 28.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 28-35, 38, 39, 43 and 44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stokes, Jr. et al. (US 2012/0123257 A1).
Regarding claim 28, Stokes, Jr. discloses an injection apparatus 10 (figures 1 and 2) comprising:
a multi-use subassembly 200, 1100 comprising a first valve (one of the two elements 1150) in fluid communication with a first container 1120 (connected to one of the two elements 1150), and a second valve (other of two elements 1150) in fluid communication with a second container 1120 (connected to other of the two elements 1150);
an injector housing 22, 202 supporting the multi-use subassembly 200, 1100 and comprising a first valve actuator 220 and a second valve actuator 220;
a fitting connector 1176 (figure 15) of the multi-use subassembly releasably 200, 1100 connectable (paragraph 0116, lines 39-45) to a single-use subassembly 1500 to fluidly connect the first valve and second valve to the single-use subassembly; and
a processor (paragraph 0146, lines 25-27, “electronic control device(s) associated with the injector 20”), the processor being configured to control operations comprising:
actuating (paragraph 0146, lines 25-27) the first valve actuator 220 to move the first valve to a first valve fill position (paragraph 0148, lines 1-5, paragraph 0119, lines 6, “fill position”),
actuating (paragraph 0146, lines 25-27) the second valve actuator 220 to move the second valve 178 to a second valve fill position (paragraph 0148, lines 1-5, paragraph 0119, lines 6, “fill position”),
drawing (paragraph 0119, lines 6-9) a first fluid (fluid contained in element 36) through the first valve in the first valve fill position and into the first container 36 (examiner considers one of the two elements 1150 is connected to element 36),
drawing (paragraph 0119, lines 6-9) of a second fluid (fluid contained in element 38) through the second valve in the second valve fill position and into the second container 38 (examiner considers other of the two elements 1150 is connected to element 38),
actuating (paragraph 0146, lines 25-27) the first valve actuator 220 to move the first valve (one of the two elements 1150) to a first inject position (paragraph 0119, lines 4-6),
actuating (paragraph 0146, lines 25-27) the second valve actuator 220 to move the second valve (other of two elements 1150) to a second inject position (paragraph 0119, lines 4-6),
displacing (paragraph 0146, lines 25-27) the first fluid from the first container and the through the first valve in the first inject position and the fitting connector 1176, and
displacing (paragraph 0146, lines 25-27) the second fluid from the second container and the through the second valve in the second inject position and the fitting connector 1176.
Regarding claim 29, Stokes, Jr. discloses the processor being programmed to control a ratio (paragraphs 0210, 0221) of an amount of the first fluid displaced from the first container relative to an amount of the second fluid displaced from the second container.
Regarding claim 30, Stokes, Jr. teaches including a supply of the first fluid and a supply of the second fluid, the first fluid comprising saline (paragraph 0221, lines 1-5, “saline”) and the second fluid comprising contrast (paragraph 0221, lines 1-5, “contrast”).
Regarding claim 31, Stokes, Jr. teaches the injector housing 22, 202 further comprising a first piston 60 (engaging with 1120 connected to one of the two elements 1150) for drawing the first fluid into the first container 1120 (connected to one of the two elements 1150) and displacing the first fluid from the first container, and a second piston 60 (engaging with 1120 connected to other of the two elements 1150) for drawing the second fluid into the second container and displacing the second fluid from the second container.
Regarding claim 32, Stokes, Jr. teaches further comprising the single-use subassembly 1500 having a corresponding fitting connector 1506 releasably connectable (paragraph 0116, lines 39-45, paragraph 0105, lines 3-13) to the fitting connector 1176 of the multi-use subassembly 200, 1100 to fluidly connect the single-use subassembly 1500 to the multi-use subassembly 200, 1100, the single-use subassembly 1500 comprising a first line 1502 for receiving the first fluid (fluid contained in element 36) from the multi-use subassembly 200, 1100, a second line 1504 for receiving the second fluid (fluid contained in element 38) from the multi-use subassembly 200, 1100, a junction 1508 connected to the first line 1502 and the second line 1504 and permitting mixing of the first fluid and the second fluid (mixture would occur since both liquids are delivered through single tube 1514, paragraph 0221, lines 1-5), and a patient line 1514 connected to the junction and for receiving a mixture of the first fluid and the second fluid and conveying the mixture to a patient.
Regarding claim 33, Stokes, Jr. teaches further comprising a supply (36 or 38 containing saline and the element 1120 connected to 36 or 38 containing saline is construed as a first container) of the first fluid and a supply (36 or 38 containing contrast and the element 1120 connected to 36 or 38 containing contrast is construed as a first container) of the second fluid, the first fluid comprising saline and the second fluid comprising contrast (paragraph 0143, lines 29-32).
Regarding claim 34, Strokes, Jr. teaches wherein the injector housing 22, 202 further comprises a first piston 60 (figure 44A, associated with the first container) for drawing (paragraph 168, lines 24-27) the first fluid into the first container and displacing the first fluid from the first container, and a second piston 60 (associated with the second container) for drawing (paragraph 168, lines 24-27) the second fluid into the second container and displacing the second fluid from the second container.
Regarding claim 35, Stokes, Jr. teaches the processor being programmed to control a ratio (paragraphs 0210, 0221) of an amount of the first fluid displaced from the first container relative to an amount of the second fluid displaced from the second container.
Regarding claim 38, Stokes, Jr. teaches the processor is further configured to control operations comprising: receive input (paragraph 0007, lines 3-6, paragraphs 0207, 0208) to deliver a predetermined volume of the first fluid; and in response to receiving the input, displacing the predetermined volume of the first fluid from the first container and through the first valve and fitting connector.
Regarding claim 39, Stokes, Jr discloses further comprising a mount 90 (figure 38, paragraph 0142, lines 1-9, using “clamp”, one can remove when needed, “patient examination table or like surface having a rail for attaching equipment to the examination table” can be construed as “a stationary object”) attached to the injector housing 22, 202, the mount to removably secure the injector housing to a stationary object.
Regarding claim 43, Stokes, Jr. teaches the processor is further configured to control operations comprising: receive input (paragraph 0007, lines 3-6, paragraphs 0207, 0208) to deliver a predetermined volume of the first fluid; and in response to receiving the input, displacing the predetermined volume of the first fluid from the first container and through the first valve and fitting connector.
Regarding claim 44, Stokes, Jr discloses further comprising a mount 90 (figure 38, paragraph 0142, lines 1-9, using “clamp”, one can remove when needed, “patient examination table or like surface having a rail for attaching equipment to the examination table” can be construed as “a stationary object”) attached to the injector housing 22, 202, the mount to removably secure the injector housing to a stationary object.
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.
Claims 36, 37 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Stokes, Jr. et al. (US 2012/0123257 A1) in view of Brooks et al. (US 2006/0079843 A1).
Regarding claim 36, Stokes, Jr. discloses the claimed invention substantially as claimed, as set forth above in claim 32. Stokes, Jr. further discloses a controller 34 (figure 1) operably coupled (paragraph 0098, lines 16-28, paragraph 0048, lines 13-20) to the processor, the controller 34 including one or more inputs to receive input from an operator, the processor (paragraph 0098, lines 16-28, paragraph 0048, lines 13-20) configured to execute the control operations responsive to input received at the controller.
Stokes, Jr. is silent regarding a controller being a handheld controller.
However, Brooks teaches a design of a power injector comprising a controller 24 (figure 1A, “remote consoles, remote hand or foot control switches” in paragraph 0042) wherein the controller is a handheld controller (element 24 could be held by hand, “remote consoles, remote hand or foot control switches” in paragraph 0042) for the purpose of operating the device from a remote location (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Stokes, Jr. to incorporate a handheld controller as taught by Brooks for the purpose of operating the device from a remote location (paragraph 0042).
Examiner further construes that one of ordinary skill in the art, when modifying Stokes, Jr. in view of Brooks will result in having an additional controller instead of making the existing controller of Stokes, Jr. as handheld because Brooks also discloses having a handheld controller separate from the controller existing on the apparatus.
Regarding claim 37, Stokes, Jr. discloses the claimed invention substantially as claimed, as set forth above in claim 32. Stokes, Jr. further discloses wherein the controller 34 includes: plurality of inputs to control the device (paragraph 0098, lines 16-28). While Stokes, Jr. does not explicitly recite to have a first input to effect the displacing of the first fluid from the first container and through the first valve and the fitting connector; and a second input to effect the displacing of the second fluid from the second container and through the second valve and the fitting connector, one of ordinary skill in the art, would construe that using element 34, one can provide the claimed first input and second input for performing the claimed activity because Stokes, Jr. discloses the actuation of the appropriate plungers to deliver the fluid (paragraph 0146, lines 1-59).
Stokes, Jr. is silent regarding a controller being a handheld controller.
However, Brooks teaches a design of a power injector comprising a controller 24 (figure 1A, “remote consoles, remote hand or foot control switches” in paragraph 0042) wherein the controller is a handheld controller (element 24 could be held by hand, “remote consoles, remote hand or foot control switches” in paragraph 0042) for the purpose of operating the device from a remote location (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Stokes, Jr. to incorporate a handheld controller as taught by Brooks for the purpose of operating the device from a remote location (paragraph 0042).
Examiner further construes that one of ordinary skill in the art, when modifying Stokes, Jr. in view of Brooks will result in having an additional controller instead of making the existing controller of Stokes, Jr. as handheld because Brooks also discloses having a handheld controller separate from the controller existing on the apparatus.
Regarding claim 40, Stokes, Jr. discloses the claimed invention substantially as claimed, as set forth above in claim 28. Stokes, Jr. further discloses a controller 34 (figure 1) operably coupled (paragraph 0098, lines 16-28, paragraph 0048, lines 13-20) to the processor, the controller 34 including one or more inputs to receive input from an operator, the processor (paragraph 0098, lines 16-28, paragraph 0048, lines 13-20) configured to execute the control operations responsive to input received at the controller.
Stokes, Jr. is silent regarding a controller being a handheld controller.
However, Brooks teaches a design of a power injector comprising a controller 24 (figure 1A, “remote consoles, remote hand or foot control switches” in paragraph 0042) wherein the controller is a handheld controller (element 24 could be held by hand, “remote consoles, remote hand or foot control switches” in paragraph 0042) for the purpose of operating the device from a remote location (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Stokes, Jr. to incorporate a handheld controller as taught by Brooks for the purpose of operating the device from a remote location (paragraph 0042).
Examiner further construes that one of ordinary skill in the art, when modifying Stokes, Jr. in view of Brooks will result in having an additional controller instead of making the existing controller of Stokes, Jr. as handheld because Brooks also discloses having a handheld controller separate from the controller existing on the apparatus.
Regarding claim 41, Stokes, Jr. is silent regarding the handheld controller being movable with respect to the multi-use subassembly.
However, Brooks teaches the handheld controller 24 (figure 1A, “remote consoles, remote hand or foot control switches” in paragraph 0042, use of cable and being located remote is construed that the handheld controllers are able to move entirely with respect to the device shown in figure 1B, alternatively, elements 28a, 28b, 36a, 36b could be separated from the device to move the handheld controller with respect to the subassembly formed by elements 28a, 28b, 36a, 36b) being movable with respect to the multi-use subassembly (assembly formed by elements 28a, 28b, 36a, 36b) for the purpose of operating the device from a remote location (paragraph 0042).
Therefore, it would have been prima facie obvious to modify the injection apparatus of Stokes, jr. to incorporate the handheld controller being movable with respect to the multi-use subassembly as taught by Brooks for the purpose of operating the device from a remote location (paragraph 0042).
Regarding claim 42, Stokes, Jr. discloses the claimed invention substantially as claimed, as set forth above in claim 40. Stokes, Jr. further discloses wherein the controller 34 includes: plurality of inputs to control the device (paragraph 0098, lines 16-28). While Stokes, Jr. does not explicitly recite to have a first input to effect the displacing of the first fluid from the first container and through the first valve and the fitting connector; and a second input to effect the displacing of the second fluid from the second container and through the second valve and the fitting connector, one of ordinary skill in the art, would construe that using element 34, one can provide the claimed first input and second input for performing the claimed activity because Stokes, Jr. discloses the actuation of the appropriate plungers to deliver the fluid (paragraph 0146, lines 1-59).
Stokes, Jr. is silent regarding a controller being a handheld controller.
However, Brooks teaches a design of a power injector comprising a controller 24 (figure 1A, “remote consoles, remote hand or foot control switches” in paragraph 0042) wherein the controller is a handheld controller (element 24 could be held by hand, “remote consoles, remote hand or foot control switches” in paragraph 0042) for the purpose of operating the device from a remote location (paragraph 0042).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Stokes, Jr. to incorporate a handheld controller as taught by Brooks for the purpose of operating the device from a remote location (paragraph 0042).
Examiner further construes that one of ordinary skill in the art, when modifying Stokes, Jr. in view of Brooks will result in having an additional controller instead of making the existing controller of Stokes, Jr. as handheld because Brooks also discloses having a handheld controller separate from the controller existing on the apparatus.
Response to Arguments
Applicant's arguments filed 10/1/2025 have been fully considered but they are not persuasive.
Applicant argues on page 10, lines 5-9 that Stokes, Jr. does not disclose or suggest a fitting connector to releasably connect to a single-use subassembly and through which the first fluid and second fluid are displaced as claimed and therefore, requests to withdraw the rejection. Examiner respectfully disagrees. As explained in the rejection of claim 28 above, Stokes, Jr. discloses each and every claimed limitation.
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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783