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 .
Acknowledgments
In the reply, filed on September 21, 2022, Applicant amended claims 1, 3-16, and 18-21.
Applicant cancelled claim 17.
Currently, claims 1-16 and 18-21 are under examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
U.S. Patent Publication No. 2016/0331951 (paragraph [0087])
WO 2019/204617 (paragraph [00117])
WO 2020/046929 (paragraph [00118])
The information disclosure statement filed January 21, 2023, fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translations have been provided for understanding of foreign patent documents 4-8
The information disclosure statement filed February 17, 2024 (24 pages), fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copies have been provided of foreign patent documents 4, 8-11, and 15
The information disclosure statement filed February 17, 2024 (24 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
Non-patent literature document citation 14 is missing a date (with at least the year)
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed February 17, 2024 (40 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 3839708 has been provided with the incorrect name of patentee of Lyons; Fus et al. The correct name of patentee for US 3839708 is Bredesen et al. Thus, it is unclear whether Applicant is intending to cite US 3839708 or another document to Lyons; Fus et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed February 17, 2024 (40 pages), fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy has been provided of foreign patent document 7
No copies have been provided of non-patent literature documents 2, 28, 42
Specification
The abstract of the disclosure is objected to because:
In line 2, “a fluid path includes” should be changed to “a fluid path, the method includes”
In line 4, “the fluid injector system” should be changed to “a fluid injector system”
In line 5, “the presence” should be changed to “a presence”
In line 5, “one or more air bubbles” should be changed to “the one or more air bubbles”
In line 6, “fluid” should be changed to “the at least one medical fluid”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 5-8, 12-15, and 19-21 are objected to because of the following informalities:
In regards to claim 1, line 6, “one or more air bubbles” should be changed to “the one or more air bubbles”.
In regards to claim 1, line 8, “fluid” should be changed to “the at least one medical fluid”.
In regards to claim 5, line 2, “calculating” should be changed to “the calculating”.
In regards to claim 5, line 2, “the flow rate in the fluid path” should be changed to “the flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 5, lines 2-3, “an actual flow rate in the fluid path” should be changed to “an actual flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 6, line 2, “initiating” should be changed to “the initiating”.
In regards to claim 7, line 3, “initiating” should be changed to “the initiating”.
In regards to claim 8, line 9, “one or more air bubbles” should be changed to “the one or more air bubbles”.
In regards to claim 8, line 10, “fluid” should be changed to “the at least one medical fluid”.
In regards to claim 12, line 2, “calculating” should be changed to “the at least one processor programmed or configured to calculate”.
In regards to claim 12, line 2, “the flow rate in the fluid path” should be changed to “the flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 12, lines 2-3, “an actual flow rate in the fluid path” should be changed to “an actual flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 13, line 3, “initiating” should be changed to “the at least one processor programmed or configured to initiate”.
In regards to claim 14, line 3, “initiating” should be changed to “the at least one processor programmed or configured to initiate”.
In regards to claim 15, lines 9-10, “one or more air bubbles” should be changed to “the one or more air bubbles”.
In regards to claim 15, line 11, “fluid” should be changed to “the at least one medical fluid”.
In regards to claim 19, line 2, “calculating” should be changed to “the at least one processor to calculate”.
In regards to claim 19, line 2, “the flow rate in the fluid path” should be changed to “the flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 19, lines 2-3, “an actual flow rate in the fluid path” should be changed to “an actual flow rate of the at least one medical fluid in the fluid path”.
In regards to claim 20, line 3, “initiating” should be changed to “the at least one processor to initiate”.
In regards to claim 21, line 3, “initiating” should be changed to “the at least one processor to initiate”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-16 and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capone et al (US 2014/0224829).
In regards to claim 1, Capone et al teaches a method for determining a volume of one or more air bubbles in a fluid path (40) of a fluid injector system (10), the method comprising:
initiating an injection procedure in which at least one medical fluid is injected into the fluid path (paragraph [0270]: the control system 800 indicates that it is in an armed state and enables a "Start" button, which the user presses to execute the programmed patient protocol. The user interface display 806 is updated to indicate that the fluid delivery system 2 is injecting fluid)
receiving an electrical signal from an air detector (810) of the fluid injector system, wherein the electrical signal indicates a presence of one or more air bubbles in the fluid path (paragraph [0238]: the patient outlet air detector 810, discussed previously, provide air bubble detection information to the control system 800 for operational control of the fluid delivery system 2)(paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored)
calculating a flow rate of fluid in the fluid path (paragraph [0273]: information about the prevailing flow rate)
determining a fluid pressure in the fluid path (paragraph [0273]: information about… fluid pressure)
determining a count value of the one or more air bubbles based on a duration for which the electrical signal is received, the flow rate, and the fluid pressure, wherein the count value is representative of the volume of the one or more air bubbles (paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored, and this information is combined with information about the prevailing flow rate and fluid pressure to calculate the volume of air that has been detected. When one or more air bubbles with a total predetermined volume have been detected)
updating a cumulative counter with the count value of the one or more air bubbles, wherein the cumulative counter is representative of a cumulative volume of air that has passed through the fluid path during the injection procedure (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection)
In regards to claim 2, Capone et al teaches halting the injection procedure in response to the cumulative counter exceeding a predetermined threshold (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection).
In regards to claim 3, Capone et al teaches continuing the injection procedure in response to the cumulative counter being below a predetermined threshold (paragraph [0273] states “throughout the fluid injection, the patient outlet air detector 810 is monitored, and this information is combined with information about the prevailing flow rate and fluid pressure to calculate the volume of air that has been detected. When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection” from which it is understood that the injection procedure is halted when the cumulative counter exceeds a predetermined threshold; and thus, it is understood that the injection procedure would continue until the cumulative counter exceeds the predetermined threshold (i.e. if the cumulative counter has not exceeded or is below the predetermined threshold, the injection procedure would continue)).
In regards to claim 4, Capone et al teaches wherein the predetermined threshold is programmed into a memory of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… recalling a previously stored patient protocol from the memory of the control system 800 (or the system controller 822) and the recalled protocol may be used as is or modified by the user before use)(paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection).
In regards to claim 5, Capone et al teaches wherein calculating the flow rate in the fluid path comprises estimating an actual flow rate in the fluid path based on: a commanded flow rate for the injection procedure; and a compliance of one or more components of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… manually programming the patient protocol, specifying the relevant parameters for each phase (fluid type, flow rate, volume, etc.))(paragraph [0273]: throughout the fluid injection… information about the prevailing flow rate)(paragraph [0274: execution of the programmed patient protocol is completed).
In regards to claim 6, Capone et al teaches setting the cumulative counter to zero prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air; and thus, it is understood that the cumulative counter would be set to zero to indicate no air in the patient supply set 40).
In regards to claim 7, Capone et al teaches purging the one or more air bubbles from the fluid injector system prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air bubbles).
In regards to claim 8, Capone et al teaches a fluid injector system (Figures 1-60, fluid pump device 10) comprising:
at least one syringe (22) configured for injecting at least one medical fluid
a fluid path (40) in fluid communication with the at least one syringe
an air detector (810) configured to detect one or more air bubbles in the fluid path
at least one processor (822) programmed or configured to:
initiate an injection procedure in which the at least one medical fluid is injected from the at least one syringe into the fluid path (Figure 1)(paragraph [0270]: the control system 800 indicates that it is in an armed state and enables a "Start" button, which the user presses to execute the programmed patient protocol. The user interface display 806 is updated to indicate that the fluid delivery system 2 is injecting fluid)
receive an electrical signal from the air detector, wherein the electrical signal indicates a presence of one or more air bubbles in the fluid path (paragraph [0238]: the patient outlet air detector 810, discussed previously, provide air bubble detection information to the control system 800 for operational control of the fluid delivery system 2)(paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored)
calculate a flow rate of fluid in the fluid path (paragraph [0273]: information about the prevailing flow rate)
determine a fluid pressure in the fluid path (paragraph [0273]: information about… fluid pressure)
determine a count value of the one or more air bubbles based on a duration for which the electrical signal is received, the flow rate, and the fluid pressure, wherein the count value is representative of a volume of the one or more air bubbles (paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored, and this information is combined with information about the prevailing flow rate and fluid pressure to calculate the volume of air that has been detected. When one or more air bubbles with a total predetermined volume have been detected)
update a cumulative counter with the count value of the one or more air bubbles, wherein the cumulative counter is representative of a cumulative volume of air that has passed through the fluid path during the injection procedure (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection)
In regards to claim 9, Capone et al teaches wherein the at least one processor is further programmed or configured to halt the injection procedure in response to the cumulative counter exceeding a predetermined threshold (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection).
In regards to claim 10, Capone et al teaches wherein the at least one processor is further programmed or configured to continue the injection procedure in response to the cumulative counter being below a predetermined threshold (paragraph [0273] states “throughout the fluid injection, the patient outlet air detector 810 is monitored, and this information is combined with information about the prevailing flow rate and fluid pressure to calculate the volume of air that has been detected. When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection” from which it is understood that the injection procedure is halted when the cumulative counter exceeds a predetermined threshold; and thus, it is understood that the injection procedure would continue until the cumulative counter exceeds the predetermined threshold (i.e. if the cumulative counter has not exceeded or is below the predetermined threshold, the injection procedure would continue)).
In regards to claim 11, Capone et al teaches wherein the predetermined threshold is programmed into a memory of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… recalling a previously stored patient protocol from the memory of the control system 800 (or the system controller 822) and the recalled protocol may be used as is or modified by the user before use)(paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection).
In regards to claim 12, Capone et al teaches wherein calculating the flow rate in the fluid path comprises estimating an actual flow rate in the fluid path based on: a commanded flow rate for the injection procedure; and a compliance of one or more components of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… manually programming the patient protocol, specifying the relevant parameters for each phase (fluid type, flow rate, volume, etc.))(paragraph [0273]: throughout the fluid injection… information about the prevailing flow rate)(paragraph [0274: execution of the programmed patient protocol is completed).
In regards to claim 13, Capone et al teaches wherein the at least one processor is further programmed or configured to set the cumulative counter to zero prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air; and thus, it is understood that the cumulative counter would be set to zero to indicate no air in the patient supply set 40).
In regards to claim 14, Capone et al teaches wherein the at least one processor is further programmed or configured to purge the one or more air bubbles from the fluid injector system prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air bubbles).
In regards to claim 15, Capone et al teaches a computer program product (822) for determining a volume of one or more air bubbles in a fluid path of a fluid injector system, the computer program product comprising: non-transitory computer readable media comprising one or more instructions (paragraph [0242]: system controller or computer 822 with appropriate software for controlling operation of the fluid delivery system 2) that, when executed by at least one processor of the fluid injector system, cause the at least one processor to:
initiate an injection procedure in which at least one medical fluid is injected into the fluid path (paragraph [0270]: the control system 800 indicates that it is in an armed state and enables a "Start" button, which the user presses to execute the programmed patient protocol. The user interface display 806 is updated to indicate that the fluid delivery system 2 is injecting fluid)
receive an electrical signal from an air detector of the fluid injector system, wherein the electrical signal indicates a presence of one or more air bubbles in the fluid path (paragraph [0238]: the patient outlet air detector 810, discussed previously, provide air bubble detection information to the control system 800 for operational control of the fluid delivery system 2)(paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored)
calculate a flow rate of fluid in the fluid path (paragraph [0273]: information about the prevailing flow rate)
determine a fluid pressure in the fluid path (paragraph [0273]: information about… fluid pressure)
determine a count value of the one or more air bubbles based on a duration for which the electrical signal is received, the flow rate, and the fluid pressure, wherein the count value is representative of the volume of the one or more air bubbles (paragraph [0268]: the control system 800 monitors the output air detector signal from the patient outlet air detector 810)(paragraph [0273]: the patient outlet air detector 810 is monitored, and this information is combined with information about the prevailing flow rate and fluid pressure to calculate the volume of air that has been detected. When one or more air bubbles with a total predetermined volume have been detected)
update a cumulative counter with the count value of the one or more air bubbles, wherein the cumulative counter is representative of a cumulative volume of air that has passed through the fluid path during the injection procedure (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection)
In regards to claim 16, Capone et al teaches wherein the one or more instructions further cause the at least one processor to halt the injection procedure in response to the cumulative counter exceeding a predetermined threshold (paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection. In other words, once a predetermined total "allowable" volume of air has been detected as having passed through the patient outlet air detector 810, the control system 800 is operable to abort the fluid injection).
In regards to claim 18, Capone et al teaches wherein the predetermined threshold is programmed into a memory of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… recalling a previously stored patient protocol from the memory of the control system 800 (or the system controller 822) and the recalled protocol may be used as is or modified by the user before use)(paragraph [0273]: When one or more air bubbles with a total predetermined volume have been detected, the control system 800 may be programmed to abort the fluid injection).
In regards to claim 19, Capone et al teaches wherein calculating the flow rate in the fluid path comprises estimating an actual flow rate in the fluid path based on: a commanded flow rate for the injection procedure; and a compliance of one or more components of the fluid injector system (paragraph [0265]: the user will specify a patient protocol that is used to perform a fluid injection… manually programming the patient protocol, specifying the relevant parameters for each phase (fluid type, flow rate, volume, etc.))(paragraph [0273]: throughout the fluid injection… information about the prevailing flow rate)(paragraph [0274: execution of the programmed patient protocol is completed).
In regards to claim 20, Capone et al teaches wherein the one or more instructions further cause the at least one processor to set the cumulative counter to zero prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air; and thus, it is understood that the cumulative counter would be set to zero to indicate no air in the patient supply set 40).
In regards to claim 21, Capone et al teaches wherein the one or more instructions further cause the at least one processor to purge the one or more air bubbles from the fluid injector system prior to initiating the injection procedure (paragraph [0253] states “prime the patient supply set 40 and perform a saline-only injection” from which it is understood that the patient supply set 40 is filled with saline to flush out all air bubbles).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783