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 § 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.
(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) 1, 2, 7 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by James, et al. (“James”) (U.S. Pub. 2024/0293786).
James has an effective filing date of June 30. 2021 and is prior art under 35 U.S.C. 102(a)(2) and 102(d).
Regarding claim 1, James discloses a quantitative dispensing device for biological agents, namely a liquid-handling system for preparing and dispensing low-volume cell-therapy formulations. James discloses a storage container containing biological agents, namely bag (210), and a dispensing container, namely bag (220), connected through a delivery tube. Peristaltic pump (230) draws fluid from bag (210) through the delivery tube and delivers the fluid to bag (220) (James, Fig. 2; ¶¶ [0117]-[0119]).
James further discloses a first non-contact sensor and a second non-contact sensor arranged at spaced locations along the delivery tube between bag (210) and bag (220), namely ultrasonic bubble sensors (215, 225). Bubble sensors (215, 225) detect the presence or absence of fluid inside the tube "by means of differential ultrasonic impedance across the tube" and provide signals indicating the passage of liquid and air through the tube (James, Fig. 2; ,¶¶ [0120]-[0121]).
Regarding claim 2, James further discloses, in the same Figure 2 fluid-transfer arrangement, a quantifier arranged on the delivery tube between first bubble sensor (215) and second bubble sensor (225), namely the fixed-geometry portion of the delivery tube extending between bubble sensors (215, 225). James explains that the tubing is supported in a carrier frame that controls the tubing geometry and that "the volume of fluid contained within the tubing between the bubble sensors can therefore be consistent" (James, ¶ [0100]). James further states that "volumes of the tubes between each bubble sensor is known or can be calculated based on the fixed geometry of the manifold" and that a fluid block moving between two bubble sensors may be used for measurement and pump verification (James, ¶ [0138]).
Regarding claim 7, James discloses a pumping member for supplying delivery power to the delivery tube, namely peristaltic pump (30, 230, 410, 810) engaging flexible pump tube (60, 440, 830). James explains that peristaltic pump (230) draws fluid from input bag (210) and pushes the fluid through the tube to bag (220) (James, Fig. 2 and accompanying description).
Regarding claim 8, James discloses a plurality of dispensing containers arranged in parallel, namely the plurality of small output bags connected to branched output fluid paths in Figs. 6-7. James states that "a plurality of small bags are connected to outputs of the fluid paths, into which treatment volumes of the formulation can be dispensed" (James, Figs. 6-7 and accompanying description). James further discloses valve assembly (20), comprising a plurality of valves respectively engaging the fluid paths of manifold (50), and states that the valves may be selectively actuated to direct liquid through selected fluid paths (James, Figs. 1 and 7).
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) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over James as applied to claim 1 above, and further in view of Landy, et al. (“Landy”) (U.S. Pub. 2020/0001022).
Regarding claim 3, James discloses the device of claim 2, including fixed-geometry measurement loop (tubing) positioned between bubble sensors and defining a known fluid volume (¶ [0040]: “a volume of liquid into a flow path having a known volume between a first bubble sensor and a second bubble sensor”). James further discloses that the tubing is supported in a carrier frame that controls the tubing geometry when installed in the instrument housing (James, Fig. 6).
James does not expressly disclose that the quantifier comprises a main body containing a flow-guide tube extending along a preset path having a length greater than the distance between its inlet and outlet.
Landy discloses a medical blood and fluid infusion apparatus having an insulating housing containing a spiral inductive tube (Landy, Figs. l0A-l0E). Landy discloses that the spiral tube provides a single flow path from an inlet to an outlet and that the same tube may be repeatedly circularly formed, thereby creating a spiral tube (Landy, Figs. l0A-l0E and ¶ [0128]). Because the tube follows one or more circular windings between its inlet and outlet tails, the length of the tube path is greater than the direct distance between its inlet and outlet.
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to configure fixed-geometry measurement loop (830) of James as a flow-guide tube following Landy's spiral path within a supporting main body or housing, because Landy expressly teaches adjusting the inner and outer diameters, number of windings, and total surface area of the spiral tube "based on the type and/or volume of fluids" (¶ [0132]) handled by the system and increasing the windings or total surface area "in order to accommodate a higher heating capacity" (Landy, Figs. l0A-l0E and ¶ [0113]).
Regarding claim 4, Landy further discloses that primary inductor winding (55) and ferrite bobbin core (56) are inserted into a central opening of the spiral inductive tube (Landy, Figs. l0A-l0E). The spiral tube is therefore arranged around a center line extending through the central opening. Landy also discloses that unheated fluid enters through an extended inlet tail, passes through the spiral tube, and exits through an extended outlet tail, such that the spiral flow-guide portion communicates with the adjoining delivery-tube portions (Landy, Figs. l0A-l0E and ¶ [0118]).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to arrange the flow-guide tube of the modified James device around the center line of its main body and in communication with the adjoining delivery tube, as taught by Landy, because Landy expressly teaches repeatedly circularly forming the same fluid tube around a central opening and adjusting the number of windings and total surface area "based on the type and/or volume of fluids" handled by the system (Landy, Figs. l0A-l0E and (¶ [0132]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over James and Landy as applied to claim 4 above, and further in view of Brown, et al. (“Brown”) (U.S. Pub. 2017/0354941)
Regarding claim 5, Landy teaches forming the inlet tail, spiral tube, and outlet tail from the same tube, thereby providing a single continuous medical-fluid flow path (Landy, Figs. 10A-20E).
James and Landy do not expressly disclose that the cross-sectional area of the flowguide tube is equal to the cross-sectional area of the delivery tube.
Brown discloses a pharmaceutical-compounding system using source containers (4a, 4b), receiving bag (80), manifold (20), peristaltic pump (40), and micro and macro tubing lines (2011, 2021). Brown expressly identifies tubing internal diameter as a parameter used to determine the volume delivered: “The device calculates the volume delivered by the precision of the delivery mechanism, internal diameter of the pump tubing, viscosity of the solution, and the diameter and length of the distal and proximal tubing.” (Brown, Background).
Brown further states: “Delivery from these devices can be affected by many factors including: variances in the pump tubing's material, length, elasticity, and diameter.” (Brown, Background.)
Brown accordingly configures shunt (33g) and strain-relief clip (33) to preserve the tubing's inner-diameter characteristics. Brown states that shunt (33g) prevents the inner diameter from being "squeezed or otherwise reduced" and that strain-relief clip (33) "does not significantly change the inner diameter characteristics for the lines" (Brown, Figs. 3C-3F and 5 and ¶ [0072]). Brown additionally states that "Accuracy can also be a function of pump tubing inner diameter" (Brown, discussion of platen lock (44a), cam (444), spring (443), and pump (40); Fig. 3H, ¶ [0065]).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to form the flow-guide tube and adjoining delivery tube of James as modified by Landy with equal cross-sectional areas, because Brown expressly teaches that delivered-volume calculations depend upon tubing internal diameter, that variations in tubing diameter affect delivery accuracy, and that the tubing should be supported so that its "inner diameter characteristics" are not changed (Brown, Background; Figs. 3C-3F, 3H, and 5 and ¶ [0072]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over James as applied to claim 1 above, and further in view of Hertzer (U.S. Pat. 4,846,794).
Regarding claim 6, James discloses the device of claim 1, including first and second bubble sensors positioned along a delivery tube James discloses that the volume of tube between bubble sensors is known and is used for volume measurement and pump calibration.
James does not expressly disclose that the portion of delivery tube between bubble sensors is spirally arranged to extend its circulation path.
Hertzer discloses medical tubing for intravenous and intra-arterial applications comprising a resilient conduit helically coiled along substantially its entire length (Hertzer, Abstract; col. 3, lines 4-15). Hertzer further discloses that the conduit has first and second ends and a substantially circular cross-section (col. 3, lines 16-38).
Therefore, it would have been obvious to one with ordinary skill in the art prior to the effective filing date of the claimed invention, to arrange the portion of delivery tube extending between bubble sensors of James as a helical coil, as taught by Hertzer, because Hertzer expressly states that "a much longer length of tubing can be conveniently incorporated in a helical coil configuration than in a straight piece of tubing" (col. 3, lines 57-60). The modification would thereby extend the circulation path between the sensors by incorporating the longer tube length in the helical configuration expressly taught by Hertzer.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over James view of Sage, et al. (“Sage”) (WO 03/097120).
Regarding claim 9, James discloses a quantitative dispensing method for biological agents. James transfers an input cell suspension from input bag (210). through tubing, to bag (220) using peristaltic pump (230), control valves (240, 245), and bubble sensors (215, 225) (James, Fig. 2).
James discloses obtaining bubble-detection signals from bubble sensors (215, 225), detecting passage of liquid and air through the tubing. determining transferred-liquid volume based upon pump operation and bubble-sensor signals and controlling delivery of a target volume into bag (220) (James, Fig. 2 and accompanying description). James further discloses a known volume of tube (440) between bubble sensors and detecting the same edge of a liquid block at the spaced sensors (James, Figs. 4a-4b).
James does not expressly disclose calculating a time difference between first and second bubble-detection signals, obtaining actual volume now rate from the relationship between that time difference and the known inter-sensor tube volume, and controlling flow time based upon the resulting flow rate.
Sage discloses a medical-fluid dispensing method based upon the transit time of an increment of liquid between two fixed points of a flow tube. Sage expressly discloses: "establishing nominal values for 1) the volume of medicament between two points of said replaceable flow tube, and 2) the time required for an increment of medicament to flow between said two points," and "measuring the actual time required for said liquid medicament to flow between said two points." (pages 22-23)
Sage further discloses using the desired delivery, actual time, nominal time, and nominal volume "to calculate the time required to keep open said valving means" to provide the desired delivery (Sage, Summary of the Invention; corresponding method claim).
Sage also explains that, if actual flow rate is measured, "the required time of flow may be calculated using the actual flow rate to achieve the desired volume" (Sage, Background of the Invention).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to configure the controller of James to calculate the elapsed time between detection of the liquid/air transition at the two spaced bubble sensors, determine actual volume flow rate from that elapsed time and the known volume of tubing between the sensors, and control the permitted flow time to dispense the desired volume, because Sage expressly teaches measuring "the actual time required" for liquid to flow between two points having a known nominal volume and using the measured time and known volume "to calculate the time required to keep open said valving means" to provide the desired delivery (Sage, Summary of the Invention; corresponding method claim).
Regarding claim 10, James discloses peristaltic pump (230), control valves (240, 245), batch process and pump controller (310), and valve controller (330) (James, Figs. 2 and 3a). James further discloses controlling fluid volume and flow rate according to the rotational speed or indexed movement of peristaltic pump (230).
James does not expressly disclose controlling the on-off time of a switch valve at the inlet of each dispensing container under a preset peristaltic-pump flow rate.
Sage discloses controlling the time during which valve (14) remains open according to the measured transit time and desired delivery rate. Sage states that the microprocessor "calculates the amount of time the pinching mechanism needs to continue to remain open during the cycle to achieve the desired drug delivery rate" (Sage, Summary of the Invention; Figs. 1-2).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to control the on-off time of control valve (245) of James while operating peristaltic pump (230) at the selected flow rate, because Sage expressly teaches calculating "the amount of time the pinching mechanism needs to continue to remain open during the cycle to achieve the desired drug delivery rate" (Sage, Summary of the Invention; Figs. 1-2).
Claim(s) 11, 12, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over James as applied to claim 1 above, and further in view of Sage, et al. (“Sage”) (WO 03/097120).
Regarding claim 11, James in view of Sage discloses the recited quantitative dispensing method for the reasons set forth regarding claim 9, above.
Regarding claim 12, James discloses the quantitative dispensing device of claim 2, including measurement loop positioned between bubble sensors, for the reasons set forth in the anticipation rejection of claim 2, above. James in view of Sage discloses the recited quantitative dispensing method for the reasons set forth regarding claim 9, above.
Regarding claim 17, James discloses the device of claim 7, including peristaltic pump (30, 230), for the reasons set forth in the anticipation rejection of claim 7, above. James in view of Sage discloses the recited quantitative dispensing method for the reasons set forth regarding claim 9, above.
Regarding claim 18, James discloses the device of claim 8, including the plurality of small output bags connected to respective branched and valved output paths, for the reasons set forth in the anticipation rejection of claim 8. James in view of Sage discloses the recited quantitative dispensing method for the reasons set forth regarding claim 9, above.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over James and Landy as applied to claims 3 and 4, respectively, above, and further in view of Sage, et al. (“Sage”) (WO 03/097120)
Regarding claim 13, James in view of Landy discloses the quantitative dispensing device of claim 3 for the reasons set forth above. The combination discloses a quantifier having a main body containing a flow-guide tube extending along a preset path having a length greater than the distance between its inlet and outlet.
James in view of Landy does not expressly disclose calculating a time difference between detection signals generated by the first and second non-contact sensors, calculating an actual volume flow rate from the time difference and the known volume between the sensors, and controlling the dispensing time according to the calculated actual volume flow rate.
Sage teaches measuring "the actual time required" for an increment of liquid to flow between two points of a flow tube having a known nominal volume. Sage further teaches using the desired delivery, measured actual time, nominal time, and nominal volume "to calculate the time required to keep open said valving means" to provide the desired delivery (Sage, Summary of the Invention). Sage also explains that, when the actual flow rate is measured, "the required time of flow may be calculated using the actual flow rate to achieve the desired volume" (Sage, Background of the Invention).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to configure the controller of James as modified by Landy to calculate the elapsed time between detection of the same liquid/air boundary by the first and second non-contact sensors, calculate the actual volume flow rate from that elapsed time and the known inter-sensor volume, and calculate the required dispensing time from the actual volume flow rate, because Sage expressly teaches measuring "the actual time required" for liquid to flow between two points of known volume and using the measured time and known volume "to calculate the time required to keep open said valving means" to provide the desired delivery (Sage, Summary of the Invention).
Regarding claim 14, James in view of Landy discloses the quantitative dispensing device of claim 4 for the reasons set forth above, including the flow-guide tube arranged around the center line of the main body and communicating with the delivery tube.
James in view of Landy and further in view of Sage discloses the additional quantitative dispensing method limitations for the reasons set forth regarding claim 13, above.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over James, Landy and Brown as applied to claim 5 above, and further in view of Sage, et al. (“Sage”) (WO 03/097120).
Regarding claim 15, James in view of Sage and Landy discloses the method and device of claim 5 for the reasons set forth above. The combination does not expressly disclose that the cross-sectional area of the flow-guide tube is equal to the cross-sectional area of the delivery tube.
Brown teaches that delivered volume calculations depend upon the internal diameter of the pump tubing and the diameters of the proximal and distal tubing and that delivery accuracy is affected by variations in tubing diameter (Brown, Background). Brown further configures shunt (33g) and strain-relief clip (33) to prevent the tubing inner diameter from being squeezed or reduced and to avoid significantly changing the "inner diameter characteristics for the lines" (Brown, Figs. 3C-3F and 5 and ¶ [0072]).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to implement the method of James as modified by Sage and Landy using a flow-guide tube and delivery tube having equal cross-sectional areas, because Brown expressly teaches that delivered-volume calculations depend upon tubing internal diameter, that variations in tubing diameter affect delivery accuracy, and that the tubing should be supported so that its "inner diameter characteristics" are not changed (Brown, Background; Figs. 3C-3F, 3H, and 5 and ¶ [0072]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over James and Hertzer as applied to claim 6 above, and further in view of Hertzer (U.S. Pat. 4,846,794).
Regarding claim 16, James in view of Sage discloses the quantitative dispensing method recited in claim 6 for the reasons set forth regarding claim 9. James does not expressly disclose that the portion of the delivery tube between the first and second non-contact sensors is spirally arranged to extend its circulation path.
Hertzer discloses medical tubing for intravenous and intra-arterial applications comprising a resilient conduit helically coiled along substantially its entire length (Hertzer, Abstract; col. 3, lines 4-15).
Therefore, it would have been obvious to one with ordinary skill in the art, prior to the effective filing date of the claimed invention, to perform the method of James as modified by Sage using an inter-sensor delivery-tube portion arranged as the helical coil taught by Hertzer, because Hertzer expressly states that "a much longer length of tubing can be conveniently incorporated in a helical coil configuration than in a straight piece of tubing" (col. 3, lines 57-60). The modification would thereby extend the circulation path between the sensors by incorporating the longer tube length in Hertzer’s helical configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See form PTO-892, attached.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J MELARAGNO whose telephone number is (571)270-7735. The examiner can normally be reached Mon - Fri: 8 am - 5 pm +/- flex.
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, Paul Durand can be reached at (571) 272-4459. 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.
/MICHAEL J. MELARAGNO/ Examiner, Art Unit 3754
Prosecution Insights