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 .
Election/Restrictions
Claims 17-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method of creating and delivering contrast medium, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/5/26.
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, 2, 4, 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee-Sepsick et al (US Pub 2019/0076169).
Re claim 1: Lee-Sepsick discloses a sonographic device for creating and delivering contrast medium (device for making and using contrast agents for sonographically observing organs or bodily structures. para [0009]), comprising:
a first syringe body for containing a liquid (see 4b, Fig 7; syringe body 4b can contain liquid such as saline, para [0075]), the first syringe body having a first plunger positioned therein (see plunger end 7b with unshown plunger within 4b, Fig 7; plunger end 7b attached to plunger maintained within 4b, para [0075]);
a second syringe body for containing a gas (see 4a, Fig 7; syringe body 4a can contain a gas, para [0075]), the second syringe body having a second plunger positioned therein (see plunger end 7a with unshown plunger within 4a, Fig 7; plunger end 7a attached to plunger maintained within 4a, para [0075]);
liquid connecting tubing (see tubing segment 3b for flow of liquid, Fig 7; conduit 3b, para [0075]) in fluid connection with the first syringe body (see how 3b is in fluid connection with 4b, Fig 7. para [0075]);
air connecting tubing (see vertical tubing segment 3a, Fig 7, para [0075]) in fluid connection with the second syringe body (see how 3a is in fluid connection with 4a, Fig 7, para [0075]);
Y-shaped tubing (see Y-shaped tubing comprising chamber 1 with legs 11b and 11a, Fig 7; chamber 1 with connections 11a and 11b, para [0075]) in fluid connection with both the liquid connecting tubing and the air connecting tubing (see how 11b is in fluid connection with 3b and 11a is in fluid connection with 3a, Fig 7, para [0075]);
an air inlet port (see 5, Fig 7; air port opening 5, para [0075]) in fluid connection with the second syringe body (see how 5 is in fluid connection with 4a via tubing 10, 2a, and 3a, Fig 7, air drawn in through 5, through 10, through 2a, through 3a, and into 4a, para [0075]);
a fluid port (see 6, Fig 7; port 6 for filling the device with saline, para [0077]) in fluid connection with both syringe bodies through the Y-shaped tubing (see how 6 is in fluid connection with 4b and 4a through the Y-shaped tubing, Fig 7, para [0075]-[0076]);
a first one-way valve (see 2a, Fig 7; check valve 2a, para [0075]) positioned between the air inlet port and the second syringe body (see how 2a is between 5 and 4a, Fig 7); and
a second one-way valve (see 2b, Fig 7; check valve 2b, para [0075]) positioned between the second syringe body and the Y-shaped tubing (see how 2b is between 4a and the leg 11a of the Y-shaped tubing, Fig 7);
wherein the device is configured such that both syringe bodies fill simultaneously (see how 4b and 4a fill simultaneously when plunger 7b and 7a are moved proximally and ports 6 and 5 are in communication with saline and air, Fig 7; plunger ends 7a and 7b may be actuated simultaneously, 4a filled with air, para [0075]; saline drawn into 4h by moving plunger 7h proximally, para [0077]; containers/syringes may
be filled simultaneously by withdrawing plungers in proximal direction, para [0041]) and at a same rate (plungers withdrawn proximally and controlled simultaneously, such that when reaching the proximal end the syringes are filled with 10 mL of air and 10 mL of saline, and when have ceased moving the fluid containers contain same amount, hence at a same rate, para [0041-0043]) when the first and second plungers are moved proximally (para [0075], para [0077], para [0041]), and when the first and second plungers are moved distally contrast medium composition comprising alternating segments of liquid and gas exits the fluid port as the first fluid (in depressing the plungers simultaneously, contrast medium is generated comprising a gas/liquid interface pattern of alternating phases, para [0082]-[0083]; alternating pattern of gas phase and liquid phase which is a contrast medium composition, para [0045]).
Re claim 2: The device includes a casing (not shown in Fig 7 is a casing that may enclose the components, para [0075]; container assembly provided with casing, para [0025]) defining an enclosed portion (casing that may enclose the components, hence defining an enclosed portion enclosing the tubings, para [0075]), a connecting portion (casing that may enclose the components, hence a connecting portion enclosing an upper part of the connected syringes, para [0075]), and a handle (both plunger ends may be found on exterior of casing, hence exterior of casing with plunger ends is a handle, para [0025]), wherein the first syringe body and second syringe body are positioned within the casing (casing may enclose the components shown, hence including 4b and 4a, para [0075]).
Re claim 4: The device includes a syringe plunger actuator operatively connected to both the first plunger and the second plunger (see 35, Fig 10; actuator 35 connecting the two plunger ends, para [0075]), wherein the syringe plunger actuator is configured to move both plungers simultaneously and at the same rate (35 so the two plunger ends may be actuated simultaneously, para [0075]).
Re claim 6: The fluid port comprises an attachment element for connecting to a catheter or catheter assembly (see 7, Fig 7; connector 7 for connecting a catheter, para [0075]).
Re claim 7: The device includes an air inlet connecting tubing (see 10, Fig 7) and a tubing connection positioned between the first one-way valve and the air connecting tubing (see a tubing connection between 2a and 3a, Fig 7).
Re claim 8: The device includes air exiting connecting tubing positioned between the second one-way valve and the Y-shaped tubing (see a vertical tubing between 2b and the Y shaped tubing part 11a, Fig 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.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lee-Sepsick et al (US Pub 2019/0076169) in view of Langley et al (US Pub 2023/0173177 -cited by applicant).
Re claim 3: Lee-Sepsick discloses the syringe flanges are located at the handle (see flanges at the bottom of the syringes 4b, 4a, Fig 7; the casing may optionally not enclose the plunger ends, hence including a handle portion including the lower part of the syringes near the plunger ends, para [0075]) but does not disclose the casing comprises slots formed in the handle through which syringe flanges of the first and second syringe bodies protrude. However, Langley teaches a casing for a syringe (see a case 104 for a syringe 105, Fig 1A, Fig 3, Fig 4A-D; case 104, para [0037]; syringe 105, para [0036]), wherein a portion of the casing for the bottom of the syringe (see 124 for the bottom of 105, Fig 1A) comprises a slot through which the syringe flange protrudes (see syringe flange 117, Fig 1C; see how 124 includes a slot/opening into a cavity 404 for the flange, Fig 4A-C; cavity 404 of size/shape to contain flange 117, para [0041]) so that the syringe may be stable and secured within the casing (para [0039]). It would have been obvious to a person having ordinary skill in the art to modify the casing such that it comprises slots formed in the handle through which syringe flanges of the first and second syringe bodies protrude as taught by Lee-Sepsick in order to more stably and securely hold the syringes within the casing.
Re claim 5: Lee-Sepsick discloses wherein the upper portion of the syringes are located at the connecting portion (casing that may enclose the components, hence a connecting portion enclosing an upper part of the connected syringes, para [0075]) but does not specify how the connecting portion is configured. However, Langley teaches a casing for a syringe (see 120 for a syringe 105, Fig 1A; housing 120 for syringe 105, para [0035]-[0036]) comprising a chamher for the syringe (see chamber 124 for syringe 105, Fig 1A; chamber 124, para [0037]) comprised of first and second components that are joined together at connection sites (see a first rear casing part 104 and cover part 106 that are joined together an hinged connection sites 107, Fig 1A, Fig 3; cover 106 attached via pair of hinges 107. para [0037]) in order to provide the casing with two components which may be opened to allow for inserting the syringe (para [0037]). It would have been obvious to a person having ordinary skill in the art to modify the
connecting portion such that it comprises first and second components that are joined together at connection sites as taught by Langley in order to provide the casing with two components which may be opened to allow for inserting the syringes.
Claims 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee-Sepsick et al (US Pub 2019/0076169).
Re claims 9-13: Lee-Sepsick discloses all features except that the first and second one-way valve has a cracking pressure of approximately from 0.014 to 0.087 Ib/in2. Lee-Sepsick does teach wherein the first and second one-way valve is a check valve that allows air to be drawn into the second syringe body (para [0075]) but does not specify its cracking pressure. However, it is well known in the art that routine experimentation and various experimental design choices of materials and configuration of the valve could have been used to have arrived at the first and second one-way valve having a cracking pressure of approximately from 0.014 to 0.087 lb/in2 or for the first value to have a higher cracking pressure than the second valve in order to allow for it easily opening as desired for allowing air to be drawn into the second syringe body as the plunger is moved. Similarly, it is well known in the art that routine experimentation and various experimental design choices of the materials and configuration of the valve could have been used to have arrived at the second one-way valve has a cracking pressure of approximately less than 0.087 Ib/in2 such that the valve opens at low pressure to allow gas to flow quickly through from a start of movement of the plungers in order to allow for it quickly opening as desired for allowing air to be delivered from the second syringe body.
Re claim 14: Lee-Sepsick discloses at the cracking pressure, the second one-way valve is completely open and gas flows freely through the valve at the pressure provided by distal movement of the second plunger (check valve 2b so that gas moves from 4a due to applying pressure to move the piston through the interior of 4a, hence fully open at the cracking pressure, para [0075]).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lee-Sepsick et al (US Pub 2019/0076169) in view of D’Arienzo et al (US Pub 2022/0387733 -cited by applicant).
Re claims 15, 16: Lee-Sepsick discloses all features including that the device is configured such that both syringe bodies fill simultaneously (see how 4b and 4a fill simultaneously when plunger 7b and 7a are moved proximally and ports 6 and 5 are in communication with saline and air, Fig 7; plunger ends 7a and 7b may be actuated simultaneously, 4a filled with air, para [0075]; saline drawn into 4b by moving plunger 7b proximally, para [0077]; containers/syringes may be filled simultaneously by withdrawing plungers in proximal direction, para [0041]) and at a same rate (plungers withdrawn proximally and controlled simultaneously, such that when reaching the proximal end the syringes are filled with 10 mL of air and 10 mL of saline, hence at a same rate, para [0041]-[0043]) when the first and second plungers are moved proximally (para [0075], para [0077], para [0041]), and when the first and second plungers are moved distally contrast medium composition comprising alternating segments of liquid and gas exits the fluid port as the first fluid (in depressing the plungers simultaneously, contrast medium is generated comprising a gas/liquid interface pattern of alternating phases, para [0082]-[0083]; alternating pattern of gas phase and liquid phase which is a contrast medium composition, para [0045]) but does not explicitly teach how the various tubings are sized/configured to achieve it. However, D’Arienzo teaches a device for creating and delivering a composition comprised of different components (two solutions forming a hemostatic gel, sealant or hydrogel, para [0203]; double-barrel syringe loaded with a two-component tissue glue and radioisotope loaded microspheres and injected with a dual-lumen catheter, para [0019]), wherein the components have different viscosities (para [0203]), and therefore having tubing configured so that the two components flow in and out at the same rate (para [0209], para [0211], para [0216]) by having a larger diameter tubing for the component with the greater viscosity (para [0211], para [0213], para [0216]). D’Arienzo further teaches wherein a diameter of the liquid connecting tubing and a diameter than the air connecting tubing are selected to equalize rates of filling both syringe bodies (para [0209], para [0211], para [0216]).
It would have been obvious to a person having ordinary skill in the art to modify the device such that the liquid connecting tubing for liquid having a higher viscosity has a larger diameter than the air connecting tubing for air having a lower viscosity as taught by D’Arienzo in order to configure the tubing so that the liquid and gas components flow in and out at the same rate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
