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 May 18, 2026 has been entered. Claims 33-36 and 39-54 remain pending in the application. Claims 1-32 and 37-38 were previously cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Rejection mailed September 18, 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17584826, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Prior-filed application 17584826 does not provide adequate support for:
“a surfactant additive disposed in the fluidly continuous channel” as required by claim 33
“the surfactant additive is infused in foam insert that is disposed input port section” as required by claim 35
“wherein the surfactant additive comprises polysorbate” as required by claim 36
“a foam insert disposed in the input port section, wherein the foam insert is infused with polysorbate that is configured to be released from the foam insert when saline or another liquid passes therethrough” as required by claim 40
“a foam insert disposed in the input port section, wherein the foam insert is infused with polysorbate that is configured to be released from the foam insert when the saline is pushed from the syringe into the fluidly continuous channel” as required by claim 43
Prior-filed application 17584826 discloses a body-compatible solution comprising a surfactant/polysorbate disposed in the barrel of a syringe (see at least [0011] and [0015]); however, prior-filed application 17584826 does not provide support for the surfactant additive is disposed in the fluidly continuous channel of the aerator as required by claim 33 or a foam insert infused with polysorbate as required by claims 35-36, 40, and 43.
Accordingly, claims 33-36 and 39-43 of the present application are not entitled to the benefit of the earlier filing dates of the prior-filed applications. The presently pending claims have the actual filing date of the present application: March 25, 2024.
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)(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 33-34, 39, 41, 44, and 47-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arcand et al. (US 20220233761)1.
Regarding claim 33, Arcand discloses a device (microbubble generator 100; Figures 2A-2D) comprising:
an aerator (converging nozzle 115 and interior structures of aerator 133) having a coupling end (coupling end 118) that is configured to removably couple to a syringe (Figure 2A; “a coupling end 118 that is configured to engage the tip 112 of the syringe 103.” [0050]) with an aerator fitting (at coupling end 118) that cooperates with a corresponding syringe fitting (“the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]), a flange (laterally extending flange and distally extending outer surface having grooves 235A of nozzle 115), and an aerator body (Figure 2C); the aerator body having a channel (Figure 2C) therethrough that comprises an inlet port section (proximal end of interior fluid channel 127), an inlet section (proximal portion of through 230), a throat section (distal portion of throat 230), a diffusing section (proximal portion of discharge channel 147 having gradually increasing diameter), and an outlet section (distal end of discharge channel 147); wherein the inlet port section, the outlet section, the diffusing section, the throat section, the inlet section, and the inlet port section form a fluidly continuous channel that couples the inlet port section to the outlet section (Figure 2C);
a housing (outer wall 245) having a sealing-end opening that couples to the flange (Figures 2B-2C; “the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described. In some implementations, the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]), a discharge tip (see annotated Figure 2C below) that couples to the outlet section (Figure 2C), and an interior that forms a gas pocket (interior air chamber 241) around the aerator body (Figure 2C; “the interior air chamber 241 is formed by the outer wall 245 of the aerator.” [0057]);
a surfactant additive (“the body-compatible solution includes a surfactant that lowers an interfacial tension of the solution” [0125]) disposed in the fluidly continuous channel (“the device includes a body-compatible solution that is disposed in the barrel.” [0011]; “The method may further include generating microbubbles by forcing the body-compatible fluid out of the syringe, through the interior cavity, and through the housing discharge tip.” [0013], wherein the body-compatible solution is disposed in the fluidly continuous channel as is it forced through the interior cavity and out through the discharge channel 147);
wherein the aerator further includes a vent (one of series of air channels 246; Figures 2C and 2D) that couples the gas pocket to at least one of the throat section or the diverging section (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]); and wherein the flange is disposed partially exterior to the housing (Figure 2C, wherein the laterally extending flange of nozzle 115 is exterior to the housing), wherein the sealing-end opening seals around a perimeter of the flange, and wherein the flange separates the gas pocket from an area exterior to the housing (Figure 2C; “the converging nozzle 115 includes grooves 235A for receiving the O-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose…the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]).
Regarding claim 34, Arcand discloses the device of claim 33, further comprising a second vent (second of one of series of air channels 246; Figures 2C and 2D) that fluidly couples the outlet section (distal end of discharge channel 147) to the gas pocket (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]; coupled via the fluidly continuous channel).
Regarding claim 39, Arcand discloses the device of claim 33, further comprising a removable volume-consuming material (o-ring 134) disposed against an inner surface of the housing and in the gas pocket (see Figure 2C showing at least a portion of o-ring 134 in air chamber 241) that reduces a volume of the gas pocket relative to the volume without the removable volume-consuming material disposed therein (Figures 2B-2C); wherein the volume-consuming material comprises comprising at least one of a discrete washer, a discrete ring, or a discrete cylinder disposed around the inlet nozzle or in the housing (“the converging nozzle 115 includes grooves 235A for receiving the o-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose. This structure allows the O-ring 134 to be slipped into the grooves 235A, and for the retention end 236 of the aerator 133 to be slid over the converging tip 121 and for the grooves 235B to engage and be retained by the O-ring 134…the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]).
Regarding claim 41, Arcand discloses the device of claim 33, further comprising a syringe (syringe 103) to which the coupling end is coupled (Figure 2A; “The converging nozzle 115, in the implementation shown, has a coupling end 118 that is configured to engage the tip 112 of the syringe 103” [0050]).
Regarding claim 44, Arcand discloses the device of claim 33, wherein the syringe fitting and the aerator fitting are Luer fittings (“The tip 112 can include a Luer lock connector” [0048]; “the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]).
Regarding claim 47, Arcand discloses the device of claim 33, wherein the sealing-end opening seals around the perimeter of the flange with a groove-and-notch interface (Figures 2B-2C; “the converging nozzle 115 includes grooves 235A for receiving the o-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose. This structure allows the O-ring 134 to be slipped into the grooves 235A, and for the retention end 236 of the aerator 133 to be slid over the converging tip 121 and for the grooves 235B to engage and be retained by the O-ring 134. In such an implementation, the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described.” [0055].
Regarding claim 48, Arcand discloses the device of claim 33, wherein the sealing-end opening seals around the perimeter of the flange with an ultrasonically welded joint (“the converging nozzle 115 and aerator 133 may be ultrasonically welded together” [0052])
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 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Arcand et al. (US 20220233761) in view of Lee-Sepsick et al. (US 20100086492).
Regarding claim 35, Arcand discloses the device of claim 33.
Arcand fails to explicitly disclose the surfactant additive is infused in a foam insert that is disposed in the input port section.
Lee-Sepsick teaches a device (Figure 4) comprising a surfactant additive that is infused in a foam insert (“a porous substance, such as open cell foams” [0034]; “A porous substance may be any substance that can contain gas and liquid and release the gas and liquid easily upon compression or physical force upon the porous substance. For example, a porous substance may be a sponge, such as open cell polyurethane sponge, that may be compressible. For example, a porous substance may be material that contains a gas and a liquid is rigid, but collapses upon compression, to release the gas and liquid…It is theorized that the porous substance comprises a gas within its pores and a liquid associated therewith the porous substance. The liquid and gas may be found within the pores or associated with the porous material in an easily releasable fashion, such as by surface tension, hydrogen bonding or other weak bonding associations.” [0052]; “The liquids provided to containers or porous substances may further comprise a surfactant” [0053]) disposed in a input port section (Figure 4; “a container comprising a flexible porous material contained within the container. An example wherein the container is a syringe body is described, such as one shown in FIG. 4.” [0024]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Arcand to include the surfactant additive is infused in a foam insert disposed in the input port section based on the teachings of Lee-Sepsick to stabilize the gas-liquid interface of the microbubbles as they are released from the device in a manner that creates an irregular pattern (Lee-Sepsick [0026, 0028, 0052-0053]).
Regarding claim 36, modified Arcand discloses the device of claim 35, wherein the surfactant additive comprises polysorbate (“the body-compatible fluid comprises saline and polysorbate.” [0015]).
Claims 40, 42-43, 45-46, and 48-52 are rejected under 35 U.S.C. 103 as being unpatentable over Arcand et al. (US 20220233761) in view of Lee-Sepsick et al. (US 20100086492) in further view of Bergmann et al. (WO 9726016).
Regarding claim 40, Arcand discloses a device (microbubble generator 100; Figures 2A-2D) comprising:
an aerator (converging nozzle 115 and interior structures of aerator 133) having a coupling end (coupling end 118) with an aerator fitting (“the coupling end 118 includes mating Luer lock threads” [0050]) that is configured to removably couple to a syringe fitting of a syringe (“the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]), a flange (laterally extending flange and distally extending outer surface having grooves 235A of nozzle 115), and an aerator body (Figure 2C); the aerator body having a channel (Figure 2C) therethrough that comprises an inlet port section (proximal end of interior fluid channel 127), an inlet section (proximal portion of through 230), a throat section (distal portion of throat 230), a diffusing section (proximal portion of discharge channel 147 having gradually increasing diameter), and an outlet section (distal end of discharge channel 147); wherein the outlet section, the diffusing section, the throat section, the inlet section, and the inlet port section form a fluidly continuous channel that couples the inlet port section to the outlet section (Figure 2C);
a housing (outer wall 245) having a sealing-end opening that couples to the flange (Figures 2B-2C; “the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described. In some implementations, the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]), a discharge tip (see annotated Figure 2C above) that couples to the outlet section, and an interior that forms a gas pocket (interior air chamber 241) around the aerator body (Figure 2C; “the interior air chamber 241 is formed by the outer wall 245 of the aerator.” [0057]);
wherein the aerator further includes a first vent (one of series of air channels 246; Figures 2C and 2D) that couples the gas pocket to at least one of the throat section or the diverging section (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]) and a second vent (second of one of series of air channels 246; Figures 2C and 2D) that fluidly couples the outlet section (distal end of discharge channel 147) to the gas pocket (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]; coupled via the fluidly continuous channel); and
wherein the housing seals around the aerator such that the gas pocket is fluidly coupled to the channel via the first vent and the second vent but is otherwise fluidly isolated from an area exterior to the housing (Figure 2C; “A small fluid coupling exists between this interior air chamber 241 and the passageway formed by the interior channel 127, throat 230 and discharge channel 147—specifically by an air channel 246 (see magnified inset) that is configured to exist between the exterior mating surface 224 and the circumferential lip 244. This air channel 246 allows air or other gas in the interior air chamber 241 to be drawn into the aforementioned passageway (throat 230 and discharge channel 147—referred to as the “230/147 passageway”).” [0057]); wherein the sealing-end opening seals around a perimeter of the flange such that one surface of the flange is in contact with the gas pocket and an opposite surface of the flange is in contact with an area exterior to the housing (Figure 2C showing grooves 235A in contact with the air chamber 241 and the laterally extending flange of nozzle 115 is exterior to the housing; “the converging nozzle 115 includes grooves 235A for receiving the O-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose…the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]).
Arcand fails to explicitly disclose a foam insert disposed in the input port section, wherein the foam insert is infused with polysorbate that is configured to be released from the foam insert when saline or another liquid passes therethrough.
Lee-Sepsick teaches a device (Figure 4) comprising a foam insert (“a porous substance, such as open cell foams” [0034]) disposed in an input port section (“a container comprising a flexible porous material contained within the container. An example wherein the container is a syringe body is described, such as one shown in FIG. 4.” [0024]), wherein the foam insert is infused with polysorbate (“The liquids provided to containers or porous substances may further comprise a surfactant” [0053]; “Surfactants include…esters of fatty acids with polyoxyalklated sorbitan…polyoxyethylenesorbitans” [0028] wherein polyoxyalklated sorbitan and polyoxyethylenesorbitans are polysorbates) that is configured to be released from the foam insert (“A porous substance may be any substance that can contain gas and liquid and release the gas and liquid easily upon compression or physical force upon the porous substance. For example, a porous substance may be a sponge, such as open cell polyurethane sponge, that may be compressible. For example, a porous substance may be material that contains a gas and a liquid is rigid, but collapses upon compression, to release the gas and liquid…It is theorized that the porous substance comprises a gas within its pores and a liquid associated therewith the porous substance. The liquid and gas may be found within the pores or associated with the porous material in an easily releasable fashion, such as by surface tension, hydrogen bonding or other weak bonding associations.” [0052]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Arcand to include a foam insert disposed in the input port section, wherein the foam insert is infused with polysorbate that is configured to be released from the foam insert based on the teachings of Lee-Sepsick to stabilize the gas-liquid interface of the microbubbles as they are released from the device in a manner that creates an irregular pattern (Lee-Sepsick [0026, 0028, 0052-0053]).
Arcand in view of Lee-Sepsick fails to explicitly disclose the polysorbate is configured to be released from the foam insert when saline or another liquid passes therethrough.
Bergmann teaches a foam insert (“a porous, solid, water-soluble matrix containing a low molecular weight scaffold, a surfactant and a gas” [Page 3]) infused with polysorbate (“Suitable surfactants are water-soluble, nonionic surfactants, those with a perfluorinated hydrocarbon building block and / or with a molecular weight of <15,000 daltons being preferred. Examples include sorbitan fatty acid esters, polyoxyethylene sorbitan, polyoxyethylene sorbitol” [Page 4], wherein polyoxyethylene sorbitan is a polysorbate) that is configured to be released from the foam insert when saline or another liquid passes therethrough (“gas bubbles are released after the matrix is dissolved.” [Page 3]; “The desired particle-free ultrasound contrast agents can easily be produced from the matrices according to the invention by adding an aqueous medium” [Page 5], wherein the polysorbate/surfactant is part of the soluble matrix, which is dissolved).
Before the effective filing date of the claimed invention, it would have been obvious to further modify the device of Arcand in view of Lee-Sepsick to include the foam insert infused with polysorbate that is configured to be released from the foam insert when saline or another liquid passes therethrough based on the teachings of Bergmann to stabilize the microbubbles as they are delivered from the device in a manner that reduces the risk of accidental delivery of undesired particulates (Bergmann [Pages 3-4]).
Regarding claim 42, modified Arcand discloses the device of claim 40, further comprising a syringe (syringe 103) to which the coupling end is coupled (Figure 2A; “The converging nozzle 115, in the implementation shown, has a coupling end 118 that is configured to engage the tip 112 of the syringe 103” [0050]).
Regarding claim 43, Arcand discloses a device (microbubble generator 100; Figures 2A-2D) comprising:
a syringe (syringe 103) comprising saline (“The syringe 103 may be pre-filled with saline” [0048]) and having a syringe fitting at a discharge tip (Figure 2A; “The tip 112 can include a Luer lock connector” [0048]);
an aerator (converging nozzle 115 and interior structures of aerator 133) having a coupling end (coupling end 118) that is removably coupled to the syringe via an aerator fitting (“the coupling end 118 includes mating Luer lock threads” [0050]) that cooperates with the syringe fitting (“the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]), a flange (laterally extending flange and distally extending outer surface having grooves 235A of nozzle 115), and an aerator body (Figure 2C) characterized by an outer surface (Figure 2C); the aerator body having a channel (Figure 2C) therethrough that is characterized by a longitudinal axis (Figure 2C) and that comprises an inlet port section (proximal end of interior fluid channel 127), an inlet section (proximal portion of through 230), a throat section (distal portion of throat 230), a diffusing section (proximal portion of discharge channel 147 having gradually increasing diameter), and an outlet section (distal end of discharge channel 147); wherein the outlet section, the diffusing section, the throat section, the inlet section, and the inlet port section form a fluidly continuous channel that couples the inlet port section to the outlet section (Figure 2C);
a housing (outer wall 245) having a sealing-end opening that couples to the flange (Figures 2B-2C; “the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described. In some implementations, the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]), a discharge tip (see annotated Figure 2C above) that couples to the outlet section, and an interior surface that, with the outer surface, characterizes and bounds a gas pocket (interior air chamber 241) around the aerator body (Figure 2C; “the interior air chamber 241 is formed by the outer wall 245 of the aerator.” [0057]); and
polysorbate that lowers interfacial tension of saline when saline is pushed from the syringe into the fluidly continuous channel (“Surfactants in solution tend reduce the interfacial tension between molecules of the solution (independent of effects on interfacial tension that surface energies of materials in contact with the solution may have at the contact surface). That is, in the absence of a surfactant, the intermolecular forces holding individual molecules of the solution to each other may be relatively strong, whereas addition of a surfactant reduces the intermolecular attractive forces, or interfacial tension. It is understood that this reduction of interfacial tension, caused by the presence of a surfactant (e.g., dextrose or polysorbate), increases a solution's ability to attract air or gas, in the form of microbubbles (e.g., in or near the venturi throat, when the solution is moving through said venturi throat).” [0149], see also [0125] and [0150]);
wherein the aerator further includes a first vent (one of series of air channels 246; Figures 2C and 2D) that couples the gas pocket to at least one of the throat section or the diverging section (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]) and a second vent (second of one of series of air channels 246; Figures 2C and 2D) that fluidly couples the outlet section (distal end of discharge channel 147) to the gas pocket (“FIG. 2D illustrates the air channel 246 (or series of air channels 246) that fluidly couple the interior air chamber 241 to the throat 230-discharge channel 147 passageway.” [0058]; coupled via the fluidly continuous channel); and
wherein the housing seals around the aerator such that the gas pocket is fluidly coupled to the channel via the first vent and the second vent but is otherwise fluidly isolated from an area exterior to the housing (Figure 2C; “A small fluid coupling exists between this interior air chamber 241 and the passageway formed by the interior channel 127, throat 230 and discharge channel 147—specifically by an air channel 246 (see magnified inset) that is configured to exist between the exterior mating surface 224 and the circumferential lip 244. This air channel 246 allows air or other gas in the interior air chamber 241 to be drawn into the aforementioned passageway (throat 230 and discharge channel 147—referred to as the “230/147 passageway”).” [0057]); and wherein the flange is perpendicular to the longitudinal axis (Figure 2C showing that the laterally extending flange of nozzle 115 is perpendicular to the housing) and separates the gas pocket form an area exterior to the housing (Figure 2C) and where the sealing-end opening seals around a perimeter of the flange such that one surface of the flange is in contact with the gas pocket and an opposite surface of the flange is in contact with an area exterior to the housing (Figure 2C showing grooves 235A in contact with the air chamber 241 and the laterally extending flange of nozzle 115 is exterior to the housing; “the converging nozzle 115 includes grooves 235A for receiving the O-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose…the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]).
Arcand fails to explicitly disclose a foam insert disposed in the input port section, wherein the foam insert is infused with the polysorbate that is configured to be released from the foam insert when the saline is pushed from the syringe.
Lee-Sepsick teaches a device (Figure 4) comprising a foam insert (“a porous substance, such as open cell foams” [0034]) disposed in an input port section (“a container comprising a flexible porous material contained within the container. An example wherein the container is a syringe body is described, such as one shown in FIG. 4.” [0024]), wherein the foam insert is infused with polysorbate (“The liquids provided to containers or porous substances may further comprise a surfactant” [0053]; “Surfactants include…esters of fatty acids with polyoxyalklated sorbitan…polyoxyethylenesorbitans” [0028] wherein polyoxyalklated sorbitan and polyoxyethylenesorbitans are polysorbates) that is configured to be released from the foam insert (“A porous substance may be any substance that can contain gas and liquid and release the gas and liquid easily upon compression or physical force upon the porous substance. For example, a porous substance may be a sponge, such as open cell polyurethane sponge, that may be compressible. For example, a porous substance may be material that contains a gas and a liquid is rigid, but collapses upon compression, to release the gas and liquid…It is theorized that the porous substance comprises a gas within its pores and a liquid associated therewith the porous substance. The liquid and gas may be found within the pores or associated with the porous material in an easily releasable fashion, such as by surface tension, hydrogen bonding or other weak bonding associations.” [0052]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Arcand to include a foam insert disposed in the input port section, wherein the foam insert is infused with polysorbate that is configured to be released from the foam insert based on the teachings of Lee-Sepsick to stabilize the gas-liquid interface of the microbubbles as they are released from the device in a manner that creates an irregular pattern (Lee-Sepsick [0026, 0028, 0052-0053]).
Modified Arcand in view of Lee-Sepsick fails to explicitly disclose the polysorbate that is configured to be released from the foam insert when the saline is pushed from the syringe.
Bergmann teaches a foam insert (“a porous, solid, water-soluble matrix containing a low molecular weight scaffold, a surfactant and a gas” [Page 3]) infused with polysorbate (“Suitable surfactants are water-soluble, nonionic surfactants, those with a perfluorinated hydrocarbon building block and / or with a molecular weight of <15,000 daltons being preferred. Examples include sorbitan fatty acid esters, polyoxyethylene sorbitan, polyoxyethylene sorbitol” [Page 4], wherein polyoxyethylene sorbitan is a polysorbate) that is configured to be released from the foam insert when liquid passes therethrough (“gas bubbles are released after the matrix is dissolved.” [Page 3]; “The desired particle-free ultrasound contrast agents can easily be produced from the matrices according to the invention by adding an aqueous medium” [Page 5], wherein the polysorbate/surfactant is part of the soluble matrix, which is dissolved).
Before the effective filing date of the claimed invention, it would have been obvious to further modify the device of Arcand in view of Lee-Sepsick to include the foam insert infused with polysorbate is configured to be released from the foam insert when the saline is pushed from the syringe into the fluidly continuous channel based on the teachings of Bergmann to stabilize the microbubbles as they are delivered from the device in a manner that reduces the risk of accidental delivery of undesired particulates (Bergmann [Pages 3-4]).
Regarding claim 45, Arcand discloses the device of claim 40, wherein the syringe fitting and the aerator fitting are Luer fittings (“The tip 112 can include a Luer lock connector” [0048]; “the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]).
Regarding claim 46, Arcand discloses the device of claim 43, wherein the syringe fitting and the aerator fitting are Luer fittings (“The tip 112 can include a Luer lock connector” [0048]; “the coupling end 118 includes mating Luer lock threads to facilitate a twist-on engagement with the syringe 103” [0050]; “the converging nozzle 115 is disposed on the syringe 103 via a Luer lock fitting 218” [0053]).
Regarding claim 49, Arcand discloses the device of claim 40, wherein the sealing-end opening seals around the perimeter of the flange with a groove-and-notch interface (Figures 2B-2C; “the converging nozzle 115 includes grooves 235A for receiving the o-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose. This structure allows the O-ring 134 to be slipped into the grooves 235A, and for the retention end 236 of the aerator 133 to be slid over the converging tip 121 and for the grooves 235B to engage and be retained by the O-ring 134. In such an implementation, the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described.” [0055].
Regarding claim 50, Arcand discloses the device of claim 40, wherein the sealing-end opening seals around the perimeter of the flange with an ultrasonically welded joint (“the converging nozzle 115 and aerator 133 may be ultrasonically welded together” [0052])
Regarding claim 51, Arcand discloses the device of claim 43, wherein the sealing-end opening seals around the perimeter of the flange with a groove-and-notch interface (Figures 2B-2C; “the converging nozzle 115 includes grooves 235A for receiving the o-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose. This structure allows the O-ring 134 to be slipped into the grooves 235A, and for the retention end 236 of the aerator 133 to be slid over the converging tip 121 and for the grooves 235B to engage and be retained by the O-ring 134. In such an implementation, the O-ring 134 may be made of an elastic material that has sufficient elasticity and compressibility to facilitate engagement of the converging nozzle 115 and aerator 133, and sufficient resilience to securely couple the converging nozzle 115 and aerator 133 once the grooves 235A and 235B of these components 115 and 133 are aligned as described.” [0055].
Regarding claim 52, Arcand discloses the device of claim 43, wherein the sealing-end opening seals around the perimeter of the flange with an ultrasonically welded joint (“the converging nozzle 115 and aerator 133 may be ultrasonically welded together” [0052])
Claims 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Arcand et al. (US 20220233761).
Regarding claims 53-54, Arcand, in the embodiment of Figures 2A-2C, discloses the device of claim 33.
Arcand, in the embodiment of Figures 2A-2C, fails to explicitly disclose a removable sealing pin disposed in the housing and configured to seal off a smallest-diameter portion of the throat section, as required by claim 53; and wherein the sealing pin comprises a cap portion that is configured to removably couple to the discharge tip and an elastic portion that biases the sealing pin toward the smallest-diameter portion of the throat section, as required by claim 54.
Arcand, in the embodiment of Figures 3A-3C, discloses a device (microbubble generator 300) comprising an aerator (converging nozzle 315 and interior structures of aerator 333) and a housing (outer wall of aerator 333), further comprising a removable sealing pin (sealing pin 353; “such a pin 353 may be removed immediately prior to use of the microbubble generator 300.” [0069]) disposed in the housing (Figure 3A) and configured to seal off a smallest-diameter portion of a throat section (Figure 3A; “The pin 353…seals off the tip of the throat 330 and a discharge channel 347.” [0070]); and wherein the sealing pin comprises a cap portion that is configured to removably couple to the discharge tip (Figure 3A, see laterally extending portion of sealing pin 353 at discharge end 339: “The pin 353 may be adhesively sealed to the discharge end 339 of the aerator, such that some amount of twisting or pulling force is required by a user to dislodge the pin 353 prior to use of the microbubble generator 300.” [0070]) and an elastic portion that biases the sealing pin toward the smallest-diameter portion of the throat section (“the pin 353 may be made of a…resilient elastic material that seals off the tip of the throat 330 and a discharge channel 347.” [0070])
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Arcand in the embodiment of Figures 2A-2C to include a removable sealing pin comprising a cap portion that is configured to removably couple to the discharge tip and an elastic portion that biases the sealing pin toward the smallest-diameter portion of the throat section based on the teachings of Arcand in the embodiment of Figures 3A-3C to maintain the sterility of the saline within the syringe and prevent fluid ingress into the aerator (Arcand [0069]).
Response to Arguments
Applicant’s arguments with respect to claims 33-36 and 39-54 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the arguments that Arcand et al. (US 20220233761), Arcand 2022, does not disclose the amended limitations of independent claims 33, 40 and 43 (Remarks, page 7-8), the examiner respectfully disagrees. As detailed above, Arcand 2022 in the embodiment of Figures 2A-2C discloses an aerator (converging nozzle 115 and interior structures of aerator 133) having a coupling end (118) that is configured to removably couple to a syringe (Figure 2A; [0050]) with an aerator fitting that cooperates with a corresponding syringe fitting ([0050]; [0053]) and a flange (laterally extending flange and distally extending outer surface having grooves 235A of nozzle 115) disposed partially exterior to the housing (Figure 2C, wherein the laterally extending flange of nozzle 115 is exterior to the housing), wherein the sealing-end opening seals around a perimeter of the flange, and wherein the flange separates the gas pocket from an area exterior to the housing such that one surface of the flange is in contact with the gas pocket and an opposite surface of the flange is in contact with an area exterior to the housing (Figure 2C; “the converging nozzle 115 includes grooves 235A for receiving the O-ring 134 and facilitating a compression-fit coupling; and the aerator 133 includes corresponding grooves 235B for the same purpose…the O-ring 134 and grooves 235A and 235B may provide an air-tight, sterile seal.” [0055]); and wherein an interior surface that, with the outer surface, characterizes and bounds a gas pocket (interior air chamber 241) around the aerator body (Figure 2C; “the interior air chamber 241 is formed by the outer wall 245 of the aerator.” [0057]).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
1 It is noted that Arcand et al. (US 20220233761) qualifies as prior art because the currently pending claims are not entitled to the benefit of the earlier filing dates of the prior-filed applications and have the actual filing date of the present application: March 25, 2024 (see Priority Section).
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