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 on 8/11/2025 has been entered. Claims 57-61, 63-71, and 73-90 are pending in the application. Claims 1-56, 62, 72, and 91 are cancelled.
Claim Rejections - 35 USC § 103
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 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 57, 59-61, 63-71, 73-81, 86-87, and 89-90 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon et al. (US 2016/0256625 A1) in view of Douglas et al. (US 2002/0055722 A1).
Regarding claim 57, Sealfon discloses a pre-connected and inseparable assembly (precision variable flow rate infusion system PVFRIS 100, see Figs. 1-4 and 7) for delivering an infusion molecule to a patient and having a known maximum flow rate through the assembly for the infusion molecule (see par. [0032]-[0033], [0050], [0069], and [0088]), the assembly comprising:
a first tubing element (first flexible flow rate tubing 108) sized to deliver the known maximum flow rate (see Figs. 1-4, par. [0051] and [0069]);
an administration set (second flexible flow rate tubing 120 and needle set(s) 118), including a second tubing element (second flexible flow rate tubing 120) inseparably connected to a needle set (needle set(s) 118), serving a first infusion site (see par. [0051], [0084], and [0087]-[0088]); and
an adjustable flow rate controller (adjustable flow rate controller 110) disposed between and inseparably connected to the first tubing element (first flexible flow rate tubing 108) and the second tubing element (second flexible flow rate tubing 120) and having a scale (visual guide strip 700) to indicate an actual flow rate of the infusion molecule to the infusion site through the administration set (second flexible flow rate tubing 120 and needle set(s) 118) to the patient (see Figs. 2 and 7, par. [0088] and [0106], visual guide strip 700 can include a range of numbers corresponding to different flow rates);
wherein the assembly (PVFRIS 100) can only be used a single time for the single infusion molecule (see par. [0087]- [0088], [0102], and [0105], note: this is a functional limitation and not structurally required. PVFRIS 100 is capable of being used a single time for a single fluid. Further, PVFRIS 100 can be inseparably connected to tubing 108/120 and the needle set(s) and is sterilized and calibrated with the actual flow rates for a specific fluid prior to use. Since PVFRIS 100 is no longer sterile after its first use and cannot be disconnected from tubing 108/120 and the needle set(s), it would not be reused).
While Sealfon further teaches that the second tubing element (second flexible flow rate tubing 120) is inseparably connected to the needle set (needle set(s) 118) (see par. [0087]) and that the second tubing element (second flexible flow rate tubing 120) and the needle set (needle set(s) 118) are specifically structured to connect only with each other (see par. [0084]), Sealfon fails to state the second tubing element inseparably connected to a needle set without a luer connection.
Douglas teaches an assembly (see Fig. 1) comprising a tubing element (tube 1 and hub 95) inseparably connected to a needle set (needle 5) without a luer connection (see par. [0040]-[0042]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Sealfon such that the second tubing element is inseparably connected to the needle set without a luer connection, as taught by Douglas, as an alternative means to provide the inseparable and specific connection between the second tubing element and the needle set (see Sealfon par. [0084] and [0087] and Douglas par. [0040]-[0042]) and to potentially reduce costs associated with manufacturing and assembling the device (see Douglas par. [0040]-[0042]).
Regarding claim 59, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the adjustable flow rate controller (adjustable flow rate controller 110) can be adjusted such that the scale (visual guide strip 700) correspondingly reflects the adjusted actual flow rate to the first infusion site (see Fig. 7, par. [0068]-[0069], [0106], and [0112], visual guide strip 700 can include a range of numbers corresponding to different flow rates and reflects the flow rate for the entire assembly).
Regarding claim 60, modified Sealfon teaches the assembly of claim 59 substantially as claimed. Sealfon further teaches wherein the adjustable flow rate controller (adjustable flow rate controller 110) can be adjusted in response to changes in an infusion flow rate, an infusion pressure, or a specific infusion viscosity (see par. [0050]-[0051] and [0062], PVFRIS 100 is adjustable and delivers Newtonian fluids at a specific viscosity, pressure, and flow rate).
Regarding claim 61, modified Sealfon teaches the assembly of claim 60 substantially as claimed. Sealfon further teaches wherein the adjustable flow rate controller (adjustable flow rate controller 110) can be adjusted to provide the adjusted actual flow rate before, during or in between infusions (see par. [0068], the adjustable flow rate controller 110 is manually adjustable by a user such that the adjustable flow rate controller 110 is capable of being adjusted at any point before, during, or in between infusions).
Regarding claim 63, modified Sealfon teaches the assembly of claim 60 substantially as claimed. Sealfon further teaches an infusion driver (constant pressure pump 122) for driving the infusion molecule through the pre-connected assembly (PVFRIS 100) to the first infusion site at a substantially constant pressure (see par. [0062] and [0064]).
Regarding claim 64, modified Sealfon teaches the assembly of claim 63 substantially as claimed. Sealfon further teaches wherein a change in the infusion pressure during an infusion changes the actual flow rate of the infusion molecule (see par. [0062] and [0064]) and the changed flow rate is a measurable and determinable flow rate that may be adjusted to the adjusted actual flow rate using the adjustable flow rate controller (adjustable flow rate controller 110) (see par. [0068], the adjustable flow rate controller 110 is manually adjustable by a user to achieve certain flow rates).
Regarding claim 65, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the adjustable flow rate controller (adjustable flow rate controller 110) may be set and fixed at the actual flow rate indicated by the scale (visual guide strip 700) (see par. [0077]-[0078] and [0106]).
Regarding claim 66, modified Sealfon teaches the assembly of claim 65 substantially as claimed. Sealfon further teaches wherein the actual flow rate is visually indicated by the scale (visual guide strip 700) without an aid of an infusion flow rate calculator or a flow rate table (see par. [0106]).
Regarding claim 67, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the known maximum flow rate through the assembly (PVFRIS 100) does not exceed a maximum flow rate limitation for the infusion molecule (see par. [0076], the maximum flow rate through PVFRIS 100 does not exceed a maximum dosage flow rate for the liquid).
Regarding claim 68, modified Sealfon teaches the assembly of claim 67 substantially as claimed. Sealfon further teaches wherein the maximum flow for the infusion molecule is determined by a manufacturer of the specific infusion molecule (see par. [0004], pharmaceuticals have a proper delivery flow rate defined by the manufacturer).
Regarding claim 69, modified Sealfon teaches the assembly of claim 67 substantially as claimed. Sealfon further teaches wherein the pre-connected assembly (PVFRIS 100) provides for all flow rates required by the infusion molecule, continuously, from a zero-flow rate to the maximum flow rate limitation for the infusion molecule (see par. [0068], [0076], and [0106]).
Regarding claim 70, modified Sealfon teaches the assembly of claim 79 substantially as claimed. Sealfon further teaches wherein a single configuration of the pre-connected assembly (PVFRIS 100) provides for all flow rates, including the known maximum flow rate, required by the infusion molecule regardless of a number of the at least two infusion sites served (see par. [0068], [0076], and [0087], the flow rate is determined by the adjustable flow rate controller 110 and tubings 108/120, not by the needle(s)) and the actual flow rate can be set directly on the scale (visual guide strip 700) of the adjustable flow rate controller (adjustable flow rate controller 110) (see par. [0106]).
Regarding claim 71, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the pre-connected assembly (PVFRIS 100) is manufactured to be inseparably connected (see par. [0087]-[0088]).
Regarding claim 73, modified Sealfon teaches the assembly of claim 79 substantially as claimed. Sealfon further teaches wherein when fluid is flowing through the assembly and the actual flow rate is not zero, an actual total flow rate of the infusion molecule for the assembly (PVFRIS 100) would be equal to the actual flow rate on the scale (visual guide strip 700) multiplied by two to reflect the actual flow rate of the infusion molecule to each of the first and second infusion sites (see par. [0068], [0087], and [0106]; see claim 10, the visual guide strip 700 is tuned to each part of the assembly such that the flow rate to each of the infusion sites in assemblies with two needles can be provided).
Regarding claim 74, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the first tubing element (first flexible flow rate tubing 108) and the administration set (second flexible flow rate tubing 120 and needle set(s) 118) are coordinately selected (see par. [0087]-[0088], the components of PVFRIS 100 are bonded).
Regarding claim 75, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the first tubing element (first flexible flow rate tubing 108) and the administration set (second flexible flow rate tubing 120 and needle set(s) 118) are selected in specific dimensions of lengths and diameters to achieve specific flowrates for the specific infusion molecule (see par. [0033]-[0035], [0060]- [0061], and [0087]).
Regarding claim 76, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the administration set (second flexible flow rate tubing 120 and needle set(s) 118) is a second tubing element for intravenous infusions (see Fig. 2, par. [0057] and [0087], second flexible flow rate tubing 120 is a tube and PVFRIS 100 is capable of being used with a number of different needle/tubing sizes such that it is capable of being used for intravenous infusions).
Regarding claim 77, modified Sealfon teaches the assembly of claim 76 substantially as claimed. Sealfon further teaches wherein the administration set (second flexible flow rate tubing 120 and needle set(s) 118) further comprises a 26-gauge needle (see par. [0087]) and provides all flow rates required by the specific infusion molecule (see Fig. 2, par. [0087], second flexible flow rate tubing 120 is inseparably bonded to a needle set(s)).
Regarding claim 78, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein during an infusion an infusion flow rate can be firstly delivered at the maximum flow rate of the infusion molecule and the infusion flow rate can be later decreased to a known infusion flow rate during the infusion using the adjustable flow rate controller (adjustable flow rate controller 110) to obviate adverse infusion reactions (see par. [0068], the adjustable flow rate controller 110 is manually adjustable by a user to adjust the flow rate through the controller 110 and is not limited to being adjusted at specific times during an infusion procedure such that PVFRIS 100 is capable of achieving this function).
Regarding claim 79, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the administration set (second flexible flow rate tubing 120 and needle set(s) 118) also serves a second infusion site (see par. [0087]) and the scale on the adjustable flow rate controller (adjustable flow rate controller 110) indicates the actual flow rate of the infusion molecule to each of the first and second infusion sites (see par. [0087], [0106], and [0112], the scale on the controller 110 can indicate the actual flow rate for the PVFRIS 100. When second flexible flow rate tubing 120 serves two needle sets/infusion sites, the actual flow rate on the scale is still considered the flow rate to each of the first and second infusion site).
Regarding claim 80, modified Sealfon teaches the assembly of claim 79 substantially as claimed. Sealfon further teaches a manifold (structure of separation between single outlet 114 and two or more needles, see par. [0087]) between the adjustable flow rate controller (adjustable flow rate controller 110) and the first and second infusion sites (see Figs. 1-2, par. [0087]).
Regarding claim 81, modified Sealfon teaches the assembly of claim 80 substantially as claimed. Sealfon further teaches a pressurizing mechanism (constant pressure pump 122) to deliver the infusion molecule into an anatomic space of the patient at a substantially constant pressure regardless of a number of infusion sites (see Fig. 1, par. [0062]).
Regarding claim 86, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the specific infusion molecule is a pharmaceutical (see par. [0050] and [0087]).
Regarding claim 87, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the specific infusion molecule is an immunoglobulin (see par. [0087], note: Hizentra® is an immunoglobulin).
Regarding claim 89, modified Sealfon teaches the assembly of claim 57 substantially as claimed. Sealfon further teaches wherein the administration set (second flexible flow rate tubing 120) also serves a plurality of infusion sites including the first infusion site (see par. [0087]) and the scale on the adjustable flow rate controller (adjustable flow rate controller 110) indicates the actual flow rate of the specific infusion molecule to each of the plurality of infusion sites (see par. [0087], [0106], and [0112], the scale on the controller 110 can indicate the actual total flow rate for the PVFRIS 100. When second flexible flow rate tubing 120 serves a plurality of needle sets/infusion sites, the total/actual flow rate on the scale is still considered the flow rate to each of the plurality of infusion sites).
Regarding claim 90, modified Sealfon teaches the assembly of claim 89 substantially as claimed. Sealfon further teaches wherein when fluid is flowing through the assembly and the actual flow rate is not zero, an actual total flow rate of the specific infusion molecule for the assembly (PVFRIS 100) would be equal to the actual flow rate on the scale (visual guide strip 700) multiplied by two to reflect the actual flow rate of the specific infusion molecule to each of the two infusion sites (see par. [0068], [0087], and [0106]; see claim 10, the visual guide strip 700 is tuned to each part of the assembly such that the flow rate to each of the infusion sites in assemblies with two needles can be provided).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon et al. (US 2016/0256625 A1) in view of Douglas et al. (US 2002/0055722 A1), as applied to claim 57 above, further in view of Aslanian et al. (US 4,361,147 A).
Regarding claim 58, modified Sealfon teaches the assembly of claim 57 substantially as claimed. However, modified Sealfon fails to explicitly state wherein the first tubing element, the administration set, and the adjustable flow rate controller are packaged in a single-use package.
Aslanian teaches an assembly (embodiment 200, see Fig. 17) wherein the first tubing element (spike 208 and chamber 210), the administration set (tubing 226 and 240), and the adjustable flow rate controller (flow control device 202) are packaged in a single-use package (see col. 8 line 49 - col. 9 line 5 and col. 11 lines 31-52).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sealfon such that the first tubing element, the administration set, and the adjustable flow rate controller are packaged in a single-use package, as taught by Aslanian, in order to provide a simply constructed, disposable, sterilized device that minimizes cross-contamination and is used more efficiently (see Aslanian col. 11 lines 31-52).
Claims 82-83 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon et al. (US 2016/0256625 A1) in view of Douglas et al. (US 2002/0055722 A1), as applied to claim 81 above, further in view of Sims et al. (US 2011/0092908 A1).
Regarding claim 82, modified Sealfon teaches the assembly of claim 81 substantially as claimed. However, modified Sealfon fails to explicitly state wherein the pressurizing mechanism includes a substantially constant force spring mechanism in contact with a pressurizer and an actuator to gradually load the substantially constant force spring mechanism.
Sims teaches a pressurizing mechanism (device 10, IV line 102, and IV needle 104, see Figs. 1-10), wherein the pressurizing mechanism (device 10) includes a substantially constant force spring mechanism (force-delivery element 50) in contact with a pressurizer (plunger 62) and an actuator (puller 40) to gradually load the substantially constant force spring mechanism (force-delivery element 50) (see par. [0040] and [0054]-[0055]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressurizing mechanism of the assembly of modified Sealfon to include a substantially constant force spring mechanism in contact with a pressurizer and an actuator to gradually load the substantially constant force spring mechanism, in order to provide the structural mechanism for delivering the specific infusion molecule (see Sims abstract).
Regarding claim 83, modified Sealfon teaches the assembly of claim 82 substantially as claimed. Modified Sealfon further teaches wherein the substantially constant force spring mechanism (Sims, force-delivery element 50) comprises one or two springs (see Sims par. [0040]), the pressurizer (Sims, plunger 62) comprises a plunger (see Sims par. [0054]-[0055]), and the actuator (Sims, puller 40) comprises a lever and a ratcheting mechanism (see Sims par. [0043], puller 40 engages with a frame 12 which includes ramped engagement surfaces (lever) and bumps/detents (ratcheting mechanism) for transferring movement) (see previous modifications to Sealfon in view of Sims in the rejection of claim 82 above).
Claims 84-85 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon et al. (US 2016/0256625 A1) in view of Douglas et al. (US 2002/0055722 A1), as applied to claim 57 above, further in view of Aslanian et al. (US 4,361,147 A) and further in view of Thome, Jr. et al. (US 2009/0306621 A1).
Regarding claim 84, modified Sealfon teaches the assembly of claim 57 substantially as claimed. However, modified Sealfon fails to explicitly state wherein the administration set and the adjustable flow rate controller are packaged and labeled in a single-use package for the specific infusion molecule.
Aslanian teaches an assembly (embodiment 200, see Fig. 17) wherein the administration set (tubing 226 and 240) and the adjustable flow rate controller (flow control device 202) are packaged in a single-use package for the specific infusion molecule (see col. 8 line 49 - col. 9 line 5 and col. 11 lines 31-52).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sealfon such that the administration set and the adjustable flow rate controller are packaged in a single-use package for the specific infusion molecule, as taught by Aslanian, in order to provide a simply constructed, disposable, sterilized device that minimizes cross-contamination and is used more efficiently (see Aslanian col. 11 lines 31-52).
However, modified Sealfon still fails to state wherein the administration set and the adjustable flow rate controller are labeled for the specific infusion molecule.
Thome, Jr. teaches an assembly (assembled kit 100, see Figs. 3-4) wherein the assembly (assembled kit 100) is labeled for the specific infusion molecule (see par. [0079]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sealfon, which includes the administration set and the adjustable flow rate controller, to be labeled for the specific infusion molecule, as suggested by Thome, Jr. in order to provide a sealed, labeled, and sterilized kit which is convenient for transport and use by the user (see Thome, Jr. par. [0079]).
Regarding claim 85, modified Sealfon teaches the assembly of claim 84 substantially as claimed. Sealfon further teaches wherein the scale (visual guide strip 700) of the adjustable flow rate controller (adjustable flow rate controller 110) would not indicate an actual flow rate of a different liquid than the specific infusion molecule to the infusion site through the administration set (needle system 118) (see par. [0102]-[0106] and [0112], the visual guide strip 700 is calibrated to display flow rates for a specific fluid having a defined fluid viscosity, pressure, and temperature).
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon et al. (US 2016/0256625 A1) in view of Aslanian et al. (US 4,361,147 A), further in view of Thome, Jr. et al. (US 2009/0306621 A1), and further in view of Douglas et al. (US 2002/0055722 A1).
Regarding claim 88, Sealfon discloses a pre-connected, inseparable assembly (precision variable flow rate infusion system PVFRIS 100, see Figs. 1-4 and 7, par. [0087]-[0088]) for delivering a specific immunoglobulin (see par. [0087], note: Hizentra® is an immunoglobulin) to a patient and having a known maximum flow rate through the assembly for the specific immunoglobulin (see par. [0032]-[0033], [0050], and [0087]), the assembly comprising:
a first tubing element (first flexible flow rate tubing 108) sized to deliver the known maximum flow rate (see Figs. 1-4, par. [0051]);
an administration set (second flexible flow rate tubing 120 and needle sets 118), including a second tubing element (second flexible flow rate tubing 120) inseparably connected to a needle set (needle sets 118), serving at least two infusion sites (see par. [0051], [0084], and [0087]-[0088]);
an adjustable flow rate controller (adjustable flow rate controller 110) disposed between the first tubing element (first flexible flow rate tubing 108) and the second tubing element (second flexible flow rate tubing 120) and having a scale (visual guide strip 700) to indicate an actual flow rate of the specific immunoglobulin to each of the at least two infusion sites (see Fig. 7, par. [0087] and [0102]-[0106], visual guide strip 700 can include a range of numbers corresponding to different flow rates and is calibrated to the specific immunoglobulin) and the adjustable flow rate controller (adjustable flow rate controller 110) being adjustable such that the actual flow rate to the at least two infusion sites can be adjusted and the scale (visual guide strip 700) correspondingly reflects the adjusted actual flow rate to each of the at least two infusion sites (see Fig. 7, par. [0068]-[0069], [0106], and [0112], visual guide strip 700 can include a range of numbers corresponding to different flow rates and reflects the flow rate for the entire assembly); and
a manifold (structure of separation between single outlet 114 and two or more needles, see par. [0087]) between the adjustable flow rate controller (adjustable flow rate controller 110) and the administration set (second flexible flow rate tubing 120 and needle sets 118) to divide a flow between the at least two infusion sites (see Figs. 1-2, par. [0087]).
However, Sealfon fails to explicitly state wherein the assembly is packaged in a single-use package and labeled for the specific immunoglobulin. Additionally, while Sealfon further teaches that the second tubing element (second flexible flow rate tubing 120) is inseparably connected to the needle set (needle set(s) 118) (see par. [0087]) and that the second tubing element (second flexible flow rate tubing 120) and the needle set (needle set(s) 118) are specifically structured to connect only with each other (see par. [0084]), Sealfon fails to state the second tubing element inseparably connected to a needle set without a luer connection.
Aslanian teaches an assembly (embodiment 200, see Fig. 17) wherein the assembly (embodiment 200, see Fig. 17) is packaged in a single-use package (see col. 8 line 49 - col. 9 line 5 and col. 11 lines 31-52).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of Sealfon to be packaged in a single-use package, as taught by Aslanian, in order to provide a simply constructed, disposable, sterilized device that minimizes cross- contamination and is used more efficiently (see Aslanian col. 11 lines 31-52).
However, modified Sealfon still fails to explicitly state wherein the assembly is labeled for the specific immunoglobulin. Additionally, while Sealfon further teaches that the second tubing element (second flexible flow rate tubing 120) is inseparably connected to the needle set (needle set(s) 118) (see par. [0087]) and that the second tubing element (second flexible flow rate tubing 120) and the needle set (needle set(s) 118) are specifically structured to connect only with each other (see par. [0084]), Sealfon fails to state the second tubing element inseparably connected to a needle set without a luer connection.
Thome, Jr. teaches an assembly (assembled kit 100, see Figs. 3-4) wherein the assembly (assembled kit 100) is labeled for the specific drug (see par. [0079]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sealfon to be labeled for the specific immunoglobulin, as suggested by Thome, Jr. in order to provide a sealed, labeled, and sterilized kit which is convenient for transport and use by the user (see Thome, Jr. par. [0079]).
However, while Sealfon further teaches that the second tubing element (second flexible flow rate tubing 120) is inseparably connected to the needle set (needle set(s) 118) (see par. [0087]) and that the second tubing element (second flexible flow rate tubing 120) and the needle set (needle set(s) 118) are specifically structured to connect only with each other (see par. [0084]), Sealfon fails to state the second tubing element inseparably connected to a needle set without a luer connection.
Douglas teaches an assembly (see Fig. 1) comprising a tubing element (tube 1 and hub 95) inseparably connected to a needle set (needle 5) without a luer connection (see par. [0040]-[0042]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sealfon such that the second tubing element is inseparably connected to the needle set without a luer connection, as taught by Douglas, as an alternative means to provide the inseparable and specific connection between the second tubing element and the needle set (see Sealfon par. [0084] and [0087] and Douglas par. [0040]-[0042]) and to potentially reduce costs associated with manufacturing and assembling the device (see Douglas par. [0040]-[0042]).
Response to Arguments
Applicant’s arguments with respect to claim 57 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to claims 73 and 80 have been fully considered but they are not persuasive.
Regarding claim 73, Applicant’s argument is based on an interpretation of the Sealfon reference and how it applied to the previous version of claim 73 filed on 12/30/2024. However, claim 73 has been amended and the scope has changed. The Examiner interprets that Sealfon still teaches the amended version of claim 73 for the reasons described in the rejection of claim 73 above.
Regarding claim 80, Applicant argues that Sealfon fails to describe a manifold. However, this argument is not found to be persuasive. In paragraph [0087] and Figs. 1-2, Sealfon shows/describes a tubing 120, one or multiple needle sets 118, and an outlet 114/connector 218 in between the tubing 120 and the one or multiple needle sets 118. In situations with multiple needle sets 118, the outlet 114/connector 218 must be a manifold to connect the single tubing 120 to the multiple needle sets 118.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783