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 16 July 2026 has been entered. Claim(s) 1-3 and 5-21 remain pending in this application. Claim(s) 4 has been cancelled. Claim(s) 21 is new.
The amendment to the claims has overcome the claim objections and §112(b) rejections set forth in the office action mailed 25 March 2026.
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) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon (U.S. Patent No. 10,420,886), hereinafter Sealfon in view of Sealfon (U.S. Patent No. 10,709,839), hereinafter Sealfon ‘839.
Regarding Independent Claim 1, Sealfon discloses an apparatus (Figure 1) configured to deliver a therapeutic medication to a patient (Column 1, Lines 54-65 – the apparatus provides a therapeutic agent/medication to a patient), the apparatus comprising:
a reservoir (Column 2, Lines 40-45 – the syringe that contains the medication is a reservoir) containing a therapeutic medication (Column 2, Lines 40-45 – the syringe contains the medication);
a patient interface, 22, configured to deliver contents of the reservoir into the body of the patient (Column 4, Lines 35-37 – the interface, 22, delivers the medication from the reservoir into the patient);
a flexible tubing set, 21, 31, 32, 33, 41, 42 and 43, in fluid communication with the reservoir at a proximal end of the flexible tubing set (Column 2, lines 40-45 – the tubing set is connected to the syringe/reservoir at the connector, 43, which is a proximal end of the tubing set), and the patient interface at a distal end of the flexible tubing set (Figure 1 – the patient interface, 22, is located at the end of the tubing set opposite the proximal end and therefore is located at the distal end of the tubing set); and
a fluid pump (Column 2, Lines 40-45 – the apparatus includes a syringe pump, which is a fluid pump) configured to expel the therapeutic medication from the reservoir through the flexible tubing set and into the patient interface (Column 2, Lines 40-45 and Column 4, Lines 35-37 – the pump expels the medication through the tubing set to the patient),
wherein the flexible tubing set comprises a predetermined length and an internal lumen comprising a consistent internal diameter (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – the tubing set has a predetermined length and internal diameter over the length of the tubing), the flexible tubing set configured to provide a predetermined, calibrated flow rate based on specific characteristics of the therapeutic medication passing through the internal lumen (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – tubing set has a pre-set/calibrated flow rate based on the viscosity of the medication as it passes through the predetermined length and diameter of the tubing), the specific characteristic being viscosity (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – the pre-set flow rate uses viscosity as a characteristic that determines the flow rate through the tubing).
Sealfon does not disclose at least one filter in fluid communication with the flexible tubing set.
However, Sealfon ‘839 teaches a system for infusing a medication (Title) with a flexible tubing set, 108 and 118, and at least one filter in fluid communication with the flexible tubing set (Column 12, Lines 48-51 – a filter is provided for the flow into the flexible tubing set).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon by including at least one filter in fluid communication with the flexible tubing set, as taught by Sealfon ‘839, in order to filter containments from the liquid before entering the tubing set (Sealfon ‘839 – Column 12, Lines 48-51).
Regarding Claim 2, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon further discloses the fluid pump comprises a substantially constant pressure device (Column 2, Lines 55-63 – the pump is a constant pressure pump).
Regarding Claim 15, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. It is noted that the limitation “the reservoir is administered by the fluid pump only after elapse of a pre-determined time delay” is intended use of the structure claimed as it describes how the structure is being used in method steps – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Further the structure of Sealfon would be capable of being used as claimed. Thus Sealfon discloses the limitations of the claim.
Regarding Claim 16, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 disclose as discussed so far, do not disclose the flexible tubing set is configured to provide a flow rate less than a flow rate at which a therapeutic medication may cause an infusion reaction.
However, Sealfon ‘839 teaches the tubing set is configured to provide a flow rate less than a flow rate at which a therapeutic medication may cause an infusion reaction (Column 3, Lines 43-48Column 4, Lines 11-32 – the predefined flowrate of the tubing is less than the maximum dosage flowrate of the medication that would be dangerous to the patient).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the predetermined flow rate less than a flow rate at which a therapeutic medication may cause an infusion reaction, as taught by Sealfon ‘839, in order to provide a safeguard against overdose (Sealfon – Column 1, Lines 14-19).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Cawthon (U.S. Pre-grant Publication 2019/0388611), hereinafter Cawthon.
Regarding Claim 3, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon does not disclose the fluid pump comprises a substantially constant flow device.
However, Cawthon teaches an infusion apparatus (Title) with a fluid pump that is a constant flow device (Paragraph 0078 – the pump is a constant flow rate pump).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the fluid pump a constant flow device, as taught by Cawthon, in order to have a pump that meets a specific target flow rate with high accuracy (Cawthon – Paragraph 0078).
Claim(s) 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Gibson (U.S. Pre-grant Publication 2019/0022306), hereinafter Gibson.
Regarding Claim 5, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the therapeutic medication exhibits a substantially non-Newtonian fluid.
However, Gibson teaches a medication delivery device (Title) where the therapeutic medication exhibits a substantially non-Newtonian fluid (Paragraph 0285 – the medication is a non-Newtonian fluid).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the therapeutic medication a substantially non-Newtonian fluid, as taught by Gibson, since it has been held that the selection of a known material (in the present case a non-Newtonian fluid) based on its suitability for its intended use (providing the desired medication) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Regarding Claim 6, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the therapeutic medication exhibits a non-linear relationship between viscosity and shear stress.
However, Gibson teaches a medication delivery device (Title) where the therapeutic medication exhibits a non-linear relationship between viscosity and shear stress (Paragraph 0285 – the medication is a non-Newtonian fluid with shear thinning; further since the fluid is non-Newtonian the relationship between viscosity and shear stress is nonlinear).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the therapeutic medication a substantially non-Newtonian fluid, as taught by Gibson, since it has been held that the selection of a known material (in the present case a medication with a non-linear relationship between viscosity and shear stress/non-Newtonian fluid) based on its suitability for its intended use (providing the desired medication) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Regarding Claim 7, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the therapeutic medication exhibits non-linear viscosity changes based on temperature of the medication.
However, Gibson teaches a medication delivery device (Title) where the therapeutic medication exhibits non-linear viscosity changes based on temperature of the medication (Paragraphs 0285 and 0694 – the medication is a non-Newtonian fluid whose viscosity changes based on temperature, therefore due to the medication being non-Newtonian the relationship between viscosity and temperature is non-linear).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the therapeutic medication a substantially non-Newtonian fluid, as taught by Gibson, since it has been held that the selection of a known material (in the present case a medication with a non-linear viscosity changes based on temperature of the medication/non-Newtonian fluid) based on its suitability for its intended use (providing the desired medication) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Regarding Claim 8, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the therapeutic medication is a biologic, recombinant therapeutic protein, gene therapy, monoclonal antibody, antibody-drug conjugate, or fusion protein.
However, Gibson teaches a medication delivery device (Title) where the therapeutic medication is a biologic (Paragraph 0285 – the medication is a biologic).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the therapeutic medication a biologic, as taught by Gibson, since it has been held that the selection of a known material (in the present case a biologic medication) based on its suitability for its intended use (providing the desired medication) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Oshinski (Foreign Patent Publication WO 2019/183088), hereinafter Oshinski.
Regarding Claim 9, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the fluid pump is disposable and designed for one-time use.
However, Oshinski teaches a medical infusion pump (Title) that is disposable (Paragraph 0071 – the pump is disposable) and designed for a one-time use (The limitation is intended use – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) – In this case any pump is capable of being used for only one-time thus unless addition structure is claimed the already disclosed structure meets the claimed limitations).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the fluid pump disposable, as taught by Oshinski, in order to eliminate cleaning, sterilizing, and tracking costs (Oshinski – Paragraph 0071).
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Admani (U.S. Pre-grant Publication 2019/0143031), hereinafter Admani.
Regarding Claim 10, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the fluid pump is reusable and designed for multiple-time use.
However, Admani teaches a fluid pump (Title) that is reusable and designed for multiple-time use (Paragraph 0027 – the pump is reusable and thus can be used multiple times).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the fluid pump reusable and designed for multiple-time use, as taught by Admani, in order to lower costs (Admani – Paragraph 0027).
Regarding Claim 11, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the fluid pump is reusable and designed for use over a course of a single cycle of a medication regimen.
However, Admani teaches a fluid pump (Title) that is reusable (Paragraph 0027 – the pump is reusable and thus can be used multiple times) and designed for use over a course of a single cycle of a medication regimen (The limitation is intended use – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) – In this case any reusable pump is capable of being used for over a course of a single cycle of a medication regimen; thus unless addition structure is claimed the already disclosed structure meets the claimed limitations).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the fluid pump reusable and designed for use over a course of a single cycle of a medication regimen, as taught by Admani, in order to lower costs (Admani – Paragraph 0027).
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Pesach (U.S. Patent No. 9,220,837), hereinafter Pesach.
Regarding Claim 12, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose a controller that is reusable and designed for use over the course of a single cycle of a medication regimen.
However, Pesach teaches a medication delivery system (Title) with a controller (Column 2, Lines 53-60 – the system includes a processor/controller) that is reusable (Column 12, Lines 43-56 – the controller/processor is reusable) and designed for use over the course of a single cycle of a medication regimen (The limitation is intended use – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) – In this case any reusable pump is capable of being used for over a course of a single cycle of a medication regimen; thus unless addition structure is claimed the already disclosed structure meets the claimed limitations).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by including a controller that is reusable and designed for use over a course of a single cycle of a medication regimen, as taught by Pesach, in order to reduce the variability of the drug delivery process (Pesach – Column 2, Lines 53-60).
Regarding Claim 13, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose a controller that is disposable and designed for one-time use.
However, Pesach teaches a medication delivery device (Title) with a controller (Column 2, Lines 53-60 – the system includes a processor/controller) that is disposable (Column 6, Lines 1-11 – the control unit/controller is disposable) and designed for one-time use (The limitation is intended use – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) – In this case any pump is capable of being used for only one-time thus unless addition structure is claimed the already disclosed structure meets the claimed limitations).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by including a controller that is disposable and designed for one-time use, as taught by Pesach, in order to reduce the variability of the drug delivery process (Pesach – Column 2, Lines 53-60).
Regarding Claim 14, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose a controller that is reusable and designed for multiple-time use.
However, Pesach teaches a medication delivery system (Title) with a controller (Column 2, Lines 53-60 – the system includes a processor/controller) that is reusable and designed for multiple-time use (Column 12, Lines 43-56 – the controller/processor is reusable and thus can be used multiple times).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by including a controller that is reusable and designed for multiple-time use, as taught by Pesach, in order to reduce the variability of the drug delivery process (Pesach – Column 2, Lines 53-60).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of RMS Medical Products (Non-Patent Literature – Freedom 60 Syringe Infusion System), hereinafter RMS.
Regarding Claim 17, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon further discloses a plurality of flexible tubing sets comprising the flexible tubing set and an at least second flexible tubing set (Figure 1 – the flexible tubing set, 21, 31, 32, 33, 41, 42 and 43, includes at least two tubing sets the first set, 21, 31, 32 and 33, and the second set, 41, 42 and 43).
Sealfon in view of Sealfon ‘839 do not disclose wherein at least one flexible tubing set of the plurality of flexible tubing sets is labeled with an actual flow rate in mL/hour of the therapeutic medication at room temperature based on an experimentally determined concentration-temperature-viscosity relationship.
However, RMS teaches a precision infusion system (Title) with tubing sets (Page 2, Figure and Table “RMS Precision Flow Rate Tubing”) that is labeled with an actual flow rate in mL/hour of the therapeutic medication (Page 2, Figure and Table “RMS Precision Flow Rate Tubing” and Page 4, Sections “Checking Infusion Progress” and “Administering Subcutaneous Immunoglobulin (SCIg)” the tubing is labeled with a flow rate/identification that is used to determine the flow rate of the medication) at room temperature based on an experimentally determined concentration-temperature-viscosity relationship (Page 7, “Technical Specifications”, Lines 9-12 – the flow rate is determined based on data record/experiments that take into account temperature, viscosity and concentration data).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making at least one flexible tubing set of the plurality of flexible tubing sets is labeled with an actual flow rate in mL/hour of the therapeutic medication at room temperature based on an experimentally determined concentration-temperature-viscosity relationship, as taught by RMS, in order to ensure proper infusion of the medication in a proper amount of time (RMS – Page 4, Section “Administering Subcutaneous Immunoglobulin (SCIg)”).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Sealfon in view of Sealfon ‘839 as applied to claim 1 above, and further in view of Boyle (U.S. Patent No. 10,729,825), hereinafter Boyle.
Regarding Claim 21, Sealfon in view of Sealfon ‘839 disclose the invention as claimed and discussed above. Sealfon in view of Sealfon ‘839 do not disclose the tubing set comprises a lubricious coating on its exterior.
However, Boyle teaches a medical tubing set, 100, that comprises a lubricious coating on its exterior (Column 26, Lines 56-61 – the exterior of the tube has a friction-reducing agent/lubricious coating).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Sealfon in view of Sealfon ‘839 by making the tubing set comprise a lubricious coating on its exterior, as taught by Boyle, in order to reduce the friction of the tubing (Boyle – Column 26, Lines 56-61).
Claim(s) 1, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nystrom (U.S. Patent No. 9,511,186), hereinafter Nystrom, in view of Sealfon and Sealfon ‘839.
Regarding Independent Claim 1, Nystrom discloses an apparatus (Figure 2A) configured to deliver a therapeutic medication to a patient (Abstract – the apparatus provides a fluid to a patient and thus is capable of delivering a therapeutic medication), the apparatus comprising:
a reservoir, 232A, containing a fluid (Column 2, Lines 40-45 – the reservoir contains the fluid);
a patient interface (the end of the patient line, 269, is the patient interface) configured to deliver contents of the reservoir into the body of the patient (Column 3, Lines 27-34 – the line, 269, is a patient line therefore the patient interface at the end of the patient line provides the fluid into the body of the patient);
a flexible tubing set, 217I, 227I, 265, 269 and 274, in fluid communication with the reservoir at the proximal end (the flexible tubing set is connected to the reservoir, 232A, at the left/proximal end connected to the pump, 230) and the patient interface at a distal end of the flexible tubing set (Figure 2A – the patient interface is located at the end of the tubing set opposite the proximal end and therefore is located at the distal end of the tubing set).
Nystrom does not disclose the fluid being a therapeutic medication; at least one filter in fluid communication with the flexible tubing set or wherein the flexible tubing set comprises a predetermined length and an internal lumen comprising a consistent internal diameter, the flexible tubing set configured to provide a predetermined, calibrated flow rate based on specific characteristics of the therapeutic medication passing through the internal lumen, the specific characteristics selected from the group consisting of viscosity, shear thinning behaviors, shear thickening behaviors, desired delivery time to the patient, and combinations thereof.
However, Sealfon teaches an apparatus (Figure 1) configured to deliver a therapeutic medication to a patient (Column 1, Lines 54-65 – the apparatus provides a therapeutic agent/medication to a patient).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Nystrom by making the fluid a therapeutic medication, as taught by Sealfon, since it has been held that the selection of a known material (in the present case a therapeutic medication) based on its suitability for its intended use (providing a fluid provided through an injection system) would have been an obvious extension of prior art teachings. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960), MPEP 2144.07.
Sealfon further teaches a flexible tubing set, 21, 31, 32, 33, 41, 42 and 43, in fluid communication with a reservoir (Column 2, Lines 40-45 – the syringe that contains the medication is a reservoir) wherein the flexible tubing set comprises a predetermined length and an internal lumen comprising a consistent internal diameter (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – the tubing set has a predetermined length and internal diameter over the length of the tubing), the flexible tubing set configured to provide a predetermined, calibrated flow rate based on specific characteristics of the therapeutic medication passing through the internal lumen (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – tubing set has a pre-set/calibrated flow rate based on the viscosity of the medication as it passes through the predetermined length and diameter of the tubing), the specific characteristic being viscosity (Column 2, Line 64 – Column 3, Line 18 and Column 8, Line 56-62 – the pre-set flow rate uses viscosity as a characteristic that determines the flow rate through the tubing).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Nystrom in view of Sealfon by replacing the flexible tubing set with a flexible tubing set, as taught by Sealfon, resulting in the flexible tubing set comprising a predetermined length and an internal lumen comprising a consistent internal diameter, the flexible tubing set configured to provide a predetermined, calibrated flow rate based on specific characteristics of the therapeutic medication passing through the internal lumen, the specific characteristic being viscosity in order to provide an affordable system that allows the user to vary the rate of administration with ease (Sealfon – Column 1, Lines 48-50).
Nystrom in view of Sealfon do not disclose at least one filter in fluid communication with the flexible tubing set.
However, Sealfon ‘839 teaches a system for infusing a medication (Title) with a flexible tubing set, 108 and 118, and at least one filter in fluid communication with the flexible tubing set (Column 12, Lines 48-51 – a filter is provided for the flow into the flexible tubing set).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Nystrom in view of Sealfon by including at least one filter in fluid communication with the flexible tubing set, as taught by Sealfon ‘839, in order to filter containments from the liquid before entering the tubing set (Sealfon ‘839 – Column 12, Lines 48-51).
Regarding Claim 18, Nystrom in view of Sealfon and Sealfon ‘839 disclose the invention as claimed and discussed above. Nystrom further discloses the apparatus comprising a plurality of reservoirs comprising the reservoir, 232A, 232B and 238.
Thus the combination of Nystrom in view of Sealfon, as discussed above, would result in a plurality of reservoirs, each containing one or more therapeutic medications.
Regarding Claim 20, Nystrom in view of Sealfon and Sealfon ‘839 disclose the invention as claimed and discussed above. Nystrom further discloses fluid communication between one or more of the plurality of reservoirs and the proximal end of the flexible tubing set is provided by a manifold (the manifold, 224, connects the plurality of reservoirs to the proximal end of the tubing set).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nystrom in view of Sealfon and Sealfon ‘839 as applied to claim 18 above, and further in view of Admani.
Regarding Claim 19, Nystrom in view of Sealfon and Sealfon ‘839 disclose the invention as claimed and discussed above. Nystrom in view of Sealfon and Sealfon ‘839 do not disclose the fluid pump is reusable and designed for use over a course of a single cycle of a medication regimen.
However, Admani teaches a fluid pump (Title) that is reusable (Paragraph 0027 – the pump is reusable and thus can be used multiple times) and designed for use over a course of a single cycle of a medication regimen (The limitation is intended use – It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex paste Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) – In this case any reusable pump is capable of being used for over a course of a single cycle of a medication regimen; thus unless addition structure is claimed the already disclosed structure meets the claimed limitations).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Nystrom in view of Sealfon and Sealfon ‘839 by making the fluid pump reusable and designed for use over a course of a single cycle of a medication regimen, as taught by Admani, in order to lower costs (Admani – Paragraph 0027).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new grounds of rejection set forth herein.
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.
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/KYLE ROBERT THOMAS/Examiner, Art Unit 3741
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