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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/25/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 02/25/2026. As directed by the amendment: claims 1, 8, 17, 20, 33, and 35-36 have been amended, claims 16, 19, and 34 have been cancelled, and claims 37-39 have been added. Thus, claims 1-15, 18, 20-33, and 35-39 are presently pending in this application. Applicant’s amendments to the specification and claims have overcome each and every objection, 112(a) rejection, and some of the 112(b) rejections set forth in the Final Office Action mailed on 08/26/2025. The 112(b) rejections for claims 33 and 36 have been maintained. Examiner invites applicant to set up an interview to discuss amendments to overcome the prior art.
The examiner notes that the amended claims contain language which is incorrectly marked based upon the previously filed claims. For example, “compring an electromechanical air pump” in lines 10-11 of claim 1 should read “comprising an electromechanical air pump”. The examiner respectfully notes that all claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version (MPEP 714). The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 33, and 35-36 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.
Examiner notes in response to the argument on p.3-4 of “Remarks” filed on 02/25/2026 arguing the rejection of record improperly combines references directed to fundamentally incompatible device categories, the examiner respectfully disagrees. The primary references below teach the handheld, multi-use, closed-loop infusion pumping system as claimed, and the teaching references are analogous art providing teachings with motivation for proper obviousness rejections. Examiner further notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, the teachings references provided below are analogous references that a person of ordinary skill in the art would have been able to utilize as teachings for modifying the primary reference to teach the claim limitations.
Claim Objections
Claims 1 and 35-36 are objected to because of the following informalities:
Regarding claim 1, the phrase “compriing” in lines 10-11 should read “comprising” for proper grammar,
Regarding claim 35, the phrase “the pressure delivery chamber the movable delivery element” in lines 7-8 should read “the pressure delivery chamber, the movable delivery element” to add a comma for proper grammar,
Regarding claim 36, the phrase “the pressure delivery chamber the movable delivery element” in line 12 should read “the pressure delivery chamber, the movable delivery element” to add a comma for proper grammar,
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18, 20, 33, and 36-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the phrases “a pressure delivery chamber pressure sensor” in line 2, “a first pressure value” in line 3, and “a second pressure value” in line 8 render the claim indefinite because they are unclear. It is unclear whether this pressure delivery chamber pressure sensor and the first pressure value it generates are the same sensor and value aforementioned in claim 1 or if they are different. Examiner is interpreting them as the same sensor and value. It is further unclear whether the second pressure value is the same second pressure value aforementioned in claim 1 or if it is different. Examiner is interpreting this as a different, third pressure value wherein the control sub-system calculates the amount of medical fluid within the medication chamber based on a differential pressure measurement using the first pressure value and the third pressure value.
Claim 20 recites the limitation "the pneumatic pump" in 1. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to recite “the electromechanical air pump is a piezoelectric air pump”
Regarding claims 33, the phrase “the medication chamber configured to receive an external medical container storing medicinal fluid, the external medication container having an outlet forming a fluid communication path to the patient” in lines 5-7 renders the claim indefinite because it is unclear. Para. 0039 and Fig. 2 discloses “the medication chamber 144 comprises a lid 210 which may be opened such that a container such as a pre-filled syringe 220 can be inserted therein. The pre-filled syringe can, in some variations, be mechanically and fluidically coupled to the fluid delivery system 102 using a mechanical connector 230 (such as a Luer lock compatible with threads on a tip of the pre-filled syringe or a proprietary connector) thus forming part of the medication chamber 144.” If the medication chamber 144 is the chamber within lid 210 as seen in Fig. 2 and it is configured to receive a pre-filled syringe 220 forming part of the medication chamber 144, then it becomes unclear from the block diagram of Fig. 1 where the pressure delivery chamber 140 and the movable delivery element 142 are located such that the medication chamber 144 is fluidically isolated from the pressure delivery chamber and the movable delivery element 142 being disposed between the medication chamber 144 and the pressure delivery chamber 140 claimed in claim 33. Examiner is interpreting external medical container (syringe 220) having an internal chamber that is the medication chamber (144) such that the external medical container stores the medicinal fluid and has an outlet forming a fluid communication path to the patient.
Regarding claim 33, the phrase “between a medication chamber” in line 8 renders the claim indefinite because it is unclear. It is unclear whether this is a different medication chamber or the aforementioned medication chamber. Examiner is interpreting it as the aforementioned medication chamber.
Regarding claim 36, the phrase “a housing having a shape and size to be handheld and to receive and secure a medication container, the medication container being a pre-filled syringe without a plunger, the housing comprising a hinged lid to secure the medication container” in liens 2-4 and “a medication chamber within the housing having a variable volume and fluidically isolated from the pressure delivery chamber” in lines 7-9 render the claim indefinite because it is unclear. From Fig. 3, the housing shown in Fig. 3 such as that formed by lid 210 and the fluid delivery system 102 is sized and shaped to receive the pre-filled syringe 220, with the medication chamber 144 being labelled as an interior chamber formed by lid 210 and system 102. Firstly, if the medication chamber 144 is the chamber within lid 210 as seen in Fig. 2 and it is configured to receive a pre-filled syringe 220 forming part of the medication chamber 144, then it becomes unclear from the block diagram of Fig. 1 where the pressure delivery chamber 140 and the movable delivery element 142 are located meet the claim limitations. Further, para. 0039 states “in other variations, the medical container such as the pre-filled syringe does not form part of the medication chamber 144. For example, with reference to FIG. 3, initially the pre-filled syringe is connected to coupler 240 which is configured to interconnect hermetically with connector 230.” If the pre-filled syringe 220 does not form part of the medication chamber 144, then it becomes unclear from the block diagram of Fig. 1 where the pressure delivery chamber 140 and the movable delivery element 142 are located such that the medication chamber 144 is fluidically isolated from the pressure delivery chamber and the movable delivery element 142 being disposed between the medication chamber 144 and the pressure delivery chamber 140 in claim 36. Examiner is interpreting the pre-filled syringe (syringe 220) as having an internal chamber that is the medication chamber (144) such that the pre-filled syringe stores the medicinal fluid and has an outlet forming a fluid communication path to the patient.
Regarding claim 36, the phrase “a handheld housing” in line 23 renders the claim indefinite because it is unclear if this is a different housing or the aforementioned housing in line 2 of claim 36. Examiner is interpreting this as the same housing introduced in line 2.
Regarding claim 37, the phrase “the housing comprising a hinged lid configured to open to receive a pre-filled syringe without an integral plunger and close to secure the prefilled syringe” in lines 3-5 and “a medication chamber within the housing having a variable volume and fluidically isolated from the pressure delivery chamber, the pre-filled syringe being configured to couple to and form part of the medication chamber when secured, the medication chamber having an outlet forming a fluid communication path to the patient” in lines 8-11 render the claim indefinite because it is unclear. Firstly, if the medication chamber 144 is the chamber within lid 210 as seen in Fig. 2 and it is configured to receive a pre-filled syringe 220 forming part of the medication chamber 144, then it becomes unclear from the block diagram of Fig. 1 where the pressure delivery chamber 140 and the movable delivery element 142 are located meet the claim limitations. Secondly, it is unclear how the pre-filled syringe would be coupled to the medication chamber if it also forms a part of the medication chamber. Examiner is interpreting the pre-filled syringe (syringe 220) as having an internal chamber that is the medication chamber (144) such that the pre-filled syringe stores the medicinal fluid and has an outlet forming a fluid communication path to the patient.
Regarding claim 37, the phrase “wherein the housing encapsulates… the user interface” in lines 44-48 render the claim indefinite because it is unclear. It is unclear how the user interface comprising an electronic display and at least one input element are to be encapsulated in the housing if the user is intended to actuate the at least one input element. Examiner is interpreting this limitation as the housing partially encapsulates the user interface in such a way that it is still accessible to a user.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 33 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Menz et al. (U.S Patent Pub. No. 20220273876 A1, “Menz”)
Regarding claim 33, Menz discloses the limitations of a system (1 in at least Fig. 1-3) for delivering a medicinal fluid to a patient (see para. 0045) comprising:
a pressure delivery chamber having a variable volume and configured to store pressure controllably (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the right-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the pressure delivery chamber as its volume changes as it stores pressure and the plunger 5 displaces);
a medication chamber having a variable volume and fluidically isolated from the pressure delivery chamber (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the left-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the medication chamber as varies in volume with the substance to be delivered as the plunger 5 is displaced and its fluidically isolated from the right-hand chamber by the plunger 5), the medication chamber configured to receive an external medical container (3 in Fig. 3) storing medicinal fluid (examiner notes this limitation is being interpreted in light of the 112(b) rejection as the external medical container has an internal chamber that is the medication chamber such that the external medical container stores the medicinal fluid and has an outlet forming a fluid communication path to the patient, see annotated Menz drawing 1 below for medication chamber, see Fig. 3 and para. 0046 – external medical container is in the form of a detachable syringe 3 which has an internal container on the right-hand side of the plunger 5 forming the medication chamber for storing the medicinal fluid), the external medication container (3 in Fig. 3) having an outlet (6 in Fig. 3) forming a fluid communication path to the patient
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(see para. 0054);
a movable delivery element (5 in Fig. 3) disposed between the medication chamber and the pressure delivery chamber (see annotated Menz drawing 1 above for chambers and para. 0054), the movable delivery element (5) having a shape and size to fluidically isolate the medication chamber and the pressure delivery chamber (see Fig. 3 and para. 0054);
a pressure source (9 in Fig. 3) coupled to the pressure delivery chamber (see annotated Menz drawing 1 above, Fig. 3, and para. 0049 and 0051 – pressure source 9 is an electrically operated diaphragm pump coupled to the right-hand chamber of syringe barrel 4 by tubing 13), the pressure source (9) comprising an elastomeric device that is pressurized with an impelling fluid (see para. 0017 – pressure source 9 is in the form of an electrically operated diaphragm pump which uses an impelling fluid to pressurize the diaphragm), the impelling fluid being isolated from the medicinal fluid (see para. 0017 – the diaphragm pump in pressure source 9 is fluidically isolated from medicinal fluid on the right-hand side of plunger 5), the pressure source (9) being configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (see para. 0065-0066 – the system 1 and thus the pressure source 9 are reusable wherein the syringe 3 may be replaced indicating the pressure source is configured to be utilized multiple times, the pressure source 9 may also be configured to set or limit pressure produced and thus can selectively increase or decrease pressure within the right-hand chamber of syringe barrel 4 as set);
a control sub-system configured to send signals to cause pressure to be delivered from the pressure source (9 in Fig. 3) to the pressure delivery chamber thereby causing the movable delivery element (5 in Fig. 3) to apply pressure to the medicinal fluid in the medication chamber (see annotated Menz drawing 1 above for chambers, see para. 0054 and 0066 – system 1 may incorporate a device for setting the pressure produced by the pressure source 9 interpreted as the control sub-system which would be capable of being configured to send signals incorporate the set pressure to the pressure source 9), the application of pressure to the medicinal fluid in the medication chamber causing the medicinal fluid to exit the medication chamber at the outlet (6 in Fig. 3) along the fluid communication path to the patient (see para. 0054 and 0066),
a handheld housing (2, 8 in Fig. 1-2) encapsulating each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), and the control sub- system (see annotated Menz drawing 1 above for chambers, see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 7, 17, 25-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Menz et al. (U.S Patent Pub. No. 20220273876 A1, “Menz”) in view of Bryant et al. (U.S Patent No. 6302653 B1, “Bryant”).
Regarding claim 1, Menz discloses the limitations of a system (1 in at least Fig. 1-3) for delivering a medicinal fluid to a patient (see para. 0045) comprising:
a pressure delivery chamber having a variable volume and configured to store pressure controllably (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the right-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the pressure delivery chamber as its volume changes as it stores pressure and the plunger 5 displaces);
a medication chamber having a variable volume and fluidically isolated from the pressure delivery chamber (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the left-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the medication chamber as varies in volume with the substance to be delivered as the plunger 5 is displaced and its fluidically isolated from the right-hand chamber by the plunger 5), the medication chamber configured to store medicinal fluid and having an outlet (6 in Fig. 3) forming a fluid communication path to the patient (see para. 0054);
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a movable delivery element (5 in Fig. 3) disposed between the medication chamber and the pressure delivery chamber (see annotated Menz drawing 1 above for chambers and para. 0054), the movable delivery element (5) having a shape and size to fluidically isolate the medication chamber and the pressure delivery chamber (see Fig. 3 and para. 0054);
a pressure source (9 in Fig. 3) coupled to the pressure delivery chamber (see annotated Menz drawing 1 above, Fig. 3, and para. 0049 and 0051 – pressure source 9 is an electrically operated diaphragm pump coupled to the right-hand chamber of syringe barrel 4 by tubing 13), the pressure source (9) compriing electromechanical air pump that is configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (see para. 0049 – pressure source 9 is an electrically operated diaphragm pump for pumping air making it an electromechanical air pump, see para. 0065-0066 – the system 1 and thus the pressure source 9 are reusable wherein the syringe 3 may be replaced indicating the pressure source is configured to be utilized multiple times, the pressure source 9 may also be configured to set or limit pressure produced and thus can selectively increase or decrease pressure within the right-hand chamber of syringe barrel 4 as set);
a control sub-system configured to send signals to the electromechanical air pump to selectively cause pressure to be delivered from the pressure source (9 in Fig. 3) to the pressure delivery chamber (see para. 0066 – system 1 may incorporate a device for setting the pressure produced by the pressure source 9 interpreted as the control sub-system which would be capable of being configured to send signals incorporate the set pressure to the pressure source 9), causing the movable delivery element (5 in Fig. 3) to apply pressure to the medicinal fluid in the medication chamber (see para. 0054 and 0066), the application of pressure to the medicinal fluid thereby causing the medicinal fluid to exit the medication chamber at the outlet (6 in Fig. 3) along the fluid communication path to the patient (see para. 0054 and 0066),
a handheld housing (2, 8 in Fig. 1-2) encapsulating each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), and the control sub- system (see annotated Menz drawing 1 above for chambers, see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system).
However, Menz fails to disclose (Claim 1) a pressure delivery chamber pressure sensor coupled to or adjacent to the pressure delivery chamber and configured to generate a first pressure value; a reference pressure chamber having a fixed volume and a reference pressure chamber pressure sensor coupled to or adjacent to the reference pressure chamber and configured to generate a second pressure value;
the control sub-system being configured to calculate an amount of medicinal fluid within the medication chamber based on a differential pressure measurement using the first pressure value and the second pressure value; and the handheld housing encapsulating each of the pressure delivery chamber pressure sensor, the reference pressure chamber, and the reference pressure chamber pressure sensor.
Bryant discloses a system (300 in Fig. 5) for detecting the volume of fluid in a variable volume medication chamber (108 in Fig. 5) using pressure differentials (see Col.21, lines 56-67 and Col.22, lines 1-6), wherein Bryant discloses a pressure delivery chamber (110 in Fig. 5), a movable delivery element in the form of a flexible membrane (112 in Fig. 5), a pressure source (312 in Fig. 5), a reference chamber (308 in Fig. 5), and a control sub-system (324 in Fig. 5, see Col.21, lines 56-67 and Col.22, lines 1-6). Bryant teaches (Claim 1) a pressure delivery chamber pressure sensor (122 in Fig. 5) coupled to or adjacent to the pressure delivery chamber (110) and configured to generate a first pressure value (see Col.22, lines 60-62);
a reference pressure chamber (308 in Fig. 5) having a fixed volume and a reference pressure chamber pressure sensor (316 in Fig. 5) coupled to or adjacent to the reference pressure chamber (308) and configured to generate a second pressure value (see Col. Col.21, lines 62-67, see Col. 22, lines 65-67 – Col.23, lines 1-2, and Col.23, lines 21-45 – examiner notes the reference pressure chamber 308 has a known volume which is used as a reference volume in the ideal gas law equation to determine the volume of the pressure delivery chamber and thus the volume of the medication chamber indicating that the reference pressure chamber 308 is a fixed, reference volume); and
the control sub-system (324 in Fig. 5) being configured to calculate an amount of medicinal fluid within the medication chamber (108) based on a differential pressure measurement using the first pressure value and the second pressure value (see Col.21, lines 67- Col. 22, lines 1-6 and Col.23, lines 21-58 – processor 324 uses the pressure values of pressure delivery chamber 110 and reference chamber 308 to determine the volume of the pressure delivery chamber 110 and thus the volume of the medication chamber 108 which is equivalent to the amount of medicinal fluid within medication chamber 108); and
a housing (housing of 231 and 302 in Fig. 5) housing each of the pressure delivery chamber pressure sensor (122), the reference pressure chamber (308), the reference pressure chamber pressure sensor (316, see Fig. 5 and Col.31, lines 45-58 – the combined housing of the disposable component 231 that couples to the housing of the reusable component 302 form the housing for each of the components above).
Since Menz discloses a hand-held housing encapsulating a system comprising the medication chamber, movable delivery element, and the pressure delivery chamber, and Bryant discloses a pumping system comprising a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, a control-sub system, and a housing for housing said components therein, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Menz to incorporate a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, and a control sub-system as taught by Bryant such that these components are all encapsulated by the hand-held housing (2, 8) of Menz. Bryant provides an improved pumping system with an improved ability to control and measure volumes and flow rates and thus can determine the volume of the medication chamber based on pressure differentials (see Col.2, lines 37-47 and Col.5, lines 43-66). Such volume measurement would be beneficial in a hand-held pump such as Menz as it would assist the user in determining when the syringe (3) is empty and in need of replacement.
Regarding claim 2, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 2) wherein the movable delivery element (5 in Fig. 3) is at least partially movable within at least a portion of the medication chamber (see annotated Menz drawing 1 above, see para. 0054 – plunger 5 is movable within the left-hand chamber of syringe barrel 4 to dispense the substance).
Regarding claim 4, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 4) wherein a volume of the pressure delivery chamber varies based on an amount of pressure delivered by the pressure source (9, see annotated Menz drawing 1 above for chamber, see Fig.3, and para. 0054 – volume of the right-hand chamber of syringe barrel 4 varies based on amount of pressurized air delivered by pressure source 9).
Regarding claim 5, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 5) wherein the medication chamber comprises at least a portion of a syringe (3, see annotated Menz drawing 1 above for chamber, see Fig. 3, and para. 0045 – the right-hand chamber is comprised of at least a portion of the syringe barrel 4 of syringe 3).
Regarding claim 7, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 7) wherein the movable delivery element (5) comprises a syringe plunger (see para. 0046).
Regarding claim 17, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Bryant discloses (Claim 17) wherein the control sub-subsystem (324 in Fig. 5) further calculates occlusions within the fluid communication path using the first pressure value and the second pressure value (see Col.30, lines 31-51 – processor 324 can determine if occlusions are present within the flow communication path of medication chamber 108 using the volume of medication chamber 108 determined by the pressure values).
Regarding claim 25, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 25) further comprising: a user interface comprising a display and at least one input element (16 in Fig. 3) configured to alter a parameter associated with delivery of the medicinal fluid to the patient (see para. 0066 – system 1 may comprise a display element, see para. 0050 – system 1 comprises a user-actuated button 16 allowing the user to actuate the pressure source 9 and thus alter the activation of applied pressure to the medicinal fluid for delivery).
Regarding claim 26, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 26) wherein the handheld housing (2, 8 in Fig. 3) further encapsulates at least portion of the medication chamber (see annotated Menz drawing 1 above and para. 0046 – the entire syringe 3 and thus the medication chamber annotated therewithin are encapsulated by the handheld housing formed by holder 2 and housing 8).
Regarding claim 28, modified Menz discloses the system of claim 1, as discussed above. In modified Menz, Menz discloses (Claim 28) wherein the medication chamber further comprises a detachable medication container configured to hold medication and interact with the movable delivery element (5 in Fig. 3, see annotated Menz drawing 1 above for medication chamber and see para. 0046 – the medication chamber is part of a detachable syringe 3 and thus forms a detachable medication chamber which holds the medicinal fluid and interacts with the plunger 5).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Kreidemacher et al (BR. Patent Pub. No. 112020016503 A2, “Kreidemacher”).
Regarding claim 3, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 3) wherein the movable delivery element is at least partially deformable.
Kreidemacher discloses an electromechanical pump assembly comprising a rubber piston for sealing the cartridge. Kreidemacher teaches (Claim 3) wherein the movable delivery element (124) is at least partially deformable (see Fig. 3 and para. 0023 – the piston 123 interpreted as the movable delivery element as it is slidable disposed within cartridge 114 may be comprised of a flexible material such as rubber or an elastomeric material which under pressure at least partially deforms to provide a seal with the wall of the cartridge 114).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe plunger taught by modified Menz to be comprised of a flexible material as taught by Kreidemacher such that plunger (5) of modified Menz is comprised of a flexible material and at least partially deforms under pressure. Kreidemacher teaches that a piston comprised of a flexible material allows the piston to provide a movable seal between it and the wall of the cartridge during continuous linear movement (see para. 0023).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Mallett (U.S Patent Pub. No. 20070264130 A1).
Regarding claim 6, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 6) further comprising: a valve manifold disposed between the pressure source and the pressure delivery chamber for selectively delivering pressure from the pressure source to the pressure delivery chamber in response to receiving a signal from the control sub-system.
Mallett discloses a gas-driven infusion pump with a check valve. Mallett teaches (Claim 6) further comprising: a valve manifold (52) disposed between the pressure source (10) and the pressure delivery chamber (11) for selectively delivering pressure from the pressure source (10) to the pressure delivery chamber (11) in response to receiving a signal from the control sub-system (58, see Fig. 4A and para. 0050 and para. 0053-0054).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz incorporate a valve between the pressure source and the pressure delivery chamber which can be controlled by the control sub-system as taught by Mallett. Mallet teaches incorporating a solenoid valve for controlling the flow rate of the gas entering the pressure delivery chamber (see para. 0053-0054).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Hedmann et al. (U.S Patent Pub. No. 20170290971 A1, “Hedmann”).
Regarding claim 8, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 8) further comprising a position sensor coupled or adjacent to the medication chamber, the position sensor being in communication with the control sub-system, the position sensor generating data indicative of a volume of medicinal fluid within the medication chamber.
Hedmann discloses a medical membrane pump comprising a pressure sensor and length sensor for determining volumes within the device. Hedmann teaches (Claim 8) further comprising a position sensor (11) coupled to the medication chamber (4), the position sensors (11) in communication with the control sub-system (see Fig. 1 and para. 0068 and 0070-0073 – membrane pump drive of Fig. 1 comprises a drive chamber 1 interpreted as the delivery chamber and a pump chamber 4 interpreted as the medication chamber, wherein a length sensor 11 for determining the position of piston 8 is indirectly coupled to the pump chamber 4 and in communication with a control that is not shown), the position sensor (11) generating data indicative of a volume of medicinal fluid within the medication chamber (4, see para. 0073 – the stroke volume of the piston-in-cylinder unit 7 is equal to the pump volume and thus the position of the piston 8 sensed by the length sensor 11 is capable of indicating a volume of fluid within the pump chamber 4).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a length sensor in communication with the control sub-system as taught by Hedmann such that the length sensor in combination with the control sub-system would determine the position of the plunger (5) of modified Menz to provide data indicative of the volume of the medication chamber of modified Menz. The motivation for this modification is Hedmann teaches a length sensor for determining the position of the piston provides an exact measurement and thus conveys volumes of fluids with a very exact quantity (see para. 0073).
Regarding claim 9, modified Menz discloses the position sensor of claim 8, as discussed above. In modified Menz, Hedmann discloses (Claim 9) wherein the control sub-system calculates a flow rate and/or volume of the medicinal fluid exiting the outlet (outlet of 4) of the medication chamber (4) based on the data generated by the position sensor (11, see para. 0072-0073 – the membrane pump drive further comprises a control connected to the length sensor 11 to evaluate its signals such as determining the volume of fluid conveyed by the pump out of pump chamber 4 using the position of the piston 8 provided by the length sensor 11).
Claim(s) 10-11 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Li et al. (U.S Patent Pub. No. 20130184640 A1, “Li”).
Regarding claim 10, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 10) further comprising a flow sensor coupled or adjacent to the medication chamber, the flow sensor being in communication with the control sub-system, the flow sensor generating data indicative of a rate of flow of medicinal fluid exiting the medication chamber.
Li discloses a drug pump device comprising a flow sensor for indicating rate of flow of fluid within the exit member of the pump device. Li teaches (Claim 10) further comprising a flow sensor (114) coupled to the medication chamber (102), the flow sensor being in communication with the control sub- system (see Fig. 1-2A and para. 0046-0047 – pump 100 comprises a control system as seen in Fig. 1 having system controller 112 which receives signals from flow sensor 114 coupled to the drug reservoir 102 at the cannula 108 which is the fluid exit of drug reservoir 102), the flow sensor (114) generating data indicative of a rate of flow of medicinal fluid exiting the medication chamber (102, see para. 0047 – flow sensor 114 measure the flow rate of fluid exiting drug reservoir 102 and within the cannula 108).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a flow sensor in communication with the control sub-system as taught by Li such that the flow sensor in communication with control sub-system would determine the flow rate of the fluid exiting the outlet (6 in Fig. 3) of the medication chamber of modified Menz. The motivation for this modification is Li teaches a flow sensor that works in combination with a pressure sensor as a fail-safe and to increase accuracy and precision of the feedback control loop for controlling the pressure used to drive the drug delivery (see para. 0007 and 0047).
Regarding claim 11, modified Menz discloses the flow sensor of claim 10, as discussed above. In modified Menz, Li discloses (Claim 11) wherein the control sub-system calculates a flow rate and/or volume of the medicinal fluid exiting the outlet (108) of the medication chamber (102) based on the data generated by the flow sensor (114, see para. 0046-0047 – controller 112 of control system calculates a flow rate of the fluid flowing through cannula 108 at the exit of drug reservoir 102 based on the signals from flow sensor 114).
Regarding claim 27, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 27) further comprising: a communications interface configured to bi-directionally exchange data over a communications network with a remote computing device associated with delivery of the medicinal fluid.
Li teaches (Claim 27) further comprising: a communications interface (124) configured to bi-directionally exchange data over a communications network with a remote computing device (150) associated with delivery of the medicinal fluid (see para. 0050 – electronic circuitry 118 may further comprise a transmitter/receiver 124 for bi-directional transfer of control data over an infrared link to a remote, handheld device 150, the remote device 150 may provide control or programming information for operation of the pump device 100).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic circuitry taught by modified Menz to incorporate a communications interface as taught by Li such that the processor (324) of Bryant in of modified Menz would incorporate a transmitter/receiver allowing the pump to be remotely pre-programmed and controlled by a wireless handheld device as taught by Li (see para. 0050).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Fangrow et al. (U.S Patent Pub. No. 20190151569 A1, “Fangrow”)
Regarding claim 12, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 12) further comprising a mass sensor coupled or adjacent to the medication chamber, the mass sensor being in communication with the control sub- system, the mass sensor generating data indicative of a mass of medicinal fluid within the medication chamber.
Fangrow discloses a medical fluid pump comprising volume sensing means to control or provide a record of the fluid transferred to the patient. Fangrow teaches (Claim 12) further comprising a mass sensor coupled to the medication chamber (40), the mass sensor being in communication with the control sub- system (74), the mass sensor generating data indicative of a mass of medicinal fluid within the medication chamber (40, see Fig 1A-1B, Fig. 2Eii and para. 0067-0069 – the fluid transfer system shown in Fig. 1A and Fig. 2Ai as a specific embodiment comprises a pumping region 40 which may be coupled to a volume sensor such that the volume sensor can sense the fluid within the pump region 40, the volume sensor may be a mass or weight sensor that is in communication with the fluid transfer management system 74 and provides data indicative of the volume of fluid that is transferred to the patient and thus the mass that exits the pumping region 40).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a mass sensor in communication with the control sub-system as taught by Fangrow such that the electronic circuitry of modified Menz would be able to communicate with a mass sensor to control and record the volume of fluid that is transferred to the patient (see para. 0068-0069).
Regarding claim 13, modified Menz discloses the mass sensor of claim 12, as discussed above. In modified Menz, Fangrow discloses (Claim 13) wherein the control sub-system (74) calculates a flow rate and/or volume of the medicinal fluid exiting the outlet of the medication chamber (40) based on the data generated by the mass sensor (see para. 0067-0069 and 0093 – the volume sensor which may be a mass sensor provides signals to the fluid transfer system 74 that are used to determine the volume of fluid transferred to the patient and thus the volume of fluid that exited the pumping region 40).
Claim(s) 14-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Gray et al. (U.S Patent Pub. No. 20120265174 A1, “Gray”).
Regarding claim 14, modified Menz discloses the system of claim 1, as discussed above.
While Bryant discloses two pressures sensors disposed in the pressure delivery chamber and reference pressure chamber, respectively, to provide signals for determining the volume of medicinal fluid within the medication chamber, modified Menz fails to disclose (Claim 14) further comprising a medication chamber pressure sensor coupled or adjacent to the medication chamber, the medication chamber pressure sensor being in communication with the control sub-system, the medication chamber pressure sensor generating data indicative of a volume of medicinal fluid within the medication chamber.
Gray discloses an implantable medical device (12 in Fig. 3A-4) comprising a pressure delivery chamber (62 in Fig. 3B), a medication reservoir (34 in Fig. 3B), and a movable delivery element in the form of an expandible and contractible bellows disposed therebetween (see para. 0035), wherein a propellant within pressure delivery chamber (62) pressurizes the bellows which pressurizes the medication reservoir (34) to dispense the medicinal fluid (see para. 0035). Gray teaches (Claim 14) a medication chamber pressure sensor (42 in Fig. 4) coupled or adjacent to the medication chamber (42 in Fig. 3B, see para. 0055), the medication chamber pressure sensor (42) being in communication with the control sub-system (26 in Fig. 4 and para. 0055), the medication chamber pressure sensor (42) generating data indicative of a volume of medicinal fluid within the medication chamber (34, see para. 0055 – medication chamber pressure sensor 42 measures pressure in medication chamber 34 which can be used to determine volume of medicinal fluid therewithin).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a medication chamber pressure sensor in communication with the control sub-system as taught by Gray such that the medication chamber of modified Menz would have an associated pressure sensor which as provided by Gray allows for the determination of the volume of medicinal fluid in the reservoir and the rate at which medicinal fluid is removed from the reservoir (see para. 0055).
Regarding claim 15, modified Menz discloses the system of claim 14, as discussed above. In modified Menz, Gray discloses (Claim 15) wherein the control sub-system (26) calculates a flow rate and/or volume of the medicinal fluid exiting the outlet (38 in Fig. 4) of the medication chamber (34) based on the data generated by the medication chamber pressure sensor (34, see para. 0055).
Regarding claim 18, modified Menz discloses the system of claim 1, as discussed above.
In modified Menz, Bryant discloses (Claim 18) a pressure delivery chamber pressure sensor (122 in Fig. 5) coupled to or adjacent to the pressure delivery chamber (110, see Col.22, lines 60-62), the pressure delivery chamber pressure sensor (122) being in communication with the control sub-system (324 in Fig. 5) and which generates a first pressure value characterizing a level of pressure within the pressure delivery chamber (110, see Col.22, lines 60-62).
However, modified Menz fails to disclose (Claim 18) a medication chamber pressure sensor coupled to or adjacent to the medication chamber, the medication chamber pressure sensor being in communication with the control sub-system and which generates a second pressure value characterizing a level of pressure within the medication chamber; wherein the control sub-system calculates an amount of medical fluid amount within the medication chamber based on a differential pressure measurement using the first pressure values and the second pressure value.
Gray teaches a pressure delivery chamber pressure sensor (43 in Fig. 4) coupled to or adjacent to the pressure delivery chamber (62 in Fig. 3B, see para. 0036), the pressure delivery chamber pressure sensor (43) being in communication with the control sub-system (26 in Fig. 4) and which generates a first pressure value characterizing a level of pressure within the pressure delivery chamber (62, see para. 0038 and 0055); and a medication chamber pressure sensor (42 in Fig. 4) coupled to or adjacent to the medication chamber (34 in Fig. 3B, see para. 0055), the medication chamber pressure sensor (42) being in communication with the control sub-system (26) and which generates a second pressure value characterizing a level of pressure within the medication chamber (34, see para. 0055); wherein the control sub-system (26) calculates an amount of medical fluid within the medication chamber (34) based on a differential pressure measurement using the first pressure value and the second pressure value (see para. 0055).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a medication chamber pressure sensor in communication with the control sub-system to calculate an amount of medicinal fluid within the medication chamber as taught by Gray. In combination, modified Menz which already comprises a pressure delivery chamber pressure sensor, reference chamber pressure sensor, and control sub-system in communication therewith would further be modified to comprise a medication chamber pressure sensor such that the control sub-system of modified Menz would also be able to determine the volume of the medication chamber using the pressure value from the pressure delivery chamber pressure sensor and medication chamber pressure sensor. Gray allows for the determination of the volume of medicinal fluid in the reservoir and the rate at which medicinal fluid is removed from the reservoir (see para. 0055). Such a modification to modified Menz would provide a more robust sensing system.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant in view of Gray as applied to claim 18 above, and further in view of Heller et al (U.S Patent Pub. No. 20160278899 A1, “Heller”).
Regarding claim 20, modified Menz discloses the system of claim 18, as discussed above.
While Menz discloses an electromechanical air pump (9), modified Menz fails to disclose (Claim 20) wherein the pneumatic pump is a piezoelectric air pump. Examiner is interpreting this limitation as the electromechanical air pump of claim 1 is a piezoelectric air pump.
Heller discloses a drug delivery device comprising a piezoelectric air pump for driving drug out of an elastomeric reservoir. Heller teaches (Claim 20) wherein the electromechanical air pump (11) is a piezoelectric air pump (see Fig. 17A-17C and p. 53, lines 29-38 – the drug delivery device comprising a piezoelectric air pump 11 for pumping air into second elastomeric reservoir 7, wherein the pressure from the second elastomeric reservoir 7 compresses the drug reservoir 3 to dispel the drug out of the drug reservoir 3).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromechanical air pump taught by modified Menz to be a piezoelectric air pump as taught by Heller such that the electrically operated diaphragm pump of modified Menz would be replaced by the piezoelectric air pump of Heller to pump air into the pressure delivery chamber of modified Menz. The motivation for this modification is Heller teaches piezoelectric air pumps are able to more accurately deliver materials of both high and low viscosities as well as solids such as granules or powders (see p.45, lines 32-39).
Claim(s) 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and further in view of Mohr et al. (U.S Patent Pub. No. 20160346485 A1, “Mohr).
Regarding claim 22, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 22) further comprising: a bubble detection sensor coupled to or adjacent to the medication chamber, the bubble detection sensor being in communication with the control sub-system, the bubble detection sensor being configured to identify bubbles within the medicinal fluid.
Mohr discloses an intravenous delivery system comprising a gas detection and elimination apparatus. Mohr teaches (Claim 22) further comprising: a bubble detection sensor (181, 182) coupled to or adjacent to the medication chamber (143), the bubble detection sensor (181, 182) being in communication with the control sub-system (170), the bubble detection sensor (181, 182) configured to identify bubbles within the medicinal fluid (see Fig. 1 and para. 0026-0028 – the system of Fig. 1 comprises a container 143 storing the intravenous liquid 150 which is coupled and adjacent to the first bubble sensor 181 and second bubble sensor 182, system further comprises controller 170 which is in communication with bubble sensors 181 and 182 for identifying bubbles in the fluid line 130 before intravenous liquid 150 is delivered to the patient).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by modified Menz to incorporate a bubble sensor as taught by Mohr such that the outlet (6 in Fig. 3) of modified Menz would incorporate a bubble sensor that is coupled to and adjacent the medication chamber and said bubble sensor would be in communication with the electronic circuitry of modified Menz. The motivation for this modification is Mohr teaches incorporating bubble sensors to provide information for the controller to program the bubble elimination apparatus with an appropriate bubble elimination rate for an improved gas elimination system (see para. 0004 and 0027-0028).
Regarding claim 23, modified Menz discloses the system of claim 22, as discussed above.
However, modified Menz fails to disclose (Claim 23) further comprising: a bubble elimination system coupled to or adjacent to the medication chamber, the bubble elimination system being in communication with the control sub-system, the bubble elimination system being configured to selectively remove bubbles within the medicinal fluid identified by the bubble detection sensor.
Mohr teaches (Claim 23) further comprising: a bubble elimination system (100) coupled to or adjacent to the medication chamber (123), the bubble elimination system (100) being in communication with the control sub-system (170), the bubble elimination system (100) configured to selectively remove bubbles within the medicinal fluid identified by the bubble detection sensor (181, 182, see Fig. 1 and para. 0028 – the system of Fig. 1 further comprises a gas elimination apparatus 100 coupled to and adjacent the fluid container 143, gas elimination apparatus 100 is in communication with controller 170 to receive signals for removing air bubbles based upon the signals from the bubble sensors 181 and 182).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by modified Menz to incorporate a bubble elimination apparatus as taught by Mohr such that the outlet (6 in Fig. 3) would incorporate the bubble elimination apparatus that is coupled to and adjacent the medication chamber and said bubble elimination apparatus would be in communication with the electronic circuitry of modified Menz. The motivation for this modification is Mohr teaches an improved air elimination device which can efficiently remove a wide range of bubble sizes across a wide range of flows for IV fluids and independent of orientation when incorporated into the fluid delivery tubing (see para. 0004 and 0007).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Bryant as applied to claim 1 above, and in further view of Kamen et al (U.S Patent Pub. No. 20130184676 A1, “Kamen”).
Regarding claim 24, modified Menz discloses the system of claim 1, as discussed above.
However, modified Menz fails to disclose (Claim 24) further comprising: an occlusion detection sensor coupled to or adjacent to the medication chamber, the occlusion detection sensor being in communication with the control sub-system, the occlusion detection sensor being configured to identify an occlusion within the fluid communication path.
Kamen discloses pump for administering an agent to a patient and comprising an occlusion sensor. Kamen teaches (Claim 24) further comprising: an occlusion detection (3535) sensor coupled to the medication chamber (504), the occlusion detection sensor (3535) being in communication with the control sub-system (4000), the occlusion detection sensor (3535) being configured to identify an occlusion within the fluid communication path (see Fig. 28 and 59C, see para. 0186 and 0317 – syringe pump 500 comprises a syringe 504 containing the drug wherein pump 500 is controlled by the electrical system 4000 shown in Fig. 59C, see para. 0319 and 0321-0322 – electrical system 4000 comprises an occlusion sensor 3535 which may be the same as or in addition to the downstream pressure sensor 513 such that the occlusion sensor 3535 is coupled to the syringe 504 through the infusion line wherein the occlusion sensor 3535 senses an occlusion in the infusion line).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet taught by modified Menz to incorporate an occlusion sensor as taught by Kamen such that the outlet (6 in Fig. 3) would incorporate the occlusion sensor that is coupled to and adjacent the medication chamber and said occlusion sensor would be in communication with the electronic circuitry of modified Menz. The motivation for this modification is Kamen teaches incorporating an occlusion sensor to contribute to safety of the pump operation by alerting if an occlusion is detected so the pump can be stopped and the occlusion corrected (see para. 0197 and 0218). Such a modification to modified Menz would provide a more robust sensing system.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (U.S Patent Pub. No. 20140276415 A1, “Davis”) in view of Menz.
Regarding claim 35, Davis discloses the limitations of (Claim 35) a system (200 in Fig. 4) for delivering a medicinal fluid to a patient (see para. 0032) comprising:
a pressure delivery chamber (235 in Fig. 4) having a variable volume and configured to store pressure controllably (see para. 0033);
a medication chamber (245 in Fig. 4) having a variable volume and fluidically isolated from the pressure delivery chamber (235, see para. 0033), the medication chamber (245) configured to store medicinal fluid and having an outlet (255 in Fig. 4) forming a fluid communication path to the patient (see para. 0033);
a movable delivery element (240 in Fig. 4) disposed between the medication chamber (245) and the pressure delivery chamber (235, see para. 033 – movable delivery element 240 is in the form of a flexible divider), the movable delivery element (240) having a shape and size to fluidically isolate the medication chamber (245) and the pressure delivery chamber (235, see Fig. 4 and par. 0033);
a pressure source (232 in Fig. 4) coupled to the pressure delivery chamber (235, see para. 0034), the pressure source (232) configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (235, see para. 0035 – pressure source 232 is configured to be utilized to apply positive pressure and negative pressure multiple times within pressure delivery chamber 235);
a medication reservoir coupled to the medication chamber (245 in Fig. 4) and holding additional medicinal fluid (see para. 0045 – a separate syringe or other container may be coupled to the medication chamber 245 for refilling of the medication chamber 245);
and a control sub-system (see para. 0034 – the system 200 may comprise control features for controlling the system 200), the pressure source (232) selectively delivers pressure from the pressure source (232) to the pressure delivery chamber (235) causing the movable delivery element (240) to apply pressure to the medicinal fluid in the medication chamber (245, see para. 0033), the application of pressure to the medicinal fluid thereby causing the medicinal fluid to exit the medication chamber (245) at the outlet (255) along the fluid communication path to the patient (see para. 0033);
wherein when the medication chamber (245) is at or below a level of medicinal fluid, pressure applied from the pressure delivery chamber (235) causes a suction effect when an opening between the medication reservoir and the medication chamber (245) is open thereby drawing medicinal fluid from the medication reservoir into the medication chamber (245, see para. 0035 and 0045 – when medication chamber 245 is at a level of medicinal fluid deeming refilling, pressure source 232 can apply negative pressure to pressure delivery chamber 235 to provide a suction effect when an opening of stopcock 294 between medication chamber 245 and the attached syringe is open to refill the medication chamber 245 with medicinal fluid).
However, Davis fails to disclose (Claim 35) the pressure source comprising a pneumatic pump, a control sub-system configured to send signals to cause pressure to be delivered from the pressure source to the pressure delivery chamber, and a handheld housing encapsulating each of the pressure delivery chamber, the movable delivery element, the pressure source, and the control sub- system.
Menz discloses a hand-held, syringe system (1 in Fig. 1-3) comprising a medication chamber on the left-hand side of a movable delivery element (5 in Fig. 2) and a pressure delivery chamber on the right-hand side of the movable delivery element (5), wherein a pressure source (9) in the form of an electromechanical air pump that pumps air into the pressure delivery chamber (see par. 0051). Menz teaches the limitations (Claim 35) the pressure source (9) comprising a pneumatic pump (see para. 0017 and 0051 – pressure source 9 is an electrically operated diaphragm pump for pumping air and is thus a pneumatic pump), a control sub-system configured to send signals to cause pressure to be delivered from the pressure source (9) to the pressure delivery chamber (see para. 0066 – system 1 may comprise a control device to set or limit the pressure produced by pressure source 9), and a handheld housing (2, 8) encapsulating each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), and the control sub- system (see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system).
Since Davis discloses the infusion system driven by a drive fluid that may include water, saline, oil, or another appropriate fluid type (see para. 0033) with a pressure source that can be any suitable type for pumping (see para. 0034), and Menz discloses a handheld infusion system driven by air and by an electromechanical air pump, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Davis to have an electromechanical air pump for pumping air as the drive fluid, a control sub-system for sending signals to the electromechanical air pump for operation of the system, and a handheld housing encapsulating the components of the system as taught by Menz. Menz provides that using an electrically operated diaphragm pump forming a micro pneumatic system enables the plunger of the syringe to be operated in a particularly simple and advantageous fashion using a very robust and insensitive pump mechanism (see para. 0017). Menz further provides a control device that allows the user to set or limit the pressure produced by the pressure source for enhanced control over the dispensing operation (see para. 0066). Menz further provides the handheld housing of the infusion system offers an ergonomic system that enables simple and convenient operation irrespective of the hand size of the user while allowing safe and simple holding and guiding (see para. 011). In combination, the system of Davis would be implemented as a handheld system encapsulated by the handheld housing of Menz and the pressure source (232) of Davis would be modified to be an electromechanical air pump utilizing air in a pneumatic system controlled by the control sub-system as taught by Menz.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Hagen (U.S Patent No. 5354273) in view of Li.
Regarding claim 36, Menz discloses the limitations of (Claim 36) a system (1 in at least Fig. 1-3) for delivering a medicinal fluid to a patient (see para. 0045) comprising:
a housing (2, 8 in Fig. 1-2) having a shape and size to be handheld and to receive and secure a medication container (3 in Fig. 1-2, see para. 0045-0046 and 0060), the medication container (3) being a pre-filled syringe (see para. 0065), the housing (2, 8) comprising a hinged lid (2 in Fig. 1-2) to secure the medication container (3, see para. 0045-0046 – the syringe holder 2 acts as a hinged lid that hinges around join 24 to secure the syringe 3 within the housing)
a pressure delivery chamber within the housing (2,8) having a variable volume and configured to store pressure controllably (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the right-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the pressure delivery chamber as its volume changes as it stores pressure and the plunger 5 displaces);
a medication chamber within the housing (2, 8) having a variable volume and fluidically isolated from the pressure delivery chamber (examiner notes this limitation is being interpreted in light of the 112(b) rejection above as the pre-filled syringe has an internal chamber that is the medication chamber such that the pre-filled syringe stores the medicinal fluid and has an outlet forming a fluid communication path to the patient, see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the left-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the medication chamber as varies in volume with the substance to be delivered as the plunger 5 is displaced and its fluidically isolated from the right-hand chamber by the plunger 5), the medication chamber configured to store medicinal fluid and having an outlet (6 in Fig. 3) forming a fluid communication path to the patient (see para. 0054);
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a movable delivery element (5 in Fig. 3) within the housing (2,8) and disposed between the medication chamber and the pressure delivery chamber (see annotated Menz drawing 1 above for chambers and para. 0054), the movable delivery element (5) having a shape and size to fluidically isolate the medication chamber and the pressure delivery chamber (see Fig. 3 and para. 0054);
a pressure source (9 in Fig. 3) self-contained within the housing (2,8) and which is coupled to the pressure delivery chamber (see annotated Menz drawing 1 above, Fig. 3, and para. 0049 and 0051 – pressure source 9 is an electrically operated diaphragm pump self-contained within drive housing 8 and coupled to the right-hand chamber of syringe barrel 4 by tubing 13), the pressure source (9) comprising electromechanical air pump that is configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (see para. 0049 – pressure source 9 is an electrically operated diaphragm pump for pumping air making it an electromechanical air pump, see para. 0065-0066 – the system 1 and thus the pressure source 9 are reusable wherein the syringe 3 may be replaced indicating the pressure source is configured to be utilized multiple times, the pressure source 9 may also be configured to set or limit pressure produced and thus can selectively increase or decrease pressure within the right-hand chamber of syringe barrel 4 as set);
a control sub-system configured to send signals to cause pressure to be delivered from the pressure source (9 in Fig. 3) to the pressure delivery chamber thereby causing the movable delivery element (5 in Fig. 3) to apply pressure to the medicinal fluid in the medication chamber (see annotated Menz drawing 1 above for chambers, see para. 0054 and 0066 – system 1 may incorporate a device for setting the pressure produced by the pressure source 9 interpreted as the control sub-system which would be capable of being configured to send signals incorporate the set pressure to the pressure source 9), the application of pressure to the medicinal fluid thereby causing the medicinal fluid to exit the medication chamber at the outlet (6 in Fig. 3) along the fluid communication path to the patient (see para. 0054 and 0066),
a handheld housing (2, 8 in Fig. 1-2) encapsulating each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), and the control sub- system (examiner notes this is being interpreted as the same housing recited above, see annotated Menz drawing 1 above for chambers, see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system).
However, Menz fails to disclose the limitations of (Claim 36) the medication container being a pre-filled syringe without a plunger, a wireless communications interface configured to bi-directionally exchange data over a communications network with a remote computing device associated with delivery of the medicinal fluid including instructions to the control sub-system, and a handheld housing encapsulating the wireless communications interface.
Hagen discloses a fluid delivery apparatus comprising a pre-filled, disposable syringe (12 in Fig. 1), wherein Hagen teaches the limitation (Claim 36) the medication container (12) being a pre-filled syringe without a plunger (see Fig. 1 and Col.2, lines 21-22 and Col.3, lines 1-4).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-filled syringe taught by Menz to not include the plunger as taught by Hagen and instead have the pre-filled syringe be configured to interact with the plunger by known methods to yield predictable results. One of ordinary skill in the art could have modified the pre-filled syringe with the plunger of Menz to instead be a pre-filled syringe without a plunger that when coupled to the device interacts with the plunger in a sterile manner as claimed by known methods and that in combination, the pre-filled syringe would perform the same function therein. The results of this combination would have been recognized as predictable.
Li teaches (Claim 36) further comprising: a wireless communications interface (124) configured to bi-directionally exchange data over a communications network with a remote computing device (150) associated with delivery of the medicinal fluid including instructions to the control sub-system (see Fig. 1 and para. 0050 – electronic circuitry 118 may further comprise a transmitter/receiver 124 for bi-directional transfer of control data over an infrared link to a remote, handheld device 150, the remote device 150 may provide control or programming information to the control system seen in Fig. 1 for operation of the pump device 100), and a housing encapsulating the wireless communications interface 124 (see para. 0053).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic circuitry taught by modified Menz to incorporate a communications interface as taught by Li such that the control device (see para. 0066) of modified Menz would incorporate a transmitter/receiver allowing the system to be remotely pre-programmed and controlled by a wireless handheld device (see para. 0050).
Claim(s) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Hagen in view of Krulevitch et al. (U.S Patent Pub. No. 20080154187 A1, “Krulevitch”) in view of Heller in view of Mallet in view of Bryant in view of Li.
Regarding claim 37, Menz discloses the limitations of (Claim 37) a handheld system (1 in at least Fig. 1-3) for delivering a medicinal fluid to a patient (see para. 0045) comprising:
a housing (2, 8 in Fig. 1-2) sized and shaped to be held in one hand of a user while at least one input element (16 in Fig. 1-2) is activated by another hand of the user (see para. 0060), the housing (2, 8) comprising a hinged lid (2 in Fig. 1-2) configured to open to receive a pre-filled syringe (3) and close to secure the pre-filled syringe (3, see para. 0045-0046 – the syringe holder 2 acts as a hinged lid that hinges around join 24 to secure the syringe 3 within the housing);
a pressure delivery chamber within the housing (2,8) having a variable volume and configured to store pressure controllably (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the right-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the pressure delivery chamber as its volume changes as it stores pressure and the plunger 5 displaces);
a medication chamber within the housing (2, 8) having a variable volume and fluidically isolated from the pressure delivery chamber (see annotated Menz drawing 1 below, Fig. 3, and para. 0054 – the left-hand chamber defined by the plunger 5 of the syringe barrel 4 is interpreted as the medication chamber as varies in volume with the substance to be delivered as the plunger 5 is displaced and its fluidically isolated from the right-hand chamber by the plunger 5), the pre-filled syringe (3) being configured to couple to and form part of the medication chamber when secured (examiner notes this limitation is being interpreted in light of the 112(b) rejection above as the pre-filled syringe has an internal chamber that is the medication chamber such that the pre-filled syringe stores the medicinal fluid and has an outlet forming a fluid communication path to the patient, see annotated Menz drawing 1 below and para. 0054 – pre-filled syringe 3 forms the medication chamber as annotated below), the medication chamber having an outlet (6 in Fig. 3) forming a fluid communication path to the patient (see para. 0054);
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a movable delivery element (5 in Fig. 3) within the housing (2,8) and disposed between the medication chamber and the pressure delivery chamber (see annotated Menz drawing 1 above for chambers and para. 0054), the movable delivery element (5) having a shape and size to fluidically isolate the medication chamber and the pressure delivery chamber (see Fig. 3 and para. 0054);
a pressure source (9 in Fig. 3) self-contained within the housing (2,8) and coupled to the pressure delivery chamber (see annotated Menz drawing 1 above, Fig. 3, and para. 0049 and 0051 – pressure source 9 is an electrically operated diaphragm pump self-contained within drive housing 8 and coupled to the right-hand chamber of syringe barrel 4 by tubing 13), the pressure source (9) comprising an electromechanical air pump that is configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (see para. 0049 – pressure source 9 is an electrically operated diaphragm pump for pumping air making it an electromechanical air pump, see para. 0065-0066 – the system 1 and thus the pressure source 9 are reusable wherein the syringe 3 may be replaced indicating the pressure source is configured to be utilized multiple times, the pressure source 9 may also be configured to set or limit pressure produced and thus can selectively increase or decrease pressure within the right-hand chamber of syringe barrel 4 as set);
a control sub-system configured to send signals to the electromechanical air pump (9) to selectively cause pressure to be delivered from the pressure source (9 in Fig. 3) to the pressure delivery chamber at the controlled rate (see annotated Menz drawing 1 above for chambers, see para. 0054 and 0066 – system 1 may incorporate a device for setting the pressure produced by the pressure source 9 interpreted as the control sub-system which would be capable of being configured to send signals incorporate the set pressure to the pressure source 9), thereby causing the movable delivery element (5 in Fig. 3) to apply pressure to the medicinal fluid in the medication chamber (see para. 0054), the application of pressure to the medicinal fluid thereby causing the medicinal fluid to exit the medication chamber at the outlet (6 in Fig. 3) along the fluid communication path to the patient (see para. 0054 and 0066),
a user interface comprising an electronic display and at least one input element (16 in Fig. 3) configured to alter a parameter associated with delivery of the medicinal fluid to the patient (see para. 0066 – system 1 may comprise a display element power electronically through power supply 10, see para. 0050 – system 1 comprises a user-actuated button 16 allowing the user to actuate the pressure source 9 and thus alter the activation of applied pressure to the medicinal fluid for delivery);
wherein the housing (2, 8 in Fig. 1-2) encapsulates each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), the control sub- system, and the user interface (examiner notes this limitation is being interpreted in light of the 112(b) above as the housing partially encapsulates the user interface in such a way that it is still accessible to a user, see annotated Menz drawing 1 above for chambers, see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system, the display element is arranged on the drive housing 8 such that it is partially encapsulated by the housing, see para. 0060 – button 16 is arranged on holder 2 such that it is partially encapsulated by the housing).
However, Menz fails to disclose the limitations of (Claim 37) a pre-filled syringe without an integral plunger, the movable delivery element comprising an elastomeric membrane or a bellows element with collapsible sides, the pressure source comprising a piezoelectric air pump, a valve manifold disposed between the pressure source and the pressure delivery chamber for selectively delivering pressure from the pressure source to the pressure delivery chamber at a controlled rate; a pressure delivery chamber pressure sensor coupled to or adjacent to the pressure delivery chamber and configured to generate a first pressure value characterizing a level of pressure within the pressure delivery chamber; a reference pressure chamber having a fixed volume and a reference pressure chamber pressure sensor coupled to or adjacent to the reference pressure chamber, the reference pressure chamber pressure sensor configured to generate a second pressure value characterizing a level of pressure within the reference pressure chamber, the control sub-system being configured to calculate an amount of medicinal fluid within the medication chamber based on a differential pressure measurement using the first pressure value and the second pressure value, and the control sub-system being further configured to calculate occlusions within the fluid communication path using the first pressure value and the second pressure value, a wireless communications interface configured to bi-directionally exchange data over a communications network with a remote computing device associated with delivery of the medicinal fluid including instructions to the control sub-system, and the housing encapsulates each of the valve manifold, the pressure delivery chamber pressure sensor, the reference pressure chamber, the reference pressure chamber pressure sensor, and the wireless communications interface.
Hagen discloses a fluid delivery apparatus comprising a pre-filled, disposable syringe (12 in Fig. 1), wherein Hagen teaches the limitation (Claim 37) a pre-filled syringe without an integral plunger (see Fig. 1 and Col.2, lines 21-22 and Col.3, lines 1-4).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-filled syringe taught by Menz to not include the plunger as taught by Hagen and instead have the pre-filled syringe be configured to interact with the plunger by known methods to yield predictable results. One of ordinary skill in the art could have modified the pre-filled syringe with the plunger of Menz to instead be a pre-filled syringe without an integral plunger that when coupled to the device interacts with the plunger in a sterile manner as claimed by known methods and that in combination, the pre-filled syringe would perform the same function therein. The results of this combination would have been recognized as predictable.
Krulevitch discloses an electrokinetic infusion pump (103 in Fig. 4A-4B) utilizing an impelling fluid (114 in Fig. 4A-4B) for applying a pressure to a movable delivery element (120 in Fig. 4A-4B) which applies a pressure to a medication chamber comprising the infusion liquid (124 in Fig. 4A-4B, see para. 0046). Krulevitch teaches that the movable delivery element (120) may be in the form of a piston-like structure, a membrane, and/or a bellows (see para. 0053).
Since Menz discloses the movable delivery element (5) as a syringe plunger, and Krulevitch discloses a movable delivery element (120) that may take the form of a piston-like structure, a membrane, or a bellows, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the plunger of modified Menz to be an elastomeric membrane or bellows element with collapsible side as taught by Krulevitch. The syringe plunger (5) of Menz operates in the same manner as the movable delivery element (120) of Krulevitch by being pressurized by an impelling fluid to move some degree to apply a force to the medicinal fluid in the medication chamber. Krulevitch further provides that an elastomeric membrane or bellows element are known alternative structures to a piston-like element to be pressurized by an impelling fluid and deform to some degree to apply a force to the medicinal fluid (see para. 0053). One of ordinary skill in the art could have substituted the syringe plunger of Menz with either the membrane or bellows of Krulevitch, and the results of said substitution would have been predictable.
Heller discloses a drug delivery device comprising a piezoelectric air pump for driving drug out of an elastomeric reservoir. Heller teaches (Claim 37) wherein the electromechanical air pump (11) is a piezoelectric air pump (see Fig. 17A-17C and p. 53, lines 29-38 – the drug delivery device comprising a piezoelectric air pump 11 for pumping air into second elastomeric reservoir 7, wherein the pressure from the second elastomeric reservoir 7 compresses the drug reservoir 3 to dispel the drug out of the drug reservoir 3).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electromechanical air pump taught by modified Menz to be a piezoelectric air pump as taught by Heller such that the electrically operated diaphragm pump of modified Menz would be replaced by the piezoelectric air pump of Heller to pump air into the pressure delivery chamber of modified Menz. The motivation for this modification is Heller teaches piezoelectric air pumps are able to more accurately deliver materials of both high and low viscosities as well as solids such as granules or powders (see p.45, lines 32-39).
Mallett discloses a gas-driven infusion pump with a check valve. Mallett teaches (Claim 37) a valve manifold (52) disposed between the pressure source (10) and the pressure delivery chamber (11) for selectively delivering pressure from the pressure source (10) to the pressure delivery chamber (11) at a controlled rate (see Fig. 4A and para. 0050 and para. 0053-0054).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz incorporate a valve between the pressure source and the pressure delivery chamber as taught by Mallett. Mallet teaches incorporating a solenoid valve to be able to selectively control the flow rate of the gas entering the pressure delivery chamber (see para. 0053-0054).
Bryant discloses a system (300 in Fig. 5) for detecting the volume of fluid in a variable volume medication chamber (108 in Fig. 5) using pressure differentials (see Col.21, lines 56-67 and Col.22, lines 1-6), wherein Bryant discloses a pressure delivery chamber (110 in Fig. 5), a movable delivery element in the form of a flexible membrane (112 in Fig. 5), a pressure source (312 in Fig. 5), a reference chamber (308 in Fig. 5), and a control sub-system (324 in Fig. 5, see Col.21, lines 56-67 and Col.22, lines 1-6). Bryant teaches (Claim 37) a pressure delivery chamber pressure sensor (122 in Fig. 5) coupled to or adjacent to the pressure delivery chamber (110) and configured to generate a first pressure value characterizing a level of pressure with the pressure delivery chamber (110, see Col.22, lines 60-62);
a reference pressure chamber (308 in Fig. 5) having a fixed volume and a reference pressure chamber pressure sensor (316 in Fig. 5) coupled to or adjacent to the reference pressure chamber (308), the reference pressure chamber pressure sensor (316) configured to generate a second pressure value characterizing a level of pressure within the reference pressure chamber (308, see Col. Col.21, lines 62-67, see Col. 22, lines 65-67 – Col.23, lines 1-2, and Col.23, lines 21-45 – examiner notes the reference pressure chamber 308 has a known volume which is used as a reference volume in the ideal gas law equation to determine the volume of the pressure delivery chamber and thus the volume of the medication chamber indicating that the reference pressure chamber 308 is a fixed, reference volume); and
the control sub-system (324 in Fig. 5) being configured to calculate an amount of medicinal fluid within the medication chamber (108) based on a differential pressure measurement using the first pressure value and the second pressure value (see Col.21, lines 67- Col. 22, lines 1-6 and Col.23, lines 21-58 – processor 324 uses the pressure values of pressure delivery chamber 110 and reference chamber 308 to determine the volume of the pressure delivery chamber 110 and thus the volume of the medication chamber 108 which is equivalent to the amount of medicinal fluid within medication chamber 108), and the control sub-subsystem (324 in Fig. 5) being further configured to calculate occlusions within the fluid communication path using the first pressure value and the second pressure value (see Col.30, lines 31-51 – processor 324 can determine if occlusions are present within the flow communication path of medication chamber 108 using the volume of medication chamber 108 determined by the pressure values);
and a housing (housing of 231 and 302 in Fig. 5) housing each of the pressure delivery chamber pressure sensor (122), the reference pressure chamber (308), the reference pressure chamber pressure sensor (316, see Fig. 5 and Col.31, lines 45-58 – the combined housing of the disposable component 231 that couples to the housing of the reusable component 302 form the housing for each of the components above).
Since Menz discloses a hand-held housing encapsulating a system comprising the medication chamber, movable delivery element, and the pressure delivery chamber, and Bryant discloses a pumping system comprising a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, a control-sub system, and a housing for housing said components therein, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Menz to incorporate a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, and a control sub-system as taught by Bryant such that these components are all encapsulated by the hand-held housing (2, 8) of Menz. Bryant provides an improved pumping system with an improved ability to control and measure volumes and flow rates and thus can determine the volume of the medication chamber based on pressure differentials (see Col.2, lines 37-47 and Col.5, lines 43-66). Such volume measurement would be beneficial in a hand-held pump such as Menz as it would assist the user in determining when the syringe (3) is empty and in need of replacement.
Li teaches (Claim 37) further comprising: a wireless communications interface (124) configured to bi-directionally exchange data over a communications network with a remote computing device (150) associated with delivery of the medicinal fluid including instructions to the control sub-system (see Fig. 1 and para. 0050 – electronic circuitry 118 may further comprise a transmitter/receiver 124 for bi-directional transfer of control data over an infrared link to a remote, handheld device 150, the remote device 150 may provide control or programming information to the control system seen in Fig. 1 for operation of the pump device 100), and a housing encapsulating the wireless communications interface 124 (see para. 0053).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic circuitry taught by modified Menz to incorporate a communications interface as taught by Li such that the control device (see para. 0066) of modified Menz would incorporate a transmitter/receiver allowing the system to be remotely pre-programmed and controlled by a wireless handheld device (see para. 0050).
Regarding claim 38, modified Menz discloses the handheld system of claim 37, as discussed above. In modified Menz, Mallet discloses (Claim 38) wherein the control sub-system (58 in Fig. 4) is configured to generate signals that cause the pressure source in concert with the valve manifold (54) to dispense medicinal fluid out of the medication chamber (14 in Fig. 3) in a stepped manner to deliver a series of discrete medicinal fluid volumes (see para. 0050 and 0053-0054 – electronic assembly 58 controls the pump mechanism in first chamber 10 and solenoid valve 54 together to pressurize the medication chamber 14 with repeated aliquots of gas which would thus cause dispensing of medicinal fluid 13 in repeated aliquots which indicates a stepped manner of delivery in a series of discrete volumes).
Claim(s) 39 is rejected under 35 U.S.C. 103 as being unpatentable over Menz in view of Hagen in view of Krulevitch in view of Heller in view of Mallet in view of Bryant in view of Li as applied to claim 37 above, and further in view of Hayashi (U.S Patent Pub. No. 20160023233 A1).
Regarding claim 39, modified Menz discloses the handheld system of claim 37, as discussed above.
While Menz discloses the pre-filled syringe (3) comprises a Luer Lock on its outlet nozzle (6, see para. 0046), Menz fails to disclose (Claim 39) wherein the pre-filled syringe is mechanically and fluidically coupled to the housing using a mechanical connector comprising a Luer lock.
Hayashi discloses a system (see Fig. 1) comprising a housing (6) configured to house a syringe (1 in Fig. 1, see para. 0148), wherein Hayashi teaches (Claim 39) wherein the syringe (1) is mechanically and fluidically coupled to the housing (6) using a mechanical connector (85 in Fig. 8) comprising a Luer lock (see para. 0148 – housing 6 comprises a seat holder 85 that may be in the form of a Luer Lock for fixedly screwing the threaded portion of the syringe 1 into).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing taught by modified Menz to incorporate a Luer Lock mechanical connector for mechanically and fluidically coupling the syringe to the housing as taught by Hayashi as such a connection fixedly seats the syringe within the housing to prevent rotational and axial movement once fully connected (see para. 0148). Such a modification would be advantageous for Menz as the syringe (3) is only coupled through its proximal flange (7 in Fig. 2, see para. 0046) and a Luer Lock at its distal end would ensure rotational locking of the syringe (3).
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Menz in view of Bryant.
Regarding claim 1, Davis discloses the limitations of (Claim 1) a system (200 in Fig. 4) for delivering a medicinal fluid to a patient (see para. 0032) comprising:
a pressure delivery chamber (235 in Fig. 4) having a variable volume and configured to store pressure controllably (see para. 0033);
a medication chamber (245 in Fig. 4) having a variable volume and fluidically isolated from the pressure delivery chamber (235, see para. 0033), the medication chamber (245) configured to store medicinal fluid and having an outlet (255 in Fig. 4) forming a fluid communication path to the patient (see para. 0033);
a movable delivery element (240 in Fig. 4) disposed between the medication chamber (245) and the pressure delivery chamber (235, see para. 033 – movable delivery element 240 is in the form of a flexible divider), the movable delivery element (240) having a shape and size to fluidically isolate the medication chamber (245) and the pressure delivery chamber (235, see Fig. 4 and par. 0033);
a pressure source (232 in Fig. 4) coupled to the pressure delivery chamber (235, see para. 0034), the pressure source (232) configured to be utilized multiple times to selectively increase or decrease pressure within the pressure delivery chamber (235, see para. 0035 – pressure source 232 is configured to be utilized to apply positive pressure and negative pressure multiple times within pressure delivery chamber 235);
and a control sub-system (see para. 0034 – the system 200 may comprise control features for controlling the system 200), the pressure source (232) selectively delivers pressure from the pressure source (232) to the pressure delivery chamber (235) causing the movable delivery element (240) to apply pressure to the medicinal fluid in the medication chamber (245, see para. 0033), the application of pressure to the medicinal fluid thereby causing the medicinal fluid to exit the medication chamber (245) at the outlet (255) along the fluid communication path to the patient (see para. 0033).
However, Davis fails to disclose (Claim 1) the pressure source comprising an electromechanical air pump, a pressure delivery chamber pressure sensor coupled to or adjacent to the pressure delivery chamber and configured to generate a first pressure value; a reference pressure chamber having a fixed volume and a reference pressure chamber pressure sensor coupled to or adjacent to the reference pressure chamber and configured to generate a second pressure value; and a control sub-system configured to send signals to the electromechanical air pump to selectively cause pressure to be delivered from the pressure source to the pressure delivery chamber, the control sub-system being configured to calculate an amount of medicinal fluid within the medication chamber based on a differential pressure measurement using the first pressure value and the second pressure value; and a handheld housing encapsulating each of the pressure delivery chamber, the movable delivery element, the pressure source, the pressure delivery chamber pressure sensor, the reference pressure chamber, the reference pressure chamber pressure sensor, and the control sub- system.
Menz discloses a hand-held, syringe system (1 in Fig. 1-3) comprising a medication chamber on the left-hand side of a movable delivery element (5 in Fig. 2) and a pressure delivery chamber on the right-hand side of the movable delivery element (5), wherein a pressure source (9) in the form of an electromechanical air pump that pumps air into the pressure delivery chamber (see par. 0051). Menz teaches the limitations (Claim 1) the pressure source (9) comprising an electromechanical air pump (see para. 0017 and 0051 – pressure source 9 is an electrically operated diaphragm pump for pumping air and thus is an electromechanical air pump), a control sub-system configured to send signals to the electromechanical air pump (9) to selectively cause pressure to be delivered from the pressure source (9) to the pressure delivery chamber (see para. 0066 – system 1 may comprise a control device to set or limit the pressure produced by pressure source 9), and a handheld housing (2, 8) encapsulating each of the pressure delivery chamber, the movable delivery element (5), the pressure source (9), and the control sub- system (see para. 0045, 0065, and 0066 – the syringe holder 2 and drive housing 8 which are coupled by hinge joint 24 to form a handheld housing encapsulating the chambers within syringe 3, pressure source 9, and the device interpreted as the control-sub system).
Since Davis discloses the infusion system driven by a drive fluid that may include water, saline, oil, or another appropriate fluid type (see para. 0033) with a pressure source that can be any suitable type for pumping (see para. 0034), and Menz discloses a handheld infusion system driven by air and by an electromechanical air pump, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Davis to have an electromechanical air pump for pumping air as the drive fluid, a control sub-system for sending signals to the electromechanical air pump for operation of the system, and a handheld housing encapsulating the components of the system as taught by Menz. Menz provides that using an electrically operated diaphragm pump forming a micro pneumatic system enables the plunger of the syringe to be operated in a particularly simple and advantageous fashion using a very robust and insensitive pump mechanism (see para. 0017). Menz further provides a control device that allows the user to set or limit the pressure produced by the pressure source for enhanced control over the dispensing operation (see para. 0066). Menz further provides the handheld housing of the infusion system offers an ergonomic system that enables simple and convenient operation irrespective of the hand size of the user while allowing safe and simple holding and guiding (see para. 011). In combination, the system of Davis would be implemented as a handheld system encapsulated by the handheld housing of Menz and the pressure source (232) of Davis would be modified to be an electromechanical air pump utilizing air in a pneumatic system controlled by the control sub-system as taught by Menz.
Bryant discloses a system (300 in Fig. 5) for detecting the volume of fluid in a variable volume medication chamber (108 in Fig. 5) using pressure differentials (see Col.21, lines 56-67 and Col.22, lines 1-6), wherein Bryant discloses a pressure delivery chamber (110 in Fig. 5), a movable delivery element in the form of a flexible membrane (112 in Fig. 5), a pressure source (312 in Fig. 5), a reference chamber (308 in Fig. 5), and a control sub-system (324 in Fig. 5, see Col.21, lines 56-67 and Col.22, lines 1-6). Bryant teaches (Claim 1) a pressure delivery chamber pressure sensor (122 in Fig. 5) coupled to or adjacent to the pressure delivery chamber (110) and configured to generate a first pressure value (110, see Col.22, lines 60-62);
a reference pressure chamber (308 in Fig. 5) having a fixed volume and a reference pressure chamber pressure sensor (316 in Fig. 5) coupled to or adjacent to the reference pressure chamber (308) and configured to generate a second pressure value (308, see Col. Col.21, lines 62-67, see Col. 22, lines 65-67 – Col.23, lines 1-2, and Col.23, lines 21-45 – examiner notes the reference pressure chamber 308 has a known volume which is used as a reference volume in the ideal gas law equation to determine the volume of the pressure delivery chamber and thus the volume of the medication chamber indicating that the reference pressure chamber 308 is a fixed, reference volume); and
the control sub-system (324 in Fig. 5) being configured to calculate an amount of medicinal fluid within the medication chamber (108) based on a differential pressure measurement using the first pressure value and the second pressure value (see Col.21, lines 67- Col. 22, lines 1-6 and Col.23, lines 21-58 – processor 324 uses the pressure values of pressure delivery chamber 110 and reference chamber 308 to determine the volume of the pressure delivery chamber 110 and thus the volume of the medication chamber 108 which is equivalent to the amount of medicinal fluid within medication chamber 108),
and a housing (housing of 231 and 302 in Fig. 5) housing each of the pressure delivery chamber pressure sensor (122), the reference pressure chamber (308), the reference pressure chamber pressure sensor (316, see Fig. 5 and Col.31, lines 45-58 – the combined housing of the disposable component 231 that couples to the housing of the reusable component 302 form the housing for each of the components above).
Since modified Davis discloses a hand-held housing encapsulating a system comprising the medication chamber, movable delivery element, and the pressure delivery chamber which may incorporate pressure sensors (see para. 0035), and Bryant discloses a pumping system comprising a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, a control-sub system, and a housing for housing said components therein, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Davis to incorporate a pressure delivery chamber pressure sensor, a reference pressure chamber, a reference pressure chamber pressure sensor, and a control sub-system as taught by Bryant such that these components are all encapsulated by the hand-held housing (2, 8) of Menz in modified Davis. Bryant provides an improved pumping system with an improved ability to control and measure volumes and flow rates and thus can determine the volume of the medication chamber based on pressure differentials (see Col.2, lines 37-47 and Col.5, lines 43-66).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Menz in view of Bryant as applied to claim 1 above, and further in view of Geipel et al. (U.S Patent Pub. No. 20140039392 A1, “Geipel”).
Regarding claim 21, modified Davis discloses the system of claim 1, as discussed above. In modified Davis, Davis discloses (Claim 21) further comprising a medication reservoir coupled to the medication chamber (245 in Fig. 4) and holding additional medicinal fluid (see para. 0045 – a separate syringe or other container may be coupled to the medication chamber 245 for refilling of the medication chamber 245).
While Davis discloses that medicinal fluid can be extracted from the medication reservoir and transferred to the medication chamber (245) for refilling, Davis fails to disclose (Claim 21) wherein the control sub-system is configured to automatically extract fluid from the medication reservoir and transfer the extracted fluid to the medication chamber.
Geipel discloses an infusion pump with a reservoir used for repeated filling and emptying of a pump chamber. Geipel teaches (Claim 21) further comprising: a medication reservoir (11) coupled to the medication chamber (15) and holding additional medicinal fluid (see Fig. 2 and para. 0014), wherein the control sub-system (22) is configured to automatically extract fluid from the medication reservoir (11) and transfer the extracted fluid to the medication chamber (15, see Fig. 2 and 6a-6b and para. 0014, 0091 and 0123-0124 – controller 22 controls movement of piston 16 based upon information from the dosing unit 12 during a refilling process to create negative pressure to suction medicinal fluid from reservoir 11 into medication chamber 15).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by modified Davis to have a medication reservoir wherein the medicinal fluid can be drawn from the medication reservoir into the medication chamber under control of the control sub-system as taught by Geipel such the control sub-system is modified to control the pressure source (232) to draw medicinal fluid from the medication reservoir into the medication chamber (245) of modified Davis as taught by Geipel. Geipel discloses an infusion pump that can restrict the volume of liquid present in the medication reservoir at any time to a certain value thereby generally reducing the risk related to any major malfunction, without having an influence on the normal operation of the device, namely the administration of the distinct doses of the medicament (see para. 0093).
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783