DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 12/3/2025. As directed by the amendment: claim 27 has been added, claims 1 and 22 have been amended, and claim 23 has been cancelled. Thus, claims 1, 3, 6-22 and 24-27 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 12/3/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the independent claims on page 9-10:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"wherein the lid is positionable in an open configuration and a closed configuration, wherein in the open configuration, the volume of the medication reservoir is exposed,"
See examiner's rejection as necessitated by the amendment, below, which details the manner by which the claimed lid of the prior art of Dhami can be considered positionable between open and closed configurations such that in an open configuration the volume of the medication reservoir accommodation portion is exposed, best illustrated by the open configuration of the invention in fig 1.
Examiner notes that the present amendments to the claims particularly regard the medication reservoir accommodation portion and the manner by which that element receives, retains, and in some configurations permits exposure of a medication reservoir. Examiner notes for applicant that if they wish to distinguish the claimed invention from the prior art rejections presently of record in this regard then incorporating more specific disclosed subject matter which better defines the specific medication reservoir, such as the disclosed drug bag 14 having a tag 16 disposed in its pocket 17, and having an outlet 18 which connects to the inlet 32 of the infusion pump tube segment 30 illustrated in applicant’s fig 2+4, may distinguish such amended claims from the prior art rejections presently of record and may itself constitute allowable subject matter. Depending on the language of such claim amendments, further search and consideration may be required examiner to confirm or deny the allowability of such subject matter.
Regarding applicant’s argument regarding new dependent claims on page 10:
Applicant's arguments regarding new claim 27, are persuasive, however the claim does not constitute allowable subject matter as detailed in examiner's rejection as necessitated by the amendment below.
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 1, 3, 6-22 and 24-27 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 1
The claim recites “the volume of the medication reservoir is exposed”, however only “a volume for accommodating a medication reservoir” included with the medication reservoir accommodation portion is previously recited. Accordingly, such claim language is indefinite as it is unclear whether the claim is intending to for the lid in the open configuration to expose the volume of the medication reservoir or the volume of medication reservoir accommodation portion which receives the medication reservoir should be exposed by the lid. As the written disclosure does not reference these specific volumes and the manner by which they may be exposed, for examination purposes the claim language is to be interpreted as referring to the medication reservoir accommodation portion, as demonstrated by applicant’s fig 1 which shows the lid in an open configuration and exposing compartment 4 which accommodates the medication reservoir bag 14.
Regarding the claims 3, 6-22 and 24-27
The dependent claims are at least rejected for being dependent upon the rejected independent claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1, 3, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150182688 A1, henceforth written as Dhami.
Regarding claim 1, Dhami discloses:
An infusion pump device, comprising a pump unit having an inlet and an outlet,
(delivery device 100 has pump 30 actuating tube 23 with its inlet (not enumerated) at end fitting 24b and its outlet (not enumerated) at end fitting 24a; fig 1-4)
a connector being in fluid communication with the inlet of said pump unit,
(end fitting 24b mating to inlet (not enumerated) of tube 23; fig 1-4)
a medication reservoir accommodation portion wherein the medication reservoir accommodation portion includes a volume
(paragraph 67; pump 30 has receiving region 32, best seen in fig 1-2+5d-e, for mating with cassette base region 13)
for accommodating a medication reservoir
(cassette 10 can be considered the claimed medication reservoir by the manner by which it stores liquid therapeutic agent in a reservoir 12; fig 1+13)
having a label or tag so that
(tag 18; fig 5)
an outlet of the medication reservoir is to be coupled to said connector,
(paragraph 75; end fitting 24a, therein an outlet of cassette 10, is coupled to end fitting 24b via their mutual support of tube 23 indirectly coupling the two together; fig 4+13)
a reader which is provided at said medication reservoir accommodation portion so that the reader is adapted to read a label or tag of the medication reservoir when arranged at said medication reservoir accommodation portion.
(paragraph 89+92-94; reader 37 detects tag 18 when cassette 10 has been mated to region 32; fig 1-5)
and a single housing which includes at least said pump unit, said medication reservoir accommodation portion and said reader,
(paragraph 68+93; the claimed singular housing, illustrated in its complete form as fig 4, includes the housing 31 and housing 11 which as a singular unit enclose the delivery device 100, within them encompassing pump 30, receiving region 32, and reader 37; fig 1-5; note examiner's broadest reasonable interpretation of the claim term "single housing" provided in the preceding office action)
wherein the single housing further includes a lid configured to cover the pump unit, the medication reservoir accommodation portion, and the reader,
(housing 11 can be considered the claimed lid by the manner by which it covers tube 23 of the claimed pump unit, receiving region 32 and reader 37 as illustrated in the lid closed configuration of fig 4; note examiner's broadest reasonable interpretation of the claim term "lid" provided in the preceding office action)
wherein the lid is positionable in an open configuration and a closed configuration, wherein in the open configuration, the volume of the medication reservoir is exposed,
(fig 1 illustrates the claimed lid in an open configuration wherein the receiving region is exposed for a user to view, and fig 3 illustrates the claimed lid in a closed configuration)
wherein said medication reservoir accommodation portion comprises a compartment which is adapted to accommodate a medication reservoir, and comprises a bottom and at least one sidewall,
(see fig 5+6, region 32 constitutes a compartment between flat surface 83, which is considered to be the claimed bottom, and the following elements which are considered the claimed sidewalls of the compartment: the walls which protrusions 33 extend from, the wall of occlusion block 9 spanning the distance between the walls which protrusions 33 extend from, & the base block 1)
wherein said reader is provided at said bottom or the at least one sidewall.
(fig 5, shows reader 37 disposed at flat surface 83)
Regarding claim 3, Dhami discloses:
The infusion pump device according to claim 1, wherein said reader is further adapted to read the tag or label of a patient as long as a medication reservoir is absent from said medication reservoir accommodation portion.
(paragraph 55+89-94; the device 100 used for delivering therapy to patients has reader 37 detects when tag 18 has/hasn't entered a vicinity where it is considered connected; fig 1-5)
Regarding claim 6, Dhami discloses:
The infusion pump device according to claim 1, wherein said reader is an RFID/NFC and/or barcode reader.
(paragraph 89-94; tag 18 is an RFID tag)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 4689043 A, henceforth written as Bisha, in view of Dhami.
Regarding Claim 1,
Bisha discloses:
An infusion pump device,
(invention of fig 1)
comprising a pump unit having
(the claimed pump unit is considered the portion of IV tube 12 which spans from fitment 22, where tubing 12 enters device 10, to the portion of tube 12 which exits from device 10, illustrated at the bottom of device 10 in figure 2, and the peristaltic pumping means 28; fig 2)
an inlet and an outlet,
(see examiner's annotation of Bisha's figure 2 noting the claimed inlet and outlet of the claimed pump unit as the point which tubing 12 mates with fitment 22 at its entry point into device 10 and the point which tubing 12 exits from device 10)
a connector being in fluid communication with the inlet of said pump unit,
(see examiner's annotation of Bisha's figure 2 noting the claimed connector as the tubing which spans from the claimed inlet to the claimed outlet)
a medication reservoir accommodation portion, wherein the medication reservoir accommodation portion includes a volume accommodating
( see examiner's annotation of Bisha's figure 2 noting the structures which accommodate the claimed medication reservoir, pumping section 18, and can then be considered the claimed medication reservoir accommodation portion )
a medication reservoir -- so that an outlet of the medication reservoir is to be coupled to said connector,
(pumping section 18 contains the IV medicament conveyed by tubing 12 from bag 14, therein pumping section 18 can be considered the claimed medication reservoir; see examiner's annotation of Bisha's figure 2 noting the claimed outlet of the medication reservoir and demonstrating the manner by which outlet of the medication reservoir is connected to the claimed connector)
--and a single housing which includes at least said pump unit, said medication reservoir accommodation portion--
(housing (not enumerated) of device 10 is demonstrated in fig 2 as including the claimed pump unit and medication reservoir accommodation portion; see examiner's annotation of Bisha's figure 2 noting the claimed single housing)
wherein the single housing further includes a lid configured to cover the pump unit, the medication reservoir accommodation portion, --, wherein the lid is positionable in an open configuration and a closed configuration, wherein in the open configuration, the volume of the medication reservoir is exposed,
(fig 2 illustrates the open configuration of door 76, the claimed lid, where the volume of claimed medication reservoir accommodation portion is exposed and visible, and fig 1 illustrates the closed configuration of door 76 which covers the claimed pump unit and medication reservoir accommodation portion.)
wherein said medication reservoir accommodation portion comprises a compartment which is adapted to accommodate a medication reservoir, and comprises a bottom and at least one sidewall, --
(see examiner's annotation of Bisha's figure 2 noting the claimed compartment of the medication reservoir accommodation portion, and the compartment's bottom & sidewall)
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Bisha discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a medication reservoir having a label or tag so that an outlet of the medication reservoir is to be coupled to said connector,
a reader which is provided at said medication reservoir accommodation portion so that the reader is adapted to read a label or tag of the medication reservoir when arranged at said medication reservoir accommodation portion--
--and a single housing which includes -- said reader,--
--wherein the single housing further includes a lid configured to cover--the reader, --
--wherein said reader is provided at said bottom or the at least one sidewall
However Dhami teaches a manner of identifying a medication reservoir disposed in a pump:
a reader which is provided at said medication reservoir accommodation portion so that the reader is adapted to read a label or tag of the medication reservoir when arranged at said medication reservoir accommodation portion
(paragraph 89+92-94; reader 37 detects tag 18 when cassette 10 has been mated to region 32; fig 1-5)
and a single housing which includes said reader,
(paragraph 68+93; the claimed singular housing, illustrated in its complete form as fig 4, includes the housing 31 and housing 11 which as a singular unit enclose the delivery device 100, within them encompassing pump 30, receiving region 32, and reader 37; fig 1-5;)
a lid configured to cover the reader,
(housing 11 can be considered the claimed lid by the manner by which it covers tube 23 of the claimed pump unit, receiving region 32 and reader 37 as illustrated in the lid closed configuration of fig 4)
wherein said reader is provided at said bottom or the at least one sidewall [of a compartment of the medication reservoir accommodation portion]
(fig 5, shows reader 37 disposed at flat surface 83, the bottom of the compartment receiving the claimed medication reservoir(see fig 5+6, region 32 constitutes a compartment between flat surface 83, which is considered to be the claimed bottom, and the following elements which are considered the claimed sidewalls of the compartment: the walls which protrusions 33 extend from, the wall of occlusion block 9 spanning the distance between the walls which protrusions 33 extend from, & the base block 1)
Examiner notes that upon Dhami’s medication reservoir being received in its medication reservoir accommodation portion such that Dhami’s reader reads the tag of medication reservoir, Dhami’s invention enlists numerous consequent processing and pump controlling structures and functions such as but not limited to a processor/storing unit identifying beneficial agent attribute information on the tag and determining dosing protocols automatically, see paragraph 88-89+93-94, user interfaces/input units like buttons 85 for inputting dosage settings and display 86 for communicating dosing protocols to a user, see paragraph 69, in order to operate its pump unit, pump 30, by modulating/initiating/stopping its function to deliver a desired therapeutic regiment with the medicament in its received medicament reservoir.
Examiner notes that Bisha is silent regarding how its peristaltic pumping means 28 is operated by a clinician/user to adjust its function and deliver medicament in accordance with a prescribed/preferred therapeutic treatment’s dosing regimen.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Dhami’s teachings of setting and delivering a prescribed treatment regimen through its manners of identifying and reading medication reservoir tags, receiving and communicating user inputs regarding a treatment regimen, and processing circuitry which considers and communicates this read and received treatment information to control the pump and dispense the desired dose to the peristaltic infusion device disclosed by Bisha in order to advantageously arrive at the predictable resulting invention of an infusion device which can set and deliver a desired therapeutic regimen by applying a known technique of setting a therapeutic treatment regimen and delivering that regimen via a peristaltic pump to a base invention of a peristaltic pump, which is silent regarding how it delivers a treatment regimen, see MPEP 2143(I)(C) .
Regarding claim 3, the modified invention of Bisha in view of Dhami teaches:
The infusion pump device according to claim 1, wherein said reader is further adapted to read the tag or label of a patient as long as a medication reservoir is absent from said medication reservoir accommodation portion.
Dhami: (paragraph 55+89-94; the device 100 used for delivering therapy to patients has reader 37 detects when tag 18 has/hasn't entered a vicinity where it is considered connected; fig 1-5)
Regarding claim 6, the modified invention of Bisha in view of Dhami teaches:
The infusion pump device according to claim 1, wherein said reader is an RFID/NFC and/or barcode reader.
Dhami: (paragraph 89-94; tag 18 is an RFID tag)
Claims 7-12, 14-21, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Dhami as applied to claim 1 above, in view of US 8551038 B2, henceforth written as Tsoukalis.
Regarding Claim 7,
Dhami discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Dhami is silent regarding:
The infusion pump device according to claim 1, further comprising a communication unit adapted to communicate with a remote server.
However, Tsoukalis teaches a pump infusion system
a communication unit adapted to communicate with a remote server.
(col 13 line 57 - col 14 line 67; invention includes a telecommunications means (not enumerated) which communicates with a device 16 or server 2 to communicate information such as protocol lists, drug information, patient identification, etc. ; fig 1)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the telecommunications means communicating with a remote server teachings of Tsoukalis to the infusion pump device of Dhami in order to arrive at an invention which can advantageously communicate and consider infusion protocols, medication information, historic data, patient(s) identifiers/protocols, safety limits, and etc. to improve the safety of the therapeutic delivery process, see col 14 line 46 - col 15 line 40 of Tsoukalis.
Regarding claim 8, Dhami in view of Tsoukalis discloses:
The infusion pump device according to claim 7, further comprising a storing unit adapted to store at least a drug library downloaded from the remote server and including a list of different drugs, and an infusion protocol list downloaded from the remote server and including different specific infusion protocols each of which requires at least one specific drug taken from said drug library and defines a specific drug delivery and/or application to a patient.
Dhami: (paragraph 69+89+94; processor (not enumerated/illustrated) receives/verifies, the beneficial agent information on the tag 18 and determines dosing protocols based at least on the concentration of the agent and other encoded information, as well as presenting therapy settings on display 86, consequently the processor is adapted to store the information, such as drug, drugs per therapy, & protocol data and therein drug lists and infusion protocols lists, received by Tsoukalis’ communication means from Tsoukalis’ server)
Regarding claim 9, Dhami in view of Tsoukalis discloses:
The infusion pump device according to claim 8, further comprising an input unit adapted to enable a selection of a predetermined specific infusion protocol from the infusion protocol list.
Dhami: (paragraph 69; input buttons 85 allows for input of dosage setting and other device settings therein is adapted to enable a selection of infusion protocols; fig 5)
Regarding claim 10, Dham in view of Tsoukalis discloses:
The infusion pump device according to claim 9, wherein said input unit is further adapted to enable a modification of the predetermined specific infusion protocol, said storing unit is further adapted on the basis of said modification to amend said predetermined specific infusion protocol to a modified specific infusion protocol in the infusion protocol list stored, and said input unit is further adapted to then enable a selection of a predetermined specific infusion protocol being said modified specific infusion protocol from the infusion protocol list.
Dhami: (paragraph 69; input buttons 85 allows for input of dosage setting and other device settings, where output display 86 is capable of providing any visual information to the user, for instance set and modified dosing protocols, accordingly the input buttons 85 and display 86 are adapted to adjust dosage settings of the invention’s present infusion protocol(s) which are consequently executed; fig 5)
Regarding Claim 11,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Dhami in view of Tsoukalis is silent regarding
The infusion pump device according to claim 9, further comprising a processing unit adapted to check if the read drug data read by said reader and indicating the characteristics of the drug included in the medication reservoir matches with the requirements of the predetermined specific infusion protocol and only in case there is a match allows said pump unit to be started.
However, Dhami further discloses
a processor adapted to check if the read drug data read by said reader and indicating the characteristics of the drug included in the medication reservoir matches with the requirements of the predetermined specific infusion protocol and only in case there is a match allows said pump unit to be started.
(paragraph 89; processor (not enumerated/illustrated) prohibits operation of the pump if the reader 37 detects tag 18 indicates its beneficial agent has expired; an agent not being expired is a requirement of all prescribed treatment regimens)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the processor disclosed by Dhami in order to provide dedicated processing elements for storing information and reading information in order to reduce risk of information transmission/reception errors and improve device redundancy, see MPEP 2144.04(VI)(B), such redundancy which protects against these errors which may result in failure to deliver the prescribed medicament or delivering the wrong medicament which may kill a patient.
Regarding claim 12,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The infusion pump device according to claim 11, further comprising a user interface, wherein said processing unit is adapted on the basis of the read drug data to find only those specific infusion protocols which are relevant for the read drug --.
Dhami: (paragraph 69; output display 86 can display visual information to the user; fig 5a; paragraph 94; processor (not enumerated/illustrated) determines one or more dosing options based on the beneficial agent associated with tag 18)
However, Dhami in view of Tsoukalis is silent regarding:
wherein said processing unit is adapted on the basis of the read drug data to find only those specific infusion protocols which are relevant for the read drug and to present them by said user interface
However, Dhami teaches:
A user interface for displaying information such as drug protocols
(paragraph 69; output display 86 can display any visual information, including specific infusion protocols, to the user; including that information read from tag 18 or communicated from an external server)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, communicate the read drug protocol data taught by Dhami via the display of the modified invention of Dhami in view of Tsoukalis in order to advantageously arrive at an invention which permits a user to visually confirm that the treatment regimen they intend to administer is accurate, therein improving the useability of the invention for lay persons and reducing the likelihood that dangerous or inappropriate treatment regimens are mistakenly administered which could kill the patient.
Regarding claim 14, Dhami discloses:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to select only those specific infusion protocols which require the administration of a drug with the same name and concentration as with the read drug.
Dhami: (paragraph 94; the processor coupled to reader 37 determines the dosing regimen based on the beneficial agent identity and concentration as read by reader 37, therein only selects specific infusion protocols associated with that drug and its concentration)
Regarding claim 15, Dhami in view of Tsoukalis discloses:
The infusion pump device according to claim 11, wherein said storing unit is further adapted to store a patient list downloaded from the remote server,
Dhami: (as described in claim 7 above, processor (not enumerated/illustrated) is adapted to receive/store the information received from Tsoukalis’ server, including patient specific data and therein a patient list, via Tsoukalis’ communication means)
and said input unit is further adapted to enable a selection of a specific patient profile from the patient list.
Dhami: (paragraph 69; input buttons 85 permit a selection of dosage settings, and other device settings, therein is enabled to select a profile)
Regarding claim 16, Dhami discloses:
The infusion pump device according to claim 15, wherein said processing unit is further adapted to provide for said selected specific patient profile a patient-medication link for downloading a relative infusion protocol and a 5R list including patient verification, drug, infusion protocol, time of the start of the infusion and delivery route from the remote server or for reading them from the label or tag of the medication reservoir, and to validate the specific patient and drug.
(paragraph 94, “RFID reader 37 can be coupled to a processor, [therein forming a communicative link] which can be configured to receive and verify the identification information for cassette 10 encoded on the RFID tag”, therein processor is adapted to verify the information it receives, such as patient ID and drug information read from the Dhami’s tag 18, or the information received via Tsoukalis’ communication means and downloaded from the server.)
Regarding Claim 17,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim.
The infusion pump device according to claim 15, wherein said processing unit is further adapted, after having read the drug data by said reader, to find a predetermined specific infusion protocol from the infusion protocol list by using the specific patient profile,
Dhami: (paragraph 94; processor (not enumerated/illustrated) can determine one or more dosing options based on at least the information encoded on tag 18, and as noted above including the information communicated from the remote server of Tsoukalis, therein processor (not enumerated/illustrated) is adapted to determine a infusion protocol based on reading identifying patient information)
However Dhami in view of Tsoukalis is silent regarding
and in case said patient profile indicates a chronic patient to omit this step if the predetermined specific infusion protocol has already used once and the patient is the same.
However, Tsoukalis further teaches
(Col 14 line 46 - col 15 line 2 + col 16 line 33-37; Determining parameters, and governing pump based on time since last infusion per the prescribed therapy parameters/limitations)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Tsoukalis’ further teachings of considering time since previous infusion for chronic/regular use to regulate infusion in order to arrive at an invention which can advantageously treat chronic conditions while adhering to limitations on dose interval/quanity, see col 16 line 33-36 of Tsoukalis.
Regarding claim 18, Dhami in view of Tsoukalis disclose:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to validate the read drug by using a 5R list including patent verification, drug, infusion protocol, time of the start of the infusion and delivery route downloaded from the remote server.
Dhami: (paragraph 94; processor (not enumerated/illustrated) coupled to reader 37 verifies identification information on tag 18, therein processor is adapted to validate the read drug with the information downloaded via Tsoukalis’ communication means from Tsoukali’s remote server regarding the drug and treatment regimen)
Regarding claim 19, Dhami disclose:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to detect from the read drug data the content of the drug as a characteristic and patient specific and/or infusion specific data and/or a link for downloading a 5R list including patent verification, drug, infusion protocol, time of the start of the infusion and delivery route from the remote server.
(paragraph 88, "The RFID tag can include attribute information of a beneficial agent contained in the fluid reservoir encoded thereon [for being read by reader 37 and interpreted by the processor (not enumerated/illustrated) ]. The attribute information can include one or more of a concentration, a formation date, and an expiration date of the beneficial agent.", therein processor is adapted to detect the claimed information read from tag 18)
Regarding claim 20,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim.
The infusion pump device according to claim 11, wherein said processing unit is further adapted on the basis of a selection of the therapy and the drug as well as a profile defining a subcategory of the selected therapy to provide a selection of predetermined specific infusion protocols to be used.
Dhami: (paragraph 89+93; processor can determine a therapy based on information read from tag 18 and as inputted from buttons 85, adjusting infusion/device settings)
However it is silent regarding
to provide a selection of predetermined specific infusion protocols to be used.
However, Dhami teaches:
A user interface for displaying information such as drug protocols
(paragraph 69; output display 86 can display any visual information, including specific infusion protocols, to the user; including that information read from tag 18 or as input from buttons 85)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, communicate the drug protocol data taught by Dhami via the display of the modified invention of Bisha in view of Dhami and Tsoukalis in order to advantageously arrive at an invention which permits a user to visually confirm that the treatment regimen they intend to administer is accurate, therein improving the useability of the invention for lay persons and reducing the likelihood that dangerous or inappropriate treatment regimens are mistakenly administered which could kill the patient.
Regarding claim 21,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Dhami in view of Tsoukalis is silent regarding
The infusion pump device according to claim 7, further comprising a location detection unit adapted to receive and process the signals from said communication unit and on the basis of said signals to determine the actual location of the infusion pump device.
However, Dhami further discloses
a processor adapted to receive and process the signals to determine the actual location of the infusion pump device.
(paragraph 89+93; reader 37's processor determines when the tag 18 is within a range of detection, therein the processor is adapted to determine the location of the pump device from a received signal)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the processor disclosed by Dhami for communicating with Tsoukalis’ communication means and Dhami’s tag in order to provide dedicated processing elements for detecting a position of the infusion device in order to reduce risk of information transmission/reception errors and improve device redundancy, see MPEP 2144.04(VI)(B), such device redundancy which mitigates transmission/reception errors that may lead to failure modes associated with inadequate/inappropriate treatment delivery and death.
Regarding claim 24,
Dhami discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
A medication reservoir for the infusion pump device according to claim 1, (see examiner’s interpretation of claim 1 above) comprising a label or tag and including a drug pre-filled in a pharmaceutical company or compounded in a hospital
(paragraph 88, "The RFID tag [on cassette 10] can include attribute information of a beneficial agent contained in the fluid reservoir encoded thereon [for being read by reader 37 and interpreted by the processor (not enumerated/illustrated) ]. The attribute information can include one or more of a concentration, a formation date, and an expiration date of the beneficial agent.")
However Dhami is silent regarding:
drug comprises an analgesic medication.
Notably, Dhami does disclose in paragraph 55 that the invention can be used “administering any of a variety of suitable therapeutic agents or substances, such as a drug or biologic agent, to a patient”
However, Tsoukalis teaches a pump infusion system wherein
drug comprises an analgesic medication.
(col 1 line 14-50; dispensing analgesic medication has a beneficial therapeutic effect)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the analgesic therapeutic media dispensing teachings of Tsoukalis to the therapeutic media dispensed by Dhami in order to advantageously arrive at an invention which can apply therapies related to pain relief, see paragraph 55 of Dhami, col 1 line 14-50 of Tsoukalis, and MPEP 2144.07.
Regarding Claim 25,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Dhami is silent regarding:
The infusion pump device according to claim 7, wherein the communication unit comprises a wireless communication unit.
However, Tsoukalis teaches a pump infusion system
wherein the communication unit comprises a wireless communication unit.
(col 13 line 57 - col 14 line 67; invention includes a telecommunications means (not enumerated) which communicates with a device 16 or server 2, wirelessly, to communicate information such as protocol lists, drug information, patient identification, etc. ; fig 1)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the telecommunications means communicating with a remote server teachings of Tsoukalis to the infusion pump device of Dhami in order to arrive at an invention which can advantageously communicate and consider infusion protocols, medication information, historic data, patient(s) identifiers/protocols, safety limits, and etc. to improve the safety of the therapeutic delivery process, see col 14 line 46 - col 15 line 40 of Tsoukalis.
Regarding claim 26, Tsoukalis teaches
The infusion pump device according to claim 25, wherein the wireless communication unit comprises one of a WiFi unit, a GSM unit, a GPS unit, a 3G unit, a 4G unit, a 5G unit, or a cellular unit
(col 13 line 57 - col 14 line 67; telecommunications means may use WIFI or GSM protocols to send wireless communications)
Claims 7-12, 14-22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Bisha in view of Dhami as applied to claim 1 above, in view of US 8551038 B2, henceforth written as Tsoukalis.
Regarding Claim 7,
Bisha in view of Dhami discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Bisha in view of Dhami is silent regarding:
The infusion pump device according to claim 1, further comprising a communication unit adapted to communicate with a remote server.
However, Tsoukalis teaches a pump infusion system
a communication unit adapted to communicate with a remote server.
(col 13 line 57 - col 14 line 67; invention includes a telecommunications means (not enumerated) which communicates with a device 16 or server 2 to communicate information such as protocol lists, drug information, patient identification, etc. ; fig 1)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the telecommunications means communicating with a remote server teachings of Tsoukalis to the modified infusion pump device of Bisha in view of Dhami in order to arrive at an invention which can advantageously communicate and consider infusion protocols, medication information, historic data, patient(s) identifiers/protocols, safety limits, and etc. to improve the safety of the therapeutic delivery process, see col 14 line 46 - col 15 line 40 of Tsoukalis.
Regarding claim 8, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 7, further comprising a storing unit adapted to store at least a drug library downloaded from the remote server and including a list of different drugs, and an infusion protocol list downloaded from the remote server and including different specific infusion protocols each of which requires at least one specific drug taken from said drug library and defines a specific drug delivery and/or application to a patient.
Dhami: (paragraph 69+89+94; processor (not enumerated/illustrated) receives/verifies, the beneficial agent information on the tag 18 and determines dosing protocols based at least on the concentration of the agent and other encoded information, as well as presenting therapy settings on display 86, consequently the processor is adapted to store the information, such as drug, drugs per therapy, & protocol data and therein drug lists and infusion protocols lists, received by Tsoukalis’ communication means from Tsoukalis’ server)
Regarding claim 9, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 8, further comprising an input unit adapted to enable a selection of a predetermined specific infusion protocol from the infusion protocol list.
Dhami: (paragraph 69; input buttons 85 allows for input of dosage setting and other device settings therein is adapted to enable a selection of infusion protocols; fig 5)
Regarding claim 10, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 9, wherein said input unit is further adapted to enable a modification of the predetermined specific infusion protocol, said storing unit is further adapted on the basis of said modification to amend said predetermined specific infusion protocol to a modified specific infusion protocol in the infusion protocol list stored, and said input unit is further adapted to then enable a selection of a predetermined specific infusion protocol being said modified specific infusion protocol from the infusion protocol list.
Dhami: (paragraph 69; input buttons 85 allows for input of dosage setting and other device settings, where output display 86 is capable of providing any visual information to the user, for instance set and modified dosing protocols, accordingly the input buttons 85 and display 86 are adapted to adjust dosage settings of the invention’s present infusion protocol(s) which are consequently executed; fig 5)
Regarding Claim 11,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However it is silent regarding
The infusion pump device according to claim 9, further comprising a processing unit adapted to check if the read drug data read by said reader and indicating the characteristics of the drug included in the medication reservoir matches with the requirements of the predetermined specific infusion protocol and only in case there is a match allows said pump unit to be started.
However, Dhami further teaches:
a processor adapted to check if the read drug data read by said reader and indicating the characteristics of the drug included in the medication reservoir matches with the requirements of the predetermined specific infusion protocol and only in case there is a match allows said pump unit to be started.
(paragraph 89; processor (not enumerated/illustrated) prohibits operation of the pump if the reader 37 detects tag 18 indicates its beneficial agent has expired; an agent not being expired is a requirement of all prescribed treatment regimens)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the processor disclosed by Dhami in order to provide dedicated processing elements for storing information and reading information in order to reduce risk of information transmission/reception errors and improve device redundancy, see MPEP 2144.04(VI)(B), such redundancy which protects against these errors which may result in failure to deliver the prescribed medicament or delivering the wrong medicament which may kill a patient.
Regarding Claim 12,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The infusion pump device according to claim 11, further comprising a user interface, wherein said processing unit is adapted on the basis of the read drug data to find only those specific infusion protocols which are relevant for the read drug --.
Dhami: (paragraph 69; output display 86 can display visual information to the user; fig 5a; paragraph 94; processor (not enumerated/illustrated) determines one or more dosing options based on the beneficial agent associated with tag 18)
However, Bisha in view of Dhami and Tsoukalis is silent regarding:
wherein said processing unit is adapted on the basis of the read drug data to find only those specific infusion protocols which are relevant for the read drug and to present them by said user interface
However, Dhami teaches:
A user interface for displaying information such as drug protocols
(paragraph 69; output display 86 can display any visual information, including specific infusion protocols, to the user; including that information read from tag 18 or communicated from an external server)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, communicate the read drug protocol data taught by Dhami via the display of the modified invention of Bisha in view of Dhami and Tsoukalis in order to advantageously arrive at an invention which permits a user to visually confirm that the treatment regimen they intend to administer is accurate, therein improving the useability of the invention for lay persons and reducing the likelihood that dangerous or inappropriate treatment regimens are mistakenly administered which could kill the patient.
Regarding claim 14, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to select only those specific infusion protocols which require the administration of a drug with the same name and concentration as with the read drug.
Dhami: (paragraph 94; the processor coupled to reader 37 determines the dosing regiment based on the beneficial agent identity and concentration as read by reader 37, therein only selects specific infusion protocols associated with that drug and its concentration)
Regarding claim 15, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 11, wherein said storing unit is further adapted to store a patient list downloaded from the remote server,
Dhami: (as described in claim 7 above, processor (not enumerated/illustrated) is adapted to receive/store the information received from Tsoukalis’ server, including patient specific data and therein a patient list, via Tsoukalis’ communication means)
and said input unit is further adapted to enable a selection of a specific patient profile from the patient list.
Dhami: (paragraph 69; input buttons 85 permit a selection of dosage settings, and other device settings, therein is enabled to select a profile)
Regarding claim 16, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 15, wherein said processing unit is further adapted to provide for said selected specific patient profile a patient-medication link for downloading a relative infusion protocol and a 5R list including patient verification, drug, infusion protocol, time of the start of the infusion and delivery route from the remote server or for reading them from the label or tag of the medication reservoir, and to validate the specific patient and drug.
Dhami: (paragraph 94, “RFID reader 37 can be coupled to a processor, [therein forming a communicative link] which can be configured to receive and verify the identification information for cassette 10 encoded on the RFID tag”, therein processor is adapted to verify the information it receives, such as patient ID and drug information read from the Dhami’s tag 18, and the information received via Tsoukalis’ communication means and downloaded from the server.
Regarding Claim 17,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim.
The infusion pump device according to claim 15, wherein said processing unit is further adapted, after having read the drug data by said reader, to find a predetermined specific infusion protocol from the infusion protocol list by using the specific patient profile,
Dhami: (paragraph 94; processor (not enumerated/illustrated) can determine one or more dosing options based on at least the information encoded on tag 18, and as noted above including the information communicated from the remote server of Tsoukalis, therein processor (not enumerated/illustrated) is adapted to determine a infusion protocol based on reading identifying patient information)
However it is silent regarding
and in case said patient profile indicates a chronic patient to omit this step if the predetermined specific infusion protocol has already used once and the patient is the same.
However, Tsoukalis further teaches
(Col 14 line 46 - col 15 line 2 + col 16 line 33-37; Determining parameters, and governing pump based on time since last infusion per the prescribed therapy parameters/limitations)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Tsoukalis’ further teachings of considering time since previous infusion for chronic/regular use to regulate infusion in order to arrive at an invention which can advantageously treat chronic conditions while adhering to limitations on dose interval/quantity, see col 16 line 33-36 of Tsoukalis.
Regarding claim 18, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to validate the read drug by using a 5R list including patent verification, drug, infusion protocol, time of the start of the infusion and delivery route downloaded from the remote server.
Dhami: (paragraph 94; processor (not enumerated/illustrated) coupled to reader 37 verifies identification information on tag 18, therein processor is adapted to validate the read drug with the information downloaded via Tsoukalis’ communication means from Tsoukali’s remote server regarding the drug and treatment regimen)
Regarding claim 19, Bisha in view of Dhami and Tsoukalis teaches:
The infusion pump device according to claim 11, wherein said processing unit is further adapted to detect from the read drug data the content of the drug as a characteristic and patient specific and/or infusion specific data and/or a link for downloading a 5R list including patent verification, drug, infusion protocol, time of the start of the infusion and delivery route from the remote server.
Dhami: (paragraph 88, "The RFID tag can include attribute information of a beneficial agent contained in the fluid reservoir encoded thereon [for being read by reader 37 and interpreted by the processor (not enumerated/illustrated) ]. The attribute information can include one or more of a concentration, a formation date, and an expiration date of the beneficial agent.", therein processor is adapted to detect the claimed information read from tag 18)
Regarding claim 20,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim.
The infusion pump device according to claim 11, wherein said processing unit is further adapted on the basis of a selection of the therapy and the drug as well as a profile defining a subcategory of the selected therapy to provide a selection of predetermined specific infusion protocols to be used.
Dhami: (paragraph 89+93; processor can determine a therapy based on information read from tag 18 and as inputted from buttons 85, adjusting infusion/device settings)
However it is silent regarding
to provide a selection of predetermined specific infusion protocols to be used.
However, Dhami teaches:
A user interface for displaying information such as drug protocols
(paragraph 69; output display 86 can display any visual information, including specific infusion protocols, to the user; including that information read from tag 18 or as input from buttons 85)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, communicate the drug protocol data taught by Dhami via the display of the modified invention of Bisha in view of Dhami and Tsoukalis in order to advantageously arrive at an invention which permits a user to visually confirm that the treatment regimen they intend to administer is accurate, therein improving the useability of the invention for lay persons and reducing the likelihood that dangerous or inappropriate treatment regimens are mistakenly administered which could kill the patient.
Regarding claim 21,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding
The infusion pump device according to claim 7, further comprising a location detection unit adapted to receive and process the signals from said communication unit and on the basis of said signals to determine the actual location of the infusion pump device.
However, Dhami further discloses
a processor adapted to receive and process the signals to determine the actual location of the infusion pump device.
(paragraph 89+93; reader 37's processor determines when the tag 18 is within a range of detection, therein the processor is adapted to determine the location of the pump device from a received signal)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to duplicate the processor disclosed by Dhami for communicating with Tsoukalis’ communication means and Dhami’s tag in order to provide dedicated processing elements for detecting a position of the infusion device in order to reduce risk of information transmission/reception errors and improve device redundancy, see MPEP 2144.04(VI)(B), such device redundancy which mitigates transmission/reception errors that may lead to failure modes associated with inadequate/inappropriate treatment delivery and death.
Regarding claim 24,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
A medication reservoir for the infusion pump device according to claim 1, (see examiner’s interpretation of claim 1 above) comprising a label or tag and including a drug pre-filled in a pharmaceutical company or compounded in a hospital
Dhami: (paragraph 88, "The RFID tag [on cassette 10] can include attribute information of a beneficial agent contained in the fluid reservoir encoded thereon [for being read by reader 37 and interpreted by the processor (not enumerated/illustrated) ]. The attribute information can include one or more of a concentration, a formation date, and an expiration date of the beneficial agent.")
However Dhami is silent regarding:
drug comprises an analgesic medication.
Notably, Dhami does disclose in paragraph 55 that the invention can be used “administering any of a variety of suitable therapeutic agents or substances, such as a drug or biologic agent, to a patient”
However, Tsoukalis teaches a pump infusion system wherein
drug comprises an analgesic medication.
(col 1 line 14-50; dispensing analgesic medication has a beneficial therapeutic effect)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the analgesic therapeutic media dispensing teachings of Tsoukalis to the therapeutic media dispensed by the modified invention in order to advantageously arrive at an invention which can apply therapies related to pain relief, see paragraph 55 of Dhami, col 1 line 14-50 of Tsoukalis, and MPEP 2144.07.
Regarding Claim 25, Bisha in view of Dhami and Tsoukalis teaches:
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, it is silent regarding:
The infusion pump device according to claim 7, wherein the communication unit comprises a wireless communication unit.
However, Tsoukalis teaches a pump infusion system
wherein the communication unit comprises a wireless communication unit.
Tsoukalis: (col 13 line 57 - col 14 line 67; invention includes a telecommunications means (not enumerated) which wirelessly communicates with a device 16 or server 2, wirelessly, to communicate information such as protocol lists, drug information, patient identification, etc. ; fig 1)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the telecommunications means communicating with a remote server teachings of Tsoukalis to the infusion pump device of Bisha in view of Dhami and Tsoukalis in order to arrive at an invention which can advantageously communicate and consider infusion protocols, medication information, historic data, patient(s) identifiers/protocols, safety limits, and etc. to improve the safety of the therapeutic delivery process, see col 14 line 46 - col 15 line 40 of Tsoukalis.
Regarding claim 26, Bisha in view of Dhami and Tsoukalis teaches
The infusion pump device according to claim 25, wherein the wireless communication unit comprises one of a WiFi unit, a GSM unit, a GPS unit, a 3G unit, a 4G unit, a 5G unit, or a cellular unit
Tsoukalis: (col 13 line 57 - col 14 line 67; telecommunications means may use WIFI or GSM protocols to send wireless communications)
Regarding claim 27, Bisha in view of Dhami and Tsoukalis discloses:
The infusion pump device according to claim 1, wherein the single housing further includes hinge, wherein the lid is configured to lock to a key mechanism by rotating about the hinge, and wherein the key mechanism is disposed on an opposing side of the single housing from the hinge.
Bisha: (fig 1-2 demonstrate that the claimed housing's lid, door 76, rotates about hinges (not enumerated), to mate and lock with latch extension 86, the claimed key mechanism; fig 2 best illustrates the opposing disposal of the hinge and key mechanism)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dhami in view of Tsoukalis, as applied to claim 12 above, further in view of US 20110040247 A1, henceforth written as Mandro.
Regarding Claim 13,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Dhami in view of Tsoukalis is silent regarding
The infusion pump device according to claim 12, wherein said processing unit is further adapted to find from said relevant specific infusion protocols the specific infusion protocol which has been most used within a given time interval in the past and to present this specific infusion protocol at a first place in an order by said user interface.
However, Mandro teaches an infusion pump system
wherein said processing unit is further adapted to find from said relevant specific infusion protocols the specific infusion protocol which has been most used within a given time interval in the past and to present this specific infusion protocol at a first place in an order by said user interface.
(paragraph 87+244-247; processing logic (not enumerated/illustrated) can aggregate historical data to display a therapy diary which displays the most recent infusion protocols from the current date to earliest date in the diary; fig 26)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Mandro’s therapy diary display setting to the processor and display disclosed by Dhami in view of Tsoukalis in order to arrive at invention which can advantageously inform its user or their clinician of its exact therapeutic intervals and treatment type over time.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bisha in view of Dhami and Tsoukalis, as applied to claim 12 above, further in view of US 20110040247 A1, henceforth written as Mandro.
Regarding Claim 13,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However Bisha in view of Dhami and Tsoukalis is silent regarding
The infusion pump device according to claim 12, wherein said processing unit is further adapted to find from said relevant specific infusion protocols the specific infusion protocol which has been most used within a given time interval in the past and to present this specific infusion protocol at a first place in an order by said user interface.
However, Mandro teaches an infusion pump system
wherein said processing unit is further adapted to find from said relevant specific infusion protocols the specific infusion protocol which has been most used within a given time interval in the past and to present this specific infusion protocol at a first place in an order by said user interface.
(paragraph 87+244-247; processing logic (not enumerated/illustrated) can aggregate historical data to display a therapy diary which displays the most recent infusion protocols from the current date to earliest date in the diary; fig 26)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Mandro’s therapy diary display setting to the processor and display disclosed by Bisha in view of Dhami and Tsoukalis in order to arrive at invention which can advantageously inform its user or their clinician of its exact therapeutic intervals and treatment type over time.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Dhami in view of Tsoukalis, as applied to claim 21 above, further in view of US 20170290974 A1, henceforth written as Micrel.
Regarding Claim 22,
Dhami in view of Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The infusion pump device according to claim 21, further comprising a display,
Dhami: (display 86; fig 5)
wherein said location detection unit is further adapted to store the determined actual location.
Dhami: (paragraph 89+93; pump 30 is enabled only when it is confirmed that cassette housing 11 is joined to pump housing 31, therein retaining the information of the location of the housing)
However Dhami in view of Tsoukalis is silent regarding:
wherein said location detection unit is further adapted to still operate even when said display is deactivated.
However, Micrel teaches an infusion pump system
wherein a display, wherein said location detection unit is further adapted to still operate even when said display is deactivated.
(paragraph 79, “infusion pump 2 shuts OFF display and keeps location tracking to find its position after it is on standby”)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the display power switching teachings of Micrel in order to arrive at an invention which advantageously limits power demands on the system when the display is not in use but leaves critical features, like the claimed location detection unit on, see paragraph 79 of Micrel.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bisha in view of Dhami and Tsoukalis, as applied to claim 21 above, further in view of US 20170290974 A1, henceforth written as Micrel.
Regarding Claim 22,
Bisha in view of Dhami and Tsoukalis discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The infusion pump device according to claim 21, further comprising a display,
Dhami: (display 86; fig 5)
wherein said location detection unit is further adapted to store the determined actual location.
Dhami: (paragraph 89+93; pump 30 is enabled only when it is confirmed that cassette housing 11 is joined to pump housing 31, therein retaining the information of the location of the housing)
However Bisha in view of Dhami and Tsoukalis is silent regarding:
wherein said location detection unit is further adapted to still operate even when said display is deactivated.
However, Micrel teaches an infusion pump system
wherein a display, wherein said location detection unit is further adapted to still operate even when said display is deactivated.
(paragraph 79, “infusion pump 2 shuts OFF display and keeps location tracking to find its position after it is on standby”)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the display power switching teachings of Micrel in order to arrive at an invention which advantageously limits power demands on the system when the display is not in use but leaves critical features, like the claimed location detection unit on, see paragraph 79 of Micrel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783