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 6/08/2026. As directed by the amendment: claims 1, 24, and 27 have been amended. Thus, claims 1, 3, 6-22 and 24-27 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 9:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of the claims.
Regarding applicant’s argument regarding the independent claims on page 9-10:
Applicant’s arguments with respect to the independent claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding applicant’s argument regarding new dependent claims on page 11:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Claim Objections
Claims 1 and 24 is objected to because of the following informalities: claim 1 recites “…adapted to accommodate a medication reservoir…” and instead should recite “…adapted to accommodate the medication reservoir…”, claim 24 mistakenly refers to “the bad” instead of “the bag” . Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1 recites “a pump unit” which consequently performs a pumping function.
Claim 7 recites “a communication unit adapted to communicate with a remote server”. Examiner noting that claim 25 recites further functions of this communication unit.
Claim 8 recites “a storing unit adapted to store at least a drug library… an infusion protocol list… including different specific infusion protocols”.
Claim 9 recites “an input unit adapted to enable a selection of a predetermined specific infusion protocol from the infusion protocol list”. Examiner noting claim 10 recites further functions of this input unit.
Claim 11 recites “a processing unit adapted to check if the read drug data … 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”. Examiner noting that claim 12-20 recites further functions of this processing unit.
Claim 21 recites a “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”. Examiner noting that claim 22 recites further functions of this location detection unit.
Claim 25 recites “a wireless communication unit” which consequently performs a wireless communication function. Examiner noting that claim 26 recites further functions of this wireless communication unit.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a pump unit,” in light of applicant’s disclosure page 2, is considered to comprise a fluidic line or passage part for guiding a medication fluid or drug from the inlet to the outlet of the pump unit and a mechanism for pumping the medication or drug through the fluidic line or passage part, and structural equivalents thereof.
Regarding “a communication unit” and “wireless communication unit”, in light of applicant’s disclosure page 2 and 15, is considered to comprise some functional means enabled for the function of WiFi/GSM/GPS/3G/4G/5G wireless communication and is connectable in some manner to a location detection unit and processing unit.
Regarding “a storing unit”, in light of applicant’s disclosure page 3+4+15+30 is considered to comprise some functional means enabled for the claimed functions of storing data.
Regarding “an input unit”, in light of applicant’s disclosure page 15, comprises the structure of keys or some functional means part of internal circuitry of the system to perform the claimed functions.
Regarding “a processing unit”, in light of applicant’s disclosure page 15, is considered to comprise some functional means part of internal circuitry of the system enabled for the claimed functions of processing data.
Regarding “a location detection unit”, in light of applicant’s disclosure page 15, is considered to comprise some functional means part of internal circuitry of the system enabled for the claimed functions of location detection.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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, 6-16, 19-22, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190316948 A1, henceforth written as Karol, in view of US 20180330321 A1, henceforth written as Capelli.
Regarding Claim 1,
Karol discloses:
An infusion pump device,
(system 10; fig 1)
comprising a pump unit having an inlet and an outlet,
(cassette 24 having inlet from source component 6000 at spikes 160 and outlets at the connectors which mate with lines 26 28 34; fig 1-9+155)
a connector being in fluid communication with the inlet of said pump unit,
(source spike 63 of spikes 160; fig 3+155)
a medication reservoir accommodation portion, wherein the medication reservoir accommodation portion includes a volume accommodating a medication reservoir comprising a bag
( source heater 6270 is a pouch which receives source components 6000, a bag; fig 170, particularly the source component embodiment of fig 238)
having a label or tag so that
(paragraph 1210-1213; RFID/NFC tag 6540 contains certain critical therapy information pertinent; fig 238)
an outlet of the medication reservoir is to be coupled to an inlet of said connector,
(paragraph 1034; source component 6000 connects to an inlet of source spike 63 via a fluid line; fig 155+238)
wherein the label or tag is disposed [with the] medication reservoir--
(paragraph 1210; RFID tag 6540 is embedded within or attached to source component 6000; fig 238)
a reader --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 1211-1212; interrogator 6542 reads data from tag 6540 while source 6000 and its attached tag 6540 is disposed within source heater pouch 6270; fig 238)
and a single housing which includes at least said pump unit, said medication reservoir accommodation portion and said reader,
(housing 82 of cycler 14; fig 1)
wherein the single housing further includes a lid configured to cover the pump unit, the medication reservoir accommodation portion, and the reader, wherein the lid is positionable in an open configuration and a closed configuration, wherein in the open configuration, the volume of the medication reservoir accommodation portion is exposed,
(fig 170-171 illustrate front door 141 in an open configuration exposing source heater pouch 6270, and fig 1 illustrating the claimed closed configuration of door 141)
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, --
(space (not enumerated/illustrated) within source heater pouch 6270, therein having a bottom and sidewall, for receiving source component 6000; fig 170)
Karol discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
, wherein the label or tag is disposed inside a pocket of the medication reservoir, wherein the pocket is integral with the bag,
However Capelli teaches a bag of therapeutic media with an rfid tag comprising:
wherein the label or tag is disposed inside a pocket of the medication reservoir, wherein the pocket is integral with the bag,
(paragraph 61+81; pocket 6 formed in a wall 7 of bag 4, therein integral with, receives electronic device 5 and is sealed to prevent tampering or misuse, corruption of the data and to ensure the use can treat the data as reliable; fig 2)
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 apply Capelli’s teachings of disposing an RFID tag within a pocket of a medication reservoir to the invention of Karol, such that Karol’s tag 6540 is disposed and sealed with Capelli’s pocket 6 integrated with Karol’s source component bag 6000, in order to advantageously arrive at an invention which prevents tampering or misuse, corruption of the data contained on its tag and to ensure the use can treat the data as reliable, see paragraph 81 of Capelli.
Karol in view of Capelli discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
a reader which is provided at [a bottom or sidewall of the] medication reservoir accommodation portion
However Karol teaches in paragraph 1212-1213 that its interrogator 6542 may be a stand-alone component or may be a piece of hardware included within some part of cycler 14.
Notably, MPEP 2144.04(vi)(c) holds that a modification merely involving a rearrangement of parts, i.e. rearranging a position of a reader within a device such that the reader is in a different part of the device adjacent the element it would be intended to read data from, would not modify the operation of the device, only involve routine skill in the art and not be considered patentable as such a modification is a matter of obvious design choice.
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 rearrange the position of Karol’s reader such that it is disposed adjacent a receiving region of the tag on the medication reservoir, thereby disposing Karol’s reader in a wall of Karol’s source heater pouch 6270, as a matter of obvious design choice only involving routine skill in the art and which does not modify the operation of the prior art device, see MPEP 2144.04(vi)(c) and paragraph 1213 of Karol.
Regarding claim 3, Karol in view of Capelli 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.
Karol: (paragraph 1210-1213; interrogator 6542 is an RFID/NFC reader therein is functionally capable of reading the tag 6540 when source 6000 is within a proximity of interrogator compatible with its radiofrequency field detection range )
Regarding claim 6, Karol in view of Capelli discloses:
The infusion pump device according to claim 1, wherein said reader is an RFID/NFC and/or barcode reader.
Karol: (paragraph 1210; RFID/NFC tag 6540 therein interrogator 6542 is an RFID/NFC reader)
Regarding claim 7, Karol in view of Capelli discloses:
The infusion pump device according to claim 1, further comprising a communication unit adapted to communicate with a remote server.
Karol: (paragraph 564+1001-1003; network interface 318 of computer 302 may communicate with a remote database server 366 to permit cycler 14 to interface with therapeutic information; fig 78+99)
Regarding claim 8, Karol in view of Capelli 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.
Karol: (paragraph 1001-1005; memory 304 314 store data of the cycler controller 16, including therapy formulation parameters which comprises mixing parameters for multiple dialysates or a single dialysate, therein storing library list of different dialysates and lists of specific infusion protocols for each specific type of pertinent dialysate to be administered; fig 78 )
Regarding claim 9, Karol in view of Capelli 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.
Karol: (paragraph 342+1001-1005; a user may select, via a user interface including buttons and displays, specific therapy to administer or an adjustment to be made to a specific therapy; fig 1)
Regarding claim 10, Karol in view of Capelli 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.
Karol: (paragraph 790-798+812+946-948; user may update therapy parameters and select from previous infusion protocols comprising modified and unmodified protocols; fig 110+114-116)
Regarding claim 11, Karol in view of Capelli discloses:
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.
Karol: (paragraph 1212; interrogator 6542 reads data from tag 6540 ensures that only expected source components 6000, i.e. those matching the requirements of the therapy protocol, are used such that the claimed pump unit is not activated if source 6000 doesn't match)
Regarding claim 12, Karol in view of Capelli discloses:
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 and to present them by said user interface.
Karol: (paragraph 364+907+1003; user interface displays infusion parameters specific to the information read on tag )
Regarding claim 14, Karol in view of Capelli 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.
Karol: (paragraph 364+907+1003; user interface displays infusion parameters specific to the information read on tag, therein only selects specific infusion protocols associated with that drug and its concentration)
Regarding claim 15, Karol in view of Capelli 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, and said input unit is further adapted to enable a selection of a specific patient profile from the patient list.
Karol: (paragraph 812; cycler 14 has a clinician mode where a clinician may select a particular patient/user's therapy for execution/modification, out of a number of patients whose therapy may have been or may be executed by the device, the clinician mode read and writing -therein downloading information- from a database server 366)
Regarding Claim 16, Karol in view of Capelli 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.
Karol: (paragraph 1211-1212; tag 6540 contains source component type or contents (e.g. chemical composition), source component reservoir volume, lot number, manufacturer, manufacture date, expiration date -therein a time when infusion must be started by-, and admixture instructions, and confirms that only expected components are present for the specific patient’s prescribed therapy and thus verifies and validates the specific patient and drug to be administered according to a prescription to a specific patient)
Regarding claim 19, Karol in view of Capelli discloses:
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.
Karol: (paragraph 1210; Tag 6540 contains information about the contents of source component 6000)
Regarding claim 20, Karol in view of Capelli discloses:
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.
Karol: (paragraph 790-798+812+946-948; user may update therapy parameters, therein subcategories of the therapy based on the therapy type and drug type, and select from previous infusion protocols comprising modified and unmodified protocols; fig 110+114-116)
Regarding claim 21, Karol in view of Capelli discloses:
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.
Karol: (paragraph 954-974; head height of system 10 relative to a patient, therein an actual location of system 10, may be determined; fig 131-133)
Regarding claim 22, Karol in view of Capelli discloses:
The infusion pump device according to claim 21, further comprising a display,
Karol: (paragraph 342; interface 144 has display 324; fig 1+16)
wherein said location detection unit is further adapted to store the determined actual location, and
Karol: (paragraph 954-974; storage of head height information during processing and determination)
wherein said location detection unit is further adapted to still operate even when said display is deactivated.
Karol: (paragraph 755-762+775; during regular operation, therein when the claimed location detection unit is in operation, after some amount of time since the last interaction of the user with the display, the display may be dimmed, such that the display is considered deactivated from one power level to another lower power level)
Regarding claim 25, Karol in view of Capelli discloses:
The infusion pump device according to claim 7, wherein the communication unit comprises a wireless communication unit.
Karol: (paragraph 561-564;1213; system 10 having wireless communication protocol)
Regarding claim 26, Karol in view of Capelli discloses:
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
Karol: (paragraph 561-564+695; gps tracker on cycler 14)
Regarding claim 27, Karol in view of Capelli discloses:
The infusion pump device according to claim 1, wherein the single housing further includes hinge, wherein the lid is configured to lock with a key mechanism by rotating about a hinge, and wherein the key mechanism is disposed on an opposing side of the single housing from the hinge.
Karol: (paragraph 329+332-333+335; hinge on lower part of door 141, such that door 141 rotates to lock latch 1080 in a closed position; fig 15)
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Karol in view of Capelli as applied to claims above, and further in view of US 20110040247 A1, henceforth written as Mandro.
Regarding Claim 13,
Karol in view of Capelli discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Karol in view of Capelli 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 Karol in view of Capelli in order to arrive at invention which can advantageously inform its user or their clinician of exact therapeutic intervals, treatment type over time, and recent treatment types.
Claim(s) 17-18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Karol in view of Capelli as applied to claims above, and further in view of US 8551038 B2, henceforth written as Tsoukalis.
Regarding Claim 17,
Karol in view of Capelli 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,
Karol: (paragraph 1211-1214; cycler 14 identifies mixture protocol prescribed to a patient from data read from tag 6540)
However, Karol in view of Capelli is silent regarding:
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, 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 teaches
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, 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.
(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 of the modified invention of Karol in view of Capelli 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,
Karol in view of Capelli discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Karol in view of Capelli is silent regarding:
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.
Notably Karol does teach in paragraph 555+573+591+609 that it is desirable to verify and validate certain critical parameters utilizing data from remote sources.
However, Tsoukalis teaches
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.
Tsoukalis: (col 1 line 9- col 18 line 59 : certain medical device safety critical information -including that received from rfid tags on medicament bags- such as patient identity verification, intended drug type, infusion protocol, time of infusion/time between infusions, and administration route should be verified and validated to ensure therapeutic compliance and safety, this verification/validation information may be received from a remote server)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Tsoukalis teachings of verifying and validating safety critical information received from medicament containers with information specific to a patient that is received from a remote server to the modified invention of Karol in view of Capelli, in order to advantageously arrive at an invention which improves the safety of a therapeutic regiment by verifying/validating safety critical information.
Regarding Claim 24,
Karol in view of Capelli 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, wherein the bag includes a drug pre-filled in a pharmaceutical company or compounded in a hospital.
Karol: (paragraph 994-996; source component 6000 may contain beneficial or therapeutic additives produced by a manufacturer)
However, Karol in view of Capelli is silent regarding:
drug comprises an analgesic medication
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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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