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 action is in response to the amendments filed on 02/13/2026. Claims 1, 3, and 5-10 have been amended. Claims 1-10 are examined 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 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 10, it is unclear as to what a “backend” entails. It is unclear as to whether “backend” refers to some physical component of the infusion pump system, a period of undertaking, or a software computing component. A review of the specification fails to disclose the metes and bounds of "a backend". For the purposes of compact prosecution, the claim will be interpreted in a manner as best understood by the examiner to refer to a software component that operates on the “backend” such that it is a process not visible or required by a user. Accordingly, where the prior art teaches some type of automatic process, then it meets the claimed limitation of “backend”, which is consistent with the broadest reasonable interpretation of “backend” (e.g., see Merriam Webster Dictionary).
Regarding claim 1, the limitation “receiving from an input means assigned to the at least one infusion pump a second human-readable verification code, wherein the second human-readable verification code is obtained from the information carrier and manually entered into the input means without use of a scanner” is indefinite. The limitation is preceded by “receiving a medication container associated with said one of the infusion orders, the medication container being equipped or connected with an information carrier containing the one of the first human-readable verification codes”. Based on this, it is unclear if the information carrier contains two separate verification codes, or if the first and second verification codes are one and the same. In other words, if the information carrier is recited as containing the first verification code, how is a separate second verification code obtained?
Dependent claims 2-9 are rejected as well since they inherit the limitations of independent claim 1.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites (additional limitations crossed out):
A method for performing infusion therapy of a patient with at least one infusion pump, the method comprising:
Receiving, beds for intermediate storage of the infusion orders, the infusion orders including first human-readable verification codes assigned by the patient data management system as a unique identifier, the first human-readable verification codes being included in transmissions of the infusion orders from the patient data management system;
retrieving,
receiving from an input means assigned to the at least one infusion pump a second human-readable verification code, wherein the second human-readable verification code is obtained from the information carrier and manually entered into the input means without use of a scanner;
comparing the one of the first human-readable verification codes to the second human-readable verification code; and
when the one of the first human-readable verification codes matches the second human-readable verification code, executing the retrieved one of the infusion orders
The above limitations, as drafted, are processes that, under their broadest reasonable interpretation, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people. That is, other than reciting the claims as being performed by a “patient data management system”, “at least one infusion pump being connected to a backend of an infusion pump system” and “electronic interfaces”, nothing in the claims precludes the steps as being described as managing personal behavior or relationships or interactions between people. The claims, as written describe receiving infusion orders that include a first verification code, receiving a second (the first?) verification code obtained from an information carrier (i.e., label), comparing the first and second verification code, and executing the infusion order if the first and second verification codes match. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Accordingly, the claim recites an abstract idea
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a “patient data management system”, “at least one infusion pump being connected to a backend of an infusion pump system” and “electronic interfaces” to perform the steps. However, these additional elements merely serve to place the judicial exception into a particular environment. The claims further recite “receiving a medication container associated with said one of the infusion orders, the medication container being equipped or connected with an information carrier containing the one of the first human-readable verification codes”, “placing the medication container in a receptable or a connection of the at least one infusion pump adapted to receive the medication container”, and “performing infusion therapy of a patient at the bed location of the at least one infusion pump in accordance with the said one of the infusion orders”. (bolded portions are physical components) However, these limitations merely describe components used for their ordinary intended purpose. The claim does not require a modification to the physical structure of the infusion pump, medication container, or information carrier that improves the operation of these devices. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a “patient data management system”, “at least one infusion pump being connected to a backend of an infusion pump system” and “electronic interfaces” to perform the claimed steps amounts to no more than placing the judicial exception into a particular environment. These additional elements are merely invoked as tools to perform an existing medical process. In regards to the limitations of “receiving a medication container associated with said one of the infusion orders, the medication container being equipped or connected with an information carrier containing the one of the first human-readable verification codes”, “placing the medication container in a receptable or a connection of the at least one infusion pump adapted to receive the medication container”, and “performing infusion therapy of a patient at the bed location of the at least one infusion pump in accordance with the said one of the infusion orders”, these limitations are merely conventional functions. The act of receiving a medication container and placing the container in a receptacle or connection of the infusion pump is conventional preparatory activity associated with operating an infusion pump. Further, the performance of the infusion therapy merely applies the result of verified data to the particular field of infusion therapy. The infusion pump is used for its ordinary purpose of administering medication. The claim does not recite an improvement to the infusion process itself, such as an improved pumping mechanism, or other technological improvement resulting from the claimed process. Therefore, the claims are not found to be patent eligible.
Claims 10 features limitations similar to those of claim 1, but for the additional recitation of a “verification unit” (which appears to have no structure) to perform the steps. Claim 10 is also found to be directed to an abstract idea without significantly more.
Claims 2-9 are dependent on claim 1 and include all the limitations of claim 1. Therefore, they are also found to be directed to an abstract idea. Claim 4 states “wherein the step of comparing the one of the first human-readable verification code to the second human-readable verification code is carried out in a control system integrated into the at least one infusion pump”. However, this merely places the judicial exception into a computer environment. Claim 5 states “wherein retrieving the one of the infusion orders by the at least one infusion pump comprises retrieving the one of the infusion orders indirectly assigned to the at least one infusion pump from the backend via pull communication via the second electronic interface.”, and claim 6 states “wherein receiving infusion orders from the patient data management system comprises receiving infusion orders from the backend via push communication via the first electronic interface”. However, these functions are conventional as evidenced by at least Symantec which featured the conventional activities of receiving or transmitting data over a network. The remaining dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since it merely further narrows the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-7 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coutre (US 5,317,506) in view of Cavendish (US 2021/0170101), Gray (US 2017/0136176) and De La Huerga (US 2002/0038392).
Regarding claim 1, Coutre partially discloses A method for performing infusion therapy of a patient with at least one infusion pump, the method comprising:
Receiving, via a first electronic interface, at a backend of a least one infusion pump, infusion orders from a patient data management system of a medical facility having a plurality of beds for intermediate storage of the infusion orders, the infusion orders including first-human-readable verification codes assigned by the patient data management system as a unique identifier, the first human-readable verification codes being included in transmissions of the infusion orders from the patient data management system;
(Coutre discloses infusion pumps receiving infusion orders that includes at least patient identification data (i.e., human-readable verification codes) (See at least Col. 1, Lines 67-68 and Col. 2 Lines 1-15 and 31-35). However, the cited excerpts do not seem to explicitly disclose the direct transmission of the infusion orders to a backend of the infusion pumps. See at least Cavendish, Para. [0028] – “In embodiment of FIG. 1, the POC client 3126 in the POC system 3125 may communicate through the POC server 3124 with the MMU server 3108. The MMU server 3108 may interface or communicate wirelessly with the infusion pump 3130 through the same wireless nodes utilized by the POC system 3125 and a connectivity engine and antenna on or in the infusion pump 3130. Communication between the infusion pump 3130 and the POC client 3126 may take place through the MMU server 3108 and POC server 3124.”, Para. [0035] – “The POC system 3125 then automatically bundles the information into a program pump request containing the "order details" and in one embodiment, without further interaction with the caregiver 3132, transmits this information to the MMU server 3108.”, and Para. [0039] – “Once the MMU server 3108 transforms the information from the program pump request into infusion pump settings or delivery parameters and other information in a format acceptable to the infusion pump 3130, the MMU server 3108 may wirelessly download a command message to the infusion pump 3130.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre to utilize the teachings of Cavendish since it would allow for the remote programming of infusion pumps.
Coutre partially discloses retrieving, by the at the at least one infusion pump, one of the infusion orders associated with a bed location of the at least one infusion pump from the backend via a second electronic interface, the one of the infusion orders having one of the first human-readable verification codes assigned thereto by the patient data management system; (Coutre discloses infusion pumps receiving infusion orders that includes at least patient identification data (i.e., human-readable verification codes) (See at least Col. 1, Lines 67-68 and Col. 2 Lines 1-15 and 31-35). However, Coutre does not explicitly disclose “retrieving” (e.g., pulling) the data from the backend, or explicitly disclose that the orders are associated with a bed location. See Grey, at least Para. [0045] – “In some further embodiments, the infusion device 5 may send a request to the infusion management server (IMS) 10 for all outstanding (i.e. not already administered) orders 6 for a patient that is associated with the infusion device. Additionally, the user may request information on any orders 6 directed to that infusion device 5.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre and Fryman to utilize the teachings of Gray since they are in the same field of endeavor (i.e., control of infusion pumps), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Coutre also discloses:
receiving a medication container associated with said one of the infusion orders, the medication container being equipped or connected with an information carrier containing the one of the first human-readable verification codes;
Placing the medication container in a receptable or a connection of the at least one infusion pump adapted to receive the medication container;
(See at least Col. 9, lines 14-18, "After each prescription label has been generated by the pharmacy management system, the label is placed on the bag containing the solution to be infused. The bag is carried or transported by the hospital's usual method to the patient's location.”, and Col. 9, Lines 40-42 – “The user hangs the line medication or medications on the rack in step 402.”)
Coutre also discloses:
receiving from an input means assigned to the at least one infusion pump a second human-readable verification code,, the second human-readable verification code is obtained from the information carrier and manually entered into the input means without use of a scanner;
comparing the one of the first human-readable verification codes to the second human-readable verification code;
See at least Col. 2, Lines 28-38 – “The labeled container containing the infusion formulation is transferred to the patient by usual methods either within the hospital or to the patient's home in the case of remote infusion control. The user, a nurse or other health practitioner, using a bar code reader associated with each pump system, enters the data from the formulation container label into the infusion pumping system where it is displayed and accepted. The pumps serial port may be used for this purpose. Data can also be entered manually in addition to or in lieu of entry by bar code reader.”, Col. 9, Lines 40-44 – “The user hangs the line medication or medications on the rack in step 402. The user selects the method of inputting the data to the system, either through the bar codes or manually through a keypad as in the prior art systems.”, Col. 10, Lines 18-28 – “The infusion pumping system 38, 40 includes a database memory 38-4, 40-4, a small screen, generally a liquid crystal display, which prompts the user for the data to be wanded or entered through the keypad. The system will prompt the user for the user's personal identification number. This data may be provided in bar code format on, for example, a nurse's badge. The system will then request entry of the data contained on the solution label. Finally, the patient identification data must be entered. This data may also be in bar code format on the patient's chart or bracelet. The system verifies that the patient identification from the chart or bracelet matches the patient identification on the solution label and provides a mismatch indication.” Alternatively, see De La Huerga, Para. [0157] – “After a pump 100 is associated with a specific patient (e.g., via number 130 stored in controller memory 105), upon obtaining information from an IV bag 140 including the patient identification number 223 that indicates the patient for which a medicant in corresponding bag was dispensed, processor 104 can compare the patient number 130 stored in memory 105 with the number 223 obtained from the bag 140 to determine if the medicant in the IV bag 140 was dispensed for delivery to the patient 12 associated with the pump 100 (i.e., the patient whose ID device 10 was most recently used to associate the pump).”, and Claim 171 – “The method of claim 169 wherein the step of obtaining includes providing an interface device linked to the controller and manually entering the patient identifier.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre and Fryman to utilize the teachings of De La Huerga since it may reduce facility errors (Para. [0333]).
Coutre does not explicitly disclose when the one of the first human-readable verification codes matches the second human-readable verification code, executing the retrieved one of the infusion orders by the at least one infusion pump and performing infusion therapy of a patient at the bed location of the at least one infusion pump in accordance with the said one of the infusion orders (See De La Huerga, Para. [0157] – “If the compared numbers are identical, processor 104 may proceed to facilitate medicant delivery to the patient (i.e., may enable a pump unit corresponding to the medicant, unlock a compartment (not illustrated) on an infusion pump unit 108 to allow the IV bag 140 to be mounted thereon, and/or provide an audible or visual indication to the attending physician). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre, Fryman, and Gray to utilize the teachings of De La Huerga since it may reduce facility errors (Para. [0333]).
Regarding claim 2, Coutre discloses the method according to claim 1, further comprising the patient data management system assigning the plurality of beds to patients. (See at least Col. 5, Lines 33-39 – “The patient identification screen also contains data fields requesting or displaying data on the patient’s room number or other location identifier, total number of intravenous solution labels required for the patient, the patient’s physician, and physician identification number.”)
Regarding claim 4, Coutre discloses the method according to claim 1, wherein the step of comparing the one of the first human-readable verification codes to the second human-readable verification code is carried out in a control system integrated into the at least one infusion pump. (See at least Abstract – “The data on the label is transferred to an infusion pumping system by a bar code reader at the infusion pumping system. The pumping system checks that all necessary data has been entered.”)
Regarding claim 5, Coutre does not explicitly disclose the method according to claim 1, wherein retrieving the one of the infusion orders by the at least one infusion pump comprises retrieving the one of the infusion orders indirectly assigned to the at least one infusion pump from the backend via pull communication via the second electronic interface. (See Grey, at least Para. [0045] – “In some further embodiments, the infusion device 5 may send a request to the infusion management server (IMS) 10 for all outstanding (i.e. not already administered) orders 6 for a patient that is associated with the infusion device. Additionally, the user may request information on any orders 6 directed to that infusion device 5.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre to utilize the teachings of Gray since they are in the same field of endeavor (i.e., control of infusion pumps), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.)
Regarding claim 6, Coutre does not explicitly discloses the method according to claim 1, wherein receiving infusion orders from the patient data management system comprises receiving infusion orders from the backend via push communication via the first electronic interface. (See at least Cavendish, Para. [0028] – “In embodiment of FIG. 1, the POC client 3126 in the POC system 3125 may communicate through the POC server 3124 with the MMU server 3108. The MMU server 3108 may interface or communicate wirelessly with the infusion pump 3130 through the same wireless nodes utilized by the POC system 3125 and a connectivity engine and antenna on or in the infusion pump 3130. Communication between the infusion pump 3130 and the POC client 3126 may take place through the MMU server 3108 and POC server 3124.”, Para. [0035] – “The POC system 3125 then automatically bundles the information into a program pump request containing the "order details" and in one embodiment, without further interaction with the caregiver 3132, transmits this information to the MMU server 3108.”, and Para. [0039] – “Once the MMU server 3108 transforms the information from the program pump request into infusion pump settings or delivery parameters and other information in a format acceptable to the infusion pump 3130, the MMU server 3108 may wirelessly download a command message to the infusion pump 3130.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre to utilize the teachings of Cavendish since it would allow for the remote programming of infusion pumps.)
Regarding claim 7, Coutre discloses the method according to claim 1, further comprising assigning, by the patient data management system, a validity period or a validity duration to said at least one of the infusion orders and considering the validity period or the validity duration in the step of comparing the one of the first human-readable verification codes to the second human-readable verification code. (See at least Col. 5, Lines 63-68 – “In addition the expiration date is usually set for one day later but can be adjusted by a higher level of authorization. This data is placed into the system as default data, but it can be changed by the user during the next step of processing the script in step 168.”)
Regarding claim 9, Coutre discloses the method according to claim 1, further comprising labeling or marking the medication container with the second human-readable verification code. (See at least Col. 9, Lines 14-16 – “After each prescription label has been generated by the pharmacy management system, the label is placed on the bag containing the solution to be infused.”)
Claim 10 features limitation similar to those of claim 1 and is therefore rejected using the same rationale.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coutre (US 5,317,506) in view of Cavendish (US 2021/0170101), Gray (US 2017/0136176) and De La Huerga (US 2002/0038392), and in further view of Fryman (US 2023/0130432).
Regarding claim 3, Coutre discloses the method according to claim 1, wherein the at least one infusion pump comprises a plurality of infusion pumps, the method further comprising providing to the backend an assignment of the plurality of beds to the plurality of infusion pumps. (See at least Col. 4, Lines 4-7 – “While only two patients 34, 36 and associated pumping systems 38 and 40 are shown in FIG. 1 each hospital will generally have many such patients.” Alternatively, see at least Fryman Para. [0071] – “Advancing to a step 526 of process 500, patient information is matched against infusion devices known to be assigned to the patient to prevent infusion of the medication to the wrong patient due to use on the wrong infusion device.”, and Fig. 5, Item 526. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre , Cavendish, Gray, and De La Huerga to utilize the teachings of Fryman since it may prevent infusion of the medication to the wrong patient due to use on the wrong infusion device (Para. [0071]).)
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coutre (US 5,317,506) in view of Cavendish (US 2021/0170101), Gray (US 2017/0136176) and De La Huerga (US 2002/0038392), and in further view of Mercolino (US 2020/0279632)
Regarding claim 8, Coutre partially discloses the method according to claim 1, wherein the first verification code is an alphanumeric code valid within a limited time window. (See at least Col. 4, lines 38-39, "The delivery instructions are printed in bar code format as well as in human readable format on the label." However, Coutre does not explicitly disclose that the bar code is valid within a limited time window. See Mercolino, at least Para. [0075] – “In some embodiments, a code rendering may be sent to a mobile device to activate dispensing. Codes would only be sent to authorized persons (e.g., the nurses on duty at the time). Codes would expire according to controlling rules (e.g., could only be used once and not after a set time). This feature has additional benefits once the patient takes a device home, as it monitors compliance with release order and number of doses taken, data from which could positively affect physician prescribing practices. In preferred embodiments, the code sent to the mobile device may be a TraxSecur code.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Coutre, Fryman, Gray, and De la Huerga to utilize the teachings of Mercolino since it may limit use of the system’s infusion pump.)
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the claims “provid[e] patent eligible subject matter in the form of a particular machine or system under the machine or transformation test”. This is not persuasive. See MPEP 2106.05(b) – “For example, as described in MPEP § 2106.05(f), additional elements that invoke computers or other machinery merely as a tool to perform an existing process will generally not amount to significantly more than a judicial exception. See, e.g., Versata Development Group v. SAP America, 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015) (explaining that in order for a machine to add significantly more, it must "play a significant part in permitting the claimed method to be performed, rather than function solely as an obvious mechanism for permitting a solution to be achieved more quickly"). The alleged particular system of a patient data management system, infusion pump system having a backend, and verification unit merely serves as a vessel for executing the abstract idea, and therefore merely links the abstract idea to a particular technological environment or field of use.
Applicant argues that the claims provide a practical application. The Examiner respectfully disagrees. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. More specifically, the additional elements fail to include (1) improvements to the functioning of a computer or to any other technology or technical field (see MPEP 2106.05(a)), (2) applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda memo), (3) applying the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), (4) effecting a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)), or (5) applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (see MPEP 2106.05(e) and Vanda memo). 9. Rather, the limitations merely add the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)) or generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)), particularly as it relates to the recited “display”, “ID reader”, “processor comprising hardware”, “countdown timer”, and “communication interface” elements.
Based at least on the reasons above, the 101 rejection is maintained.
Applicant's arguments regarding claims rejected under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the prior art “makes no mention of a human-readable verification code that may be used to call up the infusion delivery data”. This is not persuasive as this is not featured in the claims. While the claims recite “human-readable verification codes”, there is no mention of calling up infusion delivery data. Further, as indicated by at least pages 5-6 of the Applicant’s specification, said “human-readable verification codes” are merely described as being alphanumeric. By broadest reasonable interpretation, this would encompass any combination of letters and numbers that would include at least the patient identification data (i.e., patient name) disclosed in reference Coutre.
Applicant argues that the prior art does not suggest the elimination of scanners. The Examiner respectfully disagrees. As indicated in the body of the rejection above, Coutre allows for the manual inputting of data. See at least Coutre, Col. 9, Lines 40-44 – “The user hangs the line medication or medications on the rack in step 402. The user selects the method of inputting the data to the system, either through the bar codes or manually through a keypad as in the prior art systems.”.
Based at least on the reasons above, the 103 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:.
“Barcode Medication Administration: Lessons Learned from an Intensive Care Unit Implementation” by Mary Wideman1, available February 2025 discloses that manual input of Internal Entry Numbers in a BCMA system is a common work-around and even potentially introduces risk. (See page 6 (442) – “If a medication can’t be scanned on a clinical care ward, it is likely the nurse will employ a work-around technique and enter the Internal Entry Number (IEN) for the medication manually, thereby bypassing BCMA and placing the patient at significant potential risk for a medication error. An example of a work-around is shown in Figure 3, Panel C.”, and page 7 (443) – “Panel C: This multi-dose insulin vial was found during BCMA rounds. Pharmacy did not supply a barcoded label with the medication, so a member of the nursing staff wrote the IEN (Internal Entry Number) on the bottle, allowing nurses to manually type in the mapped identification number instead of scanning a barcode, thereby effectively bypassing the BCMA nursing verification algorithm.”
“Alaris System User Manual”2 available November 2014 demonstrates that manual input of data has been available for infusion pumps for at least the past decade (see at least page 21 – “To manually enter patient identifier, use numeric data entry keys and/or alpha speed keys.”, page 357 – “Patient ID can be entered manually using the PC unit keypad.”
Batch (US 2024/0242823) – Para. [0061] – “As mentioned above, the controller processor 46 always compares the programmed information, whether obtained from scanning a label on a medication or obtained from manual input by a clinician, to an internal or external drug library 44 having institution-determined safe delivery limits for the medication.”
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://www.ncbi.nlm.nih.gov/books/NBK20569/
2 Available at https://www.manualslib.com/manual/2995145/Carefusion-Alaris-8015.html?page=2#manual
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