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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/11/2024 and 01/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: 235a, 235b, 235c, 300i, 340j, 342l, 345l, 352g, 352h, 352l.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 233a, 233b, 340h, 342i, 345i.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the two electrical first terminals and two electrical second terminals, as disclosed in claim 27, must be shown or the features canceled from the claims. No new matter should be entered. Per the examiner’s understanding, the figures only disclose intravenous line connector assemblies having three electrical first terminals and three electrical second terminals.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
In paragraph [0070], the specification states “Figure 5b is a determined topology for the intravenous line network of figure 5b.” The second recitation of “figure 5b” in the sentence should be corrected to “figure 5a” to align with what has been detailed in the “Brief Description of the Drawings”.
In paragraph [0081], the description of Figure 1 in the specification does not correlate with how it has been drawn in the drawings. The specification states “the positive and negative first terminals 103a, 104a are formed as projections on the outside of the first connector”, yet in Figure 1, the projections have been labeled 104a and 105a. Further, the specification states “The data terminal 105a is formed around the inside of the tube around the lumen of the first connector”, yet the inside terminal has been labeled 103a. The examiner is confused as to how the drawing is meant to look when viewed in light of the specification. The examiner suggest modifying the drawing to present what has been detailed in the specification, or vice versa, in order that the two align.
In paragraph [0083], the specification states “data first terminal 103a”. However, previously in paragraph [0081], the “data first terminal” was associated with the reference number 105a. In light of the above objection to paragraph [0081], the examiner remains confused as to where on the first connector all the terminals belong.
In paragraph [0085], the specification states “the positive and second terminals 104a, 105a”. However, in paragraph [0079], the reference number 104a was associated with “a negative terminal”, and there has been no previous mention to a numbering (i.e. first, second, etc.) in regards to the terminals. Therefore, the examiner remains confused as to how the applicant is identifying the terminals of the first connector and their qualities.
In paragraph [0092], the specification states “the first connector 201b is the same as the first connector in the embodiment of figure 1”. Therefore, the objection in regards to paragraph [0081] and how the terminals are placed on the first connector also applies to figure 2.
In paragraph [0095], the specification states “the first data terminal 203a”. The use of the article “the” indicates there has been a previous reference to 203a as a “first data terminal”. However, the has been no previous mention in the specification identifying 203a as anything other than an “electrical first terminal”. The examiner is confused as to why this part has been identified as such.
In paragraph [0097], the specification states “the positive and second terminals 204a, 205a”. However, in paragraph [0090], the reference numbers 204a, 205a were associated with “an electrical first terminals”, and there has been no previous mention to a numbering (i.e. first, second, etc.) in regards to the terminals. Therefore, the examiner remains confused as to how the applicant is identifying the terminals of the first connector and their qualities.
In paragraph [0102], the specification identifies “input terminals 104b, 105b”. However, in paragraph [0076] reference numbers 104b, 105b are referred to as “electrical second terminals”. The examiner is confused by the change of name, as well as if figure 2b is the same embodiment as figure 1 or figure 2a.
In paragraph [0108], the specification identifies reference number 342h and 342i as both a “bag IV line” and a “bag of fluid”. When read in light of the drawings, the examiner believes the reference numbers associated with a “bag of fluid”, so 342g,h,i, should be corrected to 344g,h,i.
In paragraph [0136], the specification states “the data first terminal 403a”. The use of the article “the” indicates there has been a previous reference to 403a as a “data first terminal”. However, the has been no previous mention in the specification identifying 403a as anything other than an “electrical first terminal”. The examiner is confused as to why this part has been identified as such.
Appropriate correction is required.
Claim Objections
Claim 25 objected to because of the following informalities: Claim 25 states “a rotatable sleeve which is rotatable independently of the lumen”. However, in claim 21, upon which claim 25 is dependent, there are two lumens mentioned: a first lumen and a second lumen. It is unclear to the examiner which lumen claim 25 is referencing. The examiner suggests modifying the claim to be more specific as to which lumen the rotatable sleeve is rotatable independently of. For the purposes of examination, the examiner will interpret the claim to mean either lumen is acceptable for the rotatable sleeve to be rotatably independent of. 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 limitations use 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 limitations are:
The recitation, in claim 33, of “a controller configured to receive the fluid identity data transmitted from each data source via the electrical wires in the intravenous lines and the electrical connections provided by the intravenous line connector assemblies.” has been interpreted as structurally “a central computer attached to the electrical network formed by the intravenous line network” ([0112]).
The recitation, in claim 38, of “a data source configured to communicate a size of a lumen to the controller” has been interpreted as structurally “a data tag” ([0043]) or “a chip storing information” ([0113]).
The recitation, in claim 38, of “the controller configured to adjust flow rates being delivered by multiple fluid sources” has been interpreted as structurally “a central computer attached to the electrical network formed by the intravenous line network” ([0112]).
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.
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.
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 32 and 33 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 32, in the second line of the claim, the claim references “multiple intravenous components”. Although the claim goes on to specify “including at least one intravenous line”, the limitation of “multiple intravenous components” renders the claim indefinite by lacking specificity. A clear claim boundary does not exist as “intravenous components” could abound to a plethora of parts and devices that support intravenous medical work, and not just those disclosed in paragraph [0043] of the specification. Further, including the term “multiple” fails to particularly point out the numbers of components being used. For the purposes of examination, the examiner will interpret the limitation “multiple intravenous components” to mean more than one part or device that supports intravenous medical work. Later, in the sixth line of the claim, the claim references “electrical equipment”. The limitation “electrical equipment” renders the claim indefinite by lacking specificity. A clear claim boundary does not exist as “electrical equipment” could abound to a plethora of tools, parts, or devices the support the movement or containment of electricity. For the purposes of examination, the examiner will interpret “electrical equipment” as any tool, part, or device that support the movement or containment of electricity.
Claim 33 recites the limitation "the respective fluid" in the fifth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-23, 26, 27, and 29-31 are rejected under 35 U.S.C. 102(a) as being anticipated by Peer et al. (United States Patent Application Publication No. US 2017/0224975 A1; herein, Peer).
Regarding claim 21, Peer discloses an intravenous line connector assembly (Luer connector 300) comprising: a first connector (Luer male connector 310) comprising a first lumen (fluid flow channel 318) and one or more electrical first terminals (electrical terminals 364, 366); and a second connector (Luer female connector 320) comprising a second lumen (fluid flow channel 334) and one or more electrical second terminals (conductive elements 370, 380), wherein when the first connector is connected to the second connector (Fig. 3B), the first lumen is connected to the second lumen to allow fluid communication between the first and second connectors ([0074], “When Luer male connector 310 and Luer female connector 320 properly mate, all fluid flow channels form a continuous fluid flow channel.”), and the first terminals are connected with the second terminals to allow electrical signals to pass between the first and second connectors ([0079], “When the Luer male connector and the Luer female connector are not properly engaged, conducting rings 370 and 380 do not touch terminals 364 and 366 and, therefore, they do not receive power from power supply source 391 of medical system 392.”).
Regarding claim 22, Peer discloses the first and second connectors comprise respective complementary engagement surfaces configured to physically maintain connection between the first and second connectors (Fig. 3B, [0059], "Primary male member 312 and primary female member 322 have a screwing mechanism and are engageable using the screwing mechanism." Connection is maintained by screwing mechanism, which is complementary between the male and female connectors.).
Regarding claim 23, Peer discloses the complementary engagement surfaces comprise screw threads (Fig. 3B, [0059], "Primary male member 312 and primary female member 322 have a screwing mechanism and are engageable using the screwing mechanism." Screw threads can be seen on the screw mechanism in Fig. 3B).
Regarding claim 26, Peer discloses at least one of the first terminals is formed on a surface which is circularly symmetric about a lumen axis (Fig. 3A, electrical terminals 364, 366).
Regarding claim 27, Peer discloses the intravenous line connector assembly comprises two electrical first terminals and two electrical second terminals (Fig. 3A, Luer male connector 310 has electrical terminals 364, 366 and Luer female connector 320 has conductive elements 370, 380).
Regarding claim 29, Peer discloses at least one of the first and second connectors has no moving parts (Fig. 3A and Fig. 3B, Luer female connector 320 has no moving parts as the screwing mechanism rotatable cap would be a part of Luer male connector 310 as seen in Fig. 3B).
Regarding claim 30, Peer disclose the electrical signals comprise power signals ([0076], "System 392 may use electrical cable 311, for example, to transfer electrical power from a power supply source 391 of system 392 to (power up) Luer connector's electric circuit 313").
Regarding claim 31, Peer discloses the electrical signals comprise data signals ([0076], "System 392 may use electrical cable 311, for example, to transfer electrical power from a power supply source 391 of system 392 to (power up) Luer connector's electric circuit 313, including electronic chip 305 (an example electronic circuit), that may use cable 311 to transfer signals or data to, and exchange information with, system 392." and [0080], "During a communication session, electronic chip 305 may send to controller 395 various types of data that are stored in a memory of electronic chip 305.").
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Peer as applied to claim 23 above, and further in view of King (United States Patent Application Publication No. US 20080017642 A1).
Regarding claim 24, Peer does not disclose the screw threads comprise multiple thread starts, each start providing a separate said first terminal. However, King teaches the screw threads comprise multiple thread starts (FIG. 1, six second thread segments comprising upper portion 36 and lower portion 37), each start providing a separate said first terminal (FIG. 1 and FIG. 2, six first thread segments 14 individually abut with the six second thread segments). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the complementary engagement surfaces disclosed by Peer to have multiple thread starts providing a separate first terminal as taught by King in order to achieve an effective seal ([0089]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Peer as applied to claim 23 above, and further in view of another embodiment of Peer.
Regarding claim 25, the primary embodiment of Peer does not disclose one of the first and second connectors comprise a rotatable sleeve which is rotatable independently of the lumen, the rotatable sleeve comprising engagement surfaces for physically connecting with the other connector. However, an alternative embodiment of Peer teaches one of the first and second connectors comprise a rotatable sleeve (Fig. 4C, Luer male connector 460 has a screwing thread 466) which is rotatable independently of the lumen ([0089], “To engage the Luer female connector with Luer male connector 460, the primary female member of the Luer female connector is to be screwed into Luer male connector 460” It would be commonly understood in the art that a user could rotate the Luer male connector around the Luer female connector having a separate lumen), the rotatable sleeve comprising engagement surfaces for physically connecting with the other connector (Fig. 4C, screwing thread 466). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector disclosed by Peer to include a rotatable sleeve having engagement surfaces for connecting with another connector as taught by an alternative embodiment of Peer in order to establish a connection in which a ‘light’ mechanical resistance to engagement is felt at first, and, after some additional rotation of the connector, the resistance decreases, at which point proper engagement is achieved ([0089]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Peer as applied to claim 21 above, and further in view of Carbunaru (United States Patent Application Publication No. US 2013/0218154 A1).
Regarding claim 28, Peer does not disclose the intravenous line connector assembly comprises three electrical first terminals and three electrical second terminals. However, Carbunaru teaches wherein the intravenous line connector assembly comprises three electrical first terminals and three electrical second terminals (FIG. 2, [0036], “ the terminals 202 and the connector contacts 122 are designed so that each terminal 202 aligns with a corresponding connector contact 122 on the connector 118”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connector disclosed by Peer to include three electrical first terminals and three electrical second terminals as taught by Carbunaru in order to provide electrical current to multiple electrical components ([0038]).
Claims 32-34, 36, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Peer as applied to claim 21 above, and further in view of Seufert (United States Patent Application Publication No. US 2018/0294050 A1).
Regarding claim 32, Peer discloses multiple intravenous components including at least one intravenous line (Fig. 3C, tube 302 or [0081] "controller 395 may activate a pump"), the intravenous line connector assembly according to claim 21 (Luer connector 300), and electrical equipment (controller 295).
Peer does not disclose an intravenous line network comprising: each intravenous component comprising at least one electrical wire; the intravenous line connector assembly connecting the multiple intravenous components; and the electrical equipment electrically connected to at least one of the electrical wires.
However, Seufert teaches an intravenous line network (entire embodiment of FIG. 1) comprising: each intravenous component comprising at least one electrical wire ([0027] "All components…connect via electrical wires"); the intravenous line connector assembly connecting the multiple intravenous components (FIG. 1, FIG. 2, and FIG. 4, connection between tubings 32,23 occurs at port 27); and the electrical equipment electrically connected to at least one of the electrical wires ([0027] "All components including 2D camera, IV pump channel, internal switch, proximity sensor, hollow IV pole and hook, connect via electrical wires, data transfer cables and inter-unit interface (IUI) connectors." Electrical components are connected by electrical wires). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravenous line connector assembly disclosed by Peer to be a part of a larger intravenous line network which connects intravenous components together physically and electrically as taught by Seufert in order to provide external devices that give purpose to the connector and electrical equipment disclosed by Peer as well as provide medication from an IV pump in a way that increases safety measures with regard to IV administration of medication ([0026]).
Regarding claim 33, in the modified network disclosed by Peer and Seufert, Peer discloses a controller (controller 395).
Peer does not disclose the multiple intravenous components comprise multiple fluid sources connected to a common intravenous line, and wherein the electrical equipment comprises: a respective data source associated with each fluid source, the data source being configured to transmit fluid identity data identifying the respective fluid; and the controller configured to receive the fluid identity data transmitted from each data source via the electrical wires in the intravenous lines and the electrical connections provided by the intravenous line connector assemblies.
Seufert teaches the multiple intravenous components comprise multiple fluid sources (FIG. 1, IV medications and/or fluids 24,25) connected to a common intravenous line (FIG. 4, connection between tubings 32,23 occurs at port 27), and wherein the electrical equipment comprises: a respective data source associated with each fluid source (bar code 30), the data source being configured to transmit fluid identity data identifying the respective fluid ([0045], "When the scan initiator (that permits acquisition of scanning identification information obtained from the medication storage container, the identification information associated with the respective medication selectively included with the medication storage container), permits acquisition of the scanning identification information responsive to the medication storage container detector detecting presence of the medication storage container."); and the controller configured to receive the fluid identity data transmitted from each data source via the electrical wires in the intravenous lines and the electrical connections provided by the intravenous line connector assemblies ([0042], "Hall effect sensor and 3 pins is embedded inside a stationary plastic housing that acts as a switch, connected to the scanner to collect data via wires (for example), to transmit data from the camera via data transfer cables to IV pump PC. The scanner connects to the IV pump PC via data transfer cables inside the IV pole as an example of connection." Data is being received and transferred.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravenous line network taught by Seufert to include multiple fluid sources and data sources that provide identification data to a controller through electrical wires as further taught by Seufert in order to administer IV medications and fluids through a controlled pump channel and infuse them at a safe rate into a patient's vein via primary IV tubing ([0104]).
Regarding claim 34, in the modified network disclosed by Peer and Seufert, Peer does not disclose the controller is configured to identify whether the fluids are compatible or incompatible. However, Seufert teaches the controller is configured to identify whether the fluids are compatible or incompatible ([0089], "safety guardrails integrated into pump software inside pump PC 2, displaying on interface 38, will alert medical professions to drug-drug, or drug-IV fluid interactions"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified controller disclosed by Peer to identify whether fluids are compatible or incompatible as taught by Seufert in order to increase compliance with safety measures to prevent medication errors ([0056]).
Regarding claim 36, in the modified network disclosed by Peer and Seufert, Peer discloses the electrical equipment comprises a controller (controller 395), the controller being configured to: record a time at which one or more of the multiple intravenous components of the intravenous line network is first connected, and calculate an age of the components based on the time elapsed between first connection and a current time ([0065], [0063], "The controller may be configured to read (receive) data from an external system (e.g., medical system) and write the data into the memory, and to read (retrieve) data from the memory and send the read data to the external system." and "Data stored in the memory may include, for example, information related to, for example: (1) an identification or serial number (ID) of the tube and/or of the connector and/or of a system that can be paired with the tube, (2) the class or type of the tube and/or of the connector and/or of a system that is in use, (3) the number of times that the tube was used, (4) an accumulated time that the tube was in use, etc." Controller is able to record what tube was used and how many times, as well as the amount of time used for.).
Regarding claim 39, in the modified network disclosed by Peer and Seufert, Peer discloses the electrical equipment comprises a controller (controller 395), the controller being configured to: receive data via the electrical wires relating to a type of the multiple intravenous components ([0063]-[0065], controller 395 is able to intake data regarding an identification of a tube, which would include lumen size); and, based on the received intravenous component types, determine a network topology for a fluid network (controller would understand a map of the device like Fig. 3C in order to know where power comes from, as well as where fluid is being moved).
Regarding claim 40, in the modified network disclosed by Peer and Seufert, Peer does not disclose the electrical equipment comprises multiple pumps, and wherein at least one of the pumps is a controller pump having a controller configured to control at least one of the other said pumps.
However, Seufert teaches the electrical equipment comprises multiple pumps (FIG. 1 and FIG. 6, each IV pump channel 31 is one of multiple channels that act as individual pumps for various connected medications/fluids), and wherein at least one of the pumps is a controller pump having a controller configured to control at least one of the other said pumps (FIG. 1 and FIG. 6, IV pump 6 acts as controller pump). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravenous line network taught by Seufert to include multiple pumps, with one of the pumps being a controller pump as further taught by Seufert in order regulate the movement of fluid from the fluid sources to the patient ([0078]).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Peer in view of Seufert as applied to claim 34 above, and further in view of Uber, III et al. (United States Patent Application Publication No. US 2015/0231363 A1; herein, Uber).
Regarding claim 35, in the modified network disclosed by Peer and Seufert, Peer does not disclose the controller is configured, in response to identifying an incompatibility between two or more of the fluids, to create a flushing protocol to avoid the incompatible fluids coming in contact within the intravenous line network. However, Uber teaches the controller is configured, in response to identifying an incompatibility between two or more of the fluids, to create a flushing protocol to avoid the incompatible fluids coming in contact within the intravenous line network ([0085], “in situations where two or more of the possible multiple fluids are incompatible, the flushing fluid can be used to separate the incompatible fluids before delivery to the patient” and [0037], “The system further includes a second pump operably connected to the fluid path for injecting a fluid sufficient to flush the hazardous pharmaceutical out of the fluid path”, Pump is programmed to release fluid at a certain flow rate, which would be controlled by a controller). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified controller disclosed by Peer to create a flushing protocol to avoid the incompatible fluids coming in contact within the intravenous line network as taught by Uber in order to protect the patient by ensuring a fluid has completely been infused from the network before more fluids are injected (Table 1, [0085]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Peer in view of Seufert as applied to claim 32 above, and further in view of Gylland et al. (United States Patent Application Publication No. US 2019/0282757 A1; herein Gylland).
Regarding claim 37, in the modified network disclosed by Peer and Seufert, Peer discloses the electrical equipment comprises a controller (controller 395).
Peer does not disclose multiple pumps delivering fluid from multiple fluid sources, the controller being configured to switch between pumps and fluid sources based on when the fluid source is exhausted.
However, Seufert teaches multiple pumps delivering fluid from multiple fluid sources (FIG. 1 and FIG. 6, each IV pump channel 31 acts as an individual pump for various connected medications/fluids). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravenous line network taught by Seufert to include multiple pumps to deliver fluid from multiple fluid sources as further taught by Seufert in order to administer IV medications and fluids through a controlled pump channel and infuse them at a safe rate into a patient's vein via primary IV tubing ([0104]).
Peer in view of Seufert still does not disclose the controller being configured to switch between pumps and fluid sources based on when the fluid source is exhausted. However Gylland teaches the controller being configured to switch between pumps and fluid sources based on when the fluid source is exhausted ([0053], “the flow controller 235 can determine to switch infusion from the first reservoir to the second reservoir.”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified controller disclosed by Peer to be able to switch between fluid sources as taught by Gylland in order that more than one therapeutic fluid can be released from the same infusion pump ([0004]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Peer in view of Seufert as applied to claim 32 above, and further in view of Butterfield et al. (United States Patent No. US 8,777,894 B2; herein, Butterfield)
Regarding claim 38, in the modified network disclosed by Peer and Seufert, Peer discloses the electrical equipment comprises a controller (controller 395) and a data source configured to communicate a size of a lumen to the controller ([0063]-[0065], controller 395 is able to intake data regarding an identification of a tube, which would include lumen size).
Peer does not disclose the lumen receiving fluids from multiple fluid sources, the controller configured to adjust flow rates being delivered by multiple fluid sources such that a total flow rate delivered to the lumen is below a predetermined threshold.
However, Seufert the lumen receiving fluids from multiple fluid sources (FIG. 2 and FIG. 4, connection between tubings 32,23 occurs at port 27 which are connected to various IV medications and/or fluids 24,25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the intravenous line network taught by Seufert to include multiple pumps to deliver fluid from multiple fluid sources as further taught by Seufert in order to administer IV medications and fluids through a controlled pump channel and infuse them at a safe rate into a patient's vein via primary IV tubing ([0104]).
Peer in view of Seufert still does not disclose the controller configured to adjust flow rates being delivered by multiple fluid sources such that a total flow rate delivered to the lumen is below a predetermined threshold. However, Butterfield teaches the controller configured to adjust flow rates being delivered by multiple fluid sources such that a total flow rate delivered to the lumen is below a predetermined threshold (col. 12 line 55 - col. 13 line 3, flow rates of various drugs may be stored in a drug library for the processor to access and select the correct flow rate for the appropriate drug being infused). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified controller disclosed by Peer to be able to switch between flow rates delivered by multiple fluid sources as taught by Butterfield in order check the operating parameters of the pump before infusing a different fluid to protect both the patient and device (col. 13 lines 1-3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
De La Huerga (United States Patent Application Publication No. US 2002/0038392 A1) is considered relevant prior art with regards to controlling IV medication delivering and monitoring from multiple IV bags.
Kamen et al. (United States Patent Application Publication No. US 2012/0185267 A1) is considered relevant prior art with regards to electronically monitoring patient care and infusion from multiple sources using a shared line.
Utz (United States Patent Application Publication No. US 2017/0258983 A1) is considered relevant prior art with regards to a medical infusion system which transfers multiple fluids through a shared line.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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