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Patent Application 17359400 - INTRAVENOUS FLUID CONTAINER VOLUME MONITORING - Rejection

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Patent Application 17359400 - INTRAVENOUS FLUID CONTAINER VOLUME MONITORING

Title: INTRAVENOUS FLUID CONTAINER VOLUME MONITORING SYSTEM

Application Information

  • Invention Title: INTRAVENOUS FLUID CONTAINER VOLUME MONITORING SYSTEM
  • Application Number: 17359400
  • Submission Date: 2025-05-19T00:00:00.000Z
  • Effective Filing Date: 2021-06-25T00:00:00.000Z
  • Filing Date: 2021-06-25T00:00:00.000Z
  • National Class: 604
  • National Sub-Class: 506000
  • Examiner Employee Number: 86970
  • Art Unit: 3783
  • Tech Center: 3700

Rejection Summary

  • 102 Rejections: 0
  • 103 Rejections: 3

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    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 .

Status of Claims
This office action is in response to the Amendments filed on April 11, 2025. Claims 1, 5, 15, 16, 18, and 19 are amended. Currently, claims 1, 3-8, 10, 11, and 13-20 are still pending and further examined below.

Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114.  Applicant's submission filed on April 11, 2025 has been entered.

Claim Objections
Claims 1, 3-8, 10, 11, and 13-20 are objected to because of the following informalities: 
Claim 1: the recitations of “the threshold signal level” on lines 27, 30, and 31 should be recited as --the obtained threshold signal level-- to be consistent with the recitation in line 24 and avoid confusion of antecedent basis for the recitation.
Claim 5: the recitation of “each RFID tag of RFID tags” on line 12 should be recited as --each RFID tag of the plurality of RFID tags-- so as to avoid confusion of antecedent basis. The recitation of “a second returned RF signal associated with a second RFID tag” on line 23 should be recited as --a second returned RF signal returned by a second RFID tag-- to be consistent with the amendment on line 20.
Claims 3, 4, 6-8, 10, 11, and 13-20 are objected to for incorporating the above informalities through their respective claim dependencies. Appropriate correction is required.

Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

Claims 1, 3, 4, 6, and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the recitation of “a signal strength of returned RF signals from the plurality of RFID tags, wherein the plurality of RFID tags are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container” on lines 14-17 is confusing because it is unclear what a corresponding RFID tag is referring to. However, as best understood for the purpose of continuous examination, the recitation is interpreted as referring to a signal strength of returned RF signals from each of the plurality of RFID tags and a corresponding RFID tag is the RFID tag of the plurality of RFID tags returning the returned RF signal. Accordingly, it is suggested that the recitation be amended to recite --a signal strength of returned RF signals from each of the plurality of RFID tags, wherein the plurality of RFID tags are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag of the plurality of RFID tags that is covered by a fluid within the medication container-- so as to clarify the confusion.
Regarding claim 6, the recitation of “the one or more RFID tags” is still confusing because it is still unclear whether this recitation is referring to the plurality of RFID tags recited in line 4 of the claim and first introduced on line 4 of claim 5 or another different set of one or more RFID tags. However, as best understood for the purpose of continuous examination, the recitation is still interpreted as referring to the same plurality of RFID tags of line 4 of claim 5. Accordingly, the recitation is suggested to be recited as --the plurality of RFID tags--.
Regarding claim 8, the recitations of “the determined threshold signal level” on lines 2-3 and 4 is confusing because it is unclear what this limitation is referring to. Is this referring to the same threshold signal recited on line 18 of claim 5 or another different determined threshold signal level. However, as best understood for the purpose of continuous examination, the recitation is interpreted as referring to the same threshold signal level of claim 5. Accordingly, it is suggested that the recitation be amended to recite --the threshold signal level-- so as to clarify the confusion. Moreover, it is further suggested that the recitation of “and determining” on line 3 be amended to recite --and while determining-- to be consistent with the recitation in lines 20-25 of claim 5. 
For all of the above interpretations, if another different claim scope is intended to be required, appropriate clarification is required with citation of support suggested to avoid issues of new matter.
Claims 3 and 4 are also rejected for incorporating the above confusion through their respective claim dependencies. 

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.

Claims 1, 3-8, 10, 11, 13-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Braun (US Pub. No. 2010/0214106 A1) in view of Perkins (US Pub. No. 2010/0134303 A1) further in view of Ludin (US Pub. No. 2018/0280236 A1).
Claim 1. Braun discloses a monitoring device for monitoring a volume of a medication container comprising: 
one or more radio frequency (RF) devices (16, 18) providing an RF transmitting source (18) and a RF receiving source (16); 
one or more processors (110) ([0039]); and 
a non-transitory memory device (112) having instructions thereon ([0039]) that, when executed by the one or more processors, cause the monitoring device to perform operations comprising: 
transmitting, via the RF transmitting source, an RF signal toward a plurality of RF identification (RFID) tags (16) ([0021]) disposed on a side (12) of a medication container (10) associated with an infusion device administering a medication from the medication container ([0020]), wherein the side of the medication container is opposite a side of the medication container nearest the RF transmitting source such that the RF signal passes through the medication container before interacting with the plurality of RFID tags (Figs. 2, 3; [0021]-[0022]); 
detecting, via the RF receiving source, a signal strength of returned RF signals from the plurality of RFID tags, wherein the plurality of RFID tags are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container ([0026]; i.e., since the signal strength of signaling tag depends on spacings 26,30 and spacings 26,30 depends on the fill level of fluid bag 10 which is also proportional to an amount of surface area of tag 16 that is covered by the fluid in fluid bag 10, wherein with spacing 26, the surface area of tag 16 is fully covered by the fluid while with spacing 30, the surface area of tag 16 is uncovered by the fluid), each of the returned RF signals including an identifier identifying a respective RFID tag of the plurality of RFID tags ([0045]; i.e., unique code or identifier for identifying the particular signaling tag 16); 
performing a data lookup using at least one of the identifiers of the returned RF signals to obtain information associated with detecting the fluid within the medication container ([0045]; i.e., looking up in the memory 112 for information associated with signaling tag 16); 
determining that a first returned RF signal associated with a first RFID tag of the plurality of RFID tags (i.e., signal of one of the one or more signaling tags 16) satisfies the obtained threshold signal level, indicating that there is no fluid in the medical container at a location of the first RFID tag ([0024]; i.e., the signaling tag 16 being located on fluid bag 10 such that the trigger state is satisfied due to side walls 12 and 14 coming into sufficient proximity of each other as fluid is evacuated from the fluid bag 10), and while determining that a second returned RF signal is not detected or does not satisfy the threshold signal level, indicating that there is fluid in the medical container at a location ([0024]; i.e., the signaling tag 16 being located on fluid bag 10 such that the volume is above a predefined threshold and the trigger state is not achieved due to the sidewalls 12 and 14 being caused to flex outward, thus providing a buffer between the signaling tag 16 and inducer 18); 
determining a volume of the fluid within the medication container based on the first returned RF signal satisfying the threshold signal level while the second returned RF signal not being detected or not satisfying the threshold signal level, and on respective locations of the first second RFID tag on the medication container ([0024]-[0027]); and 
providing an electronic indication of the volume ([0027]-[0028]; i.e., signal state change).
While Braun discloses that a plurality of RFID tags disposed on the side of the medication container ([0021] and [0045]) and how signals from the RFID tags are determined to indicating whether there is fluid ([0024]-[0027]), Braun does not explicitly disclose of how the plurality of RFID tags are disposed. Thus, Braun does not explicitly disclose that the plurality of RFID tags being disposed in a predetermined order on the side of the medication container; that determining of the second RF signal is an RF signal from a second RFID tag of the plurality of RFID tags at the location of the second RFID tag, and that the determining of the volume of the fluid within the medication container is based on the first returned RF signal satisfying the threshold signal and the second RF signal not being detected or not satisfying the threshold signal level, and on the respective locations of the first and second RFID tags on the medication container; or that the plurality of RFID tags are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container.
It is noted that Perkins also discloses a monitoring device for monitoring a volume of a medication container, comprising: one or more devices providing a transmitting source (220) and a receiving source (230) ([0030]); one or more processors ([0037]; i.e., processor in circuit 290); and a non-transitory memory device (i.e., memory of circuit 290 since circuit 290 performs the required operations) having instructions thereon that, when executed by the one or more processors, cause the monitoring device to perform operations comprising:
transmitting, via the transmitting source, a signal toward a plurality of sensors (i.e., sensors in light sensor array 230) disposed in a predetermined order on a side of a medication container (i.e., side of container wall 206 at which sensor array 230 is positioned in Fig. 6) associated with an infusion device administering a medication from the medication container ([0004]; i.e., infusion device of ophthalmic surgical system administering the infusion fluid in the infusion fluid container), wherein the side of the medication container is opposite a side of the medication container nearest the transmitting source such that the signal passes through the medication container before interacting with the plurality of sensors (Fig. 6; [0034]); 
detecting, via the receiving source, a signal strength of returned signals from the plurality of sensors, wherein the plurality of sensors are configured such that the detected signal strength of each returned signal is proportional to an amount of surface area of a corresponding sensor that is covered by a fluid within the medication container, each of the returned signals including an identifier identifying a respective sensor of the plurality of sensors ([0037]; i.e., signal strength of the signal from light sensors 230 to circuit 290 comprises an identifier in order for circuit 290 to determine which of the light sensor of the sensor array 230 the received signal is from); 
determining, based on at least one of the identifiers of the signals, a threshold signal level associated with detecting a fluid within the medication container ([0037]; i.e., threshold corresponding to receipt of light beam 250); 
determining that a first returned signal associated with a first sensor of the plurality of sensors satisfies the threshold signal level, indicating that there is no fluid in the medical container at a location of the first sensor, and while determining that a second signal associated with a second sensor of the plurality of sensors is not detected or does not satisfy the threshold signal level, indicating that there is fluid in the medical container at a location of the second sensor ([0034]-[0036]; i.e., wherein the first sensor is a sensor in sensor array 230 receiving the light beam 250 corresponding to the absence of fluid and the second sensor is a sensor in sensor array 230 not receiving light beam 250 since the position of this sensor corresponding to the presence of fluid where light beam 260 is refracted); 
determining a volume of the fluid within the medication container based on the first returned signal satisfying the threshold signal while the second signal not being detected or not satisfying the threshold signal level, and on respective locations of the first and second sensors on the medication container ([0037]); and 
providing an electronic indication of the volume ([0037]-[0038]; via circuit 290).
Therefore, since both Braun and Perkins are drawn to a monitoring device for monitoring a volume of a medication via transmitting and receiving an emitted signal through the medication container, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Braun with the feature of the plurality of RFID tags being disposed in a predetermined order on the side of the medication container as disclosed by Perkins since such orientation of the plurality of sensors to provide detection of the fluid level along a length of the side of the medication container ([0021] of Perkins) and since such modification would be considered a simple substitution of one known element (i.e., a plurality of signaling tags 16 receiving RF signals of Braun without specified relative orientation when disposed on the side of the medication container) for another (i.e., a plurality of optical sensors of Perkins oriented in a predetermined order as a sensor array 230 when disposed on the side of medication container) to obtain predictable results (i.e., receiving emitted signals through the medication container), see MPEP 2143(I)(B) for additional details and since Braun discloses that signaling tags 16 may be configured to emit other signals such as optical signals instead of RF signals ([0021]). 
Thus, since Braun in view of Perkins discloses that the plurality of RFID tags being disposed in a predetermined order on the side of the medication container such that signaling tags 16 are positioned in an array along the side in a similar manner as the light sensors of sensor array 230 of Perkins, it also would have been further obvious to one of ordinary skill in the art that Braun in view of Perkins discloses determining of the second RF signal is an RF signal from a second RFID tag of the plurality of RFID tags at a location of the second RFID tag, and that the determining of the volume of the fluid within the medication container is based on the first returned RF signal satisfying the threshold signal and the second RF signal not being detected or not satisfying the threshold signal level, and on the respective locations of the first and second RFID tags on the medication container since the second RFID tag is a second signaling tag 16 of the plurality of signaling tags 16 positioned in an array and the location of the second RFID tag is the position of this second signaling tag 16 of Braun in view of Perkins; and wherein the plurality of RFID tags of Braun in view of Perkins are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container in similar manner for how the signal strength of signaling tag 16 illustrated in Figs. 2, 3 of Braun is dependent on spacings 26,30 ([0026] of Braun).
Moreover, while Braun further discloses performing a data lookup using the identifier of the returned RF signal to obtain information associated with the signaling tag 16 from memory 112 ([0045]), Braun in view of Perkins does not explicitly disclose that this information comprising a threshold signal level associated with detecting the fluid within the medication container. It is noted that Ludin also discloses a monitoring device for monitoring a volume of a medication container using a RFID tag (Abstract), wherein an identifier of the RFID tag is associated to information in a memory ([0048]) including transmission threshold ([0065]) a set of volume for transmitting an alert ([0078]). Therefore, since Braun in view of Perkins and Ludin are drawn to a monitoring device for monitoring a volume of a medication, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Braun in view of Perkins with the feature of information looked up by Braun ([0045]) to include threshold signal level associated with detecting the fluid within the medication container as disclosed by Ludin since Ludin discloses that such information is known to be provided information in the memory for lookup via the identifier for the RFID tag. 
Claim 3. Braun in view of Perkins and Ludin discloses the monitoring device of claim 1, wherein Braun further discloses providing the electronic indication of the volume comprises: providing the electronic indication to the infusion device for display at the infusion device ([0042], [0044]).
Claim 4. Braun in view of Perkins and Ludin discloses the monitoring device of claim 1, wherein Braun further discloses comprising: a display screen (i.e., display of user interface 116), wherein the operations further comprise: displaying a representation of the electronic indication on the display screen ([0044]).
Claim 5. Braun discloses a method of determining a volume of a fluid in a medication container, comprising: 
initiating an infusion of a medication from a medication container (10) ([0020]), wherein the medication container comprises a plurality of radio frequency identification (RFID) tags (16) affixed along a side (12) of the medication container ([0021]); 
directing a radio frequency (RF) signal, from an RF source (18), toward the plurality of RFID tags disposed on the medication container, wherein the side of the medication container to which the plurality of RFID tags are affixed to is opposite of the medication container nearest the RF source such that the RF signal passes through the medication container before interacting with the plurality of RFID tags ([0022]; i.e., since signaling tags 16 and inducer 18 are positioned on opposite side walls); 
detecting, using an RF reader (i.e., reader), a signal strength of returned respective RF signals from the plurality of RFID tags ([0031]), each RFID tag of the RFID tags returns a returned RF signal, each returned RF signal including an identifier identifying the respective RFID tag ([0045]), and a signal strength proportional to an amount of surface area of the respective RFID tag that is covered by a fluid within the medication container ([0026]; i.e., since the signal strength of signaling tag depends on spacings 26,30 and spacings 26,30 depends on the fill level of fluid bag 10 which is also proportional to an amount of surface area of tag 16 that is covered by the fluid in fluid bag 10, wherein with spacing 26, the surface area of tag 16 is fully covered by the fluid while with spacing 30, the surface area of tag 16 is uncovered by the fluid); 
determining, based on the one or more identifiers, a threshold signal level for determining a level of fluid within the medication container  ([0024]; i.e., signal depends on the flex inward or outward of the sidewalls 12,14 since);
determining that the signal strength of a first returned RF signal returned by a first RFID tag of the plurality of RFID tags (i.e., signal strength of the signal of one of the one or more signaling tags 16) satisfies the threshold signal level, indicating that there is no fluid in the medical container at a location of the first RFID tag ([0024]; i.e., the signaling tag 16 being located on fluid bag 10 such that the trigger state is satisfied due to side walls 12 and 14 coming into sufficient proximity of each other as fluid is evacuated from the fluid bag 10), and while determining that a second returned RF signal associated with a second RFID tag of the plurality of RFID tags is not detected or does not satisfy the threshold signal level, indicating that there is fluid in the medical container at a location ([0024]; i.e., the signaling tag 16 being located on fluid bag 10 such that the volume is above a predefined threshold and the trigger state is not achieved due to the sidewalls 12 and 14 being caused to flex outward, thus providing a buffer between the signaling tag 16 and inducer 18) ([0024]-[0027]); 
determining a volume of the fluid within the medication container based on the first returned RF signal satisfying the threshold signal and the second RF signal not being detected or not satisfying the threshold signal level, and on the location of the first RFID tag on the medication container ([0024]-[0027]); and 
Again, while Braun discloses that a plurality of RFID tags disposed on the side of the medication container ([0021] and [0045]) and how signals from the RFID tags are determined to indicating whether there is fluid ([0024]-[0027]), Braun does not explicitly disclose of how the plurality of RFID tags are disposed. Thus, Braun does not explicitly disclose that the plurality of RFID tags being affixed in a predetermined order along the side of the medication container; that the determining of the second RF signal is an RF signal from a second RFID tag of the plurality of RFID tags at the location of the second RFID tag, and that the determining of the volume of the fluid within the medication container is based on the first returned RF signal satisfying the threshold signal and the second RF signal not being detected or not satisfying the threshold signal level, and on the respective locations of the first and second RFID tags on the medication container.
It is noted that Perkins also discloses a monitoring device for monitoring a volume of a medication container as explained above, wherein a method of determining volume of a fluid in a medication container, comprising the operations performed by the monitoring device (see above rejection for claim 1 for details). In particular, Perkins discloses that a plurality of light sensors affixed in a predetermined order along a side of the medication container (Fig. 6; i.e., light sensors of sensor array 230); wherein directing an optical signal via the optical light source toward the plurality of light sensors (i.e., sensors in light sensor array 230) disposed on the side of the medication container (i.e., side of container wall 206 at which sensor array 230 is positioned in Fig. 6), the side of the medication container to which the plurality of RFID tags are affixed is opposite a side of the medication container nearest the optical light source such that the optical signal passes through the medication container before interacting with the plurality of light sensors (Fig. 6; [0034]). 
Therefore, since both Braun and Perkins are drawn to a monitoring device for monitoring a volume of a medication via transmitting and receiving an emitted signal through the medication container, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Braun with the feature of the plurality of RFID tags being affixed in a predetermined order along the side of the medication container as disclosed by Perkins since such orientation of the plurality of sensors to provide detection of the fluid level along a length of the side of the medication container ([0021] of Perkins) and since such modification would be considered a simple substitution of one known element (i.e., a plurality of signaling tags 16 receiving RF signals of Braun without specified relative orientation when disposed on the side of the medication container) for another (i.e., a plurality of optical sensors of Perkins oriented in a predetermined order as a sensor array 230 when disposed on the side of medication container) to obtain predictable results (i.e., receiving emitted signals through the medication container), see MPEP 2143(I)(B) for additional details and since Braun discloses that signaling tags 16 may be configured to emit other signals such as optical signals instead of RF signals ([0021]).
Moreover, since Braun in view of Perkins discloses that the plurality of RFID tags being disposed in a predetermined order on the side of the medication container such that signaling tags 16 are positioned in an array along the side in a similar manner as the light sensors of sensor array 230 of Perkins, it also would have been further obvious to one of ordinary skill in the art that method of Braun in view of Perkins discloses that the initiating is with initiating the infusion of the medication from the medication container, wherein the medication container comprises the plurality of RFID tags affixed in a predetermined order along the side of the medication container; the second determining is with while determining of the second RF signal is an RF signal from a second RFID tag of the plurality of RFID tags at a location of the second RFID tag; and that the third determining is with determining of the volume of the fluid within the medication container is based on the first returned RF signal satisfying the threshold signal and the second RF signal not being detected or not satisfying the threshold signal level, and on the respective locations of the first and second RFID tags on the medication container since the second RFID tag is a second signaling tag 16 of the plurality of signaling tags 16 positioned in an array affixed along the side wall 12 of fluid bag 10 and the location of the second RFID tag is the position of this second signaling tag 16 of Braun in view of Perkins; and wherein the plurality of RFID tags of Braun in view of Perkins are configured such that the detected signal strength of each returned RF signal is proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container in similar manner for how the signal strength of signaling tag 16 illustrated in Figs. 2, 3 of Braun is dependent on spacings 26,30 ([0026] of Braun).
Moreover, while Braun further discloses performing a data lookup using the identifier of the returned RF signal to obtain information associated with the signaling tag 16 from memory 112 ([0045]), Braun in view of Perkins does not explicitly disclose that this information comprising a threshold signal level associated with detecting the fluid within the medication container. It is noted that Ludin also discloses a monitoring device for monitoring a volume of a medication container using a RFID tag (Abstract), wherein an identifier of the RFID tag is associated to information in a memory ([0048]) including transmission threshold ([0065]) a set of volume for transmitting an alert ([0078]). Therefore, since Braun in view of Perkins and Ludin are drawn to a monitoring device for monitoring a volume of a medication, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Braun in view of Perkins with the feature of information looked up by Braun ([0045]) to include threshold signal level associated with detecting the fluid within the medication container as disclosed by Ludin since Ludin discloses that such information is known to be provided information in the memory for lookup via the identifier for the RFID tag. 
Claim 6. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun in view of Perkins further discloses comprising: calculating the volume of fluid in the medication container based on the signal strength and a location of each of the RFID tags on the medication container, and a number of the plurality of RFID tags on the medication container ([0025]-[0026] of Braun; i.e., volume corresponding to the predefined threshold based on the signal strength and the location of RF tag 16).
Claim 7. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising: generating an alarm when the fluid in the medication container is below a predetermined minimum volume ([0027]).
Claim 8. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses the determining the first returned RF signal satisfying the determined threshold signal level and determining the second returned RF signal is not detected or does not satisfy the determined threshold signal level is performed by a processor of a server system ([0044], [0047]).
Claim 10. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising determining the volume of the fluid in the medication container based on a look-up table that stores a correspondence between RFID tag identifiers and a respective volume of the fluid within the medication container ([0040]).
Claim 11. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising identifying a medication of the medication container based on information provided by a respective RFID tag affixed to the medication container ([0045]).
Claim 13. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising: checking a volume of the fluid remaining in the medication container against an expected volume infused ([0044]; i.e., when determining low fluid condition requiring replacing of the fluid bag 10 is a checking of the fluid remaining and requesting for the replacing by the volume monitoring unit 118).
Claim 14. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses that the method further comprising: directing multiple RF signals to the plurality of RFID tags, and receiving a response from a portion of the plurality of RFID tags; and determining the volume of the fluid within the medication container based on a number of responses received from the plurality of RFID tags ([0021]-[0022]; i.e., since Braun discloses that the invention includes comprising a plurality of RF tags 16 and 18).
Claim 15. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising using a look-up table to convert a magnitude of each of the returned respective RF signals to a volume of the fluid in the medication container ([0028]-[0029]).
Claim 16. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses that the location of the RFID tag (16) is at a position on the medication container associated with a lowest level of fluid in the medication container, below which the medication container is empty ([0044]). Thus, Braun in view of Perkins discloses that the RFID tag being at a position on the medication container associated with a lowest level of fluid in the medication container, below which the medication container is empty be the second RFID tag so as to allow the detection of low fluid level disclosed by Braun ([0044]).
Claim 18. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses that the first RFID tag (16) is affixed at a position of the medication container associated with the medication container becoming empty in less than a predetermined time at a particular flow rate of the medication container ([0027]), the method further comprising: determining, based on a strength of the RF signal returned from the first RFID tag and a current flow rate of the infusion of the medication, that the medication container will become empty in less than the predetermined time; and generating an alert indicating that the medication container will become empty in less than the predetermined time ([0027]; i.e., since the volume threshold is selected to give the medical personnel sufficient time, the volume threshold is selected based on the flow rate of the infusion so as to provide an alert with the RF tag 16 location associated to the volume level that would provide sufficient time for the medical personnel to receive the alert and take action).
Claim 19. Braun in view of Perkins and Ludin discloses the method of claim 5, wherein Braun further discloses comprising calculating a volume delivered from the medication container based on the signal strengths of the returned RF signals from a respective RFID tag of the plurality of RFID tags changing from below the threshold signal level to above the threshold signal level ([0025]-[0027]; i.e., since replacing the fluid bag with a new fluid bag would result in the changing signal from below threshold to above threshold which is recorded by volume monitoring unit 118).

Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Braun (US Pub. No. 2010/0214106 A1) in view of Perkins (US Pub. No. 2010/0134303 A1) and Ludin (US Pub. No. 2018/0280236 A1) further in view of Tsoukalis (US Pub. No. 2019/0001057 A1).
Claim 17. Braun in view of Perkins and Ludin discloses the method of claim 16, wherein Braun further discloses comprising a pump (i.e., IV pump) and transmit a notification to a clinician device when the medication container is empty ([0044]) but does not explicitly discloses causing the pump to which the medication container is connected to stop infusing. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify that to replace the fluid bag 10, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Braun in view of Perkins and Ludin to cause the pump to stop infusing so as to replace the bag ([0044]). Moreover, Tsoukalis also discloses a system with a tag for monitoring volume in the medication reservoir, wherein when the detected remaining volume is near empty, an alarm is indicated and the infusion is stopped so as to prevent air from entering the line ([0026]). Therefore, since both Braun in view of Perkins and Ludin and Tsoukalis are drawn to monitoring volume of a medication reservoir with tags, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Braun in view of Perkins and Ludin with the feature of causing the pump to which the medication container is connected to stop infusing and transmit a notification to a clinician device when the medication container is empty disclosed by Tsoukalis so as to prevent air from being delivered to the patient ([0026] of Tsoukalis).

Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Braun (US Pub. No. 2010/0214106 A1) in view of Perkins (US Pub. No. 2010/0134303 A1) and Ludin (US Pub. No. 2018/0280236 A1) further in view of Nelson Konen (US Pub. No. 2011/0257591 A1).
Claim 20. Braun in view of Perkins and Ludin discloses the method of claim 19, wherein Braun further discloses comprising tracking the volume via volume monitoring unit 114 but does not explicitly disclose of comparing the volume delivered with an expected volume infused and sounding an alarm when a difference between the volume delivered and the expected volume infused is greater than a threshold. However, Nelson Konen also discloses monitoring volume for a fluid delivery device including determining a difference between the actual volume (which is an indication of the volume delivered) and the expected volume of the fluid reservoir (which is an indication of the expected volume infused) and triggering an alert if the difference between the actual volume and the expected volume exceed a threshold ([0098]-[0099]). Therefore, since both Braun in view of Perkins and Ludin and Nelson Konen are drawn to fluid monitoring of a container for fluid delivery, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify to further modify Braun in view of Perkins and Ludin with the feature of comparing the volume delivered with an expected volume infused and sounding an alarm when a difference between the volume delivered and the expected volume infused is greater than a threshold as disclosed by Nelson Konen so as to alert the clinician of the patient infusion condition.

Response to Arguments
With respect to the previous claim objections, the amendments to the claims are considered sufficient to clarify the previous informalities. Therefore, the previous objections are hereby withdrawn. However, the amended claims still contain informalities, see above for details.

With respect to the previous 35 U.S.C. 112(b) rejections, the amendments to the claims are considered sufficient to clarifying most of the previous confusion. However, the amendments also introduce new confusion to claims 1 and 8. Therefore, these amended claims are rejected under 35 U.S.C. 112(b) as further explained above.

Applicant’s arguments with respect to amended claims 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. In particular, it is noted that Braun in view of Perkins and Ludin discloses the newly added limitations drawn to the how the threshold signal level is obtained.
However, applicant that Braun does not disclose the specifics of the signal strength of each returned RF signal being proportional to an amount of surface area of a corresponding RFID tag that is covered by a fluid within the medication container as claims 1 and 5 are amended to require is not persuasive. In particular, Braun discloses that the spacing between signaling tag 16 and inducer 18 is proportional to the fluid level within fluid bag 10 which is proportional to the amount of surface area of signaling tag such as illustrated with spacings 26, 30 in Figs. 2, 3 where the surface area of signaling tag 16 fully covered by fluid at spacing 26 (Fig. 2) and fully uncovered at spacing 30 (Fig. 3). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how the signal strength is proportional to the amount of surface area of the RFID tag that is different from the signal strengths of signaling tag 16 at spacing 26 and spacing 30 of Braun) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).

Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA ZHANG whose telephone number is (571)270-5369. The examiner can normally be reached Monday-Thursday 9AM - 5PM EST.
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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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNA ZHANG/Primary Examiner, Art Unit 3783


    
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
        
            
    


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