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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP20290020, filed on 02/20/2020.
Response to Amendment
The Amendments filed 09/26/2025 have been entered.
Claims 1 and 13 have thereby been amended.
Claims 14-17 have been added.
Claims 1-17 are being examined in this office action.
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 1-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 20150370973) in view of Barnes (US 20120078218).
Regarding claim 1, Jones discloses a system for administering a medical fluid to a patient, comprising: an infusion station comprising a rack (31; para. [0049], sentence 4) and a control device (41, 310; para. [0021], sentences 2-3; para. [0069]: control device integrated into rack), wherein the control device is configured to store reference patient data (para. [0065], the data transferred from the control device where it was stored, the data on the infusion station including drug library defined by patient-specific parameters: para. [0050]), and to synchronize the reference patient data between infusion devices attached to said rack (para. [0069]), wherein the reference patient data and the device patient data are prioritized (Fig. 5: S1-S3, para. [0081], the data are prioritized for transfer at the respective steps), and a new infusion device (32) to be attached to the rack (para. [0070], sentence 2), wherein the control device is configured, on an occasion of attaching the new infusion device to one of the multiplicity of slots of the rack, to receive, from the new infusion device, device patient data defined on the new infusion device, and to update said reference patient data based on the device patient data (Fig. 5: S1-S3, para. [0081]; para. [0070], sentence 2). Jones fails, however, to explicitly disclose that the reference patient data is data of the patient to be infused, or that the rack is defined by a multiplicity of slots by which the infusion device(s) is/are attached, and that the update to the reference data is dependent on a status of the new infusion device and the infusion station.
Borges teaches an analogous multi-infusion device infusion station with a rack in with reference patient data stored on a control unit (Fig. 1: 25; para. [0021], sentence 2), said reference patient data being of the patient to be administered with the medical fluid using the infusion station (para. [0021], sentences 3-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patient data of Jones, referenced above, by incorporating the teaching of Borges of the patient reference data being specific to the patient to be infused, in order to obtain infusion parameters that are patient-specific for the most effective results (Jones: para. [0050], sentences 2-3). However, Jones in view of Borges still fails to teach that the rack is defined by a multiplicity of slots by which the infusion device(s) is/are attached, and that the update to the reference data is dependent on a status of the new infusion device and the infusion station.
Barnes teaches an analogous multi-infusion device infusion station with a rack in which the rack defining a multiplicity of slots (Fig. 4: 40D slot that receives connector 42 shown in Fig. 5) which the infusion device(s) is/are attached via, and teaches status indicators on the infusion device(s) and station (Fig. 6: 54, 56A, 56B, 56C, 56D; page 2, para. [0031], second-to-last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rack of the Jones system in the Jones-Borges combination by incorporating the slots for accepting the infusion devices, taught by Barnes, in order to provide a secure and compact means of securing the infusion devices to the rack/station (Fig. 4). It would have also been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infusion devices and infusion station of the Jones system by incorporating the status indicators taught by Barnes in order to have visual verification of the infusion device(s) being in operation (page 2, para. [0031], second-to-last sentence). It directly follows that upon this incorporation into the Jones system, the update of the reference patient data based on the device patient data disclosed by Jones by the user described in the steps of Fig. 5 and page 6, para. [0081], as well as the prioritization or the reference patient data and the device patient data leading to their use, also disclosed by Jones, would be dependent on an infusion status of the new infusion device (Barnes: 54, 56A, 56B, 56C, 56D) and on an infusion status of the infusion station (Barnes: 54, 56A, 56B, 56C, 56D), in order to ensure that the data is not transferred while the infusion device(s) is/are in use or when there is an error (Jones: page 6, para. [0082], sentence 1) to ensure proper and safe drug infusion to patients.
Regarding claim 2, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to identify a connection event on the occasion of attaching the new infusion device to one of the multiplicity of slots of the rack, and to update said reference patient data based on the device patient data subsequent to the connection event (Jones: page 5, para. [0070], sentence 2), the control device integrated into rack: page 5, para. [0069]).
Regarding claim 3, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the new infusion device is configured to transfer said device patient data to the control device on the occasion of attaching the new infusion device to one of the multiplicity of slots of the rack (Jones: page 5, para. [0070], sentence 2), the control device integrated into rack: page 5, para. [0069]).
Regarding claim 4, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to synchronize the updated reference patient data between the infusion devices attached to said multiplicity of slots (Jones: para. [0069]).
Regarding claim 5, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the infusion status of the new infusion device is indicative of whether the new infusion device is currently carrying out an infusion operation (Barnes: 56C, page 2, para. [0031], second-to-last sentence).
Regarding claim 6, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the infusion status of the infusion station is indicative of whether at least one of the infusion devices attached to said multiplicity of slots is currently carrying out an infusion operation (Barnes: 56C, page 2, para. [0031], second-to-last sentence; see Fig. 4 for this status on the other infusion devices indicative of the station’s operation).
Regarding claim 7, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to set the reference patient data to the device patient data dependent on the infusion status of the new infusion device and on the infusion status of the infusion station (Jones: Fig. 5: S1-S3, page 6, para. [0081], page 5, para. [0070], sentence 2; wherein the data transfer only occurs when infusion devices are not operating based on the status indicator taught by Barnes, as described in the combination above).
Regarding claim 8, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to set the reference patient data to the device patient data (Jones: Fig. 5: S1-S3, page 6, para. [0081], page 5, para. [0070], sentence 2) if the infusion status of the new infusion device indicates that the new infusion device is currently carrying out an infusion operation (status of Barnes: 56C), and if in addition the infusion status of the infusion station indicates that none of the infusion devices attached to said multiplicity of slots is currently carrying out an infusion operation (status of Barnes: 56C on other devices shown in Fig. 4; Jones: page 6, para. [0082], sentence 1). The Jones-Borges-Barnes system fails to explicitly teach that the described data transfer occurs on the condition of the infusion status of the new infusion device indicates that the new infusion device is in pumping operation. However, the functional language of this claim has been carefully considered by deemed not to impose any structural limitation on the claims distinguishable over the structure of the described Jones-Borges-Barnes system. Since the system of Jones-Borges-Barnes has the same structure and elements as disclosed in the instant application, Jones-Borges-Barnes is able to be used in the same manner as set forth in the claim for which the described data transfer occurs when the status 56C of the new infusion device indicates it is in operation.
Regarding claim 9, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to not update said reference patient data if the infusion status of the new infusion device indicates that the new infusion device is currently not carrying out an infusion operation, or if the infusion status of the infusion station indicates that at least one of the infusion devices attached to said multiplicity of slots is currently carrying out an infusion operation (status of Barnes: 56C on other devices shown in Fig. 4; Jones: page 6, para. [0082], sentence 1).
Regarding claim 10, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the control device is configured to transfer said reference patient data to the new infusion device if the infusion status of the new infusion device indicates that the new infusion device is currently not carrying out an infusion operation (status of Barnes: 56C on other devices shown in Fig. 4; Jones: page 6, para. [0082], sentence 1), or if the infusion status of the infusion station indicates that at least one of the infusion devices attached to said multiplicity of slots is currently carrying out an infusion operation.
Regarding claim 11, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the new infusion device is configured to initiate a conflict workflow for adjusting at least one parameter of the infusion operation according to the reference patient data (Jones: page 6, para. [0077]; page 6, para. [0073], last sentence). The Jones-Borges-Barnes system fails to explicitly teach that the described conflict workflow occurs on the condition of the new infusion device is currently carrying out an infusion operation. However, the functional language of this claim has been carefully considered by deemed not to impose any structural limitation on the claims distinguishable over the structure of the described Jones-Borges-Barnes system. Since the system of Jones-Borges-Barnes has the same structure and elements as disclosed in the instant application, and Jones discloses that this parameter adjustment workflow occurs when it is necessary, Jones-Borges-Barnes is able to be used in the same manner as set forth in the claim for which the described parameter adjustment workflow occurs when the necessary when the new infusion device is in operation.
Regarding claim 12, Jones in view of Borges in further view of Barnes teaches the system according to claim 11, as described above, wherein the new infusion device is configured, within the conflict workflow, to adjust at least one parameter of the infusion operation upon a user confirmation (Barnes: para. [0043], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this user confirmation taught by Barnes into the Jones-Borges-Barnes system in order to verify the adjusted parameters to ensure patient safety with proper infusion (page 4, para. [0043], last two sentences).
Regarding claim 13, Jones discloses a method for administering a medical fluid to a patient, comprising: providing an infusion station comprising a rack (31; para. [0049], sentence 4) and a control device (41, 310; para. [0021], sentences 2-3; para. [0069]: control device integrated into rack), wherein the control device is configured to store reference patient data (para. [0065], the data transferred from the control device where it was stored, the data on the infusion station including drug library defined by patient-specific parameters: para. [0050]), and to synchronize the reference patient data between infusion devices attached to said rack (para. [0069]), wherein the reference patient data and the device patient data are prioritized (Fig. 5: S1-S3, para. [0081], the data are prioritized for transfer at the respective steps), and a new infusion device (32) to be attached to the rack (para. [0070], sentence 2), wherein the control device is configured, on an occasion of attaching the new infusion device to one of the multiplicity of slots of the rack, to receive, from the new infusion device, device patient data defined on the new infusion device, and to update said reference patient data based on the device patient data (Fig. 5: S1-S3, para. [0081]; para. [0070], sentence 2). Jones fails, however, to explicitly disclose that the reference patient data is data of the patient to be infused, or that the rack is defined by a multiplicity of slots by which the infusion device(s) is/are attached, and that the update to the reference data is dependent on a status of the new infusion device and the infusion station.
Borges teaches an analogous multi-infusion device infusion station with a rack in with reference patient data stored on a control unit (Fig. 1: 25; para. [0021], sentence 2), said reference patient data being of the patient to be administered with the medical fluid using the infusion station (para. [0021], sentences 3-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference patient data of Jones, referenced above, by incorporating the teaching of Borges of the patient reference data being specific to the patient to be infused, in order to obtain infusion parameters that are patient-specific for the most effective results (Jones: para. [0050], sentences 2-3). However, Jones in view of Borges still fails to teach that the rack is defined by a multiplicity of slots by which the infusion device(s) is/are attached, and that the update to the reference data is dependent on a status of the new infusion device and the infusion station.
Barnes teaches an analogous multi-infusion device infusion station with a rack in which the rack defining a multiplicity of slots (Fig. 4: 40D slot that receives connector 42 shown in Fig. 5) which the infusion device(s) is/are attached via, and teaches status indicators on the infusion device(s) and station (Fig. 6: 54, 56A, 56B, 56C, 56D; page 2, para. [0031], second-to-last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rack of the Jones system in the Jones-Borges combination by incorporating the slots for accepting the infusion devices, taught by Barnes, in order to provide a secure and compact means of securing the infusion devices to the rack/station (Fig. 4). It would have also been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infusion devices and infusion station of the Jones system by incorporating the status indicators taught by Barnes in order to have visual verification of the infusion device(s) being in operation (page 2, para. [0031], second-to-last sentence). It directly follows that upon this incorporation into the Jones system, the update of the reference patient data based on the device patient data disclosed by Jones by the user described in the steps of Fig. 5 and page 6, para. [0081], as well as the prioritization or the reference patient data and the device patient data leading to their use, also disclosed by Jones, would be dependent on an infusion status of the new infusion device (Barnes: 54, 56A, 56B, 56C, 56D) and on an infusion status of the infusion station (Barnes: 54, 56A, 56B, 56C, 56D), in order to ensure that the data is not transferred while the infusion device(s) is/are in use or when there is an error (Jones: page 6, para. [0082], sentence 1) to ensure proper and safe drug infusion to patients.
Regarding claim 14, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein the reference patient data comprises one or more of the patient’s age, weight, gender, body surface area, and body mass index (Borges: para. [0021], sentence).
Regarding claim 17, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, wherein if prioritization dependent on the infusion status of the new infusion device and on the infusion status of the infusion station causes a conflict, the control device is configured to ask a user to confirm an adjustment to overcome the conflict (Barnes: para. [0043], last two sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated this user confirmation taught by Barnes into the Jones-Borges-Barnes system in order to verify the adjusted parameters to ensure patient safety with proper infusion (page 4, para. [0043], last two sentences).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 20150370973) in view of Barnes (US 20120078218) in further view of Silkaitis (US 20080133265).
Regarding claim 15, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, but fails to explicitly teach the reference data values being replaced or amended by the device data.
Silkaitis teaches an analogous system of linking and updating patient data for drug delivery, wherein the control device is configured to update said reference patient data based on the device patient data by replacing or amending some values in the reference patient data and leaving other values in the reference patient data unchanged (para. [0093] and [0095] sentence 1, the data points being updated as necessitated). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the updates to the data occurring in Jones-Borges-Barnes by incorporating the teaching of Silkaitis that specific patient data values are updated as necessitated for the most up-to-date patient-specific parameters such that all future infusions can be performed effectively for the patient.
Regarding claim 16, Jones in view of Borges in further view of Barnes teaches the system according to claim 1, as described above, but fails to explicitly teach the reference data values being merged with the device data.
Silkaitis teaches an analogous system of linking and updating patient data for drug delivery, wherein the control device is configured to update said reference patient data based on the device patient data by merging the reference patient data stored in the control device with the device patient data (para. [0093] and [0095] sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the updates to the data occurring in Jones-Borges-Barnes by incorporating the teaching of Silkaitis that specific patient data values are updated and thereby merged as necessitated for the most up-to-date patient-specific parameters such that all future infusions can be performed effectively for the patient.
Response to Arguments
Applicant’s arguments, filed 09/26/2025, with respect to the rejections of independent claim 1 by Jones in view of Barnes, have been fully considered and are persuasive in view of the newly amended claims. However, upon further consideration, a new ground of rejection in light of the change in scope of independent claim 1 is made by Jones in view of Borges in further view of Barnes, as described above, which teaches all limitations of the amended claims, including the reference patient data being of the patient to be administered with the medical fluid using the infusion station.
Regarding Applicant’s argument that the data being “prioritized” is not taught by the cited prior art, Examiner asserts that the limitation of being “prioritized” is broad, and the claim language does not provide further specificity for any reordering, overwriting, etc. that may occur as “prioritization.” Therefore, as Examiner interprets this prioritization to encompass the data being transferred and used at the particular stages described, Examiner maintains that this limitation is taught by Jones in view of Borges in further view of Barnes.
Regarding Applicant’s argument that Jones fails to teach the transfer of the data to the control device, Examiner maintains the rejection under the grounds that Jones alone is not relied upon, but rather Jones in view of Borges in further view of Barnes, as described in the independent claim. Furthermore, Borges additionally teaches this limitation (para. [0005] and [0021].
For these reasons, claims 1-17 stand rejected as recited in the rejections above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783