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(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
Claim 10, and all claims depending therefrom, is/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.
Claim 10 is objected to because it appears to contain one or more typographical and/or grammatical errors in the recitation of “upon selection of the one of a localized single or a multiple-channel lumen, a first medical fluid being already assigned to the one of the localized single or the multiple-channel lumen…”
For the purpose of examination, the examiner will interpret this recitation to mean “upon selection of the one of a localized single or a multiple-channel lumen, a first medical fluid is assigned to the one of the localized single or the multiple-channel lumen…”
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 1-8 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orkin et al (U.S. Pat. 4,925,444 A, hereinafter “Orkin”).
Regarding claim 1, Orkin discloses a system for managing multiple infusions to a patient, the system comprising:
a control device (combination of control system 102 and video display 96; see Fig. 3) configured to control a multiplicity of infusion devices for administering a multiplicity of medical fluids (i.e., from containers 56a-56e) through at least one infusion line of an infusion set to the patient (see element 90 in Fig. 3; and see Abstract, disclosing that output from a pump “via a further fluid flow conduit, can be coupled to the patient's catheter”), the multiplicity of medical fluids to the multiplicity of infusion devices being assigned (i.e., each medical fluid is contained in a different container; see col. 12, lines 24-27), wherein:
the control device is configured to determine compatibility and non-compatibility of the assigned multiplicity of medical fluids (see col. 3, lines 64-68, disclosing that the control device “includes information relating to inter-fluid and drug compatibility” which can then be “examined prior to activating the scheduled delivery sequences”);
the control device is configured to display to a user compatibility information regarding the compatibility or non-compatibility of the multiplicity of medical fluids (see col. 5, lines 47-53; and see Screen 7, which represents an output of the compatibility check, the details of are disclosed at col. 19, lines 14-37), and
at least one of the multiplicity of medical fluids to the at least one infusion line is assigned, by the user in accordance with the compatibility information (see col. 19, lines 28-37 disclosing assigning the drugs to various pumps and occluders based on the compatibility information).
Regarding claim 2, Orkin discloses the system according to claim 1, wherein the multiplicity of medical fluids comprise at least one medical fluid selected from a group consisting of drugs, lactated ringer's solution, saline solution and dextrose solution (see Screen 7 showing drugs such as potassium chloride, tobramycin and flagyl chosen as the multiplicity of medical fluids).
Regarding claim 3, Orkin discloses the system according to claim 1, wherein the compatibility information is provided as a compatibility list (see compatibility summary in Screen 7).
Regarding claim 4, Orkin discloses the system according to claim 3, wherein the compatibility list is a matrix of columns and lines (see Screen 7 and col. 19, lines 14-37), specifically:
rows 7, 8 and 9 of Screen 7 show the previously listed drugs;
columns identify each aforementioned drugs as “drug 1”, “drug 2” and “drug 3”;
and indicia “C” in the matrix indicates that two compared drugs are compatible, while “I” indicates that the two compared drugs are incompatible).
Regarding claim 5, Orkin discloses the system according to claim 1, wherein the compatibility information is editable and searchable by the user (the user can select “Prior Screen” on row 22 of Screen 7 to return to a previous screen to make changes to the individual drugs, thus editing the compatibility information).
Regarding claim 6, Orkin discloses the system according to claim 1, wherein, upon the selection of one of the multiplicity of medical fluids, information on the compatibility or non-compatibility of the one of the multiplicity of medical fluids with at least one another of the multiplicity of medical fluids is provided at the control device to the user, based on the compatibility information (when all of the desired drugs are selected—implicitly including one of the multiplicity—the control device determines the compatibility of the drugs with one another (see col. 3, lines 63-65, disclosing that the compatibility information is included in the control unit) and then outputs this information to the user on Screen 7; see also col. 18, lines 43-46, disclosing that each line of the screen can be selected by highlighting).
Regarding claim 7, Orkin discloses the system according to claim 1, wherein, upon selection of two incompatible fluids, the information of the non-compatibility is displayed at the control device to the user, based on the compatibility information (when all of the desired drugs are selected—implicitly including two of the multiplicity—the control device determines the compatibility of the drugs with one another (see col. 3, lines 63-65, disclosing that the compatibility information is included in the control unit) and then outputs this information to the user on Screen 7; see also col. 18, lines 43-46, disclosing that each line of the screen can be selected by highlighting).
Regarding claim 8, Orkin discloses the system according to claim 1, wherein the control device is further configured to assist the user with a drug-to-lumen assignation based on the compatibility information by providing guidance to address one or several medical fluids of the multiplicity of medical fluids to one or several lumens for administration (the interpretation of “…guidance to address…” is broad; but the control device furnishes the user with the compatibility information on Screen 7, which is then used on Screen 8 to control the pump “P” and occluder “OC” for each drug; the “lumens” in this case can be the lines 74a-74e that carry the drugs from their respective containers through the occluders 64-64e depending on the results of the compatibility determination).
Regarding claim 15, Orkin discloses a method for managing multiple infusions to a patient (via tubing 90; see Fig. 3) by controlling, using a control device (combination of control system 102 and video display 96; see Fig. 3), a multiplicity of infusion devices for administering a multiplicity of medical fluids (i.e., from containers 56a-56e) through at least one infusion line of an infusion set to the patient (see element 90 in Fig. 3; and see Abstract, disclosing that output from a pump “via a further fluid flow conduit, can be coupled to the patient's catheter”), the method comprising:
assigning by a user the multiplicity of medical fluids to the multiplicity of infusion devices (i.e., each medical fluid is contained in a different container; see col. 12, lines 24-27),
determining, by the control device, compatibility and non-compatibility of the assigned multiplicity of medical fluids (see col. 3, lines 64-68, disclosing that the control device “includes information relating to inter-fluid and drug compatibility” which can then be “examined prior to activating the scheduled delivery sequences”),
displaying to the user, at the control device, compatibility information regarding the compatibility or non-compatibility of the multiplicity of medical fluids (see col. 5, lines 47-53; and see Screen 7, which represents an output of the compatibility check, the details of are disclosed at col. 19, lines 14-37), and
assigning by the user at least one of the multiplicity of medical fluids to the at least one infusion line in accordance with the compatibility information (see col. 19, lines 28-37 disclosing assigning the drugs to various pumps and occluders based on the compatibility information).
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.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Orkin, in view of Kamiyama (JP 2005177228 A, hereinafter “Kamiyama”).
Regarding claim 9, it is noted that Orkin does not appear to disclose that the control device is further configured to display a schematic patient body shape with at least one of a localized single or a multiple-channel lumen entry, which is selectable by the user.
Kamiyama discloses a medical image diagnostic apparatus, comprising a schematic patient body shape (e.g., a patient arm, torso or leg shown in Fig. 4) and localized entry points 18 (see Fig. 4) for a needle (in this case, an acupuncture point), which are selectable by a user (see English translation, attached, at pg. 6).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Orkin, so that the control device is further configured to display a schematic patient body shape with at least one of a localized single or a multiple-channel lumen entry, which is selectable by the user, as taught in Kamiyama, since such display, diagnostic and selection schematics were known at the time of the invention for selecting entry points for medical devices; and a skilled artisan would have found it obvious to improve the accuracy of the placement of the infusion device of Orkin using a similar type of schematic, with a reasonable expectation of success.
Regarding claim 10 (as best understood by the examiner), Orkin discloses that the control device is further configured to provide information on compatibility or non-compatibility of a first medical fluid and second medical fluid based on the compatibility information (see rejection of claim 4, above), and a first medical fluid has already been assigned to a lumen for infusion into the body (see Screen 5) before the compatibility information is displayed.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Orkin, in view of Japanese patent JP3188890U assigned to Olympus Medical Systems Corp, hereinafter “Olympus”.
Regarding claim 11, Orkin discloses the system according to claim 1, wherein:
at least one association of an infusion device and an assigned medical fluid to the infusion device is displayed at the control device (see Screen 2, showing a screen for inputting a drug and the pump and occluder assigned to each drug, thus permitting the user to assign the drugs to the same or different occluders),
the control device being further configured to provide the user with an updated view of the at least one association with a corresponding lumen indicator (see Screen 5, which is a review screen that shows the drugs to be delivered and the occluder “OC” through which each drug is delivered; each occluder indicates a different lumen through which fluid can flow between the fluid containers and the fluid flow junction 70).
Orkin does not appear to disclose that the at least one association being displayed as a progress bar.
Olympus discloses a medical system in which information is processed and saved, comprising a progress bar that indicates the progress of the saving (see Fig. 16).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Orkin so that the association is displayed as a progress bar, based on the teaching in Olympus of it being well-known show a progress bar indicating the progress of processing/storing/saving information; a skilled artisan would have known how to implement a similar progress bar to indicate the progress of the association, and would have had a reasonable expectation of success in doing so to alert the user when the association has completed.
Regarding claim 12, Orkin discloses that the lumen indicator is a number (see Screen 5, showing the occluders numerically represented by “1”, “2” and “3”).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Orkin, in view of Le Naour et al (U.S. Pub. 2021/0233646 A1, hereinafter “Le Naour”).
Regarding claim 13, Orkin does not appear to disclose that the lumen indicator has a dedicated color depending on a selected lumen.
Le Naour discloses a system for processing and displaying information in a medical context, comprising information which is indicated on a screen and annotated by color to distinguish different selected information (see paras [0087], [0122], [0135], [0146], [0150], [0213], [0128], [0219]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Orkin so that the lumen indicator has a dedicated color depending on a selected lumen, based on the teaching in Le Naour of processing and displaying information in a medical context, and distinguishing the information based on color, with a reasonable expectation of success in providing the user with clearer information to make an informed medical decision (such as recording, verifying or editing the indicators for the desired infusion).
Regarding claim 14, Orkin discloses that the control device comprises a touchscreen in a wired or wireless connection to the multiplicity of infusion devices (see col. 10, lines 3-6, disclosing the screen 96 of the control device is a touchscreen that can work with a light pen; the connection between the touchscreen and the multiplicity of infusion devices appears to be wired), the touchscreen commanding the infusion of the multiplicity of infusion devices (see col. 18, lines 54-56, disclosing that the operator selects a function on Screen 5 to initiate infusion).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 12/10/2025