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 .
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.
Claim(s) 1-3, 7-9, 11, 17-19, 23, 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2015/081109 to Agris et al. (“Agris”).
Regarding claim 1, Agris teaches a drug administration system (see fig. 2), comprising: a first reservoir (fig. 2, 104a) containing a first volume of a first drug therein and including a first data storage component storing data indicative of the first volume (fig. 4, 22, see para. [0046]); a second reservoir having a same size as the first reservoir (fig. 2, 104b), containing a second volume of a second drug therein (see para. [0022]), and including a second data storage component storing data indicative of the second volume (fig. 4, 22, see para. [0046]), the second volume being different from the first volume (see para. [0022] disclosing saline and contrast media); and a pump (fig. 2, 102) configured to receive each of the first and second reservoirs therein, the pump comprising: a reader configured to read the stored data from the first and second data storage components (see para. [0047]); a pumping assembly configured to drive the first drug from the pump for delivery to a patient and to drive the second drug from the pump for delivery to the patient (see para. [0022]), and control circuitry operably coupled to the reader and to the pumping assembly and configured to receive first data from the reader indicative of the stored data read from the first data storage component, establish a first dosing regimen for delivery of the first drug using the received first data, cause the pumping assembly to drive the first drug from the pump based on the first dosing regimen, receive second data from the reader indicative of the stored data read from the second data storage component, establish a second dosing regimen for delivery of the second drug using the received second data, and cause the pumping assembly to drive the second drug from the pump based on the second dosing regimen (see paras. [0023] and [0047]).
Regarding claim 2, Agris teaches the system of claim 1 and wherein the control circuitry is configured to establish the first dosing regimen prior to any delivery of the first drug from the pump to the patient; and the control circuitry is configured to establish the second dosing regimen prior to any delivery of the second drug from the pump to the patient (see “recommended procedure or protocol,” para. [0047]).
Regarding claim 3, Agris teaches the system of claim 1 and wherein: the reader includes a Near Field Communication (NFC) reader, the first data storage component includes a first NFC tag, and the second data storage component includes a second NFC tag; or the reader includes a QR code scanner, the first data storage component includes a first QR code, and the second data storage component includes a second QR code (see QR code sensor 152, para. [0047]).
Regarding claim 7, Agris teaches the system of claim 1 and wherein the first drug is different from the second drug (saline and contrast, see para. [0022]).
Regarding claims 8-9, Agris teaches the system of claim 1 and wherein the first and second reservoirs are configured to be pre-loaded into the pump by a user (see fig. 2).
Regarding claims 11 and 36, Agris teaches a drug administration method (title), comprising: a reader (detecting device, sensor or reader, see para. [0047])) of a pump reading stored data from first and second data storage components (QR code 22); control circuitry (160) of the pump establishing a first dosing regimen and causing a pumping assembly of the pump to drive a first drug from a first reservoir in the pump based on the first dosing regimen; and the control circuitry establishing a second dosing regimen and causing the pumping assembly to drive a second drug from a second reservoir in the pump based on the second dosing regimen; wherein the first reservoir contains a first volume of the first drug therein and includes the first data storage component storing data indicative of the first volume; the second reservoir has a same size as the first reservoir, contains a second volume of the second drug therein, and includes the second data storage component storing data indicative of the second volume; the second volume is different from the first volume; and the control circuitry receives first data from the reader indicative of the stored data read from the first data storage component, establishes the first dosing regimen using the received first data, receives second data from the reader indicative of the stored data read from the second data storage component, and establishes the second dosing regimen using the received second data (see paras. [0022-0023]).
Regarding claim 12, Agris teaches the system of claim 11 and wherein the control circuitry is configured to establish the first dosing regimen prior to any delivery of the first drug from the pump to the patient; and the control circuitry is configured to establish the second dosing regimen prior to any delivery of the second drug from the pump to the patient (see “recommended procedure or protocol,” para. [0047]).
Regarding claim 13, Agris teaches the system of claim 11 and wherein: the reader includes a Near Field Communication (NFC) reader, the first data storage component includes a first NFC tag, and the second data storage component includes a second NFC tag; or the reader includes a QR code scanner, the first data storage component includes a first QR code, and the second data storage component includes a second QR code (see QR code sensor 152, para. [0047]).
Regarding claim 17, Agris teaches the system of claim 11 and wherein the first drug is different from the second drug (saline and contrast, see para. [0022]).
Regarding claims 18-19, Agris teaches the system of claim 11 and wherein the first and second reservoirs are configured to be pre-loaded into the pump by a user (see fig. 2).
Regarding claim 23, Agris teaches a drug administration system (see fig. 2), comprising: a pump (fig. 2, 102) including a housing (see fig. 2), a reader, and control circuitry; and a reservoir (104) configured to contain a drug therein (contrast media, saline, etc.), the reservoir including a data storage component (22) configured to be preprogrammed, prior to the reservoir being received in the housing of the pump, with data indicating a dose amount of the drug to be delivered to a patient using the pump; wherein the reader is configured to, with the reservoir received in the housing of the pump, read the data indicating the dose amount from the data storage component; the control circuitry is configured to receive data from the reader indicative of the read data indicating the dose amount; and the control circuitry is configured to cause a dose of the drug, at the dose amount, to be delivered from the pump to the patient (see para. [0047]).
Regarding claim 24, Agris teaches the system of claim 23, wherein the dose amount is based on at least one of a pre-identified therapy and a pre-identified prescription of the drug for the patient (see para. [0002]).
Regarding claim 26, Agris teaches the system of claim 23, wherein the dose amount is based on at least one of gender, ethnicity, and genetic makeup (see para. [0002]).
Claim(s) 1, 6, 10, 11, 16, 20, 23 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP3636300 to Katsunuma (“Katsunuma”).
Regarding claims 1 and 23, Katsunuma teaches a drug administration system (fig. 1), comprising: a first reservoir (200) containing a first volume of a first drug therein and including a first data storage component storing data indicative of the first volume (300, para. [0028]); a second reservoir having a same size as the first reservoir (i.e. a second replacement syringe 200, para. [0008]), containing a second volume of a second drug therein, and including a second data storage component storing data indicative of the second volume, the second volume being different from the first volume (para. [0009]); and a pump (100) configured to receive each of the first and second reservoirs therein, the pump comprising: a reader (170) configured to read the stored data from the first and second data storage components (para. [0070]); a pumping assembly (100) configured to drive the first drug from the pump for delivery to a patient and to drive the second drug from the pump for delivery to the patient, and control circuitry operably coupled to the reader and to the pumping assembly and configured to receive first data from the reader indicative of the stored data read from the first data storage component, establish a first dosing regimen for delivery of the first drug using the received first data, cause the pumping assembly to drive the first drug from the pump based on the first dosing regimen, receive second data from the reader indicative of the stored data read from the second data storage component, establish a second dosing regimen for delivery of the second drug using the received second data, and cause the pumping assembly to drive the second drug from the pump based on the second dosing regimen (para. [0028-0030]).
Regarding claim 6, Katsunuma teaches the system of claim 1 and wherein the first drug is the same as the second drug (para. [0008-0009]).
Regarding claim 10, Katsunuma teaches the system of claim 1 and wherein the first reservoir is configured to be removed from the pump before the second reservoir is received in the pump (replacement syringe, para. [0009]).
Regarding claims 11 and 36, Katsunuma teaches a drug administration method (see para. [0001]), comprising: a reader (170) of a pump reading stored data from first and second data storage components (para. [0070]); control circuitry of the pump establishing a first dosing regimen and causing a pumping assembly of the pump to drive a first drug from a first reservoir in the pump based on the first dosing regimen; and the control circuitry establishing a second dosing regimen and causing the pumping assembly to drive a second drug from a second reservoir in the pump based on the second dosing regimen; wherein the first reservoir contains a first volume of the first drug therein and includes the first data storage component storing data indicative of the first volume; the second reservoir has a same size as the first reservoir, contains a second volume of the second drug therein, and includes the second data storage component storing data indicative of the second volume; the second volume is different from the first volume; and the control circuitry receives first data from the reader indicative of the stored data read from the first data storage component, establishes the first dosing regimen using the received first data, receives second data from the reader indicative of the stored data read from the second data storage component, and establishes the second dosing regimen using the received second data (para. [0028-0030]).
Regarding claim 16, Katsunuma teaches the system of claim 11 and wherein the first drug is the same as the second drug (para. [0008-0009]).
Regarding claim 20, Katsunuma teaches the system of claim 11 and wherein the first reservoir is configured to be removed from the pump before the second reservoir is received in the pump (replacement syringe, para. [0009]).
Regarding claim 24, Katsunuma teaches the system of claim 23, wherein the dose amount is based on at least one of a pre-identified therapy and a pre-identified prescription of the drug for the patient (see para. [0006]).
Regarding claim 25, Katsunuma teaches the system of claim 23 and wherein the dose amount is based on a pre-identified weight of the patient (see para. [0090]).
Claim(s) 1, 5, 7, 11, 15, 17, 23-26 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2020/0111556 to Schmidlin et al. (“Schmidlin”).
Regarding claims 1 and 23, Schmidlin teaches a drug administration system (100), comprising: a first reservoir (102) containing a first volume of a first drug therein and including a first data storage component (116) storing data indicative of the first volume (para. [0005]); a second reservoir having a same size as the first reservoir (references drugs para. [0021]), containing a second volume of a second drug therein, and including a second data storage component storing data indicative of the second volume, the second volume being different from the first volume (references drugs para. [0021]); and a pump (208) configured to receive each of the first and second reservoirs therein, the pump comprising: a reader (cell phone, para. [0050])) configured to read the stored data from the first and second data storage components (para. [0050]); a pumping assembly (208) configured to drive the first drug from the pump for delivery to a patient and to drive the second drug from the pump for delivery to the patient, and control circuitry operably coupled to the reader and to the pumping assembly and configured to receive first data from the reader indicative of the stored data read from the first data storage component, establish a first dosing regimen for delivery of the first drug using the received first data, cause the pumping assembly to drive the first drug from the pump based on the first dosing regimen, receive second data from the reader indicative of the stored data read from the second data storage component, establish a second dosing regimen for delivery of the second drug using the received second data, and cause the pumping assembly to drive the second drug from the pump based on the second dosing regimen (para. [0050]).
Regarding claim 5, Schmidlin teaches the system of claim 1 and wherein the first data storage component includes a first electrically erasable programmable read-only memory (EEPROM), and the second data storage component includes a second EEPROM (para. [0046]).
Regarding claim 7, Schmidlin teaches the system of claim 1 and wherein the first drug is different from the second drug (disclosure of drugs, para. [0021]).
Regarding claims 11 and 36, Schmidlin teaches a drug administration method (implicit in the disclosure), comprising: a reader (cell phone, para. [0050]) of a pump reading stored data from first and second data storage components (110); control circuitry of the pump establishing a first dosing regimen and causing a pumping assembly of the pump to drive a first drug from a first reservoir in the pump based on the first dosing regimen; and the control circuitry establishing a second dosing regimen and causing the pumping assembly to drive a second drug from a second reservoir in the pump based on the second dosing regimen; wherein the first reservoir contains a first volume of the first drug therein and includes the first data storage component storing data indicative of the first volume; the second reservoir has a same size as the first reservoir, contains a second volume of the second drug therein, and includes the second data storage component storing data indicative of the second volume; the second volume is different from the first volume; and the control circuitry receives first data from the reader indicative of the stored data read from the first data storage component, establishes the first dosing regimen using the received first data, receives second data from the reader indicative of the stored data read from the second data storage component, and establishes the second dosing regimen using the received second data (para. [0050]).
Regarding claim 15, Schmidlin teaches the system of claim 11 and wherein the first data storage component includes a first electrically erasable programmable read-only memory (EEPROM), and the second data storage component includes a second EEPROM (para. [0046]).
Regarding claim 17, Schmidlin teaches the system of claim 11 and wherein the first drug is different from the second drug (disclosure of drugs, para. [0021]).
Regarding claims 24-26, Schmidlin teaches the system of claim 23 and wherein the dose amount is based on at least one of a pre-identified therapy and a pre-identified prescription of the drug for the patient; wherein the dose amount is based on a pre-identified weight of the patient; and wherein the dose amount is based on at least one of gender, ethnicity, and genetic makeup (para. [0021] and [0086]).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agris.
Agris meets the claim limitations as described above for claim 23 but fails to specifically teach wherein the dose amount is based on a pre-identified weight of the patient.
However, at the time of the invention, it would have been obvious to one of ordinary skill in the art to base the dose amount on a pre-identified weight of the patient since most injected drugs and therapies are prescribed based on patient weight. This is considered a standard of care in the medical profession and deviation from this practice could result in medical malpractice. Therefore, one would be motivated to follow the standard of care in order to provide the patient with the highest level of care.
Conclusion
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
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