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 Objections
Claim 1 is objected to because the claim is awkwardly worded and can potentially be interpreted as indefinite. Line 6 of the claim states “at least one sensor, sensitive to at least one physical quantity within said container and capable of affecting the integrity of said at least one drug present in said container.” As the claim stands, it can be interpreted that the sensor is capable of affecting the integrity of the at least one drug within the container. It is recommended by the examiner to reword the claim to definitively state what can affect the integrity of the drug. It is understood by the examiner that applicant is intending to state that the at least one physical quantity is what affects the integrity of the drug, per paragraph 0008 of the specification. Thus the claim will be interpreted as such for the purpose of this examination.
Claim 12 is objected to because of the following informalities: starting on line 2, “characterized in that it is presented…” should read “characterized in that the device is presented” in order to maintain clear terms with regard to the claimed invention. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: starting on line 2, “characterized in that it is presented…” should read “characterized in that the device is presented” in order to maintain clear terms with regard to the claimed invention. 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.
Claim 7 is 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. The claim is considered indefinite because it cannot be ascertained exactly what elements are being claimed. Claim 7 recites “…a module for measuring a quantity of a drug exiting the container via the dispensing opening; and/or a management unit configured to allow, or not, dispensing of the drug to the user as a function of at least one data item stored in the electronic chip and of at least one predefined condition applicable to said data item.” The use of “and/or” combined with the listed elements does not make definite whether the claimed invention requires all four elements (the biometric reader, the module for communicating, the module for measuring, and the management unit) or only one of the four elements. It is recommended by the examiner to replace “and/or” with either “and” or “or” or to premise the list of four elements with “at least one of”. For the purpose of this examination, the claim will be interpreted as though it says “or” instead of “and/or”.
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 1-3, 8, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Carrico (US 20200060931 A1).
Regarding Claim 1, Carrico teaches a device for packaging, transporting and/or dispensing drugs comprising:
a closed container (shown in Figure 1, closable with a cover 1) for a drug, provided to receive at least one drug to be dispensed and comprising an opening (cover 1 caps an opening to a cavity described in paragraph 0033) for dispensing a drug, intended to be released when a drug is dispensed (described in paragraph 0010, wherein the cap is released to dispense the drug);
and at least one sensor (5), sensitive to at least one physical quantity within said container and capable of affecting the integrity of said at least one drug present in said container (described in paragraph 0031).
Regarding Claim 2, Carrico further teaches wherein the at least one said sensor is arranged in the container (shown in Figure 2).
Regarding Claim 3, Carrico further teaches wherein the at least one said sensor is arranged in a housing provided in said container (shown in Figure 2).
Regarding Claim 8, Carrico further teaches a closure means that can be displaced between a first position allowing the passage of a drug through the dispensing opening and a second position preventing the passage of a drug through the dispensing opening (cover or cap 1 is described in paragraph 0048 to have an embodiment on a hinge, which enables the cap to be displaced between a first open position and a second closed position).
Regarding Claim 9, Carrico further teaches the closure means comprises a first mechanism, which can be displaced between an open position allowing the passage of a drug through the dispensing opening and a closed position preventing the passage of a drug through the dispensing opening, and provided to be actuated by the user (wherein the first mechanism is the hinge described in paragraph 0048).
Regarding Claim 11, Carrico further teaches wherein the container is formed by a cover assembled with the rest of said device (shown in Figure 1-3).
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.
Claims 6 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Carrico (US 20200060931 A1) in view of Chen (US 10722431 B2).
Carrico teaches the claim limitations of Claim 1 as above. They do not teach an electronic chip for storing: at least one data item relating to the at least one drug present in said container, at least one data item relating to a user, and/or at least one data item relating to a dosage.
Chen teaches a medicine dispensing system comprising an electronic chip for storing: at least one data item relating to the at least one drug present in said container, at least one data item relating to a user, and/or at least one data item relating to a dosage (column 9 line 61 - column 10 line 5 describes the chip and column 11 line 63 – column 12 line 15 describes information that can be stored onto it).
Regarding Claim 6, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the electronic chip from the medicine dispensing system of Chen to the drug transporting/dispensing device of Carrico. The result would provide the device of Carrico with an information trackable chip that can be scanned to provide pharmacists, doctors and medicine users with information regarding the medicine being taken. One of ordinary skill in the art could apply the electronic chip of Chen to the device of Carrico without undue experimentation. Further, the application of the electronic chip of Chen to the device of Carrico would produce the predictable results of storing, for either transporting and/or dispensing, a prescribed medicine for a user.
Carrico does not teach their device is presented in the form of a cartridge forming said container for a drug, and provided to be used in an appliance for dispensing a drug.
Chen further teaches containers being used in an appliance for dispensing a drug (shown in Figure 1, described in column 6 line 24-41)
Regarding Claim 12, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the dispensing appliance taught by Chen to the to the drug transporting/dispensing device of Carrico such that the device of Carrico is used as containers in the dispensing appliance of Chen. The result would enable an automatic dispensing system so that medicine users can have a more optimized way to receive prescribed medication. One of ordinary skill in the art could apply the dispensing appliance of Chen to the device of Carrico without undue experimentation. Further, the application of the dispensing appliance of Chen to the device of Carrico would produce the predictable results of storing, for either transporting and/or dispensing, a prescribed medicine for a user.
Regarding Claim 13, Chen further teaches an appliance for dispensing a drug comprising: the container (containers 150a-d), and at least one part forming a base to said container (container identification unit 385), and cooperating with said container (shown in Figure 4B) for dispensing a drug present in said container (described in Abstract). It would have been further obvious to incorporate this when applying the dispensing appliance of Chen to the device of Carrico for the purpose of tracking identification of drugs, prescriptions and/or users when dispensing medicine to people.
Regarding Claim 14, Chen further teaches characterized in that the container is removably coupled to the base (shown in Figure 4B) such that said base can interchangeably receive a container from among several containers (column 10 line 29-57 describes attaching medicine storage containers 320 to dispensing system 345, via the base as shown in Figure 4B). It would have been further obvious to incorporate this when applying the dispensing appliance of Chen to the device of Carrico for the purpose of ensuring medicine containers can be secured in an automated dispensing device while still allowing the containers to be filled with medicine.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Carrico (US 20200060931 A1) in view of Valentine (US 20210319872 A1).
Carrico teaches the claim limitations of Claim 1 as above, they do not teach:
at least one biometric reader for reading at least one biometric data item of a user;
a module for communicating with a remote site, via a connection, wired or not, for sending and/or receiving data items;
a module for measuring a quantity of a drug exiting the container via the dispensing opening; or
a management unit configured to allow, or not, dispensing of the drug to the user as a function of at least one data item stored in the electronic chip and of at least one predefined condition applicable to said data item.
Valentine teaches a drug dispensing system comprising:
at least one biometric reader for reading at least one biometric data item of a user (described in paragraph 0062 and 0063);
a module for communicating with a remote site, via a connection, wired or not, for sending and/or receiving data items (described in paragraph 0066); and
a management unit configured to allow, or not, dispensing of the drug to the user as a function of at least one data item stored in the electronic chip and of at least one predefined condition applicable to said data item (described in paragraph 0083).
Regarding Claim 7, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the biometric reader, module and management unit taught by Valentine to the to the drug transporting/dispensing device of Carrico. This would enable improved security to the device of Carrico to ensure only the correct user is taking an appropriate dosage of medication. One of ordinary skill in the art could apply the reader, module and management unit of Valentine to the device of Carrico without undue experimentation. Further, the application of the reader, module and management unit of Valentine to the device of Carrico would produce the predictable results of securing and dispensing medicines to one or more prescribed users.
Regarding Claim 15, Valentine further teaches a central server; and at least one device for dispensing a drug in communication with said central server (described in paragraph 0141). It would have been further obvious to one of ordinary skill in the art to incorporate this when modifying the device of Carrico. This would enable the device of Carrico to store information regarding the prescription and user to a database.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carrico (US 20200060931 A1) in view of Liu (CN 206384803 U).
Carrico teaches the claim limitations of Claim 1 and 8 as above. They do not teach the closure means comprises a second mechanism, which can be displaced between an open position allowing the passage of a drug and a closed position preventing the passage of a drug, and provided to be actuated automatically.
Liu teaches a hinge that can be automatically actuated via a motor (described in Abstract).
Regarding Claim 10, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the automatically actuatable hinge taught by Liu to the drug transporting/dispensing device of Carrico. The result would provide the device of Carrico with controllable means to open the container in order to assist medicine users who may need handicap accessibility for their medication. One of ordinary skill in the art could apply the hinge of Liu to the device of Carrico without undue experimentation. Further, the application of the hinge of Liu to the device of Carrico would produce the predictable results of securely containing prescribed medicine designated for a user.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims or if the allowable subject matter is incorporated into an existing independent claim. The closest prior art: the dispensing device of Carrico (US 20200060931 A1) does not teach the at least one said sensor is a sensor that degrades when the value of at least one physical quantity exceeds a threshold value.
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims or if the allowable subject matter is incorporated into an existing independent claim. The closest prior art: the dispensing device of Carrico (US 20200060931 A1) does not teach the at least one said sensor is a passive RFID tag, comprising a chip and an antenna, and which can no longer be read when the value of at least one physical quantity exceeds a threshold value.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIRAJ T PATEL whose telephone number is (571)272 -9330. The examiner can normally be reached M-F 8:00-5:00.
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/M.T.P./Examiner, Art Unit 3655
/JACOB S. SCOTT/Supervisory Patent Examiner, Art Unit 3655