DETAILED ACTION
Non-Final Rejection
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-33 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Each of claims 16-33 falls within one of the four statutory categories. See MPEP § 2106.03. Each of claim 16-25 falls within category of machine, i.e., a “concrete thing, consisting of parts, or of certain devices and combination of devices.” Digitech, 758 F.3d at 1348–49, 111 USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)); For example, each of claims 16-33 fall within category of process.
Regarding Claims 16-25
Step 2A – Prong 1
Exemplary claim 16 is directed to an abstract idea of administering medicaments.
The abstract idea is set forth or described by the following italicized limitations:
16. An apparatus for administering medicaments, comprising: a dispenser comprising a i) housing, ii) a dispensing device connected to the housing and iii) a multi-dose amount of a medicament contained in the housing, wherein the dispensing device is configured for dispensing unit doses of said medicament when actuated by a user;
a label or tag comprising a machine-readable code comprising or linked to data of the dispenser, wherein the label or tag is i) fixed to the dispenser and/or iia) contained in or iib) attached to a packaging for the dispenser, wherein the data of the dispenser comprise an in- use life period (ATin_use) of the medicament;
a portable electronic device comprising an electronic control unit and reading devices configured for reading the data of the dispenser from the machine-readable code;
an application loaded in the electronic control unit or in a remote location and configured for:
receiving and optionally storing the data of the dispenser and a date of reading (Tread) when the reading devices read the machine-readable code at said date of reading;
if at least one of said data of the dispenser is new, thus indicating that the machine- readable code has been read for the first time after manufacturing the dispenser, then:
calculating and storing an in-use expiry date (Texpin_use) from the date of reading and the in-use life period as Texpin_use = Tread + ATin_use and/or starting an in-use expiry counter; and
enabling at least one alert as a function of the in-use expiry date and/or of the in-use life period, so that the portable electronic device issues said at least one alert i) when the in-use expiry date is reached or approaching or ii) when the in-use life period is elapsed or about to elapse.
The italicized limitations above represent a combination of mathematical concept (i.e., a process that can be performed by mathematical relationships or rules or idea) and mental step (i.e., a process that can be performed by can be performed mentally and/or with pen and paper or a mental judgment) . Therefore, the italicized limitations fall within the subject matter groupings of abstract ideas enumerated in Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance.
For example, the limitations “if at least one of said data of the dispenser is new, thus indicating that the machine- readable code has been read for the first time after manufacturing the dispenser, then: calculating and storing an in-use expiry date (Texpin_use) from the date of reading and the in-use life period as Texpin_use = Tread + ATin_use and/or starting an in-use expiry counter;” are mathematical concept and/ or mental step (i.e., a process that can be performed by can be performed mentally and/or with pen and paper or a mental judgment), see 2106.04(a)(2). Limitations are considered together as a single abstract idea for further analysis. (discussing Bilski v. Kappos, 561 U.S. 593 (2010)).
Step 2A – Prong 2
Claims 1 does not include additional elements (when considered individually, as an ordered combination, and/or within the claim as a whole) that are sufficient to integrate the abstract idea into a practical application.
For example, 1st additional first element is “An apparatus comprising: a dispenser comprising a i) housing, ii) a dispensing device connected to the housing and iii) a multi-dose amount of a medicament contained in the housing, wherein the dispensing device is configured for dispensing unit doses of said medicament when actuated by a user; a label or tag comprising a machine-readable code comprising or linked to data of the dispenser; wherein the label or tag is i) fixed to the dispenser and/or iia) contained in or iib) attached to a packaging for the dispenser, wherein the data of the dispenser comprise an in- use life period (ATin_use) of the medicament”. This element amounts to mere use of a generic dispensing system, which is well understood routine and conventional (see background of current discloser and IDS and PTO 892) and this element individually does not provide a practical application. In view of the above, the “additional element” individually or combine does not provide a practical application of the abstract idea. see MPEP 2106.05(d).
For example, 2nd additional first element is “a portable electronic device comprising an electronic control unit and reading devices configured for reading the data of the dispenser from the machine-readable code; an application loaded in the electronic control unit or in a remote location and configured for:”. This element amounts to mere use of a generic device with computer components, which is well understood routine and conventional (see background of current discloser and IDS and PTO 892) and this element individually does not provide a practical application. In view of the above, the “additional element” individually or combine does not provide a practical application of the abstract idea. see MPEP 2106.05(d).
For example, 3rd additional first element is “ receiving and optionally storing the data of the dispenser and a date of reading (Tread) when the reading devices read the machine-readable code at said date of reading; enabling at least one alert as a function of the in-use expiry date and/or of the in-use life period, so that the portable electronic device issues said at least one alert i) when the in-use expiry date is reached or approaching or ii) when the in-use life period is elapsed or about to elapse” to be performed, at least in-part, these additional elements appear to only add insignificant extra-solution activity (e.g., data gathering) and only generally link the abstract idea to a particular field. Therefore, this element individually or as a whole does not provide a practical application. See MPEP 2106.05(g).
In view of the above, the three “additional elements” individually do not provide a practical application of the abstract idea. Furthermore, the “additional elements” in combination amount to a plurality of generic device with computer component with software, where such computers and software amount to mere instructions to implement the abstract idea on a computer(s) and/or mere use of a generic computer component(s) as a tool to perform the abstract idea. Therefore, these elements in combination do not provide a practical application. The combination of additional elements does no more than generally link the use of the abstract idea to a particular technological environment, and for this additional reason, the combination of additional elements does not provide a practical application of the abstract idea.
.
Step 2B
Claims1 does not include additional elements, when considered individually and as an ordered combination, that are sufficient to amount to significantly more than the abstract idea. For example, the limitation of Claim 1 contains additional elements that are, i.e. dispenser, label or tag, portable electronic device”, generic devices, which are well understood, routine and conventional (see background of current discloser and IDS and PTO 892) and MPEP 2106.05(d))The reasons for reaching this conclusion are substantially the same as the reasons given above in § Step 2A – Prong 2. For brevity only, those reasons are not repeated in this section. See MPEP §§ 2106.05(g) and MPEP §§2106.05(II).
.
Dependent Claims 17-25
Dependent claims 17-25 fail to cure this deficiency of independent claim 1 (set forth above) and are rejected accordingly. Particularly, claims 17-25 recite limitations that represent (in addition to the limitations already noted above) either the abstract idea or an additional element that is merely extra-solution activity, mere use of instructions and/or generic computer component(s) as a tool to implement the abstract idea, and/or merely limits the abstract idea to a particular technological environment.
For Examples, claim 17: a combination of mathematical concept (i.e., a process that can be performed by mathematical relationships or rules or idea) and mental step (i.e., a process that can be performed by can be performed mentally and/or with pen and paper or a mental judgment).
For Examples, claim 18-20:(data gathering) to be performed, at least in-part, these additional elements appear to only add insignificant extra-solution activity (e.g., data gathering and/ or field of use) and only generally link the abstract idea to a particular field. Therefore, this element individually or as a whole does not provide a practical application. See MPEP 2106.05(g)
For Examples, claim 21-25: This element amounts to mere use of a generic dispensing system, which is well understood routine and conventional (see background of current discloser and IDS and PTO 892) and this element individually does not provide a practical application. In view of the above, the “additional element” individually or combine does not provide a practical application of the abstract idea. see MPEP 2106.05(d).
Regarding Claims 26-33
Claims 26-33 contains language similar to claims 16-25 as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 26-33 are also rejected under 35 U.S.C. § 101(abstract idea).
Examiner Notes
Three is no prior art rejection over claims 16-33,specifically claims 16 and 26 however there is 101 rejection. Closes prior arts fail to teach the limitations of, specifically claim 16 and 26 “if at least one of said data of the dispenser is new, thus indicating that the machine- readable code has been read for the first time after manufacturing the dispenser, then: calculating and storing an in-use expiry date (Texpin_use) from the date of reading and the in-use life period as Texpin_use = Tread + ATin_use and/or starting an in-use expiry counter”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
a) US 2024/0374834: disclose the pre-determined age threshold may be stored in the electronic system, for example in the memory. The age threshold may include an expiry date. Alternatively, the age threshold may include a production date and an expiry duration. The microcontroller system may be configured to compare the date and time information obtained from the electronic clock for the corresponding dose delivery operation with the age threshold. The age threshold may be based on a shelf-life of the drug delivery device. It is envisaged that the risk of malfunctions increases if the age of the drug delivery device is beyond the shelf-life. Furthermore, this feature is particularly advantageous in for non-reusable drug delivery devices (for example non-reusable pen-type drug delivery devices) which comprise the medicament to be delivered. The pre-determined age threshold may be related to a shelf-life of the medicament and/or a guarantee time for sterility, for example.
b) US 2023/0385450: disclose computing entity 106 may connect or log into the Human-Centric EHR system 102 and select the third-party that the patient desires to share his health records with (e.g., such as at step 1302), as is shown in example illustrated in FIG. 16F. The patient may be able to set a start and end date (and time) or an expiry date (and time) for which the third-party physician can have access to the patient's health records.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD K ISLAM whose telephone number is (571)270-0328. The examiner can normally be reached M-F 9:00 a.m. - 5:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelby A Turner can be reached at 571-272-6334. 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.
/MOHAMMAD K ISLAM/Primary Examiner, Art Unit 2857
Prosecution Insights