DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 June 2026 has been entered. Claims 1-3, 6, 8-12, 14, 15, 18, 20-22, 24-26, 39, 43 and newly added claims 76-78 remain pending.
Election/Restrictions
3. Newly submitted claims 77 and 78 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I and II are directed to related inventions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design, function and effect, since invention I recites a device providing a generic detectable visual output, a sensor on a computer system, a server and a database, and producing a patient personalized assessment, formulating a customized intervention, and presenting the assessment and/or intervention, while invention II recites a delivery device comprising a drug for delivery and a barcode, and an accessory device comprising a reader that reads an identification component, such as a barcode reader. The inventions are also mutually exclusive, and are not obvious variants. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 77 and 78 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections – 35 USC § 101
4. 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 1-3, 6, 8-12, 14, 15, 18, 20-22, 24-26, 39, 43 and 76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites a method comprising:
(i) responsive to patient input data, producing a patient personalized assessment;
(ii) formulating a customized intervention for the patient based on the patient input data and/or personalized assessment; and
(iii) presenting the patient personalized assessment and/or customized intervention on the display.
The limitations of producing a patient personalized assessment, formulating a customized intervention and/or assessment, and presenting the assessment and/or intervention, as drafted, constitutes a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a system comprising a patient computer system and a server, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the “computer system” and “server” language, “producing”, “formulating” and “presenting” in the context of this claim encompasses a user manually producing the assessment, formulating and delivering the intervention, for example using a pen and paper. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites using a computer system and server to perform the claimed steps. The computer and server in these steps are recited at a high-level of generality (i.e., as a generic computer and server performing generic computer functions of producing an assessment and formulating and presenting an assessment or intervention) such that they amount to no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim further recites a medicament delivery training device and/or a medicament delivery device configured to provide a detectable visual output, the visual output comprising an image associated with the medicament delivery device, and the patient computer system comprising a sensor, wherein the computer system is configured to detect the detectable visual output by the at least one sensor of the patient computer system. This training and/or delivery device with a visual output detectable by a sensor of the computer system is involved only in pre-solution data gathering, and amounts to no more than insignificant extra-solution activity in the form of pre-solution data gathering. This data gathering is akin to those described in See MPEP 2106.05(g), such as “Testing a system for a response” in In re Meyers and “Printing or downloading generated menus” in Amaranth. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer and server to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. As noted above, the claim also recites a training or delivery device providing a detectable output detectable by a sensor of the computer, which amounts to no more than pre-solution data gathering. See MPEP 2106.05(g). The claim is not patent eligible.
Dependent claims 2-3, 6, 8-12, 14, 15, 18, 20-22, 24-26, 39, 43 and 76 recite the same abstract idea as in claim 1, and only recite further abstract steps of receiving patient data and displaying information to the patient, performed by the computer system and/or server. Accordingly, these claims do not recite additional limitations sufficient to direct the claimed invention to significantly more.
Response to Arguments
5. Applicant’s arguments with respect to the section 102 rejection of claim 1 have been fully considered and are persuasive. The section 102 and 103 rejections have been withdrawn.
Applicant's arguments filed with respect to the section 101 rejection have been fully considered but they are not persuasive. Applicant argues that the newly added features pertain to a unique interaction between a medicament delivery device and a sensor to provide functionality for the computer system, and provide additional structural elements to the system. However, as detailed in the rejection above the additional elements of a training and/or delivery device that provide a visual output for the patient computer to detect is generally untethered from the abstract idea (producing an assessment or intervention responsive to patient input data), and therefore do not serve to integrate the judicial exception into a practical application. This visual output and detection is recited at a high level of generality and is only involved in the pre-solution data gathering, similar to the examples found in MPEP 2106.05(g) discussed above.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571) 270-3548. The examiner can normally be reached 9:00 AM – 5:00 PM, Monday through Friday Eastern.
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, Xuan Thai, can be reached at 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter R Egloff/
Primary Examiner, Art Unit 3715
Prosecution Insights