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 .
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.
Notice to Applicant
Claims 1 – 20 are pending.
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 therefore, subject to the conditions and requirements of this title.
Claims 1 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims, understood as a whole, recites subject matter within a statutory category as a process (claims 16 – 20), machine (claims 1 – 15) which recite the abstract idea steps of
Claim 1
analyze measurement data and determine injection authorization based on a predetermined health parameter,
provide a user control for an injection authorization process based on the analysis.
Claim 9
predict optimal injection timing and dosage based on a physiological parameter,
permit injection only when determined that current physiological parameter indicates a preferred administration condition.
Claim 16
collecting measurement data;
analyzing the measurement data to determine an injection authorization based on a predetermined health parameter;
control injection authorization based on the analysis.
These steps of claims 1 – 20, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. The Examiner understands the claimed invention, as a whole, in light of the Specification.
BACKGROUND
[0003] Understanding administration of drugs and their interaction in the healthcare ecosystem are important in delivering beneficial patient care. Applicant appreciates that regular pharmaceutical therapy and a need for real time data management related to both timing of and compliance in dosing bundled with increased information sharing across the care continuum can provide valuable insight for improving care and, in turn, reducing fraud, waste, and abuse.
[0020] In some aspects, the techniques described herein relate to a method, wherein analyzing the measurement data includes using sensor fusion to generate a prediction related to an instance of medical dosage administration.
Further, see paragraphs 60 – 62. The invention is not described as being a technological improvement or an improvement of technology. The invention result is information as to the proper timing to perform an injection. The invention is not directed towards the device. As stated in paragraph 61, “Using the intelligent dosing platform 100, as disclosed herein, may allow an individual patient, a clinician, a healthcare facility, pharmaceutical corporation, manufacturer and/or distributor or some other entity to more accurately collect and maintain intelligent injection device data in a confidential format and system and better manage their intelligent injection device practices.
As noted in MPEP 2106.05(h) Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include:
vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 8, 10 – 15, and 17 – 20, reciting particular aspects of how predicting proper injection timing may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of server configured to amounts to invoking computers as a tool to perform the abstract idea)
add insignificant extra-solution activity to the abstract idea (such as recitation of measurement data from a wearable device amounts to mere data gathering, recitation of control injection amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 8, 10 – 15, and 17 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; receive data, provide a user interface, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i))
Additional Elements
intelligent injection device – paragraph 69, e.g., syringes, intravenous devices (IVs), and the like
Wireless – paragraph 248 wireless module 504 may include a Bluetooth interface, a Bluetooth low energy interface, a Wi-Fi interface, an infrared interface, a cellular interface (e.g., a fixed area transceiver), a near field communication (NFC) interface, a radio-frequency identification (RFID) interface, or any other suitable communication interface
Smartphone – Clark paragraph 67 user device
Smartphone application – Saint, paragraph 30
wearable device – paragraphs 5 – 7 and Sain paragraph 184
server – paragraph 270 computer, server, or other device
a cloud-based management platform – paragraph 320 server may be cloud-based or paragraph 437 examples of servers
artificial intelligence – paragraph 99 the artificial intelligence module 104 may include methods and systems for data and analytic optimization, prediction, decision support, simulation, machine learning, process automation, inference modeling, neural network modeling, digital twins modeling, and the like ( collectively referred to herein as "intelligence functions 202," "artificial intelligence modules 104")
network – paragraph 281 internet
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 8, 10 – 15, and 17 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, describing how the information is obtained, processed, and output, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: platform and module in claim claims 1 – 15.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 7, 9 – 11, 13, 14, 16, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saint et al., U.S. Pre-Grant Publication 2025/ 0050030 .
As per claim 1,
Saint teaches an intelligent injection management system comprising:
an intelligent injection device with wireless communication capabilities (paragraph 32 pen device #10 in wireless communication with…);
a smartphone application configured to interface with the intelligent injection device (paragraph 30, patient’s companion device e.g. smartphone);
at least one wearable device (paragraph 34 continuous glucose monitor, paragraph 189 smartwatch or smart-glasses);
a server configured to receive administration data from the intelligent injection device and measurement data from the wearable device (figure 4A $#20 and paragraph 52);
an artificial intelligence module configured to analyze the measurement data and determine injection authorization based on a predetermined health parameter (Paragraphs 52 and 56 learning does calculator module #220 and paragraph 74 machine learning to optimize),
wherein the smartphone application provides user interface control for an injection authorization process based on the artificial intelligence module analysis (paragraphs 32 and 73 control functionalities of the pen device).
As per claim 2, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the wearable device is a physiological monitor (paragraph 34 continuous glucose monitor).
As per claim 3, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the wearable device is a smart watch (paragraph 30).
As per claim 4, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the wearable device is smart eyeglasses (paragraph 30).
As per claim 5, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the system further comprises an injectable administration compliance management platform for real-time monitoring and management of adherence to an injectable administration plan that receives data collected by the wearable device (paragraph 104).
As per claim 6, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the artificial intelligence module is configured to calculate a compliance score for an injection event based at least in part on a conformance of the administration data to at least one criterion of a treatment schedule (paragraph 74).
The Examiner notes that the Specification does not describe how the compliance score is calculated.
As per claim 7, Saint teaches the system of claim 1 as described above.
Saint further teaches the system wherein the artificial intelligence module comprises a generative AI system configured to generate a data story related to the intelligent injection device or to an instance of medical dosage administration (paragraph 66 recommendations).
The Specification does not describe what a “data story” is or how the “data story” is created.
As per claim 9,
Saint further teaches an intelligent injection management system comprising:
an intelligent injection device having a reporting component (paragraph 32 pen device #10 in wireless communication with…);
a network of connected wearable devices configured to continuously monitor a user's physiological parameter (paragraph 34 continuous glucose monitor, paragraph 189 smartwatch or smart-glasses);
a cloud-based management platform configured to receive data from both the intelligent injection device and the wearable device (paragraph 107 cloud-based infrastructure);
a machine learning system trained to predict optimal injection timing and dosage based on the continuously monitored physiological parameter (Paragraphs 52 and 56 learning does calculator module #220 and paragraph 74 machine learning to optimize),
wherein the intelligent injection device is configured to automatically unlock and permit injection only when the machine learning system determines that current physiological parameter indicates a preferred administration condition (paragraph 46).
As per claim 10, Saint teaches the system of claim 9 as described above.
Saint further teaches the system as described above in claim 5.
As per claim 11, Saint teaches the system of claim 9 as described above.
Saint further teaches the system wherein the machine learning system uses sensor fusion to generate a prediction related to the intelligent injection device (paragraph 75).
As per claim 13, Saint teaches the system of claim 9 as described above.
Saint further teaches the system as described above in claim 6.
As per claim 14, Saint teaches the system of claim 9 as described above.
Saint further teaches the system as described above in claim 7.
As per claim 16,
Saint teaches a method of managing pharmaceutical injection using multiple connected devices
as described above in claim 1.
As per claim 17, Saint teaches the method of claim 16 as described above.
Saint further teaches the method as described above in claim 11.
As per claim 19, Saint teaches the method of claim 16 as described above.
Saint further teaches the method wherein the artificial intelligence module is trained on a training data set of medical dosages administration data to output at least one of a prediction, a classification, a recommendation, an analytic result, a report or a control instruction and uses sensor fusion to classify an instance of medical dosage administration (paragraph 73, recommendation).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Saint et al., U.S. Pre-Grant Publication 2025/ 0050030 in view of Forkort, U.S. Pre-Grant Publication 2026/ 0004150.
As per claim 8, Saint teaches the system of claim 1 as described above.
Saint does not explicitly teach, however Forkort further teaches the system wherein the artificial intelligence module is configured to improve differences between supply and demand of a set of intelligent injection devices across a set of locations and times (paragraph 169).
The Specification does not describe the result of this optimization. The Specification does not describe how this process occurs.
It would have been obvious to one of ordinary skill in the art before the effective filing date to add these features into Saint. One of ordinary skill in the art before the effective filing date would have added these features into Saint with the motivation to enhance decision-making, operational efficiency, and predictive capabilities (Forkort, paragraph 169).
Claims 12, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Saint et al., U.S. Pre-Grant Publication 2025/ 0050030 in view of Warner et al, U.S. Pre-Grant Publication 2026/ 0104317.
As per claim 12, Saint teaches the system of claim 9 as described above.
Saint does not explicitly teach, however Warner further teaches the system wherein the cloud-based management platform further comprises a digital twin that combines data from a plurality of sensors to model at least one feature of the intelligent injection device to inform a prediction relating to one or more of its status, condition, operation, utilization or maintenance (paragraphs 51 and 52 operation).
It would have been obvious to one of ordinary skill in the art before the effective filing date to add these features into Saint. One of ordinary skill in the art before the effective filing date would have added these features into Saint with the motivation to configure and control medical equipment using a digital assistant are disclosed. (Warner, Abstract).
As per claim 15, Saint teaches the system of claim 9 as described above.
Saint further teaches the system as described above in claim 12.
As per claim 18, Saint teaches the method of claim 16 as described above.
Saint further teaches the method as described above in claim 12.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Saint et al., U.S. Pre-Grant Publication 2025/ 0050030 in view of Albertini et al, U.S. Pre-Grant Publication 2022/ 0409127.
As per claim 20, Saint teaches the method of claim 16 as described above.
Saint does not explicitly teach, however Albertini further teaches the method wherein the intelligent injection device comprises a microprocessor in electronic communication with a damage detection system for detecting damage to the device (paragraphs 13 and 152).
The Examiner notes that although paragraph 138 describes the result of the damage detection, paragraph 138 does not disclose how these results are obtained.
It would have been obvious to one of ordinary skill in the art before the effective filing date to add these features into Saint. One of ordinary skill in the art before the effective filing date would have added these features into Saint with the motivation to identify a malfunction in the administration of the drug (Albertini, Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Selman et al Pub. No.: US 2023/0178205 to administration systems and to methods which can improve the safety of administration systems, more particularly the safety of an infusion system, in which system it is checked, when the medication container is exchanged, whether the new container is appropriate for the system.
Clark Pub. No.: US 2019/0189259 provide systems and methods for generating an optimized treatment experience for a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
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