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 17 is objected to because of the following informalities:
Claim 17 recites “determine whether to unlock the vial is based on,” which contains a grammatical error.
Appropriate correction is required.
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 16-35 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. Claims 16-21 are drawn to a system, while claims 22-35 are drawn to a method, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of:
outputting to a clinician a session capturing dispensing and consumption of a dose of a consumable from a vial by a patient, the session captured by the patient, the session initiated based on input data obtained from the patient;
outputting one or more messages to the patient during the session;
terminate the session; and
generate a report based on the consumption of the dose.
These steps amount to a form of managing personal behavior or relationships or interactions between people, and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of a patient initiating an interaction with a clinician in which the clinician observes the patient taking a dose of a consumable from a vial and communicates messages to the patient, and then generates a report based on the consumption of the dose. This constitutes a form of managing the behavior of the patient in taking the dose as well as managing an interaction between the patient and clinician.
Independent claim 22 contains similar limitations and recites an abstract idea on the same grounds set out above.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 16 recites additional elements of a) at least one processor recited as causing the system to perform the subsequent steps, b) a memory storing instructions which are executed by the processor, c) the session being a video session, d) a clinician interface recited as outputting the video session, e) a computing device associated with the patient and recited as capturing the video session and obtaining input from the patient, and f) a patient interface recited as outputting the messages.
Claim 22 recites additional elements of a) the session being a video session, b) a computing device associated with the patient and recited as capturing the video session and obtaining input from the patient, c) a clinician interface recited as outputting the video session, and d) a patient interface recited as outputting the messages.
Paragraphs 31, 84, and 87 describe the system elements as including servers and computing devices comprising processors, memory, and input/output devices, where each of these is described as encompassing generic forms such as CPUs, RAM, and display devices. The processor and memory are therefore construed as encompassing generic computing elements.
Figure 1 element 106 and paragraphs 40 and 71 describe a patient side portal as “any computer or smart device that allows video conferences and an interface to issue and receive commands,” such as an app running on a cell phone, and that “any type of computer portal may be used.” The computing device associated with the patient and patient interface are construed accordingly as encompassing generic computing devices and interface components.
Figure 1 element 102 and paragraph 39 describe a clinician side portal as “any computer or smart device that allows for video conferences and an interface to issue and receive commands,” such as a standard internet browser on a computer, and that “any type of computer portal may be used.” Paragraph 51 further states that video sessions may be conducted over commercially available video services and are not limited to any particular video service or methodology. The clinician interface and video session are construed accordingly as encompassing generic computing devices and video communications.
The above elements amount to mere instructions to implement the abstract idea using computing elements as tools. For example, the processor and memory are each only recited at a high level of generality as used to perform data processing functions and to store executable instructions and are disclosed as encompassing generic forms of computing elements. The computing device, patient interface, and clinician interface are likewise only recited at a high level of generality as used to conduct the video session and receive input from the users, and are disclosed as encompassing generic forms of computing elements. These elements are therefore not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 16 and 22 only recite the processor, memory, video session, clinician interface, computing device associated with the patient, and patient interface as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 17 recites determining whether to unlock the vial is based on whether, after a prior distribution of a dose of the consumable, a weight of the consumable in the vial or an amount of the consumable correspond to expected amounts. These limitations fall within the scope of the abstract idea as set out above.
Claim 18 recites the additional elements of a client side portal in communication with at least one of the at least one processor, a sensor reader, or the vial.
As cited above, figure 1 element 102 and paragraph 39 describe a clinician and client side portal as “any computer or smart device that allows for video conferences and an interface to issue and receive commands,” such as a standard internet browser on a computer, and that “any type of computer portal may be used.” Paragraphs 31, 84, and 87 describe the system elements as including servers and computing devices comprising processors such as CPUs. The client side portal and processors are construed accordingly as encompassing generic computing elements.
Paragraphs 42, 45, and 65 describe the sensor reader as a sensor which detects an ingestion signal from a consumable. The sensor reader is construed accordingly as encompassing generic forms of signal reading devices.
Paragraphs 47, 57, 69, 71, and 73 describe various types and embodiments of vials as storing a quantity of consumables. While the above paragraphs describe different potential embodiments as having components such as a built-in scale and electronic lock, the vial is disclosed as not requiring specific or any of the disclosed features. The vial is therefore construed as encompassing a generic electronic container capable of communication.
The above elements only amount to instructions to implement the abstract idea using computing elements as tools. For example, the client interface is only recited at a high level of generality as “in communication with” at least one of the processor, a sensor reader, and vial, and each of these elements is likewise only recited at a high level of generality as capable of communicating with the client side portal. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 19 recites wherein the consumable is an orally consumed medication. These limitations fall within the scope of the abstract idea as set out above.
Claim 19 recites the additional element of an ingestion sensor responsive to a presence of stomach contents.
Paragraphs 42, 44, and 65 state that “[e]ach sensor 114 is configured to detect contact with stomach contents, and to transmit an ingestion confirmation signal in response thereto,” and that “[w]hen consumable 112 is digested to the point that sensor 114 is exposed to stomach contents, sensor 112 detects the stomach contents and issues a corresponding ingestion confirmation signal.” The ingestion sensor is construed as encompassing any sensing element which is responsive to a presence of stomach contents.
The recited ingestion sensor only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the ingestion sensor is only recited at a high level of generality as “responsive to a presence of stomach contents” and similarly disclosed broadly in terms of its function of detecting the presence of stomach contents. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 20 and 33 recite wherein the vial includes manual tamper detection. These limitations fall within the scope of the abstract idea as set out above.
Claims 21 and 34 recite storing at least one of the report or the session.
Claims 21 and 34 further describe the additional elements of the session being a video session and the storing being uploading to a database.
As cited above, paragraphs 39 and 51 describe a clinician side portal as “any computer or smart device that allows for video conferences” and that video sessions may be conducted over commercially available video services and are not limited to any particular video service or methodology. The video session is construed accordingly as encompassing generic video communications.
Paragraphs 81 and 86 describe relaying “all necessary data to the web server for automatic logging” and that “the Web server can run any of a variety of server or mid-tier applications, including HTTP servers, FTP servers, CGI servers, data servers, Java servers, and business application servers.” Paragraph 13 similarly states that “patient-facing and physician-facing interfaces may access a common cloud database to log and view medication use and compliance data.” The database is construed as encompassing generic computer storage devices.
The above elements only amount to instructions to implement the abstract idea using computing elements as tools. For example, the video session is only recited at a high level of generality, while the database and uploading are likewise only recited at a high level of generality as used to store the report and video session while being disclosed as using general-purpose computing elements. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 23 recites authorizing dispensing of the dose from the vial by sending an authorization signal. These limitations fall within the scope of the abstract idea as set out above.
Claim 23 further recites the additional element of the vial receiving the authorization signal.
As cited above, paragraphs 47, 57, 68, 69, 71, and 73 describe various types and embodiments of vials as storing a quantity of consumables. While the above paragraphs describe different potential embodiments, the vial is disclosed as not requiring specific or any of the disclosed features. The vial is therefore construed as encompassing a generic electronic container capable of communication.
The above element only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the vial is recited at a high level of generality as receiving the authorization signal, and is disclosed broadly. The vial receiving the authorization signal is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 24 recites the additional elements of the vial having an electronic lock, the electronic lock operable to convert from a locked configuration to an unlocked configuration when the authorization signal is received by the electronic lock.
Paragraph 48 states that the vial has “some type of electronic lock,” paragraph 57 provides that “[i]f vial 110 includes a cap with an electronic lock, then the authorization may include the clinician sending an unlock signal to vial 110… receipt of which unlocks vial 110 and subsequent can be opened by the patient.” Paragraph 68 further states that the vial “may include…electronic lock 406 that is operable to be converted from a locked configuration, with a cap of the vial 110 unable to be removed, to an unlocked configuration, with the cap of the vial 110 able to be removed, when the authorization signal is received by the electronic lock.” However, the disclosure does not further describe the lock or cap structure beyond its functionality of preventing access when locked and the capability to be unlocked via a received signal. Given the breadth of disclosure and high-level recitation as unlocking when an authorization signal is received, the electronic lock is construed as encompassing any form of electronic locking device.
The above elements only amount to instructions to implement the abstract idea using computing elements as tools. As noted above, the electronic lock itself is only recited at a high level of generality as operable to convert from a locked configuration to an unlocked configuration when an authorization signal is received, and is only broadly described in the disclosure as an electronic lock having this functionality. Based on this, the vial having an electronic lock is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 25 recites wherein the vial is operable to dispense the dose of the consumable when the authorization signal is received. These limitations fall within the scope of the abstract idea as set out above. Examiner notes that the claim does not positively recite the authorization signal controlling the vial to dispense the dose of the consumable.
Claim 25 further recites the additional element of the vial receiving the authorization signal.
As cited above, paragraphs 47, 57, 68, 69, 71, and 73 describe various types and embodiments of vials as storing a quantity of consumables. While the above paragraphs describe different potential embodiments, the vial is disclosed as not requiring specific or any of the disclosed features. The vial is therefore construed as encompassing a generic electronic container capable of communication.
The above element only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the vial is recited at a high level of generality as receiving the authorization signal, and is disclosed broadly. The vial receiving the authorization signal is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 26 recites measuring a characteristic of the consumable in the vial; and declining to authorize remote distribution of the dose in response to the characteristic of the consumable in the vial being different from an expected characteristic of the consumable. These limitations fall within the scope of the abstract idea as set out above.
Claim 27 recites wherein the characteristic is at least one of a weight of the consumable in the vial or an amount of the consumable in the vial. These limitations fall within the scope of the abstract idea as set out above.
Claim 28 recites measuring the weight of the consumable in the vial, and declining to authorize remote distribution of the dose in response to the weight of the consumable in the vial, or an amount of the consumable in the vial as determined from the weight, being different than a predetermined value. These limitations fall within the scope of the abstract idea as set out above.
Claim 28 further recites the additional element of the vial including an integrated scale used to measure a weight of a consumable in the vial.
Paragraphs 47, 60, and 68 each describe the vial as including a scale which measures the weight of pills in the vial. However, no further disclosure of the scale itself beyond its function of measuring the weight of pills within the container is provided. The scale is therefore construed as encompassing a generic scale component.
The recited scale only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the integrated scale is recited at a high level of generality as integrated in the vial and used to measure the weight of the consumable, and is likewise only disclosed broadly as a scale used to perform that function. The integrated scale is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 29 recites wherein the vial has tamper detection, and declining to authorize remote distribution of the dose in response the tamper detection identifying that the vial has been tampered with. These limitations fall within the scope of the abstract idea as set out above.
Claim 29 recites the additional element of the tamper detection being tamper detection circuitry.
Paragraph 68 states that the vial may include tamper detection circuitry. Paragraph 72 further states that “[t]amper detection for vial 110 may come in a variety of forms. By way of non-limiting example, the interior of vial 110 could include a light sensor that activates in the presence of external light. Another example is an electronic integrity circuit that breaks when the vial is opened. The present inventive concept is not limited to any particular type of tamper detection.” The tamper detection circuitry is therefore construed as encompassing any such form of circuitry.
The recited tamper detection circuitry only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the tamper detection circuitry is only recited at a high level of generality as part of the vial and as used identify that the vial has been tampered with, and is likewise expressly disclosed broadly as not limited to any particular type of tamper detection. The tamper detection circuitry is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 30 recites determining, based on receipt of confirmation of ingestion of multiple consumables, that the patient consumed an amount of the consumable in excess of the dose. These limitations fall within the scope of the abstract idea as set out above.
Claim 30 recites the additional element of each consumable having an ingestion sensor used to determine ingestion of each consumable.
Paragraphs 42, 44, 46, and 65 describe the ingestion sensor as a sensor triggered by digestion, with a non-limiting example being detection of stomach contents. Given the breadth of the ingestion sensor’s recitation and scope of disclosure, the ingestion sensor is construed as encompassing a generic sensing element which can determine ingestion.
The recited ingestion sensor only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the ingestion sensor is only recited at a high level of generality in the context of each consumable having an ingestion sensor and similarly disclosed broadly in terms of its function of determining ingestion of a consumable. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 31 recites in response to the patient consuming the amount of the consumable in excess of the dose: contacting emergency services; sending instructions to the patient to administer an antidote; and contacting a contact of the patient. These limitations fall within the scope of the abstract idea as set out above.
Claim 32 recites declining to authorize remote distribution of the dose in response to a failure to receive, for a prior dose of the consumable, an ingestion confirmation for the prior dose. These limitations fall within the scope of the abstract idea as set out above.
Claim 32 further recites the additional element of each consumable having an ingestion sensor that issues an ingestion confirmation signal triggered by digestion of the consumable.
Paragraphs 42, 44, 46, and 65 describe the ingestion sensor as a sensor triggered by digestion, with a non-limiting example being detection of stomach contents. Given the breadth of the ingestion sensor’s recitation and scope of disclosure, the ingestion sensor is construed as encompassing a generic sensing element which issues a signal upon digestion.
The recited ingestion sensor and signal only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the ingestion sensor itself is only recited at a high level of generality in terms of its function of issuing a signal when it detects digestion of the consumable and as used to determine whether the prior dose was ingested, and is similarly disclosed broadly in terms of its function of determining ingestion of a consumable. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 35 recites wherein the one or more messages include instructions to take the dose. These limitations fall within the scope of the abstract idea as set out above.
Claim 35 recites the additional element of the computing devices as receiving the one or more messages.
Figure 1 element 106 and paragraphs 40 and 71 describe a patient side portal as “any computer or smart device that allows video conferences and an interface to issue and receive commands,” such as an app running on a cell phone, and that “any type of computer portal may be used.” The computing device associated with the patient is construed accordingly as encompassing generic computing devices and interface components.
The recited computing device only amounts to instructions to implement the abstract idea using computing elements as tools. Specifically, the computing devices is recited at a high level of generality as receiving the messages and is disclosed broadly. The recited computing device is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 16-35 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 35 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.
Claim 35 recites the limitation "the one or more messages to the computing device" in line 1. There is insufficient antecedent basis for this limitation in the claim because while the claim previously recites a computing device and one or more messages outputted on a patient interface, it does not previously recite the one or more messages as “to the computing device” or the patient interface as presented on the computing device.
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)(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 16, 18, 21-25, and 34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pavlovic et al (US Patent Application Publication 2015/0061832).
With respect to claim 16, Pavlovic discloses the claimed system comprising:
at least one processor and a memory storing instructions that when executed by the at least one processor ([13] describes the disclosed functions as performed using a processor executing instructions stored on a computer readable medium) causes the system to:
generate a clinician interface, the clinician interface outputting a video session capturing dispensing and consumption of a dose of a consumable from a vial by a patient ([15]-[17], [19], and [29] describe a clinician device which displays video of the patient removing a dose of medication from a vial and swallowing the dose. Examiner notes paragraphs 40 and 69-71 of Applicant’s specification stating that the vial may be structured as an integrated series of compartments and/or integrated with the patient computing device), the video session captured by a computing device associated with the patient ([8], [15], [16], and [29] describe the patient device capturing the video), the video session initiated based on input data obtained by the computing device ([29] describes the patient initiating the session by selecting a button on the patient computing device);
generate a patient interface, the patient interface outputting one or more messages during the video session ([29] describes the clinician communicating with the patient during the video session, such as by asking the patient questions, which is construed as the patient interface outputting verbal/visual messages);
terminate the video session ([29] describes terminating the video connection); and
generate a report based on the consumption of the dose ([18], [21], and [29] describe the system recording the video of the patient taking the dose and storing the video along with additional metadata).
With respect to claim 18, Pavlovic discloses the system of claim 16. Pavlovic further discloses:
a client side portal in communication with at least one of the at least one processor, a sensor reader, or the vial (Figure 1 elements 12-14, [15], [17], [19], and [29] describe a clinician device and interface which performs functions including displaying video of the patient and receiving inputs from the clinician. Examiner notes paragraph 39 of Applicant’s specification in which element 102 refers to both the clinician side portal and client side portal and in combination with paragraph 31 which describe the client side portal as part of a central monitoring location for provider-side operations).
With respect to claim 21, Pavlovic discloses the system of claim 16. Pavlovic further discloses, wherein the memory stores instructions that when executed by the at least one processor further causes the system to:
uploading at least one of the report or the video session to a database ([18], [21], and [29] describe the system recording the video of the patient taking the dose and storing the video along with additional metadata).
With respect to claim 22, Pavlovic discloses the claimed method to dispense a consumable, the method comprising:
initiating a video session based on input data obtained by a computing device associated with a patient ([15], [16], and [29] describe a video session initiated by a patient selecting a button on a patient computing device), the video session capturing dispensing and consumption of a dose of a consumable from a vial by the patient ([15]-[17], [19], and [29] describe a clinician device which displays video of the patient removing a dose of medication from a vial and swallowing the dose. Examiner notes paragraphs 40 and 69-71 of Applicant’s specification stating that the vial may be structured as an integrated series of compartments and/or integrated with the patient computing device), the video session captured by the computing device ([8], [15], [16], and [29] describe the patient device capturing the video);
generating a clinician interface, the clinician interface outputting the video session ([15]-[17], [19], and [29] describe the clinician device displaying the video of the patient);
generating a patient interface, the patient interface outputting one or more messages during the video session ([29] describes the clinician communicating with the patient during the video session, such as by asking the patient questions, which is construed as the patient interface outputting verbal/visual messages);
terminating the video session ([29] describes terminating the video connection); and
generating a report based on the consumption of the dose ([18], [21], and [29] describe the system recording the video of the patient taking the dose and storing the video along with additional metadata).
With respect to claim 23, Pavlovic discloses the method of claim 22. Pavlovic further discloses:
authorizing dispensing of the dose from the vial by sending an authorization signal to the vial ([17], [19], [20], and [29] describe the system unlocking the medication dispensing device by sending an authorization signal to the medication dispensing device, i.e. authorizing dispensing of the dose).
With respect to claim 24, Pavlovic discloses the method of claim 23. Pavlovic further discloses:
wherein the vial has an electronic lock, the electronic lock operable to convert from a locked configuration to an unlocked configuration when the authorization signal is received by the electronic lock ([17], [19], [20], and [29] describe the system unlocking the medication dispensing device by sending an authorization signal to the medication dispensing device).
With respect to claim 25, Pavlovic discloses the method of claim 23. Pavlovic further discloses:
wherein the vial is operable to dispense the dose of the consumable when the authorization signal is received by the vial ([17], [19], [20], and [29] describe the system unlocking the medication dispensing device by sending an authorization signal to the medication dispensing device followed by the patient removing and swallowing a dose of the medication).
Claim 34 recites limitations similar to those recited in claim 21, and is rejected on the same grounds set out above with respect to claim 21.
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.
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 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pavlovic et al (US Patent Application Publication 2015/0061832) as applied to claim 16 above, and further in view of Euliano et al (US Patent Application Publication 2018/0132784).
With respect to claim 19, Pavlovic discloses the system of claim 16. Pavlovic further discloses:
wherein the consumable is an orally consumed medication ([22] and [29] describe the patient swallowing the medication).
but does not expressly disclose:
an ingestion sensor responsive to a presence of stomach contents.
However, Euliano teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to include an ingestion sensor responsive to a presence of stomach contents ([48], [72], [78], and [88] describe an orally consumed medication incorporating a sensor responsive to stomach contents).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to include an ingestion sensor responsive to a presence of stomach contents as taught by Euliano since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses tracking whether a patient has swallowed an oral medication, and including an ingestion sensor responsive to a presence of stomach contents as taught by Euliano would serve that same function in Pavlovic, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims 20, 26, 29, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Pavlovic et al (US Patent Application Publication 2015/0061832) as applied to claim 16 and 22 above, and further in view of Valentine (US Patent Application Publication 2021/0319872).
With respect to claim 20, Pavlovic discloses the system of claim 16. Pavlovic does not expressly disclose wherein the vial includes manual tamper detection.
However, Valentine teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to include manual tamper detection in a medication vial (Figures 2 and 29, [43], [77], [372], and [519] describe a medication dispensing vial incorporating sensors to detect manual tampering by a user).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to include manual tamper detection in a medication vial as taught by Valentine since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses a medication vial, and having the vial include manual tamper detection as taught by Valentine would serve that same function in Pavlovic as in Valentine, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 26, Pavlovic discloses the method of claim 22. Pavlovic does not expressly disclose measuring a characteristic of the consumable in the vial; and declining to authorize remote distribution of the dose in response to the characteristic of the consumable in the vial being different from an expected characteristic of the consumable.
However, Valentine teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to measure a characteristic of a consumable in a vial and decline to authorize remote distribution of a dose in response to the characteristic of the consumable in the vial being different from an expected characteristic of the consumable (Figures 11 and 18A, [43], [48], [296]-[298], and [372] describe measuring characteristics of the consumables including whether they have been stored at a correct temperature and humidity, and refusing to dispense a dose if those values deviate from expected values).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to include manual tamper detection in a medication vial as taught by Valentine since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses determining whether to authorize a remote distribution of a consumable from a vial, and measuring a characteristic of a consumable in the vial and declining to authorize remote distribution of a dose in response to the characteristic of the consumable in the vial being different from an expected characteristic of the consumable as taught by Valentine would serve that same function in Pavlovic, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 29, Pavlovic discloses the method of claim 22. Pavlovic does not expressly disclose wherein the vial has tamper detection circuitry; the method further comprising: declining to authorize remote distribution of the dose in response the tamper detection circuitry identifying that the vial has been tampered with.
However, Valentine teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to include tamper detection circuitry in a medication vial and to decline to authorize remote distribution of a dose in response the tamper detection circuitry identifying that the vial has been tampered with (Figures 2 and 29, [77], [372], [519], and [521] describe a medication dispensing vial incorporating sensors to detect tampering by a user as well as locking the drug dispenser and alerting a third party if tampering is detected).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to include tamper detection circuitry in a medication vial and to decline to authorize remote distribution of a dose in response the tamper detection circuitry identifying that the vial has been tampered with as taught by Valentine since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses a medication vial as well as declining to authorize dispensing, and having the vial include tamper detection circuitry and declining to authorize remote distribution of a dose in response the tamper detection circuitry identifying that the vial has been tampered with as taught by Valentine would serve the same function in Pavlovic as in Valentine, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 33 recites limitations similar to those recited in claim 20, and is rejected on the same grounds set out above with respect to claim 20.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Pavlovic et al (US Patent Application Publication 2015/0061832) as applied to claim 22 above, and further in view of Einav et al (US Patent Application Publication 2011/0163871).
With respect to claim 30, Pavlovic discloses the method of claim 22. Pavlovic does not expressly disclose wherein each consumable has an ingestion sensor; and the method further comprising: determining, based on receipt of confirmation of ingestion from multiple ingestion sensors, that the patient consumed an amount of the consumable in excess of the dose.
However, Einav teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention for each consumable to have an ingestion sensor and to determine, based on receipt of confirmation of ingestion from multiple ingestion sensors, that the patient consumed an amount of the consumable in excess of the dose ([7] and [14]-[17] describe a plurality of pills having sensors detecting ingestion by a patient and issuing an alert if the system detects that the patient has ingested an excessive number of pills).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to have each consumable include an ingestion sensor and to determine, based on receipt of confirmation of ingestion from multiple ingestion sensors, that the patient consumed an amount of the consumable in excess of the dose as taught by Einav since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses a plurality of consumables as well as whether a patient has taken an incorrect number of pills (see e.g. [22]), and having each consumable include an ingestion sensor and determining that the patient consumed an amount of the consumable in excess of the dose based on receipt of confirmation of ingestion from multiple ingestion sensors as taught by Einav would serve that same function in Pavlovic, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Pavlovic et al (US Patent Application Publication 2015/0061832) and Einav et al (US Patent Application Publication 2011/0163871) as applied to claim 30 above, and further in view of Kiani et al (US Patent Application Publication 2019/0374713).
With respect to claim 31, Pavlovic/Einav teach the method of claim 30. Pavlovic does not expressly disclose, in response to the patient consuming the amount of the consumable in excess of the dose: contacting emergency services; sending instructions to the patient to administer an antidote; and contacting a contact of the patient.
However, Einav teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to contact a contact of a patient in response to determining that the patient consumed an amount of the consumable in excess of a dose ([7] and [14]-[17] describe sending an alert to a caregiver if the system detects that the patient has ingested an excessive number of pills).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the combination of Pavlovic and Einav to contact a contact of a patient in response to determining that the patient consumed an amount of the consumable in excess of the dose as taught by Einav since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Pavlovic and Einav already teaches contacting a third party in response to determining that a patient has taken an incorrect number of pills (see e.g. [22]), and contacting a contact of a patient in response to determining that the patient consumed an amount of the consumable in excess of the dose as taught by Einav would serve that same function in Pavlovic and Einav, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Kiani further teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to contact emergency services and send instructions to the patient to administer an antidote in response to determining that the patient consumed an amount of the consumable in excess of a dose ([96], [99], [138], and [199] describe contacting emergency services and sending a notification to the user’s mobile device to administer naloxone in response to determining that a user is about to overdose or is overdosing).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the combination of Pavlovic and Einav to contact emergency services and send instructions to the patient to administer an antidote in response to determining that the patient consumed an amount of the consumable in excess of a dose as taught by Kiani since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case the combination of Pavlovic and Einav already teaches determining that the patient has consumed an amount of a consumable in excess of a dose as well as contacting third parties, and further contacting emergency services and sending instructions to the patient to administer an antidote as taught by Kiani would serve that same function in Pavlovic and Einav, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Pavlovic et al (US Patent Application Publication 2015/0061832) as applied to claim 22 above, and further in view of Koester et al (US Patent Application Publication 2016/0259911).
With respect to claim 35, Pavlovic discloses the method of claim 22. Pavlovic does not expressly disclose wherein the one or more messages to the computing device include instructions to take the dose.
However, Koester teaches that it was old and well known in the art of patient medication monitoring before the effective filing date of the claimed invention to provide a patient with a message to take a dose of medication ([13]-[15], [28], and [32] describe a medication monitoring system where a remote individual instructs a patient to take a dose of medication during a session).
Therefore it would have been obvious to one of ordinary skill in the art of patient medication monitoring before the effective filing date of the claimed invention to modify the system of Pavlovic to provide a patient with a message to take a dose of medication as taught by Koester since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Pavlovic already discloses a patient interface outputting messages during a video session, and having the messages include instructions to take the dose as taught by Koester would serve that same function in Pavlovic, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims not Presently Rejected Under 35 USC 102/103
Claims 17, 27, 28, and 32 are not presently rejected under 35 USC 102/103 in light of the closest prior art of record.
Conclusion
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