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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-18 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more, wherein the abstract idea comprises a mental process of optimizing an alert based on history and condition.
For independent claim 1, the claim(s) recite(s) a process of receiving analyte measurements, determining a unique identifier, comparing the unique identifier to historical unique identifiers, and conditionally suppressing an alert based on the comparing.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to is an alert should not be issued based on historical comparison. Assuming arguendo that issuing an alert was positively recited and/or required, this could be done verbally and/or via pen and paper.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps of receiving data are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity
Additionally, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the generic recitation of a “first device”, which receives, determines, compares, and conditionally suppresses alert, is well-known, routine and conventional amounting to insignificant generic data reception and manipulation structure(s).
Depending claims 2-18 inherit and do not remedy the non-statutory deficiency noted above. Despite further specifying steps relating to determining, conditionally suppressing, allowing presentation of alert, determining user response to alert, escalating notification(s) and/or urgency, clearing alerts or setting/resetting timers, the additional steps do not integrate into a practical application nor amount to significantly more than the abstract idea. The positive recitation of a second device suffers similar as above and fails to amount to significantly more than the abstract idea.
For independent claim 20, the claim(s) recite(s) a computer programmed code executed method including the process of receiving analyte measurements, determining a unique identifier, comparing the unique identifier to historical unique identifiers, and conditionally suppressing an alert based on the comparing.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to is an alert should not be issued based on historical comparison. Assuming arguendo that issuing an alert was positively recited and/or required, this could be done verbally and/or via pen and paper.
Although the judicial exception is arguably integrated into a practical application of a special purpose computer, the claimed steps achieve no practical result because alerts are not issued and are instead only conditionally suppressed.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stadler et al. (WO 2022/191963 A1, hereinafter Stadler).
For claim 1, Stadler discloses a method of alert optimization (Figs 1-5) ([0018-0150]), the method comprising inter alia:
receiving, at a first device (20), one or more analyte measurements produced by an analyte sensor worn by a patient (10) (Figs 1-5) ([0002, 0018-0150, especially 0102]);
determining, at the first device, a first unique identifier for a first alert based on the one or more analyte measurements (via 238) (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]);
comparing, at the first device, the first unique identifier for the first alert to a stored record comprising unique identifiers for historical alerts (via 230) (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); and
conditionally suppressing the first alert on the first device based on the comparing (via 234) (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 2, Stadler discloses the method of claim 1, wherein the determining the first unique identifier comprises deterministically generating the first unique identifier based on a type of the first alert and a time associated with at least one of the one or more analyte measurements (via 238) (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 3, Stadler discloses the method of claim 1, wherein the conditionally suppressing comprises suppressing the first alert responsive to a determination that the first unique identifier matches at least one of the unique identifiers for historical alerts (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 4, Stadler discloses the method of claim 1, further comprising determining that criteria associated with a type of the first alert is satisfied (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]), wherein the determining of the first unique identifier is performed responsive to the determining that the criteria is satisfied (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 5, Stadler discloses the method of claim 1, wherein: the conditionally suppressing comprises allowing presentation of the first alert at the first device responsive to a determination that the first unique identifier does not match any of the unique identifiers for historical alerts (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]), and the method further comprises updating the stored record to include the first unique identifier in the unique identifiers for historical alerts (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 6, Stadler discloses the method of claim 5, further comprising: receiving, at the first device, an alert notification from a second device (42), the alert notification comprising a second unique identifier for a second alert (Figs 1-5) ([0002, 0018-0150]); comparing, at the first device, the second unique identifier to the updated stored record (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); and suppressing the second alert responsive to a determination that the second unique identifier matches the first unique identifier (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 7, Stadler discloses the method of claim 5, further comprising: receiving, at the first device, an alert notification from a second device(42), the alert notification comprising a second unique identifier for a second alert (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); comparing, at the first device, the second unique identifier to the updated stored record (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); and allowing presentation of the second alert at the first device responsive to a determination that the second unique identifier for the second alert does not match any of the unique identifiers for historical alerts (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 8, Stadler discloses the method of claim 5, further comprising: determining a user response to the first alert (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); and updating a state of the first alert in the stored record based on the determined user response (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 9, Stadler discloses the method of claim 8, wherein the user response comprises at least one of a user acknowledgement of the first alert or an indication of treatment in response to the first alert (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 10, Stadler discloses the method of claim 8, further comprising notifying at least one of a second device or a remote target of the updated state of the first alert (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 11, Stadler discloses the method of claim 10, wherein the notifying further comprises notifying the second device of an elevated urgency associated with the first alert to overcome a do-not-disturb mode at the second device (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 12, Stadler discloses the method of claim 8, further comprising caching the updated state of the first alert for later transmission to a second device responsive to a determination that the first device is not currently connected to the second device (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 13, Stadler discloses the method of claim 12, further comprising notifying the second device of the updated state of the first alert responsive to a determination that a connection with the second device has been reestablished (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 14, Stadler discloses the method of claim 1, further comprising: receiving, from a second device, a notification of an updated alert state related to the first alert, the notification comprising the first unique identifier (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]); and updating, at the first device, the stored record based on the updated alert state (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 15, Stadler discloses the method of claim 14, wherein the updating comprising updating a state of the first alert in the stored record based on the updated alert state (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 16, Stadler discloses the method of claim 14, wherein the updating comprises clearing the first alert in the stored record (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 17, Stadler discloses the method of claim 14, further comprising, responsive to the updated alert state, resetting a timer for presenting the first alert at the first device (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 18, Stadler discloses the method of claim 17, wherein the resetting comprises resetting the timer to correspond to a timestamp associated with the updated alert state (Figs 1-5) ([0018-0150,especially 0038-42, 0101-0102,0118-0123, 0135]).
For claim 19, Stadler discloses a system for alert optimization, comprising inter alia:
an analyte sensor (10) configured to generate measurements associated with an analyte level of a patient (Figs 1-5) ([0002, 0018-0150, especially 0102]);
a device (20) in data communication with the analyte sensor (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]) and configured to:
receive one or more analyte measurements produced by the analyte sensor (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]);
determine a unique identifier for a first alert based on the one or more analyte measurements (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]);
compare the unique identifier for the first alert to a stored record comprising unique identifiers for historical alerts (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]); and
conditionally suppress the first alert on the device based on the comparing (Figs 1-5) ([0002, 0018-0150, especially 0126-0135]).
For claim 20, Stadler discloses a computer-program product comprising a non-transitory computer-usable medium having computer-readable program code embodied therein, the computer-readable program code adapted to be executed to implement a method of alert optimization, the method comprising inter alia:
receiving one or more analyte measurements produced by an analyte sensor worn by a patient (Figs 1-5, especially 4-5) ([0002, 0018-0150, especially 0126-0135]);
determining a unique identifier for a first alert based on the one or more analyte measurements (Figs 1-5, especially 4-5) ([0002, 0018-0150, especially 0126-0135]);
comparing the unique identifier for the first alert to a stored record comprising unique identifiers for historical alerts (Figs 1-5, especially 4-5) ([0002, 0018-0150, especially 0126-0135]); and
conditionally suppressing the first alert on a device based on the comparing (Figs 1-5, especially 4-5) ([0002, 0018-0150, especially 0126-0135]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for processing and alerting based on conditions of analyte measurement
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights