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 .
DETAILED ACTION
The present office action represents the first action on the merits.
Claims 1-20 are pending.
Priority
This application claims priority to U.S. Patent Application No. 16/944,069 dated 30 July 2020.
Information Disclosure Statement
The three (3) Information Disclosure Statement(s) (lDSs) submitted on 09 September 2025, 24 February 2026 and 31 March 2026 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
The information disclosure statement filed 06 August 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the translated copy of the Chinese Office Action is unreadable (poor quality copy and tiny font).
Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Notice to Applicant
The Examiner has rejected the claims as not being subject matter eligible because the recitation of (Claim 1 being representative) “automatically configuring, via a non-medical device, the medical device…causing, via the non-medical device, the medical device to deliver insulin” are interpreted to encompass a person causing the medical device to deliver insulin using the non-medical device and the settings. The “via” implies that the non-medical device is being used as a tool by a human to implement the results of the abstraction. This constitutes an “apply it” step, i.e., applying the results of the abstraction. This interpretation is supported by Spec. Para. 0098.
The Examiner suggests positively reciting that the one or more processors of a cloud-based server device (or processor / CRM of Claim 10) causes the non-medical device to both configure and control the medical device (and the second medical device of Claim 19). The Examiner notes that for Claim 10, the “wherein” clause at the end appears to be an intended use of the configuring step and should be positively recited per the above suggestion.
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 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.
Claims 1, 10, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method or processor-readable medium (“CRM”), which are within a statutory category.
Step 2A1
The limitations of (Claim 1 being representative) receiving patient data; obtaining, and based on the patient data, a value of a total daily dose of insulin for the specific patient; automatically selecting, before the medical device has been set up to deliver insulin to the specific patient, a therapy configuration for the medical device from a plurality of therapy configurations based upon at least the patient data; determining, upon selecting the therapy configuration, a set of therapy settings for the selected therapy configuration for the specific patient based upon the value of the total daily dose, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to determine insulin pump therapy settings (see Spec. Para. 0007 describing insulin pump configuration as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receiving …selecting …and, determining” as indicated supra.
Other than reciting generic computer components (discussed infra), the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements (Claims 1 and 19) one or more processors of a cloud-based server device and (Claim 10) at least one processor device and a non-transitory processor-readable medium that implements the identified abstract idea. These items are not described by the applicant and is recited at a high-level of generality (i.e., a generic server or computer) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims further recite one or more of the additional elements of (Claim 19 being representative) “automatically configuring, via a non-medical device, the first medical device with the set of therapy settings in a startup mode to complete set up of the first medical device before using the first medical device for insulin delivery for the specific patient; causing, via the non-medical device, the first medical device to deliver insulin to the specific patient based on the set of therapy settings; and automatically configuring a second medical device, different from the first medical device, to be used by the specific patient, using the selected therapy configuration and the set of therapy settings used by the first medical device.” The configuring and causing steps equate to an application of the abstract idea (i.e., “apply it” steps). These Steps are discussed in the Specification as being performed by a user rather than the server or processor/CRM. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
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 (Claims 1 and 19) one or more processors of a cloud-based server device and (Claim 10) at least one processor device and a non-transitory processor-readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “automatically configuring, via a non-medical device, the first medical device with the set of therapy settings in a startup mode to complete set up of the first medical device before using the first medical device for insulin delivery for the specific patient; causing, via the non-medical device, the first medical device to deliver insulin to the specific patient based on the set of therapy settings; and automatically configuring a second medical device, different from the first medical device, to be used by the specific patient, using the selected therapy configuration and the set of therapy settings used by the first medical device” were determined to represent “apply it” steps. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). The Examiner also notes that the Specification at Para. 0003-0008 appears to indicate that the features are well-understood, routine, and conventional in the field. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2-9, 11-18, and 20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 11 merely describe(s) generating and transmitting data, which further defines the abstract idea.
Claim(s) 3, 12 merely describe(s) selecting data, which further defines the abstract idea.
Claim(s) 4, 13 merely describe(s) the type of data selected, which further defines the abstract idea.
Claim(s) 5, 14 merely describe(s) the patient data and how it is obtained, which further defines the abstract idea.
Claim(s) 6, 7, 8, 15, 16, 17, 20 merely describe(s) the therapy settings, which further defines the abstract idea.
Claim(s) 9, 19 merely describe(s) data that is received, which further defines the abstract idea.
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.
Claims 3, 4, 12, and 13 are 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 pre-AIA the applicant regards as the invention.
Claims 3 and 12 recites “wherein automatically selecting a therapy configuration comprises automatically selecting a type of control algorithm or software.” The claim is indefinite because it can be read two different ways which affects the scope of the claim. It is unclear whether “a type of” applies to both the control algorithm and the software, or just the control algorithm. The disclosure does not provide any clarity (see Spec. Para. 00107, 00118) as the only discussion of “type” is in reference to “therapy type.” For the purposes of examination, the Examiner interprets the claim to state: selecting (1) a type of control algorithm or (2) software.
By virtue of their dependence from Claim 3 or 12, this basis of rejection also applies to dependent Claims 4 and 13.
Claim Rejections - 35 USC § 103
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 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.
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 of this title, 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 sHill not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 10-15 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Hill (U.S. Pre-Grant Patent Publication No. 2011/0098637) in view of Cronin et al. (U.S. Pre-Grant Patent Publication No. 2020/0265951).
REGARDING CLAIM 1
Hill teaches the claimed method for configuring therapy settings of a medical device for a specific patient, the method comprising:
receiving patient data […]; [Para. 0158 teaches that body weight (patient data) is received as part of setting up an insulin infusion device via a Start-up Wizard.]
obtaining, […] and based on the patient data, a value of a total daily dose of insulin for the specific patient; [Para. 0160 teaches that the patient’s total daily dose of insulin (TDD) is determined based on their body weight.]
automatically selecting […] before the medical device has been set up to deliver insulin to the specific patient, a therapy configuration for the medical device from a plurality of therapy configurations based upon at least the patient data; [Para. 0158 teaches that the Start-Up wizard programs the insulin infusion pump with initial settings for the patient to begin using the insulin pump. Para. 0165 teaches that any percentage of the patient’s TDD (75% to 100%; a therapy configuration) may be used to calculate the initial settings. Thus, there are a plurality of configurations, configurations that utilize both the patient’s weight and which correspond to TDDs ranging from 75% to 100%. And, the disclosure of Hill is setting up the infusion device prior to use.]
determining, […] and upon selecting the therapy configuration, a set of therapy settings for the selected therapy configuration for the specific patient based upon the value of the total daily dose; [Para. 0158, 0165 teaches that the Start-Up wizard programs the insulin infusion pump with initial settings for the patient to begin using the insulin pump.]
automatically configuring, via a non-medical device, the medical device with the set of therapy settings in a startup mode to complete set up of the medical device before using the medical device for insulin delivery for the specific patient; and [Para. 0158 teaches that the insulin pump is programmed via a controller/programmer (a non-medical device).]
causing, via the non-medical device, the medical device to deliver insulin to the specific patient based on the set of therapy settings. [Para. 0165, 0166 teaches that the insulin pump is used according to the settings (interpreted as causing delivery).
Hill may not explicitly teach that the setup wizard is performed
by one or more processors of a cloud-based server device
Cronin at Para. 0021, 0026, 0033 teaches that it was known in the art of computerized healthcare, at the time of filing, to determine an implement infusion pump settings at a cloud server
by one or more processors of a cloud-based server device [Cronin at Para. 0021, 0026, 0033 teaches determining and implementing infusion pump settings on a cloud-based server. Cronin at Para. 0026 also teaches that the recommendations (settings) are transmitted to a virtual infusion pump (on a smartphone, see Para. 0024) and then are downloaded to the infusion pump.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the infusion pump set-up wizard functionality of Hill to determine an implement infusion pump settings at a cloud server as taught by Cronin, with the motivation of improving patient treatment (see Cronin at Para. 0003).
REGARDING CLAIM 2
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin further teaches
further comprising generating a parameter load comprising information indicative of the selected therapy configuration and the set of therapy settings, [Cronin at Para. 0026 teaches that the recommendation (information indicative of the selected therapy configuration and the set of therapy settings) is created at the cloud server and is provided as instructions to the infusion pump. The provided instruction data is interpreted as “a parameter load.”]
wherein automatically configuring the medical device comprises transmitting, from the cloud based server device to the non-medical device, the generated parameter load. [Para. 0026 teaches that the virtual infusion pump (smartphone; the controller/programmer of Hill) downloads the instructions from the cloud server and provides them to the infusion pump.]
REGARDING CLAIM 3
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin further teaches
wherein automatically selecting a therapy configuration comprises automatically selecting a type of control algorithm or software. [Cronin at Para. 0026 teaches that instructions (software) is provided to the infusion pump, thus the instructions (software) is selected.]
REGARDING CLAIM 4
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claims 1 and 3.
wherein the type of control algorithm comprises an operating mode. [The Examiner notes that the “a type of control algorithm” was optional in Claim 3 (“or”; see also, 112(b) rejection) and that the option was not selected. As such, the Examiner declines to address this unselected option.]
REGARDING CLAIM 5
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin further teaches
wherein the patient data comprises a weight of the specific patient, and wherein obtaining the value of the total daily dose of insulin for the specific patient comprises computing the value of the total daily dose based on the weight of the specific patient. [Para. 0160 teaches that the patient’s total daily dose of insulin (TDD) is determined based on their body weight.]
REGARDING CLAIM 6
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin further teaches
wherein the set of therapy settings for the specific patient comprise:
a basal rate for the specific patient, [Para. 0163, 0166 teaches that a setting is basal rate.]
an insulin sensitivity factor for the specific patient, [Para. 0163, 0166 teaches that a setting is ISF.]
an insulin to carbohydrate ratio for the specific patient, [Para. 0163, 0166 teaches that a setting is I:C ratio.]
an active insulin time for the specific patient,
a maximum bolus limit for the specific patient,
a maximum basal rate for the specific patient,
a bolus increment for the specific patient,
a basal increment for the specific patient, or
combination thereof.
REGARDING CLAIM(S) 10
Claim(s) 10 is/are analogous to Claim(s) 1, thus Claim(s) 10 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
REGARDING CLAIM(S) 11-15
Claim(s) 11-15 is/are analogous to Claim(s) 2-6, thus Claim(s) 11-15 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2-6.
Claim(s) 7, 8, 16, 17, 19, and 20 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Hill (U.S. Pre-Grant Patent Publication No. 2011/0098637) in view of Cronin et al. (U.S. Pre-Grant Patent Publication No. 2020/0265951) in view of Estes et al. (U.S. Pre-Grant Patent Publication No. 2007/0124002).
REGARDING CLAIM 7
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin may not explicitly teach
wherein the patient data comprises therapy settings used by the specific patient on a previously used medical device, and
wherein the set of therapy settings are determined based on the therapy settings used by the specific patient on the previously used medical device.
Estes at Para. 0099, 0100, Claim 1 teaches that it was known in the art of computerized healthcare, at the time of filing, to transfer parameters from a current infusion pump to a new infusion pump
wherein the patient data comprises therapy settings used by the specific patient on a previously used medical device, and [Estes at Para. 0099, 0100 teaches that pump parameters (the settings of Hill) are transferred from a current pump to a new pump of a user (patient). Estes at Para. 0100 teaches that the transferred pump parameters include basal rate which Claim 6 defines as a setting.]
wherein the set of therapy settings are determined based on the therapy settings used by the specific patient on the previously used medical device. [Estes at Para. 0100 teaches that pump parameters (the settings of Hill) are transferred from a current pump to a new pump of a user (patient).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the infusion pump set-up wizard functionality of Hill having the determination of an implement infusion pump settings at a cloud server of Cronin to transfer parameters from a current infusion pump to a new infusion pump as taught by Estes, with the motivation of ensuring proper patient treatment (see Estes at Para. 0099).
REGARDING CLAIM 8
Hill/Cronin/Estes teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claims 1 and 7. Hill/Cronin/Estes further teaches
wherein the previously used medical device and the medical device are of different models. [Estes at Para. 0099 teaches that the new pump has a new pump mechanism as compared to the old pump. This is interpreted as the new pump being of a different model that the old/current pump.]
REGARDING CLAIM(S) 16 AND 17
Claim(s) 16 and 17 is/are analogous to Claim(s) 7 and 8, thus Claim(s) 16 and 17 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 7 and 8.
REGARDING CLAIM(S) 19
Claim(s) 10 is/are analogous to Claim(s) 1, thus Claim(s) 10 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
Hill/Cronin further teaches
using the selected therapy configuration and the set of therapy settings […]. [Hill at Para. 0165 teaches that the patient uses the infusion device using the settings.]
Hill/Cronin may not explicitly teach
automatically configuring a second medical device, different from the first medical device, to be used by the specific patient,
[…] used by the first medical device
Estes at Para. 0099, 0100, Claim 1 teaches that it was known in the art of computerized healthcare, at the time of filing, to transfer parameters from a current infusion pump to a new infusion pump
automatically configuring a second medical device, different from the first medical device, to be used by the specific patient, [Estes at Para. 0099, 0100 teaches that pump parameters (the settings of Hill) are transferred from a current pump (a first medical device) to a new pump (a second medical device) of a user (patient). Estes at Para. 0100 teaches that the transferred pump parameters include basal rate which Claim 6 defines as a setting.]
using the selected therapy configuration and the set of therapy settings used by the first medical device. [Estes at Para. 0100 teaches that pump parameters (the settings of Hill) are transferred from a current pump to a new pump of a user (patient).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the infusion pump set-up wizard functionality of Hill having the determination of an implement infusion pump settings at a cloud server of Cronin to transfer parameters from a current infusion pump to a new infusion pump as taught by Estes, with the motivation of ensuring proper patient treatment (see Estes at Para. 0099).
REGARDING CLAIM(S) 20
Claim(s) 20 is/are analogous to Claim(s) 8, thus Claim(s) 20 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 8.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Hill (U.S. Pre-Grant Patent Publication No. 2011/0098637) in view of Cronin et al. (U.S. Pre-Grant Patent Publication No. 2020/0265951) in view of Czerniecki et al. (U.S. Pre-Grant Patent Publication No. 2021/0375472).
REGARDING CLAIM 9
Hill/Cronin teaches the claimed method for configuring therapy settings of a medical device for a specific patient of Claim 1. Hill/Cronin may not explicitly teach
wherein the patient data is received from a second non-medical device, different from the medical device, and
wherein the second non-medical device is a computing device associated with a healthcare provider.
Czerniecki at Para. 0050 teaches that it was known in the art of computerized healthcare, at the time of filing, to receive patient weight data from a user device of a physician
wherein the patient data is received from a second non-medical device, different from the medical device, and [Czerniecki at Para. 0050 teaches receiving patient weight data (the weight data of Hill) from a user device of a physician (a second non-medical device; see Spec. Para. 0081). Czerniecki at Para. 0050 teaches that the patient condition is diabetes.]
wherein the second non-medical device is a computing device associated with a healthcare provider. [Czerniecki at Para. 0050 teaches that the user device is a smartphone of a physician (a healthcare provider).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, at the time of filing, to modify the infusion pump set-up wizard functionality of Hill having the determination of an implement infusion pump settings at a cloud server of Cronin to receive patient weight data from a user device of a physician as taught by Czerniecki, with the motivation of providing an improved individualized approach to decision-making and improved predictive data (see Czerniecki at Para. 0005).
REGARDING CLAIM(S) 18
Claim(s) 18 is/are analogous to Claim(s) 9, thus Claim(s) 18 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 9.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Campbell et al. (U.S. Pre-Grant Patent Publication No. 2005/0022274) which discloses an infusion pump control system that enters a set-up mode upon initial power-up allowing the patient to set up the pump.
Barzargan et al. (U.S. Pre-Grant Patent Publication No. 2021/0402089) which discloses configuring a medical device with user-specific information and transferring the configuration data to a second medical device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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, 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.
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.
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
Prosecution Insights