DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 10/25/2022, 05/02/2023, 10/31/2023, 02/09/2024, 05/07/2024, 12/11/2024, 01/02/2025, 03/10/2025, and 05/19/2025, have been considered by the examiner.
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claims 1, 11, and 20] The claims recite the limitation of “receiving insulin therapy data describing insulin delivered to the host by an insulin pump.” The examiner is unable to determine the metes and bounds of the claims, as the wording is ambiguous as to whether the “insulin therapy data” must be received from the “insulin pump” itself, or if the data is permitted to be received from any source. For purposes of examination, it is interpreted that the “insulin therapy data” can be received from any source.
[Claims 2-10 and 12-19] The claims are rejected based upon their dependence from independent claims 1 and 11.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ginsberg (PGPub 2005/0192494).
[Claims 1, 10, 11, and 20] Ginsberg teaches a system and method (figure 2, item 50), comprising at least a memory (figure 2, item 54) and a processor (figure 2, item 52) (paragraphs [0032], [0033]) to perform operations comprising:
receiving glucose data (“blood glucose readings”) of a host from a glucose monitor/continuous glucose monitor (figure 2, items 60/62/64) worn by a host (paragraphs [0013], [0034], [0037]-[0042]);
receiving insulin therapy data (“amount of insulin administered”) describing insulin delivered to the host by an insulin pump (figure 2, items 62/64) (see 112, 2nd paragraph, interpretation above) (paragraphs [0013], [0034], [0037]-[0042]);
determining an insulin sensitivity (“insulin sensitivity factor”/”ISF”) of the host by analyzing the glucose data and the insulin therapy data (paragraphs [0011], [0013], [0030], [0048], [0049]); and
adjusting an insulin dose (“insulin dosage recommendation”) for the host based at least in part on the insulin sensitivity of the host (paragraphs [0013], [0030], [0032], [0052], [0055]).
[Claims 2 and 12] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 2 and 12 depend. In addition, Ginsberg discloses wherein the determining the insulin sensitivity (“insulin sensitivity factor”/”ISF”) further comprises monitoring the glucose data to determine a metabolic response of the host to the insulin delivered to the host (Although Ginsberg discloses the ISF’s can be determined values which differ temporally, the examiner notes the term “monitoring” could be applied to the collection of a mere plurality of data points) (paragraph [0053]).
[Claims 3 and 13] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 3 and 13 depend. Ginsberg also discloses predicting glucose values (“target glucose values”) of the host based on the determined insulin sensitivity of the host, the glucose data, and the insulin therapy data (paragraphs [0007], [0009], [0030], [0064]).
[Claims 4-6 and 14-16] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 4-6 and 14-16 depend. Ginsberg also teaches
receiving meal information from the host, wherein the insulin dose for the host is adjusted based at least in part on the meal information (paragraphs [0013], [0039], [0042]);
wherein the meal information comprises an amount of carbohydrates consumed by the host (paragraphs [0039], [0042]); and
wherein the meal information is received via user input to a user interface displayed by a computing device (paragraph [0042]).
[Claims 7 and 17] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 7 and 17 depend. In addition, Ginsburg discloses causing the insulin pump to deliver the adjusted insulin dose to the host (“The insulin administration data can be provided automatically (e.g., the device 62 with sensor 64 is an insulin pump or medication delivery pen with automated output feature)”) (paragraphs [0030], [0034], [0042], [0055]).
[Claims 8, 9, 18, and 19] Ginsberg teaches the limitations of claims 1 and 11, upon which claims 8, 9, 18, and 19, depend. Ginsburg also teaches wherein the adjusting comprises adjusting a bolus or basal insulin dose for the host based on the insulin sensitivity of the host (Ginsburg teaches the calculated insulin sensitivity values, and thus the determined adjusted insulin doses, can be determined for various temporal periods; as such, said adjustments could be termed as meeting a temporary (bolus) or continuous (basal) insulin requirement) (figure 3; paragraphs [0043], [0053]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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, Bhisma Mehta can be reached at 571-272-3383. 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 E FLICK/Primary Examiner, Art Unit 3783 01/21/2026