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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 11, 2026 has been entered.
Status of the Claims
Claims 1, 10, and 13 have been amended; and claims 3-6, 16-18 and 24 have been cancelled. Claims 1-2, 7-15, and 19-23 are examined herein.
Status of the Rejection
New grounds of claim objection are necessitated by the amendment.
All 35 U.S.C. § 112(a) and 112(b) rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of rejection under 35 U.S.C. § 112(a) and 112(d) are necessitated by the amendment.
All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New grounds of double patenting objection are necessitated by the amendment as outlined below.
Claim Objection
Claims 22-23 are objected to because of the following informalities:
Claim 22: please amend “wherein the one or more processors are further configured to execute the executable instructions to receive patient treatment data corresponding to the patient, wherein the patient treatment data comprises medication information associated with the pharmacologic agent, and” to --
Claim 23: please amend “a euglycemic diabetic ketoacidosis prediction” to – [[a]] the euglycemic diabetic ketoacidosis prediction --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 7-15 and 19-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites: one or more processors … configured to execute the executable instructions to: receive, from the display device, the glucose measurements and the ketone measurement; wherein the fusion model applies a weighted algorithm to prioritize ketone measurements over glucose measurements when ketone levels exceed a predefined threshold, which is not supported in the specification/figures. Therefore, claim 1 is a new matter. Claims 2, 7-15, and 19-23 are further rejected by virtue of their dependence upon claim 1.
Claim 13 recites: wherein the prediction is generated using a multi-factor model that incorporates patient-specific insulin sensitivity data and historical ketone trends, which is not supported in the specification/figures. Therefore, claim 13 is a new matter.
Claim 14 is further rejected by virtue of its dependence upon claim 13.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites: “wherein the one or more processors are further configured to generate a euglycemic diabetic ketoacidosis prediction based, at least in part, on the analyte metrics”, and claim 1 recites: the one or more processors … configured to execute the executable instructions to: generate a euglycemic diabetic ketoacidosis prediction using the analyte metrics and the patient treatment data. Claim 12 does not further limit the generating a euglycemic diabetic ketoacidosis prediction. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
Applicant is advised that should claim 1 be found allowable, claims 8-9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note that the limitations of claims 8-9 are already incorporated in the amended claim 1.
Applicant is advised that should claim 22 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note that the limitations of claim 23 are already incorporated in the amended claim 1.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 7-12, filed 5/11/2026, with respect to the 35 U.S.C. § 112(a), 112(3) and prior art rejections have been fully considered, and all rejections from the previous office action are withdrawn in response to the amendment to claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
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, Luan V. Van can be reached on (571) 272-8521. 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.
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
Prosecution Insights