Prosecution Insights
Last updated: October 25, 2026
Application No. 17/110,879

METHOD OF HYPOGLYCEMIA RISK DETERMINATION

Final Rejection §101§103§112§DOUBLEPATENT
Filed
Dec 03, 2020
Priority
Feb 11, 2011 — provisional 61/442,085 +5 more
Examiner
VANNI, GEORGE STEVEN
Art Unit
1686
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Abbott Laboratories
OA Round
2 (Final)
67%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
405 granted / 606 resolved
+6.8% vs TC avg
Strong +25% interview lift
Without
With
+25.2%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
51 currently pending
Career history
651
Total Applications
across all art units

Statute-Specific Performance

§101
29.2%
-10.8% vs TC avg
§103
24.6%
-15.4% vs TC avg
§102
7.3%
-32.7% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 606 resolved cases

Office Action

§101 §103 §112 §DOUBLEPATENT
DETAILED ACTION This application is being examined under pre-AIA first-to-invent provisions. Status of claims Canceled: 1-116 Pending: 117-138 Withdrawn: 118, 120, 124, 127, 129, 131, 135 and 138 Examined: 117, 119, 121-123, 125-126, 128, 130, 132-134 and 136-137 Independent: 117 and 128 Allowable: none Rejections applied Abbreviations x 112/b Indefiniteness PHOSITA "a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention" 112/b "Means for" BRI Broadest Reasonable Interpretation x 112/a Enablement, Written description CRM "Computer-Readable Media" and equivalent language 112 Other IDS Information Disclosure Statement x 102, 103 JE Judicial Exception 101 JE(s) 112/a 35 USC 112(a) and similarly for 112/b, etc. x 101 Other N:N page:line x Double Patenting MM/DD/YYYY date format Restriction/election Applicant’s 3/2/2026 election is acknowledged. Because no errors in the restriction requirement were alleged distinctly and specifically, the election has been treated as an election constructively without traverse (MPEP § 818.01(a)). As listed above, claims are withdrawn as drawn to nonelected inventions pursuant to 37 CFR 1.142(b), and the remaining claims have been examined as listed above. The restriction requirement is made final. Note: claim 123 was elected with Species B.i (remarks p. 6, restriction p. 3), and claim 124 similarly was non-elected. The claim status identifiers should be updated in the next filing. Priority As detailed on the 12/15/2020 filing receipt, this application claims priority to no earlier than 2/11/2011. All claims have been interpreted as being accorded this priority date. Objection to the specification: title The title should be amended to more specifically reflect the claims, particularly referencing steps/elements: setting the context of the invention, particular to all claims, and distinguishing the instant application from any related applications, for example: bodily fluid senor, central tendency, variability. The title should be "descriptive" and "as... specific as possible" (MPEP 606, 1st para. and 37 CFR 1.72; also MPEP 606.01 pertains). Claim objections Claims 117, 123-124 and 128 are objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate. The following issues are objected to: Claim Recitation Comment 117, 128 risk determination and treatment recommendation In the preamble, objectives of "risk determination" and "treatment recommendation" are recited, but the rest of the claim does not recite corresponding limitations nor generally accomplish these objectives. 117 wherein the one or more computing devices comprises The recited "...devices comprises..." should read "...devices comprise[[s]]..." 117 the memory storing software that... cause the one or more processors Subject-verb agreement: should read "...causes..." 123 (Withdrawn) Should read "(Previously Presented)" 124 (Previously Presented) Should read "(Withdrawn)" Claim rejections - 112/2nd The following is a quotation of 112/2nd: 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 117, 119, 121-123, 125-126, 128, 130, 132-134 and 136-137 are rejected under 112/2nd, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However, equivalent amendments also would be acceptable. The following issues cause the respective claims to be rejected under 112/2nd as indefinite: Claim Recitation Comment (suggestions in bold) 117 one or more computing devices... the memory storing software that, when executed by the one or more processors, cause the one or more processors to perform... Claim 117 is rejected as directly reciting a machine and a process in the same claim. A claim to a machine, e.g. here a "system," cannot directly recite a process step such as "cause." It may suffice to recite "configured to" before "cause" so as to properly focus on claimed structure, but also attention should be given to the recited "...when executed by the one or more processors..." MPEP 2173.05(p).II pertains regarding a claim directed to both product and process. 117, 128 (d)... then output a recommendation related to reducing variability The relationship is unclear between this instance of "recommendation" and that in the preamble. 117, 128 (c)... a higher variability The recited "higher" is a term of relative or vague degree or form of association, neither defined in the specification (e.g. [86, 133-145]) nor having a well-known and sufficiently particular definition in the art and in the instant context. The term is recited without an accompanying reference point as to "higher" than some reference and appears to mean "higher" as in relatively high or simply high. The term "higher" is not disclosed in the context of "variability." (MPEP 2173.05(b) pertains.) A related 112/1st rejection also is applied below. 123, 134 the variability line In claim 123, the recitation requires but lacks clear antecedent. Possibly claim 123 should depend from claim 121 or 122. Claim 134 is rejected similarly. Claim rejections - 112/1st The following is a quotation of 112/1st: 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. Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.). Written description Claims 117 and 128 are rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable. Claim 117 recites "(c)... higher variability..." The term "higher" is not disclosed in the context of "variability." The recited "higher" is neither defined in the specification (e.g. [86, 133-145]) nor does it have a well-known and sufficiently particular definition in the art and in the instant context. The term is recited without an accompanying reference point as to "higher" than some reference and appears to mean "higher" as in relatively high or simply high. The written description provided is not clearly commensurate with the recitation. Although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification. (MPEP 2145.VI pertains.) MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. Claim 128 similarly lacks support. As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations. In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure. MPEP 2163 generally pertains. A related 112/2nd rejection also is applied above. Claim 117 recites "risk determination," "treatment recommendation" and "analyte monitoring... in contact with a bodily fluid of a user." There is disclosed support for diabetes, hypoglycemia risk and blood glucose and/or ketone monitoring (e.g. [69-70]). There does not appear to be written description support for the claim's entire scope of any risk, any treatment, any analyte relating to any disease. The written description provided is not clearly commensurate with the claim's recitation. Also, MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. Claim 128 similarly lacks support. As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations. In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure. MPEP 2163 generally pertains. Claim rejections - 35 USC 103 In the event the determination of the status of the application as subject to AIA 35 USC 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 USC 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 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 USC 102(b)(2)(C) for any potential 35 USC 102(a)(2) prior art against the later invention. Claims 117, 119, 125-126, 128, 130 and 136-138 Claims 117, 119, 125-126, 128, 130 and 136-138 are rejected under 35 USC 103 as unpatentable over Ray (2008/0234992 as cited on the 12/3/2020 IDS). Regarding claims 117 and 125-126, the analyte monitoring system reads on "blood glucose meter" (Ray: abstract; and entire document). The recited central tendency reads on "median of glucose concentration" (Ray: [99]; and entire document). The recited variability reads on "variability" (Ray: [99]; and entire document). The recited zone in central tendence and variability space reads on "Variability can also be associated graphically..." and "...a two dimensional coordinate graph having glucose values and test times" (Ray: [99]; and entire document). The recited recommendation reads on "recommendation for testing" (Ray: [166]; and entire document), noting that the purpose of Ray's recommendation for testing is monitoring and, when necessary, reducing variability. Also (Ray: [2]): After identifying a particular pattern with the data management system or process, a warning message may be displayed on a screen of a personal computer or a glucose meter. Other messages can also be provided to ensure compliance of any prescribed diabetes regiments or to guide the patient in managing the patient's diabetes. Claim 117 teaches each of the limitations as described above, however claim 117 does not teach the limitations in a single embodiment in the same, consecutive sequence as recited. It would have been prima facie obvious to try the recited sequence as an example of combining prior art elements taught within the same reference according to known methods to yield predictable results. Claim 119 specifies recommendations relating to food intake and reads on Ray's "Goals for Diabetes... Additional Comments... Diet..." (Ray: FIG. 19B; also [125 and 166]; and entire document). The art similarly is applied to claims 128, 130 and 136-138 as described above. Prior art made of record but not relied upon Additional art is listed on the attached form 892, made of record but not relied upon, and also is considered pertinent to applicant's disclosure. Claim rejections - 101 35 USC 101 reads: 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. For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted. Judicial exceptions (JE) to 101 patentability Claims 117, 119, 121-123, 125-126, 128, 130, 132-134 and 136-137 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below. In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE? MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials. Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03 [Step 1: claims 117, 119, 121-123, 125-126, 128, 130, 132-134 and 136-137: YES] Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04 Preliminarily, in a 1st prong of Step 2A, elements of independent claim 117 are interpreted as directed to the abstract idea of calculating a recommendation to reduce variability including the JE steps (a) through (d), each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below. Claim 128 is analyzed similarly. BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process. BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106). Instant examples of math concepts include recited calculations of central tendency, variability and zone categorization, as well as relationships inherent in recitations as the only supported embodiments. The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field. Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank, 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1321-33, Fed. Cir. 2004). In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions (JEs). Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states: In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement." While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle. It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law. [Step 2A, 1st prong, abstract idea: claims 117 and 128: YES] Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d) MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application: An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2); Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b); Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e). In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B. Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application. At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record. For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: [75, 111, 114, 123-127, 210, 252]). [Step 2A, 2nd prong: claims 117 and 128: NO] Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05 Addressing the second Mayo/Alice question, all elements of claims 117 and 128 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions: The recited "in vivo analyte monitoring system" and "computing devices" are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g), and as exemplified by Ray (2008/0234992 as cited on the 12/3/2020 IDS), and generally it is understood that the examples in the reference are well-known and routine. Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering is insufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)). It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE. [Step 2B: claims 117 and 128: NO] Summary and conclusion regarding claims 117 and 128 Summing up the above analysis of claims 117 and 128, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim. Remaining claims Claims 119, 121-123, 125-126, 130, 132-134 and 136-137 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101. None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101. Nonstatutory double patenting The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.). In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional. A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b). Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Double patenting rejections Instant claims 117, 119, 121-123, 125-126, 128, 130, 132-134 and 136-137 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference patents 10,383,580 (from application 14/145,554), 10,872,696 (from application 15/427,586) and 12,178,617 (from application 16/459,203) and one or more claims in reference application 17/698,757 (NOA mailed 1/15/2026) in view of Ray (2008/0234992 as cited on the 12/3/2020 IDS) and Eslami (as cited on the attached form 892). Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims. Each reference patent and application recites claims which read on diabetes risk, glucose monitoring and glucose variability. It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art. Citations to art In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well. Prior art made of record but not relied upon Additional art is listed on the attached form 892, made of record but not relied upon, and also is considered pertinent to applicant's disclosure. Conclusion No claim is allowed. A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication. Inquiries Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further information is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx. The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000. The examiner for this Office action, G. Steven Vanni, may be contacted at: (571) 272-3855 Tu-F 8-7 (ET). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062. /G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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Prosecution Timeline

Dec 03, 2020
Application Filed
Apr 16, 2026
Non-Final Rejection mailed — §101, §103, §112
Sep 11, 2026
Response Filed
Oct 20, 2026
Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
67%
Grant Probability
92%
With Interview (+25.2%)
4y 0m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 606 resolved cases by this examiner. Grant probability derived from career allowance rate.

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