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 .
This Office action is responsive to an amendment filed August 6, 2026. Claims 1-27 are pending. Claims 1-3, 5, 7, 14-17, 19 & 21 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 13, 2025 and April 1, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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.
Claims 1, 3-6, 11-12, 14-15, 17, 19 & 27 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10-11, 13-14, 16 & 18-19 of U.S. Patent No. 12,232,867 in view of Dunn et al. (US 2018/0235524) (“Dunn” hereinafter).
It is clear that all the elements of claims 1, 4-6, 11-12, 14-15, 19 & 27 of the application are to be found in claims 1-3, 10-11, 13-14, 16 & 18-19 of the patent. The difference between claims 1, 4-6, 11-12, 14-15, 19 & 27 of the application and claims 1-3, 10-11, 13-14, 16 & 18-19 of the patent lies in the fact that the patent fail(s) to explicitly teach a step of calculating a glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage; and outputting a recommended insulin dosage based on a comparison of the calculated glucose level target to a current glucose level for the subject and a system comprising an analyte sensor configured to measure a glucose level in for the subject; and
a monitoring device.
However, Dunn teaches that it is known to provide a method comprising calculating a glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level (see at least fig. 1 and par 0200 & 0202), and (3) the calculated kage; and outputting a recommended insulin dosage based on a comparison of the calculated glucose level target to a current glucose level for the subject (see at least par 0108, 0112-0114 & 0118) and and a system comprising an analyte sensor 882 configured to measure a glucose level in for the subject (see at least par 0154-0155); and a monitoring device (see at least par 0062-0064).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method and system of the patent comprising a step of calculating a glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage; and outputting a recommended insulin dosage based on a comparison of the calculated glucose level target to a current glucose level for the subject and a system comprising an analyte sensor configured to measure a glucose level in for the subject; and a monitoring device as taught by Dunn since such a modification would amount to applying a known technique (i.e., as taught by Dunn) to a known device (i.e., the patent) ready for improvement to achieve a predictable result such as measuring a plurality of glucose levels over a time period of the patient to measure a personalized physiological parameter so as to provide a subject's personalized diabetes management (see at least par 0052-0054 of Dunn)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
It is clear that all the elements of claims 3 & 17 of the application are to be found in claims 1- of the patent. The difference between claims 3 & 17 of the application and claims 1 16 of the patent lies in the fact the invention of claims 1 & 16 of the patent fail(s) to explicitly teach a step wherein the calculated glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage is determined using at least Equation C:
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However, Dunn teaches that it is known to provide a method and system wherein the calculated glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage is determined using at least Equation C:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method and system of the patent wherein the calculated glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage is determined using at least Equation C:
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as taught by Dunn since such a modification would amount to applying a known technique (i.e., as taught by Dunn) to a known device (i.e., as taught by the patent) ready for improvement to achieve a predictable result such as estimating the value of HbA1c using a kinetic model (see at least par 0039 of Dunn)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
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 1-27 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1 recite(s), at least in part the following step(s):
“calculating a red blood cell elimination constant (kage) based on the RPI value,” and,
“calculating a glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the calculated kage.”
These step(s), when given its/their broadest reasonable interpretation(s), describe(s) carrying out said step(s) mentally (i.e., a mental task in the human mind), and/or by a mathematical process (In re Grams). In other words, nothing precludes the claimed step from practically being performed mentally, and/or by a mathematical process (In re Grams). For example, the “calculating” in the step(s) involves the user mentally (by a mental task in the human mind, visually, and/or using pen and paper), and/or by a mathematical process (In re Grams) (using a mathematical algorithm, arithmetics, function(s) and/or equation(s)) “calculating.” In view of the foregoing, claim(s) 1 recite(s) an abstract idea.
For example, the following caselaw: Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) contains the following analysis: “Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea.” [Emphasis added].
The judicial exception(s) is/are not integrated into a practical application. Particularly, the claim(s) recite(s) the following additional element(s):
“measuring a plurality of first glucose levels for the subject over a first time period,”
“measuring an ending glycated hemoglobin (HbA1c) level corresponding to an end of the first time period,”
“measuring a reticulocyte production index (RPI) value,” and,
“outputting a recommended insulin dosage based on a comparison of the calculated glucose level target to a current glucose level for the subject.”
Neither the arrangement of the additional elements, nor the additional elements themselves, apply, rely on, or use the judicial exception recited supra in a manner that imposes a meaningful limit on the judicial exception. Rather, the additional element(s) is/are recited with a high level of generality (i.e., as a generic data collection steps such as measuring a plurality of glucose levels, and, a generic data outputting step such as outputting a recommendation for insulin glucose dosage based on a target glucose level) such that it amounts to no more than instructions to apply the exception using a generic computer component. Therefore, the additional element(s) does not integrate the exception(s) 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 and/or law of nature.
The claim(s) include(s) the additional step(s)/element(s) recited above. The additional step(s)/element(s) are not sufficient to amount to significantly more than the judicial exception(s) since such additional step(s)/element(s) are generically claimed to enable an insignificant extra-solution activity including the collection of data by performing the basic functions of: (i) receiving, processing, and/or calculating data, and/or (ii) automating mental tasks and/or a mathematical process. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements are well-understood, routine and convention. In the instant case, Applicant admits at par 0003-0004 of the instant application that commercially available devices can provide glucose level measurements as well as HbA1c values. Merely adding hardware that performs ‘“well understood, routine, conventional activities]’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). In other words, the additional step(s)/element(s) amount(s) to no more than mere instructions to apply the exception(s) using generic computer component(s). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, Claim(s) 1 do(es) not amount to significantly more than the abstract idea itself.
In regards to claim(s) 2 & 13-14, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application (i.e., the determining step in claim 2, the calculating and determining steps in claim 13, the calculating and identifying steps in claim 14) and/or providing additional elements (i.e., the measuring steps in claim 2, the receiving steps in claims 13-14) that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
In regards to claim(s) 3-7, 12, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application for reasons provided supra.
In regards to claim(s) 8-11, the claimed invention(s) further recite(s) additional element(s) (e.g., measuring step) that do(es) not integrate the judicial exception into a practical application and is/are not sufficient to amount to significantly more than the judicial exception for the reasons provided supra.
Claim(s) 15 recite(s), at least in part the following step(s):
“determine a reticulocyte production index (RPI) value;”
“determine a red blood cell elimination constant (kage) based on the RPI value;” and
“determine a glucose level target based on at least (1) the plurality of first glucose levels, (2) the ending HbA1c level, and (3) the kage.”
These step(s), when given its/their broadest reasonable interpretation(s), describe(s) carrying out said step(s) mentally (i.e., a mental task in the human mind), and/or by a mathematical process (In re Grams) but for the recitation of generic computer components. In other words, absent the recitation of “one or more processors” and “a memory operatively coupled to the one or more processors and having instructions stored thereon which, when executed by the one or more processors,” nothing precludes the claimed step from practically being performed mentally, and/or by a mathematical process (In re Grams). For example, absent the limitation(s) “one or more processors” and “a memory operatively coupled to the one or more processors and having instructions stored thereon which, when executed by the one or more processors,” in the step(s), the “determine[ing]” in the step(s) involves the user mentally (by a mental task in the human mind, visually, and/or using pen and paper), and/or by a mathematical process (In re Grams) (using a mathematical algorithm, arithmetics, function(s) and/or equation(s)) “determine[ing].” In view of the foregoing, claim(s) 15 recite(s) an abstract idea.
For example, the following caselaw: Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) contains the following analysis: “Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea.” [Emphasis added].
The judicial exception(s) is/are not integrated into a practical application. Particularly, the claim(s) recite(s) the following additional element(s):
“an analyte sensor configured to measure a glucose level in for the subject;” and
“a monitoring device comprising:
one or more processors and
a memory operatively coupled to the one or more processors and having instructions stored thereon which, when executed by the one or more processors, , causes the one or more processors to…
output a recommended insulin dosage based on a comparison of the determined glucose level target to a current glucose level for the subject”
Neither the arrangement of the additional elements, nor the additional elements themselves, apply, rely on, or use the judicial exception recited supra in a manner that imposes a meaningful limit on the judicial exception. Rather, the additional element(s) is/are recited with a high level of generality (i.e., as a generic data collection means performing a generic data collection function such as an analyte sensor configured to measure a glucose level in for the subject, and/or a generic computer performing a generic computer function such as outputting information) such that it amounts to no more than instructions to apply the exception using a generic computer component. Therefore, the additional element(s) does not integrate the exception(s) 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 and/or law of nature.
The claim(s) include(s) the additional step(s)/element(s) recited above. The additional step(s)/element(s) are not sufficient to amount to significantly more than the judicial exception(s) since such additional step(s)/element(s) are generically claimed to enable an insignificant extra-solution activity including the collection of data by performing the basic functions of: (i) receiving, processing, and/or calculating data, and/or (ii) automating mental tasks and/or a mathematical process. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements are well-understood, routine and convention. In the instant case, Applicant admits at par 0003-0004 of the instant application that commercially available devices can provide glucose level measurements as well as HbA1c values. Merely adding hardware that performs ‘“well understood, routine, conventional activities]’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). In other words, the additional step(s)/element(s) amount(s) to no more than mere instructions to apply the exception(s) using generic computer component(s). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, Claim(s) 15 do(es) not amount to significantly more than the abstract idea itself.
In regards to claim(s) 16 & 25-27, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application (i.e., the determining step in claim 6, the determining step in claim 25 & 27, the determining and identifying steps in claim 26) and/or providing additional elements (i.e., the receiving steps in claim 16, the receiving steps in claims 25-26, the transmitting step in claim 27) that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
In regards to claim(s) 17-21 & 24, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application for reasons provided supra.
In regards to claim(s) 22-23, the claimed invention(s) further recite(s) additional element(s) (e.g., a display in claim 22, the receiving step, display and alarm in claim 23) that do(es) not integrate the judicial exception into a practical application and is/are not sufficient to amount to significantly more than the judicial exception for the reasons provided supra.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0364262 to Malka et al. discloses methods of estimating blood glucose and related systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
