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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-9) in the reply filed on 11/11/2025 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/11/2025.
Information Disclosure Statement
The Information Disclosure Statements filed 10/23/2023 (x3) have been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 229, 231, and 2102. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Note: Reference characters 229 and 231 are shown in Fig. 2, but not mentioned in the specification. Reference character 2102 is shown in Fig. 21, but is not mentioned in the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 900. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Reference character 900 is mentioned in Par. [0056] of the specification, but is not shown in Fig. 9.
The drawings are objected to because the “storage” element for the Medicament Delivery Device 202 in Fig. 2 should be reference character 214, instead of 218, as shown in Par. [0038-0039] of the specification. Reference character 218 was used for the storage of the Management Device 204, according to Par. [0044] of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Par. [0008], line 6: “where the estimate” should be changed to “Where the estimate”. “Where” should be capitalized.
Par. [0050], line 2: “may one medicament” should be changed to “may deliver one medicament”.
Par. [0069], line 3: “may viewed” should be changed to “may be viewed”.
Par. [0073], line 2: “At 2100” should be changed to “At 2102”.
Appropriate correction is required.
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 1-9 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.
Claim 1 recites the limitation “medicament” in line 12, whereas a medicament was already introduced in claim 1 (line 11). It is unclear whether the Applicant intended to claim the same or a different medicament. Consider changing to “the medicament”.
Claim 1 recites the limitation “medicament” in line 13, whereas a medicament was already introduced in claim 1 (line 11). It is unclear whether the Applicant intended to claim the same or a different medicament. Consider changing to “the medicament”.
Claim 5 recites the limitation “medicament” in line 3, whereas a medicament was already introduced in claim 1 (line 11). It is unclear whether the Applicant intended to claim the same or a different medicament. Consider changing to “the medicament”.
Claim 5 recites the limitation “medicament” in line 4, whereas a medicament was already introduced in claim 1 (line 11). It is unclear whether the Applicant intended to claim the same or a different medicament. Consider changing to “the medicament”.
The limitation “wherein the computer programming instructions also cause the processor to initiate delivery of the specified amount of medicament to the user” renders claim 6 indefinite. It is unclear how delivery of the specified amount of medicament is being initiated after a specified amount of medicament was already delivered in claim 1. Is the “specified amount of medicament” being re-delivered? Or, did the Applicant intend to claim that the processor initiates delivery of the dose of medicament that was determined in the last limitation of claim 1 (i.e., initiate delivery of the determined dose of medicament for the user to be output by the medicament delivery system)?
Claim 8 recites the limitation “medicament” in line 3, whereas a medicament was already introduced in claim 1 (line 11). It is unclear whether the Applicant intended to claim the same or a different medicament. Consider changing to “the medicament”.
*All other claims are rejected due to their dependency on a rejected claim.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of analyzing data to create a model and making a determination based on the analysis) without significantly more.
Step 1
Independent claim 1 is directed to a medicament delivery system (i.e., system/apparatus) and thus meets the requirements for step 1.
Step 2A, Prong 1
Regarding claim 1, the following steps recite an abstract idea:
“creat[ing] a model of analyte-medicament interactions that is customized for the user” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could observe and evaluate trends relating to analyte-medicament interactions in order to create a customized model for the user.
“determin[ing] a standard impulse response for the model” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could evaluate and make judgements relating to a standard impulse response for the model.
“determin[ing] an indication of how much medicament is on board over time for the user after a specified amount of medicament is delivered” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could evaluate and make a judgement on how much medicament is on board over time for the user.
“determin[ing] a dose of medicament for the user to be output by the medicament delivery system” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could make a determination/judgement on a dose of medicament for the user to be output by the medicament delivery system.
*The Applicant is reminded that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). (see also MPEP 2106.04(a)(2)(III))
Step 2A – Prong 2
Regarding claim 1, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
“a non-transitory readable storage medium storing computer programming instructions”, “a processor”, “analyte level history”, “medicament delivery history”, and “a medicament” are all recited with a high level of generality. The non-transitory readable storage medium storing computer programming instructions is recited with a high level of generality, as it can be associated with primary memory, secondary memory, random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like (Par. [0039] of Applicant’s specification). The processor is recited with a high level of generality, as it can be for example, a microprocessor, a logic circuit, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) or a microcontroller (Par. [0038] of Applicant’s specification). The involvement of “a non-transitory readable storage medium storing computer programming instructions” and “a processor” is insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. The involvement of “analyte level history” and “medicament delivery history” is considered insignificant extra-solution activity in that it is merely involved with gathering and collecting data [MPEP 2106.05(g)]. The involvement of the “medicament” is considered insignificant extra-solution activity in that it is merely involved with selecting a particular data source or type of data to be manipulated [MPEP 2106.05(g)].
Step 2B
The additional elements of claim 1, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “non-transitory readable storage medium storing computer programming instructions”, “processor”, “analyte level history”, “medicament delivery history”, and “medicament”, along with their associated functions and components, are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
The involvement of the “non-transitory readable storage medium storing computer programming instructions” and the “processor” is storing and retrieving information in memory, a well-understood, routine, and conventional computer activity [MPEP 2106.05(d)(II) Verstata Dev. Group, Inc.].
Additionally, “[receiving] analyte level history and medicament delivery history” is receiving data, a well-understood, routine, and conventional computer activity [MPEP 2106.05(d)II) Symantec].
In this case, well-known elements of a general computer system and well-known elements for data collection/analysis/outputting are used to implement the abstract idea. Also, generally linking the use of the judicial exception to the field of medicament delivery is not indicative of an inventive concept [MPEP 2106.06(h)].
Dependent claims
Regarding dependent claims 2-4 and 7, the limitations only further generally link the use of the judicial exception to the field of medicament delivery.
Regarding dependent claims 5 and 8-9, the limitations only further define the abstract idea.
Regarding dependent claim 6, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Therefore, claims 1-9 are unpatentable under 35 U.S.C. 101.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Thukral, et al. (U.S. PGPub No. 2009/0006129 – cited on IDS).
Regarding claim 1, Thurkral teaches (Fig. 2, # 48) a medicament delivery system for delivering medicament to a user (Par. [0135] – the patient data measurement/collection device 48 is a medication delivery unit, e.g. a programmable insulin pump, which operates automatically to the recommended therapy of the system), comprising:
(Fig. 2, # 14 – client computer, 34 – processor, 38 – memory, i.e. non-transitory readable storage medium; Fig. 3, # 50 – software) a non-transitory readable storage medium storing computer programming instructions;
a processor configured for executing the computer programming instructions (Par. [0064]; Par. [0066] – The processor 34 of the client computer 14 provides information to, or receives information from, an external device 48, such as in the form of a patient data measurement and/or collection device (e.g., externally worn drug infusion pump), via the device interface 46; Par. [0068-0069] – software portions, i.e., computer programming instructions), which cause the processor to:
(Fig. 3, # 72 – patient models module) create a model of analyte-medicament interactions that is customized for the user based on analyte level history and medicament delivery history (Par. [0007]; Par. [0010] – patient models; Par. [0050-0051] – a systematic tool that directly addresses the need to determine patient specific insulin therapy is provided; Par. [0075] – data collection protocols that provide for the collection of patient blood or tissue glucose measurements as a function of time, …, of insulin delivery information over time; Par. [0077] – For example, the patient models module 72 may model glucose absorption in humans while one or more other models may model one or more effects of administering insulin (or other glucose raising or lowering drug); Par. [0083]);
(Fig. 8, # 804 – insulin set point module) determine a standard impulse response for the model (Par. [0098-0099]; Par. [0170-0171] - Table 4 – Basal set example; For this module 804, basal insulin rate (i.e., the insulin infusion rate used to maintain a glucose value) is the basal profile that is normally defined for a typical day);
(Fig. 9, # 846) determine, from the standard impulse response, an indication of how much medicament is on board over time for the user after a specified amount of medicament is delivered (Par. [0216] – the insulin recommendation module 846 computes an insulin dose using the current predicted glucose value. In particular, the insulin recommendation for an insulin dose is computed by projecting the effects of on board insulin, future basal input and effects of other events entered); and
(Fig. 2, # 48; Fig. 4, # 160; Fig. 9, # 848) use the indication in determining a dose of medicament for the user to be output by the medicament delivery system (Par. [0106] – step 160 where the one or more patient therapies and/or therapy actions is/are presented to the user of the system; Par. [0135] – the patient data measurement/collection device 48 (Fig. 2) is a medication delivery unit, e.g. a programmable insulin pump, which operates automatically to the recommended therapy of the system as assigned as a prescription by the healthcare professional at the end of step 160 (Fig. 4); Par. [0223]).
Therefore, claim 1 is unpatentable over Thukral, et al.
Regarding claim 2, Thukral teaches (Fig. 2, # 48) the medicament delivery system of claim 1, further comprising a reservoir for storing the medicament (Par. [0066] – externally worn drug infusion pump, e.g., for administration of insulin (i.e., implies a reservoir for medicament/insulin); Par. [0230] – Table 9 – reservoir volume; Pump structure).
Therefore, claim 2 is unpatentable over Thukral, et al.
Regarding claim 3, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 2, # 48) the medicament is insulin, a glucagon like peptide-1 agonist, pramlintide, another glucose regulating agent, or combinations thereof (Par. [0007]; Par. [0050]; Par. [0066] – externally worn drug infusion pump, e.g., for administration of insulin or one or more other blood glucose lowering or raising drugs).
Therefore, claim 3 is unpatentable over Thukral, et al.
Regarding claim 4, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 2, # 48) the analyte level is a glucose level (Par. [0007]; Par. [0060]; Par. [0066]; Par. [0077] – For example, the patient models module 72 may model glucose absorption in humans while one or more other models may model one or more effects of administering insulin (or other glucose raising or lowering drug);).
Therefore, claim 4 is unpatentable over Thukral, et al.
Regarding claim 5, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 17; Fig. 19) the indication is a curve, a function, an equation, a set of equations, a table, or a storage holding values that are indicative of how much medicament is on board for the user over time after the specified amount of medicament is delivered (Par. [0029]; Par. [0031]; Par. [0203]; Par. [0208]).
Therefore, claim 5 is unpatentable over Thukral, et al.
Regarding claim 6, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 2, # 48; Fig. 4, # 160; Fig. 9, # 848) the computer programming instructions also cause the processor to initiate delivery of the specified amount of medicament to the user (Par. [0050]; Par. [0106] – step 160 where the one or more patient therapies and/or therapy actions is/are presented to the user of the system; Par. [0135] – the patient data measurement/collection device 48 (Fig. 2) is a medication delivery unit, e.g. a programmable insulin pump, which operates automatically to the recommended therapy of the system as assigned as a prescription by the healthcare professional at the end of step 160 (Fig. 4); Par. [0223]).
Therefore, claim 6 is unpatentable over Thukral, et al.
Regarding claim 7, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 2, # 48) the medicament is insulin and wherein the model is a glucose prediction model that predicts a future glucose level value of the user based on earlier glucose level values for the user (Par. [0007]; Par. [0050]; Par. [0066] – externally worn drug infusion pump, e.g., for administration of insulin or one or more other blood glucose lowering or raising drugs; Par. [0143-0144] – Glucose prediction predicts the glucose value for control cycles utilizing the past glucose measurement values, past insulin measurements, past events and future scheduled events).
Therefore, claim 7 is unpatentable over Thukral, et al.
Regarding claim 8, Thukral teaches the medicament delivery system of claim 1, further comprising (Fig. 8, # 808 – glucose update module) updating the indication to account for recent analyte level values for the user and using the updated indication in determining a next dose of medicament for the user to be output by the medicament delivery device (Par. [0177] – when the sensor provides new glucose values, the insulin recommendation module 846 reworks the glucose prediction using the latest measured glucose).
Therefore, claim 8 is unpatentable over Thukral, et al.
Regarding claim 9, Thukral teaches the medicament delivery system of claim 1, wherein (Fig. 17) the indication of how much medicament is on board over time for the user after a specified amount of medicament is delivered is a nonlinear curve (Par. [0029]; Par. [0203]).
Therefore, claim 9 is unpatentable over Thukral, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mastrototaro, et al. (U.S. PGPub No. 2014/0066887)
Constantin, et al. (U.S. PGPub No. 2019/0252079)
Saint, et al. (U.S. PGPub No. 2015/0073337)
Sloan, et al. (U.S. PGPub No. 2019/0150808)
Dobbles, et al. (U.S. PGPub No. 2020/0261650)
Davis, et al. (U.S. PGPub No. 2017/0220751)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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, Jennifer McDonald can be reached at (571) 270-3061. 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.
/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796