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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 8, 2025 is in compliance with the provisions of 37 CFR 1.97, and has been considered by the examiner.
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).
Non-statutory Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 5, 6, 9-13, and 15 of U.S. Patent No. 12,233,238. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
Claim 1 in the Present Application (Application Serial No. 19/022,236)
Claim 1 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
1. A system for therapy delivery for diabetes treatment, the system comprising: one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of:
1. A system for therapy delivery for diabetes treatment, the system comprising: one or more sensors configured to capture a representation of an object; and processing circuitry configured to:
identifying an object as a food item based on a representation of the object;
determine data corresponding to the representation of the object, wherein the data comprises information identifying the object as a particular food item;
generating nutrition information or volume information of the food item;
generate food item information based on the information identifying the object as the particular food item, wherein the food item information comprises at least one of nutrition information or volume information of the particular food item;
determining that the nutrition information or the volume information of the food item exceeds a threshold;
determine that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold;
determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold;
predict the patient’s glucose level will rise based on the nutrition information or the volume information of the particular food item exceeds the threshold;
responsive to determining that the patient’s glucose level will rise, generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
responsive to determining the nutrition information or the volume information of the particular food item exceeds the threshold, generate therapy information for a patient based on the food item information and the prediction the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food idem exceeds the threshold, wherein generating the therapy information comprises determining at least an insulin type and an insulin dosage based on the food item information; output content indicative of at least one of the therapy information or the food item information; and;
automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information.
automatically administer insulin to the patient in accordance with the insulin type and the insulin dosage, wherein the insulin type comprises at least one of basal insulin or bolus insulin, wherein administration of the insulin to the patient corresponds to the diabetes treatment by causing the glucose level of the patient to lower to within a predetermined range.
Claim 2 in the Present Application (Application Serial No. 19/022,236)
Claim 1 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 1 in the present application to claim 1 of Patent No. US 12,233,238)
2. The system of claim 1, wherein the system further comprises one or more sensors, and wherein the representation of the object is obtained from the one or more sensors.
1. A system for therapy delivery for diabetes treatment, the system comprising: one or more sensors configured to capture a representation of an object; and processing circuitry configured to: […].
Claim 3 in the Present Application (Application Serial No. 19/022,236)
Claim 9 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 1 in the present application to claim 1 of Patent No. US 12,233,238)
3. The system of claim 2, wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object.
9. The system of claim 1, wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object.
Claim 4 in the Present Application (Application Serial No. 19/022,236)
Claim 2 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
4. The system of claim 1, wherein the system further comprises a wearable device, and wherein the representation of the object is obtained from the wearable device.
2. The system of claim 1 further comprising a wearable device configured to perform at least one of generating at least a portion of the data corresponding to the representation of the object or generating data indicating consumption of the object by the patient.
Claim 5 in the Present Application (Application Serial No. 19/022,236)
Claim 5 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
5. The system of claim 1, wherein generating the nutrition information comprises generating a mesh model of the object and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object.
5. The system of claim 1, wherein to generate food item information, the processing circuitry is further configured to generate a mesh model of the object and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object.
Claim 6 in the Present Application (Application Serial No. 19/022,236)
Claim 6 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 1 in the present application to claim 1 of Patent No. US 12,233,238)
6. The system of claim 5, wherein the instructions further cause performance of aligning a
three-dimensional mesh model of the object and a two-dimensional mesh model of the object to
generate a co-registered mesh model of the object from which the food item of the plurality of food
items is identified.
6. The system of claim 1, wherein to generate food item information, the processing circuitry is further configured to align a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model.
Claim 7 in the Present Application (Application Serial No. 19/022,236)
Claim 1 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 1 in the present application to claim 1 of Patent No. US 12,233,238)
7. The system of claim 1, wherein determining that the nutrition information or the volume
information of the food item exceeds the threshold comprises accessing a food library that defines
the threshold.
1. A system for therapy delivery for diabetes treatment, the system comprising: […] determine that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold; […].
Claim 8 in the Present Application (Application Serial No. 19/022,236)
Claim 3 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
8. The system of claim 7, wherein the food library comprises a trained machine learning model.
3. The system of claim 1, wherein to generate food item information, the processing circuitry is further configured to generate the food item information based on a machine learning model, wherein the machine learning model is trained to map the food item information to feature data corresponding to at least one of a three-dimensional or a two-dimensional representation of the object.
Claim 9 in the Present Application (Application Serial No. 19/022,236)
Claim 1 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
9. The system of claim 1, wherein generating the therapy information comprises determining an insulin type and an insulin dosage.
1. A system for therapy delivery for diabetes treatment, the system comprising: […] wherein generating the therapy information comprises determining at least an insulin type and an insulin dosage based on the food item information; […].
Claim 10 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
10. A method for therapy delivery for diabetes treatment, the method comprising:
10. A method for therapy delivery for diabetes treatment, the method comprising:
identifying an object as a food item based on a representation of the object;
capturing, by processing circuitry using one or more sensors, at least one representation of an object; determining, by the processing circuitry, data corresponding to the at least one representation of the object, wherein the data comprises information identifying the object as a particular food item;
generating nutrition information or volume information of the food item;
generating, by the processing circuitry, food item information based on the information identifying the object as the particular food item, wherein the food item information comprises at least one of nutrition information or volume information of the particular food item;
determining that the nutrition information or the volume information of the food item exceeds a threshold;
determining that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold;
determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold; responsive to determining that the patient’s glucose level will rise, generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
responsive to determining the nutrition information or the volume information of the particular food item exceeds the threshold, generating, by the processing circuitry, therapy information for a patient based on the food item information and a prediction the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food idem exceeds the threshold, wherein generating the therapy information comprises determining at least an insulin type and an insulin dosage based on the food item information;
automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information.
outputting, by the processing circuitry, content indicative of at least one of the therapy information or the food item information; and automatically administering insulin to the patient in accordance with the insulin type and the insulin dosage, wherein the insulin type comprises at least one of basal insulin or bolus insulin, wherein administration of the insulin to the patient corresponds to the diabetes treatment by causing the glucose level of the patient to lower to within a predetermined range.
Claim 11 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 10 in the present application to claim 10 of Patent No. US 12,233,238)
11. The method of claim 10, wherein the representation of the object is obtained from one or more sensors.
10. A method for therapy delivery for diabetes treatment, the method comprising: capturing, by processing circuitry using one or more sensors, at least one representation of an object; […].
Claim 12 in the Present Application (Application Serial No. 19/022,236)
Claim 15 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
12. The method of claim 11, wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object.
15. The method of claim 10, wherein capturing the at least one representation of the object further comprises concurrently capturing a two-dimensional representation using a camera and a three-dimensional representation using a LiDAR sensor.
Claim 13 in the Present Application (Application Serial No. 19/022,236)
Claim 11 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
13. The method of claim 10, wherein the representation of the object is obtained from a wearable device.
11. The method of claim 10, wherein a wearable device may comprise at least one of the one or more sensors, wherein the wearable device is configured to generate at least a portion of the data corresponding to the at least one representation of the object.
Claim 14 in the Present Application (Application Serial No. 19/022,236)
Claim 13 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 10 in the present application to claim 10 of Patent No. US 12,233,238)
14. The method of claim 10, wherein generating the nutrition information comprises generating a mesh model of the object and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object.
13. The method of claim 10, wherein generating the food item information further comprises generating a mesh model of the object and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object.
Claim 15 in the Present Application (Application Serial No. 19/022,236)
Claim 6 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
15. The method of claim 13, further comprising aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified.
6. The system of claim 1, wherein to generate food item information, the processing circuitry is further configured to align a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model.
Claim 16 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 10 in the present application to claim 10 of Patent No. US 12,233,238)
16. The method of claim 10, wherein determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold.
10. A method for therapy delivery for diabetes treatment, the method comprising: […] determining that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold; […].
Claim 17 in the Present Application (Application Serial No. 19/022,236)
Claim 12 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
17. The method of claim 16, wherein the food library comprises a trained machine learning
model.
12. The method of claim 10, wherein generating the food item information further comprises generating the food item information based on a machine learning model, wherein the machine learning model is trained to map the food item information to feature data corresponding to at least one of a three-dimensional or a two-dimensional representation of the object.
Claim 18 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with the only differences being the minor differences identified above in the comparison of claim 10 in the present application to claim 10 of Patent No. US 12,233,238)
18. The method of claim 10, wherein generating the therapy information comprises determining an insulin type and an insulin dosage.
10. A method for therapy delivery for diabetes treatment, the method comprising: […] wherein generating the therapy information comprises determining at least an insulin type and an insulin dosage based on the food item information; […].
Claim 19 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
19. A method for therapy delivery for diabetes treatment, the method comprising:
18. A method for therapy delivery for diabetes treatment, the method comprising:
generating nutrition information or portion information of a food item based on a
representation of the food item obtained from one or more sensors;
capturing, by processing circuitry using one or more sensors, at least one representation of an object; determining, by the processing circuitry, data corresponding to the at least one representation of the object, wherein the data comprises information identifying the object as a particular food item; generating, by the processing circuitry, food item information based on the information identifying the object as the particular food item, wherein the food item information comprises at least one of nutrition information or volume information of the particular food item;
determining that the nutrition information or the portion information of the food item exceeds
a threshold;
determining that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold;
determining that the patient’s glucose level will rise based on the determination the nutrition
information or the portion information of the particular food item exceeds the threshold; generating therapy information for a patient based on the determination that the patient’s
glucose level will rise; and
responsive to determining the nutrition information or the volume information of the particular food item exceeds the threshold, generating, by the processing circuitry, therapy information for a patient based on the food item information and a prediction the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food idem exceeds the threshold, wherein generating the therapy information comprises determining at least an insulin type and an insulin dosage based on the food item information;
automatically administering insulin to the patient in accordance with the therapy information
to cause the glucose level of the patient to lower.
outputting, by the processing circuitry, content indicative of at least one of the therapy information or the food item information; and automatically administering insulin to the patient in accordance with the insulin type and the insulin dosage, wherein the insulin type comprises at least one of basal insulin or bolus insulin, wherein administration of the insulin to the patient corresponds to the diabetes treatment by causing the glucose level of the patient to lower to within a predetermined range.
Claim 20 in the Present Application (Application Serial No. 19/022,236)
Claim 10 of Patent No. US 12,233,238, issued on February 25, 2025 (with minor differences identified in bold and underlined font)
20. The method of claim 19, wherein the threshold is specified in a food library, and wherein determining that the nutrition information or the portion information of the food item exceeds the threshold is determined by accessing the food library.
10. A method for therapy delivery for diabetes treatment, the method comprising: […] determining that the nutrition information or the volume information of the particular food item exceeds a threshold by accessing a food library that defines the threshold; […].
Claim Objections
Claims 1-20 are objected to because of the following informalities:
- Claims 1, 10, and 19 recite a limitation directed to "generating therapy information for a patient based on the determination that the patient's glucose level will rise" in lines 13-14 of claim 1; lines 8-9 of claim 10; and lines 8-9 of claim 19. However, since the claim previously recited a patient, there appears to be a typographical error (i.e., this limitation should be "generating therapy information for [[a]] the patient based on the determination that the patient's glucose level will rise"). For examination purposes, "generating therapy information for a patient based on the determination that the patient's glucose level will rise" in lines 13-14 of claim 1; lines 8-9 of claim 10; and lines 8-9 of claim 19, will be interpreted and read the same as "generating therapy information for the patient based on the determination that the patient's glucose level will rise". Appropriate correction is required.
Claims 2-9, 11-18, and 20 are also objected to for depending on claims are objected to.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 10, and 19 recite “determining that the patient's glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold”. However, there is insufficient antecedent basis for this limitation in the claims. See MPEP § 2173.05(e). Neither of a patient or a patient’s glucose level were previously recited in claims 1, 10, and 19. Examiner suggests that Applicant amend the term “the patient's glucose level” in claims 1, 10, and 19 to “[[the]] a patient's glucose level”, or make some other appropriate correction of course. For examination purposes and in the interest of compact prosecution, the term “the patient's glucose level” in claims 1, 10, and 19 will be interpreted and read the same as “a patient's glucose level.”
Claims 2-9, 11-18, and 20 are rejected under rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for similar reasons as the § 112(b) rejection applied to claims 1, 10, and 19 described above (due to their individual dependencies on claims 1, 10, and 19).
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1-9 are directed to a system for therapy delivery for diabetes treatment, which is within one of the four statutory categories (i.e., a machine or apparatus). See MPEP § 2106.03. Claims 10-18 are directed to a method for therapy delivery for diabetes treatment, which is also within one of the four statutory categories (i.e., a process). See id. Claims 19 and 20 are also directed to a method for therapy delivery for diabetes treatment, which is also within one of the four statutory categories (i.e., a process). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-20 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1, 10, and 19 include limitations that recite an abstract idea. Note that independent claim 1 is a system claim, while claims 10 covers the matching method claim and claim 19 covers a similar method claim. Specifically, independent claim 1 recites (and claim 10 substantially recites) the following limitations:
A system for therapy delivery for diabetes treatment, the system comprising:
one or more processors; and
one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance of:
identifying an object as a food item based on a representation of the object;
generating nutrition information or volume information of the food item;
determining that the nutrition information or the volume information of the food item exceeds a threshold;
determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold;
responsive to determining that the patient’s glucose level will rise, generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information.
Similarly, independent claim 19 recites the following limitations:
A method for therapy delivery for diabetes treatment, the method comprising:
generating nutrition information or portion information of a food item based on a representation of the food item obtained from one or more sensors;
determining that the nutrition information or the portion information of the food item exceeds a threshold;
determining that the patient's glucose level will rise based on the determination the nutrition information or the portion information of the particular food item exceeds the threshold;
generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., a method for therapy delivery for diabetes treatment, comprising: identifying an object as a food item based on a representation of the object; generating nutrition information or volume information [or the portion information] of the food item; determining that the nutrition information or the volume information [or the portion information] of the food item exceeds a threshold; determining that the patient's glucose level will rise based on the determination the nutrition information or the volume information [or the portion information] of the particular food item exceeds the threshold; and generating therapy information for a patient based on the determination that the patient’s glucose level will rise). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claims 1, 10, and 19 which are not underlined), the context of claims 1, 10, and 19 encompass concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., a method for therapy delivery for diabetes treatment, comprising: identifying an object as a food item based on a representation of the object; generating nutrition information or volume information [or the portion information] of the food item; determining that the nutrition information or the volume information [or the portion information] of the food item exceeds a threshold; determining that the patient's glucose level will rise based on the determination the nutrition information or the volume information [or the portion information] of the particular food item exceeds the threshold; and generating therapy information for a patient based on the determination that the patient’s glucose level will rise).
The aforementioned claim limitations described in claims 1, 10, and 19 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompasses a person mentally and/or manually observing, evaluating, making judgments, opinions related to: (1) identifying an object as a food item based on a representation of the object (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally identify an object as a particular food); (2) generate nutrition information or volume information [or the portion information] for the identified food item (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually write down the nutrition, volume, or portion information of a food item); (3) determine that the nutrition information or the volume information [or the portion information] of the food item exceeds a threshold (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally compare the nutrition, volume, or portion information of the food item to a threshold and determine that the nutrition, volume, or portion information of the food item is greater than the threshold); (4) determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information [or the portion information] of the particular food item exceeds the threshold (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally determine that the patient’s glucose level will rise based on the determination that the nutrition, volume, or portion information of the food item is greater than the threshold); and (5) generate therapy information for a patient based on the determination that the patient’s glucose level will rise (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally come up therapy information for a patient, such as determining the type or amount of insulin a patient needs, based on the determination that the patient’s glucose level will rise). Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1, 10, and 19 recite an abstract idea that falls within the Mental Processes category.
Furthermore, Examiner notes that dependent claims 9 and 18 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 2-8, 11-17, and 20 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A; and (2) dependent claims 9 and 18 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 9 and 18 merely recite that the generated therapy information comprises determining an insulin type and an insulin dosage. This step is reasonably performed mentally or manually using a pen and paper, because a person is capable of mentally determining a type of insulin and a dosage of insulin for a patient based on the previous mental determination that the patient’s glucose level will rise (i.e., also a form of an observation, evaluation, judgment, and/or opinion). Therefore, the limitations in dependent claims 9 and 18 do not provide any limitations that are deemed to be additional elements outside of the aforementioned abstract idea.
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP § 2106.05 (f), (g), and (h).
In the present case, for independent claims 1, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system for therapy delivery for diabetes treatment (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), the system comprising:
one or more processors (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)); and
one or more processor-readable media storing instructions which, when executed by the one or more processors (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), cause performance of:
identifying an object as a food item based on a representation of the object;
generating nutrition information or volume information of the food item;
determining that the nutrition information or the volume information of the food item exceeds a threshold;
determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold;
responsive to determining that the patient’s glucose level will rise, generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information (the Examiner submits that this additional element is not a particular treatment or prophylaxis, and instead amounts to mere instructions to “apply” the exception in a generic way, see MPEP § 2106.04(d)(2); and generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e)).
Similarly, for independent claim 19, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method for therapy delivery for diabetes treatment, the method comprising:
generating nutrition information or portion information of a food item based on a representation of the food item obtained from one or more sensors (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
determining that the nutrition information or the portion information of the food item exceeds a threshold;
determining that the patient's glucose level will rise based on the determination the nutrition information or the portion information of the particular food item exceeds the threshold;
generating therapy information for a patient based on the determination that the patient’s glucose level will rise; and
automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower (the Examiner submits that this additional element is not a particular treatment or prophylaxis, and instead amounts to mere instructions to “apply” the exception in a generic way, see MPEP § 2106.04(d)(2); and generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e)).
However, the recitation of these generic computer components and functions in claims 1, 11, and 19 are recited at a high-level of generality (i.e., using generic computer devices to perform the abstract idea of: identifying an object as a food item based on a representation of the object; generating nutrition information or volume information [or the portion information] of the food item; determining that the nutrition information or the volume information [or the portion information] of the food item exceeds a threshold; determining that the patient's glucose level will rise based on the determination the nutrition information or the volume information [or the portion information] of the particular food item exceeds the threshold; and generating therapy information for a patient based on the determination that the patient’s glucose level will rise), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of the particularity or generality of the treatment or prophylaxis (e.g., see MPEP § 2106.04(d)(2)):
- Consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications and a step of “administering a suitable medication to a patient”. See MPEP § 2106.04(d)(2). This administration step is not particular, and is instead mere instructions to “apply” the exception in a generic way. Similarly, the current invention incorporates an administration steps in a generic way, because the claims, for example, do not describe what type of insulin is administered or what dosage of the insulin is administered. The treatment is described in a generic way. Therefore, the steps directed to: “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information” and “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower”, are deemed to be the equivalent of mere instructions to “apply” the exception in a generic way.
- The following are examples of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. v. CLS Bank Int’l – similarly, the current invention implements the commonplace medical business method of: identifying food items that a diabetic patient consumes and generating therapy for the patient based on determining that the patient’s glucose level will rise (i.e., the Examiner submits that the additional elements directed to the system comprising one or more processors, one or more processor-readable media storing instructions, and the one or more sensors, are generic computer devices).; and
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g., see Intellectual Ventures I LLC v. Capital One Bank (USA) – similarly, the current inventions requires the use of one or more processors and one or more processor-media storing instructions to perform the aforementioned identified abstract idea.
- The following are examples of generally linking the use of a judicial exception to a particular technological environment or field of use (e.g., see MPEP § 2106.05(h)):
- (1) Specifying that the abstract idea of monitoring audit log data relates to transactions or activities that are executed in a computer environment, because this requirement merely limits the claims to the computer field, i.e., to execution on a generic computer, FairWarning v. Iatric Sys.; (2) Specifying that the abstract idea of using advertising as currency is used on the Internet, because this narrowing limitation is merely an attempt to limit the use of the abstract idea to a particular technological environment, Ultramercial, Inc. v. Hulu; and (3) Requiring that the abstract idea of creating a contractual relationship that guarantees performance of a transaction (a) be performed using a computer that receives and sends information over a network, or (b) be limited to guaranteeing online transactions, because these limitations simply attempted to limit the use of the abstract idea to computer environments, buySAFE Inc. v. Google, Inc. - similarly, the limitations directed to: “automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information”; and “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower”, amounts to limiting the abstract idea to the field of insulin treatments. See MPEP 2106.05(h).
Thus, the additional elements in independent claims 1, 10, and 19 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 9 and 18 do not recite any additional elements outside of those identified as being directed to the abstract idea described above. Examiner notes that dependent claims 2-8, 11-17, and 20 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font):
wherein the system further comprises one or more sensors (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), and wherein the representation of the object is obtained from the one or more sensors (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 2 and 11);
wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 3 and 12);
wherein the system further comprises a wearable device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), and wherein the representation of the object is obtained from the wearable device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 4 and 13);
wherein generating the nutrition information comprises generating a mesh model of the object (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object (as described in claims 5 and 14);
wherein the instructions further cause performance of aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claims 6 and 15);
wherein determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claims 7, 16, and 20); and
wherein the food library comprises a trained machine learning model (the Examiner submits that this additional element amounts to generally linking the abstract idea to a particular field of use, as noted below, see MPEP § 2106.05(e)) (as described in claims 8 and 17).
As such, the additional elements in claims 1-20 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-20: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use 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 whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-20 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claims 1-20 amount to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1-20, as recited, the system for therapy delivery for diabetes treatment; one or more processors; one or more processor-readable media storing instructions; one or more sensors; camera; LiDAR sensor; wearable device; food library; trained machine learning model; and the steps directed to: “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower”; “wherein the representation of the object is obtained from the one or more sensors”; “wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object”; “wherein the representation of the object is obtained from the wearable device”; “wherein generating the nutrition information comprises generating a mesh model of the object”; “wherein the instructions further cause performance of aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified”; and “wherein determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the system for therapy delivery for diabetes treatment; one or more processors; one or more processor-readable media storing instructions; one or more sensors; camera; LiDAR sensor; wearable device; food library; trained machine learning model; and the steps directed to: “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower”; “wherein the representation of the object is obtained from the one or more sensors”; “wherein the one or more sensors includes a camera configured to capture a two-dimensional image of the object and a LiDAR sensor configured to capture a three-dimensional representation of the object”; “wherein the representation of the object is obtained from the wearable device”; “wherein generating the nutrition information comprises generating a mesh model of the object”; and “wherein the instructions further cause performance of aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant discloses that: (1) the processors or processing circuitry may be implemented as fixed- function circuits, programmable circuits, or a combination thereof (see Applicant’s specification as filed on January 15, 2025, paragraph [0146]); (2) the computer-readable media may include tangible, non-transitory media (see Applicant’s specification as filed on January 15, 2025, paragraph [0144]); and (3) the wearable device includes a smart glasses, goggles as part of a headset, goggles without a headset, a necklace, and any other gear configured to be worn on a patient’s head, neck, or face (see Applicant’s specification as filed on January 15, 2025, paragraph [0062]). These descriptions in the specification describes these additional elements as basic computer components and functions, such as sending and receiving data. Therefore, the Examiner submits that these computer components and functions represent well-understood, routine, and conventional computer components and functions which are known in the medical industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
- The Examiner submits that these limitations generally link the use of the judicial exception to a particular technological environment or field of use – for example, the limitations directed to “automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower” amounts to limiting the abstract idea to the field of insulin treatments (see MPEP § 2106.05(h) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the step and feature directed to “wherein determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – similarly the limitation directed to: “wherein determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold”, is similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere transmission of a signal to cloud storage over a network (i.e., accessing the food library, which Applicant describes as cloud storage in the specification – Applicant’s specification as filed on January 15, 2025, paragraph [0063], is the equivalent of receiving and transmitting a signal to a cloud storage over a network).
Therefore, the additional elements described in claims 1-20 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above. Thus, taken alone, the additional elements of claims 1-20 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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.
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 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 7, 9-11, 13, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
- Chiu et al. (Pub. No. US 2019/0341149), in view of:
- Bennett et al. (Pub. No. US 2015/0194071); and
- Duke et al. (Pub. No. US 2017/0348483).
Regarding claims 1, 10, and 19,
- Chiu et al. (Pub. No. US 2019/0341149) teaches:
- a system for therapy delivery for diabetes treatment (Chiu, paragraphs [0033] and [0081]; Paragraph [0081] teaches that a processing system that facilitates a client application 708 that supports communicating with the medical device 702 via the network 710. Paragraph [0033] teaches that the subject matter described herein can be utilized more generally in the context of overall diabetes management or other physiological conditions (i.e., the system is for therapy delivery for diabetes treatment).), the system comprising (as described in claim 1):
- one or more processors (as described in claim 1) (Chiu, paragraph [0081]; Paragraph [0081] teaches that the processing system is implemented using any suitable processing system and/or device, such as, for example, one or more processors.); and
- one or more processor-readable media storing instructions which, when executed by the one or more processors (as described in claim 1) (Chiu, paragraph [0096]; Paragraph [0096] teaches that the control module 802 [of the client computing device 706 - see paragraph [0093]] may be realized using any sort of non-transitory computer-readable medium capable of storing programming instructions for execution by the control module 802 (i.e., one or more processor-readable media storing instructions), where the computer-executable programming instructions are read and executed by the control module 802 (executed by the one or more processors).), cause performance of:
- a method for therapy delivery for diabetes treatment (Chiu, paragraphs [0008] and [0033]; Paragraph [0008] teaches a method of providing guidance to a patient. Paragraph [0033] teaches that the subject matter described herein can be utilized more generally in the context of overall diabetes management or other physiological conditions (i.e., the method is for therapy delivery for diabetes treatment).), the method comprising (as described in claim 10):
- a method for therapy delivery for diabetes treatment (Chiu, paragraphs [0008] and [0033]; Paragraph [0008] teaches a method of providing guidance to a patient. Paragraph [0033] teaches that the subject matter described herein can be utilized more generally in the context of overall diabetes management or other physiological conditions (i.e., the method is for therapy delivery for diabetes treatment).), the method comprising (as described in claim 19):
- identifying an object as a food item based on a representation of the object (as described in claims 1 and 10) (Chiu, paragraph [0036]; Paragraph [0036] teaches that food, beverages, or other consumable items (or indicia thereof) may be identified within a captured image (i.e., identifying an object as a food item based on a representation of the object).);
- generating nutrition information or volume information of the food item (as described in claims 1 and 10); and generating nutrition information or portion information of a food item based on a representation of the food item obtained from one or more sensors (as described in claim 19) (Chiu, paragraph [0036]; Paragraph [0036] teaches that carbohydrate amounts or other attributes (e.g., fiber, fat, protein, and/or the like) associated with the captured consumable(s) may be estimated from the consumables captured by the imaging device (i.e., generating nutrition information based on a representation of the food item that was obtained from one or more sensors). Further, paragraph [0037] teaches that when a patient is about to begin consuming a meal, an image of the meal may be analyzed to identify the type of food being consumed, the nutritional characteristics or other content of the meal device (i.e., generating nutrition information based on a representation of the food item that was obtained from one or more sensors), the estimated portion size device (i.e., generating portion information based on a representation of the food item that was obtained from one or more sensors), and/or the like. The estimated portion size, nutritional characteristics or food type, and other attributes identified based on the captured image may be utilized to calculate or otherwise determine an estimated amount of carbohydrates expected to be consumed by the patient device (i.e., generating nutrition information based on a representation of the food item that was obtained from one or more sensors).);
…
- determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item … (as described in claims 1 and 10); and determining that the patient's glucose level will rise based on the determination the nutrition information or the portion information of the particular food item … (as described in claim 19) (Chiu, paragraph [0128]; Paragraph [0128] teaches that a graphical overlay may be provided visually overlying or adjacent to captured content corresponding to a lifestyle event that indicates how much a patient's glucose levels are predicted to rise or fall if that lifestyle event corresponding to the captured image is engaged in by the patient in the predicted manner (i.e., determining whether the patient’s glucose level will rise [or fall] based on the determination that the nutrition information, volume information, or portion information of the particular food item exceeds the threshold).);
- responsive to determining that the patient's glucose level will rise, generating therapy information for a patient based on the determination that the patient's glucose level will rise (as described in claims 1 and 10); and generating therapy information for a patient based on the determination that the patient’s glucose level will rise (as described in claim 19) (Chiu, paragraph [0089]; Paragraph [0089] teaches that one or more aspects of the infusion device 102, 200, 402 that control or regulate insulin delivery may then be modified or adjusted (i.e., generating therapy information for a patient) to proactively account for the patient’s likely meal activity and glycemic response (i.e., in response to determining that the patient’s glucose level will rise, generating therapy information for the patient).); and
- automatically administering insulin to the patient to cause the glucose level of the patient to lower to within a predetermined range and based on the therapy information (as described in claims 1 and 10); and automatically administering insulin to the patient in accordance with the therapy information to cause the glucose level of the patient to lower (as described in claim 19) (Chiu, paragraph [0136]; Paragraph [0136] teaches that the patient consuming a meal may be recognized or otherwise identified based on one or more captured images, which, in turn may be utilized to deliver a bolus of insulin or adjust one or more settings or control parameters for an autonomous operating mode to account for the meal event captured within the image(s) (i.e., automatically administering insulin to the patient). For example, paragraph [0139] teaches that proactive delivery adjustment process 2100 calculates or otherwise determines a delivery adjustment to be implemented by the patient’s infusion device (task 2106). For example, in one or more embodiments, a bolus amount of insulin to be delivered may be determined based on the assigned attributes (e.g., estimated carbohydrates or the like) to account for the patient’s probable glycemic response to the lifestyle event (i.e., automatically administering insulin to the patient which naturally requires the process to cause the glucose level of the patient to lower to within a predetermined range based on the therapy information). In this regard, bolus dosage amounts or bolus delivery schedules may be determined or otherwise adjusted in a manner that accounts for the predicted postprandial glycemic response to the nutritional content of the meal captured by the imaging device. After determining the delivery adjustment, the proactive delivery adjustment process 2100 instructs, commands, or otherwise configures the infusion device associated with the patient to automatically adjust fluid delivery to deliver fluid in accordance with the delivery adjustment (task 2108) (i.e., automatically administering insulin to the patient).).
- Chiu does not explicitly teach, however, in analogous art of systems and methods for providing personalized nutritional analysis and recommendations based on a user’s current nutritional intake, Bennett et al. (Pub. No. US 2015/0194071) a system and method for therapy delivery for diabetes treatment, comprising:
- determining that the nutrition information or the volume information of the food item exceeds a threshold (as described in claims 1 and 10); and determining that the nutrition information or the portion information of the food item exceeds a threshold (as described in claim 19) (Bennett, paragraphs [0155] and [0165]; Paragraph [0165] teaches that the method provides an analysis of the nutritional content of the food consumed by the user in comparison to nutrient levels recommended for or specified by the user, according to the user's health-related goals. For example, paragraph [0165] teaches that the index is calculated by determining the nutritional content of the consumed food and identifying a deviation between the nutrient levels in the consumed food and target nutrient levels (i.e., determining that the nutrition information of the food item exceeds a threshold, where the target nutrient levels described in Bennett is interpreted as a threshold of the nutrition information). Paragraph [0155] teaches that this feature is beneficial for determining an index based on the nutrient content of a consumed food and target nutrient levels.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for providing personalized nutritional analysis and recommendations based on a user’s current nutritional intake at the time of the effective filing date of the claimed invention to modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, to incorporate a step and feature directed to determining that the nutrition information of a food item exceeds a threshold, as taught by Bennett, in order to determine an index based on the nutrient content of a consumed food and target nutrient levels. See Bennett, paragraph [0155]; see also MPEP § 2143 G.
- Further, the combination of: Chiu, as modified in view of Bennett, does not explicitly teach, however, in analogous art of systems and methods for generating therapy for diabetes treatment, Duke et al. (Pub. No. US 2017/0348483) a system and method for therapy delivery for diabetes treatment, comprising:
- determining that the patient’s glucose level will rise based on the determination the nutrition information or the volume information of the particular food item exceeds the threshold (as described in claims 1 and 10); and determining that the patient's glucose level will rise based on the determination the nutrition information or the portion information of the particular food item exceeds the threshold (as described in claim 19) (Duke, paragraphs [0036] and [0038]; Paragraph [0036] teaches that at time t1, meal event 114 occurs when the user consumes a meal and enters carbohydrate data into management device 26 indicating the amount of carbohydrates consumed with the meal. Paragraph [0036] further teaches that the Bolus calculator module 48 determines a projected glucose level rise and a duration of the glucose rise based on the carbohydrates consumed (i.e., determining that the patient’s glucose level will rise based on a determination of the nutrition information of a particular food item), where paragraph [0038] teaches that the maximum allowed glucose increase is based on an allowed rise value 124, and the level of glucose increase may be determined for meal events above a threshold amount of carbohydrates (i.e., determining that the patient’s glucose level will rise based on the determination of the nutrition information of a particular food item exceeding a threshold). Paragraph [0036] teaches that this feature is beneficial for determining a projected glucose level rise based on the carbohydrates consumed.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for generating therapy for diabetes treatment at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of Bennett, to incorporate a step and feature directed to determining that the patient’s glucose level will rise based on a determination of the nutrition information of a particular food item exceeding a threshold, as taught by Duke, in order to a determine a projected glucose level rise based on the carbohydrates consumed. See Duke, paragraph [0036]; see also MPEP § 2143 G.
Regarding claim 2 and 11,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 1 (which claim 2 depends on) and claim 10 (which claim 11 depends on), as described above.
- Chiu teaches a system and method, wherein:
- the system further comprises one or more sensors, and wherein the representation of the object is obtained from the one or more sensors (as described in claim 2); and wherein the representation of the object is obtained from the one or more sensors (as described in claim 11) (Chiu, paragraphs [0036] and [0095]; Paragraph [0095] teaches that the imaging device 808 is realized as a camera (i.e., the system further comprises one or more sensors), where paragraph [0036] teaches that the consumable items are captured by the imaging device (i.e., the representation of the object is obtained from the one or more sensors).).
The motivations and rationales for modifying the system and method for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, in view of: Bennett and Duke, described in the analysis of the obviousness rejection of claims 1, 10, and 19 above similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claims 4 and 13,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 1 (which claim 4 depends on) and claim 10 (which claim 13 depends on), as described above.
- Chiu teaches a system and method, wherein:
- the system further comprises a wearable device, and wherein the representation of the object is obtained from the wearable device (as described in claim 4); and wherein the representation of the object is obtained from a wearable device (as described in claim 13) (Chiu, paragraph [0123] and FIG. 8; Paragraph [0123] teaches that the computing device 706, 800 implementing the proactive guidance process 1800 is realized as smartglasses or another head-worn device (i.e., the system further comprises a wearable device) where the imaging device 808 continually captures images (i.e., the representation of the object is obtained from the imaging device that is part of the wearable device – see FIG. 8, where the imaging device 808 is part of the electronic device 800, which paragraph [0123] explicitly teaches may be realized as smartglasses or another head-worn device), the control module 802 may continually analyze and monitor the captured images output by the imaging device 808 to recognize or identify one or more items that correspond to a lifestyle event (e.g., an item of food, an exercise machine, or the like).).
The motivations and rationales for modifying the system and method for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, in view of: Bennett and Duke, described in the analysis of the obviousness rejection of claims 1, 10, and 19 above similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claims 7, 16, and 20,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 1 (which claim 7 depends on); claim 10 (which claim 16 depends on); and claim 19 (which claim 20 depends on), as described above.
- Bennett teaches a system and method, wherein:
- determining that the nutrition information or the volume information of the food item exceeds the threshold comprises accessing a food library that defines the threshold (as described in claims 7 and 16); and the threshold is specified in a food library, and wherein determining that the nutrition information or the portion information of the food item exceeds the threshold is determined by accessing the food library (as described in claim 20) (Bennett, paragraphs [0007], [0083], and [0091]; Paragraph [0007] teaches that target level of the first nutrient (i.e., the threshold of the nutrition information) is received from at least one electronic database (i.e., the threshold is defined by accessing a food library, where the electronic database is deemed to be the equivalent of a food library). Paragraph [0083] teaches that the electronic database includes data representative of a target nutrition profile for a person, which includes target levels of nutrients (i.e., the threshold is specified in a food library) that are indicative of a suggested or required amount of the nutrient over the predetermined time period and is determined according to a user-specified nutritional goal (i.e., determining that the nutrition information of the food item exceeds the threshold comprises accessing a food library that defines the threshold). Paragraph [0091] teaches that this feature is beneficial for providing an assessment of an impact on an alignment between the user's diet and the user's dietary goals).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for generating therapy for diabetes treatment at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to accessing a food library that defines the threshold, as taught by Bennett, in order to provide an assessment of an impact on an alignment between the user's diet and the user's dietary goals. See Bennett, paragraph [0091]; see also MPEP § 2143 G.
Regarding claims 9 and 18,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 1 (which claim 9 depends on) and claim 10 (which claim 18 depends on), as described above.
- Duke teaches a system and method, wherein:
- generating the therapy information comprises determining an insulin type and an insulin dosage (as described in claims 9 and 18) (Duke, paragraph [0022]; Paragraph [0022] teaches that the system can automatically suggest a change in therapy such as an increased insulin basal rate or delivery of a bolus (i.e., determining an insulin type, where basal rates and bolus insulin are insulin types). Similarly, the basal rate of the basal insulin is set based on user input or in response to a command from management device 26 (i.e., determining another insulin type). Paragraph [0022] also teaches that insulin doses are calculated based on the CGM readings (i.e., determining an insulin dosage) and are automatically delivered to the patient based on the CGM reading). Paragraph [0022] teaches that this feature is beneficial for calculating an insulin dose necessary to reduce the user’s blood glucose level below a threshold level or to a target level and automatically deliver the dose.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for generating therapy for diabetes treatment at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to generating therapy information comprising determining an insulin type and an insulin dosage, as taught by Duke, in order to calculate an insulin dose necessary to reduce the user’s blood glucose level below a threshold level or to a target level and automatically deliver the dose. See Duke, paragraph [0022]; see also MPEP § 2143 G.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Chiu et al. (Pub. No. US 2019/0341149), as modified in view of: Bennett et al. (Pub. No. US 2015/0194071) and Duke et al. (Pub. No. US 2017/0348483), as applied to claims 2 and 11 above, and further in view of:
- Fitzpatrick (Pub. No. US 2019/0000382).
Regarding claims 3 and 12,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 2 (which claim 3 depends on) and claim 11 (which claim 12 depends on), as described above.
- Chiu further teaches a system and method, wherein:
- the one or more sensors includes a camera configured to capture a two-dimensional image of the object … (as described in claims 3 and 12) (Chiu, paragraphs [0036] and [0095]; Paragraph [0095] teaches that the imaging device 808 is realized as a camera (i.e., the one or more sensors includes a camera), where paragraph [0036] teaches that the consumable items are captured by the imaging device (i.e., the capture naturally captures a two-dimensional image of the objects).).
- The combination of: Chiu, as modified in view of: Bennett and Duke, does not explicitly teach, however, in analogous art of systems and methods for systems and methods for analyzing items using image recognition technology, Fitzpatrick (Pub. No. US 2019/0000382) teaches a system and method, wherein:
- the one or more sensors includes a LiDAR sensor configured to capture a three-dimensional representation of the object (as described in claims 3 and 12) (Fitzpatrick, paragraphs [0022], [0038], and [0202]; Paragraph [0023] teaches that the system is for analyzing items, including analyzing foods whether they are in a store, on a plate, on a menu, in a picture, and the like, and paragraph [0032[ teaches that the system allows a user to keep track and analyze all of the food they use, eat, buy, and consume. Paragraph [0202] teaches that some embodiments of database interface 201 provide multiple types of abstracted APIs that allow unified access to different categories of indexed data, such as: (i) imagery data (e.g., Electro-Optic (EO). Multi-/Hyper-spectral Imagery (MSI/HSI), etc.) and (ii) three-dimensional data (e.g., Light Detection and Ranging (LIDAR) (i.e., the one or more sensors includes a LiDAR sensor configured to capture a three-dimensional representation of an object). Paragraph [0022] teaches that this feature is beneficial for identifying and analyzing the composition of items through image recognition.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for analyzing items using image recognition technology at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to using a LiDAR sensor to capture three-dimensional images of objects, as taught by Fitzpatrick, in order to identify and analyze the composition of items through image recognition. See Fitzpatrick, paragraph [0022]; see also MPEP § 2143 G.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Chiu et al. (Pub. No. US 2019/0341149), as modified in view of: Bennett et al. (Pub. No. US 2015/0194071) and Duke et al. (Pub. No. US 2017/0348483), as applied to claims 1 and 10 above, and further in view of:
- Zadeh et al. (Pub. No. US 2018/0204111).
Regarding claims 5 and 14,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 1 (which claim 5 depends on) and claim 10 (which claim 14 depends on), as described above.
- The combination of: Chiu, as modified in view of: Bennett and Duke, does not explicitly teach, however, in analogous art of systems and methods for image and pattern recognition, Zadeh et al. (Pub. No. US 2018/0204111) teaches a system and method, wherein:
- generating the nutrition information comprises generating a mesh model of the object and based on the mesh model, determine which one amongst a plurality of food items corresponds to the object (as described in claims 5 and 14) (Zadeh, paragraphs [1868] and [2054]; Paragraph [1868] teaches that the computer generated types are based on real images of real objects, as well, which are classified as different types by the computer, and an average or typical sample is stored as an example of that specific type in the database. In one embodiment, the storage of the example is either analytical, e.g. mathematical formulation of curves and meshes (i.e., generating mesh models of the object), to mimic the surfaces in 3-D, or brute force storage as a point-by-point storage of coordinates of data points, in 3-D (x, y, z) coordinates. Paragraph [2054] teaches that from a picture of food plate, the system extracts the objects and recognizes them, e.g. peanut, and from the library (i.e., determining which amongst a plurality of food items corresponds to the object). Paragraph [2054] teaches that this feature is beneficial for getting all of the nutritional facts and proper diet for a person when compared to a recommended regimen for the specific person.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for image and pattern recognition at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to generating mesh models and using the models to determine the food items corresponding to the object, as taught by Zadeh, in order to identify all of the nutritional facts and proper diet for a person when compared to a recommended regimen for the specific person. See Zadeh, paragraph [2054]; see also MPEP § 2143 G.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Chiu et al. (Pub. No. US 2019/0341149), as modified in view of: Bennett et al. (Pub. No. US 2015/0194071); Duke et al. (Pub. No. US 2017/0348483); and Zadeh et al. (Pub. No. US 2018/0204111), as applied to claim 5 above, and further in view of:
- Schloter (Pub. No. US 2020/0090417).
Regarding claim 6,
- The combination of: Chiu, as modified in view of: Bennett; Duke; and Zadeh, teaches the limitations of claim 5 (which claim 6 depends on), as described above.
- The combination of: Chiu, as modified in view of: Bennett; Duke; and Zadeh, does not explicitly teach, however, in analogous art of systems and methods for generating images of objects, Schloter (Pub. No. US 2020/0090417) teaches a system, wherein:
- the instructions further cause performance of aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified (Schloter, paragraphs [0014] and [0032]; Paragraph [0032] teaches that the image aligning module 116 may perform UV mapping to align the portions of the image and model. UV mapping, PTEX, or similar methods may be used to project two dimensional (2D) image data onto a surface of a three dimensional (3D) model for texture mapping. (i.e., aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object). Paragraph [0014] teaches that this feature is beneficial for providing an enhanced appearance and more accurately depicting an environment.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for generating images of objects at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett; Duke; and Zadeh, to incorporate a step and feature directed to aligning images by projecting two-dimensional images onto a surface of three-dimensional images, as taught by Schloter, in order to provide an enhanced appearance and more accurately depict an environment. See Schloter, paragraph [0014]; see also MPEP § 2143 G.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Chiu et al. (Pub. No. US 2019/0341149), as modified in view of: Bennett et al. (Pub. No. US 2015/0194071) and Duke et al. (Pub. No. US 2017/0348483), as applied to claims 7 and 16 above, and further in view of:
- Tran et al. (Pub. No. US 2017/0323481).
Regarding claims 8 and 17,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of: claim 7 (which claim 8 depends on) and claim 16 (which claim 17 depends on), as described above.
- The combination of: Chiu, as modified in view of: Bennett and Duke, does not explicitly teach, however, in analogous art of systems and methods for assisting in monitoring diabetic patients, Tran et al. (Pub. No. US 2017/0323481) teaches a system and method, wherein:
- the food library comprises a trained machine learning model (as described in claims 8 and 17) (Tran, paragraphs [0146], [0173], and [0174]; Paragraph [0173] teaches that data concerning food consumption can be analyzed to identify and track consumption of selected types and amounts of foods, ingredients, or nutrient consumed using one or more methods selected from the group consisting of: linear regression and/or multivariate linear regression, logistic regression and/or probit analysis, Fourier transformation and/or fast Fourier transform (FFT), linear discriminant analysis, non-linear programming, analysis of variance, chi-squared analysis, cluster analysis, energy balance tracking, factor analysis, principal components analysis, survival analysis, time series analysis, volumetric modeling, neural network and machine learning (i.e., generating the food item information is based on machine learning). Paragraph [0174] teaches that food pictures can be analyzed for automated food identification using methods selected from the group consisting of: image attribute adjustment or normalization; inter-food boundary determination and food portion segmentation; image pattern recognition and comparison with images in a food database to identify food type; comparison of a vector of food characteristics with a database of such characteristics for different types of food; scale determination based on a fiduciary marker and/or three-dimensional modeling to estimate food quantity (i.e., the machine learning model is trained); and association of selected types and amounts of ingredients or nutrients with selected types and amounts of food portions based on a food database that links common types and amounts of foods with common types and amounts of ingredients or nutrients. Paragraph [0146] teaches that this feature is beneficial for automatically analyzing and identifying the types and quantities of foods consumed.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for assisting in monitoring diabetic patients at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to the food library comprising a trained machine learning model, as taught by Tran, in order to automatically analyzing and identifying the types and quantities of foods consumed. See Tran, paragraph [0146]; see also MPEP § 2143 G.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Chiu et al. (Pub. No. US 2019/0341149), as modified in view of: Bennett et al. (Pub. No. US 2015/0194071) and Duke et al. (Pub. No. US 2017/0348483), as applied to claim 13 above, and further in view of:
- Schloter (Pub. No. US 2020/0090417).
Regarding claim 15,
- The combination of: Chiu, as modified in view of: Bennett and Duke, teaches the limitations of claim 13 (which claim 15 depends on), as described above.
- The combination of: Chiu, as modified in view of: Bennett and Duke, does not explicitly teach, however, in analogous art of systems and methods for generating images of objects, Schloter (Pub. No. US 2020/0090417) teaches a method, further comprising:
- aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object from which the food item of the plurality of food items is identified (Schloter, paragraphs [0014] and [0032]; Paragraph [0032] teaches that the image aligning module 116 may perform UV mapping to align the portions of the image and model. UV mapping, PTEX, or similar methods may be used to project two dimensional (2D) image data onto a surface of a three dimensional (3D) model for texture mapping. (i.e., aligning a three-dimensional mesh model of the object and a two-dimensional mesh model of the object to generate a co-registered mesh model of the object). Paragraph [0014] teaches that this feature is beneficial for providing an enhanced appearance and more accurately depicting an environment.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for generating images of objects at the time of the effective filing date of the claimed invention to further modify the system and methods for facilitating operation of a medical device to provide diabetes therapy to a user taught by Chiu, as modified in view of: Bennett and Duke, to incorporate a step and feature directed to aligning images by projecting two-dimensional images onto a surface of three-dimensional images, as taught by Schloter, in order to provide an enhanced appearance and more accurately depict an environment. See Schloter, paragraph [0014]; see also MPEP § 2143 G.
Conclusion
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686