DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/26/2026 has been entered.
Response to Amendment
This action is in response to the amendment filed on 08/20/2026. Claims 1, 7, and 13 have been amended. Claims 1-18 are examined below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-12 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.
Regarding claim 7, the limitation “generating, a prescription…” is indefinite. The term “prescription” is defined as orders for medication from a doctor.1 Based on this, it is unclear if the system itself is generating a prescription, or if the prescription is being input into the system by a doctor.
Claims 8-12 are rejected as well since they inherit the limitations of independent claim 7.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 7 recites (additional limitations crossed out):
A system
receiving, from a user terminal, a first set of volumes of liquid insulin used for each different meal in a day for a first user;
determining, based on the first set of volumes of liquid insulin a number of powdered insulin units required for each different meal in the day;
rounding the number of insulin units up to a nearest predetermined powdered insulin dose for each of the different meals;
determining a number and capacity of powdered insulin cartridges to achieve the nearest predetermined powdered insulin doses for each of the different meals wherein determining the number and capacity of powdered insulin cartridges comprises determining, for each different meal, a combination of cartridge capacities to achieve the nearest predetermined powdered insulin dose;
multiplying the number of powdered insulin cartridges of each capacity for each different meal by a number of the different meals in a prescription period;
determining a number of boxes of powdered insulin cartridges of each capacity to be prescribed for the prescription period;
generating, based on the number of boxes of powdered insulin cartridges for each capacity, a prescription; and
generating administration instructions for the first user based on the first set of volumes of liquid insulin and the number and capacity of powdered insulin cartridges, and wherein the powdered insulin cartridges are configured for delivery via inhalation..
The above limitations, as drafted, are processes that, under their broadest reasonable interpretation, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, as well as mathematical calculations.. That is, other than reciting the claims as being performed by a “computing apparatus having a processor and a memory with computer readable program code…”, and a “terminal”, nothing in the claims precludes the steps as being described as managing personal behavior or relationships or interactions between people, and mathematical calculations. The claims, as written describe determining a number of powdered insulin units based on an a received volume of liquid insulin from a user, rounding the number of powdered insulin units up to a predetermined powdered insulin dose, determining a number and capacity of powdered insulin cartridges to achieve the nearest predetermined powdered insulin dose, multiplying the number of powdered insulin cartridges of each capacity by a number of different meals in a prescription period, determining a number of boxes of powdered insulin cartridges of each capacity for the prescription period, and generating administration instructions for the user This merely describes determining instructions for medication administration, as well as a series of simple mathematical calculations (i.e., multiplying insulin required for each meal by a total number of meals for a time period). If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes mathematical calculations, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a “computing apparatus having a processor and a memory with computer readable program code…” and a “terminal” to perform the steps. However, this additional element is recited at a high level of generality (see at least Para. [0052]) such that it amounts to no more than mere instructions to apply the exception using generic computing components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims 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 the abstract idea into a practical application, the additional element of a “computing apparatus having a processor and a memory with computer readable program code…” and a “terminal” to perform the claimed steps amounts to no more mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Therefore, the claims are not found to be patent eligible.
Claims 1 and 13 feature limitations similar to those of claim 17 and are also found to be directed to an abstract idea without significantly more. The Examiner further notes that aside from receiving the first set of volumes of liquid insulin from a user terminal, there are no recitations of any computing elements, thus bolstering the claims being directed to an abstract idea without significantly more.
Claims 2-6 are dependent on claim 1 and include all the limitations of claim 1. Claims 8-12 are dependent on claim 7 and include all the limitations of claim 7. Claims 14-18 are dependent on claim 13 and include all the limitations of claim 13. Therefore, they are also found to be directed to an abstract idea. The dependent claims have not been found to integrate the judicial exception into a practical application or provide significantly more than the abstract idea since it merely further narrows the abstract idea. Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-4, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Taking Afrezza” available March 1, 2021, hereinafter referred to as Afrezza12, in view of “Product Reference Guide” available October 16, 2021, hereinafter referred to as Afrezza23, and McCormick (US 2002/0035484).
Regarding claim 1, Afrezza1 discloses A method of treating a patient with diabetes comprising:
receiving, from a first user, a first set of volumes of liquid insulin used for each different meal in a day;
determining, based on the first set of volumes of liquid insulin used for each meal in the day, a number of powdered insulin units required for each different meal in the day;
rounding the number of powdered insulin units up to a nearest predetermined powdered insulin dose for each of the different meals;
determining a number and capacity of powdered insulin cartridges to achieve the nearest predetermined powdered insulin doses for each of the different meals wherein determining the number and capacity of powdered insulin cartridges comprises determining, for each different meal, a combination of cartridge capacities to achieve the nearest predetermined powdered insulin dose;
(See “Based on clinical trials, it may take 1.5x the amount of Afrezza® to achieve the same blood sugar control as injected insulin. This table can help provide a starting point for mealtime dose conversion, but you and your healthcare provider should decide on the appropriate starting dose, and any dose adjustments, for your specific needs”, the language indicating the different cartridge combinations used to achieve 12 units of Afrezza (i.e., 4 units +8 units, or 12 units), and the table.
Afrezza1 does not explicitly disclose:
multiplying the number of powdered insulin cartridges of each capacity for each different meal by a number of the different meals in a prescription period;
determining a number of boxes of powdered insulin cartridges of each capacity for the prescription period, wherein determining the number of boxes comprises aggregating powdered insulin requirements for each different meal over the prescription period and determining box quantities corresponding to the number and capacities of powdered insulin cartridges; and
generating, based on the number of powdered insulin units for each different meal of the day, a set of instructions, wherein the set of instructions comprises instructions for administration of the powdered insulin based on the first set of volumes of liquid insulin and the number and capacity of powdered insulin cartridges, and wherein the powdered insulin cartridges are configured for delivery via inhalation
See Afrezza2 which teaches a 30 day supply of medication featuring 90 4-unit cartridges and 90 8-unit cartridges (i.e., 30 days x 3 daily meals), and providing options to prescribe 1-3 boxes based on the amount needed. Afrezza2 also discloses generating sets of instructions. See “Example Directions for Use:”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Afrezza1 to utilize the teachings of Afrezza2 since both are in the same field of endeavor (i.e. allocation of medication), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
While heavily implied, Afrezza1 and Afrezza2 do not explicitly disclose generating, a prescription comprising the determined number of boxes of powdered insulin cartridges of each capacity. Afrezza2 teaches providing options to prescribe 1-3 boxes based on the amount of insulin units needed. However, Afrezza1 and Afrezza2 are silent in regard to actually “prescribing”. See McCormick , at least Para. [0048] - “For example, when the doctor taps on the "PRESCRIPTION" program on the handheld terminal, the terminal displays a number of available menu items, such as types of drugs (e.g., pain relievers, antibiotics and antihistamines) as icons either in the text or graphic format. When the particular type of drugs, such as antibiotics, is selected by the physician tapping on the displayed icon, then the PRESCRIPTION program further displays specific antibiotics. By using such a tapping method, the doctor inputs all the necessary information for writing a prescription: the drug name, dosage, frequency of intake, quantity, refill information and any other relevant information.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Afrezza1 and Afrezza2 to utilize the teachings of McCormick since it would allow for authorized personnel to prescribe mediation (Abstract).
Regarding claim 2, Afrezza1 discloses The method of claim 1, wherein the predetermined powdered insulin cartridge capacities comprise 2, 4,8, 12, 16, 20, and/or 24 units. (See images next to table displaying cartridges of 4, 8, and 12 units.)
Regarding claim 3, Afrezza1 does not explicitly disclose The method of claim 1, wherein the prescription period comprises 30, 60, 90, or 120 days. (See Afrezza2 which features a 30-day supply of cartridges. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Afrezza1 to utilize the teachings of Afrezza2 since both are in the same field of endeavor (i.e. allocation of medication), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 4, Afrezza1 does not explicitly disclose The method of claim 1, wherein a box of powdered insulin cartridges comprises 60 or 90 cartridges. (See Afrezza2 which features a least a box of 90 4-unit cartridges. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Afrezza1 to utilize the teachings of Afrezza2 since both are in the same field of endeavor (i.e. allocation of medication), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 6, Afrezza1 discloses The method of claim 1, wherein the diabetes comprises one or more of the diseases selected from the group consisting of type 1 diabetes, type 2 diabetes, gestational diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY) and cystic fibrosis-related diabetes (CFRD). (See “Afrezza® is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.”, and “Afrezza® is not for use in place of long-acting insulin. Afrezza® must be used with long-acting insulin in people who have type 1 diabetes mellitus.”
Claim(s) 7-10, 12-16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Taking Afrezza” available March 1, 2021, hereinafter referred to as Afrezza1, in view of “Product Reference Guide” available October 16, 2021, hereinafter referred to as Afrezza2, McCormick (US 2002/0035484) and Saint (US 2018/0353698)
Regarding claim 7, Afrezza1 and Afrezza2 do not explicitly disclose “A system comprising a computing apparatus having a processor and a memory with computer readable program code, the processor under control of the computer readable program code configured to aid in determining a required number of boxes of powdered insulin cartridges of different capacities for a prescription period by:” and receiving the volumes of liquid insulin from a user terminal.(i.e., computer implementation) (See at least Para. [0052] – “As shown in FIG. 2, the software architecture 200 includes a data aggregator module 210 configured to obtain the health data from a device, such as the pen device 10, sensor device 50, and/or other devices or apps in communication with the companion device 5. The software architecture 200 includes a learning dose calculator module 220 to adaptively and autonomously calculate a dose of the medicine associated with dose injections from the pen device 10 based on time-relevant and context or circumstances-relevant data specific to the patient user of the pen device 10. The software architecture 200 includes a food identification module 230 to process data associated with food, activity, and other contextual data for use by the learning dose calculator module 220.”, Para. [0054] – “It is noted that while the app is described as resident on the companion device 5, it is understood that some or all of the software modules of the app may be resident on the pen device 10 or in a centralized networked computer server, e.g., the cloud, and may be distributed across multiple locations.”, and Para. [0074] – “In some implementations, for example, the recommended calculated dose output can be displayed on an output of the companion device 5 or pen device 10;”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Afrezza1 and Afrezza2 to utilize the teachings of Saint since they are all in the same field of endeavor (i.e. allocation of medication), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
The remaining limitations of claim 7 are similar to those of claim 1 and are therefore rejected using the same rationale.
Claim 13 features limitations similar to those of claims 1 and 7 and is therefore rejected using the same rationale.
Claim 8 and 14 feature limitations similar to those of claim 2 and are therefore rejected using the same rationale.
Claim 9 and 15 feature limitations similar to those of claim 3 and are therefore rejected using the same rationale.
Claim 10 and 16 feature limitations similar to those of claim 4 and are therefore rejected using the same rationale.
Claim 12 and 18 feature limitations similar to those of claim 6 and is therefore rejected using the same rationale.
Claim(s) 5, 11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Taking Afrezza” available March 1, 2021, hereinafter referred to as Afrezza1, in view of “Product Reference Guide” available October 16, 2021, hereinafter referred to as Afrezza2See “Important Safety Information for Afrezza® (insulin human) Inhalation Powder” and McCormick (US 2002/0035484), and in further view of “PHARMACOLOGY REVIEW(S)” by Miyun Tsai-Turton, hereinafter referred to as Tsai-Turton.
Regarding claim 5, Afrezza1, Afrezza2, and McCormick do not explicitly disclose The method of claim 1, wherein the powdered insulin is in a composition comprising human insulin, fumaryl diketopiperazine and polysorbate 80. (See Tsai-Turton – “Afrezza or Technosphere insulin (TI) is inhaled as a dry powder with the aid of a Gen2 inhaler. Technosphere insulin is comprised of recombinant human insulin, a novel excipient fumaryl diketopiperazine (FDKP), the MannKind proprietary excipient and primary component of Technosphere, and polysorbate 80 (PS80).” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Afrezza1, Afrezza2, and McCormick to utilize the teachings of Tsai-Turton since Tsai-Turton provides a further description of the insulin medication described in Afrezza1 and Afrezza2.
Claims 11 and 17 feature limitations similar to those of claim 5 and are therefore rejected using the same rationale.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that Afrezza1 and Arezza2 do not disclose a method to determine through combinations of different capacity powdered insulin cartridges the required dose for each meal, based on the volume of liquid insulin received from a user terminal. The Examiner respectfully disagrees. Afrezza1 features a table indicating how injected insulin doses are converted to Afrezza doses, as well as possible combinations of cartridges to achieve the determined dose.
Applicant argues that Afrezza1 and Afrezza2 do not disclose “determining the number of boxes comprises aggregating powdered insulin requirements for each different meal over the prescription period and determining box quantities corresponding to the number and capacities of powdered insulin cartridges”. The Examiner respectfully disagrees. As stated in the body of the rejection above, Afrezza2 teaches a 30-day supply of medication featuring 90 4-unit cartridges and 90 8-unit cartridges (i.e., 30 days x 3 daily meals) and providing options to prescribe 1-3 boxes based on the amount needed.
Applicant’s arguments regarding “generating a prescription…” have been considered but are moot due to the application of additional prior art.
Applicant argues that Afrezza1 and Afrezza2 do not disclose “generating instructions”. Applicant argues that Afrezza2 merely features examples of directions. This is not persuasive as an example of a direction is still a direction/instruction.
For at least the above reasons, the 103 rejection is maintained.
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that the claims “recite a specific method for determining required doses of powdered insulin for a user, based on the volume of liquid insulin previously used, and generation a prescription for the required number and capacity of powdered insulin cartridges and administration instructions specific to a use” and therefore cannot be properly characterized under managing personal behavior or relationships or interactions between people. This is unpersuasive as it is merely a conclusory statement.
Applicant argues that the claims do not fall within the “Mathematical Concept” grouping of abstract ideas due to failing to recite a mathematical concept. The Examiner respectfully disagrees and points to at least the limitations of “rounding the number of powdered insulin units up to a nearest predetermined powdered insulin dose for each of the different meals” and “multiplying the number of powdered insulin cartridges of each capacity for each different meal by a number of the different meals in a prescription period”. The functions of “rounding” and “multiplying” are clearly mathematical concepts.
Applicant argues that the claims implement the abstract idea in a specific treatment and prescription-delivery context. The Examiner respectfully disagrees. The Examiner respectfully disagrees. The claims merely feature instructions for the calculation of a dosage. The fact that the dosage is in a particular format (i.e., inhalable) does not change this.
Applicant argues that the claims “produce an accurate and user-specific output, such as a prescription and administration instructions”. This is not persuasive. The providing of particular data does not make the claim any less abstract.
Applicant argues again that the claims present an improvement to an existing technology. This is still not persuasive as the functioning capabilities of any involved computing elements remain unchanged. If anything, the claims merely present a series of simple calculations via computer implementation.
Based on at least the above, the 101 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Afrezza (Insulin Human) Inhalation Powder” by Tamara Goldberg, available November 20154 discusses converting subcutaneous insulin doses to inhaled dose amounts (See at least Table 4).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685 /KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 See at least https://www.cancer.gov/publications/dictionaries/cancer-terms/def/prescription
2 Found at https://web.archive.org/web/20210301002446/https://afrezza.com/taking-afrezza/#what_to_expand
3 Found at https://web.archive.org/web/20211016015051/https://afrezzahcp.com/wp-content/uploads/2021/07/US-AFR-1226-Afrezza-Digital-Product-Reference-Guide.pdf
4 Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC4634344/
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