DETAILED ACTION
Claims 1-17 (filed 09/13/2026) have been considered in this action. Claims 1-5 and 8-17 have been amended. Claims 6-7 have been canceled.
Response to Arguments
Applicant’s arguments, see page 16 paragraph 3, filed 09/13/2026, with respect to objections to the drawings and the filing of replacement drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 17 paragraph 1, filed 09/13/2026, with respect to objections to claims 1, 2, 5, 6 and 7 have been fully considered and are persuasive. The objection of claims 1, 2, 5, 6 and 7 has been withdrawn.
Applicant’s arguments, see page 17 paragraph 3, filed 09/13/2026, with respect to interpretation of claims under 35 U.S.C. 112(f) have been fully considered and are partially persuasive. The interpretation of “detection module”, “program module” and “infusion module” of claims 1-5 and 8-17 has been withdrawn.
Applicant’s arguments, see page 19 paragraph 2, filed 09/13/2026, with respect to rejection of claims 1-17 under 35 U.S.C. 112(b) in relation to the indefiniteness of having element interpreted under 35 U.S.C. 112(f) have been fully considered and are persuasive. The rejection of claims 1-17 under 35 U.S.C 112(b) has been withdrawn.
Applicant’s arguments, see page 19 paragraph 3, filed 09/13/2026, with respect to rejection of claims 3, 5, 7 and 9 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 3, 5, 7 and 9 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see page 20 paragraph 1, filed 09/13/2026, with respect to rejection of claims 1-5 and 8-17 under 35 U.S.C. 103 have been fully considered and are persuasive. The incorporation of subject matter from claim 6 into claim 1 is found convincing. The rejection of claims 1-5 and 8-17 under 35 U.S.C. 103 has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: The use of PID as an acronym without expansion of the acronym in the claim (i.e. proportional-integral-derivative type control algorithm) is improper.
Claims 2 and 3 are objected to because of the following informalities: The use of MPC as an acronym without expansion of the acronym in the claim (i.e. Model Predictive Control type control algorithm) is improper.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 8-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 falls into the statutory category of invention of a machine or product, a physical device embodied as a system. Claim 1 recites that the claimed closed-loop artificial pancreas insulin infusion system comprises a detection module, program module, and infusion module. As noted above, these elements were previously recited to reflect 35 U.S.C. 112(f) type interpretation, which has been overcome through the incorporation of claimed structural elements. However, the claimed “program module” has been claimed to recite inclusion of structure in the form of memory without any other type of structure. The inclusion of memory alone is non-enabling for the functions performed by the program module. For example, while PHOISITA would understand the use of a processor, particularly in the form of a computer processor, would enable the claimed limitation performed by the program module, no such structure is claimed or recited in the provided disclosure and thus the claims are considered non-enabling.
When looking at the Wands factors for enablement, the following analysis is performed:
The breadth of the claims – the program module is claimed as including a memory with no other structural element. The program module is claimed as performing “calculate an insulin infusion amount required by a user” and which is “preset with a hybrid artificial pancreas algorithm”, the breadth of the claim therefore requires a structure capable of calculation and running an artificial pancreas algorithm. Even when considering the use of memory under the BRI, PHOSITA would understand that memory alone is incapable of performing such functionality.
The nature of the invention – the invention is directed towards a system that detects a current blood glucose continuously, calculates an infusion amount using algorithms, and infuses insulin according to the calculated infusion amount. The nature of the invention is a control system by which a sensed amount is read, a calculated infusion amount is determined, and the calculated infusion amount is determined. The nature of the invention can generically be described as a computer/processor-controlled insulin infusion system.
The level of one of ordinary skill – PHOSITA would understand that in order for the program module to operate, a processor or computer that performs the functionality of the program module would be required because they would understand that memory on its own is incapable of making algorithmic determinations of how much insulin to infuse. PHOSITA would understand that memory is capable by itself to store information, however the determinations on values stored in that memory would be performed by a processor, not by the memory
The level of predictability in the art – the level of predictability in the art is high as the use of algorithms for a control operation is a deterministic process that could easily be performed by a processor. However, as previously noted, there is no processor claimed and without this crucial structure the level of predictability becomes low because there is no well-known and predictable structure capable of performing the functionality of the program module as is disclosed by the inventor
The amount of direction provided by the inventor – The inventor has related the actions of the program module to making algorithmic determinations and linked the various claimed modules to being connected together electrically. Paragraph [0332] links the program module towards containing memory, but fails to explicit recite that the program module includes a form of processor or computer (i.e. processor and memory). The inventor never explicitly describes what essential components make up the program module, and has claimed it as only containing memory.
The existence of working examples – no working examples have been provided as nowhere in the disclosure is there disclosed a processor or computer with processor that performs the algorithmic determinations of the claimed system.
Based upon the above factors, it is found that the claims as written are non-enabling as they fail to disclose or describe a processor or computer for performing the actions of the program module. The program module is claimed as only containing memory, a structure which by itself is incapable of performing the claimed functionality. Accordingly, claims 1-5 and 8-17 are rejected under 35 U.S.C. 112(a) for a lack of enabling disclosure.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 8-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the element:
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The term G with no subscript in the definition of xt is indefinite because it is unclear what its meaning is in relationship with the terms that define the prediction model. While claim 1 recites that Gt represents a blood glucose at the current moment, it is unclear at which point in time G with no subscript represents. It is the same or different from Gt or does it represent a particular time point? The lack in definitiveness of the term G in the current state parameter is considered indefinite because PHOSITA would not be advised to the metes and bounds of the claims. Accordingly, claim 1 is rejected as being indefinite under 35 U.S.C. 112(b).
Claims 2-5 and 8-17 are dependent upon claim 1, and thus inherit the rejection of claim 1 under 35 U.S.C. 112(b).
Conclusion
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 JONATHAN M SKRZYCKI whose telephone number is (571)272-0933. The examiner can normally be reached M-Th 7:30-3:30.
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/JONATHAN MICHAEL SKRZYCKI/ Examiner, Art Unit 2116
