DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/04/2026 has been entered.
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 21, 27 and all claims depending therefrom, 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 21, the new matter is: at least one processor configured to determine a current volume of medicament disposed in the reservoir; and set one or more therapeutic parameters for delivery of the medicament based on the current volume, wherein the at least one processor is configured to set one or more therapeutic parameters higher for higher detected current volumes and lower for lower detected current volumes, wherein setting one or more therapeutic parameters includes setting a maximum bolus setting; and store the maximum bolus setting in the memory.
Applicant's specification discuses detecting a volume of a fluid disposed in a collapsible reservoir and "analyzing obtained data on the volume of the fluid to determine the setting of therapeutic parameters" (see pg. 3). One such parameter can be a "max bolus volume range" (Id.). However, the disclosure does not support that the claimed maximum bolus setting (corresponding to the "max bolus volume range" in the specification) is based on the current volume of the medicament disposed in the reservoir, as claimed.
Applicant's specification also discloses that therapeutic parameter, such as a max bolus volume range, of the infusion pump may be set lower for infusion cartridges with a smaller volume than for infusion cartridges with a larger volume (see pg. 23) but this disclosure relates to the capacity of the reservoir, not the current volume of the medicament disposed in the reservoir.
Claim 27 recites substantially the same subject matter, and is rejected accordingly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lebel et al (WO2001054753A2, hereinafter “Lebel”) discloses a portable infusion pump system (the device is disclosed to be “ambulatory”; see pg. 1, line 5), comprising:
a reservoir 84 (see Fig.3) configured to contain a medicament;
a pump mechanism 86 (see Fig. 3) configured to deliver the medicament in the reservoir to a user; and
a memory (see pg. 18, lines 1-5, disclosing a memory for storing a plurality of parameter values that are used for predefined time periods, to control the treatment provided to the body or monitoring thereof; see also pg. 34, lines 3-12 disclosing a memory for storing program code and data);
at least one processor (such as a CPU; see pg. 13, lines 12-15 and pg. 55, lines 1-2) configured to:
determine a current volume of medicament disposed in the reservoir (in a 25th aspect of the invention, described at pg. 19, beginning at line 9, disclosing changing an operational mode of a the pump based on a detected or estimated amount of drug remaining in the reservoir; or in a 26th aspect of the invention, described at pg. 20, lines 20-25, a “second signal” indicates the amount of drug remaining in the reservoir being at or below a predetermined amount less than a specified low level; see pg. 20, lines 20-25) and
wherein setting one or more therapeutic parameters includes setting a maximum bolus setting (see pg. 46, lines 17-20, disclosing a therapeutic parameter being a bolus maximum) and configured to store the maximum bolus setting in the memory (see pg. 50, lines 23-30, disclosing that the bolus maximum is programmed into the system; based on the discussion of the memory, cited above, the bolus maximum is understood to be stored in the memory as setting of the aforementioned program code/data).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
03/03/2026
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