DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Regarding claim 27, the limitation is "at least one processor configured to…adjust one of the one or more therapeutic parameters based on the volume, including adjusting the maximum bolus setting" may be unclear because it is not known whether the "adjusting the maximum bolus setting" is also based on the volume.
For the purpose of examination, the limitation will be interpreted to mean "at least one processor configured to…adjust one of the one or more therapeutic parameters based on the volume, wherein the one or more therapeutic p[parameters includes the maximum bolus setting."
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 21, 23, 27, 32 and 33 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Poulsen et al (U.S. Pat. 6,340,357 B1, hereinafter "Poulsen").
Regarding claim 21, Poulsen discloses a portable infusion pump system, comprising:
a reservoir 1 (see Fig. 1) configured to contain a medicament;
a pump mechanism (motor 11, gear 12, toothing 13 and nut 4 which engages and moves piston rod 3 to pump fluid from the reservoir) configured to deliver the medicament in the reservoir to a user;
a memory (an electronic circuit on which are stored the limits described below); and
at least one processor (the portion of the electronic circuit configured to perform the following steps, as described below) configured to:
determine a volume (indicated as a number of units) of medicament disposed in the reservoir (the number of units of medicament delivered may be cumulated so that the circuit can calculate the number of units left in the cartridge; see col. 5, lines 18-23);
set one or more therapeutic parameters for delivery of the medicament based on the volume, wherein setting one or more therapeutic parameters includes setting a maximum bolus setting (the number of units left in the cartridge is set as the maximum, or upper limit, of the dose; this dose is considered to be a "bolus maximum" since it is delivered as a single dose at one time; see col. 5, lines 18-23); and
store the maximum bolus setting in the memory (the number is "set", i.e., understood to be stored in the electronic circuit; see also col. 3, lines 25-30, disclosing setting a maximum dose and programming that number into the electronic circuit).
Regarding claim 23, Poulsen discloses that the at least one processor is configured to set one or more therapeutic parameters by modifying a previously set parameter based on the current volume (e.g., the previously set parameter is the previous maximum bolus setting, which can be modified based on the number of units left in the cartridge, as described above).
Regarding claim 27, Poulsen discloses a portable infusion pump system, comprising:
a reservoir 1 (see Fig. 1) configured to contain a medicament;
a pump mechanism (motor 11, gear 12, toothing 13 and nut 4 which engages and moves piston rod 3 to pump fluid from the reservoir) configured to deliver the medicament in the reservoir to a user;
a memory (an electronic circuit on which are stored the limits described below); and
at least one processor (the portion of the electronic circuit configured to perform the following steps, as described below) configured to:
store one or more therapeutic parameters including a maximum bolus setting for delivery of the medicament in the memory (the number of units left in the cartridge is set as the maximum, or upper limit, of the dose; this dose is considered to be a "bolus maximum" since it is delivered as a single dose at one time, and is then stored in the electronic circuit; see col. 5, lines 18-30);
determine a volume (indicated as a number of units) of medicament disposed in the reservoir (the number of units of medicament delivered may be cumulated so that the circuit can calculate the number of units left in the cartridge; see col. 5, lines 18-23);
adjust one of the one or more therapeutic parameters based on the volume, including adjusting the maximum bolus setting (as noted above the number of units left in the cartridge is set as the maximum, or upper limit, of the dose; this dose is considered to be a "bolus maximum" since it is delivered as a single dose at one time; see col. 5, lines 18-23);
store the adjusted maximum bolus setting in the memory (the number is "set", i.e., understood to be stored in the electronic circuit; see also col. 3, lines 25-30, disclosing setting a maximum dose and programming that number into the electronic circuit).
Regarding claim 32, Poulsen discloses that the at least one processor is configured to determine the volume of medicament disposed in the reservoir based on measurements made during an operation that results in dispensing a portion of the medicament to the user (units of medicament are dispensed, and then number of units dispensed is cumulated in order to calculate the number of units left in the cartridge).
Regarding claim 33, Poulsen discloses that the at least one processor is configured to determine the volume of medicament disposed in the reservoir based on measurements made during an operation that results in dispensing a portion of the medicament to the user (units of medicament are dispensed, and then number of units dispensed is cumulated in order to calculate the number of units left in the cartridge).
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23, 25, 27, 30, 32 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lebel et al (WO2001054753A2, hereinafter “Lebel”) in view of Poulsen.
Regarding claim 21, 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); and
at least one processor (such as a CPU; see pg. 13, lines 12-15 and pg. 55, lines 1-2) configured to:
determine a 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 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
set one or more therapeutic parameters for delivery of the medicament, wherein setting one or more therapeutic parameters includes setting a maximum bolus setting (see pg. 50, lines 23-30, disclosing that the bolus maximum is programmed into the system); and
store, in the memory, the maximum bolus setting for delivery of the medicament (see pg. 46, lines 17-20, disclosing a therapeutic parameter being a bolus maximum).
It is noted that Lebel does not appear to disclose that the processor is configured to set the one or more therapeutic parameters, including the maximum bolus setting, based on the volume.
Poulsen discloses a portable infusion pump system, comprising:
a reservoir 1 (see Fig. 1) configured to contain a medicament;
a pump mechanism (motor 11, gear 12, toothing 13 and nut 4 which engages and moves piston rod 3 to pump fluid from the reservoir) configured to deliver the medicament in the reservoir to a user;
a memory (an electronic circuit on which are stored the limits described below); and
at least one processor (the portion of the electronic circuit configured to perform the following steps, as described below) configured to:
determine a volume (indicated as a number of units) of medicament disposed in the reservoir (the number of units of medicament delivered may be cumulated so that the circuit can calculate the number of units left in the cartridge; see col. 5, lines 18-23);
set one or more therapeutic parameters for delivery of the medicament based on the volume, wherein setting one or more therapeutic parameters includes setting a maximum bolus setting (the number of units left in the cartridge is set as the maximum, or upper limit, of the dose; this dose is considered to be a "bolus maximum" since it is delivered as a single dose at one time; see col. 5, lines 18-23); and
store the maximum bolus setting in the memory (the number is "set", i.e., understood to be stored in the electronic circuit; see also col. 3, lines 25-30, disclosing setting a maximum dose and programming that number into the electronic circuit).
A skilled artisan would have found it obvious at the time of the invention to modify the processor of Lebel to be configured to set one of the one or more therapeutic parameters based on the volume, including setting the maximum bolus setting, as taught by Poulsen, in order to avoid setting a dose that exceeds the amount of remaining medicament in the cartridge, with a reasonable expectation of success (see Poulsen at col. 4, lines 63-65 and col. 5, lines 18-20; Poulsen discloses avoiding setting of a dose that exceeds the amount of remaining medicament in the cartridge, which can be done electronically).
Regarding claim 23, the processor of Lebel is configured to set one or more therapeutic parameters by modifying a previously set parameter based on the current volume (see the above description with respect to claim 21; the operational mode can be changed when more drug is added to the reservoir).
Regarding claim 25, Lebel discloses that setting one or more therapeutic parameters includes setting a basal rate (see delivery modes, described on pg. 41, lines 10-30, including a "suspend mode" where the system reduces infusion delivery to an insignificant amount by interrupting delivery of a basal rate).
Regarding claim 27, 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); and
at least one processor (such as a CPU; see pg. 13, lines 12-15 and pg. 55, lines 1-2) configured to:
store, in the memory, one or more therapeutic parameters including a maximum bolus setting for delivery of the medicament (see pg. 46, lines 17-20, disclosing a therapeutic parameter being a bolus maximum),
determine a 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 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
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).
It is noted that Lebel does not appear to disclose that the processor is configured to adjust one of the one or more therapeutic parameters based on the volume, including adjusting the maximum bolus setting.
Poulsen discloses a portable infusion pump system, comprising:
a reservoir 1 (see Fig. 1) configured to contain a medicament;
a pump mechanism (motor 11, gear 12, toothing 13 and nut 4 which engages and moves piston rod 3 to pump fluid from the reservoir) configured to deliver the medicament in the reservoir to a user;
a memory (an electronic circuit on which are stored the limits described below); and
at least one processor (the portion of the electronic circuit configured to perform the following steps, as described below) configured to:
determine a volume (indicated as a number of units) of medicament disposed in the reservoir (the number of units of medicament delivered may be cumulated so that the circuit can calculate the number of units left in the cartridge; see col. 5, lines 18-23);
set one or more therapeutic parameters for delivery of the medicament based on the volume, wherein setting one or more therapeutic parameters includes setting a maximum bolus setting (the number of units left in the cartridge is set as the maximum, or upper limit, of the dose; this dose is considered to be a "bolus maximum" since it is delivered as a single dose at one time; see col. 5, lines 18-23); and
store the maximum bolus setting in the memory (the number is "set", i.e., understood to be stored in the electronic circuit; see also col. 3, lines 25-30, disclosing setting a maximum dose and programming that number into the electronic circuit).
A skilled artisan would have found it obvious at the time of the invention to modify the processor of Lebel to be configured to adjust one of the one or more therapeutic parameters based on the volume, including adjusting the maximum bolus setting, as taught in Poulsen, in order to avoid setting of a dose which exceeds the amount of remaining medicament in the cartridge, with a reasonable expectation of success (see Poulsen at col. 4, lines 63-65 and col. 5, lines 18-20; Poulsen discloses avoiding setting of a dose which exceeds the amount of remaining medicament in the cartridge, which can be done electronically).
Regarding claim 32, Lebel discloses that the at least one processor is configured to determine the volume of medicament disposed in the reservoir based on measurements made during an operation that results in dispensing a portion of the medicament to the user (in a 25th aspect of the invention, described at pg. 19, beginning at line 9, disclosing changing an operational mode of the pump based on a detected or estimated amount of drug remaining in the reservoir, which is a function of a dispensing action; 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, which is also a function of a dispensing action; see pg. 20, lines 20-25).
Regarding claim 33, Lebel discloses that the at least one processor is configured to determine the volume of medicament disposed in the reservoir based on measurements made during an operation that results in dispensing a portion of the medicament to the user (in a 25th aspect of the invention, described at pg. 19, beginning at line 9, disclosing changing an operational mode of the pump based on a detected or estimated amount of drug remaining in the reservoir, which is a function of a dispensing action; 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, which is also a function of a dispensing action; see pg. 20, lines 20-25).
Response to Arguments
Applicant's arguments, filed on 06/05/2026, have been fully considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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 08/17/2026
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