DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 09/16/2026 is acknowledged. In the present case, all claims are directed to Group I and thus, no claims are withdrawn.
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 20-29 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Alderete et al. (USPGPub 2012/0259282).
Re Claim 20, Alderete teaches an ambulatory infusion pump system (100), comprising: an infusion cartridge (111) including a reservoir configured to contain a medicament (Alderete Figs. 2-3; ¶ 0065-0066); an infusion pump configured to selectively receive the infusion cartridge (111) (Alderete Figs. 2-3; ¶ 0065-0066), the infusion pump including a pump motor (124) configured to operate a drive mechanism (125) to cause medicament from the infusion cartridge (111) to be delivered to a user (Alderete ¶ 0070-0071); and at least one processor (122) configured to: execute a closed loop motor control algorithm configured to generate pulse width modulation (PWM) commands as electrical command input into the pump motor to operate the drive mechanism; control a velocity output of the pump motor with the PWM commands such that a value of the PWM commands is proportional to a load on the pump motor (Alderete ¶ 0220, 0215-0259); compare values of the PWM commands to a threshold value (Alderete ¶ 0217-0259); and generate a missing cartridge indication if the values of the PWM commands drop below the threshold value by a predetermined amount (Alderete ¶ 0238).
Re Claim 21, Alderete teaches wherein the threshold value is determined based off of PWM commands applied to the pump motor during a loading sequence of the infusion cartridge onto the infusion pump (Alderete ¶ 0244, 0215-0259).
Re Claim 22, Alderete teaches wherein the PWM commands are uniform amplitude voltage pulses (Alderete ¶ 0076).
Re Claim 23, Alderete teaches wherein the predetermined amount is based on a pumping speed of pump operations (Alderete ¶ 0013-0017; 0230-0242 – teaching encoder counts).
Re Claim 24, Alderete teaches wherein the predetermined amount is lower for lower pumping speeds and higher for higher pumping speeds (Alderete ¶ 0230-0242).
Re Claim 25, Alderete teaches the infusion pump system further comprising a user interface (104, 106) configured to display the missing cartridge indication (Alderete ¶ 0062, 0082-0083, 0094, 0238).
Re Claim 26, Alderete teaches wherein the user interface (104, 106) is part of the infusion pump (100) (as seen in Alderete Fig. 1).
Re Claim 27, Alderete teaches wherein the value of each of the PWM commands is a duty cycle of a series of electrical pulses provided as input to power the pump motor for each motor move of a pumping cycle (Alderete ¶ 0155, 0198-0204).
Re Claim 28, Alderete teaches wherein the value of each PWM command is a unitless number (Alderete ¶ 0155, 0198-0204).
Re Claim 29, Alderete teaches wherein the unitless number is a percentage (Alderete ¶ 0155, 0198-0204).
Claim Rejections - 35 USC § 103
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 30-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alderete et al. (USPGPub 2012/0259282) in view of Bazargan et al. (USPGPub 2010/0164727).
Re Claim 30, Alderete teaches an ambulatory infusion pump system (100), comprising: an infusion cartridge (111) including a reservoir configured to contain a medicament (Alderete Figs. 2-3; ¶ 0065-0066); an infusion pump configured to selectively receive the infusion cartridge (111) (Alderete Figs. 2-3; ¶ 0065-0066), the infusion pump including a pump motor (124) configured to operate a drive mechanism (125) to cause medicament from the infusion cartridge (111) to be delivered to a user (Alderete ¶ 0070-0071), and at least one processor (122) configured to: generate operational pulse width modulation (PWM) commands as electrical command input into the pump motor (124) causing the pump motor to operate the drive mechanism; control a velocity output of the pump motor with a velocity loop algorithm by generating the operational PWM commands as electrical command input into the pump motor (Alderete ¶ 0220, 0215-0259); compare values of the operational PWM commands that are generated as electrical command input into the pump motor during pumping operations to a threshold value of PWM commands (Alderete ¶ 0217-0259); and generate a cartridge indication if the values of the operational PWM commands drop below the threshold value of PWM commands by a predetermined amount (Alderete ¶ 0238).
Alderete fails to explicitly disclose the generation of the cartridge indication being a missing cartridge indication. Bazargan discloses a system for detecting the presence of a cartridge comprising initiating a safety check to inform a user of a missing cartridge and prompt the user to insert a cartridge, or otherwise investigate the reason for why no cartridge is detected, thus improving the safety of the device (Bazargan ¶ 0059-0060). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the cartridge indication of Alderete to be a missing cartridge indication as disclosed by Bazargan wherein the indication can prompt a user to insert a cartridge, or otherwise investigate the reason for why no cartridge is detected, thus improving the safety of the device (Bazargan ¶ 0059-0060).
Re Claim 31, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein the at least one processor is further configured to: initiate an infusion cartridge loading sequence when the infusion cartridge is loaded onto the infusion pump (Alderete ¶ 0214-0215); record loading PWM commands applied to the pump motor during the loading sequence (Alderete ¶ 0215-0216), and wherein the threshold value is determined based off of the loading PWM commands (Alderete ¶ 0244, 0215-0259).
Re Claim 32, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein the PWM commands are uniform amplitude voltage pulses (Alderete ¶ 0076).
Re Claim 33, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein the predetermined amount is based on a pumping speed of pump operations (Alderete ¶ 0013-0017; 0230-0242 - encoder counts).
Re Claim 34, Alderete in view of Bazargan teach all of the limitations of Claim 33. Alderete teaches wherein the predetermined amount is lower for lower pumping speeds and higher for higher pumping speeds (Alderete ¶ 0230-0242).
Re Claim 35, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein generating a cartridge indication includes displaying the cartridge indication on a user interface (104, 106) of the infusion pump system (Alderete Fig. 1; ¶ 0238). However, Alderete fails to explicitly teach wherein generating a missing cartridge indication includes displaying the missing cartridge indication on a user interface of the infusion pump system. Bazargan discloses generating a missing cartridge indication includes displaying the missing cartridge indication on a user interface of the infusion pump system as a safety check to inform a user of a missing cartridge and prompt the user to insert a cartridge, or otherwise investigate the reason for why no cartridge is detected, thus improving the safety of the device (Bazargan ¶ 0059-0060). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the cartridge indication of Alderete in view of Bazargan wherein generating a missing cartridge indication includes displaying the missing cartridge indication on a user interface of the infusion pump system as disclosed by Bazargan wherein the indication can prompt a user to insert a cartridge, or otherwise investigate the reason for why no cartridge is detected, thus improving the safety of the device (Bazargan ¶ 0059-0060).
Re Claim 36, Alderete in view of Bazargan teach all of the limitations of Claim 35. Alderete teaches wherein the user interface (104, 106) is part of the infusion pump (100) (as seen in Alderete Fig. 1).
Re Claim 37, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein the value of each of the PWM commands is a duty cycle of a series of electrical pulses provided as input to power the pump motor for each motor move of a pumping cycle (Alderete ¶ 0155, 0198-0204).
Re Claim 38, Alderete in view of Bazargan teach all of the limitations of Claim 30. Alderete teaches wherein the value of each PWM command is a unitless number (Alderete ¶ 0155, 0198-0204).
Re Claim 39, Alderete in view of Bazargan teach all of the limitations of Claim 38. Alderete teaches wherein the unitless number is a percentage (Alderete ¶ 0155, 0198-0204).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
