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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered.
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.
Claims 1-8 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (USPGPub 2012/0238851) in view of Garibotto (USPGPub 2002/0040208).
Re Claim 1, Kamen teaches a medical infusion pump system, comprising: a pump assembly (Kamen Figs. 1A-5F) that includes a pump device (104) and a controller device (102) (Kamen ¶ 0066-0073), wherein the pump device (104) is operable to receive a fluid cartridge and is in a first housing (102-1) (Kamen ¶ 0067, 0074-0077; Figs. 1A-1B; Annotated Fig. 1A below), the controller device (102) is operable to control the pump device (104) and is in a second housing (104-1) separate from the first housing (102-1) (Kamen ¶ 0066-0074 Annotated Fig. 1A below), and the first housing (102-1) and the second housing (104-1) are configured to slidably engage one another (Kamen ¶ 0068, 0072); and a mobile device (600, 700, 802) comprising a memory for storing computer-readable instructions to access a dosage calculator application for calculating a suggested medication bolus dosage (Kamen ¶ 0224, 0228, 0230-0232), the mobile device (600, 700, 802) configured to wirelessly transfer data to the pump assembly to cause the pump assembly to deliver the suggested medication bolus dosage to a user (Kamen ¶ 0224, 0228, 0230-0232), wherein the mobile device (600, 700, 802) is operable to prompt the user for confirmation of acceptance of a suggested medication bolus dosage before wirelessly transferring data to the pump assembly to cause the pump assembly to deliver the suggested medication bolus dosage to the user (Kamen ¶ 0480).
Kamen further teaches wherein the controller device (102) comprises a drive system (108) for dispensing a fluid (Kamen ¶ 0068). However, Kamen fails to teach wherein the pump device comprises the drive system for dispensing a fluid. Garibotto teaches a medical infusion pump system, comprising: a pump assembly (Garibotto Fig. 9) that includes a pump device (94) and a controller device (93) (Garibotto ¶ 0091), wherein the pump device (94) comprises a drive system (48) for dispensing a fluid (Garibotto ¶ 0091; Fig. 9), wherein the pump device (94) comprising the drive system (48) wherein the configuration is simple in design, and inexpensive and easy to manufacture, to further reduce the size, complexity and costs of the devices, such that the devices or portions thereof lend themselves to being small and disposable in nature (Garibotto ¶ 0013). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pump device of Kamen to have the pump device comprise the drive system for dispensing the fluid as disclosed by Garibotto wherein the configuration is simple in design, and inexpensive and easy to manufacture, to further reduce the size, complexity and costs of the devices, such that the devices or portions thereof lend themselves to being small and disposable in nature (Garibotto ¶ 0013).
PNG
media_image1.png
533
507
media_image1.png
Greyscale
Re Claim 2, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen further teaches wherein the mobile device is a smartphone (Kamen ¶ 0412).
Re Claim 3, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the confirmation of acceptance of the suggested medication bolus dosage by the user is provided by physically bumping the mobile device (600, 700, 802) against the pump assembly (Kamen ¶ 0012, 0345, 0412, 0428, 0486 - teaching "to prevent unintentional confirmation when a therapy change is being made, in some embodiments, the system requires a different action, for example, a slide rather than a touch/tap and in addition, in some embodiments, the start of the slide is in a opposite side from the "next" or "ok" buttons").
Re Claim 4, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches the infusion pump system further comprising: an accelerometer wherein movement information from the accelerometer is used by the controller device (102) to verify detection of a bump between the pump assembly and the mobile device (Kamen ¶ 0012, 0345, 0412, 0428, 0486).
Re Claim 5, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches the infusion pump system further comprising: a glucose monitoring device configured to communicate to the controller a blood glucose level of the user (Kamen ¶ 0014).
Re Claim 6, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches the medical infusion pump system wherein the dosage calculator application takes into account previously delivered insulin that has not acted on the user (Kamen ¶ 0427, 0481 - calculation includes insulin on board).
Re Claim 7, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the dosage calculator application is operable to: provide the user with an option to modify the medication bolus dosage to an amount different from the suggested medication bolus dosage (Kamen ¶ 0481, 0486).
Re Claim 8, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the pump device (104) is a disposable component of the pump assembly and the controller device (102) is a reusable component (Kamen ¶ 0008, 0067-0068).
Re Claim 11, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the first housing has a number of features that mate with complementary features of the second housing (Kamen ¶ 0395; Figs. 16A-16B), wherein the second housing of the controller device (102) is operable to removably attach with the pump device in a generally side-by-side configuration (Kamen Figs. 1A-5F and 16A-16B).
Re Claim 12, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches the medical infusion pump system further comprising: a tube (106) extending from the pump assembly (104) to an infusion location (Kamen ¶ 0068; Fig. 1A).
Re Claim 13, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the pump assembly is operable to: provide a confirmation signal of bolus delivery (Kamen ¶ 0486).
Re Claim 14, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen teaches wherein the pump assembly is operable to receive data indicative of food consumption prior to determining suggested bolus dosage (Kamen ¶ 0477-0479, 0487).
Re Claim 15, Kamen teaches a medical infusion pump system, comprising: a pump assembly (Kamen Figs. 1A-5F) that includes a pump device (104), wherein the pump device is operable to receive a fluid cartridge and is in a first housing (102-1) (Kamen ¶ 0067, 0074-0077; Figs. 1A-1B; Annotated Fig. 1A above); a controller device (102), wherein the controller device (102) is operable to control the pump device (104) (Kamen ¶ 0066-0074) and is in a second housing (104-1) separate from the first housing (102-1) (Kamen ¶ 0066-0074 Annotated Fig. 1A above), and the first housing and the second housing are configured to slidably engage one another (Kamen ¶ 0068 - "a screw - on, twist-lock, or compression fit configuration, or other configuration"); and a mobile device (600, 700, 802) comprising a memory for storing computer-readable instructions to access a dosage calculator application for calculating a suggested medication bolus dosage (Kamen ¶ 0224, 0228, 0230-0232), the mobile device (600, 700, 802) operable to: wirelessly transfer data to the pump assembly to cause the pump assembly to deliver the suggested medication bolus dosage to a user, and prompt the user for confirmation of acceptance of a suggested medication bolus dosage before wirelessly transferring data to the pump assembly to cause the pump assembly to deliver the suggested medication bolus dosage to the user (Kamen ¶ 0480).
Kamen further teaches wherein the controller device (102) comprises a drive system (108) for dispensing a fluid (Kamen ¶ 0068). However, Kamen fails to teach wherein the pump device comprises the drive system for dispensing a fluid. Garibotto teaches a medical infusion pump system, comprising: a pump assembly (Garibotto Fig. 9) that includes a pump device (94) and a controller device (93) (Garibotto ¶ 0091), wherein the pump device (94) comprises a drive system (48) for dispensing a fluid (Garibotto ¶ 0091; Fig. 9), wherein the pump device (94) comprising the drive system (48) wherein the configuration is simple in design, and inexpensive and easy to manufacture, to further reduce the size, complexity and costs of the devices, such that the devices or portions thereof lend themselves to being small and disposable in nature (Garibotto ¶ 0013). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pump device of Kamen to have the pump device comprise the drive system for dispensing the fluid as disclosed by Garibotto wherein the configuration is simple in design, and inexpensive and easy to manufacture, to further reduce the size, complexity and costs of the devices, such that the devices or portions thereof lend themselves to being small and disposable in nature (Garibotto ¶ 0013).
Re Claim 16, Kamen in view of Garibotto teach all of the limitations of Claim 15. Kamen teaches wherein the controller device (102) is incorporated in the mobile device (600, 700, 802) (Kamen ¶ 0084).
Re Claim 17, Kamen in view of Garibotto teach all of the limitations of Claim 15. Kamen teaches wherein the controller device (102) is incorporated with the pump assembly (Kamen Figs. 1A-5F).
Re Claim 18, Kamen in view of Garibotto teach all of the limitations of Claim 15. Kamen teaches the medical infusion pump system further comprising: a glucose monitoring device communicate with the mobile device (600, 700, 802) (Kamen ¶ 0014), wherein the controller device (102) is incorporated in the mobile device (600, 700, 802) (Kamen ¶ 0084).
Re Claim 19, Kamen in view of Garibotto teach all of the limitations of Claim 15. Kamen teaches the medical infusion pump system further comprising: a glucose monitoring device communicate with the mobile device (600, 700, 802) (Kamen ¶ 0014), wherein the controller device is incorporated with the pump assembly (Kamen Figs. 1A- 5F).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (USPGPub 2012/0238851) in view of Garibotto (USPGPub 2002/0040208) as applied to Claim 1 above, and further in view of Bazargan et al. (USPGPub 2012/0116309).
Re Claim 9, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen fails to teach wherein the pump device comprises: one or more anchors that penetrate and retain the fluid cartridge inserted in the pump device to prevent removal of the fluid cartridge. Bazargan teaches a pump device (100) (Bazargan Fig. 1) comprising one or more anchors (210a, 210b) that penetrate and retain a fluid cartridge (104) inserted in the pump device (100) to prevent removal of the fluid cartridge (104) (Bazargan ¶ 0015; Figs. 2A-2C), the one or more anchors for preventing children from accidentally removing the fluid cartridge (Bazargan ¶ 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the pump device of Kamen in view of Garibotto one or more anchors that penetrate and retain the fluid cartridge inserted in the pump device to prevent removal of the fluid cartridge as disclosed by Bazargan for preventing children from accidentally removing the fluid cartridge (Bazargan ¶ 0024).
Re Claim 10, Kamen in view of Garibotto teach all of the limitations of Claim 1. Kamen fails to teach wherein the pump device comprises: a cap device that covers the fluid cartridge, wherein the cap device is non-reversibly attached to the first housing. Bazargan discloses a pump device (100) (Bazargan Fig. 1) comprising a housing (110) and a fluid cartridge (104) with a cap device (102, 202) for covering the fluid cartridge (104) (Bazargan Figs. 1-2C), wherein the cap device (102, 202) is non-reversibly attached to the housing (110) (Bazargan ¶ 0015-0019) for preventing children from accidentally removing the fluid cartridge (Bazargan ¶ 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the pump device of Kamen in view of Garibotto a cap device that covers the fluid cartridge, wherein the cap device is non-reversibly attached to the first housing as disclosed by Bazargan for preventing children from accidentally removing the fluid cartridge (Bazargan ¶ 0024).
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive. Applicant’s arguments start on Page 6 of the response, directed to 102 anticipation rejections. The present case is not rejected under 102, these arguments are therefore moot. At the bottom of Page 7 of the response, applicant’s arguments turn to 103 rejections where applicant argues Kamen fails to teach “the first housing and the second housing are configured to slidably engage one another.” However, Kamen teaches the aforementioned limitation at paragraphs 0068 and 0072 where “the reusable portion 102 may include a locking ring assembly 110 and a position nub 808 that may facilitate rotation of the locking ring assembly 110.” Examiner is treating this as an explicit teaching of the limitation “the first housing and the second housing are configured to slidably engage one another.”
Near the bottom of Page 8 of the response, applicant’s arguments turn to “could modify” not being an articulated reason with rational underpinning and a reasonable expectation of success. Examiner does not rely on the language “could modify” in the present rejection or any previous rejection. This argument is therefore moot. In the middle of Page 9 of the response, applicant’s arguments turn to the modification of primary reference Kamen with the teachings of secondary reference Garibotto. Applicant argues the references teach away from one another, arguing,
Kamen [0008] describes the first medical device as including "at least one disposable portion and at least two reusable portions" - the entire architecture is organized around this partition. By explicitly placing the drive in the reusable portion and limiting the disposable portion to the wetted path, Kamen discourages making the drive disposable.
However, there is no reason the modified disposable portion 104 pf Kamen in view of Garibotto would not still be disposable. Garibotto explicitly teaches its configuration being simple in design, and inexpensive and easy to manufacture, to further reduce the size, complexity and costs of the devices, such that the devices or portions thereof lend themselves to being small and disposable in nature (Garibotto ¶ 0013). This teaching is in regard to all of the embodiments described in Garibotto, not a different system as applicant suggests. Applicant then argues the “Office Action does not identify any benefit or motivation within Kamen from making the drive system disposable.” Examiner respectfully disagrees where a disposable device can be made more cheaply. Furthermore, a disposable device reduces maintenance and cleaning.
On Page 10 of the response, applicant argues the modification of Kamen with the teachings of Garibotto would require substantial redesign. Examiner disagrees where moving a drive system from one side of a device to another is well within the ordinary skill of the art, particularly where secondary reference Garibotto provides examples of just such a configuration. At the bottom of Page 11 leading into Page 12 of the response, applicant argues secondary reference Bazargan’s arms 210a/210b “do not penetrate or retain the fluid cartridge. Examiner respectfully disagrees where arms 210a and 210b penetrate and retain cap 102 of a fluid cartridge 104 as described Bazargan paragraphs 0017-0019. On Page 12 of the response, applicant’s arguments turn to Claim 10 arguing Bazargan’s cap 102 is removably coupled, not non-reversibly attached. However, as described at Bazargan paragraphs 0015-0019, once the guard 200 is placed on cap 102, cap cannot be removed. Examiner is considering this an explicit teaching of Claim 10.
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.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights