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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 16, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on June 16, 2026. As directed by the amendment: claims 1, 7, and 14 have been amended. Thus, claims 1-19 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed June 16, 2026, with respect to the 102(a)(1) rejection of claims 1, 7, and 14 have been fully considered and are persuasive, specifically in regards to previously relied upon embodiment of Yodfat not teaching or disclosing the newly added limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different embodiment of Yodfat, explained below.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5-9, 12-15, 18, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yodfat (US 20120277667).
Regarding claim 1, Yodfat discloses an ambulatory infusion pump (dispensing unit 10 in fig. 10), comprising:
a housing (housing of reusable part 100 in fig. 10);
a reservoir configured to contain a medicament (reservoir 230 in fig. 10);
a pumping mechanism configured to deliver the medicament from the reservoir to a user (driving mechanism 188 in fig. 10);
an exterior electrical contact exposed on an outermost exterior surface of the housing (connector 121 in fig. 29d is shown to protrude from a bottom surface of the reusable part 100, which is an outermost exterior surface of the housing), the electrical contact configured to receive data from a glucose sensor (paragraph 219 discloses the connector 121 engages protrusion 21 so that wires 235-237 can convey currents generated on the electrodes to the processor; paragraph 183 discloses the electrodes sense glucose levels); and
at least one processor (processor 130 in fig. 10) configured to control the pumping mechanism to deliver the medicament from the reservoir to the user (paragraph 159), the at least one processor configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters (paragraph 159).
Regarding claim 7, Yodfat discloses an ambulatory infusion pump system (fig. 10), comprising:
a glucose sensor configured to be inserted into a user (probe 30 in fig. 10; paragraph 170 discloses the probe senses analyte levels such as glucose); and
an ambulatory infusion pump (dispensing unit 10 in fig. 10) including a housing (housing of reusable part 100 in fig. 10), a reservoir configured to contain a medicament (reservoir 230 in fig. 10), a pumping mechanism configured to deliver the medicament from the reservoir to a user (driving mechanism 188 in fig. 10) and an exterior electrical contact exposed on an outermost exterior surface of the housing (connector 121 in fig. 29d is shown to protrude from a bottom surface of the reusable part 100, which is an outermost exterior surface of the housing) configured to receive data from the glucose sensor via an electrical connection (paragraph 219 discloses the connector 121 engages protrusion 21 so that wires 235-237 can convey currents generated on the electrodes to the processor; paragraph 183 discloses the electrodes sense glucose levels), wherein the pump further includes at least one processor (processor 130 in fig. 10) configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters (paragraph 159).
Regarding claim 14, Yodfat discloses an ambulatory infusion pump system (fig. 10), comprising:
an ambulatory infusion pump (dispensing unit 10 in fig. 10) including a housing (housing of reusable part 100 in fig. 10), a reservoir configured to contain a medicament (reservoir 230 in fig. 10), a pumping mechanism configured to deliver the medicament from the reservoir to a user (driving mechanism 188 in fig. 10) and an exterior electrical contact exposed on an exterior surface of the housing (connector 121 in fig. 29d is shown to protrude from a bottom surface of the reusable part 100, which is an exterior surface of the housing) configured to receive data from a glucose sensor via an electrical connection (paragraph 219 discloses the connector 121 engages protrusion 21 so that wires 235-237 can convey currents generated on the electrodes to the processor; paragraph 183 discloses the electrodes sense glucose levels), wherein the pump further includes at least one processor (processor 130 in fig. 10) configured to receive and process the data from the glucose sensor for use in calculating medicament delivery parameters (paragraph 159); and
a tray configured to releasably hold the ambulatory infusion pump (cradle 20 in fig. 10; paragraph 20 discloses that the patch unit can be “repeatedly connected or disconnected” from the cradle), wherein the tray facilitates the electrical connection between the ambulatory infusion pump and the glucose sensor (cradle 20 in fig. 10 allows for an electrical connection between the connector 28 and probe 30; see 112b rejection/interpretation above for claims 16 and 17),
wherein the exterior surface of the housing that includes the electrical contact engages a wall of the tray when the ambulatory infusion pump is releasably held by the tray (at least a portion of the bottom surface of the reusable part 100 is configured to engage a top surface of cradle 20 in fig. 29d).
Regarding claims 2, 9, and 15, Yodfat discloses the electrical contact is configured to receive data from the glucose sensor via a direct electrical connection through the tray (fig. 10 shows the connector 28 directly connecting connector 21 of the cradle 20).
Regarding claims 5, 12, and 18, Yodfat discloses the at least one processor is configured to receive the data from the glucose sensor without undergoing a pairing procedure that pairs the ambulatory infusion pump with the glucose sensor over wireless communications (paragraph 64 discloses that the sensor signal is transferred from the connector to the processor via a wire so that the processor receives data without a wireless pairing procedure).
Regarding claim 6, 13, and 19, Yodfat discloses the ambulatory infusion pump further comprises a battery (battery 220 in fig. 11), and wherein the at least one processor is configured to provide power to the glucose sensor with the battery (fig. 11 shows that the battery 220 is connected to the processor 130 which is in turn connected to probe 30).
Regarding claim 8, Yodfat discloses a tray configured to releasably hold the ambulatory infusion pump (cradle 20 in fig. 10; paragraph 20 discloses that the patch unit can be “repeatedly connected or disconnected” from the cradle), wherein the tray facilitates the electrical connection between the ambulatory infusion pump and the glucose sensor (fig. 10 shows the connector 28 directly connecting connector 21 of the cradle 20).
Claim(s) 3, 4, 10, 11, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat, as applied to claims 1, 7, and 14 above, and further in view of Nazzaro (US 20220233765).
Regarding claims 3, 4, 10, 11, 16, and 17, Yodfat discloses all of the claimed limitations set forth in claims 1, 7, and 14, respectively, but does not teach or disclose the electrical contact is configured to receive data from the glucose sensor via an indirect electrical connection [claims 3, 10, and 16] in the form of a capacitive coupling [claims 4, 11, and 17].
Nazzaro is directed towards an ambulatory infusion pump (on-body drug delivery device 102 in fig. 1) and a separate glucose sensor (sensor 106 in fig. 1; paragraph 24) which communicates with the infusion pump using “the coupler for BCC communications” (paragraph 24). Nazzaro further teaches that this coupler is a capacitive coupling (paragraph 17) involving two electrically conductive elements (paragraph 17) in order to wirelessly transmit data (paragraph 17).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the electrical contact of modified Yodfat to be configured to receive data from the conductive elements of the glucose sensor via an indirect electrical connection in the form of capacitive coupling, as taught by Nazzaro. Nazzaro teaches that this coupling would provide for a suitable alternative coupling to a wired coupling and which decreases interference and signal loss (paragraph 28).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yodfat (US 8147446) discloses a similar infusion pump (patch unit 10 in fig. 12a) comprising an electrical contact on an outermost exterior surface (conductive surfaces 18/19 in fig. 12a) configured to engage a surface of the tray (cradle 20 in fig. 12b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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, BHISMA MEHTA can be reached at 571-272-3383. 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.
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
