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 .
Response to Amendment
This office action is responsive to the amendment filed on April 6, 2026. As directed by the amendment: claims 1, 2, 6, 7, 9, 13-15, and 19 have been amended. Thus, claims 1-19 are presently pending in this application.
Applicant’s amendments/arguments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed January 13, 2026.
Response to Arguments
Applicant's arguments filed April 6, 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 7 of the Remarks that “An electrical contact that is recessed into the outer surface of the pump is not "exposed on an exterior surface" of the pump as claimed in independent claims 1, 7 and 14”. The examiner respectfully disagrees and maintains that a pump can have more than one exterior surface and that the surface which comprises connector 28 is one of the exterior surfaces of the pump. Fig. 18a of Yodfat shows that connector 28 is exposed on a recessed, outer surface as it allows connection with mating connector 21 of the cradle. While the recessed surface is not an “outer-most” surface of the pump housing, the surface is still an exterior surface since the surface faces the outside area of the pump. If the recessed surface were not an exterior surface of the pump housing, then the surface would be considered to be an “interior surface” of the pump housing. However, an interior surface of the pump housing is inside the pump housing where the electronics are housed. For these reasons, the examiner maintains that Yodfat discloses the claimed electrical contact.
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 exterior surface of the housing (connector 28 in fig. 10; fig. 18a shows the connector 28 positioned on an exterior, bottom surface of the housing 100, see response to arguments above), the electrical contact configured to receive data from a glucose sensor (paragraph 183 discloses transmitting glucose level sensed from the electrode 30 to the processor 130 via wires 23 and connectors 21/28); 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 exterior surface of the housing (connector 28 in fig. 10; fig. 18a shows the connector 28 positioned on an exterior, bottom surface of the housing 100, see response to arguments above) configured to receive data from the glucose sensor via an electrical connection (paragraph 183 discloses transmitting glucose level sensed from the electrode 30 to the processor 130 via wires 23 and connectors 21/28), 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 28 in fig. 10; fig. 18a shows the connector 28 positioned on an exterior, bottom surface of the housing 100, see response to arguments above) configured to receive data from a glucose sensor via an electrical connection (paragraph 183 discloses transmitting glucose level sensed from the probe 30 to the processor 130 via wires 23 and connectors 21/28), 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).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 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
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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