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
The amendment filed on 12/30/2025 has been entered. Claims 1-2, 6-7, 9-12, 14, 31-32, and 47-49 are pending in the application. Claims 3-5, 8, 13, 15-30, and 33-46 are cancelled. Claims 47-49 are new. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 9/30/2025.
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 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 1-2, 31-32, and 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Petainen et al. (US 2018/0147345 A1) in view of Wochner et al. (US 2010/0022988 A1).
Regarding claim 1, Petainen discloses an infusion set adapter (see Figs. 1-5) comprising:
a housing (infusion pump unit 200, tubing 110, and connector 415) comprising a controller (processor 235) and a power source (battery 250), the power source (battery 250) configured to power the controller (processor 235) (see Figs. 1-3, par. [0032]);
an interface adapter (housing 435) configured to be removably connected to the housing (infusion pump unit 200, tubing 110, and connector 415) (see Fig. 3, par. [0037], [0043]), the interface adapter (housing 435) comprising at least one retention member configured to be releasably connected to a body of an infusion set (cannula set 300) (Figs. 3 and 5, par. [0037], [0043]-[0044], [0046], portion of housing 435 for receiving form lock 520 to connect the housing 435 and the cannula set 300), and the interface adapter (housing 435) defining a channel (hole of housing 435) configured to receive a cannula (connection port 330) of the infusion set (cannula set 300) (see Figs. 3 and 5, par. [0037], [0043]).
However, Petainen fails to state a priming sensor in electrical communication with the controller, the priming sensor adjacent the cannula when the cannula is received in the channel and configured to detect a presence of a medicament in the cannula.
Wochner teaches an infusion set adapter (see Fig. 3) comprising a priming sensor (sensor 5) in electrical communication with the controller (read and control device 4), the priming sensor (sensor 5) configured to detect a presence of a medicament in the cannula (cannula of catheter head 1f) (see Fig. 3, par. [0044], [0049], [0051]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of Petainen to include a priming sensor in electrical communication with the controller, the priming sensor configured to detect a presence of a medicament in the cannula, as taught by Wochner, in order to detect in real-time the arrival of the medicament in the cannula and provide feedback to the controller for controlling the medicament delivery (see Wochner par. [0044]). Since Petainen teaches that the cannula (connection port 330) is received in the channel (hole of housing 435) prior to medicament delivery through the cannula (connection port 330) (see Figs. 3 and 5, par. [0037], [0043]) and Wochner teaches that the priming sensor (sensor 5) is adjacent the cannula (cannula of catheter head 1f) (see Fig. 3, par. [0044], [0049], [0051]), this modification would teach that the priming sensor (Wochner, sensor 5) is adjacent the cannula (Petainen, connection port 330) when the cannula (Petainen, connection port 330) is received in the channel (Petainen, hole of housing 435).
Regarding claim 2, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state wherein the controller is configured to cause a notification of the presence of the medicament in the cannula in response to receiving a signal from the priming sensor.
Wochner teaches an infusion set adapter (see Fig. 3) wherein the controller (read and control device 4) is configured to cause a notification of the presence of the medicament in the cannula (cannula of catheter head 1f) in response to receiving a signal from the priming sensor (sensor 5) (see par. [0044] and [0049]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include wherein the controller is configured to cause a notification of the presence of the medicament in the cannula in response to receiving a signal from the priming sensor, as taught by Wochner, in order to detect in real-time the arrival of the medicament in the cannula and provide feedback to the controller for controlling the medicament delivery (see Wochner par. [0044]).
Regarding claim 31, modified Petainen teaches an infusion set (cannula set 300) for delivering a medicament from a medicament source to an infusion site (see Figs. 1-5, par. [0038]), the infusion set comprising:
a body (skin attachment member 320) configured to attach to the infusion site (see Fig. 3, par. [0038]);
a needle (cannula 310) extending from the body (skin attachment member 320), the needle (cannula 310) being configured to pierce the infusion site (see Fig. 3, par. [0037]-[0039]);
a cannula (connection port 330) connected to the body (skin attachment member 320), the cannula (connection port 330) configured to receive the medicament from the medicament source in the cannula (connection port 330) (see Fig. 3, par. [0039]); and
the infusion set adapter of claim 1 (see claim 1 rejection above).
Regarding claim 32, modified Petainen teaches the infusion set of claim 31, wherein the infusion set adapter (see claim 1 rejection above) is configured to be separated from the infusion set (cannula set 300) and is sterilizable (see par. [0037], [0043]-[0044]).
Regarding claim 48, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. Petainen further teaches a connection sensor (connection detector 405) configured to detect a parameter associated with the connection of the interface adapter (housing 435) with the housing (infusion pump unit 200, tubing 110, and connector 415) (see par. [0041], [0046]).
Regarding claim 49, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state wherein the priming sensor comprises multiple priming sensors located along the length of the cannula and configured to determine the presence of the medicament along different portions of the cannula.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include multiple priming sensors since such a modification would have involved a mere duplication of parts. A duplication of parts is generally recognized as being within the level of ordinary skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Since the priming sensors must be located along the length of the cannula (see Wochner par. [0044]) but must be in different positions so as not to occupy the exact same space, this modification further teaches that the priming sensors are located along the length of the cannula and configured to determine the presence of the medicament along different portions of the cannula (see Wochner par. [0044]).
Claims 6-7 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Petainen et al. (US 2018/0147345 A1) in view of Wochner et al. (US 2010/0022988 A1), as applied to claim 1 above, in view of Cole et al. (US 2014/0276576 A1).
Regarding claim 6, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state wherein the at least one retention member comprises a plurality of retention members configured to connect the interface adapter to the body of the infusion set.
Cole teaches an infusion set adapter (see Figs. 1-2) wherein the at least one retention member (snap arms 83-84 and hooks 95-96) comprises a plurality of retention members (snap arms 83-84 and hooks 95-96) configured to connect the interface adapter (connector 7) to the body of the infusion set (base member 4) (see Figs. 1-2, par. [0078], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include wherein the at least one retention member comprises a plurality of retention members configured to connect the interface adapter to the body of the infusion set, as taught by Cole, in order to form the structure for providing the form lock to releasably connect the interface adapter and the infusion set (see Petainen par. [0037], [0043]-[0044], [0046]; Cole par. [0078], [0081]).
Regarding claim 7, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state wherein the at least one retention member is resilient and configured to deform to move over a retention section of the body of the infusion set as the interface adapter is being connected to the body of the infusion set.
Cole teaches an infusion set adapter (see Figs. 1-2) wherein the at least one retention member (snap arms 83-84 and hooks 95-96) is resilient and configured to deform to move over a retention section (recesses 97-98) of the body of the infusion set (base member 4) as the interface adapter (connector 7) is being connected to the body of the infusion set (base member 4) (see Figs. 1-2, par. [0078], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include wherein the at least one retention member is resilient and configured to deform to move over a retention section of the body of the infusion set as the interface adapter is being connected to the body of the infusion set, as taught by Cole, in order to form the structure for providing the form lock to releasably connect the interface adapter and the infusion set (see Petainen par. [0037], [0043]-[0044], [0046]; Cole par. [0078], [0081]).
Regarding claim 47, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state wherein the at least one retention member comprises at least one lateral retention member and at least one vertical retention member.
Cole teaches an infusion set adapter (see Figs. 1-2) wherein the at least one retention member (snap arms 83-84 and hooks 95-96) comprises at least one lateral retention member (hooks 95-96) and at least one vertical retention member (snap arms 83-84) (see Figs. 1-2, par. [0078], [0081]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include wherein the at least one retention member comprises at least one lateral retention member and at least one vertical retention member, as taught by Cole, in order to form the structure for providing the form lock to releasably connect the interface adapter and the infusion set (see Petainen par. [0037], [0043]-[0044], [0046]; Cole par. [0078], [0081]).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Petainen et al. (US 2018/0147345 A1) in view of Wochner et al. (US 2010/0022988 A1), as applied to claim 1 above, in view of Lintern et al. (US 2013/0296807 A1).
Regarding claim 12, modified Petainen teaches the infusion set adapter of claim 1 substantially as claimed. However, modified Petainen fails to state a proximity sensor configured to measure a characteristic of an infusion site, wherein the controller is configured to determine if the infusion set adapter is within a predetermined distance from the infusion site based on the measured characteristic of the infusion site received from the proximity sensor.
Lintern teaches an infusion set adapter (see Figs. 1-2) comprising a proximity sensor configured to measure a characteristic of an infusion site (see par. [0042]-[0043], [0045]), wherein the controller (controller 33) is configured to determine if the infusion set adapter is within a predetermined distance from the infusion site based on the measured characteristic of the infusion site received from the proximity sensor (see par. [0045]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include a proximity sensor configured to measure a characteristic of an infusion site, wherein the controller is configured to determine if the infusion set adapter is within a predetermined distance from the infusion site based on the measured characteristic of the infusion site received from the proximity sensor, as taught by Lintern, in order to allow the medicament to be delivered only when the infusion set adapter is at the infusion site (see Lintern par. [0045]).
Regarding claim 14, modified Petainen teaches the infusion set adapter of claim 12 substantially as claimed. Modified Petainen further teaches wherein the proximity sensor (see Lintern par. [0045]) includes:
an optical sensor configured to transmit a first optical signal to the infusion site and to receive a second optical signal reflected from the infusion site (see Lintern par. [0045], optical sensors function by reflecting and detecting light), or
a mechanical sensor or an electromechanical sensor configured to detect physical contact between the infusion set adapter and the infusion site (see Lintern par. [0045]) (see previous modifications in rejection of claim 12 above).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Petainen et al. (US 2018/0147345 A1) in view of Wochner et al. (US 2010/0022988 A1), as applied to claim 31 above, in view of Yigal et al. (WO 2018/222697 A1).
Regarding claim 9, modified Petainen teaches the infusion set adapter of claim 31 substantially as claimed. However, modified Petainen fails to state a needle sensor configured to detect a characteristic of a needle tip of the needle within the infusion site, the needle sensor being in electrical communication with the controller.
Yigal teaches an infusion set adapter (see Figs. 1-4 and 8A-C) comprising a needle sensor (needle optical detector 13) configured to detect a characteristic of a needle tip of the needle (needle 31) within the infusion site, the needle sensor (needle optical detector 13) being in electrical communication with the controller (processor 19) (see par. [0035] and [0038]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include a needle sensor configured to detect a characteristic of a needle tip of the needle within the infusion site, the needle sensor being in electrical communication with the controller, as taught by Yigal, in order to determine whether the needle is inserted or retracted (see Yigal par. [0035] and [0038]).
Regarding claim 10, modified Petainen teaches the infusion set adapter of claim 31 substantially as claimed. However, modified Petainen fails to state a needle guard configured to cover a needle tip of the needle when the needle is not in the infusion site.
Yigal teaches an infusion set adapter (see Figs. 1-4 and 8A-C) comprising a needle guard (needle shield assembly 32) configured to cover a needle tip of the needle (needle 31) when the needle (needle 31) is not in the infusion site (see Figs. 1-4 and 8A-C, par. [0036]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include a needle guard configured to cover a needle tip of the needle when the needle is not in the infusion site, as taught by Yigal, in order to cover the needle when not in use (see Yigal par. [0036] and [0041]).
Regarding claim 11, modified Petainen teaches the infusion set adapter of claim 10 substantially as claimed. However, modified Petainen fails to state a needle guard sensor configured to detect a characteristic of the needle guard relative to the needle tip, the needle guard sensor being in electrical communication with the controller.
Yigal teaches an infusion set adapter (see Figs. 1-4 and 8A-C) comprising a needle guard sensor (needle shield optical detector 14) configured to detect a characteristic of the needle guard (needle shield assembly 32) relative to the needle tip, the needle guard sensor (needle shield optical detector 14) being in electrical communication with the controller (processor 19) (see par. [0036] and [0038]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set adapter of modified Petainen to include a needle guard sensor configured to detect a characteristic of the needle guard relative to the needle tip, the needle guard sensor being in electrical communication with the controller, as taught by Yigal, in order to determine whether the needle is shielded or exposed (see Yigal par. [0036] and [0038]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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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.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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