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 2/27/2026 has been entered. Claims 1-26 and 28-30 are pending in the application. Claim 27 is cancelled.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] of the Specification should be updated to include the patent number and issue date of application 17/652,460.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, the limitation “the applicator comprising a housing configured to cover an entirety of the outermost edge of the pad skeleton” appears to introduce new matter to the claim. As shown and described regarding Figs. 4A-B, the applicator housing 110 appears to sit on a top surface of an outermost edge of the pad skeleton 104; however, portions of the outermost edge of the pad skeleton 104 appear to remain exposed below the bottom of the applicator housing 110. Thus, the applicator housing 110 does not appear to cover an entirety (i.e. completely enclose such that it is not exposed/viewable by the user) of the outermost edge of the pad skeleton 104. The specification does not further provide written support for the exact language claimed; therefore, the limitation appears to introduce new matter.
Claims 2-23 are rejected by virtue of their dependency on rejected claim 1.
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 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Da Ros et al. (US 2013/0338594 A1) in view of Yodfat et al. (US 2008/0319414 A1).
Regarding claim 1, Da Ros discloses a system (see Figs. 1-16) for use with a medication infusion device configured to be removably adhered to skin of a wearer for delivering doses of a medication transcutaneously (see par. [0001] and [0081]), the system comprising:
a pad (patch 7) configured to be adhered to the skin of the wearer (see par. [0028], [0035], [0064]), the pad (patch 7) comprising a pad skeleton with an outermost edge (see Fig. 1, par. [0064], patch 7 can be considered a skeleton and has an outermost perimeter/edge); and
an applicator (inserter comprising casing 5, trigger 4, and the internal structures, see Figs. 1 and 4, par. [0059]) configured to be locked to the pad (patch 7) during placement of the pad (patch 7) on the skin of the wearer (see par. [0077]), the applicator (inserter comprising casing 5, trigger 4, and the internal structures) comprising a housing (casing 5) configured to define an enclosed interior therebetween (see Fig. 5b, at least portions of casing 5 are flush with the outermost edge of patch 7) to house a cannula (cannula 11) therewithin such that the cannula (cannula 11) is entirely disposed within the enclosed interior of the housing (casing 5) and integrated with the applicator (inserter comprising casing 5, trigger 4, and the internal structures) during a pre-deployment state (see Fig. 4, par. [0062]-[0063]) and an actuator (trigger 4) on the housing (casing 5) configured to, upon actuation, cause the cannula (cannula 11) to be advanced to lock the cannula (cannula 11) to the pad (patch 7) and unlock the applicator (inserter comprising casing 5, trigger 4, and the internal structures) from the pad (patch 7) such that at least a portion of the cannula (cannula 11) is advanced into the skin of the wearer in a deployment state (see Figs. 5a-6b) wherein the pad (patch 7) remains adhered to the skin of the wearer and the applicator (inserter comprising casing 5, trigger 4, and the internal structures), once unlocked, is removable from the pad (patch 7) (see Figs. 5a- 6b, par. [0028], [0034]-[0035], [0063]-[0066]),
wherein the outermost edge is further configured to, once the applicator (inserter comprising casing 5, trigger 4, and the internal structures) is unlocked and removed from the pad (patch 7), contact and surround a pump-cap assembly of a patch pump to securely couple the pad (patch 7) to the pump-cap assembly for wearing by the wearer (see par. [0081]).
However, Da Ros fails to expressly state that the housing is configured to cover an entirety of the outermost edge of the pad skeleton.
Yodfat teaches a system (see Figs. 20a-b) comprising a housing (inserter 90) configured to cover an entirety of the outermost edge of the pad skeleton (cradle unit 20) (see Figs. 20a-b, par. [0119]).
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 system of Da Ros to expand the housing (Da Ros, casing 5) such that it extends to cover an entirety of the outermost edge of the pad skeleton (Da Ros, patch 7), as taught by Figs. 20a-b of Yodfat, in order to conform the housing to the user’s hand to make the housing more ergonomic and comfortable to hold and handle (see Yodfat, par. [0119]).
Regarding claim 2, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the applicator (inserter comprising casing 5, trigger 4, and the internal structures) further comprises at least one attachment pad coupler (release element 15) configured to lock the applicator (inserter comprising casing 5, trigger 4, and the internal structures) to the pad (patch 7) in the pre-deployment state (see Fig. 4, par. [0034] and [0065]).
Regarding claim 3, modified Da Ros teaches the system of claim 2 substantially as claimed. Da Ros further teaches wherein the pad (patch 7) is configured to be locked to at least one clip at a proximal end of the cannula (cannula 11) to lock the cannula (cannula 11) to the pad (patch 7) in the deployment state (see Figs. 5a-6b, par. [0064] and [0070]).
Regarding claim 4, modified Da Ros teaches the system of claim 3 substantially as claimed. Da Ros further teaches wherein the actuator (trigger 4) is configured to, upon actuation, cause the at least one clip of the cannula (cannula 11) to be advanced such that the at least one attachment pad coupler (release element 15) of the applicator (inserter comprising casing 5, trigger 4, and the internal structures) is moved to unlock the applicator (inserter comprising casing 5, trigger 4, and the internal structures) from the pad (patch 7) (see Fig. 5b, par. [0034], [0064]-[0066], and [0070]).
Regarding claim 5, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches further comprising the cannula (cannula 11) (see Fig. 1, par. [0059]).
Regarding claim 6, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the patch pump is configured to deliver insulin to the wearer in need thereof, the wearer having diabetes (see par. [0010] and [0081]).
Regarding claim 7, modified Da Ros teaches the system of claim 1 substantially as claimed. However, modified Da Ros fails to expressly state wherein the pad skeleton is disposed on a first surface of the pad and an adhesive is disposed on a second, opposing surface of the pad.
Yodfat teaches a system (see Fig. 4a) wherein the pad skeleton (cradle base 300) is disposed on a first surface of the pad (cradle 20) and an adhesive is disposed on a second, opposing surface of the pad (cradle 20) (see Fig. 4a, par. [0075]-[0077]).
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 system of modified Da Ros to include wherein the pad skeleton is disposed on a first surface of the pad and an adhesive is disposed on a second, opposing surface of the pad, as taught by Yodfat, in order to further adhere the pad and thus better adhere the system to the skin of the user (see Yodfat par. [0067] and [0075]-[0077]).
Regarding claim 8, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches further comprising the patch pump (see par. [0081]).
Regarding claim 9, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the pad skeleton (patch 7) comprises one or more attachment mechanisms (clips and retaining means 16) configured to lock the pad (patch 7) to the applicator (inserter comprising casing 5, trigger 4, and the internal structures) and to unlock upon actuation of the applicator (inserter comprising casing 5, trigger 4, and the internal structures) (see Fig. 5b, par. [0034], [0064]-[0066], and [0070]).
Regarding claim 10, modified Da Ros teaches the system of claim 9 substantially as claimed. Da Ros further teaches wherein the one or more attachment mechanisms (clips and retaining means 16) are further configured to lock the cannula (cannula 11) to the pad (patch 7) after actuation (see par. [0034], [0064]-[0066], and [0070]).
Regarding claim 11, modified Da Ros teaches the system of claim 1 substantially as claimed. However, modified Da Ros fails to expressly state wherein the pad skeleton comprises pad attachments at a first end of the pad and a pad back clip at a second end of the pad.
Yodfat teaches a system (see Figs. 17a-b) wherein the pad skeleton (cradle base 300) comprises pad attachments (protrusion 302 and wall of well 310) at a first end of the pad (cradle unit 20) and a pad back clip (latch 304) at a second end of the pad (cradle unit 20) (see Figs. 17a-b, par. [0115]).
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 system of modified Da Ros to enlarge the applicator and cause the pad skeleton to comprises pad attachments at a first end of the pad and a pad back clip at a second end of the pad, as taught by Yodfat, in order to allow the applicator and the patch pump to more securely attach to the entirety of the pad on both sides of the pad (see Yodfat par. [0075], [0084], and [0115]).
Regarding claim 12, modified Da Ros teaches the system of claim 11 substantially as claimed. Modified Da Ros further teaches wherein the pad attachments (Yodfat, protrusion 302 and wall of well 310) and the pad back clip (Yodfat, latch 304) are configured to interact with the applicator (Da Ros, inserter comprising casing 5, trigger 4, and the internal structures) to lock the pad (Da Ros, patch 7) to the applicator (Da Ros, inserter comprising casing 5, trigger 4, and the internal structures) (see previous modifications in rejection of claim 11 above, Yodfat Figs. 17a-b, Yodfat par. [0115] and [0124]).
Regarding claim 13, modified Da Ros teaches the system of claim 11 substantially as claimed. Modified Da Ros further teaches wherein the pad attachments (Yodfat, protrusion 302 and wall of well 310) are configured to interact with the patch pump to lock the pad (Da Ros, patch 7) to the patch pump (see previous modifications in rejection of claim 11 above, Yodfat par. [0124] and [0126]; see Yodfat for example Figs. 10h-i and par. [0094]-[0095] describing connecting a dispensing patch unit to the same cradle unit 20).
Regarding claim 14, modified Da Ros teaches the system of claim 11 substantially as claimed. Modified Da Ros further teaches wherein the pad attachments (Yodfat, protrusion 302 and wall of well 310) comprise at least two arms (Yodfat, protrusion 302 and wall of well 310 are at least two arms) that protrude upwards from the pad (Da Ros, patch 7) and away from a surface of the skin of the wearer (see previous modifications in rejection of claim 11 above, Yodfat Figs. 17a and 21h-i).
Regarding claim 15, modified Da Ros teaches the system of claim 14 substantially as claimed. Modified Da Ros further teaches wherein each of the at least two arms (Yodfat, protrusion 302 and wall of well 310 are at least two arms) has an opening (Yodfat, opening below protrusion 302 and central opening of well 310) to receive extensions (Yodfat, extension of inserter 90 below recess 902 and cannula hub 714) from the applicator (Yodfat, inserter 90) before actuation of the actuator (Yodfat, actuation structures within inserter 90) and extensions from the cannula (Yodfat, cannula 713) after actuation of the actuator (Yodfat, actuation structures within inserter 90) (see previous modifications in rejection of claim 11 above, Yodfat Figs. 17a-b and 21h-i, Yodfat par. [0115] and [0124]).
Regarding claim 16, modified Da Ros teaches the system of claim 15 substantially as claimed. Modified Da Ros further teaches wherein each of the at least two arms (Yodfat, protrusion 302 and wall of well 310 are at least two arms) has a U-shape (Yodfat, protrusion 302 is curved to form a U-shape as shown in Figs. 17a-b and the wall of well 310 defines a U-shaped cavity for receiving cannula hub 714 as shown in Figs. 21e and 21h-i) and the openings (Yodfat, opening below protrusion 302 and central opening of well 310) of each of the at least two arms (Yodfat, protrusion 302 and wall of well 310 are at least two arms) are used to lock to both the applicator (Yodfat, inserter 90) and the cannula (Yodfat, cannula 713) (see previous modifications in rejection of claim 11 above, Yodfat Figs. 17a-b and 21h-i, Yodfat par. [0115] and [0124]).
Regarding claim 17, modified Da Ros teaches the system of claim 1 substantially as claimed. However, modified Da Ros fails to expressly state wherein the pad skeleton comprises pad clip holes disposed on sides of the pad skeleton and configured to interact with a corresponding feature of the pump-cap assembly to lock the pump-cap assembly to the pad.
Yodfat discloses a system (see Figs. 10h-i and 17a-b) wherein the pad skeleton (cradle base 300) comprises pad clip holes (protrusion 302 and latch 304 each have grooves/holes beneath them, see Figs. 17a-b) disposed on sides of the pad skeleton (cradle base 300) and configured to interact with a corresponding feature of the pump-cap assembly to lock the pump-cap assembly to the pad (cradle unit 20) (see par. [0126]; see for example Figs. 10h-i and par. [0094]-[0095] describing connecting a dispensing patch unit to the same cradle unit 20).
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 system of modified Da Ros to include wherein the pad skeleton comprises pad clip holes disposed on sides of the pad skeleton and configured to interact with a corresponding feature of the pump-cap assembly to lock the pump-cap assembly to the pad, as taught by Yodfat, in order to lock the patch pump to the pad after insertion of the cannula (see Yodfat par. [0084] and [0094]-[0095]).
Regarding claim 18, modified Da Ros teaches the system of claim 1 substantially as claimed. However, modified Da Ros fails to expressly state wherein the pad skeleton comprises an angled interface disposed between pad attachments of the pad skeleton, the angled interface at an angle the cannula is inserted such that the angled interface engages with ahead of the cannula in the deployment state.
Yodfat teaches a system (see Figs. 24a-b) wherein the pad skeleton (cradle base 300) comprises an angled interface (well 310 has three angled interfaces, see Figs. 24a-b) disposed between pad attachments (protrusion 302 and latch 304) of the pad skeleton (cradle base 300), the angled interface (well 310 has three angled interfaces, see Figs. 24a-b) angled at an angle the cannula (cannula 713) is inserted such that the angled interface (well 310 has three angled interfaces, see Figs. 24a-b) engages with a head (cannula hub 714) of the cannula (cannula 713) in the deployment state (see Figs. 24a-b, par. [0127]-[0128]).
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 pad skeleton of the system of modified Da Ros to include an angled interface, as taught by Yodfat, in order to allow insertion of the cannula at various angles which can be adjusted by the user (see Yodfat par. [0127]-[0128]).
Regarding claim 19, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the applicator (inserter comprising casing 5, trigger 4, and the internal structures) comprises a channel (space within casing 5) configured to interact with one or more clips protruding from the cannula (cannula 11) to guide the cannula (cannula 11) in a substantially linear direction during insertion (see Figs. 5a-6b, par. [0064]).
Regarding claim 20, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the applicator (inserter comprising casing 5, trigger 4, and the internal structures) comprises a guiding arm (needle 10 and needle support 2) configured to interact with one or more wings (cannula support 6) protruding from the cannula (cannula 11) towards the skin of the wearer to prevent the cannula from rotating around a longitudinal axis of the cannula (cannula 11) during and after insertion (see Figs. 7a-b, par. [0064]-[0070]).
Regarding claim 21, modified Da Ros teaches the system of claim 1 substantially as claimed. However, modified Da Ros fails to expressly state wherein the pad comprises a plurality of attachments extending therefrom, the plurality of attachments configured to receive wings extending from the cannula therebetween, each of the plurality of attachments having a slot configured to receive clips extending in a different direction from the cannula, thereby locking the cannula to the pad.
Yodfat teaches a system (see Fig. 14c) wherein the pad (cradle unit 20) comprises a plurality of attachments (spring protrusions 715/715') extending therefrom, the plurality of attachments (spring protrusions 715/715') configured to receive wings (cannula hub 714) extending from the cannula (cannula 713) therebetween, each of the plurality of attachments (spring protrusions 715/715') having a slot (see Fig. 14c, space below spring protrusions 715/715' forms a slot) configured to receive clips (see Fig. 14c, outward extensions on cannula hub 714 interacting with spring protrusions 715/715' form clips) extending in a different direction from the cannula (cannula 713), thereby locking the cannula (cannula 713) to the pad (cradle unit 20) (see Fig. 14c, par. [0108]).
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 system of modified Da Ros to include a plurality of attachments, wings, slots, and clips as taught by Yodfat, in order to help retain the cannula to the pad (see Yodfat par. [0108]).
Regarding claim 22, modified Da Ros teaches the system of claim 1 substantially as claimed. Da Ros further teaches wherein the pad (patch 7) is configured to be locked to the patch pump while adhered to the skin of the wearer after the applicator (inserter comprising casing 5, trigger 4, and the internal structures) has been removed from the pad (patch 7) (see par. [0081]).
Regarding claim 23, modified Da Ros teaches the system of claim 22 substantially as claimed. Da Ros further teaches further comprising the patch pump, the patch pump configured to pump the doses of the medication to the cannula (cannula 11) for transcutaneous delivery to the wearer (see par. [0010] and [0081]).
Allowable Subject Matter
Claims 24-26 and 28-30 are allowable.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to independent claim 24, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the method as claimed, specifically including the combination of claimed limitations with “wherein a single actuation causes the cannula to lock to the pad, the applicator to unlock from the pad, and the portion of the cannula to be advanced into the skin of the wearer”.
The closest prior art of record is Da Ros et al. (US 2013/0338594 A1). Da Ros teaches a method (see Figs. 1-16) for applying a cannula (cannula 11) for delivering doses of a medication transcutaneously (see par. [0001] and [0081]), the method comprising: selecting a pad (patch 7) locked to an applicator (inserter comprising casing 5, trigger 4, and the internal structures, see Figs. 1 and 4, par. [0059]) including a housing (casing 5), the pad (patch 7) comprising a pad skeleton with an outermost edge (see Fig. 1, par. [0064], patch 7 can be considered a skeleton and has an outermost perimeter/edge), wherein the outermost edge is in contact with the housing (casing 5) of the applicator (inserter comprising casing 5, trigger 4, and the internal structures) to define an enclosed housing therebetween (see Fig. 5b, at least portions of casing 5 are flush with the outermost edge of patch 7); adhering the pad (patch 7) to skin of a wearer (see par. [0028], [0035], [0064]), the pad (patch 7) locked to the applicator (inserter comprising casing 5, trigger 4, and the internal structures) during placement of the pad (patch 7) on the skin of the wearer (see par. [0077]), the applicator (inserter comprising casing 5, trigger 4, and the internal structures) housing the cannula (cannula 11) within the enclosed housing such that the cannula (cannula 11) is entirely disposed within the enclosed housing and integrated with the applicator (inserter comprising casing 5, trigger 4, and the internal structures) during a pre-deployment state (see Fig. 4, par. [0062]-[0063]); actuating the applicator (inserter comprising casing 5, trigger 4, and the internal structures) with an actuator (trigger 4) disposed on the housing (casing 5) to cause the cannula (cannula 11) to be advanced to lock the cannula (cannula 11) to the pad (patch 7) and unlock the applicator (inserter comprising casing 5, trigger 4, and the internal structures) from the pad (patch 7) such that at least a portion of the cannula (cannula 11) is advanced into the skin of the wearer in a deployment state (see Figs. 5a-6b, par. [0028], [0034]-[0035], [0063]-[0066]); removing the applicator (inserter comprising casing 5, trigger 4, and the internal structures) from the pad (patch 7) once unlocked while the pad (patch 7) remains adhered to the skin of the wearer (see Figs. 5a-6b, par. [0028], [0034]-[0035], [0063]-[0066]); and coupling a pump-cap assembly of a patch pump to the pad skeleton (patch 7) such that the outermost edge of the pad skeleton (patch 7) contacts and surrounds the pump-cap assembly to securely couple the pad (patch 7) to the pump-cap assembly for wearing by the wearer (see par. [0081]).
However, Da Ros teaches that two separate actuations are required: one to cause the cannula to lock to the pad and the portion of the cannula to be advanced into the skin of the wearer, and another to cause the applicator to unlock from the pad (see par. [0063]-[0065]). Therefore, Da Ros does not teach “wherein a single actuation causes the cannula to lock to the pad, the applicator to unlock from the pad, and the portion of the cannula to be advanced into the skin of the wearer”. It would not be obvious to incorporate such a limitation into Da Ros’s invention because it would require a substantial redesign of its actuation mechanism.
Dependent claims 25-26 and 28-30 are allowable by virtue of their dependency on allowable claim 24.
Response to Arguments
In the amendment of 2/27/2026, Applicant added a limitation (“the applicator comprising a housing configured to cover an entirety of the outermost edge of the pad skeleton”) into claim 1. Although this limitation was discussed in the interview held on 2/12/2026 (see the Examiner’s Interview Summary on 2/19/2026 and Applicant’s Interview Summary on 2/27/2026), upon a full consideration and search of the amendment it was determined that the exact language introduced new matter (see rejection of claim 1 under 35 U.S.C. 112(a) above). Further, although it was discussed in the interview that Da Ros itself does not teach the aforementioned limitation as a rejection under 35 U.S.C. 102, it appears that an obviousness rejection under 35 U.S.C. 103 of Da Ros in view of Yodfat would be appropriate (see rejection of claim 1 under 35 U.S.C. 103 above).
Applicant incorporated a limitation from dependent claim 27 (see claim 27 in the claim set filed 8/8/2025) into independent claim 24. Because the Examiner agrees that Applicant’s arguments regarding the rejection of claim 27 were persuasive, a second non-final Office Action is issued.
Conclusion
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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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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