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
Examiner acknowledges the reply filed 10/10/2025. Claims 17, 42, 45, 47 and 48 were amended. Claims 1-9 and 19-34 are canceled. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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.
Claims 10, 12-18, 35, 37-44 and 46-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hadvary et al (U.S. Pat. 10,080,582 B2, hereinafter “Hadvary”).
Regarding claim 10, Hadvary discloses a method (hereinafter “Method 1”) of placing a medical device (such as a syringe 38 and a needle 11; see Fig. 5A) of an inserter assembly (combination of coupling element 4 and needle holder 3) on a patient comprising:
coupling the inserter assembly to skin (see Fig. 5A and col. 7, lines 8-10, showing the inserter assembly coupled to the skin with adhesive layer 1);
lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “3” in Fig. 5A, which causes lifting of the skin as shown in Fig. 5B); and
triggering an actuation assembly of the inserter assembly automatically as the skin is lifted (as the skin is lifted, hook 41 automatically engages mechanism 8 and decouples the mechanism 8 from its engagement with a shoulder in part 38; upon such decoupling, part 38 is allowed to move downward in the direction indicated by downward arrow “5” in Fig. 5B).
In an alternative method (hereinafter “Method 2”), Hadvary discloses placing a medical device (such as a cannula 11 and a cannula holder 3; see Fig. 1A) of an inserter assembly (combination of plate 2, coupling element 4 and means 5) on a patient comprising:
coupling the inserter assembly to skin (see Fig. 1A showing the inserter assembly coupled to the skin with adhesive layer 1);
lifting the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “2” in Fig. 1A, which would expectedly cause at least some lifting of the skin); and
triggering an actuation assembly of the inserter assembly automatically as the skin is lifted (as the skin is lifted, a mechanism 8 is moved over a wedge 16 to cause the stay 17 to automatically engage with a hook 19 upon downward force on the release element 6).
Regarding claim 12, Hadvary discloses, in Method 2, after the inserter device is removed, the medical device can be fully assembled with an infusion set sub-assembly having a cover 24, a connector 27 and a cannula 28, with the infusion set having been assembled by driving the cannula 28 into the top of the needle holder of the infusion set (such as by connection by Luer-Lock or septum-needle mechanism; see col. 6, lines 14-17).
Regarding claim 13, Hadvary discloses, in Method 1, releasing a retraction prevention latch (see col. 8, lines 14-24) and driving the at least one insertion sharp in a direction away from the skin (in the direction indicated by the upward arrows “7”, which is the step of removing the entire device by pulling the device axially away from the skin; see col. 8, lines 10-12).
Regarding claim 14, Hadvary discloses, in Method 1, removing a lock member 12 which prevents triggering of the actuation assembly (i.e., the ridge portion of ridge-and-groove member 12 normally prevents movement of the coupling element 4 in the direction of upward arrows “3” until it is able to be removed from the groove portion).
Regarding claim 15, Hadvary discloses, in Method 1, coupling the inserter assembly to the skin comprises adhering a portion of the medical device to the skin via adhesive 1 (see Fig. 5A).
Regarding claim 16, Hadvary discloses, in Method 1, inhibiting relative movement between a casing of the inserter assembly and a second portion of the inserter assembly (such as an adhesive 10) at least when the skin begins to be lifted (i.e., the adhesive is adhered to the skin and the casing is adhered to the adhesive such that the adhesive prevents movement between the casing and the adhesive).
Regarding claim 17, Hadvary discloses, in Method 2, releasing the medical device from a portion of the inserter assembly (after moving into the configuration shown in Fig. 2, the means 4 and 5 are released from the medical device).
Regarding claim 18, Hadvary discloses, in Method 1, assembling the inserter assembly by coupling a disposable cartridge 6 (although Hadvary does not explicitly disclose that the cartridge 6 is disposable, a skilled artisan would know that it could be disposed of) containing the medical device to a reusable portion of the inserter assembly (e.g., the coupling element 4); see Fig. 5A, showing that the disposable cartridge 6 and coupling element 4 are already assembled, which implicitly requires them to have undergone assembly before use).
Regarding claim 35, Hadvary discloses, in Method 1, a method of placing a medical device (such as a syringe 38 and a needle 11; see Fig. 5A) of an inserter assembly (combination of coupling element 4 and needle holder 3) on a surface (i.e., skin) comprising:
coupling the inserter assembly to surface (see Fig. 5A and col. 7, lines 8-10, showing the inserter assembly coupled to the skin with adhesive layer 1);
lifting the surface from a resting position by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “3” in Fig. 5A, which causes lifting of the skin as shown in Fig. 5B); and
triggering an actuation assembly of the inserter assembly automatically as the surface is lifted (as the skin is lifted, hook 41 automatically engages mechanism 8 and decouples the mechanism 8 from its engagement with a shoulder in part 38; upon such decoupling, part 38 is allowed to move downward in the direction indicated by downward arrow “5” in Fig. 5B).
In an alternative method, Method 2, Hadvary discloses placing a medical device (such as a cannula 11 and a cannula holder 3; see Fig. 1A) of an inserter assembly (combination of plate 2, coupling element 4 and means 5) on a surface comprising:
coupling the inserter assembly to the surface (see Fig. 1A showing the inserter assembly coupled to the skin with adhesive layer 1);
lifting the surface from the resting position by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “2” in Fig. 1A, which would expectedly cause at least some lifting of the skin); and
triggering an actuation assembly of the inserter assembly automatically as the surface is lifted (as the skin is lifted, a mechanism 8 is moved over a wedge 16 to cause the stay 17 to automatically engage with a hook 19 upon downward force on the release element 6).
Regarding claim 37, Hadvary discloses, in Method 2, after the inserter device is removed, the medical device can be fully assembled with an infusion set sub-assembly having a cover 24, a connector 27 and a cannula 28, with the infusion set having been assembled by driving the cannula 28 into the top of the needle holder of the infusion set (such as by connection by Luer-Lock or septum-needle mechanism; see col. 6, lines 14-17).
Regarding claim 38, Hadvary discloses, in Method 1, releasing a retraction prevention latch (see col. 8, lines 14-24) and driving the at least one insertion sharp in a direction away from the surface (in the direction indicated by the upward arrows “7”, which is the step of removing the entire device by pulling the device axially away from the skin; see col. 8, lines 10-12).
Regarding claim 39, Hadvary discloses, in Method 1, removing a lock member 12 which prevents triggering of the actuation assembly (i.e., the ridge portion of ridge-and-groove member 12 normally prevents movement of the coupling element 4 in the direction of upward arrows “3” until it is able to be removed from the groove portion).
Regarding claim 40, Hadvary discloses, in Method 1, coupling the inserter assembly to the surface comprises adhering a portion of the medical device to the surface via adhesive 1 (see Fig. 5A).
Regarding claim 41, Hadvary discloses, in Method 1, inhibiting relative movement between a casing of the inserter assembly and a second portion of the inserter assembly (such as an adhesive 10) at least when the surface begins to be lifted (i.e., the adhesive is adhered to the skin and the casing is adhered to the adhesive such that the adhesive prevents movement between the casing and the adhesive).
Regarding claim 42, Hadvary discloses, in Method 2, releasing the medical device from a portion of the inserter assembly (after moving into the configuration shown in Fig. 2, the means 4 and 5 are released from the medical device).
Regarding claim 43, Hadvary discloses, in Method 1, assembling the inserter assembly by coupling a disposable cartridge 6 (although Hadvary does not explicitly disclose that the cartridge 6 is disposable, a skilled artisan would know that it could be disposed of) containing the medical device to a reusable portion of the inserter assembly (e.g., the coupling element 4); see Fig. 5A, showing that the disposable cartridge 6 and coupling element 4 are already assembled, which implicitly requires them to have undergone assembly before use).
Regarding claim 44, Hadvary discloses, in Method 1, a method of placing a medical device (such as a syringe 38 and a needle 11; see Fig. 5A) of an inserter assembly (combination of coupling element 4 and needle holder 3) on a patient comprising:
coupling the inserter assembly to skin (see Fig. 5A and col. 7, lines 8-10, showing the inserter assembly coupled to the skin with adhesive layer 1);
stretching the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “3” in Fig. 5A, which causes stretching and lifting of the skin as shown in Fig. 5B); and
triggering an actuation assembly of the inserter assembly automatically as the skin is stretched with a force exerted by the skin (as the skin is lifted, hook 41 automatically engages mechanism 8 and decouples the mechanism 8 from its engagement with a shoulder in part 38; upon such decoupling, part 38 is allowed to move downward in the direction indicated by downward arrow “5” in Fig. 5B).
In an alternative method, Method 2, Hadvary discloses placing a medical device (such as a cannula 11 and a cannula holder 3; see Fig. 1A) of an inserter assembly (combination of plate 2, coupling element 4 and means 5) on a patient comprising:
coupling the inserter assembly to skin (see Fig. 1A showing the inserter assembly coupled to the skin with adhesive layer 1);
stretching the skin from underlying anatomy by displacing the inserter assembly in a direction away from the skin (the inserter assembly is displaced in the direction indicated by upward arrow “2” in Fig. 1A, which would expectedly cause at least some lifting of the skin); and
triggering an actuation assembly of the inserter assembly automatically as the skin is stretched (as the skin is lifted and stretched, a mechanism 8 is moved over a wedge 16 to cause the stay 17 to automatically engage with a hook 19 upon downward force on the release element 6).
Regarding claim 46, Hadvary discloses, in Method 2, after the inserter device is removed, the medical device can be fully assembled with an infusion set sub-assembly having a cover 24, a connector 27 and a cannula 28, with the infusion set having been assembled by driving the cannula 28 into the top of the needle holder of the infusion set (such as by connection by Luer-Lock or septum-needle mechanism; see col. 6, lines 14-17).
Regarding claim 47, Hadvary discloses, in Method 1, releasing a retraction prevention latch (see col. 8, lines 14-24) and driving the at least one insertion sharp in a direction away from the skin (in the direction indicated by the upward arrows “7”, which is the step of removing the entire device by pulling the device axially away from the skin; see col. 8, lines 10-12).
Regarding claim 48, Hadvary discloses, in Method 1, inhibiting relative movement between a casing of the inserter assembly and a second portion of the inserter assembly (such as an adhesive 10) at least when the surface begins to be lifted (i.e., the adhesive is adhered to the skin and the casing is adhered to the adhesive such that the adhesive prevents movement between the casing and the adhesive).
Regarding claim 49, Hadvary discloses, in Method 1, assembling the inserter assembly by coupling a disposable cartridge 6 (although Hadvary does not explicitly disclose that the cartridge 6 is disposable, a skilled artisan would know that it could be disposed of) containing the medical device to a reusable portion of the inserter assembly (e.g., the coupling element 4); see Fig. 5A, showing that the disposable cartridge 6 and coupling element 4 are already assembled, which implicitly requires them to have undergone assembly before use).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11, 36 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Hadvary.
Regarding claims 11, 36 and 45, Hadvary, in Method 1, does not specifically disclose that the method further comprises releasing a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp (the needle 11) through the skin (claims 36 and 45 recite a similar limitation to claim 11).
However, Hadvary teaches an alternative construction of the actuation assembly a bias member, in the form of a spring, is provided to release energy in order to drive the needle 11 through the skin (see col 3, lines 60-64; the spring is used to deblock the release element in order to release the actuation mechanism).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify Method 1 of Hadvary, in order to release a bias member of the actuation assembly from an energy storing state to drive at least one insertion sharp (the needle 11), in order to ensure sufficient acceleration of the assembly to thereby ensure skin piercing and insertion of the needle (see Hadvary at col. 3, lines 48-60).
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered.
Rejections under 35 U.S.C. 112
Applicant’s amendments to the claims have overcome the previously applied rejections under 35 U.S.C. 112(b).
Rejections under 35 U.S.C. 102
Applicant noted that claims 10, 12-18, 35 37-44 and 46-49 were apparently intended to be rejected under 35 U.S.C. 102, and responded accordingly (see Remarks, pg. 7). Examiner affirms this treatment, and has corrected the Office action to reflect the appropriate rejection.
With respect to claims 1, 35 and 44, Applicant argued that Method 1 of Hadvary does not teach or suggest an inserter assembly which is triggered as the skin is lifted (claim 1 discussed at Remarks, pgs. 7-8; claim 35 discussed at Remarks, pgs. 9-10; claim 44 discussed at Remarks, pgs. 11-13). Applicant argued that Hadvary instead teaches that “pressure toward the skin…accelerates the needle holder to the skin” and that Hadvary’s device does not trigger and effectuate an insertion with lifting (see Remarks, pg. 8).
Examiner acknowledges the above-mentioned teaching in Hadvary; however, Hadvary also discloses that the skin attachment plate 2 (which is attached to the skin) moves upward “towards the needle holder 3” resulting in the needle 11 piercing the skin (see Fig. 5B and col. 7, lines 59-62). As the skin is lifted in this step, the hook 41 automatically engages mechanism 8 and decouples the mechanism 8 from its engagement with a shoulder in part 38. Thus, part 38 is allowed to move downward in the direction indicated by downward arrow “5” in Fig. 5B). Applicant argued that the disclosure of Hadvary, which includes depressing its device against underlying anatomy, is in contrast to what is recited in claim 10 (see Remarks, pg. 10). But the claimed invention provides neither an explicit or implicit exclusion of a downward pressure step.
Applicant argued that Method 2 of Hadvary does not teach or suggest an inserter assembly which is triggered as the skin is lifted, for substantially the same reasons, i.e., Hadvary requires downward pressure toward the skin to be met for movement of the needle holder (see Remarks, pg. 8-9, 10-11, 13). Examiner directs Applicant to the explanation above; the claimed invention provides neither an explicit or implicit exclusion of a downward pressure step.
Rejections under 35 U.S.C. 103
Applicant traversed the rejection of claims 11, 36 and 35, arguing that Hadvary does not teach use of a spring to drive a needle (see Remarks, pg. 14).
Examiner directs Applicant to the previously cited portion of Hadvary at col 3, lines 60-64, which teaches a construction in which a spring is used to deblock the release element in order to release the actuation mechanism, repeated verbatim hereafter:
“In this construction, the bending of the hook-type components for de-blocking can define the necessary trigger point pressure for release, but also alternative constructions with e.g., a spring can be used for this purpose.”
For these reasons, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 01/05/2025