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 10/10/2025 has been entered. Claims 1-26 are pending in the application. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 7/11/2025.
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 1-16, 19, and 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mogensen et al. (US 10,369,277 B2).
Regarding claim 1, Mogensen discloses an inserter assembly (see Figs. 1-5) comprising:
a casing (housing 1) having an open end (bottom end of housing 1 with opening) and a closed end (top end of housing 1) (see Figs. 1-5);
a first unit at least partially within the casing (housing 1) movable relative to the casing (housing 1) comprising:
a device base (infusion part 8);
an insertion sharp (insertion needle 6) displaceable between a raised state (see Fig. 1), a forward state (see Figs. 2-3), and a retracted state (see Figs. 4-5);
a body (needle hub 3) configured to displace in tandem with the insertion sharp (insertion needle 6) at least during displacement of the insertion sharp (insertion needle 6) from the forward state (see Figs. 2-3) to the retracted state (see Figs. 4-5);
a first bias member (spring 5) configured to urge the body (needle hub 3) toward the closed end (top end of housing 1) of the casing (housing 1) (see Figs. 3-4, col. 6 lines 9-13); and
a bias member release latch (locking members 2a) having an engaged state (locking members 2a engaged) and a released state (locking members 2a released), the first bias member (spring 5) displacing the body (needle hub 3) toward the closed end (top end of housing 1) and displacing the insertion sharp (insertion needle 6) to the retracted state (see Figs. 4-5) when the bias member release latch (locking members 2a) is transitioned from the engaged state (locking members 2a engaged) to the released state (locking members 2a released) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13); and
wherein the casing (housing 1) includes a tipping projection (inner wall/guiding means 1a) which obstructs displacement of a portion of the body (needle hub 3) and engenders tilting of the body (needle hub 3) as the body (needle hub 3) and the insertion sharp (insertion needle 6) are displaced by the first bias member (spring 5) (see Figs. 2-3, col. 5 lines 11-41 and col. 6 lines 1-13).
Regarding claim 2, Mogensen discloses the inserter assembly of claim 1, wherein the inserter assembly (see Figs. 1-5) includes at least one guide (outer wall/guiding means 1b), the body (needle hub 3) being displaced along and then out of engagement with the at least one guide (outer wall/guiding means 1b) as the body (needle hub 3) is displaced toward the closed end (top end of housing 1) by the first bias member (spring 5) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13).
Regarding claim 3, Mogensen discloses the inserter assembly of claim 1, wherein the first unit further comprises a second bias member (spring 4) configured to propel the insertion sharp (insertion needle 6) from the raised state (see Fig. 1) to the forward state (see Figs. 2-3) (see col. 5 lines 64-67).
Regarding claim 4, Mogensen discloses the inserter assembly of claim 3, wherein the inserter assembly further comprises a release latch for the second bias member (spring 4) configured to be transitioned from an engaged state to a released state after a magnitude of displacement of the casing (housing 1) relative to the first unit exceeds a threshold (see col. 5 lines 48-67, carrier body 2 has two protruding members/latches which are initially engaged with and then released from corresponding openings in housing 1 to allow the release of spring 4).
Regarding claim 5, Mogensen discloses the inserter assembly of claim 4, wherein the device base (infusion part 8) is coupled to an adhesive (adhesive pad 7), the adhesive (adhesive pad 7) configured to anchor the first unit against a patient while the casing (housing 1) is pulled away from the patient and the magnitude of displacement of the casing (housing 1) relative to the first unit increases (see Fig. 5, col. 6 lines 14-19).
Regarding claim 6, Mogensen discloses the inserter assembly of claim 1, wherein the first unit further comprises a cannula assembly (cannula 6a of infusion part 8) carried by the insertion sharp (insertion needle 6) (see Fig. 1, col. 4 lines 46-53).
Regarding claim 7, Mogensen discloses the inserter assembly of claim 6, wherein the cannula assembly (cannula 6a of infusion part 8) is configured to couple to the device base (infusion part 8) and transition the bias member release latch (locking members 2a) to the released state (locking members 2a released) when the insertion sharp (insertion needle 6) reaches the forward state (see Figs. 2-3) (see Figs. 1-3, col. 4 lines 46-53, col. 5 lines 11-41).
Regarding claim 8, Mogensen discloses the inserter assembly of claim 1, wherein the inserter assembly (see Figs. 1-5) includes an interior housing (carrier body 2) within the casing (housing 1) (see Figs. 1-5), the interior housing (carrier body 2) including a guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6), at least a tip of the insertion sharp (insertion needle 6) being displaced into the guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6) as the insertion sharp (insertion needle 6) is displaced to the retracted state (see Figs. 4-5) (see col. 5 lines 35-41, col. 6 lines 9-13).
Regarding claim 9, Mogensen discloses the inserter assembly of claim 8, wherein the guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6) doubles as a guide which directs displacement of the body (needle hub 3) as the body (needle hub 3) is displaced toward the closed end (top end of housing 1) (see Figs. 3-5, col. 5 lines 35-41, col. 6 lines 9-13).
Regarding claim 10, Mogensen discloses an inserter assembly (see Figs. 1-5) comprising:
a casing (housing 1) having an open end (bottom end of housing 1 with opening) and a closed end (top end of housing 1) (see Figs. 1-5);
a first unit at least partially within the casing (housing 1) movable relative to the casing (housing 1) comprising:
a device base (infusion part 8);
a sharp holder (needle hub 3) including an insertion sharp (insertion needle 6), the sharp holder (needle hub 3) displaceable between a raised state (see Fig. 1), a forward state (see Figs. 2-3), and a retracted state (see Figs. 4-5);
a retractor (protruding members 3a), the sharp holder (needle hub 3) being at least partially disposed within the retractor (protruding members 3a) (see Figs. 1-5);
a first bias member (spring 5) configured to displace the retractor (protruding members 3a) from an initial position (see Fig. 3) to a retracted position (see Fig. 4) (see Figs. 3-4, col. 6 lines 9-13); and
a bias member release latch (locking members 2a) having an engaged state (locking members 2a engaged) and a released state (locking members 2a released), the first bias member (spring 5) displacing the retractor (protruding members 3a) and the insertion sharp (insertion needle 6) to a retracted state (see Figs. 4-5) when the bias member release latch (locking members 2a) is transitioned from the engaged state (locking members 2a engaged) to the released state (locking members 2a released) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13); and
wherein the casing (housing 1) includes a tipping projection (inner wall/guiding means 1a) which obstructs displacement of a portion of the retractor (protruding members 3a) and engenders tilting of the retractor (protruding members 3a) as the retractor (protruding members 3a) and the insertion sharp (insertion needle 6) are displaced to the retracted state (see Figs. 4-5) (see Figs. 2-3, col. 5 lines 11-41 and col. 6 lines 1-13).
Regarding claim 11, Mogensen discloses the inserter assembly of claim 10, wherein the inserter assembly (see Figs. 1-5) includes an interior housing (outer wall/guiding means 1b) within the casing (housing 1) defining at least one retractor guide (outer wall/guiding means 1b), the retractor (protruding members 3a) being displaced along and then out of engagement with the at least one retractor guide (outer wall/guiding means 1b) as the retractor (protruding members 3a) and the insertion sharp (insertion needle 6) are displaced to the retracted state (see Figs. 4-5) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13).
Regarding claim 12, Mogensen discloses the inserter assembly of claim 10, wherein the retractor (protruding members 3a) and the sharp holder (needle hub 3) move together in unison for at least a portion of the displacement of the retractor (protruding members 3a) and the insertion sharp (insertion needle 6) to the retracted state (see Figs. 1-5).
Regarding claim 13, Mogensen discloses the inserter assembly of claim 10, wherein the first unit further comprises a second bias member (spring 4) configured to propel the sharp holder (needle hub 3) from the raised state (see Fig. 1) to the forward state (see Figs. 2-3) (see col. 5 lines 64-67).
Regarding claim 14, Mogensen discloses the inserter assembly of claim 13, wherein the inserter assembly further comprises a release latch for the second bias member (spring 4) configured to be transitioned from an engaged state to a released state after a magnitude of displacement of the casing (housing 1) relative to the first unit exceeds a threshold (see col. 5 lines 48-67, carrier body 2 has two protruding members/latches which are initially engaged with and then released from corresponding openings in housing 1 to allow the release of spring 4).
Regarding claim 15, Mogensen discloses the inserter assembly of claim 14, wherein the device base (infusion part 8) is coupled to an adhesive (adhesive pad 7), the adhesive (adhesive pad 7) configured to anchor the first unit against a patient while the casing (housing 1) is pulled away from the patient and the magnitude of displacement of the casing (housing 1) relative to the first unit increases (see Fig. 5, col. 6 lines 14-19).
Regarding claim 16, Mogensen discloses the inserter assembly of claim 10, wherein the first unit further comprises a cannula assembly (cannula 6a of infusion part 8) carried by the insertion sharp (insertion needle 6) (see Fig. 1, col. 4 lines 46-53), the cannula assembly (cannula 6a of infusion part 8) configured to couple to the device base (infusion part 8) and transition the bias member release latch (locking members 2a) to the released state (locking members 2a released) when the sharp holder (needle hub 3) is in the forward position (see Figs. 2-3) (see Figs. 1-3, col. 4 lines 46-53, col. 5 lines 11-41).
Regarding claim 19, Mogensen discloses an inserter assembly (see Figs. 1-5) comprising:
a casing (housing 1) having an open end (bottom end of housing 1 with opening) and a closed end (top end of housing 1) (see Figs. 1-5), a tipping projection (inner wall/guiding means 1a) being disposed at the closed end (top end of housing 1) (see Figs. 2-3, col. 5 lines 11-41 and col. 6 lines 1-13);
a guide body (outer wall/guiding means 1b) disposed within the casing (housing 1) and including at least one guide (outer wall/guiding means 1b) (see Figs. 1-5);
a patient care assembly base (infusion part 8);
a sharp holder (needle hub 3) including an insertion sharp (insertion needle 6), the sharp holder (needle hub 3) displaceable between a raised state (see Fig. 1), a forward state (see Figs. 2-3), and a retracted state (see Figs. 4-5);
a sharp retractor (protruding members 3a), the sharp holder (needle hub 3) being at least partially disposed within the sharp retractor (protruding members 3a) (see Figs. 1-5);
a retraction spring (spring 5) configured to displace the sharp retractor (protruding members 3a) from an initial position (see Fig. 3) to a retracted position (see Fig. 4) (see Figs. 3-4, col. 6 lines 9-13);
a retraction spring release latch (locking members 2a) having an engaged state (locking members 2a engaged) and a released state (locking members 2a released), the retraction spring (spring 5) displacing the sharp retractor (protruding members 3a) and the insertion sharp (insertion needle 6) along a retraction stroke (entirety of the movement of Figs. 1-5) when the retraction spring release latch (locking members 2a) is transitioned from the engaged state (locking members 2a engaged) to the released state (locking members 2a released) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13); and
wherein the sharp retractor (protruding members 3a) displaces along the at least one guide (outer wall/guiding means 1b) in a first portion (initial movement in Fig. 1) of the retraction stroke (entirety of the movement of Figs. 1-5) and is unguided for a second portion (movement in Figs. 2-5) of the retraction stroke (entirety of the movement of Figs. 1-5), the tipping projection (inner wall/guiding means 1a) blocking displacement of a portion of the sharp retractor (protruding members 3a) during at least a part (movement in Fig. 2 before protruding members 3a are pushed inward) of the second portion (movement in Figs. 2-5) of the retraction stroke (see Figs. 2-3, col. 5 lines 11-41 and col. 6 lines 1-13).
Regarding claim 21, Mogensen discloses the inserter assembly of claim 19, wherein the guide body (outer wall/guiding means 1b) includes a guard (carrier body 2), at least a tip of the insertion sharp (insertion needle 6) being displaced into the guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6) during the second portion of the retraction stroke (see col. 5 lines 35-41, col. 6 lines 9-13).
Regarding claim 22, Mogensen discloses the inserter assembly of claim 19, wherein the sharp retractor (protruding members 3a) and the sharp holder (needle hub 3) move together in unison for at least a portion of the retraction stroke (see Figs. 1-5).
Regarding claim 23, Mogensen discloses the inserter assembly of claim 19, wherein the patient care assembly base (infusion part 8) is an infusion set base (see Figs. 1-5, col. 4 lines 48-53) and the inserter assembly (see Figs. 1-5) further comprises a cannula assembly (cannula 6a of infusion part 8) carried by the insertion sharp (insertion needle 6) (see Fig. 1, col. 4 lines 46-53).
Regarding claim 24, Mogensen discloses the inserter assembly of claim 23, wherein the cannula assembly (cannula 6a of infusion part 8) is coupled to the infusion set base (infusion part 8) when the sharp holder (needle hub 3) is displaced to the forward state (see Figs. 1-5, col. 4 lines 46-53).
Regarding claim 25, Mogensen discloses the inserter assembly of claim 23, wherein the retraction spring release latch (locking members 2a) couples the patient care assembly base (infusion part 8) to the sharp retractor (protruding members 3a) when the retraction spring release latch (locking members 2a) is in the engaged state (see Figs. 1-5, col. 4 lines 46-53, col. 5 lines 11-41, col. 6 lines 1-13).
Regarding claim 26, Mogensen discloses the inserter assembly of claim 19, wherein the insertion sharp (insertion needle 6) is closer to the closed end (top end of housing 1) of the casing (housing 1) when in the retracted state (see Figs. 4-5) compared to the raised state (see Fig. 1).
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.
Claims 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mogensen et al. (US 10,369,277 B2), as applied to claims 10 and 19 above, in view of Lavi et al. (US 2002/0055711 A1).
Regarding claim 17, Mogensen discloses the inserter assembly of claim 10, wherein the inserter assembly (see Figs. 1-5) includes an interior housing (carrier body 2) within the casing (housing 1) (see Figs. 1-5), the interior housing (carrier body 2) including a guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6).
However, Mogensen fails to state the insertion sharp tilting at least partially into the guard as the retractor and the insertion sharp are displaced to the retracted state.
Lavi teaches an inserter assembly (see Figs. 28-30) wherein the insertion sharp (needle N) tilts at least partially into the guard (base 540) as the retractor (needle actuator 520) and the insertion sharp (needle N) are displaced to the retracted state (see Figs. 28-30, par. [0141]-[0144]).
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 inserter assembly of Mogensen such that the insertion sharp tilts at least partially into the guard as the retractor and the insertion sharp are displaced to the retracted state, as taught by Lavi, in order to render the insertion assembly inoperable after a single use (see Lavi par. [0141] and [0144]).
Regarding claim 18, modified Mogensen teaches the inserter assembly of claim 17 substantially as claimed. Mogensen further teaches wherein the guard (see Figs. 4-5, carrier body 2 guards against the tip of insertion needle 6) doubles as a retractor guide which directs displacement of the retractor (protruding arms 3a) as the retractor (protruding arms 3a) is displaced to the retracted state (see Figs. 4-5) (see col. 5 lines 35-41, col. 6 lines 9-13).
Regarding claim 20, Mogensen discloses the inserter assembly of claim 19. However, Mogensen fails to state wherein the sharp retractor and the insertion sharp are non-parallel to an axis of the casing at a conclusion of the retraction stroke.
Lavi teaches an inserter assembly (see Figs. 28-30) wherein the sharp retractor (needle actuator 520) and the insertion sharp (needle N) are non-parallel to an axis of the casing (outer housing of device of Figs. 28-30) (see Figs. 28-30, par. [0141]-[0144]).
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 inserter assembly of Mogensen such that the sharp retractor and the insertion sharp are non-parallel to an axis of the casing at a conclusion of the retraction stroke, as taught by Lavi, in order to render the insertion assembly inoperable after a single use (see Lavi par. [0141] and [0144]).
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
In regards to claim 1, Applicant argues that Mogensen fails to teach the limitation "one of the casing or the body includes a tipping projection which obstruct displacement of a portion of the body and engenders tilting of the body as the body and the insertion sharp are displaced by the first bias member". Specifically, Applicant argues that the inner wall/guiding means 1a (identified by the Examiner as the "tipping projection") does not tilt the needle hub 3 (identified by the Examiner as the "body"). This argument is not found to be persuasive. Mogensen shows and describes that protruding members 3a of needle hub 3 are held between locking members 2a and the inner wall/guiding means 1a as the assembly transitions from the position of Fig. 1 to the position of Fig. 2. Once the top of protruding members 3a pass below the bottom edge of the inner wall/guiding means 1a, the locking members 2a push the protruding members 3a such that they are tilted inward to the position of Fig. 3. The force of the spring 5 then pushes the needle hub 3 upward to the position of Fig. 4. See Figs. 1-4, col. 5 lines 11-41. In other words, the inner wall/guiding means 1a obstructs an inward displacement of the protruding members 3a of the needle hub 3 before the top of protruding members pass below the bottom edge of the inner wall/guiding means 1a. The inner wall/guiding means 1a further engenders/facilitates an inward tilting of the protruding members 3a of the needle hub 3 as the needle hub 3 and the insertion needle 6 are displaced upward by the spring 5. Thus, the Examiner maintains that Mogensen anticipates the claim as currently recited.
In regards to claim 10, Applicant states that the needle hub 3 (identified by the Examiner as the "sharp holder") and the protruding members 3a (identified by the Examiner as the "retractor") are part of the same structural feature and thus cannot be relied upon for teaching both the sharp holder and the retractor. This argument is not found to be persuasive. The needle hub 3 is pointed to in each of Mogensen's Figs. 1-5 as the central t-shaped portion from which insertion needle 6 extends. Thus, this portion is appropriately considered the "sharp holder". The protruding arms 3a are arms which are shown to extend upward from opposite sides of the t-shaped needle hub 3. Thus, Mogensen teaches a structural distinction between the protruding arms 3a and the t-shaped needle hub 3 itself and these two structures appropriately meet the language of the claim as currently recited. Applicant further argues that the lower section of the needle hub 3 is only shown to be below the protruding arms 3a and thus would not be able to be considered "within" the protruding arms 3a. This argument is not found to be persuasive. Since protruding arms 3a extend from opposite sides of the t-shaped portion of needle hub 3, the t-shaped portion of needle hub 3 is located between/within the protruding arms 3a. For example, if looking downward directly at the top of the protruding arms 3a and needle hub 3, the needle hub 3 would clearly be shown as being between/within the protruding arms 3a. Thus, the Examiner maintains that Mogensen anticipates the claim as currently recited.
In regards to claim 19, Applicant submits the same two arguments set forth in regards to claim 10. These arguments are not found persuasive for the same reasons described in regards to claim 10 above. Applicant further argues that the entirety of the movement of Figs. 1-5 (identified by the Examiner as the "retraction stroke") cannot be considered the claimed "retraction stroke" because Mogensen describes a raised state of Fig. 1 transitioning to a forward state in Figs. 2-3 which would not be considered "retraction". This argument is not found to be persuasive. Although lines 12-19 of the claim recite certain structural movements which must be included within the "retraction stroke", these lines do not prohibit additional structural movements from occurring during the "retraction stroke". Mogensen's device can be considered as operating in a single stroke/motion where the user actuates the device once, then a single, unpaused chain of events ("stroke") occurs to both insert and retract the needle. See Figs. 1-5, col. 5 lines 11-41, col. 5 line 48-col. 6 line 13. Retraction is clearly included in this single stroke and thus the entirety of motions of Mogensen's Figs. 1-5 can be considered the "retraction stroke" as currently recited. Applicant further argues that the protruding members 3a (identified by the Examiner as the "sharp retractor") do not displace along the outer wall/guiding means 1b (identified by the Examiner as the "at least one guide") in a first portion of the retraction stroke and further the protruding members 3a (identified by the Examiner as the "sharp retractor") do not transition from guided to unguided during a second portion of the retraction stroke. This argument is not found to be persuasive. The protruding members 3a displace downward parallel and along the longitudinal direction of the outer wall/guiding means 1b as the protruding members 3a are held between the inner wall/guiding means 1a, the locking members 2a, and the outer wall/guiding means 1b. Once the top of protruding members 3a pass below the bottom edge of the inner wall/guiding means 1a, the locking members 2a push the protruding members 3a inward such that they are unguided for the remainder of the movements of Figs. 2-5. Thus, the Examiner maintains that Mogensen anticipates the claim as currently recited. Applicant further argues that the Examiner's interpretation of the Mogensen reference as it relates to the retraction stroke in claim 19 contradicts the Examiner's interpretation of the Mogensen reference as it relates to the raised, forward, and retracted states in claim 1. This argument is not found to be persuasive. The language that is recited in claim 1 vs. claim 19 is different. For example, a "retraction stroke" is not even mentioned in claim 1. Further, a "stroke" is a movement whereas a "state" is a position. The Examiner's interpretation of what is taught in the Mogensen reference is consistent. The scope of claims 1 and 19 is different and thus Mogensen appropriately applies to the different claim scope differently.
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 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