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 .
Status of the Application
Claims 1-26 are pending in the application.
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 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 and protruding members 3a) 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 and protruding members 3a) 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 and protruding members 3a) 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 protruding members 3a) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13, protruding members 3a cannot displace inward until they clear the distal ends of inner wall/guiding means 1a) and engenders tilting of the body (needle hub 3 and protruding members 3a) as the body (needle hub 3 and protruding members 3a) and the insertion sharp (insertion needle 6) are displaced by the first bias member (spring 5) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13; after protruding members 3a clear the distal ends of inner wall/guiding means 1a, they are able to tilt inward which coincides with upward displacement of the protruding members 3a, the needle hub 3, and the insertion needle 6 due to the force from spring 5; further, the angled shapes of protruding members 3a and the distal ends of inner wall/guiding means 1a shown in Figs. 1-3 will also allow the protruding members 3a to slide along and tilt inward from the inner wall/guiding means 1a as the spring 5 displaces the protruding members 3a, the needle hub 3, and the insertion needle 6 upward).
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 and protruding members 3a) 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 and protruding members 3a) 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 and protruding members 3a) as the body (needle hub 3 and protruding members 3a) 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) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13, protruding members 3a cannot displace inward until they clear the distal ends of inner wall/guiding means 1a) 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. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13; after protruding members 3a clear the distal ends of inner wall/guiding means 1a, they are able to tilt inward which coincides with upward displacement of the protruding members 3a and the insertion needle 6 to the retracted state; further, the angled shapes of protruding members 3a and the distal ends of inner wall/guiding means 1a shown in Figs. 1-3 will also allow the protruding members 3a to slide along and tilt inward from the inner wall/guiding means 1a as the protruding members 3a and the insertion needle 6 are displaced upward to the retracted state).
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).
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 are rejected under 35 U.S.C. 103 as being unpatentable over Mogensen et al. (US 10,369,277 B2), as applied to claim 10 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).
Response to Arguments
Applicant’s arguments, see the Pre-Appeal Brief Conference Request, filed 5/11/2026, with respect to the rejection of claim 19 have been fully considered. Specifically, Applicant’s arguments regarding the retraction stroke in the last four lines of claim 19 are persuasive. Therefore, the rejection under 35 U.S.C. 102 of claim 19 (and all rejections under 35 U.S.C. 102 or 35 U.S.C. 103 of the claims which depend from claim 19) has been withdrawn.
Applicant's arguments with respect to the rejections of claims 1 and 10 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Mogensen fails to teach the limitation “wherein one of the casing or the body includes a tipping projection which…engenders tilting of the body as the body and the insertion sharp are displaced by the first bias member” because guiding means 1a do not cause inward tilting of protruding members 3a as needle hub 3 and insertion needle 6 are displaced upward by spring. It is noted that the rejection of claim 1 above includes further citations and descriptions from Mogensen as to how these limitations are taught by Mogensen. The rejection of claim 1 above also further describes that the body includes both the needle hub 3 and the protruding members 3a of Mogensen. The aforementioned limitation is taught by Mogensen because 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 protruding members 3a) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13, protruding members 3a cannot displace inward until they clear the distal ends of inner wall/guiding means 1a). Further, the tipping projection (inner wall/guiding means 1a) engenders tilting of the body (needle hub 3 and protruding members 3a) as the body (needle hub 3 and protruding members 3a) and the insertion sharp (insertion needle 6) are displaced by the first bias member (spring 5) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13; after protruding members 3a clear the distal ends of inner wall/guiding means 1a, they are able to tilt inward which coincides with upward displacement of the protruding members 3a, the needle hub 3, and the insertion needle 6 due to the force from spring 5). The angled shapes of protruding members 3a and the distal ends of inner wall/guiding means 1a shown in Figs. 1-3 will also allow the protruding members 3a to slide along and tilt inward from the inner wall/guiding means 1a as the spring 5 displaces the protruding members 3a, the needle hub 3, and the insertion needle 6 upward. Applicant also argues that needle hub 3 does not tilt at any point; however, this argument is moot since the rejection now includes both protruding members 3a and needle hub 3 as corresponding to the “body”.
Regarding claim 10, Applicant argues that Mogensen fails to teach the limitation “wherein one of the casing or the retractor includes a tipping projection which…engenders tilting of the retractor as the retractor and the insertion sharp are displaced by to the retracted state” because guiding means 1a do not cause inward tilting of protruding members 3a as needle hub 3 and insertion needle 6 are retracted. It is noted that the rejection of claim 10 above includes further citations and descriptions from Mogensen as to how these limitations are taught by Mogensen. The aforementioned limitation is taught by Mogensen because 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) (see Figs. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13, protruding members 3a cannot displace inward until they clear the distal ends of inner wall/guiding means 1a). Further, the tipping projection (inner wall/guiding means 1a) 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. 1-3, col. 5 lines 11-41 and col. 6 lines 1-13; after protruding members 3a clear the distal ends of inner wall/guiding means 1a, they are able to tilt inward which coincides with upward displacement of the protruding members 3a and the insertion needle 6 to the retracted state). The angled shapes of protruding members 3a and the distal ends of inner wall/guiding means 1a shown in Figs. 1-3 will also allow the protruding members 3a to slide along and tilt inward from the inner wall/guiding means 1a as the protruding members 3a and the insertion needle 6 are displaced upward to the retracted state.
Allowable Subject Matter
Claims 19-26 are allowable.
The following is a statement of reasons for the indication of allowable subject matter:
In regarding to independent claim 19, the prior art of record fails to disclose or render obvious before the effective filing date of the claimed invention the inserter assembly as claimed, specifically including: wherein the sharp retractor displaces along the at least one guide in a first portion of the retraction stroke and is unguided for a second portion of the retraction stroke, the tipping projection blocking displacement of a portion of the sharp retractor during at least a part of the second portion of the retraction stroke. The closest prior art of record is Mogensen et al. (US 10,369,277 B2). 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 (retraction movements of Figs. 3-4) 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). However, Mogensen fails to state wherein the sharp retractor displaces along the at least one guide in a first portion of the retraction stroke and is unguided for a second portion of the retraction stroke, the tipping projection blocking displacement of a portion of the sharp retractor during at least a part of the second portion of the retraction stroke.
Dependent claims 20-26 are allowable by virtue of their dependency on allowable claim 19.
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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