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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 8-11, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Destefano et al. (US Patent Pub. 20180021508 hereinafter “Destefano”).
Regarding Claim 1, Destefano teaches (Fig 14A-15B) A torsional insertion mechanism, comprising:
a torsion spring (2210, Fig 14a; See [0125] teaching 2210 is a rotational biasing member) configured to rotate a bushing (2202) around a rotational axis (longitudinal axis) between a first bushing position (Fig 14A) and a second bushing position (Fig 14B; see [0125]), and further rotate the bushing around the rotational axis between the second bushing position (Fig 14B) and a third bushing position (Fig 14C; see [0126]); and
an insertion assembly (2212, 2260, 2214) including a cannula (2260) and a captive introducer needle (2214) configured to pierce tissue, wherein the cannula and captive introducer needle are coaxially aligned with the rotational axis (See Figs 14A-14C, the needle and cannula are in the longitudinal axis),
wherein the cannula (2260) and the captive introducer needle (2214) are configured to move in an insertion direction (distal direction as seen between Fig 14A to Fig 14B) during the rotation of the bushing between the first (Fig 14A) and second bushing positions (Fig 14B; see [0125]),
and wherein the captive introducer needle (2214) is configured to move in a retraction direction (proximal direction as seen in Fig 14C) opposite the insertion direction during the rotation of the bushing between the second (Fig 14B) and third bushing positions (Fig 14C; see [0126]).
Regarding Claim 2, Destefano teaches the torsional insertion mechanism according to claim 1, wherein the bushing (2202) includes an inner surface including an angled ramp (2204, Fig 15A-15B; also see [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 3, Destefano teaches the torsional insertion mechanism according to claim 2, wherein the insertion assembly (2212, 2260, 2214) includes a tubular boss (2212A) configured to contact the angled ramp (2204) and move from a first boss position (Fig 14A) to a second boss position (Fig 14B) in response to the rotation of the bushing (See [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 4, Destefano teaches the torsional insertion mechanism according to claim 2, wherein the angled ramp (2204) contacts the insertion assembly (2212; see [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 5, Destefano teaches the torsional insertion mechanism according to claim 2, wherein the angled ramp includes a first track portion (part of 2204; see Figs 15A-15B) that pushes the captive introducer needle (2214) down (See [0125] teaching that the rotation along track guides needle distally) and a second track portion (remaining portion of 2204 in the rotation occurring between Fig 14b-14c) pulls the captive introducer needle out in response to rotation of the bushing (See [0125] and [0126] teaching how the rotation along the track/ramp 2204 leads to the insertion and retraction of needle 2214; also see Figs 14a-14c, the bushing 2202 is rotating between three positions, therefore the track is considered to have multiple ‘portions’ or ‘sections’ corresponding with each part of the rotation occurring between Figs 14a-14c).
Regarding Claim 8, Destefano teaches the torsional insertion mechanism according to claim 2, wherein the insertion assembly further includes: a cannula carrier (2252) configured to capture the cannula (2260; see [0125] " the cannula 2260 is initially disposed within sterile boot 2250 and septum 2270 is disposed in aperture 2252E in base 2252"); a needle guide (2290)configured to guide the cannula (2260) in the cannula carrier (2252); and a fluid flow path (2218) that passes through the needle guide (2290) to the cannula (2260) in the cannula carrier (2252),wherein the fluid flow path is configured for fluid communication between the cannula and a medical reservoir (See [0126] "This creates a fluid path through conduit 2218, needle 2214, and cannula 2260 for delivery of the medicament to the target tissue").
Regarding Claim 9, Destefano teaches the torsional insertion mechanism according to claim 8, wherein the needle guide (2290) further includes a tubular boss (see annotated Fig 14C) extended from a bottom of the needle guide (2290), wherein the cannula carrier (2252) includes a bore (where 2270 is in carrier 2252); and wherein the cannula (2260) is captured in a radial gap (opening in 2270 in Fig 14C where cannula 2260 is located) between the bore in the cannula carrier and the tubular boss (See Fig 14C).
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Annotated Fig 14C (Destefano)
Regarding Claim 10, Destefano teaches the torsional insertion mechanism according to claim 2, wherein the introducer needle (2214) and the cannula (2260) are configured to move from a first needle position (Fig 14A) to a second needle position (Fig 14B) in response to the insertion assembly moving from the first insertion position (Fig 14A) to the second insertion position (Fig 14B; see [0125]).
Regarding Claim 11, Destefano teaches the torsional insertion mechanism according to claim 10, wherein the introducer needle (2214) is configured to move to the first needle position (Fig 14A and Fig 14C) from the second needle position (Fig 14B) and the cannula (2260) remains in the second needle position (Fig 14B and Fig 14C) in response to the insertion assembly moving from the second insertion position (Fig 14B) to a third insertion position (fig 14C; see Fig 14C the needle 2214 is retracted to a first position and the cannula 2260 remains in the second extended position).
Regarding Claim 18, Destefano teaches (Figs 14a-15B) a method for operating a torsional inserter of an insulin infusion system, the method comprising:
rotating a bushing (2202) around a rotational axis (longitudinal axis) between a first bushing position (Fig 14A) and a second bushing position (Fig 14B) by a torsion spring (2210, see [0125] teaching rotational biasing member 2202 and the movement between the first position Fig 14A to second position Fig 14B); and
moving at least a first portion (2260) of an insertion assembly (2212, 2260, 2214) in an insertion direction (distal direction, see 2260 movement between Fig 14A and Fig 14B) during the rotation of the bushing between the first (Fig 14A) and second bushing positions (Fig 14B), wherein the first portion comprises a cannula (2260) coaxially aligned with the rotational axis (longitudinal axis);
rotating the bushing (2202) around the rotational axis between the second bushing position (Fig 14B) and a third bushing position (Fig 14C) by the torsion spring (2210; see [0126]); and moving at least a second portion (2214) of the insertion assembly (2212, 2260, 2214) in a retraction direction opposite the insertion direction during the rotation of the bushing between the second (Fig 14B) and third bushing positions (Fig 14C; see [00126]), wherein the second portion comprises a needle (2214) coaxially aligned with the rotational axis (longitudinal axis).
Regarding Claim 19, Destefano teaches the method according to claim 18, further comprising: moving the needle (2214) and the cannula (2260) from a first needle position (Fig 14A) to a second needle position (Fig 14B) in response to the bushing (2202) rotating from the first bushing position (Fig 14A) to the second bushing position (Fig 14B; see [0125]).
Regarding Claim 20, Destefano teaches the method according to claim 19, further comprising: moving the needle (2214) to the first needle position (Fig 14A, 14C) from the second needle position(Fig 14B) and the cannula (2260) remaining in the second needle position (Fig 14B, also see cannula 2260 in the second position in Fig 14C) in response to the bushing (2202) rotating from the second bushing position (Fig 14B) to a third bushing position (Fig 14C; see [0126]).
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Destefano (US Patent Pub. 20180021508) as applied to claim 1 above, and further in view of Destefano (US Patent Pub. 20180021508).
Regarding Claim 6, Destefano teaches all elements of claim 1 as described above. Destefano embodiment of Figs 14A-15B does not specify the torsional insertion mechanism further comprising a stop member configured to selectively prevent rotation of the bushing.
Destefano does teach in the embodiment of Figures 24a-24B a torsional insertion mechanism further comprising a stop member configured to selectively prevent rotation of the bushing (See [0111] “By way of example, activation member 14 may be engaged with a slide which, in an initial configuration, prevents rotation of housing 202 by interaction with protrusion 202A. Depression of trigger member 14 may displace the slide, disengaging the slide, or another component, from the protrusion 202A of housing 202, thereby allowing rotation of housing 202”; also see [0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torsional insertion mechanism of Destefano such that it includes a stop member configured to selectively prevent rotation of the bushing as taught by Destefano embodiment of Figures 24A-24B. One of ordinary skill in the art would have been motivated to do so in order to prevent the activation of the device until the desired movement, additionally one of ordinary skill in the art would recognize this as an alternative activation mechanism for the torsional insertion mechanism (Destefano [0112]) (Gravesen [0062]).
Regarding Claim 7, the modified Destefano teaches the torsional insertion mechanism according to claim 6, wherein the stop member (202A) is configured to move from a first stop position to prevent rotation of the bushing by engaging a stop recess (610) in an outer surface of the bushing (200), to a second stop position to enable rotation of the bushing by disengaging the stop recess of the bushing (see Destefano [0112]).
Claim(s) 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Destefano (US Patent Pub. 20180021508).
Regarding Claim 12, Destefano teaches (Figs 14A-15B) infusion pump system (see [0096] teaching the system includes a pump 10), comprising: a torsional insertion mechanism, including:
a torsion spring (2210, Fig 14a; See [0125] teaching 2210 is a rotational biasing member) configured to rotate a bushing (2202) around a rotational axis (longitudinal axis) between a first bushing position (Fig 14A) and a second bushing position (Fig 14B; see [0125]), and further rotate the bushing around the rotational axis between the second bushing position (Fig 14B) and a third bushing position (Fig 14C; see [0126]), wherein the bushing includes an angled ramp (2204) having a first track portion (portion of 2204 that 2202 is rotating on between Figs 14a-14b) and a second track portion (portion of 2204 that 2202 is rotating on between Figs 14b-14c and slot 2208; also see [0125-0126] teaching how 2202 rotates on track/ramp 2204);
an insertion assembly (2212, 2260, 2214) comprising a cannula (2260) and a needle (2214), wherein the cannula (2260) and the needle (2214) are coaxially aligned with the rotational axis (longitudinal axis), wherein at least a first portion (2260) of the insertion assembly is configured to be driven in an insertion direction (distal direction, see movement between Fig 14A to Fig 14B) by the interaction between the insertion assembly and the first track portion during the rotation of the bushing between the first (Fig 14A) and second bushing positions (Fig 14B; see [0125]), and wherein at least a second portion (2214) of the insertion assembly is configured to be driven in a retraction direction opposite the insertion direction by interaction between the insertion assembly and the second track portion (portion of 2204 that is used to rotate 2202 between Fig 14b to Fig 14c and the slot 2208) during the rotation of the bushing between the second (Fig 14B) and third bushing positions (Fig 14C; see [0126], the position of 2202 has been rotated between Fig 14B and 14C, and the needle has been retracted between these positions, , also see [0126] teaching how during this rotation the needle assembly hub 2212 interacts with slot 2208); and
a medical reservoir (50, Fig 1B) in fluid communication with the insertion assembly (See [0126] teaching a fluid flow path, it is interpreted that this flow path is connected to the medical reservoir);
Destefano embodiment of Figures 14a-15B does not teach a stop member configured to at least one of enable or disable rotation of the bushing, or a motor configured to at least one of engage or disengage the stop member.
Destefano does teach in the embodiment of Figures 24a-24B a torsional insertion mechanism further comprising a stop member configured to selectively prevent rotation of the bushing (See [0111] “By way of example, activation member 14 may be engaged with a slide which, in an initial configuration, prevents rotation of housing 202 by interaction with protrusion 202A. Depression of trigger member 14 may displace the slide, disengaging the slide, or another component, from the protrusion 202A of housing 202, thereby allowing rotation of housing 202”; also see [0112]). Destefano further teaches a motor configured to at least one of engage or disengage the stop member (see [0149], “rotation of a motor causes or allows rotation of a gear, thereby allowing rotation of the housing of the insertion mechanism”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the torsional insertion mechanism of Destefano such that it includes a stop member configured to selectively prevent rotation of the bushing as taught by Destefano embodiment of Figures 24A-24B. One of ordinary skill in the art would have been motivated to do so in order to prevent the activation of the device until the desired movement, additionally one of ordinary skill in the art would recognize this as an alternative activation mechanism for the torsional insertion mechanism (Destefano [0112]) (Gravesen [0062]).
Regarding Claim 13, the modified Destefano teaches the infusion pump system according to claim 12, wherein the bushing (2202) includes an inner surface having the angled ramp (2204) formed therein (Fig 15A-15B; also see [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 14, the modified Destefano teaches the infusion pump system according to claim 13, wherein the insertion assembly (2212, 2260, 2214) includes a tubular boss (2212A) configured to contact the angled ramp (2204) and move from a first boss position (Fig 14A) to a second boss position (Fig 14B) in response to the rotation of the bushing (See [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 15, the modified Destefano teaches the infusion pump system according to claim 13, wherein the angled ramp (2204) contacts the insertion assembly (2212; see [0125] "This translation may be guided by contact of followers/arms 2212A of hub 2212 with guide surfaces 2204 on the interior of housing 2202 as described above and as shown in FIGS. 15A-15B").
Regarding Claim 16, the modified Destefano teaches the infusion pump system according to claim 13, wherein the insertion assembly (2212, 2260, 2214) includes a captive introducer needle (2214), and a cannula (2260) configured for insertion in tissue in response to rotational motion of the bushing (see [0125]).
Regarding Claim 17, the modified Destefano teaches the infusion pump system according to claim 16, wherein the first track portion (portion of 2204 that is used to rotate 2202 between the position in Fig 14a and 14B) is configured to push the captive introducer needle (2214) down (See [0125] teaching how rotation of 2202 along 2204 moves needle distally) and the second track portion is configured to pull the captive introducer needle out on response to the rotation of the bushing (See [0126] and Figs 14b-14c, bushing 2202 has been rotated, therefore the portion of track 2204 that is used to rotate the bushing between the position in Fig 14b and 14C is considered the second track portion).
Response to Arguments
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive.
As to the remarks on Pgs. 7-9, the applicant argues that Destefano does not teach the limitation “wherein the capacitive introducer needle is configured to move in a retraction direction opposite the insertion direction during the rotation of the bushing”. The applicant argues that the [0126] of Destefano teaches that the needle retraction is occurring after the rotation of the bushing not during the rotation. The examiner does not find this persuasive. Paragraph [0126] of Destefano does not specify that the retraction is occurring “After” the rotation of bushing 2202. Destefano [0126] recites that the further rotation of the housing aligns the arms of bub 2212 that allows for the retraction. Furthermore, the bushing 2202 appears to have three distinct positions between Figures 14a, 14b and 14c. These positions would only be possible due to a rotation occurring between each of these figures. This is further shown with the track in Figures 15a-15b. As such, the retraction of the needle is considered to be occurring during the rotation between Fig 14b and Fig 14c of Destefano. For these reasons the rejection is maintained.
As to the remarks on the last paragraph of Pg 9 – Pg. 10, the applicant argues that the Destefano does not teach the needle is driven by interaction between an insertion assembly and a second track portion of the guide surfaces 2204. The examiner does not find this persuasive. As described above, Figures 14A-14C show three different positions of bushing 2202, which could only occur due to a rotation of the bushing 2202. Paragraph [0126] supports this as it recites how the housing ‘continues to rotate’ which ‘permit[s] the retraction biasing member). With the amendments to the claim, the second track portion is considered to be the portion of 2204 where the bushing 2202 is rotating between Fig 14b and 14c, along with 2208. This portion 2208 interacts with the insertion assembly as recited in the amendments. For these reasons the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Connor (US 20130060233) teaches an insertion mechanism with a stop/lockout mechanism.
Perriere (US 20100121271) teaches a stop mechanism in the form of a ring.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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