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 .
Claims 1-2 are objected to because of the following informalities:
Claim 1 line 7 and line 10, “a syringe assembly” should read “the syringe assembly” as these line appear to be referring to the same syringe assembly introduced in line 3.
Claim 2 lines 1-2, “The drug delivery device of claim 1, the syringe assembly further comprising” should read “The drug delivery device of claim 1, wherein the syringe assembly further comprises”.
Appropriate correction is required.
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) 1-4 and 6-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coles et al. (US Patent Pub. 20190143043 hereinafter “Coles”) in view of Johansen (US Patent Pub. 20170043091) and McLoughlin (WO 2012164406).
Regarding Claim 1, Coles teaches (Figs 1, 2H, 3, 5B and 6C) A drug delivery device comprising:
a first subassembly comprising a cap (240), a needle cover (266), a syringe holder (220) configured to receive a syringe assembly (260), a cassette body (200, 210), and a lower housing shell (306, 308), the cap (240) receiving at least a portion of the needle cover (266);
a second subassembly comprising a drive assembly configured to move a stopper (264) of the syringe assembly (260), and a motor body (341), the motor body receiving at least a portion of the drive assembly (340, 342) the cassette body (200) of the first subassembly is configured to receive at least a portion of the motor body (341; indirectly receives the portions as they are all functional together once the cassette is inserted in the shell);
the syringe assembly comprising a cannula (265); and
a locking clip (290, 292) configured to secure the first subassembly to the second subassembly upon assembly of the first subassembly to the second subassembly (See [0097] teaching how the insertion drive interacts/interfaces with the lock 292), wherein the lower housing shell receives the syringe holder and the cassette body (See annotated Fig 1 (Coles)).
Coles does not specify the needle cover being at least partially external to the lower housing shell.
Johansen teaches [0080] a needle cover (5) that is protruding from the lower housing shell (2).
With this modification, the examiner interprets that the needle cover 266 of Coles would extend into the opening (See annotated Fig 5B) such that the needle cover would be protruding from the lower housing shell of Coles, while still being retained within the cap 240.
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Annotated Fig 5B (Coles)
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 needle cover of Coles such that the needle cover being at least partially external to the lower housing shell as taught by Johansen. One of ordinary skill in the art would have recognized this as an alternative design that still allows for the same result of the needle being covered inside the cassette and removed before the device can be operated to deliver a drug (Johansen [0080]). One of ordinary skill in the art would recognize that this elongated needle cover would also allow for better engagement between the cap and needle shield to prevent the needle shield from damaging the needle (Coles [0080]).
The combination does not specify the syringe assembly comprising a rigid needle shield receiving at least a portion of the cannula.
McLoughlin teaches (Figs 1, 17-18b) a syringe assembly comprising a cap (50), a needle cover (17) and a rigid needle shield (19) that receives at least a portion of the cannula (15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle cover of Coles with the rigid needle shield and needle sheath as taught by McLoughlin. This would result in the syringe assembly including a rigid needle shield, a needle cover and a cap. One of ordinary skill in the art would recognize this is a simple substitution of one known element (needle cover of Coles) for another (two piece needle cover including a rigid needle shield and a needle sheath as taught by McLoughlin) to obtain predictable results (protecting a cannula of the device).
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Annotated Fig 1 (Coles)
Regarding Claim 2, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 1 as described above. Coles further teaches the drug delivery device wherein the syringe assembly further comprises a barrel (walls of 260), and a stopper (264).
Regarding Claim 3, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 1. Coles further teaches the drug delivery device wherein the locking clip (292) comprises a body having a projection (see the various hand and feet members 292h, 292a, 292f described in [0097]) configured to engage a clip surface defined by the motor body of the second subassembly (See [0097] “the cantilever lock arm 292 extends from a marginally distal, bottom portion 220b of the inner sleeve, or any other portion of the sleeve which is capable of interfacing with the autoinjector's insertion drive.”; the examiner interprets that the insertion drive is a part of the motor body of the second subassembly).
Regarding Claim 4, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 1 as described above. Coles further teaches the drug delivery device of claim 1, wherein the cassette body (210) defines a clip opening (294) configured to receive a portion of the locking clip (290; see [0098] “the inner sleeve locking arrangement 290 may further comprise one or more locking feet receiving slots 294 provided in the bottom wall 210b of the cassette outer housing 210,”).
Regarding Claim 6, the combination of Coles, Johansen and Mcloughlin teaches all elements of claim 3 as described above. The combination does not specify the drug delivery device wherein the clip surface is defined by a recessed portion of the motor body, the clip opening of the cassette body is configured to be aligned with the clip surface of the motor body when the first subassembly is assembled with the second subassembly, a portion of the locking clip configured to extend through the clip opening of the cassette body and the recessed portion of the motor body with the projection of the locking clip engaging the clip surface of the motor body.
Mcloughlin teaches a drug delivery device wherein the locking clip comprises a body (Fig 33, 190) having a projection (Fig 33, 192) configured to engage a clip surface (Fig 33 and 37a,b, outer surface 194, 195, 197) defined by the motor body (Fig 33, 177) of the second subassembly (Pg. 76 last paragraph);
wherein the clip surface is defined by a recessed portion (Fig 37a,b, 195) of the motor body (177; see Fig 33, showing 190 is a part of motor body 177), the clip opening (96) of the cassette body is configured to be aligned with the clip surface (outer surface 194, 195, 197) of the motor body when the first subassembly is assembled with the second subassembly (Figs 35-36), a portion of the locking clip (Fig 33 and Fig 37a,b, 190, 192, 194) configured to extend through the clip opening (Fig 33 and Fig 37a,b, 96) of the cassette body and the recessed portion (Fig 37a,b, 195) of the motor body with the projection of the locking clip engaging the clip surface of the motor body (See Figs 37a-37b; Pg. 77 last paragraph- Pg. 78 line 3).
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 locking clip of Coles such that the clip surface is defined by a recessed portion of the motor body, the clip opening of the cassette body is configured to be aligned with the clip surface of the motor body when the first subassembly is assembled with the second subassembly, a portion of the locking clip configured to extend through the clip opening of the cassette body and the recessed portion of the motor body with the projection of the locking clip engaging the clip surface of the motor body as taught by Mcloughlin. One of ordinary skill in the art would have been motivated to do so in order to provide an alternative locking method to attach the cassette to the device drive unit (Mcloughlin Pg. 76 last paragraph).
Regarding Claim 7, the combination of Coles, Johansen and Mcloughlin teaches all elements of claim 1 as described above. The combination does not specify the drug delivery device wherein the cassette body defines first and second grooves and the motor body defines first and second ribs, the first groove of the cassette body configured to receive the first rib of the motor body, and the second groove of the cassette body configured to receive the second rib of the motor body.
Mcloughlin a drug delivery device wherein the cassette body (Fig 5a, 120) defines first and second grooves (96; see annotated Fig 36) and the motor body (Fig 33, 177) defines first and second ribs (see Fig 33, 190 is a part of body 177; also see annotated Fig 36), the first groove of the cassette body configured to receive the first rib of the motor body, and the second groove of the cassette body configured to receive the second rib of the motor body (See annotated Fig 36; Pg. 76 last paragraph and Pg. 77 last paragraph – Pg. 78 line 3).
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 cassette body of Coles such that the cassette body defines first and second grooves and the motor body defines first and second ribs, the first groove of the cassette body configured to receive the first rib of the motor body, and the second groove of the cassette body configured to receive the second rib of the motor body as taught by McLoughlin. One of ordinary skill in the art would have been motivated to do so in order to provide an alternative locking method to attach the cassette to the device drive unit (Mcloughlin Pg. 76 last paragraph).
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Annotated Fig 36 (Mcloughlin)
Regarding Claim 8, the combination of Coles, Johansen and Mcloughlin teaches the drug delivery device of claim 1, wherein the locking clip is formed integrally with the cassette body (this is a product by process limitation, as the combination of Coles and Johansen teaches a locking clip (Coles 290) and a cassette body (Coles 210), it is interpreted that Coles and Johansen meet all structural elements of the claim recited).
Regarding Claim 9, the combination of Coles, Johansen and Mcloughlin teaches all elements of claim 8 as described above. Coles further teaches the drug delivery device wherein the locking clip (290) comprises a first locking clip (292f) positioned on a first side of the cassette body and a second locking clip (292f) positioned on a second side of the cassette body (see [0098-0099] teaching how there are more than one slots 294 on cassette 210 which receive locking feet 292f; it is interpreted that these locking feet 292f/slots 294 are on a first side and a second side of the cassette body 210).
Regarding Claim 10, the combination of Coles, Johansen and Mcloughlin teaches all elements of claim 8 as described above. Coles further teaches the drug delivery device wherein the motor body defines a clip surface configured to engage the locking clip(s) of the cassette body (See [0097] “the cantilever lock arm 292 extends from a marginally distal, bottom portion 220b of the inner sleeve, or any other portion of the sleeve which is capable of interfacing with the autoinjector's insertion drive.” It is interpreted that the insertion drive is the motor body that is engaged with the locking clip 290).
Regarding Claim 11, the combination of Coles, Johansen and Mcloughlin teaches the drug delivery device of claim 1, further comprising an upper housing shell (portion where 304 is labeled in Fig 2H) configured to be positioned adjacent to the lower housing shell (portion where 306 Is labeled in Fig 2H; see how Fig 1 shows the lower housing shell partially detached from the upper housing shell).
Regarding Claim 12, the combination of Coles, Johansen and Mcloughlin teaches all elements of claim 9 as described above. The combination does not specify the drug delivery device wherein the motor body includes a first extension defining a first channel and the cassette body defines a second extension defining a second channel, the first channel of the motor body configured to receive the second extension of the cassette body.
Mcloughlin teaches a drug delivery device wherein the locking clip comprises a first locking clip positioned on a first side of the cassette body and a second locking clip positioned on a second side of the cassette body (See annotated Fig 36, the first and second grooves and ribs are the first and second locking clips on the first and second sides); wherein the motor body includes a first extension defining a first channel (see annotated Fig 33 and annotated Fig 35/36) and the cassette body defines a second extension defining a second channel (See annotated Fig 35/36), the first channel of the motor body configured to receive the second extension of the cassette body (see annotated Fig 35/36).
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 motor body and cassette of Coles such that the motor body includes a first extension defining a first channel and the cassette body defines a second extension defining a second channel, the first channel of the motor body configured to receive the second extension of the cassette body as taught by Mcloughlin. One of ordinary skill in the art would have been motivated to do so in order to provide an alternative locking method to attach the cassette to the device drive unit (Mcloughlin Pg. 76 last paragraph).
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Annotated Fig 33 (Mcloughlin)
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Annotated Fig 35/36 (Mcloughlin)
Regarding Claim 13, the combination of Coles, Johansen and Mcloughlin teaches the drug delivery device of claim 12, wherein the second channel of the cassette body is configured to receive the first extension of the motor body (See annotated Fig 35/36).
Regarding Claim 14, Coles teaches (Figs 1, 2H, 3, 5B and 6C) A method of assembling a drug delivery device comprising:
moving a first subassembly (240, 266, 220, 260, 200, 210) into engagement with a second subassembly (340, 341, 342), the first subassembly comprising a cap (240), a needle cover (266), a syringe holder (220) configured to receive a syringe assembly (260),the syringe assembly (260) having a cannula (265), a cassette body (200, 210), and a lower housing shell (306, 308), the lower housing shell (306, 308) receiving the syringe holder (220) and the cassette body (200, 210) the second subassembly comprising a drive assembly (340, 342) configured to move a stopper (264) of a syringe assembly (260), and a motor body (341);
securing the first subassembly to the second subassembly with a locking clip (290, 292; See [0097] teaching how the insertion drive interacts/interfaces with the lock 292); and moving an upper housing shell (portion where 304 is labeled in Fig 2H) into engagement with the second subassembly; wherein the cassette body of the first subassembly receives at least a portion of the motor body (cassette body 210 indirectly receives motor body 341 through element 343).
Coles does not specify the needle cover being at least partially external to the lower housing shell.
Johansen teaches [0080] a needle cover (5) that is protruding from the lower housing shell (2).
With this modification, the examiner interprets that the needle cover 266 of Coles would extend into the opening (See annotated Fig 5B) such that the needle cover would be protruding from the lower housing shell of Coles, while still being retained within the cap 240.
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 needle cover of Coles such that the needle cover being at least partially external to the lower housing shell as taught by Johansen. One of ordinary skill in the art would have recognized this as an alternative design that still allows for the same result of the needle being covered inside the cassette and removed before the device can be operated to deliver a drug (Johansen [0080]). One of ordinary skill in the art would recognize that this elongated needle cover would also allow for better engagement between the cap and needle shield to prevent the needle shield from damaging the needle (Coles [0080]).
The combination does not specify the syringe assembly comprising a rigid needle shield receiving at least a portion of the cannula.
McLoughlin teaches (Figs 1, 17-18b) a syringe assembly comprising a cap (50), a needle cover (17) and a rigid needle shield (19) that receives at least a portion of the cannula (15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle cover of Coles with the rigid needle shield and needle sheath as taught by McLoughlin. This would result in the syringe assembly including a rigid needle shield, a needle cover and a cap. One of ordinary skill in the art would recognize this is a simple substitution of one known element (needle cover of Coles) for another (two piece needle cover including a rigid needle shield and a needle sheath as taught by McLoughlin) to obtain predictable results (protecting a cannula of the device).
Regarding Claim 15, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 14 as described above. Coles further teaches (Figs 2H and 5B) the method further comprising: positioning the syringe assembly (260) in the syringe holder (220) of the first subassembly, the syringe assembly comprising a barrel (walls of 260), and a stopper (264).
Regarding Claim 16, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 14 as described above. The combination does not specify the method of claim wherein the locking clip comprises a body having a projection and the motor body defines a clip surface, and wherein the cassette body defines a clip opening configured to receive a portion of the locking clip, the method further comprising: inserting a portion of the locking clip through the clip opening of the cassette body and engaging the clip surface of the motor body to secure the cassette body to the motor body.
Mcloughlin teaches a locking clip comprising a body (Fig 33, 190) having a projection (Fig 33, 192) and the motor body (Fig 33, 177) defines a clip surface (Fig 37a,b, 194), wherein the cassette body (1, 101) defines a clip opening (Fig 33 and Fig 37a,b, 96) configured to receive a portion of the locking clip (Fig 37a,b, 194), the method further comprising: inserting a portion of the locking clip through the clip opening of the cassette body and engaging the clip surface of the motor body to secure the cassette body to the motor body (Figs 37a,b; Pg. 76 last paragraph and Pg. 77 last paragraph – Pg. 78 line 3).
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 locking clip, motor body and cassette body of Coles such that the locking clip comprises a body having a projection and the motor body defines a clip surface, and wherein the cassette body defines a clip opening configured to receive a portion of the locking clip, the method further comprising: inserting a portion of the locking clip through the clip opening of the cassette body and engaging the clip surface of the motor body to secure the cassette body to the motor body as taught by Mcloughlin. One of ordinary skill in the art would have been motivated to do so in order to provide an alternative locking method to attach the cassette to the device drive unit (Mcloughlin Pg. 76 last paragraph).
Regarding Claim 17, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 14 as described above. The combination does not specify the method wherein the locking clip is formed integrally with the cassette body, and wherein the motor body defines a clip surface, the method further comprising: positioning the motor body within the cassette body until the locking clip of the cassette body engages the clip surface of the motor body thereby securing the first subassembly to the second subassembly.
Mcloughlin teaches a locking clip comprises a body (Fig 33, 190) having a projection (Fig 33, 192) and the motor is formed integrally with the cassette body (this is considered a product by process limitation, Mcloughlin teaches all structural elements of claim, therefore Mcloughlin meets this limitation), and wherein the motor body defines a clip surface (Fig 37a,b, 194), the method further comprising:
positioning the motor body within the cassette body until the locking clip of the cassette body engages the clip surface of the motor body thereby securing the first subassembly to the second subassembly (Figs 37a,b; Pg. 76 last paragraph and Pg. 77 last paragraph – Pg. 78 line 3).
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 locking clip, cassette and motor body of Coles such that the locking clip is formed integrally with the cassette body, and wherein the motor body defines a clip surface, the method further comprising: positioning the motor body within the cassette body until the locking clip of the cassette body engages the clip surface of the motor body thereby securing the first subassembly to the second subassembly as taught by Mcloughlin. One of ordinary skill in the art would have been motivated to do so in order to provide an alternative locking method to attach the cassette to the device drive unit (Mcloughlin Pg. 76 last paragraph).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coles (US Patent Pub. 20190143043) in view of Johansen (US Patent Pub. 20170043091) and McLoughlin (WO 2012164406) as applied to claim 1 above, and further in view of Stamp (US Patent Pub. 20170258998 note this reference was previously cited).
Regarding Claim 5, the combination of Coles, Johansen and McLoughlin teaches all elements of claim 1 as described above. The combination does not specify the drug delivery device wherein the locking clip is C-shaped.
Stamp (Fig 21) teaches a c-shaped locking clip (112).
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 locking clip of Coles such that it is a C-shaped clip as taught by Stamp. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 3/10/2025.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Day (US Patent Pub. 20140114258) teaches a medicament injection device with a lower housing shell adjacent to the upper housing shell.
Slate (WO 2009143255) teaches an autoinjector system including a cassette body that is inserted into a housing portion, a motor drive system and locking detents.
Estes (US 8287487) teaches an autoinjector system including a syringe that is inserted into a housing portion, a motor drive system and a locking system.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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