DETAILED ACTION
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 9-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chae et al. (US 2021/0290115).
As to claim 1, Chae teaches an installation unit of analyte detection device (10), comprising: a sensor unit (20), the sensor unit comprising a sensor base and a sensor (520) arranged on the sensor base (510), and the sensor comprising an external part (522) and an internal part (521); a trigger component (110), wherein an installation unit does not implement an installation action before starting the trigger component ([0074]) ; an auxiliary-needle module ([0097] – 20), the auxiliary-needle module comprising an auxiliary-needle (Fig. 2 – end of 550), and the auxiliary-needle at least comprises an opening area which encloses the internal part (Fig. 2) and is suitable for feeding the internal part into a subcutaneous ([0014]); a parallel slider module (300) suitable for carrying the sensor unit (Fig. 5); a base (200) embedded into the installation unit from a front end of the installation unit (Fig. 3), and an installation area (531) suitable for installing the sensor unit is arranged on the base (Fig. 6 - 203), and the sensor unit is detachably connected to the base ([0077]); an outer shell (100) used for carrying the trigger component, the auxiliary-needle module, the parallel slider module and the base (Fig. 3); an elastic component (S1, 400, S2), sleeved on the auxiliary needle module (Fig. 20), wherein the comprises the first elastic component (S1) and the second elastic component (S2), in a compressed state and suitable for providing the elastic force required by the installation unit to implement the installation action ([0113]).
As to claim 2, Chae teaches the external part is a plane structure (Fig. 32).
As to claim 3, Chae teaches the external part is bent or bent towards a top of the sensor base, laid flat on the top of the sensor base, and the external part is in a working position (Fig. 27).
As to claim 4, Chae teaches the external part and the internal part are perpendicular (Fig. 32).
As to claim 5, Chae teaches wherein the outer shell is provided with a first clamp part on the outer shell, the sensor unit is provided with a first clamp part of the sensor, and the first clamp part of the outer shell and the first clamp part of the sensor are mutually clamped (152).
As to claim 6, Chae teaches the trigger component comprises a trigger paddle 110), the outer shell comprises a through-hole arranged on a side wall (Fig. 9), and the trigger paddle enters into the outer shell through the through-hole (Fig. 9).
As to claim 7, Chae teaches when implementing the installation action, the trigger paddle pushes the first clamp part of the outer shell to release a snap state of the first clamp part of the outer shell and the first clamp part of the sensor (Fig. 12).
As to claim 9, Chae teaches the trigger component comprises a reset elastic component (152), which is suitable for returning the trigger button to an initial position after starting (Fig 12, Fig. 16 – trigger is back into initial position after sensor has been deployed).
As to claim 10, Chae the trigger component also comprises a limit clip (113), the outer shell comprises a limit hole (1012), and the limit clip and the limit hole form a snap connection to prevent the trigger button from separating from the outer shell when the trigger button returns to the initial position (Fig. 16).
As to claim 11, Chae teaches the opening area is circular arc or "V" shape (Fig. 2 – see area around 550).
As to claim 12, Chae teaches the outer shell comprises a limit column (Fig. 4 – the central area within the top portion of 102)), the auxiliary-needle module comprises a chute (Fig. 13), the parallel slider module comprises a through-hole of the limit column (Fig. 4), the chute and the through-hole of the limit column are respectively matched with the limit column (Fig. 4), which is suitable for making the auxiliary-needle module and the parallel slider module slide in the outer shell (Fig. 16 – reflecting the downward motion).
As to claim 13, Chae teaches the first elastic component is located between the outer shell and the parallel slider module (Fig. 15).
As to claim 14, Chae the second elastic component is located between the auxiliary-needle module and the parallel slider module (Fig. 24).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al. (US 2021/0290115) in view of Halac et al. (US 2019/0342637).
As to claim 8, Chae teaches wherein the trigger component comprises a trigger button (110) and an anti-trigger structure (1012) for preventing the installation action ([0087]), but fails to teach that the anti-trigger structure comprises a breakable structure and a break button, the break button being suitable for preventing the trigger button from starting before a break of the breakable structure. However, Halac teaches an implantable analyte sensor (Fig. 3A) in which the there are several different applicator safety mechanisms, including the use of a breakable portion on the trigger that must be removed to enable triggering or a breaking of a frangible member prior to deployment of the analyte sensor system ([0226]). Accordingly, it would have been obvious to modify Chae with Halac to utilize an alternate anti-trigger structure to prevent premature deployment of the sensor as it would have been obvious to try.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al. (US 2021/0290115)
As to claim 15, Chae teaches the auxiliary-needle module is provided with a cylinder clamp part (201), but does not necessarily teach the other components. However, Chae teaches various parts within both the parallel slider module and the outer shell to allow the auxiliary needle module slide with the parallel slider module, and when the auxiliary needle module slides to a preset position, other parts interact to push the auxiliary needle module back to the initial position (see Figs. 17-19, 25). As applicant fails to disclose that these specific portions interacting in the recited manner does not solve any stated problem that the taught structure of Chae is unable to perform, and as Chae’s structure performs the same function of making the auxiliary module slide toward a base direction and back to its initial position, the specific components are a matter of obvious design choice.
As to claim 16, the structures taught by Chae perform the same function of fixing the base to the outer shell (Fig. 4), and as such, the specific elements and its arrangements are a matter of obvious design choice.
As to claim 17, the structures taught by Chae perform the same function of releasing the base from the outer shell (Fig. 25), and as such, the specific elements and its arrangements are a matter of obvious design choice.
As to claim 18, the structures taught by Chae perform the same function of assembling the sensor unit to the base (Fig. 27), and as such, the specific elements and its arrangements are a matter of obvious design choice.
As to claim 19, while Chae does not teach the adhesive tape on the base, it does teach that the bottom of the on-body unit comprises adhesive tape (560), which is suitable for pasting the base on a surface of human skin ([0124]). It would have been obvious to modify Chae to move the adhesive to the portion of the device which is configured to make contact with the skin.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, in light of the amended claims, the Chae reference has been reinterpreted to reflect that different components are now being used to teach various elements, such as the auxiliary-needle module and the base.
Conclusion
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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 3/21/26