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 § 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) 1-2, 17-27 and 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2011/0054285 to Searle et al. (Searle hereinafter) in view of US Pre-Grant Publication 2019/0219193 to Xin et al. (Xin) and US Pre-Grant Publication 2015/0194413 to Lee et al. (Lee).
Regarding claim 1, Searle teaches a wearable device (e.g. 100 and other embodiments) including a housing (202, 204), a reservoir (106), a needle (within 108, see paragraph 39), a micropump (114, see also 1014) including a MEMS pump (1014) and a valve (1010), control circuitry (on 116), and an interposer (116/516) configured for mounting the reservoir, micropump, and needle and distributing medication through channels to the needle (of 108).
Searle does not explicitly teach a MEMS valve. Xin teaches such a valve (10) for controlling fluid. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a valve as taught by Xin in the pump of Searle, either in addition to or in the place of outlet valve (1010) thereof, in order to actively control fluid flow therein.
Searle also does not teach fluid channels through the interposer. Lee teaches another interposer (234C, see Fig. 4) generally with a fluid device (e.g. 404) having channels (402, 216) therethrough for fluid flow from a source (404) to a destination (208C). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide channels through the interposer of Searle, or alternately to provide an interposer having fluid channels as taught by Lee in order to provide the functions of Searle in a modular fashion as evinced by Lee (see e.g. discussion of manifold fluid distribution effects in paragraph 44).
Regarding claim 2, Searle does not teach the ports on first and second sides, but this is taught by Lee (Fig. 4) as part of the fluid distribution structure thereof which would therefore have been obvious to include for the same reasons above.
Regarding claim 17, Searle teaches a channel (in which 1010 is disposed).
Regarding claim 18, the examiner takes official notice that pressure sensors are known for the purpose of providing feedback for pump control and were so known at the time of the effective filing date, based on the commercial availability of systems incorporating such sensors and controls at that time and significantly before. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a pressure sensor to the system of Searle for providing feedback to guide pump control.
Regarding claim 19, Searle teaches that the patient is the user (see e.g. paragraph 72, “infusion rate of the drug to the user”).
Regarding claim 21, Searle teaches a continuous blood glucose sensor (paragraph 84) having a needle and transmitting data.
Regarding claim 22, Searle teaches interconnects for all elements (see e.g. Fig. 1 where they are shown schematically). The examiner further notes that vias are explicitly taught by Lee as well.
Regarding claim 23, Searle teaches insulin (paragraph 39).
Regarding claim 24, Searle teaches transmission between control circuitry (on 116/516) and the pump (1014, see paragraph 39 “directing... the pump mechanism 114 as well as monitoring and/or controlling other preferred operations”).
Regarding claim 25, Searle teaches a battery (118).
Regarding claim 26, Searle teaches a needle (1122, see e.g. Fig. 11C-D), a cannula (1132, paragraph 79), a stopper (1126) configured to stop flow by holding the needle back when the apparatus is in a deployed position on the skin of the user, and a channel (of cannula 1132) through which the needle advances to puncture the user’s skin.
Regarding claim 27, Searle teaches separate components.
Regarding claim 31, Searle teaches first (1014) and second (1010) MEMS (as modified in view of Xin).
Regarding claim 32, Searle teaches a wearable device (e.g. 100 and other embodiments) including a housing (202, 204), a reservoir (106), a needle (within 108, see paragraph 39), a micropump (114, see also 1014) including a MEMS pump (1014) and a valve (1010), control circuitry (on 116), and an interposer (116/516) configured for mounting the reservoir, micropump, and needle and distributing medication through channels to the needle (of 108).
Searle does not explicitly teach a MEMS valve. Xin teaches such a valve (10) for controlling fluid. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a valve as taught by Xin in the pump of Searle, either in addition to or in the place of outlet valve (1010) thereof, in order to actively control fluid flow therein.
Searle also does not teach fluid channels through the interposer. Lee teaches another interposer (234C, see Fig. 4) generally with a fluid device (e.g. 404) having channels (402, 216) therethrough for fluid flow from a source (404) to a destination (208C). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide channels through the interposer of Searle, or alternately to provide an interposer having fluid channels as taught by Lee in order to provide the functions of Searle in a modular fashion as evinced by Lee (see e.g. discussion of manifold fluid distribution effects in paragraph 44).
Regarding claim 33, Searle teaches that the patient is the user (see e.g. paragraph 72, “infusion rate of the drug to the user”).
Regarding claim 34, Searle teaches separate components.
Claim(s) 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Searle in view of Lee.
Regarding claim 1, Searle teaches a wearable device (e.g. 100 and other embodiments) including a housing (202, 204), a reservoir (106), a needle (within 108, see paragraph 39), a micropump (114, see also 1014) including a MEMS pump (1014) and a valve (1010), control circuitry (on 116), and an interposer (116/516) configured for mounting the reservoir, micropump, and needle and distributing medication through channels to the needle (of 108).
Searle does not teach fluid channels through the interposer. Lee teaches another interposer (234C, see Fig. 4) generally with a fluid device (e.g. 404) having channels (402, 216) therethrough for fluid flow from a source (404) to a destination (208C). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide channels through the interposer of Searle, or alternately to provide an interposer having fluid channels as taught by Lee in order to provide the functions of Searle in a modular fashion as evinced by Lee (see e.g. discussion of manifold fluid distribution effects in paragraph 44).
Regarding claim 29, Searle teaches a continuous blood glucose sensor (paragraph 84) having a needle and transmitting data.
Regarding claim 30, Searle does not explicitly teach a MEMS valve. Xin teaches such a valve (10) for controlling fluid. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a valve as taught by Xin in the pump of Searle, either in addition to or in the place of outlet valve (1010) thereof, in order to actively control fluid flow therein.
Response to Arguments
Applicant’s arguments, see page 9, filed 11 November 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Searle in view of Xin and Lee as discussed above.
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.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 3 March 2026