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 Claims
This office action is responsive to the amendment filed 20 November 2025.
Claims 1 and 5 are amended.
Claims 1-8 are presently pending in this application.
Claim Rejections - 35 USC § 102
(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.
(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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Searle et al. (US Patent Application No. 20180036495 A1), hereinafter Searle.
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Regarding claim 1, Searle teaches a flow sensor (Searle: Fig. 2 and 12, flow sensor 104) comprising:
a flow manifold (Searle: Fig. 12, flow manifold 1204) comprising:
a proximal end (Searle: Fig. 12, piercing cannula 122) shaped for connection to an insulin pen (Searle: piercing cannula 122 attaches to standard hub of insulin pen; para. 0062), the proximal end (Searle: Fig. 12, piercing cannula 122) having a piercing member (Searle: Fig. 12, piercing cannula 122 has a piercing member; para. 0062) extending therefrom (Searle: Fig. 12, piercing member of piercing cannula 122 extends from tip of piercing cannula 122);
a threaded distal end (Searle: Fig. 12, opposite end of manifold 1204 is threaded; para. 0062) shaped for connection to a pen needle (Searle: opposite end of flow manifold 1204 configured for connection for insulin pen needles; para. 0062), the threaded distal end having a septum (Searle: Fig. 12, opposite end of flow manifold 1204 contains an elastomeric septum; para. 0062);
a metal flow channel (Searle: flow manifold 1204 includes flow channel 1206, which can be made of metal; para. 0062 and 0067) having an interior for fluid flow (Searle: Fig. 12, flow manifold has an interior for fluid flow; para. 0062) extending from the proximal end to the distal end (Searle: flow channel 1206 extends from inlet cannula 122 to the pen needle end; para 0062), the metal flow channel (Searle: 1204) having a sensor window (Searle: Fig. 12 above, metal flow channel 1204 has a sensor window A in which the sensor 1200 is mounted to; para. 0062), where the metal flow channel (Searle: flow channel 1206) is a metal tube formed from metal sheet (Searle: metal flow channel 1206 can be comprised of a stack of laminations including a metallic foil or layer; para. 0118) and having a rectangular cross section (the flow channel has a substantially rectangular cross section; see claim 22); and
a thermal time of flight flow sensor (Searle: Fig. 12, sensor chip 1200 can be a thermal time of flight sensor; para. 0007, 0046, 0115) having a sensor face (sensor 1200 face; para. 0062) for sensing a velocity of fluid flowing in the metal flow channel (Searle: Fig. 12, sensor chip 1200 is configured to sense flow rate in flow channel 1206; para. 0062), such that fluid flowing (para. 0062) in the interior of the metal flow channel (Searle: 1206) is in contact with the sensor face (sensor 1200 face is in shear zone of fluid flow; para. 0062).
Regarding claim 2, Searle teaches the flow sensor above, wherein the metal flow channel (Searle: Fig. 13, metal flow channel 1301) has a circular cross section (Searle: Fig. 13, metal flow channel 1301 distal end has a circular cross section).
Regarding claim 3, Searle teaches the flow sensor above, wherein the metal flow channel (Searle: Fig. 13, metal flow channel 1301) has a rectangular cross section (Searle: Fig. 13, metal flow channel 1301 proximal end has a rectangular cross section).
Regarding claim 4, Searle teaches the flow sensor above, wherein the metal flow channel (Searle: Fig. 13, metal flow channel 1301) has a rectangular cross section (Searle: Fig. 13, metal flow channel 1301 proximal end has a rectangular cross section) and a circular cross section (Searle: Fig. 13, metal flow channel 1301 distal end has a circular cross section), and a smooth transitions (Searle: Fig. 13, metal flow channel 1301 has a transition point between the distal and proximal end. The metal flow channel is micro-fabricated to provide a smooth transition; para. 0067) between the rectangular cross section (Searle: Fig. 13, metal flow channel 1301 proximal end has a rectangular cross section) and the circular cross section (Searle: Fig. 13, metal flow channel 1301 distal end has a circular cross section).
Regarding claim 5, Searle teaches a method of manufacturing (Searle: device is manufactured; para. 0071) a flow sensor (Searle: Fig. 2 and 12, flow sensor 104) comprising the steps of:
forming a metal flow channel (Searle: 1204) having an interior for fluid flow (Searle: Fig. 12, flow manifold has an interior for fluid flow; para. 0062) as a metal tube (Searle: flow channel 1204 can be metal; para. 0067) having a predetermined internal cross-sectional area (Searle: designed with a cross sectional area; para. 0062) from a metal sheet (Searle: metal flow channel 1301 can be comprised of a stack of laminations including a metallic foil or layer; para. 0118), the metal flow channel (1301) having a rectangular cross section (Fig. 13, tubing 1301 is shown to have a rectangular cross section);
forming a sensor window (Searle: Fig. 12 above, metal flow channel 1204 has a sensor window A in which the sensor 1200 is mounted to; para. 0062) in a side wall of the rectangular cross section (the flow channel has a substantially rectangular cross section; claim 22) of the metal flow channel (1204), the sensor window (A) being open to the interior (sensor 1200 face is in shear zone of fluid flow, which requires the sensor window A being open to the interior; para. 0062);
injection molding a flow manifold (Searle: Fig. 12, flow manifold 1204) around the metal flow channel (injection molded; para. 0067); and
mounting a thermal time of flight flow sensor (Searle: Fig. 12, sensor chip 1200 can be a thermal time of flight sensor; para. 0007, 0046, 0115) having a sensor face (sensor 1200 face; para. 0062) within the sensor window (sensor 1200 face is in shear zone of fluid flow, which requires the sensor window A being open to the interior; para. 0062), such that fluid flowing (para. 0062) in the interior of the metal flow channel (Searle: 1206) is in contact with the sensor face (sensor 1200 face is in shear zone of fluid flow; para. 0062).
Regarding claim 6, Searle teaches the method of manufacturing a flow sensor above comprising: forming an insulin pen connector (Searle: piercing cannula 122 attaches to standard hub of insulin pen; para. 0062) at a proximal end (Searle: Fig. 12, piercing cannula 122) of the flow manifold (Searle: Fig. 12, flow manifold 1204).
Regarding claim 7, Searle teaches the method of manufacturing a flow sensor above comprising: forming a threaded pen needle connector (Searle: Fig. 12, opposite end of flow manifold 1204 configured for connection for insulin pen needles and is threaded; para. 0062) at a distal end (Searle: Fig. 12, opposite end of manifold 1204) of the flow manifold (Searle: Fig. 12, flow manifold 1204).
Regarding claim 8, Searle teaches the method of manufacturing a flow sensor above comprising: installing a septum (Searle: Fig. 12, opposite end of flow manifold 1204 contains an elastomeric septum; para. 0062) in the distal end (Searle: Fig. 12, opposite end of manifold 1204) of the flow manifold (Searle: Fig. 12, flow manifold 1204).
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 20 November 2025, with respect to the rejections of claims 1-8 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Searle.
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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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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