DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-9 and 11-16 have been considered but are moot because the new ground of rejection does not rely on any reference or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
4. Claim 1 was previously objected to for minor informalities. Claim 1 has been amended to overcome these objections; therefore, they have been withdrawn.
Claim Rejections - 35 USC § 112
4. Claims 6, 7, 9, and 10, as well as claim 8 based on its dependency to claim 6, were previously rejected under 35 U.S.C. 112(b) as being indefinite. Claim 6 has been amended to correct its dependency. Claim 7 has been amended to correct its dependency. Claim 10 has been cancelled.
5. Therefore, Claims 6, 7, and 9, as well as claim 8 based on its dependency to claim 6, overcome the previous rejections. These rejections have been withdrawn from the present office action.
Claim Rejections - 35 USC § 103
6. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
7. Claims 1-3, 11-13, and 16 rejected under 35 U.S.C. 103 as being unpatentable over Harttig U.S. 2018/0296146 (herein referred to as “Harttig”) and in view of Halac U.S. 2021/0290122 (herein referred to as “Halac”).
8. Regarding Claim 1, Harttig teaches a high reliability analyte detection device (Figs. 9A, 9B, 10A, 10B; Abstract, “a sensor assembly (256) for detecting at least one analyte in a body fluid”), comprising:
a. a transmitter (Figs. 9A-9B and 10A-10B, ref num 186) which is provided with at least one first clamp part (Fig. 10B, ref num 206) and at least two mutually insulated first electrical connection areas (Figs. 5A-5B, ref num 210; para 0007, 0020);
b.1 a bottom shell (Figs. 6A-6C, 9A-9B, 10A-10B, ref num 212) which is provided with at least one second clamp part (10B, ref num 228) corresponding to the first clamp part (para 0247, “the receptacle 228 may receive the protruding rim 206”), wherein the first clamp part and the second clamp part are clamped to each other (para 0247, “the receptacle 228 may receive the protruding rim 206”; see Fig. 10A, ref nums 206 and 228 are clamped together), and the transmitter is assembled on the bottom shell (Fig. 10A, ref num 186 is assembled on the bottom shell, ref num 212),
b.2 the bottom shell comprises: a fixed part (Figs. 6A and 6B, ref num 217) and a forced part (Figs. 6A and 6B, ref num 218), during separating the bottom shell and the transmitter, the fixed part is fixed and a force is applied to the forced part in one direction (see Fig. 10B, ref num 186 is separated from ref num 212, wherein ref num 217 is fixed and ref num 218 is forced in an upward direction via ref num 223/225), the bottom shell is in a failure mode, the at least one first clamp part and the at least one second clamp part that are clamped to each other are separated from each other (see Fig. 10B, ref nums 206 and 218 are separated from one another), and further separating the bottom shell from the transmitter (see Fig. 10B, ref num 186 is separated from ref num 206; para 0070, “the electronics unit may be attachable to the body mount”; para 0249, “the locking mechanism 216 may have an open state or open position, such as when the lever 218 is opened or pivoted in a vertical position, in which the electronics unit 186 may be taken out of the body mount 212”; and para 0262, “in a disassembled state, in which the locking mechanism 216 is unlocked and in an opened state or opened position”);
c. a sensor (Figs. 9A-9B and 10A-10B, ref num 110) is assembled on the bottom shell (Fig. 9A, ref num 110 is assembled on ref num 212), wherein the sensor comprises a signal output end (Fig. 4B, ref num 124) and a detection end (Fig. 1B, ref num 116), the signal output end is provided with at least two second electrical connection areas (Fig. 4B, ref num 124, in which ref num 118 is located in ref num 124; para 0205, “The contact pads 118 may be located in the contact portion 124”; also see para 0227); corresponding to the first electrical connection areas and mutually insulated (para 0264, “such that a mutual electrical contact between corresponding contact pads 118 and the electrical contacts 210 may be established”); the first electrical connection areas are electrically connected with the second electrical connection area (para 0264, “such that a mutual electrical contact between corresponding contact pads 118 and the electrical contacts 210 may be established”), respectively;
d. an elastic member (Fig. 4C, ref num 180; para 0228, “plate 180 comprises a deformable material such as an elastomeric material”), wherein the signal output end contacts the elastic member (Fig. 4C, ref num 124 contacts ref nums 180); and
e. a battery (Fig. 5b, ref num 208; para 0242), connected to the transmitter, for supplying power to the transmitter (see Figs. 5A and 5B, ref nums 208 and 186; para 0242, “The electronics unit 186, such as by using one or more of the electronics components 208, specifically may be configured for one or more of controlling the detection of the analyte or transmitting measurement data to another component, such as a receiver outside the sensor assembly. Therein, a wireless or a wire bound transmission may take place”),
f. wherein the bottom shell comprises an assembly through hole (Fig. 9A, ref num 235; para 0252, “body mount 212 may further comprise at least one opening 235”).
While Harttig teaches that the sensor may be assembled to the assembly through hole (para 0252, “he opening 235 may be used for guiding the cannula 242 and/or the sensor 11o into the body tissue and, thus, the cannula 242 and/or the shaft 122 of the sensor 110 may pass through the opening 235”), Harttig fails to explicitly teach a first clamp structure located beside the assembly through hole; and that a sensor base is detachably assembled to the assembly through hole, wherein the sensor is disposed at the sensor base, the sensor base comprises a second clamp structure corresponding to the first clamp structure, when the sensor base is installed in the assembly through hole, and the second clamp structure is clamped with the first clamp structure, the sensor is mounted to the bottom shell through the sensor base.
Halac teaches an analyte detection device of analogous art (Fig. 3A and 9), wherein the device comprises a bottom shell (Fig. 9, ref num 126), a sensor (Figs. 4A-4C, 9, and 11, ref num 138), and a sensor base (Fig. 9, ref num 400) detachably assembled through an assembly through hole of the bottom shell (Fig. 3B, 6, and 9, ref num 180 is the through hole; para 0205, “implementation the sensor 138 extends from is distal end up into the through-hole 180”). The bottom shell also comprises a first clamp structure located beside the through hole (Fig. 9, ref num 900). The sensor is disposed at the sensor base (see Fig. 9, ref num 138 is disposed at the sensor base, ref num 400), such that the sensor base comprises a second clamp structure corresponding to the first clamp structure (Fig. 9, ref num 902 corresponds to ref num 900), such that when the sensor base is installed in the assembly through hole, and the second clamp structure is clamped with the first clamp structure, the sensor is mounted to the bottom shell through the sensor base (para 0237, “coupling features such as arm 902… may be sized and shaped for releasably mechanically attaching substrate 404 to a connector… attachment to features 900 of housing 128”; see Figs. 3C and 6-8). This allows the user to attach different types of sensors to the shell as needed by the desired application (para 0225). Therefore, 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 Harttig to have a sensor base and clamp structures to attachably connect the bottom shell to the sensor base, in order to install the appropriate sensor to the shell/housing based on the appropriate application and desired measurement.
9. Regarding Claim 2, Harttig teaches the first electrical connection areas are metal contacts (Figs. 5A-5B, ref nums 210; para 0044, 0067 discuss metallic materials and the electrical contacts, ref nums 210).
10. Regarding Claim 3, Harttig teaches the signal output end (Figs. 4B-4C, ref num 124) is curved or bent towards a bottom surface of the bottom shell (Fig. 4B, ref num 124 is bent downward; para 0231).
11. Regarding Claim 12, Harttig teaches a part of the bottom shell that is equipped with the transmitter is the forced part (Figs. 6A and 6C, ref num 218 and Figs 10A-10B, ref num 218 is equipped with ref num 186).
13. Regarding Claim 13, Harttig teaches a side of the bottom shell is provided with a convex part which is outward (Figs. 6A and 6C, ref num 217) and the convex part is the forced part (Figs. 6A and 6C, ref num 217).
14. Regarding Claim 16, Harttig the failure mode of the bottom shell comprises one or more of a break of a bottom plate of the bottom shell, a break of the bottom shell, a break of the second clamp part, and a deformation of the bottom shell (para 0070, 0077, 0249, 0252, and 0262).
15. Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Harttig and Halac, and further in view of Kamath U.S. 2014/0121989 (herein referred to as “Kamath”).
16. Regarding Claim 4, Harttig teaches the first electrical connections areas are directly connected with the second electrical connection areas, respectively (Fig. 9A ref num 210 and 124, which comprises ref nums 118; para 0264, “such that a mutual electrical contact between corresponding contact pads 118 and the electrical contacts 210 may be established”).
Harttig fails to teach the signal output end is arranged on a top of the elastic member.
Kamath teaches a device of analogous art (Fig. 1), wherein the device comprises a transmitter (Fig. 3, ref num 16), a sensor comprising a signal output end (Fig. 4A, ref num 28), and an elastic member (Figs. 4D and 4F, ref num 36). The signal output end is arranged on top of the elastic member (Figs. 4A, 4D, and 4F, ref nums 28 are arranged on top of ref num 36). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the signal output end arranged on top of the elastic member, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
17. Regarding Claim 5, Harttig fails to teach the elastic member comprises at least two conductive areas and at least one insulating area, the insulating area is arranged between the two conductive areas adjacent to each other, the at least two first electrical connection areas are indirectly electrically connected with the second electrical connection areas through the conductive areas, and the first electrical connection areas or the second electrical connection areas are indirectly electrically connected with the conductive areas.
Kamath teaches a device of analogous art (Fig. 1), wherein the device comprises a transmitter (Fig. 3, ref num 16), a sensor comprising a signal output end (Fig. 4A, ref num 28), and an elastic member (Figs. 4D and 4F, ref num 36). The elastic member comprises at least two conductive areas (Fig. 4H, ref nums 408 and 410) and at least one insulating area (Fig. 4H, ref num 400), the insulating area is arranged between the two conductive areas adjacent to each other (see Fig. 4H, ref num 400 separates ref nums 408 and 410). The transmitter has a two first electrical connection areas (para 0184, “The electronics unit 16 includes contacts on its backside), wherein the first electrical connection areas are indirectly electrically connected with the second electrical connection areas through the conductive areas (para 0184, “The electronics unit 16 includes contacts on its backside (not shown) configured to electrically connect with the contacts 28”; para 0203, “Contacts 28 fit within the seal 36 and provide for electrical connection between the sensor 32 and the electronics unit 16”; also see para 0217), and the first electrical connection areas or the second electrical connection areas are indirectly electrically connected with the conductive areas (see Fig. 4H, the second electrical connection areas, i.e., ref nums 28, are electrically connected with ref nums 408 and 410). This configuration can provide the ease of manufacture and product assembly while still sealing the device together (para 0215). Therefore, 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 Harttig to arrange the device in this configuration in order to provide the ease of manufacture and product assembly while still sealing the device together.
18. Regarding Claim 6, Harttig fails to teach the conductive areas and the insulating area pass through the elastic member in a longitudinal direction, respectively.
Kamath teaches the conductive areas and insulating area pass through the elastic member in a longitudinal direction (see Fig. 4H, ref nums 408, 410, and 400 pass longitudinally). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have areas and the insulating area pass through the elastic member in a longitudinal direction, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
19. Regarding Claim 7, Harttig teaches the signal output end is arranged at the bottom of the elastic member (Fig. 4C, ref num 124 is at the bottom of ref num 180).
20. Regarding Claim 8, Harttig teaches the first electrically connections areas are set on different parts of the signal output end (see Fig. 5C, ref nums 210 are separate, therefore would be on different parts of the signal output end),and the different parts of the signal output end are independent of each other (para 0243 and 0264; also see para 0045, 0238).
21. Regarding Claim 9, Harttig fails to teach wherein the signal output end is embedded in the elastic member, and heights of embedded positions of different parts of the signal output end in the elastic member are not the same.
Kamath teaches the signal output end is embedded in the elastic member (Fig. 4D and 4H, ref nums 28 are embedded in ref num 36). This seals the signal output end from moisture (para 0208, 0211). Therefore, 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 Harttig to have the signal output end embedded in the elastic member to reduce moisture to the area.
While Harttig as modified fails to teach the heights of the different parts of the signal output end in the elastic member are not the same, it would have been an obvious matter of design choice to make them different heights, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
22. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Harttig and Halac.
23. Regarding Claim 11, Harttig teaches a number of the first electrical connection areas is two (para 0243, “at least two electrical contacts 210”) and a number of the second electrical connection areas is three (Fig. 4C, ref nums 118, there are three present). While Harttig fails to teach that the number of first electrical connection areas is three, Harttig does mention that there are at least two connection areas (para 0243) indicating that there may be three in other circumstances. Also, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have three first electrical connection areas, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
24. Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Harttig and Halac, and further in view of Shah U.S. 2019/0336055 (herein referred to as “Shah”).
25. Regarding Claim 14, Harttig fails to teach the battery is arranged in the bottom shell, and at least one connection hole is arranged in the bottom shell, the transmitter is electrically connected with the two poles of the battery through the connection hole, and a battery part is the forced part.
Shah teaches a device of analogous art (Fig. 10A-10B, para 0250-0254) wherein the battery is arranged in the bottom of the shell (Fig. 10A, ref num 1018), and at least one connection hole is arranged in the bottom of the shell (see Fig. 10B), the transmitter is electrically connected with the two poles of the battery through the connection hole (Fig. 10B, ref nums 1026, 1028 connect battery to transmitter; see Fig. 10A), and the battery is a forced part (para 0254). This arrangement allows the advantage of replacing inexpensive parts to the device as necessary (para 0299). Therefore, 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 Harttig to have the battery arranged in the bottom shell as this provides the advantage of reuse or replacement of certain components of the device.
26. Regarding Claim 15, Harttig fails to teach a sealing ring is arranged around the connection hole to seal, when the force is applied to the forced part, the sealing ring provides elastic force to promote separation of the bottom shell and the transmitter.
Shah teaches a sealing ring (para 0252, 0254) arranged around the connection hole to seal (para 0254), when the force is applied to the forced part, the sealing ring provides elastic force to promote separation of the bottom shell and the transmitter (0253-0254). This arrangement allows the advantage of replacing inexpensive parts to the device as necessary (para 0299). Therefore, 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 Harttig to have a sealing ring in order to provide ease of replacing components of the device as necessary.
Conclusion
27. 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.
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794