DETAILED ACTION
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) 1-7 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US 2017/0290532) in view of Moein et al. (US 2012/0323098).
As to claim 1, Antonio teaches a high reliability analyte detection device (Abstract) characterized in that, comprising: a bottom case (112); a sensor (404), assembled on the bottom case (Fig. 2B), wherein the sensor comprises a signal output portion and a detection portion (Fig. 4 – see sensor 404 with the vertical portion being the detection portion and the horizontal portion being the signal output portion), which has a shape of a polyline or an arc toward a top of the bottom case (Fig. 7A), is provided with at least two first electrical connection ends insulated from each other(Fig. 15A – 1535); a transmitter (106), fastened with the bottom case (Fig. 2A), wherein the transmitter is provided with at least two second electrical connection ends which are insulated from each other (1517) and corresponding to the first electrical ends (Fig. 15A); and one elastic member contacted with the signal output portion (402), and a sensor base (219), wherein the bottom case comprises an assembly hole (Fig. 2B – center hole).
Antonio fails to teach a first fastening structure around the assembly hole, a second fastening structure provided around the sensor base, the second fastening structure and the first fastening structure being engaged with each other to install the sensor base into the assembly hole of the bottom case, the sensor being installed on the sensor base. Still, it recognizes the importance of having components engaged with each other to make tight connections, including the use of cavities to insert components (415), and various rings to make a watertight connection (e.g. 403, 405, 406, etc).
Moein teaches analyte sensors (Abstract) in which the sensor (913) is installed on a sensor base (912), the sensor assembly (Fig. 22) having a bottom case (bottom component) comprising an assembly hole (904D) and a first fastening structure (the entirety of the inner ring of 904D), a sensor base (912) with a second fastening structure (bottom portion of 912 which is sized to fit into 904D) in which the two fastening structures are engaged with each other to install the sensor base into the assembly hole of the bottom case (Fig. 26D – fully assembled). It would have been obvious to modify Antonio with Moein to utilize a different structure in how the sensor is engaged with the rest of the device, as both are expected to work equally well and would thus be obvious to try.
As to claim 2, Antonio teaches the second electrical connection ends are contact pins (Fig. 12B - 1204). Antonio also states that the elastomeric connectors can be metallic ([0313]). Accordingly, the examiner gives official notice that the use of metal contact pins for electrical connection ends is well known in the art and would have been obvious to utilize within the teachings of Antonio as it would be an obvious substitution yielding similar results.
As to claim 3, Antonio teaches the signal output portion is disposed on a top of the elastic member (Fig. 21 – 2140 placed on top of 2132a). It does not teach that the electrical connection ends is directly connected with a corresponding second electrical connection end of the second electrical connection end. However, Antonio teaches that another sensor end can be placed directly on top of the sensor with certain connectors making direct contact ([0343-0345]). It would have been obvious to modify Antonio to allow for direct contact between the sensor connection ends and the transmitter connection ends as it would have been an obvious substitution yielding similar results.
As to claim 4, Antonio teaches the elastic member teaches at least two conductive areas (1128a) and at least one insulation area ([0326]), and the insulation area is provided between two adjacent conductive areas of the at least two conductive areas (Fig. 11B), and the at least two first electrical connection ends, through different conductive areas of the at least two conductive areas, are respectively electrically connected to the corresponding second electrical connection ends of the second electrical connection ends (Fig. 23), and the first electrical connection ends or the second electrical connection ends are respectively electrically connected to the different conductive areas (Fig. 23).
As to claim 5, Antonio teaches the conductive area and the insulation area expand across the elastic member in a vertical direction, respectively (Fig. 23; [0033]).
As to claim 6, Antonio teaches the signal output portion is embedded inside the elastic member or disposed at a bottom of the elastic member (Fig. 21).
As to claim 7, Antonio teaches first electrical connection ends are provided on different parts of the signal output portion which are independent of each other and do not interfere with each other (Fig. 16).
As to claim 10, while Antonio teaches the number of electrical connection ends are three on each ([0324] – teaches that the elastomeric connector can accommodate any number of contacts such as 3, implying that the number of connection ends can be 3).
As to claim 11, Antonio teaches the bottom case further comprises a sensor base (219) where the signal output portion and the elastic member is disposed (Fig. 6) and the signal output portion has a shape of a polyline or an arc towards a top of the sensor base (Fig. 7A).
Response to Arguments
Applicant has argued that Moen fails to teach “the second fastening structure and the first fastening structure are engaged with each other”. In particular, the applicant has argued that Moein’s teaching merely pertains to a “dimensional fitting” rather than any form of “mechanical engagement” as Moein states that the sensor support is “sized to fit into” the needle opening. To start, the claim is absent any recitation of “mechanical engagement”. It merely requires that the first and second fastening structures be “engaged” with each other. Moreover, even had it recited the phrase “mechanical engagement” verbatim, the structures taught by Moein would meet the limitation, as there is nothing within the terminology that is further limiting than what Moein teaches, as the engagement of the noted portions would at least restrict movement in the same plane as the base. The claims do not require any specific type of engagement, such as the “snap-fit structure” that applicant asserts is shown in Fig 2 of the present application, but is not even taught in the specifications, much less recited in the claim language.
In addition, while applicant asserts that the structure of Moein is not associated with fastening or securing the sensor support, as noted above, the engagement of the structure taught by Moein at least prevents movement in the same plane as the base. Moreoever, Moein also appears to teach that the opening 904D isn’t a circle but oval shaped, which would also prevent rotation of the sensor support, further “fastening” the structures together. And even if the shape of 904D isn’t necessarily oval, it even teaches another structural element 912 which, in combination with the cited portions, would certainly prevent rotation, which is more than currently required by the recited claim language.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, while applicant asserts that there would be no motivation to combine, as Antonio already teaches other structures which keeps a sensor module in place, the argument is not persuasive. Even if other portions are secured to each other, one of ordinary skill in the art would recognize the idealness of having all interlocking portions be closely engaged with each other, to eliminate even slight movements like “rattling”, particularly for devices in which interstitial fluid/blood can otherwise penetrate into undesired parts of the device if the parts were allowed to move freely with respect to each other. The rejections are maintained.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. 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 6/2/26