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 .
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 22 March 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [“This application is a 371 of international application of PCT application serial no. PCT/CN2021/136529, filed on December 08, 2021, which claims the priority benefit of China application no. PCT/CN2021/120856, filed September 27, 2021. The entirety of each of the above mentioned patent applications is hereby incorporated by reference herein and made a part of the this specification” (emphasis applied by Examiner)]. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action.
Appropriate correction is required.
Claim Objections
Claim(s) 2-14 is/are objected to because of the following informalities:
Each of dependent claims 2-14 should be amended to read “The analyte detection device with battery and shell integrated of claim…” [lines 1-2 in each dependent claim; see MPEP § 608.01(n)(IV) regarding dependent claim form and arrangement].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 8, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio (US-20170290546-A1) in view of Liao (US-20180309168-A1) and Al-Ali (US-20170055896-A1).
Regarding claim 1, Antonio teaches
An analyte detection device with battery and shell integrated, which comprises:
an outer shell comprising an upper outer shell [upper housing 120 (Antonio Fig. 5)] and a lower outer shell [lower shell/housing 130 (Antonio Fig. 5)], wherein a sensor is arranged on the upper outer shell [The sensor gaskets 340 form face seals between the upper housing 120, lower housing 130, and the sensors 12A, 12B (Antonio ¶0090, Fig. 9), such that as depicted in Antonio Fig. 9, the sensors 12A-B are considered to be “arranged on” the upper outer shell (upper housing 120)];
a circuit board arranged inside the lower shell and provided with a transmitter antenna, wherein the transmitter antenna is used for communicating with external devices [A printed circuit board assembly (PCBA) 320 fits inside the lower housing 130 and is supported by one of the major walls (upper or lower housing)… Electrical components of the sensing device are electrically connected to the PCBA (Antonio ¶0084, Fig. 4); sensor electronics (including a wireless transmitter) to an appropriate monitoring device (not shown) for recordation and/or display to monitor patient condition (Antonio ¶0083)];
a battery cavity arranged inside the lower outer shell and comprising a cavity shell and a conductive strip, wherein the cavity shell comprises a lower shell [the battery 300 is a coin cell battery (Antonio ¶0084, Fig. 4); Battery connector pads 204 on the PCBA are shorted together to connect the positive side of the battery 300 to the PCBA 320 (Antonio ¶0089, Fig. 8B); It is further possible to hold the battery in place by shaping the upper and/or lower housings in a way to confine the battery and prevent it from moving when the upper and lower housings are connected to each other (Antonio ¶0085), wherein a portion of the lower housing being shaped to contain the battery is considered to define a lower shell of the battery].
However, while Antonio notes that any suitable battery may be used [Any suitable battery that is small in size with sufficient life for the sensing device may be used (Antonio ¶0084)] and that the battery may be held into place by integrated solder pads on a circuit board [Alternatively, the battery (or batteries) may be held into place by other methods such as integrated solder pads on a flex or rigid or rigid/flex circuit board (Antonio ¶0085)], Antonio fails to explicitly disclose a battery cavity arranged inside the lower outer shell and comprising a cavity shell, a diaphragm, an electrolyte, an anode plate, a cathode plate and a conductive strip, wherein the cavity shell comprises an upper cover shell and a lower shell, the upper cover shell is integrated with the circuit board.
Liao discloses that batteries are known in the art to comprise a diaphragm, an electrolyte, an anode plate, and a cathode plate [The electrolytes can be incorporated in a lithium ion electrochemical cell comprising a positive electrode (cathode), a negative electrode (anode), and a porous separator between the cathode and anode, with the electrolyte in contact with both the anode and cathode, as is well known in the battery art. A battery can be formed by electrically connecting two or more such electrochemical cells in series, parallel or a combination of series and parallel. The electrolyte can be utilized with any anode or cathode compositions useful in lithium-ion batteries. Electrochemical cell and battery designs and configurations, anode and cathode materials, as well as electrolyte salts, solvents and other battery components, are well known in the lithium battery art (Liao ¶0048), wherein the porous separator is considered to read on the claimed diaphragm].
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 the device of Antonio to employ a battery comprising a diaphragm, an electrolyte, an anode plate, and a cathode plate, as known in the art of batteries.
Al-Ali discloses an analyte detection device, wherein a battery of the analyte detection device is housed in a battery cavity defined by an upper cover shell integrated with a circuit board of the device [Assembly of the wireless sensor 102 is as follows: The circuit board 340 and battery holder 342 holding the battery 214 are placed into the housing 350 (Al-Ali ¶0103), wherein the battery being held onto the bottom of the circuit board is considered to define at least a portion of the circuit board forming an upper cover shell for the batter].
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 the device of Antonio in view of Liao to employ wherein the cavity shell comprises an upper cover shell integrated with the circuit board, as this modification would amount to mere rearrangement of parts [MPEP § 2144.04(VI)(B); In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)].
Regarding claim 2, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 1, wherein the lower shell is integrated with the lower outer shell [Antonio ¶0091, Fig. 11].
Regarding claim 8, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 1, wherein the circuit board also comprises a power electrode, a first end of the conductive strip is fixedly connected with the anode plate or the cathode plate, and a second end of the conductive strip is electrically connected with the power electrode [Battery connector pads 204 on the PCBA are shorted together to connect the positive side of the battery 300 to the PCBA 320 (Antonio ¶0089, Fig. 8B); see § 103 modification of claim 1 above regarding the anode plate/cathode plate as modified].
Regarding claim 11, Antonio in view of Liao, and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 8, wherein the second end of the conductive strip is fixedly connected with the power electrode through solder or solder paste [FIG. 8A shows a bottom view of the PCBA 320 with the battery 300 held by battery clips 302, which may be welded to pads on the underside of the PCBA 320. FIG. 8B shows the same configuration but with a top view of the PCBA 320. The battery 300 is held by battery clips 302. Battery connector pads 204 on the PCBA are shorted together to connect the positive side of the battery 300 to the PCBA 320 (Antonio ¶0089); see § 103 modification of claim 1 above regarding the conductive strip as modified].
Regarding claim 12, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 1, wherein a material of the upper outer shell or the lower outer shell is one of PE, PP, HDPE, PVC, ABS, PMMA, PC, PPS and PU [the sensor housing may be made out of a flexible material such as silicone or polyurethane. Other flexible materials that can successfully house and protect the electronics of the sensing device may also be used. Some examples include silicon, fabric, plastic (e.g., polycarbonate or ABS), or other flexible polymers (Antonio ¶0134)].
Regarding claim 13, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 1, wherein the sensor comprises an internal part [sensor chemistry 123A, 123B of upper sensor 12A and lower sensor 12B, respectively (Antonio ¶0087, Fig.6), wherein internal is considered to refer to the portion of the sensors 12A-B that is inserted into a subject’s body] and an external part [contact pads 121A, 121B of upper sensor 12A and lower sensor 12B, respectively (Antonio ¶0087, Fig.6)] and the internal part is bent with the external part [Upper sensor 12A has its contact pads 121A facing up and its sensor chemistry 123A facing left. Lower sensor 12B has its contact pads 121B facing down and chemistry 123B facing right… The lower housing 130 shows lower housing sensor opening 132, through which the sensors 12A, 12B and, during insertion, a needle may extend (Antonio ¶0087, Fig. 6), wherein as depicted in Antonio Fig. 6, sensor chemistry 123A/123B (external part) is bent with contact pads 121A/121B (internal part)].
Regarding claim 14, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 13, wherein the external part is tiled in the upper cover shell, and the internal part passes through the upper outer shell to the outside [Antonio ¶0087, Fig. 6-7B, wherein as depicted in Antonio Fig. 6-7B, the contact pads 121A/121B are flat, which is considered to read on the broadest reasonable interpretation of being tiled].
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio in view of Liao and Al-Ali, as applied to claim 1 above, in further view of Liu (CN-102569680-A, foreign reference and translation attached).
Regarding claim 6 [written in longhand format to incorporate the subject matter of claims 3-5 therein], Antonio in view of Liao and Al-Ali teaches
The analyte detection device with battery and shell integrated mentioned in claim 1.
However, Antonio in view of Liao and Al-Ali fails to explicitly disclose wherein an electrolyte isolation layer is arranged inside the cavity shell, wherein the electrolyte isolation layer is made of TPE or PET material, wherein the electrolyte isolation layer is a thin film coated on an inner wall of the cavity shell, and wherein a thickness of the electrolyte isolation layer is 300-500um.
Liu discloses a shell for a battery, wherein the battery is surrounding by an electrolyte isolation layer [a lithium ion secondary battery shell and lithium ion battery with insulating heat conducting layer (Liu ¶0017)], wherein the electrolyte isolation layer is made of TPE or PET material, and wherein a thickness of the electrolyte isolation layer is 300-500um [outside the metal shell of battery is made of PET sleeve with thermal contraction function… the other common heat-shrinkable insulated packaging material PVC, PE and P0F heat-shrinkable insulating film… the thickness range of usually 0.1-0.3 mm (Liu ¶0008)].
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 the device of Antonio in view of Liao and Al-Ali to employ wherein the battery is surrounding by an electrolyte isolation layer, wherein the electrolyte isolation layer is made of TPE or PET material, and wherein a thickness of the electrolyte isolation layer is 300-500um, to improve insulation of the battery from heat and improve the service life of the battery. Based on the modification of Antonio in view of Liao, Al-Ali, and Liu to employ wherein the battery is surrounding by an electrolyte isolation layer is considered to read on the limitation wherein the electrolyte isolation layer is a thin film coated on an inner wall of the cavity shell, as the battery of Antonio is held by the cavity shell as modified [see § 103 modification of claim 1 above].
Regarding claim 7 [written in longhand format to incorporate the subject matter of claims 3-4 therein], Antonio in view of Liao and Al-Ali teaches
The analyte detection device with battery and shell integrated mentioned in claim 1.
However, Antonio in view of Liao and Al-Ali fails to explicitly disclose wherein an electrolyte isolation layer is arranged inside the cavity shell, wherein the electrolyte isolation layer is made of TPE or PET material, and wherein the electrolyte isolation layer is a closed shell independent of the cavity shell.
Liu discloses a shell for a battery, wherein the battery is surrounding by an electrolyte isolation layer [Liu ¶0017], wherein the electrolyte isolation layer is made of TPE or PET material [Liu ¶0008].
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 the device of Antonio in view of Liao and Al-Ali to employ wherein the battery is surrounding by an electrolyte isolation layer, and wherein the electrolyte isolation layer is made of TPE or PET material, to improve insulation of the battery from heat and improve the service life of the battery. Based on the modification of Antonio in view of Liao, Al-Ali, and Liu to employ wherein the battery is surrounding by an electrolyte isolation layer is considered to read on the limitation wherein the electrolyte isolation layer is a closed shell independent of the cavity shell, as the battery of Antonio is held by the cavity shell as modified [see § 103 modification of claim 1 above].
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio in view of Liao and Al-Ali, as applied to claim 8 above, in further view of Huang (CN-112294309-A, foreign reference and translation attached).
Regarding claim 9, Antonio in view of Liao and Al-Ali teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 8.
However, Antonio in view of Liao and Al-Ali fails to explicitly disclose wherein a connection between the upper cover shell and the lower shell is coated with insulating sealant.
Huang discloses an analyte detection device, wherein an interior of the device is filled with an insulating sealant to seal the inner space of the device [Referring to FIG. 5, the emitter 3 of the inner space 30 is filled with curing agent 5, to bond the top shell 31 and the bottom shell 32, and fixing the battery 35, the circuit board 33 and the processing unit 34, and sealing the inner space 30. Therefore, it can improve the mechanical strength of the emitter, so that it is more firm and not easy to deform and has anti-falling and anti-shock function, at the same time, it can reduce the locating structure and fixing structure needed in the emitter 3, and is beneficial for simplifying the use of space. In this embodiment, the curing agent 5 is epoxy resin (Epoxy), but the curing agent also can be silica gel (Silicone) (Translated Huang p. 7)].
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 the device of Antonio in view of Liao and Al-Ali to employ wherein an interior of the device is filled with insulating sealant, so as to impart mechanical strength, anti-falling, and anti-shock properties to the device. Based on the modification by Huang, a connection point between the upper cover shell and the lower cover shell as modified in claim 1 above [A printed circuit board assembly (PCBA) 320 fits inside the lower housing 130 and is supported by one of the major walls (upper or lower housing) (Antonio ¶0084); It is further possible to hold the battery in place by shaping the upper and/or lower housings in a way to confine the battery and prevent it from moving when the upper and lower housings are connected to each other (Antonio ¶0085), such that based on the modification of claim 1 above, the PCBA and the lower housing as shaped to contain the battery may be considered to be connected] may be considered to be coated with the modified insulating sealant.
Regarding claim 10, Antonio in view of Liao, Al-Ali, and Huang teaches
According to the analyte detection device with battery and shell integrated mentioned in claim 9, wherein the insulation sealant is one of hot melt adhesive and silica gel [Huang p. 7].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791