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 .
Response to Preliminary Amendment
This Office Action is responsive to the preliminary amendment filed on 20 November 2023. As directed by the amendment: Claims 1-15 have been amended, no claims have been cancelled, and no claims have been added. Thus, Claims 1-15 are presently pending in this application.
Specification
The disclosure is objected to because of the following informalities:
Throughout the Specification, element 1237 is referred to as both “the electrolyte insulation layer” and “the electrolyte isolation layer”. It appears that this is the same element. For purposes of examination, this will be interpreted as “the electrolyte insulation layer”.
Appropriate correction is required.
Double Patenting/35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12, and 15 of this application is patentably indistinct from Claims 1-13, and 19 of Application No. 18/562,840. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-12, and 15 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of Claims 1-13 and 19 of copending Application No. 18/562,840.
Claim 1 of the instant application is identical to Claim 1 of Application No. 18/562,840.
Claim 2 of the instant application is identical to Claim 2 of Application No. 18/562,840.
Claim 3 of the instant application is identical to Claim 3 of Application No. 18/562,840.
Claim 4 of the instant application is nearly identical to and fully encompassed by Claims 4 and 13 of Application No. 18/562,840.
Claim 5 of the instant application is identical to Claim 5 of Application No. 18/562,840.
Claim 6 of the instant application is identical to Claim 6 of Application No. 18/562,840.
Claim 7 of the instant application is identical to Claim 7 of Application No. 18/562,840.
Claim 8 of the instant application is identical to Claim 8 of Application No. 18/562,840.
Claim 9 of the instant application is identical to Claim 9 of Application No. 18/562,840.
Claim 10 of the instant application is identical to Claim 10 of Application No. 18/562,840.
Claim 11 of the instant application is identical to Claim 11 of Application No. 18/562,840.
Claim 12 of the instant application is identical to Claim 12 of Application No. 18/562,840.
Claim 15 of the instant application is identical to Claim 19 of Application No. 18/562,840.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the claim recites “an analyte detection device with circuit board and shell integration”. However, it is unclear as to whether “circuit board” and “shell” are claimed components, or how this is descriptive of the structure of the device. Furthermore, it is unclear as to whether these are the same or different components from “an electronic circuit”, “a shell”, and “electronic components” as recited in the claims. Therefore, this limitation is indefinite. For purposes of examination, the Examiner is interpreting these limitations as the same components as recited in other limitations of the claims. Appropriate correction or clarification is required. Claims 2-15 are rejected for depending on Claim 1.
Regarding Claim 5, the claim recites “the upper cover body”. There is lack of antecedent basis for this limitation in the claims. It appears that based on Claim 4, this was intended to recite “the upper cover shell”, and thus will be interpreted as such for purposes of Examination. Appropriate correction or clarification is required. Claims 6-10 are rejected for depending on Claim 5.
Regarding Claims 6-10, the claims recite both “the electrolyte insulation layer” and “the electrolyte isolation layer”. It appears that these limitations are referring to the same component, therefore these limitations are indefinite. For purposes of examination, both elements will be interpreted as “the electrolyte insulation layer”. Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 1, 2, 3, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Antonio et al. (US Publication No. 2017/0290512).
Regarding Claim 1, Antonio et al. discloses an analyte detection device with circuit board and shell integration (Abstract, Paragraph 0270), which comprises:
a bottom case (casing components 222, 224, 219 of sensor assembly 112, Fig. 3A, 4; Paragraphs 0302, 0304) used for mounting on a skin surface of human skin a user (Abstract; Paragraph 0011);
a sensor assembled (sensor components, e.g. 209, 404, 409, Fig. 3A, 4; Paragraph 0308) on the bottom case for detecting analyte parameter information in a body of the user (analyte sensor, Paragraph 0207);
a transmitter module (transmitter assembly, 106, Fig. 4A; 906, Fig. 9; 1012, Fig. 10A-B; Paragraph 0304, 0322-0325) comprising a shell (shell 907, Fig. 9-10; see also shell for 1012 in Figs. 10A-B and 1106 in Figs. 11A-C) and an electronic circuit (918, 912, Fig. 9; 1012, 1018, 1032; Fig. 10A-B; Paragraph 0322-0323) arranged on the shell, wherein the electronic circuit comprises at least one electronic component the electronic component at least comprises a transmitter antenna (antenna 1032; Fig. 10A), the transmitter antenna (antenna 1032; Fig. 10A; Paragraph 0323, 0298) is used to communicate with an external equipment to send the analyte parameter information to the external equipment (sensor/transmitter communicates data with remote device, Paragraph 0008, 0022, 0298; Claim 12);
and a battery (914, Fig. 9; 1014, Fig. 10A) located in the transmitter module, wherein the battery is used to provide electric energy for the transmitter module (Paragraph 0322-0324).
Regarding Claim 2, Antonio et al. discloses an analyte detection device further wherein the electronic circuit (918, 912, Fig. 9; 1012, 1018, 1032; Fig. 10A-B; Paragraph 0322-0323) also comprises a substrate (substrate PCB 1018, Figs. 9, 10A, 10B; see also 1118, Figs. 11A-11B; Paragraph 0322-0325) embedded in an inner side of the shell (shell 907, Fig. 9-10; see also shell in Figs. 11A-C) of the transmitter module (transmitter assembly, 106, Fig. 4A; 906, Fig. 9; 1012, Fig. 10A-B; Paragraph 0304, 0322-0325), at least one electronic component comprises electronic components (Paragraph 0322-0325), and the electronic components are fixed on the substrate (substrate PCB 1018 with electronic components, Figs. 9, 10A, 10B; see also 1118, Figs. 11A-11B; Paragraph 0322-0325).
Regarding Claim 3, Antonio et al. discloses an analyte detection device further wherein the electronic circuit (918, 912, Fig. 9; 1012, 1018, 1032; Fig. 10A-B; Paragraph 0322-0323) is integrated with the shell (shell 907, Fig. 9-10; see also shell in Figs. 11A-C) of the transmitter module (transmitter assembly, 106, Fig. 4A; 906, Fig. 9; 1012, Fig. 10A-B; Paragraph 0304, 0322-0325), at least one electronic component comprises electronic components (Paragraph 0322-0325), and the electronic components are fixed on an inner side of the shell of the transmitter module (electronic components are fixed on substrate PCB 1018 and fixed on inner side of shell, see Figs. 9, 10A, 10B; see also 1118, Figs. 11A-11B; Paragraph 0322-0325).
Regarding Claim 15, Antonio et al. discloses an analyte detection device further wherein the electronic circuit (918, 912, Fig. 9; 1012, 1018, 1032; Fig. 10A-B; Paragraph 0322-0323) also comprises an electrical contact (contacts/connectors 1132a-b, 1128a-b, Fig. 11; Paragraph 0324; see also connection of transmitter module to sensor assembly using contacts/connections, Fig. 13) that is electrically connected to the sensor to obtain the analyte parameter information (Paragraph 0331-0332, 0324).
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.
Claims 4-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio et al. (US Publication No. 2017/0290512) in view of Mitani et al. (US Publication No. 2008/0182159).
Regarding Claim 4, Antonio et al. discloses an analyte detection device further comprising a battery (1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458) comprising a cavity shell (see shell of battery 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), the cavity shell comprises an upper cover shell and a lower shell (see shell of battery, with upper section and lower section, 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458).
However, Antonio et al. does not explicitly disclose wherein the battery comprises an electric core and electrolyte, and the electric core comprises a diaphragm, an anode plate, a cathode plate and a conductive strip.
Mitani et al. teaches a battery (Abstract) comprising a cavity shell (housing 10, lid 20, Fig. 1; Paragraph 0023), an electric core (cylindrical core in housing 10, see Fig. 1; Paragraph 0020, 0023) and electrolyte (Paragraph 0028, 0033), the cavity shell comprises an upper cover shell and a lower shell (housing 10 with metal bottom and upper lid 20, Fig. 1; Paragraph 0023), and the electric core comprises a diaphragm (2, Figs. 1-2; Paragraph 0024-0025) , an anode plate (anode plate, Paragraph 0020, 0022, 0023), a cathode plate (cathode plate, Paragraph 0020, 0021, 0023) and a conductive strip (conductive tab/ring/plate elements, Paragraphs 0022-0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a battery with an electric core and electrolyte, and the electric core comprises a diaphragm, an anode plate, a cathode plate and a conductive strip, as taught by Mitani et al., as the battery in the analyte detection device disclosed by Antonio et al., since these are known elements in a battery to achieve high capacity while decreasing risk of battery failure (Paragraph 0007-0009, 0002-0003 of Mitani et al.).
Regarding Claim 5, Antonio et al. discloses an analyte detection device further comprising a battery comprising a cavity shell (see shell of battery 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), the cavity shell comprises an upper cover shell and a lower shell (see shell of battery, with upper section and lower section, 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458). Although it appears that one of the upper cover shell/body or the lower shell (depending on the frame of reference for upper/lower, see shell of battery, with upper section and lower section, 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458) is integrally formed with the housing shell of transmitter module (shell 907, Fig. 9-10; see also shell for 1012 in Figs. 10A-B and 1106 in Figs. 11A-C), however Antonio et al. does not explicitly disclose that the upper cover shell/body or the lower shell are integrally formed with the shell housing of the transmitter module. Antonio et al. does disclose, “Advantageously, the components are compressed or otherwise fit together such that no solder or other connections are necessary for the subassembly. In this way, the arrangement minimizes dead volume and reduces the height of the subassembly.” (Paragraph 0323).
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the upper cover shell/body or the lower shell to be integrally formed with the shell housing of the transmitter module, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893). In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding Claims 6-8 and 10, Antonio et al. discloses an analyte detection device further comprising a battery comprising a cavity shell (see shell of battery 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), however Antonio et al. does not explicitly disclose that the battery includes an electrolyte insulation layer is arranged in the cavity shell, wherein the electrolyte isolation layer is a film arranged on an inner wall of the cavity shell, and the electrolyte isolation layer is a closed shell independent of the cavity shell.
Mitani et al. teaches a battery (Abstract) comprising a cavity shell (housing 10, lid 20, Fig. 1; Paragraph 0023), an electric core (cylindrical core in housing 10, see Fig. 1; Paragraph 0020, 0023) and electrolyte (Paragraph 0028, 0033), the cavity shell comprises an upper cover shell and a lower shell (housing 10 with metal bottom and upper lid 20, Fig. 1; Paragraph 0023), including an electrolyte insulation layer (insulating ring 3, Figs. 1-2; polyethylene film separator, Paragraph 0020, 0027, 0039) is arranged in the cavity shell (housing 10, lid 20, Fig. 1; Paragraph 0023), wherein the electrolyte isolation layer is a film (insulating ring 3, Figs. 1-2; polyethylene film separator, Paragraph 0020, 0027, 0039) arranged on an inner wall of the cavity shell, and the electrolyte isolation layer (insulating ring 3, Figs. 1-2; polyethylene film separator, Paragraph 0020, 0027, 0039) is a closed shell (insulating ring 3 and polyethylene film separator are enclosed within other components within the cavity shell, see Figs. 1, 2; Paragraph 0023, 0024, 0026-0028) independent of the cavity shell.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a battery with an electrolyte insulation layer is arranged in the cavity shell, wherein the electrolyte isolation layer is a film arranged on an inner wall of the cavity shell, and the electrolyte isolation layer is a closed shell independent of the cavity shell, as taught by Mitani et al., as the battery in the analyte detection device disclosed by Antonio et al., since these are known elements in a battery to achieve high capacity while decreasing risk of battery failure (Paragraph 0007-0009, 0002-0003, 0027 of Mitani et al.).
Furthermore, Mitani et al. teaches wherein electrolyte insulation layer comprises polyethylene (Paragraph 0020), but does not explicitly disclose that the electrolyte insulation layer is made of TPE or PET material. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrolyte insulation layer to be made of specifically TPE or PET material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding Claim 9, Antonio et al. discloses an analyte detection device further comprising a battery comprising a cavity shell (see shell of battery 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), and Mitani et al. teaches a battery (Abstract) comprising a cavity shell (housing 10, lid 20, Fig. 1; Paragraph 0023) including an electrolyte insulation layer (insulating ring 3, Figs. 1-2; polyethylene film separator, Paragraph 0020, 0027, 0039) is arranged in the cavity shell (housing 10, lid 20, Fig. 1; Paragraph 0023), wherein the electrolyte isolation layer is a film (insulating ring 3, Figs. 1-2; polyethylene film separator, Paragraph 0020, 0027, 0039).
Antonio et al. discloses that the components including the battery of the analyte detection device are small in size (Paragraph 0300, 0302, 0323), and Mitani et al. teaches that components of the battery are on the order of um in size (Paragraph 0021, 0022). However, neither Antonio et al. nor Mitani et al. teach wherein the thickness of the electrolyte isolation layer is 300-500um.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrolyte insulation layer to have a thickness of 300-500um, since such a modification would have involved a mere change in the size of a component (the thickness of the electrolyte insulation/isolation layer). 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).
Regarding Claim 13, Antonio et al. discloses an analyte detection device further wherein the electronic circuit (918, 912, Fig. 9; 1012, 1018, 1032; Fig. 10A-B; Paragraph 0322-0323) also comprises a power electrode (connectors 1132a-b connected to battery; contacts 1128a-b connected to battery, Figs. 11A-B; Paragraph 0324). However, Antonio et al. does not explicitly disclose wherein the anode plate and the cathode plate are electrically connected to the power electrode through the conductive strip.
Mitani et al. teaches a battery (Abstract) comprising an anode plate (anode plate, Paragraph 0020, 0022, 0023), a cathode plate (cathode plate, Paragraph 0020, 0021, 0023) and a conductive strip (conductive tab/ring/plate elements, Paragraphs 0022-0024), wherein the anode plate (anode plate, Paragraph 0020, 0022, 0023) and the cathode plate (cathode plate, Paragraph 0020, 0021, 0023) are electrically connected to a power electrode (electrode plates/windings, Paragraph 0020-0021, 0023-0024) through the conductive strip (conductive tab/ring/plate elements, Paragraphs 0022-0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to electrically connect the power electrode to the anode plate and the cathode plate through the conductive strip, as taught by Mitani et al., in the analyte detection device disclosed by Antonio et al., in order to provide functional power to the electronic components in the transmitter module.
Claims 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio et al. (US Publication No. 2017/0290512) in view of Mitani et al. (US Publication No. 2008/0182159), further in view of Flitsch et al. (US Publication 2018/0074345).
Regarding Claims 11, 12, and 14, Antonio et al. discloses an analyte detection device further comprising a battery comprising a cavity shell (see shell of battery 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), the cavity shell comprises an upper cover shell and a lower shell (see shell of battery, with upper section and lower section, 1014, Fig. 10A-B; 1114, Fig. 11A-B; Paragraph 0322-0324, 0458), wherein connections can be made by soldering (Paragraph 0357, 0473) or adhesive (Paragraph 0323). Mitani et al. teaches connections comprising sealing the battery shell (Paragraph 0028, 0004).
However, neither Antonio et al. nor Mitani et al. teach explicitly wherein a sealant is coated at a junction of the upper cover shell and the lower shell, wherein the sealant is one of hot melt adhesive or silica gel, or wherein the conductive strip is fixedly connected to the power electrode by solder or solder paste.
Flitsch et al. further teaches a biomedical battery which a sealant is coated at a junction of the upper cover shell and the lower shell (Paragraph 0212-0213), wherein the sealant is hot melt adhesive (Paragraph 0212-0213), and wherein electrical connections of conductive components are connected by solder material (Paragraph 0083, 0088, 0121, 0210). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure a sealant to be coated at a junction of the upper cover shell and the lower shell, wherein the sealant is hot melt adhesive, and to configure the conductive strip to be fixedly connected to the power electrode by solder, as taught by Flitsch et al., in the analyte detection device and battery disclosed by Antonio et al. and Mitani et al. in combination, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796