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 .
Claim Objections
Applicant is advised that should claim 13 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 6 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hsu et al (U.S. Patent Application Publication Number: US 2020/0192423 A1, hereinafter “Hsu”).
Regarding claim 1, Hsu teaches a wearable device (e.g. Abstract, [0025],[0033]), comprising:
a bendable carrier having a surface (e.g. 52 Figs 1,2, [0035]);
a first electronic component (e.g. [0052 Fig.2, [0033], [0034]) disposed over the surface of the bendable carrier;
a sensing element disposed over the surface of the bendable carrier and configured to detect a biosignal (e.g. [0029], [0057]-[0060],[0070] Fig. 18, [0068]) and
an encapsulant defining a space, wherein the space is configured to accommodate the sensing element (e.g. Figs. 9-11, [0051]-[0053]).
Regarding claim 6, Hsu teaches the sensing element is formed on flexible printed circuits formed of metal traces (e.g. [0056]) and therefore they teach that the sensing element is electrically connected to the bendable carrier through a conductive wire.
Regarding claim 15, Hsu teaches a wearable device (e.g. Abstract, [0025],[0033]), comprising:
a bendable carrier having a having a top surface and a bottom surface opposite to the top surface (e.g. [0050]: band is formed by laminating and therefore has a plurality of layers including a top and bottom surface Fig.11);
a layer (e.g. 72 Fig.11 [0052]: cavities have clear polymer that exposes the top surface of the bottom layer) disposed over the top surface of the bendable carrier, the top surface of the bendable carrier being partially exposed by the layer; and
a sensing element (e.g. 56 Fig.11) disposed over the bottom surface of the bendable carrier and configured to detect a biosignal (e.g. [0029], [0057]-[0060],[0070] Fig. 18, [0068]).
Regarding claims 16 and 17, Hsu teaches flexible printed circuits formed of metal traces (e.g.[0045],[0046] [0056],[0064) in the band and therefore they teach a wiring layer of the bendable carrier is physically separated from the layer and that the sensing element is electrically connected to the wiring layer of the bendable carrier through a conductive pad.
Claim Rejections - 35 USC § 103
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 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 2-5 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hsu et al (U.S. Patent Application Publication Number: US 2020/0192423 A1, hereinafter “Hsu”) in view of Yamashita et al (U.S. Patent Application Publication Number: US 2011/0275918 A1, hereinafter “Yamashita”).
Regarding claims 2 and 3, Hsu teaches the claimed invention as discussed above except for a further comprising a fluid collecting region disposed on the surface of the bendable carrier and a surface of the fluid collecting region facing a wearer, wherein a first distance between the surface of the bendable carrier and a sensing surface of the sensing element is less than a second distance between the surface of the bendable carrier and the surface of the fluid collecting region in a cross section view and wherein the sensing surface of the sensing element is closer to the fluid collecting region compared with the first electronic component in a cross section view.
In a similar field of endeavor, Yamashita teaches a wearable device ( e.g. Fig. 15) comprising a wristwatch with an analyzer main body 72 and a body fluid collecting chip capable of being attached to the interior of the analyzer main body 72 ( e.g. [0183] Fig. 13) comprising a fluid collecting region (e.g. 22 Fig.13) disposed on the surface of the bendable carrier (e.g. 74 Fig.13) that is attached to the patient’s arm and a surface of the fluid collecting region facing a wearer, wherein a first distance between the surface of the bendable carrier and a sensing surface of the sensing element is less than a second distance between the surface of the bendable carrier and the surface of the fluid collecting region in a cross section view and wherein the sensing surface of the sensing element is closer to the fluid collecting region compared with the first electronic component in a cross section view (e.g. Fig. 13, [0182]-[0183]: body fluid collecting chip 22 (considered as the sensor) collects fluid through the opening 29 and the body fluid collecting chip is closer to the surface of the bendable carrier than the analyzer 72). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the encapsulated cavities in the band in the teachings of Hsu to have a sensing chip comprising a hole that collects body fluids and tests the fluids and is located as taught by Yamashita in order to provide the predictable results of allowing for the monitoring and treatment of conditions such as diabetes.
Regarding claims 4 and 5, Hsu teaches the claimed invention as discussed above and teach that the encapsulant encapsulates the first electronic component (e.g. [0033]: circuitry of FIG. 1 may be located entirely in band 42 and/or may be located partially in main unit 52 and partially in band 52.).
They do not specifically further teach a hole disposed between the first electronic component and the sensing element in a cross section view and wherein the hole penetrates the encapsulant. In a similar field of endeavor, Yamashita teaches a wearable device (e.g. Fig. 15) comprising a wristwatch with an analyzer main body 72 and a body fluid collecting chip capable of being attached to the interior of the analyzer main body 72 (e.g. [0183] Fig. 13) comprising a fluid collecting region (e.g. 22 Fig.13) disposed on the surface of the bendable carrier (e.g. 74 Fig.13) that is attached to the patient’s arm and a surface of the fluid collecting region facing a wearer and teach a hole (e.g. 29 Fig. 13) disposed between the control circuit (i.e. first electronic component e.g. 30 Fig. 13 i.e. test unit [0103]) and the sensing element ( e.g. 22 Fig. 13)in a cross section view. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the band comprising encapsulated cavities in the teachings of Hsu to include a sensing chip with a hole and test unit in one of the encapsulated cavities as in order to provide the predictable results of allowing for the monitoring and treatment of conditions such as diabetes.
Regarding claims 7-9, Hsu teaches the claimed invention as discussed above and teach that the encapsulant encapsulates the first electronic component (e.g. [0033]: circuitry of FIG. 1 may be located entirely in band 42 and/or may be located partially in main unit 52 and partially in band 52.). they also teach a plurality of sensors as discussed above but do not specifically teach a second electronic component disposed on the surface of the bendable carrier, wherein a thickness of the first electronic component is different from a thickness of the second electronic component and the thickness of the first electronic component is less than the thickness of the second electronic component and the encapsulant encapsulates the first electronic component and the second electronic component, and the sensing element is exposed by the encapsulant.
In a similar field of endeavor, Yamashita teaches a wearable device (e.g. Fig. 15) comprising a wristwatch with an analyzer main body 72 and a body fluid collecting chip capable of being attached to the interior of the analyzer main body 72 (e.g. [0183] Fig. 13) comprising a fluid collecting region (e.g. 22 Fig.13) disposed on the surface of the bendable carrier (e.g. 74 Fig.13) that is attached to the patient’s arm and a surface of the fluid collecting region facing a wearer and teach a hole (e.g. 29 Fig. 13). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the band comprising encapsulated cavities in the teachings of Hsu to include a sensing chip with a hole and test unit in one of the encapsulated cavities as in order to provide the predictable results of allowing for the monitoring and treatment of conditions such as diabetes.
Regarding claims 10-12, Hsu teaches a wearable device (e.g. Abstract, [0025],[0033]), comprising:
a bendable carrier having a surface (e.g. 52 Figs 1,2, [0035]);
an electronic component (e.g. [0052 Fig.2, [0033], [0034]) disposed over the surface of the bendable carrier.
While Hsu teaches a sensing element disposed over the surface of the bendable carrier and configured to detect a biosignal (e.g. [0029], [0057]-[0060],[0070] Fig. 18, [0068]) they do not specifically teach a fluid collecting region disposed on the surface of the bendable carrier and defining an opening; and the sensing element disposed within the opening of the fluid collecting region and a sensing surface of the sensing element is exposed by the fluid collecting region and a coating of the fluid collecting region is directly in contact with a skin of a wearer.
In a similar field of endeavor, Yamashita teaches a wearable device (e.g. Fig. 15) comprising a wristwatch with an analyzer main body 72 and a body fluid collecting chip capable of being attached to the interior of the analyzer main body 72 (e.g. [0183] Fig. 13) comprising a fluid collecting region (e.g. 22 Fig.13) disposed on the surface of the bendable carrier (e.g. 74 Fig.13) that is attached to the patient’s arm and comprising an opening (e.g. Fig. 13, [0182]-[0183]: body fluid collecting chip 22 (considered as the sensor comprising a surface with coating) collects fluid through the opening 29 and the body fluid collecting chip is closer to the surface of the bendable carrier than the analyzer 72). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the encapsulated cavities in the band in the teachings of Hsu to have a sensing chip comprising a hole that collects body fluids and tests the fluids as taught by Yamashita in order to provide the predictable results of allowing for the monitoring and treatment of conditions such as diabetes.
Regarding claims 13-14, Hsu in view of Yamashita teaches the claimed invention as discussed above and Hsu further teaches a high-penetrability region and a low- penetrability region, wherein the bendable carrier has different penetrability at the high- penetrability region and the low-penetrability region (e.g. [0047],[0048]: cavity 70 comprises clear polymer that includes light scattering particles for light diffusion and therefore have higher penetrability than the rest of the band).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent Number: US 12186094. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the of the instant application are anticipated by or obvious over the claims of the current application are directed to a wearable apparatus comprising a bendable carrier having a surface; a first electronic component disposed over the surface of the bendable carrier; a sensing element disposed over the surface of the bendable carrier and configured to detect a biosignal; and an encapsulant defining a space, wherein the space is configured to accommodate the sensing element which is similar to U.S. Patent Number: US 12186094.
Further dependent claims of the current application also recite limitation that are similar to the dependent claims of U.S. Patent Number: US 12186094.
While no prior art rejection has been applied for dependent claims 18-20 they cannot be indicated as allowable due to the double patenting rejection discussed above.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically "the fluid collecting region and the layer include the same material” as claimed in dependent claim 18 and “a hole is aligned with the layer and filled with a porous material” as claimed in claim 19 in combination with the recited structural limitations of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al (U.S. Patent Application Publication Number: US 2019/0226931 A1, hereinafter “Chen”) teaches a wearable device a bendable carrier having a surface ( e.g. Fig.3A); a first electronic component disposed over the surface of the bendable carrier; a sensing element disposed over the surface of the bendable carrier and configured to detect a biosignal; and an encapsulant defining a space, wherein the space is configured to accommodate the sensing element (e.g. Figs.1A,C) .
Baxi et al (U.S. Patent Application Publication Number: US 2016/0157779 A1, hereinafter “Baxi”) teaches a wearable device comprising sensors on a flexible carrier (e.g. Figs.1, 2, 5)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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