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 Amendment
The amendment filed December 26, 2025 has been entered. Claim 1 has been amended. Claims 1-37 remain pending in this application with claims 15-37 standing withdrawn. The amendments to the claims have overcome the rejections under 35 U.S.C. § 112(b) previously submitted in the Non Final Office action mailed September 25, 2025.
Response to Arguments
Applicant’s arguments, see pg. 12, filed December 26, 2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive. The rejection under 35 USC 102 of September 25, 2025 has been withdrawn.
Applicant's arguments filed December 26, 2025 with respect to the rejection of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Examiner notes that many amended limitations in claim 1 were previously recited in the dependent claims. However, the dependent claims have not been amended accordingly and there are redundant limitations and indefiniteness issues with the claims - see the rejections under 35 USC 112 below.
Applicant alleges the cited combination of Jeong and Moein fails to teach via-hole jointless continuous sputter coating, laser-etched trenches defining conductive islands, and insulating layers attached after the trench/island patterning (Remarks pg. 16, section b). However, Applicant does not address the portions of Jeong and Moein cited to teach these limitations. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Jeong teaches the base layer comprises via-holes (via holes 5201a, Fig. 4), the at least one via-hole is coated with a single metal material continuously sputtered without a joint along a top surface of the base layer, inner walls of the at least one via-holes, and a bottom surface of the base layer (“This electrode connection layer (5201b) can be formed by depositing conductive particles…on the inner surface of the via hole (5201a) and the area adjacent thereto through a sputtering process,” underline added, par. 73; Fig. 4 shows that electrode connection layer 5201b comprises continuous material on both surfaces of the base layer and within the via holes 5201a), trenches (the parts of substrate 5201 visible between conductive portions 5202, 5204a can be considered trenches, Fig. 6a) and conductive islands (electrode 5202 and second sensor contact portion 5204a can be considered conductive islands as they are separated from each other on substrate 5201, Fig. 6a) formed in the conductive layer.
Moein teaches an analogous continuous analyte meter (analyte monitoring system 100) comprising: an electrochemical sensor (101) and the electrochemical sensor comprises a flexible base layer (flexible dielectric substrate 501; “the substrate is flexible,” par. 147), a conductive layer applied on the base layer (electrodes 502, 504, 507, Fig. 6), and insulating layers attached on top of the islands and trenches of the conductive layer (dielectric layers 506, 508). Moein teaches that insulating layers cover the conductive layers from the environment (“insulative layers 13 and/or 15, may extend into these spaces thereby covering side edges of conductive layer 12 and 14 respectively,” par. 114) and that electrodes may be formed from a combination of techniques including physical vapor deposition, sputtering, laser ablation and etching (par. 154).
It would be obvious to one of ordinary skill in the art to modify Jeong to comprise insulative layers and use laser-etching to define the islands because those techniques were known in the art and for the advantages indicated in the rejection below. Additionally, in combination, the insulating layers would have to be applied after the trench/island patterning (Jeong’s electrode 5202 and second sensor contact portion 5204a, Fig. 6a) because Moein teaches there is are outermost insulative layers applied over the electrode traces (see insulative layers 24, 25 in Fig. 2; layers 34, 35 in Fig. 3; layers 44, 45 in Fig. 4; dielectric layers 506, 508 in Figs. 12, 14). Applicant has not specifically addressed the teachings of both Jeong and Moein or shown nonobviousness of the combination. Thus, the arguments are unpersuasive.
Regarding claim 3, Applicant alleges Chen’s laser-formed holes are directed to a different purpose rather than a via-hole (Remarks pg. 17, section b). It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Jeong does not explicitly teach how the via holes are formed through the substrate, so one would be motivated to look at known methods for forming holes through a sensor substrate. Although Chen teaches the through holes are for a different purpose in the sensor, Chen’s teachings of laser-formed holes are still relevant as to how a through hole can be made through a sensor substrate.
Regarding the remaining dependent claims, Applicant relies on the same arguments. Since the arguments were not persuasive, the claims are still rejected under Jeong in view of Moein.
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 1-14 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.
Claim 1 recites “the at least one via-hole” in line 15. There is insufficient antecedent basis for this limitation in the claim. It seems “the” should be deleted from the claim.
Claims 3, 5, and 7-11 all recite “via-holes” in line 2 of the claims. Claim 8 recites “via-holes” in line 5. It is unclear whether this via-hole is a different via-hole from the one recited in claim 1 or if it refers to the same via-hole of claim 1. To expedite prosecution, the via-holes of claims 3 and 5 will be interpreted as the same one in claim 1.
Claims 13 and 14 recite “trenches” and “a plurality of conductive islands”. It is unclear whether these limitations are the same as the trenches and conductive islands recited in claim 1 or if they specifically refer to additional elements. To expedite prosecution, they will be interpreted as the same trenches and conductive islands recited in claim 1.
Claims 2, 4, 6, and 12 are rejected by virtue of dependency.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Amended claim 1 includes the same limitations as claim 5. Claim 5 fails to further limit the subject matter of amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-2, 4-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jeong (WO 2021/033863) in view of Moein. Text citations to Jeong refer instead to a machine translation, which is attached to this Office Action.
Regarding claim 1 (see interpretation under the 112b rejections above), Jeong teaches a continuous analyte meter (“a continuous blood glucose measurement device,” par. 44; Fig. 1) comprising:
an electrochemical sensor (520) comprising a distal portion on which a plurality of electrodes (electrodes 5202 and 5204, Fig. 4) configured to react with an in vivo analyte are provided (“The first electrode layer (5202) and the second electrode layer (5204) are configured to function as a working electrode and a counter electrode, respectively, to measure blood sugar information from body fluid,” par. 64), a proximal portion on which sensor pads connected to the electrodes are provided (first sensor contact portion 5202a and second sensor contact portion 5204a, Fig. 4), and an intermediate portion positioned between the distal portion and the proximal portion (see bend in Fig. 4); and
a transmitter (housing 510, Fig. 7) comprising a main substrate (PCB substrate 530) on which at least one of a power source (battery 535) and a communication unit (wireless communication chip 540) is provided and a housing (upper housing 512 and lower housing 511) in which the main substrate is accommodated (Fig. 8), the transmitter being configured to be attached to the skin (“an adhesive tape (560) is attached to the body contact surface of the body attachment unit (20) so that the body attachment unit (20) can be attached to the body,” par. 53),
wherein the distal portion of the electrochemical sensor is provided on a portion exposed in a longitudinal direction of a needle (see inset in Fig. 3);
the distal portion of the electrochemical sensor (sensor probe portion 521) is configured to be inserted into a body after the skin is cut by the needle (“insertion guide needle (550) in configured to be inserted into the body together with the sensor member (520),” par. 58; “a sensor probe portion (521)…that is bent from one side of the sensor body portion (522) and inserted into the body,” par. 77); and
the electrochemical sensor comprises a base layer (substrate 5201) and a conductive layer applied on the base layer (layers 5202 and 5204, Fig. 5),
wherein the base layer comprises via-holes (via holes 5201a, Fig. 4), the at least one via-hole is coated with a single metal material continuously sputtered without a joint along a top surface of the base layer, inner walls of the at least one via-holes, and a bottom surface of the base layer (“This electrode connection layer (5201b) can be formed by depositing conductive particles…on the inner surface of the via hole (5201a) and the area adjacent thereto through a sputtering process,” par. 73; Fig. 4 shows that electrode connection layer 5201b comprises material on both surfaces of the base layer and within the via holes 5201a),
trenches (the parts of substrate 5201 visible between conductive portions 5202, 5204a can be considered trenches, Fig. 6a) and conductive islands (electrode 5202 and second sensor contact portion 5204a can be considered conductive islands as they are separated from each other on substrate 5201, Fig. 6a) formed in the conductive layer.
Jeong teaches all limitations of claim 1 except for a flexible base layer, insulating layers attached on top of the conductive layer after the trenches and conductive islands are formed, the conductive islands being formed by laser etching in which portions of the conductive layer are removed by irradiating the conductive layer with a laser beam.
Moein teaches an analogous continuous analyte meter (analyte monitoring system 100) comprising: an electrochemical sensor (101) and the electrochemical sensor comprises a flexible base layer (flexible dielectric substrate 501; “the substrate is flexible,” par. 147), a conductive layer applied on the base layer (electrodes 502, 504, 507, Fig. 6) and comprising conductive islands and trenches (individual electrode traces may be interpreted as conductive islands, and spacing between them on the substrate can be interpreted as trenches; see spacing between electrodes 502 and 504 in Fig. 11; counter electrode trace 507 forms an island on the substrate, Fig. 13), and insulating layers attached on top of the islands and trenches of the conductive layer (dielectric layers 506, 508). Moein teaches that a flexible substrate may help increase comfort during sensor insertion (“the sensor may be made flexible (although rigid sensors may also be used for implantable sensors) to reduce pain to the user and damage to the tissue caused by the implantation of and/or the wearing of the sensor. A flexible substrate often increases the user's comfort,” par. 147). Moein further teaches that insulating layers cover the conductive layers from the environment (“insulative layers 13 and/or 15, may extend into these spaces thereby covering side edges of conductive layer 12 and 14 respectively,” par. 114). Moein further teaches that electrodes may be formed from a combination of techniques including physical vapor deposition, sputtering, laser ablation and etching (par. 154).
Regarding the flexible base, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong to comprise a flexible base layer. One would be motivated to do so in order to reduce pain and discomfort from wearing the sensor, as taught by Moein (par. 147). Since Moein teaches that rigid and flexible sensors operate similarly (“rigid sensors may also be used for implantable sensors,” par. 147; “ for many sensors and sensor applications, both rigid and flexible sensors will operate adequately,” par. 149), this modification should not affect the function of Jeong’s sensor.
Regarding the insulating layers, it would further be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong to comprise insulating layers on top of the conductive layer including the trenches and conductive islands. One would be motivated to do so because Moein teaches the insulating layers protect portions of the conductive layers from the environment (“secondary conductive material 33A which extend along the side edges of the substrate 31 are not covered by insulative layer 35 and, as such, are exposed to the environment when in operative use,” par. 90). Since Moein teaches various arrangements of conductive and insulative layers in an analyte sensor (Figs. 1-6), then the addition of insulative layers to Jeong should not affect its function.
Regarding the laser etching, It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the conductive layers are first deposited (i.e., sputtered or dip-coated) and then laser ablated to form the trenches and conductive islands. One would be motivated to do so because Moein teaches that these methods were known in the art to create electrodes (par. 154), and one could have substituted different methods to create electrodes on an analyte sensor. Since Jeong in view of Moein suggests that electrodes may be formed through laser ablation, the prior art meets the structure implied by the product-by-process limitations.
Regarding claim 2, Jeong in view of Moein teaches the insulating layers have open areas extending through the insulating layer and are bonded on top of the conductive layer (Moein Fig. 9 show the dielectric layers do not fully cover the conductive traces; dielectric layers can comprise UV curable dielectrics, Moein pars. 103, 105, 107); the electrodes are exposed externally through the open areas (Moein Fig. 5) and the electrodes are provided on both surfaces of the distal portion (Moein Fig. 5).
Regarding claim 4, Jeong teaches the conductive layer comprises layer portions provided on both surfaces of the base layer by sputtering metal on the base layer (“This electrode connection layer (5201b) can be formed by depositing conductive particles…on the inner surface of the via hole (5201a) and the area adjacent thereto through a sputtering process,” par. 73; Fig. 4 shows that electrode connection layer 5201b comprises material on both surfaces of the base layer; “layer portions” as currently recited does not limit the claim to particular areas of the conductive layer). Moein also teaches the conductive layer comprises layer portions provided on both surfaces of the base layer by sputtering metal on the base layer (“Electrodes…may be applied or otherwise processed using any suitable technology, e.g., chemical vapor deposition (CVD), physical vapor deposition, sputtering, reactive sputtering,” par. 154).
Regarding claim 5 (see rejections under 35 USC 112 above), Jeong teaches the base layer comprises via-holes provided in cut portions thereof (via holes 5201a, Fig. 4; Jeong meets all structural limitations of the claimed cut portions since “cut portions” is a product-by-process limitation, and patentability of a product does not depend on its method of production, MPEP § 2113(I)). Jeong further teaches the conductive layer comprises a single metal material continuing along and applied on a top surface of the base layer, surfaces of the via-holes, and a bottom surface of the base layer without a joint (“This electrode connection layer (5201b) can be formed by depositing conductive particles…on the inner surface of the via hole (5201a) and the area adjacent thereto through a sputtering process,” par. 73; Fig. 4 shows that electrode connection layer 5201b comprises material on both surfaces of the base layer and within the via holes 5201a). “Comprises” is open-ended, so “the conductive layer comprises” is interpreted as not excluding additional elements. Thus, the conductive layer may comprise a single metal material in addition to other elements. “Top surface” and “bottom surface” recited in the claim encompass any portion of surfaces of the base layer, so the sputtered metal on the top surface, via holes, and bottom surface in the electrode connection layer 5201b meet the claim limitation of a single metal material continuing along and applied on top and bottom surfaces of the base layer and the surfaces of the via-holes without a joint.
Additionally, following a narrower interpretation that the conductive layer must continue along a larger extent of the top and bottom surfaces, Moein teaches that electrodes may be formed through sputtering and may be made of metals such as Au and Ag (par. 154). It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the electrode layers 5202 and 5204 of Jeong are made via sputtered gold or silver. One would be motivated to do so because Moein teaches that sputtering metal was known in the art to create electrodes (par. 154), and one could have substituted one technology for another to create electrodes on an analyte sensor. With this modification, the electrodes 5202, 5204, and electrode connection layer 5201b of Jeong’s Fig. 4 would all be created from the same sputtered metal material without any joints.
Regarding claim 6, Jeong teaches an electrical contact of the PCB substrate contacts the sensor (“An electrical contact (531) is formed on the PCB substrate (530) to be electrically connected to the sensor member (520),” par. 89). Jeong does not teach the sensor pads are all in the same direction. Moein teaches the sensor pads are provided only on one surface of the proximal portion (single sided analyte sensor embodiment, pars. 79-81); all of the sensor pads and the contact pads are exposed in a single direction and the sensor pads are electrically connected to the contact pads while facing the contact pads (Fig. 16A; in single-sided analyte sensor embodiments, the rivet may only physically connect the analyte sensor and the electronics unit, thus, it follows that the analyte sensor may directly electrically connect to the electronics unit, par. 82; “the proximal end of the analyte sensor 913 including the electrode contacts is positioned in a facing relationship relative to the plane of PCB assembly 906,” par. 185).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein to comprise sensor pads exposed in the same direction of contact pads on the transmitter, with the sensor pads on the proximal portion. One would be motivated to do so because single-sided analyte sensors were known in the art as an alternative to double-sided sensors, as taught by Moein (“Embodiments of the present disclosure relate to analyte detection/monitoring systems and devices which utilize analyte sensors including single-sided and double-sided analyte sensors,” par. 59; “one or more electrodes may be provided on the same side of the insulative base substrate in either a layered or co-planar manner,” par. 80).
Regarding claim 7 (see rejections under 35 USC 112 above), Jeong teaches the base layer comprises via-holes extending therethrough (via holes 5201a, Fig. 4); the conductive layer comprises layer portions applied on both surfaces of the base layer to be electrically connected to each other through the via-holes (“the second electrode layer (5204) formed on the other surface of the substrate (5201) is connected to the second sensor contact portion (5204a) formed on one surface of the substrate (5201) through the electrode connection layer (5201b),” par. 82); and the via-holes are provided on at least one of the proximal portion, the intermediate portion, and the distal portion (Figs. 4-5 show the via holes are provided on a proximal portion).
Regarding claim 8 (see rejections under 35 USC 112 above), Jeong teaches the conductive layer comprises a plurality of conductive islands separated from each other (electrode 5202, electrode 5204, and second sensor contact portion 5204a can be considered conductive islands as they are separated from each other on substrate 5201, Fig. 6a), the base layer comprises via-holes extending therethrough (via holes 5201a, Fig. 4); and a first conductive island (electrode 5204) among the plurality of conductive islands provided on one surface of the base layer and a second conductive island (second sensor contact portion 5204a) among the plurality of conductive islands provided on the other surface of the base layer are electrically connected through the via-holes (“the second electrode layer (5204) formed on the other surface of the substrate (5201) is connected to the second sensor contact portion (5204a) formed on one surface of the substrate (5201) through the electrode connection layer (5201b),” par. 82). Jeong does not explicitly teach or suggest the conductive islands being separated from each other by laser etching in which portions of the conductive layer are removed with a laser beam projected on the conductive layer and instead teaches that the conductive layer is printed (par. 74). Moein teaches that electrodes may be formed from a combination of techniques including physical vapor deposition, laser ablation, and etching (par. 154).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the conductive layers are first deposited (i.e., sputtered or dip-coated) and then laser ablated to form the electrodes. One would be motivated to do so because Moein teaches that these methods were known in the art to create electrodes (par. 154), and one could have substituted different methods to create electrodes on an analyte sensor. Since Jeong in view of Moein suggests that electrodes may be formed through laser ablation, the prior art meets the structure implied by the product-by-process limitations.
Regarding claim 10 (see rejections under 35 USC 112 above), Jeong teaches the proximal portion comprises via-holes extending therethrough (via holes 5201a, Fig. 4); the electrodes comprise a first electrode provided on a first surface of the distal portion to be exposed in a first direction (electrode 5202, Fig. 6a) and a second electrode provided on a second surface of the distal portion to be exposed in a second direction (electrode 5204, Fig. 6b); the first direction and the second direction are opposite each other (Fig. 5); all of the sensor pads are provided on the first surface of the proximal portion to be exposed in the first direction (Figs. 5-6 shows sensor contact pads 5202a and 5204a are on the same side of the sensor); and the second electrodes on the second surface are electrically connected to the sensor pads on the first surface in a one-to-one correspondence manner through the via-holes (“the second electrode layer (5204) formed on the other surface of the substrate (5201) is connected to the second sensor contact portion (5204a) formed on one surface of the substrate (5201) through the electrode connection layer (5201b),” par. 82).
While Jeong does not explicitly teach plural first electrodes on the first surface and plural second electrodes on the second surface, Moein teaches that analyte sensors may comprise more electrodes placed either side by side on a surface or layered (“a sensor may have some electrodes side by side on a substrate surface, and at least one other electrode on the opposing side of the substrate which may be side by side if more than one or layered one on top of the other on the opposing substrate surface, or a combination thereof,” par. 59; “a different number of electrodes may be provided than depicted in FIGS. 2-4 by adjusting the number of conductive and insulative layers. For example, a 3 or four electrode sensor may be provided,” par. 92).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein to comprise additional electrodes on each surface of the sensor substrate. One would be motivated to do so in order to have additional working, counter, or reference electrodes in the sensor, as suggested by Moein (“one or more working electrodes, counter electrodes…reference electrodes…may be attached to individual conductive contacts,” par. 179). Additionally, different electrode configurations were known in the art, as taught by Moein (pars. 59, 92). This modification could be carried out successfully as Moein indicates it is within the ordinary skill in the art (“one of skill in the art will readily understand that this embodiment may be adjusted to accommodate analyte sensors having any of a variety of electrode configurations,” par. 110).
Regarding claim 12, Jeong teaches a plurality of leads provided on the intermediate portion to connect the electrodes and the sensor pads (the conductive layers 5202, 5204 on probe portion 521 can be considered two leads, Figs. 5-6); and the leads are arranged such that each one of the leads does not cross or is twisted with another one of the leads (the conductive layers 5202, 5204 do not intersect or cross each other since they are on opposite surfaces of the substrate, Figs. 5-6). Jeong does not explicitly teach or suggest the plurality of leads are provided by laser etching in which portions of the conductive layer are removed with a laser beam projected on the conductive layer and instead teaches that the conductive layer is printed (par. 74). Moein teaches that electrodes may be formed from a combination of techniques including physical vapor deposition, laser ablation and etching (par. 154).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the conductive layers are first deposited (i.e., sputtered or dip-coated) and then laser ablated to form the electrodes. One would be motivated to do so because Moein teaches that these methods were known in the art to create electrodes (par. 154), and one could have substituted different methods to create electrodes on an analyte sensor. Since Jeong in view of Moein suggests that electrodes may be formed through laser ablation, the prior art meets the structure implied by the product-by-process limitations.
Regarding claim 13 (see rejections under 35 USC 112 above), Jeong teaches the conductive layer comprises trenches therein (the parts of substrate 5201 visible between conductive portions 5202, 5204a can be considered trenches, Fig. 6a), the conductive layer comprises a plurality of conductive islands separated from each other by the trenches (electrode 5202 and second sensor contact portion 5204a can be considered conductive islands as they are separated from each other on substrate 5201, Fig. 6a); and the plurality of conductive islands share the trenches positioned between the plurality of conductive islands (Fig. 6a). Jeong does not explicitly teach or suggest the trenches being provided in portions of the conductive layer removed by laser etching in which a laser beam is projected on the portions of the conductive layer and instead teaches that the conductive layer is printed (par. 74). Moein teaches that electrodes may be formed from a combination of techniques including physical vapor deposition, laser ablation and etching (par. 154).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the conductive layers are first deposited (i.e., sputtered or dip-coated) and then laser ablated to form the electrodes. One would be motivated to do so because Moein teaches that these methods were known in the art to create electrodes (par. 154), and one could have substituted different methods to create electrodes on an analyte sensor. Since Jeong in view of Moein suggests that electrodes may be formed through laser ablation, the prior art meets the structure implied by the product-by-process limitations.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jeong in view of Moein as applied to claim 1 above, and further in view of Chen (US 2019/0290170).
Regarding claim 3 (see rejections under 35 USC 112 above), Jeong teaches the base layer comprises via-holes (via holes 5201a, Fig. 4) extending therethrough but does not explicitly teach or suggest the via-holes are provided by removing portions of the base layer by laser etching in which the portions of the base layer are irradiated with a laser beam. Chen teaches an analogous continuous analyte sensor (Abstract). Chen teaches a through hole (9, 91, or 92 in Figs. 2-4) in the sensor base layer (electrode matrix 1, Fig. 1A) can be formed by laser etching the base layer (“Making a through hole (9) by laser on the surface of the set electrode working area to form a working area, and setting the pore size at 0.12 mm,” par. 70).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that vias are formed through laser etching. Since Jeong does not explicitly teach how the via holes are formed, one would be motivated to look at known methods in the prior art, such as laser etching taught by Chen. Chen further teaches that the through holes formed in this process can be different sizes (through hole 9 has a pore size of 0.12 mm, par. 70; Fig. 3 shows a larger rectangular hole 91), thus this method should successfully create a through hole sized for an electrical via. Since Jeong in view of Moein and Chen suggests that vias may be formed using a laser, the prior art meets the structure implied by the product-by-process limitations.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jeong in view of Moein as applied to claim 1 above, and further in view of Achmann (WO 2014/001382).
Regarding claim 9 (see rejections under 35 USC 112 above), Jeong teaches the base layer comprises via-holes (via holes 5201a) extending therethrough; the via-holes comprise a first via-hole and a second via- hole (Fig. 4 shows 3 via-holes). Jeong teaches at least one end of the second via-hole is exposed externally (Fig. 4). Moein teaches dielectric layers (dielectric layers 503, 506, 508) over the conductive layers (electrodes 502, 504, 507, Fig. 6), but Jeong and Moein do not explicitly teach or suggest the first via-hole is blocked from outside by the insulating layers. Achmann teaches an analogous electrochemical analyte sensor (Abstract). Achmann teaches a double-sided sensor embodiment (Fig. 7) comprising a base layer (substrate 112), a conductive layer (contact pad 150 and electrodes 146, 114, 116), an insulating layer over the conductive layer (insulating layers 130, 132); and vias (“one or more vias 156,” pg. 34, line 23) through the base layer, where the via may be blocked from outside by the insulating layers (Fig. 7).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the insulating layers block both sides of a via. One would be motivated to do so because such a structure is known in the art, as shown by Achmann Fig. 7, and Achmann teaches this reduces the complexity of the sensor (“the layer setup may significantly be simplified in terms of complexity,” pg. 34, lines 23-24). Jeong in view of Moein may be improved in the same way and would only require applying a dielectric layer, as taught by Moein and Achmann, over a via hole. Since Jeong teaches that the electrode connection layer 5201b connects electrode portions on the sensor substrate (“the second electrode layer (5204) formed on the other surface of the substrate (5201) is connected to the second sensor contact portion (5204a) formed on one surface of the substrate (5201) through the electrode connection layer (5201b),” par. 82) and does not directly contact the transmitter, blocking a first via-hole using the insulating layers would not affect the internal connections in electrode connection layer 5201b.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jeong in view of Moein as applied to claim 1 above, and further in view of Peterson (US 2020/0015720).
Regarding claim 11 (see rejections under 35 USC 112 above), Jeong teaches the base layer comprises via-holes (via holes 5201a) extending therethrough; the electrodes comprise a first electrode (5202) provided on a first surface of the distal portion to be exposed in a first direction (Fig. 6a) and a second electrode provided (5204) on a second surface of the distal portion to be exposed in a second direction opposite the first direction (Fig. 6b). Jeong teaches electrodes 5202 and 5240 are working and counter electrodes (par. 64). Jeong and Moein do not explicitly teach or suggest the via-holes are on the distal portion of the sensor; the first electrodes and the second electrodes are electrically connected through the via-holes; and the first electrodes and the second electrodes are electrodes of a single type selected from among a working electrode, a reference electrode, and a counter electrode.
While Jeong does not explicitly teach plural first electrodes on the first surface and plural second electrodes on the second surface, Moein teaches that analyte sensors may comprise more electrodes placed either side by side on a surface or layered (“a sensor may have some electrodes side by side on a substrate surface, and at least one other electrode on the opposing side of the substrate which may be side by side if more than one or layered one on top of the other on the opposing substrate surface, or a combination thereof,” par. 59; “a different number of electrodes may be provided than depicted in FIGS. 2-4 by adjusting the number of conductive and insulative layers. For example, a 3 or four electrode sensor may be provided,” par. 92).
Regarding the first and second electrodes electrically connected through the via-holes on a distal portion and being of the same type, Peterson teaches an analogous electrochemical analyte sensor (Figs. 42-50) comprising a distal portion (end comprising pads 526, 562, Figs.44-49) with first electrodes (contact pads 526a2, 526b, Fig. 46) on a first surface and second electrodes (contact pads 562b, 562d, Fig. 49) on a second surface (Fig. 50 shows a cross section of a via hole and shows that conductive layers are on opposite sides of middle layer substrate 552) and a proximal portion (end comprising contact pads 520, 564, Figs. 44-49). Peterson further teaches the via-holes are on the distal portion of the sensor (vias 564c and 564d, Fig. 49); the first electrodes and the second electrodes are electrically connected through the via-holes (“opening 564c at with contact pad 562b (e.g., for blank electrode 133) having electrical continuity to base metallized layer 520 at contact pad 526b… opening 564d with contact pad 562d having electrical continuity with contact pad 526a2,” par. 204), and the first electrodes and the second electrodes are electrodes of a single type selected from among a working electrode, a reference electrode, and a counter electrode (contact pad 562b and 526b correspond to working electrode 133 and contact pads 526a2 and 564d correspond to working electrode 130, Fig. 42; par. 191).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein to comprise additional electrodes of the same kind on each surface of the sensor substrate, with the same electrodes connected by a via. One would be motivated to do so in order to have additional working, counter, or reference electrodes in the sensor, as suggested by Moein (“one or more working electrodes, counter electrodes…reference electrodes…may be attached to individual conductive contacts,” par. 179) and Peterson’s working electrodes 130 and 133. Additionally, different electrode configurations were known in the art, as taught by Moein paragraphs 59 and 92 of Moein and Figs. 42-49 of Peterson. This modification could be carried out successfully as Moein indicates it is within the ordinary skill in the art (“one of skill in the art will readily understand that this embodiment may be adjusted to accommodate analyte sensors having any of a variety of electrode configurations,” par. 110).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jeong in view of Moein as applied to claim 1 above, and further in view of Reggiardo (US 2007/0135697) and Halac (US 2019/0120785).
Regarding claim 14 (see rejections under 35 USC 112 above), Jeong teaches the conductive layer comprises trenches therein (the parts of substrate 5201 visible between conductive portions 5202, 5204a can be considered trenches, Fig. 6a); the conductive layer comprises conductive islands, wherein the electrodes and the sensor pads are provided in the conductive islands (electrode 5202, 5204 and second sensor contact portion 5204a can be considered conductive islands as they are separated from each other on substrate 5201, Fig. 6a). Jeong does not explicitly teach or suggest the trenches being provided in portions of the conductive layer removed by laser etching in which a laser beam is projected on the portions of the conductive layer; a dummy portion divided by the trenches, and the dummy portion is entirely covered with the insulating layers so as not to be exposed externally; and the dummy portion and at least one trench among the trenches are provided between the conductive islands.
Regarding the laser etching, Moein teaches that electrodes may be formed from a combination of techniques including physical vapor deposition, laser ablation and etching (par. 154).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein such that the conductive layers are first deposited (i.e., sputtered or dip-coated) and then laser ablated to form the trenches and conductive islands. One would be motivated to do so because Moein teaches that these methods were known in the art to create electrodes (par. 154), and one could have substituted different methods to create electrodes on an analyte sensor. Since Jeong in view of Moein suggests that electrodes may be formed through laser ablation, the prior art meets the structure implied by the product-by-process limitations.
Jeong in view of Moein still does not teach or suggest a dummy portion divided by the trenches, the dummy portion is entirely covered with the insulating layers so as not to be exposed externally; and the dummy portion and at least one trench among the trenches are provided between the conductive islands. Reggiardo teaches an analogous continuous analyte monitor (“continuous glucose monitoring systems,” par. 3) with a dummy portion (guard trace 502) divided by trenches formed in the conductive layer (areas between the electrodes 502, 503, and 504, Fig. 5A), the dummy portion is partially covered with an insulating layer (dielectric layer 507, Fig. 5B), and the dummy portion and at least one trench are provided between the conductive islands (guard trace 502 and portions of dielectric layer 507 are disposed between electrodes 503 and 504, Fig. 5A). Reggiardo teaches a dummy portion (guard trace 502) protects the working electrode from leakage currents (“current leakage path to the work electrode from any of the other electrodes (such as reference and/or counter electrodes) in the sensor configuration, may be protected by the guard contact,” par. 7). Halac teaches an analogous analyte sensor (Figs. 4A-4C) with a guard trace 407 and a solder mask 780 over the guard trace “to eliminate the risk of the analyte sensor electrodes shorting to it” (par. 253; Fig. 15A)
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Jeong in view of Moein to comprise a dummy portion covered by an insulating layer between the conductive islands. One would be motivated to do so in order to reduce leakage currents at the working electrode, as taught by Reggiardo (pars. 7-9). While Reggiardo and Halac only demonstrate portions of guard trace covered by an insulating layer (Reggiardo Fig. 5B and Halac), it would further be obvious to try to fully cover the dummy portion in order to eliminate risk of the sensor electrodes shorting to the guard trace, as suggested by Halac paragraph 253. Thus, Jeong in view of Moein, Reggiardo, and Halac teach or suggest all limitations of claim 14.
Conclusion
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.
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/ALICE LING ZOU/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791