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 .
Applicant' s arguments, filed 11/17/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicants have amended their claims, filed 11/17/2025.
Claims 1-3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, 38, 55, and 57 are the current claims hereby under examination, with claims 56 and 58 having been canceled.
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 22, 28, and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 22 recites “proximate a distal end” in line 5 and “proximate a tip” in line 6, but it is unclear how these two limitations differ since the distal end is the tip, rendering this claim indefinite. The examiner is interpreting these to be the same limitation.
Claim 22 recites “a tip” in line 6, but it is not clear if this recitation is the same as or different from “a tip” of claim 22, line 4. The Examiner is interpreting that they could be the same or different tip.
Claim 28 recites “analytes” in line 5, “one or more analytes” in line 6, “analytes” in line 7, “at least some analytes” in line 12 , “at least some analytes” in line 13, “analytes” in line 16, “different analytes” in line 17, “different combination of analytes” in line 18, “analytes” in line 19, “at least one analytes” in line 23, and “at least one analyte” in line 24, but it is not clear if any of these recitations are the same as or different from each other or “analytes” in claim 28, line 4. The Examiner is interpreting that they can be the same or different analytes.
Claim 28 recites “at least one substance” in line 11, “at least one substance” in line 21, and “at least one substance” in line 22, but it is not clear if any of these recitations are the same as or different from each other or “at least one substance” in claim 28, line 10. The Examiner is interpreting that they can be the same or different substances.
Claim 35 recites “analytes” in line 4, but it is not clear if this recitation is the same as or different from “analytes” in claim 35, line 3. The Examiner is interpreting that they can be the same or different analytes.
Claim 35 recites “at least one substance” in line 11 and “at least one substance” in line 23 but it is not clear if this recitation is the same as or different from “at least one substance” in claim 35, line 10. The Examiner is interpreting that they can be the same or different substances.
Claim 35 recites “a material” in line 21 and “a material” in line 22, but it is not clear if this recitation is the same as or different from “a material” in claim 35, line 19. The Examiner is interpreting that it can be the same or different material.
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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, and 38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 9, 11-12, and 14 of U.S. Patent No. US12048558B2, hereto referred to as Reference 1, and in view of Gill et al. (US 20140170299 A1), hereto referred as Gill, and further in view of Patolsky et al. (US 20190223795 A1), hereto referred as Patolsky, and in further view of Negi et al. (US 20170007813 A1), hereto referred as Negi.
The analysis as follows (please note the bolded and underlined portions of the entries under the Instant Application, IA, are those portions of the IA claims that the claims of Patent US12048558B2, Reference 1, does not have or are different from in some form):
Claim Element (Instant Application, IA)
Reference 1 (US12048558B2)
Analysis
Claim 1: "An electrode arrangement for use with a system for performing measurements on a biological subject, the electrode arrangement including:"
"a) a substrate; and"
"b) a plurality of plate microstructures extending from the substrate,"
"the plurality of plate microstructures being configured to breach the stratum corneum of the biological subject"
“and wherein each of the plurality of plate microstructures include a substantially planar face having an electrode thereon”
“to allow electrical stimulatory signals to be applied to and electrical response signals to be received from the biological subject via the plurality of plate microstructures,
wherein each of the plurality of plate microstructures includes a conductive material, wherein the electrode of each of the plurality of plate microstructures is defined, at least in part, by an insulating coating extending over only a part of a surface of the microstructure, so that an uncoated part of the microstructure acts as the electrode,
wherein at least some of the plurality of plate microstructures are arranged in groups,
wherein each group is a pair of spaced apart microstructures having electrodes in opposition, and wherein at least some of the electrical stimulatory signals are applied between microstructures in a pair;
wherein the substrate includes electrical connections to allow the electrical stimulatory signals to be applied to, and the electrical response signals received from, respective plate microstructures in the pair;
Claim 1: "A system for performing fluid level measurements on a biological subject, the system including:"
Claim 1, Element (a): "at least one substrate"
Claim 1, Element (a): "a plurality of microstructures"
Claim 1, Element (a): "microstructures configured to breach a stratum corneum of the biological subject"
Claim 1, Element (a): "at least some microstructures including an electrode…";
Claim 1, Element (c): "a signal generator operatively connected...to apply an electrical stimulatory signal";
Claim 1, Element (b): "at least one sensor...configured to measure electrical response signals between microstructures"
Claim 1, Element (a): "microstructures are conductive";
Claim 1, Element (a):
“include an insulating layer extending over an end of the microstructure proximate the substrate so that at least a tip portion of the microstructure is uncoated and acts as the electrode”
Claim 2, Element (b, c, d, e):
“pairs of microstructures are orthogonally arranged… arranged in rows… orthogonally arranged relative to pairs…”
Claim 1, Element (b):
“wherein microstructures in the at least one microstructure pair each have respective electrodes in opposition from one microstructure and another microstructure, and wherein the electrical stimulatory signal generates an electric field between the respective electrodes”
Both the IA and Reference 1 describe a system for use with a biological subject, but the IA focuses on an electrode arrangement, while Reference 1 focuses on a broader system.
Both the IA and Reference 1 mention a substrate. However, Reference 1 includes microstructures in conjunction with the substrate, a level of detail that is absent in the IA.
IA specifies "plate" microstructures, whereas the Reference 1 does not include this detail. However, Gill who investigates a similar art of making coated microstructures that can be adapted with biosensors including electrodes, has microstructures that have a plate form (Gill, Fig. 3D). It would have been prima
facie obvious to one of ordinary skill in the art before the effective filing date of the claimed
invention to have modified Reference 1 in view of Gill to specify that the microstructures are plate microstructures. As show in Gill, these planar microstructures can be cut from a metal sheet using a laser (Gill, ¶[0051]), which has the benefit of a fast and easy manufacturing process.
Both claims describe microstructures configured to breach the stratum corneum, showing similar functionality.
Both claims discuss electrodes associated with microstructures and signal application/measurement. Reference 1 includes additional details regarding the signal generator and sensor (could be electrodes) for applying and measuring signals, whereas IA only mentions ‘electrodes to allow ‘electrical stimulatory signals’ and ‘electrical response signals’.
Both discuss grouping electrodes into pairs that are in opposition such that the signals are applied between these paired groups.
IA specifies "the substrate includes electrical connections", whereas Reference 1 does not include this detail. However, Patolsky expressly teaches electrodes on needles that are connected by conductors on the substrate (Patolsky, [0141]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed
invention to have modified Reference 1 in view of Patolsky to have electrical connections on the substrate.
and wherein the electrical connections are conductive tracks provided on the surface of the substrate; an insulating layer is provided on the surface of the substrate to cover the conductive tracks, so that the conductive tracks do not make electrical contact with skin of the biological subject.
IA specifies "electrical connections" are “tracks” located and the surface of the substrate covered by an insulating layer to electrically insulate against the skin, whereas Reference 1 does not include this detail. Negi teaches that conductive traces run along the microneedles and across the surface of the substrate, and that an insulating coating is applied over those traces such that the traces are covered and not exposed to the environment (Negi, FIGS. 10H–10I; [0062]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the modified Ref 1 in view of Negi to have the electrical connections/traces that are on the surface of the substrate covered in insulation as to not make contact with the environment/skin.
Claim 3: "An electrode arrangement according to claim 1, wherein the insulating coating extending over at least one of:
(a) a proximal end of the microstructure;
(b) at least half of a length of the microstructure;
(c) 60 μm, 90 μm or 150 μm of a proximal end of the microstructure; and
(e) at least part of a tip portion of the microstructure."
Claim 1, Element (a): "microstructures are conductive and include an insulating layer extending over an end of the microstructure"
Claim 11: “A system according to claim 1, the insulating layer extending over at least one of:
b) about 90 μm of a proximal end of the microstructure; and,
a) at least half of a length of the microstructure;
b) about 90 μm of a proximal end of the microstructure; and,
c) at least part of a tip portion of the microstructure.”
Both the IA and the combination of Reference 1 and Gill mention conductive microstructures with an insulation extending over a portion of the microstructure.
The IA states the insulation is a coating, while Reference 1 uses the language of “layer”. However, the specification of Reference 1 indicates that the word layer is synonymous with coating as it states “this allows the blade to be partially covered with an insulative coating” (Reference 1, ¶[0328]).
Claim 3 of the IA provides a combination of limitations. Where the IA provides additional optional limitations regarding insulation locations as indicated. However, Reference 1 only needs to teach one of these limitation options, to which claim 11 of Reference 1 includes some of those options.
Claim 5: "An electrode arrangement according to claim 1, wherein
the electrical response signals are measured between the microstructures in the group"
Claim 1, Element (b): “the at least one microstructure pair”
Claim 1, Element (c): "at least one sensor...configured to measure electrical response signals between microstructures in the pair"
Both IA and the combination of Reference 1 and Gill mention applying electrical stimulation signals and measuring response signals between microstructures with the language differing between “arranged in groups” vs “pairs”, and groups at least include a pair.
Claim 6: "An electrode arrangement according to claim 5, wherein one of:
(a) the group is the pair of the microstructures including spaced apart plate microstructures having planar electrodes in opposition; and
(b) the group is a pair of the microstructures including spaced apart plate microstructures having planar electrodes in opposition and at least one of: (i) at least some pairs of the microstructures are angularly offset;
(ii) at least some pairs of the microstructures are orthogonally arranged;
(iii) adjacent pairs of the microstructures are orthogonally arranged;
(iv) pairs the of microstructures are arranged in rows, and the pairs of microstructures in one row are angularly offset relative to pairs of microstructures in other rows;
(v) pairs of the microstructures are arranged in rows, and the pairs of the microstructures in one row are orthogonally arranged relative to pairs of the microstructures in other rows."
see above, IA claim 5 vs Reference 1 Claim 1
Claim 1, Element (b): “microstructures in the at least one microstructure pair each have respective electrodes in opposition from one microstructure and another microstructure”
Claim 2:
“a) at least some pairs of microstructures are angularly offset;
b) at least some pairs of microstructures are orthogonally arranged;
c)adjacent pairs of microstructures are orthogonally arranged;
d) pairs of microstructures are arranged in rows, and the pairs of microstructures in one row are angularly offset relative to pairs of microstructures in other rows;
e) pairs of microstructures are arranged in rows, and the pairs of microstructures in one row are orthogonally arranged relative to pairs of microstructures in other rows.”
Both the IA and the combination of the modified Ref 1 Reference 1 and Gill have electrodes in opposition with corresponding limitations.
Claim 8: “An electrode arrangement according to claim 1, wherein at least one of:
a) a spacing between the electrodes in each group are at least one of: i) less than 10 mm; ii) less than 1 mm; iii) 0.1 mm; and, iv) more than 10 µm; and
b) a spacing between groups of microstructures is at least one of: i) less than 50 mm; ii) more than 20 mm; iii) less than 20 mm; iv) less than 10 mm; v) more than 10 mm; vi) less than 1 mm; vii) more than 1 mm; viii) 0.5 mm; and, ix) more than 0.2 mm.”
Claim 3: “A system according to claim 1, wherein:
a) a spacing between the plurality of microstructures is at least one of: i) less than 1 mm; ii) about 0.5 mm; iii) about 0.2 mm; iv) about 0.1 mm; and, v) more than 10 μm; and,
b) a spacing between pairs of microstructures is at least one of: i) less than 1 mm; ii) about 0.5 mm; and, iii) more than 0.2 mm.”
Both IA and the combination of modified Reference 1 and Gill as shown in the sections for the IA claims 1 and, as well as claim 3 of the Reference 1
Where according to Claim 1 of the Reference 1, the microstructures contain electrodes, thus the spacing of the microstructures is also the spacing of the electrodes. The IA has an extra optional electrode spacing of “less than 10 mm”.
There is also a difference in language between “groups” and “pairs”, where groups at least include a pair.
Claim 8 of the IA provides a combination of optional electrode/microstructure spacings as limitations with more options as indicated. However, the modified Reference 1 only needs to teach one, to which claim 3 of Reference 1 includes some of those options.
Claim 9: "An electrode arrangement according to claim 1, wherein at least one of:
(a) the electrodes are configured to be operatively connected to at least one of: (i) at least one sensor operatively configured to measure electrical response signals from at least one of the microstructures; and, (ii) a signal generator configured to apply an electrical stimulatory signals to the at least one of the microstructures; and
(b) the electrodes are configured to be connected to one or more switches for selectively connecting at least one of the at least one sensor and the at least one signal generator to the electrodes."
Claim 1, Element (c): “microstructures including an electrode”
Claim 1, Element (c): "at least one sensor operatively connected to the at least one microstructure pair, the at least one sensor being configured to measure electrical response signals";
Claim 1, Element (c): "a signal generator operatively connected...to apply an electrical stimulatory signal";
Claim 9: "one or more switches for selectively connecting at least one sensor and signal generator to the microstructures"
Both IA and the combination of the modified Reference 1 and Gill describe connections for applying and measuring signals through electrodes and sensors. The Reference 1 also mentions the use of switches, similar to the IA.
Claim 17: "A system according to claim 1, wherein at least some of the microstructures include at least one of:
(a) a shoulder that is configured to abut against the stratum corneum to control a depth of penetration; and
(b) a shaft extending from the shoulder to a tip, the shaft being configured to control a position of the tip in the subject."
Claim 1, Element (a): "wherein at least some of the microstructures include a shoulder that is configured to abut against the stratum corneum to control a depth of penetration"
Claim 6, Element (a): “a shaft extending from a shoulder to the tip, the shaft being configured to control a position of the tip in the subject”
Both IA and the combination of the modified Reference 1 and Gill mention a shoulder feature on the microstructures to control penetration depth. Both also mentions a shaft extending from the shoulder.
Claim 20: "An electrode arrangement according to claim 1, wherein at least some of microstructures include at least part of an active sensor."
Claim 1, Element (c): "at least one sensor operatively connected"
Both IA and the combination of the modified Reference 1 and Gill mention a sensor associated with the microstructures. However, IA specifies an "active sensor," which implies functionality beyond what is explicitly described in Reference 1. However, Gill describes both passive and active sensors as potentially being part of the microstructures, where “heat, electricity, light or other energy forms may be precisely transmitted to directly stimulate, damage, or heal a specific tissue or for diagnostic purposes”, showing the sensors to be active sensors (Gill, ¶[0114]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Reference 1 in view of Gill to specify that the sensor may be an active sensor. As previously stated, this has the benefits of being able to “directly stimulate, damage, or heal a specific tissue or for diagnostic purposes” (Gill, ¶[0114]).
Claim 22: "A system according to claim 1, wherein the plurality of electrodes at least one of:
(a) extends over a length of a distal portion of the microstructure;
(b) extends over a length of a portion of the microstructure spaced from a tip;
(c) is positioned proximate a distal end of the microstructure;
(d) is positioned proximate a tip of the microstructure;
(e) extends over at least 25% of a length of the microstructure;
(f) extends over less than 50% of a length of the microstructure;
(g) extends over 60 µm, 90 µm or 150 µm of the microstructure;
(h) is configured to be positioned in a viable epidermis of the subject in use; and
(i) has a surface area of at least one of: i) less than 200,000 μm2; ii) about 22,500 μm2; iii) at least 10 mm2; iv) at least 1 mm2; v) at least 100,000 μm2; vi) at least 10,000 μm2; vii) at least 7,500 μm2; viii) at least 5,000 μm2; ix) at least 2,000 μm2; x) at least 1,000 μm2; xi) at least 500 μm2; xii) at least 100 μm2; and xiii) at least 10 μm2."
Claim 12: "A system according to claim 1, wherein at least one planar electrode has at least one of:
b) extends over a length of a distal portion of the microstructure;
c) extends over a length of a portion of the microstructure spaced from the tip;
d) is positioned proximate a distal end of the microstructure;
e) is positioned proximate a tip of the microstructure;
f) extends over at least 25% of a length of the microstructure;
g) extends over less than 50% of a length of the microstructure;
h) extends over about 60 μm of the microstructure; and,
i) is configured to be positioned in a viable epidermis of the subject in use.
a) has a surface area of at least one of: i) less than 200,000 μm.2; ii) about 22,500 μm; iii) at least 2,000 μm;
Where electrodes of both are described as either planer or being part of a planar structure.
Both IA and the combination of the modified Reference 1 and Gill describe the positioning and surface area of electrodes. Claim 3 of the IA provides a combination of limitations. Where the IA provides more details on the specific positioning and extent of coverage in optional elements (g) and (i) as shown. However, the modified Reference 1 only needs to teach one of these limitation options, to which claim 11 of Reference 1 includes some of those options.
Claim 24: "An electrode arrangement according to claim 1, wherein the plurality of electrodes at least one of:
(a) has a width that is at least one of:
i) less than 50000 μm;
ii) less than 40000 μm;
iii) less than 30000 μm;
iv) less than 20000 μm;
v) less than 10000 μm;
vi) less than 1000 μm;
vii) at least 500 μm;
viii) at least 200 μm;
ix) at least 100 μm;
x) at least 75 μm;
xi) at least 50 μm;
xii) at least 20 μm;
xiii) at least 10 μm; and
xiv) at least 1 μm;
(b) has a height that is at least one of:
i) up to 2500 μm
ii) at least 500 μm;
iii) at least 200 μm;
iv) at least 100 μm;
v) at least 75 μm;
vi) at least 50 μm;
vii) at least 20 μm;
viii) at least 10 μm; and,
ix) at least 1 μm."
Claim 4: A system according to claim 1…wherein at least some of the plurality of microstructures at least one of:
c) have a maximum width that is at least one of:
i) about the same order of magnitude to the length;
ii) greater than the length;
iii) about the same as the length;
iv) less than 300 μm;
v) about 150 μm; and,
vi) greater than 50 μm; and,
b) have a length that is at least one of:
i) less than 300 μm;
ii) about 150 μm;
iii) greater than 100 μm; and,
iv) greater than 50 μm;
Where the microstructure acts as an electrode according to claim 1 of the modified Reference 1.
The term maximum in modified Reference 1 does not alter the limitations in a meaningful way as compared to the IA.
Both the IA and the combination of the modified Reference 1 and Gill have optional width limitations covering an infinite range, and thus cover the same structural dimensions.
The modified Reference 1 optional height/length (height/ length are used interchangeably) limitations cover an infinite range, and thus covers the same structural dimensions as in the IA.
Claim 26: "An electrode arrangement according to claim 1, wherein at least one of:
(a) the microstructure electrodes interact with one or more analytes of interest such that the electrical response signal is dependent on a presence, absence, level or concentration of the analytes of interest; and
(b) analytes interact with the coating on the microstructures to change electrical properties of the coating, thereby allowing the analytes to be detected."
Claim 1: “the microstructure… acts as the electrode… configured to measure electrical response signals…being at least partially indicative of a bioimpedance”
Claim 14: “A system according to claim 1, wherein at least some of the plurality of microstructures are coated with a coating and wherein the coating… includes at least one of:
i) a permeable membrane…
v) zwitterions;
vi) peptides;
vii) hydrogels; and,
viii) self-assembled monolayer.”
The IA response signal is dependent on an interaction with analytes of interest, but the modified Reference 1 does not specify the response signal being dependent on analytes. Gill, who also effectively includes microstructure electrodes, shows that the “microneedle devices also may be adapted to use the one or more microneedles as a sensor to detect analytes”, depicting that the microstructure electrodes interact with analytes of interest to detect their presence (Gill, ¶[0114]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Reference 1 in view of Gill to have the microstructure electrodes’ response signal be dependent on analytes of interest (through their presence, absence, level or concentration). This would have the benefit of providing a specific, sensitive, real-time detection of analytes through measurable changes in the electrical properties, greatly enhancing the device’s diagnostic abilities for things such as glucose monitoring.
The IA specifies a coating that interacts with analytes, but the modified Reference 1 only lists optional coatings which are commonly used to detect electrical changes due to analytes without specifying their purpose. However, Gill discusses analyte detection with potentiometric and amperometric transducers where “the microneedle coating may release a diagnostic agent and the microneedle detects a reaction product following reaction of the diagnostic agent with an analyte” (Gill, ¶[0114]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Reference 1 in view of Gill to specifically state that the listed coatings could be used to detect changes in their electrical properties due to their interactions with analytes. This would have the benefit of providing a specific, sensitive, real-time detection of analytes through measurable changes in the electrical properties, greatly enhancing the device’s diagnostic abilities for things such as glucose monitoring.
Claim 28: "An electrode arrangement according to claim 1, wherein at least one of:
(a) the microstructures include a material including at least one of:
i) a bioactive material;
ii) a reagent for reacting with analytes in the subject;
iii) a binding agent for binding with analytes of interest;
iv) a material for binding one or more analytes of interest;
v) a probe for selectively targeting analytes of interest;
vi) an insulator;
vii) a material to reduce biofouling;
viii) a material to attract at least one substance to the plurality of plate microstructures;
ix) a material to repel at least one substance from the plurality of plate microstructures;
x) a material to attract at least some analytes to the plurality of plate microstructures; and
xi) a material to repel at least some analytes from the plurality of plate microstructures;
(b) the substrate includes the plurality of plate microstructures and wherein different microstructures are at least one of: i) differentially responsive to analytes; ii) responsive to different analytes; iii) responsive to different combinations of analytes; and iv) responsive to different concentrations of analytes; and
(c) at least some of the microstructures at least one of: i) attract at least one substance to the plurality of plate microstructures;
ii) repel at least one substance from the plurality of plate microstructures;
iii) attract at least one analyte to the plurality of plate microstructures; and
iv) repel at least one analyte from the plurality of plate microstructures."
Claim 14: "A system according to claim 1… at least some of the plurality of microstructures are coated with a coating and wherein the coating at least one of:”
Claim 14: “…includes… peptides”
Claim 1: “the microstructures… include an insulating layer”
Claim 14: “…modifies surface properties to… minimize biofouling;”
Claim 14: “attracts at least one substance to the microstructures”
Claim 14: “repels at least one substance from the microstructures”
Claim 14:
b) attracts at least one substance to the microstructures;
c) repels at least one substance from the microstructures;
Where the coating on the microstructures from the modified Reference 1 is interpreted to be part of the microstructure such that the coating material is now included as part of the microstructure in relation to the IA term “the microstructures include a material”.
Where the modified Reference 1 Claim 14 has peptides which are a bioactive material.
Both the IA and the combination of the modified Reference 1 and Gill describe the material of the microstructure or its properties. Claim 28 of the IA provides a combination of optional limitations with additional limitations to the microstructure’s material/properties as shown. However, the modified Reference 1 only needs to teach one of these limitation options, to which claims 1 and 14 of Reference 1 includes some of those options.
Claim 31: "An electrode arrangement according to claim 1, wherein at least one of:
(a) at least some of the plurality of plate microstructures are uncoated;
(b) at least some of the plurality of plate microstructures are porous with an internal coating;
(c) at least some of the plurality of plate microstructures are partially coated;
(d) different of the plurality of plate microstructures have different coatings;
(e) different parts of the plurality of plate microstructures include different coatings;
(f) at least some of the plurality of plate microstructures include multiple coatings;
(g) at least some of the of the plurality of plate microstructures are coated with a selectively dissolvable coating; and
(h) at least some of the plurality of plate microstructures are coated with a selectively dissolvable coating that dissolves at least one of:
i) after a defined time period;
ii) in response to the presence of one or more reagents in the subject;
iii) in response to application of the electrical stimulatory signals;
iv) in response to a presence, absence, level or concentration of analytes; and
v) upon breaching or penetration of a functional barrier."
Claim 1: “microstructures… include an insulating layer extending over an end of the microstructure proximate the substrate so that at least a tip portion of the microstructure is uncoated”
Both IA and the combination of the modified Reference 1 and Gill describe the microstructures as being partially covered. The IA states the microstructures are coated, while Reference 1 says layer. However, the specification of Reference 1 indicates that the word layer is synonymous with coating as it states “this allows the blade to be partially covered with an insulative coating” (Reference 1, ¶[0328]). Thus, the modified Reference 1 shows a partially coated microstructure.
The IA provides more detailed options for coatings, including selectively dissolvable coatings and multiple types of coatings, which are not explicitly detailed in the modified Reference 1. However, the modified Reference 1 only needs to teach one of these limitation options, to which claims 1 of Reference 1 includes one of those options.
Claim 35: "An electrode arrangement according to claim 1,wherein the coating at least one of:
(a) interacts with analytes;
(b) undergoes a change in properties upon exposure to analytes;
(c) undergoes a shape change to selectively anchor microstructures;
(d) modifies surface properties to at least one of: i) increase hydrophilicity; ii) increase hydrophobicity; and iii) minimize biofouling;
(e) attracts at least one substance to the microstructures;
(f) repels at least one substance from the microstructures;
(g) provides a physical structure to at least one of: i) facilitate penetration of a barrier; ii) strengthen the microstructures; and iii) anchor the microstructures in the subject;
(h) dissolves to at least one of: i) expose a microstructure of the plurality of the plate microstructures; ii) expose a further coating; and iii) expose a material;
(i) provides stimulation to the subject;
(j) contains a material;
(k) selectively releases a material;
(l) acts as a barrier to preclude at least one substance from the microstructures; and
(m) includes at least one of: i) polyethylene; ii) polyethylene glycol; iii) polyethylene oxide; iv) zwitterions; v) peptides; vi) hydrogels; and vii) self-assembled monolayer."
Claim 14: "A system according to claim 1… at least some of the plurality of microstructures are coated with a coating and wherein the coating at least one of:
a) modifies surface properties to at least one of: i) increase hydrophilicity; ii) increase hydrophobicity; and, iii) minimize biofouling;
b) attracts at least one substance to the microstructures;
c) repels at least one substance from the microstructures;
d) acts as a barrier to preclude at least one substance from the microstructures; and,
e) includes at least one of: i) a permeable membrane; ii) polyethylene; iii) polyethylene glycol; iv) polyethylene oxide; v) zwitterions; vi) peptides; vii) hydrogels; and, viii) self-assembled monolayer."
Both IA and the combination of the modified Reference 1 and Gill describe coatings on microstructures and their properties. Claim 35 of the IA provides a combination of limitations, where the IA includes additional optional limitations (as shown) of properties and functionalities such as shape change, stimulation, and selective release, which are not explicitly described in the modified Reference 1. However, the modified Reference 1 only needs to teach one of these limitation options, to which claim 14 of the modified Reference 1 includes some of those options.
Claim 38: "A system according to claim 1, wherein the plate microstructures are at least partially tapered and have a substantially rounded rectangular cross sectional shape."
Claim 4: "A system according to claim 1, wherein at least some of the plurality of microstructures at least one of: a) are at least partially tapered and have a rounded rectangular cross sectional shape"
Both the IA and the combination of the modified Reference 1 and Gill mention tapered microstructures with a substantially rounded rectangular cross-sectional shape.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US12048558B2, hereto referred to as Reference 1, and in view of Gill et al. (US 20140170299 A1), hereto referred as Gill, and further in view of Patolsky et al. (US 20190223795 A1), hereto referred as Patolsky, and in further view of Negi et al. (US 20170007813 A1), hereto referred as Negi, and in further view of Rajaraman et al. (US 20140303471 A1), hereto referred as Rajaraman.
The analysis as follows (please note the bolded and underlined portions of the entries under the Instant Application, IA, are those portions of the IA claims that the claims of Patent US12048558B2, Reference 1, does not have or are different from in some form):
Claim Element (Instant Application, IA)
Reference 1 (US12048558B2)
Analysis
Claim 2: "An electrode arrangement according to claim 1, wherein the electrode is a surface electrode coated on at least part of the microstructure."
Claim 1, Element (a): "at least some microstructures including an electrode"
Both the IA and the combination of the modified Reference 1, Gill, and Patolsky mention electrodes in combination with microstructures. However, the IA specifically mentions a "surface electrode coated on at least part of…", whereas Reference 1 lacks this explicit coating detail. Rajaraman, who investigates a similar area of biological microdevices that incorporate electrodes, encompasses “microneedle structures and functionally coating the structures with a conductive layer” for the purpose of making them an electrode (Rajaraman, ¶[0046]).
Additionally, Gill already implies this feature where “the coating material may aid in operation of the sensor”, but does not specify that the coating is used as an electrode (Gill, ¶[0061]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modified Reference 1 in view of Rajaraman to specify that one of the coatings used on the microstructures was that of a conductive material to use as a surface electrode. This would have the benefit of making the microstructures have “improved impedance” resulting in better signal quality and efficiency (Rajaraman, ¶[0026] and Fig. 9).
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.
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.
Claims 1, 3, 5-6, 8-9, 17, 20, 22, 24, 26, 28, 31, 35, 38, 55, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al. (US 20140170299 A1), hereto referred as Gill, and in further view of Negi et al. (US 20170007813 A1), hereto referred as Negi, and further in view of Patolsky et al. (US 20190223795 A1), hereto referred as Patolsky.
Regarding Claim 1, Gill teaches an electrode arrangement for use with a system for performing measurements on a biological subject (Gill, [0114]: "The microneedle devices also may be adapted to... detect analytes, electrical activity, and optical or other signals... [with a] biosensor... potentiometric, amperometric" and can be arranged in configurations such as, [0118]: "single microneedles, individual rows of microneedles, or as two-dimensional arrays of microneedles"; showing that the microneedle arrangements can function as electrodes for measurement of a biologic subject), the electrode arrangement including: a) a substrate (Gill, [0022]: "includes an array two or more microneedles extending out of plane from a substrate"; where the microneedles function as electrodes); and b) a plurality of plate microstructures extending from the substrate (Gill, Fig. 3D: depicts a plurality of microstructures that have a plate like form referred to as "microneedles"), the plurality of plate microstructures being configured to breach the stratum corneum of the biologic subject (Gill, Fig. 3D, [0104]: "The microneedle devices described herein may be used to deliver substances into and through the various biological tissues... into the skin", where the microneedles are depicted as plate-like structures, and with particular interest in the stratum corneum as shown in [0005]; where penetrating the skin necessitates breaching the stratum corneum of the subject), and wherein each of the plurality of plate microstructures include a substantially planar face having an electrode thereon to allow electrical stimulatory signals to be applied to and electrical response signals to be received from the biologic subject via the plurality of plate microstructures (Biosensors can be located on the microneedle surface, which are planar in form and serve as plate microstructures (Gill, [0114]); these biosensors may be "potentiometric, amperometric..." and are used "to detect analytes, electrical activity, and optical or other signals," indicating that they can receive electrical response signals; it also explains that "electricity, light or other energy forms may be precisely transmitted to directly stimulate, damage, or heal a specific tissue or for diagnostic purposes", connoting communication between the electrodes through biological tissue with electric stimulation (Gill, [0114])), wherein each of the plurality of plate microstructures includes a conductive material (Gill, [0041] ... The microneedle can be formed/constructed of different biocompatible materials, including metals, glasses, semi-conductor materials, ceramics, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium...", where the metals listed are known to be conductive materials and the microneedle is the microstructure), wherein the electrode of each of the plurality of plate microstructures is defined, at least in part by an insulating coating (Gill, [0153]: "(pre) coating the microneedles with a thin silicon dioxide layer", where the microneedles are the microstructures and silicon dioxide is known to be a strong insulator, thus part of the electrode has an insulating coating), and at least some of the plurality of plate microstructures being arranged in groups (Gill, [0048]: "The microneedles can be fabricated as, or combined to form microneedle arrays... an array may include microneedles having various lengths, base portion diameters, tip portion shapes, spacings between microneedles, drug coatings, etc"; demonstrating the arrangement of various potential groups of microneedles (i.e. microstructures); [0114]: the use of "potentiometric" and "amperometric" biosensors as part of the microneedles (i.e. microstructures) connotes groups (even if it is a group of one positive and a group of one negative electrode) though measuring electrical signals between microneedles, or with stimulation signals applied to these groups to monitor physiological responses).
Also regarding claim 1, Gill does not expressly teach that the insulating coating extends over only a part of a surface of the microstructure, so that an uncoated part of the microstructure acts as the electrode. Rather, Gill teaches that microneedles may be coated with insulating material, stating "(pre) coating the microneedles with a thin silicon dioxide layer" (Gill, [0153]). Since silicon dioxide is a well-known electrical insulator, this disclosure supports that Gill includes microneedles (i.e., microstructures) with an insulating coating. However, Gill does not expressly disclose that the insulating coating covers only part of the microneedle surface such that an uncoated portion acts as the electrode. Negi describes a microneedle system in which the needle is covered in an insulating coating leaving an exposed conductive tip showing that part of the microneedle surface is insulated, while another part (the tip) is left uncoated to function as the electrode (Negi, FIG. 4, [0061]). While Gill discloses the use of insulating coatings on microneedles, it does not explain that the coating covers only a portion of the microstructure to expose a region for electrode function. Negi fills this gap by teaching a structure in which an insulating layer is selectively applied, leaving the tip of the microneedle uncoated to act as an electrode. It would have been obvious to one of ordinary skill in the art to combine Gill with Negi because both involve fabrication methods and design choices for microneedle electrodes. The partially coated structure in Negi is functionally compatible with the coated microneedles in Gill, making it technically feasible to implement a configuration where only part of the microneedle is coated, leaving the rest exposed for electrical functionality. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gill in view of Negi to configure the insulating coating to extend over only part of a surface of the microstructure so that an uncoated part acts as the electrode. The benefit of this combination would be to improve selectivity and electrical isolation of the electrode surface, reducing unwanted signal interference while maintaining effective electrical contact with the biological subject. This design enhances both stimulation and sensing precision in bioelectronic applications.
Also regarding claim 1, Gill does not fully teach that each group is a pair of spaced apart microstructures having electrodes in opposition, and wherein at least some of the electrical stimulatory signals are applied between microstructures in the pair. Gill does not explicitly mention pairs of electrodes in opposition. However, the use of “potentiometric” and “amperometric” biosensors implicitly connotes that there are pairs of electrodes, since such measurements inherently require an active and a reference electrode (Gill, ¶[0114]). As can be seen in Fig. 3D, there are microstructures that are positioned in opposition, and the disclosure that “Biosensors can be... in communication with the body tissue via the microneedle” connotes that the plate microstructure is acting as the electrode (Gill, Fig. 3D, ¶[0114]). Gill also explains that “electricity, light or other energy forms may be precisely transmitted to directly stimulate, damage, or heal a specific tissue or for diagnostic purposes,” indicating that electrical stimulation occurs between electrodes (Gill, ¶[0114]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gill to configure each group as a pair of spaced apart microstructures having electrodes in opposition, with at least some stimulatory signals applied between the microstructures. This modification would have been technically feasible because Gill already teaches arrays of electrodes with spacing and orientation, and selecting two electrodes from an array to function as an opposing pair requires only conventional electrode cir