DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 22 is objected to because of the following informalities:
in claim 22, line 13: a semicolon should be inserted after “barrier layer”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 8, 11-12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,105,080 (Kam)(previously cited), in view of U.S. Patent Application Publication No. 2019/0167112 (Kane)(previously cited), and further in view of U.S. Patent Application Publication No. 2021/0228119 (Ng)(previously cited), and further in view of U.S. Patent Application Publication No. 2016/0058342 (Maiz-Aguinaga)(previously cited), and further in view of U.S. Patent No. 6,652,478 (Gartstein).
Kam teaches an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Kam also teaches that the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c are disposed within their respective sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam.
Kane teaches the use of an analyte window formed of a permeable material used to filter the analyte of interest as it proceeds in the path to the sensing element (see analyte diffusion window 308 in FIGS. 6-7 and 12-13 of Kane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use analyte windows in the paths (or lumens of the microneedles) as the analytes proceed to their respective sensing portions since they remove components that would interfere with or obscure the measurements.
Ng teaches the use of a dissolvable plug made from a dissolvable, degradable, or disintegradable material that dissolves, degrades, or disintegrates during use (paragraph 0019 of Ng). The plug protects the interior of the microneedle from bearing the full force of the impact of the microneedle on the biological surface (paragraph 0047 of Ng). The plug at least partially dissolves in a biological environment to form an opening in the top of the hollow interior, thereby exposing the interior of the hollow microneedle to the biological environment (paragraph 0047 of Ng). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dissolvable plugs of Ng at the entrance of the lumens of the microneedles so as to protect the interior of the microneedle before and during insertion into the patient.
Kam teaches:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
cavities in the form of sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam); and
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam.
However, Kam teaches the schematic construction of the device to the extent that the cavities, emitters, and detectors are arranged inside in the layer that forms the microneedles. Kam further teaches that the device can be formed from multiple components (col. 8, lines 35-50 of Kam), but no specifics as to how this construction is done in structural terms. Maiz-Aguinaga teaches that such structures are formed by a stacking of a series of layers, such as, a layer that forms the shaft and tip of the needle (the microneedles 106), a layer forming a base (the microneedle substrate 102), a layer (the element 210) with a space for forming the cavity 214, and a covering layer (the substrate 222) to which the detecting elements (the micro-sensors 208) are positioned on the bottom surface facing the cavity (FIGS. 3a-3b and paragraph 0029 of Maiz-Aguinaga). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the layout such that the optical transmission layer is formed from a microneedle substrate, the cavity forming substrate, and a covering substrate, as suggested by Maiz-Aguinaga, since it provides a concrete structure for easy formation of the layout of the combination.
The combination teaches or suggests a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material that forms the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam), wherein each of the plurality of microneedles comprises a hollow internal portion (the lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Gartstein teaches that, for hollow circular microneedles, a useful outer diameter range is from 20-100 microns, and more preferably in the range of 20-50 microns (col. 6, lines 27-45 of Gartstein). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the microneedles have a diameter of 20 microns since a diameter of the microneedles is required and Gartstein teaches one such diameter and/or it is a simple substitution of one known element for another to obtain predictable results. Alternatively, Gartstein is suggesting that the diameter of the microneedles is subject to change. The diameter of the microneedles would depend upon the factors of designer preference, patient comfort, and manufacturing cost. As such, the diameter of the microneedles is a results-effective variable that would have been optimized through routine experimentation based on the factors of designer preference, patient comfort, and manufacturing cost. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the diameter of the microneedles, using the range of 20-50 microns of Gartstein, so as to obtain the desired designer preference, patient comfort, and manufacturing cost.
With respect to claim 1, the combination teaches or suggests a chemical sensing device comprising:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material that forms the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam), wherein each of the plurality of microneedles comprises a hollow internal portion (the lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
a plurality of sensor elements (the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c of Kim; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam) in fluid communication with the microneedles, wherein each of the plurality of sensor elements is disposed within the optical transmission layer;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam), wherein the one or more optical emitters are configured to emit light into the plurality of sensor elements; and
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam), wherein the plurality of optical detectors is configured to receive light from the plurality of sensor elements (the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57, col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam);
a top barrier layer (the covering substrate suggested by Maiz-Aguinaga) disposed over all of the plurality of sensor elements;
a plurality of membrane barriers (the analyte windows in the lumens of the microneedles), wherein each one of the plurality of membrane barriers is positioned proximal to a corresponding one of the plurality of sensor elements, wherein each one of the plurality of membrane barriers is disposed within the hollow internal portion of a corresponding one of the plurality of microneedles (the analyte windows in the lumens of the microneedles between the dissolvable plugs of Ng and the nanosensors of Kam); and
a plurality of filter plugs (the dissolvable plugs of Ng), wherein each one of the plurality of filter plugs is positioned proximal to a corresponding one of the plurality of membrane barriers, wherein each one of the plurality of filter plugs is disposed within the hollow internal portion of a corresponding one of the plurality of microneedles (the dissolvable plugs of Ng at the entrance of the lumens); and
wherein each of the plurality of microneedles comprises a width of between 20 and 250 µm and a tip diameter between 1 and 25 µm (the diameter of 20 microns suggested by Gartstein results in this width and tip diameter and/or the optimization rationale would make these dimensions obvious).
With respect to claim 2, the combination teaches or suggests the optical transmission layer defining a plurality of sensing wells (the sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam; col. 5, lines 20-57, col. 19, lines 40-65, col. 20, lines 34-62, col. 25, line 65 to col. 26, line 60, col. 27, line 1-40 of Kam).
With respect to claim 3, the combination teaches or suggests that each of the plurality of sensing wells is in fluid communication with at least one of the plurality of microneedles (see the fluid communication of the sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c with their respective microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; col. 5, lines 20-57, col. 19, lines 40-65, col. 20, lines 34-62, col. 25, line 65 to col. 26, line 60, col. 27, line 1-40 of Kam).
With respect to claim 4, the combination teaches or suggests that each of the plurality of sensing wells and each of the plurality of microneedles are configured such that fluids and/or analytes entering each of the plurality of microneedles migrate to each of the plurality of sensing wells (see the fluid communication of the sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c with their respective microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; col. 5, lines 20-57, col. 19, lines 40-65, col. 20, lines 34-62, col. 25, line 65 to col. 26, line 60, col. 27, line 1-40 of Kam).
With respect to claim 6, the combination teaches or suggests that the top barrier layer is configured to seal tops of all of the sensing wells (the covering substrate suggested by Maiz-Aguinaga).
With respect to claim 8, the combination teaches or suggests that one or more of the plurality of optical detectors are disposed over a top surface of the optical transmission layer (the placement of the light sensor 450 relative to the layer that forms the microneedle 410a of Kam; the plurality of detectors being taught in col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam).
With respect to claim 11, the combination teaches or suggests that the optical transmission layer is formed of a material including one or more of a polymer, a glass, and a ceramic (col. 4, lines 10-35, col. 11, lines 10-50, col. 23, lines 40-55 of Kam).
With respect to claim 12, the combination teaches or suggests each of the plurality of microneedles further comprising a tip and an aperture in the tip, wherein the aperture leads to the hollow internal portion (see the tip, aperture, and lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam).
With respect to claim 16, Kam teaches the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c (the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Kam teaches that such nanosensors could include nanoparticles that have one or more chemicals, proteins, or other elements incorporated within and/or adsorbed onto the surface of the nanoparticles. Such nanosensors could include analyte-selective agents (e.g., ionophores, receptors, proteins, ion channels) configured to selectively interact with a particular analyte in interstitial (or other) fluid. Such nanosensors could additionally include fluorophores, chromophores, or other components having an optical property that is changed, directly or indirectly, by interaction of the nanosensor with the analyte. In some examples, interaction with the analyte (e.g., binding with the analyte) could cause a quenching of a fluorophore, changing of a color of a chromophore moiety, or some other optical effect due to modification of the fluorophore or chromophore, positioning of a quencher or other element(s) proximate to the fluorophore or chromophore (e.g., in a manner similar to Forster resonance energy transfer (FRET) imaging). Additionally or alternatively, interaction with the analyte could cause a change in local properties (e.g., pH, osmolality, charge, voltage, hydrophobicity) of the environment of the fluorophore or chromophore. For example, the analyte could be selectively altered by and/or selectively cause the production of a chemical product (e.g., hydrogen peroxide) by a protein of the nanosensor, and the fluorophore or chromophore could have a property (e.g., a fluorescent property, a fluorescence amplitude, a color) that is dependent upon the presence and/or concentration of the altered analyte and/or chemical product. In another example, the analyte could be an ion, and the nanosensor could include an ionophore. The nanosensor could further include a linking agent that changes a local pH in response to the ionophore selectively interacting with the analyte. The nanosensor could further include a pH-sensitive fluorophore having a fluorescent property that is dependent upon the local pH. A fluorescent or other optical property of a fluorophore of a nanosensor could be detected (e.g., by a detector of the payload 130a and/or by a detector in a reader device) by emitting light at an excitation wavelength of the fluorophore (e.g., using an LED, a laser, or some other light source and/or light filters or other optical elements) and receiving responsively emitted light from the fluorophore at an emission wavelength of the fluorophore (e.g., using a phototransistor, photodiode, photoresistor, camera, CCD, active pixel sensor, or other light-sensitive element(s) and/or light filters or other optical elements). Other methods of detecting a fluorescent or other optical property of a nanosensor are anticipated (col. 12, line 60 to col. 13, line 44 of Kam).
Kane teaches that such nanosensors can be chromoionophores (paragraphs 0099-0105 of Kane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use chromoionophores in the nanosensors of Kam since Kam teaches other materials may be used may be used and Kane teaches such materials and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 16, the combination teaches or suggests the sensor elements including a chromoionophore (the chromoionophores of Kane).
With respect to claim 17, the combination teaches or suggests the sensor elements configured to sense at least one of electrolytes, hormones, proteins, sugars, and metabolites (the sensing of electrolytes, metabolites, and proteins of Kam; col. 6, lines 1-15, col. 20, line 6 to col. 21, line 30 of Kam).
With respect to claim 18, the combination teaches or suggests the sensor elements configured to sense potassium (the potassium sensing of Kam; col. 6, lines 1-15, col. 20, line 6 to col. 21, line 30 of Kam).
With respect to claim 19, the combination teaches or suggests that the chemical sensing device is a wearable device (the device is wearable; col. 4, lines 10-35, col. 6, lines 15-55, col. 8, lines 13-35 of Kam).
With respect to claim 20, the combination teaches or suggests an adhesive patch, wherein the adhesive patch is configured to hold the chemical sensing device onto skin of a patient (the adhesive substrate of a skin-mountable patch of Kam; col. 4, lines 10-35, col. 8, lines 13-35 of Kam).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kam, in view of Kane, and further in view of Ng, and further in view of Maiz-Aguinaga, and further in view of Gartstein, and further in view of U.S. Patent Application Publication No. 2012/0029328 (Shimizu)(previously cited).
Kam teaches that the device can be partially composed of transparent materials, which suggests being partially composed of non-transparent materials (col. 25, lines 50-65 of Kam). Shimizu teaches that an opaque layer above the optical elements so as to keep out external light (paragraphs 0131, 0155, 0200, and 0205 of Shimizu). It would have been obvious to one of ordinary skill in the art to have the covering substrate suggested by Maiz-Aguinaga be opaque since it keeps out external light. Thus, the combination teaches or suggests that the top barrier layer is configured as an optical shroud to prevent the light from entering from top sides of all of the sensing wells (the opaqueness of the covering substrate suggested by Maiz-Aguinaga).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kam, in view of Kane, and further in view of Ng, and further in view of Maiz-Aguinaga, and further in view of Gartstein, and further in view of U.S. Patent No. 4,825,872 (Tan)(previously cited).
Kam teaches that the device can be partially composed of transparent materials, which suggests being partially composed of non-transparent materials (col. 25, lines 50-65 of Kam). Tan teaches that an opaque layer above the optical elements to prevent ambient light from degrading the readings of the detectors (col. 3, line 60 to col. 4, line 10 of Tan). It would have been obvious to one of ordinary skill in the art to have the covering substrate suggested by Maiz-Aguinaga be opaque since it prevents ambient light from degrading the readings of the detectors. Thus, the combination teaches or suggests that the top barrier layer is configured as an optical shroud to prevent the light from entering from top sides of all of the sensing wells (the opaqueness of the covering substrate suggested by Maiz-Aguinaga).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kam, in view of Kane, and further in view of Ng, and further in view of Maiz-Aguinaga, and further in view of Gartstein, and further in view of U.S. Patent Application Publication No. 2022/0409100 (Sipple)(previously cited).
Kam teaches an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material that forms the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Kam also teaches the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c disposed within their respective sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam; the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam; and the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam.
Sipple teaches that arranging a material to have total internal reflection focuses the light to the intended target (paragraph 0053 of Sipple).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; and/or the layer that forms the microneedles 510a, 510b, 510c of Kam so as to have total internal reflection so as to improve the light impinging on the nanosensors.
With respect to claim 10, the combination teaches or suggests that at least portions of the optical transmission layer exhibit total internal reflection (the total internal reflection capability of the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; and/or the layer that forms the microneedles 510a, 510b, 510c of Kam).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,105,080 (Kam)(previously cited), in view of U.S. Patent Application Publication No. 2019/0167112 (Kane)(previously cited), and further in view of U.S. Patent No. 4,705,503 (Dorman), and further in view of U.S. Patent Application Publication No. 2016/0058342 (Maiz-Aguinaga)(previously cited).
Kam teaches an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Kam also teaches that the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c are disposed within their respective sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam.
Kane teaches the use of an analyte window formed of a permeable material used to filter the analyte of interest as it proceeds in the path to the sensing element (see analyte diffusion window 308 in FIGS. 6-7 and 12-13 of Kane). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use analyte windows in the paths (or lumens of the microneedles) as the analytes proceed to their respective sensing portions since they remove components that would interfere with or obscure the measurements.
Kane teaches the use of a guard or membrane 1230 over the analyte window (paragraph 0084 and FIG. 12 of Kane). Dorman teaches that sodium polystyrene sulfonate is a suitable material for a membrane covering an inlet (col 6, line 54 to col. 7, line 20 of Dorman). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the guard or membrane 1230 of Kane and have that membrane made from sodium polystyrene sulfonate of Dorman since it better protects the interior of the microneedle and the analyte window before and during insertion into the patient.
Kam teaches:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
cavities in the form of sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam); and
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam.
However, Kam teaches the schematic construction of the device to the extent that the cavities, emitters, and detectors are arranged inside in the layer that forms the microneedles. Kam further teaches that the device can be formed from multiple components (col. 8, lines 35-50 of Kam), but no specifics as to how this construction is done in structural terms. Maiz-Aguinaga teaches that such structures are formed by a stacking of a series of layers, such as, a layer that forms the shaft and tip of the needle (the microneedles 106), a layer forming a base (the microneedle substrate 102), a layer (the element 210) with a space for forming the cavity 214, and a covering layer (the substrate 222) to which the detecting elements (the micro-sensors 208) are positioned on the bottom surface facing the cavity (FIGS. 3a-3b and paragraph 0029 of Maiz-Aguinaga). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the layout such that the optical transmission layer is formed from a microneedle substrate, the cavity forming substrate, and a covering substrate, as suggested by Maiz-Aguinaga, since it provides a concrete structure for easy formation of the layout of the combination.
With respect to claim 21, the combination teaches or suggests a chemical sensing device comprising:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material that forms the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; or the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam), wherein each of the plurality of microneedles comprises a hollow internal portion (the lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
a plurality of sensor elements (the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c of Kim; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam) in fluid communication with the microneedles, wherein each of the plurality of sensor elements is disposed within the optical transmission layer;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam), wherein the one or more optical emitters are configured to emit light into the plurality of sensor elements;
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam), wherein the plurality of optical detectors is configured to receive the light from the plurality of sensor elements (the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57, col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam);
a top barrier layer (the covering substrate suggested by Maiz-Aguinaga) disposed over all
a plurality of membrane barriers (Kam teaches that the device may include a coating of the channel so as to control fluid flow though the channel (col. 14, lines 50-67 of Kam). It would have been obvious to one of ordinary skill in the art to include a coating layer on the inside of the lumens in the microchannel of Kam so as to control the fluid flow though the channel. Thus, the flow-control coating of Kam is considered to be the membrane barriers), wherein each one of the plurality of membrane barriers is disposed proximal to a corresponding one of the plurality of sensor elements contained within the hollow internal portion of a corresponding one of the plurality of microneedles;
a plurality of filter plugs (the analyte windows in the lumens of the microneedles), wherein each of the plurality of filter plugs is disposed proximal to each of the plurality of membrane barriers within the hollow internal portion of each of the plurality of microneedles (with respect to the analyte windows being proximal to the flow-control coating of Kam, such a placement (1) would have been a mere rearrangement of parts; (2) would have been subject to routine optimization since it is based on factors of desirable sampling yield and/or cost; and/or (3) would have been obvious to perform such filtering as soon as possible so as to not interfere with the flow of the analyte toward the nanosensors or to limit the pollution of the flow path with the interfering components);
a plurality of delay layers (the guard or membrane 1230 of Kane made from sodium polystyrene sulfonate of Dorman), wherein each of the plurality of delay layers is disposed proximal to each of the plurality of filter plugs at a second end within the hollow internal portion of each of the plurality of microneedles (FIG. 12 of Kane suggests this placement);
wherein at least some of the plurality of optical detectors are disposed over, and in contact with, the top barrier layer (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam are disposed over and in contact with a bottom surface of the covering substrate suggested by Maiz-Aguinaga); and
wherein each of the plurality of delay layers comprises a potassium binder disposed therein (the guard or membrane 1230 of Kane is made from sodium polystyrene sulfonate of Dorman, which is a potassium binder).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kam, in view of Maiz-Aguinaga, and further in view of Gartstein, and further in view of Sipple.
Kam teaches an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Kam also teaches the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c disposed within their respective sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam; the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam; and the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam.
Kam teaches:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the layer that forms the microneedles 210 and 270; the layer that forms the microneedle 310a; the layer that forms the microneedle 310b; the layer that forms the microneedle 310c; the layer that forms the microneedle 410a; the layer that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
cavities in the form of sensing portions 235, 335a, 334b, 435, 535a, 535b, 535c of Kam;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam); and
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam.
However, Kam teaches the schematic construction of the device to the extent that the cavities, emitters, and detectors are arranged inside in the layer that forms the microneedles. Kam further teaches that the device can be formed from multiple components (col. 8, lines 35-50 of Kam), but no specifics as to how this construction is done in structural terms. Maiz-Aguinaga teaches that such structures are formed by a stacking of a series of layers, such as, a layer that forms the shaft and tip of the needle (the microneedles 106), a layer forming a base (the microneedle substrate 102), a layer (the element 210) with a space for forming the cavity 214, and a covering layer (the substrate 222) to which the detecting elements (the micro-sensors 208) are positioned on the bottom surface facing the cavity (FIGS. 3a-3b and paragraph 0029 of Maiz-Aguinaga). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the layout such that the optical transmission layer is formed from a microneedle substrate, the cavity forming substrate, and a covering substrate, as suggested by Maiz-Aguinaga, since it provides a concrete structure for easy formation of the layout.
The combination teaches or suggests a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material forming the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; or the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam), wherein each of the plurality of microneedles comprises a hollow internal portion (the lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam). Gartstein teaches that, for hollow circular microneedles, a useful outer diameter range is from 20-100 microns, and more preferably in the range of 20-50 microns (col. 6, lines 27-45 of Gartstein). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the microneedles have a diameter of 20 microns since a diameter of the microneedles is required and Gartstein teaches one such diameter and/or it is a simple substitution of one known element for another to obtain predictable results. Alternatively, Gartstein is suggesting that the diameter of the microneedles is subject to change. The diameter of the microneedles would depend upon the factors of designer preference, patient comfort, and manufacturing cost. As such, the diameter of the microneedles is a results-effective variable that would have been optimized through routine experimentation based on the factors of designer preference, patient comfort, and manufacturing cost. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the diameter of the microneedles, using the range of 20-50 microns of Gartstein, so as to obtain the desired designer preference, patient comfort, and manufacturing cost.
Sipple teaches that arranging a material to have total internal reflection focuses the light to the intended target (paragraph 0053 of Sipple).2 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material forming the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; or the material that forms the microneedles 510a, 510b, 510c of Kam so as to have total internal reflection so as to improve the light impinging on the nanosensors.
With respect to claim 22, the combination teaches or suggests a chemical sensing device comprising:
an optical transmission layer, the optical transmission layer defining a plurality of microneedles (the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material forming the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; or the material that forms the microneedles 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam), wherein each of the plurality of microneedles comprises a hollow internal portion (the lumens of the microneedles 210, 270, 310a, 310b, 310c, 410a, 510a, 510b, 510c of Kam; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam);
a plurality of sensor elements (the nanosensors 230, 330a, 330b, 330c, 430, 530a, 530b, 530c of Kim; the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57 of Kam) in fluid communication with the microneedles;
one or more optical emitters (the light source 240, 340a, 340b, 340c, 440, 540a, 540b, 540c of Kam), wherein the one or more optical emitters are configured to emit light into the plurality of sensor elements; and
a plurality of optical detectors (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam; col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam), wherein the plurality of optical detectors is configured to receive the light from the plurality of sensor elements (the abstract, col. 1, line 50 to col. 2, line 50, col. 3, line 59 to col. 5, line 57, col. 20, lines 34-61, col. 25, line 65 to col. 26, line 15, col. 29, lines 10-30 of Kam); and
a top barrier layer (the covering substrate suggested by Maiz-Aguinaga) disposed over all of the plurality of sensor elements;
wherein at least portions of the optical transmission layer exhibit total internal reflection (the total internal reflection capability of the cavity-forming substrate and microneedle substrate suggested by Maiz-Aguinaga along with the material forming the microneedles 210 and 270; the material that forms the microneedle 310a; the material that forms the microneedle 310b; the material that forms the microneedle 310c; the material that forms the microneedle 410a; or the material that forms the microneedles 510a, 510b, 510c of Kam); and
wherein at least some of the plurality of optical detectors are disposed over, and in contact with, the top barrier layer (the light sensors 250, 350a, 350b, 350c, 450, 550a, 550b, 550c of Kam are disposed over and in contact with a bottom surface of the covering substrate suggested by Maiz-Aguinaga), and
wherein each of the plurality of microneedles comprises a width of between 20 and 250 µm and a tip diameter between 1 and 25 µm (the diameter of 20 microns suggested by Gartstein results in this width and tip diameter and/or the optimization rationale would make these dimensions obvious).
Response to Arguments
The Applicant’s arguments filed on 4/9/2026 have been fully considered.
Drawing objections
In view of the claim amendments filed on 4/9/2026, the previous drawing objections are withdrawn.
Claim objections
In view of the claim amendments filed on 4/9/2026, the previous claim objections are withdrawn.
There are new grounds of claim objections that were necessitated by the claim amendments filed on 4/9/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 4/9/2026, the previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1-4, 6-8, 10-12, and 16-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of prior art rejections that were necessitated by the claim amendments filed on 4/9/2026.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Paragraph 0020 of U.S. Patent Application Publication No. 2004/0157341 (Reynolds)(previously cited) and paragraph 0046 of U.S. Patent Application Publication No. 2004/0191119 (Zanzucchi)(previously cited) teach this as well.
2 Paragraph 0020 of U.S. Patent Application Publication No. 2004/0157341 (Reynolds) and paragraph 0046 of U.S. Patent Application Publication No. 2004/0191119 (Zanzucchi) teach this as well.
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