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 limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 7-8 are objected to because of the following informalities:
in claim 7, line 2: “evaluating” should be “the evaluation of”; and
in claim 8, line 2: “evaluating” should be “the evaluation of”.
Appropriate correction is required.
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 5-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight, wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” in lines 2-8, which renders the claim indefinite. The recitation “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight” connotes that the claimed method only requires the first molecular weight or the second molecular weight. However, if this is true, it is not clear what is meant by “wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” since such a recitation either (1) requires the existence of both the first and second molecular weights in the claimed method or (2) further defines an element (one of the first and second molecular weights) not required by the claimed method. It is not clear if both the first and second molecular weights are required for the claimed method. If they are both required, it is not clear how both molecular weights are to be incorporated into the claimed method. If they are both not required, it is not clear what the meaning of the further definition of the molecular weight that is not required is intended to be with respect to the claim’s scope. These issues render claim 5 indefinite.
Claim 6 recites “wherein, after the separation, the device is configured to: quantitatively analyze the proteins from the subject, adsorbed onto surfaces of the plurality of microneedles of the microneedle patch” in lines 12-13, but it is not clear how this function relates to the purpose of diagnosing atopic dermatitis as recited in lines 1-2. The functions of the device in lines 14-17 (“read amounts of interleukin-4 and interleukin-13 adsorbed onto the surfaces of the plurality of microneedles of the microneedle patch, and evaluate an activity of atopic dermatitis based on the amounts of the interleukin-4 and the interleukin-13”) relate to the purpose of the diagnosis of atopic dermatitis, but the device’s function in lines 12-13 is presented as to be wholly separate and unrelated to the device’s function in lines 14-17. The ambiguity in the relationship of the functions of the device in relation to the claimed purpose of the kit renders claim 6 indefinite.
Claims 7-10 are rejected by virtue of their dependence from claim 6.
Claim 9 recites “the biodegradable polymer hyaluronic acid forming the plurality of microneedles” in lines 4-5, but this recitation deviates from the recitation “each microneedle including biodegradable polymer hyaluronic acid” in claim 6, lines 6-7. This deviation creates an ambiguity as to the nature of the biodegradable polymer hyaluronic acid relative the plurality of microneedles. This ambiguity renders claim 9 indefinite.
Claim 10 is rejected by virtue of their dependence from claim 9. Also, claim 10 compounds the indefiniteness issue of claim 9 since claim 10 also recites “the biodegradable polymer hyaluronic acid forming the plurality of microneedles” in lines 2-3 and suffers from the same deviation in phraseology from the recitation “each microneedle including biodegradable polymer hyaluronic acid” in claim 6, lines 6-7 that leads to the indefiniteness rejection.
Claim 10 recites “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight, wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” in lines 2-7, which renders the claim indefinite. The recitation “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight” connotes that the claimed kit only requires the first molecular weight or the second molecular weight. However, if this is true, it is not clear what is meant by “wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” since such a recitation either (1) requires the existence of both the first and second molecular weights in the claimed kit or (2) further defines an element (one of the first and second molecular weights) not required by the claimed kit. It is not clear if both the first and second molecular weights are required for the claimed kit. If they are both required, it is not clear how both molecular weights are to be incorporated into the claimed kit. If they are both not required, it is not clear what the meaning of the further definition of the molecular weight that is not required is intended to be with respect to the claim’s scope. These issues render claim 10 indefinite.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0287942 (Mahmood)(previously cited), in view of U.S. Patent Application Publication No. 2017/0000837 (Shraibom)(previously cited).
Mahmood teaches a kit portion that uses ELISA for assaying the biomarkers (paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood) in which atopic dermatitis (also known as “eczema”) may be diagnosed (paragraphs 0134 and 0139 of Mahmood); and a microneedle patch comprising a plurality of microneedles, which are formed of biodegradable polymer hyaluronic acid and have a solid structure (the microneedle array formed of hyaluronic acid (paragraph 0077 of Mahmood) and having a solid structure (paragraphs 0029 and 0087 of Mahmood), and a bottom layer on which the plurality of microneedles are formed (the substrate of Mahmood; paragraphs 0007, 0011, 0071, 0077-0078, and 0087 of Mahmood).
Shraibom teaches that reading amounts of IL-4 and IL13 can be used to diagnose atopic dermatitis or eczema (paragraph 0063 of Shraibom1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to read amounts of IL-4 and IL13 from the sample extracted using the microneedles of Mahmood so as to diagnose atopic dermatitis or eczema since Mahmood discloses that biomarkers collected by the microneedles may be used to diagnose atopic dermatitis or eczema and Shraibom teaches such biomarkers and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claims 1, the combination teaches or suggests minimally invasive method for diagnosing atopic dermatitis, the minimally invasive method comprising:
applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles (the application to the skin of Mahmood; the abstract, paragraph 0048, 0071, 0073, 0086, 0088, 0091, 0127, 0137, 0142, 0180 of Mahmood), each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure (the microneedle array formed of hyaluronic acid of Mahmood (paragraph 0077 of Mahmood) and having a solid structure of Mahmood (paragraphs 0029 and 0087 of Mahmood)), a bottom layer on which the plurality of microneedles are formed (the substrate of Mahmood; paragraphs 0007, 0011, 0071, 0077-0078, and 0087 of Mahmood);
maintaining the microneedle patch for a predetermined time in a state in which the microneedle patch is attached to the skin of the subject (maintaining application for the time period of Mahmood; paragraphs 0049 of Mahmood);
separating the microneedle patch from the skin of the subject after the predetermined time (the removal of the patch from the skin; paragraphs 0049 and 0116 of Mahmood) and putting the microneedle patch into a quantitative testing (the ELISA testing of Mahmood; paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood);
reading amounts of interleukin-4 and interleukin-13, adsorbed onto surfaces of the plurality of microneedles of the microneedle patch (the binding of the biomarkers; paragraphs 0017, 0022-0023, 0029, 0048-0049, 0093, 0098, 0104, 0113, 0116, 0129, 0137 of Mahmood), in the quantitative testing (the determination of interleukin-4 and interleukin-13 of Shraibom); and
evaluating an activity of atopic dermatitis based on the amounts of the interleukin-4 and the interleukin-13 (the diagnosis of atopic dermatitis or eczema).
With respect to the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed”, the combination meets this limitation in the following ways.
First, according to one interpretation, the combination meets the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are considered part of plurality of microneedles. The claim language does not require that that the plurality of microneedles only consists of biodegradable polymer hyaluronic acid. That is, there is no limitation on what the microneedles are composed of. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, according to another interpretation, the combination meets the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are added to the patch before application and there are considered separate and distinct from the microneedle patch (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). The claim language does not require that only the microneedle patch is applied to the skin. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to claim 2, the combination teaches or suggests that the quantitative testing is ELISA measurement (the ELISA testing of Mahmood; paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood).
With respect to claims 3, the combination teaches or suggests that an amount of detected IFN-gamma is not considered in evaluating the activity of atopic dermatitis (the determination of interleukin-4 and interleukin-13 of Shraibom is used in the diagnosis of atopic dermatitis or eczema).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0287942 (Mahmood)(previously cited), in view of U.S. Patent Application Publication No. 2017/0000837 (Shraibom)(previously cited), and further in view of Research Article “Hyaluronic Acid: Evaluation of Efficacy with Different Molecular Weights” (Mazzucco)(previously cited).
Mahmood teaches that the time needed for biomarkers to bind to the microneedles will depend on a number of parameters, including, but not limited to, the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, and the physical and chemical dimensions of microneedle probes (e.g., the surface area, the number of probes, the number of binding sites)(paragraph 0049 of Mahmood). Also, Mahmood teaches that the application time can vary, for example, the application time can range from less than 10 seconds to 60 minutes (paragraph 0049 of Mahmood). Further, Mazzucco teaches, “Attention must be paid to the solubility of hyaluronic acid, which has a solubilization rate dependent on its molecular weight; the higher molecular weight molecules dissolve slower” (page 15 of Mazzucco). Thus, the molecular weight of the hyaluronic acid forming the microneedles must be paid attention to since the microneedles should not breakdown beyond a usable point during collection. The application time of the patch and the molecular weight of the hyaluronic acid would depend upon the factors of the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. As such, the application time of the patch and the molecular weight of the hyaluronic acid are results-effective variables that would have been optimized through routine experimentation based on the factors of the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. 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 application time of the patch and the molecular weight of the hyaluronic acid so as to obtain the desired collection based on the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. Accordingly, the features of “wherein the predetermined time is predetermined in consideration of a molecular weight-dependent dissolution rate of the biodegradable polymer hyaluronic acid forming the plurality of microneedles” of claim 4 and “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight, wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” of claim 5 would have been obvious.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0287942 (Mahmood)(previously cited), in view of U.S. Patent Application Publication No. 2017/0000837 (Shraibom)(previously cited), and further in view of U.S. Patent No. 6,824,986 (Finkelman)(previously cited).
Mahmood teaches a kit portion that uses ELISA for assaying the biomarkers (paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood) in which atopic dermatitis (also known as “eczema”) may be diagnosed (paragraphs 0134 and 0139 of Mahmood); and a microneedle patch comprising a plurality of microneedles, which are formed of biodegradable polymer hyaluronic acid and have a solid structure (the microneedle array formed of hyaluronic acid (paragraph 0077 of Mahmood) and having a solid structure (paragraphs 0029 and 0087 of Mahmood), and a bottom layer on which the plurality of microneedles are formed (the substrate of Mahmood; paragraphs 0007, 0011, 0071, 0077-0078, and 0087 of Mahmood).
Shraibom teaches that reading amounts of IL-4 and IL13 can be used to diagnose atopic dermatitis or eczema (paragraph 0063 of Shraibom2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to read amounts of IL-4 and IL13 from the sample extracted using the microneedles of Mahmood so as to diagnose atopic dermatitis or eczema since Mahmood discloses that biomarkers collected by the microneedles may be used to diagnose atopic dermatitis or eczema and Shraibom teaches such biomarkers and/or it is a simple substitution of one known element for another to obtain predictable results.
Finkelman teaches that a spectrophotometric ELISA plate reader is a suitable device for assaying using the ELISA method (col. 12, line 65 to col. 13, line 15 of Finkelman). 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 spectrophotometric ELISA plate reader of Finkelman in the combination since ELISA is used for assaying the biomarkers in which atopic dermatitis or eczema is diagnosed, as suggested by Mahmood, and the device of Finkelman provides a mechanism for performing such an analysis.
With respect to claim 6, the combination teaches or suggests a minimally invasive kit for diagnosing atopic dermatitis, the minimally invasive kit comprising:
a device configured to quantitatively analyze amounts of proteins extracted from a skin of a subject (the spectrophotometric ELISA plate reader of Finkelman); and
a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure (the microneedle array formed of hyaluronic acid of Mahmood (paragraph 0077 of Mahmood) and having a solid structure of Mahmood (paragraphs 0029 and 0087 of Mahmood)), and a bottom layer on which the plurality of microneedles are disposed (the substrate of Mahmood; paragraphs 0007, 0011, 0071, 0077-0078, and 0087 of Mahmood),
wherein the microneedle patch is configured to be applied to the skin of the subject (the application to the skin of Mahmood; the abstract, paragraph 0048, 0071, 0073, 0086, 0088, 0091, 0127, 0137, 0142, 0180 of Mahmood), maintained for a predetermined time (maintaining application for the time period of Mahmood; paragraphs 0049 of Mahmood), and then separated from the skin (the removal of the patch from the skin; paragraphs 0049 and 0116 of Mahmood), and
wherein, after the separation, the device is configured to: quantitatively analyze the proteins from the subject, adsorbed onto surfaces of the plurality of microneedles of the microneedle patch (analyzing the biomarkers; paragraphs 0017, 0022-0023, 0029, 0048-0049, 0093, 0098, 0104, 0113, 0116, 0129, 0137 of Mahmood), read amounts of interleukin-4 and interleukin-13 adsorbed onto the surfaces of the plurality of microneedles of the microneedle patch (the determination of interleukin-4 and interleukin-13 of Shraibom), and evaluate an activity of atopic dermatitis based on the amounts of the interleukin-4 and the interleukin-13 (the diagnosis of atopic dermatitis or eczema).
With respect to the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed”, the combination meets this limitation in the following ways.
First, according to one interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are considered part of plurality of microneedles. The claim language does not require that the plurality of microneedles only consists of biodegradable polymer hyaluronic acid. That is, there is no limitation on what the microneedles are composed of. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, according to another interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are added to the patch before application and are therefore considered separate and distinct from the microneedle patch (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). The claim language does not exclude components other than the microneedle patch applied to the skin. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Third, according to yet another interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are not attached to the patch before application and are therefore separate and distinct from the microneedle patch before application (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). That is, there are times when the microneedle patch is only made up of the microneedles and bottom layer (i.e., the times when the probes are not connected to the microneedles at all). At these times, the combination teaches this physical construction of the kit of claim 6.
With respect to claim 7, the combination teaches or suggests that the device is configured to perform ELISA measurement in evaluating the activity of the atopic dermatitis (the spectrophotometric ELISA plate reader of Finkelman performs the ELISA measurement).
With respect to claim 8, the combination teaches or suggests that the device is configured to not consider an amount of detected IFN-gamma in evaluating the activity of atopic dermatitis (the determination of interleukin-4 and interleukin-13 of Shraibom is used in the diagnosis of atopic dermatitis or eczema).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0287942 (Mahmood)(previously cited), in view of U.S. Patent Application Publication No. 2017/0000837 (Shraibom)(previously cited), and further in view of U.S. Patent No. 6,824,986 (Finkelman)(previously cited), and further in view of Research Article “Hyaluronic Acid: Evaluation of Efficacy with Different Molecular Weights” (Mazzucco)(previously cited).
Mahmood teaches that the time needed for biomarkers to bind to the microneedles will depend on a number of parameters, including, but not limited to, the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, and the physical and chemical dimensions of microneedle probes (e.g., the surface area, the number of probes, the number of binding sites)(paragraph 0049 of Mahmood). Also, Mahmood teaches that the application time can vary, for example, the application time can range from less than 10 seconds to 60 minutes (paragraph 0049 of Mahmood). Further, Mazzucco teaches, “Attention must be paid to the solubility of hyaluronic acid, which has a solubilization rate dependent on its molecular weight; the higher molecular weight molecules dissolve slower” (page 15 of Mazzucco). Thus, the molecular weight of the hyaluronic acid forming the microneedles must be paid attention to since the microneedles should not breakdown beyond a usable point during collection. The application time of the patch and the molecular weight of the hyaluronic acid would depend upon the factors of the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. As such, the application time of the patch and the molecular weight of the hyaluronic acid are results-effective variables that would have been optimized through routine experimentation based on the factors of the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. 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 application time of the patch and the molecular weight of the hyaluronic acid so as to obtain the desired collection based on the prevalent quantity, the biodistribution and concentration of biomarkers, the tissue organization, the physical and chemical dimensions of microneedle probes, the surface area, the number of probes, the number of binding sites, and breakdown avoidance. Accordingly, the features of “wherein the microneedle patch is configured to be maintained on the skin of the subject for the predetermined time in consideration of a molecular weight-dependent dissolution rate of the biodegradable polymer hyaluronic acid forming the plurality of microneedles” of claim 9 and “wherein a molecular weight of the biodegradable polymer hyaluronic acid forming the plurality of microneedles is a first molecular weight or a second molecular weight greater than the first molecular weight, wherein the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the second molecular weight are greater than the predetermined time and the amounts of the interleukin-4 and the interleukin-13 for the first molecular weight” of claim 10 would have been obvious.
Alternatively, with respect to claims 9-10, the combination teaches or suggests the features of claims 9-10 since the combination already teaches or suggests a particular time of attachment to the subject and the relationship between the molecular weights and the time of attachment is merely a property that a microneedle formed of hyaluronic acid would have. Thus, claims 9-10 do not recite a structure that defines over the structure suggested by the combination.
Response to Arguments
Applicant’s arguments filed on 11/11/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 11/11/2025, the previous claim objections are withdrawn.
There are new grounds of claim objections that were necessitated by the claim amendments filed on 11/11/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 11/11/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), that were necessitated by the claim amendments filed on 11/11/2025.
Prior are rejections
The Applicant asserts:
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These arguments are not persuasive. With respect to the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed” of claim 1, the combination meets this limitation in the following ways.
First, according to one interpretation, the combination meets the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are considered part of plurality of microneedles. The claim language does not require that that the plurality of microneedles only consists of biodegradable polymer hyaluronic acid. That is, there is no limitation on what the microneedles are composed of. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, according to another interpretation, the combination meets the recitation “applying, to a skin of a subject, a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle being formed of biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are formed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are added to the patch before application and there are considered separate and distinct from the microneedle patch (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). The claim language does not require that only the microneedle patch is applied to the skin. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” of claim 6, the combination meets this limitation in the following ways.
First, according to one interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are considered part of plurality of microneedles. The claim language does not require that the plurality of microneedles only consists of biodegradable polymer hyaluronic acid. That is, there is no limitation on what the microneedles are composed of. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, according to another interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are added to the patch before application and are therefore considered separate and distinct from the microneedle patch (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). The claim language does not exclude components other than the microneedle patch applied to the skin. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Third, according to yet another interpretation, the combination meets the recitation “a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid and having a solid structure; and a bottom layer on which the plurality of microneedles are disposed” to the extent that the microneedle patch of the combination applied to the skin of the subject is only made up of the microneedle array of Mahmood and the substrate of Mahmood. In this interpretation, the probes are not considered part of the microneedle patch at all since the probes are not attached to the patch before application and are therefore separate and distinct from the microneedle patch before application (see paragraph 0150 of Mahmood: “In some other kits, probes for detecting one or more biomarkers and reagents for their conjugation to the microneedles are provided as separate components.”). That is, there are times when the microneedle patch is only made up of the microneedles and bottom layer (i.e., the times when the probes are not connected to the microneedles at all). At these times, the combination teaches this physical construction of the kit of claim 6.
For the above reasons, claims 1 and 6 are properly rejected.
Claims 2-5 and 7-10 are properly rejected because claims 1 and 6 are properly rejected and the prior art teaches or suggests all the features of these claims. The Applicant’s vague assertion that the dependent claims are allowable “on their own merits” is not persuasive since no specific reasons were provided and the Examiner cannot find a reason to withdraw the rejections.
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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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 “[0063] ...The method includes measuring a level or combination of levels of one or more of ...IL-13, ...IL-4, ... or combinations thereof, in a first bodily fluid or skin sample, or both, extracted from a patient. The method also includes formulating a diagnosis of ...atopic dermatitis, eczema, ... or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measured level or combination of levels and on one or more expected correlations between said level or combination of levels and manifestation within said patient of one or more diseases....”
2 “[0063] ...The method includes measuring a level or combination of levels of one or more of ...IL-13, ...IL-4, ... or combinations thereof, in a first bodily fluid or skin sample, or both, extracted from a patient. The method also includes formulating a diagnosis of ...atopic dermatitis, eczema, ... or a skin ailment, lesion or sore, particularly of the scalp and also for other skin regions affected by an ailment that is susceptible to topical or hair treatment, as well as hair fall or hair loss conditions, or combinations thereof, for the patient based on said measured level or combination of levels and on one or more expected correlations between said level or combination of levels and manifestation within said patient of one or more diseases....”