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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 3/26/2026 has been entered.
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 1, and 6 are objected to because of the following informalities:
in claim 1, line 16: “ELISA” should be “enzyme-linked immunosorbent assay (ELISA)”;
in claim 1, line 17: “the” should be inserted before “interleukin-4”;
in claim 1, line 15: “ELISA” should be “enzyme-linked immunosorbent assay (ELISA)”.
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 and 6 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 (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).
Paragraph 0063 of Shraibom, in part states:
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From the above passage, Shraibom teaches explicitly or implicitly that:
(1) any one of these options is sufficient for diagnosis or more than one of these options used in combination with others are sufficient for diagnosis;
(2) since IL-4 and IL13 are listed, point (1) then explicitly or implicitly connotes that one of these cytokines is sufficient for diagnosis or both of these cytokines is sufficient for diagnosis;
(3) any of the other members of the list (such as IFN-γ) could be used for diagnosis, but are not required if any other member is used (including IL-4 and IL13); and
(4) the diagnosis is eczema, i.e., atopic dermatitis;
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.
Mahmood teaches the use of probes attached to the microneedles. However, Mahmood teaches that the probes could be optional. For example, paragraph 0009 of Mahmood teaches that “In some cases, the device provides for a microneedle comprising a polymer, a metal or a ceramic. A first probe can be attached, covalently or non-covalently to a plurality of microneedles”. The “can be attached” indicates that the probe is optional. More importantly, paragraphs 0097 teaches that “In some cases, the total number of probes in a microneedle is less than about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…”. Similarly, paragraph 0109 of Mahmood teaches that “In some cases, the total number of probes in a microneedle device is less than about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…” while paragraph 0108 teaches that “In some cases, the total number of probes in a microneedle device is at least about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…”. Additionally, the number of microneedles can range from at least one to at most 10000 (paragraphs 0074-0076 of Mahmood). From these teachings, Mahmood contemplates less than one probe on the microneedle device (or zero probes on the total device). Further, Mahmood contemplates one probe on one microneedle on a device that has tens, hundreds, or thousands of microneedles with microneedles having “less than about 1” probe (i.e., zero probes on every microneedle except one with the one microneedle having one).
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 claims 1, the combination teaches or suggests a 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 (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)), each microneedle having an outer surface configured to adsorb thereto proteins from the skin of the subject (hyaluronic acid is an adsorbent; see paragraph 0055 of U.S. Patent Application Publication No. 2014/0012097); 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)(Mahmood contemplates zero probes on the microneedle device or one probe on one microneedle on a microneedle device that has tens, hundreds, or thousands of microneedles; thus, making the patch consistent essentially of the plurality of microneedles and the substrate);
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 (using the spectrophotometric ELISA plate reader of Finkelman as the ELISA testing of Mahmood; paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood);
reading amounts of interleukin-4 and interleukin-13, adsorbed onto the outer surfaces of the plurality of microneedles of the microneedle patch (the adsorption by the hyaluronic acid; paragraphs 0017, 0022-0023, 0029, 0048-0049, 0093, 0098, 0104, 0113, 0116, 0129, 0137 of Mahmood; hyaluronic acid is an adsorbent; see paragraph 0055 of U.S. Patent Application Publication No. 2014/0012097), 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),
wherein the quantitative testing is ELISA measurement (using the spectrophotometric ELISA plate reader of Finkelman as the ELISA testing of Mahmood; paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood),
wherein, in the ELISA measurement, interleukin-4 and the interleukin-13 are separated from the proteins including IFN-gamma (the ELISA plate reader of Finkelman reads IN-4 and IN-13 separately from the proteins not determined; also, the Applicant admits in the Remarks filed on 3/26/2026 that the ELISA, by definition, “relies on a physical separation step to work. The process uses antibodies that act like a magnet, grabbing only the specific targets…from the extracted…proteins. Once these targets are grabbed, a washing step flushes away everything else…This washing physically separates the biomarkers you need from the rest of the sample”).
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 as the ELISA testing of Mahmood; paragraphs 0049, 0070, 0128, 0130, and 0152 of Mahmood); and
a microneedle patch consisting essentially of: a plurality of microneedles, each microneedle including biodegradable polymer hyaluronic acid (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)), each microneedle having an outer surface configured to adsorb thereto the proteins (hyaluronic acid is an adsorbent; see paragraph 0055 of U.S. Patent Application Publication No. 2014/0012097); 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)(Mahmood contemplates zero probes on the microneedle device or one probe on one microneedle on a microneedle device that has tens, hundreds, or thousands of microneedles; thus, making the patch consist essentially of the plurality of microneedles and the substrate),
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:
perform ELISA measurement, wherein the device includes antibodies specific to interleukin-4 and interleukin-13 to separate the interleukin-4 and the interleukin-13 from the proteins including IFN-gamma by using the antibodies in the ELISA measurement (the ELISA plate reader of Finkelman reads IN-4 and IN-13 separately from the proteins not determined; also, the Applicant admits in the Remarks filed on 3/26/2026 that the ELISA, by definition, “relies on a physical separation step to work. The process uses antibodies that act like a magnet, grabbing only the specific targets…from the extracted …proteins. Once these targets are grabbed, a washing step flushes away everything else…This washing physically separates the biomarkers you need from the rest of the sample”),
read amounts of the interleukin-4 and the interleukin-13 adsorbed onto the outer 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).
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable 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 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 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 included in the plurality of microneedles” of claim 9 would have been obvious.
Alternatively, with respect to claim 9, the combination teaches or suggests the features of claim 9 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, claim 9 does not recite a structure that defines over the structure suggested by the combination.
Response to Arguments
Applicant’s arguments filed on 3/26/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 3/26/2026, the previous claim objections are withdrawn. However, there are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 3/26/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior are rejections
The Applicant asserts that Shraibom is completely silent with respect to the recitation “wherein the quantitative testing is ELISA measurement, wherein, in the ELISA measurement, interleukin-4 and the interleukin-13 are separated from the proteins including IFN-gamma”. In particular, the Applicant asserts that paragraph 0063 “specifically discloses IFN-gamma (i.e. IFN-γ) as a molecule that is used for diagnosing atopic dermatitis”. The Examiner respectfully disagrees. From paragraph 0063 of Shraibom (quoted in the above rejection of claims 1 and 6), Shraibom teaches explicitly or implicitly that:
(1) any one of the options is sufficient for diagnosis or more than one of the options used in combination with others are sufficient for diagnosis;
(2) since IL-4 and IL13 are listed, point (1) then explicitly or implicitly teaches that one of these cytokines is sufficient for diagnosis or both of these cytokines is sufficient for diagnosis;
(3) any of the other members of the list (such as IFN-γ) could be used for diagnosis, but are not required if any other member is used (including IL-4 and IL13); and
(4) the diagnosis is eczema, i.e., atopic dermatitis;
This is the plain language of the passage. 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.
The Applicant asserts that Shraibom is completely silent with regards to the ELISA. This argument is not persuasive since Mahmood and Finkelman are used to teach the ELISA.
The Applicant asserts:
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In particular, the Applicant discusses how the inclusion of the probes and the necessary surface functionalization to attach the probes would materially affect the basic and novel properties of the hyaluronic acid structure. According to the Applicant:
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These arguments are not persuasive since it is not commensurate with the rejection. Mahmood teaches the use of probes attached to the microneedles. However, Mahmood teaches that the probes could be optional. For example, paragraph 0009 of Mahmood teaches that “In some cases, the device provides for a microneedle comprising a polymer, a metal or a ceramic. A first probe can be attached, covalently or non-covalently to a plurality of microneedles”. The “can be attached” indicates that the probe is optional. More importantly, paragraphs 0097 teaches that “In some cases, the total number of probes in a microneedle is less than about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…”. Similarly, paragraph 0109 of Mahmood teaches that “In some cases, the total number of probes in a microneedle device is less than about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…” while paragraph 0108 teaches that “In some cases, the total number of probes in a microneedle device is at least about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 12…”. Additionally, the number of microneedles can range from at least one to at most 10000 (paragraphs 0074-0076 of Mahmood). From these teachings, Mahmood contemplates less than one probe on the microneedle device (or zero probes on the total device). Further, Mahmood contemplates one probe on one microneedle on a device that has tens, hundreds, or thousands of microneedles with microneedles having “less than about 1” probe (i.e., zero probes on every microneedle except one).
From these teachings, the probes are optional or are so scarce as to not materially affect the basic form and function of the combination relative to the claimed device. Additionally, the hyaluronic acid (an adsorbent material) remains primarily intact at the surface due to the lack of or extreme scarcity of probes.
The Applicant also states that Mahmood teaches away from the microneedles having no probe. The Examiner respectfully disagrees for the same reasons as provided above. That is Mahmood explicitly or implicitly teaches the lack of or extreme scarcity of probes on the microneedle device. An embodiment that is not preferred or optimal is not teaching away from an embodiment.
For at least the above reasons, the rejections of the claims are proper.
Conclusion
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
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