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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a monitoring device” in claim 18;
“a monitoring device” in claim 34; and
“at least one monitoring device” in claim 37.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 18, 30 and 37 is/are objected to because of the following informalities: the positive recitation of “for introducing said allergen or allergens into the skin” is recommended to recite “configured for introducing said allergen or allergens into the skin”, or the like, to avoid any semblance of non-statutory nature such that a portion of a human organism is not explicitly, implicitly, inferentially, and/or inherently required by the claim language. Appropriate correction is required.
Claim 37 is objected to because of the following informalities: there appears to be a missing “,” or “;” at the end of line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 29 and 35 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.
The term “preferably” in claim 29 is a relative/conditional term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to if “preferably on a relative scale” is required.
The term “preferably” in claim 35 is a relative/conditional term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to if “preferably the microneedle array comprises pyrolytic carbon” is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24 and 26-28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 24 recites “array can detect…”. Claims 26-28 each positively recite “the allergic reaction can be detected within…”. However, the recitation of the optional “can” is not required such that the claims fail to further limit. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sexton et al. (WO 2009/079589 A2, hereinafter Sexton).
For claim 18, Sexton discloses a system for determining an allergic reaction in skin (Figs 19-22) (Pgs 34-47), the system comprising inter alia:
allergen or allergens (1020) (Figs 19-22) (Pgs 34-47),
a microneedle array (810) with a microneedle configured (810) to receive said allergen or allergens (Figs 19-22) (Pgs 34-47), for introducing said allergen or allergens into the skin (Figs 19-22) (Pgs 34-47), wherein the microneedle is able to detect an electrochemical signal as a response to the introduced allergen (Figs 19-22) (Pgs 34-47), and
a monitoring device (510) for receiving the electrochemical signal detected by said microneedle, said electrochemical signal being indicative for an allergic reaction in the skin (Figs 19-22) (Pgs 34-47).
For claim 19, Sexton discloses the system according to claim 18, wherein said electrochemical signal is detected by said microneedle in the skin (Figs 19-22) (Pgs 34-47).
For claim 20, Sexton discloses the system according to claim 18, wherein said electrochemical signal is detected by said microneedle outside the skin (Figs 19-22) (Pgs 34-47).
For claim 21, Sexton discloses the system according to claim 18, wherein said electrochemical signal is triggered by biomarkers inherently released by activated mast cells (Figs 19-22) (Pgs 34-47).
For claim 22, Sexton discloses the system according to claim 18, wherein the electrochemical signal is triggered by biomarkers selected from the list consisting of histamine, chymase, and tryptase (Figs 19-22) (Pgs 34-47).
For claim 23, Sexton discloses the system according to claim 18, wherein the electrochemical signal is triggered by histamine inherently released by activated mast cells (Figs 19-22) (Pgs 34-47).
For claim 24, Sexton discloses the system according to claim 21, wherein said microneedle array can detect signals triggered by said biomarkers in concentration below 900 nM (Figs 19-22) (Pgs 34-47).
For claim 25, Sexton discloses the system according to claim 18, wherein the monitoring device is configured to receive, process and/or record an electrochemical signal from one or more electrode(s) arranged in said microneedle (Figs 19-22) (Pgs 9-15, 34-47).
For claim 26, Sexton discloses the system according to claim 18, wherein the allergic reaction can be detected within an hour (Figs 19-22) (Pgs 34-47).
For claim 27, Sexton discloses the system according to claim 18, wherein the allergic reaction can be detected within 20 minutes (Figs 19-22) (Pgs 34-47).
For claim 28, Sexton discloses the system according to claim 18, wherein the allergic reaction can be detected within 10 minutes (Figs 19-22) (Pgs 34-47).
For claim 29, Sexton discloses the system according to claim 18, wherein the system is adapted for measuring said electrochemical signal as a response to the introduced allergen so as to provide a quantitative indication for said allergic reaction in the skin (Figs 19-22) (Pgs 9-15, 34-47), preferably on a relative scale.
For claim 30, Sexton discloses a microneedle array, comprising inter alia:
a microneedle (810) configured to receive an allergen (1020) (Figs 19-22) (Pgs 9-15, 34-47), wherein the microneedle comprises an electrochemical sensor (Figs 19-22) (Pgs 9-15, 34-47) configured to receive, process and/or record an electrochemical signal triggered by the allergen (Figs 19-22) (Pgs 9-15, 34-47).
For claim 31, Sexton discloses the microneedle array according to claim 30, wherein the microneedle array comprises a plurality of microneedles (810) arranged in a predetermined pattern (Figs 19-22) (Pgs 9-15, 34-47).
For claim 32, Sexton discloses the microneedle array according to claim 30, wherein the microneedle array comprises at least 2 microneedles (Figs 19-22) (Pgs 9-15, 34-47).
For claim 33, Sexton discloses the microneedle array according to claim 30, wherein the microneedles are connectable to a monitoring device in groups of 2 or more (Figs 19-22) (Pgs 9-15, 34-47).
For claim 34, Sexton discloses the microneedle array according to claim 30, wherein the microneedles are individually connectable to a monitoring device (Figs 19-22) (Pgs 9-15, 34-47).
For claim 35, Sexton discloses the microneedle array according to claim 30, wherein the microneedle array comprises a conductive material (Figs 19-22) (Pgs 9-15, 34-47), preferably the microneedle array comprises pyrolytic carbon.
For claim 36, Sexton discloses the microneedle array according to claim 30, wherein the of microneedles have a length of at least 400 µm (Figs 19-22) (Pgs 9-15, 34-47).
For claim 37, Sexton discloses a set of parts for detecting an allergic reaction in the skin (Figs 19-22) (Pgs 9-15, 34-47), the set of parts comprising inter alia:
allergen or allergens (1020) (Figs 19-22) (Pgs 9-15, 34-47),
a microneedle array according to claim 30 (as above), and
at least one monitoring device (510) for receiving the electrochemical signal detected by said microneedle array in the skin (Figs 19-22) (Pgs 9-15, 34-47), said electrochemical signal being indicative for an allergic reaction in the skin (Figs 19-22) (Pgs 9-15, 34-47).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring a microneedle assay to electrochemically evaluate and monitor allergic reaction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791