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.
Specifically, claim 1 recites “means for determining concentration of macrophage migration inhibitory factor (MIF) or fragment thereof and N-terminal prohormone of brain natriuretic peptide (Nt-proBNP) or fragment thereof in a sample from a subject”, which has been interpreted to mean any mechanism by which MIF, Nt-proBNP (or BNP) or troponin can be determined (assayed or quantified). For instance, plasma MIF, Nt-proBNP (or BNP) or troponin may be determined in a sample using any method known to those skilled in the art for detecting proteins including, but not limited to, for example immunoassays such as, for example ELISA, enzyme immunoassay (EIA), Western blot, slot blot, dot blot, or immunoprecipitation followed by sodium dodecyl sulfate polyacrylamide gel electrophoresis, (SDS-PAGE), chromatography and the like (as described on page 24 of the instant specification).
In addition, claim 2 recites “means for performing an immunoassay”, which is interpreted as immunoassays such as, for example ELISA, enzyme immunoassay (EIA), Western blot, slot blot, dot blot, or immunoprecipitation followed by sodium dodecyl sulfate polyacrylamide gel electrophoresis, (SDS-PAGE), chromatography, dendrimer-enhanced radial partition immunoassays and immunofluorescence assays (as described on pages 24-25 of the instant specification).
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amir et al (US PGPub 2015/0065372 A1).
Regarding Claims 1-2, Amir et al teaches a device comprising means for determining concentration of macrophage migration inhibitory factor (MIF) or fragment thereof and N-terminal prohormone of brain natriuretic peptide (Nt-proBNP) or fragment thereof in a sample from a subject (such as an immunoassay, such as ELISA or SDS-PAGE, for use in a method of treating acute coronary syndrome (ACS) in the subject (see [0013]-[0014], [0121], [0139], [0191] and [0217]).
Regarding Claim 3, Amir et al teaches that the device is a point of care device (see [0155]).
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henkin (US PGPub 2011/0166166 A1).
Regarding Claims 1-2, Henkin teaches a device comprising means for determining concentration of macrophage migration inhibitory factor (MIF) or fragment thereof and N-terminal prohormone of brain natriuretic peptide (Nt-proBNP) or fragment thereof in a sample from a subject (such as an immunoassay, such as ELISA or SDS-PAGE, for use in a method of treating acute coronary syndrome (ACS) in the subject (see [0039], [0175], [0224] and [0227]).
Regarding Claim 3, Henkin teaches that the device is a point of care device (see [0006], [0012] and [0058]).
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Buechler et al (US PGPub 2005/0148029).
Regarding Claims 1-2, Buechler et al teaches a device comprising means for determining concentration of macrophage migration inhibitory factor (MIF) or fragment thereof and N-terminal prohormone of brain natriuretic peptide (Nt-proBNP) or fragment thereof in a sample from a subject (such as an immunoassay, such as ELISA), for use in a method of treating acute coronary syndrome (ACS) in the subject ([0026], [0034], [0040] and [0149]).
Regarding Claim 3, Buechler et al teaches that the device is a point of care device (see [0027], [0043] and [0122]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
BEINEKE et al (US PGPub 20180356432) discloses markers (such as MIF and NT-proBN and methods useful for assessing coronary artery disease in a subject are provided, along with related kits, systems, and media. Also provided are predictive models, based on the markers, as well as computer systems, and software embodiments of the models for scoring and optionally classifying samples (see abstract, [0102] and Figure 1A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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