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 .
Status of the Claims
Claims 1-8 are pending in the application.
Claims 4-8 are withdrawn.
Claims 1-3 are the subject of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3 in the reply filed on 10 February 2026 is acknowledged.
Priority
The instant application is a divisional of App. No 16/805,634, filed 28 February 2020, which claims provisional application 62/811,617 filed 28 February 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 January 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
An embedded hyperlink and/or other form of browser-executable code appears in at least Par. 67 of the instant 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:
In claim 1: “the first and second antibodies are configured to form a complex comprising a pathogen, the nonmagnetic metal, and the magnetic object
This limitation is interpreted under 112(f) because it recites a particular function associated with a particular element, wherein the structural description of the associated element is insufficient to support the recited function. That is, a generic first and second antibody are not necessarily capable of forming a complex comprising a pathogen, the nonmagnetic metal, and the magnetic object. As such, this limitation is interpreted in view of the associated structure provided in the instant specification. The instant specification indicates that formation of such a complex is facilitated by a first antibody which is capable of specifically binding to the pathogen and a second antibody which is either capable of specifically binding to the pathogen or is capable of specifically binding to the Fc region of the first antibody (see instant specification Par. 9-10 and instant claims 2-3).
In claim 1: “the nonmagnetic metal configured to associate with the electrode”
This limitation is interpreted under 112(f) because it recites a particular function associated with a particular element, wherein the structural description of the associated element in the claim is insufficient to support the recited function. That is, a generic nonmagnetic metal is not necessarily capable of associating with a generic electrode in any particular way, and the language “configured to” further implies some particular modification or disposition of the nonmagnetic metal which is responsible for facilitating this function. It is additionally noted, that the phrasing “associate with the electrode” is broad and not particularly defined. The instant specification does not explicitly define a particular type of association between the electrode and the nonmagnetic metal. The specification provides some discussion of an embodiment in which the nonmagnetic metal associates with the electrode by adhering to the surface of an electrode (see Par. 46), however, the particular structure(s) or modification(s) of the nonmagnetic metal required for or associated with this adherence are not defined. Further discussion of this limitation is provided in the 112(b) section below.
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 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 1-3 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 limitation “the nonmagnetic metal configured to associate with the electrode” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
As noted in the claim interpretation section above, the phrasing “associate with” is very broad and can encompass a wide variety of relationships between the electrode and the nonmagnetic metal which the specification does not explicitly define or enumerate. Additionally, the phrasing “configured to” implies some particular modification or disposition of the nonmagnetic metal which makes it suited for the recited function (i.e. it implies that this is not necessarily an inherent property of the nonmagnetic metal, but rather a result of some specific configuration of the magnetic metal).
The specification provides some discussion of an embodiment wherein the nonmagnetic metal adheres to the surface of an electrode (Par. 46) but it is not clear from the description what particular structural features facilitate this adherence. In light of this and the disclosure as a whole, the particular structural features of the nonmagnetic metal that are responsible for facilitating the recited association with the electrode are unclear, and thus the metes and bounds of the limitation “the nonmagnetic metal configured to associate with the electrode” are unclear.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Dependent claims 2-3 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al (US 2011/0053289 A1; IDS entered) in view of Mattingly (US 2009/0246800 A1; IDS entered).
Regarding claims 1-2, Lowe teaches a system for detecting an analyte in a sample comprising:
A first antibody coupled to a nonmagnetic metal (Par. 24-25: the second reagent may comprise a binding agent capable of binding to analyte in the first liquid. The binding agent of the second reagent may be capable of binding to a different epitope of the analyte than the binding agent of the first reagent. The binding agent of the second reagent may be an antibody. The second reagent may be conjugated to a second particle (e.g. a non-magnetic particle such as a sol particle (e.g. a gold sol)). The second particle may comprise at least one label; Par. 83, 458, 559, 645)
A second antibody coupled to a magnetic object (Par. 23: the first reagent may comprise magnetically susceptible particles comprising a binding agent adapted to bind to an analyte in the first liquid. The first binding agent may be an antibody that binds specifically to the analyte; Par. 82)
First and second antibodies configured to form a complex comprising a pathogen, the nonmagnetic metal, and the magnetic object (Par. 80: the method may include forming complexes of magnetically susceptible particle, analyte and second binding agent; Par. 464, 23-25)
A sample mixing chamber (Par. 75: introducing a liquid sample to a first portion of a channel of a microfluidic device and contacting the liquid sample with the magnetic particles)
A magnet positioned to be adjacent to the sample mixing chamber (Par. 75; Par. 98: positioning the magnetic particles can be performed using a magnet located external to the channel)
An electrode in selective communication with the sample mixing chamber (Par. 54: any sensor of the device may include at least one electrode; Par. 14: the device comprises an inlet in fluid connection with a first portion of a channel, the inlet configured to receive a liquid; a second portion of the channel connected to the first portion at a junction and containing flowable media between the junction and a detection zone is a second channel portion; Par. 18, 33, 423, 426-437, 479, 503)
The nonmagnetic metal configured to associated with the electrode (Par. 108-109: the method may comprise magnetically moving the magnetic particle adjacent to or upon a sensor located in or juxtaposed to the second channel portion of the device. The particle may be magnetically retained adjacent to or upon the sensor for an amount of time sufficient for the sensor to detect a characteristic of the second liquid. The method may include magnetically positioning the magnetic particles adjacent to or upon the one or more electrode for the detection of the analyte). That is, the nonmagnetic metal is understood to be “configured to associate” with the electrode in the invention of Lowe in that the nonmagnetic metal is configured to form a complex with the analyte and the magnetic particles (via specific binding of the first antibody to the analyte) such that the complex (comprising the nonmagnetic metal) may be magnetically positioned onto the electrode for detection of the analyte.
A voltmeter in communication with the electrode (Par. 336, 447, 471, 598).
Lowe teaches that the analyte is not particularly limited, but does not explicitly teach that the analyte is a pathogen (Par. 434: the analyte may be any analyte, and more particularly any analyte to which a binding agent, such as an antibody may be raised). Lowe teaches that it is particularly desirable to detect analytes which facilitate diagnosis of a pathological condition (Par. 411, 438)
Regarding claims 1-2, Mattingly teaches a method of detecting a pathogen in a sample which comprises a sandwich format immunoassay comprising anti-pathogen antibodies (Abstract; Par. 105). Mattingly teaches that the analyte detected may be a pathogen, wherein detection of a pathogen may be useful in diagnosis or monitoring of disease (Par. 29, 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Lowe for the detection of a pathogen, as taught by Mattingly. One of ordinary skill in the art would be motivated to make this modification because Lowe teaches that the system may be used for the detection of any analyte and that analytes which are useful for the detection of pathological conditions are of particular interest, while Mattingly teaches that pathogens may be detected by antibodies in an immunoassay and may be used to diagnose and monitor disease/pathological conditions. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Lowe teaches that the analyte may be any analyte that can be specifically bound by an antibody, and Mattingly teaches that pathogen analytes may be specifically bound and detected by antibodies.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al (US 2011/0053289 A1; IDS entered) in view of Mattingly (US 2009/0246800 A1; IDS entered) as applied to claim 1 above, and further in view of Thermo Fisher Scientific (Thermo Fisher Scientific Inc. Tech Tip #59: Choosing a secondary antibody: a guide to fragment specificity. 2007).
Regarding claim 3, Lowe differs from the instant claim in that it does not explicitly teach the system wherein the first antibody is specific for the pathogen and the second antibody is specific for the Fc region of the first antibody.
Regarding claim 3, Thermo Fisher Scientific teaches that the use of labeled secondary antibodies which bind to the Fc region of a primary antibody-analyte complex is a well-known and common method of labeling and thereby detecting a primary antibody-analyte complex. Thermo Fisher Scientific teaches that the use of a secondary antibody that binds to a primary antibody can be advantageous (Pg. 1, Introduction, Sections A and C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Lowe such that the first antibody is specific for the pathogen and the second antibody is specific for the Fc region of the first antibody. One would be motivated to make this modification because the use of a secondary antibody that binds specifically to the Fc region of an anti-analyte primary antibody is well-known in the art, as taught by Thermo Fisher Scientific and has a number of advantages. For example, the use of a secondary antibody that binds to the primary antibody mitigates potential steric hindrance between a first and second antibody that both bind to the same analyte molecule; a secondary antibody only needs to be specific for binding to the host species of the primary antibody (rather than specific to a particular epitope of the target analyte), and as such, these reagents are more generally available and easy to obtain, and can be used in a broader range of applications (i.e. the same Fc-binding secondary antibody can be used in the detection of a number of different analytes, as long as it is capable of binding to the chosen primary antibody, whereas an analyte-specific second antibody can only be used in the detection of one analyte); because they have a broader range of applications and are more generally available, secondary antibodies that bind to the Fc region of a primary antibody are generally commercially available and can be purchased in a pre-labeled state. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because Lowe teaches that a target analyte can be detected by a complex comprising first and second antibodies, while Thermo Fisher Scientific teaches that first and second antibodies used in the detection of an analyte may comprise a primary antibody that binds to the target analyte and a secondary antibody that binds to the Fc region of the primary antibody, and that this is a well-known detection method in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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