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.
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:
"an affecter molecule" in claim 3 and 20.
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. The specification does not clearly state what the affecter molecule is and/or its corresponding structure.
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
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.
Claim(s) 3 and 20 is/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 pre-AIA the applicant regards as the invention.
Claim limitation "an effecter molecule" in claims 3 and 20 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. 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-9, 13, and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hellinga (US 2003/0129622).
Regarding claim 1, Hellinga teaches a sensor comprising:
a first binding protein (Fig. 1; ¶21: protein which has a nature to be used dependent upon the analyte to be detected) configured to have a first conformation and a second conformation, wherein the first binding protein is in the first conformation when there is an analyte bound to a binding site of the first binding protein, and the first binding protein is in the second conformation when there is no analyte bound to the binding site of the first binding protein (¶21: the protein undergoes a conformational change upon binding to a ligand (analyte)),
wherein an electric signal is generated when the first binding protein is in the first conformation (Fig. 2; ¶9: upon ligand binding, the changes in the protein conformation, from open to closed, alter the interaction between the cofactor and electrode surface, and therefore the observed current flowing between these two component), the first binding protein comprising a binding site (¶21: ligand-binding site); and
a sensing electrode (Fig. 2; ¶9: gold electrode).
Regarding claim 2, Hellinga teaches a redox mediator (Fig. 2; ¶5: redox reporter; ¶8: Ru(II) redox cofactor) configured to create the electrical signal (¶9),
wherein
the redox mediator is not active or partially active when the first binding protein is in the first conformation (since the binding of the analyte to the binding protein would alter the interaction between the redox mediator and the electrode surface for generating the electrical signal, the first conformation of the binding protein, i.e., with bound analyte, would be deemed less active because it would not generate more electrical signal),
the redox mediator is active or relatively more active in comparison to the first conformation when the first binding protein is in the second conformation (since the binding of the analyte to the binding protein would alter the interaction between the redox mediator and the electrode surface for generating the electrical signal, the second conformation of the binding protein, i.e., without bound analyte, would be deemed more active because it would generate the electrical signal upon binding of the analyte).
Regarding claim 3, Hellinga teaches an affecter molecule (Fig. 2; ¶15: a self-assembled monolayer SAM bound to the conducting layer) configured to shift the electrical activity of the redox mediator when the redox mediator and the affecter molecule are in proximity;
wherein the redox mediator and affecter molecule are not in proximity when the first binding protein is in the first conformation,
the redox mediator and affecter molecule are in proximity when the first binding protein is in the second conformation (upon the ligand binding, i.e., the first conformation of the binding protein with bound analyte, the redox mediator is away from the SAM on the gold electrode, shown as grey in Fig. 2, which shows the redox mediator and SAM are not in proximity, and they are in proximity when the binding protein is in the second conformation, i.e., the redox mediator is approaching the SAM on the gold electrode, shown as black in Fig. 2; thus, the SAM is deemed to shift the electrical activity between the two conformations or when the redox mediator and the affecter molecule are in proximity).
Regarding claim 4, Hellinga teaches wherein the redox mediator is a Ru(II) cofactor (Fig. 2; ¶8: Ru(II) redox cofactor).
Regarding claim 5, Hellinga teaches the first binding protein comprising a glucose binding protein (Fig. 1B; ¶8: glucose binding protein GBP).
Regarding claim 6, Hellinga teaches wherein the glucose binding protein has a binding constant between about 100 nM to about 200 mM (e.g., Fig. 4B; ¶11: 2.0 µM).
Regarding claim 7, Hellinga teaches wherein the glucose binding protein has a binding constant between about 2 mM to about 22 mM (e.g., Fig. 5; ¶12: 18 mM).
Regarding claim 8, Hellinga teaches wherein the analyte comprises glucose (¶26: glucose).
Regarding claim 9, Hellinga teaches wherein the binding site of the first binding protein comprises a glucose binding site (Fig. 1B: GBP; ¶21; GBP must have a glucose binding site).
Regarding claim 13, Hellinga teaches a method of measuring a concentration of an analyte (¶2), comprising:
exposing the sensor of claim 1 (as described in claim 1) to a sample fluid (¶26: the blood stream); and
measuring an electrical signal generated from the sensor (¶18: a means for measuring a voltage or current generated by interaction between the reporter and the electrode).
Regarding claim 15, Hellinga teaches wherein the analyte comprises glucose (¶26: glucose).
Regarding claim 16, Hellinga teaches wherein the binding protein comprises a glucose binding protein (Fig. 1B; ¶8: glucose binding protein GBP).
Regarding claim 17, Hellinga teaches wherein the binding site comprises a glucose binding site (Fig. 1B: GBP; ¶21; GBP must have a glucose binding site).
Regarding claim 18, Hellinga teaches wherein the electrical signal is generated by a redox mediator (¶9: upon ligand binding, the changes in the protein conformation, from open to closed, alter the interaction between the cofactor and electrode surface, and therefore the observed current flowing between these two component).
Regarding claim 19, Hellinga teaches wherein
the redox mediator is not active or partially active when the binding protein is in the first conformation (since the binding of the analyte to the binding protein would alter the interaction between the redox mediator and the electrode surface for generating the electrical signal, the first conformation of the binding protein, i.e., with bound analyte, would be deemed less active because it would not generate more electrical signal),
the redox mediator is active or relatively more active in comparison to the first conformation when the binding protein is in the second conformation (since the binding of the analyte to the binding protein would alter the interaction between the redox mediator and the electrode surface for generating the electrical signal, the second conformation of the binding protein, i.e., without bound analyte, would be deemed more active because it would generate the electrical signal upon binding of the analyte).
Regarding claim 20, Hellinga teaches an affecter molecule (Fig. 2; ¶15: a self-assembled monolayer SAM bound to the conducting layer) configured to shift the electrical activity of the redox mediator when the redox mediator and the affecter molecule are in proximity;
wherein the redox mediator and affecter molecule are not in proximity when the first binding protein is in the first conformation,
the redox mediator and affecter molecule are in proximity when the first binding protein is in the second conformation (upon the ligand binding, i.e., the first conformation of the binding protein with bound analyte, the redox mediator is away from the SAM on the gold electrode, shown as grey in Fig. 2, which shows the redox mediator and SAM are not in proximity, and they are in proximity when the binding protein is in the second conformation, i.e., the redox mediator is approaching the SAM on the gold electrode, shown as black in Fig. 2; thus, the SAM is deemed to shift the electrical activity between the two conformations or when the redox mediator and the affecter molecule are in proximity).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hellinga in view of Amiss (US 2013/0302908).
Regarding claim 10, Hellinga discloses all limitations of claim 1, but fails to teach a second binding protein, wherein the first binding protein and second binding protein do not have the same binding constant.
However, Amiss teaches functional, modified glucose-galactose binding proteins (GGBPs), that have a greater melting temperature than a reference GGBP ([Abstract]). The modified glucose-galactose binding proteins may be used in an in vivo analyte assay, may have a greater dissociation constant than a reference protein (i.e., the binding of the modified protein to the target analyte is weaker; decreased binding affinity), or a smaller dissociation constant than a reference protein (i.e., the binding of the modified protein to the target analyte is stronger; increased binding affinity) (¶42). The modified proteins may be able to bind only one or more analyte that the reference binding protein does not bind (¶48).
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 Hellinga by incorporating a second binding protein, e.g., a modified protein having different binding affinity, as taught by Amiss because such modified protein may bind more analytes (¶48) so that the modified biosensor would detect multiple analytes. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 11-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hellinga in view of Shi (Q. Shi, Kinetically controlled synthesis of AuPt bi-metallic aerogels and their enhanced electrocatalytic performances, J. Mater. Chem. A, 2017(5), pp. 19626-31).
Regarding claims 11-12 and 14, Hellinga discloses all limitations of claims 1 and 13, respectively. Hellinga fails to teach wherein the sensing electrode comprises a nanowire network (claim 11) or the sensing electrode comprising a hydrogel (claim 12) or wherein measuring the electrical signal comprises using an electrode comprising a nanowire network (claim 14).
However, Shi teaches metallic hydrogels/aerogels have ultra-low density, profuse, porosity, and extra-large surface area combined with metals of excellent conductivity and catalytic performances (p. 19626, col. 1, para. 1), and thus result in remarkably enhanced electrochemical performances (p. 19626, col. 2, para. 1). Shi synthesizes AuPt5 metallic hydrogels having a 3D self-supported architectures from the macro-scope with typical jelly-like features, which indicate high electrochemical activities due to numerous open channels for mass diffusion and access to the inner active sites of the catalyst (p. 19629: Scheme 1; Fig. 1C; p. 19627, col. 1, para. 3). The detailed composition distribution of the nanowires was confirmed by HAADF-STEM-EDS mapping images, and the nanowires were composed of elements Pt and Au (Fig. (G-I), p. 19627, col. 1, para. 3).
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 Hellinga by incorporating a metallic hydrogel of nanowires into the sensing electrode as taught by Shi because the synthesizes AuPt5 metallic hydrogels have numerous open channels for mass diffusion and access to the inner active sites of the catalyst and thus result in high electrochemical activities (Fig. 1; p. 19627, col. 1, para. 3). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795