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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 3-5 and 10, in the reply filed on May 25, 2026 is acknowledged. The traversal is on the ground(s) that Groups II and III share a common technical feature which makes a special technical contribution over the prior art. Applicant asserts that the shared technical features between Groups II and III include an electrode for the electrochemical detection of an analyte in a biological sample, wherein the electrode is a printed miniaturized carbon-based electrode comprising magnetic nanoparticles, said magnetic nanoparticles comprising on their surface the compound of formula (I). Applicant asserts that the Office Action has not shown that those features define a contribution over the prior art. This is not found persuasive because unity of invention considers the shared technical feature among all of the groups. It is not the comparison of each pair of groups.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2 and 6-9 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 25, 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 Objections
Claim 3 is objected to because of the following informalities:
In line 1, “the electrochemical detection” should read “electrochemical detection”.
In line 7, “PO(OX)2 and (CH2)2(OH)” should read “PO(OX)2 or (CH2)2(OH)”.
In line 10, “CH2SO3X, CH2PO(OX)2” should read “CH2SO3X, or CH2PO(OX)2”.
In line 16, “C4H3S, C6H4-N2Y” should read “C4H3S, or C6H4-N2Y”.
In line 17, “positively charged atoms or groups” should read “a positively charged atom or group”.
In lines 17-18, “K+, NH4+” should read “K+, or NH4+”.
In line 19, “negatively charged atoms or groups” should read “a negatively charged atom or group”.
In line 19, “Cl-, BF4-” should read “Cl- or BF4-”.
Appropriate correction is required.
Claims 4-5 are objected to because of the following informalities: in lines 1-2 of each claim, “an analyte in a biological sample” should read “the analyte in the biological sample”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities:
In line 1, “the electrochemical detection” should read “electrochemical detection”.
In line 3, “said nanoparticles” should read “said gold-coated nanoparticles”.
In line 7, “PO(OX)2, (CH2)2(OH)” should read “PO(OX)2, or (CH2)2(OH)”.
In line 10, “CH2SO3X, CH2PO(OX)2” should read “CH2SO3X, or CH2PO(OX)2”.
In line 16, “C4H3S, C6H4-N2Y” should read “C4H3S, or C6H4-N2Y”.
In line 17, “positively charged atoms or groups” should read “a positively charged atom or group”.
In lines 17-18, “K+, NH4+” should read “K+, or NH4+”.
In line 19, “negatively charged atoms or groups” should read “a negatively charged atom or group”.
In line 19, “Cl-, BF4-” should read “Cl- or BF4-”.
Appropriate correction is required.
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.
Claims 3-5 and 10 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 “miniaturized” in claim 3 is a relative term which renders the claim indefinite. The term “miniaturized” 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. Claims 4-5 are rejected as dependent thereon.
Claim 3 recites the limitation "the compound of formula (I)" in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 4-5 are rejected as dependent thereon.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “R2 is selected from hydrogen, [heterocycle]-C(=O)OX, CH2-[heterocycle]-C(=O)OX, CH2SO3X, CH2PO(OX)2”, and the claim also recites “preferably said [heterocycle] is selected from piperidine, pyrrolidine or piperazine” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 4-5 are rejected as dependent thereon.
The term “miniaturized” in claim 4 is a relative term which renders the claim indefinite. The term “miniaturized” 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 term “miniaturized” in claim 10 is a relative term which renders the claim indefinite. The term “miniaturized” 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “R2 is selected from hydrogen, [heterocycle]-C(=O)OX, CH2-[heterocycle]-C(=O)OX, CH2SO3X, CH2PO(OX)2”, and the claim also recites “preferably said [heterocycle] is selected from piperidine, pyrrolidine or piperazine” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Montes-Garcia et al., Metal Nanoparticles and Supramolecular Macrocycles: A Tale of Synergy, Chem. Eur. J., Vol. 20, Issue 35, pp. 10874-10883 (2014) (hereinafter “Montes-Garcia”) in view of Motamedi et al. (US 2020/0300849 A1) and further in view of Thoden et al., Self-Assembled Monolayers of Receptor Adsorbates on Gold: Preparation and Characterization, J. Am. Chem. Soc., Vol. 116, pp. 3597-3598 (1994) (hereinafter “Thoden”) (provided in Applicant’s IDS filed on July 12, 2024) and further in view of Nunziata et al. (WO 2006/136950 A1).
Regarding claim 3, Montes-Garcia teaches an electrode for the electrochemical detection of an analyte in a biological sample (an electrode of a biocompatible electrochemical sensor for detection of analytes, Montes-Garcia, pg. 10875, left column, first paragraph, pg. 10881, right column, second paragraph), wherein the electrode is a printed miniaturized carbon-based electrode comprising nanoparticles (the electrode is a glassy carbon electrode comprising the combination of metal nanoparticles and supramolecular macrocycles on the electrode surface, Montes-Garcia, pg. 10881, right column, second paragraph).
Montes-Garcia teaches that the assembly of metal nanoparticles is highly appealing since it often leads to nanomaterials with unique or enhanced properties as a result of electromagnetic coupling (Montes-Garcia, pg. 10878, right column, second paragraph). Montes-Garcia teaches that the metal nanoparticles may be gold nanoparticles which are functionalized with calixarenes or resorcinarenes (Montes-Garcia, pg. 10878, left column, second paragraph, pg. 10879, right column, first paragraph). Montes-Garcia does not explicitly teach that the gold nanoparticles are magnetic.
Motamedi teaches microfluidic detection of a biological marker in a biospecimen using nanoparticle-based nanosensors comprising supramolecular recognition sequences (Motamedi, abstract). Motamedi teaches that the metal nanoparticles are bimagnetic and comprise a metal core and a metal shell (Motamedi, para. [0056]). Motamedi teaches that a preferred metal core/shell combination includes Fe/Au (Motamedi, para. [0056]). Motamedi teaches that the Fe core is magnetic (Motamedi, para. [0056]). Motamedi teaches that ligands such as resorcinarenes are attached to the nanoparticle’s metal surface (Motamedi, para. [0059]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the gold nanoparticles of Montes-Garcia with magnetic Fe core / Au shell nanoparticles as taught by Motamedi in order to yield the predictable result of metal nanoparticles functionalized with calixarenes or resorcinarenes to detect analytes. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Modified Montes-Garcia teaches said magnetic nanoparticles comprising on their surface calixarenes or resorcinarenes (Montes-Garcia, Figs. 2-3, pg. 10878, left column, second paragraph, right column, first paragraph, pg. 10879, right column, first paragraph). Modified Montes-Garcia fails to teach specifically the compound of formula (I)
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wherein:
R1 is selected from C2-6alkyl, (CH2)nC(=O)OX, SO3X, PO(OX)2 and (CH2)2OH, wherein n is an integer from 1 to 5;
R2 is selected from hydrogen, [heterocycle]-C(=O)OX, CH2-[heterocycle]-C(=O)OX, CH2SO3X, CH2PO(OX)2; preferably said [heterocycle] is selected from piperidine, pyrrolidine or piperazine;
R3 is selected from
- a saturated linear aliphatic group containing sulfur of molecular formula (CH2)mSH or (CH2)mS(CH2)mCH3 wherein m is independently at each occurrence an integer from 5 to 11; or
- an aromatic group of molecular formula C6H4-SH, C4H3S, C6H4-N2Y;
X is independently selected from positively charged atoms or groups comprising: Na+, K+, NH4+;
Y is selected from negatively charged atoms or groups comprising: Cl-, BF4-.
Thoden teaches host-guest interactions between macrocyclic receptor molecules and various guest species (Thoden, pg. 3597, left column, first paragraph). Thoden teaches resorcin[4]arene-based receptor molecules containing four alkyl sulfide chains which self-assemble on gold surfaces for use as active layers of sensors (Thoden, pg. 3597, left column, first paragraph, pg. 3598, right column, second paragraph). Thoden teaches compound 4b of Scheme 1 (Thoden, pg. 3598):
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wherein compound 4b teaches R = CH3, so when mapping to the claimed limitations:
R1 = CH3,
R2 = hydrogen,
R3 = (CH2)10S(CH2)9CH3.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the resorcinarenes of Modified Montes-Garcia with the compound 4b of Thoden in order to yield the predictable result of resorcinarene-based receptor molecules on the gold surface of the magnetic nanoparticles for sensing. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Thus, the compound 4b of Modified Montes-Garcia teaches the compound of formula (I) of claim 3, but R1 = CH3, and therefore fails to teach wherein R1 is C2-6alkyl.
Nunziata teaches the use of resorcin[4]arenes to absorb one or more analytes in a medium (Nunziata, abstract). Nunziata teaches host-guest complexes formed upon interaction between the analyte and resorc[4]arenes (Nunziata, pg. 1, lns. 21-22). Nunziata teaches that the resorc[4]arene is of formula I (Nunziata, pg. 9, lns. 19-20, pg. 10, lns. 1-10):
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wherein R1 is alkyl (Nunziata, pg. 9, lns. 19-20, pg. 10, lns. 1-10), and the alkyl group is preferably a C1-6 alkyl group (Nunziata, pg. 10, lns. 14-16). Thus, there is a finite number of identified, predictable alkyl groups (C1-6alkyl).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to have chosen C2-6alkyl from the finite number of identified alkyl groups as identified by Nunziata for R1 in order to achieve the predictable result of resorcarenes that can form complexes upon interaction with analytes with a reasonable expectation of success. MPEP § 2143(I)(E). Therefore, the compound 4b of Modified Montes-Garcia has been modified to teach wherein R1 is C2-6alkyl, and thus Modified Montes-Garcia teaches the compound of formula (I) of claim 3, wherein
R1 = C2-6alkyl,
R2 = hydrogen,
R3 = (CH2)10S(CH2)9CH3.
The Applicant is advised that the limitation “wherein the electrode is a printed… electrode” is a product-by-process limitation. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Thus, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I). The process of printing does not structurally change the electrode, so Modified Montes-Garcia’s electrode teaches the structure implied by the printed electrode as claimed.
The limitation “for the electrochemical detection of an analyte in a biological sample” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrode disclosed by Modified Montes-Garcia teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as recited in the rejection supra.
Regarding claim 4, Modified Montes-Garcia teaches wherein the magnetic nanoparticles are gold-coated magnetic nanoparticles (magnetic Fe core / Au shell nanoparticles, Motamedi, para. [0056], see modification supra).
Regarding claim 5, Modified Montes-Garcia teaches that the surface modification of the nanoparticles with the macrocycles can allow noncovalent interactions and host-guest interactions with a particular family of target analytes (Montes-Garcia, pg. 10875, left column, second paragraph, pg. 10881, left column, first paragraph, right column, first paragraph). The calixarene/resorcinarene embodiment of Modified Montes-Garcia is silent with respect to wherein the compound of formula (I) is non-covalently linked to at least one antibody able to detect said analyte.
However, another embodiment of Montes-Garcia teaches an antibody linked to the cyclodextrin macrocycles functionalized on the metallic nanoparticles (Montes-Garcia, abstract, Fig. 6, pg. 10875, left column, last paragraph). Montes-Garcia teaches the combination of metal nanoparticles and different families of supramolecular macrocycles including cyclo-dextrins and calixarenes which have noncovalent interactions in host-guest chemistry (Montes-Garcia, abstract, pg. 10875, left column, second paragraph, pg. 10881, left column, first paragraph).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of formula (I) of Modified Montes-Garcia to be noncovalently linked to an antibody as taught by an alternative embodiment in Fig. 6 of Montes-Garcia in order to yield the predictable result of the detection of analytes. Furthermore, 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).
The limitation “able to detect said analyte” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrode disclosed by Modified Montes-Garcia teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as recited in the rejection supra.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Montes-Garcia et al., Metal Nanoparticles and Supramolecular Macrocycles: A Tale of Synergy, Chem. Eur. J., Vol. 20, Issue 35, pp. 10874-10883 (2014) (hereinafter “Montes-Garcia”) in view of Motamedi et al. (US 2020/0300849 A1) and further in view of Thoden et al., Self-Assembled Monolayers of Receptor Adsorbates on Gold: Preparation and Characterization, J. Am. Chem. Soc., Vol. 116, pp. 3597-3598 (1994) (hereinafter “Thoden”) (provided in Applicant’s IDS filed on July 12, 2024).
Regarding claim 10, Montes-Garcia teaches an electrode for the electrochemical detection of an analyte in a biological sample (an electrode of a biocompatible electrochemical sensor for detection of analytes, Montes-Garcia, pg. 10875, left column, first paragraph, pg. 10881, right column, second paragraph), wherein the electrode is a printed miniaturized carbon-based electrode comprising nanoparticles (the electrode is a glassy carbon electrode comprising the combination of metal nanoparticles and supramolecular macrocycles on the electrode surface, Montes-Garcia, pg. 10881, right column, second paragraph).
Montes-Garcia teaches that the assembly of metal nanoparticles is highly appealing since it often leads to nanomaterials with unique or enhanced properties as a result of electromagnetic coupling (Montes-Garcia, pg. 10878, right column, second paragraph). Montes-Garcia teaches that the metal nanoparticles may be gold nanoparticles which are functionalized with calixarenes or resorcinarenes (Montes-Garcia, pg. 10878, left column, second paragraph, pg. 10879, right column, first paragraph). Montes-Garcia does not explicitly teach that the nanoparticles are gold-coated.
Motamedi teaches microfluidic detection of a biological marker in a biospecimen using nanoparticle-based nanosensors comprising supramolecular recognition sequences (Motamedi, abstract). Motamedi teaches that the metal nanoparticles are bimagnetic and comprise a metal core and a metal shell (Motamedi, para. [0056]). Motamedi teaches that a preferred metal core/shell combination includes Fe/Au (Motamedi, para. [0056]). Motamedi teaches that ligands such as resorcinarenes are attached to the nanoparticle’s metal surface (Motamedi, para. [0059]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the gold nanoparticles of Montes-Garcia with magnetic Fe core / Au shell nanoparticles as taught by Motamedi in order to yield the predictable result of metal nanoparticles functionalized with calixarenes or resorcinarenes to detect analytes. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Modified Montes-Garcia teaches said nanoparticles comprising on their surface calixarenes or resorcinarenes (Montes-Garcia, Figs. 2-3, pg. 10878, left column, second paragraph, right column, first paragraph, pg. 10879, right column, first paragraph). Modified Montes-Garcia fails to teach specifically the compound of formula (II):
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wherein
R1 is selected from hydrogen, alkyl, (CH2)nC(=O)OX, SO3X, PO(OX)2, (CH2)2OH, wherein n is an integer from 1 to 5;
R2 is selected from hydrogen, [heterocycle]-C(=O)OX, CH2-[heterocycle]-C(=O)OX, CH2SO3X, CH2PO(OX)2; preferably said [heterocycle] is selected from piperidine, pyrrolidine or piperazine;
R3 is selected from
- a saturated linear aliphatic group containing sulfur of molecular formula (CH2)mSH or (CH2)mS(CH2)mCH3; wherein m is independently at each occurrence an integer from 5 to 11; or
- an aromatic group of molecular formula C6H4-SH, C4H3S, C6H4-N2Y;
X is independently selected from positively charged atoms or groups comprising: Na+, K+, NH4+;
Y is selected from negatively charged atoms or groups comprising: Cl-, BF4-.
Thoden teaches host-guest interactions between macrocyclic receptor molecules and various guest species (Thoden, pg. 3597, left column, first paragraph). Thoden teaches resorcin[4]arene-based receptor molecules containing four alkyl sulfide chains which self-assemble on gold surfaces for use as active layers of sensors (Thoden, pg. 3597, left column, first paragraph, pg. 3598, right column, second paragraph). Thoden teaches compound 4b of Scheme 1 (Thoden, pg. 3598):
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wherein compound 4b teaches R = CH3, so when mapping to the claimed limitations:
R1 = CH3 (alkyl),
R2 = hydrogen,
R3 = (CH2)10S(CH2)9CH3.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the resorcinarenes of Modified Montes-Garcia with the compound 4b of Thoden in order to yield the predictable result of resorcinarene-based receptor molecules on the gold surface of the magnetic nanoparticles for sensing. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Modified Montes-Garcia teaches that the surface modification of the nanoparticles with the macrocycles can allow noncovalent interactions and host-guest interactions with a particular family of target analytes (Montes-Garcia, pg. 10875, left column, second paragraph, pg. 10881, left column, first paragraph, right column, first paragraph). The calixarene/resorcinarene embodiment of Modified Montes-Garcia is silent with respect to wherein said compound of formula (II) is non-covalently bound to at least one antibody able to detect said analyte.
However, another embodiment of Montes-Garcia teaches an antibody linked to the cyclodextrin macrocycles functionalized on the metallic nanoparticles (Montes-Garcia, abstract, Fig. 6, pg. 10875, left column, last paragraph). Montes-Garcia teaches the combination of metal nanoparticles and different families of supramolecular macrocycles including cyclo-dextrins and calixarenes which have noncovalent interactions in host-guest chemistry (Montes-Garcia, abstract, pg. 10875, left column, second paragraph, pg. 10881, left column, first paragraph).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of formula (II) of Modified Montes-Garcia to be noncovalently linked to an antibody as taught by an alternative embodiment in Fig. 6 of Montes-Garcia in order to yield the predictable result of the detection of analytes. Furthermore, 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).
The Applicant is advised that the limitation “wherein the electrode is a printed… electrode” is a product-by-process limitation. Generally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. Thus, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art. MPEP § 2113(I). The process of printing does not structurally change the electrode, so Modified Montes-Garcia’s electrode teaches the structure implied by the printed electrode as claimed.
The limitations “for the electrochemical detection of an analyte in a biological sample” and “able to detect said analyte” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The electrode disclosed by Modified Montes-Garcia teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or functional language as recited in the rejection supra.
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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