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 .
Response to Amendment
The Amendment filed 04/22/2026 has been entered. Claims 16-25 and 32-33 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 01/26/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 33 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 33, claim 33 recites “a face having a free surface”. While the specification (paragraph [0126]) and Fig. 2 teaches the port 41 having an outer face 42, the disclosure fails to describe “a free surface”. Note that any negative limitation or exclusionary proviso must have basis in the original disclosure (MPEP 2173.05 (i)). Therefore, the claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
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 16-18, 20-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Grant et al. (GRANT et al., "Effects of immobilization on a FRET immunosensor for the detection of myocardial infarction", ANAL. BIOANAL. CHEM., vol 381, No. 5, March 2005, pages 1012-1018, XP019327187; cited in the IDS filed 03/10/2023) in view of Kalkum et al. (US 20090176259 A1).
Regarding claim 16, Grant teaches a device (abstract and Figs. 1-2 teach an optical biosensor) for detecting a target molecule and/or measuring the concentration of a target molecule (interpreted as an intended use of the device, see MPEP 2114; abstract and Figs. 3-5 teach the optical biosensor is for detecting a target molecule and concentration response of the biosensors) comprising:
a substrate (Figs. 1-2 and page 1014, sections “preparation of optical fibers” and “treatment of fibers with MTS and GMBS” teach silica fibers, i.e. substrate) at the surface of which a grafting molecule is covalently attached (page 1014, sections “preparation of optical fibers” and “treatment of fibers with MTS and GMBS” teach silanization was used as the immobilization technique, where the silica fibers were silanized and treated with MTS and GMBS; therefore, the surface has a grafting molecule that includes silane and GMBS covalently bonded to the surface);
at least one fluorescent probe (Fig. 1; page 1013, section “Materials”) comprising:
at least one receptor (antibody) bonded to a polypeptide (protein A);
two fluorochromes Fa (donor fluorophore) and Fb (acceptor fluorophore);
wherein the fluorochrome Fa is bonded to the receptor (Fig. 1 teaches “antibody-donor”, where the donor fluorophore is bonded or attached to the antibody) and the fluorochrome Fb is bonded to the polypeptide (Fig. 1 teaches “protein A-acceptor”, where the acceptor fluorophore is bonded or attached to the protein A); and
the fluorochromes Fa and Fb form a FRET (Fluorescence Resonance Energy Transfer) donor/acceptor pair (Fig. 1 teaches a FRET immunosensor; page 1013, second full paragraph teaches the FRET biosensor formed from the donor and acceptor fluorophores, therefore the donor and acceptor fluorophores form the FRET donor/acceptor pair);
wherein the polypeptide is bonded to the grafting molecule (page 1014, section “immobilization of PA and antibody” teaches the protein A was immobilized to the silanized fibers, therefore the protein A is bonded to the grafting molecule of the fiber surface).
Grant fails to teach: the at least one receptor bonded to the polypeptide via a covalent bond; wherein the polypeptide is bonded to the grafting molecule via a covalent bond.
Grant teaches protein A was immobilized to the silanized fibers (page 1014, section “immobilization of PA and antibody”).
Kalkum teaches an assay for detection of toxin or enzyme (abstract). Kalkum teaches antibodies are cross-linked to protein A (paragraph [0012]; Fig. 1), wherein cross-linking is implied to have a covalent bond. Kalkum teaches embodiments comprising a FRET pair with a donor and acceptor (paragraph [0074]). Kalkum teaches immobilization of antibodies to a matrix can be by a variety of methods, such as covalent crosslinking (paragraph [0041]). Kalkum teaches antibodies covalently linked to a protein A support (paragraph [0055]).
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 fluorescent probe of Grant to incorporate Kalkum’s teachings of bonding an antibody with a protein (Fig. 1; paragraph [0012]) and covalent crosslinking of antibodies with a matrix or support (paragraphs [0041],[0055]) and Grant’s teachings of protein A was immobilized to the silanized fibers (page 1014, section “immobilization of PA and antibody”) to provide: the at least one receptor bonded to the polypeptide via a covalent bond; wherein the polypeptide is bonded to the grafting molecule via a covalent bond. Doing so would have a reasonable expectation of successfully improving attaching the receptor with the polypeptide and the polypeptide to the grafting molecule of the substrate.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. bonding of the claimed elements via a covalent bond) by known methods with no change in their respective functions, and the combinations yielded nothing more than predictable results (i.e. providing the elements bonded via a covalent bond would yield nothing more than the obvious and predictable result of improving attaching the receptor with the polypeptide and the polypeptide to the grafting molecule of the substrate). See MPEP 2143(A).
Regarding claim 17, Grant further teaches wherein the receptor is chosen from antibody, antibody fragment, aptamer, peptides, or a derivative thereof (Fig. 1, antibody).
Regarding claim 18, Grant further teaches wherein the polypeptide is a binding protein chosen from protein G, protein L, protein A, protein Z, protein M, immunoglobulin, a complete or partial immunoglobulin, or a derivative thereof (Fig. 1, protein A).
Regarding claim 20, Grant further teaches wherein the fluorochromes Fa (Fig. 1; page 1013, section “Materials”, donor fluorophore) and/or Fb (Fig. 1; page 1013, section “Materials”, acceptor fluorophore) are chosen from fluorescent molecules or fluorescent proteins (page 1013, section “Materials” teaches Alexa Fluor 546 (AF546) and Alexa Fluor 594 (AF594) are used as the donor and acceptor fluorophores, i.e. fluorescent molecules).
Regarding claim 21, Grant further teaches wherein the substrate is chosen from a cell culture plate, a well plate, a film, a strip, an agarose gel, a cellulose gel, nanoparticles or microparticles, a microscope slide, a glass strip, the periphery of an optical fibre or a substrate configured to be attached to head of an optical fibre (Figs. 1-2 and page 1014, sections “preparation of optical fibers” and “treatment of fibers with MTS and GMBS” teach silica fibers, i.e. the periphery of an optical fibre or a substrate configured to be attached to head of an optical fibre).
Regarding claim 24, Grant further teaches wherein the grafting molecule (page 1014, sections “preparation of optical fibers” and “treatment of fibers with MTS and GMBS” teach silanization was used as the immobilization technique, where the silica fibers were silanized and treated with MTS and GMBS; therefore, the surface has a grafting molecule that includes silane and GMBS covalently bonded to the surface) comprises at least two reactive groups chosen from maleimide, N- Hydroxysuccinimide (NHS) ester, sulfo N-hydroxysuccinimide ester, sulfo-NHS, azide, alkyne, epoxide, carboxylic acid, aldehyde, aziridine, alkene, or a derivative thereof (page 1014, sections “preparation of optical fibers” and “treatment of fibers with MTS and GMBS” teach silanization was used as the immobilization technique, where the silica fibers were silanized and treated with MTS and GMBS; therefore the grafting molecule including GMBS, which structurally includes maleimide and NHS ester groups).
Claims 19 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Kalkum as applied to claim 16 above, and further in view of Wilson et al. (US 20210178290 A1; effectively filed 04/18/2018).
Regarding claim 19, while Grant teaches the polypeptide is protein A (abstract), modified Grant fails to teach: wherein the polypeptide comprises between 2 and 100 amino acids.
Wilson teaches detection of analytes in a flow cell using fluorescence (abstract). Wilson teaches detection of fluorescence intensity can use multiple molecular recognitions agents recognizing the target, which interact by FRET (paragraph [0030]). Wilson teaches a recognition element can be proteins including but not limited to protein A or short peptide chain with the specific binding capability, such as TWKTSRISIF (SEQ ID NO: 1) and RRGW (SEQ ID NO: 16), which comprises 10 and 4 amino acids respectively (paragraph [0013]).
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 polypeptide of modified Grant to incorporate the teachings of polypeptides comprising between 2 and 100 amino acids of Wilson (paragraph [0013]) to provide: wherein the polypeptide comprises between 2 and 100 amino acids. Doing so would have a reasonable expectation of successfully improving recognition of desired targets a taught by Wilson.
Additionally, since Wilson teaches known alternatives of polypeptides to Protein A, such as comprising between 2 and 100 amino acids of Wilson (paragraph [0013]), 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 Grant to incorporate the teachings of polypeptides comprising between 2 and 100 amino acids of Wilson (paragraph [0013]) to provide: wherein the polypeptide comprises between 2 and 100 amino acids. I.e. It would have been obvious to have substituted one known element (Grant’s Protein A) for another (Wilson’s short peptides having 4 or 10 peptides), and the results of the substitution would have been predictable (allowing for detection of a desired target via FRET). See MPEP 2143(I)(B).
Regarding claim 32, modified Grant fails to teach: wherein the polypeptide comprises between 4 and 50 amino acids.
Wilson teaches detection of analytes in a flow cell using fluorescence (abstract). Wilson teaches detection of fluorescence intensity can use multiple molecular recognitions agents recognizing the target, which interact by FRET (paragraph [0030]). Wilson teaches a recognition element can be proteins including but not limited to protein A or short peptide chain with the specific binding capability, such as TWKTSRISIF (SEQ ID NO: 1) and RRGW (SEQ ID NO: 16), which comprises 10 and 4 amino acids respectively (paragraph [0013]).
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 polypeptide of modified Grant to incorporate the teachings of polypeptides comprising between 4 and 50 amino acids of Wilson (paragraph [0013]) to provide: wherein the polypeptide comprises between 4 and 50 amino acids. Doing so would have a reasonable expectation of successfully improving recognition of desired targets a taught by Wilson.
Additionally, since Wilson teaches known alternatives of polypeptides to Protein A, such as comprising between 4 and 50 amino acids of Wilson (paragraph [0013]), 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 Grant to incorporate the teachings of polypeptides comprising between 4 and 50 amino acids of Wilson (paragraph [0013]) to provide: wherein the polypeptide comprises between 4 and 50 amino acids. I.e. It would have been obvious to have substituted one known element (Grant’s Protein A) for another (Wilson’s short peptides having 4 or 10 peptides), and the results of the substitution would have been predictable (allowing for detection of a desired target via FRET). See MPEP 2143(I)(B).
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Kalkum as applied to claim 21 above, and further in view of Loeb et al. (US 20070010726 A1).
Regarding claim 22, modified Grant fails to teach: wherein the substrate is a polymer film.
Loeb teaches a biosensing device for detecting biological analytes, wherein the device comprises an optical fiber, and light from fluorescent molecules are analyzed (abstract; Figs. 1-2). Loeb teaches the optical fiber has an end comprising a polymer matrix and at least one fluorescent molecule covalently bound to the polymer matrix upon interaction with a molecule (paragraph [0010]). Loeb teaches a biosensing material comprises an analyte-specific biomolecule immobilized in a polymer matrix which is in contact with the internal end of the transmitting member, wherein analytes bind to the biosensing material and results in fluorescent changes (paragraph [0044]; Figs. 1-2). Loeb teaches coatings could be applied to the outer surface of the optical fiber or transmitting member to enhance the attachment of the biosensing material and/or the containment matrix thereto (paragraphs [0060]-[0061]); and these coatings may facilitate a stable interface between the transmitting member and the biosensing material such that these components of the device remain in operative communication; and these coatings may encourage a stable interface between the transmitting member and the containment matrix, so that where desired, the biosensing material is isolated from the patient tissue and reaction products are maintained in a concentrated area for detection (paragraph [0061]). Loeb teaches a typical Teflon outer jacket, i.e. polymer film, provides a surface that binds tightly to PEG derivatives that have been end-functionalized (paragraph [0061]).
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 substrate of modified Grant to incorporate the teachings of biosensing devices comprising an optical fiber with a Teflon outer jacket and polymer matrix of Loeb (paragraphs [0010],[0044],[0060]-[0061]) to provide: wherein the substrate is a polymer film. Doing so would have a reasonable expectation of successfully enhancing the attachment of a biosensing material and/or the containment matrix to the substrate, facilitating a stable interface between a transmitting member and biosensing material, and therefore improving sensing as taught by Loeb (paragraphs [0060]-[0061]).
Regarding claim 23, modified Grant fails to teach: wherein the polymer film is chosen from polyethylene terephthalate, fluorinated polyethylene-co-propylene, polymethylmethacrylate, polytetrafluoroethylene, polymethylpentene, polyvinyl chloride, styrene methyl methacrylate, polyethylene naphthalate, derivatives thereof or a mixture thereof.
Loeb teaches a biosensing device for detecting biological analytes, wherein the device comprises an optical fiber, and light from fluorescent molecules are analyzed (abstract; Figs. 1-2). Loeb teaches the optical fiber has an end comprising a polymer matrix and at least one fluorescent molecule covalently bound to the polymer matrix upon interaction with a molecule (paragraph [0010]). Loeb teaches a biosensing material comprises an analyte-specific biomolecule immobilized in a polymer matrix which is in contact with the internal end of the transmitting member, wherein analytes bind to the biosensing material and results in fluorescent changes (paragraph [0044]; Figs. 1-2). Loeb teaches coatings could be applied to the outer surface of the optical fiber or transmitting member to enhance the attachment of the biosensing material and/or the containment matrix thereto (paragraphs [0060]-[0061]); and these coatings may facilitate a stable interface between the transmitting member and the biosensing material such that these components of the device remain in operative communication; and these coatings may encourage a stable interface between the transmitting member and the containment matrix, so that where desired, the biosensing material is isolated from the patient tissue and reaction products are maintained in a concentrated area for detection (paragraph [0061]). Loeb teaches a typical Teflon outer jacket, i.e. polytetrafluoroethylene film, provides a surface that binds tightly to PEG derivatives that have been end-functionalized (paragraph [0061]).
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 substrate of modified Grant to incorporate the teachings of biosensing devices comprising an optical fiber with a Teflon outer jacket and polymer matrix of Loeb (paragraphs [0010],[0044],[0060]-[0061]) to provide: wherein the polymer film is chosen from polytetrafluoroethylene. Doing so would have a reasonable expectation of successfully enhancing the attachment of a biosensing material and/or the containment matrix to the substrate, facilitating a stable interface between a transmitting member and biosensing material, and therefore improving sensing as taught by Loeb (paragraphs [0060]-[0061]).
Claims 25 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Kalkum as applied to claim 16 above, and further in view of Tan et al. (US 20050254062 A1).
Regarding claim 25, Grant further teaches the device according to claim 16, further comprising an optical fibre (Fig. 2, “fiber”) and an exploration head (Fig. 2, sensing tip). Modified Grant fails to teach: wherein said exploration head comprises a body and an emission face, at least a part of the emission face is transparent forming a port, the substrate being said port.
Tan teaches an apparatus for detecting the presence or amount of an analyte in a sample solution, the apparatus including an optical assembly and a surface formed by a layer of analyte binding molecules (abstract). Tan teaches the apparatus is based on fiber optic interferometry (paragraph [0004]). Tan teaches an exploration head (Figs. 1-2) comprises a body (body of optical fiber 32) and an emission face (face of transparent optical element 38), at least a part of the emission face is transparent forming a port, i.e. substrate, (Fig. 2 and paragraph [0054] teaches a transparent optical element 38 which is interpreted as forming a port or substrate at the end of the optical fiber 32). Tan teaches the transparent optical element in the assembly allows for detection of analyte via measurement of change in interference of light (paragraphs [0012]-[0014]).
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 said exploration head of modified Grant to incorporate the teachings of an optical assembly with an exploration head including a transparent port or substrate of Tan (Figs. 1-2; paragraphs [0004],[0012]-[0014],[0054]) to provide: wherein said exploration head comprises a body and an emission face, at least a part of the emission face is transparent forming a port, the substrate being said port. Doing so would have a reasonable expectation of successfully improving optical transmission and detection of desired light for detection of an analyte as taught by Tan.
Regarding claim 33, modified Grant fails to explicitly teach: the device according to claim 25, wherein the port comprises a single element and presents a face contacting the optical fibre and a face having a free surface.
Tan teaches an apparatus for detecting the presence or amount of an analyte in a sample solution, the apparatus including an optical assembly and a surface formed by a layer of analyte binding molecules (abstract). Tan teaches the apparatus is based on fiber optic interferometry (paragraph [0004]). Tan teaches an exploration head (Figs. 1-2) comprises a body (body of optical fiber 32) and an emission face (face of transparent optical element 38), at least a part of the emission face is transparent forming a port, i.e. substrate, (Fig. 2 and paragraph [0054] teaches a transparent optical element 38 which is interpreted as forming a port or substrate at the end of the optical fiber 32); wherein the port (Fig. 2 and paragraph [0054] teaches a transparent optical element 38 which is interpreted as forming a port or substrate at the end of the optical fiber 32) comprises a single element (Fig. 2, transparent optical element 38 is a single element) and presents a face (Fig. 2, face of optical element 38 at surface 40) contacting the optical fibre (Fig. 2, face of optical element 38 at surface 40 is contacting optical fiber 32 that includes surface 40) and a face (Fig. 2, lower distal surface of element 38) having a free surface (Fig. 2, the lower distal surface of element 38 is interpreted as a “free surface” which is free and open since it is not attached to the optical fiber 32). Tan teaches the transparent optical element in the assembly allows for detection of analyte via measurement of change in interference of light (paragraphs [0012]-[0014]).
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 said exploration head of modified Grant to incorporate the teachings of an optical assembly with an exploration head including a transparent port or substrate of Tan (Figs. 1-2; paragraphs [0004],[0012]-[0014],[0054]) to provide: wherein the port comprises a single element and presents a face contacting the optical fibre and a face having a free surface. Doing so would have a reasonable expectation of successfully improving optical transmission and detection of desired light for detection of an analyte as taught by Tan.
Response to Arguments
Applicant’s arguments, see page 5, filed 04/22/2026, with respect to the claim objections and rejection under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejection under 35 U.S.C. 112(b) of 01/26/2026 have been withdrawn.
Applicant's arguments, pages 5-9, filed 04/22/2026, with respect to the rejections under 35 U.S.C. 103, specifically regarding claim 16, have been fully considered but they are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references of Grant and Kalkum since they teach crosslinking to different materials and the modification would reduce antibody affinity (Remarks, pages 7-9), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Grant provides teachings that protein A was immobilized to the silanized fibers (page 1014, section “immobilization of PA and antibody”), but is silent on the specific type of bonds used to bind elements together. Specifically, Grant fails to teach: the at least one receptor bonded to the polypeptide via a covalent bond; wherein the polypeptide is bonded to the grafting molecule via a covalent bond.
Kalkum provides teachings teaches an assay for detection of toxin or enzyme (abstract), which is an analogous art since it is in the same field of endeavor. Kalkum provides teachings of: antibodies are cross-linked to protein A (paragraph [0012]; Fig. 1), wherein cross-linking is implied to have a covalent bond; embodiments comprising a FRET pair with a donor and acceptor (paragraph [0074]); immobilization of antibodies to a matrix can be by a variety of methods, such as covalent crosslinking (paragraph [0041]); and antibodies covalently linked to a protein A support (paragraph [0055]). Kalkum teaches that immobilization of the antibodies to a matrix via covalent crosslinking allows for a target molecule to be captured while retaining enzymatic function and specificity for its substrate (paragraph [0041]).
Since Kalkum teaches an assay for detection of a target molecule including antibodies and protein A, similar to Grant, it would have been obvious to one of ordinary skill in the art to have modified the fluorescent probe of Grant to incorporate Kalkum’s teachings of cross-linked bonding of an antibody with a protein A (Fig. 1; paragraph [0012]) and covalent crosslinking of antibodies with a matrix or support (paragraphs [0041],[0055]) and Grant’s teachings of protein A was immobilized to the silanized fibers (page 1014, section “immobilization of PA and antibody”) to provide: the at least one receptor bonded to the polypeptide via a covalent bond; wherein the polypeptide is bonded to the grafting molecule via a covalent bond. Doing so would have a reasonable expectation of successfully improving attaching the receptor with the polypeptide and the polypeptide to the grafting molecule of the substrate; and therefore allowing for appropriate interaction with a target molecule as taught by Kalkum (paragraph [0041]).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. bonding of the claimed elements via a covalent bond) by known methods with no change in their respective functions, and the combinations yielded nothing more than predictable results (i.e. providing the elements bonded via a covalent bond would yield nothing more than the obvious and predictable result of improving attaching the receptor with the polypeptide and the polypeptide to the grafting molecule of the substrate). See MPEP 2143(A).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed limitations of bonding via a covalent bond since one of ordinary skill in the art would be motivated to ensure proper immobilization and binding of the components of the receptor, polypeptide, and grafting molecule. Note that the reference provided by the applicant (Remarks, page 8) discuss antibody-cross linking, however, the references are not utilized in the rejection. As discussed above, there is some teaching, suggestion, or motivation to do so found either in the references themselves (e.g. Grant and Kalkum) or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed limitations of bonding via a covalent bond. Nonetheless, the references provided, such as [2] Qoronfleh, appears to provide teachings and suggestions that covalent cross-linking an antibody to a protein A is known in the art (Qoronfleh, abstract and Scheme 1), which would also provide teaching, suggestion, or motivation to have arrived at the claimed limitations of bonding via a covalent bond.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks, pages 8-9), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, there is some teaching, suggestion, or motivation to do so found either in the references themselves (i.e. Grant and Kalkum) or in the knowledge generally available to one of ordinary skill in the art to have arrived at the claimed limitations of bonding via a covalent bond.
Applicant's arguments, pages 9-10, filed 04/22/2026, with respect to the new claim 33, have been fully considered but they are not persuasive.
In response to applicant’s argument that the prior art fails to teach new claim 33, the examiner disagrees.
Modified Grant fails to explicitly teach: the device according to claim 25, wherein the port comprises a single element and presents a face contacting the optical fibre and a face having a free surface.
Tan teaches an apparatus for detecting the presence or amount of an analyte in a sample solution, the apparatus including an optical assembly and a surface formed by a layer of analyte binding molecules (abstract). Tan teaches the apparatus is based on fiber optic interferometry (paragraph [0004]). Tan teaches an exploration head (Figs. 1-2) comprises a body (body of optical fiber 32) and an emission face (face of transparent optical element 38), at least a part of the emission face is transparent forming a port, i.e. substrate, (Fig. 2 and paragraph [0054] teaches a transparent optical element 38 which is interpreted as forming a port or substrate at the end of the optical fiber 32); wherein the port (Fig. 2 and paragraph [0054] teaches a transparent optical element 38 which is interpreted as forming a port or substrate at the end of the optical fiber 32) comprises a single element (Fig. 2, transparent optical element 38 is a single element) and presents a face (Fig. 2, face of optical element 38 at surface 40) contacting the optical fibre (Fig. 2, face of optical element 38 at surface 40 is contacting optical fiber 32 that includes surface 40) and a face (Fig. 2, lower distal surface of element 38) having a free surface (Fig. 2, the lower distal surface of element 38 is interpreted as a “free surface” which is free and open since it is not attached to the optical fiber 32). Tan teaches the transparent optical element in the assembly allows for detection of analyte via measurement of change in interference of light (paragraphs [0012]-[0014]).
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 said exploration head of modified Grant to incorporate the teachings of an optical assembly with an exploration head including a transparent port or substrate of Tan (Figs. 1-2; paragraphs [0004],[0012]-[0014],[0054]) to provide: wherein the port comprises a single element and presents a face contacting the optical fibre and a face having a free surface. Doing so would have a reasonable expectation of successfully improving optical transmission and detection of desired light for detection of an analyte as taught by Tan.
Additionally, note that the BRI “single element” does not exclude additional elements from the claim. The claims utilizes the transitional phrase “comprising”, which is inclusive or open-ended and does not exclude additional, unrecited elements (MPEP 2111.03). Therefore, Tan’s transparent optical element 38 that has surfaces 40 and 42 reads on the claimed “single element” that presents “a face contacting the optical fibre and a face having a free surface” (Fig. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ko et al. (KO et al., "A novel FRET-based optical fiber biosensor for rapid detection of Salmonella typhimurium", BIOSENS. BIOELECTRON., vol 21, No. 7, July 22, 2005, pages 1283-1290, XP024961411; cited in the IDS filed 03/10/2023) teaches an acceptor fluorophore bound to a Protein G, which is bound to a tapered fiber core (Fig. 1). Ko teaches covalent interaction between protein G and the silica fibre core by means of crosslinkers bound to the silane film on the fiber surface (section 3.1).
Takeuchi et al. (US 20200110084 A1) teaches a measurement system to detect a target (abstract). Takeuchi teaches a group for binding antibody substance can be an irreversible binding group, a reversible binding group, a covalent binding group, or a non-covalent binding group (paragraph [0082],[0085],[0088]).
Tan et al. (US 20070070356 A1) teaches an apparatus for detecting an analyte (abstract). Tan teaches conventional immobilization chemistries are used in chemically, e.g., covalently, attaching a layer of analyte-binding molecules to the lower surface of the optical element (paragraph [0049]).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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