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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 6/23/2026 is acknowledged.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/23/2026.
Claims 1-14 are examined herein.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2022/062793, filed 05/11/2022. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. EP21305617.9, filed on 05/12/2021 in Europe.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 11/10/2023 is being considered by the examiner.
Claim Objections
Claims 9-10 are objected to because of the following informalities:
In claim 9 lines 6-7, "wherein the HPA is a RET and the donor is selected from a luminescent donor compound or a fluorescent donor compound" is suggested to read as "wherein the HPA is a RET and the donor is selected from a fluorescent luminescent
In claim 10 lines 12 and 17, “mOrange, DsRed” appears to be a typographical error, namely it is suggested that “mOrange, DsRed” read as “mOrange, and DsRed” (annotations added) as per claim 9.
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 2-4, 6-7, 9-10 and 13 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.
Regarding claim 2, the phrase "such as" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the LOCI must consist of ALPHA, RET and SPARC, or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Regarding claim 3, the phrase "such as" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the IgG must consist of IgG1, IgG2 and IgG4, or rather if this language is merely exemplary. Similarly, "preferably" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the IgG must consist of IgG1 or IgG2 or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Regarding claim 4, the phrase "such as" (2 instances in lines 2-3) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the anti-Fab antibody must consist of a murine antibody or rather if this language is merely exemplary. Similarly, it is not clear whether the murine anti-Fab antibody must consist of a mouse antibody or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Regarding claim 6, the phrase "such as" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the HPA partners must consist of RET and LOCI or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Regarding claim 7, the phrase "such as" in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the HPA partners must consist of RET and LOCI or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 9 recites “…wherein the HPA is a RET and the donor is selected from a luminescent donor compound or a fluorescent donor compound…”. 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 9 recites the broad recitation "luminescent donor", and the claim also recites "fluorescent donor" 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.
Regarding claim 9, the phrase "such as" in line 7 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the donor compounds must consist of the FRET and BRET compounds recited in lines 8-14, or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 10 recites “…wherein the HPA is a RET and the acceptor is selected from a fluorescent acceptor compound or a non-fluorescent acceptor compound (quencher), such as: a FRET acceptor selected from allophycocyanins, rhodamines, cyanins, squarains, coumarins, proflavins, acridins, fluoresceins, boron-dipyrromethene derivatives, nitrobenzoxadiazole, a quantum dot, GFP, GFP variants selected from GFP10, GFP2 and eGFP, YFP, YFP variants selected from eYFP, YFP topaz, YFP citrine, YFP venus and YPet, mOrange, DsRed; or - a BRET acceptor selected from allophycocyanins, rhodamines, cyanins, squarains, coumarins, proflavins, acridins, fluoresceins, boron-dipyrromethene derivatives, nitrobenzoxadiazole, a quantum dot, GFP, GFP variants selected from GFP10, GFP2 and eGFP, YFP, YFP variants selected from eYFP, YFP topaz, YFP citrine, YFP venus and YPet, mOrange, DsRed”.
However, it is not clear how both the fluorescent and non-fluorescent compounds are the same. Note that the compounds listed under the FRET category and the compounds listed under the BRET category are the same, but the claim recites these as being fluorescent and non-fluorescent compounds, respectively. Because of this contradiction, a person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Furthermore, regarding claim 10, the phrase "such as" in line 7 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the donor compounds must consist of the FRET and BRET compounds recited in lines 8-17, or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim. It is suggested that the phrase “such as” be replaced with “wherein the fluorescent acceptor compound and the non-fluorescent acceptor compound are optionally”.
Regarding claim 13, the phrase "preferably" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear whether the method must consist of step c., or rather if this language is merely exemplary. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim. It is suggested that the phrase “preferably,” be replaced with “optionally wherein”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by "Human C1Q Binding Kits Protocol at a Glance", 1 May 2021, pages 1-6, XP055849003 URL:https://www.cisbio.eu/media/asset/c/i/cisbio_dd_pi_04cigpet-64cgpeg.pdf. -Cite No. 3 of IDS 11/10/2023 (“D1”).
Regarding claim 1, D1 teaches an in vitro method for determining the binding of an antibody (tested antibody) to a complement component lq (Clq) (“This kit is intended for measuring the binding of the Fc region of lgG antibodies to human complement component C1q in buffeted solution” page 1 para. 1), comprising the following steps: a) Contacting into a measurement medium (“Unlike conventional methods that require the immobilization of antibodies on a solid phase, this assay enables simple and rapid characterization of antibodies in a homogeneous generic format” page 1 para. 1):- a tested antibody,- a biotinylated anti-Fab ligand, said biotinylated anti-Fab ligand being able to bind the Fab region of the tested antibody, (“As shown in Figure 1, an antihuman IgG Fab-biotin complexed to streptavidin is used to capture and aggregate the tested antibody in solution” page 1 para. 1)- a streptavidin directly or indirectly labelled with the first member of a pair of HPA (Homogeneous Proximity Assay) partners and - a Clq directly or indirectly labelled with the second member of a pair of HPA partners (“The detection principle is based on HTRF® technology (Homogeneous Time-Resolved Fluorescence)…Antibodies bound to human C1 q are detected in a sandwich assay format using an anti-C1 q antibody (anti-collagen-like region) labelled with Europium cryptate (donor), and the streptavidin labelled with d2 (acceptor)” page 1 para. 1, see Figure 1); b) Measuring the HPA signal in the measurement medium, the existence of a HPA signal being representative of the binding of the tested antibody to the Clq (“When the dyes are in close proximity, the excitation of the donor with a light source (laser or flash lamp) triggers a Fluorescence Resonance Energy Transfer (FRET) towards the acceptor, which in turn fluoresces at a specific wavelength (665 nm). Signal intensity is directly proportional to the capacity of the antibody Fc region to interact with human C1q” page 1 para. 1).
Regarding claim 2, D1 further teaches wherein the HPA is Resonance Energy Transfer (RET) (“Fluorescence Resonance Energy Transfer (FRET)” page 1 para. 1).
Regarding claim 3, D1 further teaches wherein the tested antibody is IgG1, IgG2 or IgG4 (“The assay is compatible with chimeric, humanized and fully human antibodies, as well as with igG1, lgG2 and lgG4 isotypes” page 1 para. 2).
Regarding claim 4, D1 teaches wherein the biotinylated anti-Fab ligand is a biotinylated anti-Fab antibody (“an antihuman IgG Fab-biotin” page 1 para. 1).
Regarding claim 6, D1 teaches wherein the streptavidin is directly labelled with the first member of a pair of HPA partners, such as RET partners (“the streptavidin labelled with d2 (acceptor)” page 1 para. 1, Fig. 1).
Regarding claim 7, D1 teaches wherein the C1q is indirectly labelled with an anti-Clq ligand labelled with the second member of a pair of HPA partners, such as the second member of a pair of RET partners (“anti-C1 q antibody (anti-collagen-like region) labelled with Europium cryptate (donor)” page 1 para. 1, Fig. 1).
Regarding claims 8-10, although claim 10 is indefinite (see 112b rejection above), in the interest of compact prosecution, the limitations following “such as” are interpreted to be exemplary and not required to be taught in the prior art in order to address the claim.
D1 teaches wherein: (i) the first member of a pair of HPA partners is an acceptor and the second member of a pair of HPA partners is a donor (“an anti-C1 q antibody (anti-collagen-like region) labelled with Europium cryptate (donor), and the streptavidin labelled with d2 (acceptor)” page 1 para. 1), wherein the HPA is a RET and the donor is europium cryptate a FRET fluorescent donor (“Europium cryptate (donor)” page 1 para. 1), wherein the acceptor is a fluorescent acceptor (“d2 (acceptor)” page 1 para. 1). Note that although D1 fails to use the language “fluorescent acceptor”, the teachings of “d2” inherently provide a “fluorescent acceptor” as per the specification page 64 lines 9-10 (“a fluorescent acceptor dye (acceptor), the d2”).
Regarding claim 13, D1 further teaches wherein steps (a) and (b) are repeated with different concentrations of the tested antibody, and said method comprises an additional step ( c) of determining the EC50 of the binding of the tested antibody to the C1q (“The assay standard curve is created by plotting HTRF ratio versus log antibody concentration (M)” page 6 para. 3, see “Human C1q Binding-Standard curve” showing the “EC50: 22.1 nM” page 6 see RESULTS showing different concentrations of the tested antibody).
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sakita and Yoshimori (US 20100190266 A1)-Cite No. 1 of IDS 11/10/2023 ("Sakita").
Regarding claim 1, Sakita teaches an in vitro method for determining the binding of an antibody (tested antibody) to a complement component lq (Clq) (“Method for measuring bonding activity of an antibody which mimics antibody-dependent cell medicated cytotoxic activity” Title, “Further, in the measurement of CDC activity which is activated by the binding of a complement (C1) to a specific site of an antibody bound to an antigen's molecule, it becomes possible to measure CDC activity as well as ADCC activity by labeling the antigen and the complement (e.g., C1 such as C1q, C1r or C1s or C2, C3 or C4, preferably C1) with an acceptor or a donor” para. 23), comprising the following steps: a) Contacting into a measurement medium:- a tested antibody (“The present invention provides a simple method which is capable of evaluating the binding activities of an antibody to both an antigen and an Fc receptor” Abstract),- a biotinylated anti-Fab ligand, said biotinylated anti-Fab ligand being able to bind the Fab region of the tested antibody,- a streptavidin directly or indirectly labelled with the first member of a pair of HPA (Homogeneous Proximity Assay) partners (“An antigen or antigen … labeled, directly or indirectly, with a donor or an acceptor that are capable of fluorescent resonance energy transfer” para. 35, “Streptavidin-linked allophycocyanin is also available commercially. Therefore, if biotin is attached to an appropriate site of an antigen (or antigen epitope) …it is possible to label the antigen (or antigen epitope) … with the acceptor by allowing the formation of a complex with avidin” para. 37, “An antigen (or antigen epitope) labeled as described above with one member of a set of donor and acceptor capable of fluorescent resonance energy transfer… mixed with an antibody and then incubated for an appropriate time period” para. 38) and - a Clq directly or indirectly labelled with the second member of a pair of HPA partners (“the antigen and the complement (e.g., C1 such as C1q, C1r or C1s or C2, C3 or C4, preferably C1) with an acceptor or a donor” para. 23); b) Measuring the HPA signal in the measurement medium, the existence of a HPA signal being representative of the binding of the tested antibody to the Clq (“a step of measuring the fluorescence level of the mixture” Abstract, “The measurement of fluorescence may be performed by determining the level of fluorescence emitted from the acceptor as a result of FRET between the donor and the acceptor… Since the method of the present invention for measuring antibody binding activity evaluates the binding mode of an antibody according to the mode of action of ADCC, it is believed that the antibody binding activity (total binding activity) measured by the method of the invention is highly correlated with ADCC activity. Thus, it is possible to estimate ADCC activity from the total binding activity… Similarly, in the case of measuring the CDC activity of an antibody or the binding activities of a bi-specific antibody, these biological activities can be easily estimated from the total binding activity measured by the present invention” para. 45). Although Sakita fails to use the language “anti-Fab ligand”, the teaching of “antigen” inherently provides anti-Fab ligand because antigens by definition bind to the Fab region of an antibody, i.e. are an anti-Fab ligand.
Regarding claim 2, Sakita further teaches wherein the HPA is Resonance Energy Transfer (RET) (“fluorescent resonance energy transfer” Abstract).
Regarding claim 3, Sakita further teaches wherein the tested antibody is IgG (“any antibody may be used as long as it has both antigen binding activity and complement (C1) binding activity… preferably, an antibody of IgG or IgM class is used” paras. 28-29).
Regarding claim 5, Sakita further teaches wherein the biotinylated anti-Fab ligand is a biotinylated antigen or antigen fragment (“The present invention provides a simple method which is capable of evaluating the binding activities of an antibody to both an antigen and an Fc receptor” Abstract).
Regarding claim 6, Sakita teaches wherein the streptavidin is directly labelled with the first member of a pair of HPA partners, such as RET partners (“Streptavidin-linked allophycocyanin is also available commercially” para. 37).
Regarding claim 7, Sakita teaches wherein the C1q is indirectly labelled with an anti-Clq ligand labelled with the second member of a pair of HPA partners, such as the second member of a pair of RET partners (“Further, in the measurement of CDC activity which is activated by the binding of a complement (C1) to a specific site of an antibody bound to an antigen's molecule, it becomes possible to measure CDC activity as well as ADCC activity by labeling the antigen and the complement (e.g., C1 such as C1q, C1r or C1s or C2, C3 or C4, preferably C1) with an acceptor or a donor” para. 23, “an Fc receptor or a fragment thereof are used after they are labeled, directly or indirectly, with a donor or an acceptor that are capable of fluorescent resonance energy transfer” para. 35, “2) Similarly, the donor or the acceptor that was not used in 1) is directly attached to an Fc receptor… or indirectly attached thereto by a known method through an antibody such as anti-6XHis antibody” para. 58). Note that although Sakita fails to use the language “the C1q is indirectly labelled with an anti-Clq ligand” the teachings of indirectly labelling the Fc receptor with a ligand is reasonably interpreted as providing the limitation of the C1q being indirectly labelled with a ligand because C1q is an FC receptor (see instant specification page 1 line 22 “The Clq binding site on IgG is CH2 domain of the Fc region”). Furthermore, Sakita teaches through the document “measuring bonding activity of an antibody which mimics antibody-dependent cell medicated cytotoxic activity” (Title) and teaches that this activity is activated by C1q binding (para. 23). Therefore, the teachings from paragraph 58 of Sakita directed to “Fc receptor” is reasonably interpreted to belong with the labeling of the C1q from paragraph 23 of Sakita.
Regarding claims 8-10, Sakita teaches wherein: (i) the first member of a pair of HPA partners is an acceptor and the second member of a pair of HPA partners is a donor (“Streptavidin-linked allophycocyanin is also available commercially. Therefore, if biotin is attached to an appropriate site of an antigen (or antigen epitope) or an Fc receptor (or a fragment thereof), it is possible to label the antigen (or antigen epitope) or the Fc receptor (or a fragment thereof) with the acceptor” para. 37, “labeling…C1q…with…a donor” para. 23) wherein the HPA is a RET and the donor is europium chelate a FRET fluorescent donor (“Examples of donors capable of fluorescent resonance energy transfer include, but are not limited to, lanthanide chelates… europium (Eu)” para. 30), wherein the acceptor is allophycocyanins (“Examples of acceptors capable of fluorescent resonance energy transfer include, but are not limited to, allophycocyanin” para. 31) .
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 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sakita as applied to claim 1 above, and further in view of Pease et al. (JP 2003532119 A).
Regarding claims 11-12, Sakita teaches the method according to claim 1 as discussed above.
Sakita fails to teach wherein the HPA is a LOCI and the donor is phthalocyanine, and wherein the acceptor comprises (i) thioxene, anthracene, and rubrene, or (ii) thioxene and Europium chelate.
Pease suggests an in vitro method for determining the binding of an antibody (tested antibody) to C1q comprising the following steps: a) contacting into a measurement medium: -a tested antibody, a C1q and a first and second member of a pair of HPA partners (“The members of a specific binding pair are referred to as ligand and receptor (anti-ligand)” para. 81, “Ligand-any organic compound for which a receptor naturally exists or can be prepared” para. 83, “Exemplary receptors…complement components C1q” para. 84, “One particular application of the methods and compositions of the present invention is in methods for determining the presence or relative amount of a plurality of analytes, each of which is a member of a specific binding pair (sbp). In some embodiments A combination is provided that includes a medium suspected of containing a plurality of analytes, a plurality of photosensitizers, and one or more reactive reagents…Each photosensitizer reagent has a first sbp bound to a particle with which the photosensitizer is associated. Each first sbp member is capable of binding an analyte or a second sbp member to form a complex that is related to the amount of each analyte. The combination is incubated in a medium under conditions sufficient to allow the sbp member to bind to the analyte or the respective second sbp member” para. 110, “One type of assay includes an analyte that is an sbp member” para. 115, “In a sandwich assay format, the analyte brings both the sensitizer particle and the chemiluminescer particle into close proximity. Activation of the sensitizer particle by light results in the formation of singlet oxygen, which reaches the particle labeling reagent. Typically, the sensitizer reagents are differentially activated and the light emitted by each chemiluminescent composition is sequentially detected and measured” para. 116). Note that although Pease fails to use the language “binding of an antibody (tested antibody) to C1q” the teachings of using C1q as a receptor in the homogeneous proximity binding assay inherently provides binding of an antibody (tested antibody) to C1q because the ligand of C1q is an antibody (see instant specification page 1 line 22 “The Clq binding site on IgG is CH2 domain of the Fc region”). Pease suggests determining the binding between C1q and a test antibody when teaching the determining of the presence of an analyte in a sample by measuring the binding between C1q and its specific binding pair (paras. 110 and 115-116). Pease further suggests b) Measuring the HPA signal in the measurement medium, the existence of a HPA signal being representative of the binding of the tested antibody to the Clq (para. 110, “The sensitizer reagent is differentially activated and the amount of signal generated in response to activation of the reactive reagent by the product is measured. The amount of signal is related to the amount of each of the components in the medium” para. 113, para. 116). Pease further suggest wherein the HPA is a LOCI (“Activation of the sensitizer particle by light results in the formation of singlet oxygen, which reaches the particle labeling reagent” para. 116) and the donor is phthalocyanine (“Typical photosensitizers are…phthalocyanines” para. 38, “Preparation of Phthalocyanine Dye Sensitizer Beads” para. 141) and wherein the acceptor comprises (i) thioxene, anthracene, and rubrene (“TAR beads-latex particles dyed with a mixture of thioxene, 1-chloro-9,10-bisphenyl ester ethyl anthracene and rubrene” para. 132). Note that although Pease fails to use the language “LOCI” the teaching of using particles with photosensitizers and a singlet oxygen-based proximity assay inherently provides LOCI (see instant specification page 13 lines 17-18 “the donor bead releases singlet oxygen, and if the two beads are in close proximity, the singlet oxygen is transferred to the acceptor bead”). Pease further suggests that the LOCI and the donor being phthalocyanine, and wherein the acceptor comprises (i) thioxene, anthracene, and rubrene enables the multiplexing of in vitro assays for determining the binding of antibodies to a complement component 1q with high sensitivity and wide dynamic range (“Each of the sensitizer reagents includes (1) a sensitizer composition capable of generating singlet oxygen and associated with the particle, and (2) a member of a specific binding pair (sbp). Some or all of the sensitizer compositions have different wavelengths of sensitization” para. 17, “The primary control of differential activation in the method of the present invention is related to the nature of the sensitizer… If an energy transfer mechanism is used, the same sensitizer component may be selected in combination with different fluorophores for modulation of the emission wavelength for photoactivation. This improves the degree of multiplexing. The efficiency of singlet oxygen generation is also a factor in the choice of sensitizer” para. 106, “By carefully selecting sensitizer reagents with different wavelengths of activation or different modes of activation and reactive reagents with different lifetimes and different emission maxima, assays can be performed with high sensitivity and a wide dynamic range” para. 117).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Sakita to rely on the HPA being a LOCI and the donor being phthalocyanine, and wherein the acceptor comprises (i) thioxene, anthracene, and rubrene taught by Pease because Pease suggests that this enables the multiplexing of in vitro assays for determining the binding of antibodies to a complement component 1q with high sensitivity and wide dynamic range. A person having ordinary skill in the art would have had a reasonable expectation of success because both Sakita and Pease are interested in determining the binding of an antibody to C1q using homogeneous proximity assays.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sakita as applied to claim 1 above, and further in view of Friebel et al. Journal of Biomedical Optics 15_5_, 055005 _September/October 2010_ 1083-3668/2010/15_5_/055005/6/$25.00 © 2010 SPIE (“Friebel”).
Regarding claim 14, Sakita teaches the method of claim 1 as discussed above.
Sakita further teaches that “[t]he human body is equipped with a defense system called immunity. When a foreign substance such as bacterium or virus ( antigen) enters the body, a protein called antibody is produced and attacks the antigen to protect the living body. Antibody medicine is a medicine using this effect of antibody. As the mechanisms of action of antibody medicine, activities such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), neutralizing activity or apoptosis induction activity have been reported to be important. In particular, it has been reported that Fc receptor-mediated ADCC activity is the most important anti tumor mechanism in Herceptin ( therapeutic for metastatic breast cancer) and Rituxan (therapeutic for nonHodgkin's lymphoma) (Non-Patent Document 1)…The effect of ADCC injures a target cell through the binding of an antibody to an antigen expressed on the target cell and the binding of the Fc portion of the antibody to an Fc receptor expressed on an effecter cell” (paras. 2-3).
Sakita fails to teach wherein the measurement medium has an osmolarity from 250 mOsm/L to 500 mOsm/L.
Friebel teaches “Influence of osmolarity on the optical properties of human erythrocytes” (Title). Friebel further teaches “Mean values of _µs_rel in the spectral range 250 to 1100 nm of RBCs in saline solution dependent on osmolarity and values for 225 and 400 mosmol/L calculated by Mie theory relative to 300 mosmol/L” (Figure 3 page 3). Friebel further teaches that “the relative scattering coefficient also increases with increasing osmolarity” (page 3 col. 1 para. 3). Friebel further suggests that the osmolarity has a big influence on optical scattering (“As observed for the absorption, _µs_rel of RBC solutions show no significant dependence on wavelength but are significantly influenced by changes in osmolarity” page 3 col. 1 para. 3). With regards to the claimed range of osmolarity, the prior art teaches a range of 225 and 400 mosmol/L. In such a case, since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Sakita to rely on the measurement medium having an osmolarity from 250 mOsm/L to 400 mOsm/L taught by Friebel because Friebel teaches the corresponding coefficients of scattering for this osmolarity range and shows a linear dependence with optical scattering of biological cells and Sakita is interested in optical measurements of biological cells. A person having ordinary skill in the art would have had a reasonable expectation of success because both Sakita and Friebel teach optical measurements in biological samples.
Conclusion
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/Fernando Ivich/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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