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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1-13, without traverse, filed December 19, 2025 is acknowledged and has been entered. Claims 14 and 15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1-15 are pending. Claims 1-13 are under examination.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a continuation of PCT/US22/11632 filed 01/07/2022, which claims the benefit of Provisional Application Number 63/135,363 filed 01/08/2021. Based on the filing receipt, the effective filing date of this application is January 8, 2021 which is the filing date of Provisional Application Number 63/135,363 from which the benefit of priority is claimed.
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.
3. Claims 1-13 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.
Claim 1 is vague and indefinite in reciting “introducing a plurality of target molecules to a first location which comprises… a plurality of probe molecules” and “monitoring… a first amount of an intermolecular complex generated by the plurality of probe molecules and the plurality of target molecules” because it fails to clearly define how the first amount of intermolecular complex is generated. Perhaps, Applicant intends that “the plurality of probe molecules bind specifically to the plurality of target molecules” or that the “intermolecular complex generated by the plurality of probe molecules bound to the plurality of target molecules.”
Claim 1 is further vague and indefinite in reciting “introducing a plurality of competitive inhibitor molecules to the first location” and “monitoring… a second amount of the intermolecular complex” because it is unclear what is encompassed in the recitation of “second amount of the intermolecular complex” since the plurality of competitive inhibitor molecules appear to compete with the target molecules for binding to the probe molecules. As such, it is therefore further unclear how the kinetic parameter is estimated based on the second amount.
Claim 1 is ambiguous in reciting “estimating the kinetic parameter based upon the second amount” because it is unclear what how the kinetic parameter is estimated simply on the basis of the second amount.
Claim 4 is indefinite in reciting “monitoring … a second location” which “comprises a second surface” because it is unclear how the second location is structurally related to the first location and functionally configured relative to the first surface. Same analogous comments and problems apply to claim 5.
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.
4. Claims 1-6, 8, and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuck et al. (Determination of Binding Constants by Equilibrium Titration with Circulating Sample in a Surface Plasmon Resonance Biosensor. Analytical Biochemistry 265: 79-91 (1998)).
Schuck et al. teach an assay method for estimating a kinetic parameter using a Surface Plasmon Resonance (SPR) Biosensor having a first location and a second location (two sensor spots) (Abstract). The method comprises introducing a plurality of target molecules (mobile binding/reaction partner) to a first location which comprises: (i) a first sensor surface, (ii) a matrix bound to the first surface, wherein the surface comprises hydrogel (carboxymethylated dextran), and (iii) a plurality of probe molecules (immobilized binding sites: Proteins αMb antibody, tern, whale NA) bound to the matrix (p. 81, left col. 1st & 2nd full ¶s; p. 83, right col. last full ¶ to p. 84: Competitive Kinetic Dissociation; Figure 1); monitoring, via SPR detection method, a first amount of an intermolecular complex generated by the plurality of probe molecules; wherein the intermolecular complex is specifically generated from reversible affinity interactions between the plurality of probe molecules and the plurality of target molecules; when the first amount exceeds a threshold value (steady state), stopping an introduction of the plurality of target molecules and introducing a plurality of competitive inhibitor molecules (competitor: mobile form of the “immobilized” binding sites) to the first location; monitoring, via the SPR detection method, a second amount of the intermolecular complex; and estimating the kinetic parameter based upon the second amount (p. 81, left col. 1st & 2nd full ¶s; p. 83, right col. last full ¶ to p. 84: Competitive Kinetic Dissociation; Figure 1). The first amount of intermolecular complexes increases over a plurality of points in time or wherein the second amount of intermolecular complexes decreases over the plurality of points in time (Figure 8). Prior to (a), the matrix is bound to the first surface and the plurality of probe molecules are bound to the matrix (p. 81, left col. 1st full ¶). Figure 1 shows that the first location is a first channel of a flow cell (BIACORE X). Schuck et al. teach the kinetic parameter as comprising an association (binding) rate constant between the plurality of target molecules and the plurality of competitive inhibitor molecules; and a dissociation rate constant between the plurality of target molecules and the plurality of competitive inhibitor molecules (Abstract; p. 88, right col. last ¶ to p. 89, left col.; p. 89, right col. 1st & 2nd full ¶s: Discussion; Figure 7; Figure 8). The method further comprises monitoring, via the detection method, the second location which comprises a second surface (reference surface) having a second channel in the flow cell; wherein the second location does not comprise a probe molecule bound to the second surface, does not comprise a matrix, and does not comprise a plurality of probe molecules (Abstract; p. 81, left col. 1st & 2nd full ¶s; Figure 1). Accordingly, Schuck et al. appears to read on Applicant’s 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.
5. Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Schuck et al. 1 (Analytical Biochemistry 265: 79-91 (1998)) in view of Schuck et al. 2 (The Role of Mass Transport Limitation and Surface Heterogeneity in the Biophysical Characterization of Macromolecular Binding Processes by SPR Biosensing. Methods Mol Biol. 627: 15-54 (2010)).
Schuck et al. 1 is discussed supra. Schuck et al. 1 differ from the instant invention in failing to teach that the one or more dimensions of the matrix are within a range from 5 nanometers (nm) to 1,000 nm; and that the kinetic parameter is within a predetermined range with one or more dimensions of the matrix chosen to sensitize the assay method to the predetermined range; and a density of the plurality of probe molecules is chosen to sensitize the assay method to the predetermined range.
Schuck et al. 2 teach assay methods for estimating a kinetic parameter (kinetic analysis) using a surface plasmon resonance (SPR) biosensor (Abstract). Schuck et al. 2 teach introducing a plurality of target molecules (soluble/second binding partner: analyte; mobile reaction partner) to a first location which comprises: (i) a first surface (sensor surface), (ii) a matrix (immobilization matrix) bound to the first surface, wherein the matrix comprises hydrogel (carboxymethylated dextran, hydrophilic polymer matrix), and (iii) a plurality of probe molecules (immobilized first binding partner, immobilized surface binding sites) bound to the matrix (Abstract; pp. 15-16: Introduction; pp. 19-23, 30-33; Figure 2.2; Figure 2.5 (b); Figure 9(e); Figure 9(f)); and monitoring, via SPR (i.e. detection method), an amount of an intermolecular complex (biomolecular interactions) generated by the plurality of probe molecules and the plurality of target molecules. Schuck et al. 2 teach that prior to (a), the matrix is bound to the first surface and the plurality of probe molecules are bound to the matrix (if a polymeric immobilization matrix is used) (pp. 30-33; Figure 2.9 (e)). Schuck et al. 2 further teach that the kinetic parameter is within a predetermined range and that one or more dimensions of the matrix can be chosen to sensitize the assay method to the predetermined range. The one or more dimensions of the matrix are within a range from 100-400 nm (encompassed within 5 to 1,000 nm in claim 8) (pp. 30-33; Figure 2.5 (b), (c); Figure 2.6). The density of the plurality of probe molecules (number of immobilized surface sites) can also be chosen (adjusted) to sensitize the assay method to the predetermined range (Introduction: p.16, 1st full ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate the parameters taught by Schuck 2 into the method of Schuck 1 because Schuck 1 appears to be generic in the type of SPR biosensor used and Schuck 2 teaches that the hydrogel matrix structural parameters and probe molecule density can be chosen and adjusted to a predetermined range for optimization in sensitizing kinetic assay methods. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of Schuck 2 into the method of Schuck 1 because both of Schuck 1 and Schuck 2 teach analogous art.
6. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
March 20, 2026