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 without traverse of Group II, claims 10-14 and 16, in the reply filed on 09/04/2026 is acknowledged.
Claims 1-9 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/04/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a solid support material comprising binding molecules attached thereto, said binding molecules having affinity specific for prolactin with the binding molecules being in discrete locations on the support material” (claim 10) and the limitations of dependent claims 11-14 and 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 14 is objected to because of the following informalities: It is suggested to recite “the support” in line 2 as “the solid support material”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: It is suggested to recite “binding molecule to LASP-1” as “binding molecule for LIM And SH3 Protein 1 (LASP-1)”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Glezer et al. (US 20030113713 A1).
Regarding claim 10, Glezer teaches a solid support material (abstract and [0006] teaches assay modules having one or more assay cells such as wells of a plate, i.e. solid support material; Fig. 1A teaches a well 100, i.e. solid support material) comprising binding molecules attached thereto (Fig. 1A and [0054] teaches immobilized binding reagents 110A-C attached to well 100 of a plate), said binding molecules having affinity specific for prolactin (Fig. 1A and [0054] teaches a panel of binding assays; [0058] teaches panels of assays for analytes include immunoassays for prolactin) with the binding molecules being in discrete locations on the support material (Fig. 1A teaches binding reagents 110A-C are in discrete locations on the surface of the well 100; [0006] teaches assay domains include discrete locations on a surface where an assay reaction occurs for carrying out a plurality of assay measurements).
Regarding claim 11, Glezer further teaches the solid support material according to claim 10, further comprising, each in discrete locations, binding molecules for one or more biomarker (Fig. 1A and [0054] teaches immobilized binding reagents 110A-C, i.e. binding molecules, for binding to analytes 115A-C; [0011] teaches a plurality of analytes associated with a biological system are measured, i.e. biomarkers; [0058] teaches panels of assays for analytes associated with a specific biochemical system includes various markers, i.e. biomarkers) selected from neuron specific enolase (NSE), Plasminogen Activator Inhibitor 1/Tissue Plasminogen Activator complex (PAI-1/tPA), Matrix Metalloprotein 9/Tissue Inhibitor of Metalloprotein 1 complex (MMP-9/TIMP-1), Neutrophil Gelatinase Associated Lipocalin Complex (NGAL), Midkine, Albumin: creatinine ratio (ACR), bladder tumour antigen (BTA), cluster of differentiation 44 (CD44), carcinoembryonic antigen (CEA), cytokeratin 18 (CK-18), cytokeratin 20 (CK-20), Clusterin, Creatinine, C reactive protein (CRP), C-X-C motif chemokine ligand 1(CXCL1), C-X-C Motif Chemokine Ligand 16 (CXCL16), Cystatin B, Cystatin C, D-dimer, epidermal growth factor (EGF), fatty acid-binding protein A (FABP-A), FAS protein (FAS), interferon gamma (IFNγ), interleukin 1a (IL-1a), interleukin 2 receptor alpha chain (IL-2Ra), interleukin 6 (IL-6), interleukin 7 (IL-7), interleukin 8 (IL-8), interleukin-10 (IL-10), monocyte chemotactic protein 1 (MCP-1), Microalbumin, Matrix Metalloprotein-9/Neutrophil Gelatinase-Associated Lipocalin Complex (MMP- 9/NGAL), Osmolality, Progranulin, total urinary Protein, free prostate-specific antigen to total prostate specific antigen ratio (PSA TPSA), Protein S100-A4 (S100A4), Transforming growth factor beta 1 (TGF31), Tumour necrosis factor alpha (TNFa), soluble tumour necrosis factor receptor 1 (sTNFR1), soluble tumour necrosis factor receptor 2 (sTNFR2), Tissue Type Plasminogen Activator (TPA), Vascular Endothelial Growth Factor (VEGF) and cholesterol ([0058], “D-dimer”, “EGF”, “TNF-a”; [0205], “IFN-γ”, “interleukin 6”, tumor necrosis factor alpha “VEGF”; [0019] teaches an assay domain measures “free PSA vs total PSA”, i.e. free prostate-specific antigen to total prostate specific antigen ratio).
Regarding claim 13, Glezer further teaches wherein the binding molecules are antibodies ([0021] teaches the binding reagent is an antibody; [0054] teaches suitable binding reagent/analyte pairs include antibodies; [0058] teaches antibodies).
Regarding claim 14, Glezer further teaches wherein the support is a biochip (abstract and [0006] teaches assay modules having one or more assay cells such as wells of a plate, which is interpreted as a biochip or chip for biological assays; Fig. 1A teaches a well 100, i.e. which is interpreted as a biochip or chip for biological assays).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Glezer as applied to claim 10 above, and further in view of Ruddock et al. (WO 2020099895 A1; cited in the IDS filed 03/28/2024).
Regarding claim 12, Glezer further teaches the solid support material according to claim 11, wherein the binding molecules have affinity for the biomarker prolactin (Fig. 1A and [0054] teaches a panel of binding assays; [0058] teaches panels of assays for analytes include immunoassays for prolactin).
Glezer fails to teach: the solid support material according to claim 11, wherein the binding molecules, separately, have affinity for the biomarkers NSE, PAI-1/tPA, Midkine, NGAL, MMP-9/TIMP-1.
Glezer teaches panels of assays for measuring a plurality of analytes or activities associated with a particular biological system, such as identifying the state of the biological system or identifying components of the biological system that are affected by disease ([0011]). Glezer teaches testing samples for analyte or activity of interest, the samples including urine and serum ([0129]).
Ruddock teaches a method for detecting the presence or risk of bladder cancer by detecting the presence of a panel of biomarkers including biomarkers selected from Midkine, PAI-1/tPA, MMP9TIMP1, NGAL, NSE (abstract). Ruddock teaches panel of biomarkers can be any combination of biomarkers (page 5, lines 16-17). Ruddock teaches various biomarkers including NSE, PAI-1/tPA, Midkine, NGAL, MMP-9/TIMP-1, and prolactin (pages 20-21, table 1). Ruddock teaches biomarkers are identified by contacting a sample with a substrate having biomolecules specific for each biomarker included in the panel of biomarkers, the substrate having at least two binding molecules immobilized thereon (page 6, lines 10-19). Ruddock teaches urine and serum samples were collected from patients for analysis (page 12, lines 8-12).
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 binding molecules of Glezer to incorporate Glezer’s teachings of panels of assays for measuring a plurality of analytes associated with biological systems for disease ([0011],[0129]) and Ruddock’s teachings of panels of biomarkers for detecting the presence or risk of bladder cancer including PAI-1/tPA, MMP9TIMP1, NGAL, NSE (abstract; pages 20-21, table 1; page 5, lines 16-17; page 6, lines 10-19) to provide: the solid support material according to claim 11, wherein the binding molecules, separately, have affinity for the biomarkers NSE, PAI-1/tPA, Midkine, NGAL, MMP-9/TIMP-1. Doing so would have a reasonable expectation of successfully improving of analysis of patient samples for known biomarkers to improve detection and diagnosis of disease or cancer, such as bladder cancer.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Glezer as applied to claim 10 above, and further in view of Rutherford et al. (US 20190120860 A1; cited in the IDS filed 03/28/2024).
Regarding claim 16, Glezer further teaches wherein the binding molecules are at discrete locations on the support material (Fig. 1A teaches binding reagents 110A-C are in discrete locations on the surface of the well 100; [0006] teaches assay domains include discrete locations on a surface where an assay reaction occurs for carrying out a plurality of assay measurements).
Glezer fails to teach: the solid support material of claim 10, further comprising a binding molecule to LASP-1.
Glezer teaches panels of assays for measuring a plurality of analytes or activities associated with a particular biological system, such as identifying the state of the biological system or identifying components of the biological system that are affected by disease ([0011]).
Rutherford teaches methods for measuring levels of identified biomarkers as compared to a control for detecting brain related maladies (abstract). Rutherford teaches biomarkers include LIM and SH3 domain protein 1, i.e. LASP-1, and prolactin ([0012]). Rutherford teaches a diagnostic assay capable of diagnosing these maladies prior to the patient's death will provide additional treatment options for medical practitioners, ultimately improving the quality of life for the patients and potentially one day provide for a cure ([0006]).
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 solid support material of Glezer to incorporate Glezer’s teachings of panels of assays for measuring a plurality of analytes associated with biological systems for disease ([0011],[0129]) and Rutherford’s teachings of measuring biomarkers for brain related maladies, the biomarkers including LASP-1 and prolactin ([0012]) to provide: the solid support material of claim 10, further comprising a binding molecule to LASP-1. Doing so would have a reasonable expectation of successfully improving of analysis of patient samples for known biomarkers to improve detection and diagnosis of maladies, therefore improving treatment and ultimately improving quality of life for patients as taught by Rutherford ([0006]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schettini et al. (US 20150301058 A1) teaches biomarkers can be assessed for diagnostics, therapy-related or prognostic methods, such as for a condition or disease (abstract). Schettini teaches biomarkers such as: prolactin (page 81, table 5), LASP1 (page 86, table 5), NSE (page 88, table 5), NGAL ([0417]), midkine ([0409]), CD44 ([0037]), CEA (page 83, table 5), CK-18 ([0025],[0410]), CK20 ([0410]), clusterin ([0025] , creatinine (page 84, table 5), CRP ([0468]), cystatin C (page 84, table 5), D-dimer (page 122, table 7), and EGF (page 81, table 5), interferon gamma (page 44, table 4). Schettini teaches arrays can include antibody arrays comprise antibodies spotted onto the protein chip that are used as capture molecules to detect proteins or other biological materials from a sample ([0218]). Schettini teaches binding agent may be linked to a solid surface or substrate, such as arrays, particles, wells and other substrates described above ([0225]). Schettini teaches techniques of detecting biomarkers for use with the invention include the use of a planar substrate such as an array (e.g., biochip or microarray), with molecules immobilized to the substrate as capture agents that facilitate the detection of a particular biosignature ([0526]).
Watanabe et al. (US 20130078738 A1) teaches a method for measuring a test substance (abstract). Watanabe teaches a test substance measurement chip used in measuring a test substance including, a test area and a control area on a substrate ([0018]). Watanabe teaches the test substance to be measured includes prolactin ([0035]). Watanabe teaches binding substances immobilized at different positions on the same substrate ([0061]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
