DETAILED ACTION
1. This action is written in response to applicant’s correspondence filed on 8/17/2026. Applicant has amended claims 1-3, 10, 13 and 15-20, and canceled claims 4 and 6. Claims 8 and 11-20 were previously withdrawn due to an election/restriction requirement. Claims 1-3, 5 and 7-10 are currently under examination. All the amendments and arguments have been thoroughly reviewed but are found insufficient to place the instantly examined claims in condition for allowance. In view of applicant’s amendment to claim 1, the rejection of claims 1-3, 5, 7 and 9 under 35 USC 102 has been withdrawn. However, the rejection of claim 10 under 35 USC 102 is maintained.
Claim Rejections - 35 USC § 102
2. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
3. Claim 10 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Barrett et al. (US 2009/0258002 A1).
Barrett et al. teach a kit (see paragraphs [0027] and [0391]), panel or microarray (see paragraphs [0019], [0210], [0215], [0223], [0232]-[0233], [0257], [0293] and [0391]) comprising multiple diagnostic reagents, each reagent identifying a different biomarker selected from Table 9 (see paragraph [0027] and Table 9), wherein the multiple diagnostic reagents comprise two or more of: (a) a ligand (e.g., antibody) capable of specifically complexing with, binding to, or quantitatively detecting or identifying the biomarker chloride intracellular channel protein 4 (CLIC4) or an isoform, pro-form, modified molecular form, posttranslational modification, or unique peptide fragment or unique nucleic acid fragment thereof (e.g., CLIC4. See Table 9 at page 72; Table 15 at page 119); (b) a ligand (e.g., antibody) capable of specifically complexing with, binding to, or quantitatively detecting or identifying the biomarker chloride intracellular channel protein 1 (CLIC1) or an isoform, pro-form, modified molecular form, posttranslational modification, or unique peptide fragment or unique nucleic acid fragment thereof (e.g., CLIC1. See Table 9 at page 79; Table 15 at page 119); (c) a ligand capable of specifically complexing with, binding to, or quantitatively detecting or identifying the biomarker cancer antigen 125 (CA125) or an isoform, pro-form, modified molecular form, posttranslational modification, or unique peptide fragment or unique nucleic acid fragment thereof; and (d) a ligand capable of specifically complexing with, binding to, or quantitatively detecting or identifying the biomarker human epididymis protein-4 (HE4) or an isoform, pro-form, modified molecular form, posttranslational modification, or unique peptide fragment or unique nucleic acid fragment thereof, wherein at least one ligand is attached to a detectable label (e.g., fluorescent label. See paragraphs [0225], [0262] and [0278]) or immobilized on a solid substrate (e.g., solid substrate of the antibody microarray or chip) (see paragraphs [0120], [0213], [0223] and [0233]).
Allowable Subject Matter
4. Claims 1-3, 5, 7 and 9 are allowed.
Response to Argument(s)
5. Applicant argues the following: “Claim 1 has been amended to recite a diagnostic reagent consisting of the recited ligands. Barrett et al does not teach the specific combination of ligands directed to CLIC4, CLIC1, CA125 and HE4 that is now required by the claims.”
In response, the rejection of claims 1-3, 5, 7 and 9 under 35 USC 102 has been withdrawn in view of applicant’s amendment to claim 1. As for claim 10, due to the term “comprising” as used, the claimed kit, panel or microarray can comprise additional diagnostic reagents (or ligands or capture reagents) that bind to any other biomarkers selected from Table 9 of the Barrett reference.
Furthermore, the term “diagnostic reagents” as used in claim 10 appears to refer to ligands, as suggested by the recitation “each [diagnostic] reagent identifying a different biomarker”. As such, the “multiple diagnostic reagents” comprised in the claimed kit, panel or microarray can be just any two of the 4 ligands as listed in claim 1.
Even if the claimed kit, panel or microarray comprises the combination of the 4 ligands as specified in claim 1, due to the term “comprising” as used in claim 10, it can comprise the corresponding ligands for all the biomarkers listed in Table 9 of the Barrett reference. Thus, claim 10 is clearly anticipated by the Barrett reference.
Conclusion
6. 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 KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
