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 .
Notice of New Examiner
This case has been transferred to a new examiner for continued examination. Any further communications regarding this case may be directed to the contact information included in the conclusion of this office action.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-24 and 35-36 drawn to products, namely compositions and kits used to detect allograft rejection in the reply filed on 27 October 2025 is acknowledged. The traversal is on the ground(s) that the Applicants "dispute the assertion in the Office Action that the five claim groups lack a common inventive concept" (Remarks 10/27/2025 p. 2). This is not found persuasive because the Office Action did not assert that the five claim groups lack a common inventive concept. As explained in the Restriction/Election requirement dated 9/8/2025, Groups I-V lack unity of invention because even though the inventions of these groups require the technical feature of a composition used to detect allograft rejection as comprising a collection of solid-phase substrates coasted with binding agents as recited in claim 1, this is not a special technical feature because US20030003516 A1 to Robinson et. al. teaches a composition for diagnosis comprising a collection of solid-phase substrates coated with one or more homogenous populations of binding agent, wherein each homogenous population of binding agents is directed against a single antigen selected from the group consisting of: DEXI, CXCL11, KRT18, KRT8, tubulin, LPHN1, CSF2, STAT6, LGLACS3, TG etc. (see [0009], [0037], [0042], [0054], [0063], and [0071]).
The requirement is still deemed proper and is therefore made FINAL.
Applicant further elects the species: A. CSF2 B. ENO1 C. Non-porous D. Non-porous E. Beads; and F. Fluorescently labeled.
Claims 25-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 27 October 2025.
Claims 15, 16, 18, 19, 20, 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 27 October 2025.
Claim Status
Claims 1-36 are pending. Claims 15, 16, 18, 19, 20, 23 and 25-34 are withdrawn from consideration as described in the Restriction/election section above. Claims 1-14, 17, 21-22, 24, and 35-36 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statements (IDSs) have been considered except where lined through. The Chinese Office Action dated March 29, 2025 from corresponding CN Application 3,136,684 has not been considered because no translation or English abstract was provided. For the purposes of expedited prosecution, the Examiner has attached (PTO-892) the translation of an Office Action in CN 202080034058 dated March 28, 2025 from Global Dossier which appears to be the relevant translation; however, this could not be verified due to the different dates and application numbers.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 4-14, 17, 21-22, 24, and 35-36 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiply dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim 1 is objected to because of the following informalities: Claim 1 recites "nephrosis 1, congenital, Finnish type" among a list of antigens. Because the greater list is also separated by commas and because it is unclear that the “nephrosis 1, congenital, Finnish type” refers to only one antigen. Appropriate correction is required. See also the 112(b) below.
Claim Rejections - 35 USC § 112(b)
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 1-3 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 indefinite for the recitation of “nephrosis 1, congenital, Finnish type (NPHS1)” in line 15 because “nephrosis 1, congenital, Finnish type” refers to a genetic disease/phenotype rather than a protein or an antigen (See OMIM #256300 “Nephrotic Syndrome, Type 1; NPHS1”, Web. Accessed 14 February 2026). The protein encoded by the gene NPHS1 is Nephrin (NPHS1).
Dependent claims are rejected for failing to resolve the indefiniteness as described.
Claim Rejections - 35 USC § 102
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.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCutcheon, Krista, Edward O'Hara, and David Fei. "Multiplexed serum measurement of IgG, IgA, IgM, and IgE antibody responses to therapeutic biologicals." Immunological investigations 34.2 (2005): 199-213 published 2005 as evidenced by Meager, et al. "Spontaneously occurring neutralizing antibodies against granulocyte–macrophage colony‐stimulating factor in patients with autoimmune disease." Immunology 97.3 (1999): 526-532 published July 1999; Ye, Yao, et al. "Anti α-enolase antibody is a novel autoimmune biomarker for unexplained recurrent miscarriages." EBioMedicine 41 (2019): 610-622 published 1 March 2019; and Chou J, Wong J, Christodoulides N, Floriano PN, Sanchez X, McDevitt J. Porous bead-based diagnostic platforms: bridging the gaps in healthcare. Sensors (Basel). 2012 Nov 9;12(11):15467-99. doi: 10.3390/s121115467. PMID: 23202219; PMCID: PMC3522972 published 9 November 2012.
Claim interpretation: Instant claim 1 is directed towards “A composition comprising a collection of solid-phase substrates coated with one or more homogenous binding agents, wherein each homogenous population of agents specifically binds to an antibody that is directed against a single antigen selected from the group consisting of: […]”. Regarding “binding agent” the instant specification states “The term “binding agent” refers to a molecule that specifically recognizes and binds to a target molecule of interest” [0049]. The instant specification does not define the term “specifically binds”; as defined in the art, specific binding means the selective interaction of an agent with a particular target above other targets (e.g. McBride JM, Eckmann JP, Tlusty T. General Theory of Specific Binding: Insights from a Genetic-Mechano-Chemical Protein Model. Mol Biol Evol. 2022 Nov 3;39(11):msac217. doi: 10.1093/molbev/msac217. PMID: 36208205; PMCID: PMC9641994, Abstract). Thus, the broadest reasonable interpretation of the claim is that the claim requires a composition comprising a collection of solid-phase substrates coated with one or more homogenous binding agents capable of selective interaction with an antibody, wherein the antibody is directed against a single antigen selected from the group consisting of the list of target antigens recited. In particular, the Examiner notes that nothing in the claims requires the binding agent specifically binds to an epitope of an antibody directed against a single target antigen or that that binding agent must interact selectively with certain single antigen-directed antibodies above others.
Regarding claims 1 and 2, McCutcheon et. al. teaches a collection of capture microspheres (beads) coated with the binding agents Protein G, anti-human IgM, anti-human IgA, and anti-human IgE (p. 201-202 “Preparation of capture microspheres”). McCutcheon et. al. teaches Protein G, anti-human IgM, anti-human IgA, and anti-human IgE beads specifically bind to antibodies of the IgG, IgM, IgA and IgE isotype in a Luminex assay. As evidenced by Meager et. al., anti-GM-CSF antibodies (synonymous for specific for CSF2) are “mainly IgG, with the IgG1 subclass predominating, though with smaller minor amounts of IgG2, IgG3, IgG4 and IgM also present” (p. 529, right column). As evidenced by Ye et. al., at least one anti-ENO1 antibody is IgG (Fig. 1, Abstract, p. 617 left column section 3.4). Therefore, the composition of McCutcheon et. al. comprises a first bead coated by a binding agent (anti-human IgM) that specifically binds to an IgM anti-CSF2 antibody (reads on claim 1) and further comprises a second bead coated by a binding agent (protein G) that specifically binds to an antibody that binds to an IgG anti-ENO1 antibody (reads on claim 2).
Regarding claim 3, as evidenced by Chou et. al., the microspheres/beads for Luminex 100 as taught by McCutcheon (p. 203 ¶1) are non-porous ( Chou p. 15473 ¶2, last sentence and Fig. 1).
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Leclerc, Claude, et al. "Immobilized cytokines as biomaterials for manufacturing immune cell based vaccines." Journal of Biomedical Materials Research Part A: An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials and the Korean Society for Biomaterials 86.4 (2008): 1033-1040 teaches GM-CSF (equivalent to CSF2) antigen coated onto a collection of beads.
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/KATHLEEN CUNNINGCHEN/Examiner, Art Unit 1646
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678