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 .
Response to Amendment/Election/Restrictions
Applicant’s amendment filed 02/18/2026 is acknowledged. Claims 1-5 and 8 are amended, claim 7 is canceled and claims 9-19 are new.
Applicant's election with traverse of Group I (claim 1) in the reply filed on 02/18/2026 is acknowledged. The traversal is on the following grounds:
Applicant argues that there would be no serious search and/or examination burden placed on the examiner if restriction is not required, citing MPEP § 803.
The international search authority did not restrict between inventions.
Applicant takes issue with the examiner’s determination that the technical feature of anti-spectrin β is not a special technical feature and cites to 37 CFR § 1.475(b) to argue to argue that different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
A product and a process specially adapted for the manufacture of said product; or
A product and process of use of said product; or
A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
A process and an apparatus or means specifically designed for carrying out the said process; or
A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This is not found persuasive. First, as noted by Applicant, the instant application is national stage application, therefore, burden is not a consideration. Second, the Office is not bound by what the international search authority determined. Third, the Office did consider the relationship of the inventions of Groups I to IV with respect to 37 CFR § 1.475(b)(2). The screening assay of claim 4, the therapeutic agents of claims 5 and 6 and the method of treatment in claim 8 do not share a special technical feature with the method of claim 1, and therefore, do not fall into one of the categories (1)-(5) represented in CFR § 1.475(b)(2).
Applicant has amended claims 2 and 3 from a “diagnostic agent” to a method of diagnosis. Since the method steps in the now amended claims overlap with those in claim 1, the restriction with respect to claims 2 and 3 (Group II at p. 3 of the Office action mailed 12/18/2025) is hereby withdrawn and claims 2 and 3 will be examined with claim 1. In addition, new claims 9-19 read upon the elected methods for measuring autoantibodies and diagnosing an IgA nephropathy. Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Since the restriction requirement between Groups I and II is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable with respect to these inventions. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-6 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/18/2016.
Claims 1-3 and 9-19 are under examination.
Sequence Rules
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), however, this application fails to comply with the requirements of 37 CFR 1.821-1.825 for the reason set forth below. The instant application is not in compliance with 37 CFR 1.821(d), which requires that reference be made to a particular sequence identifier (SEQ ID NO: X) in the specification and claims at each disclosure of a sequence encompassed by the definitions set forth in 37 CFR § 1.821(a)(1) and (a)(2). Specifically, p. 30 of the instant specification contains a nucleic acid sequence without any corresponding sequence identifier. Appropriate correction is required.
Claim Objections
Claim 18 is objected to because of the following informalities. Claim 18 is grammatically awkward. The wherein clause could be amended to recite something like “wherein the labelled antibodies as labels”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 9-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite methods for measuring autoantibodies related to IgA nephropathy and diagnosing an IgA nephropathy comprising contacting a human or mouse sample with an anti-spectrin β IgA antibody measurement reagent; measuring, in an immunoassay, an amount of anti-spectrin β IgA antibodies by allowing labeled antibodies specific to spectrin β to bind to the spectrin β bound to the anti-spectrin β IgA antibodies; determining the amount of the anti-spectrin β IgA antibodies in the sample, comparing a determined amount of the anti-spectrin β IgA antibodies to an amount of the anti-spectrin β IgA antibodies in a healthy subject or a patient with renal disease other than IgA nephropathy (i.e., controls), and determining that a subject has an IgA nephropathy when the determined amount is larger than the amount in the control(s). Therefore, the claims are drawn to the statutory category of a process (see Step 1 in the Revised Guidelines).
The first step in determining whether a claim recites patent eligible subject matter is to consider whether the claims recite an abstract idea, law of nature or a natural phenomenon. See Prong One of Step 2A in the Revised Guidelines. Claims 2, 9 and 10 are drawn to measuring an amount of anti-spectrin β IgA antibodies by allowing labeled antibodies specific to spectrin β to bind the spectrin β bound to the anti-spectrin β IgA antibodies, determining the amount of the anti-spectrin IgA antibodies to an amount of the anti-spectrin β IgA antibodies in a control and determining the subject has an IgA nephropathy when the determined amount is larger than the amount in the control. In these claims, the judicial exception is the relationship between the determined amount of anti-spectrin β antibodies and whether a subject has IgA nephropathy (diagnosis).
Claims 1 and 11-19 recite a method for measuring autoantibodies related to IgA nephropathy. According to MPEP 2106.04 (II)(A)(1):
Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms “set forth” and “described” are thus both equated with “recite”, their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims “set forth” an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
In this case, “[a] method for measuring autoantibodies related to IgA nephropathy” is describing a judicial exception. The preamble is relaying the information that the autoantibodies to be measured are related to IgA nephropathy. In the method steps of the claim the artisan is measuring said autoantibodies. Once the claim is practiced, the artisan has accomplished the task set forth in the preamble, namely, detecting autoantibodies that are related to or indicative of, IgA nephropathy, even though there is no “wherein” clause stating that the presence of the autoantibodies is correlated to the disease or there is no explicit diagnosis step. The measuring of the autoantibodies, in other words, their presence in the sample, indicates a relationship between the autoantibodies and IgA nephropathy that is stated in the preamble.
The mental step of comparing biomarker levels is similar to comparing information regarding a sample or test subject to a control or target data (see Univ. of Utah Research Found, v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014), or diagnosing an abnormal condition by performing clinical tests and thinking about the results (see In re Grams, 12 USPQ2d 1824 (Fed. Cir. 1989). The answer to Prong One of Step 2A is yes.
The second step in determining patent-eligibility of claimed subject matter is to consider whether the claims recite additional elements that integrate the judicial exception into a practical application. The claims require performing a measurement, but does not recite any particular elements or methods of measuring. Further, the “labeled antibodies specific to spectrin β”, “labeled antibodies specific to spectrin β and the “anti-spectrin β IgA antibody measurement reagent” are not identified in claims 1 or 2. Measuring biomarkers is part of the necessary data gathering required in order to perform the mental analysis steps of comparison and diagnosis/prognosis. The discovery of a relationship between biomarkers and a particular condition is not sufficient to integrate the judicial exception into a practical application. See MPEP 2106.04(I), which instructs:
The Supreme Court’s cited rationale for considering even “just discovered” judicial exceptions as exceptions stems from the concern that “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’” Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 (“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”). The Federal Circuit has also applied this principle, for example, when holding a concept of using advertising as an exchange or currency to be an abstract idea, despite the patentee’s arguments that the concept was “new”. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 714-15, 112 USPQ2d 1750, 1753-54 (Fed. Cir. 2014). Cf. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a new abstract idea is still an abstract idea”) (emphasis in original).
Further, in explaining Prong Two of Step 2A, MPEP 2104.04(II)(A)(2) states patent “eligibility ‘cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself’”. In summary, the judicial exception is not integrated into a practical application because the additional steps constitute mere data gathering. The answer to Prong Two of Step 2A is no.
The final step in determining whether the claims recite patent eligible subject matter is to consider whether the claims recite additional elements that amount to significantly more than the judicial exception. Claims 1 and 2 do not recite any particular assays or steps, though dependent claims 15 and 16 recite well known immunoassays. The specification also discloses known methods of measurement (see p. 16, paragraph [0014]):
The means for measuring the amount of anti-spectrin β IgA antibodies is preferably an immunoassay using a reagent containing spectrin β, which is an autoantigen. The immunoassay may be any known immunological measurement method, and examples thereof include radioimmunoassay (RIA), enzyme immunoassay (EIA or ELISA), fluoroimmunoassay (FIA), indirect fluorescence assay, luminescent immunoassay, physicochemical assays (TIA, LAPIA, and PCIA), Western blotting, and the like; preferred is ELISA.
In addition, Brown (WO 03/100426) teaches measuring anti-spectrin β autoantibodies in patients suspected to have Sjögren’s syndrome by contacting a serum or tissue sample with a substrate including an identifying antigen bound on a surface of said substrate, wherein said identifying antigen comprises a purified βII spectrin protein or a fragment thereof and at least one reagent for detection of said autoantibodies in said biological sample, wherein said autoantibodies bind to said identifying antigen; (see claims 1-13; p. 8, lines 12-22 through p. 9, lines 1-15; p. 10, lines 5-10). For a claim reciting a judicial exception to be eligible, the additional elements in the claim must “transform the nature of the claim” either at Prong Two or in Step 2B. In the instant case, the additional steps are simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (see MPEP 2106.05(d)). Thus, the claims are not patent eligible.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 9-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to methods for measuring autoantibodies related to IgA nephropathy and diagnosing an IgA nephropathy comprising contacting a human or mouse sample with an anti-spectrin β IgA antibody measurement reagent; measuring, in an immunoassay, an amount of anti-spectrin β IgA antibodies by allowing labeled antibodies specific to spectrin β to bind to the spectrin β bound to the anti-spectrin β IgA antibodies; determining the amount of the anti-spectrin β IgA antibodies in the sample, comparing a determined amount of the anti-spectrin β IgA antibodies to an amount of the anti-spectrin β IgA antibodies in a healthy subject or a patient with renal disease other than IgA nephropathy (i.e., controls), and determining that a subject has an IgA nephropathy when the determined amount is larger than the amount in the control(s). The claims encompass methods of measurement requiring an “anti-spectrin β IgA antibody measurement reagent”, “labeled antibodies specific to spectrin β” and “antibodies specific to spectrin β”, although the claims do not recite any structure for said reagent/antibodies. Therefore, the recited reagent” and antibodies specific to spectrin β represent a large genus of molecules requiring the specific functions of carrying out the claimed measuring/diagnosis methods.
In deciding whether the application complies with the written description requirement of 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, it is necessary to understand what Applicant is claiming (see above) and what Applicant has possession of. To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The “anti-spectrin β IgA antibody measurement reagent” is disclosed in the specification as “comprising spectrin β” (p. 5, 2nd full paragraph; p. 16, 3rd full paragraph; p. 22, paragraph [0028]), though as acknowledged in the instant specification, there are five types of spectrin β (see p. 15, paragraph [0010]). Instant claim 3 also recites the reagent comprises spectrin β while instant claim 13 recites that the reagent comprises antibodies recognizing spectrin β-II. The specification discloses measuring the anti-spectrin β IgA antibodies (p. 16-17, paragraphs [0014]-[0015]):
The means for measuring the amount of anti-spectrin β IgA antibodies is preferably an immunoassay using a reagent containing spectrin β, which is an autoantigen. The immunoassay may be any known immunological measurement method…[In the] solid phase sandwich method…spectrin β, which is an antigen, is first immobilized on a solid phase, and a specimen as a test sample is added thereto. As a result, an antigen-antibody reaction occurs between the solid phase antigen and antibodies in the sample, and anti-spectrin β IgA antibodies present in the specimen bind to the solid-phase antigen. Next, the bound antibodies are detected with an antibody detection reagent to measure the anti-spectrin β IgA antibodies present in the sample.
In the above method, the target anti-spectrin β IgA antibodies present in the test sample can also be detected and measured by immobilizing the antibody detection reagent on a solid phase to thereby capture antibodies in the specimen, then adding antigen spectrin β, allowing it to bind to anti-spectrin β IgA antibodies among the captured antibodies, and further allowing labeled antibodies specific to the antigen to bind thereto.
Thus, the anti-spectrin β IgA antibodies may be present in the sample or be immobilized on the solid phase. The specification discloses that plasmablasts or plasma cells are used as primary antibodies or alternatively, various antibody clones (see p. 11, description of Figures 6B-6D; p. 12, description of Figures 6E and 6G). The specification does not, however, disclose the structure of reagents or anti-spectrin β IgA antibodies.
Regarding antibodies, it is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. Small changes in the amino acid structure of the CDRs can have large effects on activity. The specification discloses recombinant antibodies were used as primary antibodies to stain mesangial cells (p. 39, 2nd paragraph):
In order to confirm that IgA+ PBs in the kidney of gddY mice produce IgA autoantibodies against antigens in MCs [mesangial cells], single IgA+ PBs [plasmablasts] were isolated from the kidney of gddY mice, and their heavy and light chain genes were cloned to produce recombinant IgA antibodies. Most of the H and L chains contained a considerable number of mutations in their amino acid sequences, which suggests that PBs had undergone somatic hypermutation (Figure 10). Using these recombinant antibodies as the primary antibodies, intracellular staining of MCs was performed, followed by analysis by flow cytometry. As a result, it was revealed that although the intensity of staining differed among the antibodies, 8 out of 20 recombinant antibodies recognized antigens present in MCs (Figures 6E and F).
The specification never discloses the physical structure of these recombinant antibodies or of the genus of the “anti-spectrin β IgA antibody measurement reagents” and the “antibodies specific to spectrin β”. Other than the spectrin β itself, of which there are five types, there is no disclosure of complete or partial structure, physical/chemical properties of the reagents/antibodies or how they are made. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed reagents and antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Closest Prior Art
Brown (WO 03/100426—on IDS filed 12/04/2024) teaches measuring anti-spectrin β autoantibodies in patients suspected to have Sjögren’s syndrome by contacting a serum or tissue sample with a substrate including an identifying antigen bound on a surface of said substrate, wherein said identifying antigen comprises a purified βII spectrin protein or a fragment thereof and at least one reagent for detection of said autoantibodies in said biological sample, wherein said autoantibodies bind to said identifying antigen; (see claims 1-13; p. 8, lines 12-22 through p. 9, lines 1-15; p. 10, lines 5-10). In describing the kit encompassed by their invention, Brown teaches the kit contains anti-human IgG (claims 14-15), therefore they do not suggest measuring an amount of anti-spectrin β IgA antibodies by allowing labeled antibodies specific to spectrin β to bind to the spectrin β, bound to the anti-spectrin β IgA antibodies. Tsai et al. (Vasculitis (2008), Renal Failure, 30:7, 755-758) teach (p. 757, left column, 3rd paragraph):
Sjögren’s syndrome may be accompanied by a dysregulation of IgA system, implying the presence of increased serum polymeric IgA or circulating immune complexes and their consequent deposition within the kidney. IgA nephropathy may represent only one of the complications brought by IgA deposition.
Nevertheless, Tsai et al. teach the overlap between Sjögren’s syndrome and IgA nephropathy is “not common” (see p. 757, right column, last paragraph). In summary, while the prior art teaches that anti-spectrin β antibodies are involved in the pathogenesis of other autoimmune diseases, it does not teach or suggest measuring spectrin β bound to anti-spectrin β IgA antibodies.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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