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 .
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.
Election/Restrictions
Applicant's election with traverse of Group II of claims 5-8 and of species of NDMC-ASK1 species in the reply filed on 11/24/2025 is acknowledged. The traversal is on the ground that it should be no undue burden on the Examiner to consider all claims in the single application. This is not found persuasive because all the inventions listed in this application are independent or distinct for the reasons given in the restriction requirement of 09/26/2025 and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different
classification;
The inventions have acquired a separate status in the art due to their recognized divergent
subject matter; and/or
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Therefore, the restriction requirement regarding the groups of claims is still deemed proper and is therefore made FINAL.
Claims 1-4 and 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/24/2025.
However, upon further review and consideration, the election of species for Group II is withdrawn.
Thus, claims 5-8 are under examination.
Priority
This application claims priority to U.S. Provisional Application No. 63/154,919 filed on 03/01/2021.
Claim Objections
Claim 7 is objected to because of the following informalities: The claim recites “wherein the antibody is select from”. The Examiner suggests to amend the claim for proper English Grammer to recite “wherein the antibody is selected from the group consisting of”. Appropriate correction is required.
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 5-8 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.
Specifically, claim 5 comprises obtaining a biological sample from a subject (i.e., human) and using any antibody in any immunoassay (i.e., direct or indirect binding ) to detect any galactose-deficient glycopeptide of IgA1 (i.e., sequence) in the subject from whom the biological specimen was collected. That is, the claims do not even require that the antibody binds to the target of the immunoassay, i.e., galactose-deficient glycopeptide of IgA.
The specification does not describe a common structure or function among the widely varying species of used antibody to detect galactose-deficient glycopeptide of IgA1 such that its function could be correlated to specific structure of the used antibody in the detection method of the claims.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), 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).
In the instant case, the skilled artisan cannot envision any structure-function correlation for the widely varying species of antibodies having the function of detecting a galactose-deficient glycopeptide of IgA1 in the subject as required by the claim, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. 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 antibody 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 (Fed. Cir. 1991).
Moreover, the specification does not disclose the structure of the claimed antibodies and fails to disclose which region of the antibodies is responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, the Applicant has not described a reasonable number of members of the genus of antibodies that can bind to widely varying species of galactose-deficient glycopeptide of IgA1, i.e., the required starting materials for the claims, but rather has presented the public with an idea of how to perform an assay that might identify some species that fall within the scope of the claim. Of course, depending on what antibodies are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face. Because claim 5 (the broadest claim) recites an undefined antibody that comprise widely varying species that are capable of detecting any galactose-deficient glycopeptide of IgA1 that is qualified by the claim, and the specification only provides evidence that these widely varying species can perhaps detect galactose-deficient glycopeptide of IgA1 (Specification, pages 8-16 Examples 1-7), the specification does not disclose a structure/function correlation.
The specification provides seven examples on reagent preparation, assay protocol and identified patients (see Examples 1-7 in the specification on pages 8-16). The specification does not describe the structure of the full genus of antibodies responsible for each of the functions claimed. The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AIA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional.
While generically the structure of antibodies is known, the structure of the presently recited antibodies can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about
the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a
‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal
citations omitted). The relevant antibody art confirms this quandary, indicating that “knowledge of
an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original
antibody available, even if suitable in vitro test systems for screening are used.” See p. 8, lines 3-5 of
WO 2009/033743 A1. Therefore, those of skill in the art would not accept that the inventor had
been in possession of the full genus of antibodies in the present claims. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005). Here, the used antibody is claimed only by function, i.e., the antibody is used to detect widely varying species of galactose-deficient glycopeptide of IgA1 in the subject.
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of antibodies nor guidance as to which of the myriad of molecules encompassed by the claimed antibodies would meet the limitations of the claims. Further, given the well-known high level of polymorphism of immunoglobulins and antibodies, the skilled artisan would not have recognized that the Applicant was in possession of the vast repertoire of antibodies encompassed by the claimed invention.
Therefore, claims 5-8 of the instant application do not meet the written description requirement.
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 5-8 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 5 is indefinite because it merely recites using an antibody in an immunoassay without any active positive steps delimiting how this use is actually practiced “using an antibody in an immunoassay to detect a galactose-deficient glycopeptide of IgA1 in the subject”. Per MPEP 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Regarding claim 6, the claim recites “N-terminal of the antibody”, but it is not clear if the claim is reciting the N-terminal of the light chain or the N-terminal of the heavy chain of the antibody and thus this phrase renders the claim indefinite. The phrase “N-terminal of the antibody” is not defined by claim, the specification does not provide which chain is covered by the phrase , and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A one of ordinary skill in the art would have known that an antibody is made of two light chains and two heavy chains, and thus from the claim language, it would not have been clear to the skilled artisan which chain is meant by the phrase “N-terminal of the antibody”.
Similarly, claim 7 recites “the antibody is select from NDMC-ASK1 (SEQ ID NO: 1), NDMC-ASK2 (SEQ ID NO: 2), and NDMC-ASK3 (SEQ ID NO: 3)”, but it is not clear how they represent the antibody. These sequences are approximately made of 117 to 119 amino acid residues so would not represent a full antibody sequence , or even a light chain or heavy chain or even a fragment.
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 5 and 8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Fan et al. (WO 2010/138621 A2).
Regarding claim 5, Fan teaches a method for detecting galactose-deficient IgA1 in a subject (Page 2, line 19). Fan teaches obtaining a biological sample from a subject (Page 2, line 20). Fan teaches using an antibody in an immunoassay to detect a galactose-deficient glycopeptide of IgA1 in the subject (Page 2, lines 20-22; page 12, lines 3-8 and 22).
Regarding claim 8, Fan teaches that the biological sample is blood (Page 32, line 24). Fan teaches that the subject is selected from IgA nephropathy (IgAN) subjects, lupus nephritis (LN) subjects, and healthy subjects (Page 32, lines 24-29).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5 of allowed Application No. 18/180,745 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 5 pertaining to a method for detecting galactose-deficient IgA1 in a subject by obtaining a biological sample from a subject and using an antibody in an immunoassay to detect a galactose-deficient glycopeptide of IgA1 in the subject, ‘745 teaches a method for detecting galactose-deficient O-glycosyl IgA1 by obtaining a biological sample from the subject and using first IgG monoclonal antibody and a second IgG monoclonal antibody in an immunoassay to detect galactose deficient O-glycosyl IgA1 in the subject (See claim 3 of ‘745).
Regarding claim 8 pertaining to that the biological sample is selected from plasma, serum, or blood; and the subject is selected from IgA nephropathy (IgAN) subject, lupus nephritis (LN) subjects, and healthy subjects; ‘745 teaches that the biological sample is plasma, serum, or blood; and that the subject is selected from the group consisting of IgA nephropathy (IgAN) subjects, lupus nephritis (LN) subjects and healthy subjects (See claims 4-5 of ‘745).
Conclusion
No claims are allowed.
Claims 6 and 7 are free of the prior art for the following reasons:
there is no prior art that teach or suggest the method of detecting galactose deficient IgA1 in a subject using an antibody for which the 6th to 11th amino acids from the N terminal is QSGPEL and for which 19th to 27th amino acid from N terminal is KISCKASGY.
The closest prior art is Nishimura et al. which teaches the two sequences of claim 6 of the instant application in one antibody (US 20190218298 A1, page 39, Informal Sequence Listing, SEQ ID No 10). But the antibody of Nishimura is not directed to a galactose-deficient glycopeptide of IgA1, and thus it cannot be combined with the method invention of claim 5 for detecting galactose-deficient glycopeptide of IgA1. Thus, the antibody of Nishimura cannot be combined with the method of Fan et al., as cited in the 102 rejection above, because there is no teaching, suggestion or motivation to combine.
On the contrary to claim 6, the exact sequences in claim 7 are novel and no prior art is anticipating or rendering the sequences as obvious before the effective filing date of the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678