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 .
Status of the Claims
Claims 9, and 12-15 have been cancelled by Applicant’s amendment filed 02/13/2026. Claims 16-24 have been added. Claims 1-8 and 16-24 are pending and examined herein.
Priority
This application, filed 08/12/2022, is a 371 of PCT/EP2021/053462, filed 02/12/2021, which claims benefit to UNITED KINGDOM 2002072.3, filed 02/14/2020. This benefit is acknowledged and the claims examined herein are treated as having an effective filing date of 02/14/2020.
Claim Rejections - 35 USC § 112
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 20 and 24 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.
Regarding claims 20 and 24, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-7, 16-21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al., “Anti-HLA IgM Antibodies Are Reduced in Highly-HLA Sensitized Patients Transplanted after Imlifidase (IdeS) Treatment” Am J Transplant. (published 06/02/2019, IDS dated 11/23/2022, referred to herein as Zhang) as evidenced by GenBank NCBI Reference Sequence: WP_010922160.1 immunoglobulin G-degrading enzyme IdeS (https://www.ncbi.nlm.nih.gov/protein/WP_010922160.1/).
Regarding claim 1, 2, 4, and 6, Zhang teaches a method for detecting IgM antibodies by treating with IdeS, an IgG cysteine protease, and detecting IgM with an IgM-specific antibody in a patient sample (p. 2, para. 1, lines 1-4). Zhang teaches that the IgM was affected by IgG cysteine protease treatment (Figure 1), which indicates that the samples comprised IgG complexed with IgM (Instant specification, p. 7, lines 20-25), regardless of whether Zhang realized that the complexes were present in the sample.
Regarding claims 3 and 16-18, Zhang teaches the use of S. pyogenes immunoglobulin-degrading enzyme, IdeS (“Imlifidase”, p. 1, para. 1, line 1). The full-length IdeS protein, identical to SEQ. ID 1, is over 90% identical to Seq. ID 2, as evidenced by GenBank NCBI Reference Sequence: WP_010922160.1 immunoglobulin G-degrading enzyme IdeS (https://www.ncbi.nlm.nih.gov/protein/WP_010922160.1/). The full-length IdeS protein is 91.45% identical to Seq. ID 2 and 91.15% identical to Seq. ID 55 with a methionine at the N terminus, which is not present in the claimed sequences.
Regarding claims 5, 7, and 19-21 Zhang teaches contacting the sample with HLA to identify anti-HLA IgM antibodies using a single antigen bead-based assay (p. 2, para. 1, lines 1-3).
Regarding claim 23, Zhang teaches obtaining a sample from patients that has been diagnosed as requiring an organ transplant (p. 1, para. 1, lines 1-5).
Claim Rejections - 35 USC § 103
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 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.
Claims 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of US 4,208,479 “Label modified immunoassays” (Published 06/17/1980, referred to herein as Zuk).
Regarding claims 8 and 24, Zhang teaches the use of IgG cysteine protease, HLA, and an anti-IgM antibody used in an immunoassay together (p. 2, para. 1, lines 1-6, Figure 1).
However, Zhang does not specifically teach a kit for performing the assay comprising IgG cysteine protease, HLA, and an anti-IgM antibody.
Zuk teaches that in performing assays, it is convenient to combine the necessary reagents together in a kit (column 22, lines 20-68 in particular). Zuk further teaches that this may improve assay accuracy.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the IgG cysteine protease and an anti-IgM antibody of Zhang together in a kit. Doing so would provide convenience and increase assay accuracy, as taught by Zuk (col. 22, lines 20-68).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Visentin et al., “Deciphering IgM interference in IgG anti-HLA antibody detection with flow beads assays” Human Immunology (published 02/20/2016, referred to herein as Visentin).
The teachings of Zhang as applied to claim 1 are incorporated herein.
Regarding claim 22, Zhang teaches a method of detecting anti-HLA IgM antibodies in patient sample (p. 2, para. 1, lines 1-6, Figure 1).
However, Zhang does not specifically teach that the sample is a serum sample.
Visentin teaches a method of detecting anti-HLA IgM antibodies in human serum (p. 1049, col. 1, para. 5, lines 1-6). Visentin teaches that IgM and IgG are present and can interefere with each other in serum (p. 1048, col. 2, para. 3, lines 1-4).
It would have been obvious to one of ordinary skill in the art to perform the method taught by Zhang on a serum sample, as taught by Visentin. An artisan would have been motivated to perform the assay on a serum sample and had a reasonable expectation of success because, as taught by Visentin, detection of anti-HLA antibodies in serum is routine in the art of antibody detection (p. 1049, col. 1, para. 5, lines 1-2).
Response to Arguments
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on pages 7 and 8 on the rejection of claims 1-7 under 35 U.S.C. 102, Applicant argues that Zhang does not teach that a sample is contacted with an IgG cysteine protease because Zhang teaches that a patient is treated with an IgG cysteine protease before a sample is tested.
This argument is not persuasive. The sample is obtained from the patient which has been treated with an IgG cysteine protease; therefore, the sample has been contacted with the IgG cysteine protease. The sample that is tested is considered to be the sample whether it is in the patient or has been withdrawn from the patient and the timing by which it is contacted by the IgG cysteine protease has no impact on whether it is considered to be the sample.
Regarding the remarks on pages 8 and 9 on the rejection of claim 8 under 35 U.S.C. 103, Applicant argues that an artisan would not have any need to provide an IgG cysteine protease in a kit because Zhang teaches treating a patient with an IgG cysteine protease, but that the IgG cysteine protease is not used to detect any antibodies.
This argument is not persuasive. Zhang teaches an immunoassay detecting IgM before and after treatment with IgG cysteine protease and is an essential part of the assay; therefore, inclusion of the IgG cysteine protease would be necessary to replicate the assay taught by Zhang and would be included for convenience and accuracy as taught by Zuk.
Further regarding the remarks on page 9, Applicant argues that the inventors have made the surprising discovery that IgG cysteine protease are useful for improving assays for detecting other classes of antibodies.
This argument is not persuasive. In response to applicant's argument that IgG cysteine protease are useful for improving assays for detecting other classes of antibodies, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, the steps of the assay have been taught and performed by Zhang, regardless of whether Zhang recognized that the sample contained complexes of IgG and IgM and that the treatment with the IgG cysteine protease could be used to improve other assays.
Conclusion
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.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 1, 2026
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