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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-9 and 19-21) in the reply filed on 7/1/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 19-21 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 19 recites in the preamble a “method of determining whether a donor tissue intended for transplant or transfusion is suitable for transplantation or transfusion to a human recipient… However such limitation is not recited in the body of the claim, and therefore it is not clear if the claim requires a step of determining whether a donor tissue intended for transplant or transfusion is suitable for transplantation or transfusion to a human recipient. For examination purposes, claim 19 (and thus dependent claims 20-21) is interpreted to require a step of determining whether a donor tissue intended for transplant or transfusion is suitable for transplantation or transfusion to a human recipient.
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 19-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea or natural phenomenon without significantly more.
The claims recite, in the preamble of independent claim 19, a “method of determining whether a donor tissue intended for transplant or transfusion is suitable for transplantation or transfusion to a human recipient…”. This is an abstract idea (e.g., mental step).
The claims also recite, in step (c) of independent claim 19, “wherein the presence of the complex indicates that the donor tissue is unsuitable for transplantation to the human recipient”. This is an abstract idea (i.e., a indication) or natural phenomenon (i.e., a correlation).
These judicial exceptions are not integrated into a practical application because the additional steps [i.e., steps other than the judicial exceptions] merely recite data gathering steps required to use the judicial exceptions [i.e. the steps of obtaining a sample , contacting the sample and reagents, and detecting a complex are data gathering steps required to use the judicial exceptions], and data gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
Moreover, these steps, when considered separately and in combination, do not add significantly more (also known as an “inventive concept”) to the exception, as they are recited at a high level of generality, encompassing well-understood, routine, and conventional techniques [for example, the recited detection step is general and encompasses ELISA’s and Western blots]. Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. Examiner notes that the specific heterodimers recited in claims 19-21 are part of the judicial exceptions (i.e., the abstract idea or natural phenomenon discussed above), and as such, cannot be considered a practical application of the judicial exceptions nor elements that amount to significantly more than the judicial exceptions.
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.
Claim(s) 1, 2, 4, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lotteau (“A novel HLA class II molecule (DRα-DQβ) created by mismatched isotype pairing”, Nature, vol. 329, 24 September 1987, Lotteau et al.) (cited in Applicant’s specification in para. 0010 in US Pre-Grant Publication 20240272174).
Regarding Applicant’s claim 1, Lotteau teaches a method of screening a biological sample for antibodies that bind to a heterodimer selected from the group consisting of DRα:DQβ and DPα:DQβ heterodimers comprising the steps of:
obtaining a biological sample from a subject,
contacting the biological sample with a heterodimer selected from the group consisting of DRa:DQP and DPa:DQP heterodimers,
[see p. 339, left col, disclosing mixing DRα:DQβ heterodimers with human B-cell lines, (which Examiner notes is equivalent to a biological sample from a subject under the broadest reasonable interpretation since it is a sample that includes a biological sample from a subject)]
and detecting the binding of antibodies in said sample to the heterodimer
[see p. 339, right col., disclosing 2D-PaGE profiles;
see p. 340, left col. disclosing Western blot experiments that confirm that DRα chain associated with DQβ chain;
see p. 340, rt col, disclosing 2D-PAGE profiles].
As to claim 2, the heterodimer is DRα:DQβ heterodimer [see page 339, left column and page 340 disclosing detection of DRα:DQβ heterodimers.]
As to claim 4, the subject is a human subject [see p. 339, left col. disclosing that the sample is from B-cell lines; see p. 341, top of left col disclosing human cells].
As to claim 6, the antibody binding is detected with a secondary antibody [see p. 339 , paras under “Fig. 1” and “Fig. 2” disclosing labelling and immunoprecipitations, which appear to indicate use of a secondary antibody; or alternatively, use of a secondary antibody is well known in the art for labelling and detection of analytes)].
As to claim 7, see above discussion of claim 6 regarding the secondary antibody. Asto the label being a radioactive label, see page 340, left col, first full para., disclosing a radiolabel; see also page 340, rt col., under “Fig. 4” disclosing 125I label.]
Claim Rejections - 35 USC § 103
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lotteau (“A novel HLA class II molecule (DRα-DQβ) created by mismatched isotype pairing”, Nature, vol. 329, 24 September 1987, Lotteau et al.) in view of Weber (CA 2667463).
Lotteau, disclosed above, does not disclose flow cytometry as the means to detect binding of an antibody. Lotteau discloses 2D-PAGE profiles and Western blot experiments using antibodies (page 399, rt col., and page 340, left col. and rt col.)
However, using a known alternative for analysis would have been obvious to one skilled in the art since it would have been a known technique performed in a familiar manner with a predictable outcome of being a substitute technique, and Weber discloses flow cytometry among a list of known analysis techniques, including 2D-PAGE and ELISA (p. 125).
Allowable Subject Matter
Claims 3, 8 and 9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter. The prior art does not teach or suggest detecting DPα-DQβ heterodimers. The prior art also does not teach or suggest detecting DRα-DQβ specifically in a human subject that is a transplant or transfusion recipient, or a transplant or transfusion donor. While detecting DRα-DQβ in B cell lines from a human sample is known in the art [see discussion of Lotteau above], there is no motivation to specifically select a human subject that is a transplant or transfusion recipient, or a transplant or transfusion donor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karp et al., “Structural Requirements for Pairing of α and β Chains in HLA-DR and HLA-DP Molecules”, The Journal of Experimental Medicine, Vol. 171, March 1990, 615-628. [Cited by Applicant in the specification of the US PreGrant Publication. 20240272174, para. 0010.]
Ladowski et al. “Examining the Biosynthesis and Xenoantigenicity of Class II SLA Proteins”, J. Immunol. 2018 April 15; 200(8): 2957-2964. [Cited in Applicant’s IDS of 8/6/24]. This reference discloses study of swine leukocyte antigen (SLA) as a target of epitope-restricted antibody binding (see abstract). The report shows that class I SLA molecules are xenoantigens, and elimination of multiple xenoantigens may bypass antibody-mediated rejection (page 7, last 2 paras.)
Tait, “Detection of HLA Antibodies in Organ Transplant Recipients-Triumphs and Challenges of the Solid Phase Bead Assay”, Frontiers in Immunology, December 2016, Vol. 7, Article 570. [Cited in Applicant’s IDS of 8/6/24]. This reference teaches detection of HLA antibodies in organ transplant recipients. See abstract.
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/Ann Montgomery/ Primary Examiner, Art Unit 1678
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