DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed May 26, 2026. Currently, claims 18, 20, 28, 30-31, 33-39 pending. Claims 28, 30-31, 35-37 have been withdrawn as directed to non-elected subject matter. All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
Any objections and rejections not reiterated below are hereby withdrawn.
The Improper Markush rejection has been withdrawn in view of the amendments to the claims to recite a single allele.
The 101 rejection has been withdrawn as the claims were cancelled.
Election/Restrictions
Applicant's election without traverse of HLA-B*3802 and Sulfasalazine, claims 13-21 in the paper filed May 5, 2025 is acknowledged.
Claims 22-23 have been withdrawn as directed to non-elected subject matter.
In view of the arguments with respect to phenotypes, the Examiner has rejoined SJS and TEN. Thus, SJS and TEN have been examined.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
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.
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.
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.
Claim(s) 18, 20, 33-34, 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Longjou et al. (Pharmacogenetics and Genomics, Vol. 18, pages 99-107, 2008) in view of Zawodniak et al. (Int Arch Allergy Immunol. Vol. 153, No. 2, pages 152-156, 2010).
Longjou teaches analysis of HLA-B in Stevens-Johnson syndrome and toxic epidermal necrolysis. SJS and TEN are life-threatening cutaneous adverse reactions to drugs including sulfamethoxazole (abstract). Longjou teaches the B*3802 allele is associated with SJS or TEN in relation to high-risk drugs (Table 6, page 104). Table 6 illustrates B*3802 is associated with poor response to sulfamethoxazole (p-value 0.27). Longjou teaches significant associations were observed with B*38 related to SMX (page 105, col. 2). Longjou teaches the analysis may be performed prospectively or retrospectively (page 104 col. 1). Longjou teaches analysis of genomic DNA from blood samples (page 100, col. 2)(limitations of Claims 20, 34). Loungjou teaches genotyping with sequence specific primers which are allele specific (limitations of Claims 38-39).
Longjou is directed to sulfamethoxazole (SMX) and does not teach administering a disease-modifying drug that is not sulfasalazine.
However, Zawodniak teaches cross-reactivity in drug hypersensitivity reactions to sulfasalazine and sulfamethoxazole. Zawodniak teaches patients with hypersensitivity to sulfasalazine or sulfamethoxazole should be specifically advised to avoid both drugs.
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have analyzed patients for HLA-B*3802 to determine sensitivity to sulfonamides. Longjou teaches the B*3802 allele is associated with poor response to sulfamethoxazole and Zawodniak teaches patients who are sensitivity to sulfamethoxazole should be specifically advised to avoid sulfasalazine also. Therefore, the ordinary artisan would have been motivated to have analyzed B*3802 in patients prior to administering sulfasalazine to determine whether the patient was at risk of SCAR induced by sulfasalazine that is SJS or TEN. Upon detecting the B*3802 allele the ordinary artisan would have been motivated to have avoided sulfasalazine for treating diseases.
Conclusion
No claims allowable.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.A) Wang et al. (American Academy of Allergy, Asthma & Immunology, April 2021, Vol. 147, No. 4) teaches association of HLA-B alleles with phenotypes of co-trimoxazole-induced severe cutaneous adverse reactions including HLA-B*3802 (Table IV).
Chen et al. (NZ572259. March 30, 2012) teaches HLA alleles associated with adverse drug reactions. Chen teaches detecting HLA-B 3802 in subjects. Table 2 illustrates SJS patients with CBZ induced cutaneious ADRS. Chen teaches HLA-B*1502 is associated with an increased risk for an adverse drug reaction when the drug is carbamazepine.
Hallberg et al. (Lancet Diabetes Endrocrinol. Vol. 4, NO. 6, pages 507-516, June 2016) teaches two genome-wide association studies were published describing a strong association between agranulocytosis induced by antithyroid drugs and HLA-B*38:02. Agranulocytosis is a severe reduction in neutrophils causing profound immunosuppression. This is not considered a cutaneous adverse drug reaction since the skin is not involved.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
June 16, 2026
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