DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 05/19/2026 has been entered.
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 .
Priority
This application is a 371 of PCT/EP2021/059264 filed on 04/09/2021, which has foreign applications to: EP 20169058.3 and EP 20169071.6 filed on 04/09/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05/19/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Withdrawal of Rejections
The response and amendments filed on 05/19/2026 are acknowledged and are considered sufficient to overcome the previous claims rejection as indicated in the last office action. Therefore, all previous claim rejections have been withdrawn necessitated by Applicant’s amendments. However, in light of the amendments, a new ground of rejection is set forth below.
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §102, Anticipation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6-7, 9, 11, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding (High Expression of HMGB1 in Children with Refractory Mycoplasma pneumoniae Pneumonia, 2018 - newly cited reference).
Regarding claim 1’s preamble, Ding’s present study aims to explore the role and clinical significance of HMGB1 in children with refractory Mycoplasma pneumoniae pneumonia (RMPP) or non-RMPP (NRMPP) and the potential mechanism of HMGB1 expression, and to provide new clues for MPP prevention and treatment (see page 2, left col., last ¶). Ding discloses that “Mycoplasma pneumoniae is a major bacterial pathogen of the airways that causes acute and chronic infections of the respiratory tract and accounts for approximately 10-40% of all lower respiratory tract infections including community-acquired pneumonia (CAP)” (see page 2, left col.: Background).
Regarding claim 1(a)-(b) pertaining to the HMGB1, Ding teaches that “HMGB1 is an actively secreted cytokine produced by macrophages and other inflammatory cells that participates in various infectious diseases”, “HMGB1, TNF-α, and IL-6 in peripheral blood from RMPP and non-RMPP (NRMPP) cases were detected by real-time PCR and ELISA”, and that “HMGB1 is a good diagnostic biomarker for differentiating RMPP and NRMPP” (see abstract & page 7: Conclusions). Ding teaches “As shown in Fig. 3, HMGB1 had good diagnostic ability for differentiation of RMPP with cut-off of 5.25 × 10-3, AUC of 0.876, Sig. of AUC of 0.779–0.973, and Youden index of 0.657 compared with TNF-α and IL-6” (see page 4, right col.). Ding teaches HMGB1 levels in peripheral blood, serum samples (see page 2, right col. & page 7: Conclusions).
Regarding claims 1(c) and 30 pertaining to the antibiotic treatment, Ding teaches macrolide antibiotic therapy (see page 2, left col., 3rd ¶, and page 5, right col.).
Regarding claims 6-7 pertaining to the symptoms, Ding teaches clinical symptoms include cough, wheezing, nose running, fever, difficult feeding, diarrhea, abnormal signs of lung (see page 4: Table 4).
Regarding claims 9 and 11 pertaining to the condition, Ding discloses “Pneumonia is one of the most serious infectious diseases, with high morbidity and mortality. In 2015, pneumonia
killed an estimated 922,000 children under 5 years of age, accounting for 15% of all child deaths. Mycoplasma pneumoniae is a major bacterial pathogen of the airways that causes acute and chronic infections of the respiratory tract and accounts for approximately 10-40% of all lower respiratory tract infections including community-acquired pneumonia (CAP)” (see page 2, left col.: Background). Claim interpretation: the instant specification discloses the atypical group, as second most frequent class of CAP pathogens, include Mycoplasma pneumoniae, and therefore, reads on the claim’s limitation of an atypical bacterial infection (see pre-grant specification at ¶ [0006]-[0010]).
New Grounds of Rejection Necessitated by Amendment
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ding as applied to claims 1, 6-7, 9, 11, and 30 above, in view of Shirakawa (US 2014/0171359 A1 - previously cited reference).
Ding’s disclosure is taught above as it pertains to a method of treating an atypical bacterial lower respiratory tract infection using HMGB1 as a diagnostic biomarker.
However, Ding does not teach: the additional biomarkers as seen in claim 13.
Shirakawa’s general disclosure relates to a method for detecting respiratory infection associated with bacterial infection (see abstract & ¶ [0001], [0014]). Shirakawa teaches wherein the respiratory infection associated with bacterial infection is lower respiratory tract infection or pneumonia and the causative microorganism includes mycoplasma or pneumococcus, and culture test of blood, sputum or bronchioalveolar lavage fluid (see ¶ [0025]). Shirakawa teaches comparing measured values in samples with a predetermined reference value (see ¶ [0037]-[0038]). Shirakawa teaches “wherein said methods are characterized in that they are able to appropriately select patients with respiratory infection to whom the antibiotic is to be administered, to adjust the administration period of the antibiotic, and to treat respiratory infection associated with bacterial infection” (see abstract).
Regarding the biomarker, Shirakawa teaches the “marker according to above (1-12), further comprising at least one selected from the group consisting of inflammation markers including TNF-α, lactate dehydrogenase, sialic acid, IL-1β, IL-6, and IL-10, markers associated with thrombus and hemostasis including activated partial thromboplastin time, platelet count, fibrinogen, items of the diagnostic criteria for DIC, protein C, D-dimer, thrombin, anti-thrombin III complex, and prothrombin fragment F1+2, infection markers including procalcitonin (PCT), C-reactive protein (CRP), blood urea nitrogen, white blood cell count, endotoxin, adrenomedullin, proadrenomedullin, MR-proADM, B-type natriuretic peptide, trigger receptors expressed on myeloid cell-1, and HMGB1, stress markers including cortisone and copeptin, and markers for interstitial pneumonia including KL-6, SP-A, SP-D, and MCP-1. (1-14). A method for detecting respiratory infection associated with bacterial infection, wherein sCD14-ST in a urine sample derived from a subject and at least one biomarker other than sCD14-ST are measured” (see ¶ [0025], [0070]).
It would have been obvious to determine the level of additional biomarkers including infection markers of procalcitonin, proadrenomedullin, et al. such as taught by Shirakawa in the method of Ding because the biomarkers would provide additional diagnostic and confirmatory data of infection as both references are directed to determining respiratory tract infection.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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