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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/7/2026 has been entered.
Claims 1, 3-7, 9-15, 18, 24, 27, 28, 43 and 49 are pending. Claims 1, 3-7, 9-10, 43 and 49 are withdrawn. Claims 11-15, 18, 24, 27 and 28 are currently under examination.
This office action is in response to the amendment filed on 7/7/2026.
All previous rejection not reiterated in this office action are withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/17/2026 and 8/13/2026 have been considered by the examiner.
Claim Objections
Claim 11-15, 18, 24, 27 and 28 is objected to because of the following informalities: the amended claim 11 recites “1000 pg/” at the end of step (b).
Appropriate correction is required.
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.
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) 11-15, 18, 24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (IDS). This rejection is rewritten to address the amendment.
Yang teaches a study that examined cytokines in plasma samples from 53 COVID-19 cases, divided into severe cases (34) and moderate cases (17) (lines 60-65). Yang teaches that IP10, MCP3 and IL-1ra were independent predictors for the progression of COVID-19 (lines 21-29). Yang teaches serial detection of IP10, MCP3 and IL-1ra in 14 severe cases showed continuous high levels of these cytokines were associated with disease deterioration and fatal outcome, making them biomarkers that closely associated with disease severity and outcome of COVID-19 (lines 19-32). Yang teaches both groups received antiviral treatment (lines 66-67). Yang teaches notably, IP10 in the severe cases possessed a high and similar expression level at all groups of sample collection time, whereas IP10 in moderate cases was significantly lower and further decreased a lot at >=15 d.a.o. (lines 92-97). Yang teaches the viral load showed obvious correlation with IP10 (lines 99-100). Yang teaches not only pathogen but also pathogen induced cytokine storm should be considered during the treatment, and therapy strategy with a combination of antimicrobial and immunotherapy may produce a more favorable outcome (131-134). Yang teaches IP10 plays a crucial role in the pathogenesis of SARS-CoV-2, and exacerbation of the pathology of ARD, and modulators such as antibody targeting IP10 may be a promising therapeutic strategy in the treatment of acute phase of ARDS to ameliorates acute lung injury (lines 139-146).
The teaching from Yang teaches measuring IP10 in a sample of subject (Figure 2 and lines 351-355), said subject already received antiviral treatment (lines 66-67). Figure S1 shows measuring expression of IP10 at different time points, whereas the initial IP10 level is above about 103 pg/ml in all severe cases at 0-7 d.a.o (bottom graph).
However, Yang does not specifically teach changing the treatment when the level of IP10 is above a predetermined threshold that is above 1000 pg.
It would have been obvious to an ordinary skilled in the art to conclude from the study of Yang that IP10 plays a crucial role in the pathogenesis of SARS-CoV-2, wherein high level is associated with severe cases. The ordinary skilled in the art would recognize the previous antiviral treatment alone may not be effective when the level of IP10 is high, and altering treatment to include additional agents that lowers IP10 level would have been an obvious choice as suggested by Yang (lines 144-146). Figure S1 shows measuring expression of IP10 at different time points, whereas the initial IP10 level is above about 103 pg/ml in all severe cases at 0-7 d.a.o (bottom graph). As such, IP10 level above 1000 pg/ml may serve as a predetermined threshold level for altering treatment.
Therefore, the claimed invention of claim 11-14 and 18 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Regarding claim 15, Yang teaches IP10 plays a crucial role in the pathogenesis of SARS-CoV-2, and exacerbation of the pathology of ARD, and modulators such as antibody targeting IP10 may be a promising therapeutic strategy in the treatment of acute phase of ARDS to ameliorates acute lung injury (lines 139-146).
Regarding claim 24, Yang teaches remeasuring IP10 as shown in Figure S1.
Regarding claim 27, Yang teaches patients receiving antiviral treatment and corticosteroid (line 134).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, in view of Sun et al (Experimental and Therapeutic Medicine, 2019, Vol. 18, pages 4637-4644).
Sun et al. teaches testing different dose and time course of corticosteroid treatment with acute respiratory distress (ARDS) syndrome (title). Sun et al. teaches that the use of low dose corticosteroid significantly reduced the mortality rate of patients with ARDS, and the duration of mechanical ventilation and significantly improved PaO2/FiO2 ratio (abstract, and page 4642, 1st col).
It would have been obvious to an ordinary skilled in the art to conclude from the study of Yang that IP10 plays a crucial role in the pathogenesis of SARS-CoV-2, wherein high level is associated with severe cases for reason discussed above. The ordinary skilled in the art would recognize the previous antiviral treatment alone may not be effective when the level of IP10 is high, and altering treatment to include additional agents would yield favorable outcome because Yang teaches “therapy strategy with a combination of antimicrobial and immunotherapy may produce a more favorable outcome.” Yang also teach that corticosteroids can downregulate proinflammatory cytokine transcription and subsequently inhibit the cytokine storm. Although high dose of corticosteroids may be a concern when treating H7N9, the ordinary skilled in the art would be motivated to use low dose corticosteroids because Sun et al. teaches doses and time course of corticosteroids makes a big difference in treating ARD, which may result from SARS-CoV-2 infection. Therefore, the claimed invention of claim 28 would have been prima facie obvious to an ordinary skilled in the art at the time the application was filed.
Response to Arguments
Applicant argues that Yang does not teach a predetermined threshold value of 1000 pg/ml. Applicant argues that the office derives this value from a graphical representation in Figure S1 and concludes that a level above 1000 pg/ml may serve as a threshold for altering treatment. Applicant argues that Figure S1 of Yang shows measured IP10 levels over time and does not identify 1000 pg/ml as a clinically meaningful cutoff, and the graph itself does not disclose a precise value of 1000 pg/ml. Applicant argues that one could infer various values or this threshold and selecting 1000 pg/ml and converting that approximate graphical observation into a treatment triggering threshold is in hindsight.
The above argument has been fully considered but deemed unpersuasive. As discussed in the rejection, Yang teaches “we report biomarkers that closely associated with disease severity and outcome of COVID-19.” (page 2, line 31-32), and “these results indicated that these three cytokines could be considered as biomarkers to predict disease progression and outcome of SARS-CoV-2 infections.” (line 126-128). It would have been obvious to an ordinary skilled in the art that IP10 may be used as a biomarker for monitoring treatment course(s). With regard to the argument directed to derivation of 1000 pg/ml from graphical representation, Applicant is reminded that the entire teaching from prior art, including data presented in graphical representation may be considered relevant teaching. The standard for applying obviousness rejection does not exclude teaching from prior art depending how it is presented. Yang’s teaching clearly indicates IP-10 level has extremely significant correlation with disease severity. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Yang’s teaching from Figure 4 also shows that IP-10 level above 1000 pg/ml in longer period of time results in death or critical condition. Therefore, an ordinary skilled in the art reading the entire document would have concluded that IP-10 level above 1000 pg/ml indicates the treatment needs to altered (otherwise the patient would die or get into critical condition).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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, Jennifer Dunston can be reached at 571-272-2916. 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.
/CELINE X QIAN/Primary Examiner, Art Unit 1637
Prosecution Insights