DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 3, 4, 7-9 and 11-15 are pending upon entry of amendment filed on 1/23/26.
Claims 1, 3, 4, 7-9 and 11-15 are under consideration in the instant application.
3. No oath is of record.
4. The new title filed on 1/23/26 has been entered.
5. IN light of Applicant’s amendment to the claims, the rejections under 35 U.S.C. 112(b), 112(a), 102 (a)(1)(in part) and 103 rejections have been withdrawn (see sections 6-11 and 16-17 of the office action mailed on 7/25/25).
6. The following rejections remain.
7. 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.
8. Claim(s) 1 and 3-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foster et al., (J. Allergy Clin Immunol. 2020, vol. 146, p. 218-220, IDS reference) for the reasons set forth in the office action mailed on 7/25/25.
Foster et al. teach administration of dupilumab in treatment of Covid-19 patient with severe chromic rhinosinusitis. Foster et al further teach administration of dupilumab effects level of IL-13 and claims 3-4 are included in this rejection. Therefore, the reference teachings anticipate the claimed invention.
Applicant’s response filed on 1/23/26 has been fully considered but they were not persuasive.
Applicant has asserted that Foster reference fails to teach all the limitations of the claimed invention and the Foster reference is limited to administration of dupilumab in treatment of severe chronic rhinosinusitis.
However, unlike Applicant’s assertion, dupilumab administration eased course of COVID-19 (p. 17) and combat of covid is initiated with dupilumab therapy. The dupilumab therapy has clinical benefit in Covid therapy (p. 7-8). The rejection is maintained.
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1, 3, 4, 7-9 and 11-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Application No. 18/841,169.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘169 application recites a method of treating Covid-19 disease comprising administering dupilumab and dupilumab reads on the agent neutralize IL-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
11. The following new ground of rejection is necessitated by Applicant’s amendment filed on 1/23/26.
12. 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 of this title, 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.
13. Claims 1, 3, 4, 7-9 and 11-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Foster et al., (J. Allergy Clin Immunol. 2020, vol. 146, p. 218-220, IDS reference, of record) in view of Rincon et al (Int. Biol Sci, vol. 8, p. 1281-1290, of record).
The teachings of the Foster et al., have been discussed, supra.
The disclosures of the Foster references differ from the instant claimed invention in that it does not teach the combination of the Covid related medications such as IL-13, IL-6 and measurement of plasma concentrations as 1 and 9 of the instant application.
Rincon et al. teach role of tocilizumab in treatment of pulmonary inflammation and tocilizumab effects level of IL-13, IL-4, IL-5, IL-6 and IL-6 modulates neutrophils, macrophages IL-17, TGFb, IL-8 and MIP-1b (note p. 1286-1288, Fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize or combine various indications of Covid, treatment regimens and methods to predict Covid as taught by the Foster reference and the Rincon references suggests various mechanisms of airway related diseases including pulmonary diseases.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of dupilumab improves Covid-19 disorders as IL-6 mechanisms of tocilizumab is taught by Rincon. In addition, it is prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA1980, see MPEP 2144.06.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. No claims are allowable.
15. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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, Misook Yu can be reached at 571-272-0839. 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.
Yunsoo Kim
Patent Examiner
Technology Center 1600
February 25, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641