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 reply to the Restriction Requirement, dated December 10, 2025, has been received. By way of this submission, Applicant has amended claim 39 and elected Group I with traverse, and the species of COVID-19 coronavirus (SARS-2019-nCoV), acute respiratory distress syndrome (ARDS), and ravulizumab, without traverse. Claims 1-2, 4-6, 8-14, 16-19, 25, 28, 31-32, 37, and 39-40 are pending in the application.
Applicant's election with traverse of Group I in the reply filed on December 10, 2025is acknowledged. The traversal is on the ground(s) that the inventions of Groups I and II are neither independent, nor distinct, and there would not be a serious burden on the Examiner if Group II were rejoined. Upon further consideration in view of Applicant’s amendments to the claims, the restriction requirement between inventions ONLY is hereby withdrawn. The restriction requirement between species, however, remains in effect.
Claims 10-11, 32 and 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 10, 2025.
Claims 1-2, 4-6, 8-9, 12-14, 16-19, 25, 28, 31, and 37 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on at least page 74. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1 and 4 and 31 are objected to because of the following informalities: the claims recite the limitation of “the coronavirus” without specifying which coronavirus is intended. Appropriate correction is required.
For the purpose of claim construction, it is assumed that “the coronavirus” refers to the elected species of SARS-CoV-2.
Claims 1, 4, 6, 12-14, 16-19 are objected to because of the following informalities: the claims recite a “subject”; however, the subject properly introduced in claim 1 specifies a “human subject”. Appropriate correction is required for the purpose of maintaining consistency.
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.
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.
Claims 1-2, 4, 8-9, 14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT04346797 (version 1, dated 2020-4-10, retrieved from the internet on December 19, 2025 at https://clinicaltrials.gov/study/NCT04346797?tab=history&a=1#version-content-panel).
Clinical Trial NCT04346797 teaches treating a patient who has COVID-19 (an infection of SARS-nCoV coronavirus) with eculizumab (page 2). According to Applicant's specification at page 3, eculizumab is an inhibitor of compliment C5.
Clinical Trial NCT04346797 further teaches that improved survival is one possible result (page 6), which is pertinent to claims 13 and 18.
Clinical Trial NCT04346797 further teaches dosages of 1200 mg per dose (page 5-6). Assuming a 70 kg subject, this dosage is within the boundaries of claim 14.
Clinical Trial NCT04346797 further teaches that the patient with COVID-19 may require treatment in an ICU (page 9).
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.
The factual inquiries 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 nonobviousness.
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.
Claims 1-2, 4, 8-9, 12-14, 16-19, 25, 28, 31, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04346797 in view of Fontenot (US20160168237A1).
Clinical Trial NCT04346797 teaches treating a patient who has COVID-19 (an infection of SARS-nCoV coronavirus) with eculizumab (page 2). According to Applicant's specification at page 3, eculizumab is an inhibitor of compliment C5.
Clinical Trial NCT04346797 further teaches that improved survival is one possible result (page 6), which is pertinent to claims 13 and 18.
Clinical Trial NCT04346797 further teaches dosages of 1200mg per dose (page 5-6). Assuming a 70kg subject, this dosage is within the boundaries of claim 14.
Clinical Trial NCT04346797 further teaches that the patient with COVID-19 may require treatment in an ICU (page 9).
However, Clinical Trial NCT04346797 does not teach the elected species of ravulizumab.
Fontenot teaches the anti-C5 antibody BNJ441, which is a variant of eculizumab (para. 0151). According to Applicant's specification at page 3, BNJ441 is ravulizumab.
Fontenot also teaches a method of treating a complement mediated disorder caused by an infectious agent, comprising administering an effective amount of a polypeptide inhibitor of complement C5 protein, and that the infectious agent may be a virus (para. 0062-0063).
Fontenot further teaches administering an additional therapeutic agent with a C5 inhibitor (para. 0225), which is pertinent to claim 12.
Fontenot further teaches that the dosage(s) and frequency of administration are determined according to the need of the patient, at the discretion of the treating physician (para. 0102). Fontenot also teaches that any suitable dosage(s) and frequency of administration are contemplated (para. 0211). Fontenot also teaches exemplary dosages of 300 mg, 900 mg, and 1200 mg (para. 0220).
Fontenot further teaches a serum trough concentration of the anti-C5 antibody, or antigen binding fragment thereof, of about 35 μg/mL to about 700 μg/mL during the induction phase and/or the maintenance phase (para. 0131), which is pertinent to claim 25.
Fontenot further teaches that the above treatment results in terminal complement inhibition (para. 0133), which is pertinent to claim 28.
Fontenot further teaches that the above treatment results in alleviation of elevated complement C5 level (para. 0072).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Clinical Trial NCT04346797 and Fontenot to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Clinical Trial NCT04346797 and Fontenot are concerned with the use of inhibitors of human complement C5 protein to treat viral infection. According to Clinical Trial NCT04346797, the complement C5 inhibitor eculizumab was known to be useful in treating COVID-19. Fontenot teaches that BNJ441, also known as ravulizumab, is a variant of eculizumab with similar properties. One of ordinary skill in the art could apply the ravulizumab of Fontenot to the method of Clinical Trial NCT04346797 by simple substitution, with each component of the combination performing their known, usual function, and the combination would yield nothing more than predictable results.
The difference between the claimed invention and the prior art is the dosage schedule. However, it is noted that determination of dosage is routinely determined by the ordinary artisan as of the effective filing date of the claimed invention, and was known as a result effective variable that depends on the conditions of the patients. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). One of ordinary skill in the art would appreciate the schedule or dosage of the antibody in the therapy could be adjusted to achieve optimum therapeutic efficacy, especially as Fontenot teaches that the dosage(s) and frequency of administration are determined according to the need of the patient, at the discretion of the treating physician (para. 0102).
Applicant is invited to present evidence of an unexpected criticality of the claimed dosage schedule in order to address this issue. See MPEP 2144.05(III)(A).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04346797 and Fontenot as applied to claim 1 above, and further in view of Errico (US20200230408A1).
The teachings of Clinical Trial NCT04346797 and Fontenot have been discussed supra. However, Clinical Trial NCT04346797 and Fontenot do not teach acute respiratory distress syndrome (ARDS).
Errico teaches that patients with COVID-19 can experience pneumonia and/or ARDS (Acute Respiratory Distress Syndrome) (para. 0008).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Clinical Trial NCT04346797, Fontenot, and Errico to arrive at the claimed invention. As stated above, the use of ravulizumab to treat COVID-19 was obvious in view of Clinical Trial NCT04346797 and Fontenot. Errico teaches one such symptom of COVID-19 is ARDS. The information presented in Errico could be used to select suitable patients for the method of Clinical Trial NCT04346797 and Fontenot. Each component of the combination would perform their known, usual function, and the combination would yield nothing more than predictable results.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-6, 8-9, 12-14, 16-19, 25, 28, 31, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-17, 19, and 31-32 of copending Application No. 18/011,698 in view of Clinical Trial NCT04346797, Fontenot, and Errico.
The '698 application claims a method of treating a human patient with a complement-associated condition, comprising administering to the patient an effective amount of an anti-C5 antibody or antigen binding fragment thereof (claim 1).
The '698 application further claims the antibody is ravulizumab or eculizumab (claim 16).
The '698 application further claims the treatment maintains a serum trough concentration of the anti-CS antibody or antigen binding fragment thereof, of 100 pg/mL or greater during the administration cycle (claim 17).
The '698 application further claims the treatment results in terminal complement inhibition (claim 19).
However, the '698 application does not claim treatment of a complement mediated disorder caused by a coronavirus.
Clinical Trial NCT04346797 teaches treating a patient who has COVID-19 (an infection of SARS-nCoV coronavirus) with eculizumab (page 2). According to Applicant's specification at page 3, eculizumab is an inhibitor of compliment C5.
Clinical Trial NCT04346797 further teaches that improved survival is one possible result (page 6), which is pertinent to claims 13 and 18.
Clinical Trial NCT04346797 further teaches dosages of 1200 mg per dose (page 5-6). Assuming a 70 kg subject, this dosage is within the boundaries of claim 14.
Clinical Trial NCT04346797 further teaches that the patient with COVID-19 may require treatment in an ICU (page 9).
Fontenot teaches the anti-C5 antibody BNJ441, which is a variant of eculizumab (para. 0151). According to Applicant's specification at page 3, BNJ441 is ravulizumab.
Fontenot also teaches a method of treating a complement mediated disorder caused by an infectious agent, comprising administering an effective amount of a polypeptide inhibitor of complement C5 protein, and that the infectious agent may be a virus (para. 0062-0063).
Fontenot further teaches administering an additional therapeutic agent with a C5 inhibitor (para. 0225), which is pertinent to claim 12.
Fontenot further teaches that the dosage(s) and frequency of administration are determined according to the need of the patient, at the discretion of the treating physician (para. 0102). Fontenot also teaches that any suitable dosage(s) and frequency of administration are contemplated (para. 0211). Fontenot also teaches exemplary dosages of 300 mg, 900 mg, and 1200 mg (para. 0220).
Fontenot further teaches a serum trough concentration of the anti-C5 antibody, or antigen binding fragment thereof, of about 35 μg/mL to about 700 μg/mL during the induction phase and/or the maintenance phase (para. 0131), which is pertinent to claim 25.
Fontenot further teaches that the above treatment results in terminal complement inhibition (para. 0133), which is pertinent to claim 28.
Fontenot further teaches that the above treatment results in alleviation of elevated complement C5 level (para. 0072).
Errico teaches that patients with COVID-19 can experience pneumonia and/or ARDS (Acute Respiratory Distress Syndrome) (para. 0008).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine claims of the ‘698 application with the teachings of Clinical Trial NCT04346797, Fontenot, and Errico to arrive at the claimed invention. The ‘698 application and the instant application both teach the use of anti-C5 antibodies to treat a complement-mediated condition. Clinical Trial NCT04346797 and Fontenot teaches that COVID-19 is one such condition that may be treated with anti-C5 antibodies such as eculizumab and ravulizumab. One of ordinary skill would be able to apply the treatment claimed in the ‘698 application to a patient with a complement mediated disorder caused by a virus by following the guidance found in Clinical Trial NCT04346797 and Fontenot. Each component of the combination would perform its known, usual function, and the combination would yield nothing more than predictable results.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 8:00 to 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, Daniel Kolker can be reached at (571) 272-3181. 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.
/PETER JOHANSEN/Examiner, Art Unit 1644