DETAILED ACTION
Applicant's amendment and remarks filed January 12, 2026 are acknowledged and entered. Claims 17-20 and 22 remain under examination with regard to the elected species of viral replication kinetic analysis. Claims 21 and 23-31 remain withdrawn from consideration, being directed to non-elected subject matter.
Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claim 17 is directed to a method of diagnosing and treating a patient with a BE/ANT-A11/17 strain of RSV. The method comprises:
Isolating a virus from a biological sample from the patient;
Exposing a cell line to the virus, selected from HEp-2, A549, Vero and BEAS-2B;
Culturing the cell line with the virus, thereby replicating the virus;
Isolating the amplified virus by collecting a volume of supernatant;
Characterizing the isolated virus to generate a viral profile (elected species), wherein the viral profile comprises data collected from a viral replication kinetic analysis;
Diagnosing the patient as being infected with the BE/ANT-A11/17 strain of RSV, comprising matching the viral profile to a known profile of the BE/ANT-A11/17 strain, wherein the known profile of the BE/ANT-A11/17 strain is compared to a control profile, specifically, the RSV A2 strain (claim 20); and,
Treating the diagnosed patient with a monoclonal antibody (mAb); the mAb is palivizumab (claim 18); the mAb is a human anti- BE/ANT-A11/17 antibody (claim 19).
The viral replication kinetic analysis comprises:
Culturing a second cell line with the virus for 2 hours, wherein the second cell line is selected from HEp-2, A549 and BEAS-2B;
Fixing the second cell line with paraformaldehyde after a given period of time after culturing;
Staining and permeabilizing the fixed cell line with palivizumab;
Staining the fixed cell line with goat anti-human secondary antibody conjugated with Alexa Fluor 488; and
Analyzing the stained cell line using fluoresce microscopy;
wherein an increased rate of viral replication compared to a control is associated with the BE/ANT-A11/17 strain of RSV.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 17 recites “treating the diagnosed patient with a monoclonal antibody”. Prior to the amendment filed January 12, 2026, the monoclonal antibody “binds BE/ANT-A11/17”. A generic monoclonal antibody with no binding specificity is new matter. Every instance of the specification’s disclosure of a monoclonal antibody is in the context of one that binds BE/ANT-A11/17. See paragraphs [0015] and [0016] of the published application (US 20220362371) and the claims as originally filed. Therefore, claim 17 and dependent claims 20 and 22 are rejected.
Claims 17-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The remarks filed January 12, 2026 and the accompanying declaration of Peter Delputte are acknowledged, but they fail to meet all the requirements outlined in 37 CFR 1.805 and 1.809(d)(4). Applicant states that they submitted a receipt of original deposit issued by the BCCM consortium and a viability statement, however, these items do not appear to have been submitted with the response filed January 12, 2026.
As previously made of record:
It is apparent that the BE/ANT-A11/17 strain of RSV is required to practice the claimed invention because it is a necessary limitation for the success of the invention as stated in the claims. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the BE/ANT-A11/17 strain. See 37 CFR 1.802.
One cannot practice the claimed invention without the strain because a viral profile of the virus is required in order to characterize an unknown isolate as matching the profile of the BE/ANT-A11/17 strain. Further, antibodies that bind to the strain cannot be made without access to the strain. Therefore, access to the strain is required to practice the invention. The specification does not provide a repeatable method for producing the BE/ANT-A11/17 strain without access to it, and it does not appear to be readily available material.
Deposit of the BE/ANT-A11/17 strain in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
It is noted that the specification indicates a deposit of strain BE/ANT-A11/17 at Belgian Coordinated Collection of Micro-Organisms under deposit number LMBP 11505 on August 23, 2019. However, the following issues remain outstanding:
There is no address provided for the Belgian Coordinated Collection of Micro-Organisms. This information must be added to the specification. See 37 CFR 1.809(d)(4).
The requisite statement outlined above that “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent” must be used and may be made of record in Applicant’s remarks signed by Applicant’s attorney of record (not necessarily in a declaration or affidavit). See 37 CFR 1.808(a)(2).
Claims 17-20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of diagnosis and administration of palivizumab to a subject infected with the BE/ANT-A11/17 strain of RSV, does not reasonably provide enablement for treatment of the subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims encompasses the treatment of a subject already infected with BE/ANT-A11/17 by administering a monoclonal antibody, which in some claims is a non-descript monoclonal with no designated binding specificity (i.e., claims 17, 20 and 22). Treatment means that there is an improvement in the condition of the subject that is infected by a lessening of disease symptoms. The nature of the invention is the administration of a monoclonal antibody, resulting in amelioration of the disease symptoms.
The specification does not provide any examples of treatment in animal models. The state of the art regarding palivizumab is that palivizumab is used prophylactically and has no value as a means of therapy for a subject already infected (see abstract of O’Hagan et al., Drug, Healthcare and Patient Safety, 2023, 15:103-112). Moulia et al. (MMWR Morb Mortal Wkly Rep 2025;74:508–514) report that nirsevimab and clesrovimab (mAbs that bind RSV F) are useful for passive immunization for infants.
Further, the only antibody that Applicant has provided that binds BE/ANT-A11/17 is palivizumab, which binds RSV F protein. Other antibodies that bind BE/ANT-A11/17 are not provided in the specification, nor those that effect treatment. Other monoclonal antibodies with no binding specificity indicated (claim 17, for example) are not provided that result in treatment of an existing BE/ANT-A11/17 infection.
In conclusion, the breadth of the claims, the nature of the invention, the limited guidance in the specification and working examples, the low level of predictability and the state of art, it would require undue experimentation to practice the claimed method of treating a subject infected with a BE/ANT-A11/17 strain of RSV with a monoclonal antibody whose binding specificity is not provided in the claims, or even with an antibody that binds the BE/ANT-A11/17 strain.
Applicant’s remarks filed January 12, 2026 have been considered but fail to persuade. Applicant argues that the Office has failed to provide a citation to any rule or law that requires an applicant to disclose all of the possible molecules, compounds, and/or moieties that result in a given effect. Applicant argues that palivizumab is an antibody that can be used for treatment, as claimed in claim 18.
In response, the Office is not requiring the disclosure of all possible molecule, compounds and/or moieties that treat an infection with the BE/ANT-A11/17 strain of RSV. Rather, this scope of enablement rejection is addressing the lack of enablement for the treatment of RSV. As outlined above, the breadth of the claims encompasses the treatment of a subject already infected with BE/ANT-A11/17, meaning that an improvement in the condition of the subject, i.e., lessening of disease symptoms. The nature of the invention is the administration of an antibody that binds BE/ANT-A11/17, resulting in amelioration of the disease symptoms. The specification does not provide any examples of treatment in animal models. The state of the art regarding palivizumab is that palivizumab is used prophylactically and has no value as a means of therapy for a subject already infected (see abstract of O’Hagan et al., Drug, Healthcare and Patient Safety, 2023, 15:103-112). Moulia et al. (MMWR Morb Mortal Wkly Rep 2025;74:508–514) report that nirsevimab and clesrovimab (mAbs that bind RSV F) are useful for passive immunization for infants. It is for these reasons that the claims are rejected for lack of enablement for treatment. Amendment of the claims to diagnosis and administration of palivizumab, without any reference to treatment, would overcome this rejection.
Conclusion
No claim is allowed.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672