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 .
Priority
This is a National Stage Entry under 35 U.S.C. 371 of International Patent Application
No. PCT/US2023/061335, filed January 26, 2023. This application also claims priority to US Provisional Application No. 63/303,887, filed on January 27, 2022.
Drawings
The drawings are objected to because Figures 2A, 2B, 3C, 4B, 5, 6, 7Q, 8, 9A, 9B, 11A, 13B and 15 are not of sufficient quality. The values of Figure 2A, 2B, 3C, 6, 7Q, 8, and 13B are illegible. The X axis label of 4B is illegible. The amino acids of Figure 5 are illegible. The chart tiles (“COV…”) of Figure 9A, 9B, 11A, and 15 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112 – Scope of Enablement
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.
Claim 33 is 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 treating a SARS-CoV-2 infection within a subject, does not reasonably provide enablement for preventing a SARS-CoV-2 infection in the absolute sense. While the antibody described in claim 5 can neutralize some SARS-CoV-2 viruses, it does not neutralize all SARS-CoV-2 viruses (Figure 3b, 3c). 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
• (A) The breadth of the claims;
• (B) The nature of the invention;
• (C) The state of the prior art;
• (D) The level of one of ordinary skill;
• (E) The level of predictability in the art;
• (F) The amount of direction provided by the inventor;
• (G) The existence of working examples; and
• (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Here, the instant claims are broadly drawn to a method for preventing a coronavirus infection by administering an antibody against the NTD of SARS-CoV-2. In regard for prevention of SARS-CoV-2 infection, it is noted that the term “preventing” was interpreted in an absolute sense to mean to always keep something from happening or arising.
The claims are not enabled based on that not all viral infection caused by SARS-CoV-2 are prevented by the antibody being claimed. The level of skill in the art is high and would include, e.g., Ph.D. level scientists.
The art establishes antibodies similar to those of the instant application is not 100% effecting in preventing SARS-CoV-2 infection as evidenced by Gai et al. ((biorxiv, August 10, 2020), 10.1101/2020.08.09.242867, hereinafter, “Gai”, Figure 5). Gai evidences that antibodies have some effect on lessening SARS-CoV-2 infection but that this effect is dose dependent and even at high doses is not 100% successful at preventing a SARS-CoV-2 infection (Figure 5).
Furthermore, contemporaneous with the effective filing date of the application, the art establishes that antibodies work by binding, with different efficiencies, to viral proteins from SARS-CoV-2 (Adams et al. Cell Reports Medicine, December 2023, 10.1016/j.xcrm.2023.101305, hereinafter, “Adams”). Adams evidences that while antibodies can strongly bind NTD of SARS-CoV-2, they do not confer absolute protection against SARS-CoV-2 infection (Figure1, Figure 4). Therefore, there is a reasonable expectation that an antibody that targets the NTD of SARS-CoV-2 would not prevent an infection all cases.
In view of the evidence discussed above, the antibody of claim 5 would not predictably prevent infections caused by SARS-CoV-2 in every single case.
The specification only exemplifies and reduces to practice lessening SARS-CoV-2 infection and symptoms following antibody administration in some cases (Figure 7). The specification discloses several antibodies that exhibit high potency for the neutralization of some variants of SARS-CoV-2, no antibody exhibited high potency to all SARS-CoV-2 Variants (Figure 3a-c). Figure 3D shows neutralizing activity of several antibodies based on concentration where some antibodies are only effective at higher concentrations. Figure 7 details the duration, onset, and severity of symptoms in patients with no correlation between antibodies detected and a reduction in duration, onset, and severity. One of ordinary skill in the art would be unable to determine how the use of antibodies as described in the instant invention would be able to prevent all SARS-CoV-2 infections without extensive further testing. Together, the specification offers no reasonable direction or working example for the use of antibodies that that prevent all SARS-CoV-2 infections.
In view of the foregoing, a vast quantity of experimentation, including expansive clinical trials, would be needed to use the invention based on the content of the disclosure.
Taken together, 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.
Claim Rejections - 35 USC § 112 – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 7, 11 – 17, 19, 20, 26 – 30, 32, and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the transitional phrase “having” is unclear as to whether open or closed claim language is intended. The variable regions of the antibody may be defined by the exact SEQ ID NO: 167 and 168 or may be comprised of SEQ ID NO: 167 and 168. See MPEP 2111.03 (IV). For purposes of compact prosecution and examination, “having” is interpreted as “comprising”.
Regarding claim 5, there are no CDRs defined by a CDR labeling system, thus rendering the claim indefinite. The claims could read on Kabat, IMGT, or Chothia CDRs, for example, giving multiple structural interpretations. The claims could also read on composite CDRs such as those including both Kabat and IMGT CDRs. The claim may also allow mixing and matching from multiple labeling systems, some from Kabat, some from IMGT, etc. The presence of so many different interpretations render the claims indefinite.
The dependent claims and do not add additional clarity and, therefore, are also indefinite.
Claim Rejections - 35 USC § 112 - Dependence
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 defines “an isolated anti-SARs-CoV-2 antibody or antigen-binding fragment thereof, comprising three heavy chain complementarity determining regions (HCDRs) (HCDR1, HCDR2, and HCDR3) of a heavy chain variable region having the amino acid sequence of SEQ ID NO: 167 and three light chain CDRs (LCD1, LCD2, and LCD3) of a light chain variable region having the amino acid sequence of SEQ ID NO: 168.” Claim 7 recites “The antibody or antigen-binding fragment thereof of claim 5, comprising: a heavy chain variable region (HCVR) and a light chain variable region (LCVR) that comprise a HCVR/LCVR amino acid sequence pair of SEQ ID NOs: 167-168.” Claim 7 does not further limit any aspect of claim 5 because claim 5 already defines the heavy and light chain variable regions by SEQ ID NO: 167 and 168 respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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