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/US2021/056548, filed October 26, 2021. This application also claims priority to US Provisional Application No. 63105769, filed on October 26, 2020.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 9, 10, 12 – 15, 17 – 20, and 40 in the reply filed on 01/20/2026 is acknowledged. The elected species are as follows:
SEQ ID NO: 2
Claims 14, 15, 17, and 18 are drawn to a composition comprised of two different polypeptides. Applicant elected species SEQ ID NO: 2 for examination corresponding to claims 1, 2, 9, 10, 12 -15, and 17 – 20. The same polypeptide would not satisfy the scope of the claims and therefore, claims 14, 15, 17, and 18 have been withdrawn.
Claims 22-23, 25-26, 29-31, 33,3 5-39, 41, 44-49, 52 and 54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Claims 1-2, 9-10, 12-13, 19-20, and 40 are under consideration.
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 1-2, 9-10, 12-13, 19-20, and 40 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.
Claim 1 recites a polypeptide comprised of CDRs from SEQ IN Nos: 1 – 29. It is unclear which numbering scheme is used to define the CDRs for SEQ ID Nos: 1 – 29. Kunik et al. (Nucleic Acids Res, 2012, hereinafter, “Kunik”) teaches the Paratome CDR residue numbering scheme and highlights the differences between Kabat, IMGT, and Paratome numbering schemes (Abstract). Kunik teaches Kabat and IMGT are used to define the CDR regions but that these methods devise a unique numbering system and that the identification methods may miss >20% of the residues that bind the Ag (Introduction ¶2). Altogether, Kunik teaches that the CDRs in a sequence are defined differently by competing numbering scheme and would not result in predictable sequences to one of ordinary skill in the art. Therefore, the claim is indefinite because it the claim fails to particularly point out and distinctly claim the CDRs of the polypeptide.
The dependent claims fail to limit the claim and therefore, are also indefinite.
Claim 2 further limits claim 1 so the “CDR sequences are defined using the Kabat, IMGT, or Paratome numbering schemes, or a combination of the Kabat, IMGT and Paratome numbering schemes.” Sela-Culang et al. (Fronters in Immun, 2013, hereinafter, “Sela-Culang”) teaches the general structure of antibodies including CDR and non-CDR regions of antibodies (Figure 3). Sela-Culang teaches that the numbering and definition of a CDR varies based on which numbering scheme is used (Figure 3, reproduced below). Altogether, Sela-Culang teaches that defining one CDR numbering scheme with another would result in sequences that are not readily understood in the field. Therefore, the combination of Kabat, IMGT and Paratome numbering schemes to define CDRs within the same polypeptide fails to particularly point out and distinctly claim the CDRs of the polypeptide.
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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 1-2, 10, 12-13, 19-20, and 40 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 the specific CDR1, CDR2, and CDR3 sequence combinations within a single SEQ ID NO, does not reasonably provide enablement for a combination of any CDR sequences of any one of SEQ ID Nos: 1 – 29. 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 composition for binding to SARS-CoV-2. For purposes of examination claims that do not explicitly state the CDR numbering scheme will be interpreted as being identified by the Kabat numbering scheme. Furthermore, for claim 1 and dependent claims of claim 1, “A polypeptide…comprising the complementarity determining region 1 (CDR1), CDR2, and CDR3 sequences of any one of the SEQ ID NOs” is interpreted as a polypeptide that is comprised of any combination of CDRs from any one of the SEQ ID NOs listed.
The claims are not enabled based on, but not limited to, a major line of evidence: not all CDR combinations are effective at binding SARS-CoV-2 and therefore randomly combining CDRs would not predictably produce a polypeptide that can bind to SARS-CoV-2. The level of skill in the art is high and would include, e.g., Ph.D. level scientists.
The art establishes that single domain antibodies do not have identical binding efficiencies as other single domain antibodies even when targeted to the same protein as or with similar lineage evidenced by Gai et al. ((biorxiv, August, 10, 2020, hereinafter, “Gai”), Figure 1, 4). Gai teaches several neutralizing single domain antibodies against SARS-CoV-2 that can be delivered through inhalation (Abstract). Gai evidences that single domain antibodies have some effect on binding to SARS-CoV-2 but that this effect is dose dependent and even at high doses is not 100% successful at binding to SARS-CoV-2 (Figure 4, 5). Therefore, there is not a reasonable expectation that any combination of CDRs from a multitude of polypeptides can be randomly combined to form a polypeptide that can bind to SARS-CoV-2.
In view of the evidence discussed above, combining different CDRs of claim 1 into a single polypeptide would not predictably bind to SARS-CoV-2.
The specification only exemplifies and reduces to practice the use of SEQ ID NOs: 1 – 29 to bind to SARS-CoV-2 (Figure 3A). However, the specification offers no reasonable direction or working example for the use of other CDR combinatorial single domain antibodies that bind to SARS-CoV-2.
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.
Conclusion
NO CLAIMS ARE ALLOWED
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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