DETAILED ACTION
Notice of Pre-AIA or AIA Status
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. The Amendment filed on January 23, 2026, has been received and entered.
Claim Disposition
3. Claims 8-15, 21 and 27-408 are cancelled. Claims 1-7, 16-20, 22-26 and 409-412 are pending and are under examination.
Claim objection
4. Claims 1-7, 16-20, 22-26 and 409-412 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite, “…….residues 22-44 (SEQ ID NO: 10, [[and]] residues 350-357 (SEQ ID NO: 11), [[or]] a combination thereof, [[of a reference]] or full length ACE2 amino acid sequence set forth in SEQ ID NO: 1…..[[NCBI Reference Sequence Accession Number YP 009724390.1]]……….wherein the ACE2 extracellular domain fragment or variant lacks peptidase activity, [[and]] wherein the variant has ……K26E, and wherein, optionally……”. It is suggested that all reference to NCBI is deleted. In addition, the structure of SEQ ID NO:1 can be deleted from claim 1. The dependent claims hereto are also included.
For clarity it is suggested that claim 3 is amended to read, “…is selected from the group consisting of [[any of]] serum albumin…..”.
For clarity it is suggested that claim 4 is amended to read, “…is an immunoglobulin molecule, [[or]] antibody molecule or an antibody fragment [[thereof]]”.
For clarity it is suggested that claim 24 is amended to delete reference to NCBI reference numbers.
For clarity it is suggested that claim 409 is amended to read, “…..[[or as provided in]] set forth in SEQ ID NO:14”.
For clarity it is suggested that claim 411 is amended to spell out the acronyms such as RBD-ACE2”. See also claim 18 with HHB.
For clarity it is suggested that claim 412 is amended to recite, “…..ACE2 binding to [[of]] SARS-CoV-2 virus ….”.
Appropriate correction is required.
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.
5. Claims 1-7, 16-20, 22-26 and 409-412 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “an isolated SARS-CoV-2 binding protein complex comprising an extracellular domain fragment of an ACE2 protein or its variant joined to a non-ACE2 molecule or domain fragment variant thereof (claim 1), antibody fragment thereof (claim 4), for example. The claimed invention is not adequately described because of the large variable genus encompassed in the claims with respect to the ‘variants/fragments thereof’. No correlation is made between structure and function. In addition, the claimed invention encompasses a large variable genus of immunoglobulin molecule or antibody molecule or variant or fragment thereof or domain. The claimed invention is directed to at least one amino acid change that are provided in claims 1 and 22 for example, however, it is unclear what sequence these are found in (the laundry list of domains or just in the full length sequence); and said change increases binding or binding affinity of the extracellular domain or fragment thereof. However, there is no mention of said change having the same effect on the ‘variant of the domain’ just the fragment of the domain. There are no indicia as to what single or multiple change results in the assert effect. Thus the claimed invention is not adequately described with respect to modifications and impact of the same. The claimed invention recites substitutions without a reference structure thus not adequately described. The claimed invention is directed to a protein complex which reads on fragments, variants, analogs, derivatives etc. and no activity or structure per se is recited in the claim. Thus the claimed invention encompasses a broad variable genus.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of products or diseases or conditions, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. Claims 409-410 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.
Claims 409-410 lacks clear antecedent basis for the recitation of “non-ACE2 molecule or compound…” as the ‘compound’ was deleted from the independent claim.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection under 112, first paragraph remains for the reasons stated above and herein. The rejection has been modified to reflect changes made to the claims. Applicant traverses the rejection by stating the claims have been amended, however, the amendments made were not enough to obviate this ground of rejection. As stated above, the claimed invention remains directed to a broad variable genus and the applicant has not demonstrated possession of the entire genus of fragments/variants. Thus the rejection remains and is final.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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