DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 11/25/25 has been entered in full. Claims 43-59 are canceled. Claims 60-64 and 66 are amended. New claims 72 and 73 are added. Claims 60-73 are pending.
Applicants' election with traverse of Group I, claims 43-62 and 66, was previously acknowledged. In view of the amendments to the claims of Group I, and the subsequent withdrawal of the prior art rejections over claims of Group I (see below), the claims of Group III (claims 67-71) as set forth in the restriction requirement mailed on 6/6/25 are considered to have fulfilled the requirement of unity of invention under 37 C.F.R. 1475(a). As such, the restriction requirement between Groups I and Group III is hereby withdrawn, and claims 67-71 are therefore rejoined and examined.
Claims 63-65 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II), there being no allowable generic or linking claim.
The elections, with traverse, of (1) SARS-CoV-2 as the species of disease cause, and (2) Pneumonia as the species of disease, were also previously acknowledged.
Claims 60-62 and 66-71 are under consideration.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (8/29/25).
The objection to the specification at page 2 is withdrawn in view of the amendments to the title.
All objections to and/or rejections of canceled claims 43-59 are moot.
The objections to claims 60-62 and 66 at page 3 are withdrawn in view of the amendments to the claims. (Note that withdrawn claim 65 was inadvertently listed in the group of objected claims instead of claim 66)
The rejection of claim 61 at page 4 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
The rejection of claims 60-62 and 66 at pages 4-8 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims that limit the claimed fusion protein to one that comprises an ACE2 truncated form of SEQ ID NO: 1 or SEQ ID NO: 2. The former is the extracellular domain of human ACE2 protein, and the latter is same but with two mutations to asparagine in the “enzyme active center” at positions 374 and 379; see page 4 of the specification. (Note that withdrawn claim 65 was inadvertently listed in the group of objected claims when it should have been claim 66)
The rejection of claim 66 under 35 U.S.C. 102(a)(2) at pages 11-12 as being anticipated by Tsai et al, U.S. Patent Application Publication 20230250410, published 8/10/23, is withdrawn in view of the amendment to the claim that change its dependency to claim 60.
The rejection of claims 60 and 61 under U.S.C. 103(a) at pages 14-15 as being unpatentable over either of Moore et al or Tsai et al, U.S. Patent Application Publication 20230250410, published 8/10/23, and further in view of Czajkowsky et al (2012) are withdrawn in view of the amendments to the claims.
Claim Objections
Claims 61-62 and 66-73 are objected to for the following informalities:
In each of claim 61 (line 1), claim 62 (line 1), claim 66 (lines 2-3), claim 72 (line 1) and claim 73 (line 1), the recitation of “The fusion protein multimer” should be “The Fc fusion protein multimer”. Compare with line 1 of parent claim 60, as well lines 3-4 of claim 61 and line 2 of claim 62.
In claim 62, each type of multimer is missing the word “wherein” prior to the word “each” in the description of the multimer; e.g., in line 4, “each of the polypeptide monomer units comprises” should be “wherein each of the polypeptide monomer units comprises”.
In claim 62, each type of multimer is missing the word “and” prior to both the word “wherein” and “one” in the description of the monomer; e.g., in line 6, “wherein one ACE2 truncated form, one heavy chain Fc domain along with the tail comprise” should be “and wherein one ACE2 truncated form, and one heavy chain Fc domain along with the tail comprise”.
In claim 70, line 2, “risk of exposing” should be “risk of exposure”.
In claim 71, line 2, “administrated” should be “administered”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
New rejections necessitated by Applicants’ amendment
Claim Rejections - 35 USC § 112(b)
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 60-62 and 66-73 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 pre-AIA the applicant regards as the invention.
Claim 60, line 2, recites the limitation “each of the polypeptide monomer unit”. There is insufficient antecedent basis for this limitation in the claim. Specifically, line 2 earlier recites “n polypeptide monomer units”, which is plural, while “unit” is singular. This could be rendered definite by amending line 2 to recite “each of the polypeptide monomer units”.
Claim 60, line 4, recites the limitation “the two heavy chain Fc domains of an antibody”. There is insufficient antecedent basis for this limitation in the claim. Specifically, there is no earlier recitation of two heavy chain Fc domains to provide antecedent basis for this recitation. This could be rendered definite by amending line 4 to recite “of two heavy chain Fc domains of an antibody”.
Claim 60, line 9, cites the limitation “the ACE2 truncated form”. This is indefinite because line 3 refers to two ACE2 truncated forms, and it is not clear if the recitation in line 9 applies to only one or both of the two forms. This could be rendered definite by amending claim 9 to recite “wherein each of the two ACE2 truncated forms”.
Claim 60, lines 11-12, recites “wherein the tail is an IgM and/or IgA derived tail and comprises the sequence as shown by SEQ ID NO: 17”. This is indefinite because SEQ ID NO: 17 as shown on page 8 of the specification only contains sequences from the IgM tail of SEQ ID NO: 15 and does not contain any sequences from the IgA tail of SEQ ID NO: 16.
Claim 61, line 2, recites “the heavy chain Fc domain”, but parent claim 60 refers to “two heavy chain Fc domains”, and it is not clear if the recitation in claim 61 applies to only one or both of the Fc domains.
In claim 68, line 2, use of the term “preferably” in lines 2 and 3 renders the claim indefinite because it is unclear whether the limitations following each term are part of the claimed invention. See MPEP § 2173.05(d). For example, it is unclear whether the virus of claim 68 is met by any virus of virus employing ACE2 as a receptor, or only the preferred types.
In claim 70, line 2, the recitation of “a medical worker and a person at risk of exposing to the virus” is indefinite because it is unclear whether this is a single patient (i.e., one that is a medical worker and also at risk of exposure) or two separate patients. If the latter, the claim could be clarified, for example, by amending the “and” to “or”.
In claim 71, line 2, “ocular and middle ear injection” is indefinite because middle ear injection is a type of ocular injection, and therefore it is unclear how “ocular and middle ear injection” differs from “middle ear injection”.
In claim 71, line 3, “topical, transdermal, parenteral” is indefinite because these are each adjectives without a modified noun, e.g., application or injection.
In claim 71, line 3, “subcutaneous and intravenous injection” is indefinite because subcutaneous injection and intravenous injection are two different routes of injection, and it is unclear whether the claim is referring two separate types of injection or one form that includes both routes.
New claims 72 and 73 each recite, “the soluble ACE2 or truncated form thereof”, which is indefinite because parent claim 60 does not refer to use the adjectives “soluble” and “truncated” in the alternative, but instead recites only “soluble [ACE2] truncated forms”. Claim 72 is further indefinite because it refers to a single ACE2 “form”, but parent claim 60 refers to multiple “forms”.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Conclusion
No claims are 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 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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