CTFR 18/004,104 CTFR 83445 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions and Claim Status Applicants’ amendments and arguments filed 4/15/26 are acknowledged. Any objection or rejection from the 1/15/26 office action that is not addressed below is withdrawn based on the amendments. Previously, Group 1 and the species of fusion protein of SEQ ID NO:16 (with mutation at R273 and ectodomain SEQ ID NO:6) were elected. In the reply of 4/15/26, applicants state that the claims are amended such that the elected species are canceled. As such, and in accord with MPEP 803.02 the search was extended to the extent necessary to determine patentability. 08-06 AIA Claim s 27, 29-30, 33 and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 10/1/25 . The elected fusion protein (SEQ ID NO:16) does not include a linking sequence as in claim 25 . 08-06 AIA Claim 25 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/1/25 . 12-151-10 AIA 12-51-10 Claim s 2-22, 24, 28, 31-32 and 34 have been canceled. The instant claim set does not include claim 37. Claim 37 was previously canceled and is treating as being canceled. Applicant are reminded to file amendments in accord with 37 CFR 1.121 specifically see 37 CFR 1.121(c). Claims 1, 23 and 26 are being examined. Priority The priority information is found in the filing receipt dated 6/4/24. Claim Rejections - 35 USC § 112 Claims 2 and 4 were previously rejected under 35 USC 112(b)/2 nd . Since limitations from claims 2 and 4 have been incorporated into claim 1, updated and/or new rejections appear below. 07-30-02 AIA 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. 07-34-01 Claims 1, 23 and 26 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 refer to particular residue positions and refers to SEQ ID NO: 24. Although claim 1 refers to SEQ ID NO:24, per the sequence listing SEQ ID NO:24 is 302 amino acids in length. Claim 1 refers to 402 (E402A) for example which would seem to be outside of the range of 302 amino acids. Applicants own specification recognizes that the ACE2 protein has a leader sequence and the numbering is different if the leader sequence is included (section 0034). None of dependent claims 23 and 26 clarify the claim scope. Claim 1 has been amended to delete ‘human antibody’. Claim 23 depends on claim 1 and recites ‘the human antibody’ (lines 3 and 4). There is insufficient antecedent basis for this limitation in the claim. Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification. Response to Arguments - 112 07-37 AIA Applicant's arguments filed 4/15/26 have been fully considered but they are not persuasive with respect to the rejection set forth above . Although applicants argue that the claims have been amended, the amended claims are addressed above . Claim Rejections - 35 USC § 103 The rejection below is based on previously cited art and is updated to correspond to the instant claims. 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1, 23 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lei et al. (NPL cite 5 of 6 page IDS of 1/5/24; ‘Lei’) in view of Guy et al. (NPL citation 8 of 6 page IDS of 1/5/24; ‘Guy’) . The 2 nd page of Lei (3 rd and 4 th paragraphs) refers to supplementary data. For completeness of the record a copy of the supplemental data (Supplemental Data for Lei et al. ‘Neutralization of SARS-CoV-2 spike pseudotyped virus by recombinant ACE2-Ig’ Nat Commun April 2020, 5 pages; ‘LeiSupplement’) is provided. The 4 th page of Lei et al. states that the article was published 24 April 2020. Lei teach a recombinant protein connecting the extracellular domain of human ACE2 and the Fc region of the human IgG1 specifically an ACE2 mutant with low catalytic activity (abstract) and specifically recite mutations to ‘reduce the catalytic activity’ (page 2 paragraph connecting columns 1-2). Lei teach a variant in which the histidine at position 374 is altered to reduce the catalytic activity (page 2 paragraph connecting columns 1-2). Lei teach that the mACE2-Ig fusion was expressed and purified and assayed (page 2 paragraph connecting columns 1-2). Lei teach the fusion protein has high binding affinity for SARS-CoV-2 (abstract). Lei does not teach the H374A mutation. Guy teach that the role of ACE2 residues was explored by site-directed mutagenesis (abstract). Guy teach that to investigate the role of histidine, the histidine was replaced by alanine (page 3514 first column). Guy teach that the His to Ala mutants were found to be considerably less active than the wild type (page 3514 column 1). Guy teach that site directed mutagenesis was performed and the protein was expressed (page 3518). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Lei because Lei teach an ACE2 mutant with low catalytic activity (abstract) and specifically recite mutations to ‘reduce the catalytic activity’ (page 2 paragraph connecting columns 1-2). Lei teach a variant in which the histidine at position 374 is altered to reduce the catalytic activity (page 2 paragraph connecting columns 1-2) and Guy recognizes replacement of a residue with alanine (page 3514 first paragraph) so one would have been motivated to make a H374A mutant. One would have had a reasonable expectation of success since the methods of making mutations and protein production were known (page 2 paragraph connecting columns 1-2 of Lei). Guy teach that the His to Ala mutants were found to be considerably less active than the wild type (page 3514 column 1). In relation to the fusion protein of claim 1, Lei teach a recombinant protein connecting the extracellular domain of human ACE2 and the Fc region of the human IgG1 specifically an ACE2 mutant with low catalytic activity (abstract). Lei teach a variant in which the histidine at position 374 is altered to reduce the catalytic activity (page 2 paragraph connecting columns 1-2) and Guy recognizes replacement of a residue with alanine (page 3514 first paragraph) so one would have been motivated to make a H374A mutant. In relation to the constant region of claim 23, Lei teach the Fc region of the human IgG1 (abstract) and figure 1 shows a disulfide bond. The instant specification describes the Fc as being described previously (section 00109) and as being human and from the constant region (section 0075). In relation to claim 26, Lei teach that the mACE2-Ig fusion was expressed and purified and assayed (page 2 paragraph connecting columns 1-2). Response to Arguments - 103 07-37 AIA Applicant's arguments filed 4/15/26 have been fully considered but they are not persuasive with respect to the rejection set forth above . Although applicants argue that the claims have been amended, the amended claims are addressed above. Conclusion 07-40 AIA 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. RONALD T. NIEBAUER Primary Examiner Art Unit 1658 /RONALD T NIEBAUER/Examiner, Art Unit 1658 Application/Control Number: 18/004,104 Page 2 Art Unit: 1658 Application/Control Number: 18/004,104 Page 3 Art Unit: 1658 Application/Control Number: 18/004,104 Page 4 Art Unit: 1658 Application/Control Number: 18/004,104 Page 5 Art Unit: 1658 Application/Control Number: 18/004,104 Page 6 Art Unit: 1658 Application/Control Number: 18/004,104 Page 7 Art Unit: 1658 Application/Control Number: 18/004,104 Page 8 Art Unit: 1658
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