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 .
Applicant’s response filed on 8/5/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1,4-8, and 10-11 have been made of record.
Claims 1-23 are pending.
Claims 15-23 remain withdrawn for being drawn to non-elected inventions (i.e., Groups 8-14).
Claims 1-14 are under examination to the extent they read on elected invention.
Information Disclosure Statement
The Information Disclosure Statement filed on 6/24/2026 has been considered.
Response to Arguments
Claim Rejections - 35 USC § 112-maintained
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 8 remains 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 8 recites the limitation "The recombinant protein of claim" in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant should indicate the base claim from which it depends.
Claim Rejections - 35 USC § 112-withdrawn
The rejection of claims 1-6 and 9-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of applicants’ amendments to claim 1 to recite “the fragment having at least 95% identity to amino acid sequence of SEQ ID NO: 4”.
Claim Rejections - 35 USC § 102-withdrawn
The rejection of claim(s) 1-6, and 9-14 under 35 U.S.C. 102(a)(2) as being anticipated by Han et al (US Pat. No. 11,518,788, claims priority to US provisional 63/050473 filed on 7/10/2020) is withdrawn necessitated by applicant’s amendment to claim 1 to recite “the fragment having at least 95% identity to amino acid sequence of SEQ ID NO: 4”. However, a new ground of rejection is made in view of applicants’ amendments to the claims.
New Ground of Rejection Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mammedov (WO 2022/115083 claims priority to US Provisional 63/117,487 filed on 11/22/2020).
Mammedov et al. teach a polypeptide having amino acid sequence of SEQ ID NO: 2 that comprises a signal peptide and the amino acid sequence homology is about 95.6 % (see sequence alignment below) to the instantly claimed 95% sequence identity to the amino acid sequence of SEQ ID NO: 4. They teach that the protein is for treating COVID-19 (see claim 13). They teach a composition comprising Phosphate buffer saline (PBS) (see pg. 15, line 20+). The recombinant protein binds to SARS-CoV-2 (see page 14, line29+). Because the claimed limitation of a polypeptide having 95% sequence is met, the limitations of other claims are also implicitly met, unless evidence to contrary.
RESULT 15
BLD99702
ID BLD99702 standard; protein; 763 AA.
XX
AC BLD99702;
XX
DT 07-JUL-2022 (first entry)
XX
DE Human recombinant ACE2 protein, SEQ 2.
XX
KW ACE2 protein; Angiotensin converting enzyme 2; protein production;
KW protein therapy; therapeutic.
XX
OS Homo sapiens.
OS Synthetic.
XX
CC PN WO2022115083-A1.
XX
CC PD 02-JUN-2022.
XX
CC PF 23-NOV-2021; 2021WO-TR051277.
XX
PR 24-NOV-2020; 2020US-0117487P.
XX
CC PA (UYAK-) UNIV AKDENIZ.
XX
CC PI Mammedov T;
XX
DR WPI; 2022-74647P/049.
DR N-PSDB; BLD99701.
XX
CC PT Generating polypeptide of glycosylated angiotensin-converting enzyme 2 by
CC PT replacing signal peptide of human angiotensin-converting enzyme 2 with
CC PT Nicotiana tabacum signal peptide, constructing artificial gene, inserting
CC PT into vector, introducing into Agrobacterium, and producing polypeptide.
XX
CC PS Claim 1; SEQ ID NO 2; 36pp; English.
XX
CC The present invention relates to a method for generating a polypeptide of
CC glycosylated angiotensin-converting enzyme 2 (ACE2) in a plant cell. The
CC method involves: (a) replacing signal peptide of human ACE2 with
CC Nicotiana tabacum PR-1 a signal peptide of SEQ ID NO:7 (see BLD99707),
CC adding endoplasmic reticulum (ER) retention signal of SEQ ID NO:6 (see
CC BLD99706), adding His6 tag coding sequence to C-terminus and constructing
CC an artificial ACE2 gene; (b) inserting the constructed ACE2 gene into
CC small binary vector tailored for transient expression (pEAQ vector) to
CC obtain pEAQ-ACE2-His6-KDEL plasmid having a base pair sequence having at
CC least 90 percent sequence identity to sequence of SEQ ID NO:1 (see
CC BLD99701); (c) introducing pEAQ-ACE2-His6-KDEL plasmid into an
CC Agrobacterium construct; and (d) performing infiltration of the
CC Agrobacterium construct carrying the pEAQ-ACE2-His6-KDEL plasmid into a
CC plant cell and producing a polypeptide of glycosylated ACE2 of SEQ ID NO:
CC 2 (see BLD99702). The method of the invention is useful for treating
CC COVID-19 infection.
XX
SQ Sequence 763 AA;
Query Match 95.6%; Score 3924.5; Length 763;
Best Local Similarity 97.1%;
Matches 733; Conservative 4; Mismatches 9; Indels 9; Gaps 1;
Qy 4 LVNVALVFMVVYISYIYASTIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNITEENVQ 63
||: |:|:|: | ||||||||||||||||||||||||||||||||||||||||||
Db 14 LVSTLLLFLVISHSCRAQSTIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNITEENVQ 73
Qy 64 NMNNAGDKWSAFLKEQSTLAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKRLNTIL 123
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 74 NMNNAGDKWSAFLKEQSTLAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKRLNTIL 133
Qy 124 NTMSTIYSTGKVCNPDNPQECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQLRPLY 183
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 134 NTMSTIYSTGKVCNPDNPQECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQLRPLY 193
Qy 184 EEYVVLKNEMARANHYEDYGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKPLYEHL 243
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 194 EEYVVLKNEMARANHYEDYGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKPLYEHL 253
Qy 244 HAYVRAKLMNAYPSYISPIGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTDAMVDQ 303
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 254 HAYVRAKLMNAYPSYISPIGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTDAMVDQ 313
Qy 304 AWDAQRIFKEAEKFFVSVGLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGDFRILM 363
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 314 AWDAQRIFKEAEKFFVSVGLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGDFRILM 373
Qy 364 CTKVTMDDFLXAHHEMGHIQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATPKHLKS 423
|||||||||| |||||||||||||||||||||||||||||||||||||||||||||||||
Db 374 CTKVTMDDFLTAHHEMGHIQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATPKHLKS 433
Qy 424 IGLLSPDFQEDNETEINFLLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMKKWWEM 483
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 434 IGLLSPDFQEDNETEINFLLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMKKWWEM 493
Qy 484 KREIVGVVEPVPHDETYCDPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKHEGPLH 543
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 494 KREIVGVVEPVPHDETYCDPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKHEGPLH 553
Qy 544 KCDISNSTEAGQKLFNMLRLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWLKDQNK 603
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 554 KCDISNSTEAGQKLFNMLRLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWLKDQNK 613
Qy 604 NSFVGWSTDWSPYADQSIKVRISLKSALGDKAYEWNDNEMYLFRSSVAYAMRQYFLKVKN 663
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 614 NSFVGWSTDWSPYADQSIKVRISLKSALGDKAYEWNDNEMYLFRSSVAYAMRQYFLKVKN 673
Qy 664 QMILFGEEDVRVANLKPRISFNFFVTAPKNVSDIIPRTEVEKAIRMSRSRINDAFRLNDN 723
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 674 QMILFGEEDVRVANLKPRISFNFFVTAPKNVSDIIPRTEVEKAIRMSRSRINDAFRLNDN 733
Qy 724 SLEFLGIQPTLGPPNQPPVSENLYFQGTGHHHHHH 758
|||||||||||||||||||| ||||||
Db 734 SLEFLGIQPTLGPPNQPPVS---------HHHHHH 759
Conclusion
Claims 1-4 and 7-14 are rejected.
Claims 5-6 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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