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 .
Election/Restrictions
Applicant's election with traverse of Group 2 (claims 1-14) in the reply filed on 3/20/2026 is acknowledged. The traversal is on the ground(s) that the amino acid sequence of SEQ ID NO: 4 having at least 80% sequence identity includes the amino acid sequence of SEQ ID NO: 10 which only differs by a variant T371W and the nucleic acid sequence encoding the same having nucleic acid sequence of SEQ ID NO: 18. This is not found persuasive because this has been found persuasive and therefore, Group 8 is being examined with Group 2 and because of this consideration, Groups 9-15 (see page 4 of 1/21/2026) are regrouped as Groups 8-14.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-23 are pending.
Claims 15-23 are withdrawn for being drawn to non-elected inventions (i.e., Groups 8-14).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 7/6/2023 have been considered.
Claim Objections
Claims 1, 5-6 and 10-11 are objected for reciting non-elected amino acid and nucleic acid sequences. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7-8 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.
Regarding claim 7, the claim depends from claim 5 that recites multiple amino acid sequences (SEQ ID Nos: 3-9) and it is not clear which amino acid sequence is encoded by the nucleic acid sequence of SEQ ID NO: 18. It is not clear which “the recombinant protein” out of SEQ ID NO: 3-9 comprises the amino acid sequence of SEQ ID NO: 10.
Regarding claim 8, the claim depends from claim 6 that recites multiple nucleic acid sequences (SEQ ID NO: 11-17) and it is not clear which “the recombinant nucleic acid of SEQ ID NO: 11-17” comprises the polynucleotide sequence of SEQ ID NO: 18. Therefore, the metes and bounds cannot be determined. The examiner assumes that claim 8 should depend from claim 7 that recites the amino acid sequence of SEQ ID NO:10 which is encoded by the nucleic acid sequence of SEQ ID NO: 18. See MPEP § 2173.05(d).
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.
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. 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 written description in this case only sets forth a recombinant ACE2 receptor protein comprising amino acid sequence of SEQ ID NO:4 or nucleic acid encoding the same, and therefore the written description is not commensurate in scope with the claims which read on any variant of said ACE2 receptor that has up to 10% or 20% deletion, insertion, substitution or a combination thereof that still functions as ACE2 receptor.
The claims broadly encompass any ACE2 receptor variant that comprises insertion, deletion or substitution of up to 10% or 20% as compared to the amino acid sequence of SEQ ID NO:4 and a nucleic acid encoding the same that functions as ACE2 receptor. The polypeptide of amino acid sequence of SEQ ID NO: 4 is about 760 amino acids in length that would encompass a variant of having either 75 amino acid insertion, deletion or substitution; or up to 150 amino acids deletion, insertion, substitution or a combination thereof that would function like ACE2 receptor. Thus, the claims are drawn to a genus of polypeptides that encompasses a genus of variants of ACE2 receptor having up to 150 amino acids deletion, insertion, substitution or a combination thereof that would function like ACE2 receptor.
The problem of predicting protein structure from sequence data and in turn utilizing predicted structural determinants to ascertain functional aspects of the protein is extremely complex. While it is known that many amino acid substitutions are generally possible in any given protein the positions within the protein’s sequence where such amino acid substitutions can be made with a reasonable success are limited. Certain positions in the sequence are critical to the protein’s structure/function relationship, such as various sites or regions directly involved in binding, activity and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitution (see Bowie et al., 1990, Science 247: 1306-1310, page. 1306, column 2, paragraph2; Wells, 1990, Biochemistry 29:8509-8517)
The specification on pg. 46, paragraph [00132] discloses that a computational structure study of ACE2 amino acid suggest that ACE2 stabilizes the structure of receptor using residues T371, N149, F274, H345, F504 and H505 and that a single mutation of T370W blocks the interaction between ACE2 and its receptor. The specification at pg. 51, paragraph [00154] also discloses making substitution at positions G732C and S740C. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Some of the factual considerations that are weighed when determining a written description include the level of skill and knowledge in the art, the disclosure of complete or partial structures, the disclosure of physical and or chemical properties, adequate disclosure of the functional characteristics, the correlation between structure and function, and disclosure of methods of making. The specification and claims do not provide any guidance that could polypeptides in the genus from others included in the protein class or nucleic acids. No common structural attributes identify the members of the genus. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, 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, for purposes of the written description inquiry, is 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).
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states an adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.
As discussed above, the skilled artisan cannot envision the detailed ACE2 receptor polypeptide variants of the genus “wherein the ACE2 receptor comprises insertion, deletion or substation of up to 75 or 150 amino acids” and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of making a mutation. The compound itself is required. See Fiers v.Revel, 25USPQ2d 1601 at 1606 (CAFC 1993) and Amgen v.Baird, 30 Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 148 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class.
Therefore, only ACE2 receptor having amino acid sequence of SEQ ID NO:4 or a nucleic acid encoding the same, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, and 9-14 are rejected 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).
Han 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 97% (see sequence alignment below) to the instantly claimed either at least 80% or at least 90% of the amino acid sequence of SEQ ID NO: 4. They teach a pharmaceutical composition comprising the ACE2 polypeptide for inhaler or intra-nasal spray (see col. 4, lines 4+). They teach that the pharmaceutical composition is for treating SARS virus or SARS-CoV-2 or human coronavirus (see col. 4, lines 19+). Because the claimed limitation of a polypeptide having 80% or 90% sequence is met, the limitations of other claims are also implicitly met, unless evidence to contrary.
RESULT 11
US-17-246-307A-51
Sequence 51, US/17246307A
Patent No. 11518788
GENERAL INFORMATION
APPLICANT: Han, Jang
TITLE OF INVENTION: METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING VIRAL
TITLE OF INVENTION: INFECTION
FILE REFERENCE: HAN0001-401-PC
CURRENT APPLICATION NUMBER: US/17/246,307A
CURRENT FILING DATE: 2021-04-30
PRIOR APPLICATION NUMBER: 62/965,033
PRIOR FILING DATE: 2020-01-23
PRIOR APPLICATION NUMBER: 63/050,473
PRIOR FILING DATE: 2020-07-10
NUMBER OF SEQ ID NOS: 52
SEQ ID NO 51
LENGTH: 997
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: ACE2-Fc-Strep-Tag II amino acid sequence
Query Match 94.4%; Score 3875; Length 997;
Best Local Similarity 97.7%;
Matches 728; Conservative 3; Mismatches 12; Indels 2; Gaps 1;
Qy 1 MKFLVNVALVFMVVYISYIYA--STIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT 58
|: | :|| :| | | |||||||||||||||||||||||||||||||||||||
Db 4 MQLLSCIALSLALVTNSGSRAAQSTIEEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNIT 63
Qy 59 EENVQNMNNAGDKWSAFLKEQSTLAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKR 118
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 64 EENVQNMNNAGDKWSAFLKEQSTLAQMYPLQEIQNLTVKLQLQALQQNGSSVLSEDKSKR 123
Qy 119 LNTILNTMSTIYSTGKVCNPDNPQECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQ 178
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 124 LNTILNTMSTIYSTGKVCNPDNPQECLLLEPGLNEIMANSLDYNERLWAWESWRSEVGKQ 183
Qy 179 LRPLYEEYVVLKNEMARANHYEDYGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKP 238
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 184 LRPLYEEYVVLKNEMARANHYEDYGDYWRGDYEVNGVDGYDYSRGQLIEDVEHTFEEIKP 243
Qy 239 LYEHLHAYVRAKLMNAYPSYISPIGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTD 298
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 244 LYEHLHAYVRAKLMNAYPSYISPIGCLPAHLLGDMWGRFWTNLYSLTVPFGQKPNIDVTD 303
Qy 299 AMVDQAWDAQRIFKEAEKFFVSVGLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGD 358
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 304 AMVDQAWDAQRIFKEAEKFFVSVGLPNMTQGFWENSMLTDPGNVQKAVCHPTAWDLGKGD 363
Qy 359 FRILMCTKVTMDDFLXAHHEMGHIQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATP 418
||||||||||||||| ||||||||||||||||||||||||||||||||||||||||||||
Db 364 FRILMCTKVTMDDFLTAHHEMGHIQYDMAYAAQPFLLRNGANEGFHEAVGEIMSLSAATP 423
Qy 419 KHLKSIGLLSPDFQEDNETEINFLLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMK 478
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 424 KHLKSIGLLSPDFQEDNETEINFLLKQALTIVGTLPFTYMLEKWRWMVFKGEIPKDQWMK 483
Qy 479 KWWEMKREIVGVVEPVPHDETYCDPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKH 538
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 484 KWWEMKREIVGVVEPVPHDETYCDPASLFHVSNDYSFIRYYTRTLYQFQFQEALCQAAKH 543
Qy 539 EGPLHKCDISNSTEAGQKLFNMLRLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWL 598
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 544 EGPLHKCDISNSTEAGQKLFNMLRLGKSEPWTLALENVVGAKNMNVRPLLNYFEPLFTWL 603
Qy 599 KDQNKNSFVGWSTDWSPYADQSIKVRISLKSALGDKAYEWNDNEMYLFRSSVAYAMRQYF 658
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 604 KDQNKNSFVGWSTDWSPYADQSIKVRISLKSALGDKAYEWNDNEMYLFRSSVAYAMRQYF 663
Qy 659 LKVKNQMILFGEEDVRVANLKPRISFNFFVTAPKNVSDIIPRTEVEKAIRMSRSRINDAF 718
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 664 LKVKNQMILFGEEDVRVANLKPRISFNFFVTAPKNVSDIIPRTEVEKAIRMSRSRINDAF 723
Qy 719 RLNDNSLEFLGIQPTLGPPNQPPVS 743
|||||||||||||||||||||||||
Db 724 RLNDNSLEFLGIQPTLGPPNQPPVS 748
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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, Vanessa Ford can be reached at 571-272-0857. 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.
/GYAN CHANDRA/Primary Examiner, Art Unit 1674
Prosecution Insights