DETAILED ACTION
Examiner acknowledges receipt of the reply filed 11/28/2025, in response to the non-final office action mailed 08/27/2025.
Claims 1-11, 13, and 16-18 are pending. Claims 12, 14, and 15 have been cancelled.
Claims 17 and 18 are rejoined herein. Claims 1-8 and 10 remain withdrawn from further consideration for the reasons made of record.
Claims 9, 11, 13, and 16-18 are being examined on the merits in this office 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
Upon further consideration, the search has been expanded to other species of polypeptides recited in claims 17 and 18.
Because all the species has been rejoined for prosecution, the restriction requirement between polypeptide species as set forth in the Office action mailed on 12/24/2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01
Specification- withdrawn
The objection of the abstract and specification is withdrawn in view of the amendment filed 11/28/2025.
Claim Objections- withdrawn
The objection of claims 9, 11, 15 and 16 is withdrawn in view of the amendment filed 11/28/2025.
Claim Rejections - 35 USC § 112- withdrawn
the rejection of claims 9 and 11-16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed 11/28/2025.
Claim Rejections - 35 USC § 103- withdrawn
The rejection of claims 9 and 11-15 rejected under 35 U.S.C. 103 as being unpatentable over CN104099360 (hereinafter referred to as “the ‘360 reference”; cited in IDS filed 11/11/2021), and further in view of Wan et al (Biochim Biophys Acta. 1844(6): 1059–1070 (2014)), CN102504022 (hereinafter referred to as “the ‘022 reference”; cited in IDS filed 2/24/2025), and Lau et al (WO 2006097537), is withdrawn in view of the amendment filed 11/28/2025.
Response to Arguments
Applicant’s amendment and arguments filed 11/28/2025 have been fully considered and are persuasive. Therefore, the objections and rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the amendment filed 11/28/2025.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claim Objections
Claims 9 and 16-18 are objected to because of the following informalities: This is a new objection necessitated by the amendment filed 11/28/2025.
Claim 9 should be amended at p. 6, ll. 1-2 to recite: “wherein the insoluble inclusion bodies consist of the amino acid sequence of SEQ ID NO:11, [[or]] SEQ ID NO:11 or SEQ ID NO:13;”
Claim 16 at p. 9, part (iii), line 3 should be amended to recite “under a pH
Regarding claim 17, the trademark Tween 80 should be removed from the claim and rewritten with the generic name of the compound. The claim should be amended to incorporate Roman numerals to more clearly distinguish steps of the claim. Each of the recited clauses of claim 17 encompasses multiple steps. The claim should be written in active step claim language, instead of past tense claim language removed, performed, etc.
Regarding claim 18, the trademark Tween 80 should be removed from the claim and rewritten with the generic name of the compound. The claim should be amended to incorporate Roman numerals to more clearly distinguish steps of the claim. Each of the recited clauses of claim 18 encompasses multiple steps. The claim should be written in active step claim language, instead of past tense claim language clarified, obtained, etc.
Appropriate correction is required.
Examiner recommends that claims 17 and 18 be amended in a similar to claim, as filed 11/28/2025.
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 9, 11, 13, and 16-18 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. This is a new objection necessitated by the amendment filed 11/28/2025.
Claim 9 recites at p. 6, l. 1 the limitation "the inclusion bodies". There is insufficient antecedent basis for this limitation in the claim.
Because claims 11, 13, and 16-18 depend from indefinite claim 9 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112, second paragraph.
To overcome this rejection, the claim should be amended to recite “the insoluble inclusion bodies", for consistency with claim 9, pl. 5, last line.
Claim 16 recites the limitation "the digestion system". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the digestion mixture". There is insufficient antecedent basis for this limitation in the claim.
Claims 16-18 recite the limitation "the inclusion bodies". There is insufficient antecedent basis for this limitation in the claim. Independent claim 9 refers to “insoluble inclusion bodies”.
Claims 17 and 18 are generally narrative and indefinite, failing to conform with current U.S. practice. The claim appears to be a literal translation into English from a foreign document and is replete with grammatical and idiomatic errors.
Claims 17 and 18 recite the trademark/trade name Tween 80. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe non-ionic surfactant and, accordingly, the identification/description is indefinite.
Claims 17 and 18 recite the limitation "the E. coli cells". There is insufficient antecedent basis for this limitation in the claim.
The term “pure water” in claims 17 and 18 is a relative term which renders the claim indefinite. The term “pure water” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 17 and 18 recite the limitation "the washed inclusion bodies". There is insufficient antecedent basis for this limitation in the claim.
Claims 17 and 18 recite the limitation "the concentration of a total protein". There is insufficient antecedent basis for this limitation in the claim.
Claims 17 and 18 recite the limitation "the sample". There is insufficient antecedent basis for this limitation in the claim.
The term “routinely folded” in claims 17 and 18 is a relative term which renders the claim indefinite. The term “routinely folded” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This specification and claim do not provide any specific guidance as what this term encompasses, e.g., a laboratory stir plate, rocker plate, an individual physically “folding” the components.
Claims 17 and 18 recite the limitations "the pH condition" and “the pH value”. There is insufficient antecedent basis for this limitation in the claim.
The metes and bounds of the term “packings” is deemed to be indefinite. If Applicant intends for the claim scope to refer to chromatography techniques, the claim should be amended to improve clarity.
Closest Prior Art
The closest prior art to the instant claims is CN104099360 (hereinafter referred to as “the ‘360 reference”; previously cited). Examiner refers to the provided English translations of the ‘360 reference, previously cited.
The ‘360 reference teaches a method for site-specific introduction of non-natural amino acids into mutant recombinant proteins or peptides and site-specific modification thereof. The mutation method is to introduce non-natural amino acids Lys-azido into specific sites in proteins or peptides. The azide group can specifically undergo a Click reaction with a modifier, thereby site-specifically coupling the non-natural amino acid to in the protein to the modifier (p. 11). The ‘360 reference teaches a modified target protein with site directed mutation, with the structure thereof being shown in the following formula
PNG
media_image1.png
200
400
media_image1.png
Greyscale
wherein R1 is the amino acid residues from positions 1 to N-1 of the sequence shown in the target protein without mutation; R2 is the residues from positions N+1 to the C- terminus of the sequence shown in the target protein without mutation and R3 is PEG, cyclodextrin, sugar, nucleic acid, amino acid, polypeptide or carboxyl modification group. The reference further discloses a method for preparing the protein comprising constructing a gene vector with the site directed mutation, mutating a suitable site into an amber codon (TAG), coexpressing the constructed vector with pyrrolysyl-tRNA synthetase to allow the unnatural amino acid Lys-azido to be incorporated into the protein, carrying out protein expression and purification, and then coupling the isolated/purified with mPEG-alkyne by means of click chemistry under catalysis of copper to form a triazole-linked conjugate (claims 1-20; p. 8, 11, embodiments 1-3). The ‘360 reference further uses a specific E. coli strain that allows for expression of tRNA and tRNA synthetase that recognize the unnatural amino acid Lys-azido but not the claimed Lys-alkynyl (reply filed 11/28/2025 at pp. 16-19).
However, the ‘360 reference does not teach or suggest the claimed Lys-alkynyl group. Additionally, the claimed invention uses a specific cell strain - E. coli Top 10 strain that recognize Lys-alkynyl.
Conclusion
No claims are allowed.
Claims 1-11, 13, and 16-18 are pending. Claims 1-8 and 10 are withdrawn.
Claims 9, 11, 13, and 16-18 are rejected.
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 KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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, LIANKO GARYU can be reached at 571-270-7367. 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.
/KRISTINA M HELLMAN/ Examiner, Art Unit 1654
/JULIE HA/ Primary Examiner, Art Unit 1654