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 .
Status of the Claims
The preliminary amendment filed 06/08/2023 is acknowledged. Claims 2-15 are amended and claim 16 is new. No restriction requirement is being imposed in this case. Claims 1-16 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date of the instant claims 1-16 is 12/08/2020.
Claim Interpretation
In claim 6, SEQ ID NOs: 27 and 29 are heavy chain sequences and SEQ ID NOs: 28 and 30 are light chain sequences.
Claim Objections
Claims 1, 3, 4, 7, 13 and 14 are objected to because of the following informalities. Claims 1, 3, 4, 7, 13 and 14 set forth a plurality of elements, and thus each element should be separated by a line indentation to make the claim easier to read (see MPEP 608.01(i) and 608.01(m) and CFR 1.75(i). For instance, the claims could be indented as follows:
1. An isolated antibody that specifically binds to a Strep-Tag II tag, comprising a heavy chain variable region (VH) and a light chain variable region (VL), wherein
the VH comprises: a VH-CDR1 comprising SEQ ID NO: 1, a VH-CDR2 comprising SEQ ID NO: 2, a VH-CDR 3 comprising SEQ ID NO: 3 or SEQ ID NO: 4; and
the VL comprises: a VL-CDR1 comprising SEQ ID NO: 5 or SEQ ID NO: 6, a VL-CDR2 comprising SEQ ID NO: 7 or SEQ ID NO: 8, a VL-CDR3 comprising SEQ ID NO: 9 or SEQ ID NO: 10.
3. The isolated antibody of claim 1, wherein
the VH comprises the amino acid sequence of SEQ ID NO: 23 or 24, or comprises an amino acid sequence with at least 85% identity thereto; and
the VL comprises the amino acid sequence of SEQ ID NO: 25 or 26, or comprises an amino acid sequence with at least 85% identity thereto.
4. The isolated antibody of claim 1, wherein
the VH comprises one or more framework region(s), each of the framework regions comprises an amino acid sequence, the amino acid sequence is the sequence as set forth in SEQ ID NOs: 11, 12, 13, 14, 15 and 16, or an amino acid sequence with at least 90% identity thereto;
the VL comprises one or more framework region(s), each of the framework regions comprises an amino acid sequence, the amino acid sequence is the sequence as set forth in SEQ ID NOs: 17, 18, 19, 20, 21 and 22, or an amino acid sequence with at least 90% identity thereto.
7. The isolated antibody of claim 1, wherein
the antibody comprises the amino acid sequence of SEQ ID NO: 27, or an amino acid with at least 85% identity thereto; and the antibody comprises the amino acid sequence of SEQ ID NO: 28, or an amino acid sequence with at least 85% identity thereto; or
the antibody comprises the amino acid sequence of SEQ ID NO: 29, or an amino acid sequence with at least 85% identity thereto, and the antibody comprises SEQ ID NO: 30, or an amino acid sequence with at least 85% identity thereto.
13. A method of detecting a fusion polypeptide containing a Strep-Tag II tag in a sample, comprising:
(i) contacting the sample containing the fusion polypeptide with the isolated antibody of claim 1 in vitro, under conditions that allow the interaction between the isolated antibody and the fusion polypeptide, and
(ii) detecting formation of complex between the isolated antibody and the sample; preferably, the method of detecting the complex comprises at least one of flow cytometry, Western blot, immunohistochemistry, and immunofluorescence.
14. A method of purifying a fusion polypeptide containing a Strep-Tag II tag in a sample, comprising
(i) contacting the sample with the isolated antibody of claim 1 in vitro, under conditions that allow the interaction between the isolated antibody and the polypeptide, and
(ii) purifying the complex formed between the isolated antibody and the sample; preferably, the method of purifying comprises affinity chromatography and immunoprecipitation.
Appropriate correction is required.
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 11 and 13-16 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.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP § 2173.05(d). Regarding claims 11, 13, 14 and 15, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. Specifically:
Claim 11 recites: “preferably, the fluorescent label is selected from fluorescein, rhodamine, dansyl, phycoerythrin or Texas red; preferably, the enzyme substrate label is selected from horseradish peroxidase, alkaline phosphatase, glucoamylase, lysozyme, saccharide oxidase or P-D-galactosidase; preferably, the radioactive isotope is selected from 123I, 124I, 125I, 131I, 35S, 3H, 111H, 111In, 112In, 14C, 64Cu, 86Y, 88Y, 90Y, 177Lu, 211At, 186Re, 188R3, 153Sm, 212Bi, 32P”, and “preferably, the label is selected from a luminescent label or a chromophore”;
Claim 13 recites “preferably, the method of detecting the complex comprises at least one of flow cytometry, Western blot, immunohistochemistry, and immunofluorescence”;
Claim 14 recites “preferably, the method of purifying comprises affinity chromatography and immunoprecipitation”; and
Claim 15 recites “preferably, the blood comprises at least one of serum, plasma and whole blood, preferably, the sample contains chimeric antigen receptor cells or engineered cell receptor cells”
(Emphasis added by examiner). Further, claim 11 recites “other lanthanides” in the last line of the claim, which renders the claim indefinite, because it is not clear which lanthanides are intended to be included in this group. Finally, claim 16 is included in this rejection because it depends from an indefinite claim (11) without resolving the indefiniteness.
Conclusion
Claims 11 and 13-16 are rejected and claims 1, 3, 4, 7, 13 and 14 are objected to. Claims 1-10 and 12 contain allowable subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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, Jeffrey Stucker can be reached at 5712720911. 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.
/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675