DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-20 are pending.
Claims 16-20 have been added.
Claims 2-15 have been amended.
Claims 1-20 are examined on the merits.
Drawings
3. The drawings are objected to because Figure 1 recites at least four amino acids for the linker, (GGGGS)3 on sheet 1/30 submitted February 9, 2024. The MPEP 2421.01 states “[t]he sequence rules embrace all unbranched nucleotide sequences with ten or more bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 4 “specifically defined” nucleotides or amino acids. The rules apply to all sequences in a given application, whether claimed or not. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the Examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
4. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 19A cites panels labeled a, b, c, d, e; Figure 19B cites panels labeled f, g, h, I, j and k; and Figure 19C cites panels labeled l, m, n, o and p submitted February 9, 2024. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
5. The disclosure is objected to because of the following informality: there are at
least four amino acids listed on page 2, Summary of the Invention, 5th paragraph (para.); page 13, segments 1.1 and 1); and page 25, line 5. The MPEP 2421.01 states “[t]he
sequence rules embrace all unbranched nucleotide sequences with ten or more bases
and all unbranched, non-D amino acid sequences with four or more amino acids,
provided that there are at least 4 “specifically defined” nucleotides or amino acids. The
rules apply to all sequences in a given application, whether claimed or not. All such
sequences are relevant for the purposes of building a comprehensive database and
properly assessing prior art. It is therefore essential that all sequences, whether only
disclosed or also claimed, be included in the database.” Applicants are required to
review the entire specification for similar errors. See Sequence Compliance Letter.
Correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-20 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.
a. Claim 1, lines 4, 9 and 10; claim 4, lines 5 and 6; claim 5 on page 7, lines 3, 8, 13, 14, 17 and 19; claim 8, lines 7-9 and 12; claim 13, lines 5 and 6; claim 14, lines 3 and 4; and claim 20 on page 12, line 3 and page 13, line 1 cite “preferably” and/or “more preferably”. This is an exemplary term and/or exemplary phrase, which is indefinite because the scope of the claims is not clear, as well as it is not clear if the language following the term/phrase is an example or preference and not clear limitations. Hence, the metes and bounds cannot be determined.
b. Claim 2 on page 4, lines 4, 6, 8, 10 and page 5, lines 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28 and 30, as well as page 6, line 2; claim 3, line 4; claim 4, lines 7, 10, 12, 14, 17; claim 7 on page 8, lines 3, 5, 7, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, on page 9, lines 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and page 10, lines 2, 4, 6, 8, 10; and claim 8, lines 10, 13, 16, 18, page 11, lines 2, 6, 8, 10 recite “…amino acid sequence represented by SEQ ID NO: X. The italicized recitation is indefinite exemplary claim language and does not clarify the scope of the claims. “[R]epresented by” reads on variations. Antibodies are specific, based on their sequences and therefore the language used to claim antibodies should be definite.
Hence, the metes and bounds cannot be determined. Applicant could obviate the instant rejection if they amend the claims to read, “…amino acid is sequence is SEQ ID NO: X”.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
July 8, 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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