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 .
Response to Amendment
Applicant's response, filed 04 December 2025, has been received and entered. Claims 1, 4, 7-8, 12 and 17-18 have been amended and claims 9-11, 15 and 20 have been canceled. Claims 1-8, 12-14 and 16-19 are currently pending.
Claims 6, 13 and 16 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 August 2025.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant's response and withdrawn.
Applicant's arguments filed 04 December 2025 have been fully considered but are not found to be persuasive.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 March 2026 has been considered by the examiner.
Drawings
Replacement drawings were received on 04 December 2025. These drawings are not acceptable. While FIG. 20A-20F have been amended to include a Sequence identifier for the nucleic acid sequences in the drawings, the Figures also include amino acid sequence with no identifiers (see section below regarding Nucleotide and/or Amino Acid Sequence Disclosures).
The drawings are objected to because they do not comply with multiple portions of 37 CFR 1.84.
37 CFR 1.84 (b) states that photographs, including photocopies of photographs, are not ordinarily permitted in utility and design patent applications. The Office will accept photographs in utility and design patent applications, however, if photographs are the only practicable medium for illustrating the claimed invention. The photographs must be of sufficient quality so that all details in the photographs are reproducible in the printed patent. Figures 6B, 8A, 10A, 10C, 14J, 16C, 17E, 33C do not meet the standard of sufficient quality.
Figures 25D, 25E, 26, 29B, 29C, 29D, 29F, 32A, 32B, 32C and 32D contain symbols which are so small, the distinction between the various symbols cannot be made and therefore, the information which is contained in the Figures cannot be evaluated for differences between the representative groups. See 37 CFR 1.84(p)(3) which requires that reference characters measure at least .32 cm (1/8 inch) in height.
37 CFR 1.84(u)(1) states that partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. Figure 23 is contained on 3 different pages and is labeled as FIG. 23 and FIG. 23 (Cont.) which is not compliant with 37 CFR 1.84(u)(1). Figure 26 is contained on 3 different pages and is labeled as FIG. 26 and FIG. 26 (Cont.) which is not compliant with 37 CFR 1.84(u)(1).
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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Figures 20A-20F, 33A, and 35A-35B all contain either nucleic acid and/or amino acid sequences. Figures 20A-20F have been amended (filed 04 December 2025) to include a Sequence identifier for the nucleic acid sequences in the drawing. However, Figures 20A-20F also have amino acid sequences which do not include the required Sequence identifiers. Figures 33A and 35A-35B all include amino acid sequences which do not also include the required Sequence identifiers.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The use of the term NEUTRAVIDIN at [0039], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
The use of the terms VENTANA and ultraView at [0083] and [0084], which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 17-19 are objected to because of the following informalities:
Claim 17recites “an antibody expressing at least one epitope tag construct…” However, an antibody does not express anything. An antibody is a protein and as such, it may be attached to/linked to/coupled to an epitope tag construct but it cannot “express” an epitope tag construct.
Claim 17 also recites “wherein the epitope tag comprises an amino acid sequence having a sequence selected from the group consisting of” as well as “wherein at least one of the spacers comprises an amino acid sequence having a sequence selected from the group consisting of”. The language of “comprises an amino acid sequence having a sequence” is disjointed and redundant. It is suggested that this phrase be replaced by “comprises an amino acid sequence selected from the group consisting of…”.
Claim 17 also recites “wherein the antibody expresses between 2 to 8 epitope tags”. Again, the antibody does not express an epitope tag but rather, the antibody may be attached to/linked to/coupled to or wherein the epitope tag construct contains/includes/possesses between 2 to 8 epitope tags.
Claim 18 recites “wherein the antibody expresses between 2 to 6 epitope tags”. The antibody does not express an epitope tag but rather, the antibody may be attached to/linked to/coupled to or wherein the epitope tag construct contains/includes/possesses between 2 to 6 epitope tags.
Claim 19 depends from claim 17 but does not correct the deficiencies noted in claim 17, therefore, claim 19 is also objected to for the same reasons.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 depends from claim 1. Claim 1 limits the epitope-tagged antibody to one with an epitope tag having an amino acid sequence selected from SEQ ID NO:1-9 and a spacer comprising an amino acid sequence selected from the group consisting of SEQ ID NO:10-15 and wherein the epitope tag construct has a particular formula with repeating usings of spacer and epitope tags. Claim 12 does not include all the limitations of claim 1 because it recites that the epitope tag constructs comprise an amino acid sequence having at least 90% identity to one of SEQ ID NO:16, 18, 20, 22, 24, 26, 28, 30 or 32. The introduction of % identity language into the claim means that claim 12 does not include all the limitations of the claim from which it depends because the amino acid sequences of the epitope tag and/or spacer would not be retained as up to 10% variability would be introduced. Therefore, claim 12 does not include all the limitations of the claim from which it depends
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Terminal Disclaimer
The terminal disclaimer filed on 04 December 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. No. 11,112,413 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Allowable Subject Matter
Claims 1-5, 7-8 and 14 are allowed.
Conclusion
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 Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm.
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, Daniel E Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
