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 the invention of Group I, claims 1-14, and the species of therapeutic agent in the reply filed on 04/09/2026 is acknowledged. The traversal is on the ground(s) that the inventions as claimed can be readily evaluated in one search without placing undue burden on the examiner because all the claims are so interrelated that a search of one group of claims will reveal art to the others. This argument is not found persuasive because the instant application is a national stage entry of an international patent application filed under the Patent Cooperation Treaty, and so the standard for restriction is that of unity of invention. Burden of search is not relevant to national stage entries. The Examiner properly demonstrated the lack of unity between the recited inventions in the restriction requirement mailed 02/11/2026. Even if, arguendo, burden of search was the standard for restriction in the instant application, the Examiner notes that Applicant’s assertion that “all the claims are so interrelated that a search of one group of claims will reveal art to the others” is not supported by the Examiner’s search of the elected invention, which did not reveal art to the nonelected inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The response of 04/09/2026 has been entered. Claims 1-14 and 16 are pending in this US patent application. Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claim 12 is withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/09/2026.
Claims 1-11 and 12-14 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 06/26/2024 has been received and considered.
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 3-6 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.
The instant claims are drawn to an isolated peptide comprising an X409 peptide and a payload. Claims 3-6 recite functional language regarding the binding properties of the isolated peptide of claim 1. The functional limitations of these claims can be interpreted in two ways. In the first interpretation, the functional limitations of claims 3-6 represent inherent properties of the isolated peptide of claim 1, i.e., all isolated peptides of claim 1 exhibit the binding properties recited in claims 3-6. In the second interpretation, the functional limitations of claims 3-6 represent structural limitations of the isolated peptide of claim 1, i.e., only a subset of isolated peptides of claim 1 exhibit the binding properties recited in claims 3-6. One of ordinary skill in the art would be unable to determine which of these two interpretations is intended by the functional language of claims 3-6. Additionally, if Applicant intends for these claims to represent structural limitations of the peptide of claim 1, one of ordinary skill in the art would be unable to determine how the peptide of claim 1 would need to be structurally limited in order to produce the functions recited in claims 3-6. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 3-6, rendering them indefinite. Therefore, claims 3-6 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claims 3-6 as reciting inherent properties of the isolated peptide of claim 1. As such, any prior art that reads on claim 1 will be interpreted to read on claims 3-6 as well, regardless of whether the prior art specifically discloses the particular binding properties recited in claims 3-6.
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.
Claims 1-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al., Structure 20: 707-717 (2012; cited on the IDS filed 06/26/2024).
Yu teaches recombinant variants of StcE from enterohemorrhagic E. coli serotype O157:H7 that comprise residues 36-898 of StcE, including an E447D variant that is catalytically inactive (see entire document, including page 708, right column, paragraph 3; reads on claims 1-14; the Examiner notes that instant SEQ ID NO.: 1 represents residues 794-886 of StcE from E. coli O157:H7 [claims 1-7 and 13] and that the other residues of the isolated StcE variants of Yu can be interpreted as a “payload” that are attached to residues 794-886 through a “binding moiety” [claims 8-9] of “peptide linkers” [claim 10]; amino acids may also serve as “therapeutic agents,” thus satisfying claim 11 because the claim does not require any limitation of the type of “therapeutic agent”). The variants were obtained by culturing E. coli cells that expressed the recombinant proteins (page 715, left column, paragraph 2; reads on claim 14; the Examiner notes that bacterial culture involves multiple compounds that can be interpreted as pharmaceutically acceptable carriers, including water, and that any composition comprising the StcE variants of Yu and water is capable of being administered to a patient in some way, thus representing a “pharmaceutical dosage form”).
Therefore, claims 1-11 and 13-14 are anticipated by Yu and are rejected under 35 U.S.C. 102(a)(1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 04/29/2026
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