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 .
Claim Status
The amendment of 07/17/2026 has been entered. Claims 1-14 and 16 are pending in this US patent application. Claim 16 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claim 12 remains withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim.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 13-14 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 remain 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 remain 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).
Please note that this rejection has been slightly augmented to incorporate discussion of the newly-added limitations in the amended claims of 07/24/2026. However, because the basis of the rejection is unchanged, the rejection has been maintained.
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 so residues 794-866 of Yu’s StcE represent an isolated peptide that consists of a X409 peptide according to SEQ ID NO: 1; 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 Examiner further notes that the presence of these other residues are not precluded by the overall language of claim 1, which recites a mucin-binding targeting agent comprising an isolated peptide). 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).
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 112(b) as being indefinite. Applicant states that one of ordinary skill in the art would be able to determine how to measure the binding characteristics of the targeting agent as recited in claims 3-6, and so the claims are definite (remarks, page 6). This argument has been fully considered but has not been found persuasive.
As discussed above and in the previous Office action, the indefiniteness of the claims arises from the two distinct interpretations that the claim language may have: that the binding characteristics of claims 3-6 are inherent properties of the targeting agent or, in the alternative, that the functional language of claims 3-6 is intended to structurally limit the targeting agent of claim 1 to particular embodiments that exhibit the recited binding characteristics. Whether or not one of ordinary skill in the art would be able to ascertain how to perform an assay does not address the multiple possible interpretations of the claim language.
Applicant has traversed the above rejection of the claims under 35 U.S.C. 102(a)(1) as being anticipated by Yu. Applicant states that Yu does not teach a peptide consisting of an X409 peptide according to SEQ ID NO: 1, and so Yu cannot anticipate the claims (remarks, page 7). This argument has been fully considered but has not been found persuasive.
The Examiner notes that, as discussed above, the instant claims recite a mucin-binding targeting agent comprising an isolated peptide consisting of an X409 peptide according to SEQ ID NO: 1. As such, the presence of additional amino acids in the peptide of Yu attached to Yu’s disclosed sequence that is identical to SEQ ID NO: 1 does not preclude it from anticipating the instant claims because the language of the claimed mucin-binding targeting agent as a whole is drafted using open-ended “comprising” language.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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, 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 10/01/2026
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