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 .
Claims 1-5, of record 1/23/2025, are pending and subject to prosecution.
Priority
The effective filing date of the instant application is 1/23/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
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). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. MPEP 2422.02 requires "that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and the sequence identifier ("SEQ ID NO:X') must be used, either in the drawing or in the Brief Description of the Drawings." See MPEP 2421-2422.
Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Figure 15 has amino acid sequences that are not accompanied by SEQ ID NO in the figure or in the specification.
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.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The drawings are further objected to because view number must be preceded by the abbreviation “FIG.” (See 37 CFR 1.84(u)) and because they contain nucleotide or amino acid sequences that are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. MPEP 2422.02 requires, "that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and the sequence identifier ("SEQ ID NO:X') must be used, either in the drawing or in the Brief Description of the Drawings." See MPEP 2421-2422.
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.
It is noted that this office action comprises both an objection to the Nucleotide and/or Amino Acid Disclosure AND an objection to the Drawings. Applicant need only either amend the specification at the Brief Description of the Drawings section OR provide amended drawings to overcome both objections. Applicant does not need to do both.
Specification
The use of the terms Alexa Fluor, Tween, Triton X-100, AXIO, and SYBR, which are trade names or marks used in commerce, has 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
Claim 4 is objected to because of the following informalities:
In line 1 of claim 4, “an” should be inserted in front of “αvβ3 antagonist”.
Appropriate correction is required.
Claim Interpretation
Claim 4 recites the limitation “a pharmaceutically acceptable carrier or excipient”. The carrier is interpreted as being any carrier that is compatible with the αvβ3 antagonist and the antibiotic and is not deleterious to a subject being treated, consistent with the instant specification (See page 16, 32-34 and page 17, line 1).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McDonnell et al. (Journal of Thrombosis and Haemostasis, 2016), evidenced by Viela et al. (Nano Letters, 2019).
Regarding claims 1-2 and 5: McDonnell et al. teach an in vitro assay for investigating adhesion of Staphylococcus aureus to endothelial cells (See Summary and page 2537, col. 2, full ¶2-3). Cultured human endothelial cells were pre-treated with cilengitide before being subjected to shear force (which reads on “cell culture comprising sheared human endothelial cells and cilengitide”) (See page 2537, col. 2, full ¶2-3). Cilengitide inhibited binding of S. aureus ClfA to integrin αvβ3 on the cells (See fig. 4). McDonnell et al. teach that fibrinogen acts as a bridge between ClfA and endothelial cells (See fig. 2 and 4) but do not expressly teach that fibrinogen-integrin crosslinking is inhibited by cilengitide. However, Viela et al. teach that cilengitide prevents S. aureus attachment to endothelial cells by disrupting fibrinogen binding to integrin αvβ3 (See fig. 1). The teachings of McDonnell et al., evidenced by Viela et al., therefore anticipate the claimed invention.
Claims 3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McHale et al. (Critical Care Medicine, 2018).
Regarding claims 3 and 5: McHale et al. teach a hemodynamic perfusion model for studying Escherichia coli attachment to sheared human endothelial cells (See Abstract). Pre-incubation of cells with cilengitide abrogated binding of E. coli OmpA to integrin αvβ3 on the cell surface (See page e807, full ¶1 and col. 2, ¶1-2 and fig. 2-3). The teachings of McHale et al. therefore anticipate the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hodivala-Dilke et al. (US 20240181001 A1).
Regarding claim 4: Hodivala-Dilke et al. teach cancer treatments comprising an αvβ3 integrin-targeting agent (which reads on “αvβ3 antagonist”) in combination with at least one immunotherapeutic agent and/or chemotherapeutic agent (See Abstract). The integrin-targeting agent may be a cyclic peptide such as cilengitide (See ¶0041, 0044, and 0050). The chemotherapeutic agent may be an antibiotic (See ¶0095). The active agents may be formulated into a pharmaceutical composition with a pharmaceutically acceptable excipient or carrier (See ¶0105 and 0125). The teachings of Hodivala-Dilke et al. therefore anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER S SPENCE, whose telephone number is 571-272-8590. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher M Babic, can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER S SPENCE/Examiner, Art Unit 1633
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