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
Claims 1-14 and 27-32 are pending.
Claims 15-26 and 33-35 have been canceled.
Claims 6-14 and 27-32 are withdrawn.
Claims 1-5 are currently under consideration.
Claims 1-5 are rejected.
Acknowledgement of Receipt
Applicants’ election of Group I., claims 1-5 drawn to a liposomal composition in the reply filed on 01/13/2026 is acknowledged. This Office Action is in response to Applicants’ elections, amendments and remarks filed 01/13/2026.
Election/Restrictions
Applicants’ election of in the reply filed on is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application is a 371 of PCT/US2022/015272 filed on 02/04/2022 which claims benefit of 63/146,401 filed on 02/05/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 08/07/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Spec., pg. 42, line 10). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant Claims
The instant claims are directed to a liposomal composition comprising a liposome, wherein a surface of the liposome has been conjugated to a peptide selected from the group consisting of SEQ ID NOs: 3-38, optionally wherein the liposome encapsulates an active agent selected from the group consisting of a therapeutic agent and a detectable agent (claim 1); wherein the peptide is selected from the group consisting of KTYVPTT (SEQ ID NO: 14), MDLSLKP (SEQ ID NO: 19), MNSIAIP (SEQ ID NO: 20), SLTNSSF (SEQ ID NO: 27), and SNSQDLH (SEQ ID NO: 28) (claim 2); the peptide is MDLSLKP (SEQ ID NO: 19) and the liposome is targeted to a cell expressing collagen IIIa (claim 3); wherein the therapeutic agent is an antifibrotic agent, optionally apigenin (claim 4); further comprising a pharmaceutically acceptable carrier, diluent, and/or excipient, optionally, wherein the pharmaceutically acceptable carrier, diluent, and/or excipient is pharmaceutically acceptable for use in a subject (claim 5).
Allowable Subject Matter
Claims 2 and 3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
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 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claim(s) 1, 4, and 5 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Klibanov et al. (US 2018/0360755, pub. 12/20/2018) herein referenced Klibanov.
Klibanov discloses that the invention provides liposomes with surface modifications to include peptides with affinity for cell types present in the post-infarct myocardium ([0004]). Liposomes allow for surface modifications with different targeting ligands including antibodies, antibody fragments and peptides that are specific for the diseased tissue ([0055], [0162]). The peptides can be extended away from the delivery vehicle (e.g., liposome) via the use of a chain extender/spacer ([0136-0137]). The delivery vehicles include targeting molecules on their surfaces, such as those listed in Table 1 (pg. 21-26) or derivative thereof ([0168]).
Regarding the instantly claimed SEQ ID NOs: 3-38, looking to the instant specification, Applicants describe peptide 7-mers identified in the phage screen were chemically synthesized including a C terminal addition of the amino acid linker, GGSKC (SEQ ID NO: 4) and that the lysine at position 4 of the linker was conjugated to a 5-carboxyfluorescein (5-FAM) fluorophore (see Spec., pg. 37, line 8). Klibanov discloses in the preparation of liposomes, peptides (7-mers) identified in the phage screen were chemically synthesized with the following modifications on the C-terminus: 7-mer-GGSK(FAM)C ([0229-0230]) to read on SEQ ID NO: 4 (i.e., GGSKC). Klibanov explains that the presence of FAM on the peptides enables the ability to identify the cell types recognized by the peptide-targeted liposomes by co-localization with antibodies against CD31 (endothelial marker), alpha-smooth muscle actin (aSMA, myofibroblast marker), caveolin-3 (cardio myocytes), and c-Kit (marker of progenitor cells) ([0230]).
Regarding claims 1 and 4, the Examiner notes that any claimed limitations that follow the term, “optionally,” will be considered as not required.
Regarding claims 2-3 and considering the objection to these claims as address above, while Klibanov discloses identifying marker Collagen IIIa in the extracellular matrix (pg. 2, see key under images; [0214], [0228]), the prior art does not teach any of the species recited.
Regarding claim 5, Klibanov teaches that a composition comprising one or more of the peptides disclosed includes a pharmaceutically acceptable carrier ([0007], [0110]); any material used in preparing any unit dosage form should be pharmaceutically acceptable and substantially non-toxic ([0191]); and formulated as a medicament that is used to treat a disease in a mammal, includes a pharmaceutically acceptable diluent, excipient, or carrier ([0204]).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to utilize the liposomal composition and GGSK(FAM)C taught by Klibanov with expected results. One would be motivated to do so with a reasonable expectation of success because Klibanov is focused providing cell type-specific drug delivery tools that expedite efforts to modulate the heart's maladaptive response to myocardial infarction (MI) by programming cardiac regeneration with non-invasive, systemically administered therapeutic agents delivered via targeted liposomes ([0338]). Klibanov provides compositions and uses for them in treating heart conditions, for example, to areas of the heart where cardiomyocytes have been disturbed due to surgery ([0204]) to suggest improved health outcomes for subjects.
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
Claims 1, 4 and 5 are rejected; claims 2 and 3 are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571)270-5896. The examiner can normally be reached 900-500 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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