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 included in the prosecution are claims 1-13.
Election/Restrictions
Applicant’s election of Group I, claims 1-13 in the reply filed on 01/12/2026 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)).
The species election requirement has been withdrawn.
Accordingly, claims 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 13 is objected to because of the following informalities: “NPs” should be recited in its full name since claim 1 does not recite what NP stands for. Appropriate correction is required.
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 10, 11 and 13 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.
Regarding claim 10, the phrase "for example" or “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “ultrasmall” in claim 11 is a relative term which renders the claim indefinite. The term “ultrasmall” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although page 2, lines 13-14 of the specification discloses “ultrasmall nanoparticle (e.g., about 3.5 nm in diameter)”, this is merely an exemplary size for an ultrasmall nanoparticle and the range of size for an ultrasmall nanoparticle is still unclear.
Claim 13 recites the limitation "NPs" in the last line. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites a nanoparticle and does not recite wherein there is a plurality of nanoparticles. Therefore, the scope of NPs is unclear.
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, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tae (KR 10-2017-0138861, Dec. 18, 2017).
Tae discloses a peptide-chitosan modified nanoparticle (claim 1). The peptide may be a tight junction opening peptide (claim 3). The peptide may be an occluding-derived peptide or a claudin-4-dervived peptide (claim 4). A drug (i.e., therapeutic agent payload) may be contained within the nanoparticle (claim 7).
Tae anticipates the instant claims insofar as disclosing a nanoparticle modified with an occluding-derived peptide or a claudin-4-dervived peptide, wherein a drug (i.e., payload) is within the nanoparticle.
Claim Rejections - 35 USC § 103
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Traverso et al. (US 2019/0064153, Feb. 28, 2019) (hereinafter Traverso).
The teachings of Tae are discussed above. Tae does not teach wherein the nanoparticle is modified with claudin-1.
However, Traverso discloses a tissue explant comprising tight junctions. Tight junctions are identified by the presence of Claudin-1. Claudin-1 is an integral membrane protein, which is a component of tight junctions. Tight junctions represent one mode of cell-to-cell adhesion in epithelial or endothelial cell sheets, forming continuous seals around cells and serving as physical barrier to prevent solutes and water from passing freely (¶ [0398]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Tae discloses wherein the peptide may be a tight junction opening peptide. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated claudin-1 to the nanoparticle of Tae since it is a known and effective tight junction opening peptide as taught by Traverso.
2. Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Holtzman et al. (US 2002/0086354, Jul. 4, 2002) (hereinafter Holtzman).
The teachings of Tae are discussed above. Tae does not teach wherein the peptide has the amino acid sequence shown in SEQ ID No: 2.
However, Holtzman discloses polypeptides. The polypeptides are useful as modulating agents in regulating a variety of cellular processes (abstract). SEQ ID NO: 4 on pages 34-35 is an exemplary polypeptide with a 100% amino acid sequence match to claimed SEQ ID NO:2.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Tae discloses wherein the nanoparticle is modified with a peptide. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the polypeptide of SEQ ID NO:4 to the nanoparticle since it is a known and effective peptide with the additional benefit of being useful as a modulating agent in regulating a variety of cellular processes as taught by Holtzman.
3. Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Gamero-Estevez et al. (US 2021/0130418, May 6, 2021) (hereinafter Gamero-Estevez).
The teachings of Tae are discussed above. Tae does not teach wherein the peptide has the amino acid sequence shown in SEQ ID No: 3.
However, Gamero-Estevez discloses polypeptide constructs targeting claudin proteins that are useful for transiently disrupting tight junctions in a tissue (abstract). The polypeptide construct may comprise the EL2 region of any claudin which is targeted. The EL2 region comprises the amino acid sequence set forth in any one of SEQ ID Nos: 7-12 and 15-40 (¶ [0016]). SEQ ID No. 15 shown on page 25 has a 100% amino acid sequence match with claim SEQ ID No: 3.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Tae discloses wherein the peptide may be a tight junction opening peptide. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the polypeptide of SEQ ID NO. 15 to the nanoparticle of Tae since it is a known and effective tight junction opening peptide as taught by Gamero-Estevez.
4. Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Accardo et al. (Peptide-based targeting strategies for simultaneous imaging and therapy with nanovectors, Feb. 13, 2013) (hereinafter Accardo) and Sengupta et al. (US 2017/0014528, Jan. 19, 2017) (hereinafter Sengupta).
The teachings of Tae are discussed above. Tae does not teach wherein the nanoparticle comprises an imaging agent within.
However, Accardo discloses that over recent years, multifunctional compounds that combine diagnostic and therapeutic modalities using one unified material have been developed and designated as theranostics. Accardo describes theranostic agents based on nanovectors externally modified with targeting peptides able to simultaneously carry a drug and a contrast agent, demonstrating that peptide-modified nanovectors can selectively carry a drug to target cells with an imaging probe co-incorporated into the nanovector to monitor therapy (abstract).
Sengupta discloses a conjugate comprising a targeting ligand and a molecule of interest (abstract). The molecule of interest can be an imaging or contrast agent (¶ [0127]). The imaging agent can be a PET radiotracer or a Gd contrast agent (page 14).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a PET radiotracer or a Gd contrast agent within the nanoparticle since it is desirable in the art to incorporate an imaging agent along with a drug to monitor therapy as taught by Accardo and a PET radiotracer or a Gd contrast agent are known imaging agents as taught by Sengupta.
5. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Bradbury et al. (US 2016/0166714, Jun. 16, 2016) (hereinafter Bradbury).
The teachings of Tae are discussed above. Tae does not teach wherein the nanoparticle is an ultrasmall nanoparticle or is about 3.5 nm in diameter.
However, Bradbury discloses nanoparticles bound with cyclic peptides (abstract). The nanoparticle is an ultrasmall particle (e.g., with an average diameter less than 10 nm) (¶ [0010]).
Accordingly, it would have been prima facie to one of ordinary skill in the art to have formulated the nanoparticle of Tae to be ultrasmall with an average diameter less than 10 nm since Tae does not disclose a particle size and this is a known and effective size for peptide-modified nanoparticles as taught by Bradbury.
6. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tae (KR 10-2017-0138861, Dec. 18, 2017) in view of Feng et al. (Synthesis of Fe3O4/APTES/PEG diacid functionalized magnetic nanoparticles for MR imaging, Jun. 19, 2008) (hereinafter Feng).
The teachings of Tae are discussed above. Tae does not teach wherein the nanoparticle is coated with PEG diacid.
However, Feng discloses magnetite nanoparticles coated with PEG diacid for MR imaging (abstract). The PEG coating could enhance the compatibility between nanoparticles and aqueous medium, prevent particle surface from oxidation, reduce toxicity, and facilitate storage or transport, etc. (page 52, right column).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have coated the nanoparticle of Tae with PEG diacid motivated by the beneficial properties the coating provides as taught by Feng.
Conclusion
Claims 1-13 are rejected.
Claims 14-22 are withdrawn.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614