DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 22 September 2025, in the matter of Application N° 15/738,954. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the previously filed claims. No new matter has been added.
Thus, claims 114-133 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 10 July 2025 since the art that was previously cited continues to read on the previously recited limitations.
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.
(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 114-133 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by El-Sayed et al. (US Pre-Grant Publication Nº 2009/0326614 A1).
The instantly claimed invention is directed to a particle comprising an agent and a coating. The agent is further defined as being capable of selectively binding to a target (claim 114), and compositionally, as being defined as, for instance, a cell surface receptor protein (claims 126-128). The coating is further compositionally defined as comprising coating moieties/molecules which are further defined as comprising a polymer (claims 129-133).
The particles are further defined in claim 114 as having a size and shape that allows them to circulate in the vasculature of a subject.
Lastly, claim 114 and dependent claims 115-125 recite limitations directed to the “target” to which the agent is capable of binding. As the agent is capable of binding to these targets, the Examiner broadly and reasonably interprets the “target(s)” as ancillary limitations that stand apart from the claimed particle composition. Therein, the broadest reasonable interpretation of these limitations is that they do not contribute to the overall patentability of the claimed particle.
El-Sayed discloses solid noble metal nanorods (claim 42) or nanoparticles (claim 38). Said nanoparticles are further disclosed as being targeted to cancer cells via one or more binding moieties (agents) conjugated to the solid noble metal nanoparticles (see e.g., claim 39). Claims 40 and 41 further limit the nanoparticles disclosing that they comprise a polymer coating that comprises polyethylene glycol. Paragraph [0028] further defines the “binding moieties” as being a substance that specifically binds or interacts with a target substance and that representative binding moieties include: antibodies, antigen binding antibody fragments, ligands, polypeptides, biotin/avidin (a biotin-binding protein), amino acids, DNAs, RNAs, siRNA, micro-RNA or other natural or synthetic polymers or binding fragments thereof.
As the aforementioned binding moieties are expressly disclosed as being conjugated to the surface of PEG-coated nanoparticles, the Examiner submits that the moieties define protein agents that are capable of “targeting” cells, in this case, cancer cells, as disclosed in claims 39 and 40, for instance, and therefore, meet the recited compositional and structural limitations as recited.
The reference is thus considered to meet each of the compositional and structural limitations of the newly claimed invention.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 114-133 under pre-AIA 35 USC 102(a)(1)/(a)(2) as being anticipated by El-Sayed have been fully considered, but are not persuasive.
Applicants traverse the rejection alleging that the reference fails to disclose that the coating inhibits the agent from interacting with a molecule on the surface of a cell. It is further argued that the reference discloses particles that are specifically designed to comprise binding moieties that bind to the cells, thereby targeting the particles to the cells.
The Examiner, in response, acknowledges Applicants’ observations, but maintains that El-Sayed continues to anticipate the invention of claim 114. Therein, the reference discloses particles composed of noble metal nanoparticles that are conjugated to binding moieties. The particles are coated with a polymer (i.e., PEG), thereby inhibiting the noble metal particles from interacting with the cells themselves. The disclosed particles of the reference are considered to continue to read on the breadth of the recited composition.
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained.
Claims 114-133 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (Euro. J. Pharm. Sci.; 2006; IDS reference).
The limitations of the claimed particle composition are discussed above.
Fang discloses preparing nanoparticles comprising recombinant Human tumor necrosis factor α (rHuTNF-α). The nanoparticles themselves are disclosed as being formed from PEG-poly methoxypolyethylene glycol cyanoacrylate-co-n-hexadecyl cyanoacrylate (PEG-PHDCA) having three sizes: 80, 170, and 240 nm (see e.g., Abstract; Sections 2.3 and 2.4). Section 2.4 further discloses that the surface of the PEG-PHDCA nanoparticles is occupied by (aka coated with) MePEG or monomethoxy polyethylene glycol. Section 3.3 of the reference additionally discloses that “MePEG coating on particle surface resulted in a dramatic reduction in uptake for nanoparticles of all sizes…”, thereby expressly disclosing that the rHuTNF-α protein loaded nanoparticles are also coated.
The reference is thus considered to meet each of the compositional and structural limitations of the newly claimed invention.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 114-133 under pre-AIA 35 USC 102(a)(1) as being anticipated by Fang et al. have been fully considered, but are not persuasive.
Applicants simply allege that Fang does not disclose a particle that inhibits the agent from interacting with a molecule of the surface of a cell.
Applicants’ claimed composition is directed to a particle comprising an “agent” and a coating, presumably having the structure where the coating is laid over the undefined agent.
Contrary to the assertion, Fang’s disclosure expressly meets the claimed compositional limitations presented in claim 114, as discussed in the above rejection. Therein, the article is specifically directed to reporting on the influence of MePEG molecular weight to limit their in vivo tumor targeting properties (see e.g., Abstract).
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, and 10-23 of Hawthorne (USPN 9,623,081 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 114 recites:
A particle comprising an agent and a coating, wherein:
the agent is capable of selectively binding to a target;
the coating inhibits the agent from interacting with a molecule on the surface of a cell;
the particle is shaped and sized to circulate in the vasculature of a subject; and
the target is selected from a soluble form of a cell membrane protein, a cytokine, a soluble form of a cell surface receptor protein, a matrix metallopeptidase, an immune checkpoint protein, a hormone, a growth factor, a soluble human leukocyte antigen (HLA) protein, a soluble UL16- binding protein isoform, a TGFP superfamily ligand, a soluble member of the B7 family, an amyloid protein, a precursor of an amyloid protein, and an autoantibody.
Claim 1 of the ‘081 patent discloses:
A particle having at least one surface and an agent immobilized on the surface, wherein:
the agent selectively binds to a target that is a first member of a specific binding pair;
binding of the target to the particle inhibits the interaction of the target with a second member of the specific binding pair;
the target is a soluble biomolecule;
the soluble biomolecule is a form of a cell surface receptor protein expressed by a cancer cell; and
the agent is disposed on a surface of the particle such that it is sterically inhibited from binding or activating the cell surface receptor protein on the surface of a cell.
Claim 2 of the ‘081 patent discloses:
The particle of claim 1, wherein the particle is shaped and sized to circulate in the vasculature of a subject.
Claim 5 of the ‘081 patent discloses:
The particle of claim 1, further comprising a plurality of coating molecules.
Claim 10 of the ‘081 patent discloses:
The particle of claim 9, wherein the plurality of coating molecules is biodegradable.
Claim 11 of the ‘081 patent discloses:
The particle of claim 10, wherein the plurality of coating molecules comprises a biodegradable polymer.
The biodegradable polymer is further defined as comprising the instantly claimed polymer materials (see e.g., col. 17, lines 20-45).
Lastly, claims 12-23 disclose that the agent immobilized on the surface of the particle is a generic cell surface receptor protein or a species of one.
Thus, were the reference ‘081 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘081 patent discloses at least an obvious variant over the instantly claimed composition.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-27, 41, 45, and 49-51 of Hawthorne (USPN 9,907,831 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claim 114 are discussed above.
Claim 1 of the ‘831 patent discloses:
A particle having at least one surface and an agent immobilized on the surface, wherein:
the agent selectively binds to a target that is a first member of a specific binding pair; and
binding of the target to the particle inhibits the interaction of the target with a second member of the specific binding pair;
the particle is porous;
the surface comprises outer surfaces and inner surfaces;
the inner surfaces consist of the inner walls of the pores of the particle; and
the agent is immobilized on the inner surfaces.
Claim 11 of the ‘831 patent discloses:
The particle of claim 1, wherein the agent is a small molecule, a macrocycle compound, a polypeptide, a protein, a peptide, a peptidomimetic compound, a nucleic acid, or a nucleic acid analog.
Claim 12 of the ‘831 patent discloses:
The particle of claim 1, wherein the agent is an antibody, a biomolecule-binding fragment of an antibody, or a ligand of a cell surface protein.
Claims 13-27 of the ‘831 patent further defines the agent as a generic cell surface receptor protein or species of it.
Claim 41 of the ‘831 patent discloses that the particle of claim 1 will further comprise a plurality of coating molecules. Claim 45 discloses that the plurality of coating molecules will comprise PEG. Claims 49-51 disclose that the plurality of coating molecules comprises molecules that are biodegradable and/or are a biodegradable polymer.
The biodegradable polymer is further defined as comprising the instantly claimed polymer materials (see e.g., col. 17, lines 20-45).
Thus, were the reference ‘831 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘831 patent discloses at least an obvious variant over the instantly claimed composition.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 10-25 of Hawthorne (USPN 10,420,817 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claim 114 are discussed above.
Claim 1 of the ‘817 patent discloses:
A particle having at least one surface and an agent immobilized on the surface, wherein:
the agent selectively binds to a target that is a first member of a specific binding pair;
binding of the target to the particle inhibits the interaction of the target with a second member of the specific binding pair;
the target is a soluble biomolecule;
the soluble biomolecule is a form of a cell surface protein; and
the agent is disposed on a surface of the particle such that it is sterically inhibited from binding or activating the cell surface protein on the surface of a cell.
Claim 5 of the ‘817 patent discloses:
The particle of claim 1, wherein the particle is shaped and sized to circulate in the vasculature of a subject.
Claims 10-18 of the ‘817 patent discloses that the particle of claim 1 further comprises a plurality of coating molecules that are biodegradable and/or comprise a biodegradable polymer.
The biodegradable polymer is further defined as comprising the instantly claimed polymer materials (see e.g., col. 17, lines 20-45).
Claims 19-25 of the ‘817 patent further defines the agent as a generic cell surface receptor protein or species of it.
Thus, were the reference ‘817 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘817 patent discloses at least an obvious variant over the instantly claimed composition.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Hawthorne (USPN 10,653,790 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claim 114 are discussed above.
Claim 1 of the reference ‘790 patent discloses:
A particle comprising a first plurality of reactive groups, wherein:
each reactive group of the first plurality of reactive groups (aka the agent) can selectively react with a first agent comprising a first predetermined functional group;
each reactive group of the first plurality of reactive groups is disposed on the particle such that after the first agent is linked to that reactive group through the first predetermined functional group, the first agent has a reduced ability to bind to a molecule on the surface of a cell;
the particle comprises a plurality of coating molecules, wherein the plurality of coating molecules comprises a polymer; and
the longest dimension of the particle is about 50 nm to about 5 μm.
Claim 9 discloses that the particle comprises a core subparticle and a plurality of protecting subparticles; the reactive groups of the first plurality of the reactive groups are located on the core subparticle.
Though the claims do not expressly disclose either size range for the core particles or protecting subparticles, the Examiner notes that claim 6 discloses that the particle is shaped and sized to circulate in the vasculature of a subject. As defined by the instant specification, the Examiner understands that core particles will have a preferred size range of about 100 nm to about 2 µm (see col. 33, lines 28 and 35), and protecting subparticles will preferably range in size from about 10 nm to about 1 µm (see col. 35, line 10).
The foregoing is considered to read on the limitations recited by instant claims 114-125.
Thus, were the reference ‘790 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘790 patent discloses at least an obvious variant over the instantly claimed composition.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, and 17-22 of Hawthorne (USPN 11,771,744 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claim 114 are discussed above.
Claim 1 of the ‘744 patent discloses:
A particle having at least one surface, and an agent immobilized on the surface, wherein:
the agent selectively binds to a target that is a first member of a specific binding pair;
binding of the target to the particle inhibits the interaction of the target with a second member of the specific binding pair;
the target is a ligand of a cell surface receptor protein;
the agent is disposed on a surface of the particle such that it has a reduced ability to interact with a molecule on the surface of a cell; and
the particle is shaped and sized to circulate in the vasculature of a subject.
Claim 15 of the ‘744 patent further defines the agent component of claim 1.
Claims 17-22 of the ‘744 patent discloses that the particle of claim 1 further comprises a plurality of coating molecules that are biodegradable and/or comprise a biodegradable polymer, which read on the instantly claimed polymer materials.
Thus, were the reference ‘744 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘744 patent discloses at least an obvious variant over the instantly claimed composition.
Claims 114-133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of Hawthorne (USPN 12,083,186 B2) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of instant claim 114 are discussed above.
Claim 1 of the ‘186 patent discloses:
A scavenging construct comprising:
a polymer particle shaped and sized to circulate through human vasculature; and
an agent attached to the polymer particle through a coupling group, wherein:
the agent is capable of selectively binding to a target;
the coupling group is formed in a reaction between a functional group coupled to the agent and a reactive group coupled to the polymer particle;
the functional group and the reactive group each independently comprises α-haloacyl, alkene, alkyl halide, alkyne, amine, aryl halide, azide, carbodiimide, carboxyl, diene, dienophile, glyoxal, imidoester, isocyanide, maleimide, N-hydroxysuccinimidyl ester, phosphine, tetrazine, thiol, nucleic acid, biotin, biotin-binding protein, or a member of an antibody-antigen pair; and
the polymer particle sterically inhibits the agent from binding to a molecule on the surface of a cell.
Claims 2-8 of the ‘186 patent further define the agent component of claim 1, such as a cell surface receptor protein.
Claims 9-20 of the ‘186 patent disclose that the particle of claim 1 further comprises a plurality of coating molecules that are biodegradable and/or comprise a biodegradable polymer, which read on the instantly claimed polymer materials.
Thus, were the reference ‘186 patent available as prior art, the teachings presented therein would have anticipated the instantly claimed particle composition, if not a prima facie case of obviousness. As such, the Examiner submits that the reference ‘186 patent discloses at least an obvious variant over the instantly claimed composition.
Response to Arguments
Applicants’ filed response to the rejection of claims 114-133 on the grounds of nonstatutory double patenting over the patented teachings of USPNs: 9,623,081; 9,907,831; 10,420,817; 11,881,744; and 12,083,186 has been fully considered, but is not persuasive.
A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP §714.02 and 37 CFR 1.111(b)). Thus, the double patenting rejections of record have each been maintained as no action regarding these rejections has been taken by Applicants at this time.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615