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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I without traverse in the reply filed 11/19/2025 is acknowledged.
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, 11, and 14 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 3, “n” is not defined in the structure following “wherein the amphiphilic polymer comprise the following building block…” As “n” is not defined, it’s unclear if “n” may be zero. Regarding claims 6 and 11, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “an IEP of more than 6,” and the claim also recites “an IEP… of more than 7, more than 8, or more than 9,” which are the narrower statement of the range/limitation. Claim 6 further recites “an IEP of more than 7,” and the claim also recites “an IEP… of more than 8 and more than 9,” which are the narrower statement of the range/limitation. Claim 6 further recites “more than 8,” and further recites “more than 9,” which is a narrower statement of the range/limitation. Regarding claim 11, the claim recites a hydrodynamic diameter of between “10 and 100 nm,” and further recites “between 10 and 70 nm,” “between 10 and 50 nm,” “between 20 and 40 nm,” and between “26 and 36,” which are narrower embodiments of the recitation. The claim further recites “between 10 and 70 nm,” and recites “between 10 and 50 nm,” “between 20 and 40 nm,” and between “26 and 36,” which are narrow embodiments of the recitation. The claim further recites “between 10 and 50 nm,” and further recites “between 20 and 40 nm,” and between “26 and 36,” which are narrower embodiments of the recitation. The claim further recites “between 20 and 40 nm,” and further recites between “26 and 36,” which is a narrower embodiment of the recitation. Regarding claim 14, the claim recites a composition according to claim 12, wherein (a) the composition comprises five different types of nanoparticles, where (a)(1) each type…. or (a)(2) each type… or (b) the composition comprises three different types of nanoparticles, wherein (b)(1) each type of nanoparticle comprises… or “(b2) each type of nanoparticle comprises…. Or (c) the composition comprises four different types of nanoparticles, or (c1) each type of nanoparticle comprises… or (c2) each type of nanoparticle comprises…” It’s unclear what constitutes a “different type of nanoparticle,” as each nanoparticle in the genus “five different types of nanoparticles” are defined with identical language. Similarly, each nanoparticle in the genus “four different types of nanoparticles” are defined with identical language. Further, each nanoparticle in the genus “three different types of nanoparticle” is defined with identical language. It’s therefore unclear what characteristics are required for a nanoparticle to be a “different type” as the population of nanoparticles
.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.
Claims 1-7, 9-14 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013072051 to Freund in view of WO 2021016082 to Moon in further view of US20050037086 to Tyo. Freund teaches nanoparticle preparations for the treatment of autoimmune diseases by targeted delivery of antigens (title; abstract; page 1, first paragraph to page 7, second paragraph). The composition comprises a nanoparticle, said nanoparticle comprising a) a micelle comprising an amphiphilic polymer rendering the nanoparticle water-soluble, and b) a peptide comprising at least one T cell epitope associated with the outside of the micelle, for use in generating regulatory T cells specific to said at least one T cell epitope in a subject (page 2, second full paragraph; pages 3-4, bridging paragraph; page 4, third full paragraph). The T cell receptor epitope is covalently linked to the nanoparticle (claims 1 and 6). The nanoparticles are used for treating autoimmune diseases and allergy (claim 6). The polymer may be a maleic copolymer and has a molecular weight of about 30 000 to 50 000 g/mol (page 3, paragraph 2). The nanoparticle diameter may be 5 to 30 nm (claim 5). Freund teaches a nanoparticle comprising: (a) an amphiphilic polymer with a number average molecular weight (Mn) of 20,000 g/mol or less; and (b) a peptide that is covalently linked to the polymer associated with the outside of the nanoparticle, wherein the peptide comprises an amino acid sequence of 8 to 50 amino acids, wherein the 8 to 50 amino acids comprises including an N-terminal linker sequence comprising at least one Arg amino acid residue and an amino acid sequence comprising an MHC binding sequence comprising a T cell receptor epitope, further comprising an amphiphilic polymer such as poly(maleic acid-1-octadecene) (page 3, first full paragraph). Freund teaches an aqueous solution as a carrier (a liquid carrier) (pages 2-3, bridging paragraph). Freud teaches a hydrodynamic diameter of about 40 to 50 nm (page 2, fourth full paragraph).
Freund fails to teach the “wherein the peptide comprises an amino acid sequence of 8 to 50 amino acids, wherein the 8 to 50 amino acids comprise (i) an N-terminal linker sequence comprising at least one Arg amino acid residue and (ii) an amino acid sequence comprising an MHC binding sequence,” and further fails to teach the presently claimed molecular weight range.
Moon is directed to compositions comprising nanoparticles associated with antigens (abstract). Moon teaches an arginine containing linker of SEQ ID NO: 824 (page 85, lines 11 ) which can be attached to the N-terminus of an antigen corresponding to the present the peptide comprises an amino acid sequence of 8 to 50 amino acids, wherein the 8 to 50 amino acids comprise (i) an N-terminal linker sequence comprising at least one Arg amino acid residue and (ii) an amino acid sequence comprising an MHC binding sequence, where the linker is attached to the N-terminus of the antigen (page 63, lines 9-13). Moon further teaches SEQ ID CAS RN 2594976-69-7, SEQ ID: QQPFPQPEQPFPWQP (SEQ ID 510), which corresponds to the SEQ ID recited in present claim 8. The antigen is conjugated to the phospholipid of the nanoparticle (claim 71). The nanoparticle can also be a polymer nanoparticle composed of hydrophobic polymer blocks (pages 32). The presence of the N-terminal linker sequence increases the electrostatic attraction (IEP) of the peptide (page 15, lines 4-19; page 65, lines 30-31).
Tyo is directed to production of nucleic acid-containing nanoparticles that maintain the structural integrity of associated nucleic acids for introduction into a host (abstract), and further teaches a molecular weight of 6,000 to 100,000 is an effective molecular weight for nanoparticles to deliver nucleic acids to a patient (abstract; claim 39).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a peptide that comprises an amino acid sequence of 8 to 50 amino acids, wherein the 8 to 50 amino acids comprise (i) an N-terminal linker sequence comprising at least one Arg amino acid residue and (ii) an amino acid sequence comprising an MHC binding sequence in the invention of Freund. The motivation for this would have been to allow the nanoparticle to interact specifically with the immune system for the purpose of inducing immune tolerance or treating autoimmune diseases. It would have been further obvious to optimize the molecular weight of the nanoparticle of Freund to improve the efficacy of the nanoparticle to act as a delivery system for peptide-based immunotherapy. In this way, the artisan would find the range of present range of 20,000 g/mol or less through routine experimentation. The prior art provides sufficient guidance to this end, as the range of 6,000 to 100,000 taught by Tyo overlaps with the present range. “‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)” MPEP § 2144.05, II. Regarding the recitation the number average molecular weight of the amphiphilic polymer is from 6,000 to 1,000 g/mol, it would have been obvious to find this molecular weight range through routine experimentation in the course of optimizing the nanoparticle for delivery of nucleic acids, and in this way, find the present range through routine experimentation. The prior art provides sufficient guidance to this end, as Tyo teaches nanoparticle polymer molecular weight ranges of about 6,000 to 100,000 (paragraph 11). The composition rendered obvious by Freund, Moon, and Tyo reads on claims 3 and 20 when n is zero. Regarding the recitation in claim 14, Freund teaches that different nanoparticle populations may be made (different types of nanoparticles) by using different polymers to form the nanoparticle, including poly(maleic anhydride-alt-1-octadecene), poly(maleic anhydride-alt-1-tetradecene), and polyisoprene-block polyethyleneoxide block copolymer (page 3, first full paragraph; claim 6), and further teaches different traceable materials may be used in the nanoparticle core, such as iron oxide, CdSe, silver, and gold (page 3, third full paragraph). By preparing different nanoparticles comprising different materials as suggested by Freund as modified in view of Moon and Tyu would afford a composition comprising at least five, at least four, and at least three types of nanoparticles, thereby preparing a composition that interacts specifically with the immune system for the purpose of inducing immune tolerance or treating autoimmune diseases. The motivation for this is "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (MPEP 2144.06), and using different types will treat the disease by different mechanisms. Claim 5 recites the property that the peptide without the N-terminal linker sequence has an IEP lower than 6, and claim 6 recites the property that the presence of the N-terminal linker sequence in the peptide leads to an increase in the IEP of the peptide as compared to a peptide without the N-terminal linker. These are properties of the claimed composition. As the nanoparticle rendered obvious by Freund in view of Moon in further view of Tyo is structurally identical to the present nanoparticle, it must have the same properties as the present nanoparticle, that is, the peptide without the N-terminal linker sequence has an IEP lower than 6, and the presence of the N-terminal linker sequence in the peptide leads to an increase in the IEP of the peptide as compared to a peptide without the N-terminal linker.
Claims 1-14 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013072051 to Freund (IDS filed 11/19/2025) in view of WO 2021016082 to Moon (IDS filed 11/19/2025) in further view of US20050037086 to Tyo (IDS filed 11/19/2025) in further view of EP EP2979704 A1 to Rudier (IDS filed 11/19/2025). The relevant portions of Freund, Moon, and Tyo are given above.
Freund, Moon, and Tyo fail to teach a peptide of present claim 8.
Rudier teaches a nanoparticle made of polymaleic acid-1-octadene (corresponding to applicant’s building block depicted in claim 3 when n is not zero, and further teaches SEQ ID 5, corresponding to GQQGYYPTSPQQSG of present claim 8 for delivering nucleic acids to a patient for the treatment of immune diseases (abstract; introduction; pages 3-4).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to incorporate polymaleic acid-1-octadene and the peptide of Rudier into the nanoparticle composition of Freund. The motivation for this would be to prepare a composition that can be used to deliver nucleic acids into the body for the treatment of immune diseases.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
March 9, 2026