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
The preliminary amendment filed 10/11/23 is acknowledged. Claims 4, 5, 6, 9, 10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 are amended. Claims 6, 7, 11, 14, 17, 19-21, 23, 24, 27, 28, and 30 are cancelled. Claims 1-5, 8-10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 are pending and under examination.
Claim Objections
Claims 29 and 31 are objected to because of the following informalities: Claims 29 and 31 recite administering “the nanoparticle of any of the nanoparticle of claim 1” and a kit comprising “the nanoparticle of any one of claim 1,” respectively. This language contains grammatically inconsistent plurality. Suggested claim language is “the nanoparticle of claim 1.” Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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.
Claim 8 is 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.
Claim 8 recites “wherein the peptide that targets or recognizes and binds S100A9 comprises any one or more of SEQ ID NO: 1 and/or 2 or 1, 2 or 10 to 15 or a peptide having at least 70% sequence identity thereto.” It is not clear which sequences or combination of sequences is encompassed by the claim. To advance compact prosecution, the examiner is interpreting claim 8 as “wherein the peptide that targets or recognizes and binds S100A9 comprises any one or more of SEQ ID NOs: 1, 2, and 10-15.” Appropriate correction is required.
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 9, 10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a peptide that targets or recognizes and binds S100A9,” which encompasses a genus of peptides. The specification, however, fails to adequately describe the species of peptides that are encompassed by the claim. There is no evidence in the specification to support that the inventors had possession of the genus contemplated. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species, by actual reduction to practice, reduction to drawings, by disclosure of relevant identifying characteristics, (i.e., structure or other physical and/or chemical properties), by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics sufficient to show the applicant was in possession of the claimed genus [See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163]. The specification describes 8 species that fall within the genus claimed, enumerated in SEQ ID NOs: 1, 2, and 10-15. However, the claims are not limited to those species but also includes all peptides comprising varying lengths and amino acid structures. There is not even an identification of any particular portion of a structure that must be conserved for said activity and does not require that the genus of the claims possess any particular distinguishing feature that is characteristic of the genus as a whole. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of the genus as a whole, or representative number of species within the genus, the specification does not provide adequate written description of the claimed genus. Claims 2-5, 8, 9, 10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 require the composition of claim 1 but do not materially limit the genus of agents, and are thus also included in the rejection.
Similarly, claim 1 is further rejected because it recites “a virus or virus like particle (VLP)” while the specification only describes plant virus and plant VLP embodiments. The specification does not describe a representative number of species or common structural features sufficient to demonstrate possession of the broader genus of viruses and VLPs. Claims 4, 5, 8, 9, 10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 require the composition of claim 1 but do not materially limit the genus of agents, and are thus also included in the rejection.
Regarding claim 8, the claim recites several SEQ ID NOs that would provide sufficient limitation to claim 1, but further includes “a peptide having at least 70% sequence identity thereto.” The specification fails to adequately describe the species of peptides that are encompassed by the claim and there is no evidence in the specification to support that the inventors had possession of the genus contemplated. In absence of teachings establishing relevant identifying characteristics, functional characteristics coupled with a known or disclosed correlation between function and structure, or a combination of such identifying characteristics sufficient to show the applicant was in possession of the claimed genus relationship, one would not reasonably expect that modifications comprising up to 30% would preserve binding affinity or specificity for S100A9, particularly given that binding interactions are highly dependent on precise residue identity, spatial conformation, and charge distribution.
Claim 9 recites a polynucleotide encoding the nanoparticle of claim 1. The specification, however, describes that the nanoparticle is attached using chemical conjugation techniques. While the specification generally references recombinant viral coat proteins, it does not identify or describe a polynucleotide sequence encoding the claimed nanoparticle, nor does it describe a genetically encoded construct comprising both the virus or VLP and the binding peptide. Additionally, claim 9 encompasses polynucleotides that express virus or VLPs that may contain structural components not directly encoded by a polynucleotide, such as a lipid envelope, that depend on host-derived components. Accordingly, the specification fails to reasonably demonstrate that applicant was in possession of the claimed polynucleotide.
Therefore, the claims 1-5, 8, 9, 10, 12, 13, 15, 16, 18, 22, 25, 26, 29, and 31 are rejected under 35 U.S.C. 112(a) for lack of written description.
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 9 recites a polynucleotide encoding the nanoparticle of claim 1. This is interpreted as a single polynucleotide that encodes all components of the nanoparticle of claim 1. Lampinen et al. teaches that, in regards to VLP-antigen genetic conjugations, VLP assembly and surface display of peptides are highly sensitive to structural and steric constraints, and that insertion of peptides can disrupt particle or epitope assembly [see p. 2, col. 1, par. 1, lines 11-13]. Lampinen et al. specifically teaches that the process of determining functional embodiments requires “laborious and time-intensive planning and optimization individually for each antigen,” and instead supports protein conjugation [see p. 2, col. 1, par. 1, lines 13-19]. Accordingly, successful construction of operable embodiments across the full scope of the claimed polynucleotides would not be predictable or have an expectation of success, and instead requires extensive screening and an undue experimental burden.
Claim 9 is further rejected because it encompasses polynucleotides that express virus or VLPs that may contain structural components not directly encoded by a polynucleotide, such as a lipid envelope, that depend on host-derived components. Accordingly, even if the polynucleotide could encode the viral structural components, the specification does not provide guidance sufficient to enable production of all virus or VLP embodiments by a polynucleotide as encompassed by the claim. Claim 10 requires the polynucleotide of claim 9 and is therefore included in this rejection.
Therefore, claims 9 and 10 are rejected under 35 U.S.C. 112(a) for lack of enablement.
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.
Claims 1-5, 8, 12, and 13 are rejected under 35 U.S.C. 102a1 as being anticipated by Steinmetz et al., US Patent 10385321 (herein Steinmetz ‘321).
Claims 1-5, 8, 12, and 13 are drawn to a nanoparticle.
Steinmetz ‘321 discloses peptides for targeting MRP-14, which is an alternative name for S100A9. Steinmetz ‘321 also discloses a composition comprising the MRP-14 targeting peptide and a nanocarrier comprising a plant virus particle (see claims 1 and 4) [instant claim 1]. The plant-based virus particle, also known in the art as nanoparticles, may be cowpea mosaic virus (CPMV) or cowpea chlorotic mottle virus [see col. 12, lines 53-58] (instant claim 3), which are of the Comovirus and Bromovirus genera respectively [instant claim 2]. Cowpea mosaic virus particles in their naturally occurring state have exposed lysine side chains [as evidenced by Love et al., p. 134, col. 1, par. 2, lines 16-17] (instant claim 4). The peptide may comprise a chemical linker such as N-hydroxysuccinimidyl (NHS)) linkers [see col. 14, lines 25-36] (instant claim 5). Steinmetz ‘321 discloses peptides targeting MRP-14 that comprise a sequence selected from SEQ ID NOs: 12-17, which correspond to instant SEQ ID NOs: 10-15 [see col. 24, Table 2], and specifically discloses a composition comprising a tobacco mosaic virus (TMV) nanoparticle and the peptide identified as MTP6 (TMV-MTP6), said peptide consisting of SEQ ID NO: 15 [see col. 25, lines 27-30] (instant claim 8). Steinmetz ‘321 administers a plurality of TMV-MTP6 particles to mice intravenously [see col. 26, lines 22-35] (instant claim 12) and describes several solutions suitable as intravenous “vehicles,” which is defined in the art as synonymous with acceptable “carrier,” that can be administered alongside the invention [see col. 15, lines 28-52] (instant claim 13).
Therefore, claims 1-5, 8, 12, and 13 are rejected under 35 U.S.C. 102a1.
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 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.
Claims 1, 15, 16, 18, 22, 25, 26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al., US Patent 10385321 (herein Steinmetz ‘321) in view of US Patent 11590183, and in further view of Grushchak et al.
Claim 1 is drawn to a nanoparticle and claims 15, 16, 18, 22, 25, 26, and 29 are drawn to methods of use.
The disclosure of Steinmetz ‘321 is discussed above.
Steinmetz ‘321 does not teach or suggest a method of treating cancer.
11590183 (herein ‘183) teaches that empty CPMV particles (eCPMV), which are CPMV particles devoid of RNA, are inherently immunostimulatory and induce anti-tumor immune responses [see col. 15, lines 28-34; see col. 17, lines 59-63] (instant claim 15). To reach this conclusion, ‘183 uses the B16F10 tumor model, which is a widely used metastatic melanoma model derived from murine melanoma cells that are implanted in immunocompetent C57BL/6 mice. Of note, melanoma is characterized by increased S100A9 expression [see Grushchak et al., abstract, par. 1] (instant claim 25) and S100A9 is used clinically to highlight metastasis [see Grushchak et al., introduction, par. 1, lines 5-6]. ‘183 discloses administration of either CPMV or potato virus x (PVX) particles into these mice, and finds that tumor growth rate significantly slows and survival times are extended [see col. 23, lines 6-12] (instant claims 18 and 22). ‘183 teaches that CPMV administration alters the immune cell profile [see col. 15, lines 65-67 through col. 16, lines 19] (instant claim 29) and tumor microenvironment in the lungs, where it binds to cancer cells at their vimentin surface [see col. 18, lines 15-67] (instant claim 16), emphasizing the activation of neutrophils but generally noting an overall reprogramming of tumor associated immune and cell populations towards a pro inflammatory and anti-tumor state (instant claim 18). ‘183 teaches that chemo-immuno combination treatment can be beneficial, and specifically discloses administration of the antitumor drug doxorubicin (DOX) in combination with PVX particles [see col. 22, lines 1-9] (instant claim 26). The particles may comprise a linker [see col. 10, lines 56-58].
It would have been obvious to combine these teachings and administer the S100A9-CPMV nanoparticle composition of Steinmetz ‘321 to induce an immune response (instant claim 15), alter immune cell profile (instant claim 29), or for the treatment of cancer (instant claim 18), as the art teaches that CPMV and similar plant virus nanoparticles are effective therapeutic agents that are capable of contacting cancer cells, modulating tumor associated immune suppression, and inducing anti-tumor immunity in multiple cancer models by altering the tumor microenvironment. Furthermore, melanoma was known as a cancer that exhibits elevated S100A9. One would have been motivated to combine these teachings as the use of a known targeting ligand to direct a known immunotherapeutic nanoparticle platform to a known disease-associated marker would have been expected to facilitate localization of the nanoparticles to the tumor microenvironment while maintaining the immunostimulatory properties described in ‘183. Accordingly, the combination would have been expected to provide a useful anti-cancer therapeutic effect with a reasonable expectation of success. Similarly, it would have been obvious to combine the administration of the nanoparticle of Steinmetz ‘321 with an additional cancer therapy as disclosed by ‘183 above as 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. There would be an expectation of success as ‘183 teaches the conjugation of antitumor drugs to VLPs, and further still, instant claim 26 broadly encompasses any treatment including systemic chemotherapy that does not require drug conjugation.
Therefore, claims 1, 15, 16, 18, 22, 25, 26, and 29 are rejected under 35 U.S.C. 103.
Claims 1 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al., US Patent 10385321 (herein Steinmetz ‘321).
Claim 1 is drawn to a nanoparticle and claim 31 is drawn to a kit comprising a nanoparticle.
The disclosure of Steinmetz ‘321 is discussed above.
Steinmetz ‘321 does not teach or suggest the composition as part of a kit.
However, assembling the composition into a kit with instructions would be obvious and it constitutes a routine and predictable step for pharmaceutical products to facilitate distribution and ensure proper administration (instant claim 31).
Therefore, claims 1 and 31 are rejected under 35 U.S.C. 103.
Nonstatutory 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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10385321. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a nanoparticle comprising CPMV and an S100A9 peptide.
10385321 discloses peptides for targeting MRP-14, which is an alternative name for S100A9. 10385321 also discloses a composition comprising the MRP-14 targeting peptide and a nanocarrier, said nanocarrier further comprising a plant virus particle, which is known in the art as a nanoparticle [see claims 1, 3, and 4] (instant claim 1).
Therefore, claim 1 is rejected on the ground of nonstatutory double patenting.
Claims 1-4, 12, 13, 15, 16, 18, 22, 25, 26, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10385321 in view of US Patent 11590183, and in further view of Grushchak et al. and Love et al. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a nanoparticle comprising CPMV and an S100A9 peptide.
10385321 discloses peptides for targeting MRP-14, which is an alternative name for S100A9. 10385321 also discloses a composition comprising the MRP-14 targeting peptide and a nanocarrier, said nanocarrier further comprising a plant virus particle, which is known in the art as a nanoparticle [see claims 1, 3, and 4] (instant claim 1).
10385321 does not teach or suggest that the VLP is CPMV nor does it teach or suggest a method of treating a cancer such as melanoma, inducing an immune response, or altering an immune cell profile.
11590183 teaches that empty CPMV particles (eCPMV), which are CPMV particles devoid of RNA, are inherently immunostimulatory and induce anti-tumor immune responses [see col. 15, lines 28-34; see col. 17, lines 59-63] (instant claims 3 and 15). Of note, Cowpea mosaic virus particles are of the Comovirus genus (instant claim 2) and in their naturally occurring state have exposed lysine side chains [as evidenced by Love et al., p. 134, col. 1, par. 2, lines 16-17] (instant claim 4). To test the antitumor effects of eCPMV, 11590183 uses the B16F10 tumor model, which is a widely used metastatic melanoma model derived from murine melanoma cells that are implanted in immunocompetent C57BL/6 mice. Of note, melanoma is characterized by increased S100A9 expression [see Grushchak et al., abstract, par. 1] (instant claim 25) and S100A9 is used clinically to highlight metastasis [see Grushchak et al., introduction, par. 1, lines 5-6]. 11590183 discloses administration of a plurality (instant claim 12) of either CPMV or potato virus x (PVX) particles into these mice, and finds that tumor growth rate significantly slows and survival times are extended [see col. 23, lines 6-12] (instant claims 18 and 22). 11590183 teaches that CPMV administration alters the immune cell profile [see col. 15, lines 65-67 through col. 16, lines 19] (instant claim 29) and tumor microenvironment in the lungs, where it binds to cancer cells at their vimentin surface [see col. 18, lines 15-67] (instant claim 16), emphasizing the activation of neutrophils but generally noting an overall reprogramming of tumor associated immune and cell populations towards a pro inflammatory and anti-tumor state (instant claim 18). 11590183 teaches that chemo-immuno combination treatment can be beneficial, and specifically discloses administration of the antitumor drug doxorubicin (DOX) in combination with PVX particles [see col. 22, lines 1-9] (instant claim 26). The particles may comprise a linker [see col. 10, lines 56-58].
It would have been obvious to combine these teachings and both create and administer a plurality (instant claim 12) of S100A9-CPMV nanoparticle compositions (instant claims 2-4) to induce an immune response (instant claim 15), alter immune cell profile (instant claim 29), or for the treatment of cancer (instant claim 18), particularly melanoma, as the art teaches that CPMV and similar plant virus nanoparticles are effective therapeutic agents that are capable of contacting cancer cells, modulating tumor associated immune suppression, and inducing anti-tumor immunity in multiple cancer models by altering the tumor microenvironment. Furthermore, melanoma was known as a cancer that exhibits elevated S100A9. It would have been obvious to include the composition in a suitable carrier as this would be required for proper administration (instant claim 13). One would have been motivated to combine these teachings as the use of a known targeting ligand to direct a known immunotherapeutic nanoparticle platform to a known disease-associated marker would have been expected to facilitate localization of the nanoparticles to the tumor microenvironment while maintaining the immunostimulatory properties described in 11590183. Accordingly, the combination would have been expected to provide a useful anti-cancer therapeutic effect with a reasonable expectation of success. Similarly, it would have been obvious to combine the administration of the nanoparticle of 10385321 with an additional cancer therapy as disclosed by 11590183 above as 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. There would be an expectation of success as 11590183 teaches the conjugation of antitumor drugs to VLPs, and further still, instant claim 26 broadly encompasses any treatment including systemic chemotherapy that does not require drug conjugation.
Therefore, claims 1-4, 12, 13, 15, 16, 18, 22, 25, 26, and 29 are rejected on the ground of nonstatutory double patenting.
Claims 1 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10385321. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a nanoparticle comprising CPMV and an S100A9 peptide.
10385321 discloses peptides for targeting MRP-14, which is an alternative name for S100A9. 10385321 also discloses a composition comprising the MRP-14 targeting peptide and a nanocarrier, said nanocarrier further comprising a plant virus particle, which is known in the art as a nanoparticle [see claims 1, 3, and 4] (instant claim 1).
10385321 does not teach or suggest the composition as part of a kit.
However, assembling the composition into a kit with instructions would be obvious and it constitutes a routine and predictable step for pharmaceutical products to facilitate distribution and ensure proper administration (instant claim 31).
Therefore, claim 31 is rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tirone D Johnson whose telephone number is (571)272-1256. The examiner can normally be reached M-F, 9-5 ET.
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/TIRONE D. JOHNSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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