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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 15, 2025 has been entered.
Status of Applications/Amendment/Claims
This Office action is in response to the communications filed on July 15, 2025.
Claims 1-3, 6-8, 11, 13, 15, 18, 20, 22, 58-59, 62-63, 66-67, and 72-74 are currently pending in the instant application. Claims 6, 11, 13, 15, 59, 62-63, and 66-67 are withdrawn from further consideration as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Accordingly, claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are under examination on the merits in the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Response to Arguments
Applicant's arguments filed on July 15, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims as currently amended are not obvious over the cited references of record thus the rejections under §103 should be withdrawn. In response, it is noted that the new rejections necessitated by claim amendments are set forth hereinbelow.
Applicant argues that paragraph 0103 of the specification and the Ngo declaration of record are in agreement with each other and that the examiner “has misunderstood both Ngo and Applicant’s response”. In response, it remains an indisputable fact that the Ngo declaration of record fails to support the asserted nonobviousness of the claims in their entire scope as the data submitted with the declaration pertain to “mNG-6BD” having a dendron of 6 branched oligonucleotides attached to “mNeonGreen”. See paragraph 4 of the declaration. As such, the data presented with the declaration are not commensurate in scope with the claims under examination on the merits. Furthermore, the rejections set forth hereinbelow are not established on a “spherical” oligonucleotide attachment “over the entire surface of the protein core”; rather, the obviousness of the claims is established on attaching a non-spherical oligonucleotide dendron to a protein core as set forth in the rejections below. Hence, the statements made in paragraph 5 of the Ngo declaration pertaining to the “significantly greater cellular uptake” provided by the “6BD” dendron structure attachment compared to the spherical oligonucleotide structure “over the entire surface of the protein core” is found irrelevant and unpersuasive.
Regarding the nonstatutory double patenting rejections, applicant argues that the rejections should be withdrawn. In response, it is noted that the new nonstatutory double patenting rejections necessitated by claim amendments are set forth hereinbelow.
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.
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. Applicant is 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.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected under 35 U.S.C. 103 as being unpatentable over Juliano et al. (US 2010/0280098 A1) in view of Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454; of record), and Mirkin et al. (WO 2011/028850 A1, of record).
Juliano teaches making a protein core conjugated with oligonucleotides, which are therapeutic oligonucleotides such as siRNAs and antisense oligonucleotides, wherein the oligonucleotides are conjugated to the protein surface via a “thiol derivative” or a “thiol” group and the oligonucleotides further comprise a “peptide ligand” or “a detectable tag” such as “a fluorophore.” See paragraphs 0063, 0066, 0069, 0089, 0137-0138; Figure 9A.
Juliano does not teach that the oligonucleotides have a dendron structure comprising a trebler moiety.
Hussain discloses a “branched dendrimer” structure of nine (9) EGFR mRNA-targeting antisense oligonucleotides (ODNs) that are covalently linked to a common center at their 3’ termini, wherein the dendrimer ODN is “markedly more stable to serum nucleases compared to the free ODN” and provides “improved cellular uptake” and increased “cellular association” (e.g., “approximately 100-fold greater” in A431 cells; “approximately 3-fold increase” in U87-MG cells) compared to free ODN, wherein the “nine-branched ODN-dendrimer” comprising EGFR-targeting ODNs is effective in reducing EGFR expression in cancer cells. See abstract; Figure 3; pages 145-148 and 153.
Hussain teaches that “combination therapy with conventional drugs that may be co-tethered on separate branches within the same ODN-dendrimer conjugate” can be made. See page 153. See also the dendrimer ODN structure disclosed in Figure 1B as copied below.
PNG
media_image1.png
577
636
media_image1.png
Greyscale
Hussain teaches that the above branched dendrimer structure is synthesized “using a novel phosphoramidite synthon, tris-2,2,2-(3-(4,4’-dimethoxytrityloxy) propyloxymethyl)ethyl-N,N-diisopropylaminocyanthoxy phosphororamidite as described by us previously [23,24].” See page 141. It is noted that citation 23 referred to at page 141 of Hussain is Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454; of record).
Shchepinov discloses a trebler synthon, compound 7, which was used by Hussain in Scheme 1 as copied below.
PNG
media_image2.png
149
275
media_image2.png
Greyscale
Shchepinov discloses a DNA oligonucleotide dendrimer comprising a stem oligonucleotide (“R”) that is a “15mer oligonucleotide 5’-TCTTCTTCTTCTTTT” or a 26-mer oligonucleotide “5’-GGTTTCTCTCTGACTGCATCTTGTCC” that is linked to trebler moieties of compound 7, each generating three branched DNA oligonucleotides. See page 4449 and the oligonucleotide dendrimer compounds 9, 10, and 13 in Scheme 2.
Shchepinov teaches that the stem oligonucleotide (“R”) is “tethered to a surface”, thereby orientating “the dendritic part” of the oligonucleotide dendrimer that “sticks out” away from the surface, wherein this orientation is “favourable” for target binding of DNA oligonucleotides in “the dendritic part” compared to the “unfavourable” orientation having “the dendritic part” attached toward a surface. See page 4453; Figure 4B.
Mirkin teaches making “an oligonucleotide-functionalized nanoparticle” (“ON-NPs”) comprising a plurality of oligonucleotides further comprising therapeutic agents, wherein therapeutic agents such as “antibodies” “are able to traverse a cell membrane more effectively when attached with an oligonucleotide-functionalized nanoparticle compared to when they are not attached with an oligonucleotide-functionalized nanoparticle”, wherein the therapeutic agent is covalently attached to the oligonucleotides. See paragraphs 0019, 0021, 0027, 0053, and 0123.
Mirkin discloses, “In the context of drug delivery applications, the high uptake property and high intracellular concentration of ON-NPs is extremely useful.” See paragraph 0020.
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace Juliano’s individual therapeutic oligonucleotides attached to the surface of the protein with a single dendrimer oligonucleotide structure comprising trebler moieties forming 6 or 9 oligonucleotide branches linked to a stem oligonucleotide tethered to the surface of the protein. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to enhance the cellular uptake of the protein as well as the attached individual therapeutic oligonucleotides for potential drug delivery applications, because the dendrimer oligonucleotide structure comprising oligonucleotide branches linked via trebler moieties was known to be “markedly more stable to serum nucleases compared to the free ODN” and provide “improved cellular uptake” as reported by Hussain, wherein “high uptake property and high intracellular concentration of” oligonucleotide-functionalized nanoparticle was deemed “extremely useful” in “drug delivery applications” as evidenced by Mirkin, and because the stem oligonucleotide tethered to the surface such that the oligonucleotide dendritic structure “sticks out” away from the surface was deemed as a favorable orientation as opposed to the opposite orientation as reported by Shchepinov. In addition, since attaching various agents such as a “peptide ligand”, “a detectable tag”, “conventional drugs”, and “antibodies” to oligonucleotides to be delivered to a cell was an art-recognized methodology as evidenced by the teachings of Juliano, Hussain, and Mirkin, wherein “antibodies” were known to enable the oligonucleotides to “traverse a cell membrane more effectively” as taught by Mirkin, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to attach any of the desired agents to the oligonucleotide branches of the stem oligonucleotide of the single dendrimer structure tethered to the surface of the protein.
Accordingly, claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected under 35 U.S.C. 103 as being unpatentable over Mirkin et al. (US 2017/0232109 A1, applicant’s citation) in view of Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record) and Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454, of record).
Mirkin teaches making a single protein core attached to a plurality of oligonucleotides comprising at least two oligonucleotides. See claims 1-45. See also Figure 15A illustrating the following:
PNG
media_image3.png
220
546
media_image3.png
Greyscale
Mirkin teaches that the plurality of oligonucleotides are antisense polynucleotides that are complementary to a target polynucleotide, wherein the oligonucleotides are attached to the surface of the protein core via “a thiol moiety” or “lysine residues”. See paragraph 0021-0022, 0069, and 0198.
Mirkin teaches that the plurality of oligonucleotides attached to the protein core can further comprise “an additional agent” such as “a peptide”, “a protein”, or “a contrast agent”, wherein the term “protein” includes “an antibody”. See paragraphs 0013 and 0095.
Mirkin teaches, “Proteins represent a rapidly expanding class of therapeutics,” and that “issues such as poor cellular uptake” “currently limit the therapeutic potential of proteins.” See paragraph 0004.
Mirkin teaches that the attached polynucleotides improve cellular uptake of the protein and that the protein core can be “sparsely covered with the polynucleotides.” See paragraphs 0107-0108.
Mirkin does not teach that that the plurality of the polynucleotides that sparsely cover the single protein core has a dendron structure comprising 6 or 9 oligonucleotide branches linked by a trebler moiety.
Hussain discloses a “branched dendrimer” structure of nine (9) EGFR mRNA-targeting antisense oligonucleotides (ODNs) that are covalently linked to a common center at their 3’ termini, wherein the dendrimer ODN is “markedly more stable to serum nucleases compared to the free ODN” and provides “improved cellular uptake” and increased “cellular association” (e.g., “approximately 100-fold greater” in A431 cells; “approximately 3-fold increase” in U87-MG cells) compared to free ODN, wherein the “nine-branched ODN-dendrimer” comprising EGFR-targeting ODNs is effective in reducing EGFR expression in cancer cells. See abstract; Figure 3; pages 145-148 and 153.
Hussain teaches that “combination therapy with conventional drugs that may be co-tethered on separate branches within the same ODN-dendrimer conjugate” can be made. See page 153. See also the dendrimer ODN structure disclosed in Figure 1B as copied below.
PNG
media_image1.png
577
636
media_image1.png
Greyscale
Hussain teaches that the above branched dendrimer structure is synthesized “using a novel phosphoramidite synthon, tris-2,2,2-(3-(4,4’-dimethoxytrityloxy) propyloxymethyl)ethyl-N,N-diisopropylaminocyanthoxy phosphororamidite as described by us previously [23,24].” See page 141. It is noted that citation 23 referred to at page 141 of Hussain is Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454; of record).
Shchepinov discloses a trebler synthon, compound 7, which was used by Hussain in Scheme 1 as copied below.
PNG
media_image2.png
149
275
media_image2.png
Greyscale
Shchepinov discloses a DNA oligonucleotide dendrimer comprising a stem oligonucleotide (“R”) that is a “15mer oligonucleotide 5’-TCTTCTTCTTCTTTT” or a 26-mer oligonucleotide “5’-GGTTTCTCTCTGACTGCATCTTGTCC” that is linked to trebler moieties of compound 7, each generating three branched DNA oligonucleotides. See page 4449 and the oligonucleotide dendrimer compounds 9, 10, and 13 in Scheme 2.
Shchepinov teaches that the stem oligonucleotide (“R”) is “tethered to a surface”, thereby orientating “the dendritic part” of the oligonucleotide dendrimer that “sticks out” away from the surface, wherein this orientation is “favourable” for target binding of DNA oligonucleotides in “the dendritic part” compared to the “unfavourable” orientation having “the dendritic part” attached toward a surface. See page 4453; Figure 4B.
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace Mirkin’s individual antisense oligonucleotides attached to the surface of the protein with a single dendrimer oligonucleotide structure comprising trebler moieties forming 6 or 9 oligonucleotide branches linked to a stem oligonucleotide tethered to the surface of the protein. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to enhance the cellular uptake of the protein as well as the attached individual antisense oligonucleotides for potential therapeutic applications, because the problems in using proteins as a therapeutic molecule were recognized in the relevant art to be related to the “issues such as poor cellular uptake” that “currently limit the therapeutic potential of proteins” as taught by Mirkin thus there was an art-recognized goal to improve cellular uptake of proteins, wherein Mirkin expressly suggested that the protein can be “sparsely covered with the polynucleotides” comprising “an additional agent” such as “a peptide”, “a protein” (e.g., antibody), or “a contrast agent”, and because the dendrimer oligonucleotide structure comprising 6 or 9 oligonucleotide branches linked via trebler moieties would not only “sparsely” cover the surface of the protein, but also such structure was known to be “markedly more stable to serum nucleases compared to the free ODN” and provide “improved cellular uptake” as reported by Hussain. When attaching the single dendritic structure of oligonucleotides comprising 6 or 9 branches linked by trebler moieties to the surface of Mirkin’s protein, one of ordinary skill in the art would have attached the stem oligonucleotide to the surface of the protein because the stem oligonucleotide tethered to the surface such that the oligonucleotide dendritic structure “sticks out” away from the surface was deemed as a favorable orientation as opposed to the opposite orientation as reported by Shchepinov.
Accordingly, claims 1-3, 7-8, 22, 51, 58, and 72-73 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected under 35 U.S.C. 103 as being unpatentable over Brodin et al. (JACS, 2015, 137:14838-14841, of record) in view of Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454; of record), and Mirkin et al. (WO 2011/028850 A1, of record).
Brodin discloses a spherical nucleic acid (SNA) composition comprising “a dense shell of oligonucleotides” that are “conjugated to the surface of a protein” of the “protein core”, which “should allow for the attachment of several distinct functionalities such as imaging agents, targeting moieties, and functional oligonucleotides.” See Figure 1A; pages 1 and 4 of the author manuscript copy submitted by applicant.
Brodin teaches that the DNA oligonucleotides are attached to the surface of the protein core via a linkage between “lysine amines” reacted with “azide” groups. See page 2 of the author manuscript copy submitted by applicant.
Brodin teaches that the protein core whose surface is conjugated to oligonucleotides (“ProSNA b-gal”) “showed an ~20-280-fold increase in cellular uptake” compared to the protein core without the oligonucleotides, thereby providing “enhanced cellular uptake” for “cell membrane-impermeable proteins” “at low concentrations” into multiple mammalian cells. See pages 3-4 of the author manuscript copy submitted by applicant.
Brodin does not teach that the oligonucleotides attached to the protein core have a dendron structure claimed in the instant case.
Hussain discloses a “branched dendrimer” structure of nine (9) EGFR mRNA-targeting antisense oligonucleotides (ODNs) that are covalently linked to a common center at their 3’ termini, wherein the dendrimer ODN is “markedly more stable to serum nucleases compared to the free ODN” and provides “improved cellular uptake” and increased “cellular association” (e.g., “approximately 100-fold greater” in A431 cells; “approximately 3-fold increase” in U87-MG cells) compared to free ODN, wherein the “nine-branched ODN-dendrimer” comprising EGFR-targeting ODNs is effective in reducing EGFR expression in cancer cells. See abstract; Figure 3; pages 145-148 and 153.
Hussain teaches that “combination therapy with conventional drugs that may be co-tethered on separate branches within the same ODN-dendrimer conjugate” can be made. See page 153. See also the dendrimer ODN structure disclosed in Figure 1B as copied below.
PNG
media_image1.png
577
636
media_image1.png
Greyscale
Hussain teaches that the above branched dendrimer structure is synthesized “using a novel phosphoramidite synthon, tris-2,2,2-(3-(4,4’-dimethoxytrityloxy) propyloxymethyl)ethyl-N,N-diisopropylaminocyanthoxy phosphororamidite as described by us previously [23,24].” See page 141. It is noted that citation 23 referred to at page 141 of Hussain is Shchepinov et al. (Nucleic Acids Research, 1997, 25:4447-4454; of record).
Shchepinov discloses a trebler synthon, compound 7, which was used by Hussain in Scheme 1 as copied below.
PNG
media_image2.png
149
275
media_image2.png
Greyscale
Shchepinov discloses a DNA oligonucleotide dendrimer comprising a stem oligonucleotide (“R”) that is a “15mer oligonucleotide 5’-TCTTCTTCTTCTTTT” or a 26-mer oligonucleotide “5’-GGTTTCTCTCTGACTGCATCTTGTCC” that is linked to trebler moieties of compound 7, each generating three branched DNA oligonucleotides. See page 4449 and the oligonucleotide dendrimer compounds 9, 10, and 13 in Scheme 2.
Shchepinov teaches that the stem oligonucleotide (“R”) is “tethered to a surface”, thereby orientating “the dendritic part” of the oligonucleotide dendrimer that “sticks out” away from the surface, wherein this orientation is “favourable” for target binding of DNA oligonucleotides in “the dendritic part” compared to the “unfavourable” orientation having “the dendritic part” attached toward a surface. See page 4453; Figure 4B.
Mirkin teaches making “an oligonucleotide-functionalized nanoparticle” (“ON-NPs”) comprising a plurality of oligonucleotides further comprising therapeutic agents, wherein therapeutic agents such as “antibodies” “are able to traverse a cell membrane more effectively when attached with an oligonucleotide-functionalized nanoparticle compared to when they are not attached with an oligonucleotide-functionalized nanoparticle”, wherein the therapeutic agent is covalently attached to the oligonucleotides. See paragraphs 0019, 0021, 0027, 0053, and 0123.
Mirkin discloses, “In the context of drug delivery applications, the high uptake property and high intracellular concentration of ON-NPs is extremely useful.” See paragraph 0020.
It would have been obvious to one of ordinary skill in the art before the effective filing date to replace Brodin’s “dense shell of oligonucleotides” with a single dendrimer oligonucleotide structure comprising trebler moieties forming 6 or 9 oligonucleotide branches linked to a stem oligonucleotide that is tethered to the surface of Brodin’s protein. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make a functionally equivalent, alternative structure to Brodin’s structure because both Brodin’s “dense shell of oligonucleotides” and Hussain’s “branched dendrimer” comprising nine oligonucleotides linked via trebler moieties were known to have a functionality in improving cellular uptake, wherein the use of trelber moieties would have been deemed useful for making a dendrimer comprising six oligonucleotide branches. In addition, since oligonucleotides further comprising “antibodies” were known to “traverse a cell membrane more effectively” as taught by Mirkin, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to attach antibodies to the oligonucleotide branches of the stem oligonucleotide of the single dendrimer structure tethered to the surface of the protein.
In view of the foregoing, claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 taken as a whole would have been prima facie obvious before the effective filing date.
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 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 22-24 of U.S. Patent No. 9,139,827 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘827 patent claims drawn to and require a nanoparticle composition comprising RNA or DNA oligonucleotides attached via a thiol linkage to the surface of the nanoparticle, wherein the oligonucleotides reulst in “degradation of the target polynucleotide.” It is noted that the “nanoparticle” as broadly claimed in the ‘827 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the multiple oligonucleotides, thereby arriving at the claimed structure in order to improve the cellular uptake of the nanoparticle of the ‘827 patent claims, because improving protein cellular uptake was an art-recognized goal as evidenced by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘827 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14-17 of U.S. Patent No. 10,391,116 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘116 patent claims drawn to and require a nanoparticle composition comprising RNA or DNA oligonucleotides attached via a thiol linkage to the surface of the nanoparticle, wherein the oligonucleotides are complementary to a target. It is noted that the “nanoparticle” as broadly claimed in the ‘116 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the multiple oligonucleotides, thereby arriving at the claimed structure in order to improve the cellular uptake of the nanoparticle of the ‘116 patent claims, because improving protein cellular uptake was an art-recognized goal as evidenced by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘116 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,213,593 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘593 patent claims drawn to and require a nanoparticle functionalized with RNA or DNA oligonucleotides that bind to a target. It is noted that the “nanoparticle” as broadly claimed in the ‘593 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the multiple oligonucleotides, thereby arriving at the claimed structure in order to improve the cellular uptake of the nanoparticle of the ‘593 patent claims, because improving protein cellular uptake was an art-recognized goal as evidenced by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘593 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,633,503 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ’503 patent claims that require a nanoparticle composition comprising a nanoparticle of “about 5 nanometers (nm) to about 50 nm in mean diameter” attached to “two or more polynucleotides” that are “spherical”, wherein the polynucleotides bind to a target. It is noted that the “nanoparticle” as broadly claimed in the ‘503 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “spherical” oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘503 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,264,344 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘344 patent claims that require a nanoparticle composition comprising “a single protein” core attached to a “shell” comprising a “plurality of polynucleotides” that are antisense oligonucleotides, which are further conjugated to a small molecule. It would have been obvious to design the “shell” of a “plurality of polynucleotides” attached to the single protein in the ‘344 patent claims as a dendron structure having at least 6 or 9 polynucleotide branches linked by a trebler moiety because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘344 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-20 of U.S. Patent No. 12,319,711 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ’711 patent claims drawn to a nanoparticle comprising “one or more oligonucleotides attached to the surface of the nanoparticle core”, wherein the oligonucleotides are “spherical”. It is noted that the “nanoparticle” as broadly claimed in the ‘711 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “spherical” oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘711 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6-15 of U.S. Patent No. 12,378,280 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ’280 patent claims drawn to and require a nanoparticle functionalized with “spherical” oligonucleotides. It is noted that the “nanoparticle” as broadly claimed in the ‘280 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “spherical” oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘280 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,378,560 B2 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ’560 patent claims drawn to and require a nanoparticle core whose surface is attached with a shell of oligonucleotides, wherein the nanoparticle core is “a protein core”. Further, the “nanoparticle” as broadly claimed in the ‘560 patent claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘560 patent claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-16, 21-22, 28-29, 31, 34, 36-37, 50, 53, and 56-62 of copending Application No. 16/611,548 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of nanoparticle having “a diameter of 50 nanometers or less” attached to multiple oligonucleotides claimed in the ‘548 application. As such, the “nanoparticle” as broadly claimed in the ‘548 claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the multiple oligonucleotides, thereby arriving at the claimed structure in order to improve the cellular uptake of the nanoparticle of the ‘548 claims, because improving protein cellular uptake was an art-recognized goal as evidenced by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘269 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 18, 21, 31-34, 41, 44-45, 49-50, 53, 57, 59, 61, and 68 of copending Application No. 17/684,269 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of the composition claimed in the ‘269 application drawn to and require a nanoparticle core whose surface is attached to a shell of oligonucleotides. It is noted that the “nanoparticle” as broadly claimed in the ‘269 claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘269 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 9-14, 18, 25, 28-29, 42, 44, and 46-48 of copending Application No. 17/749,977 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of the composition of the ‘977 claims comprising a nanoparticle core whose surface is attached to a shell of oligonucleotides. It is noted that the “nanoparticle” as broadly claimed in the ‘977 claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘977 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-22, 25, and 36 of copending Application No. 17/814,211 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are an obvious variation of the composition of the ‘211 claims comprising a nanoparticle core whose surface is attached to oligonucleotides. It is noted that the “nanoparticle” as broadly claimed in the ‘211 claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to conjugate oligonucleotides that “sparsely” cover the surface of the protein in nanosize for providing improved cellular uptake of the protein was an art-recognized goal/solution as evidenced by Mirkin, wherein one of ordinary skill in the art would have been particularly motivated to use a dendrimer structure comprising trebler moieties known in the art as evidenced by Hussain and Shchepinov, because such structure was known to improve cellular uptake thus would have been deemed as a suitable structure to be attached to the protein nanoparticle.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18/225,400 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘400 claims drawn to an oligonucleotide dendron comprising 6 or 9 oligonucleotide branches. It would have been obvious to attach the oligonucleotide dendron of the ‘400 claims to the surface of a protein in nanosize because conjugating oligonucleotides that “sparsely” cover the surface of the protein in nanosize for providing improved cellular uptake of the protein was an art-recognized goal/solution as evidenced by Mirkin.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 14, 30-31, 47, 49-50, 55-56, 58, 60, 62, 64-65, and 83-85 of copending Application No. 18/279,034 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘034 claims drawn to a protein core attached to a shell of oligonucleotides. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘034 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 28-30, 40, 51, 67, 69, 71-72, 74, 77, 79, 83, 85-86, and 94 of copending Application No. 18/283,699 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘699 claims drawn to a nanoparticle core whose surface is attached to a shell of oligonucleotides. It is noted that the “nanoparticle” as broadly claimed in the ‘699 claims reads on a protein that is in nanosize such as Mirkin’s protein that is 9 nm in diameter. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘699 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7-8, 18, 21-24, 30, 32, 43, and 47 of copending Application No. 18/784,244 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘244 claims drawn to a protein core attached to a shell of up to about 20 oligonucleotides that are immunostimulatory or non-immunostimulatory. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘244 claims in the manner claimed in the instant case.
Claims 1-3, 7-8, 18, 20, 22, 58, and 72-74 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-8, 13, 15, 17-19, 24, 27, 30, 33, 36, and 41-46 of copending Application No. 18/949,786 in view of Mirkin et al. (US 2017/0232109 A1, applicant’s citation), Hussain et al. (Journal of Controlled Release, 2004, 99:139-155, of record), and Shchepinov et al. (Nucleic Acids Research, 1999, 27:3035-3041, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘786 claims drawn to and require a protein core whose surface is attached to a shell of up to about 10 oligonucleotides that are immunostimulatory or non-immunostimulatory. It would have been obvious to utilize the art-recognized “branched dendrimer” structure in place of the “shell” of oligonucleotides, thereby arriving at the claimed structure because both structures were recognized to improve cellular uptake of a protein as taught by Mirkin, who also taught making a protein that is “sparsely covered with the polynucleotides”, wherein the branched dendrimer structure that would sparsely cover the surface of the protein was known to improve cellular uptake as taught by Hussain, wherein the stem-oligonucleotide branch structure linked by treblers having the stem tethered to the surface was deemed favorable as taught by Shchepinov. Further, the branched dendrimer formed by antisense oligonucleotides was also known in the art as evidenced by Hussain, As such, the skills necessary to obtain the instantly claimed structure were within the technical grasp and within the prior knowledge/guidance available in the prior art, thereby providing a reasonable expectation of success for one of ordinary skill in the art to modify the ‘786 claims in the manner claimed in the instant case.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANA H SHIN/Primary Examiner, Art Unit 1635