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 .
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.
Election/Restrictions
Applicant’s election without traverse of a particle with a positive zeta potential of at least +15 mV in the reply filed on 31 October 2025 is acknowledged.
Claims 7 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 October 2025. The reason that these claims are withdrawn is because the particles recited by these claims comprise carboxyl/carboxylate groups. Said carboxyl/carboxylate groups are deprotonated at neutral pH and thereby have a negative charge, resulting in a negative zeta potential rather than a positive zeta potential.
Regarding claim 10, the examiner clarifies that claim 10 is drawn to a particle with a negative zeta potential. To explain this, the examiner has reproduced part of claim 10 below and annotated it.
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As such, the structure of claim 10 would appear to have two negative charges for every positive charge. This would have resulted in a negative zeta potential, rendering claim 10 drawn to the non-elected species of a particle having a zeta potential of -15 mV or more negative.
Note Regarding Acronyms and Abbreviations
Instant claim 12 recites RNA and DNA; these are well-known acronyms referring to ribonucleic acid and deoxyribonucleic acid. Instant claim 14 recites “STING” on the second to last line of the claim. This acronym refers to “stimulator of interfering genes” and is a well-known acronym in the art area of immunology. All other acronyms and abbreviations appear to have been defined in the claims. Therefore, these acronyms and abbreviations do not render the instant claims indefinite.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-6, 8-9, and 11-17 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.
Claim 1 appears to recite conflicting limitations regarding whether pharmaceutically acceptable compounds are required to be present. In support of this position, the examiner has reproduced claim 1 below with arrows pointing to the conflicting limitations.
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As such, in view of the above-indicated conflicting claim limitations, it is unclear whether the claimed composition requires the presence of pharmaceutically acceptable compounds.
For the purposes of examination under prior art, the examiner will proceed in examining claim 1 with the understanding that pharmaceutically acceptable compounds are optional. However, the examiner will examine claims 11-15 with the understanding that the pharmaceutically acceptable compounds are present. With that being said, the examiner takes the position that the functional groups providing the required positive charge may themselves be understood to be pharmaceutically acceptable because such positively charged groups are known to have antimicrobial properties.
Claims 8-9 and 17 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.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d), also MPEP 2173.05(c).
In claim 8, applicant recites the broad limitation “amino-group” and the narrower limitation “(-NH2 or -NH3+).” It is unclear if the claim is drawn to only the exemplified structure of -NH2 or -NH3+ or to the full scope of amines, which would include structures like -N(CH3)2. As such, it is unclear if amines such as -N(CH3)2 are within the claim scope. A similar rationale applies to the guanidino functional group also recited by claims 9 and 17.
For the purposes of examination under prior art, the examiner understands the full scope of all amines and guanidines to be within the claim scope.
Claim 12 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.
Regarding claim 12, the claim recites the limitation of oligonucleotides, followed by “(RNA, DNA, single stranded, or double stranded)” in parentheses. It is unclear if oligonucleotides that are neither RNA or DNA (e.g. peptide nucleic acid) are within the claim scope. It is also unclear if RNA or DNAs that are too long to be considered oligonucleotides are within the claim scope.
For the purposes of examination under prior art, the examiner understands all types of oligonucleotides, as well as all DNAs and all RNAs to be within the claim scope.
Claim 14 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 14 recites the limitation “STING Ligands (Cyclic Dinucleotides (CDNs)).” As an initial matter, the examiner takes the position that the acronym “STING” is a well-known acronym referring to stimulator of interferon genes. However, it is unclear if claim 14 is drawn to all STING ligands or only to cyclic dinucleotides.
For the purposes of examination under prior art, the examiner will examine claim 14 as if it is drawn to all STING ligand and all cyclic dinucleotides, regardless of whether or not they have been identified as STING ligands.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al. (Colloid Journal, Vol. 75, No. 3, 2013, pages 311-318).
Lu et al. (hereafter referred to as Lu) is drawn to amino functionalized silica nanoparticles, as of Lu, page 311, title and abstract and page 312, figure 2, reproduced below.
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Particles appear to be sized at 40 nm in one embodiment, as of Lu, page 313, right column, Table 1, reproduced below.
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As such, Lu teaches all of the requirements of claim 17.
The examiner has not rejected claim 1 for at least the following reasons. As best understood by the examiner, the final product of Lu appears to be in the form of a solid; for example, the products in figures 3 and 4 of Lu appear to be in the form of a solid. Under these conditions, the skilled artisan would have expected the amine groups to have been in their neutral R-NH2 form rather than in their protonated R-NH3+ form, thereby resulting in a particle with a zeta potential near zero rather than greater than +15 mV. The reason that the skilled artisan would have expected the amine groups to have been neutral in the solid state is because in the solid state, the positive charges would not have been stabilized by hydrogen bonding with water because there is no water present in the solid state.
Claim Rejections - 35 USC § 103 – Obviousness
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.
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.
Claim(s) 1-2, 4-6, 8-9, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farah et al. (Polymers Advanced Technologies, Vol. 25, 2014, pages 689-692) in view of Domb et al. (US 2008/0226728 A1).
Farah et al. (hereafter referred to as Farah) is drawn to antimicrobial silica particles comprising quaternary ammonium polyethyleneimine, as of Farah, page 689, title and abstract, as well as page 690, Scheme 1, reproduced below.
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As to claim 1, the claim requires that the particles have silicon dioxide and functional groups at the surface. The above-reproduced paragraphs from Farah have silica and amine functional groups at the surface of the silica. The examiner notes that the term “silica”, as used in Farah, is understood to have the same meaning as the claimed term “silicon dioxide.”
As to claim 1, the claim requires a zeta potential of at least ±15 mV. In view of the species election, the examiner is examining the species of a zeta potential of +15 mV or more positive. Farah teaches this as of at least page 691, Table 1, reproduced below with annotation by the examiner.
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Farah differs from the claimed invention because the particles of Farah have a larger size as compared with the claimed particles.
Domb et al. (hereafter referred to as Domb) is drawn to particles comprising anti-microbially active quaternary ammonium groups, as of Domb, title and abstract, and various figures reproduced below.
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The particles of Domb are preferably sized between about 30 nm and about 150 nm, as of Domb, paragraphs 0021 and 0032. Domb teaches multiple embodiments with zeta potentials over +20 mV, as of Domb, page 11, Table 2, reproduced in part below.
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Domb is not anticipatory because Domb, although teaching silica at various locations such as paragraph 0206, does not appear to teach an embodiment comprising silica, the required zeta potential, and the required size together in the same embodiment.
It would have been prima facie obvious for one of ordinary skill in the art to have sized the particles of Farah in the size range taught by Domb. The particles of Farah are taught for antimicrobial purposes, as of Farah, page 689, title. The particles of Domb are also used for antimicrobial purposes, as of Domb, title. As such, the skilled artisan would have been motivated to have modified the sizes of the particles taught by Farah to have been in the size range taught by Domb in order to have predictably achieved an antimicrobial effect with a reasonable expectation of success.
As to claim 2, Domb teaches a surface density of at least one anti-microbially active group per square nanometer, as of paragraph 0013 of Domb. This appears to be higher than the maximum density of 0.5 groups per square nanometer. Nevertheless, the skilled artisan would have been motivated to have optimized the number of anti-microbially active groups in order to have predictably modulated the anti-microbial effect, which would have increased with more anti-microbial groups, against the cost and/or toxicity, which would also have been expected to have increased with more anti-microbial groups. Where the general conditions of a claim are disclosed in the prior art (e.g. a silica particle with antimicrobial cationic groups attached thereto with a particular surface density of cationic groups), it is not inventive to discover the optimum or workable ranges (e.g. of the surface density of cationic groups) by routine experimentation. See MPEP 2144.05(II)(A).
As to claim 4, both Farah and Domb teach embodiments with a zeta potential of more than +30 mV, as of Farah, page 691, Table 1 and Domb, Table 2.
As to claim 5, the skilled artisan would have understood that the net charges of the particles of Farah and/or Domb had a charge different from zero due to their high zeta potentials, indicating a strongly positive charge that is not zero.
As to claim 6, Farah appears to teach a covalent bond connecting the functional groups to the surface of the silica, as of Farah, scheme 1, reproduced above.
As to claim 8, Farah teaches amino groups at the particle surface, as of Farah, scheme 1, reproduced above. Domb also teaches amino -NH2 groups at least in paragraph 0006.
As to claim 9, this claim is rejected for essentially the same reason that claim 8 is rejected.
As to claim 17, this claim is rejected for essentially the same reason that claim 1 is rejected.
Claim(s) 1-6, 8-9, 11-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serda et al. (WO 2019/028387 A1).
Serda et al. (hereafter referred to as Serda) is drawn to liposome coated nanoparticles for immunotherapy, as of Serda, title and abstract. The nanoparticles of Serda may be mesoporous silica; see Serda, page 58 lines 20-27. Silica is understood to read on the required silicon dioxide.
As to claim 1, the claim requires a zeta potential exceeding +15 mV in the case of the elected species. Serda teaches the following zeta potential range, as of page 8, relevant text reproduced below.
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Also see Serda, page 23, relevant text reproduced below.
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This range in zeta potential is not fully within the claim scope; as such, Serda is not anticipatory. Nevertheless, this zeta potential range overlaps with the claimed zeta potential of greater than +15 mV. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). The examiner also notes that Serda teaches the use of positively charged species such as 8-mer polyarginine on the surface. See Serda, page 12, line 29. Polyarginine would have had a positive charge at neutral pH due to protonation of the amine group in the side chain of the arginines; therefore, the presence of polyarginine at the surface would have resulted in a positive zeta potential.
As to claim 1, the claim requires a particle size below 150 nm. Serda teaches sizes of about 75 nm to about 100 nm, as of Serda, page 10 lines 35-40.
As to claim 2, Serda does not appear to provide a numerical measure of the surface loading density; however, Serda does appear to desire a relatively low loading density, as of Serda, page 33, relevant text reproduced below.
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As such, the skilled artisan would have been motivated to have reduced the density of functional groups on the particle surface; this reduction of the density of functional groups would have been expected to have resulted in a surface loading density within the claimed range.
As to claim 3, Serda teaches the following as of figure 4, relevant portion of figure reproduced below.
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The above-reproduced figures appear to show particle sizes and polydispersity indices in the claimed range or overlapping with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claims 4-5, Serda teaches a zeta potential form -50 mV to + 50 mV on page 23. This overlaps with the claimed zeta potential range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). This also overlaps with a zeta potential different from zero.
As to claim 6, Serda teaches amine functional groups connected to the surface of the silica. This has been achieved by formulating the silica with N-(2-aminoethyl)-3-aminopropyitrimethoxysiiane (AEPTMS) or 3-aminopropyltriethoxysilane (APTES) upon formation of the silica from tetraethyl orthosilicate (TEOS). See Serda, page 8, relevant text reproduced below.
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This would have resulted in a covalent bond between the silica and the amine group at the surface.
As to claim 8, the aminosilanes discussed in the above rejection of claim 6 would have comprised the required amino group, which would have had a formula of
-NH2 (if not protonated) or -NH3+ (if protonated) at the surface.
As to claim 9, the rationale applied by the examiner for claim 8 also applies to claim 9 as claim 9 also recites an amino group.
As to claim 11, Serda teaches cargo loaded in the nanoparticle core, as of at least page 49 lines 24-32 and page 48 lines 8-25. As best understood by the examiner, particles loaded in the porous core of the silica can be considered to be loaded via absorptive attachment.
As to claim 12, Serda teaches plasmid DNA and RNA on page 48 lines 8-25, these read on the required oligonucleotides.
As to claim 13, Serda teaches pathogen and damage associated molecular patterns, as of page 69, lines 29-42.
As to claim 14, Serda teaches TLR-4 and TLR-9 activators (i.e. agonists), as of page 69 lines 25-26.
As to claim 16, Serda teaches a vaccine as of the abstract.
As to claim 17, Serda teaches silica particles with amine groups attached thereto; see the above rejection of claim 8.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serda et al. (WO 2019/028387 A1) in view of Doronina et al. (Bioconjugate Chemistry, Vol. 19, 2008, pages 1960-1963) and Gill et al. (US 2018/0250339 A1).
Serda et al. (hereafter referred to as Serda) is drawn to a liposomal coated nanoparticle for immunotherapy, as of Serda, title and abstract.
Serda does not teach a peptide comprising a C-terminal extension with an enzymatic capthesin-B cleavable linker.
Doronina et al. (hereafter referred to as Doronina) is drawn to an antibody-drug conjugate that comprises a capthesin B cleavable linker known as “MMAF”, as of Doronina, page 10, title and abstract. As best understood by the examiner, MMAF appears to be attached to the C-terminus as peptides are written from N to C and MMAF is written on the right side of the peptide, as of Doronina, page 1962, caption of figure 2. This appears to result in enhanced cellular uptake and therefore increased therapeutic effectiveness, as of Doronina, page 1960, title and abstract.
Doronina appears to differ from Serda because Serda is drawn to immunotherapy, whereas Doronina, while teaching cancer treatment, does not specifically point out immunotherapy.
Gill et al. (hereafter referred to as Gill) teaches that antibody-drug conjugates are useful for immunotherapy, as of Gill, paragraph 0002.
Neither Gill nor Doronina teach the required particle.
It would have been prima facie obvious for one of ordinary skill in the art to have included an antibody-drug conjugate, as of Gill, in the composition of Serda. Serda is drawn to a composition for immunotherapy. Gill teaches that antibody-drug conjugates are useful for immunotherapy. As such, the skilled artisan would have been motivated to have used the antibody-drug conjugate of Gill in the composition of Serda in order to have predictably provided immunotherapy with a reasonable expectation of success.
Additionally, the skilled artisan would have been motivated to have modified the antibody-drug conjugate of Gill with the capthesin B cleavable linker of Doronina. Doronina teaches that antibody-drug conjugates, when modified with cleavable linkers, have improved intracellular delivery and therefore therapeutic effectiveness, as of Doronina, abstract. As such, the skilled artisan would have been motivated to have modified the antibody-drug conjugate of Gill with the cleavable linker of Doronina in order to have predictably improved intracellular delivery and therefore therapeutic effectiveness with a reasonable expectation of success.
Non-Statutory 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 1-6, 8-9, and 11-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/924,193 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to silicon dioxide nanoparticles comprising a zeta potential of at least +15 mV (in the case of the elected species) and a size below 150 nm.
The copending claims are drawn to silicon dioxide nanoparticles comprising a zeta potential of at least +15 mV (in the case of the elected species) and a size below 150 nm. The composition of the copending claims also comprises a human papilloma virus (HPV) derived immunogenic fragment.
The copending claims differ from the instant claims because the composition of the copending claims comprises an HPV fragment that is not recited by the instant claims. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims. As such, the subject matter of the copending claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 8-9, and 11-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/252,301 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to silicon dioxide nanoparticles comprising a zeta potential of at least +15 mV (in the case of the elected species) and a size below 150 nm.
The copending claims are drawn to a method of providing immunostimulation. This method entails administering silicon dioxide nanoparticles comprising a zeta potential of at least +15 mV (in the case of the elected species) and a size below 150 nm along with poly(I:C).
The copending claims differ from the instant claims because the copending claims are drawn to a method, whereas the instant claims are drawn to a composition. Also, the composition used in the method of the copending claims comprises a poly(I:C) that is not recited by the instant claims. Nevertheless, the composition used in the method of the copending claims is within the scope of that of the instant claims. As such, the subject matter of the copending claims effectively anticipates that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612