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 .
Election/Restrictions
Applicant’s election of SEQ ID#s 174 and 277 in the reply filed on 11/12/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The disclosure is objected to because of the following informalities:
See Example 16.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See example 16.
Appropriate correction is required.
Claim Objections
Claims 1-15 are objected to because of the following informalities: all the claims are missing an initial article. Appropriate correction is required. For the purpose of this action, claim 1 is read as A composition and the remaining dependent claims are The composition.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-14 provide for the use the composition, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claims 11 and 12 are also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claims 2-3 and 7 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.
For claims 2 and 3, it is not clear if the limitation after “preferably” is required is required or optional. Also, it is not clear what “derived” changes to the sequences of the HPV or if the sequences are just “from” the recited SEQ ID#s.
For claim 7, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation loading density of 0.5, and the claim also recites preferably and most preferably narrower ranges. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Chemistry Communications 2018 54:1057-1060), Colapicchioni et al. (Journal of Materials Chemistry Part B 2015 (3): 7408-7416), Vitiello et al. (US6419931) and Neefe et al. (PGPub US20020110566).
For claim 1 and 6, Wang et al. teach mesoporous silica (silicon dioxide) particles that have a charge of 1 mV in saline which is conferred by charged surface functional groups and a size of 100 to 200 nm (see page 1057 second column last partial paragraph-page 1058 first column). For claim 7, the nanoparticles have a surface area density of 5 m2/g and are loaded with p(I:C) via adsorption to a loading level of 18.4 mg/mg nanoparticles (see page 1058 first column and supplementary information page 6; instant claims 8 and 12). They teach that the antigen ovalbumin can also adsorb to the silica nanoparticles as well as its utility in combination with P(I:C) as an antitumor active on the silica nanoparticles (see page 1058-page 1059 first column and figure 3MS-OVA-PIC sample; instant claim 3). The charge of the loaded nanoparticles is not detailed.
For claim 1, Colapicchioni et al. teach loading cationic nanoparticles with p(I:C), where the final charge depends upon the ratio of p(I:C), an immunostimulant, to the cationic carrier (see abstract, figure 1, page 7408, and page 7410 second column first-second full paragraphs; instant claims 13 and 14). Here an increase in this ratio yields an increase in the negative charge, where values of +/- 15 mV are attainable (see figure 4; instant claims 1 and 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare both varieties of the p(I:C) loaded mesoporous silica nanoparticles of Wang et al. where the final charge is optimized as a matter of routine experimentation, since it is a result effective variable as detailed by Colapicchioni et al. (see MPEP 2144.05(II)(B)). The silica nanoparticles are silicon dioxide and therefore have silicon dioxide surface groups amongst other functional groups (see instant claim 1). Further, the fact that the surface groups of the nanoparticles absorb the p(I:C) indicates that they are capable of carrying the p(I:C) (see instant claim 1). The derivatives of instant claim 3 are not required selections of the claim, therefore the p(I:C) of Wang et al. meet its limitations.
For claim 15 p(I:C) is an immunostimulant on the silica particles of Wang et al. can function as an immunostimulant as intended by these claims. In addition, the specification illustrates that silica complexed p(I:C) is capable or treating bovine respiratory disease.
Wang et al. and Colapicchioni et al. do not teach HPV.
For claims 2, 4, and 6, Neefe et al. teach YMLDLOPET as HLA A 0201 near top of table 4 (same as SEQ 174). HLA A 0201 is known in the art as MHC I. Neefe et al. also teach there is no safe and effective way to treat or prevent the diseases caused by HPV and suggest a multi-antigen therapy (para 4).
For claims 3 and 5, Vitiello et al. teach SEQ ID #66 that contains claimed SEQ ID# 271. Example 14 describes the prior art sequence as inducing CTL thus meeting the limitation of claim 5.
One of ordinary skill in the art before the effective time of filing know use of linkers and carboxy and amino groups is routine in the art and been motivated to use them as needed to construct nanoparticles. One of ordinary skill in the art before the effective time of filing would have the expectation of success as the technology has been used successfully as shown in the art.
One of ordinary skill in the art before the effective time of filing have been motivated to immunogenic treatments for HPV and use multi-peptides as taught by Neefe et al. and been motivated to use nanoparticles because they have been shown to be immunogenic as taught in Wang et al. One of ordinary skill in the art before the effective time of filing would have the expectation of success as the peptides are known to be immunogenic against HPV.
Thus, it would have been prima facie obvious before the effective time of filing to modify the silica nanoparticle of Wang et al. and Colapicchioni et al. with HPV peptides as taught by Vitiello et al. and Neefe et al. with the expectation of success.
Claim(s) 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Chemistry Communications 2018 54:1057-1060), Colapicchioni et al. (Journal of Materials Chemistry Part B 2015 (3): 7408-7416), Vitiello et al. (US6419931), and Neefe et al. (PGPub US20020110566) as applied to claims 1-8 and 15 above, and further in view of Amaria et al (Indonesian Journal of Chemistry 2017 17(2):256-263).
Wang et al., Colapicchioni et al., Vitiello et al., and Neefe et al. are discussed above.
Wang et al., Colapicchioni et al., Vitiello et al., and Neefe et al. do not teach linkers or reactive groups.
Amaria et al. teach nanoparticles with a magnetite (iron oxide) core and silica (silicon dioxide) shell that have arginine bound to their surfaces which provides both a-COOH group and a collection of terminal amine groups (see abstract 257 first column last paragraph and figure 1). The nanoparticles have a size of 37.16 nm or 45.32 nm, depending in the technique employed to provide the arginine modification (see table 1).
One of ordinary skill in the art before the effective time of filing know use of linkers and carboxy and amino groups is routine in the art and been motivated to use them as needed to construct nanoparticles. One of ordinary skill in the art before the effective time of filing would have the expectation of success as the technology has been used successfully as shown in the art.
Thus, it would have been prima facie obvious before the effective time of filing to modify the silica nanoparticle of Wang et al. and Colapicchioni et al. with the linker and reactive groups as taught by Amaria et al. with the expectation of success.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, and 6-15 of copending Application No. 17924258 (reference application) in view of Vitiello et al. (US6419931) and Neefe et al. (PGPub US20020110566).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a composition composed of nanoparticles having silicon dioxide and other functional groups on its surface that are loaded with p(I:C). The copending claims also include an antigen/epitope on the nanoparticle surface. The copending claims recite a loading density of less than 0.5, a nanoparticle size below 150 nm, and a zeta potential of the composition of at least ± 15 mV which meets or overlaps with those instantly claimed ranges. A linker bound to the nanoparticles with many of the same functional groups are recited by both sets of claims.
The reference application does not claim HPV.
For claims 1-2, 4, and 6, Neefe et al. teach YMLDLOPET as HLA A 0201 near top of table 4 (same as SEQ 174). HLA A 0201 is known in the art as MHC I. Neefe et al. also teach there is no safe and effective way to treat or prevent the diseases caused by HPV and suggest a multi-peptide therapy (para 4).
For claims 3 and 5, Vitiello et al. teach SEQ ID #66 that contains claimed SEQ ID# 271. Example 14 describes the prior art sequence as inducing CTL thus meeting the limitation of claim 5.
One of ordinary skill in the art before the effective time of filing have been motivated to immunogenic treatments for HPV and use multi-peptides as taught by Neefe et al. and been motivated to use nanoparticles because they have been shown to be immunogenic as taught in Wang et al. One of ordinary skill in the art before the effective time of filing would have the expectation of success as the peptides are known to be immunogenic against HPV.
While a single lineage of claims does not provide for each instantly claimed embodiment, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the p(I:C) loaded silica particles of the copending claims with the instantly claimed features because the claims state to do so for their composition. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Therefore the overlapping ranges of the copending claims render the claimed ranges obvious. For claims 13-14 are considered intended use claims and thus are treated as products and along with claim 15, the reference patent and cited HPV art to support the obviousness rejection.
Thus, claims 1-15 are obvious over claims 1-2, 4, and 6-15 of copending Application No. 17924258.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671