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 .
Abstract
Applicant is reminded of the proper language and format of an Abstract of
the Disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 250 words. The printer will no longer accept Abstracts that are more than 25 lines, regardless of the number of words.
Election/Restrictions
Applicant's election without traverse of claims 1-23 and 24 in the reply filed on 4-13-26 is acknowledged. Claim 24 remains withdrawn from consideration as a nonelected invention. The requirement is deemed proper and is therefore made FINAL.
Obviousness-type 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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No.17501635. Applicants claim 1 is directed to a nanoparticle comprising: a silica network comprising crosslinked polysiloxanes, wherein the crosslinks comprise disulfide linkages, and the nanoparticle has a surface bearing charged functional groups and a surface potential of either less than 30 mV or greater than +30 mV, and wherein the nanoparticle has an average diameter of 20 nm to 60 nm. Although the claims at issue are not identical, they are not patentably distinct from each other because the related claims a nano particle comprising silica network comprising crosslinked polysiloxanes, wherein the crosslinks comprises disulfide linkages, surface modifying groups attached to the silica network, and an average particle dimeter of 15nm to 200nm. The instant claims differs in that they recite charged surface functional groups having a surface potential of either less than -30mV or greater than +30mV and narrows the particle diameter to 20nm to 60nm. However, these differences are considered to constitute obvious modifications of the patented invention. Optimizing particle size within the disclosed range would have been an obvious matter of routine optimization.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over USPub20170119688 see abstract and paragraphs [0003]-[0058], Tables 1-2 and claims; in view of USP9427408 see abstract, col. 1 - col. 2, col. 15 Table A, and further in view of Chen, Guojun, et al. "A universal GSH-responsive nanoplatform for the delivery of DNA, mRNA, and Cas9/sgRNA ribonucleoprotein ACS applied materials & interfaces 10.22 (2018): 18515-18523. (Year: 2018)ACS Applied Materials and Interfaces, 2018 see Chen et al. pages 18515-18519 and abstract.
Applicants claim 1 is directed to a nanoparticle comprising: a silica network comprising crosslinked polysiloxanes, wherein the crosslinks comprise disulfide linkages, and the nanoparticle has a surface bearing charged functional groups and a surface potential of either less than 30 mV or greater than +30 mV, and wherein the nanoparticle has an average diameter of 20 nm to 60 nm.
USPub20170119688 discloses silica nanoparticles composing a silica network of crosslinked polysiloxanes having disulfide linkages, surface functionalized silica nanoparticles and particle dimeters overlapping the claimed range including particles between 25 and 200nm with preferred sizes between 40-80nm. The reference further teaches nanoparticles having a negative surface charge ranging from approximately -9mV to -30mV. See abstract and paragraphs [0003]-[0004], [0005]-[00013], [0055]-[0058], Tables 1-2 and claims.
USPub20170119688 does not disclose charged surface functional groups providing a surface potential of less than -30mV or greater than +30mV. However, Chen et al. discloses incorporating charged functional groups onto nanoparticle surfaces to promote electrostatic interactions, improve cellular uptake, and enhance delivery efficiency. See Chen et al. pages 18515-18519 and abstract.
USP9427408 shows the use of tetraethoxysilane and vinyltriethoxysilane as silica network formers suitable for preparing crosslinked polysiloxane networks. See abstract, col. 1 lines 40-68, col. 2 lines 1-60, col. 15 Table A,
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the charged surface functional groups taught by Chen et al. into the silica nanoparticles of USPub20170119688 while using the silica moieties taught by USP9427408. One skilled in the art would have been motivated to modify the nanoparticle surface charge to improve colloidal stability, electrostatic interactions and delivery efficiency with a reasonable expectation of success.
Regarding the claimed surface potential, optimization of nanoparticle surface charge to obtain a desired positive or negative zeta potential would have been an obvious matter of routine experimentation because the surface charge was recognized in the art as affecting nanoparticle performance.
Regarding the claimed particle diameter of 20-60nm, USPub20170119688 discloses ranges that overlap the claimed range. Where the claimed range overlaps a range disclosed by the art, is a prima facie case of obviousness. In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F2d 1575 (Fed. Cir. 1990).
With regard to claim 2, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches siloxy subunits having the claimed structures. See col. 15 and Table A.
With regard to claim 3, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches tetraethoxysilane and vinyltriethoxysilane as precursors for the claimed siloxy subunits. See col. 15, Table A.
With regard to claim 4, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches alkyl substituted siloxy subunits within crosslinked polysiloxane structures. Col. 15, Table A. .
With regard to claim 5, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches incorporation of imidazole functional groups to improve intracellular delivery. See abstract, and pages 18515-18517.
With regard to claim 6, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches TESPIC as n imidazole containing silane precursor. See col. 15, Table A.
With regard to claim 7, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USP9427408 teaches disulfide containing silane crosslinkers for forming crosslinked polysiloxane moieties. See col. 14 lines 59-60 and col. 15 and 16. Table A and col. 18 lines 48-51 and
With regard to claim 8, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches siloxy subunits bearing charged functional groups. See pages 18515-18517.
With regard to claim 9, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches siloxy subunits bearing charged functional groups. See pages 18515-18517.
With regard to claim 10, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches siloxy subunits bearing charged functional groups. See pages 18515-18517.
With regard to claim 11, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches siloxy subunits bearing charged functional groups. See pages 18515-18517.
With regard to claim 17, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USPub20170119688 discloses particle sizes overlapping the claimed ranges. See paragraphs [0003],[0005].
With regard to claim 18, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USPub20170119688 teaches encapsulated, bioactive biomacromolecules. See abstract, and paragraph [0003].
With regard to claim 19, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USPub20170119688 teaches encapsulation of polynucleic acids, polypeptides, and related biomacromolecules.. See abstract, and paragraph [0003].
With regard to claim 20, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches delivery of RNP, DNA and ribonucleoprotein (RNP) complexes. See abstract, Figure 1, and pages 18515-18517.
With regard to claim 21, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches delivery of RNP, plasmid DNA and mRNA. See abstract, Figure 1, pages 18515-18517.
With regard to claim 22, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since Chen et al. teaches Cas9 RNP delivery. See Title and Figure 1.
With regard to claim 23, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since USPub20170119688 teaches encapsulation of polypeptides. See abstract, and paragraph [0003].
In conclusion, in view of the above, there appears to be no significant difference between the reference(s) and that which is claimed by applicant(s). Any differences not specifically mentioned appear to be conventional. Consequently, the claimed invention cannot be deemed as unobvious and accordingly is unpatentable.
Claim Objections
Claims 12-17 are objected to as being dependent upon a rejected base claim, but may be allowable if:
1) after a further search,
2) rewritten in independent form including all of the limitations of the base claim
and any intervening claims and
Information Disclosure Statement
Note that any future and/or present information disclosure statements must comply with 37 CFR § 1.98(b), which requires a list of the publications to include: the author (if any), title, relevant pages of the publication, date and place of publication to be submitted for consideration by the Office.
Improper Claim Dependency
Prior to allowance, any dependent claims should be rechecked for proper dependency if independent claims are cancelled.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERRESSA M BOYKIN whose telephone number is (571)272-1069. The examiner can normally be reached M-F 7-5:30.
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, Heidi Kelley can be reached at 571 270-1831. 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.
/Terressa Boykin/Primary Examiner, Art Unit 1765
Prosecution Insights