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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Claims 15-22 and 28-39 were previously canceled by applicants.
Claims 1-14 and 23-27 as currently amended/presented are pending in this application.
Claims 4-8 (non-elected species of group I), and claims 23-27 (non-elected Group II) remain withdrawn.
Claims 1-3 and 9-14 (elected Group I with species “tumor cell”, without traverse; directed to “A silicified cell..”) have been examined on their merits in this action, hereinafter.
Priority
This application is a 371 of PCT/US2021/024776 (filed on 03/30/2021), which claims domestic benefit from a US provisional application 63/001,737 filed on 03/30/2020.
Claim Rejections - 35 USC § 102 – Withdrawn
In view of current amendments to pending claim 1, the 102(a)(1) rejection by WO 2019/055620 A1 (Serda et al) over claims 1-3 and 9-14, as previously made by the examiner, has been withdrawn.
The following contains new grounds of objection/rejection necessitated by applicant’s current amendments to pending claims.
Claim Terms
It is noted that instant claim 1, as currently amended, recites the limitations “a nanoparticle comprising an exogenous polynucleotide encoding a bioactive agent loaded into the silicified cell or silicifiable compartment thereof,…”, wherein the limitations of “an exogenous polynucleotide encoding a bioactive agent” does not have a literal or direct support in the disclosure (or claims/drawings) of record. However, the specification summary (SPEC, p. 1; and Figures 6-7) of record states the following:
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Considering the above implicit support for a DNA plasmid, an siRNA, or an mRNA as a “bioactive agent”, the new matter rejection under 112(a) has not been made. The claims have been interpreted (for this office action hereinafter) to encompass a nanoparticle comprising such “a bioactive agent” (i.e. a DNA plasmid, an siRNA, or an mRNA) as meeting the limitations instant claim 1 as amended.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
1. Claim 12 (as presented) is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 (directly depends from independent claim 1) recites the limitations “wherein the nanoparticle comprises a chemokine, a cytokine,….”, wherein instant claim 1 is now amended to recite “a nanoparticle comprising an exogenous polynucleotide encoding a bioactive agent loaded into the silicified cell…”. Claim 12 as presented does not appear to further limit the scope of instant claim 1 as amended because it does not further limit the ”bioactive agent” recited in instant claim 1. Alternatively, it does not recite if “the nanoparticle further comprises a chemokine, a cytokine,….”. Appropriate correction is required. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
NOTE: 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.
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.
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.
1. Claims 1-3 and 9-14 (as amended/presented) are rejected under 35 U.S.C. 103 as being unpatentable over SERDA et al (hereinafter Serda et al 2019; WO 2019/055620 A1; FOR cited in applicant’s IDS dated 07/05/2023) taken with Serda et al (hereinafter Serda et al 2015; US 8,926,994 B2; cited as ref. [A] on PTO 892 form).
Claim 1 (as currently amended) is directed to “A silicified cell comprising:
a silicified cell or silicifiable compartment thereof comprising a surface
a nanoparticle comprising an exogenous polynucleotide encoding a bioactive agent loaded into the silicified cell or silicifiable compartment thereof, and
an immunomodulatory moiety bound to the surface.”
See also limitations of the dependent claims 2, 3 and 9-14, as currently presented.
Applicant’s elected species under examination: “tumor cell” (see dependent claims 2-3, in particular).
It is to be noted that the term “bioactive agent” has not been specifically defined by the applicants on record (see SPEC, p. 1, “Summary”, and p. 6, last full paragraph).
Serda et al (March, 21st, 2019), while teaching silicified cell replicas, methods of making and using (see Title, Abstract, Summary, and claims), disclose silicified tumor cell comprising- a silicified cell comprising a surface (such as ID8-GFP- OVA ovarian cancer cells); a nanoparticle comprising a bioactive agent (such as mesoporous nanoparticles coated with an immunogenic lipid (ILM) loaded into the silicified cell; and an immunomodulatory moiety (such as lipopolysaccharide, LPS) bound to the surface (see page 12, lines 16-18, Figure 12a, for instance; and page 6, lines 3-6); wherein the cell is a silicified ovarian ID8 tumor cell- LPS-ID8-GFP-OVA; wherein Serda et al 2019 also disclose the fact that instead of tumor cells, silicified microvesicles (MV) obtained from immunogenic cancer cells that are also capable of inducing an immune response, can be used (see page 13, line 24 to page 14, line 2; and page 15, lines 16-29, for instance); wherein the immunomodulatory moiety is bound to the surface via a cationic layer disposed on the surface with the use of aminosilane compounds APTES or EDABES (see Figure 14B; and page 6, lines 18-24; page 13, lines 15-22, for instance) that generate variable surface zeta potentials/charges; wherein the immunomodulatory moiety is bound to the surface via an anionic layer (see Figure 13; and page 6, lines 13-17, for instance); and wherein the immunomodulatory moiety (such as PAMP or DAMP, or LPS) is bound to the surface via siloxane (see page 29, claims 6-8, for instance).
However, a silicified cell comprising a nanoparticle comprising an exogenous polynucleotide encoding a bioactive agent loaded into the silicified cell (see amended claim 1) has not been specifically disclosed by Serda et al 2019, as discussed above.
Serda et al (2015), while teaching mesoporous silicon particles for the presentation of tumor antigens and adjuvant for anti-cancer immunity (see Title, Abstract, col. 1, lines 29-34; and Claims 1, 12), disclose “In one embodiment, the present invention provides cancer vaccines that utilize an array of tumor antigens conjugated to the Surface of nanoparticles (i.e., tumor mimetics). The tumor mimetics are co-loaded into a larger carrier particle in association with an expression vector, creating both a vehicle for tumor antigens and a source for cytokine production (i.e., multifunctional vector vaccines)” (see col. 2, lines 47-53, for instance); wherein the nanoparticles can comprise vaccine components including one or more diagnostic, imaging, and/or therapeutic compounds (see entire col. 3) that comprise “chemical targeting moiety includes at least one moiety selected from a the group consisting of a ligand, a dendrimer, an oligomer, an aptamer, a binding protein, an antibody, an antigen binding fragment thereof, a biomolecule, an siRNA, and any combination thereof” (see col. 3, lines 45-50); wherein siRNA (small interfering ribonucleic acid, siRNA, i.e. a polynucleotide encoding “a bioactive agent”) can be incorporated and/or encapsulated into nanoparticles “knocking down negative regulators of immune system” (i.e. encoding a bioactive agent in cells for the knock down effects; see Example 5, col. 35-36) as demonstrated in the mouse model and dendritic cells (see entire disclosure on col. 36). Thus, Serda et al 2015 disclose the nanoparticles (in the form of “mesoporous silicon multi-stage vehicles” MSV; see Abstract) comprising variety of therapeutic compounds and molecules including an exogenous polynucleotides encoding a bioactive agent (such as siRNA, CpG, aptamers, etc.; see also col. 16, last paragraph; col. 18, lines 35-37, for instance) that can modulate immune response in cancer cells such as for treatment of mammalian breast cancer.
Thus, give the detailed disclosure from Serda et al 2015 for the nanoparticles comprising polynucleotide encoding a bioactive agent such as siRNA, CpG, aptamers etc., that can regulate desired targets in cells (see teachings/suggestions from Serda et al 2015, above), an artisan of ordinary skill in the art would have been motivated to modify the silicified cells disclosed by Serda et al 2019 such that they incorporate suitable exogenous polynucleotides (such as a desired siRNA, CpG) encoding a bioactive agent into nanoparticles as taught by Serda et al 2015, in order to make silicified cells comprising nanoparticles that would be highly effective in modulating immune response and/or treating neoplastic tissues or cancers such as mammalian breast cancer, as already disclosed and exemplified by Serda et al 2015 (see Example 5, in particular). Since, the all the techniques for making such multi-stage delivery nanoparticle systems has already been taught by the disclosure from Serda et al 2015 (see Example 1), as well as Serda et al 2019 (see Figure 14, in particular), such modification of the silicified cell would have been obvious and/or fully contemplated by an artisan of ordinary skill in the art, unless evidence and/or data provided on record to the contrary (which is currently lacking on record; see SPEC, Example 2; Figures 6-7).
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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.
1. Claims 1-3 and 9-14 (as currently amended) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of U.S. Patent No. 12,201,651 B2 (issued on Jan. 21, 2025 to same inventors and assignee; from US application 17/436,872). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claim 1 of the ‘651 patent is also drawn to product comprising essentially the same “silicified cell” as reproduced hereinbelow:
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It is clear that the issued product is a species (at least for the limitation of the “cationic layer” disposed on “at least a portion of the silicified surface”) of the generic claims currently under examination (i.e. in a genus-species relationship with overlapping scope; as targeted delivery of various drugs or molecules loaded within silicified cells using mesoporous silica nanoparticles have been disclosed and/or fully contemplated by the issued patent ‘651; see 2nd and 4th paragraph of Summary; col. 4, 6th paragraph; col. 7, 3rd paragraph; col. 15, last paragraph), and therefore, an ODP rejection is still deemed proper, and is therefore made and/or maintained (see also the 103a rejection discussed above using the cited prior art references of Serda et al 2019 taken with Serda et al 2015).
Examiner’s Response to Applicant’s Arguments
Applicant’s arguments filed on 02/27/2026 (see REM, p. 6-7) with respect to claim(s) as currently amended on record, have been considered but are moot in view of new grounds of objection/rejection made in this office action, as discussed above.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657