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 Group I, claims 11-20 in the reply filed on 27 October 2025 is acknowledged.
Claims 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 October 2025.
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.
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.
Claim 12 recites external factors including pH, temperature, pressure, and chemical substances. 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 12 recites the broad recitation “external factors”, and the claim also recites “pH, temperature, pressure, and chemical substances” which is the narrower statement of the range/limitation. 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.
It is also unclear if the limitation drawn to pH, temperature, pressure, and chemical substances is intended to require all of these factors or only one of these factors.
For the purposes of examination under prior art, the examiner takes the position that the claim is subject to the broader recited limitation of external factors.
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 a patient-specific coating such as a cell membrane. This phrase renders the claim indefinite for at least the following reasons.
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), especially MPEP 2173.05(d), Example (C). In this case, it is unclear whether claim 14 is drawn to a patient specific coating generically, or cell membranes specifically.
For the purposes of examination under prior art, the examiner will understand claim 14 to recite the broader limitation of a patient-specific coating.
Note Regarding Abbreviations
Claim 17 recites various abbreviations. PEG refers to polyethylene glycol, IgG and IgM refer to immunoglobulins G and M respectively, which are types of antibodies, VEGF refers to vascular endothelial growth factor, cRGD refers to a cyclic arginylglycylaspartic acid peptide, and DNA refers to deoxyribonucleic acid.
Note Regarding Polyethylene Glycol Coating
It is the examiner’s position that the skilled artisan at the time of filing would have understood that conjugation of polyethylene glycol (PEG) to a compound or supramolecular structure would have decreased immunogenicity of said compound or supramolecular structure. See Immordino et al. (International Journal of Nanomedicine, Vol. 1(3), 2006, pages 297-315). Immordino et al. (hereafter referred to as Immordino) is drawn to stealth liposomes, which are liposomes comprising PEG, as of Immordino, page 297, title and abstract. Immordino teaches the following, as of page 303, left column, third paragraph, relevant text reproduced below.
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As such, the skilled artisan would have understood that a prior art teaching of PEG would have been expected to have achieved the above-indicated effects such as decreased immunogenicity, even if the particular prior art reference relied upon did not explicitly teach the above-indicated effects.
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) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trogler et al. (US 2011/0229576 A1) in view of Curiel et al. (US Patent 5,521,291).
Trogler et al. (hereafter referred to as Trogler) is drawn to hollow nanospheres, as of Trogler, title, abstract, and figure in abstract, reproduced below.
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As to claim 11, the claim requires an interior polymer material and virus. Trogler teaches the following, as of paragraph 0091, reproduced below with various terms annotated by the examiner.
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The above-indicated viruses read on the required virus.
As to claim 11, the claim requires an exterior silica gel matrix. The silica exterior in the above-reproduced figure is understood to read on this requirement. That the silica is in the form of a gel is evident as of paragraph 0024 of Trogler.
As to claim 11, the claim requires that the outer surface of the silica comprises a secondary functionalization. This is taught in the above-reproduced figure, which teaches amine functionalization of the exterior of the shell. This functionalization is intended for binding to targeting ligands such as antibodies, as of Trogler, at least paragraphs 0008 and 0033.
As to claim 11, the claim requires that the silica gel matrix protects the virus from immune recognition and neutralization. Trogler teaches immobilization of polyethylene glycol (PEG) on the surface of the nanostructure, as of paragraph 0073. This would have been expected to have protected the virus from immune recognition and neutralization even if this feature was not explicitly taught by Trogler. Something which is old (e.g. a PEG coated silica particle) does not become patentable upon the discovery of a new property (e.g. that the PEG would have resulted in protection from immune recognition). See MPEP 2112(I). See also the section above entitled “Note Regarding Polyethylene Glycol Coating.”
Trogler appears to differ from claim 11 because Trogler does not appear to teach a polymer material bound to the surface of the virus via electrostatic interaction. The examiner notes that although Trogler may teach polystyrene, it is a sacrificial material not intended in the end product, and also does not appear to electrostatically bind to the virus.
Curiel et al. (hereafter referred to as Curiel) is drawn to introducing nucleic acid into eukaryotic cells, as of Curiel, title and abstract. Curiel teaches a combination of polylysine with viral vector (which is adenovirus in the case of Curiel), along with transferrin and a particular antibody, as of at least Curiel, column 22 lines 11-22, reproduced below with annotation by the examiner.
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As such, Curiel teaches a combination of viral vector with polylysine. This appears to improve gene transfer, as of Curiel, at least column 22 line 58 through column 23 line 4. The examiner notes that although Curiel uses the term “conjugates” in the title, which implies covalent bonding, there does not appear to be covalent bonding between the viral vector and the polylysine; in contrast, the polylysine of Curiel appears to be conjugated to an antibody in certain embodiments.
Curiel does not teach an exterior silica gel matrix.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the polylysine of Curiel with the viral vector of Trogler to be delivered via the particle of Trogler. Trogler is drawn to a silica gel coated particle that may be used to deliver a viral vector. Curiel teaches that polylysine can be used in combination with a viral vector, and that polylysine appear to improve delivery of the nucleic acid delivered by the viral vector. As such, the skilled artisan would have been motivated to have combined the polylysine of Curiel with the virus vector of Trogler to be delivered via the silica particle of Trogler for predictable improvement of effectiveness of the viral vector at delivering a nucleic acid with a reasonable expectation of success.
As to claim 12, the skilled artisan would have expected that the silica shell described by Trogler would have protected the material encapsulated therein, which may be the viral vector described by paragraph 0091 of Trogler, from external environmental factors that cause degradation. This is because the silica shell would have been expected to have acted as a physical barrier to have prevented entry of contaminants into the interior of the hollow particle where the active agent is encapsulated.
As to claim 13, Trogler appears to suggest cancer targeting in at least paragraph 0009, whereupon Trogler teaches targeting in cancer models.
As to claim 14, Trogler teaches immobilization of polyethylene glycol (PEG) on the surface of the nanostructure, as of paragraph 0073. The skilled artisan would have expected that PEG would have increased circulation by reducing uptake by undesired body systems such as the immune system.
As to claim 15, Trogler teaches immobilization of polyethylene glycol (PEG) on the surface of the nanostructure, as of paragraph 0073. The skilled artisan would have expected that PEG would have increased circulation by reducing uptake by undesired body systems such as the immune system.
As to claim 16, Trogler teaches targeting antibodies in paragraphs 0008 and 0033 and 0059. The skilled artisan would have expected that antibodies would have bound to a particular region of a cell or tissue; namely, that which has the protein to which the antibody attaches on the exterior of the cell and tissue.
As to claim 17, Trogler teaches targeting antibodies in paragraphs 0008 and 0033 and 0059.
As to claim 18, Trogler teaches immobilization of polyethylene glycol (PEG) on the surface of the nanostructure, as of paragraph 0073.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trogler et al. (US 2011/0229576 A1) in view of Curiel et al. (US Patent 5,521,291), the combination further in view of Xia et al. (Journal of Medicinal Chemistry, Vol. 53, 2010, pages 6811-6824).
Trogler is drawn to a silica nanoparticle encapsulating an active agent such as a viral vector. Curiel is drawn to combining polylysine with a viral vector for increased efficacy. See the rejection above over Trogler in view of Curiel.
Neither Trogler nor Curiel teach folate as a targeting ligand.
Xia et al. (hereafter referred to as Xia) is drawn to folate-targeted therapies for cancer, as of Xia, page 6811, title. Xia teaches that folate receptor is overexpressed on cancer cells, as of Xia, page 6812, left column, section 1.3, indicating that folate targets cancer cells. Xia provides an example of folate targeted cancer therapy on page 6813, left column, figure 2, reproduced below.
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Xia does not teach an exterior silica gel matrix.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the exterior of the particle of Trogler to have included folate ligands. Trogler teaches the use of targeting ligands that target cancer, as of Trogler, paragraph 0009. Xia teaches that folate targets cancer because folate receptors are overexpressed in cancer cells. As such, the skilled artisan would have been motivated to have derivatized the particle of Trogler with folate ligands in order to have predictably targeted cancer with a reasonable expectation of success.
As to claim 19, the folate of Xia reads on the additional requirement of this claim.
As to claim 20, Xia teaches folate functionalization and Trogler teaches PEG functionalization as of paragraph 0073.
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 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,869,841. 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 a bioactive virus delivery device comprising an interior polymer material electrostatically bound to a virus and an exterior silica gel.
The conflicting claims are drawn to a bioactive virus delivery device comprising an interior polymer material electrostatically bound to a virus and an exterior silica gel.
The instant and conflicting claims differ because the conflicting claims require that the exterior silica gel matrix does not include the interior polymer material, whereas this is not required by the instant claims. Nevertheless, the subject matter of the conflicting claims is within the scope of that of the instant claims. As such, the subject matter of the conflicting claims effectively anticipates the subject matter of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Claims 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,684,585. 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 a bioactive virus delivery device comprising an interior polymer material electrostatically bound to a virus and an exterior silica gel.
The conflicting claims are drawn to a method of making a bioactive virus delivery device. This method entails combining an interior polymer material and a virus, followed by forming an exterior silica gel matrix around this.
The instant and conflicting claims differ because the conflicting claims are drawn to a method of making a composition, whereas the instant claims are drawn to the composition itself. Nevertheless, the composition made by the method of the conflicting claims appears to be the same as the claimed composition. As such, the subject matter of the conflicting claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612