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 .
Amendments
Applicants’ amendments to the claims filed 11/20/2025 have been entered. Any objection\rejections from the previous office action filed 5/20/2025 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 102
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 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) 20-21,42-44,46-47 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Momma et al. "Clathrate compounds of silica", J. Phys.: Condens. Matter 26 (2014) 103203 (18pp). This new rejection was necessitated by amendment.
Momma discloses clathrate compounds of silica and aluminosilicate in cage structures including the geometric shape of 512, 51264, 51268, the geometric shapes feature an interior and exterior surface having vertices, angles and arms with apertures or windows within the polygonal faces. See entire disclosure, especially abstract, page 2 left col last ¶-page 3 rt col last full ¶, Fig. 1-2 and tables 1-2. Regarding the limitations on the size of the longest dimension, apertures and vertices in claims 20 and 46, it follows that since the clathrates disclosed in Momma have the same exact geometric cage shape containing the same elements (Si, O and Al) it will feature the same longest dimension, aperture and vertices size as claimed. This is because the elements are confined to the same geometric cage shape, therefore they will have the same the bond lengths, angle distances, aperture size and overall size as claimed. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972). In re Best, 562 F.2d 1252, 1255 (CCPA 1977). "[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,708 (Fed. Cir. 1990). A "prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference." SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005). Regarding claim 20, oxygen and aluminum present in the clathrate are considered to read on functional group functionalized on the surface or interior. Regarding claim 44, the clathrate of Momma is considered capable of disposing a micelle within its hollow structure as claimed. It follows that same compound will have the same properties and be capable of the same intended use.
Claim(s) 20-21,42-44,46-47 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Yu et al. "Hedgehog Buckyball: A High-Symmetry Complete Polyhedral Oligomeric Silsesquioxane (POSS)", Polymers 2016, 8, 315. This new rejection was necessitated by amendment.
Yu discloses buckyballs produced from silsesquioxane (a silica material), which feature a geometric shape of 512620, this geometric shape features an interior and exterior surface along with vertices, angles and arms with apertures or windows within the polygonal faces. See entire disclosure, especially abstract, Fig 1, ¶ bridging page 1-2. Regarding the limitations on the size of the longest dimension, apertures and vertices in claims 20 and 46, it follows that since the buckyballs disclosed in Yu have the same exact geometric cage shape containing the same elements (Si, and O) it will feature the same longest dimension, aperture and vertices size as claimed. This is because the elements are confined to the same geometric cage shape, therefore they will have the same the bond lengths, angle distances, aperture size and overall size as claimed. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972). In re Best, 562 F.2d 1252, 1255 (CCPA 1977). "[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,708 (Fed. Cir. 1990). A "prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference." SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005). Regarding claim 20, the silicon atom in the buckyball is additionally substituted by an organic R group, considered to read on the functional group recited. Regarding claim 44, the buckyball of Yu is considered capable of disposing a micelle within its hollow structure as claimed.
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.
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) 20-21,42-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu, cited above, in view of Pan et al. “Nuclear-Targeted Drug Delivery of TAT Peptide-Conjugated Monodisperse Mesoporous Silica Nanoparticles” J. Am. Chem. Soc. 2012, 134, 5722−5725. This new rejection was necessitated by amendment.
Yu is disclosed above. Yu is silent with respect to the buckyball being functionalized with the functional groups recited in claim 45, including peptides and drugs.
Pan teaches modification of silica nanoparticles with TAT peptide for nuclear targeted drug delivery and proved to be suitable for transport across the nuclear membrane. See entire disclosure, especially abstract, Fig 1 and last ¶ page 5725. The nuclear-targeted and intranuclear DOX delivery by the silica nanoparticles functionalized with TAT demonstrated a significant enhancement in the anticancer activity of the drug.
Since Yu teaches silica as the building block for the buckyball and Pan teaches it was possible to attach TAT peptide to silica one of ordinary skill in the art would have a high expectation of success in functionalizing the buckyballs of Yu with TAT peptide. Reason to make such a substitution would be to deliver the silica buckyball across the nuclear membrane by the TAT peptide for payload delivery. One of ordinary skill would expect significant enhancement in payload delivery to a cell. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 20-21,42-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Momma, cited above, in view of Pan et al. “Nuclear-Targeted Drug Delivery of TAT Peptide-Conjugated Monodisperse Mesoporous Silica Nanoparticles” J. Am. Chem. Soc. 2012, 134, 5722−5725.
Momma is disclosed above. Momma is silent with respect to the nanocage being functionalized with the functional groups recited in claim 45, including peptides and drugs. This new rejection was necessitated by amendment.
Pan teaches modification of silica nanoparticles with TAT peptide for nuclear targeted drug delivery and proved to be suitable for transport across the nuclear membrane. See entire disclosure, especially abstract, Fig 1 and last ¶ page 5725. The nuclear-targeted and intranuclear DOX delivery by the silica nanoparticles functionalized with TAT demonstrated a significant enhancement in the anticancer activity of the drug.
Since Momma teaches silica as the building block for the clathrates and Pan teaches it was possible to attach TAT peptide to silica one of ordinary skill in the art would have a high expectation of success in functionalizing the clathrates of PAN with TAT peptide. Reason to make such a substitution would be to deliver the silica nanoparticle across the nuclear membrane by the TAT peptide for payload delivery. One of ordinary skill would expect significant enhancement in payload delivery to a cell. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant’s arguments with respect to claim(s) 20-21,42-47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618