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 with traverse of Group I, claims 1-11 in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that the Office Action has not shown that a serious burden would be required to examine all of the claims. This is not found persuasive because the groups are directed to more than one combination of categories and lack unity of invention as the technical feature as instantly claimed does not make a contribution over the prior art discussed in the Restriction requirement of 09/23/2025. Accordingly, claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 11 is objected to because of the following informalities: “hydrochlotiazide” in line 3 should be recited as --- hydrochlorothiazide ---. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “dilthiazem” in line 4 should be recited as --- diltiazem ---. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “prednisolon” in the last line should be recited as --- prednisolone ---. Appropriate correction is required.
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 10 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.
The term “CNS related diseases” in claim 10 is a relative term which renders the claim indefinite. The term “related” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instant case, it is not clear which diseases are considered CNS related diseases. At best, p. 22, last paragraph of the instant Specification discloses drugs for treatment of disease related to the nerve system. However, it is unclear if said nerve system refers to specifically CNS.
The term “steroid-based drugs” in claim 10 is a relative term which renders the claim indefinite. The term “based” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instant case, neither the claim or the instant Specification discloses which modifications are considered “steroid-based”, thus it is unclear which drugs are considered steroid-based drugs.
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 10 recites the broad recitations “drugs with effect on the immune system” in line 3 and “drugs for treatment of CNS related diseases” and “drugs for treatment of pain” in line 4, and the claim also recites “antibiotics”, “anticancer drugs” and “steroid-based drugs”, respectively, which are 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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Puebla et al. (EP 2946793 A1, 11/25/2015, IDS reference) (hereinafter Puebla).
Regarding claims 1 and 10, Puebla discloses a process of producing silicon particles by means of chemical vapor deposition (CVD)in a reactor ([0101]; Ex. 1 [0158]-[0159]), and an anticancer drug loaded on these particles ([0171]-[0173]).
Accordingly, Puebla anticipates the instant claims by disclosing a process of preparing silicone particles comprising at least one drug substance, comprising the steps of preparing silicone particles via CVD ([0158]-[0159]), and loading the silicon articles with at least one drug substance including an anticancer drug ([0171]-[0173]).
Regarding claim 2, Puebla further discloses wherein the preparation of the silicon particles comprises centrifuge ([0168]-[0170]). Accordingly, the skilled artisan would immediately envision inclusion of a centrifuge method as disclosed, and in doing so, the process would be consistent with what is instantly claimed. As such, Puebla anticipates the instant claims where centrifuge would fall within the instantly claimed reactor comprising a reactor body and a rotation device operatively arranged to the reactor and configured to rotate the reactor around an axis.
Regarding claims 3 and 4, Puebla does not disclose wherein the CVD process requires milling the silicon particles or etching the silicon particles.
Regarding claim 5, since Puebla discloses loading the silicon particles with an anticancer drug, Puebla anticipates the claim since the silicon particles would have to be mixed with the anticancer drug in order to load the silicon particles with the anticancer drug.
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.
Claims 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Puebla et al. (EP 2946793 A1, 11/25/2015, IDS reference) (hereinafter Puebla).
Claims 1-5 and 10 have been rejected as being anticipated as set forth supra. However, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, claims 1-5 and 10 will be interpreted as though it requires too much picking and choosing.
As discussed in the rejection above, Puebla discloses a process of producing silicon particles by means of chemical vapor deposition in a reactor ([0101]; Ex. 1 [0158]-[0159]), and an anticancer drug loaded on these particles ([0171]-[0173]).
Accordingly, Puebla discloses a process of preparing silicone particles comprising at least one drug substance, comprising the steps of preparing silicone particles via chemical vapor deposition ([0158]-[0159]), and loading the silicon articles with at least one drug substance ([0171]-[0173]). Together these would provide a process as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination 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 yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 2, Puebla further discloses wherein the preparation of the silicon particles comprises centrifuge ([0168]-[0170]). Accordingly, it would have been obvious to one of ordinary skill in the art to have included a centrifuge process in the preparation of silicon particles. As such, the centrifuge process of Puebla would meet the limitation of a reactor comprising a reactor body and a rotation device operatively arranged to the reactor and configured to rotate the reactor around an axis as instantly claimed.
Regarding claims 3 and 4, Puebla does not explicitly disclose wherein the CVD process requires milling the silicon particles or etching the silicon particles. Therefore, it would have been obvious to one of ordinary skill in the art that the CVD of Puebla does not comprise milling the silicon particles, or that the silicon particles of Puebla are non-etched silicon particles, respectively, as instantly claimed.
Regarding claim 5, since Puebla discloses loading the silicon particles with an anticancer drug, mixing the silicon particles with the anticancer drug would have been obvious.
Regarding claim 6, Puebla further discloses wherein “silicon” refers to element Si ([0037]). Regarding the claimed amounts of elemental silicon (i.e. at least 50% by weight), although Puebla does not explicitly disclose an amount, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed amount of elemental silicon through routine experimentation depending on the microspheres desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 7, Puebla further discloses wherein the silicon particles comprise amorphous silicon ([0158]-[0159]). Regarding the claimed amounts of amorphous silicon (i.e. at least 50% by weight), although Puebla does not explicitly disclose an amount, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed amount of elemental silicon through routine experimentation depending on the microspheres desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Puebla et al. (EP 2946793 A1, 11/25/2015, IDS reference) (hereinafter Puebla) in view of Lumen et al. (“Investigation of silicon nanoparticles produced by centrifuge chemical vapor deposition for applications in therapy and diagnostics”, 12/3/2020, IDS reference) (hereinafter Lumen).
The disclosure of Puebla has been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the silicon particles comprises crystalline silicon.
However, Lumen discloses silicon particles produced by centrifuge chemical vapor deposition (CVD) using elemental silicon (abs), producing amorphous silicon particles that can be further crystallized thermally (p.261, col. 2, ¶ 2, lns. 11-13). Lumen further discloses wherein said process circumvents the limitations of milling (p.264, col. 2, ¶ 2, lns. 3-5).
Accordingly, it would have been obvious to one of ordinary skill in the art to have further crystallized the silicon particles of Puebla since it is a known and effective process suitable for production of silicon particles through chemical vapor deposition.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Puebla et al. (EP 2946793 A1, 11/25/2015, IDS reference) (hereinafter Puebla) in view of Xu (“Synthesis, characterization and functionalization of silicon nanoparticle based hybrid nanomaterials for photovoltaic and biological applications”, 2014, IDS reference).
The disclosure of Puebla has been discussed in detail supra, and differs from the instant claim insofar as not explicitly disclosing wherein the drug is in the form of a cyclodextrin complex.
However, Xu discloses wherein silicon nanoparticles may be loaded with a drug by mixing with molecules such as cyclodextrin, which can be used in cancer therapy (p.231-239).
Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the silicon particles of Puebla such that the drug is in the form of a cyclodextrin complex, since it is a known and effective way to deliver cancer therapy drugs loaded onto silicon particles as taught by Xu.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Puebla et al. (EP 2946793 A1, 11/25/2015, IDS reference) (hereinafter Puebla) in view of Sailor et al. (US 2021/0000744 A1, priority 03/26/2019) (hereinafter Sailor).
The disclosure of Puebla has been discussed in detail supra, and differs from the instant claim insofar as not explicitly disclosing a claimed drug.
However, Sailor discloses drug delivery formulations comprising a porous silicon material (abs). Suitable drugs include polyketide therapeutic agents including amphotericin B ([0076], [0127]).
Accordingly, it would have been obvious to one of ordinary skill in the art to load the silicon particles with amphotericin, since it is a known and effective drug suitable for loading onto silicon particles as taught by Sailor. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-22 of copending Application No. 18/556,490 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims encompass same or substantially similar scope as the instant claims (i.e. silicon particles for drug delivery prepared via centrifuge chemical vapor deposition (CVD)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612