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 .
Restriction Response
Applicant’s election with traverse of Group I (claims 1-9, 11, 13-14, 16, and 19-21) in the reply filed on 12/18/25 is acknowledged. The traversal is on the ground(s) that the Examiner has not alleged that there is no special technical feature. This is not persuasive because the instant application is not a 371 of a PCT application. The instant application is a US application and is not subject to PCT standards.
Applicant also argues that searching each of the Groups would not be a serious burden if all of the claims are examined together and refers to MPEP § 803. This is not persuasive because, as discussed in the Restriction requirement mailed on 10/30/25, the process for using the product of Group II can be practiced with another materially different product such as penicillin. The rationale for distinctness for all the groups is provided in the Restriction requirement. There is serious examination burden since the inventions are likely to raise different non-prior art issues under 35 U.S.C. 112, first paragraph.
Applicant’s statement that the non-elected claims will be considered for rejoinder should the elected claims be found allowable, and Applicant’s right to introduce non-elected subject matter in this or a separate continuation or divisional application are acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 22 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1-9, 11, 13-14, 16, and 19-21 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/12/24 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
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 1 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 pre-AIA the applicant regards as the invention.
In claim 1, line 5, the recitation of “one or a plurality of pores” is unclear. Could the microparticle exterior surface contain only one pore? Clarification and/or amendment are required.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-8, 11, 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kolasinski et al. (US 2021/0035811 A1 – “Kolasinski”).
Instant claim 1 is drawn to a composition comprising a solid substrate comprising silicon greater than about 90% in weight relative to total weight of the solid substrate and greater than about 0.1% weight in oxygen relative to the total weight of the solid substrate;
wherein the solid substrate is in the form of a microparticle comprising an exterior surface and one or a plurality of pores defining one or a plurality of interior surfaces;
wherein the solid substrate is no more than about 500 microns at its greatest length; and
wherein at least about 50% of the exterior surface comprises protrusions or asperities and/or a relative roughness of about 1% to about 10% of its exterior surface.
Kolasinski teaches an injection metal-assisted catalytic etching (MACE) cycle for etching Si which forms a pore in the silicon substrate ([0011]). Kolasinski teaches porous silicon microparticles produced by a low-load injection metal assisted catalytic etching (LL-iMACE) process ([0023]-[0024], [0043]-[0044], FIGS. 2A, 2B, 7(a) and 7(b), claims 1) and using copper as a catalyst that initiates nanostructure formation ([0049]-[0050]). TABLE 1 discloses the yields, surface areas, and pore volumes for powders milled to different sizes from different Si grades etched in the low load regime (LL-iMACE) and include metallurgical grade (MG) Si (99.6% polycrystalline) ([0037]). The particle size of the MG sample is 44-75 µm and has a pore volume of 0.235 cm3/g (TABLE 1). The cross-sections in FIG. 2(c) reveal a roughened Si surface ([0031]). Kolasinski teaches that nanoparticles of any metal with a positive standard reduction potential E° could be deposited galvanically, including Cu ([0012], [0032], FIGS. 2(d)-(f)).
Kolasinski does not expressly teach greater than about 0.1% weight in oxygen relative to the total weight of the solid substrate or a relative roughness of about 1% to about 10% of its exterior surface.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising roughened porous silicon microparticles comprising MG Si at 99.6%, wherein the particle size of the MG sample is 44-75 µm, as taught by Kolasinski, where the calculated remainder of the MG Si is 0.4%, adjust the surface roughness, and produce the instant invention.
One of ordinary skill in the art would have been motivated to modify the surface roughness based on the desired exterior surface to attach various moieties for different functions, unless there is evidence of criticality or unexpected results.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of a composition comprising a solid substrate comprising silicon greater than about 90% in weight relative to total weight of the solid substrate would have been obvious over the metallurgical grade (MG) Si (99.6% polycrystalline) ([0037]), as taught by Kolasinski.
Regarding instant claim 1, the limitation of greater than about 0.1% weight in oxygen relative to the total weight of the solid substrate would have been obvious over the calculated remainder of the MG Si taught by Kolasinski which is 0.4%.
Regarding instant claim 1, the limitation of the solid substrate in the form of a microparticle comprising an exterior surface and one or a plurality of pores defining one or a plurality of interior surfaces would have been obvious over the porous silicon microparticles ([0023]-[0024], [0043]-[0044], FIGS. 2A, 2B, 7(a) and 7(b), claims 1), as taught by Kolasinski.
Regarding instant claim 1, the limitation of the solid substrate not being more than about 500 microns at its greatest length would have been obvious over the particle size of the MG sample of 44-75 µm (TABLE 1), as taught by Kolasinski.
Regarding instant claim 1, the limitation of at least about 50% of the exterior surface comprising protrusions or asperities and/or a relative roughness of about 1% to about 10% of its exterior surface would have been obvious over the roughened Si surface (FIG. 2(c), [0031]), as taught by Kolasinski unless there is evidence of criticality or unexpected results. One of ordinary skill in the art would have found it obvious to prepare the roughened Si surface as taught by Kolasinski and adjusted the relative roughness based on the desired exterior surface to attach various moieties for different functions.
Regarding instant claims 2, 3, 4, and 6, the limitations of the exterior surface comprising a metal (instant claim 2), nanoparticles (instant claim 3), and wherein the metal is copper, silver, gold, platinum or palladium (instant claims 4 and 6) would have been obvious over the copper ([0049]-[0050]), and the nanoparticles of any metal including Cu that are deposited on the exterior surface ([0012], [0032], FIGS. 2(d)-(f)), as taught by Kolasinski.
Regarding instant claims 5 and 6, the limitations of the solid substrate comprising silicon at about 98% (instant claim 5) and about 99% (instant claim 6) in weight relative to total weight of the solid substrate would have been obvious over the metallurgical grade (MG) Si (99.6% polycrystalline) ([0037]), as taught by Kolasinski.
Regarding instant claim 7, the limitation of the exterior surface comprising a region of hydrophilicity would have been obvious over the copper ([0049]-[0050]), and the nanoparticles of any metal including Cu that are deposited on the exterior surface ([0012], [0032], FIGS. 2(d)-(f)), as taught by Kolasinski, since this is a property associated with the exterior surface of the solid substrate. Since the prior art teaches the same solid substrate with the same exterior surface one of ordinary skill in the art would have expected the same properties of a region of hydrophilicity to be present.
Regarding instant claim 8, the limitation of the solid substrate in an aqueous solution having a zeta potential from about +20 to about +80 mV would have been obvious over the MG Si 99.6% ([0037]) in the form of porous silicon microparticles ([0023]-[0024], [0043]-[0044], FIGS. 2A, 2B, 7(a) and 7(b), claims 1), and the Cu nanoparticles that are deposited on the exterior surface ([0012], [0032], FIGS. 2(d)-(f)), as taught by Kolasinski, since this is a property associated with the solid substrate. Since the prior art teaches the same solid substrate with the same exterior surface one of ordinary skill in the art would have expected the same properties of the zeta potential of the solid substrate in an aqueous solution to be present.
Regarding instant claim 11, the limitation of the solid substrate in powdered form would have been obvious over the MG Si 99.6% in powdered form ([0037] and TABLE 1), as taught by Kolasinski.
Regarding instant claim 13, the limitation of the microparticle Brunauer, Emmett, Teller (BET) comprising a surface area of from about 20 to about 900 cm2/g would have been obvious over the BET surface area of 58.1 m2/g (TABLE 1) and the milled Si grades ([0037]), as taught by Kolasinski. One of ordinary skill in the art would have found it obvious to mill the Si grade as taught by Kolasinski and arrive at the claimed surface area range based on the desired particle surface area for the final application of the milled Si particles, unless there is evidence of criticality or unexpected results.
Regarding instant claim 14, the limitation of the microparticle comprising a pore volume of from about 0.05 to about 1.9 cm3/g per gram of mass of the microparticle would have been obvious over the pore volume of 0.235 cm3/g of MG Si (TABLE 1), as taught by Kolasinski.
Regarding instant claim 16, the limitation of the ratio of height to length at longest dimension of the microparticle of from about 1:4 to about 1:20 would have been obvious over the porous silicon microparticles ([0023]-[0024], [0043]-[0044], FIGS. 2A, 2B, 7(a) and 7(b), claims 1), as taught by Kolasinski. One of ordinary skill in the art would have found it obvious to use the porous Si microparticles as taught by Kolasinski and determine the ratio of height to length at longest dimension of the microparticles and arrive at the claimed ratio range based on the desired particle surface area for the final application of the microparticles, unless there is evidence of criticality or unexpected results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kolasinski et al. (US 2021/0035811 A1 – “Kolasinski”), as applied to claims 1-8, 11, 13-14, and 16 above, in view of Tieu et al. (Adv. Therap. 2019, 2, 1800095, pp. 1-25 – “Tieu”).
Instant claim 9 is drawn to the composition of claim 7, wherein the region of hydrophilicity across the exterior surface comprises polar adsorbates.
The teaching of Kolasinski is discussed above.
Kolasinski does not expressly teach that the exterior surface comprises polar adsorbates.
Tieu teaches advances in porous silicon-based nanomaterials for diagnostic and therapeutic applications (Title and Abstract). The surface of the porous silicon microparticle is functionalized with arginine and polyethyleneimine, and the positive charge of the particle enabled the electrostatic binding of siRNA into the porous structure (Page 7 of 25, 3rd full ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising roughened porous silicon microparticles comprising MG Si at 99.6%, wherein the particle size of the MG sample is 44-75 µm, as taught by Kolasinski, where the calculated remainder of the MG Si is 0.4%, adjust the surface roughness, in view of the porous silicon microparticle functionalized with the polar amino acid arginine, as taught by Tieu, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because of the advantage of having a porous silicon microparticle functionalized with arginine and polyethyleneimine, wherein the positive charge of the particle enabled the electrostatic binding of siRNA into the porous structure (Page 7 of 25, 3rd full ¶), as taught by Tieu.
Regarding instant claim 9, the limitation of the exterior surface comprising polar adsorbates would have been obvious over the surface of the porous silicon microparticle functionalized with arginine and polyethyleneimine, and the positive charge of the particle enabling the electrostatic binding of siRNA into the porous structure (Page 7 of 25, 3rd full ¶), as taught by Tieu.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kolasinski et al. (US 2021/0035811 A1 – “Kolasinski”), as applied to claims 1-8, 11, 13-14, and 16 above, in view of Hussain et al. (Nat Biomed Eng. 2018 February; 2(2): 95-103, author manuscript pages 1-21 – “Hussain”).
Instant claim 19 is drawn to the composition of claim 1, wherein the exterior surface of the microparticle is bound to a therapeutic agent.
The teaching of Kolasinski is discussed above.
Kolasinski does not expressly teach that the exterior surface of the microparticle is bound to a therapeutic agent.
Hussain teaches that antibiotic-loaded nanoparticles targeted to the site of infection enhance antibacterial efficacy (Title and Abstract). Porous silicon nanoparticles have a high loading capacity for drugs and a readily modified surface to accommodate targeting groups (Page 3, 1st full ¶). The antibiotic vancomycin was incorporated into porous silicon nanoparticles (pSiNPs) (Page 5, 1st full ¶). Hussain teaches that porous silicon nanoparticles loaded with vancomycin and targeted with the CARG peptide are several times more effective than free vancomycin in eradicating a staphylococcal lung infection (Page 6 – “Discussion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising roughened porous silicon microparticles comprising MG Si at 99.6%, wherein the particle size of the MG sample is 44-75 µm, as taught by Kolasinski, where the calculated remainder of the MG Si is 0.4%, adjust the surface roughness, in view of the porous silicon nanoparticles loaded with vancomycin, as taught by Hussain, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because of the advantage of the porous silicon nanoparticles loaded with vancomycin and targeted with the CARG peptide that are several times more effective than free vancomycin in eradicating a staphylococcal lung infection (Page 6 – “Discussion”), as taught by Hussain.
Regarding instant claim 19, the limitation of the exterior surface of the microparticle bound to a therapeutic agent would have been obvious over the antibiotic vancomycin incorporated into porous silicon nanoparticles (pSiNPs) (Page 5, 1st full ¶), wherein the porous silicon nanoparticles loaded with vancomycin and targeted with the CARG peptide which are several times more effective than free vancomycin in eradicating a staphylococcal lung infection (Page 6 – “Discussion”), as taught by Hussain.
Regarding instant claim 20, the limitation of a pharmaceutical composition comprising the composition of claim 1 and a pharmaceutically acceptable carrier would have been obvious over the intravenously injected vancomycin-loaded porous silicon nanoparticles (Abstract, Page 5, last ¶, Page 11, last ¶), as taught by Hussain.
Regarding instant claim 21, the limitation of a liquid dosage form wherein the solid substrate is at a weight from about 0.1% to about 5.0% would have been obvious over the aqueous dispersion of pSiNPs (1 mg/mL in deionized water) added to an aqueous solution of vancomycin (0.5 mg/mL) in a 1:1 (v:v) ratio (Page 10, last ¶), as taught by Hussain. One of ordinary skill in the art would have found it obvious to adjust the amount of the solid substrate based on the desired therapeutic administration and the dosage of the active ingredient. The recited range would have been an obvious variant unless there is evidence of criticality or unexpected results.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615