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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 03 Nov 2025 has been entered.
Claims 1, 2, 6-9, 12, 15-18, and 21-29 remain pending in the application.
Claim 1 is amended.
Claims 3-5, 10, 11, 15, 19 and 20 are cancelled.
Claims 18, 23 and 24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 2, 6-9, 12, 13, 16, 17, 21, 22, and 25-29 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 Nov 2025, is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 01 Aug 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of the claims pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 01 Aug 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained
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.
The rejection below was applied previously as is reapplied again and updated to address the claim amendments and new claims 25 and 26.
Claims 1, 6-9, 17, 21, 22, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023) in view of Kim et al. (Chem. Mater. 2019, 31, 5502−5508).
Wang teaches a method of preparing coated particles having an active pharmaceutical ingredient (API) containing core enclosed by one or more metal oxide layers and one or more polymer layers ([0005]). Wang teaches the method includes performing atomic layer deposition to apply a metal oxide layer to particles comprising an API, thereby preparing particles comprising an API enclosed by a metal oxide layer ([0009]). Wang teaches that the metal oxide layer may be silicon dioxide ([0013]), rendering obvious the silicon oxide layer of claim 1. Wang teaches that the API or drug includes all small molecules ([0031]) such as acetaminophen ([0032]). Small molecules such as acetaminophen renders obvious the category of organic compound and thus Wang renders obvious step (a) of claim 1 and the providing uncoated particles of organic compound API. Wang teaches that the step of performing atomic layer deposition comprises (a1) loading the particles comprising the API into a reactor; (a2) applying a vaporous or gaseous metal precursor to the particles in the reactor, (a3) performing one or more pump-purge cycles of the reactor using inert gas; (a4) applying a vaporous or gaseous oxidant to the particles in the reactor; and (a5) performing one or more pump-purge cycles of the reactor using inert gas ([0010]). Wang teaches that the gases may be supplied in pulses ([0055]), rendering obvious the “pulsing” of steps (b2) and (b4) of claim 1. Wang teaches that the oxidant may be ozone ([0021]). Steps (a1-a5) taught by Wang as described above are the same active steps of (b1-b5) of instant claim 1, rendering obvious the instant method steps b1-b5. Wang teaches the coated particles as part of a pharmaceutical composition ([0009]) and that the temperature of the interior of the reactor need not exceed 100°C, 50°C, 40°C ([0021]) and the reactor system permits coating to be performed at lower processing temperatures such as below 50°C ([0041], [0074]), rendering obvious step (c) of claim 1 and the temperatures of claim 1. Wang teaches that the metal oxide layers are pin-hole free ([0008]) rendering obvious the pin-hole free limitation of step (c).
Regarding claim 6, Wang teaches that a subset of vapor or gaseous content is pumped out prior to step (a3) or (a5) ([0013]). Wang teaches that the metal oxide layer has an average thickness of 0.1 to 30 nm and a median particle size, on a volume average basis between 0.1 μm and 20 μm ([0007], ([0013]), rendering obvious claims 7, 8, 25 and 26. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Wang teaches admixing the coated particles with a pharmaceutically acceptable diluent or carrier to form a mixture and processing the mixture to form a tablet or capsule ([0018]). Combining with a pharmaceutically acceptable diluent or carrier render obvious the combination with an excipient as in claim 9. Regarding claim 17, Wang teaches that the reactor contents may be agitated during step a1, a3 or a5 ([0013]). Wang teaches hydrophobic polymer coatings for the particles ([0037]), rendering obvious the coated particles exhibiting similar or increased hydrophobicity to uncoated particles as in claim 21.
Wang does not teach the silicon precursor BDIPADS or that that the silicon oxide coating is free of HCl and Cl (claim 22). These deficiencies are made up for in the teachings of Kim.
Kim teaches a low-temperature thermal atomic layer deposition process for fabricating silicon dioxide thin films using BDIPADS together with ozone (abstract). Kim teaches that the films form without the aid of plasma-enhanced or catalyzed surface reactions and form high quality silicon dioxide films with relatively high growth rates, high film densities and low impurity content compared to conventional silicon precursors and that the films can be attained at a low growth temperature of about 50 °C (abstract). Kim teaches that the processing temperature for forming silicon dioxide layers using Kim teaches that BDIPADS and ozone form high-quality Si-O2 at 50 °C without plasma or catalytic reactions (page 5503 right column). SiCl4 and H2O can be decreased to room temperature using catalysts but that a reaction product is HCl which may impede SiO2 film growth (page 5503 left column). Kim teaches that the impurity concentration and chemical bonding features in the thin films are crucial factors that determine the resulting film quality (page 5504 right column last paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used BDIPADS as the metal precursor in the method of forming silicon dioxide coated particles as described by Wang. Forming silicon dioxide coated drug particles using ozone as an oxidant in a low temperature atomic layer deposition method is known from the teachings of Wang. Wang doesn’t teach the silicon precursor to use for the deposition process but it is known from Kim that BDIPADS is able to react with ozone to form high quality films as part of a low temperature atomic layer deposition method. Thus, it would have been obvious to use BDIPADS as the precursor as it is known to react with ozone to form high quality silicon dioxide layers at low temperature with an atomic layer deposition method. One would have a reasonable expectation of success as the deposition method for forming silicon dioxide particles is known from Wang and BDIPADS is known to be useful as a precursor for forming silicon dioxide layers with low temperature atomic layer deposition without the need for plasma or added catalysts. One of ordinary skill would easily recognize BDIPADS as a suitable precursor element for forming silicon dioxide layers with atomic layer deposition. Regarding claim 22, the teaching of Kim that HCl may impede silicon dioxide growth and impurity concentration is a critical factor in determining the resulting film quality render it obvious to maintain the silicon oxide layer free of impurities for improved film quality. One would have a reasonable expectation of success as BDIPADS and ozone form high quality films and one would desire to avoid HCl and Cl for improved layer growth and improved quality of the final film.
Therefore, the invention as a whole was 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.
Response to Arguments
Applicant's arguments filed 03 Nov 2025 have been fully considered but they are not persuasive. Applicant states that there is not a reasonable expectation of success that BDIPADS can be used to apply a pin-hole free coating to small particles at the recited temperature (page 8 of remarks). The applicant provided Exhibit A to indicate that small particles tend to agglomerate. The applicant then asserts that the agglomeration would be expected to lead to pin-holes in the coating of the particles when coating with BDIPADS as BDIPADS has high boiling point/low vapor pressure which makes it difficult to penetrate agglomerated particles (page 9 of remarks). The applicant notes that Wang did not try BDIPADS and that Kim did not coat small particles (page 9 of remarks). The examiner is not persuaded by this. The examiner notes that Wang teaches pin-hole free coatings ([0008]), rendering this an obvious feature for such particles. The sections of Exhibit A and B pointed to by the applicant do not clearly make the connections leading to the conclusion asserted by the applicant that small particles agglomerate and that high boiling point precursors are not expected to fully coat particles in the context of atomic layer deposition. Noting that Kim does not test small particles is not persuasive as Kim is used merely to indicate that BDIPADS is a suitable precursor for forming silicon films with ALD. Small particles are known from Wang and there is nothing to indicate that one of ordinary skill would not understand BDIPADS, as taught by Kim, as a suitable precursor for the same kind of atomic layer deposition method. BDIPADS is a clearly a known ALD precursor element and it would be obvious to use it for this known purpose.
The applicant argues that Wang and Kim do not teach using BDIPADS at 35-50 °C (pages 9-11 of remarks). The applicant argues that Wang teaches the low processing temperatures generally but does not teach BDIPADS. The applicant argues that Kim found BDIPADS resulted in more impurities (Si-H moieties) at low temperatures (less than 80 °C) (page 11 of remarks). The examiner is not persuaded by this argument. The observations made by Kim regarding the lower temperatures, as noted by the applicant, does not indicate that Kim considered BDIPADS as unsuitable at the lower temperatures. The emphasis in the teachings of Kim is that the ALD process is suitable at lower temperatures such as 50 °C. For example, Kim states that “our data suggest that even without the aid of plama-enhanced or catalyzed surface reactions, high-quality SiO-2 films with relatively high growth rates, high film densities and low impurity contents compared to conventional Si precursors can be attained through our process at a low growth temperature (~50 °C)” (abstract). Similarly, Kim states that “high-quality SiO2 film growth at temperatures as low as 50 °C was achieved without introducing plasma or catalytic reactions” (page 5503 right column). Again, Kim states “In summary, high-quality ALD Si-O2 thin films were grown using a novel BDIPADS precursor in conjunction with O3 for a wide range of temperatures from 50 to 250 °C. Through various analytical methods, it is clear that relatively high growth rates, high film densities, and low impurity contents can be achieved even at low growth temperatures (≤80 °C) when compared to previously reported studies of ALD SiO-2 using other Si precursors” (page 5506 Conclusions). Thus, Kim still considers the films formed at the lower temperatures to be of “high-quality.” Further, based on these statements from Kim, it is known that other precursors would result in a greater amount of impurities or a lower quality of film, further supporting the obviousness of selecting BDIPADS for use at the low temperatures of Wang as BDIPADS has been demonstrated successful by Kim. Kim does observe, as noted by the applicant, that the film has different characteristics when formed at the lower temperatures verse the higher temperatures, but does not make any further assessments that one would recognize as teaching away from the suitability of BDIPADS as a precursor at low temperatures. Instead, as noted above, Kim places the films formed at the low temperatures such as 50 °C in the category of high-quality films.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023) in view of Kim et al. (Chem. Mater. 2019, 31, 5502−5508) as applied to claims 1, 6-9, 11, 17, 21, 22, 25 and 26above and further in view of Carlsson et al. (US 2018/0221294, published 09 Aug 2018).
The teachings of Wang and Kim are described supra.
Wang and Kim do not teach that the uncoated particles are crystalline. This deficiency is made up for in the teachings of Carlsson.
Carlsson teaches drug delivery system ([0010]) nanoparticles having a solid core enclosed by an inorganic coating (abstract, [0022]) such as a metal oxide ([0068]) such as silicon dioxide ([0075]) that may be applied with ALD ([0079]). Carlsson teaches that the nanoparticle core may be comprised of a biologically active substance that is crystalline ([0061], [0062]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have the uncoated particles rendered obvious over Wang and Kim as crystalline. Coating drug particles with silicon oxide layers with ALD is known from Wang and drug delivery systems coated with silicon oxide layers with ALD is similarly known from Carlsson. It is known that crystalline particles are suitable for such a coating system as Carlsson indicates that the particle core may be comprised of a biologically active substance that is crystalline. Thus, it would have been obvious to one of ordinary skill to use crystalline particles as this is a form of biologically active substances suitable for drug delivery and one would have a reasonable expectation of success as the utility of coating such particles is taught by Carlsson.
Therefore, the invention as a whole was 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.
Claims 12, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023) in view of Kim et al. (Chem. Mater. 2019, 31, 5502−5508) as applied to claims 1, 6-9, 11, 17, 21, 22, 25 and 26 above and further in view of Won et al. (J. Vac. Sci. Technol. A 30, 01A126 (2012)).
The teaching of Wang and Kim are described supra.
Wang and Kim do not teach holding times of 1 min to 1 hour or forming ozone with an ozone generator with an oxygen flow rate of 100 sccm. These deficiencies are made up for in the teachings of Won.
Won teaches silicon oxide grown by atomic layer deposition using Bis(ethyl-methyl-amino)silane (BEMAS) and ozone (title, abstract). Won teaches that the oxygen flow rate into the ozone generator was 150 or 300 sccm, which gave an ozone concentration of ~3 or ~6 wt. % (page 01A126-2 Experiment). Won teaches that the typical ALD cycle was composed of a source pulse (1 or 2 s), source purge (2 or 4 s), reactant pulse (0.5 or 1 or 2 s), and reactant purge (4 or 8 s) process (page 01A126-2 Experiment). Won teaches that the deposition thicknesses became almost constant after a 1 s purge of BEMAS, as well as after a 4 s purge of ozone when the O2 flow rate was 300 sccm and that an ozone purge time of 2 s was sufficient for an O2 flow rate of 150 sccm (page 01A126-3 left column). Won teaches that the growth rate is directly related to the ozone concentration and that the growth rate is not altered by the oxygen flow rate when the pulse and purge times are sufficient (page 01A126-3 left column). Won determined the film thickness as function of the BEMAS and ozone pulse times (Figure 2), the BEMAS and ozone purge times (Figure 3) and the oxygen flow rate (Figure 4a).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have ozone generated using an ozone generator and to adjust the oxygen flow rate and to also adjust the pulse times for the BDIPADS and ozone for optimal growth of the silicon dioxide layer. Silicon oxide layers grown by atomic layer deposition using a silicon precursor and ozone where the ozone is derived from an ozone generator, is known from Won, rendering it obvious to use an ozone generator as a source of ozone for ALD. Regarding the holding times of 1 minute to 1 hour and the oxygen flow rate of 100 sccm, in view of the teachings of Won that the growth rate and film thickness are dependent on the ozone concentration and the pulse and purge times of the reactant precursor and ozone, the holding time and the oxygen flow rates are art-recognized result effective variables such that determining holding times of the BDIPADS and ozone of 1 minute to 1 hour and an oxygen flow rate of 100 sccm would be a matter of optimization through routine experimentation. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is clear from the teachings of Won that the growth rate of the film layers is dependent on the time the silicon precursor and ozone are applied in the reaction and on the ozone concentration which is dependent on the oxygen flow rate. One of ordinary skill would thus recognize the need to determine the optimal holding times for the BDIPADS and ozone reactants and for the oxygen flow rate with the ozone generator in order to develop the film to a desired thickness at a specific rate.
Therefore, the invention as a whole was 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.
New Grounds of Rejections
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023) in view of Kagaya (US 2021/0217609, published 16 Jul 2021, filed 27 May 2019).
Wang teaches a method of preparing coated particles having an active pharmaceutical ingredient (API) containing core enclosed by one or more metal oxide layers and one or more polymer layers ([0005]). Wang teaches the method includes performing atomic layer deposition to apply a metal oxide layer to particles comprising an API, thereby preparing particles comprising an API enclosed by a metal oxide layer ([0009]). Wang teaches that the metal oxide layer may be silicon dioxide ([0013]), rendering obvious the silicon oxide layer of claim 27. Wang teaches that the API or drug includes all small molecules ([0031]) such as acetaminophen ([0032]). Small molecules such as acetaminophen renders obvious the category of organic compound and thus Wang renders obvious step (a) of claim 27 and the providing uncoated particles of organic compound API. Wang teaches that the step of performing atomic layer deposition comprises (a1) loading the particles comprising the API into a reactor; (a2) applying a vaporous or gaseous metal precursor to the particles in the reactor, (a3) performing one or more pump-purge cycles of the reactor using inert gas; (a4) applying a vaporous or gaseous oxidant to the particles in the reactor; and (a5) performing one or more pump-purge cycles of the reactor using inert gas ([0010]). Wang teaches that the gases may be supplied in pulses ([0055]), rendering obvious the “pulsing” of steps (b2) and (b4) of claim 1. Wang teaches that the oxidant may be ozone ([0021]). Steps (a1-a5) taught by Wang as described above are the same active steps of (b1-b5) of instant claim 27, rendering obvious the instant method steps b1-b5. Wang teaches the coated particles as part of a pharmaceutical composition ([0009]) and that the temperature of the interior of the reactor need not exceed 100°C, 50°C, 40°C ([0021]) and the reactor system permits coating to be performed at lower processing temperatures such as below 50°C ([0041], [0074]), rendering obvious step (c) of claim 27 and the processing temperatures. Wang teaches that the metal oxide layers are pin-hole free ([0008]) rendering obvious the pin-hole free limitation of step (c). Wang teaches that the metal oxide layer has an average thickness of 0.1 to 30 nm and a median particle size, on a volume average basis between 0.1 μm and 20 μm ([0007], ([0013]), rendering obvious claims 28 and 29. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Wang does not teach the silicon precursor DIPAS. This deficiency is made up for in the teachings of Kagaya.
Kagaya teaches a method for forming a thin film on a substrate using atomic layer deposition ([0001]). Kagaya teaches forming a silicon oxide film by ALD with an aminosilane precursor ([0058]) and specifically teaches that the precursor is DIPAS and the reaction gas may be ozone ([0026]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used DIPAS as the silicon precursor compound in the ALD method of forming silicon dioxide coated particles as described by Wang. Forming silicon dioxide coated drug particles using ozone as an oxidant in a low temperature atomic layer deposition method is known from the teachings of Wang. Wang doesn’t teach the silicon precursor to use for the deposition process but it is known from Kagaya that DIPAS is a suitable silane precursor for forming silicon oxide films as part of an atomic layer deposition method. Thus, it would have been obvious to use DIPAS as the precursor as it is known for use in ALD as a precursor for forming silicon oxide layers. One would have a reasonable expectation of success as the deposition method for forming silicon dioxide particles is known from Wang and DIPAS is known to be useful as a precursor for forming silicon oxide layers in atomic layer deposition and thus merely represents the use of a known prior art element for its known function as a precursor in ALD.
Therefore, the invention as a whole was 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.
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.
The double patenting rejections below were previously applied are now reapplied addressing the claim amendments and new claims.
Claims 1, 2, 6-9, 12, 13, 16, 17, 21, 22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 14, 18, 22, 23, 27, 32, 51 and 52 of copending Application No. 18/674,730 in view of Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023), Kim et al. (Chem. Mater. 2019, 31, 5502−5508) , Carlsson et al. (US 2018/0221294, published 09 Aug 2018), Won et al. (J. Vac. Sci. Technol. A 30, 01A126 (2012)) and Kagaya (US 2021/0217609, published 16 Jul 2021, filed 27 May 2019).
The ‘730 application recites in claim 1 a method of preparing coated particles comprising drug-containing core enclosed by an inorganic oxide coating comprising steps of loading particles comprising a drug into a chamber of a reactor and applying precursor and reactant compounds and having purging steps (steps b1-b4), a silicon oxide precursor (claim 6) and a temperature between 25 and 60 °C (claim 18).
The method of the ’730 application comprises additional coating steps (e.g. c1-c4 and d) that are not recited in the instant claims, but these additional steps are allowed for in the instant method due to the comprising language used.
The active method steps of the ‘730 application are the same as the instant method steps except that the precursor is not specified as DIPAS or BDIPADS, the drug is not limited to an organic compound, the oxidant is not specified as ozone, the particles are not specified as part of a pharmaceutical composition, a subset of vapor or gas is not specified as being pumped out, agitating the API and that the uncoated particles are crystalline. Further the ‘730 application does not specify the pin-hole free layer, layer thickness, particle size, excipients, the holding times and the oxygen flow rate in an ozone generator, the hydrophobicity of the particles and the absences of HCl and Cl. These deficiencies are made up for in the teachings of Wang, Kim, Carlsson, Won and Kagaya.
The teachings of Wang, Kim, Carlsson, Won and Kagaya are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used BDIPADS or DIPAS as a precursor, small molecule drugs, ozone as an oxidant, to pump a subset of vapors as a processing step, agitating the API, the layers pin-hole free, crystalline uncoated particles and to have layer thickness from 0.1 to 30 nm, a particle size from 0.1 μm and 20 μm, to have incorporated the particles in a pharmaceutical composition comprising diluents (i.e. excipients), to incorporate a hydrophobic polymer layer and to have the layer free of HCl and Cl. A similar method of forming coated particles as the ‘730 application is known from Wang, who further indicates silicon oxide coatings and ozone as a suitable oxidant for such methods and teaches pin-hole free layers. Lower processing temperatures such as below 50°C, pumping out a subset of gases, agitating the API and layer thicknesses of 0.1 to 30 nm and particle size of 0.1 μm and 20 μm are known as suitable for particles formed from such methods, as taught by Wang. Small molecules such as acetaminophen and incorporating such particles into pharmaceutical compositions with acceptable diluents and adding hydrophobic polymers are likewise known as suitable for such methods from Wang. One of ordinary skill would thus have a reasonable expectation of success in incorporating these elements into the method of the ‘730 application as they are known as useful and suitable for such a similar method as taught by Wang. It would have been obvious to use BDIPADS as the precursor as it is known to react with ozone to form high quality silicon dioxide layers at low temperature with an atomic layer deposition method, as taught by Kim, and it would be desirable to form high quality films. Further, impurities such as HCl hinder layer growth, as taught by Kim, rendering it obvious to keep the layer free of HCl and Cl. It would have been obvious to include DIPAS as a precursor as it is a known ALD precursor used in forming silicon oxide films and is thus merely represents using a known prior art element for its known function. Crystalline particles are known as suitable for being coated as part of drug delivery compositions, as taught by Carlsson, rendering it obvious to have the particle crystalline as it is a suitable form for such drug particles. It would have been obvious to use an ozone generator to form ozone as this is a known means of forming ozone of ALD methods, as taught by Won. It further would have been obvious to determine the optimal holding times for the gases and the optimal oxygen flow rate through routine optimization as these are result effective variables that are related to the growth rate and layer thickness when applying ALD methods.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-9, 12, 13, 16, 17, 21, 22, and 25-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-33, 37-47 and 52-76 of copending Application No. 19/236,809 in view of Wang et al. (US 2020/0338008, published 29 Oct 2020, listed in IDS filed 01 Dec 2023), Kim et al. (Chem. Mater. 2019, 31, 5502−5508) , Carlsson et al. (US 2018/0221294, published 09 Aug 2018), Won et al. (J. Vac. Sci. Technol. A 30, 01A126 (2012)) and Kagaya (US 2021/0217609, published 16 Jul 2021, filed 27 May 2019).
The ‘809 application recites in claim 26 a method of preparing an abuse-deterrent pharmaceutical composition comprising steps of loading particles comprising as antagonist into a chamber of a reactor and applying precursor and reactant compounds and having purging steps (steps b1-b4) to generate coated antagonist particles, a silicon oxide coating (claim 29) and a temperature between 25 and 60 °C (claim 32), a layer thickness between 0.1 nm to 120 nm (claim 38) and a partial pumping out of gases between steps (claim 61).
The method of the ‘809 application comprises additional coating steps and mixing with drug particles that are not recited in the instant claims, but these additional steps are allowed for in the instant method due to the comprising language used.
The active method steps of the ‘809 application are the same as the instant method steps except that the precursor is not specified as DIPAS of BDIPADS, the drug is not limited to an organic compound, pin-hole free layer, the oxidant is not specified as ozone, agitating the API and that the uncoated particles are crystalline. Further the ‘809 application does not specify excipients, particle size, the holding times and the oxygen flow rate in an ozone generator, the hydrophobicity of the particles and the absences of HCl and Cl. These deficiencies are made up for in the teachings of Wang, Kim, Carlsson, Won and Kagaya.
The teachings of Wang, Kim, Carlsson, Won and Kagaya are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used BDIPADS or DIPAS as a precursor, small molecule drugs, ozone as an oxidant, agitating the API, the layers pin-hole free, crystalline uncoated particles, to have incorporated the particles in a pharmaceutical composition comprising diluents (i.e. excipients), a particle size from 0.1 μm and 20 μm, to incorporate a hydrophobic polymer layer and to have the layer free of HCl and Cl. A similar method of forming coated particles as the ‘809 application is known from Wang, who further indicates silicon oxide coatings and ozone as a suitable oxidant for such methods and teaches pin-hole free layers. Agitating the API is also known as suitable for particles formed from such methods, as taught by Wang. Small molecules such as acetaminophen and incorporating such particles into pharmaceutical compositions with acceptable diluents and adding hydrophobic polymers are likewise known as suitable for such methods from Wang. One of ordinary skill would thus have a reasonable expectation of success in incorporating these elements into the method of the ‘809 application as they are known as useful and suitable for such a similar method as taught by Wang. The methods of Wang and the ‘809 application are of such similarity that using small molecules such as acetaminophen would have been an obvious substitution. It would have been obvious to use BDIPADS as the precursor as it is known to react with ozone to form high quality silicon dioxide layers at low temperature with an atomic layer deposition method, as taught by Kim, and it would be desirable to form high quality films. Further, impurities such as HCl hinder layer growth, as taught by Kim, rendering it obvious to keep the layer free of HCl and Cl. It would have been obvious to include DIPAS as a precursor as it is a known ALD precursor used in forming silicon oxide films and is thus merely represents using a known prior art element for its known function. Crystalline particles are known as suitable for being coated as part of drug delivery compositions, as taught by Carlsson, rendering it obvious to have the particle crystalline as it is a suitable form for such drug particles. It would have been obvious to use an ozone generator to form ozone as this is a known means of forming ozone of ALD methods, as taught by Won. It further would have been obvious to determine the optimal holding times for the gases and the optimal oxygen flow rate through routine optimization as these are result effective variables that are related to the growth rate and layer thickness when applying ALD methods.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 03 Nov 2025 have been fully considered but they are not persuasive. Applicant states that the copending applications were filed later than the instant application and thus the rejections should be withdrawn according to MPEP 1490. The examiner is not persuaded by this as there are rejections remaining in the instant application and the provision that the double patenting rejection may be withdrawn based on the earlier filing date is only applicable if the provisional double patenting rejection is the only rejection remaining.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600