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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 May 2026 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 08 May 2026 has been entered.
Claims 1, 2, 6-9, 16, 17, 21-25, and 30-35 remain pending in the application.
Claim 1 is amended.
Claims 3-5, 10-15, 19, 20, and 26-29 are cancelled.
Claims 30-35 are new.
Claims 18, 23 and 24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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, 16, 17, 21, 22, and 25-35 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08 May 2026 and 23 Jun 2026, are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 103
The rejections under 35 U.S.C. 103 are withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejections under double patenting are withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
New Grounds of Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment filed 08 May 2026 has introduced new matter into the claims. New claims 32 and 34 recite additional coating steps between steps b1 and b2 where a metal oxide layer is applied . The response filed 5/8/2026 indicates that support for the claims can be found in examples 1-6 and Figs 3, 7 and 11. This has been fully considered but is not found persuasive. The originally filed disclosure provides support for an additional aluminum oxide coating formed from TMA and water, but does not provide support for any metal oxide layer formed from any precursor and oxidant. Instant claims 32 and 34 recite limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in new claims 32 and 34 which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claims 32 and 34 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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.
Claims 1, 6-9, 17, 21, 22, 25 and 30-35 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) and Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
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 providing uncoated particles of organic compound API as in step (a) of claim 1. 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) 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. Wang teaches that the particles are in a drum that is rotated to agitate the particles and keep them separate and ensure a large surface area of the particles is exposed ([0050]), rendering obvious the coating of separate individual particles as in claim 1. Wang teaches that one or more of the gases can be supplied in pulses in which the chamber is filled with the gas to a specified pressure, a delay time is permitted to pass, and the chamber is evacuated by the vacuum pump before the next pulse commences ([0055], [0059], [0064]). The delay time of Wang is understood to render obvious a hold time as claimed.
Wang teaches that a subset of vapor or gaseous content is pumped out prior to step (a3) or (a5) ([0013]), rendering obvious claim 6. 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 the particle size and oxide layer thickness of claims 1, 7, 8, and 25. 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 increased hydrophobicity to uncoated particles as in claim 21.
Regarding claims 32-35, Wang teaches that the deposition reactor may be used with four gas sources to enable the in-situ formation of laminate structures having alternating layers of two different metal oxides ([0044]). Wang teaches metal oxide layers including aluminum oxide ([0008], [0013]) and teaches trimethylaluminum (TMA) and water vapor ([0045], [0058], [0079]). The process steps c1-c4 are the same as steps b2-b5 in claim 1 and are obvious from Wang, as described above. Thus, the laminate structure with alternating metal oxide layers taught by Wang renders obvious claims 32-35
Wang does not teach the silicon precursor BDIPADS or that that the silicon oxide coating is free of HCl and Cl (claim 22) or the specific holding times of claims 1, 30 and 31. These deficiencies are made up for in the teachings of Kim and Karuturi.
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 BDIPADS and ozone form high-quality Si-O2 at 50 °C without plasma or catalytic reactions (page 5503 right column). Kim teaches that the processing temperature for forming silicon dioxide layers using 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).
Karuturi teaches atomic layer deposition and that there is a need for understanding the deposition kinetics and optimizing the deposition process to fabricate defect-free nanostructures (abstract). Karuturi teaches that is a stop-flow process, a pulse step is divided into fill and hold, where the precursor gases are filled up to the set pressures and held at this pressure (page 14843 right column, Figure 1). Karuturi investigated the effect of various process parameters on the uniformity of TiO2 atomic layer deposition (page 14844 left column). Karuturi teaches implementing a stop-flow process for achieving a uniform filling and teaches studying the process parameters systematically (page 14846 left column), including varying the hold time (page 14846 right column, Table 1). Karuturi teaches that varying the hold time leads to variations in filling (Fig 6a) and Karuturi demonstrated an optimal hold time of 20 seconds for their coating process and indicated that less than this time produced lower infiltration and longer times worsened the uniformity (page 14847 left column).
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.
Regarding the specific holding times of claims 1, 30, and 31, these limitations are obvious as a matter of routine experimentation. In view of the teachings of Karuturi that the filling fraction during atomic layer deposition is related to the holding time, the holding time is an art-recognized result effective variable such that determining that the holding time is between 1 min to 1 hour 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 known from Wang that gases can be supplied in pulses so the chamber is filled with gas to a specified pressure and a delay time is permitted to pass before the chamber is evacuated by the vacuum pump. It is also known from Karuturi that varying the hold time leads to variable filling response in the deposition process and that an optimal value can be reached. Thus, it would have been obvious to one of ordinary skill to optimize the delay or holding time in the deposition process in order to achieve the desired deposition on the particle surface.
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 08 May 2026 have been fully considered but they are not persuasive.
Applicant argues that one would not have been motivated to modify Wang based on Kim to use BDIPADS as the precursor (page 7 part (1) of remarks). Applicant argues that a difficulty in coating small particles is that they tend to agglomerate and that it is difficult to form a pin-hole free coating (page 7 of remarks, ¶3 of 1.132 declaration). Applicant argues that Kim does not teach coating drug particles and one would not apply the BDIPADS precursor of Kim as it is not suitable for coating very small drug particles (page 7 of remarks, ¶6 of declaration). Applicant argues that BDIPADS has a high boiling point and tends to condense at the coating temperatures which causes more agglomeration and argues that BDIPADS has a low vapor pressure which makes it hard to apply a uniform coating (page 7 of remarks, ¶6 of declaration).
Applicant argues that there is no reasonable expectation of success to modify Wang based on Kim (page 8 part (2) of remarks). Applicant argues that Wang never tried the BDIPADS chemistry which has a high tendency to condense (page 8 of remarks, ¶7 of declaration). Applicant argues that the pin-hole free coatings of Wang are not relevant as Wang used a different coating chemistry (page 8 of remarks). Applicant argues that Kim coated silicon wafers and not small particles which is different due to the possibility of agglomeration with particles (page 8 of remarks).
Applicant argues for unexpected results (page 8 part (3) of remarks). Applicant points to pin-hole free coatings in figures 3, 7, and 11 of the specification and argues this is unexpected in view o the high boiling point and low vapor pressure of BDIPADS (page 8 of remarks, ¶8 of declaration).
The examiner is not persuaded by these remarks and maintains that each of the limitations are known in the art with a reasonable expectation of success in their combination. While there were undoubtedly difficulties and challenges in determining the best manner in which to construct the particles, the examiner notes that patentability shall not be negated by the manner in which the invention was made and the question is whether the invention would have been obvious to one of ordinary skill in the art. Each of the method limitations are clearly taught by Wang except for the BDIPADS precursor and the holding times, which are obvious limitations from the teachings of Kim and Karuturi. Specifically, Wang renders obvious silicon oxide coated drug particles with size from 0.1 μm and 20 μm and formed with ALD and renders obvious the operating temperatures, and pin-hole free features for the particles. It is known from Kim that BDIPADS is a suitable precursor for forming silicon oxide coatings with ALD and that BDIPADS can form films without the aid of plasma-enhanced or catalyzed surface reactions and can form high quality silicon dioxide films with relatively high growth rates, high film densities and low impurity content compared to conventional silicon precursors. Thus, based on the teachings of Kim, BDIPADS is an obvious precursor to use when forming silicon oxide coatings. 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 and the limitation of 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 of Wang. While BDIPADS may have boiling point and vapor pressure properties that add a challenge to using BDIPADS, this is not sufficient to overcome the prima facie case of obviousness for using BDIPADS as there is nothing in the art to suggest that BDIPADS would be unsuitable for this combination. The examiner notes that a person of ordinary skill is also a person of ordinary creativity, not an automaton, and in many cases will be able to fit teachings of multiple patents together like pieces of a puzzle. Furthermore, "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." The precursor BDIPADS is known from Kim as a precursor for forming high quality silicon oxide layers and would be obvious to incorporate into the teachings of Wang. Additionally, in respect to the applicants arguments regarding the challenges in working with BDIPADS at the low operating temperatures as claimed, Kim successfully demonstrates the use of BDIPADS at the claimed low temperature, further providing a reasonable expectation of success.
Regarding the argument for unexpected results, the examiner does not find the results pointed to as sufficient for overcoming the prima facie case of obviousness as presented. The applicant points to figure 3, 7, and 11 and argues that they are the first to successfully prepare separate individual particles with a pin-hole free coating. These figures show TEM cross-section images of coated particles and water drop testing on coated particles. The examiner does not find the argument for unexpected results sufficient as it is not clearly established that the results are truly unexpected, there is no comparative data, and the results are not commensurate in scope with the claims. For example, while the figures pointed to by the applicant show small sections of particles that are apparently pin-hole free there is nothing indicating how this is different or unexpected from the results of Wang which appear to be pin-hole free (e.g. Fig 3 and 5). While the applicant used a different precursor (BDIPADS) and has noted various properties that may make it difficult to work with (e.g. high boiling point, low vapor pressure), this does not adequately indicate results that are unexpected. Is there any evidence that BDIPADS has been tried on small particles previously and found unsuccessful? It is not clearly established by the applicant what is different about their method that makes coating with BDIPADS possible and would not be unexpected. The same method steps are taught by Wang and it is not evident what is different in the claimed method that would be understood as unexpected. Further, if the data presented are to be understood as unexpected, there has not been sufficient results presented that are commensurate in scope with the claims as the claims are broad in their limitations. For example, the particle size is from 0.1 μm to 1000 μm and the holding times are from 1 min to 1 hour and the gas pressure/flow rate are open ended and data has not been demonstrated that would indicate unexpected results across these ranges.
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) and Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010) as applied to claims 1, 6-9, 17, 21, 22, 25 and 30-35 above 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, Kim, and Karuturi 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, Kim and Karuturi 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.
Claim 16 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), and Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010) as applied to claims 1, 6-9, 17, 21, 22, 25 and 30-35 above and further in view of Won et al. (J. Vac. Sci. Technol. A 30, 01A126 (2012)).
The teaching of Wang, Kim, and Karuturi are described supra.
Wang, Kim, and Karuturi do not teach forming ozone with an ozone generator with an oxygen flow rate of 100 sccm. This deficiency is 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 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 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 oxygen flow rate is an art-recognized result effective variable such that determining 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 ozone concentration which is dependent on the oxygen flow rate. One of ordinary skill would thus recognize the need to determine the optimal 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.
Response to Arguments
Applicant's arguments filed 08 May 2026 have been fully considered but they are not persuasive. Applicant argues that Won does not teach a holding time after the BEMAS and ozone pulses (page 10 of remarks). The examiner notes that this argument is no longer relevant as the limitation of holding times has been rejected above as obvious as a matter of routine optimization over the teachings of Karuturi.
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, 2, 6-9, 12, 16, 17, 21, 22, 25, and 30-35 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 Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
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) and seoncd cycling steps (c1-c4), a silicon/aluminum oxide precursor (claim 6, 52) such as TMA (claim 7) and a temperature between 25 and 60 °C (claim 18), a delay time (claim 22) and inorganic oxide layer 2-50 nm (claims 40-41, 45).
The active method steps of the ‘730 application are the same as the instant method steps except that the precursor is not specified as 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 separate particles of 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 Karuturi.
The teachings of Wang, Kim, Carlsson, Won and Karuturi 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 as a precursor, small molecule drugs, ozone as an oxidant, to pump a subset of vapors as a processing step, to optimize the delay/holding time, agitating the API, separate pin-hole free particles, 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 to separately coat 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 optimize the delay/hold time of the deposition process as this is a result effective variable that influences filling during deposition, as taught by Karuturi. 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 oxygen flow rate through routine optimization as this is a result effective variable 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, 16, 17, 21, 22, 25, and 30-35 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 Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
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) and additional coating steps (c1-c4) 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 active method steps of the ‘809 application are the same as the instant method steps except that the precursor is not specified as 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 separately coated particles, 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 Karuturi.
The teachings of Wang, Kim, Carlsson, Won and Karuturi 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 as a precursor, small molecule drugs, ozone as an oxidant, agitating the API, the layers pin-hole free for separate particles, 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 coating separate 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 optimize the delay/hold time of the deposition process as this is a result effective variable that influences filling during deposition, as taught by Karuturi. 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 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, 16, 17, 21, 22, 25, and 30-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/668,492 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 Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
The ‘492 application recites a method of preparing coated particles comprising amorphous solid dispersion of active pharmaceutical ingredients (such as ezetimibe (claim 12)) and enclosed by one or more metal oxide layers and comprising atomic layer deposition and the same deposition steps b1-b5 (claim 7) as instantly claimed. The metal oxide may be aluminum or silicon oxide (claim 8) and is done at a temperature between 25 and 50 °C (claim 10)
The active method steps of the reference application are the same as the instant method steps except that the precursor is not specified as 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 reference application does not specify additional coating steps c1-c4 and TMA precursor and water oxidant, separate particles of 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 Karuturi.
The teachings of Wang, Kim, Carlsson, Won and Karuturi 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 and TMA as a precursor, small molecule drugs, ozone/water vapor as an oxidant, to pump a subset of vapors as a processing step, to optimize the delay/holding time, agitating the API, separate pin-hole free particles, 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 and to form multiple layers of metal oxides with aluminum and silicon as a laminate. A method of forming coated particles is known from Wang, who further indicates silicon/aluminuim oxide coatings and ozone/water vapor as a suitable oxidant for such methods and teaches pin-hole free layers and forming laminates with multiple oxide layer types. Lower processing temperatures such as below 50°C, pumping out a subset of gases, agitating the API to separately coat 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 reference 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 optimize the delay/hold time of the deposition process as this is a result effective variable that influences filling during deposition, as taught by Karuturi. 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 oxygen flow rate through routine optimization as this is a result effective variable 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, 16, 17, 21, 22, 25, and 30-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-46 of copending Application No. 19/663,202 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 Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
The reference application recites a method of preparing coated particles comprising a drug containing core aluminum and silicon oxide coating layers and has steps b1-b5 and c1-c5 that render obvious the claimed method steps for deposition. BDIPADS and TMA are precursors (claim 43). The method is done at a temperature between 25 and 80 °C (claim 40)
The active method steps of the reference application are the same as the instant method steps except that the uncoated particles are not specified as crystalline, separate particles of pin-hole free layer, 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, Carlsson, Won and Karuturi.
The teachings of Wang, Kim, Carlsson, Won and Karuturi 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 to optimize the delay/holding time, agitate the API and form separate pin-hole free particles with crystalline uncoated particles and to have 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 and to form multiple layers of metal oxides with aluminum and silicon as a laminate. A method of forming coated particles is known from Wang, who further indicates silicon/aluminuim oxide coatings and ozone/water vapor as a suitable oxidant for such methods and teaches pin-hole free layers and forming laminates with multiple oxide layer types. Lower processing temperatures such as below 50°C, pumping out a subset of gases, agitating the API to separately coat 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 reference application as they are known as useful and suitable for such a similar method as taught by Wang. 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 optimize the delay/hold time of the deposition process as this is a result effective variable that influences filling during deposition, as taught by Karuturi. 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 oxygen flow rate through routine optimization as this is a result effective variable 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, 16, 17, 21, 22, 25, and 30-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 76 of copending Application No. 19/274,209 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 Karuturi et al. (J. Phys. Chem. C, Vol. 114, No. 35, 2010).
The reference application recites a method of preparing a polypeptide formulation comprising particles with a core enclosed by a coating layer comprising an organic oxide such a silicon oxide and aluminum oxide.
The reference application does not recite the claimed method steps for forming the coating. These deficiencies are made up for in the teachings of Wang, Kim, Carlsson, Won and Karuturi.
The teachings of Wang, Kim, Carlsson, Won and Karuturi 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 formed the aluminum/silicon coated particles using BDIPADS and TMA as a precursor and ozone and water vapor as oxidants and with laminate coatings formed by pulsing/purging processing steps and to optimize the delay/holding time, agitate the API, form separate pin-hole free particles, 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 and to form multiple layers of metal oxides with aluminum and silicon as a laminate. A method of forming coated particles is known from Wang, who further indicates silicon/aluminuim oxide coatings and ozone/water vapor as a suitable oxidant for such methods and teaches pin-hole free layers and forming laminates with multiple oxide layer types. Lower processing temperatures such as below 50°C, pumping out a subset of gases, agitating the API to separately coat 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 reference application as they are known as useful and suitable for forming coated particles. 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 optimize the delay/hold time of the deposition process as this is a result effective variable that influences filling during deposition, as taught by Karuturi. 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 oxygen flow rate through routine optimization as this is a result effective variable 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 08 May 2026 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 claim is allowed.
Correspondence
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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