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 .
Status of the Claims
In the Reply filed 04/06/2026, Applicant amended the claims. Accordingly claims 1-15 are pending.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on 04/06/2026 is acknowledged. The traversal is on the ground(s) that (1) “spray drying would not produce a product “prepared according to the method of claim 5,”” therefore “the product as claimed cannot be made by any other process.” Applicant also argues that (2) no serious search burden is demonstrated because “all three inventions share same CPC class (A61K) and subclass (A61K 9),” and because inventions share closely related subject matter.
Argument 1 is not found persuasive because as noted in the restriction on 03/18/2026, “the product as claimed can be made by another and materially different process such as spray drying,” which means that the inventions are distinct. Further, Wang (US 20200338008 A1) teaches that numerous technologies for encapsulating or coating both API and DP have been developed, e.g., polymer mesh coating, pan coating, aerosolized coating, fluidized bed reactor coating and atomic layer deposition coating [0004]. Any of these methods could also be used to create the instantly claimed product.
Argument 2 is not found persuasive because although inventions share the same CPC class and subclass, as noted in the restriction on 03/18/2026, ultimately they have different classifications: “A61K 9/1682 for invention I, A61K 9/1611 and A61K 31/192 for invention II, and A61K 9/0053 for invention III,” which means “there would be a serious search and/or examination burden if restriction were not required.” Further, inventions do not share closely related subject matter because they require a different field of search, also stated in the restriction on 03/18/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 04/06/2026.
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.
Instant claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20200338008 A1) as evidenced by Powder Fineness 2012 in view of Hautala 2017.
NOTE FOR CLARITY: the instant claims refer to a cycle as a set of steps that make up an ALD process (see instant claim 5 as an example); however, Wang refers to a cycle as a step in the set of steps that make up an ALD process (see claim 42, [0055] as an example).
Regarding instant claim 1, Wang teaches a method of preparing coated particles comprising an active pharmaceutical ingredient (API)-containing core enclosed by one or more metal oxide layers (claim 41).
Regarding the “powder” aspect of “powder particles,” Wang teaches that the particles comprising an API have a median particle size, on a volume average basis between 0.1 μm and 20 μm [0018]. The range “between 0.1 μm and 20 μm” is encompassed by the range “≤125 μm,” which Powder Fineness teaches is the range for very fine powders (page 1, Classification of Powders by Fineness, table at bottom of right column). Therefore, as evidenced by Powder Fineness, the particles taught by Wang would be considered very fine powder, and therefore would be considered powder and meet the instantly claimed limitation of “powder particles.” This is also true for the claims that depend on claim 1 and mention “powder particles.” Wang teaches a step of performing atomic layer deposition that comprises: (a1) loading the particles comprising the API into a reactor (claim 42, [0081]), which reads on the instantly claimed step of loading a predetermined amount of the powder particles into a rotary barrel reactor.
Wang teaches that in operation, the drum 40 rotates [0050], which reads on the “rotary” aspect of the “rotary thermal ALD system” and the “rotary barrel reactor.” As shown in figure 1 on page 2, the drum 40 has a cylindrical or “barrel” shape, which reads onto the “barrel” aspect of the “rotary barrel reactor.” Wang teaches the reactor system 10 permits a coating process (ALD), to be performed at lower processing temperature, e.g., below 50° C., e.g., at or below 35° C ([0041], Figure 1 on page 2); the specified temperature range reads on the “thermal” aspect of the “rotary thermal ALD system.” Wang teaches a controller 60 can operate the reactor system 10 ([0056], Figure 1 on page 2), and that a motor 44 rotates the drum 40 to agitate the particles ([0047, 0050, 0057], Figure 1 on page 2), which reads on the instantly claimed step of activating a motor of the rotary thermal ALD system to rotate the rotary barrel reactor such that the powder particles are in motion when carrying out the method. Wang teaches a step of (a) 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 (claim 41), which reads on the instantly claimed step of submitting the powder particles to an ALD process, thereby coating the powder particles with the metal oxide to produce coated powder particles. Wang teaches that steps (a2)-(a5) (referring to the steps of performing the atomic layer deposition, which are discussed below in detail) are performed two or more times (claim 43). “Two or more times” overlaps with the instantly claimed limitation of “at least one cycle of an ALD process.”
Regarding instant claim 2, Wang teaches a method for ALD coating that results in the aluminum oxide enclosing the drug particle core [0092].
Regarding instant claim 3, Wang teaches the particles subjected to step (a) consist of an API [0018].
Regarding instant claim 1, Wang does not teach the step of unloading the coated powder particles from the rotary thermal ALD system upon completion of the at least one cycle of the ALD process.
Regarding instant claim 1, Hautala teaches a number of ALD cycles that was 100, 300 and 500, and that after the coating, the minitablets were collected from the coating chamber (page 50, 2.5. ALD coating of minitablets), which when combined with Wang, reads on the step in instant claim 1 of unloading the coated powder particles from the rotary thermal ALD system upon completion of the at least one cycle of the ALD process.
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to improve the ALD process of coating API particles with metal oxide as taught by Wang with the step of collecting products after coating as taught by Hautala in order to provide a rapid method of coating. Wang teaches their method permits fast, uniform interaction of the particle surface with the process gas [0050]. Hautala teaches that ALD provides a simple and rapid method for the ultrathin coating (nanolayering) of minitablets) (page 57, 5. Conclusions). Use of Hautala’s teaching to improve Wang’s method for the purpose of rapid coating is an obvious modification and within the purview of the skilled artisan. One of ordinary skill in the art would find there to be a reasonable expectation of success because as taught by Hautala, the ALD technique has been successfully applied also in the design of larger-sized, single particles intended for pharmaceutical powder applications (page 48, left column).
Instant claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20200338008 A1), Powder Fineness 2012, and Hautala 2017, as applied to claims 1-3 above, in further view of IBD 2018.
As applied above, Wang, Powder Fineness, and Hautala teach the limitations of instant claims 1-3.
Regarding instant claim 4, Wang further teaches the drug (API) could be selected to be an anti-inflammatory agent [0031].
Wang, Powder Fineness, and Hautala do not teach that the active pharmaceutical ingredient (API) is 5-Aminosalicylic acid (5-ASA), though Wang does teach the drug (API) could be selected to be an anti-inflammatory agent.
IBD teaches aminosalicylates are compounds that contain 5-aminosalicylic acid (5-ASA) and reduce inflammation in the lining of the intestine (Page 1, Aminosalicylates).
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the method of preparing coated API particles taught by Wang, Powder Fineness, and Hautala, and substitute the anti-inflammatory agent of Wang with the 5-aminosalicylic acid taught by IBD. Simple substitution of one known API for another of IBD in preparing coated API particles is an obvious modification and within the purview of the skilled artisan.
Instant claims 5-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20200338008 A1), Powder Fineness 2012, and Hautala 2017, as applied to claims 1-3 above, in further view of Calvert 1990 and Lewis 2006.
As applied above, Wang, Powder Fineness, and Hautala teach the limitations of instant claims 1-3.
Regarding instant claim 5, Wang further teaches the method comprises sequential steps [0080]. Wang teaches the following steps: (a2) applying a 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; (a5) performing one pump-purge cycle of the reactor using inert gas (claim 42, [0080]). The “purge cycle” part of Wang’s “pump-purge cycle” reads on the instantly claimed purges because Wang states that in a purge cycle, the inert gas is supplied to the chamber 20 to force out the reactant gas and by-products used in the prior step [0055]. Wang teaches use of nitrogen (N2) gas as the inert gas [0063, 0080]. Wang teaches that exemplary oxidants include water [0033, 0079-0080]. Wang teaches that one or more of the gases (e.g., the reactant gases and/or the inert gas) can be supplied in pulses [0055].
Regarding instant claims 6 and 7, Wang teaches the reactor system 10 permits a coating process (ALD), to be performed at higher (above 50° C., e.g., 50-100° C.) or lower processing temperature, e.g., below 50° C., e.g., at or below 35° C
([0041], Figure 1 on page 2). Wang’s temperature ranges of “50-100° C,” “below 50° C,” and “at or below 35° C” are encompassed by the instantly claimed range of “less than 150°C;” therefore Wang’s temperature range would obviate the range in instant claim 6. The temperature 100° C in Wang’s range of “50-100° C,”is close to the temperature “120°C” in instant claim 7, therefore Wang’s temperature range would obviate the range in instant claim 7.
Regarding instant claim 8, Wang teaches that in the ALD step for applying a metal oxide coating, the vaporous or gaseous metal precursor is tri-methyl aluminum (TMA) [0079].
Regarding instant claims 9-11, Wang teaches that one or more of the gases (e.g., the reactant gases and/or the inert gas) can be supplied in pulses in which the chamber 20 is filled with the gas to a specified pressure, a delay time is permitted to pass [0055]. “Delay time” reads on “time period” in the instant claims. Wang indicates time is an optimizable parameter because it teaches a step of determining when to stop pumping by performing RGA to monitor levels of gaseous methane and unreacted TMA in the reactor [0080], and also teaches a recipe can specify the times during which the vacuum pump 24 is to operate, the times of and flow rate for each gas source 32a (gaseous trimethylaluminum (TMA)), 32b (water vapor), 32c (inert gas) [0045, 0052, 0063]. Regarding the flow rate of argon in instant claim 11, Wang indicates flow rate is an optimizable parameter because it teaches the chemical delivery system 30 can include a combination of restrictors, gas flow controllers, pressure transducers, and ultrasonic flow meters to provide controllable flow rate of the various gasses into the chamber 20 ([0044], Figure 1 on page 2).
Regarding instant claims 12-15, Wang teaches steps (a2)-(a5) are performed two or more times (claim 43). The range “two or more times” overlaps with the instantly claimed range of “between one cycle and 300 cycles,” and reads on the “additional” aspect of the instantly claimed phrase “between one additional cycle and 300 additional cycles” with routine optimization. Wang teaches that these steps can be repeated to create particles having an API-containing core enclosed by multiple layers (e.g., multiple alternating layers) of metal oxide and polymer [0005], indicating that repetition is an optimizable parameter. Wang teaches the method comprises sequential steps [0080], which reads on the “sequential” aspect of the instantly claimed “additional sequential cycles.”
Regarding instant claim 14, Hautala further teaches a number of ALD cycles that was 300 (page 50, 2.5. ALD coating of minitablets), which when combined with Wang, reads on the “300 cycles” in instant claim 14.
Regarding instant claims 5-15, Wang, as evidenced by Powder Fineness, in view of Hautala, do not teach that the inert gas is argon, or that the water is deionized, though Wang does teach that the oxidant is water.
Regarding instant claim 5, Calvert lists both nitrogen at ordinary temperatures and argon as inert gases (page 2196, Inert gas).
Regarding instant claim 5, Lewis states that for most purposes, still-prepared distilled water or deionized water is equally suitable (page 2, Water).
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the ALD process of coating API particles with metal oxide as taught by Wang, Powder Fineness, and Hautala, and substitute the nitrogen gas of Wang with the argon gas taught by Calvert. Simple substitution of one known inert gas for another of Calvert in pharmaceutical ALD is an obvious modification and within the purview of the skilled artisan.
Before the effective filing date of the claimed invention, it would be obvious to a person having ordinary skill in the art to take the ALD process of coating API particles with metal oxide taught by Wang, Powder Fineness, and Hautala, and substitute the water of Wang with the deionized water taught by Lewis. Simple substitution of one known water for another of Lewis in pharmaceutical ALD is an obvious modification and within the purview of the skilled artisan.
Regarding instant claims 6-7 and 13-14, at the time of filing, the person of ordinary skill in the art would know that Wang's ranges are obvious over the instant claims. Therefore, Wang obviates that presently claimed. "In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists" Further, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."” (See MPEP 2144.05 (I) regarding obviousness of ranges). Regarding instant claims 9-11, and 13-15, at the time of filing, the person of ordinary skill in the art would know that Wang’s ranges are obvious over the instant claims. It would be obvious to adjust the following ranges/aspects taught by Wang to match that of the claimed invention, because it would be considered routine optimization:
Regarding claims 5, 9-11, adjust pulses to be one pulse for certain steps, and adjust gaseous metal precursor pulse time, water pulse time, argon gas purge times, and argon gas flow rate to be one second, 0.5 second, 20 second flows, and 75 standard cubic centimetre per minute (sccm), respectively.
Regarding claims 13-15, change sequential cycles to be "additional" sequential cycles.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144).
Conclusion
Claims 1-15 are rejected.
No claims are allowed.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/ALLY S LIU/Examiner, Art Unit 1611
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