DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s amendment filed on January 30, 2026 was received. Claims 1, 3-4, 9, 11 were amended. Claims 21 and 22 were newly added. Support can be found in paragraphs [0026], [0029], [0040], [0043], [0044], [0082], and [0094].
The text of those sections of Title pre-AIA 35, U.S.C. code not included in this action can be found in the prior Office Action issued on April 24, 2025.
Claim Interpretation
Claim 1 recites the claim limitation “the cellulosic particle has a surface hydrophobicity such that a percentage detachment upon sonication of hydrophobized silica particles attached thereto is 50% or less” is interpreted as the hydrophobicity conditional of the cellulose.
Claim Rejections - 35 USC § 112
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 22, the term “higher” is a relative term which render the claims indefinite. The term "higher" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
The claim rejections under 35 U.S.C. 102(a)(1) as being anticipated by Popov et al. (US 2015/0265543 A1) on claims 1, 3, 9, and 12, 14-20 are maintained.
Regarding claim 1, Popov teaches a core particle comprising cellulose such as ethyl cellulose as a base constituent, and a coating may include any suitable polymer such as polyamines, wherein the coating may include more than one coating an intermediate coating between the core surface and an outer coating may include a polymer such as polyamines, the outer coating includes a wax for examples, wherein the ethyl cellulose is very hydrophobic by substituting the hydroxyl group on cellulose with ethyl ether groups, and insoluble in water, the hydrophobic property reads on the hydrophobicity of the cellulosic particle in the claim, the cellulosic particle has a surface hydrophobicity such that a percentage detachment upon sonication of hydrophobized silica particles attached thereto is 50% or less is the hydrophobicity conditional of the cellulose, therefore ethyl cellulose reads on the claim limitation of a cellulosic particle comprising cellulose as a base constituent with hydrophobicity property as claimed ([0051], [0109]-[0111], [0117], [0137], [0146], [0161]).
Regarding claim 3, Popov teaches wherein the polyamine compound is at least one selected from the group consisting of polyethyleneimine and polylysine ([0115]).
Regarding claim 9, Popov teaches wherein the second coating layer further contains a polyvalent metal salt such as calcium salt ([0076]).
Regarding claim 12, Popov teaches further comprising at least one external additive selected from the group consisting of a silicon-containing compound particle for example ([0072]).
Regarding claim 14, Popov teaches wherein the silicon-containing compound particle is a silicon oxide (silica) particle ([0072]).
Regarding claim 15, Popov teaches wherein a volume-average particle diameter of the cellulosic particles is 5 µm ([0136]).
Regarding claim 16, It is the position of the examiner that disclosure an upper geometric standard deviation by number GSDv of the cellulosic particles are inherent, given that the material and process disclosed by Popov et al. and the present application having the same material and process. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. Inherency is not established by probabilities or possibilities. In re Robertson, 49 USPQ2d 1949 (1999).
Regarding claim 17, Popov teaches wherein the cellulosic particle is substantially spherical (reads on sphericity of 0.90 or greater) ([0062]).
Regarding claim 18, Popov teaches wherein a number-average molecular weight of the cellulose is 37000 or more ([0098], [0100], [0112]).
Regarding claim 19, Popov teaches wherein a number-average molecular weight of the cellulose is 37000 or more ([0098], [0100], [0112]).
Regarding claim 20, It is the position of the examiner that disclosure surface smoothness of the cellulosic particle is inherent, given that the material and process disclosed by Popov et al. and the present application having the same material and process. A reference which is silent about a claimed invention’s features is inherently anticipatory if the missing feature is necessarily present in that which is described in the reference. Inherency is not established by probabilities or possibilities. In re Robertson, 49 USPQ2d 1949 (1999).
Claim Rejections - 35 USC § 103
The claim rejections under 35 U.S.C. 103 as being unpatentable over Popov et al. (US 2015/0265543 A1) as applied to claims 1, 3, 9, and 12, 14-20 and further in view of Kobayashi et al. (US 2022/0142900 A1) on claims 4-5, 11, 17 and 20 are maintained.
Regarding claim 4, Popov teaches a cellulose particle with wax as one of the coating components as disclosed above. Popov does not explicitly teach wherein the wax is carnauba wax. However, an analogous art, Kobayashi teaches a cellulose particle coated with a lipid component such as carnauba wax (Abstract, [0067], [0069]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a lipid component such as carnauba wax to the cellulose particle coating in Popov, because Kobayashi disclosed the use of a lipid component such as carnauba wax as a whole to yield a desirable sphericity and smoothness of the cellulose particle to provide excellent in biodegradability (Abstract).
Regarding claim 5, Popov teaches a cellulose particle with wax as one of the coating components as disclosed above. Popov does not explicitly teach wherein the wax is carnauba wax. However, an analogous art, Kobayashi teaches a cellulose particle coated with a lipid component such as carnauba wax (Abstract, [0067], [0069]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a lipid component such as carnauba wax to the cellulose particle coating in Popov, because Kobayashi disclosed the use of a lipid component such as carnauba wax as a whole to yield a desirable sphericity and smoothness of the cellulose particle to provide excellent in biodegradability (Abstract).
Regarding claim 11, Popov teaches wherein the second coating layer further contains a polyvalent metal salt such as calcium salt ([0076]).
Regarding claim 17, Popov teaches wherein the cellulosic particle is substantially spherical ([0062]). However, an analogous art, Kobayashi teaches a cellulose particle wherein sphericity of the cellulosic particle is not less than 0.9 and not greater than 1.0 for example (Abstract, [0044]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a sphericity of the cellulosic particle is not less than 0.9 and not greater than 1.0 for example to the cellulose particle coating in Popov, because Kobayashi disclosed the use of the cellulosic particle a whole to provide excellent in biodegradability and reduce aggreation (Abstract).
Regarding claim 20, Popov teaches a cellulosic particle as disclosed above. However, an analogous art, Kobayashi teaches a cellulose particle wherein the surface smoothness of the cellulosic particle is not less than 80% and not greater than 100% for example (Abstract, [0046]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a cellulose particle wherein the surface smoothness of the cellulosic particle is not less than 80% and not greater than 100% for example to the cellulose particle coating in Popov, because Kobayashi disclosed the use of the cellulosic particle a whole to provide excellent in biodegradability reduce aggregation (Abstract).
Regarding claim 21, Popov teaches wherein the coating layer has a first coating layer covering the core particle and containing polyethyeneimines for example and a second coating layer covering the first coating layer and containing the wax a polyvalent metal salt such as calcium salt for examples ([0076], [0109]-[0111], [0115], [0117], [0137], [0146], [0161], Fig. 1). Popov does not explicitly teach wherein the wax is carnauba wax. However, an analogous art, Kobayashi teaches a cellulose particle coated with a lipid component such as carnauba wax (Abstract, [0067], [0069]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a lipid component such as carnauba wax to the cellulose particle coating in Popov, because Kobayashi disclosed the use of a lipid component such as carnauba wax as a whole to yield a desirable sphericity and smoothness of the cellulose particle to provide excellent in biodegradability (Abstract). Popov does not teach the polyvalent metal salt is contained in an amount of 0.3% to 1% by mass relative to a mass of the carnauba wax. However, Popov recognizes the amount of the polyvalent metal salt is adjusted by changing the mixture of excipients ([0059], [0071], [0076], [0161]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of the polyvalent metal salt to render the particle mucus penetrating more than the first stabilizer/surface-altering agent ([0071]). Discovery of optimum value of result effective variable in know process is ordinarily within skill of art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215. 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Regarding claim 22, Popov teaches wherein the polyvalent metal salt consists of a divalent or higher-valency metal ion and an inorganic anion ([0059], [0076]).
Double Patenting
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of Patent No. US 12065547B2 (‘547) on Claims 1-20 are maintained.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of Patent No. US 12187861B2 (‘861) on Claims 1-20 are maintained.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/151,132 (‘132) on Claims 1-20 are maintained.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 4-14 of c-opending Application No. 18/365,213 (‘213) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6, 8-15 of copending Application No. 18/366,674 (‘674) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending Application No. 18/444,627 (‘627) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of copending Application No. 18/448,174 (‘174) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of copending Application No. 18/542,778 (‘778) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of copending Application No. 18/460,703 (‘703) on Claim 1 is withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of copending Application No. 18/461,482 (‘482) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of copending Application No. 18/459,442 (‘442) on Claims 1-20 are withdrawn, because the claims have been amended.
The rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of copending Application No. 18/458,986 (‘986) on Claims 1-20 are withdrawn, because the claims have been amended.
Response to Arguments
Applicant's arguments filed on January 30, 2026 have been fully considered but they are not persuasive.
Applicant’s principal arguments are
Popov does not teach more than one coating layers.
In response to Applicant’s arguments, please consider the following comments.
In response to Applicant’s arguments, the examiner respectfully disagrees. Popov teaches more than one coating layers, because Popov teaches a core particle comprising cellulose such as ethyl cellulose as a base constituent, and a coating may include any suitable polymer such as polyamines, wherein the coating may include more than one coating an intermediate coating between the core surface and an outer coating may include a polymer such as polyamines, the outer coating includes a wax for examples ([0109]-[0111], [0117], [0161]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAI YAN ZHANG whose telephone number is (571)270-7181. The examiner can normally be reached on MTTHF.
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/HAI Y ZHANG/ Primary Examiner, Art Unit 1717