DETAILED ACTION
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 .
Applicants’ arguments, filed 06/15/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – Improper Dependent Form
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Instant claim 15 recites a particle size of between 3 and 9 microns which is already recited in the newly amended claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Maintained
1) Claims 1, 2, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Takashi (WO 2022/137679 with US 2024/0041710 as English equivalent, PCT filing date 07/22/2021) and Matsumura et al. (JP 2005008538 A, publication date 1/13/2005; citing English machine translation).
Regarding instant claim 1, and 15, Takashi discloses a resin particle for cosmetic applications “obtained by surface-treating, with a solid surface treatment agent, core beads formed with a resin containing cellulose as a main component” (abstract). Takashi discloses the 5-day biodegradation of the particle to be 10% or more, as measured by JIS K6950:2000 (ISO 14851:1999) (p. 13, claim 6). Takashi also discloses the D50 of the particles is preferably 1-25 microns [0037], the D90 is preferably less than 25 microns and the coefficient of variation (CV) is preferably 20-60% [0038]. Takashi discloses the cellulose resin particles have “a degree of sphericity of 0.7 to 1.0, [and] a degree of surface smoothness of 70 to 100%” (abstract).
Takashi does not disclose the molecular weight of the cellulose.
Matsumura discloses a resin particle for cosmetic applications (abstract). The average volume size of the particles is 2μm to 20μm (p. 2, lines 5-6). The number average molecular weight of the resin particle is usually 5,000 to 1,000,000 (paragraph 32) and the resin used for the particle is selected from a group including cellulose (paragraph 42).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use celluloses having a molecular weight of 37000 or 45000 or more, since Matsumura teaches cellulose microparticles for cosmetic applications having a number-average molecular weight in the range of 5,000 to 1,000,000. The artisan would have selected celluloses having a molecular weight of 37000 or 45000 or more, based on their suitability for their intended use.
Takashi does not expressly disclose the GSDv of the particles. However, one of ordinary skill in the art would have expected the GSDv of Takashi to overlap with the instantly claimed range considering the preferred range of D90 is less than 25 and the preferred range of D50 is 1-25. Specifically, the claimed GSDv overlaps with the GSDv of Takashi at least in the following particle parameters encompassed by Takashi:
D50 (microns)
D90 (microns)
(D90/D50)1/2
8
Less than 18
Less than 1.5
7
Less than 15.75
Less than 1.5
6
Less than 13.5
Less than 1.5
5
Less than 11.25
Less than 1.5
4
Less than 9
Less than 1.5
3
Less than 6.75
Less than 1.5
Additionally, Takashi discloses 20-60%CV. According to the relationship between CV% and GSDv described in pages 9-10 of this Office Action, 20-60%CV corresponds to a GSDv of 1.09-1.26.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for 5-day biodegradation (lower than 20%), particle size (less than 9 microns and 3 microns or more) and GSDv (1.5 or less and 1 or more;) overlap with the corresponding ranges of the prior art (10% or more, 1-25 microns, and 1.09-1.26, respectively) and so a prima facie case of obviousness exists for each. Additionally, the ranges for both instantly claimed sphericity and surface smoothness overlap with the ranges disclosed in the prior art. Therefore, it would have been prima facie obvious for one of ordinary skill in the art, at the time of filling, to achieve the instantly claimed degree of sphericity and surface smoothness.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art, at the time of filling, to have formulated a cellulose particle comprising cellulose as the base constituent, wherein the particle has a 5-day percent biodegradation, a number average molecular weight, particle size and GSDv all within the instantly claimed ranges. Since the prior art teaches a cellulose particle with substantially the same characteristics, i.e., molecular weight, particle size and GSDv, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as a 60-day biodegradation rate within the instantly claimed range.
Regarding instant claim 2, Takashi discloses the surface treatment agents (i.e., coating layer compounds) include fatty acids, metal salt of a fatty acids, amino acid-based substances, and waxes (paragraph 68).
2) Claims 2, 3, 6, 7, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Takashi (WO 2022/137679 with US 2024/0041710 as English equivalent) and Matsumura et al. (JP2005008538A, publication date 1/13/2005; citing English machine translation) as applied to claims 1, 2, 15 and 19, and further in view of Bourassa et al. (WO 2013/166385 A1; publication date 11/7/2013).
Takashi and Matsumura, which are taught above, differ from instant claims 2, 3, 6, 7, 10 and 11 insofar as they do not teach two coating layers covering the core particle, and do not teach the coating layers may contain polyamines or the particular polyamines; polyethyleneimine and polylysine.
Regarding instant claims 2, 3, 6, 7, 10 and 11, Bourassa discloses a pharmaceutical nanoparticle (abstract). The nanoparticle is a core-shell type particle where "the core may be coated with a coating or shell comprising a surface altering agent" (paragraph 39). The core comprises polymeric material (paragraph 51) such as cellulose (paragraph 147). Bourassa also discloses the particle may include one or more coating layers, "[i]n some cases, an intermediate coating (i.e., a coating between the core surface and an outer coating) may include a polymer that facilitates attachment of an outer coating to the core surface” (paragraph 110). Finally, Bourassa discloses the coating polymers include polyethyleneimine (i.e., instant claim 3), poly-L-glutamic acid (i.e., amino acid compound; paragraph 112), polylysine (paragraph 116) and waxes (paragraph 118).
It would have been obvious to a person having ordinary skill in the art, at a time prior to filing, and following the teachings of Bourassa to have combined the polymers known for coating a cellulose particle in two layers as instantly claimed. One would have been motivated to include an intermediate layer (i.e., first coating layer; polyethyleneimine) to improve attachment of the outer layer (i.e., second coating layer; a wax) to the cellulose particle core.
3) Claims 4, 5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Takashi (WO 2022/137679 with US 2024/0041710 as English equivalent), Matsumura et al. (JP2005008538A, publication date 1/13/2005; citing English machine translation) and Bourassa et al. (WO 2013/166385 A1; publication date 11/7/2013) as applied to claims 1-3, 6, 7, 10, 11, 15 and 19, and further in view of Dills et al. (CA 2040116 A, publication date 10/11/1991).
Takashi, Matsumura and Bourassa, which are taught above, differ from instant claims 4, 5, 8 and 9 insofar as they do not teach carnauba wax as the specific wax for the coating layers and they do not teach a polyvalent metal salt to the second coating layer. Bourassa discloses a pharmaceutical agent may be present in the core of the particle (paragraphs 51-52).
Dills discloses “microcapsules which permit the sustained release of active agents such as therapeutic or cosmetic agents” (page 3, line 17-18). According to Dills the microcapsules “may be optionally coated with food grade wax, in order to improve the sustained release characteristics of the microcapsule” (pages 6 and 7, line 36-37 and line 1, respectively). Dills further discloses carnauba wax can be used for coating microparticles and that calcium carbonate (i.e., polyvalent metal salt) may be added to the wax in order to fill channels in the coating to provide greater sustained release of the active agent (page 7, line 5 and 12-15).
It would have been obvious to one of ordinary skill in the art, at the time of filling to select carnauba wax as the coating wax for the cellulose particle. It is obvious to select a known material based on its suitability for its intended purpose. Please refer to MPEP§2144.07. Bourassa teaches waxes, generally, may be used as an external coating (i.e. second coating layer; see rejections of instant claims 2, 3, 6, 7, 10 and 11) for particle cores loaded with a pharmaceutical agent (i.e. active agent) and Dills teaches carnauba wax, specifically, is suitable for the same purpose. Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to add calcium carbonate (i.e., polyvalent metal salt) to the wax coating layer (i.e., second coating layer). One would have been motivated to do so to improve surface coverage by filling channels in the wax thereby achieve the disclosed effect of a greater sustained release of the core loaded active agent. One would have had an expectation of success because adding a polyvalent metal salt to wax coating a microparticle was explicitly taught in the prior art. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filling, to have both selected carnauba wax as the wax coating the microparticle taught by Takashi and Bourassa above (i.e., instant claims 4 and 5), and to have added a polyvalent metal salt to the wax coating layer (i.e., second coating layer; instant claims 8 and 9).
4) Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Takashi (WO 2022/137679 with US 2024/0041710 as English equivalent), Matsumura et al. (JP2005008538A, publication date 1/13/2005; citing English machine translation) and Bourassa et al. (WO 2013/166385 A1; publication date 11/7/2013) as applied to claims 1-3, 6, 7, 10, 11, 15 and 19, and further in view of Hasegawa et al. (US 2006/0024375 A1, publication date 2/2/2006).
The combination of Takashi, Matsumura and Bourassa, which is taught above, differs from instant claim 12 insofar as it does not teach two coating layers where; the first coating layer contains an arginine compound and the second layer contains at least one selected from a group containing linear-chain fatty acids and amino acid compounds and further containing a polyvalent metal salt.
Hasegawa discloses a “coated powder having a high skin care effect and a high anti-aging effect” (abstract). The powder may be a cellulose powder where the particles are preferably from 200µm to 0.01µm (i.e. cellulose microparticles; paragraphs 31 and 33). The coating comprises N-acylated amino acids and fatty acids (abstract). Both the N-acylated amino acids and the fatty acids may be in the form of a metal salt, preferably a polyvalent metal salt (paragraph 21 and 24). Hasegawa further discloses that before application of the coating comprising N-acylated amino acids and the fatty acids, the powder may be coated (i.e. first coating layer) with an acylated amino acid “to provide a synergistic effect of coating” (paragraph 38).
It would have been obvious to one of ordinary skill in the art, at the time of filling to try an acylated arginine as the acylated amino acid needed for the disclosed first coating layer. The disclosure of an acylated amino acid encompasses a finite number of options, specifically 20. One would have been motivated to try because Hasegawa discloses that applying a first coating layer of an acylated amino acid provides a synergistic coating effect. One would have had an expectation of success because an acylated arginine is an acylated amino acid. Please refer to MPEP§2143 (E).
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to simply substitute the coatings disclosed in Takashi with the two-layer coating system as described by Hasegawa because it is obvious to substitute equivalents known for the same purpose (see MPEP§2144.06). In both cases the coating is applied to cellulose microparticles used in cosmetics. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to substitute the coating disclosed in Takashi for the two-layer coating taught by Hasegawa. The substitution would have resulted in a particle with a cellulose core covered by a first coating layer consisting of an acylated arginine compound (i.e. arginine compound) and a second coating layer consisting of linear chain fatty acid metallic salts and an amino acid compound, both present as polyvalent metal salts.
5) Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Takashi (WO 2022/137679 with US 2024/0041710 as English equivalent) and Matsumura et al. (JP2005008538A, publication date 1/13/2005; citing English machine translation) as applied to claims 1, 2, 15 and 19, and further in view of SpecialChem (SpecialChem, Silica; available 12/1/2021, accessed 2/18/25).
Takashi and Matsumura, which are taught above, differ from instant claims 13 and 14 insofar as they do not teach silica as an external additive for the cellulose particles.
SpecialChem discloses “[s]ilica acts as a texturizer and anti-cracking agent. It enhances the fluidity in make-up powders” and that “[i]t is a widely used ingredient in skin- and sun-care products” (first paragraph).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to add silica to the cosmetic microparticles disclosed in Takashi. One would have been motivated to do so to provide the desirable effect of an anti-cracking agent. One would have had an expectation of success because silica was known and widely used as a cosmetic additive. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to blend silica with the cosmetic cellulose microparticles, thereby achieving the instant limitation of silica as an external additive.
Necessitated by Amendment
6) Claim(s) 1, 3, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okuma et al. (US 5244734 A, date of patent 09/14/1993).
Okuma discloses a process for producing fine cellulose particles with an objective of having a sharp particle size distribution [abstract & col. 3, lines 51-54]. Specifically, Okuma desires that “[t]he proportion of particles having an average particle diameter +/-5 microns in the fine cellulose particles is at least […] 90% by weight” [col. 12, lines 42-44]. “In some of these fine cellulose particles, the volume of pores having a pore diameter, measured by the mercury porosimeter method, of 0.01 to 0.5 microns is not more than 60×10-3 cc/g” [col. 12, lines 64-68]. In the example of Table 1 on column 16 (reproduced below) Okuma discloses a cellulose particle with an average particle diameter of 6.64 microns, wherein 94% of the particles have a diameter +/- 5 microns of the average (i.e., at least 94% of the particles have a diameter less than 11.64 microns). The average degree of polymerization of the particles is 310 (i.e., 310*180.16g/mol glucose; 55,849.6g/mol cellulose). Okuma discloses the particles are true spheres (see Table 1 reproduced below) and teaches that peripheral speed of stirring vanes and a rotating speed produce true spheres [col. 8, lines 53-60].
PNG
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426
436
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Greyscale
The prior art does not anticipate the instant claims because it does not explicitly disclose a value for GSDv, sphericity, and surface smoothness. The prior art also does not disclose rate of biodegradation.
“[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
In regard to the GSDv of the particles, a skilled artisan would have been motivated to optimize (e.g., reduce) the deviation of particle sizes because an objective of Okuma is a sharp particle size distribution. One would have had an expectation of success because Okuma desires at least 90% of the particles may be within a range of +/- 5 microns of the average and discloses examples wherein 94% of the particles are within +/- 5 microns of the average.
In regard to the surface smoothness, as skilled artisan would have been motivated, and had an expectation of success in optimizing, e.g., reducing, the pore volume because Okuma desires a pore volume of not more than 60×10-3 cc/g.
Similarly, the instantly claimed sphericity would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, through routine optimization. A skilled partisan would has been motivated to optimize the sphericity of the particles because Okuma desires true spheres. One would have had an expectation of success because Okuma discloses how to produce true spheres.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a cellulose particle wherein the average molecular weight of the cellulose is more than 37000 and more than 45000 (i.e., 55,849), the average particle diameter is between 3 and 9 microns (i.e., 6.64 microns) and wherein the GSDv, sphericity and surface smoothness are all within the instantly claimed ranges. Since the prior art composition contains substantially the same components, i.e., a cellulose particle with the instantly claimed parameters, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as having the instantly claimed rates of biodegradation.
8) Claim(s) 2-7, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okuma et al. (US 5244734 A, date of patent 09/14/1993) as applied to claims 1, 3, and 19, and further in view of Bonner et al. (US 20140134218 A1, publication date 05/15/2014) and Bourassa et al. (WO 2013/166385 A1; publication date 11/7/2013).
Okuma, which is taught above, differs from instant claim insofar as is does not teach at least one coating layer covering the core particle. Okuma discloses “the fine cellulose particles of this invention are fine and have a sharp particle size distribution, are relatively stable to chemicals and free from toxicity. Hence, they can be used in wide industrial fields as diluents for medicines, extenders for cosmetics, or as food additives” [col. 13, lines 1-6].
Bonner relates to skin care compositions comprising hydrophobic cellulose particles [abstract]. “The cellulose particles useful in the compositions and methods of this invention may be further treated with hydrophobic agents to yield hydrophobic cellulose particles” [0033]. Bonner discloses suitable hydrophobic agents may include, but are not limited to, metal soaps, e.g., a metal myristate (i.e., linear fatty acid salt), a natural wax like carnauba wax (i.e., instant claims 4 and 5), and long chain fatty acids like stearic acid (i.e., linear fatty acid) [0034]. Bonner discloses that “It was found that the hydrophobic cellulose particles useful in the compositions of this invention have excellent water and oil absorption properties” [0158] and that “in some instances, it may be desired that the cellulose particles have enhanced or decreased hydrophobic or hydrophilic properties” [0158].
Bourassa discloses a pharmaceutical nanoparticle (abstract). The nanoparticle is a core-shell type particle where "the core may be coated with a coating or shell comprising a surface altering agent" (paragraph 39). The core comprises organic polymeric material (paragraph 51). Bourassa also discloses the particle may include one or more coating layers, "[i]n some cases, an intermediate coating (i.e., a coating between the core surface and an outer coating) may include a polymer that facilitates attachment of an outer coating to the core surface” (paragraph 110). Finally, Bourassa discloses the coating polymers include polyethyleneimine (i.e., instant claim 3), poly-L-glutamic acid (i.e., amino acid compound; paragraph 112), polylysine (paragraph 116).
First, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have applied the hydrophobic coating (e.g., carnauba wax, fatty acid salt or fatty acid) of Bonner to the particles discloses be Okuma because Bonner discloses cellulose particles with a hydrophobic coatings have excellent water and oil absorption properties. One would have had an expectation of success because Okuma discloses the cellulose particles may be used in cosmetics and Bonner discloses coatings for cosmetic cellulose particles. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Second, it would have been obvious to a person having ordinary skill in the art, at a time prior to filing, and following the teachings of Bourassa to have combined the polymers known for coating a cellulose particle in two layers as instantly claimed. One would have been motivated to include an intermediate layer (i.e., first coating layer; polyethyleneimine) to improve attachment of the outer layer (i.e., second coating layer; e.g., a wax) to the cellulose particle core. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a cellulose particles, as taught by Okuma and discussed above, to have a first layer of polyethyleneimine (i.e., polyamine compound; instant claims 2-3, 6-7 and 10-11) and a second layer of carnauba wax (instant claims 4-7) or a linear fatty metal acid and linear fatty acid salt (metal myristate; instant claims 10-11).
9) Claim(s) 8, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okuma et al. (US 5244734 A, date of patent 09/14/1993) in view of Bonner et al. (US 20140134218 A1, publication date 05/15/2014) and Bourassa et al. (WO 2013/166385 A1; publication date 11/7/2013) as applied to claims 1-7, 10-11 and 19, and in further view of Hasegawa et al. (US 2006/0024375 A1, publication date 02/02/2006).
Okuma, Bonner, and Bourassa, which are taught above, differ from the instant claims insofar as they do not teach a polyvalent salt. As discussed above, Bonner discloses suitable hydrophobic agents may include, but are not limited to, metal soaps, e.g., a metal myristate (i.e., linear fatty acid salt), and long chain fatty acids like stearic acid (i.e., linear fatty acid) [0034].
Hasegawa relates “to a coated powder having a high skin care effect and a high anti-aging effect. The powder which can be used in cosmetics is coated with a mixture (lipoamino acid composition) comprising N-acyl derivatives (also including the form of a salt) of” amino acids (i.e., amino acid compounds) “and at least one selected from fatty acids (and/or metal salts thereof)” [abstract]. According to Hasegawa, the fatty acids are selected from metal salts of fatty acid including myristic acid and calcium (i.e., polyvalent metal salt) [0024]. Hasegawa also discloses cellulose is a suitable powder material [0033]. Finally, Hasegawa discloses “the powder can be coated by any known coating method which has been so far used for improving powders used in cosmetics” [0026].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected the calcium myristate as the metal myristate desired by Bonner because Hasegawa discloses calcium myristate is a suitable metal myristate for coating cellulose particles.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the cellulose particles taught by Okuma, Bonner, and Bourassa, wherein the particle comprises a first coating layer of a polyamine compound and a second coating layer consisting of a linear fatty acid (stearic acid) and a polyvalent metal salt (calcium myristate).
10) Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okuma et al. (US 5244734 A, date of patent 09/14/1993), as applied to instant claims 1, 3, and 19 and further in view of SpecialChem (SpecialChem, Silica; available 12/1/2021, accessed 2/18/25).
Okuma, which is taught above, differ from instant claims 13 and 14 insofar as it does not teach silica as an external additive for the cellulose particles. Okuma discloses “the fine cellulose particles of this invention are fine and have a sharp particle size distribution, are relatively stable to chemicals and free from toxicity. Hence, they can be used in wide industrial fields as diluents for medicines, extenders for cosmetics, or as food additives” [col. 13, lines 1-6].
SpecialChem discloses “[s]ilica acts as a texturizer and anti-cracking agent. It enhances the fluidity in make-up powders” and that “[i]t is a widely used ingredient in skin- and sun-care products” (first paragraph).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to add silica to the cosmetic microparticles disclosed in Okuma. One would have been motivated to do so to provide the desirable effect of an anti-cracking agent. One would have had an expectation of success because silica was known and widely used as a cosmetic additive. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to blend silica with the cosmetic cellulose microparticles, thereby achieving the instant limitation of silica as an external additive.
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.
1) Claims 1-9 and 15, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,187,861 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a cellulosic particle comprising a core of at least 90 parts by mass of cellulose (i.e. base constituent) with a first coating layer and a second coating layer (claim 1). Where the first coating layer contains at least one selected from the group consisting of a polyamine, such as polyethylene and polylysine (claim 2), a hydroxy fatty acid and an amino acid compound (i.e. arginine compound; claim 1). Where the second layer consists of a wax, such as carnauba wax (claims 3 and 4), and further contains a polyvalent metal salt (claim 1). Both the instant application and US 12,187,861 B2 claim the cellulosic particle may further comprise at least one external additive, such as a silica particle (claims 5 and 6). Furthermore, they both claim the cellulosic particle to have a volume-average diameter between 3µm and 10µm (claim 1), a geometric standard deviation by number from 1.0 to 1.7 (claim 7), a sphericity greater than 0.9 (claim 8), a surface smoothness of 80% (claim 11) or higher and that the number average molecular weight of the cellulose is 37000 and 45000 or more (claims 9 and 10).
Since the cellulose particles of the conflicting claims have substantially the same characteristics as instantly claimed, they would be expected to inherently possess the same chemical and physical properties, such as the instantly claimed rates of biodegradation.
2) Claims 1-15, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,065,547 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a cellulosic particle comprising a core of cellulose as the base constituent, a first coating layer containing a polyamine, such as polyethyleneimine and polylysine (claim 2), and a second coating layer containing at least one compound selected from the group consisting of carnauba wax, linear fatty acids and hydroxy fatty acids (claims 1 and 5). Both claim the second layer further contains a polyvalent metal salt (claims 3 and 6) and a silicone-containing compound, such as silica (claim 8), as an external additive (claims 4 and 7). Furthermore, they both claim the cellulosic particle to have a volume-average diameter between 3µm and 10µm (claim 9), a geometric standard deviation by number from 1.0 to 1.7 (claim 10), a sphericity greater than 0.9 (claim 11), a surface smoothness of 80% (claim 14) or higher and that the number average molecular weight of the cellulose is 37000 and 45000 or more (claims 12 and 13).
Since the cellulose particles of the conflicting claims have substantially the same characteristics as instantly claimed, they would be expected to inherently possess the same chemical and physical properties, such as the instantly claimed rates of biodegradation.
3) Claims 1-9 and 15-17, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14-20 and 22 of copending Application No. 18/071,531. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a cellulosic particle comprising a core of cellulose as the base constituent (claim 1). They both claim the cellulose core is coated with either a single coating layer, or a first coating layer and a second coating layer (claim 2, 6-8). Where the single coating layer contains at least one from the group consisting of a polyamine, such as polyethyleneimine and polylysine (claim 3), a wax, such as carnauba wax (claim 4), a linear-chain saturated fatty acid, a hydroxy fatty acid, an amino acid compound (claims 2). Or where the first coating layer contains at least one compound selected from the group consisting of a polyamine, such as polyethylene and polylysine (claim 3), a linear-chain saturated fatty acid, a hydroxy fatty acid and an amino acid compound (claim 6-8). And where the second layer consists of a wax, such as carnauba wax (claims 4-8), and further contains a polyvalent metal salt (claim 9-11).
Both the instant application and copending application ‘531 claim the cellulosic particle may further comprise at least one external additive, such as a silica particle (claims 12-14). Furthermore, they both claim the cellulosic particle to have a volume-average diameter between 3µm and 10µm (claim 15), a geometric standard deviation by number from 1.0 to 1.7 (claim 16), a sphericity greater than 0.9 (claim 17), a surface smoothness of 80% (claim 20) or higher and that the number average molecular weight of the cellulose is 37000 and 45000 or more (claims 18 and 19).
Since the cellulose particles of the conflicting claims have substantially the same characteristics as instantly claimed, they would be expected to inherently possess the same chemical and physical properties, such as the instantly claimed rates of biodegradation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
1) On pages 8 and 9 of their Remarks, Applicant argues that the newly amended independent claim is commensurate in scope with the showing of objective evidence.
This argument is not persuasive because the independent claim recites “82% or higher” biodegradation which still captures Example 7 of Table 2-1 on page 47 of the instant specification as originally filed. The Examiner agrees with applicant that “83% or higher” would remove Example 7 of consideration and make the claims commensurate in scope with the evidence provided in the specification.
2) On page 9 of their Remarks, Applicant separately argues the patentability of instant claim 2. Specifically that the coating layer provides greater texture stability while maintaining biodegradation rates by suppressing initial surface hydrolysis while remaining permeable to microorganisms.
This argument is not persuasive. Bonner discloses that “It also was found that the textures of the compositions formulated with the hydrophobic linear cellulose particles of this invention are “fluffy”, silky and soft and aesthetically pleasing to the touch during and after the application” [0160]. While Hasegawa discloses that “More specifically, the powders coated with these mixtures (lipoamino acid compositions) are not only good in aesthetic feeling in use, extension and adhesiveness on the skin, and dispersibility, which are properties of ordinary coated powders, but also have a high skin-care effect and a high skin anti-aging effect” [0005]. Therefore, it appears that coating particles to improve texture was recognized by the prior art.
Additionally, it appears maintaining biodegrading upon coating a cellulose particle was known in the prior art. See for example, Oki et al (US 20210403660 A1, publication date 12/30/2021). MPEP 2109 VII states “35 U.S.C. 100(f) defines the term “inventor” as the individual or, if a joint invention, the individuals collectively who invented or discovered the subject matter of the invention.” Therefore, the Okie reference is considered to be of a different inventive entity because it names at least on inventor not present on the instant application and so it constitutes prior art. The relevant passage of Oki can be found at paragraphs 26-27.
“The biodegradable resin particle is required to have a high biodegradation rate. However, when the biodegradation rate is excessively high, the durability of the resin particle decreases rapidly. That is, it is required to maintain the function as the resin particle for a certain period (for example, a period of several years during the period of use).
Therefore, the second layer containing an anionic or nonionic hydrophobic compound is provided on the surface of the base particle containing a biodegradable resin via the first layer containing at least one cationic resin of a polyalkyleneimine, a polyallylamine and a polyvinylamine.”
Furthermore, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case, the Examiner points to Examples 8-84 in Table 2-1 on page 47 and Table 2-3 on page 50 which represent the coated particles of the present invention. These examples only disclose particles with a molecular weight between 44000 and 48000.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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