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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/2026 has been entered.
Applicants’ arguments, filed 01/14/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 – New Matter
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 1-17 and 19-20 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.
To satisfy the written description requirement, “the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998).
Even if the recitation were obvious over the disclosure of the Specification, that is not the standard for satisfaction of the written description requirement. See In re Huston, 308 F.3d 1267, 1277 (Fed. Cir. 2002) (‘“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.’”).
In the present case, Applicant has amended the independent claim to include the new limitation of “a volume-average particle diameter of the cellulosic particle is less than 9 μm”. The Examiner acknowledges that the instant specification recites a range of “3 μm or more and less than 10 μm, preferably 4 μm or more and 9 μm” and discloses that “If the volume-average particle diameter is less than 10 μm, furthermore, the biodegradation process, which starts at the surface, tends to proceed uniformly by virtue of a moderately large surface area” (see page 20, last 4 paragraphs). However, the full scope of the newly amended range is not supported by the instant disclosure as originally filed because the phrase “less than” has no lower limit and can read on embodiments outside the range as originally filled. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP 2163.05.
In other words, the newly amended range of “a volume-average particle diameter of the cellulosic particle is less than 9 μm” is not supported because it reads on embodiments where the particle size is less than 3 μm, and particle sizes less than 3 μm are not necessarily present in the disclosure as originally filed.
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 16 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. Claim 16 limits the GSDv as 1.0 or greater and 1.5 or less. Geometric standard deviation cannot be less than 1 and claim 1 already recites a GSDv of 1.5 or less. Therefore, claim 16 does not impose any additional limitations to the product of claim 1, the claim from which claim 16 depends. 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.
1) Claims 1, 15, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasa et al. (US 2021/0032372 A1, date of publication 02/04/2021), in view of Matsumura et al. (JP 2005008538 A, publication date 1/13/2005; citing English machine translation).
Regarding instant claims 1, 15, 16 and 19, Iwasa disclose “a method for producing cellulose particles or cellulose acetate particles” [abstract], and that “cellulose (acetate) particles having a uniform particle size distribution, specifically, a small CV (50% or less), can be obtained as compared with a conventional production method” [0101]. Iwasa also discloses that particle size and CV may be controlled with rotational speed in step (b) of the method for producing cellulose particles [0105]. The particles disclosed by Iwasa are useful in cosmetics [0110].
In one example, cellulose acetate particles were produced using the disclosed methods [0133-0139] and then saponified to produce cellulose particles as the final product [0141]. Iwasa further discloses the cellulose diacetate particles were characterized by size (see [0144-1045] and Table 1, reproduced below).
PNG
media_image1.png
282
999
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Greyscale
Iwasa differs from the instant claims because it does not disclose a molecular weight.
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.
While not expressly taught, the GSDv of the prior art can be determined. Assuming a normal distribution, the D84 is the mean particle size plus one standard deviation. That is to say, the particle size of at one standard deviation above the mean would be larger than 84% of the sample.
GSDv as define at [0071] on page 21 of the instant specification as originally filed
Coefficient of variance as defined by Iwasa at [0143]
G
S
D
v
=
√
(
D
84
/
D
50
)
C
V
%
=
σ
D
*
100
G
S
D
v
=
√
(
(
σ
+
D
)
/
D
50
)
C
V
%
100
D
=
σ
This gives the combined formula:
G
S
D
v
=
C
V
%
100
D
+
D
D
50
Assuming a normal distribution, where mean (D) and median (D50) are equal, the formula may be simplified to:
G
S
D
v
=
D
(
C
V
%
100
+
1
)
D
And further simplified to:
G
S
D
v
=
(
C
V
%
100
+
1
)
Therefore, Example 1 of Iwasa, which has a CV% of 37.1%, would have been expected to have a GSDv of 1.17 and a particle size of 4 microns. GSDv of 1.17 and a particle size of 4 microns overlap with the instantly claimed ranges of a GSDv of 1.5 or less (and 1 or greater; instant claim 16) and a particle size of less than 9 microns (and 3 microns or more; instant claim 15) and so a prima facie case of obviousness exists for both ranges. 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).
Additionally, "[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 the present case, Iwasa desires a uniform particle distribution (small CV%), and discloses how to modify CV. Therefore one would have been motivated to, and had an expectation of success in, reducing the particle CV% to reach a uniform particle distribution. Doing so would have inherently lowered to GSDv which approaches 1 at a uniform distribution.
With respect to the biodegradation, the prior art teaches all the structural limitations recited in the independent claim (i.e., cellulose particle with the claimed molecular weight, particle size and GSDv) and so one would have expected the particles of the prior art to exhibit the same properties as claimed (i.e., the same 5-day and 60-day biodegradation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a cellulose particle comprising cellulose is a base component and wherein the particle has a number average molecular weight more than 45000, a diameter less than 9 microns and an upper GSDv of 1.5 or less. Because the prior art contains substantially particle parameters as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. 5-day and 60-day biodegradation.
2) Claims 1, 2, 15-17 and 20 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, 15 and 16, 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 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; instant claim 15) and GSDv (1.5 or less and 1 or more; instant claim 16) 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.
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).
Regarding instant claim 17 and 20, 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). 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). 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.
3) 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, 15-17 and 20, 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.
4) 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 2, 3, 6, 7, 10 and 11, 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).
5) 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 2, 3, 6, 7, 10 and 11, 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.
6) 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, 15-17 and 20, 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.
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 15-17, 19 and 20 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).
While the claims of ‘861 do not disclose the degree of biodegradation, the degree of biodegradations instantly claimed would have been expected because they are both a cellulosic particle comprising cellulose as a base constituent. Additionally, instant claim 2 recites open claim language before the coating layer and therefore reads on the two layers disclosed by ‘861.
2) Claims 1-17, 19 and 20 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).
While the claims of US 12,065,547 B2 do not disclose the degree of biodegradation, the degree of biodegradations instantly claimed would have been expected because they are both cellulosic microparticles with cellulose as the base constituent.
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 1-20 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).
While the claims of copending application ‘531 do not disclose the degree of biodegradation of the cellulosic particle, the degree of biodegradations instantly claimed would have been expected because they both claim a cellulosic microparticle with cellulose as the base constituent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
1) On page 6 of their remarks, Applicant argues that Takashi fails to achieve the claimed 5-day biodegradation rate. For support, applicant cites comparative example 10 of the instant application on page 53 of the instant specification as originally filed.
This argument is not persuasive. Even though Takashi fails to disclose examples demonstrating a 5-day biodegradation less than 20%, Takashi nevertheless claims a cellulose particle “having a biodegradation rate for 5 days, as measured in accordance with JIS K6950:2000 (ISO 14851:1999), of 10% or more” [p. 13, claim 6]. Furthermore, Takashi discloses particle sizes and particle GSDv within the instantly claimed ranges, which appears to be essential for 60-day biodegradation. See, for example, inventive examples 5-7 of Table 2-1 on page 47 of the specification as originally filed (reproduced below):
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Examples 5-7 above demonstrate that even when the molecular weight is outside the claimed range, the 5-day and 60-day biodegradation rates remain as claimed if the particle size is less than 9 and the GSDv is less than 1.5. Furthermore, Matsumura remedies the deficiency of molecular weight in Takashi.
2) On page 7 of their remarks, Applicant argues that Takashi provides no guidance on how to lower the 5-day biodegradation while simultaneously maintaining a higher 60-day biodegradation rate.
This argument is not persuasive. The particles of the prior art would have been expected to have a 60-day biodegradation as instantly claimed because they are cellulose particles having a diameter if less than 9 microns, a GSDv of 1.5 or less and a molecular weight of 37000 or more. Additionally, Takashi discloses the 5-day biodegradation may be 10% or more. Therefore, the 5-day biodegradation would have been obvious because the instantly claimed rate overlaps with that of the prior art. That is to say, that because the prior art discloses overlapping 5-day biodegradation rates for particles that are substantially the same as instantly claimed, one would have expected the particle of the prior art inherently also have 60-day biodegradation rates as instantly claimed.
3) On page 7 of their remarks, Applicant argues that the asserted references fail to teach or suggest the claimed features.
This argument is not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the prior art specifically teach a celluloses particle having the claimed particle sizes that inherently has the claimed GSDv. Matsumura cures the deficiencies of the primary references insofar as it teaches the claimed molecular weights are appropriate cosmetic microparticles. See rejection above.
4) On page 8 of their remarks, Applicant argues “that a low GSDv and high number average molecular weight is not enough to achieve the claimed biodegradability, as the particle diameter is also important. Therefore, the examples demonstrate that a combination of all of these limitations are important.” Similarly, applicant asserts that the claimed biodegradation rates are an unexpected result of claimed GSDv, particle size and molecular weight.
This argument is not persuasive because the instant claims are not commensurate is scope with the objective evidence and it is unclear exactly what limitations are responsible for the biodegradation rates. First, the inventive examples 5-7 of Table 2-1, which represent uncoated cellulose particles, demonstrate that molecular weight is not essential to the claimed biodegradation rates. Examples 5-7 of Table 2-1 (reproduced below) disclose particles having a diameter and GSDv within the instantly claimed ranges. Despite having molecular weights outside the claimed range, Examples 5-7 of Table 2-1 nevertheless have biodegradation rates within the instantly claimed range. See below:
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The Examiner notes that examples 5-7 have surface smoothness values of 87-89% while Examples 1-4, with molecular weights as instantly claimed, have surface smoothness values of 93-95%.
Second, Example 5 of Table 1 on page 10 of Takashi demonstrates that the claimed particle makeup, particle size and GSDv are not enough to achieve the instantly claimed biodegradation rates. Table 1 of Takashi is reproduced below:
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Example 5 has a particle size of 8 and GSDv of less than 1.33, i.e., (D84/D50)1/2 would have been expected to be less than (D90/D50)1/2 of the same particle sample. Furthermore, according to Table 2 on page 11 of Takashi, Example 5 has a 5-day biodegradation of 49%. That is to say, Takashi discloses a cellulose particle having the claimed particle size and GSDv, but with a biodegradation rate well outside what is claimed. Therefore, Takashi suggests that particle size and GSDv are not enough to achieve the claimed biodegradation rates.
Considering inventive examples 5-7 of Table 2-1, demonstrate that molecular weight is not essential to the claimed biodegradation rates and Takashi suggests that particle size and GSDv alone are not enough to achieve the claimed biodegradation rates, the Examiner must conclude that all the limitations critical to biodegradation have not been recited in the independent claim.
Third, the comparative examples fail to demonstrate why the claims are commensurate in scope because they do not provide evidence that only the particle size, GSDv and molecular weight are responsible for the claimed rates of biodegradation. Specifically, comparative examples 1 and 2 of Table 2-5, appear to demonstrate that GSDv and surface smoothness impact degradation rates when the molecular weight is 110000. See Table 2-5 excerpt below.
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Therefore, it appears the independent claim has not recited all the limitations required to achieve the instantly claimed biodegradation rates and the claims are not commensurate in scope with the evidence. Furthermore, given the apparent disagreement on the role of molecular weight between inventive examples, Takashi, and the comparative examples, it is not entirely clear what specific features of the particle result in the claimed biodegradation.
Finally, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. MPEP § 716.02. In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense").
In this case, applicant results, showing marked improvement over results with cellulose particles having other of particle sizes, GSDv and molecular weights constitute a difference in degree from what is expected from the combination rather than a difference in kind, as required for a demonstration of unexpected results.
5) On page 8-9 of their remarks, Applicant asserts that sphericity of the cellulosic particle is 0.9 or greater makes the claims even more commensurate in scope with the unexpected results. Applicant cites comparative example 3 which shows poor 60-day biodegradation when the sphericity is below 0.9.
This argument is not persuasive. While sphericity may make the claims even more commensurate in scope, the claims are still not commensurate in scope. For example, surface smoothness also appears to impact biodegradation. Additionally, the examiner respectfully notes that comparative example 3 has a particle size outside the claimed range and so the impact of sphericity on biodegradation is not clear from the examples. However, the Examiner does note that all the inventive examples of Table 2-1 on page 47 of the instant specification (as originally filed) have a sphericity above 0.9. Furthermore, the instant specification suggests sphericity is impacts biodegradation by disclosing “Making the sphericity of the cellulosic particles according to this exemplary embodiment 0.90 or greater may make more certain that the cellulosic particles are highly biodegradable and exhibit little change in texture over time” (see p. 21-22, [0073]). Thus, the sphericity appears to be important to the claimed rate of biodegradation, but the claims are still not commensurate in scope with the evidence for the reasons discussed above.
6) On page 9 of their remarks, Applicant requests withdrawal of the double patenting rejections for the same arguments made above.
This argument is not persuasive. The instant claims continue to read on the copending claims and the rejections stand for the reasons above and of record.
Conclusion
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612