DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11 are pending and represent all claims currently under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/01/2026 has been entered.
Response to Arguments
Applicant's arguments filed 07/01/2026 have been fully considered but they are not persuasive.
Applicant argues that Spindler and Gomi do not disclose the newly recited proportion (Remarks, pages 5-6). This argument is not persuasive, because Spindler discloses a proportion which overlaps the claimed range as stated in the rejection below.
Applicant argues that the proportion of the multivalent metal salt of the resin in the entire first coating layer achieves unexpected results of improving water resistance and improving water resistance maintenance, citing [0034] of the specification as “to improve water resistance and improve water resistance maintenance… The proportion of the multivalent metal salt of the resin in the entire first coating layer is preferably 90 mass% or more and 100 mass% or less” (Remarks, pages 6-8). This argument is not persuasive, because there is no actual evidence provided to support this assertion. Further, the first section of [0034] cited by the applicant “to improve water resistance and improve water resistance maintenance” refers to the coating weight of the first coating layer on the base particles, with the reference to the preferred proportion being separate.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims 1-11 are considered to have an effective filing date of 09/01/2023.
Modified/Maintained Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Spindler (WO 2017180440 A1), further in view of Gomi (US 20040043964 A1), and as evidenced by precisionFDA. The references were cited previously by the Examiner.
Regarding claim 1, Spindler teaches particles comprising (a) a natural substrate (i.e., a base particle), (b) an active compound adsorbed onto (a) (i.e., a first coating layer disponed on a surface of a base particle), and (c) a release modifier adsorbed onto the substrate and active compound (i.e., a second coating layer disposed on the first; Spindler, page 59, amended claim 1). Spindler teaches the natural substrate material is cellulose (Spindler, claim 8), and the release modifier can be fatty acids (i.e., a hydrophobic compound from the claimed list; Spindler, amended claim 1). Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer.
Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by precisionFDA, carmellose calcium is carboxymethylcellulose (i.e., an acid functional group-containing resin as defined by the instant specification, paragraph 0030) calcium (i.e., a multivalent metal as defined by the instant specification, paragraph 0031). Spindler further teaches the ratio of the weight of the optional ingredients to the active agent is in the range of 10:1 to 1:100 (i.e., about 1-90 mass% of the optional ingredient; Spindler, page 25, lines 28-29), which overlaps the claimed range of 90-100 mass% as claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP §2144.05(I).
Spindler and Gomi are considered to be analogous to the claimed invention, because Spindler, Gomi, and the instant invention are in the same field of cellulose particle compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054). Further, it would have been obvious to optimize the amount of the optional ingredient within the range taught by Spindler, because Spindler teaches optional ingredients are included in an amount sufficient to perform its intended function (Spindler, page 24, lines 20-25).
Regarding claim 2, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer. Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by precisionFDA, carmellose calcium is carboxymethylcellulose calcium, which as per the structure is a multivalent metal salt of a polysaccharide. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Regarding claim 3, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer. Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium (i.e., the multivalent metal is Ca), can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Regarding claim 4, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer. Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by precisionFDA, carmellose calcium is carboxymethylcellulose calcium, which as per the structure contains a 1:1 molar ratio of the acid functional group-containing resin to the multivalent metal salt, which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Regarding claim 5, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer. Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by precisionFDA, carmellose calcium is carboxymethylcellulose calcium, which as per the structure contains a 1:1 molar ratio of the acid functional group-containing resin to the multivalent metal salt, which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Regarding claim 6, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. Spindler teaches the release modifier can be salts of fatty acids, such as aluminum or calcium salts (i.e., multivalent metal salts; Spindler, page 23, line 4).
Regarding claim 7, Spindler and Gomi together teach all the elements of the current invention as applied to claim 6. As above, Spindler teaches the release modifier can be salts of fatty acids, such as aluminum or calcium salts (i.e., multivalent metal salts; Spindler, page 23, line 4).
Regarding claim 8, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer. Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by precisionFDA, carmellose calcium is carboxymethylcellulose calcium, which as per the structure is a multivalent metal salt of a polysaccharide, contains a multivalent salt which is calcium, and contains a 1:1 molar ratio of the acid functional group-containing resin to the multivalent metal salt, which lies within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Regarding claim 9, Spindler and Gomi together teach all the elements of the current invention as applied to claim 8. As above, Spindler teaches the release modifier can be salts of fatty acids, such as aluminum or calcium salts (i.e., multivalent metal salts; Spindler, page 23, line 4).
Regarding claim 10, Spindler and Gomi together teach all the elements of the current invention as applied to claim 9. As above, Spindler teaches the release modifier can be salts of fatty acids, such as aluminum or calcium salts (Spindler, page 23, line 4).
Regarding claim 11, Spindler and Gomi together teach all the elements of the current invention as applied to claim 1. As above, Spindler teaches a mixture of active agent and optional ingredients can be sprayed onto the substrate (Spindler, page 27, lines 6-7) suggesting both are a part of the same first coating layer, but does not specifically teach a multivalent metal salt of an acid functional group-containing resin. However, Gomi teaches cellulose particles (Gomi, claim 1), wherein an active ingredient and additive, such as cross carmellose calcium, can be layered on the cellulose particle (Gomi, page 5, paragraph 0054). As evidenced by PubChem, croscarmellose calcium is a crosslinked (i.e., a physically crosslinked structure) carboxymethylcellulose (i.e., an acid functional group-containing resin as defined by the instant specification, paragraph 0030) calcium (i.e., a multivalent metal as defined by the instant specification, paragraph 0031).
As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the cellulose particles of Spindler to include the controlled release additive of Gomi, because Spindler teaches a controlled release composition which can include optional ingredients traditionally used in cosmetic and medicinal compositions (Spindler, page 24, lines 19-22), while Gomi teaches cross carmellose calcium is a disintegrant added for the purpose for controlling the dissolution rate of the active ingredient (Gomi, page 5, paragraph 0054).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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