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.
Response to Amendment
The amendment filed 03/12/2026 has been entered.
Claim 11 was newly added. Claims 6 and 9 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification and the previous rejections under 35 U.S.C. 112(b) of claims 6-7 and 9-10.
The rejections of claims 1-10 under 35 U.S.C. 103 are maintained.
The new claim 11 is also rejected under 35 U.S.C. 103.
Response to Arguments
Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicant argues that Spindler and Gomi fail to disclose all of the features of the claimed invention, because the specification states an advantage of the multivalent metal salt providing the first coating layer with water resistance to hinder water from entering the spaces between the base particles and the second coating layer as shown in Tables 1-1 and 1-2 of the instant specification (Remarks, pages 10-11). Applicant states that the carmellose calcium of Gomi is used as a disintegrant, which the properties thereof include excellent water absorption and swelling capacity, so to promote the breakdown of tablets into smaller fragments, thereby facilitating the dissolution process, and states the purpose of the disintegrant in Gomi is completely different than the purpose of water resistance maintenance in the present application. Applicant states a person skilled in the art would therefore not be motivated to consider the carmellose calcium used as the disintegrant, which destroys structural integrity, as the component of the coating layer, which requires the structural protection, and therefore Gomi teaches away from the present application (Remarks, page 11). This argument is not persuasive, because there is no evidence provided by the Applicant or in the teachings of Spindler or Gomi to support the stated assertions about carmellose calcium, disintegrants, and water resistance. Arguments presented by the applicant cannot take the place of evidence in the record. See MPEP 716.01(c). The examples in the referenced Tables 1-1 and 1-2 of the instant specification utilize various coating materials to demonstrate that having a multivalent salt is superior to not having one (specification, table 1-1, Comparative Example 1), and that tamarind gum and dextrin are inferior coatings (specification, table 1-1, Comparative Examples 2-3), which are not sufficient comparisons to the closest prior art. Evidence of unexpected properties should be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See MPEP 716.02(b)(III). Further, as previously stated, 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), and it would therefore be obvious to one of ordinary skill in the art to modify the teachings of Spindler with Gomi.
Applicant states Spindler relates to a particulate delivery system for topical applications which is used to protect the active ingredient and control its release, and therefore Gomi’s disintegrant would completely contradict and destroy the intended purpose of releasing control in Spindler. Applicant states that a person skilled in the art would not be motivated to combine Spindler and Gomi to arrive at the claimed invention, and that the combination is merely a hindsight (Remarks, pages 11-12). This argument is not persuasive, because as noted in MPEP § 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art. As noted above, 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), and it would therefore be obvious to one of ordinary skill in the art to modify the teachings of Spindler with Gomi.
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.
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 1-10 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 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).
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).
New Claim Rejections - 35 USC § 103
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Spindler (WO 2017180440 A1) and Gomi (US 20040043964 A1) as applied to claims 1-10, and as evidenced by PubChem. The references were cited previously by the Examiner.
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
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.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613