Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
Status of claims
The amendment filed on 09/02/2025 is acknowledged. Claims 3-7, 12, 13, 18, 19, and 26 have been canceled, claims 10, 11, 14-17, 20-25 have been withdrawn, and new claim 30 has been added. Claims 1, 2, 8, 9, and 27-30 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 09/02/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112, first paragraph rejection of claims 1, 2, 8, 9, and 26-29, 35 U.S.C. 112 (pre-AIA ), second paragraph rejections of claims 1, 2, 8, 9, and 26-29and of claims 1, 2, and 26-28, and 35 U.S.C. 112, 4th paragraph rejection of claim 26 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are maintained for reasons of record and the following. The rejections are modified based on the amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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, 2, 8, 9, and 27-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Koehler et al. (US 6,500,473 B1).
Koehler et al. teach water dispersible (the instant claim 1) compositions (abstract and claim 1, 22, 23) with particle size of ≤ 10 μm (column 5, line 41-49 and claim 25) comprising
5-10% by weight of a coloring agent (column 6, line 23-36) such as curcumin which is substantially insoluble in water at neutral pH or below but are soluble in alkaline aqueous media (the instant claims 1 and 2) (column 1, line 59-62 and column 3, line 36-49 and claim 7),
1-50%, especially 2.5%, by weight of pectin, a further hydrocolloid including modified starch (column 4, line 41-44, column 7, line 21-34, and claim 17); and
Water; and
exemplified Cleargum (octenyl succinate starch) in example 3 as the modified starch;
wherein the composition being at least partially dehydrated the initial suspension (the claimed suspension in the instant claim 1) to contain either ≥10% or ≤5% by weight of water (the instant claims 9 and 28) (column 6, line 34 through column 7, line 20 and claim 27) and pectin being ≥10% by weight of the total weight of pectin and the further hydrocolloid (claim 18).
The weight percentage of octenyl succinate starch is calculated to be ≤22.55% by total weight of the composition based on 2.5% by weight of pectin in the composition and pectin being ≥10% by weight of the total weight of pectin and the further hydrocolloid (2.5%/10% - 2.5% = 22.5%). 22.5% by weight of octenyl succinate starch as the further hydrocolloid taught by Koehler et al. is within the claimed 15-50% in the instant claim 1, 20-50% in the instant claim 8, 20-50% in the instant claim 27, and 15-40% in the instant claim 29.
Though Koehler et al. do not expressly teach the property of colouring strength of the water dispersible suspension in the new claim 30, as a result of the pigment, the hydrocolloid and its weight percentage, and the diameter of the pigment body of the water dispersible suspension taught by Koehler et al. being the same as claimed, the water dispersible suspension taught by Koehler et al. would necessarily have the claimed properties, whether expressly recognized by Koehler et al. or not. Please refer to MPEP 2112.01.II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Response to Applicants’ arguments:
Applicants argue that example 3 of Koehler et al., the only example using starch, containing 3.33% by weight of starch and there is no motivation to increase the content of starch.
However, this argument is not deemed persuasive. As stated in the rejection above and in the previous office action, Koehler et al. teach the composition comprising 2.5% by weight of pectin and a further hydrocolloid including modified starch (column 4, line 41-44, column 7, line 21-34 and claims 1, 14, 15, and 17) and pectin being ≥10% by weight of the total weight of pectin and the further hydrocolloid (claim 18). Thus, the weight percentage of octenyl succinate starch is calculated to be ≤22.55% by total weight of the composition based on 2.5% by weight of pectin in the composition and pectin being ≥10% by weight of the total weight of pectin and the further hydrocolloid (2.5%/10% - 2.5% = 22.5%).
Example 3 of Koehler et al. provides the specific example of the modified starch recited in claim 17 of Koehler et al. Example 3 does not contain beet pectin while Koehler et al. teach beet pectin being a must have component (claim 1 and table 1), thus example 3 of Koehler et al. is not an inventive example.
Applicants argue that example 3 of Koehler et al. (3.33% by weight of modified starch) has unsatisfactory chroma results in comparison to example 1 (20% by weight of modified starch) and claim 1 (≥15% by weight of modified starch).
However, this argument is not deemed persuasive.
First, the low chroma value of Example 3 of Koehler et al. demonstrates the criticality of incorporation of ≥1% by weight of beet pectin (table 1 and claim 1) while Koehler et al. teach ≥1% by weight of beet pectin being combined with further hydrocolloid including modified starch (paragraph 1414, 15, and 17); thus, a person of ordinary skill in the art would incorporate ≥1% by weight of beet pectin into example 3 of Koehler et al. with reasonable expectation of having satisfactory chroma value while beet pectin is not excluded in the instant claims.
Second, assuming – purely arguendo – there were criticality of the chroma results of 20% by weight of modified starch in example 1, the scope of claim 1 is much broader than the scope of example 1. There is no adequate basis for reasonably concluding that the great number and variety of compositions included by the claims would behave in the same manner as the single tested composition. In other words, Applicant has not shown that based on this single example, it is reasonable to expect that other embodiments falling within the scope of the claims will behave similarly. Please refer to MPEP 716.02(b) III:
Evidence of unexpected properties may 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.
Claims 1, 2, 8, 9, and 27-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Todd, Jr. (US 4,999,205).
Todd, Jr. teaches a curcumin complex with a water-soluble polysaccharide or a water-soluble or water-dispersible protein, which will not precipitate upon standing in water, gives an essentially stable yellow solution in water, and is used in the coloring of foods, drinks, and the like; wherein curcumin is water soluble at a pH > about 9 (abstract and column 5, line 55 through column 6, line 1); and
exemplified in example 3 a dried pulverized (dried powder having more or less water residual (>5%) based on drying method) comprising 40 g of Capsul (a polysaccharide, the claimed octenyl succinate starch), 20 mL of curcumin solution of example 1 (7.5%, i.e., about 1.5 g, assuming the density of the 7.5% curcumin aqueous solution being about 1 g/mL); wherein the dry product is stable indefinitely (over three years in light), and redissolves in water upon hydration of the starch. A mixture of 50:50 polysaccharide and protein is contemplated. The weight percentage of Capsul is calculated to be 96.4% by weight (40/(40+1.5)=0.964). Thus, it is contemplated dried powder comprising curcumin, 48.2% by weight of Capsul, and 48.2% by weight of a protein.
Pulverized particle can be any desired particle size, i.e., < 10 µm.
Though Koehler et al. do not expressly teach the property of colouring strength of the water dispersible suspension in the new claim 30, as a result of the pigment, the hydrocolloid and its weight percentage, and the diameter of the pigment body of the water dispersible suspension taught by Koehler et al. being the same as claimed, the water dispersible suspension taught by Koehler et al. would necessarily have the claimed properties, whether expressly recognized by Koehler et al. or not. Please refer to MPEP 2112.01.II:
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Todd, Jr. does not specify the same weight percentage of Capsul in example 3 (the instant claim 29).
This deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case the claimed range of octenyl succinate starch is ≤40% by weight, the range of Capsul taught in the prior art is 48.2% by weight, thus close enough that one skilled in the art would have expected them to have the same properties while 5-50% by weight of octenyl succinate starch is claimed in the instant claim 1 and thus 48.2% by weight would have the same property of forming water re-dispersible dry powder with curcumin. Furthermore; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Please refer to MPEP 2144.05.II.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
Response to Applicants’ arguments:
Applicant’s argument based on the new claim 30 is addressed in the modified rejection above (underlined).
Applicants argue that Todd, Jr. teach lower amount of pigment (1-15%) and would likely provide less than desired chroma level as described in Koehler et al.
However, this argument is not deemed persuasive.
First, pigment amount is not claimed in the instant claims and thus would encompass any value that is >0% and thus applicant’s allegation also applies to the instant claims.
Second, applicant merely argues that the product is different and nothing has been shown otherwise. Applicant argues that the composition taught by Todd, Jr. would like to provide less than desired chroma level. However, nothing has been shown to substantiate this. From MPEP 716.01(c) II: The arguments of counsel cannot take the place of evidence in the record.
Claims 1, 2, 8, 9, and 27-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Todd, Jr. (US 4,999,205) in view of Koehler et al. (US 6,500,473 B1).
The reference of Todd, Jr. is described in detail above and that discussion is hereby incorporated by reference. It is recognized that the teachings of Todd, Jr. were deemed to be obvious to the claims in the preceding ground of rejection. The instant ground of rejection applies an alternative interpretation of the teachings Todd, Jr., which alternative interpretation is in expectation of an argument that applicant could make regarding whether the dried pulverized curcumin-Capsul complex taught by Todd, Jr. having the claimed particle sizer and water residual, i.e., that the teaching of Todd, Jr. is not explicit enough to support an obviousness determination with regard to the particle sizer and water residual. The Examiner does not agree with such a view, but nonetheless, this alternative ground of rejection is set forth to provide an alternative rationale as to particle sizer and water residual based on the teachings of Todd, Jr. and Koehler et al. whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious at the time of the invention of the claimed invention to a person of ordinary skill in the art to combine the teachings in Todd, Jr. and Koehler et al. to specify the particle sizer and water residual of dried pulverized curcumin-Capsul complex taught by Todd, Jr. being≤ 10 μm, either ≥10% of water or ≤5%, respectively. Dried curcumin- octenyl succinate starch powder to be re-dispersed in water for coloring food, drink, etc., was well known to a person of ordinary skill in the art at the time of the invention of the claimed invention. The motivation for specifying them flows from their being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Argument regarding the 103 rejection is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614