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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 8, 2026 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-16
Withdrawn claims:
9
Previously canceled claims:
None
Newly canceled claims:
None
Amended claims:
1, 9
New claims:
16
Claims currently under consideration:
1-8, 10-16
Currently rejected claims:
1-8, 10-16
Allowed claims:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Xiong (US 6,299,925)(IDS Reference filed 11/01/2023) in view of Hermes (DE 202016002812 U1) and Taguchi (JP2018061483A)(IDS Reference filed 05/03/2022).
Regarding claim 1, Xiong teaches a formulation that generally takes the form of granules (col. 3, lines 29-30) comprising 10 to 50% by weight green tea plant extract (col. 3, lines 5-7; where “10 to 50%” overlaps with the claimed range of “20 mass% to 70 mass%”), a binding agent such as starch (col. 4, lines 62-63), a sweetening agent (col. 3, lines 25-28), and a binding agent such as hydroxyethyl cellulose (a known cellulose derivative, col. 4, lines 62-66). Although Xiong teaches that both starches and hydroxyethyl cellulose are binders than can be selected, one of ordinary skill would recognize that both compositions could be selected for the composition.
Xiong does not teach the sweetening agent being a sugar alcohol present in an amount of at least 10 mass% or the granular composition being in the form of granules having a median diameter of 0.5 to 2.0 mm and a 90% dissolution time of 6 to 44 seconds.
Regarding the sweetening agent being a sugar alcohol present in an amount of at least 10 mass%, Hermes teaches a granule particle comprising about 20 to about 80 wt.% of sugar alcohol ([0008]), which falls in the claimed range of “10 mass% or more”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the granular composition of Xiong with the use of a sugar alcohol in the range taught by Hermes. One of ordinary skill would have combined the granular composition of Xiong with the use of a sugar alcohol and range taught by Hermes by known methods and yield nothing more than predictable results. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding the granular composition being in the form of granules having a median diameter of 0.5 to 2.0 mm, Taguchi teaches of a granulated product comprising plant extract ([0009]) where the product is granulated through a hole having a pore diameter of about 0.8-1.5 mm ([0028]). It logically follows that the granules that have been extruded through a hole having a pore diameter of 0.8-1.5mm would thus have a diameter of 0.8-1.5, which falls within the claimed range of “0.5 to 2.0 mm”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the product of Xiong with the use of the diameter of the granules as taught by Taguchi. One of ordinary skill would have been motivated to consult Taguchi about the pore size of granulate plant extract products because Xiong discloses that modifications may be made to the present invention, including modification in size, without changing the function of the invention (col. 9, lines 12-25).
Although the cited prior art does not teach that the granule has a 90% dissolution time of 6 to 44 seconds, this limitation is interpreted as a property of the claimed granular composition. MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present. Additionally, Additionally, MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 2, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Although the cited prior art does not explicitly state the mass ratio of a total of the component (B) and the component (C) to the component (A) is from 0.3 to 3.2, Xiong does teach that the composition comprises 10 to 50% by weight green tea plant extract (col. 3, lines 5-7), 1 to 10 percent of a binding agent (col. 3, line 22) and that binding agents can be starch (col. 4, lines 62-63). Hermes teaches a granule particle comprising about 20 to about 80 wt.% of sugar alcohol ([0008]). Therefore, in the case where the composition comprises 50% green tea plant extract, 10 percent of a binding agent such as starch, and 20% of a sweetening agent, the ratio of a total of the component (B) and the component (C) to the component (A) is 0.6, which falls within the claimed range of “0.3 to 3.2”.
Regarding claim 3, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches the composition comprising 1 to 10 percent of a binding agent (col. 3, line 22) and that binding agents can be starch (col. 4, lines 62-63), where “1 to 10 percent” overlaps with the claimed range of “3 mass% or more”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 4, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches the composition comprising 1 to 10 percent of a binding agent (col. 3, line 22) and that binding agents can be hydroxyethyl cellulose (a known cellulose derivative, col. 4, lines 62-66), where “1 to 10%” overlaps with the claimed range of “0.2 mass% or more”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 5, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above.
Xiong does not teach wherein the sweetener is reduced maltose.
However, Hermes teaches maltitol ([0009]), which the instant specification states is also known as reduced maltose (p. 12, line 4).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Xiong with the use of maltitol in place of the sweetening agent as taught by Hermes. One of ordinary skill would have found it obvious to substitute maltitol taught by Hermes as the sweetening agent taught in Xiong because maltitol is a known type of sweetener. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another art equivalent and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B).
Regarding claim 6, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches using dextrin as a binder (col. 4, lines 62-65).
Regarding claim 7, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches using hydroxypropylmethyl cellulose or hydroxypropyl cellulose as a binder (col. 4, lines 62-67).
Regarding claim 8, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches using carboxymethyl cellulose as a binder (col. 4, lines 62-65).
Regarding claim 10, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches the composition comprising 10 to 50% by weight green tea plant extract (col. 3, lines 5-7) which overlaps with the claimed range “30 mass% to 65 mass%”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 11, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches that the plant extract is green tea extract (Abstract).
Regarding claim 12, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Although the cited prior art does not explicitly state the mass ratio of component (C) to component (A) is from 0.15 to 2, Xiong does teach that the composition comprises 10 to 50% by weight green tea plant extract (col. 3, lines 5-7) and Hermes teaches comprising about 20 to about 80 wt.% of sugar alcohol ([0008]). Therefore, in the case where the composition comprises 20% by weight of a sweetening agent and 10% by weight green tea plant extract, the mass ratio of component (C) to component (A) is 2.0, which falls within the claimed range of “0.15 to 2.0”.
Regarding claim 13, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches a carboxymethyl cellulose sodium as a binder (col. 4, lines 62-65), where carboxymethyl cellulose sodium is a salt of a carboxy cellulose.
Regarding claim 14, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Xiong also teaches using 1 to 10 percent of a binding agent (col. 3, line 22), which overlaps with the claimed range of “0.2 mass% to 5 mass%”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 15, Xiong modified by Hermes and Taguchi teaches all elements of claim 1 as described above. Although Xiong does not explicitly state the mass ratio of component (C) to component (D) is from 3 to 60, Xiong does teach that the composition comprises 1 to 10 percent of a binding agent (col. 3, line 22) and that binding agents can be hydroxyethyl cellulose (col. 4, lines 62-66) and Hermes teaches the composition comprising about 20 to about 80 wt.% of sugar alcohol ([0008]). Therefore, in case where the composition comprises 20% of a sweetening agent and 1% of hydroxyethyl cellulose, the mass ratio of component (C) to component (D) is 20, which falls within the claimed range of “3 to 60”.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Xiong (US 6,299,925)(IDS Reference filed 11/01/2023) in view of Hermes (DE 202016002812 U1) and Taguchi (JP2018061483A)(IDS Reference filed 05/03/2022) as applied to claim 1 above, and further in view of Mitra (US 2006/0110479 A1).
Regarding claim 16, Xiong also teaches the composition comprising 1 to 10 percent of a binding agent (col. 3, line 22) and that binding agents can be hydroxyethyl cellulose (a known cellulose derivative, col. 4, lines 62-66), where “1 to 10%” overlaps with the claimed range of “0.5 mass% to 5 mass%”.
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Xiong does not teach the composition comprising starch in an amount from 13 mass% to 30 mass%.
However, in the same field of endeavor of granules, Mitra teaches a composition comprising granules that contain about 50 mg of starch per 300 to 900 mg of the dosage ([0029]). Thus, when the dosage form is a granule ([0032]), the composition would comprise 5.6% to 16.7% starch, which overlaps with the claimed range of “13 mass% to 300 mass%”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the composition of Xiong to include the amount of starch as taught by Mitra. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
With respect to the overlapping ranges, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-8 and 10-15 over Xiong and Hermes: Applicant’s arguments filed January 8, 2026 have been fully considered but they are not persuasive.
Applicant argued that Xiong and Hermes do not teach the newly recited properties of median granule diameter and a 90% dissolution time (Remarks, p. 5, ¶ 8- p. 6, ¶ 1).
Applicant' s arguments have been fully considered and are persuasive to the extent that the claims as presently amended would not be anticipated/obvious in view of Xiong and Hermes. However, upon further consideration, a new ground(s) of rejection is made in view of Xiong, Hermes, and Taguchi.
Applicant argued that selecting composition, median diameter, and dissolution time to arrive at the claimed subject matter would require undue experimentation (Remarks, p. 6, ¶ 2).
This argument has been considered. However, it is not found persuasive. MPEP 716.01(c) states, “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” In the instant case, Applicant alleges undue experimentation without any evidence. Mere allegation that something is undue has zero merit unless it is based on facts and evidence. Moreover, the cited prior art(s) suggested modification of these variables. That is, the prior art has clearly established that these are result effective variables. And, adjustment of result effective variables is routinely practiced in the art.
Applicant further argued that Xiong does not teach an overlapping range for the starch content of newly introduced claim 16, and that Xiong does not contain any motivation or teaching for one of ordinary skill to exceed the amount of binger taught by Xiong (Remarks, p. 6, ¶ 3- p. 7, ¶ 1).
This argument has been considered. The Examiner agrees that Xiong does not teach the starch range of claim 16. Thus, Mitra, in the same field of endeavor of granules, is relied upon to teach the limitation of claim 16 requiring starch to be present in higher amounts than what is introduced in Xiong.
The rejections of claims 1-8 and 10-15 have been maintained herein.
Conclusion
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793