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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed November 3, 2025 is acknowledged.
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-2, 6-8
Withdrawn claims:
None
Previously canceled claims:
None
Newly canceled claims:
3-5
Amended claims:
1, 6
New claims:
None
Claims currently under consideration:
1-2, 6-8
Currently rejected claims:
1-2, 6-8
Allowed claims:
Claim Objections
Claim 1 is objected to because of the following informalities:
Amend lines 2-3 to state “having a diameter ranging from 1.8 mm to 2.2mm, [[of]] a plurality of colors, and consisting of”;
Amend line 6 to state “hydroxypropyl methylcellulose as a hydrocolloid and [[containing]] a water-soluble”.
Appropriate correction is required.
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, 2, 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wittorff (US 2018/0140554 A1)(IDS Reference filed 04/13/2023) in view of Thorengaard (WO 2009/007768A1)(IDS Reference filed 04/13/2023).
Claim 1 is a product-by-process claim. MPEP §2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). “The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.”
The structure imparted by the process of claim 1 is a compressed tablet comprising granules of a plurality of colors consisting of a sweetener core having a particle size ranging from 400 to 600 µm, where the cores are surrounded by particles of the same or another sweetener having a particle size smaller than that of the core, and a hydrocolloid containing a water-soluble active ingredient.
Regarding claim 1, Wittorff teaches of a tablet formed by compression of particles, where the tablet comprises erythritol (i.e., a sweetener core) and one or more binders (abstract). Wittorff also teaches that the particle size of at least 80% of the erythritol particles is greater than 200 microns ([0051]), which encompasses the claimed range of “400 to 600 µm” and that less than 20% of the erythritol particles have a particle size of smaller than 250 microns ([0053]). Therefore, it logically follows that the smaller particles of erythritol would at least partially coat the larger particles of erythritol. Wittorff further teaches that acceptable binders include hydroxy propyl methyl cellulose ([0021]). Wittorff teaches all elements of claim 1. Wittorff also teaches including active agents such as vitamins, minerals, or amino acids ([0136]).
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.
Wittorff does not teach wherein the granules have a diameter ranging from 1.8 mm to 2.2 mm.
However, in the same field of endeavor, Thorengaard teaches a sweetener tablet (Abstract) wherein the particles have average particle sizes in the range of 200 to 5000 µm (which corresponds to 0.2 to 5 mm; p. 13, lines 5-6), which encompasses the claimed range of “1.8 to 2.2 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 composition of Wittorff with the granular particle size taught by Thorengaard. 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.
Although the cited prior art does not teach a plurality of colors in the tablet, MPEP §2144.04(I) states “The court found that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art”, In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947). Because the plurality of colors do not provide a distinct function, they do not carry patentable weight.
Regarding claim 2, Wittorff also teaches that the particle size of at least 80% of the erythritol particles is greater than 200 microns ([0051]), which encompasses the claimed value of “500µg”.
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 6, Wittorff does not teach a confectionary product comprising the tablet of claim 1.
However, in the same field of endeavor, Thorengaard teaches a sweetener tablet (Abstract) where the sweetener granules may be compressed into a chewing gum tablet (i.e., a confectionary product; p. 16, lines 1-5).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate the tablet of Wittorff into a chewing gum composition as taught by Thorengaard. 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).
Regarding claim 7, Wittorff also teaches that less than 20% of the erythritol particles have a particle size of smaller than 250 microns ([0053]), which encompasses the claimed value of “about 100 microns”. Therefore, it logically follows that the smaller particles of erythritol would at least partially coat the larger particles of erythritol.
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 8, Wittorff does not teach wherein the granules have a diameter of 2 mm.
However, in the same field of endeavor, Thorengaard teaches a sweetener tablet (Abstract) wherein the particles have average particle sizes in the range of 200 to 5000 µm (which corresponds to 0.2 to 5 mm; p. 13, lines 5-6), which encompasses the claimed value of “2 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 composition of Wittorff with the granular particle size taught by Isager. 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).
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-3, 5, and 7 over Wittorf: Applicant’s arguments filed November 3, 2025 have been fully considered but they are not persuasive.
Applicant argued that the present claimed invention provides for unexpected and surprising results (Remarks, p. 4, ¶ 1-3).
This argument has been considered. However, MPEP §716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).” The present data in the specification is not commensurate in scope with the claims. Particularly, there are no tablet sizes tested outside of the claimed range. Furthermore, the data lacks experiments to show the performance of tablets with different combinations of water-soluble active ingredients.
Applicant further argued that Wittorff does not disclose the invention because Wittorff broadly defines the binding agent without any indication of advantages related to hydroxypropyl methylcellulose as claimed (Remarks, p. 4, ¶ 4).
This argument has been considered. However, MPEP §2123(I) states “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Additionally, MPEP §2112(I) states "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus any formerly unappreciated advantages related to the use of hydroxypropyl methylcellulose do not carry patentable weight because Wittorff discloses the use in a tablet.
Applicant argued that Wittorff is silent regarding the diameter of the tablet (Remarks, p. 4, ¶ 5).
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Wittorff is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Claim Rejections – 35 U.S.C. §103 of claims 4, 6, and 8 over Wittorff and Thorengaard: Applicant’s arguments filed November 3, 2025 have been fully considered but they are not persuasive.
Applicant argued that Thorengaard describes a very broad definition of a granule and is silent regarding tablets having a hydrocolloid (Remarks, p. 5, ¶ 5-9).
This argument has been considered. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Thorengaard is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant further argued that Thorengaard describes how to obtain chewing gum tablets which are limited by active ingredients and conditions for the tablets, and that Thorengaard does not contemplate product for conventional tablets (Remarks, p. 6, ¶ 2-3).
This argument has been considered. However, Thorengaard is directed to a broad compressed tablet for the release of ingredients (Abstract). Furthermore, the present claim 1 does not preclude a chewing gum tablet as the claimed tablet. Additionally, there is no process in the present claims that would structurally differentiate the tablet of the instant specification from the tablet of Thorengaard. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Thorengaard is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant argued that with the present invention it is possible to obtain tablets by the addition of polyol sweeteners in combination with appropriate humidity and temperature.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the requirement of polyol sweeteners in combination with appropriate humidity and temperature) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejections of claims 1, 2, and 6-8 have been maintained herein.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 7:30a-5:00p, F 8:00a-12:00p.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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