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 .
Summary
The Applicant’s arguments and claim amendments received on April 3, 2026 are entered into the file. Currently, claims 1-6 are amended; claims 7-10 are canceled; claims 11-22 are withdrawn; claim 23 is new; resulting in claims 1-6 and 23 pending for examination.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 5 of claim 1, the limitation reciting “consisting of an ink that is an edible” contains a typographical error that should read --consisting of an ink that is edible--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 3, the limitation reciting “further comprising a film coating” is considered new matter that is not adequately supported by the original specification.
Although paragraph [0088] of the as-filed specification and corresponding Fig. 3 disclose an embodiment of the claimed tablet in which a printed film-coated tablet (9) comprises a printed image (3) disposed on a top face of a tablet substrate (1) having a film-coated layer (7) formed on a surface thereof, the specification does not provide adequate support for the broadly claimed limitation of the tablet comprising a film coating. In particular, the specification more narrowly describes a configuration in which a film coating is formed on a surface of the tablet substrate (i.e., tablet body), and does not disclose the film coating being formed in any other configuration within the printed tablet (e.g., on an exterior surface of the image printed on the tablet body). In order to overcome this rejection, the Applicant could consider amending the limitation in claim 3 to recite --wherein the tablet body is a film-coated tablet-- (similar to the language of original claim 3), or --further comprising a film coating on the tablet body--, each of which is consistent with the disclosure in paragraph [0088] and Fig. 3 of the instant invention.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention
Claims 1-5 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Morikawa (JP 2020-002030, cited on IDS and ISR, machine translation previously provided) in view of Nakano (JP 2017-064032, machine translation via EPO provided).
Regarding claims 1 and 2, Morikawa teaches a tablet (9) comprising a tablet body (91) and an ink layer (92) fixed on the surface of the tablet body ([0034], Fig. 1). Since the tablet is to be orally administered to a human, the ink layer is preferably formed from an edible material (ink that is edible) [0038]. The ink contains a colorant and a solvent, wherein the colorant may be a dye that dissolves in the solvent or a pigment that is dispersed in the solvent [0037]. The colorant (food dye) may include Red No. 3, Red No. 104, Red No. 105, Red No. 106, or the like [0154].
The ink layer is used to form a multidimensional barcode (MC1) containing coloring material, where each cell (C1) in the barcode expresses multiple values according to the print density ([0129], Fig. 1). The print density may be controlled based on the size of the halftone dots (921; isolated dots) or the number of halftone dots formed in the cell (C1) ([0131], Figs. 3-4). In the cells (C11) with the highest print density, either by including relatively large halftone dots or by including a large number of relatively small halftone dots, the halftone dots (921) occupy a large area ratio relative to the cells, so that the cell appears black macroscopically [0048].
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The high print density cells (C11; image, printed area) shown in Figs. 3 and 4 each have a ratio of (i) the total area of the halftone dots to (ii) the total area of the cell which falls within the claimed range of 30-80%. Although Morikawa teaches that each of the halftone dots (921) has a circular shape, and that the print density of the cell can be adjusted by controlling the size and/or number of halftone dots therein ([0047]-[0049], [0101], Figs. 3-4), the reference is silent to a value of the diameter of the halftone dots.
However, in the analogous art of printed tablets, Nakano teaches a tablet printing method that can reduce distortion of printed image caused by inconsistent spacing between an inkjet printing nozzle and the tablet [0009]. Nakano teaches that because the surface of the tablet is not flat, the vertical distance between the nozzle and the tablet surface varies with the horizontal distance from the center of the tablet, resulting in an uneven distribution of the size of the ink droplets disposed on the surface of the tablet ([0007]-[0008], Fig. 12). Accordingly, Nakano teaches that the printing apparatus has a control unit that corrects the size of the ink droplets ejected from each nozzle of the print head according to the vertical distance from the nozzle to the surface of the tablet ([0044], Fig. 5-11). Nakano teaches that the diameter of the ink droplet after it adheres to the tablet may be controlled within the range of 20 µm to 52 µm, wherein the diameter of the printed ink droplet can be adjusted by controlling the size of the ink droplet to be ejected from the nozzle based upon the vertical distance between the nozzle and the surface of the tablet in order to achieve a printed image having reduced distortion ([0060], Figs. 8, 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the printed tablet taught by Morikawa by setting a diameter of the circular halftone dots within the claimed range, as suggested by Nakano, in order to achieve the desired print density for the respective cells and to reduce the distortion of the printed ink droplets across the surface of the tablet. Furthermore, it is noted that Nakano teaches a diameter of the printed dots which falls squarely within the claimed range of 17 µm to 170 µm. 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).
Regarding claim 3, Morikawa in view of Nakano teaches all of the limitations of claim 1 above, and Morikawa further teaches that the tablets may be film-coated or sugar-coated tablets [0033].
Regarding claim 4, Morikawa in view of Nakano teaches all of the limitations of claim 1 above but does not expressly teach an optical density (OD value) of the image formed by the ink layer.
However, Morikawa does further teach that the cells (C1) in the multidimensional barcode (MC1) represent multiple values based on differences in print density in the grayscale (e.g., black, gray, white) or by differences in print density at a predetermined saturation (e.g., dark red, red, light red) ([0042], [0109]). Morikawa et al. teaches that the print density of each of the cells (C1) may be controlled based on the size of the halftone dots, the number of halftone dots formed in the cell, or by the concentration (content) of the coloring material in the ink layer in each cell ([0048]-[0051], Figs. 3-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tablet taught by Morikawa in view of Nakano by setting an optical density (OD value) of the high print density cell (C11), and optionally the medium print density cell (C12), within the claimed range of 0.3 or more in order to ensure that the values expressed by the three different cells (C11, C12, C13) can be distinguished by their different optical characteristics.
Regarding claim 5, Morikawa in view of Nakano teaches all of the limitations of claim 1 above, and Morikawa further teaches that the multidimensional barcode (MC1) is printed onto the surface of the tablet body (91) by ink droplets using an inkjet method [0106].
Regarding claim 23, Morikawa in view of Nakano teaches all of the limitations of claim 1 above. As noted above, Morikawa teaches that the ink layer (92) is used to form a multidimensional barcode (MC1) containing coloring material with each cell (C1) in the barcode expressing multiple values according to the print density ([0129], Fig. 1), wherein an individual cell is taken to correspond to the claimed image. Although the plurality of cells (C1) together form a barcode (MC1), an individual cell which is merely a collection of halftone printed dots (921) is not itself a barcode.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Morikawa (JP 2020-002030, cited on IDS and ISR, machine translation previously provided) in view of Nakano (JP 2017-064032, machine translation via EPO provided) as applied to claim 1 above, and further in view of Enomoto et al. (JP 2018-100336, cited on IDS and ISR, machine translation previously provided).
Regarding claim 6, Morikawa in view of Nakano teaches all of the limitations of claim 1 above but does not expressly teach that the ink comprises a discoloration inhibitor as claimed.
However, in the analogous art of printed tablets, Enomoto et al. teaches an aqueous ink composition for inkjet printing on solid preparations such as pharmaceuticals and foods ([0001]-[0002]). The aqueous inkjet ink comprises an edible dye and a discoloration inhibitor, where the dye comprises at least one selected from the group consisting of Red No. 2, Red No. 4, Red No. 40, Red No. 102, Yellow No. 4, Yellow No. 5, Green No. 3, Blue No. 1, and sodium copper chlorophyllin [0016]. The discoloration inhibitor may be a monosaccharide, disaccharide (e.g., lactose), or sugar alcohol (e.g., reduced isomaltulose), and serves to inhibit penetration of the dye into the solid preparation ([0016]-[0017], [0024], [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tablet taught by Morikawa in view of Nakano by including a discoloration inhibitor such as reduced isomaltulose or lactose in the ink composition, as suggested by Enomoto et al., in order to inhibit the penetration of dye into the tablet, thus reducing the occurrence of discoloration.
Response to Arguments
Response-Claim Rejections - 35 USC § 112
The previous rejections of claims 1-10 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention are overcome by the Applicant’s amendments to claims 1 and 4 and by the cancellation of claims 7-10 in the response filed April 3, 2026.
Response-Claim Rejections - 35 USC § 102
Applicant’s arguments, see pages 5-6 of the remarks filed April 3, 2026, have been considered but are moot because they do not address the new combination of references being used in the rejections above. In light of the amendments to claim 1, the previous rejections under 35 U.S.C. 102 based on Morikawa are withdrawn, and Nakano is used as a secondary reference in combination with Morikawa to address the new limitation directed to the diameter of the circular shape of the isolated dots.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L GRUSBY whose telephone number is (571) 272-1564. The examiner can normally be reached Monday-Friday, 8:30 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Ruthkosky can be reached at (571) 272-1291. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rebecca L Grusby/Examiner, Art Unit 1785
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