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 .
Response to Arguments
Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive.
Applicant argues that the obviousness rejection of Shastry et al. in view of Adamic should be overcome because the claim 1 composition demonstrates superiority over the disclosed comparative examples. It appears that Applicant contends the prima facie obviousness rejection in view of the fact that inventive Examples 1, 3, 5, 8, and 11-12 provide superior and unexpected lightfastness over disclosed Comparative Examples 2-7. Namely, Applicant indicates the highest value of lightfastness (via ΔE) in the inventive examples is over 30% lower than the lowest value of lightfastness in the Comparative Examples. Applicant feels that such evidence supports surprising and unexpected results. While Applicant’s inventive Examples 1, 3, 5, 8, and 11-12 certainly show improved lightfastness over the disclosed Comparative Examples 2-7, Examiner maintains that the evidence of Tables 1-2 is insufficient to show that the results are surprising or unexpected.
The courts have held that a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). Burden rests with Applicant to show “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). MPEP 716.02.
While Applicant’s inventive Examples certainly demonstrate improved lightfastness as compared to the Comparative Examples, the test for unexpectedly superior results is not merely one of degree. In other words, it is insufficient to show that the inventive Examples produce better lightfastness; rather, the improved lightfastness must be statistically shown to be demonstrative of “a difference in kind, rather than one of degree,” per MPEP 716.02.
Moreover, Examiner notes that each of Applicant’s arguments of unexpected results have been made with respect to the disclosed Comparative Examples, and has yet to demonstrate that results from inventive Examples 1, 3, 5, 8, and 11-12 are unexpected over any teachings from the prior art of record. To this end, please recognize Adamic’s teachings that the inclusion of a sugar alcohol, such as reduced isomaltulose, can increase the optical density of printed matter on coated or uncoated media by “10%, 15%, 20%, or 30%,” attributable to the enhanced binding properties between the pigment and the media surface (paragraphs 44-45). Because Ademic teaches that the inclusion of such a sugar alcohol provides 30% increases in optical density, an artisan would have fully expected lightfastness to be likewise improved, as lightfastness is a functional result of optical density (see e.g. paragraph 153 of Applicant’s specification). Moreover, the previously cited prior art JP2019059925A also demonstrates that the mere addition of 5% reduced isomaltulose to an otherwise equivalent comparative ink produces color change improvements upwards of 80% (esp. comparing ΔE of inks in TABLE 2).
In light of the prior art teachings, then, it appears that an artisan would have fully expected a significant improvement in optical density/lightfastness by adding a sugar alcohol, such as the claimed reduced isomaltulose, due to the improved binding properties. Therefore, Applicant’s demonstrated improvements in lightfastness (color change) seem to be within the expected ranges already taught by the prior art of record. Applicant’s demonstrated improvements therefore do not appear unexpected over the prior art of record.
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.
Claim(s) 1, 3, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastry et al. (US 2004/0175463 A1) in view of Adamic (US 2017/0051172 A1).
Regarding claim 1:
Shastry et al. disclose an inkjet ink comprising:
4 mass% to 20 mass% of Blue No. 1 (paragraphs 40-41);
4 mass% to 20 mass% of an adhesive agent (paragraphs 42-44); and
a solvent containing water (paragraph 34) and ethanol (paragraphs 36-37),
wherein Blue No. 1 is the only dye in the inkjet ink (no suggestion of mixing colorants: paragraphs 39-41).
Shastry et al. do not expressly disclose that the adhesive agent is reduced isomaltulose.
However, Adamic disclose an inkjet ink comprising 1 mass% to 20 mass% of reduced isomaltulose (“isomalt”: paragraph 44) for the purpose of enhancing binding properties between the pigment and media surface, so as to provide optical density improvements (paragraph 45).
Therefore, at the time of filing, it would have been obvious to a person of ordinary skill in the art to use reduced isomaltulose as Shastry et al.’s adhesive agent, as taught by Adamic. In doing so, the reduced isomaltulose is the only saccharide in the inkjet ink.
Regarding claim 3:
Shastry et al.’s modified inkjet ink comprises all the limitations of claim 1, and Shastry also disclose that the solvent further contains at least one of glycerin and isopropyl alcohol (paragraph 37).
Regarding claim 8:
Shastry et al.’s modified inkjet ink comprises all the limitations of claim 1, and Shastry also disclose that the amount of ethanol in the ink is 6.5 mass% or more and 40 mass% or less (at least when the lower alcohol is ethanol alone: paragraph 37).
Regarding claim 12:
Shastry et al.’s modified inkjet ink comprises all the limitations of claim 1, and Shastry et al. also disclose that water constitutes from 41.5 to 90 mass% of the composition (paragraph 34).
Claim(s) 6-8, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastry et al. as modified by Adamic, as applied to claim 1 above, and further in view of Xu (WO 2011/128160).
Regarding claims 6-8, 11, and 13:
Shastry et al.’s modified inkjet ink comprises all the limitations of claim 1, and Shastry also disclose that the solvent further comprises a mixture of water, ethanol, and propylene glycol (paragraph 37).
Shastry et al.’s modified inkjet ink does not expressly disclose the particular amounts of water, ethanol, and propylene glycol when used as a mix.
However, Xu discloses an edible inkjet ink comprising a colorant, a binder, and a vehicle solvent, the vehicle solvent including water, ethanol, and propylene glycol (at least ink 3.1 of TABLE 1), wherein the amount of propylene glycol in the ink is 10 mass% or more and 40 mass% or less (12.5%: TABLE 1), wherein the amount of ethanol in the ink is 6.5 mass% or more and 10 mass% or less (7.8%: TABLE 1), and wherein the amount of water constitutes from 41.5 to 90 mass% of the composition (64.0%: TABLE 1).
Because both Shastry et al. and Xu disclose edible water-based inkjet inks having a colorant, a binder, and a mixture of organic solvents, it would have been obvious to a person of ordinary skill in the art to utilize the specific solvent mix taught by Xu as Shastry et al.’s solvent mixture, so as to achieve the desired purpose of providing a carrier solution for the edible ink.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shastry et al. as modified by Adamic, as applied to claim 1 above, and further in view of Enomoto et al. (JP 2019059925A).
Regarding claims 9-10:
Shastry et al.’s modified inkjet ink comprises all the limitations of claim 1, and Shastry et al. also disclose that the ink is printed to form a printed part of an edible piece (paragraphs 26-27).
Shastry et al.’s modified inkjet ink is not expressly printed on a pharmaceutical tablet.
However, Enomoto et al. disclose an inkjet ink that is used to print on a pharmaceutical tablet (paragraph 40).
Therefore, at the time of filing, it would have been obvious to a person of ordinary skill in the art to utilize Shastry et al.’s modified inkjet ink to print a printed part onto a pharmaceutical tablet, such as taught by Enomoto et al.
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.
Communication with the USPTO
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shelby L Fidler whose telephone number is (571)272-8455. The examiner can normally be reached Monday-Friday, 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Douglas Rodriguez can be reached at (571) 431-0716. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SHELBY L. FIDLER
Primary Examiner
Art Unit 2853
/SHELBY L FIDLER/Primary Examiner, Art Unit 2853