FINAL 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 .
Priority
This application is CON of 17374986 filed 07/13/2021 (ABN).
17374986 has PRO of 63054591 filed 07/21/2020.
However, the following subject matters are not present or supported in the parent application of 1737498 or the PRO application of 63054591: the subject matters of claims 41-65. Thus, claims 41-65 will not receive filing date benefit of parent application of 17374986 and the PRO application of 63054591.
In addition, the following subject matters are not present or supported in PRO application of 63054591:
the subject matters of claim 24 including: “the substrate is a transparent sheet or film,” “the first print layer incorporates text and graphics printed in reverse in relation to the forward build of the sublingual delivery device,” “the first print layer, once cured, peels off the substrate,” “an overall image is formed by sequential printing of the first print layer, the second print layer, and the third print layer,” “each print layer comprises edible ink infused with color, flavor, or active ingredients, or any combination thereof,” and “the fourth print layer and the second print layer share corresponding flavor or active ingredients, and the fifth print layer and the first print layer share corresponding flavor or active ingredients”;
the subject matter of claim 26 including “a coated cardboard”;
the subject matter of claim 27 including “the substrate comprises a polyester film or polyethylene terephthalate (PET)”;
the subject matter of claim 29 including “the edible ink is transparent or translucent”;
the subject matter of claim 31 including “further comprising inkjet printing one or more additional edible layers to form patterns comprising indicia, text, or graphic images”;
the subject matters of claim 33 including “the substrate is a transparent sheet or film,” “the first print layer incorporates text and graphics printed in reverse in relation to the forward build of the sublingual delivery device,” “the first print layer, once cured, peels off the substrate,” “depositing an opposing print layer connecting to the third print layer,” “the opposing print layer and the third print layer are the same material,” “depositing an opposing print layer connecting to the second print layer,” “the opposing print layer and the second print are the same material,” “depositing an opposing print layer connecting to the first print layer,” “each print layer comprises edible ink infused with color, flavor, or active ingredients, or any combination thereof,” and “the first print layer and its opposing print layer is the first layer to dissolve in sequence, followed by the second print layer and its opposing print layer, followed by the third print layer and its opposing print layer, followed by the fourth print layer which represents the final layer containing active ingredients or flavor that dissolves”;
the subject matter of claim 35 including “a coated cardboard”;
the subject matter of claim 36 including “the substrate comprises a polyester film or polyethylene terephthalate (PET)”;
the subject matter of claim 38 including “the edible ink is transparent or translucent”; and
the subject matter of claim 40 including “further comprising inkjet printing one or more additional edible layers to form patterns comprising indicia, text, or graphic images”.
Thus, claims 24, 26-29, 31, 33, 35-38, and 40 will not receive filing date benefit of PRO application of 63054591.
Accordingly, claims 24, 26-29, 31, 33, 35-38, and 40 are afforded the effective filing date of 07/13/2021; and claims 41-65 are afforded the effective filing date of 07/19/2023 (actual filing date of the instant application).
Status of the Claims
This action is in response to papers filed 10/03/2025 in which claims 1-23, 25, 30, 32, 34, and 39 were canceled; claims 41-65 were withdrawn; and claims 24, 27-29, 33, and 36-38 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 24, 26-29, 31, 33, 35-38, and 40 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. 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.
Drawings
The drawings filed 07/19/2023 remain objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
reference character 4 of FIG. 3 is not described in specification under FIGURE 3
reference character(s) 1 and 8 of FIG. 4 are not described in the specification under FIGURE 4
reference character 1 of FIG. 5 is not described in specification under FIGURE 5
reference character 1 of FIG. 6 is not described in specification under FIGURE 6
reference character 1 of FIG. 7 is not described in specification under FIGURE 7
reference character 1 of FIG. 8 is not described in specification under FIGURE 8
reference character 1 of FIG. 9 is not described in specification under FIGURE 9
reference character 8 of FIG. 10A is not described in specification under FIGURE 10A
reference character(s) 1 and 8 of FIG.10B are not described in the specification under FIGURE 10B
reference character 1 of FIG. 10C is not described in specification under FIGURE 10C
reference character 1 of FIG. 10D is not described in specification under FIGURE 10D
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive.
Applicant argues that “paragraphs [032], [034], [035], [036], [038], [039], and [040] are amended to address the missing reference characters not mentioned in the description with respect to FIGURES 3-9” (Remarks, page 18, last paragraph to page 19).
In response, the Examiner disagrees. The amendments of paragraphs [032], [034], [035], [036], [038], [039], and [040] from the specification filed 10/03/2025 were not entered because some the amendments (as discussed below) added new matter to the specification.
Accordingly, the objection to the drawings is maintained for the reasons discussed above in the modified objection to the Drawings. Please ensure all reference characters shown in the Drawings for all FIG(S) are properly described in the specification under the corresponding FIGURE(S).
Specification
The amendment filed 10/03/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
amendment to paragraph [036] drawn to “Printed layers 5, 2, may be comprised of the same material making a uniform dissolvable barrier to printed layers 3, 4”;
amendments to paragraph [039] drawn to “”a fifth print layer 4a,” “a sixth print layer 3a,” “a seventh print layer 2a,” and “print 2”; and
amendment to paragraph [040] drawn to “as a method of increased dosage of active ingredients, a third print layer 4, which may be different material as print layer 4, that creates two encapsulated layers 3, 4, that contain different active ingredient or flavorings, followed by a fourth print layer 5, as an encapsulating layer which may be of the same material as print layer 2.”
Applicant is required to cancel the new matter in the reply to this Office Action.
For the reason(s) above, the amendment to the Specification filed 10/03/2025 is NOT entered.
The disclosure is also objected to because of the following informalities:
paragraph [026] of the specification disclosed “as demonstrated in FIGURE 4 of a specific sublingual strip device 7.” There is no reference character 7 in FIG. 4 of the Drawings. This deficiency is the same for paragraph [034] of the specification.
paragraph [032] of the specification provides a description of FIGURE 3 and disclosed “sublingual delivery device 7.” There is no reference character 7 in FIG. 3 of the Drawings.
Paragraph [035] of the specification provides a description of FIGURE 5 and disclosed “sublingual delivery device 7”. There is no reference character 7 in FIG. 5 of the Drawings.
Paragraphs [036] and [037] of the specification provides a description of FIGURE 6 and disclosed “sublingual delivery device 7”. There is no reference character 7 in FIG. 6 of the Drawings.
Paragraph [038] of the specification provides a description of FIGURE 7 and disclosed “sublingual delivery device 7”. There is no reference character 7 in FIG. 7 of the Drawings.
Paragraph [040] of the specification provides a description of FIGURE 9 and disclosed “sublingual delivery device 7”. There is no reference character 7 in FIG. 9 of the Drawings.
Paragraphs [041] and [042] of the specification provide a description of FIGURES 10A-10D and disclosed “sublingual delivery device 7”. There is no reference character 7 in FIG(S). 10A-10D of the Drawings.
Please ensure all reference characters in the Drawings are consistent with the disclosures of the specification, and vice versa.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Appropriate corrections are required.
Claim Objections
Claim 24 is objected to because of the following informalities: please remove the “or” from “color, flavor, or active” as it is redundant to the latter “or” from “or any combination thereof”. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: please remove the “or” from “color, flavor, or active” as it is redundant to the latter “or” from “or any combination thereof”. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: the recitation of “wherein the opposing print layer and the second print layer are the same material” as recited under step e) is redundant to the recitation of “wherein the opposing print layer and the second print layer are the same material” under step d). These appeared to be duplicate recitations. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – NEW MATTER
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.
Claims 31 and 40 are 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.
Claim 31 introduces new matter as the claim recites the limitation: “further comprising inkjet printing one or more additional edible layers to form patterns comprising indicia, text, or graphic images.” There is no support in the specification for this limitation.
Claim 40 introduces new matter as the claims recite the limitation: “further comprising inkjet printing one or more additional edible layers to form patterns comprising indicia, text, or graphic images.” There is no support in the specification for this limitation.
Applicant asserted that the support for the amendments of claims 24-25, 29-34 and 30-40 can be found throughout the specification and figures as originally filed, including in: [002] (page 2); [007] (page 3); [012] (page 5) to [022] (page 6); [025] (page 7); [030] (page 8); [031] (page 8) to [046] (page 11); and the original claims. See Remarks filed 09/26/2023.
However, after a thorough review of said [002] (page 2); [007] (page 3); [012] (page 5) to [022] (page 6); [025] (page 7); [030] (page 8); [031] (page 8) to [046] (page 11); the figures as originally filed; and the original claims, as well as, throughout the specification, there appeared to be no support for the subject matters as particularly indicated above for claims 31 and 40.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 31 and 40 at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive.
On page 19 of the Remarks filed 10/03/2025, Applicant did not address the new matter issue of claims 31 and 40, nor has Applicant amended claims 31 and 40 to overcome the new matter rejection of said claims 31 and 40.
Accordingly, the new matter rejection of claims 31 and 40 is maintained for reason of record.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24, 26-29, 31, 33, 35-38, and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 24, the recitation of “the sublingual delivery device” under step a) renders claim 24 indefinite because the preamble of claim 24 is drawn to “sublingual delivery devices” in plurality and the reference to “the sublingual delivery device” is in singularity. Thus, there is lack of antecedent for “the sublingual delivery device” in claim 24. As such, it is unclear if “the sublingual delivery device” is referencing to earlier “sublingual delivery devices” or a different sublingual delivery device. Claims 26-29 and 31 are also rejected as they depend from indefinite claim 24.
Regarding claim 29, the recitation of “the edible ink” renders claim 29 indefinite because there is lack to antecedent basis for “the edible ink” in claim 24. It is noted that claim 29 is dependent from claim 24, yet claim 24 does not contain an edible ink. Thus, it is unclear what “the edible ink” is claim 29 referencing to, as the method of claim 24 does not contain an edible ink.
Regarding claim 33, the recitation of “the sublingual delivery device” under steps a) and b) renders claim 33 indefinite because the preamble of claim 33 is drawn to “sublingual delivery devices” in plurality and the reference to “the sublingual delivery device” is in singularity. Thus, there is lack of antecedent for “the sublingual delivery device” in claim 33. As such, it is unclear if “the sublingual delivery device” is referencing to earlier “sublingual delivery devices” or a different sublingual delivery device.
Furthermore, with respect to claim 33: the multiple recitations of “the opposing print layer” renders claim 33 indefinite because each of “an opposing layer” that is deposited/connected to third print layer, second print layer, and first print layer, respectively, appeared to be a different opposing layer as it relate to third print layer, second print layer, and first print layer. Thus, the multiple recitations of “the opposing print layer” do not clarify which opposing layer of third print layer, second print layer, or first print layer are they referencing to. To obviate this indefinite rejection, it is suggested that “the opposing print layer and the third print layer are the same material” be amended to “the third print layer and its opposing print layer are the same material.” Please appropriately amend for third print layer, second print layer, and first print layer as it pertain to their opposing print layers.
Claims 35-38, and 40 are also rejected as they depend from indefinite claim 33.
Regarding claim 38, the recitation of “the edible ink” renders claim 38 indefinite because there is lack to antecedent basis for “the edible ink” in claim 33. It is noted that claim 38 is dependent from claim 33, yet claim 33 does not contain an edible ink. Thus, it is unclear what “the edible ink” is claim 38 referencing to, as the method of claim 33 does not contain an edible ink.
As a result, claims 24, 26-29, 31, 33, 35-38, and 40 do not clearly set forth the metes and bounds of patent protection desired.
Conclusion
Claims 24, 26-29, 31, 33, 35-38, and 40 are rejected.
Claims 24 and 33 are objected.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613