NON-FINAL REJECTION
This application was filed May 10, 2024.
Claims 1-20, as amended, are pending.
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 14, 2024 and Oct. 17, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
During a telephone conversation with Applicant's representative, Thomas Ohman, on Aug. 24, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-11, drawn to compositions. Affirmation of this election must be made by applicant in replying to this Office action.
The invention of Group II, claims 12-20, drawn to methods of using the compositions of claim 1, are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected inventions.
In addition, Applicant’s election without traverse of the composition species comprising:
gelatin as the gelling agent;
cocoa butter as the hydrated vegetable fat;
xylitol as the carbohydrate and/or sugar alcohol;
glycerol as the solvent; and
melatonin (a Class II API) as the active pharmaceutical ingredient,
in the reply filed on May 20, 2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 20, 2026.
Claims 1-10 are currently pending and under consideration.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Curify (DE 20 2023 102 185 (U1), cited on the IDS dated 10/17/2025).
Curify discloses pharmaceutical formulations for preparing 3D-printed solid dosage forms, comprising
2 - 30 wt.% of one or more gelling agents,
1 - 10 wt.% of one or more thickeners,
1 - 40 wt.%, preferably 10 - 35 wt.% of one or more lipid-based excipients, and
40 - 70 wt% of one or more solvents
(abstract, para. [0006]).
In particular, Curify exemplifies the formulation shown in Table 1 (p. 5):
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540
968
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which comprises components falling within the ranges recited by claims 1-5 as follows:
Curify Example 1 (Table 1)
Claim 1
12.42% gelatin
5-30 wt% gelling agent (gelatin)
1.23% silicon dioxide (SiO2)
0.5-5 wt% silica (SiO2)
12.23% cocoa butter
10-35 wt% hydrated vegetable fat
20.38% xylitol
10-30 wt% sugar alcohol
42.39% purified water + 5.59% glycerin
= 47.98% total solvent
40-70 wt% solvent
The formulation exemplified by Curify further comprises raspberry flavoring as a flavoring agent, as recited by claim 6.
The formulation exemplified by Curify further comprises potassium sorbate and citric acid, as recited by claim 7.
The formulation exemplified by Curify also comprises components falling within the ranges recited by claim 8, as follows:
Curify Example 1 (Table 1)
Claim 8
12.42% gelatin
10-15 wt% gelatin
1.23% silicon dioxide (SiO2)
0.5-5 wt% silica (SiO2)
12.23% cocoa butter
10-15 wt% cocoa butter
20.38% xylitol
15-25 wt% xylitol
42.39% purified water
40-45 wt% water
5.59% glycerin
5-6 wt% glycerol
The formulations of Curify further comprise one or more active pharmaceutical ingredients (APIs), e.g., caffeine (paras. [0020], [0023]; claim 13), as recited by claim 10.
For the foregoing reasons, Curify anticipates claims 1-8 and 10.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Curify (DE 20 2023 102 185 (U1), cited on the IDS dated 10/17/2025).
Curify discloses pharmaceutical formulations for preparing 3D-printed solid dosage forms, comprising
2 - 30 wt.% of one or more gelling agents,
1 - 10 wt.% of one or more thickeners,
1 - 40 wt.%, preferably 10 - 35 wt.% of one or more lipid-based excipients, and
40 - 70 wt% of one or more solvents
(abstract, para. [0006]).
In particular, Curify exemplifies the formulation shown in Table 1 (p. 5):
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media_image1.png
540
968
media_image1.png
Greyscale
which comprises components falling within the ranges recited by claims 1-5 as follows:
Curify Example 1 (Table 1)
Claim 1
12.42% gelatin
5-30 wt% gelling agent (gelatin)
1.23% silicon dioxide (SiO2)
0.5-5 wt% silica (SiO2)
12.23% cocoa butter
10-35 wt% hydrated vegetable fat
20.38% xylitol
10-30 wt% sugar alcohol
42.39% purified water + 5.59% glycerin
= 47.98% total solvent
40-70 wt% solvent
The formulation exemplified by Curify further comprises raspberry flavoring as a flavoring agent, as recited by claim 6.
The formulation exemplified by Curify further comprises potassium sorbate and citric acid, as recited by claim 7.
The formulation exemplified by Curify also comprises components falling within the ranges recited by claim 8, as follows:
Curify Example 1 (Table 1)
Claim 8
12.42% gelatin
10-15 wt% gelatin
1.23% silicon dioxide (SiO2)
0.5-5 wt% silica (SiO2)
12.23% cocoa butter
10-15 wt% cocoa butter
20.38% xylitol
15-25 wt% xylitol
42.39% purified water
40-45 wt% water
5.59% glycerin
5-6 wt% glycerol
The formulations of Curify further comprise one or more active pharmaceutical ingredients (APIs), e.g., caffeine (paras. [0020], [0023]; claim 13), as recited by claim 10.
Curify differs from the claims in that the formulations are not explicitly disclosed as dispersions, as recited by claim 9.
However, as recognized by MPEP §2112.01, where the claimed and prior art products 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).
Curify also differs from claim 9 in that the API is typically present in an amount of from 0.1% to 10% by weight (para. [0020]; claim 11), rather than 0.1% to 5% by weight as recited by claim 9.
However, Curify discloses that, when the API is added to the formulation, its effect on viscosity depends on which phase it transfers to, i.e. lipophilic drugs into the lipid phase and hydrophilic drugs into the water-hydrophilic phase. The properties of the API can also decrease or increase viscosity. The effects depend on the solubility of the drugs in the matrix and hydrogen bonding: substances that are capable of forming hydrogen bonds tend to have higher viscosity than substances that do not form hydrogen bonds (para. [0024]).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the formulations of Curify by reducing the maximum amount of API present in the claimed formulations with a reasonable expectation of success, because the viscosity of the formulation depends on the API’s solubility and ability to form hydrogen bonds, such that optimizing the amount of API in the formulation would aid in optimizing the viscosity.
Further, as recognized by MPEP § 2144.05 (I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
ES 1296080 (U) and WO2022/235989 (both cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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