Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Request for Continued Examination
A Request for Continued Examination pursuant to 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Because this application is eligible for continued examination pursuant to 37 CFR § 1.114, and Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 13 March 2026 has been entered.
Status of the Claims
Applicants filed claims 1 – 4 and 6 - 32 with the instant application according to 37 CFR § 1.114, on 13 March 2026. In an Amendment entered with the Request for Continued Examination, Applicants amended claims 1, 4, 6, 13, 15, 20, 22 – 24, and 26 – 28, canceled claims 11, 12, 25, and 29 – 31, and added new claim 33. Claims 20 – 24 and 26 – 28 remain withdrawn as being directed to a non-elected invention. Consequently, claims 1 – 4, 6 – 10, 13 – 19, 32, and 33 are available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejections set forth in the Action of 14 October 2025 are hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 4 and 7 – 10, 13 – 19, and 33 are rejected pursuant to 35 U.S.C. § 103, as being obvious over WO 2017/158172 A1 to Stomberg, C., et al., published 21 September 2017, cited on the Information Disclosure Statement (IDS) filed 3 March 2023, cite no. 2 (FOR) (“Stomberg WO ‘172”), in view of US 2019/0209468 A1 to Deng, F., et al., claiming priority to 9 January 2018 (“Deng ‘468”).
The Invention As Claimed
Applicants claim a semi-solid or solid dosage form made of solidified filament structures that comprise at least two groups of solidified filament structures, wherein the composition of the solidified filament structures of one group is different from the composition of the solidified filament structures of the other group, and at least one group of the solidified filament structures contain at least one active agent, such as pharmaceutical active agents, nutraceutical active agents, or dietary supplemental active agents, the dosage form having at least one void which is free of solidified filament structures and which is surrounded by solidified filament structures, whereby a surface area of the dosage form having at least one void is at least double a surface area of dosage form without the at least one void, or is increased about threefold, about fourfold, about fivefold, about sixfold, about sevenfold, about eightfold, about ninefold or about tenfold of the surface area of dosage form without the at least one void, wherein the solidified filament structures of the one group contain at least one first active agent or first composition of active agents, and the solidified filament structures of the other group contain an active agent or active agents or composition of active agents which are different from the first active agent or first composition of active agents, wherein the solidified filament structures of the other group contain the same at least one first active agent as the solidified filament structures of the one group, wherein the concentration of the at least one active agent in the solidified filament structures of the one group is different from the concentration of the at least one active agent in the solidified filament structures of the other group, wherein at least one group of solidified filament structures contains no active agent, wherein solidified filament structures having the same active agent are present in a joint region of the dosage form such that the solidified filament structures having the same active agent at least partially adjoin at least on one side, wherein the regions are arranged horizontally or vertically such that solidified filament structures having the same one active agent form horizontal or vertical layers in the dosage form, wherein solidified filament structures having the same at least one active agent are arranged in a joint region and separated by a barrier of solidified filament structures having no active agent and/or of solidified filament structures having an active agent which is different from the active agent or which has a different concentration of the active agent, the barrier being impermeable for the at least one active agent, wherein the barrier between solidified filament structures having different active agents and/or solidified filament structures having different concentrations of active agent are formed by solidified filament structures having no active agent, wherein the at least one void is filled with a pharmaceutically acceptable composition containing or not containing an active agent, wherein the pharmaceutically acceptable composition contains one or more active agent(s) being different from the active agent(s) of the filament structures, wherein the dosage form comprises multiple voids, wherein the dosage form has an inhomogeneous distribution of density of solidified filament structures, wherein the solidified filament structures of one group and the solidified filament structures of the other group in the dosage form have different surface properties, wherein the dosage form contains more than two active agents, and wherein the dosage form contains 3 to 8 active agents.
The Teachings of the Cited Art
Stomberg WO ‘172 discloses a three-dimensionally printed pharmaceutical dosage form comprising a first pharmacologically active ingredient and a second pharmacologically active ingredient (see Abstract), wherein a pharmaceutical composition can be provided by extruding a filament comprising a pharmacologically active ingredient that is homogeneously distributed therein, and provided in a form that may be precisely printed (see ¶[0016]), wherein computer aided printing technology also ensures content uniformity in the course of the preparation of various pharmaceutical dosage forms which cannot be achieved by any conventional technology when two different pharmacologically active ingredients having substantially different specific efficacy are to be formulated in the same dosage form (see ¶[0017]), wherein two different pharmacologically active ingredients may be comprised in two different filaments, and to be distributed homogeneously in a large excess of other excipients (see ¶[0018]), wherein the dosage forms comprise a third and fourth active agents (see ¶[0014]; see also, ¶¶[0028] – [0029]), wherein content uniformity is achieved independently by adjusting the concentration of each pharmacologically active ingredient in each filament and, also, by adjusting the amount of each filament which is deposited in the course of printing (see ¶[0019]), wherein each type of filament comprises each pharmacologically active ingredient in the filaments, prepared by independently adjusting the concentration of the active ingredient in each type of filament and by adjusting the amount of each filament that is deposited in the course of printing, yielding the pharmaceutical dosage form, wherein the first pharmacologically active ingredient and the second pharmacologically active ingredient that are contained in the pharmaceutical dosage form differ from one another, i.e. are not identical (see ¶[0021]), wherein the filaments may comprise an additional pharmaceutical composition without an active ingredient (see ¶[0059]), wherein the pharmaceutical dosage form comprises a first three-dimensionally printed pharmaceutical composition comprising the first pharmacologically active ingredient and a second three-dimensionally printed pharmaceutical composition comprising the second pharmacologically active ingredient, wherein the second pharmaceutical composition forms one voxel, or at least two voxels, that are spatially separated from one another (see ¶[0064]), wherein the voxel (segment, element, subunit, part) may be the minimum three-dimensional microstructure than can be printed in accordance with the resolution of the printing device or an agglomerate of a multitude of such microstructures (see ¶[0065]), wherein at least one voxel comprising the second three-dimensionally printed pharmaceutical composition is embedded within the first three-dimensionally printed pharmaceutical composition, wherein the entire outer surface of the at least one voxel is surrounded by the first three-dimensionally printed pharmaceutical composition or only parts of the outer surface of the at least one voxel are surrounded by said first three-dimensionally printed pharmaceutical composition forming a discontinuity in the coherent mass which is formed by the first three-dimensionally printed pharmaceutical composition (see ¶[0068]), wherein the pharmaceutical dosage form comprises at least two voxels, which are each composed of the second three-dimensionally printed pharmaceutical composition, and which are spatially separated from one another (see ¶[0069]), and wherein the first and the second pharmaceutical composition form different layers of the pharmaceutical dosage form, which are preferably adjacent and/or parallel to one another, or the first and the second pharmaceutical composition together form a common layer of the pharmaceutical dosage form, wherein preferably the first pharmaceutical composition at least partially surrounds the second pharmaceutical composition within the plane of the layer (see ¶[0076]). The reference does not expressly disclose a dosage form comprising regions that are arranged horizontally or vertically such that filaments having the same active agent form horizontal or vertical layers in the dosage form in relation to the longest dimension of the dosage form, wherein filament structures having the same composition are arranged in a joint region and separated by a barrier of filament structures having no active agent and/or of filament structures having an active agent being different from said active agent and/or of filament structures having the same active agent but a different concentration of said active agent, the barrier being impermeable for said active agent, wherein the barrier between filament structures having different active agents and/or filament structures having different concentrations of active agent is formed by filament structures having no active agent. These deficiencies are remedied by the teachings of Deng ‘468.
Deng ‘468 discloses oral drug dosage forms, configured to provide a desired release profile, the dosage forms comprising a multi-layered structure comprising a plurality of layers of a first erodible material admixed with a compound (e.g., a drug) or a reagent, wherein the first erodible material is embedded in a second material not admixed with the compound, wherein the dosage forms are prepared by three-dimensional printing (see Abstract), wherein the dosage forms are formulated and configured to provide a desired release profile, by dispensing a first erodible material admixed with a compound (e.g., a drug) and a second material not admixed with the compound to produce a multilayered structure comprising a plurality of layers of the first erodible material, wherein the first erodible material is embedded in the second material, wherein each layer of the first erodible material has a pre-determined surface area, thickness, and mass fraction, such as a drug mass fraction, wherein the pre-determined surface area, thickness, and/or drug mass fraction correlate with the desired release profile (see ¶[0007]), wherein the first erodible material admixed with the drug and the second material not admixed with the drug are dispensed separately (see ¶[0012]), or sequentially (see ¶[0013]), wherein the drug mass fraction in each of the plurality of layers of the first erodible material are the same (see ¶[0017]), or are different from each other (see ¶[0018]), wherein the three-dimensional printing is carried out by filament fused deposition modeling (FFDM) (see ¶[0023]), wherein the process includes dispensing an intermediate material not admixed with the drug, wherein the intermediate material forms an intermediate layer between two or more layers of the first erodible material, wherein in some embodiments, the intermediate material is the same as the first erodible material or the second material (see ¶[0026]), wherein the dosage forms further comprise a second drug (see ¶[0029]), wherein the second drug is provided in a third erodible material to produce a dosage form comprising a multi-layered structure with a plurality of layers of the third erodible material, wherein the third material is embedded in the second material, wherein each layer of the third erodible material has a pre-determined surface area, thickness, and drug mass fraction and wherein the pre-determined surface area, thickness, and/or mass fraction correlate with a desired release profile (see ¶[0030]), wherein the second material is erodible, and can have the same or a different erosion rate as that of the first erodible material, or the second material is an insulating material that is impenetrable to bodily fluid, wherein the insulating material forms a barrier between the bodily fluid and at least a portion of the multi-layered structure (see ¶[0046), wherein the dosage forms are prepared by dispensing an intermediate material not admixed with the drug, wherein the intermediate material forms one or more intermediate layers between two or more layers of the first erodible material which material is the same as or different from the first erodible material (see ¶[0048; see also ¶[0167]), wherein the dosage forms comprise two or more multi-layered structures (see ¶[0054), wherein dosage forms with a desired drug release profile of one, or multiple, drugs, are designed and printed using three-dimensional printing techniques and can result in improved treatment efficacy, reduced toxicity, and increased patient compliance (see ¶[0068), wherein the erodible materials are thermoplastic materials (see ¶[0108]), wherein the 3D printing process comprises extrusion printing using fused deposition modeling with solid polymeric filaments (see ¶[0184]), and wherein, because 3D printing may handle a range of pharmaceutical materials and control both composition and architecture locally, 3D printing is well suited to the fabrication of drug dosage forms with complex geometry and composition (see ¶[0188]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare three-dimensionally printed pharmaceutical dosage forms comprising one or more pharmacologically active ingredients, wherein a pharmaceutical composition can be provided by extruding a filament comprising a pharmacologically active ingredient homogeneously distributed therein, and in a form that may be precisely printed, wherein two different pharmacologically active ingredients may be comprised in two different filaments, wherein the dosage forms comprise third and fourth active agents, wherein a designed content and release profiles are achieved independently by adjusting the concentration of each pharmacologically active ingredient in each filament and, also, by adjusting the amount of each filament that is deposited in the course of printing, wherein the first pharmacologically active ingredient and the second pharmacologically active ingredient that are contained in the pharmaceutical dosage form differ from one another, i.e. are not identical, wherein the filaments may comprise an additional pharmaceutical composition without an active ingredient, wherein the pharmaceutical dosage form comprises a first three-dimensionally printed pharmaceutical composition comprising the first pharmacologically active ingredient and a second three-dimensionally printed pharmaceutical composition comprising the second pharmacologically active ingredient, wherein the second pharmaceutical composition forms one voxel, or at least two voxels that are spatially separated from one another, wherein at least one voxel comprising the second three-dimensionally printed pharmaceutical composition is embedded within the first three-dimensionally printed pharmaceutical composition, wherein the pharmaceutical dosage forms comprise at least two voxels, which are each composed of the second three-dimensionally printed pharmaceutical composition, and which are spatially separated from one another, and wherein the first and the second pharmaceutical compositions form different layers of the pharmaceutical dosage form, which are preferably adjacent and/or parallel to one another, as taught by Stomberg ‘343, and wherein the dosage forms are configured to provide a desired release profile, the dosage forms comprising a multi-layered structure comprising a plurality of layers of a first erodible material admixed with a compound (e.g., a drug) or a reagent, wherein the first erodible material is embedded in a second material not admixed with the compound, wherein the dosage forms are formulated and configured to provide a desired release profile by dispensing a first erodible material admixed with a compound (e.g., a drug) and a second material not admixed with the compound, wherein each layer of the first erodible material has a pre-determined surface area, thickness, and mass fraction, such as a drug mass fraction, wherein the pre-determined surface area, thickness, and/or drug mass fraction correlate with the desired release profile, wherein the drug mass fraction in each of the plurality of layers of the first erodible material are the same, or are different from each other, wherein the three-dimensional printing is carried out by filament fused deposition modeling (FFDM), wherein the process includes dispensing an intermediate material not admixed with the drug, wherein the intermediate material forms an intermediate layer between two or more layers of the first erodible material, wherein a second drug is provided in a third erodible material to produce a dosage form comprising a multi-layered structure with a plurality of layers of the third erodible material, wherein each layer of the third erodible material has a pre-determined surface area, thickness, and drug mass fraction and wherein the pre-determined surface area, thickness, and/or mass fraction correlate with a desired release profile, wherein the dosage forms are prepared by dispensing an intermediate material forms one or more intermediate layers between two or more layers of the first erodible material, and wherein dosage forms with a desired drug release profile of one, or multiple, drugs, are designed and printed using three-dimensional printing techniques and can result in improved treatment efficacy, reduced toxicity, and increased patient compliance, wherein the erodible materials are thermoplastic materials, as taught by Deng ‘468. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Deng ‘468, to the effect that the 3D printing processes comprising one or more drugs capable of being released at individual, pre-determined release profiles can result in improved treatment efficacy, reduced toxicity, and increased patient compliance, wherein the erodible materials are thermoplastic materials (see ¶[0068]).
With respect to claim 7, which claim recites a limitation directed to filament structures having the same composition being present in a joint region of the dosage form such that the filament structures at least partially adjoin at least on one side, the Examiner notes that Stomberg ‘343 discloses 3D printed dosage forms wherein at least one voxel [structural element] comprising the second three-dimensionally printed pharmaceutical composition is embedded within the first three-dimensionally printed pharmaceutical composition (see ¶[0082]). It is the Examiner’s position that such structure reads on the limitation in question, rendering it obvious.
As for claim 8, which claim recites a limitation directed to regions of the dosage forms that are arranged horizontally or vertically so that filaments having the same active agent form horizontal or vertical, respectively, layers in the dosage form in relation to the longest dimension of the dosage form, the Examiner notes that Deng ‘468 discloses 3D printing a dosage form by dispensing an intermediate material not admixed with the drug, wherein the intermediate material forms an intermediate layer between two or more layers of the first erodible material, wherein a second drug is provided in a third erodible material to produce a dosage form comprising a multi-layered structure with a plurality of layers (see ¶[0030]). These parallel layers can only be arranged either horizontally or vertically and such arrangement of layers would read on the limitation in question.
Claim 9 recites limitations directed to dosage forms having filament structures arranged in a joint region and separated by a barrier. In this regard, the Examiner notes that Deng ‘468 discloses dosage forms that are prepared by dispensing an intermediate material not admixed with the drug, wherein the intermediate material forms one or more intermediate layers between two or more layers of the first erodible material which material is the same as or different from the first erodible material. It is the Examiner’s position that the structure disclosed in Deng ‘648 reads on this limitation, rendering it obvious.
With respect to claim 1, which claim recites limitations directed to dosage forms comprising one or more voids being free of filament structures, with a surface area of the dosage form with the voids is at least double the surface area of a dosage form without voids, the Examiner notes that the cited references do not expressly disclose dosage forms with such void volumes and/or relative surface areas. However, the references are all directed to 3D-printed pharmaceutical dosage forms that can be prepared with complex structures not possible with conventional solid dosage form techniques, which structures provide an unprecedented array of tailored features that can be designed to produce specific clinical effects. In this regard, Deng ‘468 discloses multi-layer structures wherein each layer of the structures has a pre-determined surface area, thickness, and drug mass fraction, and wherein the pre-determined surface area, thickness, and/or mass fraction correlate with a desired release profile (see ¶[0030]), allowing dosage forms with multiple active ingredients to release each active with predetermined release profiles for each active. It is the Examiner’s position that using the unique capabilities of 3D filament printing to achieve specific clinical outcomes, such as release profiles, through creation of complex three-dimensional structures, preparing structures comprising void volumes in accord with the claims at issue would amount to nothing more than optimization of a result-effective variable, the exercise of which is well within the capabilities of one of ordinary skill in the art. Consequently, in the absence of evidence as to the criticality of such parameters, these limitations, without more, cannot support patentability. See MPEP § 2144.05 II. A.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 4 and 7 - 19 would have been obvious within the meaning of 35 USC § 103.
Claims 6 and 32 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Stomberg WO ‘172 in view of US 2019/0209468 A1 to Deng, F., et al., claiming priority to 9 January 2018 (“Deng ‘468”), as applied in the above rejection of claims 1 – 4 and 7 - 19, and further in view of US 2021/0205228 A1 to Huang, W., et al., claiming priority to 15 February 2017 (“Huang ‘228”), and Sun, Y. and S. Soh, “Printing Tablets with Fully Customizable Release Profiles for Personalized Medicine,” Adv. Mater. 27: 7847 – 7853 (2015) (“Sun (2015)”).
The Invention As Claimed
The invention with respect to claims 1 – 4 and 7 - 19 is described above. In addition, Applicants claim a dosage form wherein the solidified filament structures having the same composition have at least one distinguishing feature detectable on the surface of the dosage form making these filament structures distinguishable from filament structures having a different composition, and wherein the distinguishing feature is selected from the group consisting of visible dyes, fluorescent dyes, surface textures, shape, gloss, porosity, roughness, and absorption or reflection, respectively, and color.
The Teachings of the Cited Art
The teachings of Stomberg WO ‘172 and Deng ‘468 are relied upon as applied to claims 1 – 4 and 7 - 19. The references do not disclose a dosage form wherein the solidified filament structures having the same composition have at least one distinguishing feature detectable on the surface of the dosage form making these filament structures distinguishable from filament structures having a different composition, and wherein the distinguishing feature is selected from the group consisting of visible dyes, fluorescent dyes, surface textures, shape, gloss, porosity, roughness, and absorption or reflection, respectively, or color. The teachings of Huang ‘228 and Sun (2015) remedy those deficiencies.
Huang ‘228 discloses a device including at least one three‐dimensional (3D) printed tablet, with each tablet including an excipient material and an active ingredient, wherein the device comprises a 3D‐printed planar structure comprising the excipient material (see Abstract), wherein the 3D‐printed structures and 3D‐printing processes may be realized using any 3D printing technology capable of printing two or more materials or compounds, such as fused deposition modeling (FDM), selective laser sintering (SLS), 3D binder jetting, and multi‐jet fusion (MJF) (see ¶[0014]), wherein a build material may be applied in layers, the build material comprising particles of electrical non‐conductive material in powder form, such that components of the 3D printer are scanned across the layer of build material to selectively fuse the build material particles in certain areas of each layer to form the desired structure (see ¶[0017]), wherein, depending on the 3D printing technology being used, there may be more than one active ingredient, as is possible with multi jet fusion (MJF) printing with multiple inkjet nozzles, the number of active ingredients being limited only by the number of nozzles (see ¶[0020]), wherein control over the level of fusing in the excipient material may be used to determine the density and porosity of the excipient material, which may be used to control the amount of active ingredient in each tablet (see ¶[0023]), wherein printed information in combination with customized 3D‐printed pharmaceutical or nutrition tablets may be used to provide patient customized dosage sequence, dosage timing and dosage profile (see ¶[0027]), and wherein additional printed information may include the patient name (e.g., John Doe) and labels such as, for example, typical labels and typical arrows or other indicia that may indicate a prescribed sequence, such as the day, date and the time of day that the pharmaceutical should be taken, as well as the name of the patient to ensure that the medication is taken by the right person (see¶[0029]).
Sun (2015) discloses a tablet consisting of three components: a surface-eroding polymer that contains the drug, a surface-eroding polymer that does not contain the drug, and an impermeable (but biodegradable) polymer that serves as a protective coating around the tablet, wherein the surface-eroding polymer that contains the drug is fabricated with a specifically designed shape that allows the drug to be released with the desired profile (see p. 7847, 2nd col., last para. – p. 7848, 1st col., 1st para.; see also, Figure 1.), wherein the different shapes of the surface-eroding polymer were fabricated by 3D printing (see p. 7848, 1st col., 2nd para.; see also, Figure 2.), wherein the release profiles can also be customized such that the entire duration of the release can be tuned to a desired amount of time, based on the rate of erosion of the polymer as a function of the ratio of cross-linkers used (see p. 7854, 1st col., 2nd para.; see also, Figure 4.), wherein the tablet design can be modified to include multiple types of drugs loaded in the same tablet, with each type of drug customized to release according to its own unique profile (see p. 7851, 1st col., 3rd para.), wherein, for a case where two drugs were packed together in the same tablet, two molds were made, each with a different release profile, wherein, in addition to the chemicals that were necessary for polymerizing the surface-eroding polymer, an orange dye (Orange G) was mixed in one of the mixtures, and a blue dye (Brilliant Blue G) in the other mixture, with the two prepolymer mixtures being poured into each mold separately and then cured with UV light (id.; see also, Figure 5.), and wherein experimental results indicated that one of the dyes released according to an increasing profile and the other dye released according to a decreasing profile (see p. 7851, 2nd col.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare three-dimensionally printed pharmaceutical dosage forms comprising one or more pharmacologically active ingredients according to the teachings of Stomberg WO ‘172 and Deng ‘468, wherein, depending on the specific 3D printing technology being used, there may be more than one active ingredient, as is possible with multi-jet fusion (MJF) printing with multiple inkjet nozzles, the number of active ingredients being limited only by the number of nozzles, wherein control over the level of fusing in the excipient material may be used to determine the density and porosity of the excipient material, which may be used to control the amount of active ingredient in each tablet, wherein printed information in combination with customized 3D-printed pharmaceutical or nutrition tablets may be used to provide patient customized dosage sequence, dosage timing and dosage profile, as taught by Huang ‘288, and wherein dosage forms comprising multiple types of drugs loaded in the same tablet, each type of drug can be released according to its own unique profile, wherein, in addition to the chemicals that were necessary for polymerizing the surface-eroding polymer, an orange dye (Orange G) was mixed in one of the mixtures, and a blue dye (Brilliant Blue G) in the other mixture, and then cured with UV light, and wherein one of the dyes released according to an increasing profile and the other dye released according to a decreasing profile, in accord with the teachings of Sun (2015). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Huang ‘228 to the effect that additional printed information, such as patient name, date and time of administration, and the active ingredient, visible on the dosage forms improves clinical effectiveness and patient compliance (see ¶[0029]), and by the teachings of Sun (2015) to the effect that release of different drugs from the same dosage form can be independently tracked by the use of colored dyes (see p. 7851, 2nd col.).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 6 and 32 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has reviewed the arguments that Applicants provided with their Response filed 13 March 2026, but does not find them persuasive.
The principal thrust of Applicants’ arguments is based on the newly added limitation recited in claim 1, wherein the claimed dosage form has “at least one void which is free of solidified filament structures and which is surrounded by solidified filament structures.” Applicants assert that the prior art reference cited for disclosing “a void” in the dosage form, Deng ‘468, does not disclose a void “surrounded by solidified filament structures.” In support of this argument, Applicants point to FIG. 8, and specifically to part number 815 in the Figure, as illustrating that the solidified filament structures do not surround the claimed void. The Examiner respectfully disagrees.
It is the Examiner’s position that Applicants’ argument is based on an overly limited interpretation of the term, “surrounded by.” Applicants further argue that the void “is not enclosed.” However, the Examiner would first point out that Applicants are arguing a distinction that is not recited in the claims, nor is it supported by disclosure in Applicants’ specification. Applicants’ argument in this regard underscores the different meanings, or interpretations of the terms, surrounded, and enclosed. The Examiner would also note that Applicants’ arguments appear to be based on an interpretation of the limitation in question wherein the void is enclosed in all three dimensions by the solidified filament structures, analogous to the void in the center of a tennis ball being surrounded by the felt-covered rubber of the ball. However, that concept is not disclosed in the specification, and is not encompassed by the term surrounded. In looking further to part 815 in FIG. 8, the “rim” (805) can be viewed as surrounding the space (815), at least in two dimensions, and through all 360° of the rim. Granted, there are no solidified filaments in the plane above the space (815), but that structure is not necessarily required by the term, surrounded. In a similar manner, a fence can surround a property, but does not need to further enclose the dimension above the property.
Applicants also argue that the newly added limitation recited in claim 1 “defines a porous/sponge-like structure.” However, Applicants have amended the current claim set to remove a recitation in claim 15 directed to a dosage form “in a spongy form.” Therefore, Applicants are again arguing an alleged distinction that is not recited in the claims.
Applicants also argue that a dosage form with an increased surface area offers advantages in a clinical context. However, as addressed in the rejection of record, the 3D printing processes disclosed in the cited references are recognized as providing unprecedented flexibility in the fabrication of solid forms such that one of ordinary skill in the at would be capable of designing and implementing a solid dosage form with increased surface area, particularly as motivated by the recognized clinical benefits of dosage form with higher surface areas, as argued by Applicants.
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive, and claims 1 – 4, 6 – 10, 13 – 19, 32, and 33 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619