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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/13/2025 has been entered.
Response to Amendment
Claims 1-4, 6, and 10-21 are pending. Claims 5 and 7-9 are canceled. Claim 21 is new.
Claims 17-20 are rejoined and examined for patentability.
In view of the amendment, filed 10/13/2025 the following rejections are withdrawn from the previous Office Action mailed 07/11/2025:
Claim rejections under 35 U.S.C. 112(a) and 112(b)
Claim rejections under 35 U.S.C. 102 and 103
New grounds of rejection are made in response to claim amendments.
Applicant’s declaration under 37 CFR 1.132 filed 10/20/2025 has been considered but is moot because the new grounds of rejection do not rely on the Albed Alhnan reference applied in the prior rejection of record for any teaching or matter specifically challenged in the declaration.
Claim Objections
Claim(s) 2 is/are objected to because of the following informalities: claim 2 still recites “the at least one printing head” in lines 2-3, which should read “the printing head.” Appropriate correction is required.
Claim Interpretation
The filed specification defines a “dot” according to the invention as an essentially round three-dimensional structure typically having the shape of a drop, an approximated rotation ellipsoid, or an approximated sphere ([0006]).
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17-20 is/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.
Claim 17 introduces “one or more building substances” (singular or plural) in the first step and then recites the limitation “the building substances” (plural) in the “providing a 3D printer” and “connecting” steps. These limitations are unclear as to whether they are intended to require multiple building substances or not, particularly since other limitations refer back to “the one or more” building substances.
Claim 18 recites the limitation “the array of dots” and “the further array of dots” in lines 1 and 2, respectively. Claim 17 encompasses multiple sets of “arrays” and “further arrays” of dots, such that the noted limitation is unclear as to what arrays are or are not referenced. For further examination, any array/further array would apply.
Claim 19 recites the limitation “where there are from 2-10 building substances…” in lines 1-2. The limitation is unclear as to the intended limiting effect of the language “there are” with respect to the claimed method and its steps. For further examination, a method that involves 2-10 building substances as claimed in any capacity is considered to meet the claim.
Claim 20 recites the limitation “the building substances” in lines 1-2. Claims 17 and 19 each introduce building substances such that reference to “the building substances” is unclear as to what particular group or subset of the previously introduced building substances is being referenced. For further examination, any of the previously introduced building substances would apply.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 6, 13-15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaesi et al., US 20210330593 A1 (of record).
Regarding claim 1, Blaesi discloses a method for producing a solid dosage form (manufacturing solid dosage form, Fig. 1, by 3D printing, Fig. 13; Abstract, [0170]), the method comprising:
(i) providing a printer (extrusion-micropatterning machine, Fig. 13, [0169]) at least capable of 3D printing of the solid dosage form (performing “micropatterning” or “3D-printing,” [0170], Fig. 13), the printer comprising a building platform on which the dosage form is printed (platform/stage on which dosage form is printed, [0170], Fig. 13), a printing head (extruder head, Fig. 13) designed for applying an array of dots of a building substance for the dosage form on the building platform (configured to perform 3D printing or 3D micro-patterning of a building substance for the dosage form, [0170]; and designed to manufacture the disclosed dosage form structures, [0047], which include an array of beads 110, equivalent to dots, making up the dosage form 100, Fig. 1a, [0075]) wherein the building substance is a flowable powder, granule, or liquid (the building substance is initially in granule form and is melt-processed/liquified in the heated extruder barrel and nozzle and extruded for printing, [0169]-[0170]), which becomes at least semisolid after it is printed (solidifies at room temperature after printing, [0171]);
(ii) applying an array of “fibers” (applying array of elongated strands, Fig. 13, deposited to form configuration of Fig. 1b, [0170]; see also “fibers” 120, 121 of Fig. 1b) of the building substance on the building platform (e.g., applying first two layers, Fig. 13) wherein the “fibers” overlap or contact each other (the applied fibers of the second layer overlapping and contacting those of the first layer, Figs. 1b and 13);
(iii) at least semi-solidifying the array of “fibers” applied in step (ii) such that the building substance becomes at least semi-solid (at least semi-solidifying such that the next layer(s) can be applied without collapse of the underlying layer, Fig. 13);
(iv) applying a further array of “fibers” of the building substance on the array of “fibers” of step (ii) (applying further layers of fibers, Fig. 13) in such a manner that “fibers” of the further array overlap the “fibers” of the array of step (ii) (Fig. 13);
(v) at least semi-solidifying the further array of “fibers” applied in step (iv) such that the building substance becomes at least semi-solid (at least semi-solidifying such that the next layer(s) can be applied without collapse of the underlying layer, Fig. 13); and
(vi) repeating steps (ii) to (v) with each array and further array of “fibers” completely overlapping the prior further array and array of “fibers” respectively (Fig. 13), whereby the solid dosage form is formed with “fibers” of a layer completely overlapping the “fibers” of a previous layer (repeating the application of alternating layers to build the dosage form, Fig. 13, [0170]-[0171]); wherein the building substance contains at least one pharmaceutical active agent and/or at least one nutraceutical active agent and/or at least one dietary supplemental active agent (containing at least one pharmaceutical active agent, acetaminophen, [0169], [0202]).
In the applied embodiment, Blaesi discloses the application of layers including arrays of elongated fibers/strands to achieve the dosage form configuration shown in Fig. 1b ([0170]) and therefore does not explicitly disclose the application of an array of “dots” in steps (ii), (iv), and (vi). However, Blaesi further discloses that the dosage form can be made from the building substance applied as layers of dot arrays (Fig. 1a, [0074]-[0075], the dosage form 100 having a lattice structure of arrays of particles or beads 110 structurally equivalent to array of dots) as an alternative to the fiber array arrangement (Fig. 1b, [0076]), and wherein each array of dots and further array of dots completely overlaps with the prior further array of dots and array of dots respectively, whereby the dosage form is formed with dots of a layer completely overlapping the dots of a previous layer (Fig. 1a – see annotated figure below with “dots” of the various “arrays” outlined/shaded for clarity).
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Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “dot” array configuration in place of the “fiber” array configuration as a substitution of one known deposition arrangement for another yielding predictable results of making up the structured solid dosage form. Furthermore, a different geometry and packing arrangement of the structures achievable by the dots in place of the elongated fibers may have been desirable depending on an intended dissolution or disintegration rate for the structured dosage form ([0132], [0141]). See MPEP 2143(I)(B).
Regarding claim 2, Blaesi discloses the method of claim 1, wherein the printing head (Fig. 13) is connected to a reservoir containing the building substance (granule feeding unit, Fig. 13, [0169]) so that the at least one printing head is capable of withdrawing an amount of the building substance for applying the building substance in steps (ii) to (v) (Fig. 13, [0169]).
Regarding claims 6 and 15, Blaesi discloses the method of claim 1. Blaesi discloses the dots are generated by applying a volume increment of the building substance (volume of each dot 110, Fig. 1a) but does not explicitly state that the volume increments have a volume of 20 pl to 30 µl.
However, Blaesi discloses an average thickness dimension of each dot (h0) being in the range of 0.1 µm to 2.5 mm ([0141]). As the dots are beads or spheres, the “thickness” dimension is a diameter (Fig. 1a, [0075]). In the melt extrusion example, Blaesi discloses a radius of the printed fibers/strands being 250 µm, equal to the inner radius of the extruder nozzle ([0170]). As such, one of ordinary skill in the art using the melt extrusion technique to apply dots would have expected the dot radius also being around 250 µm (diameter or thickness of 500 µm), in line with Blaesi’s disclosed thickness values. A dot diameter in line with these dimensions equates to each dot having a volume (4/3πr3) of around 0.065 µl.
The disclosed prior art thickness/dot diameter values yield volume ranges (4/3πr3) overlapping the claimed range, and the disclosed melt extrusion 3D printing example leads to a volume increment value within the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the volume increments of Blaesi have a volume of 20 pl to 30 µl in order to form the printed dots having dimensions in line with those disclosed by Blaesi as appropriate for achieving a suitable surface area ([0141]).
Regarding claims 13-14, Blaesi discloses the method of claim 1, wherein the building substance is flowable when heated (is heated to melt, i.e., at/above its melting temperature to enable extrusion, [0169]-[0170], i.e., is flowable) and is semisolid and ultimately solid when cooled (is solidified at room temperature after extrusion and a “solid” dosage form is produced, [0171]).
Regarding claim 17, Blaesi discloses a method for producing a solid pharmaceutical dosage form (manufacturing solid dosage form, Fig. 1, by 3D printing, Fig. 13; Abstract, [0170]), the method comprising:
Providing one or more building substances in one or more reservoirs (granule feeding unit, Fig. 13, [0169]), said one or more building substances being a flowable powder, granule, or liquid (the building substance is initially in granule form and is melt-processed/liquified in the heated extruder barrel and nozzle and extruded for printing, [0169]-[0170]) comprising one or more pharmaceutical active agents (acetaminophen, [0169]) mixed with one or more carrier materials (PEG, [0169]);
Providing a 3D printer (extrusion-micropatterning machine, Fig. 13, [0169]) having one or more printing heads (extruder head, Fig. 13) capable of printing the building substances as an array of dots of the building substances (configured to perform 3D printing or 3D micro-patterning of a building substance for the dosage form, [0170]; and designed to manufacture the disclosed dosage form structures, [0047], which include an array of beads 110, equivalent to dots, making up the dosage form 100, Fig. 1a, [0075]) on a building platform (platform on which dosage form is printed, [0170], Fig. 13),
Connecting the 3D printer to the one or more reservoirs whereby the 3D printer can 3D print the building substances on the building platform (connected in Fig. 13);
Printing an array of “fibers” (applying array of elongated strands, Fig. 13, deposited to form configuration of Fig. 1b, [0170]; see also “fibers” 120, 121 of Fig. 1b) of the building substance on the building platform (Fig. 13) wherein the array of “fibers” is an array of individual “fibers” (Figs. 1b and 13);
Semi-solidifying or solidifying the array of “fibers” such that the building substance becomes at least semi-solid or solid (at least semi-solidifying such that the next layer(s) can be applied without collapse of the underlying layer, Fig. 13);
Printing a further array of “fibers” of the building substance, wherein the further array of “fibers” is an array of individual “fibers” (Fig. 13) onto the array of “fibers” (applying further layers of fibers, Fig. 13) whereby the individual “fibers” of the further array completely overlap the individual “fibers” of the array of “fibers” (Fig. 13);
Semi-solidifying or solidifying the further array of “fibers” such that the building substance becomes at least semi-solid or solid (at least semi-solidifying such that the next layer(s) can be applied without collapse of the underlying layer, Fig. 13);
Repeating the steps of printing an array of fibers of the building substance, semi-solidifying or solidifying the array of fibers, printing a further array of individual fibers of the building substance, semi-solidifying or solidifying the further array, with each array and each further array completely overlapping with the prior further array and array of fibers respectively (repeating the application of layered arrays to build the dosage form, Fig. 13, [0170]-[0171]).
In the applied embodiment, Blaesi discloses the application of layers including arrays of elongated fibers/strands to achieve the dosage form configuration shown in Fig. 1b ([0170]) and therefore does not explicitly disclose the application of an array of “dots” in the printing steps. However, Blaesi further discloses that the dosage form can be made from the building substance applied as layers of dot arrays (Fig. 1a, [0074]-[0075], the dosage form 100 having a lattice structure of arrays of particles or beads 110 structurally equivalent to array of dots) as an alternative to the fiber array arrangement (Fig. 1b, [0076]), and wherein each array of dots and further array of dots completely overlaps with the prior further array of dots and array of dots respectively (Fig. 1a – see annotated figure above).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the “dot” array configuration in place of the “fiber” array configuration as a substitution of one known deposition arrangement for another yielding predictable results of making up the structured solid dosage form. Furthermore, a different geometry and packing arrangement of the structures achievable by the dots in place of the elongated fibers may have been desirable depending on an intended dissolution or disintegration rate for the structured dosage form ([0132], [0141]). See MPEP 2143(I)(B).
Regarding claim 18, Blaesi discloses the method of claim 17, and the claimed volume amount is rendered obvious by Blaesi as set forth above for claims 6 and 15.
Regarding claim 19, Blaesi discloses the method of claim 17, where there are from 2-10 building substances having different compositions (Fig. 13, [0169], at least two building substances including acetaminophen particles and granules of polyethylene glycol).
Regarding claim 20, Blaesi discloses the method of claim 19, wherein the building substances comprise at least building substances with a single active ingredient (example using acetaminophen, [0169]), building substances having a selected particle size (acetaminophen particle size 40-80 µm, [0169]).
Regarding claim 21, Blaesi discloses the method of claim 1, wherein the building substance comprises one or more pharmaceutical active agents (acetaminophen, [0169]) mixed with one or more carrier materials (PEG, [0169]).
Claim(s) 3-4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaesi et al., US 20210330593 A1, as applied to claim 2 above, and further in view of Freiderikos et al., US 20200188307 A1 (of record).
Regarding claim 3, Blaesi discloses the method of claim 2. Blaesi is silent as to the printer comprising more than one printing head.
In the analogous art of 3D printing pharmaceutical products (Abstract), including by melt processing (e.g., [0149], [0155]), Freiderikos teaches equipping a printer with more than one printing head (multiple print heads 5, Figs. 3, 13, [0218]). Freiderikos teaches that multiple print heads can beneficially be moved independently and can each be used to for dispensing building substances ([0136]).
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 printer of Blaesi to include more than one printing head in order to provide the capability of dispensing building substances from independently movable sources, as taught by Freiderikos. Furthermore, the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04(VI)(B). In this case, multiple print heads would have provided the predictable effect of printing more material in a shorter time via the increased number of printing heads and thus is not patentably significant.
Regarding claim 4, modified Blaesi discloses the method of claim 3, and the combination discloses each of the printing heads being connected to a reservoir containing the building substance so that the respective printing head is capable of withdrawing an amount of the building substance for applying the building substance in steps (ii) to (v) (the print head of Blaesi being connected to a reservoir and the combination as set forth for claim 3 effectively involving duplicating the existing print head; note also that Freiderikos similarly discloses the print heads being connected to a material reservoir [0220], and further that each of the print heads are functionally required to be connected to a reservoir containing the building substance in order to provide the material required for the disclosed printing).
Regarding claim 16, Blaesi discloses the method of claim 2. Blaesi is silent as to the printer comprising more than one printing head. Freiderikos as applied above renders obvious the claim limitation. See also MPEP 2144.04(VI)(B) as applied above.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaesi et al., US 20210330593 A1, as applied to claim 1 above, in view of Crump, US 5121329 A (of record).
Regarding claims 10-12, Blaesi discloses the method of claim 1, and that the extruded material is solidified following deposition ([0171]). Since steps (ii) and (iv) are directed to deposition, then following these steps, the deposited building substance is solidified and, as set forth above, becomes at least semi-solid first so as to support the subsequent layers in the additive build process. Blaesi is silent as to the building substance becoming “solid” in the steps (iii) and (v), respectively.
In the analogous art of three-dimensional fabrication (Abstract), Crump discloses that in a successful process of three-dimensional object formation by the deposition of multiple layers of material in a flowable state, the material solidifies substantially instantaneously upon extrusion and must solidify before additional material is applied on top of it to form a subsequent layer (col. 1, lines 6-14; col. 3, lines 10-20; col. 11, lines 41-47). Crump teaches that the process of dispensing in a liquid state, solidifying, and adhering adjacent layers results in a strong bond between the layers (col. 12, lines 5-7).
Accordingly, in the case it was not necessarily present, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the building substance becoming “solid” in the steps (iii) and (v) such that they could successfully support the additional material of the subsequent layers and form strong bonds between the layers, as taught by Crump.
Response to Arguments
Applicant’s arguments with respect to claim rejections over Albed Alhnan have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220105041 A1, Lubda et al. disclose manufacturing a solid administration form by 3D printing of droplets, including by hot melt extrusion (Figs. 1-4).
Kyobula et al., 3D inkjet printing of tablets exploiting bespoke complex geometries for controlled and tuneable drug release (2017) disclose 3D printing of drug loaded solid dosage forms using a hot-melt ink jetting technique.
US 20140345521 A1, Silverbrook discloses hot melt deposition of dots of a building substance for forming three dimensional objects, wherein the dots are deposited by one or more printheads as arrays of overlapping layers and are cooled to solidify (Fig. 1).
Jamroz et al., 3D Printing in Pharmaceutical and Medical Applications – Recent Achievements and Challenges (2018) describe various techniques for 3D printing dosage forms including hot melt extrusion and drop on drop deposition.
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/J.L.G./Examiner, Art Unit 1754
/SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754