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 Amendment
Claims 1-4, 6, and 10-21 are pending.
In view of the amendment, filed 06/16/2026 the following rejections are withdrawn from the previous Office Action mailed 12/16/2026:
Claim rejections under 35 U.S.C. 112(b), other than any maintained below
Prior art rejections are updated in response to claim amendments.
Claim Objections
Claim(s) 17 is/are objected to because of the following informalities: amended claim 17 should read “as an array of dots of the one or more building substances” in the “providing a 3D printer” step. 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 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.
Claim(s) 19-20 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 19 recites the limitation “the method…comprising from 2-10 building substances…” in lines 1-2. The limitation is unclear as to what step of the method is being further limited and how (e.g., are these substances part of the “one or more building substances” of claim 17? Are these substances applied in either/both of the printing steps such that there is a manipulative difference to the process?). 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” (plural) in lines 1-2. Claim 17 introduces “one or more building substances” (singular or plural) as set forth above. The limitation is unclear as to whether it is intended to require multiple building substances or not, particularly since other limitations refer back to “the one or more” building substances.
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 flowable (melt-processed and extruded, [0169]-[0170]) “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 flowable “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) forming a “brick” arrangement. 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, i.e., forming a brick arrangement (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 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 one or more 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 one or more building substances on the building platform (connected in Fig. 13);
Printing an array of flowable (melt-processed and extruded, [0169]-[0170]) “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 flowable “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 forming a “brick” arrangement. 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, forming a brick arrangement (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, comprising 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 17, 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 filed 06/16/2026 have been fully considered but they are not persuasive. Applicant argues (pp. 8-9) that Blaesi’s dosage form 100 having a lattice structure of arrays of particles or beads 110 is not structurally equivalent to the claimed arrays of dots defined in claims 1 and 17. Applicant appears to argue that the claimed “dots” are not spherical or a particle or a bead, but instead require the formation of a flattened round solid, such as a cylindrical or pancake shape, that, because it is flowable, flows into and fills any free or open spaces between existing dots of an array of dots.
This argument is not found persuasive. The examiner’s interpretation of “dots” based on the text of the present disclosure has been established on the record since the first Office Action. The specification states that a “dot” is an essentially round 3D structure typically having the shape of a drop, an approximated ellipsoid, or an approximated sphere (filed specification [0006]). Neither the claims nor the specification require the dots to be flattened round solids or cylinder- or pancake-shaped, or to flow into and fill any free or open spaces between existing dots. Blaesi as applied discloses round, essentially spherical structures (Fig. 1a) that read on “dots” as claimed and further discloses the deposition of a flowable form of the material that is melt processed and extruded for forming the layered dosage form ([0169]-[0170]).
Applicant argues (pp. 9-10) that there is no basis for substituting Blaesi’s dot array for Blaesi’s fiber array configuration. Applicant further states (pp. 9-10) that there is no teaching in Blaesi that would prompt a person of skill in the art to replace a lattice built of particles or beads that are separated and spaced apart with a solid dosage form built up of flattened dots which lacks free spaces or channels. Applicant appears to interpret a “brick” arrangement as meaning an array of dots with no gaps, free spaces, or pores (p. 10).
This argument is not found persuasive. The examiner provided a basis for substituting Blaesi’s dot array for the fiber array, in that Blaesi discloses each configuration as a known alternative arrangement for the layered material of the dosage form, and the substitution of one known element for another yields predictable results to one of ordinary skill in the art (MPEP 2143(I)(B)). The rejection additionally noted that a different geometry or arrangement achievable via the dots instead of the fibers may have been desirable based on other factors such as an intended dissolution or disintegration rate as mentioned by Blaesi (e.g., [0132], [0141]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., flattened dots or dots of a particular shape, no gaps or free spaces, non-porous structure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Neither the claims nor the specification describe the noted distinctions argued by Applicant. The lack of written description support for the argued feature of an array having no gaps or free spaces was further addressed in the Final Rejection dated 07/11/2025 (see pp. 4-5). Assuming arguendo the validity of Applicant’s arguments directed to non-claimed features, the issue still remains of how layered arrays of dots shaped as cylinders or pancakes would be arranged to achieve a structure with no gaps, free spaces, or pores, and the specification provides no further insight into this issue.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GROUX whose telephone number is (571)272-7938. The examiner can normally be reached Monday - Friday: 9am - 5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at (571) 270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L.G./Examiner, Art Unit 1754
/FARAH TAUFIQ/Primary Examiner, Art Unit 1754
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