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 .
Status of claims
The claims submitted 03/13/2026 are hereby being considered. Claims 1, 3, and 24 are currently amended. Claims 2, 4, 6, and 15 are cancelled. Claims 25-26 are new. Claims 5, 7-11, 13-14, 16-18, and 19-23 are previously presented. Claim 12 is withdrawn due to a restriction. Claims 1,3,5,7-11,13-14 and 16-26 are elected, pending and under examination.
This action is NON-FINAL to address the limitations that were not well covered in the previous prior art rejections. Note the examiner of record has changed (see contact information below).
Priority
This application is a 371 of PCT/EP2020/051167, filed 01/17/2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 19152579.9, filed on 01/18/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Rejections withdrawn
All 35 USC § 112 rejections imposed in the previous correspondence are hereby withdrawn due to applicants amendments.
Claim Objections
Objections maintained due to applicant’s failure to amend.
Claim 23 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 9. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112 (b)
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.
New Rejections:
Claims 1, 3, 5, 7-11, 13-14, and 16-26 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.
Claims 1, 5, 16-18, and 24 and 26 recite the limitation "the flowable composite material" or “the composite material”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 (independent claim) previously introduces “a flowable but setting composite material”, which is a narrower limitation than the flowable but setting composite material.
Claims 3, 7-11, 13-14, 19-23, and 25 are rejected as being dependent on a claim that does not correct the issue of indefiniteness. Note that one of the instances of indefiniteness occurs in the independent claim 1 (final “wherein” clause).
Claims 11 and 24 recite the limitation "the active pharmaceutical ingredient” or “the amorphous active pharmaceutical ingredient”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 claim previously introduces “at least one amorphous active pharmaceutical ingredient”, which is a different limitation than these limitations mentioned that follow.
Claim 21 is rejected as being dependent on an indefinite claim (claim 11).
Claim 23 is indefinite as it is unclear if the “two or more different composite materials” introduced include the flowable but setting composite material from claim 1 or if these are two or more different composite materials that are both new to the composition. If these are both new materials, then applicant might recite “further contains two or more different composite materials…” For the purpose of compact prosecution, the teaching of the flowable but setting composite material in the prior art will count as one of the two different composite materials.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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.
Rejections modified in view of amendments and arguments: Prior art added (i.e. Susnjara, Tanaka), prior art mappings added and modified, obviousness statements added and modified.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Icten et al., submitted on IDS (Içten E, Giridhar A, Nagy ZK, Reklaitis GV. Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality. AAPS PharmSciTech. 2016;17(2):284-293. doi:10.1208/s12249-015-0348-3 ) in view of Susnjara (US20180056602A1).
Icten teaches a melt-based solid oral dosage form prepared by drop-on-demand manufacturing system, wherein that production of individual dosage forms with the desired critical quality attributes: amount of active ingredient and drug morphology by monitoring and controlling critical process parameters, such as drop size and product and process temperatures, as well as bioavailability of the drug. The method includes controlled temperature cycles to control crystallization, and the method allows for desired bioavailability and dissolution of the drug (abstract).
Fig. 1 shows a dropwise additive manufacturing apparatus. For the claimed dispersed or dissolved drug in a polymer, Icten teaches a melt-based formulation consists of a polymer carrier and an API, co-melted in the material reservoir, achieved by heating the reservoir until the polymer melts and the drug dissolves in the molten polymer because the melting temperature produces melts without causing degradation of the active ingredient (lines bridging col. 1-2, p 285). Icten further teaches that the temperature control is implemented on the reservoir, on the pump, tubing and nozzle, to maintain the temperature at a set point (p 285, col. 2). Icten teaches that the selection of polymer can change the morphology by promoting or inhibiting crystallization of the drug. Icten further teaches that by manipulating the substrate temperature profile using varying temperature gradients, the drop solidification process can be controlled since the drop size also affects the drop solidification process by changing the heat transfer dynamics, precise control of the drop solidification process occurring on the substrate is critical; and that the crystallization temperature of the deposited drops is controlled. Furthermore, Icten teaches programmed temperature gradients, including step changes, ramping heating or cooling, or combination of these temperature profiles (p 286).
Icten teach Naproxen and polyethylene glycol (PEG) for forming a melt, the mixture co-melted and printed as a film in a drop wise (p 287). Icten teaches optimizing different droplet sizes needed to reach target and forming the film (solid form) (p 287 & 290) and the effect of the speed of the adding droplets on the solid dosage forms (p 291 & fig.8-9). Icten further teaches that drop wise additive manufacturing process eliminates the step of solvent evaporation after drop-wise deposition with control of drug solid state and morphology (p 285). Icten describes dropwise manufacturing on p 285, and suggests co-melted drug and a polymer carrier, maintaining the temperature in the reservoir, pump, tubing as well as the nozzle, and depositing the formulation in a drop-by -drop method.
For the liquified composite material, Icten teaches that the mixture of polymer and naproxen has been completely melted, which meets the claimed liquified and flowable material comprising polymer and active agent.
Icten teaches drop by drop discharge of the melted mixture of drug and polymer, in forming the solid drug composition and therefore at least partially meets the claimed “fabricated during delivery to at least one discharge unit and delivered as droplets.” With respect to intermittently discharging the droplets (claim 1), Icten teaches monitoring and controlling critical process parameters, such as drop size and product and process temperatures. Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to optimize parameters such as pump and nozzle sizes, so as to deliver the melt formulation i.e., intermittently or continuously, and also adjust the drop sizes with an expectation to adjust the dosage amount for patients with different therapeutic needs (p 285, col. 2). One of an ordinary skill in the art would have expected to provide a dropwise discharge of the melted formulation so at to gradually form the solid formulation having desired properties such as bioavailability and dissolution.
With respect to the claimed amorphous active pharmaceutical ingredient, Icten teaches that while PEG promotes crystallization of drug, the amorphous form of drug can be produced by using an appropriate polymer to inhibit crystallization (p 291). while Icten does not explicitly state amorphous drug, Icten teaches melted mixture of naproxen and a polymer to form a solid dosage form with different crystallinity. Instant claim 1 recites “amorphous active pharmaceutical ingredient and dispersed or dissolved”, wherein the amorphous state of the active is not maintained upon dissolution. Further, Icten teaches that the melted material is discharged in a dropwise manner and that the product temperature corresponds to the crystallization temperature of the deposited drops suggesting that the drug in the melted composition is not in a crystal form. Furthermore, one of an ordinary skill in the art would have been motivated to choose an amorphous active agent to prepare a dissolved and liquified melt formulation and further control the crystallization of the final dosage form because Icten suggests controlling the temperature of the drug deposits enables obtaining a solid product of a desired crystallinity.
However, Icten fails to expressly teach that the flowable composite material is fabricated during delivery to the discharge unit per claim 1.
Susnjara discloses an additive manufacturing method for delivering a flowable material from a nozzle of a programmable computer numeric control [¶abstract]. Susnjara teaches an additive manufacturing method wherein an extruder is actuated to form a flowable material and the resulting flowable material is thereafter delivered to a pump for delivery from a nozzle [¶11]. Susnjara further teaches that the formation of flowable material includes generating heat to melt the material within the extruder [¶12] and teaches a flowable material delivery assembly wherein the extruder is coupled to the inlet of a pump and the outlet of the pump is coupled through a conduit in fluid communication with a nozzle [¶13]. Thus, Susnjara teaches forming the flowable material by melting during its delivery through the material-delivery system toward the discharge nozzle.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the material-delivery system of Icten’s pump and discharge nozzle, as taught by Susnjara, while retaining Icten’s drop-on-demand discharge. Susnjara teaches that such an extruder/pump arrangement permits controlled delivery of molten flowable material to an additive-manufacturing nozzle and control of material flow despite variations in melt conditions. An ordinary skilled artisan would therefore have been motivated to employ the known in-line melt-generation and delivery arrangement of Susnjara in Icten’s melt-based additive manufacturing system to the nozzle, with a reasonable expectation of success because both systems convey a thermally liquified polymeric material through pump/nozzle delivery system for additive manufacture.
Claim(s) 3, 5, 7--11, 13-14, 16-19, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Icten et al ., submitted on IDS (Içten E, Giridhar A, Nagy ZK, Reklaitis GV. Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality. AAPS PharmSciTech. 2016;17(2):284-293. doi:10.1208/s12249-015-0348-3 ) in view of Susnjara (US20180056602A1) , as applied to claims 1 and 20 and further in view of Alhnan (US20210169809A1, earliest effective filing date of Aug 13, 2018) and Hanada et al (Hanada M, Jermain SV, Williams RO. Enhanced Dissolution of a Porous Carrier–Containing Ternary Amorphous Solid Dispersion System Prepared by a Hot Melt Method. Journal of Pharmaceutical Sciences. 2018;107(1):362-371. doi:10.1016/j.xphs.2017.09.025) as evidenced by Sukhotskiy (Sukhotskiy V, Karampelas IH, Garg G, et al. Magnetohydrodynamic Drop-on-Demand Liquid Metal 3D Printing. In: Solid Freeform Fabrication 2017: Proceedings of the 28th Annual International Solid Freeform Fabrication Symposium – An Additive Manufacturing Conference. University at Buffalo SUNY; 2017).
Icten and Susnjara collectively teach all required limitations of claim 1.
however, Icten and Susnjara lack the limitations of 3, 5, 7--11, 13-14, 16-19, and 21-24.
Alhnan teaches a method of preparing solid dosage form, particularly pharmaceutical dosage forms, using extrusion and 3D-printing (abstract), and extruding the composition into a desired form in association with one or more supplementary elements [0006], the composition comprises a temporary plasticizer [0009], and further the composition forms an extrudable fluid [0014-0021 and 0301] and compressing the extrudable composition into a desired form. The composition further comprises at least one active agent [0224]. Alhnan teaches that extrudate is in a fluid form. Alhnan teaches that the extrudable composition in a (substantially) fluid state [0236] and further teaches including several excipients such as lubricants, diluents, glidants etc [0489-0492]. The process of Alhnan includes a processing step to prepare an extrudable fluid i.e., melting or softening, through heating, the extrudable composition [0044], and thus meet the instant claimed hot-melt extrusion of claim 5. Further, [0208] of Alhnan teaches extrudable composition in the form of powders, granules. The extrusion apparatus includes a container for holding the extrudable composition prior to extrusion and a nozzle for dispensing the extrudable composition during the extruding step, wherein the container is heated at a temperature to maintain the extrudable composition in a (substantially) fluid state [0236].
Regarding the additions to claim 24, Alhnan further teaches an extrusion apparatus comprising a storage container such as a hopper, containing an extrudable composition or precursor thereof [¶342], wherein the composition or precursor thereof is conveyed from the storage container via a conveying means [¶343]. Alhnan further teaches that a flow-control component controlling and metering distribution of the extrudable composition from the storage container may comprise a controlled feed mechanism including an Archimedes screw [¶345]. Alhnan Additionally teaches a conveyer configured to convey the extrudable composition to and/or through an extrusion nozzle [¶329], wherein the conveyer feeds the composition toward and/or through the nozzle and feeder positioned en route to the nozzle may be heated [¶330]. Alhnan further teaches heating the extrusion nozzle to melt, soften, or otherwise liquidize the composition [¶323]. Alhnan teaches pharmaceutical extrudable compositions comprising an active ingredient and a polymeric carrier [¶442]. For Claim 24’s limitation that the solid administration form consists of the deposited droplet: As stated above, Icten teaches a solid dosage form by dropwise deposition of the liquified drug-polymer. Although Icten describes deposition into an edible substrate, Alhnan teaches additive manufacture of a pharmaceutical item upon a build platform from which the completed item is removable after manufacture [¶338-339]. Thus, thus, the build platform may function as a temporary manufacturing support rather than a constituent of the finished pharmaceutical item. It would have been obvious to an ordinarily skilled artisan to employ Alhnan’s removable build platform as the temporary support for Icten’s dropwise deposition, thereby producing a free-standing solid administration form formed by deposited droplets without incorporating the underlying support into the finished administration form. An ordinarily skilled artisan would have had a reasonable expectation of success because Alhnan teaches manufacture of pharmaceutical items on a build platform followed by removal of the completed item.
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to modify the method of discharging the molten mixture of naproxen and polymer, in the teachings of Icten and Susnjara, i.e., employ hot-melt extrusion method of discharging, because Alhnan teaches extrusion methods provide stability and also enable preparing compositions for immediate, enteric or extended-release properties [0004-0014].
Further, one of an ordinary skill in the art would have modified with an expectation to effectively extrude the solid dosage composition, in the desired shape and suitably compressed to prepare the final solid dosage form. With respect to the particle sizes (instant claims 7, 13-14, 19 and 22), Alhnan teaches particle sizes of the metered solids include in the range of 10-200 microns, greater than 10, 50 or 100 microns, and that nanoparticles are preferred for preparing suspensions [0348], and adjusting the extrusion nozzle diameter [0394], and adjusting the extrusion nozzle output diameter to sizes within the range of 0.05 to 5 mm (i.e., 50 µm to 5000 µm) [0394, 256]. Such nozzle output diameters taught by Alhnan were already known in the art to create droplet sizes within the ranges of those claimed as evidenced by Sukhotskiy et al., which teaches that drop-on-demand 3D printing orifice diameters of 100-500µm creates droplet diameter ranges of 50-500µm, and further teaches that droplet diameter depends on the orifice diameter, geometry, ejection frequency and other parameters [Sukhotskiy et al, page 1807, paragraph 3].Accordingly, one of an ordinary skill in the art would have been motivated to prepare the solid dosage form of Icten by choosing a suitable nozzle or discharge diameter with an expectation to provide a desirable drop size (as claimed sizes) because Alhnan teaches nanoparticles are suitable for preparing drug suspensions. In this regard, Icten teaches large as well as small drops (Table II) and further states that the large area drop of 660 microns X 1000 microns mapped with 100-micron step sizes (p 287, col. 2). Icten teaches that small or large drops with relatively fast cooling rate provides faster drug dissolution (col. 2, p 290). Fig. 5 shows deposits mapped to an area size of up to 600 microns. Therefore, choosing an optimum drop size of the molten drug-polymer mixture and cooling temperature with an expectation to prepare fast or slow dissolving solid formulations would have been obvious for one of an ordinary skill in the art.
Icten, Susnjara, and Alhnan do not explicitly state void spaces of claim 8. However, Alhnan teaches that the extrusion nozzle involves melting and/or softening the extrudable composition to allow it to be deposited onto the build platform, in a layer-by-layer fashion, such that the extrudable composition solidifies after being deposited onto the build platform or onto a layer that has already been extruded upon the build platform. A 3D shape is constructed in a layer-by-layer fashion through judicious depositing according to a pre-defined blueprint [0239]. Additionally, all particles (including droplets) inherently have voids between them (i.e., intermolecular spaces) per universal laws of physics and chemistry. Alhnan further teaches additive manufacture of pharmaceutical solid dosage forms by controlled layer-by-layer-deposition onto a build platform [¶¶237-238,248] and expressly teaches controlling extrusion processes according to a predetermined design that defines the layer structure, internal structure, and porosity of the resulting item [¶368]. Further, Icten also teaches optimizing/controlling the speed of discharging and depositing the discrete liquified droplets to form the solid dosage form. Alhnan also teaches extrudable composition in the form of powders, granules.
In this regard, Hanada teaches improving the dissolution of a drug by adding porous carrier in a hot-melt method of preparing the dosage form. Regarding claim 3 and 16-18, Hanada teaches the use of porous carriers such as insoluble hydrous silicon dioxide (Syloid® XDP 3050, XDP), while hypromellose and copovidone are polymeric components [p. 363, col. 2, ¶4]. Hanada teaches formulations 1-3 and 7 prepared by a hot-melt technique, while formulations 4-5 were prepared by hot-melt extrusion (p. 364, Table 1), followed by cooling, milling, and sieving (which produces granular material) [p. 364, Sample Preparation]. Hanada teaches The dissolution profiles of both the HM and HME granules are compared with those of the physical mixture and crystalline IND profiles and shown in Figure 5. Hanada teaches that the drug- polymer mixtures reduce the melting temperatures (p 365). Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing of the instant invention to employ porous carriers, in preparing the drop-by-drop discharged solid dosage form of Icten and Susnjara, such that the final dosage form can be prepared as a layered composition with porous carriers in the layers, thus resulting in the claimed void spaces and pores. One of an ordinary skill in the art would have looked to the teachings of Hanada because the reference also teaches the same process of preparing i.e., hot-melt extrusion process and thus analogous to the teachings of Icten/ Susnjara and Hanada teaches that the porous carrier in a drug dosage form reduces the melting point of the drug and also provides improved dissolution of the drug. Further, one of an ordinary skill in the art would have employed only a polymer and a drug in the flowable composite (new claim 24), without an additional material because one of an ordinary skill in the art would have recognized from Hanada that the drug delivery composition prepared by hot-melt extraction only requires a drug and a polymer and prepared by the drop-wise method collectively taught by Icten and Susnjara.
For claims 9-11, 21 and 23, Alhnan teaches that the extrusion apparatus comprises more than one nozzle, more than feeder each associated with each extrusion nozzle [0330]. Further, Alhnan teaches that the solid dosage form, produced by the above extrusion process, can include one or more extruded items that can be different or same. Hence, one of an ordinary skill in the art would have employed the multiple nozzles/pumps for discharging/extruding the molten mixture of Icten (modified Alhnan) to provide different speeds of droplet delivery or different sizes of the drops, thus resulting in solid preparations with different amounts of composite material.
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Icten et al., submitted on IDS (Içten E, Giridhar A, Nagy ZK, Reklaitis GV. Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality. AAPS PharmSciTech. 2016;17(2):284-293. doi:10.1208/s12249-015-0348-3 ) in view of Susnjara (US20180056602A1) in further view of Tanaka (US20120225208A1).
Icten and Susnjara teach all the required limitations of claim 1.
However, Icten and Susnjara teach fail to teach all the required limitations of claim 20.
Tanaka discloses a solid shaped product that is fabricated by using a liquid [¶abstract].
Regarding Claim 20: Tanaka teaches fabricating a solid shaped product by discharging discrete droplets from a liquid discharge unit and stacking the droplets above one another, wherein the droplets are discharged at a frequency of 1 Hz to 100 Hz [¶¶29-31, 78; claim 1], which corresponds to 1 to 100 drops/sec.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to employ the droplet-discharge frequencies taught by Tanaka in the dropwise additive-manufacturing process of Icten as modified by Susnjara. This is because Tanaka teaches that discharge frequency is a controllable parameter used in stacking discrete droplets to fabricate a solid shaped product, including from 1 to 100 droplets per second. An ordinary skilled artisan would have had a reasonable expectation of success because both systems fabricate solid structures by controlling sequential deposition of discrete droplets from a discharge nozzle.
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Icten et al., submitted on IDS (Içten E, Giridhar A, Nagy ZK, Reklaitis GV. Drop-on-Demand System for Manufacturing of Melt-based Solid Oral Dosage: Effect of Critical Process Parameters on Product Quality. AAPS PharmSciTech. 2016;17(2):284-293. doi:10.1208/s12249-015-0348-3 ) in view of Susnjara (US20180056602A1) in view of Kraibuhler et al. (US20140113017A1).
Icten et al. and Susnjara teaches all required limitations of present claim 1.
However, Icten et al. and Susnjara does not teach the required limitations of present claim 25.
Kraibuhler et al. teaches a device for producing a three-dimensional object [¶abstract].
Regarding claim 25: Kraibuhler et al. teaches an additive manufacturing device wherein an object is formed layer-by-layer from sequentially discharged droplets on an object support {13} within a construction space {20} [¶18]. Kraibuhler et al. further teaches that the temperature-controllable construction space {20} is surrounded by a construction-space surround {18} which surrounds the object support {13} upon which the object is produced [¶25], and that the construction space is provided with an associated sensor {21} and temperature control unit {25} for controlling temperature therein, optionally for conjunction with fans or heat exchangers to provide controlled and uniform thermal conditions [¶26]. Kraibuhler et al. further teaches that such temperature control advantageously influences bonding of the applied droplets to the object being produced [¶10].
Regarding 26: : Kraibuhler et al. teaches producing a three-dimensional object from hardenable (i.e., solidifiable) material that is fluid by sequentially discharging individual drops, such that the object is formed layer-by-layer on an object support [¶¶18-19].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the dropwise-additive manufacturing system of Icten et al. and Susnjara to include the enclosed, temperature-controlled construction space and object support taught by Kraibuhler et al, utilizing it to discharge drops to form solid material. This is because Kraibuhler et al. teaches that controlling the temperature of the construction space advantageously controls the thermal conditions experienced by the deposited droplets to the previously deposited materials [¶¶10, 25-26]. A person of ordinary skill in the art would have therefore been motivated to enclose the manufacturing platform of Icten et al. and Susnjara within such a temperature-controlled housing to provide more uniform and controllable conditions during droplet deposition and solidification, thereby improving bonding between deposited droplets and reproducibility of the resulting solid dosage form. A person of ordinary skill in the art would have had a reasonable expectation of success because Icten et al., Susnjara, and Kraibuhler et al. employ additive manufacturing by deposition of liquefied material as discrete droplets onto a support to progressively form a solid object, and Kraibuhler et al.’ enclosure, sensor, and temperature-control unit perform their known and predictable function of controlling the thermal environment surrounding the deposited droplets without requiring a change to the fundamental dropwise deposition process of Icten et al.
Response to Arguments
Applicant’s arguments (filed 03/13/2026) with respect to claims 1,3,5,7-11,13-14 and 16-24 have been considered but are moot because the new ground of rejection relies on a new combination of references than those applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusions
No claim is allowed.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights