DETAILED ACTION
In Request for Continued Examination filed on 11/07/2025, claims 13 and 22-31 are pending. Claim 21 is canceled. Claim 13 is currently amended. Claims 13 and 22-31 are considered in the current Office 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 .
Status of Previous Objections/Rejections
Previous 35 USC 103 rejections have been maintained in view of the Applicant’s amendments and arguments. See Response to Arguments below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/07/2025 has been entered.
Claim Interpretation
The Examiner wishes to point out that although the preamble of the claim recites “a system”, the Examiner is interpreting the claims as apparatus claims; thus, the application claims are directed towards an apparatus and as such will be examined under such conditions. The material worked upon or the process of using the apparatus is viewed as recitation of intended use and is given patentable weight only to the extent that structure is added to the claimed apparatus (Please see MPEP 2112.01 and 2114-2115 for further details).
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) 13, 22, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner) and US2006/0283758 (Pasbrig), or alternatively, further in view of US2018/0207932 (Kusunoki).
Regarding Claim 13, Warner teaches a system for 3D printing pharmaceutical objects (Figure 1 and [0040]), the system (Figure 1) comprising
a 3D printer (Figure 1, apparatus 5 and [0040]) with a mechanical system movable in one or more directions (Figure 1 and [0030], gantry to move the chamber 10 relative to the stage in more than one directions), at least a print head with a nozzle being movable by the mechanical system (Figure 1 and [0027], nozzle 65 attached to the chamber 10 and also moved by the gantry under CNC control) and a base system carrying a print base for receiving a prepared mixture applied by the print head (Figure 1 and [0027], the combination of rail 99, carriage 97, and stage 80 is considered as base system where the stage 80 is disposed to receive the extruded material from the nozzle);
wherein the print base comprises one or more formatted printing locations for shaping the pharmaceutical object (Figure 1 and [0027], stage 80 comprises partitionable receptacle 35 that is placed on the stage and disposed between the stage and nozzle so that material is extruded onto the partitionable receptacle ),
wherein the formatted printing locations comprise recesses in the print base ([0040], the stage 80 can provide a flat surface for placement of the containers, or the stage can be configured with fixtures for placing and/or holding the containers in specific locations. For example, the fixture can include an indentation that the container fits in) and are adapted to receive a blister such that the pharmaceutical objects can be printed directly inside the blister (Figure 5, the partitionable receptacle is configured as a plurality of containers 535 which may be drug capsules [0040] and materials are printed directly into the container [0006]).
Alternatively, in the same field of injecting pharmaceuticals materials in 3D printer to create a 3D structure ([0099]), Kusunoki teaches wherein the formatted printing locations comprise recesses in the print base (Figure 13A, the combination of positioning members 221 and 222 and plate conveyance section 220 formed a recesses within plate conveyance section 220) and are adapted to receive a blister (Figure 13A, plate 210 made of resin [0102]) such that the pharmaceutical objects can be printed directly inside the blister (Figure 13A and [0102], the plate 210 is made of resin and has a plurality of recesses 211 for holding the reagent for drug discovery).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system as disclosed by Warner such that it teaches all of the above discussed limitations as taught by Kusunoki to supply a predetermined amount of the liquid droplets ([0104]). Furthermore, the combination of the known elements provides a predictable result, namely, another known design of build platform in the field of additive manufacture. See MPEP 2143.
Warner fails to teach the system further comprises a closing device for applying a sealing membrane or film to hermetically seal the blister after the printing is completed.
However, Pasbrig teaches the system further comprises a closing device for applying a sealing membrane or film to hermetically seal the blister after the printing is completed (Figure 1 and [0022], on the side of the opening, a cover film 16 tightly seal the cup/capsules against the base part 12 which implied the presence of a closing device to perform these functions).
Warner and Pasbrig are considered to be analogous to the claimed invention because both are in the same field of manufacturing drug product comprising of using capsules. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system as disclosed by Warner to incorporated a closing device for applying a sealing membrane or film to hermetically seal the blister after the printing is completed as taught by Pasbrig to seal the opening of the cup/capsules so that the composition does not fails out of the capsule and avoid contamination during transfer ([0022]).
Regarding Claim 22, the modified Warner teaches the system according to claim 13, wherein the formatted printing locations have shapes to assist the immediate visual recognition of the pharmaceutical objects (Warner, Figure 5, the specification fails to provide specific definition for the term “immediate visual recognition”; thus, the Examiner is interpreting the limitation as any shape that is not flat which helps identify the location of the object. Warner teaches the partitionable receptacle might be a drug capsules [0040] which has a shape and reads upon the claimed limitation).
Regarding Claim 31, the modified Warner teaches the system according to claim 13, wherein the base system comprises a base holder for receiving the print base for removing and/or replacing the print base (Figure 5, rail 99, carriage 97 receives the stage and is capable of removing and/or replacing the stage. Limitations directed toward the capabilities or intended uses of the apparatus are given patentable weight to the extent which effects the structure of the apparatus. MPEP 2114).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner) and US2006/0283758 (Pasbrig) , or alternatively, further in view of US2018/0207932 (Kusunoki) as applied to claim 13 above, and further in view of US2021/0205228 (“Huang et al” hereinafter Huang).
Regarding Claim 23, the modified Warner teaches the system according to claim 13, but fails to teach a labeling device for labeling the sealed blister after the sealing is completed.
However, Huang teaches a labeling device for labeling the sealed blister after the sealing is completed ([0031]).
Warner and Huang are considered to be analogous to the claimed invention because both are in the same field of manufacturing drug product comprising of using capsules. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system as disclosed by Warner to incorporated a labeling device for labeling the sealed blister after the sealing is completed as taught by Huang to include labels on the 3D-printed tablets describing a prescribed sequence for consuming the medication ([0031]).
Claim(s) 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner) and US2006/0283758 (Pasbrig), or alternatively, further in view of US2018/0207932 (Kusunoki) as applied to claim 13 above, and further in view of US2017/0317259 (“Hatch et al” hereinafter Hatch).
Regarding Claim 24, the modified Warner teaches the system according to claim 13. Warner further teaches the stage can be heated ([00280]) but fails to teach the system comprising a thermal conductor arranged on the side of the print base opposite to the side having the formatted printing locations for heating the print base.
However, Hatch teaches the system comprising a thermal conductor arranged on the side of the print base opposite to the side having the formatted printing locations for heating the print base (Figure 4, [0021], heat transfer to and from the build plate 20 is facilitated by a thermal conduction apparatus 16 that connects to a lower side of the thermoelectric cells and the exterior of the three-dimensional printer and the thermal conduction apparatus 16 transfers heat to and from the environment surrounding the exterior of the three dimensional printer and the thermoelectric cells 12 connected to the build plate 20 [0051]-[0052]).
Warner and Hatch are considered to be analogous to the claimed invention because both are in the same field of additive manufacturing for producing a three-dimensional shaped object. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system of the modified Warner such that it teaches all of the above discussed limitations as taught by Hatch to transfers heat to and from the environment surrounding the exterior of the three dimensional printer and the thermoelectric cells connected to the build plate ([0051]) and efficiently transferring heat ([0052]).
Regarding Claim 25, the modified Warner teaches the system according to claim 24, but fails to teach comprising a temperature sensor for monitoring the temperature of the print base.
However, Hatch teaches the system comprising a temperature sensor for monitoring the temperature of the print base (Figure 9, temperature sensor 14 transmits a signal to the thermal controller 26 that indicates the temperature of the build plate 20 proximate to the immediate location of the temperature sensor 14 [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system of the modified Warner such that it teaches all of the above discussed limitations as taught by Hatch to transmits a signal to the thermal controller that indicates the temperature of the build plate proximate to the immediate location of the temperature sensor ([0057] and adjusting the temperature of the build plate based on the temperature sensor reading ([0057]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner) and US2006/0283758 (Pasbrig), or alternatively, further in view of US2018/0207932 (Kusunoki) as applied to claim 13 above, and further in view of JP2010/100883 (“Abe et al” hereinafter Abe), machine translation provided.
Regarding Claim 26, the modified Warner teaches the system according to claim 13, but fails to teach wherein the print base is made of metal and/or metal alloys, a corrosion-resistant aluminum sheet formed from high- purity aluminum with surface layers metallurgically bonded to high-strength aluminum alloy core material, a highly alloyed austenitic stainless steel used for high temperature application, plastic and/or composite materials, tempered glass, or glass-ceramics.
However, Abe teaches the print base is made of metal and/or metal alloys ([0004], the modeling plate that supports the solidified layer (that is, the three-dimensional modeled object) is a rigid body made of steel or the like).
Warner and Abe are considered to be analogous to the claimed invention because both are in the same field of additive manufacturing for producing a three-dimensional shaped object. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the print base of the modified Warner such that the print base is made of metal and/or metal alloys as taught by Abe to avoid being affected by the heat of the light beams because it is away from the irradiation position of the light beam so that the 3D shaped object does not peeled from the modeling plate during the manufacturing process ([0004]).
Claims 27- 28 is rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner), US2006/0283758 (Pasbrig), or alternatively, further in view of US2018/0207932 (Kusunoki) as applied to claim 27 above, and further in view of US2015/0328838 (“Erb et al” hereinafter Erb).
Regarding Claim 27, the modified Warner teaches the system according to claim 13, but fails to teach wherein the print base includes a coating.
However, Erb teaches the print base includes a coating ([([0077], in some embodiments, the printing plate can be coated with materials to adjust the printing performance. Some exemplary materials used to coat the printing plate include fiberglass, ceramics, PTFE, and a hydrophobic wax having a low melting temperature)).
Warner and Erb are considered to be analogous to the claimed invention because both are in the same field of additive manufacturing for producing a three-dimensional shaped object. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the print base of the modified Warner such that the print base includes a coating as taught by Erb to achieve a high melting point and low bondability with the printed 3D object ([0033]).
Regarding Claim 28, the modified Warner teaches the system according to claim 27, wherein the coating is a ceramic glaze coating (Erb, [0077], in some embodiments, the printing plate can be coated with materials to adjust the printing performance. Some exemplary materials used to coat the printing plate include fiberglass, ceramics, PTFE, and a hydrophobic wax having a low melting temperature).
Claim(s) 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner) and US2006/0283758 (Pasbrig), or alternatively, further in view of US2018/0207932 (Kusunoki) as applied to claim 13 above, and further in view of US2,157,570 (Raynolds).
Regarding Claim 29, the modified Warner teaches the system according to claim 13. Warner discloses the partitionable receptacle is removed and a new partitionable receptacle can be supplied to the machine so that additional batches can be made ([0037]) but fails to teach an object remover for removing printed objects from the print base.
However, in the same field of making tablets for pharmaceutical, Raynolds teaches an object remover for removing printed objects from the print base (page 3, left column, line 74 – right column, line 4).
Warner and Raynolds are considered to be analogous to the claimed invention because both are in the same field of producing a tablet of pharmaceutical product. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the system of the modified Warner such that it teaches all of the limitations discussed above as taught by Raynolds to have the ejector pins in contact with the periphery of the molded article and to remove the molded article coming in contact therewith (page 3, right column, lines 3-4). Furthermore, the combination of the known elements provides a predictable result, namely, another known way to removed a printed object from the print base. See MPEP 2143.
Regarding Claim 30, the modified Warner teaches the system according to claim 29, wherein the object remover comprises moveable extractor pins or gas nozzles being connected to the formatted printing locations of the print base (page 3, left column, line 74 – right column, line 4).
Response to Arguments
Applicant's arguments filed on 11/07/2025 have been fully considered but they are not persuasive.
The Applicant argues Warner fails to discloses a printing location comprising a recess in the print base and pointed to [0040] of Warner to state that Warner discloses “the stage 80 can provide a flat surface for placement of the containers” and since the stage is a flat surface, it does not include recesses. Thus, the containers of Warner are not printing locations that comprise recesses.
The Examiner respectfully disagreed. Warner also recited in [0040] and an alternative stage configuration, in particular, “the stage can be configured with fixtures for placing and/or holding the containers in specific locations. For example, the fixture can include an indentation that the container fits in”. Thus, the indentation of the fixture on the stage formed a recess that is adapted to receive a plurality of containers which may be drug capsules ([0040]). Therefore, the modified Warner does teach the amended limitations of claim 13 and the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XINWEN (Cindy) YE whose telephone number is (571)272-3010. The examiner can normally be reached Monday - Thursday 8:30 - 17:00.
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XINWEN (CINDY) YE
Examiner
Art Unit 1754
/SUSAN D LEONG/Supervisory Patent Examiner, Art Unit 1754