DETAILED ACTION
In Reply filed on 05/08/2026, claims 13 and 22-31 are pending. 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Previous 35 USC 103 rejections have been withdrawn in view of the Applicant’s amendments and arguments. However, new rejections have been established.
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), US2019/0159970 (Franck), and US2006/0283758 (Pasbrig).
Regarding Claim 13, Warner teaches a system for 3D printing pharmaceutical objects (Figure 5 and [0040]), the system (Figure 5) comprising
a 3D printer (Figure 5, apparatus 5 and [0040]) with a mechanical system movable in one or more directions (Figure 5 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 5 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 5 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);
Warner teaches 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 (Figure 5 and [0027]) but fails to teach a blister packaging, wherein the print base comprises one or more formatted printing locations for shaping the pharmaceutical object, wherein the formatted printing locations comprise recesses in the print base and the blister packaging is retained in the recesses such that the pharmaceutical objects can be printed directly inside the blister packaging.
However, Franck teaches a blister packaging (Figure 1, depressions 3 in a flat sheet or in a flat band, which ensures that the tablet-like substrate bodies 2 are always in exactly predetermined positions, namely within the depressions 3 [0026]), wherein the print base (Figure 1, blister tray 4) comprises one or more formatted printing locations for shaping the pharmaceutical object (Figure 1 and [0027], blister tray 4 comprises a plurality of formatted printing locations that allows depressions 3to be placed over) , wherein the formatted printing locations comprise recesses in the print base and the blister packaging is retained in the recesses (Figure 1 and [0027], a foil provided with corresponding depressions 3 for a subsequent blister card could also be placed over a blister tray 4 in such a way that each depression 3 of the foil engages in a depression 3 of the blister tray 4 so that a centering orientation of the foil with depressions 3 occurs as a result of the blister tray 4) such that the pharmaceutical objects can be printed directly inside the blister packaging (Figure 1 and [0027]).
Warner and Franck 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 such that it teaches all of the above limitations as taught by Franck so that the tablet-like substrate bodies are always in exactly predetermined position and orientation within the depression ([0026]-[0027]).
Warner fails to teach the system further comprises a closing device for applying a sealing membrane or film to hermetically seal the blister packaging 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 (Franck, Figure 1, 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. Franck teaches depression 3 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 (Warner, 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), US2019/0159970 (Franck), and US2006/0283758 (Pasbrig) 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 packaging after the sealing is completed.
However, Huang teaches a labeling device for labeling the sealed blister packaging after the sealing is completed ([0031]. In one example, and as described above, additional printed information may include labels on the 3D-printed tablets such as, for example, labels 303 and 304 describing a prescribed sequence for consuming the medication, such as day, date and time of day for example. Thus, the labeling device is capable of labeling the drug product after the packaging has been sealed and is capable of being used as intended as discussed above and thus meets all of the structural limitations as claimed. See MPEP 2114).
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), US2019/0159970 (Franck), and US2006/0283758 (Pasbrig) 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 ([0027]-[0028]) 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 US2019/0159970 (Franck) as applied to claim 13 above, and further in view of JP2010/100883 (“Abe et al” hereinafter Abe), machine translation provided in previous Office Action.
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 so that the 3D shaped object does not peel from the modeling plate during the manufacturing process ([0004]). Furthermore, It would have been obvious for one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the material of the print base disclosed by Warner by a metal print base as taught by Abe because utilizing one known print base material in place of another print base material also suitability in the field of additive manufacturing is well within the ambit of one of ordinary skill in the art. See MPEP 2144.07.
Claims 27-28 is rejected under 35 U.S.C. 103 as being unpatentable over US2017/0361525 (“Warner et al” hereinafter Warner), US2019/0159970 (Franck) and US2006/0283758 (Pasbrig) as applied to claim 13 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 ([0077]).
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), US2019/0159970 (Franck), and US2006/0283758 (Pasbrig) 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 remove 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 with respect to claim(s) 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
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 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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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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XINWEN (CINDY) YE
Examiner
Art Unit 1754
/SUSAN D LEONG/Supervisory Patent Examiner, Art Unit 1754
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