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 .
Claim Objections
Claim 20 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 17. 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
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.
Claims 1 – 20 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 1, line 13 recites “a stage” however, earlier in claim 1, applicant already recites having “a translating or rotating stage”, therefore, it is vague and indefinite as it is unclear as it is unclear whether (i) applicant intend to refer to earlier said rotating or translating stage, or (ii) having additional stage. For the purpose of examination, the Examiner considers that for each instance of “a stage” applicant is referring the earlier said rotating or translating stage (claim 1 line 10-11).
Claim 7 recites “the stage” thus for clarity, applicant should refer to it as “the rotating or translating stage”.
Claim 10, line 15 recites “a stage” however, earlier in claim 10, applicant already recites having “a translating or rotating stage” (line 14), therefore, it is vague and indefinite as it is unclear as it is unclear whether (i) applicant intend to refer to earlier said rotating or translating stage, or (ii) having additional stage. For the purpose of examination, the Examiner considers that for each instance of “a stage” applicant is referring the earlier said rotating or translating stage (claim 10 line 14).
Claim 19, line 13 recites “a stage” however, earlier in claim 19, applicant already recites having “a translating or rotating stage” (line 10), therefore, it is vague and indefinite as it is unclear as it is unclear whether (i) applicant intend to refer to earlier said rotating or translating stage, or (ii) having additional stage. For the purpose of examination, the Examiner considers that for each instance of “a stage” applicant is referring the earlier said rotating or translating stage (claim 19 line 10).
The dependent claims which further depend upon independent claim 1, 10, and 19, are similarly rejected for the same reasons as discussed above.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 1 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (US 4,320,041) in view of Albed Alhan (US 2018/0311169 A1) in further view of Oberhofer et al. (US 6,932,935 B1).
Examiner wishes to point out to applicant that claims 1-19 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 are viewed as recitation of intended use and are given no patentable weight (Please see MPEP 2114 R1-2115 R2 for further details).
Regarding claim 1, Abe et al. teach an apparatus that is capable of manufacture of pharmaceutical solid dosage forms (abstract; Figs. 1-2 shows extruder that mixes material and extrudes to form an article) comprising:
an internally hollow housing having an internal surface encapsulating and defining an extrusion channel having at least a first end and at least a second end and terminating into at least one exit port at the second end (see col 3 lines 40 and onward; Fig. 1 specifically shows extruder 1 which in provided with a internally with a housing 4; a first end before hopper 3, and second end after 12);
said housing having one or more feeding ports for injecting at least an excipient and at least a solvent into the extrusion channel to form a plasticized matrix in said extrusion channel (Fig. 1 shows hopper 3 is sitting on first feeding port, which is between first and second end; see col 4 lines 14-24, and col 5 lines 50 to col 6 lines 25 mentions additional feeding zone or inlets for feeding aqueous solutions or capable of injecting any materials, see Fig. 1 items a1, a2, and a3);
said apparatus further comprising at least one conveying element for extruding the plasticized matrix in the extrusion channel through at least one exit port and form at least one plasticized fiber (Fig 1-item 2-as conveying, see Fig 2, item 2,2’ which are used for conveying see col 3 lines 52-65).
However, Abe et al. fail to explicitly show a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three-dimensional structural network by depositing said fibers along a path defined by motion of said stage; wherein a stage (“said stage”) on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface.
In the same field of endeavor, pertaining to extrusion, Albed Alhan a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage (see [0169] which states “The build platform may be movable (suitably in an automated fashion or in a manner controlled by a computer or by the printer under instruction from the computer) to control the position or height of extrusion of a relevant filament upon the build platform. The build platform may be moveable in any or all of the X, Y, and Z direction, though in some embodiments the build platform is movable in the Z direction only, i.e. up and down. Movement in the Z direction allows the gap (or height) between the nozzle and the printing point to be kept substantially constant throughout the printing process to maintain layer-by-layer consistency.”); however, fails to teach wherein the rotating/translating stage on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface. In the same field of endeavor, pertaining to producing an object on a build platform, Oberhofer et al. teach a build platform including perforation for the purpose of blowing air/gas for removing or loosening powder from the build object (see Fig 4, air is used to loosen powder 11 surrounding an object formed; see col 6. Lines 35-55).
Therefore, it would have been obvious to one ordinary skill in the art at the time of the Applicant’s invention effectively filed to modify the extrusion apparatus for shaping an object as taught by Abe et al. including a forming stage that is translatable, as taught by Albed Alhan, for the benefit of producing solid dosage having desired properties, with further benefit of providing perforation on the stage, as taught by Oberhofer et al., for the benefit of removing unwanted or removing loose particles from the formed object.
Regarding claim 10, Abe et al. teach an apparatus that is capable of manufacture of pharmaceutical solid dosage forms (abstract; Figs. 1-2 shows extruder that mixes material and extrudes to form an article) comprising:
an internally hollow housing having an internal surface encapsulating and defining an extrusion channel having at least a first end and at least a second end and terminating into at least one exit port at the second end (see col 3 lines 40 and onward; Fig. 1 specifically shows extruder 1 which in provided with a internally with a housing 4; a first end before hopper 3, and second end after 12);
said housing having one or more feeding ports for injecting at least an excipient and at least a solvent into the extrusion channel to form a plasticized matrix in said extrusion channel (Fig. 1 shows hopper 3 is sitting on first feeding port, which is between first and second end; see col 4 lines 14-24, and col 5 lines 50 to col 6 lines 25 mentions additional feeding zone or inlets for feeding aqueous solutions or capable of injecting any materials, see Fig. 1 items a1, a2, and a3);
said apparatus further comprising at least one conveying element for extruding the plasticized matrix in the extrusion channel through at least one exit port and form at least one plasticized fiber (Fig 1-item 2-as conveying, see Fig 2, item 2,2’ which are used for conveying see col 3 lines 52-65); the apparatus further comprising at least one heating element for fluidizing the injected excipient so that the injected excipient forms a plasticized matrix in the extrusion channel (Fig. 1 item 12 includes heating element, see col 3 lines 50-65).
However, Abe et al. fail to explicitly show a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three-dimensional structural network by depositing said fibers along a path defined by motion of said stage; wherein a stage (“said stage”) on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface.
In the same field of endeavor, pertaining to extrusion, Albed Alhan a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage (see [0169] which states “The build platform may be movable (suitably in an automated fashion or in a manner controlled by a computer or by the printer under instruction from the computer) to control the position or height of extrusion of a relevant filament upon the build platform. The build platform may be moveable in any or all of the X, Y, and Z direction, though in some embodiments the build platform is movable in the Z direction only, i.e. up and down. Movement in the Z direction allows the gap (or height) between the nozzle and the printing point to be kept substantially constant throughout the printing process to maintain layer-by-layer consistency.”); however, fails to teach wherein the rotating/translating stage on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface. In the same field of endeavor, pertaining to producing an object on a build platform, Oberhofer et al. teach a build platform including perforation for the purpose of blowing air/gas for removing or loosening powder from the build object (see Fig 4, air is used to loosen powder 11 surrounding an object formed; see col 6. Lines 35-55).
Therefore, it would have been obvious to one ordinary skill in the art at the time of the Applicant’s invention effectively filed to modify the extrusion apparatus for shaping an object as taught by Abe et al. including a forming stage that is translatable, as taught by Albed Alhan, for the benefit of producing solid dosage having desired properties, with further benefit of providing perforation on the stage, as taught by Oberhofer et al., for the benefit of removing unwanted or removing loose particles from the formed object.
Regarding claim 19, Abe et al. teach an apparatus that is capable of manufacture of pharmaceutical solid dosage forms (abstract; Figs. 1-2 shows extruder that mixes material and extrudes to form an article) comprising:
an internally hollow housing having an internal surface encapsulating and defining an extrusion channel having at least a first end and at least a second end and terminating into at least one exit port at the second end (see col 3 lines 40 and onward; Fig. 1 specifically shows extruder 1 which in provided with a internally with a housing 4; a first end before hopper 3, and second end after 12);
said housing having one or more feeding ports for injecting at least a plasticized matrix into the extrusion channel (Fig. 1 shows hopper 3 is sitting on first feeding port, which is between first and second end; see col 4 lines 14-24, and col 5 lines 50 to col 6 lines 25 mentions additional feeding zone or inlets for feeding aqueous solutions or capable of injecting any materials, see Fig. 1 items a1, a2, and a3);
said apparatus further comprising at least one conveying element for extruding the plasticized matrix in the extrusion channel through at least one exit port and form at least one plasticized fiber (Fig 1-item 2-as conveying, see Fig 2, item 2,2’ which are used for conveying see col 3 lines 52-65).
However, Abe et al. fail to explicitly show a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three-dimensional structural network by depositing said fibers along a path defined by motion of said stage; wherein a stage (“said stage”) on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface.
In the same field of endeavor, pertaining to extrusion, Albed Alhan a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage (see [0169] which states “The build platform may be movable (suitably in an automated fashion or in a manner controlled by a computer or by the printer under instruction from the computer) to control the position or height of extrusion of a relevant filament upon the build platform. The build platform may be moveable in any or all of the X, Y, and Z direction, though in some embodiments the build platform is movable in the Z direction only, i.e. up and down. Movement in the Z direction allows the gap (or height) between the nozzle and the printing point to be kept substantially constant throughout the printing process to maintain layer-by-layer consistency.”); however, fails to teach wherein the rotating/translating stage on which one or more of said fibers are deposited comprises a perforated solid defining a deposition surface. In the same field of endeavor, pertaining to producing an object on a build platform, Oberhofer et al. teach a build platform including perforation for the purpose of blowing air/gas for removing or loosening powder from the build object (see Fig 4, air is used to loosen powder 11 surrounding an object formed; see col 6. Lines 35-55).
Therefore, it would have been obvious to one ordinary skill in the art at the time of the Applicant’s invention effectively filed to modify the extrusion apparatus for shaping an object as taught by Abe et al. including a forming stage that is translatable, as taught by Albed Alhan, for the benefit of producing solid dosage having desired properties, with further benefit of providing perforation on the stage, as taught by Oberhofer et al., for the benefit of removing unwanted or removing loose particles from the formed object.
As for claim 2 -6 and 11-13, Abe et al. further shows wherein the extrusion channel cross section tapers down before at least one exit port to the cross section of said exit port (Fig 1); wherein the extrusion channel bifurcates into at least one additional end (Fig 2); further comprising at least one solids feeding unit for injecting one or more solid excipients into the extrusion channel (Fig 1 shows additional ports in addition to hopper, a1, a2, a3); at least one solvent feeding unit attached to a feeding port for injecting at least one solvent into the extrusion channel (Fig 1 shows additional ports in addition to hopper, a1, a2, a3); wherein at least one conveying element is a screw (Fig 1 item 2).
As for claims 7 and 16, Abe et al. fails to show wherein the stage is movable in at least three directions relative to the at least one exit port for depositing one or more plasticized fibers along a path defined by the motion of said stage.
In the same field of endeavor, pertaining to extrusion, Albed Alhan a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage and wherein the stage is movable in at least three directions relative to the at least one exit port for depositing one or more plasticized fibers along a path defined by the motion of said stage (see [0169] which states “The build platform may be movable (suitably in an automated fashion or in a manner controlled by a computer or by the printer under instruction from the computer) to control the position or height of extrusion of a relevant filament upon the build platform. The build platform may be moveable in any or all of the X, Y, and Z direction, though in some embodiments the build platform is movable in the Z direction only, i.e. up and down. Movement in the Z direction allows the gap (or height) between the nozzle and the printing point to be kept substantially constant throughout the printing process to maintain layer-by-layer consistency.”), for the same benefit as discussed above.
As for claim 8-9 and 17-20, Oberhofer et al. teach a build platform including perforation for the purpose of blowing air/gas for removing or loosening powder from the build object (see Fig 4, air is used to loosen powder 11 surrounding an object formed; see col 6. Lines 35-55), thus such surface includes grid or at least one perforation as claimed.
As for claim 14 -15, Abe et al. further teach wherein the heating element is selected from the group comprising wrap around heaters or heaters embedded into the housing (see Fig. 1 item 12); wherein at least one conveying element is a screw (Fig 1 item 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,751,292. Though the claims are not identical, however, the instant claims are broader, and anticipatory over the claims of US 10, 751,292, as it teaches all structural element to produce a solid dosage.
Regarding claims 1, 10, and 19, claims of U.S. Patent 10, 751, 292 (hereinafter “USP 292”) teaches an apparatus for the manufacture of pharmaceutical solid dosage forms comprising: an internally hollow housing having an internal surface encapsulating and defining an extrusion channel having a first end and a second end and a cross section extending axially from said first end to said second end and terminating into an exit port at the second end; said housing having at least a first feeding port between the first end and second end for injecting at least one solid constituent into the extrusion channel, and at least a second feeding port between the first feeding port and the exit port for injecting at least one solvent into the extrusion channel to form a plasticized matrix by solvating at least one injected solid constituent; at least one conveying element for extruding the plasticized matrix in the extrusion channel through an exit port and form at least one plasticized fiber; and a translating or rotating stage for structuring one or more of the extruded plasticized fibers to a three dimensional structural network by depositing said fibers along a path defined by motion of said stage; wherein said stage comprises at least a perforation through which gas flows for solidifying the deposited three dimensional structural network of one of more fibers (see claims 1 – 26). The dependent claims are rejected similarly, and are either anticipatory or obvious over the reference patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2019/0125681 A1 - The present invention utilises 3D printing technology, specifically fused filament fabrication (FFF) 3D printing, to produce solid dosage forms, such as pharmaceutical tablets. The production process utilises novel printing filaments, typically on a spool, which contain the active ingredient. Such active-containing filaments have proved to be extremely robust and the principles outlined in the present disclosure provide access to a variety of viable formulations directly from a 3D printer.
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NAHIDA SULTANA
Primary Examiner
Art Unit 1743
/NAHIDA SULTANA/Primary Examiner, Art Unit 1743