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 .
This Office Action is in response to the applicant’s amendment filing on 01/26/2026.
Applicant’s cancelation of claims 2-4, 12-13, and 15-16 is acknowledged and require no further examining. Claims 1, 5-11, 14, and 17-18 are pending and examined below.
Claim Rejections - 35 USC § 103
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.
Claims 1, 5-7, 10-11, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over reference Boeckx et al. (9,713,575) in view of references Gebaurer et al. (2020/0016552), Konishi et al. (7,082,738), and Runft et al. (2012/0207272).
Regarding claim 1, Boeckx et al. disclose a system (1) for continuous production of tablets (93), the system comprising:
at least one continuous blender (4) configured to receive and continuously blend a first ingredient (91) and a second ingredient (92) to form a mixture;
at least one first feeder (col. 10 ln. 35-36) fluidically coupled to a first inlet (21) of the at least one continuous blender (4) and configured to supply the first ingredient (91) to the at least one continuous blender (4); and
at least one second feeder (col. 10 ln. 35-36) fluidically coupled to a second inlet (31) of the at least one continuous blender (4) and configured to supply the second ingredient (92) to the at least one continuous blender (4).
a tablet forming machining (6) fluidically coupled with the at least one continuous blender (4),
wherein the tablet forming machining (6) is adapted to form the tablet (93) with the mixture produced by the at least one continuous blender (4) to provide a plurality of tablets (93);
one or more sensors (51, 52) positioned at predetermined positions in the system (1) and configured to monitor one or more attributes of any or a combination of the first ingredients (91), the second ingredients (92), the mixture, the plurality of empty capsules, and the plurality of filled capsules; and
a control unit (8) operatively coupled with the one or more sensors (51, 52), the at least one continuous blender (4), the tablet forming machine (6), at least one first feeder (col. 10 ln. 35-36), and at least one second feeder (col. 10 ln. 35-36),
wherein the control unit (8) is adapted to transmit a set of control signals to any or a combination of the at least one continuous blender (4), the tablet forming machine (6), at least one first feeder (col. 10 ln. 35-36), and at least one second feeder (col. 10 ln. 35-36) to being one or more attributes sensed by the one or more sensors (51, 52), within a predefined threshold range, when the one or more of the attributes sensed by the one or more sensors (51, 52) are above or below the predefined threshold range.
(Figure 2a, 2b and Column 3 lines 26-41, Column 4 lines 31-36, 49-51, 58-65, Column 5 lines 25-35, Column 6 lines 9-14, Column 8 lines 47-51, Column 10 lines 32-37)
However, Boeckx et al. does not disclose a capsule filling machine, a diverter valve, a capsule diagnosis, and a set of further sensors.
Gebauer et al. disclose a system (1) for continuous production of filled capsules (22), the system comprising: a capsule filling machine (11) fluidically coupled with the at least one continuous blender (3, 6) wherein the capsule filling machine (11) is adapted to fill a plurality of empty capsules with the mixture produced by the at least one continuous blender (3, 6) to provide a plurality of filled capsules (22). (Figure 1, 2, 3 and Page 4 paragraph 40, Page 5 paragraph 50)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have substituted the tablet forming machine with the capsule filling machine as taught by Gebauer et al., since page 1 paragraph 14 and page 5 paragraph 50 of Gebauer et al. states the production of capsules would work equally well with the blender, thereby rendering the substitution to have predictable results.
Gebauer et al. further disclose a diverter valve (32) configured with the at least one continuous blender (3, 6), wherein the diverter valve (32) is adapted to divert the flow of the mixture having the one or more mixture attributes within a predefined range to the capsule filling machine (11), and wherein the diverter valve (32) is adapted to divert the flow of the mixture failing to have the one or more mixture attributes within the predefined range to a rejection bin. (Figure 3 and Page 5 paragraph 49, 56, Page 6 paragraph 59)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have further modified the system of Boeckx et al. by incorporating the diverter valve as taught by Gebauer et al., since page 6 paragraph 59 of Gebauer et al. states such a modification would allow the ejection of defective mixture.
Konishi et al. disclose a system (100) comprising a capsule diagnosis unit (502) configured to detect and eliminate defective empty capsules. (Column 7 lines 27-33, 38-40)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Boeckx et al. by incorporating the capsule diagnosis unit as taught by Konishi et al., since column 10 lines 1-7 of Konish et al. states such a modification would help prevent filling defective capsules.
Runft et al. disclose a system (100) comprising a set of sensors (25, 26) configured to determine net weight of capsules (c) and gross weight of capsules (c). (Page 2 paragraph 26, 28)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Boeckx et al. by incorporating the weight sensors as taught by Runft et al., since such a modification would ensure consistent filled capsules, thereby making the overall system more reliable.
Regarding claim 5, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose a set of first sensors (Boeckx et al. – col. 5 ln. 35-37) configured with the at least one first feeder (Boeckx et al. – col. 10 ln. 35-36) to monitor one or more first ingredient attributes, and a set of second sensors (Boeckx et al. – col. 5 ln. 35-37) configured with the at least one second feeder (Boeckx et al. – col. 10 ln. 35-36) to monitor one or more second ingredient attributes, wherein the one or more first ingredient attributes and the one or more second ingredient attributes comprise any or a combination of blend uniformity, concentration, fingerprint, flowability, moisture content, weight, and particle size distribution. (Boeckx et al. – Column 5 lines 29-40)
Regarding claim 6, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose first reservoir (Boeckx et al. – see figure 2a below) fluidically coupled to the at least one first feeder (Boeckx et al. – col. 10 ln. 35-36) and adapted to store the first ingredient (Boeckx et al. – 91), and a second reservoir (Boeckx et al. – see figure 2a below) fluidically coupled to the at least one second feeder (Boeckx et al. – col. 10 ln. 35-36) and adapted to store the second ingredient (Boeckx et al. – 92). (Boeckx et al. – Figure 2a, 2b and Column 8 lines 47-51, Column 10 lines 32-37)
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Regarding claim 7, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose the at least one first feeder (Boeckx et al. – col. 10 ln. 35-36) and the at least one second feeder (Boeckx et al. – col. 10 ln. 35-36) comprise any or a combination of gravimetric feeder, and volumetric feeder (Boeckx et al. – col. 12 ln. 53-54) to discharge a predefined quantity of the first ingredient (Boeckx et al. – 91) and the second ingredient (Boeckx et al. – 92) from the corresponding feeders. (Boeckx et al. – Column 10 lines 32-37, Column 12 lines 49-54)
Regarding claim 10, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose the claimed invention as stated above but do not disclose a first valve and a second valve.
Gebauer et al. disclose a first valve (23, 24) operatively coupled to the at least one first feeder (13, 14) to control outflow of the first ingredient to the at least on first feeder (13, 14), and wherein the system comprises a second valve (25, 26) operatively coupled to the at least one second feeder (15, 16) to control outflow of the second ingredient to the at least one second feeder (15, 16). (Page 4 paragraph 44)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Boeckx et al. by incorporating the valves as taught by Gebauer et al., since page 4 paragraph 44 of Gebauer et al. states such a modification would help prevent the return of material upstream.
Regarding claim 11, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose a set of fifth sensors (Boeckx et al. – 51) positioned at an outlet of the at least one continuous blender (Boeckx et al. – 4) and configured to monitor one or more mixture attributes associated with the mixture discharged from the outlet, and wherein the one or more mixture attributes comprises any or a combination of uniformity, concentration, fingerprint, flowability, moisture content, and particle size distribution. (Boeckx et al. – Column 4 lines 58-60, Column 5 lines 25-33)
Regarding claim 17, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose at least a third feeder (Boeckx et al. – col. 10 ln. 35-36) fluidically coupled to the capsule filling machine (Gebauer et al. – 11) and configured to supply a third ingredient (Boeckx et al. – 92b) to the capsule filling machine (Gebauer et al. – 11), wherein the capsule filling machine (Gebauer et al. – 11) is configured to fill any or a combination of the mixture, the tertiary ingredients (Boeckx et al. – 92b), the first ingredients (Boeckx et al. – 91), and the second ingredients (Boeckx et al. – 92a) in the plurality of empty capsules. (Boeckx et al. – Column 9 lines 4-16)
Regarding claim 18, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose a containment (Boeckx et al. – see figure 2a above) to restrict exposure of any or a combination of the mixture, the first ingredients, and the second ingredients to operator and manufacturing facility. (Boeckx et al. – Figure 2a, 2b)
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over reference Boeckx et al. (9,713,575) in view of references Gebaurer et al. (2020/0016552), Konishi et al. (7,082,738), and Runft et al. (2012/0207272) as applied to claim 1 above, and further in view of reference Yang et al. (2016/0175199).
Regarding claim 8, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose the claimed invention as stated above but do not disclose a first particle sizer and a second particle sizer.
Yang et al. disclose a feeder (26) comprising means for controlling the particle size of the ingredient. (Page 5 paragraph 73, 78, 82) The means for controlling the particle size is interpreted as the particle sizer.
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Boeckx et al. by incorporating the particle sizer as taught by Yang et al., since page 5 paragraph 79 of Yang et al. states such a modification would the ability to maintain uniformity.
Regarding claim 9, Boeckx et al. sensors configured to monitor the attributes ingredients. (Column 5 lines 25-35)
Yang et al. disclose means for controlling the particle size of the ingredient. (Page 5 paragraph 73, 78, 82)
Therefore, the Boeckx et al. modified by Gebauer et al., Konishi et al., Runft et al., and Yang et al. are interpreted to disclose a set of third sensors configured with the first particle sizer to monitor one or more first ingredient attributes of the first ingredients discharged from the first particle sizer, and a set of fourth sensors configured with the second particle sizer to monitor one or more second ingredient attributes of the second ingredients discharged from the second particle sizer.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over reference Boeckx et al. (9,713,575) in view of references Gebaurer et al. (2020/0016552), Konishi et al. (7,082,738), and Runft et al. (2012/0207272) as applied to claim 1 above, and further in view of reference Martensson et al. (2009/0232697).
Regarding claim 14, Boeckx et al. modified by Gebauer et al., Konishi et al., and Runft et al. disclose the claimed invention as stated above but do not disclose sensors to monitor locations parameters.
Martensson et al. disclose a device (1) comprising exterior sensors (27, 28), wherein the exterior sensors are configured to monitor the ambient temperature and humidity outside the device (1). (Page 4 paragraph 70)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the system of Boeckx et al. by incorporating the exterior sensors as taught by Martensson et al., since page 4 paragraph 70 of Martensson et al. state such a modification would allow better regulation of the parameters within the system.
Response to Arguments
The Amendments filed on 01/26/2026 have been entered. Applicant’s cancelation of claims 2-4, 12-13, and 15-16 is acknowledged and require no further examining. Claims 1, 5-11, 14, and 17-18 are pending in the application.
In response to the arguments of the objections towards the claims, in view of the amendments to the claims, Examiner withdraws the claim objections.
In response to the arguments of the rejections under 35 U.S.C. 112(b), in view of the amendments to the claims, Examiner withdraws the 112(b) rejections.
In response to the arguments of the rejections under 35 U.S.C. 103 with reference Boeckx et al. (9,713,575) modified by references Gebaurer et al. (2020/0016552), Konishi et al. (7,082,738), and Runft et al. (2012/0207272), Examiner finds the arguments not persuasive.
Applicant states:
Applicant respectfully submits that the Examiner's rejection relies on impermissible hindsight, combining disparate teachings directed to different manufacturing paradigms and quality- control philosophies, and fails to teach or suggest the claimed synergistic, multi-stage, proactive quality-control architecture for continuous capsule manufacturing with a reasonable expectation of success.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Boeckx et al. disclose a system for the production of tablets, wherein the system comprises a continuous blender. Gebauer et al. disclose a system for production of tablets and/or capsules, wherein the system comprises a continuous blender. Therefore, the knowledge of substituting the production of tablets with the production of capsules was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure.
Boeckx et al. modified by Gebauer et al. disclose a system for production of capsules. Konishi et al. disclose a system for production of capsules, wherein the system comprises a capsule diagnosis unit. Therefore, the knowledge to incorporate the capsule diagnosis unit was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure.
Boeckx et al. modified by Gebauer et al. disclose a system for production of capsules. Runft et al. disclose a system for processing capsules, wherein the system comprises a set of sensors configured to determine net weigh of capsules and gross weight of capsules. Therefore, the knowledge to incorporate the set of sensors was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure.
Applicant states:
However, Gebaurer et al. does not describe a truly continuous manufacturing environment.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., truly continuous manufacturing environment) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim 1 discloses a “system for continuous production”. In column 2 lines 55-58 of Boeckx et al., the disclosed invention a described as a continuous production system. Therefore, Boeckx et al. is interpreted to disclose a system for continuous production.
Furthermore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Gebauer et al. is not relied upon for the teaching of a continuous manufacturing system. Gebauer et al. is relied upon for the teaching of use of a continuous blender that is configured to work with a tablet press or a capsule filler. Boeckx et al. is relied upon for the teaching of a system for continuous production. When modifying Boeckx et al. in view of Gebauer et al., the system is interpreted to be for continuous production of capsules.
Applicant states:
There is no teaching or suggestion in either Boeckx et al. or Gebauer et al. that would motivate the person skilled in the art to directly substitute the tablet press of Boeckx et al. with the capsule filler of Gebauer et al.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Gebauer et al. is relied upon for the teaching of using of a continuous blender that is configured to work with a tablet press or a capsule filler. This implies that a continuous blender would work equally well in the production of tablets or capsules. Therefore, it would have been obvious to the person of ordinary skill in the art to substitute the tablet forming machine with a capsule filling machine since the production of capsules would work equally well, thereby rendering the substitution to have predictable results. Gebauer et al. do not disclose that such a substitution would cause complication or cause undue redesign.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant states:
However, Boeckx et al. does not disclose a control system configured to operate in conjunction with:
a capsule diagnosis unit for pre-filling inspection of empty capsules, and
in-process slug-level monitoring within a capsule filling machine.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., control system operatively coupled to a capsule diagnosis and slug-level monitor) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In amended claim 1, the control unit is disclosed to be “operatively coupled with the one or more sensors, the at least one continuous blender, the capsule filling machine, the at least one first feeder, and the at least one second feeder”. Amended claim 1 does not disclose the control unit being operatively coupled with the capsule diagnosis unit and the set of sensors.
Furthermore, amended claim 1 disclose the set of sensors are adapted to monitor one or more capsule attributes, wherein said capsule attributes comprises any or a combination of listed attributes. Amended claim 1 does not explicitly disclose the set of sensors are adapted to monitor in-process slug-level.
Applicant states:
However, Gebauer et al. does not disclose implementing such a mechanism within a truly continuous manufacturing system as taught by Boeckx et al., nor operating it as part of a real-time, multi-layered quality-gate architecture.
On page 5 paragraph 49 of Gebauer et al., the system is disclosed to have a diverter valve (32) “arranged at an entry of the final processing device 4, by means of which bifurcation a feed flow of the product to the final processing device 4 is controllable. In this case, controllable means the possibility of delivering the lot of good product into the final processing device 4, or if need be the lot of good product into an IBC (intermediate bulk container – not shown), or the lot is substandard product into a refuse container (not shown).” In other words, the diverter valve is configured to divert the flow of mixture, wherein the mixture attributes are within the desired range (i.e. considered good product) is fed to the filling machine, and wherein the mixture attributes are outside the desired range (i.e. considered substandard product) is fed to a rejection bin.
Gebauer et al. do not disclose the bifurcation mechanism can only be used in the disclosed system, nor disclose that the bifurcation mechanism cannot be incorporated into any other system. Since Applicant does not provide any evidence to support the assertion that a person of ordinary skill in the art would never incorporate the teachings of Gebauer et al. into the invention disclosed by Boeckx et al., the assertion is mere speculation. “An assertion of what seems to follow from common experience is just attorney arguments and not the kind of factual evidence that is required to rebut a prima facie case of obviousness”. [MPEP 2145 (I)] Therefore, in view of Applicant not provided support for the assertion, and in view of Gebauer et al. not teaching away from using the bifurcation mechanism in other system, Applicant’s arguments is rendered moot.
Applicant states:
Konishi et al. and Runft et al. are limited to inspection of filled capsules or finished dosage forms and do not describe or suggest pre-fill inspection of empty capsule shells or recognize preventing waste of quality-assured powder as a problem to be solved.
Runft et al. is not relied upon for the teaching of a capsule diagnosis unit. Runft et al. is relied upon for the teaching of a set of sensors configured to determine net weight of capsules and gross weight of capsules. Konishi et al. is relied upon the teaching of a capsule diagnosis unit.
In column 7 lines 34-40 of Konishi et al., the system is disclosed to have a capsule loading-separating mechanism that “separates the empty capsules into a cap and body. The capsule separation defect elimination mechanism 502 detects and eliminates defective capsules not being separated into a body and cap”, emphasis added. In column 10 lines 1-7 of Konishi et al., the capsule separation defect elimination mechanism is disclosed to detect “a separation defect wherein the cap of an empty capsule is not completely separated from the body”, emphasis added. This implies that the capsule separation defect elimination mechanism is inspecting empty capsule shells, and is allowing empty capsules that have predetermined qualities to pass to the capsule filling machine. Therefore, Konishi et al. do disclose a capsule diagnosis unit configured to inspect empty capsule shells.
Applicant states:
Runft et al. describes weighing capsules after filling and closing. However, Runft et al. does not describe monitoring slug height or slug weight during formation, prior to delivery into the capsule body.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., monitoring slug height or slug weight) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Amended claim 1 disclose the set of sensors are adapted to monitor one or more capsule attributes, wherein said capsule attributes “comprises any or a combination of net weight of each filled capsule, gross weight of each filled capsules, weight of each capsules, first ingredient concentration in each filled capsule, second ingredient concentration in each filled capsule, operating speed of the capsule filling machine, feed rate of the empty capsules, ejection rate of the filled capsules, height of the slug in the slug formation unit, and weight of the slug being delivered by the slug formation unit to the filled capsule conveying unit”, emphasis added. Amended claim 1 does not explicitly disclose the set of sensors are adapted to monitor slug height or slug weight during formation.
Conclusion
THIS ACTION IS MADE FINAL. 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 PATRICK B FRY whose telephone number is (571)272-0396. The examiner can normally be reached on Mon-Thur 7am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK B FRY/Examiner, Art Unit 3731 May 19, 2026
/SHELLEY M SELF/Supervisory Patent Examiner, Art Unit 3731
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