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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 43-56 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.
Regarding claim 43, the claim recites “devices according to claim 1”. There is lack of antecedent basis for this limitation since claim 1 appears to be cancelled.
Regarding clam 44, the claim is dependent on claim 43 and therefore inherits its deficiencies.
Regarding claim 45, the claim recites “obtaining a first differential capacitance measurement using one of the one or more capacitance sensors by measuring the capacitance between the flat surfaces of the pair of conducting elements with and without the pharmaceutical tablet positioned in the gap”. It is unclear how the differential measurement is obtained when two different physical possibilities are claimed (with and without the tablet) since the capacitance measurement would change based on the dielectric between the plates.
Regarding claim 46-56, the claims are dependent on claim 43 and therefore inherits its deficiencies.
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.
Claim 37-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shail et al., US 6504387 in Sibik et al., US 2020/0217811
Regarding claim 37, Shail discloses a device for obtaining capacitance measurements (Abstract; capacitor plate type inspection arrangement) for use in determining the relative permittivity and thickness (d.sub.t, t) of a pharmaceutical tablet (intended use limitation in preamble not given patentable weight), the device comprising multiple capacitance sensors in one or more sensing sections (Abstract; “four capacitor plates…at least two pairs of opposing or generally opposing plates”), the multiple capacitance sensors comprising: (i) a first capacitance sensor for obtaining a first capacitance measurement, the first capacitance sensor comprising a first pair of conducting elements each conducting element having a flat surface (Fig. 2; capacitor plate 10 has flat surface), wherein the flat surfaces of the first pair of conducting elements are arranged in parallel such that capacitance measurements can be obtained from a gap therebetween (Fig. 2; capacitor plate 10 arranged parallel), wherein the first capacitance measurement is to be obtained when the pharmaceutical tablet is positioned in the gap between the flat surfaces of the first pair of conducting elements in a first orientation with respect to the flat surfaces of the first pair of conducting elements (Fig. 2; capacitor plate 10 at 0 degrees and plate 10 at 180 degrees; Col. 1 line 15-18; inspection of tablets, pills, etc. ); (ii) a second capacitance sensor for obtaining a second capacitance measurement, the second capacitance sensor comprising a second pair of conducting elements each having a flat surface Fig. 2; capacitor plate 10 at 270 degrees and plate 10 at 90 degrees both have flat surface), wherein the flat surfaces of the second pair of conducting elements are arranged in parallel such that capacitance measurements can be obtained from a gap therebetween(Fig. 2; capacitor plate 10 arranged parallel), wherein the second capacitance measurement is to be obtained when the pharmaceutical tablet is positioned in the gap between the flat surfaces of the second pair of conducting elements in a second orientation with respect to the flat surfaces of the second pair of conducting elements (Fig. 2; capacitor plate 10 at 270 degrees and plate 10 at 90 degrees; Col. 1 line 15-18; inspection of tablets, pills, etc.); wherein the arrangement of the parallel flat surfaces of the first pair of conducting elements relative to the parallel flat surfaces of the second pair of conducting elements enables the first orientation to be perpendicular to the second orientation (Fig. 2; orientations are perpendicular to each other) such that in one of the first and second orientations the thickness of the pharmaceutical tablet is parallel to the parallel flat surfaces of the pair of conducting elements and in the other of the first and second orientations the thickness of the pharmaceutical tablet is perpendicular to the parallel flat surfaces of the pair of conducting elements (Fig. 2; capacitor plate 10 at 0 degrees and 180 degrees are perpendicular to the plates at 90 and 270 degrees), and wherein the device comprises a controller (Col. 1 lines 45-50).
Shail does not explicitly disclose wherein the controller is configured to determine the relative permittivity and thickness of the pharmaceutical tablet using the first and second capacitance measurements. Sibik teaches wherein a controller is configured to determine the relative permittivity and thickness of the pharmaceutical tablet using the first and second capacitance measurements (¶[0018], [0031], [0036], [0050]; Fig. 2; controller 11; permittivity and thickness of a pharmaceutical sample is measured based on capacitive measurements). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 38, Shail teaches wherein the device comprises: (i) one sensing section in which the flat surfaces of the first pair of conducting elements are arranged perpendicularly to the flat surfaces of the second pair of conducting elements; or (ii) two sensing sections arranged in series, wherein the first pair of conducting elements are arranged in the first sensing section and the second pair of conducting elements are arranged in the second sensing section, wherein the second pair of conducting elements are arranged perpendicularly to the first pair of conducting elements (Fig. 2; cap plates 10 are conducting elements).
Regarding claim 39, Shail teaches wherein the first pair of conducting elements are a first pair of parallel plates and the second pair of conducting elements are a second pair of parallel plates (Fig. 2; plates 10 are parallel).
Regarding claim 40, Shail is silent in wherein the controller comprises one or more of: (i) reference data correlating relative permittivity with solid fraction for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet, and the controller is configured to determine the solid fraction of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data; and (ii) reference data correlating relative permittivity with hardness for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet, and the controller is configured to determine the hardness of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data. Sibik teaches wherein the controller comprises one or more of: (i) reference data correlating relative permittivity with solid fraction for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet, and the controller is configured to determine the solid fraction of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data (¶[0012], [0032]; refence pharmaceutical sample having permittivity and thickness used to determine solid fraction); and (ii) reference data correlating relative permittivity with hardness for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet (¶[0011], [0079]; reference info may be solid fraction of any other data about the composition of the tablet, therefore can be a hardness info), and the controller is configured to determine the hardness of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data (¶[0079]; solid fraction influencing hardness and size and therefore can be determined). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 41, Shail teaches wherein in the first pair of conducting elements the conducting elements have flat surfaces of the same dimensions and/or in the second pair of conducting elements the conducting elements have flat surfaces of the same dimensions (Fig. 2; plates 10 are flat with same dimensions).
Regarding claim 42, Shail is silent in wherein the device comprises one or more of: (i) a conduit for the pharmaceutical tablet in which the one or more sensing sections are arranged, the conduit enabling the pharmaceutical tablet to pass through the device and the one or more sensing sections and the first capacitance measurement and the second capacitance measurement to be obtained; (ii) shielding to shield the multiple capacitance sensors from fluctuations in external conditions, optionally wherein the shielding is electromagnetic shielding; and (iii) one or more positioning elements to position the pharmaceutical tablet in the gap between the flat surfaces of the first pair of conducting elements and/or in the gap between the flat surfaces of the second pair of conducting elements. Sibik teaches one or more of: (i) a conduit for the pharmaceutical tablet in which the one or more sensing sections are arranged, the conduit enabling the pharmaceutical tablet to pass through the device and the one or more sensing sections and the first capacitance measurement and the second capacitance measurement to be obtained; (ii) shielding to shield the multiple capacitance sensors from fluctuations in external conditions, optionally wherein the shielding is electromagnetic shielding; and (iii) one or more positioning elements to position the pharmaceutical tablet in the gap between the flat surfaces of the first pair of conducting elements and/or in the gap between the flat surfaces of the second pair of conducting elements (See Fig. 3a-3b; ribbon passed through sensor 17). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 43, Shail teaches a plurality of devices are arranged in series or in parallel to increase throughput and/or the number of pharmaceutical tablets for which the capacitance measurements can be obtained (Fig. 11; four sets of capacitance devices). Shail is silent in a tableting unit for producing a plurality of pharmaceutical tablets, the tableting unit comprising: a tablet manufacturing module. Sibik teaches a tableting unit for producing a plurality of pharmaceutical tablets (Fig. 1-3b; combination of elements being a tableting unit), the tableting unit comprising: a tablet manufacturing module (Fig. 3a; roll 1, 2); and one or a plurality of devices according to claim 37 positioned inline downstream of the tablet manufacturing module such that the plurality of pharmaceutical tablets pass through the one or plurality of devices to allow the capacitance measurements to be obtained (Fig. 3a; sensor 17). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing greater efficiency and quality in tablet manufacturing systems.
Regarding claim 44, Sibik teaches wherein the tablet manufacturing module comprises a tablet press (Fig. 3a; roll 1, 2 press powder into tablet). . It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing greater efficiency and quality in tablet manufacturing systems.
Regarding claim 45, Shail teaches a method of determining a relative permittivity and a thickness (dt, t) of a pharmaceutical tablet using one or more capacitance sensors (Fig. 2; capacitive sensor), wherein each of the one or more capacitance sensors comprises a pair of conducting elements (Fig. 2; capacitor plate 10 at 0 degrees and plate 10 at 180 degrees), each conducting element of the pair having a flat surface, wherein the flat surfaces of the pair of conducting elements are arranged in parallel such that the capacitance measurements can be obtained from a gap therebetween (Fig. 2; capacitor plate 10 are flat and arranged in parallel), the method comprising: (a) obtaining a first differential capacitance measurement using one of the one or more capacitance sensors by measuring the capacitance between the flat surfaces of the pair of conducting elements with and without the pharmaceutical tablet positioned in the gap (Col. 3 lines 10-20; difference between electrode 10 obtained by circuit 15), wherein when the capacitance is measured with the pharmaceutical tablet positioned in the gap the pharmaceutical tablet is in a first orientation in which the thickness of the pharmaceutical tablet is parallel to the flat surfaces of the pair of conducting elements (Fig. 5; object 13 which may be a tablet is rotated about a horizontal axes for the capacitance measurements and therefore can have an instance in which the thickness of the tablet is parallel to the flat surface of plate 10); (b) obtaining a second differential capacitance measurement using one of the one or more capacitance sensors by measuring the capacitance between the flat surfaces of the pair of conducting elements with and without the pharmaceutical tablet positioned in the gap (Fig. 2; capacitor plate 10 at 90 degrees and plate 10 at 270 degrees), wherein when the capacitance is measured with the pharmaceutical tablet positioned in the gap the pharmaceutical tablet is in a second orientation in which the thickness of the pharmaceutical tablet is perpendicular to the flat surfaces of the pair of conducting elements (Fig. 2-5; object 13 is rotated about a horizontal axes for the capacitance measurements and therefore can have an instance in which the thickness of the tablet is perpendicular to the flat surface of plate 10).
Shail is silent in (c) determining the relative permittivity and thickness of the pharmaceutical tablet using the first and second differential capacitance measurements; wherein (a) and (b) are performed in either order. Sibik teaches determining the relative permittivity and thickness of the pharmaceutical tablet using first and second differential capacitance measurements; wherein (a) and (b) are performed in either order (¶[0018], [0031], [0036], [0050]; Fig. 2; controller 11; permittivity and thickness of a pharmaceutical sample is measured based on capacitive measurements). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 46, Shail is silent in further comprising one or both of: (d) determining the solid fraction of the pharmaceutical tablet using the determined relative permittivity and the determined thickness of the pharmaceutical tablet by comparison to reference data, the reference data correlating relative permittivity with solid fraction for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet; and (e) determining the hardness of the pharmaceutical tablet using the determined relative permittivity and the determined thickness of the pharmaceutical tablet by comparison to reference data, the reference data correlating relative permittivity with hardness for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet. Sibik teaches one or more of: (i) reference data correlating relative permittivity with solid fraction for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet, and the controller is configured to determine the solid fraction of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data (¶[0012], [0032]; refence pharmaceutical sample having permittivity and thickness used to determine solid fraction); and (ii) reference data correlating relative permittivity with hardness for a plurality of reference tablets of varying thickness and having the same chemical composition and other dimensions as the pharmaceutical tablet (¶[0011], [0079]; reference info may be solid fraction of any other data about the composition of the tablet, therefore can be a hardness info), and the controller is configured to determine the hardness of the pharmaceutical tablet using the determined relative permittivity and the determined thickness (d.sub.t, t) of the pharmaceutical tablet by comparison to the reference data (¶[0079]; solid fraction influencing hardness and size and therefore can be determined). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 47, Shail is silent in wherein one or more of (c) to (e) are performed on a computer. Sibik teaches wherein one or more of (c) to (e) are performed on a computer (Fig. 2; controller 11, storage 14). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing information about the sample so that quality assurance of the sample is obtained.
Regarding claim 48, Shail teaches wherein one capacitance sensor is used to obtain the first differential capacitance measurement and the second differential capacitance measurement, and the method comprises reorientating the pharmaceutical tablet between the first orientation and the second orientation, or vice versa, between the measurements (Fig. 2-5; multiple orientations can be done and with multiple measurements).
Regarding claim 49, Shail teaches wherein the one or more capacitance sensors are a first capacitance sensor for obtaining the first differential capacitance measurement and a second capacitance sensor for obtaining the second differential capacitance sensor, the first capacitance sensor comprising a first pair of conducting elements and the second capacitance sensor comprising a second pair of conducting elements (Fig. 2; plates 10 are conductors).
Regarding claim 50 Shail teaches wherein the first capacitance sensor and the second capacitance sensor are arranged in a device in one or more sensing sections (Fig. 2; as shown; plates are arranged in a sensing section).
Regarding claim 51, Shail teaches wherein: (i) the first capacitance sensor and the second capacitance sensor are arranged in the device in one sensing section in which the flat surfaces of the first pair of conducting elements are arranged perpendicularly to the flat surfaces of the second pair of conducting elements, and the method comprises positioning the pharmaceutical tablet in the first orientation with respect to the flat surfaces of the first pair of conducting elements which is also the second orientation with respect to the flat surfaces of the second pair of conducting elements (See Fig. 2; same reasoning as that of claim 45); (ii) the first capacitance sensor is arranged in a first sensing section and the second capacitance sensor is arranged in a second sensing sections, wherein the method comprises reorientating the pharmaceutical tablet between first orientation and the second orientation or between the second orientation and the first orientation as the pharmaceutical tablet is moved between the first and second sensing sections, or vice versa (Fig. 2 -5; tablet is rotated in multiple directions and therefore is reoriented); or (iii) the first capacitance sensor is arranged in a first sensing section and the second capacitance sensor is arranged in a second sensing section, wherein the flat surfaces of the first pair of conducting elements are arranged perpendicularly to the flat surfaces of the second pair of conducting elements (Fig. 11; multiple capacitor sections can be realized), and the method comprises moving the pharmaceutical tablet between the first and second sensing sections, or between the second and first sensing sections (Fig. 11; tablet moves through different sets of sensors).
Regarding claim 52, Shail teaches wherein the pair of conducting elements are or have one or more of: (i) a pair of parallel plates; and (ii) flat surfaces of the same dimensions (Fig. 2; plates 10 are flat with same dimensions).
Regarding claim 53, Shail teaches obtaining the capacitance measurements while the pharmaceutical tablet is stationary or while the pharmaceutical tablet is moving (Fig. 2; tablet would have to be either stationary or moving when measurement is made as there are only two possibilities).
Regarding claim 54, Shail teaches using an Out-of-Phase technique to eliminate interference with the capacitance measurements (Fig. 2; measurements are 90 degrees out of phase).
Regarding claim 55, Shail is silent in wherein the method is implemented in one or more of: (i) inline in a tableting unit; and (ii) in a pharmaceutical tableting process comprising producing pharmaceutical tablets using a tablet manufacturing module. Sibik teaches implementing a capacitance sensing in one or more of: (i) inline in a tableting unit; and (ii) in a pharmaceutical tableting process comprising producing pharmaceutical tablets using a tablet manufacturing module (Fig. 3a; roll, 1,2 with ribbon 4 and sensor 17). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing greater efficiency and quality in tablet manufacturing systems.
Regarding claim 56. Shail is silent in wherein in the pharmaceutical tableting process the tablet manufacturing module comprises a tablet press. Sibik teaches wherein in the pharmaceutical tableting process the tablet manufacturing module comprises a tablet press (Fig. 3a; roll 1, 2 press powder into tablet). It would have been obvious to one of ordinary skill in the art before the filing date of the invention to incorporate the teaching of Sibik into Shail for the benefit of providing greater efficiency and quality in tablet manufacturing systems.
Conclusion
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/FEBA POTHEN/Examiner, Art Unit 2858
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