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
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 recites “with plurality of cavities” in 7th line which needs to be modified to “with the plurality of cavities” for the purpose of claim language consistency because prior to the citation, claim 1, in 4th line, already recites “a plurality of cavities”.
Claim 1 recites “the tablet sensor is configured detects the tablets”, in 18th line, which needs to be modified to “the tablet sensor is configured to detect the tablets” for the purpose of claim language consistency.
Claim 7 recites “…comprises at least one of: (i) linear drive configured to drive a linear movement of the tablet sensor; and at least one rotary drive configured to…” that needs to be modified to “…comprises at least one of: (i) linear drive configured to drive a linear movement of the tablet sensor; and (ii) at least one rotary drive configured to…” for the purpose of claim language consistency.
Appropriate correction is required.
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 10-12 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 10 recites “the tablet sensor is configured to record measured values multiple times”, in 3rd line, wherein the term “measured values” renders the claim vague and indefinite because prior to the citation, claim 1 already recites “measured values”, in 22nd line, and it is not clear if the latter limitation in claim 10 refers to the previously cited limitation in claim 1 or refers to a new limitation. Clarification is required.
Claim 12 recites “configured to compare measured values recorded in the balancing position for the balancing of the tablet sensor with measured values recorded as part of a previously performed balancing”, in 2nd and 3rd lines, wherein the term “measured values” renders the claim vague and indefinite because prior to the citation, claim 1 already recites “measured values”, in 22nd line, and it is not clear if the latter limitation in claim 10 refers to the previously cited limitation in claim 1 or refers to a new limitation. Clarification is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim(s) 1-2 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Walter et al. (US 2021/0394133) in view of Schmidt et al. (US 2014/0144205).
As to claim 1, Walter et al. (US ‘133) discloses a rotary tablet press, comprising:
- a rotor (¶ [0040]) configured to be rotated by a rotary drive in a pressing chamber (a housing 11, ¶ [0040]);
- an upper punch guide (18, ¶ [0040]) for upper pressing punches (upper punches 14, ¶ [0015]);
- a lower punch guide (20, ¶ [0040]) for lower pressing punches (lower punches 16, ¶ [0040]);
- a die plate (10, ¶ [0040]) arranged between the upper and lower punch guides (18 and 20, ¶ [0040]) and defining a plurality of cavities (a plurality of receiving means 12, ¶ [0040]),
- wherein the upper and lower press punches (14 and 16, ¶ [0040]) are configured to cooperate with plurality of cavities (a plurality of receiving means 12, ¶ [0040]) of the die plate (10, ¶ [0040]);
- a filling apparatus (a filling reservoir 28, ¶ [0040]) configured to dispense powder material (powdered filling material, ¶ [0040]) into the plurality of cavities (a plurality of receiving means 12, ¶ [0040]) of the die plate (10, ¶ [0040]);
[AltContent: arrow][AltContent: textbox (A control apparatus (60))][AltContent: arrow][AltContent: textbox (A tablet sensor (100))][AltContent: arrow][AltContent: arrow][AltContent: textbox (A lower pressure unit (38 and 42))][AltContent: arrow][AltContent: arrow][AltContent: textbox (An upper pressure unit (36 and 40))][AltContent: textbox (A pressure apparatus (34))][AltContent: textbox (Upper pressing punches (14))][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (A filling apparatus (28))][AltContent: textbox (A plurality of cavities (12))][AltContent: arrow][AltContent: textbox (A die plate (10))][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Lower pressing punches (16))][AltContent: arrow][AltContent: arrow][AltContent: textbox (A lower punch guide (20))][AltContent: textbox (An upper punch guide (18))][AltContent: textbox (A pressing chamber (11))]
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- a pressure apparatus (the pressing apparatus 34, ¶ [0041]) comprising an upper pressure unit (an upper pre-pressure rollers 36 and an upper main pressing roller 40, ¶ [0041]) and a lower pressure unit (a lower pre-pressure rollers 38 and a lower main pressing roller 42, ¶ [0041]) that are configured to cooperate with the upper and lower pressing punches (14 and 16, ¶ [0040]) in order to press the powder material (powdered filling material, ¶ [0040]) in the plurality of cavities (a plurality of receiving means 12, ¶ [0040]) of the die plate (10, ¶ [0040]) into tablets (48, ¶ [0040]);
- a tablet sensor (one or more sensors 100, ¶ [0044]) comprising a measuring region and positioned in the pressing chamber (one or more sensors 100 positioned throughout the manufacturing plant or manufacturing line, ¶ [0044]) and configured to measure a content property of tablets (¶ [0044]: the sensors may be weight sensors, mass flow sensors to count and weigh the discharged tablets, ¶ [0031] and ¶ [0032]);
- wherein when the tablet sensor (one or more sensors 100, ¶ [0044]) is in the measuring position, the measuring region of the tablet sensor (one or more sensors 100, ¶ [0044]) is configured to detect the tablets (48, ¶ [0044]) in order to measure the content property (¶ [0031], ¶ [0032]: weight) of the tablets, and
- a control apparatus (an evaluation and control apparatus 60 for controlling the operation of the plant and for carrying out the method, ¶ [0044]) configured to receive measured values from the tablet sensor (one or more sensors 100, ¶ [0044]) and configured to balance the tablet sensor (one or more sensors 100, ¶ [0044]) when the tablet sensor is in the balancing position.
Walter et al. (US ‘133) disclose one or more sensors (100) are positioned throughout the manufacturing plant or manufacturing line. (¶ [0044]) Walter et al. (US ‘133) is silent on disclosing moving the tablet sensor between a measuring position and a balancing position by a sensor derive, as claimed in claim 1, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the positioning of the tablet sensor (100), as taught by Walter et al. (US ‘133), through moving the tablet sensor between a measuring position and a balancing position by a sensor derive in order to enable product tracking in the transient states in a simple and reliable manner.
Further, Walter et al. (US ‘133) fail to disclose an optical reference surface positioned in the pressing chamber and when the tablet sensor is in the balancing position, the measuring region of the tablet sensor is configured to detect the reference surface, as claimed in claim 1.
In the analogous art, Schmidt et al. (US ‘205) disclose a device for calibrating and balancing a measuring device (56, 71) of a tablet press, in particular a rotary tablet press, comprising at least one reference measuring device (64, 68) and at least one control device (70), wherein interfaces of the control device (70) are connected with interfaces of the measuring device (56, 71) and the reference measuring device (64, 68), wherein the control device (70) is designed to generate a plurality of reference measurement results and to record the associated measurement values of the measuring device (56, 71) and the reference measuring device (64, 68), wherein the control device (70) further comprises a comparing device, with which the recorded measurement values of the measuring device (56, 71) and the reference measuring device (64, 68) can be compared with each other, and wherein the control device (70) is designed to balance the measuring device (56, 71) if an impermissible deviation is present between the compared measurement values. (see page 5, right col, last paragraph)
[AltContent: textbox (The tablet sensor (64))][AltContent: textbox (Pressing chamber (34, 36))][AltContent: arrow][AltContent: arrow][AltContent: textbox (An optical reference surface (64, 68))]
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As to claim 1, Schmidt et al. (US ‘205) teach an optical reference surface (at least one reference measuring device 64, 68, ¶ [0035]) positioned in the pressing chamber (pre- and main pressing station 34, 36, ¶ [0032]) and when the tablet sensor (a reference force measurement sensor 64, ¶ [0034]) is in the balancing position, the measuring region of the tablet sensor (a reference force measurement sensor 64, ¶ [0034]) is configured to detect the reference surface. (¶ [0034])
It would have been obvious for one of ordinary skill in the art, prior to the time of applicant’s invention, to modify the rotary tablet press, as taught by Walter et al. (US ‘133), through providing an optical reference surface positioned wherein when the tablet sensor is in the balancing position, the measuring region of the tablet sensor is configured to detect the reference surface in order to balance of a measuring device to be checked or respectively the compensation of the determined deviations, as suggested by Schmidt et al. (US ‘205): see ¶ [0008].
As to claim 2, Schmidt et al. (US ‘205) disclose the reference surface (at least one reference measuring device 64, 68, ¶ [0035]) comprises a white or gray color, and wherein the control apparatus (control apparatus 70, ¶ [0035]) is configured to perform a white balance or a gray balance of the tablet sensor against the reference surface.
As to claim 5, Walter et al. (US ‘133) teaches the tablet sensor (one or more sensors 100, ¶ [0044]) is positioned above the die plate (10, ¶ [0040]) when the tablet sensor is in the measuring position. See Fig. 1.
As to claim 6, Walter et al. (US ‘133) disclose one or more sensors (100) are positioned throughout the manufacturing plant or manufacturing line. (¶ [0044]) Walter et al. (US ‘133) is silent on disclosing moving the tablet sensor along a horizontal plane by a sensor derive, as claimed in claim 6, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the positioning of the tablet sensor (100), as taught by Walter et al. (US ‘133), through moving the tablet sensor along a horizontal plane by a sensor derive in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 7, Walter et al. (US ‘133) disclose one or more sensors (100) are positioned throughout the manufacturing plant or manufacturing line. (¶ [0044]) Walter et al. (US ‘133) is silent on disclosing the sensor drive comprises at least one of: linear drive configured to drive a linear movement of the tablet sensor, and at least one rotary drive configured to drive a rotational movement of the tablet sensor, as claimed in claim 7, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the sensor drive structure, as taught by Walter et al. (US ‘133), so the sensor drive comprises of at least one of: linear drive configured to drive a linear movement of the tablet sensor and at least one rotary drive configured to drive a rotational movement of the tablet sensor in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 8, Walter et al. (US ‘133) disclose one or more sensors (100) are positioned throughout the manufacturing plant or manufacturing line. (¶ [0044]) Walter et al. (US ‘133) is silent on disclosing the sensor drive comprises an electric drive, as claimed in claim 8, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the sensor drive, as taught by Walter et al. (US ‘133), so the sensor drive to be an electric drive in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 9, Walter et al. (US ‘133) disclose at least one of: a suction apparatus configured to suck product dust away from the measuring region of the tablet sensor; and a blow-out apparatus configured to blow out product dust from the measuring region of the tablet sensor. (¶ [0027] and ¶ [0035])
As to claim 10, Walter et al. (US ‘133) disclose one or more sensors (100) are positioned throughout the manufacturing plant or manufacturing line. (¶ [0044]) Walter et al. (US ‘133) is silent on disclosing a sensor drive is configured to move the tablet sensor (one or more sensors 100, ¶ [0044]) along a measuring path over the reference surface for balancing, and wherein the tablet sensor (one or more sensors 100, ¶ [0044]) is configured to record measured values multiple times during the movement along the measuring path and transmit the measured values to the control apparatus (an evaluation and control apparatus 60 for controlling the operation of the plant and for carrying out the method, ¶ [0044]) for the balancing, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the sensor drive, as taught by Walter et al. (US ‘133), so to move the tablet sensor along a measuring path over the reference surface for balancing, and wherein the tablet sensor is configured to record measured values multiple times during the movement along the measuring path and transmit the measured values to the control apparatus for the balancing in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 11, Walter et al. (US ‘133) is silent on disclosing the control apparatus (an evaluation and control apparatus 60 for controlling the operation of the plant and for carrying out the method, ¶ [0044]) is configured to determine a mean or median of the measured values recorded along the measuring path for the balancing of the tablet sensor (one or more sensors 100, ¶ [0044]) against the reference surface, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the control apparatus, as taught by Walter et al. (US ‘133), so to determine a mean or median of the measured values recorded along the measuring path for the balancing of the tablet sensor against the reference surface in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 12, Walter et al. (US ‘133) is silent on teaching the control apparatus (an evaluation and control apparatus 60 for controlling the operation of the plant and for carrying out the method, ¶ [0044]) is configured to compare measured values recorded in the balancing position for the balancing of the tablet sensor (one or more sensors 100, ¶ [0044]) with measured values recorded as part of a previously performed balancing, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the control apparatus, as taught by Walter et al. (US ‘133), so to compare measured values recorded in the balancing position for the balancing of the tablet sensor with measured values recorded as part of a previously performed balancing in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 13, Walter et al. (US ‘133) is silent on disclosing the control apparatus is configured to detect or compensate for: fluctuations in at least one of: (i) radiant power, (ii) soiling of the tablet sensor and/or the reference surface, and at least one of: (i) degradation the tablet sensor; and (ii) temperature changes as part of the balancing, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the control apparatus, as taught by Walter et al. (US ‘133), so to detect or compensate for: fluctuations in at least one of: (i) radiant power; (ii) soiling of the tablet sensor and/or the reference surface; and at least one of: (i) degradation the tablet sensor; and (ii) temperature changes as part of the balancing in order to enable product tracking in the transient states in a simple and reliable manner.
As to claim 14, Walter et al. (US ‘133) is silent on disclosing the control apparatus is configured to at least one of: (i) issue a warning signal; and (ii) stop tablet production in the rotary tablet press if it is determined that at least one of, limit values have been exceed, and compensated variables have been exceeded, however, it would have been obvious for one of ordinary skill in the art, at the time of applicant’s invention, to modify the control apparatus, as taught by Walter et al. (US ‘133), so to detect or compensate for: fluctuations in at least one of: (i) radiant power; (ii) soiling of the tablet sensor and/or the reference surface; and at least one of: (i) degradation the tablet sensor; and (ii) temperature changes as part of the balancing in order to enable product tracking in the transient states in a simple and reliable manner.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Walter et al. (US 2021/0394133) in view of Schmidt et al. (US 2014/0144205)
Walter et al. (US ‘133) disclose the tablet sensor (one or more sensors 100, ¶ [0044]) comprises a spectroscopic sensor, as claimed in claim 3, and fail to disclose the spectroscopic sensor comprises one of an NIR, LIF or Raman sensor, as claimed in claim 4.
In the analogous art, Hinzpeter et al. (US ‘435) disclose a rotary tablet press comprising:
- a rotor (12 ¶ [0015]) configured to be rotated by a rotary drive in a pressing chamber (a compression chamber, ¶ [0015]);
- an upper punch guide (see the annotated Fig. 2) for upper pressing punches (upper rams 18, ¶ [0015]);
- a lower punch guide (see the annotated Fig. 2) for lower pressing punches (lower rams 20, ¶ [0015]);
- a die plate (14, ¶ [0015]) arranged between the upper and lower punch guides (see the annotated Fig. 2) and defining a plurality of cavities (a plurality of individual dies 16, ¶ [0015]),
[AltContent: arrow][AltContent: textbox (A NIR or LIF sensor (36))]
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- wherein the upper and lower press punches (a plurality of individual dies 16, ¶ [0015]) are configured to cooperate with plurality of cavities (a plurality of individual dies 16, ¶ [0015]) of the die plate (15, ¶ [0015]);
- a filling apparatus (a feed hopper 28, ¶ [0015]) configured to dispense powder material (powdered material 30, ¶ [0015]) into the plurality of cavities (a plurality of individual dies 16, ¶ [0015]) of the die plate (15, ¶ [0015]);
- a pressure apparatus comprising an upper pressure unit (upper pressure rollers 24, 26, ¶ [0015]) and a lower pressure unit (lower pressure rollers 24, 26 ¶ [0015]) that are configured to cooperate with the upper and lower pressing punches (upper and lower rams 18 and 20, ¶ [0015]) in order to press the powder material (powdered material 30, ¶ [0015]) in the plurality of cavities (a plurality of individual dies 16, ¶ [0015]) of the die plate (15, ¶ [0015]) into tablets;
- a tablet sensor (a NIR or LIF sensor 36, ¶ [0016]) comprising a measuring region (disposed above the die-plate 14 and above the graduated circle of the dies 16) and positioned in the pressing chamber (a compression chamber, ¶ [0015]);
As to claims 3 - 4, Hinzpeter et al. (US ‘435) disclose the tablet sensor (36) comprises a NIR or LIF sensor 36, (¶ [0016]) which is a spectroscopic sensor.
It would have been obvious for one of ordinary skill in the art, prior to the time of applicant’s invention, to modify the tablet sensor, as taught by Hinzpeter et al. (US ‘435), so to be a NIR or LIF sensor which is a spectroscopic sensor in order to allow detecting several important quality parameters (e. g. weight, break resistance, height of tablets, active-substance identity, active-substance content, dispersal, porosity or content of additives) without destroying the tablets, as suggested by Hinzpeter et al. (US 2005/0184435): ¶ [0004].
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEYED MASOUD MALEKZADEH whose telephone number is (571)272-6215. The examiner can normally be reached M-F 8:30AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SUSAN D. 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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/SEYED MASOUD MALEKZADEH/Primary Examiner
Art Unit 1754
08/05/2026