METHOD FOR EVALUATING THE WEAR CONDITION OF A COMPONENT OF A ROTARY PRESS AND A ROTARY PRESS CONFIGURED TO PRACTICE THE METHOD

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. 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 1 is rejected under 35 U.S.C. 103 as unpatentable over WO 2021058516 Klaer et al (April 1, 2021) hereinafter Klaer. Claim 1, Klaer teaches “A method for evaluating a wear condition of a component of a rotary press, comprising: providing the rotary press comprising” (Klaer Abstract “a method for monitoring a tablet press machine with the press punch according to the invention during continuous operation” reads on rotary press and pg 3, para 9 “the wear and functionality of the press plunger and / or the tableting machine in general” reads on “wear condition of a component”). Klaer further teaches, “a rotor configured to be rotated by a rotary drive, wherein the rotor comprises, an upper punch guide configured to guide upper pressing punches, a lower punch guide configured to guide lower pressing punches, and a die plate arranged between the upper and lower punch guides and defining a plurality of cavities, wherein the upper and lower pressing punches interact with the plurality of cavities of the die plate,” (Klaer pg 7, para 18, “A rotary press preferably comprises a press ram of the type mentioned at the beginning, a rotor, a die plate” reads on rotary drive and pressing punches(upper and lower) and die plate reads on “a plurality of cavities” ) “a filling apparatus configured to dispense a powder material into the cavities of the die plate, a pressure apparatus configured to cooperate with the upper and lower pressing punches to press the powder material in the plurality of cavities into pellets, and a plurality of control cams configured to cooperating with the upper and lower pressing punches for controlling an axial movement of the upper and lower pressing punches, wherein the plurality of control cams includes an ejector cam configured to control the lower pressing punches to eject the pellets from the plurality of cavities;”( pg, 2 para 5, “interaction of an upper and lower punch” reads on “axial movement of the upper and lower pressing punches”, pg 2,para 15, “Press rams in rotary presses are guided directly by control cams” reads on control cam, pg2, para 5 “Tableting machines are based on the principle that a die is filled with a powder mixture to be tableted” reads on powder material and tableted reads on “plurality of cavities into pellets.”) Klaer further teaches “measuring values of at least one of: (i) ejection forces acting on the ejector cam during operation of the rotary press; and (ii) vibration frequencies occurring during operation of the rotary press; and evaluating the wear condition of the component of the rotary press based on the measured values.”(pg 2, para 6, “due to vibrations. Both wear and tear as well as unsuitable operating parameters can therefore lead to faulty pressing processes and damage components of the tablet machine as a whole” reads on “vibration frequencies” and “wear and tear as well as unsuitable operating parameters” reads on “evaluation of wear condition of component” ) Klaer teaches ejection as in page 2 paragraph 15 control cam. Ejection cam is not explicitly disclosed by Klaer but It would be obvious to one of ordinary skill in the art control cam implies punches to eject of tablet in a Tableting machines, as ejecting the tablets are the ultimate outcome of the Klaer device. “Measuring values of at least one of: (i) ejection forces acting on the ejector cam during operation of the rotary press; and (ii) vibration frequencies occurring during operation of the rotary press; and evaluating the wear condition of the component of the rotary press based on the measured values.” reads on at least one of: (i) and (ii) where (i) is implicitly taught by Klaer and (ii) is explicitly taught by Klaer but either one satisfies the claim language at least one of. Supplemental rejection If and only if the explanation about the control cam above is challenged, then the following rejection is applied. Claim 1, is rejected under 35 U.S.C. 103 as unpatentable over Klaer and further in view of Schmidt et al US 7471992 B2 (Dec 30, 2008) hereinafter Schmidt. Claim 1 Klaer teaches all the limitations as discussed above and if the implicitly of the ejector cam to be challenged, “measuring values of at least one of: (i) ejection forces acting on the ejector cam during operation of the rotary press; and (ii) vibration frequencies occurring during operation of the rotary press; and evaluating the wear condition of the component of the rotary press based on the measured values” Schmidt teaches “measuring values of at least one of: (i) ejection forces acting on the ejector cam during operation of the rotary press; and (ii) vibration frequencies occurring during operation of the rotary press; and evaluating the wear condition of the component of the rotary press based on the measured values.” (Schmidt, col3, il 61-62 “the tablets 50 are ejected with the aid of the lower punches 16 and the ejection cam” reads on ejector cam). Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching and Schmidt teaching and include the ejector cam to control the lower pressing punching to eject the tablets from the cavities by applying a known technique to a known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 2, is rejected under 35 U.S.C. 103 as unpatentable over Klaer and further in view of Schmidt. Klaer teaches claim 1, does not explicitly state “wherein the component of the rotary press is the ejector cam” Schmidt teaches “wherein the component of the rotary press is the ejector cam” (Schmidt, col3, il 61-62 “the tablets 50 are ejected with the aid of the lower punches 16 and the ejection cam” reads on ejector cam). Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching with Schmidt teaching and include the ejector cam to control the lower pressing punching to eject the tablets from the cavities by applying a known technique to a known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 3-16, is rejected under 35 U.S.C. 103 as unpatentable over Klaer and Schmidt and further in view of Stiel et al, US 4100598 (Jul 11, 1978) hereinafter Stiel. Claim 3, Klaer teaches claim 1, the combination of Klaer and Schmidt does not teach “further comprising obtaining the measured values of the ejection forces acting on the ejector cam during operation of the rotary press by a force sensor arranged on the ejector cam” Stiel teaches “further comprising obtaining the measured values of the ejection forces acting on the ejector cam during operation of the rotary press by a force sensor arranged on the ejector cam.” (Abstract “force transducer mounted on the tablet press, there is provided the capability of measuring ejection force” reads on “force sensor arranged on ejector cam” ) Klaer teaching of rotary press combined with Stiel teaching of force transducer and Schmidt teaching of ejector cam results in force sensor on ejection cam. Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching in view of Stiel and add force sensor on ejection cam and calculate the average and standard deviation of ejection force data “which factors are essential in obtaining a full profile of tabletting characteristics”(Stiel, col 5,20-30) by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 4, Klaer teaches claim 1 and further teaches “further comprising obtaining the measured values of the vibration frequencies during operation of the rotary press are configured to be obtained by at least one vibration sensor, wherein the at least one vibration sensor is positioned on at least one of: (i) the ejector cam; and (ii) the pressure apparatus.” (Klaer pg 3, para 11, “Active sensors can be, for example, thermocouples, light sensors or pressure sensors” reads on vibration sensor and Klaer, pg 8, para 20 “measurement data of the pressure roller (e.g. pressing forces), the rotor” reads on pressure apparatus) Klaer teaching of vibration sensor on pressure apparatus satisfies at least one of (i) and (ii) requirement. Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching in view of Stiel and add the vibration sensor on the pressure apparatus and calculate the average and standard deviation of both compression force data “which factors are essential in obtaining a full profile of tableting characteristics” (Stiel, col 5,20-30) by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 5, Klaer teaches claim 1 and silent to “further comprising generating a time-dependent measured value curve from the measured values.” Stiel teaches “further comprising generating a time-dependent measured value curve from the measured values.” PNG media_image1.png 739 1280 media_image1.png Greyscale FIG. 1 is a graphic illustration of the analog output of the force transducer mounted on a tablet press, depicting a complete tabletting event including compression and ejection peaks; (Stiel, col 5. Il 55-60 reads on “a time-dependent measured value curve from the measured values.”) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine teaching of Klaer with Stiel and add time-dependent measured value curve from the measured values of ejection peak by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 6, Klaer teaches claim 1 and is silent “further comprising evaluating the wear condition of the component based on a comparison of the measured values with reference values.” Stiel teaches “further comprising evaluating the wear condition of the component based on a comparison of the measured values with reference values.” (Stiel, claim 7 “ejection force information in digital form relative to one of a plurality of selectable different reference levels.” reads on “comparison of the measured values with reference values”) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combining teaching of Klaer with Stiel and add evaluating wear condition (Stiel Abstract , “measuring ejection force peaks relative to a plurality of selectable reference levels”) by applying known method to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 7, Klaer teaches claim 1 and 6, and the combination of Klaer and Schmidt is silent to “further comprising detecting an increase in the wear condition of the component by determining at least one of: (i) a shift in the measured values as compared to the reference values; (ii) a change in an amplitude of the measured values compared to the reference values; and (iii) a changed slope of the measured values compared to the reference values.” Stiel teaches “further comprising detecting an increase in the wear condition of the component by determining at least one of: (i) a shift in the measured values as compared to the reference values; (ii) a change in an amplitude of the measured values compared to the reference values; and (iii) a changed slope of the measured values compared to the reference values.” (Stiel, abstract “there is provided the capability of measuring ejection force peaks relative to a plurality of selectable reference levels” reads on “a shift in the measured value compared to reference value” and force peak reads on amplitude ) PNG media_image2.png 512 825 media_image2.png Greyscale The arrangement according to the invention provides a numerial readout of the compression and ejection peaks monitored by the piezoelectric transducer 10. This readout corresponds to the peak values of these pulses minus a significant baseline.(Stiel, Col 13 il 3-33 reads on amplitude) Condition at least on of (i) and (ii) is satisfied by Fig 1 where shift of amplitude ( col 13, il 3-7,” Point A is the voltage baseline of the transducer. This represents the voltage present at the transducer output with no force present, i.e. experienced by the transducer… Point C represents the voltage present at the transducer after the compression cycle and before the tablet 20 has been ejected. This voltage, as hereinafter discussed, may or may not be the same as Point A.” reads on “change in an amplitude of the measured values compared to the reference values”) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching of wear condition with Stiel teaching of change of amplitude measured values compared to the reference values by applying known method to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 8, Klaer teaches claim 1, Klaer and Stiel teaches claim 6 and further teaches “further comprising detecting an increase in the wear condition by determining a deviation of the measured values from the reference values by at least one specified limit value “ (Klaer pg 7, para 10, “to avoid wear when predefined force limits are exceeded, the machine control system could adapt the operating parameters on the basis of the transmitted information.” reads on “deviation of the measure value from reference value”). Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching detecting wear condition in view of Stiel and add deviation of measured value by at least one specified limit value to evaluate of wear condition by applying known method to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 9, Klaer teaches claim 1, Klaer and Stiel teaches 6, 8 and further teaches “further comprising determining the at least one specified limit value by at least one of: (i) an operator; and (ii) a machine learning algorithm.”(pg 8, para 19, “the method is characterized in that the recorded measured values of the measuring device are analyzed using machine learning algorithms.” reads on least one of “(i)on operator and (ii)a machine learning algorithm”). Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention and add Klaer teaching of implementing at least one specified limit value by machine learning algorithm “to adapt parameters of a function in such a way that the function is then able to determine the target value with high accuracy from the corresponding input value. The customized function is then used after the training process to predict target data for previously invisible input data” (pg 9 2nd para) by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 10, Klaer teaches claim 1 and further teaches “further comprising displaying the wear condition of the component to an operator.” (Klaer, pg 7, para 14 “the recording of the measurement data also enables wear to be recognized at an early stage. On the basis of the information, a repair or replacement of the respective components can be displayed or the maintenance interval can be adjusted.” reads on displaying wear condition of the component to an operator). Claim 11, Klaer teaches claim 1 and further teaches “further comprising outputting a warning message upon detection of an increase in the wear condition of the component.“ (Klaer, pg 7, para 14 “the recording of the measurement data also enables wear to be recognized at an early stage. On the basis of the information, a repair or replacement of the respective components can be displayed or the maintenance interval can be adjusted” reads on warning message and wear detection). Claim 12, Klaer teaches claim 1,11 and further teaches “wherein the warning message further includes a suggestion solution for correcting the increased wear condition, wherein the suggested solution includes at least one of: (i) cleaning the component; (ii) reworking the component, and (iii) replacing the component. “ (Klaer, pg 7, para 14, “On the basis of the information, a repair or replacement of the respective components can be displayed or the maintenance interval can be adjusted.” reads on displaying warning message for at least one of (i);(ii) and (iii) as cleaning, rework, replace of component.) Claim 13, Klaer teaches “A rotary press comprising: a rotor comprising ,an upper punch guide for upper pressing punches, a lower punch guide for lower pressing punches,”( Klaer, pg 2 para 5,“interaction of an upper and lower punch” reads on “upper pressing punches ,a lower punch guide for lower pressing punches”), ”and a die plate arranged between the upper and lower punch guides and defining a plurality of cavities, wherein the upper and lower pressing punches interact with the plurality of cavities of the die plate; a filling apparatus configured to supply powder material to the plurality of cavities” (pg 2, para 5 “Tableting machines are based on the principle that a die is filled with a powder mixture to be tableted” reads on supply powder material and reads on “pellets from the plurality of cavities”, and Klaer pg2, para 5 “a powder mixture to be tableted in a first step. The mixture is then compressed into a tablet by the interaction of an upper and lower punch” reads on “upper and lower pressing punches” and “filling apparatus configured to supply powder material to the plurality of cavities” ) , “a pressure apparatus configured to interact with the upper and lower pressing punches to press the powder material in the plurality of cavities into pellets;” (pg 2, para 5 , “a die is filled with a powder mixture to be tableted in a first step. The mixture is then compressed into a tablet by the interaction of an upper and lower punch” reads on “upper and lower pressing punches to press the powder material in the plurality of cavities into pellets” ) “a plurality of control cams configured to interact with the pressing punches to control an axial movement of the upper and lower pressing punches,” (Klaer pg 2, para 15, “Press rams in rotary presses are guided directly by control cams” reads on control cam and Klaer pg, 2 para 5,“interaction of an upper and lower punch” reads on “axial movement of the upper and lower pressing punches”) Klaer is silent to “wherein the control cams comprise an 21 ejector cam configured to control the lower pressing punches to eject the pellets from the plurality of cavities;” Schmidt teaches teach “wherein the control cams comprise an 21 ejector cam configured to control the lower pressing punches to eject the pellets from the plurality of cavities;” (Schmidt “the upper punches 18 are 60 drawn back and the tablets 50 are ejected with the aid of the lower punches 16 and the ejection cam 22” reads on “ejector cam configured to control the lower pressing punches to eject the pellets from the plurality of cavities”) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combined teaching of Klaer and Schmidt and use ejector cam with control cam to eject tablets by applying a known method to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) The combination of Klaer and Schmidt is silent to “at least one sensor, wherein the at least one sensor comprises at least one of: (i) a force sensor configured to measure values of ejection forces acting on the ejector cam during operation of the rotary press; and (ii) at least one vibration sensor configured to measure values of vibrations occurring during operation of the rotary press;” Stiel teaches “at least one sensor, wherein the at least one sensor comprises at least one of: (i) a force sensor configured to measure values of ejection forces acting on the ejector cam during operation of the rotary press; and (ii) at least one vibration sensor configured to measure values of vibrations occurring during operation of the rotary press” (Stiel, Abstract “force transducer mounted on the tablet press, there is provided the capability of measuring ejection force” reads on “at least one of: (i) a force sensor configured to measure values of ejection forces acting on the ejector cam during operation of the rotary press;” ) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine teaching of Stiel and Schmidt and use force sensor on the ejector cam by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Klaer teaches “and an evaluation apparatus in electrical communication with the at least one sensor and configured to: receive the measured values from the at least one sensor, and evaluate a wear condition of a component of the rotary press based on the measured values.” (Klaer, claim 1, “measuring device comprises a sensor, a communication unit… tableting machine are set up to To receive measured value preferably processed raw data, from the measuring device” reads on “electrical communication with at least one sensor”, pg 3, para 14, “has several sensors which are set up to measure the pressing force, the temperatures of the press ram and the ram tip and to measure the linear and rotary accelerations of the press ram. By measuring these values, statements can be made about the pressing process, the functionality of the press ram and the wear in general.” reads on “at least one sensor, and evaluate a wear condition of a component of the rotary press based on the measured values”). Claim 14, The combination Klaer, Schmidt and Stiel teaches claim 13 and Stiel further teach “wherein the at least one sensor comprises the force sensor, and wherein the force sensor is arranged on the ejector cam.” (Stiel Abstract, “force transducer mounted on the tablet press, there is provided the capability of measuring ejection force peaks relative to a plurality of selectable reference levels”) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching with Stiel and Schmidt teaching and add force sensor on the ejector cam by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 15, The combination Klaer, Schmidt and Stiel teaches claim 13 and Klaer further teaches “wherein the at least one sensor comprises the vibration sensor, and wherein the vibration sensor is arranged on at least one of: (i) the ejector cam; and (ii) the pressure apparatus.”(pg 5, para 5, “a measuring device comprising an acceleration sensor is used to measure an impact of a press ram.” reads on vibration sensor and “at least one of: (i) the ejector cam; and (ii) the pressure apparatus.) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching with Stiel and Schmidt teaching and add the vibration sensor on the pressure apparatus to measure wear condition of the component ( Pg 5, para 4, “an acceleration sensor can be used in conjunction with the force measurement to provide information about wear”) by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim 16, The combination of Klaer, Schmidt and Stiel teaches claim 13, 15 and Schmidt further teaches “wherein the plurality of cams includes a metering cam, and wherein the vibration sensor is positioned on the metering cam.”(Abstract, “a metering cam adjustment equipment for height adjustment of the metering cam, a compression force measuring equipment at the pressing station” reads on metering cam and “compression force measuring equipment ” reads on vibration sensor.) Therefore, it would have been obvious for POSITA before the effective filing date of the claimed invention to combine Klaer teaching with Stiel and Schmidt teaching and add vibration sensor on the metering cam to control active ingredient to desired value ( Schmidt Abstract, “the metering cam is adjusted in accordance with the deviation of the measured amount of active ingredient from the desired active ingredient value”) by applying a known technique to known device ready for improvement to yield predictable result. (KSR Int'l Co. v. Teleflex Inc) Claim Objections Claim 1 is objected to because of the following informalities. “a rotor configured to be rotated by a rotary drive, wherein the rotor comprises, an upper punch guide configure to guide upper pressing punches”, configure should be configured. Appropriate correction is required. Conclusion Claim(s), 1-16 are rejected under 35 U.S.C. 103 over Klaer, Stiel and Schmidt. The prior art made of record and not relied upon is considered pertinent to applicant's Disclosure WO2012152373A1 which focuses on calibration and dynamical adjustment of measuring device of rotary tablet press. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOIN UDDIN AHMED whose telephone number is (571)270-3785. The examiner can normally be reached 8am-5pm ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, EMAN ALKAFAWI can be reached 571-272-4448. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Mon Ahmed/ Paten Examiner Art Unit 2858 09/30/2026 /EMAN A ALKAFAWI/Supervisory Patent Examiner, Art Unit 2858 9/30/2026