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 . Claims 1-15 are pending in this application.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding Claim 4, in Line 8 “a same direction an opposite direction” should be “a same direction or opposite direction”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 10, the limitation “the sensor level is flat or curved and/or
bent to define a curve” claims all possible versions of the level, i.e. flat or curved, and thus does not further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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(s) 1-6, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rehbein (U.S. Pre-grant Publication 2019/0217016), hereinafter Rehbein, as evidenced by Pepka (Non Patent Literature - Position and Level Sensing Using Hall Effect Sensing Technology), hereinafter Pepka, in view of Mueller-Pathle (U.S. Patent No. 10,518,040), hereinafter Mueller-Pathle.
Regarding Independent Claim 1, Rehbein discloses an actuation device (Figures 1 and 6) for an administration device for parenteral administration of a medicament (Abstract – the device is used to deliver a medicament), comprising:
a sleeve-like rotary element, 113, 114 and 115, having an axis (Figure 1 – the centerline shown in the figure is the axis of the sleeve element), the rotary element configured to be rotatable relative to an instrument housing (Paragraph 0051, 0056 and 0059 – the rotary element rotates about the axis relative to the housing, 101 and 102) and coaxially to a longitudinal axis of the actuation device (Figure 1 – the rotary element rotates about the center axis, which is also a longitudinal axis of the device) through an angle about the axis proportional to a pre-selected or delivered dose volume (Paragraphs 0048-0049 and 0054 – the rotary element rotates about the axis through angles that set the dose volume, i.e. the angle of rotation is proportional to a dose);
a pushing element, 105, 106 and 112, configured to be movable along the longitudinal axis of the actuation device relative to the instrument housing (Paragraphs 0051 and 0055 – the pushing element, 112, moves relative to the housing, 101, to dispense the medicament) and to act upon a drive, 110;
a magnetic element (Paragraphs 000024, 0027, 0031 and 0067 – the elements/scales, 146a, 146b and 148, are elements that are magnetized and therefore form a magnetic elements) configured to be operatively coupled to the rotary element and/or the pushing element (Figures 1 and Figure 6 – Paragraph 0067 – the magnetic element is coupled to the rotary element and pushing element such that the relative movements of the rotary element and pushing element and coupled magnetic element are sensed by sensors) such that a movement thereof causes a movement of the magnetic element relative to the instrument housing (Figures 1 and Figure 6 – Paragraph 0067 – the magnetic element is coupled to the rotary element and pushing element such that the relative movements of the rotary element and pushing element and coupled magnetic element relative to the housing are sensed by sensors);
a sensor arrangement, 136-S-1, 136-S-2 and 138, comprising at least three magnetic field sensors, 136-S-1, 136-S-2 and 138, wherein each magnetic field sensor exhibits a pronounced sensitivity with respect to the direction of a magnetic field component relative to a sensor axis defining a switching axis of the magnetic field sensor (Paragraph 0067 – the sensors are hall sensors that detect the changes to the magnetic field that move past the sensor; as evidenced by Pepka on Page 4 and in Figure 6, the hall effect sensor is sensitive to the direction of the magnetic field as it moves along an axis/switching axis of the sensor; the switching axis, as shown by Pepka in Figure 6 would a horizontal axis of the sensor as the magnets/magnetic field moves horizontally; thus the sensors would have a switching axis that is aligned with the movement of the magnetic element, which in Rehbein would be a tangent to the circumferential direction); and
an evaluation device (Figure 7 - Paragraph 0032 – the processing arrangement, 21, the evaluation device), wherein each magnetic field sensor comprises at least one output configured to be connected to a corresponding input of the evaluation device (Paragraphs 0073-0075 – the sensors provide an output that becomes an input into the processing arrangement), wherein at least a first and a second of the at least three magnetic field sensors, 136-S-1 and 136-S-2, are fitted such that each selectively detects changes in the magnetic field component in a circumferential direction (Paragraph 0064 – the two sensors, 136-S-1 and 136-S-2, are used to detect the circumferential movement of the rotary element by changes to the magnetic field component), and at least a third of the at least three magnetic field sensors, 138, is fitted such that the at least third magnetic field sensor selectively detects changes in the magnetic field component in the axial direction (Paragraph 0060 – the sensor, 138, is used to detect the magnetic field changes as the element, 148, moves in the axial direction).
Rehbein, as evidenced by Pepka, does not explicitly disclose the magnetic elements having a permanent magnetization.
However, Mueller-Pathle teaches a sensor arrangement for an injection device (Title) with a magnetic element, 12, having permanent magnetization (Column 2, Lines 37-57 – the element has different sections that are permanently magnetized) .
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Rehbein, as evidenced by Pepka, such that the magnetic element a permanent magnetization, as taught by Mueller-Pathle, in order to improve the precision and resolution of the system (Mueller-Pathle – Column 5, Lines 9-15).
Regarding Claim 2, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses the pushing element is configured to be actuated via a pushbutton (Paragraph 0050 – the top of the pushing element, 112, is a push button that is depressed to actuate drive the pushing element) and the rotary element is configured to be rotated via a rotary knob (Paragraph 0048 – the selector/knob, 113, is used to rotate the rotary element).
Regarding Claim 3, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses the magnetic element is magnetized alternately sector by sector, and regularly distributed (Figure 6 – the magnetic element includes alternating regularly distributed sectors, 146a and 146b).
Rehbein, as evidenced by Pepka, in view of Mueller-Pathle, as discussed so far, do not explicitly disclose the magnetic element is magnetized in such a way that pole angles are all a same size with respect to an axis of rotation.
However, Mueller-Pathle teaches sectors of magnetic element that alternate and are magnetized in such a way that pole angles are all a same size with respect to an axis of motion (Figure 2 – Column 3, Lines 7-12 and 26-55 – the use of two types magnetization sectors that alternate would have pole angles that are all the same size, i.e. 180 degrees, from each other and thus the same relative to the axis of motion).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Rehbein, as evidenced by Pepka, in view of Mueller-Pathle such that the magnetic element is magnetized in such a way that pole angles are all a same size with respect to an axis of rotation, as taught by Mueller-Pathle, for the same reasons as discussed above for Claim 1.
Regarding Claim 4, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses in an unactuated state of the actuation device, the first and the second magnetic field sensors are fitted along a first axial portion oriented above the magnetic element in the circumferential direction (Figures 1 and 6 – the first and second sensors, 136-S-1 and 136-S-2, are located in the axial position of element 136, as seen in Figure 1, above the magnetic element, 146), and about a first sensor angle relative to the angle of rotation at a distance from one another (Figure 6 – the angle between the first and second sensors relative to the longitudinal axis of the device is an angle of rotation and is the first sensor angle – See annotated figure below for clarification), and spaced radially with respect to the magnetic element at a sensor level (Figure 6 – the sensors are spaced radially from the magnetic elements at a sensor level, as shown in Figure 6), and wherein the switching axes of the first and second magnetic field sensors are aligned tangentially with respect to the first axial portion or the sensor level (Paragraph 0067 – the sensors are hall sensors that detect the changes to the magnetic field that move past the sensor; as evidenced by Pepka on Page 4 and in Figure 6, the hall effect sensor is sensitive to the direction of the magnetic field as it moves along an axis/switching axis of the sensor; the switching axis, as shown by Pepka in Figure 6 would a horizontal axis of the sensor as the magnets/magnetic field moves horizontally; thus the sensors would have a switching axis that is aligned with the movement of the magnetic element, which in Rehbein would be a tangent to the circumferential direction), and wherein the switching axes of the first and second magnetic field sensors are oriented in a same direction an opposite direction (Paragraph 0067 – the sensors measure the movement of the magnetic element in the clockwise or counter clockwise direction; thereby, as evidenced by Pepka the switching axis of a sensor is in the direction of movement of the magnetic element, the switch axes of both sensors would be either in the clockwise or counter clockwise direction thus making the directions of the switching axes either in the same direction or in the opposite direction).
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Regarding Claim 5, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses the first sensor angle is less than a pole angle (Figure 6 – the sensor angle is less than the angle between adjacent poles, i.e. pole angle – See annotated figure below for clarification).
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Regarding Claim 6, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses in the unactuated state of the actuation device, the third magnetic field sensor is fitted on the sensor level along a second axial portion (Figure 1 – the third sensor, 138, is located at the same level as the first and second sensors at a different axial location/portion), which is spaced radially relative to the magnet element and extends in the circumferential direction (Figures 1 and 6 – the third sensor is radially above the magnet element, 148), wherein the second axial portion is offset axially relative to the first portion (Figure 1 – the second portion is axially offset relative to the location/portion of the first and second sensors), wherein the switching axis of the third magnetic field sensor is oriented in the axial direction (Paragraph 0060 – the third sensor, 138, is used to detect the axial displacement of the magnetic element; thereby, as evidenced by Pepka the switching axis of a sensor is in the direction of movement of the magnetic element, the switching axis of the third sensor is in the axial direction).
Regarding Claim 10, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses wherein the sensor level is flat (Figures 1 and 6 – the sensors are shown in both cross-sections to be in the same flat plane therefore the sensor level is flat).
Regarding Claim 15, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above. Rehbein further discloses an administration device for parenteral administration of a medicament, comprising the actuation device of claim 1 (See rejection for Claim 1 above), a threaded piston rod, 106, comprising a flange, 105, and a product container, 103, held in the instrument housing (Figure 1 – the container, 103, is held in the housing, 101 and 102), wherein a drive movement of the piston rod along a longitudinal axis of the instrument housing is configured to be pre-selected by the actuation device (Paragraphs 0048, 0051 and 0055 – the dose is dialed and therefore pre-selected by the actuation device which controls the drive movement of the rod, 106, in the axial direction, i.e. along the longitudinal axis), wherein the drive movement can be driven manually via a threaded drive such that the medicament is dispensed from of the product container (Paragraphs 0046, 0048, 0051 and 0055 – the dispensing of the medicament is provided by the push button which drives the shaft, 110 and 116, which includes a locking nut, 116, and thus is a threaded drive).
Claim(s) 7-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Rehbein, as evidenced by Pepka, in view of Mueller-Pathle as applied to claim 6 above, and further in view of Bauer (U.S. Pre-grant Publication 2020/0114087), hereinafter Bauer.
Regarding Claim 7, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle disclose the invention as claimed and discussed above.
Rehbein, as evidenced by Pepka, in view of Mueller-Pathle do not explicitly disclose a fourth magnetic field sensor is fitted to the second portion and spaced by a second sensor angle with respect to the third magnetic sensor and radially with respect to the magnetic element on the sensor level over the magnetic element, wherein the switching axis of the fourth magnetic field sensor is oriented in the axial direction or is aligned transversely to the switching axes of the first and second magnetic field sensors, wherein the switching axes of the third and fourth magnetic field sensors are in a same direction or an opposite direction.
However, Bauer teaches the use of redundant sensing systems of the same type in a medication delivery device (Title - Paragraph 0100).
Further, Rehbein discloses the third sensor can be used to sense both axial and rotational movement (Paragraph 0089) and further the detection of the movement of the portion of the magnetic element, 148, may be performed using at least two sensors, i.e. the sensor arrangement, 138, may include multiple sensors.
Also, it is noted that the structure of the fourth sensor is a duplication of parts of the structure of the first, second and third sensors.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Rehbein, as evidenced by Pepka, in view of Mueller-Pathle by including a fourth magnetic field sensor that is fitted to the second portion and spaced by a second sensor angle with respect to the third magnetic sensor and radially with respect to the magnetic element on the sensor level over the magnetic element, wherein the switching axis of the fourth magnetic field sensor is oriented in the axial direction or is aligned transversely to the switching axes of the first and second magnetic field sensors, wherein the switching axes of the third and fourth magnetic field sensors are in a same direction or an opposite direction, by duplication of parts, such that the system provides redundancy of measurement, i.e. the third and fourth sensor provide a redundant measurement of the rotational measurement provided by the first and second sensor and the fourth sensor provides a redundant measurement of the axial measurement provided by the third sensor, as taught by Bauer, in order to provide redundancy in case of failure and to allow verification that sensing systems are performing appropriately (Bauer – Paragraph 0100).
Regarding Claim 8 and Claim 9, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer disclose the invention as claimed and discussed above. It is noted that the limitation “the second sensor angle is less than a pole angle or less than a pole angle increased by an integer multiple of the pole angle” is a duplication of parts of the first second sensor angle. Thus the combination of Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer would result in the second sensor angle being the same as the first sensor angle (Claim 9) and thus being less than a pole angle as shown in the annotated figure provided below.
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Regarding Claim 11, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer disclose the invention as claimed and discussed above. Rehbein further discloses the evaluation device is configured to implement at least one first decoder for evaluating at least first and second inputs as a quadrature encoded signal to quantitatively detect rotation of the rotary element (Paragraph 0067 – an output from each of the first and second sensors is provided to the processor as a first and second input such that the comparison of the phases provided by those inputs to detect the position of the rotary element; thus the two inputs are provided as a quadrature encoded signal).
Regarding Claim 12, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer disclose the invention as claimed and discussed above. Rehbein further discloses a signal change of at least a third input of the evaluation device can be decoded as a change in position of the pushing element and as the rotation of the rotary element (Paragraphs 0067 and 0089 – the signal change provided by the third sensor is usable to detect both axial movement of the pushing element and rotation of the rotary element).
Regarding Claim 13, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer disclose the invention as claimed and discussed above. It is further noted that the limitations “the evaluation device implements a second decoder configured to evaluate the third and a fourth of the inputs as a quadrature-encoded signal in order to quantitatively detect the rotation of the rotary element” is a duplication of parts. Thus since the combination of Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer would result in the redundancy of measurement systems using the same types of measuring systems the combination would further result in the evaluation device implements a second decoder configured to evaluate the third and a fourth of the inputs as a quadrature-encoded signal in order to quantitatively detect the rotation of the rotary element and thus the limitations of Claim 13.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer as applied to claim 7 above, and further in view of Ploch (U.S. Patent No. 10,245,384), hereinafter Ploch.
Regarding Claim 14, Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer disclose the invention as claimed and discussed above. Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer do not disclose a fifth magnetic field sensor is fitted along the first and/or second axial portion, and the evaluation device comprises a further input which, in response to a signal change, activates the evaluation device from an energy saving state.
However, Ploch teaches a medication delivery device (Title) with a magnetic field sensor (Column 10, Lines 2-14 – a magnetic sensor is used to provide a wake-up signal) to detect the movement of a sleeve (Column 10, Lines 2-14 – the magnetic sensor senses the movement of a sleeve, 15a), and provides an output to an evaluation device, 210, in response to a signal change, activates the evaluation device from an energy saving state (Column 7, Lines 52-65 and Column 9, Line 64 -Column 10, Line 14 – the magnetic sensor, measures a movement of the sleeve, i.e. a change in signal, and provides an output to the evaluation device to wake it from a power saving state).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Rehbein, as evidenced by Pepka, in view of Mueller-Pathle and Bauer by including a fifth magnetic field sensor that is fitted along the first and/or second axial portion, in order to measure the movement of the magnetic element/sleeve, and the evaluation device comprises a further input which, in response to a signal change, activates the evaluation device from an energy saving state, as taught by Ploch, in order to reduce power consumption (Ploch – Column 9, Lines 64-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cohen (U.S. Pre-grant Publication 2021/0016014), Dreier (U.S. Patent No. 10,105,497) and Jakobsen (U.S. Patent No. 10,682,469) all show medication delivery devices that utilize magnetic fields and sensors for measuring movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE ROBERT THOMAS whose telephone number is (571)272-4813. The examiner can normally be reached Monday-Friday 8:00am-4pm EST.
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/KYLE ROBERT THOMAS/Examiner, Art Unit 3741
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