CERTIFICATION OF TRANSLATION
`
`I, CHRISTINE DRAKE, am a TransPerfect Translations translator,
`
`hereby declare as follows:
`
`1.
`
`I am a translator and am familiar with both the English and German languages.
`
`2.
`
`1 am the translator of the document attached and certify that the respective translation of
`
`German Patent DE 19924108 A1 is a true translation to the best of my knowledge and belief.
`
`I certify under penalty of perjury under the laws of the United States of America that the
`
`foregoing is true and correct.
`
`Dated this 17‘“h day of September 2019
`
`Christine Drake
`
` 5:1 gnature of Notary
`
`
`
`BAtLEE ANN TIEHNEY
`NOTARY PUBLISWGW
`COMMONWEALTH OF
`
`
`MY commtssroN EXPIRES Nov 30, 2022
`COMMISS'ION Fr 7790344
`
`
`
`Mylan EX. 1058
`
`Mylan V. Sanofi - IPR2018-01676
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`
`
`(12)
`
`
`
`(19)
`Federal Republic of Germany German
`Patent and Trademark Office
`
`
`
`(10) DE 102 37 258 A1 2004.03.18
`
`
`
`
`
`Patent publication
`
`(21) File reference: 102 37 258.6
`
`(22) Filing date: 08/14/2002
`
`(43) Publishing date: 03/18/2004
`
`(51) Int CI.7: A61M 5/315
`A61M 5/00
`
`(71) Applicant:
`
`(72) Inventor:
`
`Disetronic Licensing AG, Burgdorf, CH
`
`Graf, Roney, Dr., Burgdorf, CH
`
`(74) Representative:
`
`Schwabe, Sandmair, Marx, 81677 Munich
`
`
`
`An application for examination has been filed pursuant to Section 44 PatG (German Patent Act)
`
`The following information has been taken from the documents submitted by the applicant
`
`(54) Title: Injection device
`
`(57) Abstract The invention relates to an injection device for
`injecting respectively selected
`liquid quantities from an
`ampule, preferably insulin. The manual actuator comprises an
`axially mobile operating head, only mobile in a (rear) resting
`position, a tubular drive element connected to the operating
`head in a torque-proof fashion, an axially fixed and torque-
`proof guide element, and an axially mobile driven member,
`held torque-proof in the device, which propels the piston of the
`ampule. A rotary catch is provided between the rotary mobile
`and the torque-proof parts of the injection device, which upon
`turning of the actuator knob generate acoustic noises, for
`example a clicking noise, matching the dosage. According to
`the invention the rotary catch is designed such that the actuator
`knob is mobile in its (rear) resting position in both directions of
`motion. An accidentally selected excessive dosage, caused by
`rotating the actuator knob too far in the rotary direction, can
`easily be reduced again according to the invention by a reverse
`rotation of the actuator knob in the opposite rotary direction,
`with once more during the reverse rotation audible acoustic
`noise being generated, based on which the patient can
`determined audibly the dosage adjusted.
`
`
`
`
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`DE 102 37 258 A1 2004.03.18
`
`
`
`Description
`
`[0001] The present invention relates to an injection
`device according to the preamble of claim 1.
`[0002] An injection device according to the preamble of
`claim 1 is known from EP 0 581 924 B1 of the applicant.
`The injection device of prior art serves for the injection
`of respectively selected liquid quantities of a product
`from a product container, particularly an ampule
`equipped with a piston, which preferably contains a
`medicinal or therapeutically effective agent. The device
`comprises a manually driven, tubular actuator, which
`includes: an actuator knob, which is mobile in the axial
`and rotational direction, a drive element connected to the
`actuator knob in a torque-proof fashion, which follows
`the motions of the actuator knob, a drive element, which
`is torque-proof in reference to a housing of the device, as
`well as a guide element for the driven element.
`[0003] In the device of prior art a drive element, at which
`the dispensing element is supported in a mobile fashion,
`is axial, i.e. the propulsion element of the piston can be
`moved from a resting position over a distance,
`predetermined by a mechanic element, to a frontal end
`position. By distorting the operating head the product
`dosage to be dispensed is adjusted.
`[0004] A rotary catch is provided between the torque-
`proof and the rotational parts of the injection device of
`prior art, which comprises
`two disk-shaped catch
`elements, which are opposite each other and respectively
`show a plurality of catch projections and preferably
`corresponding catch recesses, which cooperate with each
`other.
`[0005] In order to adjust the dosage to be injected by
`distorting the actuator knob the catch projections glide
`over the catch recesses. Here, a sound is generated,
`which clearly reflects the rotary motion of the actuator
`knob. In EP 0 581 924 B1, here a clicking noise is
`generated, when the catch projections snap into the
`correspondingly embodied catch recesses. Based on the
`noise generated, particularly based on the number of
`clicking noises, the patient can adjust by way of counting
`the amount of the new injection dosage, purely by sound,
`i.e. even without looking at the device. Such an
`adjustment of the dosage to be injected by sound has
`proven particularly advantageous, particularly
`for
`patients with sickness-related vision impairment, as is
`frequently the case in diabetes patients, for example.
`[0006] In prior art the rotary catch comprises two disk-
`shaped catch elements, on which in the circumferential
`direction in regular intervals saw-tooth shaped catch
`projections and recesses, respectively, are arranged. The
`two catch elements are pressed towards each other via a
`spring acting as the return element, so that the rotary
`catch and/or the actuator knob can only be rotated in one
`rotary direction, but is/are blocked in the other rotary
`direction. This is disadvantageous in that on the one
`hand, upon rotating the actuator knob, the dosage
`adjusted by rotation in the first rotary direction can only
`be further increased, namely by a further distortion of the
`actuator knob in said first direction, however it cannot be
`reduced by a reverse rotation of the actuator knob in the
`opposite rotary direction. If
`the patient has here
`accidentally selected an excessive dosage, for example
`
`because the number of clicking sounds were not correctly
`recognized, the wrongly set dosage must first be removed
`by advancing the drive member into the frontal end
`position, and the drive member must be returned back
`into the resting position before in another attempt can be
`made
`to set a new dosage. This procedure
`is
`cumbersome, prone to errors, and unnecessarily wastes
`some of the product.
`
`Objective
`
`[0007] The objective of the present invention is to further
`improve the generic injection device such that the dosage
`to be administered can be reliably predetermined in a
`simple fashion, and also allows to reduce the selected
`dosage at any time.
`[0008] This objective is attained in an injection device
`comprising the features of claim 1. Advantageous
`variants are disclosed in the dependent claims.
`[0009] An injection device according to the invention is
`characterized in that the rotary catch is designed such
`that the actuator knob in its resting position, i.e. when the
`drive member is distanced from the piston, can be moved
`in both rotary directions. Since the device according to
`the invention still shows a rotary catch, which generates
`acoustic sounds when twisted, preferably clicking noises,
`the patient is still able to set the dosage based on hearing,
`particularly based on the number of clicking noises, for
`example. This ensures a simple and reliable dosing. Due
`to the fact that according to the invention the rotary catch
`is mobile in both directions in the default position, even
`without any unnecessary discharge of products as
`explained above, the dosage can be easily reduced even
`after it was selected.
`[0010] Preferably the rotary catch generates the above-
`mentioned acoustic noise not only when the actuator
`knob is rotated in the first direction of rotation, for
`example clockwise, but also when the actuator knob is
`rotated in the opposite direction of rotation, i.e. counter-
`clockwise, for example. This way, based on the acoustic
`noise generated, the patient can reversely rotate the
`actuator knob and/or
`the rotary catch and draw
`conclusions regarding the respectively set dosage.
`[0011] The injection device according to the invention
`can therefore be operated reliably and easily even
`without reading it.
`[0012] According to a preferred embodiment the actuator
`knob and jointly with it the driven member are adjustable
`only axially out of the resting position in to the frontal
`end position when the rotary catch has engaged, when the
`catch protrusions essentially cooperate completely with
`the correspondingly embodied catch recesses. In this
`simple fashion it can be ensured that only one dosage can
`be administered, which is adjusted by distorting the
`actuator knob by an
`integral multiple of
`the
`circumferential
`angular distances of
`the
`catch
`projections.
`[0013] In the above-mentioned embodiment, preferably
`at the outer perimeter of the actuator knob or at an
`element arranged thereat in a torque-proof fashion, for
`example at the housing of the injection device, a plurality
`of catch bodies are arranged, for example recesses
`extending in the axial direction and corresponding
`thereto protrusions extending in the axial direction, with
`
`2/13
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`DE 102 37 258 A1 2004.03.18
`
`the number of catch bodies preferably being equivalent to
`the number of catch projections which are formed on the
`facial sides of the catch elements of the rotary catch.
`Only when the catch bodies allow an axial advance of the
`actuator knob and the driven member coupled thereto can
`the adjusted dosage actually be administered.
`[0014] Preferably the above-mentioned catch bodies
`generate an acoustic noise, particularly a clicking noise,
`which is particularly preferred synchronized with the
`acoustic noises, particularly clicking noises, generated by
`the rotary catch so that the angular position of the catch
`bodies are in particular essentially equivalent to the
`angular positions of the catch projections and/or catch
`recesses of the rotary catch.
`[0015] According to a preferred embodiment a second
`return element is provided which pushes an ampule
`holder, which forms for example a first catch element,
`e.g. a lower disk of the rotary catch or is coupled thereto,
`axially in the direction of the actuator knob such that the
`rotary catch engages, with in the engaged position of the
`rotary catch
`the catching projections essentially
`cooperating with
`the
`catch
`recesses
`embodied
`correspondingly, for example engaging them almost
`completely. The second return means can be located for
`example between the rear part of the injection device,
`where the manually driven actuator is located, and the
`ampule holder.
`[0016] It is particularly preferred when the return force
`of the second return element is lower than the one of the
`first return element so that the rotary catch is not
`supported stiffly but rather in an elastic fashion, so that
`the catch elements of the rotary catch, brought into
`mutual contacting by the return elements, snap back in an
`elastic fashion when the catching projections glide along
`the catch recesses, which allows to better hear the
`acoustic noise generated.
`[0017] The present invention is applicable in general for
`the device described in EP 0 581 924 B1, although the
`present invention is generally not limited to the specific
`embodiment described there. In such an embodiment a
`drive element, at which the driven element is supported
`in an articulate fashion, can be guided axially, i.e. in the
`direction of advance of the piston, from a resting position
`over a distance defined by the mechanics to a frontal end
`position. Over a portion of the predefined distance the
`driven member is not in contact with the piston of the
`product container. Over the remaining part of the
`predetermined distance the driven member is in contact
`with the piston plug, so that the piston is axially moved
`during the further advance of the driven member by the
`remaining part of the predefined distance such that a
`product, particularly a liquid, is dispensed from the
`product container. After the product has been dispensed
`the driven member is returned into the resting position
`with the help of a return means. During the renewed axial
`movement of the driven member by the distance adjusted
`for the previous injection, since the driven member
`cannot contact the piston, no additional product can be
`dispensed from the product container.
`[0018] The dosing occurs in this embodiment as follows:
`In the resting position the actuator knob is rotatable.
`When rotating the actuator knob in the resting position,
`for example clockwise, the driven member which is not
`
`in contact with the piston is axially advanced in a
`controlled fashion, which shortens the distance between
`the driven member and the piston. The distance by
`which the space between the driven member and the
`piston is shortened when the operating knob is rotated, is
`equivalent to the distance during which the driven
`member comes into contact with the piston when
`advanced to the frontal end position, in order to dispense
`another product dosage from the product container. The
`rotary angle by which the actuator knob is rotated in the
`first direction,
`for example clockwise,
`therefore
`unambiguously defines
`the product dosage
`to be
`dispensed.
`exemplary
`preferred
`following,
`the
`[0019]
`In
`embodiments are described based on the attached
`drawings, in which:
`[0020] Fig. 1 shows a longitudinal section through an
`injection device of prior art;
`longitudinal section
`[0021] Fig. 2 shows
`in a
`schematically a rotary catch according
`to a first
`embodiment of the invention;
`[0022] Fig. 3 shows in a layout schematically a second
`embodiment of the rotary catch according
`to the
`invention;
`[0023] Fig. 4 shows the cross-section A-A of the
`injection device according to Fig. 1;
`[0024] Fig. 5 shows the cross-section B-B of the
`injection device according to Fig. 1;
`[0025] Fig. 6 shows the cross-section C-C of the
`injection device according to Fig. 1;
`[0026] Fig. 7 shows in an enlarged illustration the detail
`D of the layout according to Fig. 3; and
`[0027] Fig. 8 shows the layout according to Fig. 3 in
`three different angular positions of the actuator knob of
`the injection device according to the invention.
`[0028] In the figures, identical reference characters mark
`identical elements or elements or functional groups with
`essentially the same function.
`[0029] In order to better illustrate an injection device
`according to the invention, in the following first the
`injection device is described as shown in Fig. 1 in a
`longitudinal section, which is known from Fig. 2 of EP 0
`581 924 B1 of the applicant. However, the present
`invention is not limited to this particular embodiment.
`The injection device comprises in a front part 2an
`exchangeable ampule 4, in which a piston 5 is located in
`an axially displaceable fashion, which dispenses the
`substance stored
`in
`the ampule, which preferably
`comprises a medicinal or therapeutic effective agent, via
`an injection syringe 6. In the rear part 3 the device
`comprises a manually operated, tubular actuator 7.It
`houses an actuator knob 8,a driven member, embodied
`essentially as a rod 9 with a flange 19, a guide element
`24 and a drive element 11.
`[0030] As shown in the cross-sections according to Figs.
`4 to 6, the rod 9 shows at both sides planar surfaces and
`comprises for the rest a circular cross-section, which
`carries a thread. This thread rests in a mother thread 27
`of the drive element 11, which rests in the injection
`device in a torque-proof fashion. The drive element 11
`can be transferred together with the entire actuator 7 via
`an axial operation of the actuator knob 8 and transfer of
`this movement via the guide element 24 against the force
`
`3/13
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`DE 102 37 258 A1 2004.03.18
`
`of a spring 16 serving as a first return means from a
`(rear) resting position to a (frontal) end position. The rod
`9 also performs this axial advance motion. Here, finally
`the flange 19 located at the rod 9 pushes against the
`piston 5 of the ampule 4,pushes it forward, and this way
`triggers the injections.
`[0031] The rod 9 is mounted torque-proof but axially
`mobile in the guide element 24, which in turn is
`connected torque-proof to the actuator knob 8. As shown
`in the cross-section according to Fig. 4,the guide element
`24comprises an interior contour, which (except for some
`potential tolerances) is adjusted to the exterior contour of
`the rod 9, The actuator knob 8, the guide element 24,
`and the rod 9 allow only a rotation in the (rear) resting
`position of the actuator 7. Here, the rod 9 rotates in the
`mother thread 27 of the drive element 11 arranged
`torque-proof in the injection device and this way moves
`forward, when the actuator knob 8 is rotated in a first
`rotary direction, for example clockwise. As shown in the
`following, in the status shown in Fig. 1 the actuator knob
`of prior art cannot be turned back in the opposite rotary
`direction, i.e. in the above-mentioned case in the counter-
`clockwise fashion.
`[0032] As described above, the injection of the substance
`is caused by axially advancing the actuator knob 8 and
`the flange 19 serving as a driven member, to the frontal
`end position. The actuator knob and thus the flange 19
`can here only be advanced by a uniform, predetermined
`distance, for example limited by stops in the direction of
`motion7 and by the maximum stroke of the actuator knob
`8. When the actuator knob 8 is returned after an injection
`into the (rear) resting position, in another axial advance
`of the actuator knob 8 and the flange 19 no additional
`substance is dispensed from the ampule4. In order to
`dispense another dosage the flange 19 must be advanced
`by rotating the actuator knob 8 in the first rotary direction
`over a distance appropriate for the dosage to be
`administered so that the distance between the flange 19
`serving as the driven member and the piston 5 is
`shortened by this predeterminable distance. This way, in
`case of another advance of the actuator knob 8 and the
`flange 19, serving as the driven member, the flange 19 at
`the end of its axial forward motion contacts the piston 5
`and displaces it by the rotary motion of the actuator knob
`8 over the adjusted distance axially forward such that a
`new dosage is dispensed from the ampule 4, which is
`clearly defined by the rotation of the actuator knob 8.
`[0033] The tubular drive element 11 is connected to the
`actuator knob 8 in a torque-proof fashion. The axially
`mobile actuator knob 8 is rotational only in its (rear)
`resting position, namely according to EP 0 581 924 B1
`only in a rotary direction, in order to trigger an axial
`advance of the flange 19, serving as the driven member.
`Inside the drive element 11 the rod 9 is held, with its
`threaded parts engaging at the circular areas 13, 13’ the
`mother thread 27 of the drive element 11. The rod 9
`engages through the drive element 11 and the guide
`element 24.The latter is connected fixed to the rear part
`3of the injection device and can perform neither an axial
`motion nor a rotary motion. The opening in the guide
`element 24 adjusted to the rod 9 causes that the rod 9 can
`perform only axial movements, but no rotary motions.
`[0034] When the actuator knob 8 is manually advanced
`
`in the axial direction, it moves the drive element 11 up to
`its (frontal) end position, which is defined by a stop
`31,for example the drive element 11 at the guide element
`24. This axial motion is transferred to the rod 9 resting
`on the mother thread 27 of the drive element 11, which
`can perform only axial motions but no rotary movements.
`[0035] The axial movement is performed against the
`spring 16 serving as the first return element, which rests
`in a recess between the drive element 11 performing the
`axial motion and a sheath part 21 of the rotary catch 20
`described in the following. The spring 18 returns the
`actuator device 7 back to the resting position.
`[0036] Since the rod 9 is supported in the guide element
`24 in a torque-proof fashion, the rotary motion performed
`for adjusting the next injection dosage at the actuator
`knob 8 cannot be transferred to the rod 9. Rather, by the
`rotating mother thread 27 of the guide element 11 the rod
`9 is driven via the threaded parts at the circular areas 13,
`13’ (compare Fig. 4) in a torque-proof fashion axially to
`the front and this way the flange 19 is brought into the
`position which is equivalent to the next injection dosage
`to be administered. During the axial advance of the
`flange 19 the distance between the flange 19 and the
`piston 5 is reduced according to the distortion of the
`actuator knob 8.
`[0037] The stroke of the flange 19 from the (rear) resting
`position into the (frontal) end position of the actuator
`device 7 remains the same at all times and is equivalent
`to the constant distance by which the flange 19 is
`separated from the piston 5before adjusting the injection
`dosage. By rotating the actuator knob 8 in the (rear)
`resting position this way the injection dosage to be
`administered can be adjusted in advance, i.e. prior to
`dispensing the product from the ampule4. By a controlled
`rotation of the actuator knob 8 in the first direction of
`rotation this way the injection dosage can be clearly
`defined.
`[0038] In order to allow reliably adjusting the injection
`dosage even by ear based on acoustic sounds a two-part
`rotary catch is known from the generic EP 0 581 924 B1,
`which allows a distortion of the actuator knob 8 only in a
`first direction of rotation. Upon distorting the rotary
`catch the catch projections glide over catch recesses such
`that a defined acoustic sound, namely a clicking sound is
`generated for the unambiguous allocation to the rotary
`motion of the actuator knob 8.
`[0039] The rotary catch 20 rests generally between the
`torque-proof and the rotational parts of the injection
`device. The rotary catch 20 is schematically shown in a
`layout in Fig.7. According to EP 0 581 924 B1 the rotary
`catch 20 comprises two catch elements 21, 22 contacting
`each other in the resting position, which comprise a
`plurality of saw-tooth shaped catch projections and
`correspondingly embodied catch recesses arranged in
`regular angular distances, as shown in Fig. 7. The catch
`element 22 is equivalent to the ampule holder 29or is
`mechanically coupled thereto. The catch element 21 is
`equivalent to a sheath part of the tubular drive element
`11, which is torque-proof with the actuator knob 8 and
`rotationally supported.
`[0040] When rotating the two catch elements 21, 22 in
`reference to each other, the saw-tooth shaped catch
`projections glide over the correspondingly embodied
`
`4/13
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`DE 102 37 258 A1 2004.03.18
`
`catch recesses. Since the two catch elements 21, 22are
`pushed against each other via the return force of the
`spring 16 serving as the first return means, the two catch
`elements 21, 22 snap back after the completed gliding
`motion of a saw-tooth shaped catch progression, which
`generates a clearly audible clicking noise, which serves
`as an acoustic sound for adjusting the injection dosage
`“by ear”. The rotary catch according to EP 0 581 924 B1
`as well as WO 87/02895 is rotational only in one rotary
`direction. Accordingly, when the actuator knob 8 is
`rotated too far in the first rotary direction, perhaps
`because the user miscounted the number of clicking
`sounds, the actuator knob 8 cannot be turned back. The
`wrongly adjusted injection dosage can therefore not be
`reduced any more. Rather, the substance must be
`unnecessarily dispensed by an axial advance of the
`actuator knob 8 and another injection dosage can only be
`adjusted anew after the return of the actuator knob 8 into
`the (rear) resting position.
`[0041] According to the present invention the rotary
`catch 20 comprises more than two catch elements that
`can be distorted in reference to each other, preferably
`precisely three catch elements that can be distorted in
`reference
`to each other.
` Figs. 2 and 3 show
`schematically two exemplary embodiments of the present
`invention.
`[0042] Fig. 2 shows in a partial longitudinal section a
`first exemplary embodiment, in which the rotary catch 20
`comprises a lower slide sheath 36, an arrow ring 37
`serving as a spacer comprising catch projections 41 and
`an upper slide sheath 38. The upper slide sheath 38 is
`connected in a torque-proof fashion with the actuator
`knob 8, not shown, for example via the cylindrical
`intermediate part 42 shown schematically.The lower
`slide sheath 36 is preferably connected to the ampule
`holder 29, for example via the schematically shown
`cylindrical intermediate part 43.
`[0043] The slide sheaths 36, 38 serving as catch elements
`and the arrow ring 37 show a plurality of catch
`projections
`41
`and
`catch
`recesses
`embodied
`correspondingly thereto.
`[0044] When the upper slide sheath 38 is rotated to the
`left, the catch recesses embodied therein glide over the
`catch projections 41, which leads to an axial return
`against the return force of the spring 16. In a further
`rotation of the upper slide sheath 38 towards the left, the
`latch recess finally engages the next catch projection 41.
`Based on the return force of the spring 16 the upper slide
`sheath 38 snaps back and generates here an audible
`clicking noise. Based on the PF-division of the catch
`projections 41 on the arrow ring 37 pointing in the same
`direction, it is blocked when rotating the upper slide
`sheath 38 towards the left, thus it remains in the catch
`recess, which is formed on the face of the upper slide
`sheath 36.
`[0045] However, when the actuator knob 8, not shown, is
`distorted in Fig. 2 to the right, thus in the opposite rotary
`direction, the catch projections 41 remain on the upper
`face of the arrow ring37 and the catch recesses embodied
`on the face of the upper slide sheath 38 remain engaged
`with each other and the catch recesses embodied on the
`lower face of the arrow ring 37 glide on the catch
`recesses embodied on the upper face of the lower slide
`
`sheath 36. Here, the arrow ring 37 and the upper slide
`sheath 38 are pushed back axially against the return force
`of the spring 16. When turning the actuator knob 8
`further to the right, finally the catch projections formed
`on the lower face of the arrow ring 37 engage the next
`catch recess on the upper face of the lower slide sheath
`36. Here, the upper slide sheaths 38 and the arrow ring
`37 snap back due to the return force of the spring 16,
`which generates a clearly audible clicking sound.
`[0046] According to the invention therefore the clicking
`sounds or similar acoustic noise is generated when
`distorting the actuator knob 8 both in the clockwise as
`well as the counter-clockwise direction. The patient
`therefore only needs to recognize in what direction
`he/she turns the actuator knob 8 and this way can
`unambiguously conclude from the number of clicking
`sounds the adjusted injection dosage. If the patient
`accidentally, by rotating the actuator knob 8 in the first
`direction of rotation, for example clockwise, set an
`excessive injection dosage, he/she can turn back the
`actuator knob 8 according to the invention in the opposite
`rotary direction, i.e. for example counter-clockwise, and
`reduce the injection dosage in this way. Even when
`turning back, here clicking sounds or similar acoustic
`noise are generated, from which the user can draw
`conclusion on the injection dosage.
`[0047] In the exemplary embodiment according to Fig. 2
`the catch projections 41 provided on the faces, opposite
`each other of the arrow ring 37 serve as an intermediate
`ring and are arranged aligned to each other in the
`advancing direction of the piston 5.
`[0048] Fig. 3 shows another exemplary embodiment
`according to the present invention, in which the catch
`projections are arranged on an upper and lower disk
`serving as catch elements in the resting position of the
`actuator knob 8, seen in the advancing direction of the
`piston 5, in angular positions offset in reference to each
`other. According to Fig. 3 the rotary catch 20 comprises
`an upper disk 21, a lower disk 22, and an intermediate
`disk 23.The upper disk 21 and the lower disk 22 show a
`plurality of saw-tooth shaped catch projections 41,
`preferably arranged
`in
`regular angular distances.
`Corresponding thereto, the intermediate disk 23 also
`shows catching projections and catching recesses. The
`upper disk 21 is pressed by the return force of a spring 16
`(not shown) and serves as the first return means to the
`lower disk 22. In the resting position of the actuator knob
`8 the catch projections 41 engage the catch recesses
`embodied correspondingly.
`[0049] When distorting the upper disk 21 relative to the
`lower disk 22 the motion develops shown schematically
`in the layout shown according to Fig. 8. Fig.8A shows
`the initial status of the rotary catch 20 in the resting
`position of the actuator knob 8, with the overall height of
`the rotary catch 20being minimal. When distorting the
`upper disk 21, which is connected torque-proof to the
`actuator knob 8 (not shown), towards the left, the catch
`projections embodied on
`the upper
`face of
`the
`intermediate disk 23remain engaged with the catch
`projections embodied on the lower face of the upper disk
`21 such that the catch projections formed on the lower
`faces of the intermediate disk 23 glide over the catch
`recesses embodied corresponding thereto on the upper
`
`5/13
`
`Mylan Ex.1058
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`DE 102 37 258 A1 2004.03.18
`
`face of the lower disk 22. Upon further distortion finally
`the catch projections embodied on the lower face of the
`intermediate disk 23 reach the next catch recesses. Based
`on a return force then the disks 21, 22, 23 are pressed to
`each other such that the initial position of the rotary catch
`20 shown in Fig. 8A is assumed once more. When the
`upper disk 21 and the intermediate disk 23 snap back, an
`audible clicking noise is generated.
`[0050] When distorting the upper disk 21 in the opposite
`rotary direction, i.e. to the right in Fig. 8c, an appropriate
`movement develops, which is clearly discernible from
`Fig. 8c.
`[0051] The various catch elements of the rotary catch 20,
`i.e. the disks 36 to 38 in the exemplary embodiment
`according to Fig. 2 and/or the disks 21 to 23 of the
`second exemplary embodiment according to Fig. 3 are
`returned as follows with the help of two return means,
`preferably springs, and made to contact each other. As
`shown in Fig. 1, the front part 2 is connected via the
`coarse thread 30 to the rear part 3 of the injection device.
`While the tubular drive element 11is located in the rear
`part 30, the ampule 4 is positioned in the frontal part 2 of
`the injection device. An ampule holder 29, which is
`preferably embodied in a hollow, cylindrical fashion, and
`which is engaged by the flange 19 serving as a driven
`member, rests on the edge of the upper face of the
`ampule 4. For the elastic support of the ampule 4 in the
`frontal part 2 of the injection device, a spring 35 is
`located between the ampule holder 29 and the rear part 3,
`serving as the second return means.When the ampule 4
`rests loosely on the ampule holder 29, for example
`because the frontal part 2has not yet been completely
`screwed onto the course thread 30, the second spring 35
`pushes the ampule 4 and the ampule holder 29 axially
`forward. Since one side of the rotary grid 20 according
`to the invention, for example the lower disk 36 in Fig. 2,
`or the lower disk 22 in Fig. 3, is coupled to the ampule
`holder 29 or is formed thereby, the rotary catch 20
`releases the engagement. In this position the actuator
`knob 8 can be turned back without catching resistance,
`for example for completely returning the flange 19 and
`the rod 9 into an initial position when a new ampule 4
`shall be inserted, with here the piston 5 initially being in
`the rear end position.
`[0052] The length of the ampule 4and the l