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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rotator, subject matter of claim 1, and the rotator being a separate component from the delivery member cover, provided with the second blocking structure, wherein the rotator is arranged concentrically with the delivery member cover radially outside of the delivery member cover, and having a first locking structure configured to engage with a second locking structure of the cap, subject matter of claim 23, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numeral 11b provided in Figure 3 is not in the written description. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Figure 6e is provided with a line that does not end in a reference numeral. It appears the reference numeral should be “15a”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 16 be found allowable, claim 30 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 24-25 are objected to because of the following informalities:
Regarding claim 24, “… configured to be arranged axially aligned with and…” should read “… configured to be arranged in axial alignment with and…”, or “… configured to be axially aligned with and…”, or similarly for correctness.
Regarding claim 25, the first recitation of “the proximal portion” should be corrected to “a proximal portion” for claim language consistency, considering claim 17 is not part of the dependency chain of claim 25.
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 16-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 16, it is unclear what the structure referenced as “a rotator” is. Based on the disclosure, the Examiner is unsure if the rotator is the proximal portion 9a of the delivery member cover, which includes the first locking structure 9c, or the proximal body 3a, which includes the second blocking structure 21, both portion 9a and body 3a, or another independent structure not illustrated in the drawings. Claim 16 indicates that the rotator is configured to be rotatable relative to the body and has a first locking structure. As best understood in light of the specification, the Examiner, for purposes of examination in regard to claim 16, is interpreting the rotator to be the proximal portion 9a of delivery member cover 9.
Claim 21 recites the limitation "the protrusion" in line 1 and claim 22 recites the limitation “the protrusion” and “the recess” in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears claims 21-22 are intended to be dependent on claim 18 and will be interpreted as dependent on claim 18 for purposes of examination.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 17 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 17, the limitation of “the delivery member cover is the rotator” fails to include all the limitations of claim 16, which claim 17 depends upon. Claim 16 appears to positively recite two independent structures, the delivery member cover and the rotator. Claim 17 further limits the delivery member cover to be the rotator which appears to delete a limitation.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 16-22, 24, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekman (US 20130331794 A1), in view of Stefanov (US 20180272075 A1).
Regarding claim 16, as best understood in light of the 112(b) rejection set forth above, Ekman discloses an assembly for a medicament delivery device (safety device 1 for injection device D, [0043] & Fig. 1), the assembly comprising: a body (support body 1.2, [0043] & Fig. 1 and 7B),
a delivery member cover arranged in the body and configured to move axially relative to the body from an extend position relative to the body to a retracted position (needle shield 1.1, “The needle shield 1.1 is received within a substantially cylindrical and hollow support body 1.2, whereas the needle shield 1.1 is slidable with respect to the support body 1.2. Prior to use of the safety device 1, the needle shield 1.1 is retained in an initial position I, wherein the needle shield 1.1 protrudes the support body 1.2.”, [0043] & Fig. 1-6 and 7B; “The needle shield rotates with respect to the support body when the needle shield is moved between an initial position, in which the needle shield protrudes the support body, and a retracted position, in which the needle shield is substantially received within the support body.”, [0014] and [0064]),
a rotator configured to be rotatable relative to the body (skin contact flange 1.1.1, which defines a proximal end of needle shield 1.1, and the proximal most end of needle shield 1.1 are being interpreted as the rotator, [0049] & Fig. 1 and 7B; “The needle shield rotates with respect to the support body when the needle shield is moved between an initial position, in which the needle shield protrudes the support body, and a retracted position, in which the needle shield is substantially received within the support body.”, [0014]; the Examiner notes that “The skin-contact flange 1.1.1 is integral part of the needle shield 1.1, or alternatively, a separate part attached to the needle shield 1.1…”, [0049]), and a cap (needle cap remover 3, [0053] & Fig. 1),
wherein the delivery member cover has a first blocking structure (camming surface 1.2.4.2 of guide track 1.2.4 disposed on needle shield 1.1 configured to block and control movement of guide pin 1.1.2, [0056], [0059], [0072], and [0084] & Fig. 7B) configured to engage with a second blocking structure, which is axially fixed relative to the body (guide pin 1.1.2 formed on, and axially fixed to, an inner surface of support body 1.2, [0084] and [0059] & Fig. 7B; “The guide pin 1.1.2 is pushed against an inclined camming surface 1.2.4.2 and leaves its start position PI indicated by the arrow in FIG. 3 in a direction oriented at an acute angle relative to the central axis A…”, [0072]), when the rotator is in the first rotational position to prevent the delivery member cover to move axially from the extended position towards the retracted position (“The guide pin 1.1.2 in the start position PI further abuts an inclined camming surface 1.2.4.2 in a proximal direction.”, [0059] & Fig. 1, 3, and 7B), wherein one of the first blocking structure and the second blocking structure has a cam surface configured to cooperate with the other one of the first blocking structure and the second blocking structure (the side surface of camming surface 1.2.4.2 configured to cooperate with guide pin 1.1.2, [0059] & Fig. 1, 3, and 7B; “The guide pin 1.1.2 is pushed against an inclined camming surface 1.2.4.2 and leaves its start position PI indicated by the arrow in FIG. 3 in a direction oriented at an acute angle relative to the central axis A...”, [0072]) such that
when the cap has been removed from the body and the delivery member cover is subjected to an axial force directed distally, the rotator is rotated in the first rotational direction, causing the first blocking structure and the second blocking structure to disengage, enabling the delivery member cover to move axially from the extended position towards the retracted position (“the needle cap remover facilitates the removal of the needle cap when the needle shield surrounds the needle cap in the initial position.”, [0031] & Fig. 1-2; needle remover 3 capable of being removed prior to a force being delivered; “The hand flange 1.3.1 supports the hand of the user to push the outer body 1.3 towards the skin surface of the patient. In a first stage of the injection, the needle shield 1.1 is pushed inside the support body 1.2, whereby the hypodermic needle 2.1 is exposed to penetrate the skin of the patient and the compression spring 1.4 is compressed and charged. The guide pin 1.1.2 is pushed against an inclined camming surface 1.2.4.2 and leaves its start position PI indicated by the arrow in FIG. 3 in a direction oriented at an acute angle relative to the central axis A, whereby the needle shield 1.1 changes an angular orientation relative to the support body 1.2 and rotates within the support body 1.2 around the central axis A about an angle of a few degrees…. The needle shield 1.1 is in the retracted position II when the guide pin 1.1.2 reaches a corresponding intermediate position PII, as indicated in”, [0071]-[0074] & Fig. 1-4 & 7B; upon complete rotation of needle shield 1.1, camming surface 1.2.4.2 and guide pin 1.1.2 disengage).
However, Ekman fails to explicitly disclose an assembly for a medicament delivery device comprising a cap configured to receive a portion of the rotator when the delivery member cover is in the extended position, and wherein the cap is configured to be removably attached to and rotationally locked relative to the body,
wherein the rotator has a first locking structure and the cap has a second locking structure configured to engage with the first locking structure when the delivery member cover is in the extended position, to prevent rotation of the rotator relative to the cap in a first rotational direction and thereby maintain the rotator in a first rotational position relative to the body.
However, Stefanov teaches an assembly for a medicament delivery device (injector 1, [0030] & Fig. 1) comprising a cap (cap 6 of cap assembly 60, [0030] & Fig. 1-3) configured to receive a portion of the rotator when the delivery member cover is in the extended position (cap 6 configured to receive a the proximal most end of needle shield 40 in an extended position, see Fig. 1-2 and 6-11), wherein the cap is configured to be removably attached to and rotationally locked relative to the body (cap assembly 60, including cap 6, is removable from the injector, [0036] & Fig. 6-11; cap assembly 60 configured to be “securely fixed” to injector 1 through a snap lock connection which necessarily creates a rotational lock between injector 1 and cap 6, see [0035] and [0037] & Fig. 6-11),
wherein the rotator has a first locking structure (the proximal end of needle shield 40 including a cut-out portion 41, which includes a nib 44, housing nib 43, and inward protrusion 47, [0033] and [0035]) and the cap has a second locking structure configured to engage with the first locking structure when the delivery member cover is in the extended position (cap 6 includes snap connector 6b which engages nib 44 of cut-out portion 41 when needle shield 40 is in an extended position, [0037] and [0035] & Fig. 6-11), to prevent displacement of the rotator relative to the cap in a first rotational direction ([0035]-[0036]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Ekman, as modified with Karlsson, with Stefanov to include the cap configured to be removably attached to and rotationally locked relative to the body, wherein the rotator has a first locking structure and the cap has a second locking structure configured to engage with the first locking structure when the delivery member cover is in the extended position to prevent displacement of the rotator relative to the cap in a first rotational direction, since such a modification would create a secure, fixed connection between the cap and the needle shield and yield predictable results pertaining to the prevention of premature displacement of the needle shield (see [0035]-[0037] of Stefanov).
As modified, cap assembly 6 of Stefanov would be included and the proximal end of needle shield 1.1, under guide track 1.2.4 (see Fig. 7B of Ekman), would include cut-out portion 41 of Stefanov. As combined, cap 6 would prevent rotation of the needle shield 1.1 relative to the cap in any direction and maintain the needle shield 1.1 in a first rotational position, initial position I, relative to support body 1.2 of Ekman. One of ordinary skill in the art would be able to size cap 6 and needle shield 1.1 as needed to facilitate connection between the two components, as in Stefanov.
Regarding claim 17, Ekman, as modified, discloses all the limitations of claim 16. Ekman, as modified, further discloses the assembly wherein the delivery member cover is the rotator (needle shield 1.1, including skin contact flange 1.1.1, can be interpreted as the delivery member cover and the rotator, [0014] and [0049] & Fig. 1 and 7B), wherein the body comprises the second blocking structure (support body 1.2 includes guide pin 1.1.2, [0084] & Fig. 7B), and
wherein the cap is configured to receive a proximal portion of the delivery member cover when the delivery member is in the extended position (as modified, front cap 7 would receive a proximal portion of needle shield 1.1 when in the extended, initial position I, see Fig. 3 of Ekman and Fig. 7 of Karlsson).
Regarding claims 18 and 22, Ekman, as modified, discloses all the limitations of claims 16-17. Ekman, as modified, further the discloses assembly wherein one of the first locking structure and the second locking structure comprises a recess and the other one of the first locking structure and the second locking structure comprises a protrusion configured to be received into the recess to prevent rotation of the delivery member cover in the first rotational direction (as modified, cut-out portion 41 of Stefanov provided on the proximal end of needle shield 1.1 of Ekman is being interpreted as a recess and snap connection 6b of Stefanov provided on cap 7 of Karlsson is being interpreted as a protrusion, which is configured to be received in cut-out portion 41, see [0037] & Fig. 6-11 of Stefanov; the connection between snap connector 6b and cut-out portion 41 prevents force to be applied to needle shield 1.1, which prevents rotation of needle shield 1.1, see [0035] of Stefanov).
Regarding claim 19, Ekman, as modified, discloses all the limitations of claim 18. Ekman, as modified, further discloses the assembly wherein the recess is arranged in a radial plane of the delivery member cover (as modified, cut-out portion 41 is seen at least partially arranged in a radial plane of needle shield 1.1, similarly to how cut-out portion is arranged on needle shield 40 of Stefanov, see Fig. 7, 9, and 12-13 of Stefanov).
Regarding claim 20, Ekman, as modified, discloses all the limitations of claim 18. Ekman, as modified, further discloses the assembly wherein the recess extends in a circumferential direction of the delivery member cover (as modified, cut-out portion 41 is seen extending in a circumferential direction of needle shield 1.1, similarly to how cut-out portion 41 is arranged on needle shield 40 of Stefanov, see Fig. 6, 8, and 10-11 of Stefanov).
Regarding claim 21, Ekman, as modified, discloses all the limitations of claims 16 and 18. Ekman, as modified, further discloses the assembly wherein the protrusion extends in an axial direction of the cap (as modified, snap connector 6b extends in an axial direction of front cap 7, similarity to how snap connector 6b is arranged on cap 6 of Stefanov, see Fig. 7 of Stefanov and [0037] of Stefanov).
Regarding claim 24, Ekman, as modified, discloses all the limitations of claims 16. Ekman, as modified, further discloses the assembly wherein the first blocking structure comprises a first radial protrusion (guide track 1.2.4 comprising inclined camming surface 1.2.4.2, which can be interpreted as a first radial protrusion as it extends at least partially radially as a result of its thickness, [0059] and [0072] & Fig. 3, 6, and 7B), and
the second blocking structure comprises a second radial protrusion (guide pin 1.1.2 comprising a radially extending pin, [0084] & Fig. 3, 6, and 7B) configured to be arranged axially aligned with and distally relative to the first radial protrusion in the first rotational position of the delivery member cover to prevent the delivery member cover to move towards the retracted position (guide pin 1.1.2 is seen axially aligned with and distal relative to camming surface 1.2.4.1 in the initial position, PI, of needle shield 1.1, [0059] & Fig. 3, 6, and 7B; camming surface 1.2.4.2 is configured to abut guide pine 1.1.2 with guide pin 1.1.2 having to be pushed against the inclined camming surface 1.2.4.2 to leave initial position PI, [0059] and [0072] & Fig. 3, 6, and 7B).
Regarding claim 30, Ekman, as modified, discloses a medicament delivery device comprising an assembly as claimed in claim 16 (injection device D comprising safety device 1, [0043] & Fig. 1 and 7B; see the rejection of claim 16 above).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekman (US 20130331794 A1), in view of Stefanov (US 20180272075 A1), and further in view of Boström (US 20190189029 A1).
Regarding claim 25, Ekman, as modified, discloses all the limitations of claims 24. However, Ekman fails to explicitly disclose the assembly wherein the delivery member cover comprises
a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover, wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion, and wherein the second radial protrusion is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position.
However, Boström teaches a guide structure 12 similar to the guide track 1.2.4 of Ekman designed to guide a protrusion along to control retraction and extension of a needle shield and disposed in an operative relationship similar to the embodiment of Fig. 7C of Ekman. Boström teaches an assembly (medicament training device 1 for a disposable auto-injector, [0039] & Fig. 1a) wherein the delivery member cover comprises a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover (rotator 11 comprises a second heel 16b, which is wedge-shaped having a ramp structure at one end and an essentially radial surface at the other end, [0052] and [0054] & Fig. 4b; wedge 16b having a slight taper from the proximal end toward a distal end of rotator 11, see Fig. 4B, 5, and 7B),
wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion (second heel 16b is located along the second leg 12b in a region of second vertex 14b, seen offset in a first rotational direction relative to second leg 12b, structure similar to surface 1.2.4.2 of Ekman, and closer to a proximal portion of rotator 11 than second leg 12b, [0052] and [0057] & Fig. 4b), and
wherein the second radial protrusion (protrusion 7g, [0057] & Fig. 5) is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position (protrusion 7g is configured to move over or pass the second heel 16b when rotator 11 is displaced to the retracted position, see [0057] & Fig. 6A-6B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Ekman, as modified, with Boström to include the delivery member cover comprising a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover, wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion, and wherein the second radial protrusion is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position, since such a modification would prevent the protrusion from returning to the initial position, providing enhanced control over the movement path of the protrusion, and yield predictable results pertaining to passage of the protrusion toward a secondary position to facilitate retraction of the needle shield (see [0017], [0052], and [0057] of Boström).
As modified, guide track 1.2.4 of Ekman would be provided with heel 16b of Boström down track of camming surface 1.2.4.2, between arcuate section 1.2.4.5 and the end of camming surface 1.2.4.2 (see Fig. 3, 6, and 7B of Ekman and Fig. 4b of Boström). The heel 16b would be placed between initial position, PI, and before the retracted position, PII, similar to how heel 16b is positioned in guide structure 12 of Boström, before protrusion 7g reaches vertex 14b (see Fig. 4b of Boström).
Alternatively, claim(s) 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekman (US 20130331794 A1), in view of Stefanov (US 20180272075 A1), in view of Schraga (US 20120226233 A1), and further in view of Karlsson (US 20150032058 A1).
Regarding claims 25-27, Ekman, as modified, discloses all the limitations of claim 24. However, Ekman fails to explicitly disclose the assembly wherein the delivery member cover comprises
a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover, wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion, and
wherein the second radial protrusion is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position, and
wherein the first ramp structure has a proximal end portion provided with a radial guide surface extending along a helical direction of the delivery member cover, the radial guide surface being configured to guide the second radial protrusion when the delivery member cover is moved towards the extended position, causing rotation of the delivery member cover in a second rotational direction opposite to the first rotational direction relative to the body,
wherein the delivery member cover has a second ramp structure which in the circumferential direction is arranged adjacent to the first ramp structure, wherein the radial guide surface is configured to guide the second radial protrusion towards the second ramp structure when the delivery member cover is moved from the retracted position towards the extended position, wherein the second ramp structure is tapering in an opposite direction relative to the tapering of the first ramp structure.
However, Schraga teaches a guiding recess GRIV (Fig. 30), similar to the guide track 1.2.4 of Ekman, designed to guide a protrusion along to control retraction and extension of a needle shield and disposed in an operative relationship similar to the embodiment of Fig. 7C of Ekman.
Schraga teaches an assembly (pen needle or needle tip 100IX, [0091]-[0092] & Fig. 39) wherein the delivery member cover (body portion 10IX, [0091] & Fig. 39) has a first blocking structure configured to engage with a second blocking structure (the outwardly protruding edge of the first angled section is being interpreted as a first blocking structure, see annotated Fig. 39 below; the first bocking structure configured to engage a guiding projection GP’’’, [0091]-[0093] & Fig. 38-39), which is axially fixed relative to the body (guiding projection GP’’’ protruding from safety shield 20IX, [0093] * Fig. 38), when the rotator is in the first rotational position to prevent the delivery member cover to move from the extended position towards the retracted position (the first blocking structure is capable of preventing body portion 10IX from moving until a rotational force is exerted, see [0092]; this structure functions similarly to camming surface 1.2.4.2 of Ekman),
wherein one of the first blocking structure and the second blocking structure has a cam surface configured to cooperate with the other one of the first blocking structure and the second blocking structure (the angled side surface of the first blocking structure is being interpreted as a cam surface configured to cooperate with guiding projection GP’’’, [0092]-[0093] & Fig. 38-39) such that when the delivery member cover is subjected to an axial force directed distally, the rotator is rotated in the first rotational direction, causing the first blocking structure and the second blocking structure to disengage, enabling the delivery member cover to move from the extended position towards the retracted position (“…when the shield 20IX moves from the initial position to a partially retracted position, it experiences axial and partial rotation movement in only one direction.” [0092] and [0061] & Fig. 38-39; when an axial force directed distally is applied (see [0061]), body portion 10IX is rotated in one direction, which ultimately causes the first blocking structure and projection GP’’’ to disengage and enables body portion 10IX to move into the retracted position), and
wherein the first blocking structure comprises a first radial protrusion (the first blocking structure can be interpreted as a first radial protrusion as it extends at least partially radially as a result of its thickness, [0093] & Fig. 39) and
the second blocking structure comprises a second radial protrusion (guiding projection GP’’’, [0091] and [0093] & Fig. 38) configured to be arranged axially aligned with and distally relative to the first radial protrusion in the first rotational position of the delivery member cover to prevent the delivery member cover to move towards the retracted position (guiding projection GP’’’ is configured to be axially aligned with and distal relative to the first blocking structure in an initial position and is capable of preventing movement of body portion 10IX to the retracted position, see [0092]-[0093] & Fig. 39; rotation must occur in order for projection GP’’’ to move past the first radial protrusion),
wherein the delivery member cover comprises a radially extending first ramp structure (first deflectable guide member DGM-1 functioning as a ramp for projection GP’’’, [0092] & Fig. 39), wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion (DGM-1 seen arranged offset in the initial position relative to the first radial protrusion and closer to the proximal end of body portion 10IX, see Fig. 39), and
wherein the second radial protrusion is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position (projection GP’’’ is configured to move over DGM-1 when body portion 10IX is moved toward the retracted position, [0092] & Fig. 39; “When the shield moves axially further back past the first deflectable guide member DGM-1 is rotates slightly in another direction.”; “…the deflectable guide members DGM-1 and DGM-2, which can be moved by the guide projection to allow the safety shield to reach the fully retracted position and to the locked fully extended position respectively,…”, [0092]), and
wherein the first ramp structure has a proximal end portion provided with a radial guide surface extending along a helical direction of the delivery member cover, the radial guide surface being configured to guide the second radial protrusion when the delivery member cover is moved towards the extended position, causing rotation of the delivery member cover in a second rotational direction opposite to the first rotational direction relative to the body (the proximal end of DGM-1 having a surface extending along a helical direction of body portion 10IX , see Fig. 39; “When the shield moves axially further back past the first deflectable guide member DGM-1 is rotates slightly in another direction”, [0092] & Fig. 39; DGM-1 guides and rotates body portion 10IX when body portion 10IX begins movement toward the extended position, [0092]; the other direction being opposite to the first direction).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Ekman, as modified with Stefanov, with Schraga to include the delivery member cover comprising
a radially extending first ramp structure, wherein the first ramp structure is arranged offset in the first rotational direction relative to the first radial protrusion and closer to the proximal portion than the first radial protrusion, and
wherein the second radial protrusion is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position, and
wherein the first ramp structure has a proximal end portion provided with a radial guide surface extending along a helical direction of the delivery member cover, the radial guide surface being configured to guide the second radial protrusion when the delivery member cover is moved towards the extended position, causing rotation of the delivery member cover in a second rotational direction opposite to the first rotational direction relative to the body.
As modified, guide track 1.2.4 of Ekman would be substituted with guiding recess GRIV of Schraga. The first blocking structure, having a cam surface and comprising a radial protrusion, would be the outwardly protruding edge of the first angled section, as cited above and annotated below. As combined, when needle shield 1.1 of Ekman is in the first rotational position, the first blocking structure would prevent needle shield 1.1 from moving axially from the extended position towards the retracted position such that when needle shield 1.1 is subjected to an axial force directed distally, needle shield 1.1 is rotated in the first rotational direction, causing the first blocking structure and guide pine 1.1.2 of Ekman to disengage, enabling needle shield 1.1 to move axially from the extended position towards the retracted position.
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Further, Karlsson teaches a guide track 98, similar to the guide track 1.2.4 of Ekman and guiding recess GRIV of Schraga, designed to guide a protrusion along to control retraction and extension of a needle shield and disposed in an operative relationship similar to the embodiment of Fig. 7C of Ekman.
Karlsson teaches an assembly (safety pen needle device of Fig. 7, see abstract) wherein the delivery member cover (rotator 91, [0067] & Fig. 10) comprises a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover (second flexible tongue 100 comprising a wedge-like outwardly directed protrusion, wedge 101, that is seen tapering in a direction from the proximal portion of rotator 91 to a distal end of rotator 91, [0067] & Fig. 8 and 10), and
wherein the second radial protrusion (guide protrusion 120, [0068] & Fig. 8-10) is configured to move over the first ramp structure when the delivery member cover is moved towards the retracted position (when rotator 91 is moved toward the retracted position “… guide protrusion[s] 120 slide along the first sections 96 of the guide tracks on the rotator passing the second wedges 101 of the second flexible tongues 100, by pressing the second flexible tongues 100 radial inwards, and then into the second section 102. After the guide protrusions 120 have passed over the second wedges 101, the second flexible tongues 100 are moved back radial outwards.”, [0072] & Fig. 10), and
wherein the first ramp structure has a proximal end portion provided with a radial guide surface extending along a helical direction of the delivery member cover, the radial guide surface being configured to guide the second radial protrusion when the delivery member cover is moved towards the extended position, causing rotation of the delivery member cover (the proximal end of tongue 100 is provided with wedge 101 which creates part of inclined section 103, [0067] and [0073] & Fig. 10; “The inclined section 103 is formed by an inclined ledge 98e which emerges from the straight ledge 98d and by the wedge-like outwardly directed protrusion 101.”, [0067]; “After the injection is performed, the user withdraws the injector and thereby the safety pen needle device from the injection site. This causes the needle shield 112 to be pushed towards the proximal direction of the device from the injection position to the initial position… This in turn causes the guide protrusions 120 of the needle shield 112 to move in the longitudinal direction along the ledge 98d until the guide protrusions 120 come in contact with a side wall of the second wedge 101. The side wall of the second wedge 101 has an inclination corresponding to the inclined ledge parts 98e and 98g, thereby forcing the guide protrusions 120 in that direction. This in turn causes the rotator 91 to turn or rotate in relation to the hub.”, [0073]; the side wall of wedge 101 is being interpreted as a radial guide surface, which is inclined and extends along a helical direction),
wherein the delivery member cover has a second ramp structure (rotator 91 including a first flexible tongue 108 including a first wedge 105, [0073] & Fig. 8-10) which in the circumferential direction is arranged adjacent to the first ramp structure (second tongue 100 arranged adjacent to first tongue 108, see Fig. 10), wherein the radial guide surface is configured to guide the second radial protrusion towards the second ramp structure when the delivery member cover is moved from the retracted position towards the extended position, wherein the second ramp structure is tapering in an opposite direction relative to the tapering of the first ramp structure (the side wall of wedge 101 configured to protrusion 120 toward tongue 108 when rotator 91 is moved from the retracted position toward the extended position, [0073] & Fig. 10; tongue 108 seen tapering in an opposite direction to tongue 100, see Fig. 8 and 10).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the assembly of Ekman, as modified with Stefanov and Schraga, with Karlsson to include the delivery member cover comprising a radially extending first ramp structure that tapers in a direction from the proximal portion towards a distal end of the delivery member cover and a second ramp structure which in the circumferential direction is arranged adjacent to the first ramp structure, wherein the radial guide surface is configured to guide the second radial protrusion towards the second ramp structure when the delivery member cover is moved from the retracted position towards the extended position, wherein the second ramp structure is tapering in an opposite direction relative to the tapering of the first ramp structure,
since Karlsson teaches such to be an art effective configuration for a deflectable member configured to guide a protrusion along to control retraction and extension of a needle shield (see [0072]-[0073] of Karlsson). The modification would provide means for controlling the path of the guide protrusion while yielding the same predictable results of needle shield extension, retraction, and locking (see [0067] and [0072]-[0073] of Karlsson).
As modified, the deflectable members DGM-1, DGM-2, and the subsequent track between them of guiding recess GRIV of Schraga would be substituted with tongues 100 and 108 of Karlsson. As combined, guiding recess GRIV of Schraga would substantially adopt the shape and features of guide track 98, with the first angled section and blocking structure of Schraga remaining.
Regarding claim 28, Ekman, as modified, discloses all the limitations of claim 27. Ekman, as modified, further discloses the assembly wherein the second ramp structure has a snap-lock functionality configured to prevent the delivery member cover to move towards the retracted position when the second radial protrusion has moved axially past the second ramp structure (“Finally the guide protrusions move over the first flexible tongues 108, causing them to flex radial inwards, thereby permitting the passing of the guide protrusions 120, FIGS. 10 and 12, where the guide protrusions are prevented from further longitudinal movement by the third semi-circular ledges 98f and a side wall of the first wedges 105 of the first flexible tongues 108.” [0073] & Fig. 10).
Regarding claim 29, Ekman, as modified, discloses all the limitations of claim 28. Ekman, as modified, further discloses the assembly wherein the delivery member cover comprises a radial structure axially aligned with and arranged distally relative to the second ramp structure (ledge 98f extending radially and axially aligned with and arranged distally relative to wedge 105, [0067] and [0073] & Fig. 10), the radial structure being configured to prevent the delivery member cover to move further proximally when the second radial protrusion has moved past the second ramp structure (“…where the guide protrusions are prevented from further longitudinal movement by the third semi-circular ledges 98f…”, [0073] & Fig. 10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karlsson (US 20140148763 A1), Sall (US-20180361082-A1), Kramer (US-20130317431-A1), Giambattista (US-20150335829-A1), Brunnberg (US-20150209517-A1), Stefanov ‘773 (US-20180296773-A1), Dowds (US-20140025013-A1), Lewkonya (US-20200108210-A1), Sall ‘984 (US-20180228984-A1), Finkelstein (US-20210093796-A1), Perot (US-8939942-B2), Daniel (US-10420898-B2), and Gross (US-6830560-B1).
Karlsson teaches an assembly for a medicament delivery device (injection device 1, Fig. 1-2) comprising a cap (front cap 7, [0075] & Fig. 1-2) configured to receive a portion of the rotator when the delivery member cover is in the extended position (cap 7 closes the proximal opening of housing part 2 and receives part of needle shield sleeve 17 when needle shield 17 is in an extended position over needle 13, [0073], [0077], and [0089] & see Fig. 7), and wherein the cap is configured to be removably attached to the body ([0075] & Fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783