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 .
Response to Amendment
This office action is responsive to the amendments filed on 10/30/2025. As directed by the amendment: claims 1 and 9 have been amended, and claims 16-17 have been added. Thus, claims 1-17 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
Claims 1-4, 6-10, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190374727 A1, henceforth written as Dugand.
Regarding Claim 1,
Dugand discloses:
A shield removal assembly
(Removal device 36; fig 1-10)
for an autoinjector comprising a syringe barrel, a needle, and a needle shield at least partially surrounding the needle, the shield removal assembly comprising:
(injection syringe 26 having injection needle 30 protected by cap 32; fig 1-10)
a cap remover configured to be grasped by a user and having a proximal end and a distal end, --
(gripping member 40; fig 1-10)
--and a retainer received within the cap remover and having a proximal end and a distal end,
(Slide 42; fig 1-10)
the retainer comprising at least one grasping feature configured to engage at least one complementary grasping feature of the needle shield,
(paragraph 90; resistance end 46r of extractor 46 on slide 42 engages proximal end edge 32p of cap 32; fig 1-10)
and the distal end comprising an opening therethrough,
(fig 7+9 best illustrate the opening at the distal end of slide 42)
wherein the shield removal assembly is removably connected to the autoinjector, removal of the shield removal assembly from the autoinjector removes the needle shield from the autoinjector,
(paragraph 113-115)
the retainer is axially moveable with respect to the cap remover,
(Fig 8+10 best illustrates the relative moveability of the slide 42 relative to member 40)
and the retainer comprises at least one radially-extending protrusion, and the cap remover comprises at least one window in a radially-most exterior outer sidewall of the cap remover --, wherein the at least one window is configured to receive the radially-extending protrusion.
(Paragraph 95-97; coupling lugs 56, therein radially extending protrusions, on slide 42 engage with locking windows 64 to facilitate removal of cap 32 during removal of member 40; fig 7-10)
Dugand discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the distal end of the cap remover comprising at least one opening therethrough; -- a radially-most exterior outer sidewall of the cap remover that defines the at least one opening therethrough at the distal end of the cap remover
However, Dugand teaches an alternative embodiment comprising:
the distal end of the cap remover comprising at least one opening therethrough; -- a radially-most exterior outer sidewall of the cap remover that defines the at least one opening therethrough at the distal end of the cap remover
(fig 11-20 demonstrate that member 40 has a distal opening at its distal end 40d, defined by its radially most outerwall, enabling visual confirmation of the presence of cap 32 and member 78)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Dugand’s alternative embodiment’s teachings of a cap remover with a distal end opening in the cap remover of the primary embodiment of Dugand in order to advantageously arrive at an invention which enables an operator to examine the invention after assembly and visually verify the presence of certain components, like the cap 32 and slide 42, improving the efficacy of quality control checks during the invention’s assembly process and enabling an end-user to verify the invention is sterile and compliant with safety standards.
Regarding claim 2, the modified invention of Dugand discloses:
The shield removal assembly of claim 1, wherein the at least one grasping feature comprises at least one protrusion, and the at least one complementary grasping feature comprises a proximal edge of the needle shield.
(paragraph 90; resistance end 46r, therein a protrusion, of extractor 46 engages proximal end edge 32p of cap 32; fig 1-10)
Regarding claim 3, the modified invention of Dugand discloses:
The shield removal assembly of claim 1, wherein the shield removal assembly is configured such that the needle shield of the autoinjector can be advanced through the shield removal assembly from a first position in which the at least one grasping feature is spaced longitudinally and located proximally of the at least one complementary grasping feature of the needle shield to a second position in which the at least one grasping feature engages the at least one complementary grasping feature of the needle shield.
(paragraph 103-106; cap 32 is passed into slide 42 during assembly, such that prior to assembly cap 32 is in the claimed first position, and upon the extractors 46 returning to their retracted position the claimed grasping features are in the claimed second position configuration)
Regarding claim 4, the modified invention of Dugand discloses:
The shield removal assembly of claim 1, wherein the at least one grasping feature is located at the proximal end of the retainer,
(fig 6-10 best illustrates end 46r at the proximal end of slide 42)
the shield removal assembly configured such that the needle shield of the autoinjector can be advanced through the shield removal assembly from a first position in which the proximal end of the needle shield is longitudinally spaced from the at least one grasping feature of the retainer to a second position in which the proximal end of the needle shield abuts the at least one grasping feature of the retainer.
(paragraph 103-106; cap 32 is passed into slide 42 during assembly, such that prior to assembly cap 32 is in the claimed first position, and upon the extractors 46 returning to their retracted position the claimed grasping features are in the claimed second position configuration)
Regarding claim 6, the modified invention of Dugand teaches:
The shield removal assembly of claim 1, wherein the opening in the distal end of the cap remover has a greater diameter than the opening in the distal end of the retainer.
Examiner notes that in light of the modification of Dugand made in claims above, the opening in gripping member 40 is of a size larger than the opening in slide 42
Regarding claim 7, the modified invention of Dugand discloses:
An autoinjector comprising:
(injection assembly 22; fig 1-10)
a housing having a proximal end, an open distal end, and defining a longitudinal axis;
(housing of device 24; fig 1-10)
a syringe held within the housing and having a barrel;
(syringe 26 with body 28; fig 1-10)
a needle attached to a distal end of the syringe barrel;
(needle 30; fig 1-10)
a removable needle shield having a proximal end and a distal end, the needle shield configured to at least partially surround the needle;
(cap 32; fig 1-10)
and a shield removal assembly according to claim 1.
(removal device 36; fig 1-10)
Regarding claim 8, the modified invention of Dugand discloses:
The autoinjector of claim 7, wherein the cap remover is not rotatable relative to the housing.
(paragraph 90-93; slide 42 is fixed relative to support 34 of device 24 such that member 40 may only translate axially and not rotationally; fig 1-10)
Regarding Claim 9,
Dugand discloses:
A method of assembling an autoinjector comprising:
(injection assembly 22; fig 1-10)
providing a lower assembly, the lower assembly comprising: a lower housing having a proximal end and a distal end, and defining a longitudinal axis;
(support 34 and its housing (not enumerated); fig 1-10 )
and a shield removal assembly arranged at the distal end of the lower housing,
(Removal device 36; fig 1-10)
comprising: a cap remover configured to be grasped by a user and having a proximal end and a distal end, --
(gripping member 40; fig 1-10)
--and a retainer received within the cap remover
(Slide 42; fig 1-10)
and having a proximal end comprising at least one grasping feature and a distal end,
(paragraph 90; resistance end 46r of extractor 46 on slide 42 engages proximal end edge 32p of cap 32; fig 1-10)
the distal end of the retainer comprising at least one opening therethrough and spaced from the distal end of the cap remover in an initial configuration;
(fig 7+9 best illustrate the opening at the distal end of slide 42 and demonstrate it spaced from the distal end of member 40)
wherein the retainer is axially moveable with respect to the cap remover
(Fig 8+10 best illustrates the relative moveability of the slide 42 relative to member 40)
and the shield removal assembly is removably connected to the lower housing,
(paragraph 91)
wherein the retainer comprises at least one radially- extending protrusion, and the cap remover comprises at least one window in a radially-most exterior outer sidewall of the cap remover --, and wherein the at least one window is configured to receive the radially-extending protrusion;
(Paragraph 95-97; coupling lugs 56, therein radially extending protrusions, on slide 42 engage with locking windows 64 to facilitate removal of cap 32 during removal of member 40; fig 7-10)
inserting a syringe into the lower assembly,
(paragraph 101-106; syringe 26 inserted into support 34; fig 1-10)
the syringe comprising: a barrel having a proximal end and a distal end;
(syringe 26 with body 28; fig 1-10)
a needle arranged at the distal end of the barrel;
(needle 30; fig 1-10)
and a removable needle shield having a proximal end comprising at least one complimentary grasping feature and a distal end, the needle shield configured to at least partially surround the needle,
(cap 32 having edge 32p and surrounding needle 30; fig 1-10)
wherein the step of inserting comprises moving the syringe towards the distal end of the lower housing along the longitudinal axis such that the at least one grasping feature of the retainer is spaced longitudinally and located proximally of the at least one complementary grasping feature of the needle shield;
(paragraph 101-106; syringe 26 is moved longitudinally such that resisting end 46r occupies a different space from edge 32p, therein is spaced longitudinally, and end 46r is shown as being proximal of edge 32p; fig 7-8)
and placing an upper assembly comprising an upper housing on the lower assembly.
(see examiner's annotation of Dugand fig 1 below, denoting the upper assembly and its housing on the support 34)
Dugand discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the distal end of the cap remover comprising at least one opening therethrough; -- a radially-most exterior outer sidewall of the cap remover that defines the at least one opening therethrough at the distal end of the cap remover
However, Dugand teaches an alternative embodiment comprising:
the distal end of the cap remover comprising at least one opening therethrough; -- a radially-most exterior outer sidewall of the cap remover that defines the at least one opening therethrough at the distal end of the cap remover
(fig 11-20 demonstrate that member 40 has a distal opening at its distal end 40d, defined by its radially most outerwall, enabling visual confirmation of the presence of cap 32 and member 78)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Dugand’s alternative embodiment’s teachings of a cap remover with a distal end opening in the cap remover of the primary embodiment of Dugand in order to advantageously arrive at an invention which enables an operator to examine the invention after assembly and visually verify the presence of certain components, like the cap 32 and slide 42, improving the efficacy of quality control checks during the invention’s assembly process and enabling an end-user to verify the invention is sterile and compliant with safety standards.
Regarding claim 10, the modified invention of Dugand discloses:
The method of claim 9, wherein the at least one grasping feature of the retainer is a projection configured to engage a proximal edge of the needle shield, and wherein the step of inserting the syringe into the lower assembly comprises urging the syringe distally such that the at least one projection is positioned proximally and is longitudinally spaced from the proximal edge of the needle shield.
(paragraph 101-106; syringe 26 is moved longitudinally such that resisting end 46r, therein a projection, on extractor 46 on slide 42 occupies a different space from edge 32p on cap 32, therein is spaced longitudinally, and end 46r is shown as being proximal of edge 32p; fig 7-8
Regarding Claim 13,
The modified invention of Dugand discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 10, wherein the proximal end of the syringe barrel comprises a flange
(the flange (not enumerated) of syringe 26 of the embodiment of fig 1-10, is best illustrated in fig 16+20)
However, presently modified invention of Dugand is silent regarding:
the proximal end of the lower housing comprises a ring.
However, Dugand teaches in its alternative embodiment, particularly fig 20, that a flange of the syringe is supported on its distal side by a lower structure, illustrated as a ring shape wrapping around the flange, in lower housing assembly, support 34.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Dugand’s alternative embodiments teachings of structures within an autoinjector supporting a disposed syringe such that the presently modified invention of Dugand has a likewise disposed on its lower assembly housing to support the flange of Dugand’s syringe, and therein advantageously arrive at an invention with improved means for stabilizing a syringe within a house and consequently decreasing the likelihood the syringe becomes dislodged during incidental drops/damage during shipping after assembly.
Regarding claim 14, the modified invention of Dugand teaches:
The method of claim 13, wherein, after insertion of the syringe, the syringe flange abuts the ring.
Examiner notes that in light of the modification of Dugand made in claims above, the claimed flange of the modified invention of Dugand abuts the claimed ring of Dugand after the syringe 26 has been inserted.
Regarding claim 16, the modified invention of Dugand discloses:
The shield removal assembly of claim 1, wherein the cap remover is configured to be grasped by the user by the radially-most exterior outer sidewall of the cap remover having an ergonomic gripping surface.
(paragraph 79-81; gripping member 40 intended to be maneuvered by a user, therein having an ergonomic gripping surface; fig 1-10)
Regarding claim 17, the modified invention of Dugand discloses:
The method of claim 9, wherein the cap remover is grasped by a user by the radially-most exterior outer sidewall of the cap remover having an ergonomic gripping surface.
(paragraph 79-81; gripping member 40 intended to be maneuvered by a user, therein having an ergonomic gripping surface; fig 1-10)
Allowable Subject Matter
Claims 5, 11-12, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783
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