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 .
Claim Objections
Claim 15 is objected to because of the following informalities:
Please spell out what the symbol “/” means in line 7 of claim 15 , so that the usage of “ and/ or” ca neb searched.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 15-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groetzbach et al. (US 20190151565 A1) (“Groetzbach”) in view of Bendek (US 20170354789 A1)
Re claim 15, Groetzbach discloses a sub-assembly (Fig. 1-2i and Fig. 7a-c for the gripping sleeve) for a medicament delivery device (1, Fig. 1, ¶0078), comprising: a housing (1, ¶0078); a delivery member cover (7and or 1a, Fig. 2h, ¶0091) arranged in the housing (Fig. 2h) and configured to move axially in the housing from an extended position towards a retracted position (Fig. 2h, ¶0091 and wherein 7 moves from needle protecting to needle uncover), the delivery member cover having a radial wall provided with an axial through-opening (wall of 7 and lower opening of 7, ¶0091, Fig.2h); and a removable cap assembly (include 2, , 2a-f), the removable cap assembly comprising: a cap (2b) configured to be fitted to the delivery member cover and/or to the housing (Fig.2h), the cap having a proximal cap end (lower end of 2, Fig. 2h) and a distal cap end ( upper end of 2); a delivery member shield gripping sleeve (2d, Fig. 2i) having a radially flexible axially extending arm (2c), wherein the delivery member shield gripping sleeve is arranged in the cap (Fig. 1) and the delivery member shield gripping sleeve is configured to slide in the cap towards the distal cap end from an initial position in which the arm extends through the through-opening of the delivery member cover (Fig. 1), to a second position when the cap is pulled from the delivery member cover (Fig, 2h), wherein the cap assembly comprises an axial structure (2d) configured to extend parallel with the delivery member shield gripping sleeve (Fig. 2h) when the delivery member shield gripping sleeve is in the initial position (Fig. 1), but it fails to disclose that the that the structure is configured to restrict radial inwards movement of the arm so that the arm has a radial dimension that extends beyond a radial dimension of the through-opening, thereby preventing the delivery member cover to move towards the retracted position, and wherein the delivery member shield gripping sleeve is configured to move relative to the axial structure when the delivery member shield gripping sleeve is moved towards the second position, enabling the arm to flex radially inwards and move through the through-opening of the delivery member cover.
However, Bendek discloses a cap assembly (Fig. 5a-c) and wherein the cap (7’) comprises a structure (7’a, ¶0069) and the structure is configured to restrict radial inwards movement of the arm (9e., ¶0070, Fig. 5a) so that the arm has a radial dimension that extends beyond a radial dimension of the through-opening (Annotated Fig.5b of Bendek ), and wherein the delivery member shield gripping sleeve is configured to move relative to the axial structure when the delivery member shield gripping sleeve is moved towards the second position (Fig.5c, ¶0072), enabling the arm to flex radially inwards and move through the through-opening of the delivery member cover( capable to be move inside the through-opening , Fig. 5c).
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Annotated Fig.5b of Bendek
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the structure of Groetzbach so that the structure is configured to restrict radial inwards movement of the arm so that the arm has a radial dimension that extends beyond a radial dimension of the through-opening, thereby preventing the delivery member cover to move towards the retracted position, and wherein the delivery member shield gripping sleeve is configured to move relative to the axial structure when the delivery member shield gripping sleeve is moved towards the second position, enabling the arm to flex radially inwards and move through the through-opening of the delivery member cover as taught by Bendek for the purpose of controlling the delivery member shield gripping sleeve shape and ensuring gripping the removing cover (Bendek , ¶0072, Note that the arm of Groetzbach is attached to the needle cove see Fig, 2h and the structure is replaced with the one of Bendek so that the arm can be grip the needle cover as it moves out of the pen so that let the drug delivery cover to move to cover the needle ).
Re claim 16, Groetzbach discloses wherein the cap comprises a proximally directed radial stop surface (2e, ¶0081 and top surface of 2d) and the delivery member shield gripping sleeve comprises a distally directed sleeve radial surface facing (lower surface of 1a , Fig. 2h) and being axially spaced apart from the radial stop surface when the delivery member shield gripping sleeve is in the initial position (Fig. 1), the sleeve radial surface being configured to contact the radial stop surface when the delivery member shield gripping sleeve is in the second position (Fig. 2h).
Re claim 17, Groetzbach discloses wherein the delivery member shield gripping sleeve has an axial slot that is provided with the sleeve radial surface (2f, ¶0081, Fig. 2d), and the radial stop surface is provided on a radially inwards extending protrusion (2e, ¶0081) extending into the slot with a play to delimit axial movement of the delivery member shield gripping sleeve between the initial position and the second position (¶0081).
Re claim 18, Groetzbach discloses wherein the arm and the axial structure form a torsional snap fit with the radial wall (Fig. 2e).
Re claim 19, Groetzbach discloses wherein the arm is a first arm extending towards the distal cap end ( top arm, Fig. 7b) and forms part of a see-saw structure ( Fig. 7b), but it fails to disclose that the first arm comprising a radially flexible second arm extending axially towards the proximal cap end, wherein the axial structure is arranged radially outwards of the second arm urging the second arm radially inwards when the delivery member shield gripping sleeve is in the initial position, causing the first arm to flex radially outwards and obtain a radial dimension that is greater than a radial dimension of the through-opening.
However, Bendek discloses a cap assembly (Fig. 5a-c) and wherein the cap (7’) comprises a structure (7’a, ¶0069) and the first arm( 10, 9e’) comprising a radially flexible second arm (10) extending axially towards the proximal cap end,( left side) wherein the axial structure (12) is arranged radially outwards of the second arm (Fig. 5a) urging the second arm radially inwards (Fig. 5c) when the delivery member shield gripping sleeve is in the initial position (Fig. 5a), causing the first arm to flex radially outwards and obtain a radial dimension that is greater than a radial dimension of the through-opening (Annotated Fig.5b of Bendek ).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the structure of Groetzbach so that the first arm comprising a radially flexible second arm extending axially towards the proximal cap end, wherein the axial structure is arranged radially outwards of the second arm urging the second arm radially inwards when the delivery member shield gripping sleeve is in the initial position, causing the first arm to flex radially outwards and obtain a radial dimension that is greater than a radial dimension of the through-opening as taught by Bendek for the purpose of controlling the delivery member shield gripping sleeve shape and ensuring gripping the removing cover (Bendek , ¶0072)
Re claim 20, the modified Groetzbach discloses wherein the axial structure has an inclined inner surface (Bendek, 7a is tubular shape so it has an inclination around the diameter) configured to bear against and urge the second arm radially inward (Bendek , Fig. 5c), the inclined surface increasing a radial dimension of the axial structure in a direction towards the proximal cap end (Fig .5c, Bendek).
Re claim 21, the modified Groetzbach discloses wherein the delivery member shield gripping sleeve has a radially outwards extending sleeve flange defining the sleeve radial surface (surface 9 of Fig .5c, Bendek), and the radial stop surface extends radially inwards (9f’, Fig .5c, Bendek) and is arranged axially spaced apart from the sleeve radial surface when the delivery member shield gripping sleeve is in the initial position (Fig .5c, Bendek), the radial stop surface being configured to bear against the sleeve flange when the delivery member shield gripping sleeve is in the second position (Fig .5a, Bendek).
Re claim 22, the modified Groetzbach discloses wherein the axial structure is arranged radially inwards of the arm (Fig. 5c, Bendek).
Re claim 23, the modified Groetzbach discloses wherein the arm includes an inclined portion (9e’, Fig. 5c, Bendek) that gradually increases a radial dimension of the delivery member shield gripping sleeve in a direction towards a distal sleeve end of the delivery member shield gripping sleeve (Fig. 5c, Bendek) when the delivery member shield gripping sleeve is in the initial position (Fig. 5c, Bendek), the inclined portion having a maximum radial dimension that is greater than the radial dimension of the through-opening (Annotated Fig.5b of Bendek ).
Re claim 24, the modified Groetzbach discloses wherein the radial wall has a distally directed wall surface (close to 9f’, Fig. 5c, Bendek), wherein inclined portion is arranged distally relative to the distally directed wall surface when the delivery member shield gripping sleeve is in the initial position (Fig. 5c, Bendek).
Re claim 25, Groetzbach discloses wherein the delivery member shield gripping sleeve has radially inwards extending flexible tabs (2i, Fig. 1, Fig. 7b, ¶0095) configure to engage with a delivery member shield (5).
Re claim 26, Groetzbach discloses wherein the delivery member shield gripping sleeve extends out from the cap at the distal cap end (Fig. 2i), wherein the arm is arranged at a proximal portion of the delivery member shield gripping sleeve (Fig, 2i), and the tabs are arranged at a distal portion of the delivery member shield gripping sleeve (Fig. 2h).
Re claim 27, Groetzbach discloses, wherein the housing has a proximally facing surface (left1b) configured to bear against the cap when the cap is fitted to the delivery member cover (Fig. 1).
Re claim 28, Groetzbach discloses medicament delivery device comprising the sub-assembly as claimed in claim 15 (see the rejection of claim 1, Fig. 1 of Groetzbach).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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