Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 are examined in this office action.
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) 1-3, 5-9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell et al. (US Pub No. 20010044608 A1) in view of Christie et al. (US Pub No. 20230157927 A1).
Regarding claim 1, Odell in view of Christie discloses a needle cover (Odell, needle sheath 24, Fig. 10) for an injection device (Odell, syringe assembly 20, Fig. 1), comprising:
a needle cover body (Odell, needle sheath 24, Fig. 10) having a longitudinal axis (A) (Odell, See annotated Fig. 11) extending between a proximal end (Odell, first end 42, Fig. 3) and a distal end (Odell, second end 44, Fig. 3), the needle cover body having a cavity (Odell, cavity 40, Fig. 3) extending into the needle cover body from the proximal end thereof (Odell, Fig. 3), the cavity defined by an inner surface of the needle cover body (Odell, inner surface 52, Fig. 3) (Odell, "The cavity 40 has an inner surface 52, Fig. 3), the cavity configured to receive a distal end of an injection device therein (Odell, "The first end 42 defines the cavity opening and is received over the neck portion 28." - Para [0022]), the cavity comprising:
a first portion (Odell, See annotated Fig. 11) having a width measured perpendicular to the longitudinal axis (A) (Odell, See annotated Fig. 11); and
a second portion (Odell, See annotated Fig. 11) located distally relative to the first portion and having a width measured perpendicular to the longitudinal axis (A) that is less than the width of the first portion (Odell, See annotated Fig. 11), the first portion and the second portion configured such that, when the needle cover is disposed on an injection device, the second portion is at least partially engaged with a distal end of the injection device (Odell, Fig. 2);
Odell does not expressly disclose that wherein the inner surface of the needle cover body defining the second portion has a surface roughness extending in a range from 2 µm to 12 µm, inclusive.
Christie teaches that wherein the inner surface of the needle cover body defining the second portion has a surface roughness extending in a range from 2 µm to 12 µm, inclusive ("… the upper sealing surface 110 comprises a surface roughness that is greater than or equal to a threshold value (e.g., 3 microns, 5 microns, 10 microns) …" - Para [0147]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include that wherein the inner surface of the needle cover body defining the second portion has a surface roughness extending in a range from 2 µm to 12 µm, inclusive as taught by Christie to prevent stopper from pulling away from the upper sealing surface (Christie, Para [0146]).
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Regarding claim 2, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the inner surface defining the second portion (Odell, inner surface 52, Fig. 3) (Odell, See annotated Fig. 11 above) comprises a plurality of reliefs extending into the needle cover body (Odell, "In FIG. 9, a plurality of ridges 60 are formed on the inner surface 52 of the cavity 40." - Para [0029], Fig. 9).
Regarding claim 3, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the plurality of reliefs (Odell, ridges 60, Fig. 11) are distributed along a length of the second portion and about a perimeter of the second portion (Odell, "In FIG. 9, a plurality of ridges 60 are formed on the inner surface 52 of the cavity 40." - Para [0029]).
Regarding claim 5, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the plurality of reliefs (Odell, plurality of ridges 60, Fig. 11) are orderly distributed along the inner surface of the needle cover body (Odell, "In FIG. 9, a plurality of ridges 60 are formed on the inner surface 52 of the cavity 40." - Para [0029]).
Regarding claim 6, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the needle cover body (Odell, needle sheath 24, Fig. 10) comprises an elastomeric material (Odell, "The needle sheath can be formed of materials such as thermoplastic elastomers …" - Abstract).
Regarding claim 7, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the cavity (Odell, cavity 40, Fig. 3) further comprises a third portion (Odell, See annotated Fig. 11 above) located distally relative to the second portion (Odell, See annotated Fig. 11 above), the third portion configured such that, when the needle cover is disposed on the injection device (Odell, Fig. 2), the third portion is sealingly engaged with a needle of the injection device (Odell, "The cavity receives the needle cannula …" - Para [0007]).
Regarding claim 8, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the inner surface of the needle cover body of the first portion (Odell, See annotated Fig. 11 above).
Odell does not expressly disclose that the inner surface of the first portion is a smooth surface, the smooth surface having a surface roughness greater than or equal to 0 µm and less than 2 µm.
Christie teaches that the inner surface of the first portion is a smooth surface, the smooth surface having a surface roughness greater than or equal to 0 µm and less than 2 µm ("… may comprise a surface roughness that is less than or equal to a threshold value (e.g., .1 micron …" - Para [0146]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include that the inner surface of the first portion is a smooth surface, the smooth surface having a surface roughness greater than or equal to 0 µm and less than 2 µm as taught by Christie to prevent stopper from pulling away from the upper sealing surface (Christie, Para [0146]).
Regarding claim 9, Odell in view of Christie discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
the inner surface of the needle cover body of the first portion (Odell, inner surface 52, Fig. 3) comprises a plurality of features (Odell, 54, Fig. 3) different from the plurality of reliefs (Odell, ridges 60, Fig. 9)
Odell does not expressly that the inner surface of the first portion has a surface roughness extending in a range from 2 µm to 100 µm, inclusive.
Christie teaches that the inner surface of the first portion has a surface roughness extending in a range from 2 µm to 100 µm, inclusive ("… the upper sealing surface 110 comprises a surface roughness that is greater than or equal to a threshold value (e.g., 3 microns, 5 microns, 10 microns) …" - Para [0147]).
Therefore, it would have been obvious, before the effective fling date of the claimed invention, to modify the needle cover of Odell to include that the inner surface of the first portion has a surface roughness extending in a range from 2 µm to 100 µm, inclusive as taught by Christie to prevent stopper from pulling away from the upper sealing surface (Christie, Para [0146]).
Regarding claim 11, Odell in view of Christie discloses an injection device (Odell, syringe assembly 20, Fig. 1) comprising:
a syringe (Odell, syringe assembly 20, Fig. 1) comprising a barrel (Odell, interior chamber 26, Fig. 1) having a medicament fluid (Odell, medicament 32, Fig. 1) disposed therein, a hub disposed at a distal end of the barrel (Odell, neck portion 28, Fig. 1), and a needle coupled to a distal end of the hub (Odell, needle cannula 46, Fig. 2); and
the needle cover according to claim 1 (Odell, needle sheath 24, Fig. 10) disposed on a distal end of the syringe (Odell, Fig. 1) such that at least a part of the inner surface of the needle cover body is in contact with and sealingly engaged with the needle (Odell, “The cavity receives the needle cannula …” – Para [0007]) and an exterior surface of the distal end of the syringe (Odell, neck portion 28, Fig. 2).
Claim(s) 4, 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell et al. (US Pub No. 20010044608 A1) in view of Christie et al. (US Pub No. 20230157927 A1) and Okihara (US Patent No. 12318596 B2).
Regarding claim 4, Odell in view of Christie and Okihara discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
Odell in view of Christie does not expressly disclose that the plurality of reliefs are randomly distributed along the inner surface of the needle cover body.
Okihara teaches that the plurality of reliefs are randomly distributed along the inner surface of the needle cover body ("An inner peripheral surface of the cover member 36 has a rough surface section 104 roughened (i.e., having an uneven or an irregular surface) …" - Col. 8 Line 40).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include that the plurality of reliefs are randomly distributed along the inner surface of the needle cover body as taught by Okihra to reliably visually recognize the second space (Okihara, Col. 9 Line 10).
Regarding claim 10, Odell in view of Christie and Okihara discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, further comprising
Odell in view of Christie does not expressly disclose a rigid shield in which the needle cover body is disposed.
Okihara teaches a rigid shield (cap 10, Fig. 3) in which the needle cover body (cap body 34, Fig. 3) is disposed.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell in view of Christie to include a rigid shield in which the needle cover body is disposed as taught by Okihara to seal the drug discharge port (Okihara, Col. 9 Line 30).
Regarding claim 14, Odell in view of Christie and Okihara discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, comprising
Odell does not expressly disclose injection molding the needle cover body using a mold having a surface roughness in a range from 2 µm to 12 µm, inclusive.
Christie teaches injection molding the needle cover body using a mold having a surface roughness in a range from 2 µm to 12 µm, inclusive ("… the upper sealing surface 110 comprises a surface roughness that is greater than or equal to a threshold value (e.g., 3 microns, 5 microns, 10 microns) …" - Para [0147]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include injection molding the needle cover body using a mold having a surface roughness in a range from 2 µm to 12 µm, inclusive as taught by Christie to prevent stopper from pulling away from the upper sealing surface (Christie, Para [0146]).
Christie does not expressly disclose injection molding the needle cover body using a mold.
Okihara teaches injection molding the needle cover body using a mold ("… injection molding … of the tubular member 50 …" - Col. 7 Line 25).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include injection molding the needle cover body using a mold as taught by Okihara to in order to form one continuous inner peripheral surface (Okihara, Col. 11 Line 25).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odell et al. (US Pub No. 20010044608 A1) in view of Christie et al. (US Pub No. 20230157927 A1) and Sanchez et al. (US Pub No. 20220288315 A1).
Regarding claim 12, Odell in view of Christie and Sanchez discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
Odell in view of Christie does not expressly disclose that the barrel is made of glass.
Sanchez teaches that the barrel (drug storage container 20, Fig. 3) is made of glass ("The drug storage container 20 may include a rigid wall … the wall may be made of glass …" - Para [0050]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell in view of Christie to include that the barrel is made of glass as taught by Sanchez in order to expel the drug from the reservoir (Sanchez, Para [0050]).
Regarding claim 13, Odell in view of Christie and Sanchez discloses the needle cover (Odell, needle sheath 24, Fig. 10) as recited above, wherein
Odell in view of Christie does not expressly disclose a pull out force for removing the needle cover from the syringe is in a range from 7N to 16N, preferably 7-10 or 10-15 N, when measured between 0 and 90 days after the needle cover is subjected to a sterilization process.
Sanchez teaches a pull out force for removing the needle cover from the syringe is in a range from 7N to 16N, preferably 7-10 or 10-15 N ("…to remove the removable cap 19 from the housing 12 via axial force/movement (e.g., "straight pull-force") a user may be required to exert … approximately 10 to 15 Newtons …" - Para [0067]), when measured between 0 and 90 days after the needle cover is subjected to a sterilization process.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the needle cover of Odell to include a pull out force for removing the needle cover from the syringe is in a range from 7N to 16N, preferably 7-10 or 10-15 N, when measured between 0 and 90 days after the needle cover is subjected to a sterilization process as taught by Sanchez for facilitating and/or easing removal of the cap (Sanchez, Para [0067]).
Examiner interprets the needle cover from Odell to be sterilized and then tested using the method from Sanchez. Additionally, it would have been obvious to include the number of days after sterilization that the needle cover is tested since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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