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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/10/2026 has been entered.
Response to Amendment
This office action is responsive to the claim amendments filed on 3/10/2026. As directed by the amendment: claims 1 have been amended; claims 11-15 have been withdrawn; and no claims have been added. Thus, claims 1-15 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 03/10/2026 with regards to newly presented amended limitations of claim 1 are not found persuasive. Applicant argues beginning pg. 5 line 24 US 2017/0354789 to Bendek “fails to disclose or suggest an inner member that is configured to remove a cap from an injector housing based on radial compression from the axial pressure force asserted by the activation member”. Fig. 4c demonstrates element 15 being removed with elements 9e rotated to a horizontal position due to the axial force of element 7a, in order to secure element 9f to the base of element 15. This demonstrates and radial compression of elements 9e due to the axial force of element 7a. Examiner notes without radial compression of elements 9e elements 9f would not grip and maintain that grip to remove element 15; they would slip off. Therefore, Applicant’s arguments are not found persuasive.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 4-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0354789 A1 to Bendek.
In regard to claim 1:
A cap remover (Figs. 4a-b elements 7 and 9), comprising: an outer member (Figs. 4a-b elements 7); an activation member (Figs. 4a-b element 7a) at least partially received within the outer member and configured to move relative to the outer member (Figs. 4a-b element 7a).
Element 7a is considered to move relative to the outer member as it moves with the outer member. Therefore, the movement of the activation member is directly related to the movement of the outer member in a 1 to 1 fashion.
An inner member positioned within the outer member (Figs. 4a-4c element 9) and configured to radially compress under an axial pressure force asserted by the activation member that moves the activation member from a first axial position to a second axial position, such that the inner member compresses from a first position to a second position (Figs. 4a-4c elements 9e and 9f. Paras. 52-54) such that the inner member is configured to remove the cap from an injector housing based on radial compression from the axial pressure force asserted by the activation member (Figs. 2 and 4a-4c elements 9, 9a-9g, inner member and subcomponents thereof, and 15. Element 15 considered to be the cap.)
Figs. 4a through 4c show the capability of element 9, and subcomponents thereof, to grip the cap due to axial force applied to elements 9e by element 7a as described in paras. 52-54. The axial force from element 7a is considered to squeeze elements 9e towards element 15 as show in Figs. 4a-4c. The axial force acting upon elements 9e causes them to rotate applying radial compression upon the outer shell of element 15. Thus element 9 and subcomponents thereof are considered fully capable of removing the cap from the injector housing.
In regard to claim 2:
The cap remover of claim 1, wherein, in the first position, the inner member has a first inner diameter (See annotated Fig. 4a below inner diameter of element 9f subcomponent of element 9) and, in the second position, the inner member has a second inner diameter, and wherein the second inner diameter is smaller than the first inner diameter (See annotated Fig. 4b below inner diameter of element 9f, smaller than first diameter).
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In regard to claim 4:
The cap remover of claim 1, wherein the inner member (Fig. 4b element 9) comprises a rubber gasket (Fig. 4b element 15 para. 65 “medicament delivery member shield 15 is made of a rubbery or flexible material,”. Considered a gasket as it performs the task of keeping the needle sterile, para. 3 “In order to protect and to keep the medicament delivery member sterile, the medicament delivery member may be provided with a medicament delivery member shield, or sheath, such as a Flexible Needle Shield (FNS) or a Rigid Needle Shield (RNS). The medicament delivery member shield may thus be attached to the medicament container to cover the medicament delivery member, during assembly of the medicament container or of the medicament delivery device.”)
In regard to claim 5:
The cap remover of claim 1, wherein the inner member (Figs. 4a-b element 9) comprises at least one resilient retaining arm (Figs. 4a-b elements 9e, para. 52 “Each of the first leg 9a and the second leg 9b has a respective proximal portion 9d extending longitudinally in the distal direction from the transverse portion 9c. The proximal portions 9d are parallel or essentially parallel with each other and thus parallel with the central axis of the gripping member 9. Each of the first leg 9a and the second leg 9b also has a respective distal portion 9e.”) that is configured to compress inwardly under the axial pressure force applied by the activation member (para. 54 “The distal portions 9e are radially flexible or elastic, so that when sufficiently large radial inward-pointing forces are applied to the distal portions 9e during assembly of the medicament delivery device 1, the distal portions 9e will be bent radially inwards, as indicated by the arrows in FIG. 2, so that the medicament delivery member shield grippers 9f are moved towards each other until the distal portions 9e are essentially parallel. The medicament delivery member shield grippers 9f may thereby engage with a medicament delivery member shield.”. Fig. 4b elements 9e flexed radially inward due to axial pressure force of activation member 7a).
In regard to claim 6:
The cap remover of claim 5, wherein the at least one retaining arm (Figs. 4a-b elements 9e) compresses in a radial direction under the axial pressure force asserted by the activation member (Figs. 4a-b elements 9e).
In regard to claim 7:
The cap remover of claim 5, wherein the inner member (Figs. 4a-b element 9) further comprises at least one retaining tab (Figs. 4a-b elements 9f) positioned on an end of the at least one retaining arm (para. 65 “shield grippers 9f”).
In regard to claim 8:
The cap remover of claim 5, wherein the at least one retaining tab (Fig. 2 elements 9f) extends inwardly relative to the at least one retaining arm (Fig. 2 elements 9f).
In regard to claim 9:
The cap remover of claim 6, wherein the inner member (Fig. 2 element 9) further comprises at least one stabilizing arm (See annotated Fig. 2 below).
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Annotated Fig. 2
In regard to claim 10:
The cap remover of claim 1, wherein at least a portion of the inner member is positioned between a proximal end of the activation member (See annotated Fig. 4b below) and an inner projection that extends inwardly from an inner surface of the outer member (See annotated Fig. 4b below).
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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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0354789 A1 to Bendek in view of US 2019/0151564 A1 to Schrul et al.
In regard to claim 3:
The cap remover of claim 1, taught by Bendek as described in parent claim rejection above.
Bendek does not appear to explicitly disclose the outer member retaining tab or activation member recess as claimed. Schrul teaches, wherein the activation member (Fig 2 element 25) defines at least one retaining recess (Fig. 2 element 27a), wherein the outer member (Fig. 1 element 20) comprises at least one retaining tab (Fig. 1 element 24), and wherein the activation member is held in the outer member in a non-activated position when the at least one retaining tab is held in the at least one retaining recess (Fig. 1 element 24 held within element 27a).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the activation member and outer member taught by Bendek to be separate parts held together by a retaining recess and retaining tab as taught by Schrul. This would have been motivated by Schrul para. 75 “At the end of the first sub-movement h, the cap 20, in particular its projection 24 strikes the axial stop of the removal element 25, in particular the distal end of the recess 27a”. This is considered to be a motivation as it would have provided a positive stop feedback point to the user. Such feedback would have alerted the user the activation member was fully pressed in and removal of the cap in the reverse direction could begin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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