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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 25, 2026, has been entered.
Acknowledgments
In the reply, filed on August 25, 2026, Applicant amended claims 10, 18-19, and 22.
Applicant added new claims 23-24.
In the final rejection of July 2, 2026, Examiner objected to claims 10 and 19. Applicant amended claims 10 and 19. Objection is withdrawn.
Examiner rejected claims 10-12, 16-20, and 22 under 35 U.S.C. 112(b). Applicant amended claims 10, 19, and 22. Objection is withdrawn.
Claim Objections
Claims 11, 18, and 24 are objected to because of the following informalities:
In regards to claim 11, line 2, “an inner surface” should be changed to “the inner surface”.
In regards to claim 18, line 2, “the side walls of the filling sleeve is arranged” should be changed to “the side walls of the filling sleeve are arranged”.
In regards to claim 18, line 3, “the side walls is provided” should be changed to “the side walls are provided”.
In regards to claim 24, line 3, “with openings” should be changed to “openings”.
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.
Claim 23 is 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.
In regards to claim 23, line 1 recites: The medicament delivery device of claim 1. However, claim 1 is a cancelled claim. Thus, the dependency of claim 23 is unclear. For the purposes of examination, claim 23 is being examined as if dependent upon claim 10.
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.
Claims 10-12, 16-20, and 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bostrom (WO 2018/091257).
In regards to claim 10, Bostrom teaches a medicament delivery device (Figures 1- 18) comprising:
a housing (10)
a plunger rod (96) biased in a proximal direction of the medicament delivery device
a plunger holder (80) configured to receive the plunger rod and to radially engage with the plunger rod, wherein the plunger holder is configured to be biased in the proximal direction, and wherein the plunger holder has a radial recess (86)
an inner body (106) arranged radially outside the plunger holder and provided with a radially flexible gripping member (112) configured to engage with the radial recess to hold the plunger holder in a fixed axial position and with an inner sleeve (108) and an outer sleeve (114), the outer sleeve contacting an inner surface of the housing, wherein the inner sleeve and the outer sleeve are arranged concentrically
a movable sleeve (48) configured to be moved axially in the housing from a first position relative to the housing, towards which the movable sleeve is biased, to a second position
wherein the movable sleeve has a blocking wall (56) which in the first position is arranged radially outside the gripping member and which is prevented from flexing radially outwards by a radially inwards directed force applied onto the blocking wall by the housing, thereby preventing the gripping member to flex radially outwards and disengage from the recess, and wherein the movable sleeve has a radial opening (58) arranged proximally relative to the blocking wall, the radial opening being configured to align axially with the gripping member in the second position of the movable sleeve to allow the gripping member to flex radially outwards and release the plunger holder
a filling sleeve (130) arranged radially outside of the movable sleeve and the radially flexible gripping member so that the filling sleeve is arranged in a radial space between the inner sleeve and the outer sleeve of the inner body, wherein the filling sleeve comprises side walls (132) arranged to bear against the blocking wall of the movable sleeve when the movable sleeve is in the first position, wherein the sides walls are prevented from radial movement by the outer sleeve of the inner body and by the inner surface of the housing which bears against the outer sleeve
a rear cap (138) configured to be connected to the inner body
In regards to claim 11, Bostrom teaches wherein the blocking wall extends between the gripping member and an inner surface of the housing or a radially outwards arranged surface of the inner body to restrict the radial flexing of the blocking wall (Figure 5B).
In regards to claim 12, Bostrom teaches wherein the blocking wall extends all the way to the inner surface of the housing or to the radially outwards arranged surface (Figure 5B).
In regards to claim 16, Bostrom teaches wherein the filling sleeve is provided with a plurality of outer sleeve ribs, wherein the outer sleeve ribs extend all the way to the inner surface of the housing or the radially outwards arranged surface (Figure 7b).
In regards to claim 17, Bostrom teaches wherein the filling sleeve has an axial through-opening configured to receive a distal end portion of the movable sleeve when the movable sleeve is moved towards the second position (Figure 8).
In regards to claim 18, Bostrom teaches wherein the side walls of the filling sleeve is arranged radially outside the blocking wall when the movable sleeve is in the first position, wherein the side walls is provided with a filling sleeve opening (134) arranged proximally relative to a surface of the side walls that prevents the blocking wall to flex radially outwards in the first position of the movable sleeve, wherein the radial opening is configured to axially align with the filling sleeve opening in the second position of the movable sleeve.
In regards to claim 19, Bostrom teaches a medicament delivery device (Figures 1-18) comprising:
a housing (10)
a plunger rod (96)
a plunger holder (80) comprising a radial recess (86), wherein the plunger holder radially engages the plunger rod and wherein the plunger holder is biased in a proximal direction
an inner body (106) surrounding the plunger holder and comprising a radially flexible gripping member (112) that engages the radial recess holding the plunger holder in a fixed axial position, wherein the inner body has an inner sleeve (108) and an outer sleeve (114) arranged concentrically
a movable sleeve (48) biased and movable axially relative to the housing from a first position to a second position
a filling sleeve (130) arranged radially outside the movable sleeve and the radially flexible gripping member and further arranged in a radial space between the inner sleeve and the outer sleeve
a rear cap (138) configured to be connected to the inner body
wherein the movable sleeve has a blocking wall (56) which in the first position is positioned adjacent the gripping member preventing the gripping member from flexing radially outward and disengaging from the recess
wherein the movable sleeve has a radial opening (58) arranged proximally relative to the blocking wall, wherein the radial opening aligns axially with the gripping member when the movable sleeve is in the second position such that the gripping member flexes radially outwards releasing the plunger holder to move axially
In regards to claim 20, Bostrom teaches wherein the blocking wall exerts a radially inward directed force caused by engagement with an inside surface of the housing (Figure 5b).
In regards to claim 22, Bostrom teaches wherein the filling sleeve further extends between an outer surface of the blocking wall and an inner surface of the housing (Figure 5b).
In regards to claim 23, Bostrom teaches wherein the rear cap comprises proximally extending rear cap arms (144), and wherein the proximally extending rear cap arms include openings (146) configured to engage with radial protrusions of the inner body.
In regards to claim 24, Bostrom teaches wherein the rear cap comprises proximally extending rear cap arms (144), and wherein the proximally extending rear cap arms include with openings (146) configured to engage with radial protrusions of the inner body.
Response to Arguments
Applicant’s arguments with respect to claims 10-12, 16-20, and 22 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEFALI D PATEL whose telephone number is (571)270-3645. The examiner can normally be reached Monday-Friday 8:30am-4:30pm EST.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
