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 .
Acknowledgments
In the reply, filed on April 29, 2026, Applicant amended claims 10-11, 16-19, and 22.
Applicant cancelled claim 15.
In the non-final rejection of February 23, 2026, Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 11, 15, 19, and 22. Applicant amended claims 11, 19, and 22, and cancelled claim 15; however, Applicant did not address all of the objections. Objection is maintained.
Claim Objections
Claims 10 and 19 are objected to because of the following informalities:
In regards to claim 10, line 14, “the sides walls” should be changed to “the side walls”.
In regards to claim 19, line 5, “the plunger rod holder” should be changed to “the plunger holder”.
In regards to claim 19, line 11, “a fillable sleeve” should be changed to “a filling sleeve”.
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.
Claims 10-12, 16-20, and 22 are 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 10, line 13 recites “the blocking wall”. There is insufficient antecedent basis for this limitation in the claim. Claims 11-12 and 16-18 are rejected by virtue of being dependent upon claim 10.
In regards to claim 10, line 17 recites “a blocking wall”. Claim 10, line 13 previously recites “the blocking wall”. It is unclear whether the two recitations are the same or different. Claims 11-12 and 16-18 are rejected by virtue of being dependent upon claim 10.
In regards to claim 10, line 19 recites “the blocking wall”. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 10, line 19. Claims 11-12 and 16-18 are rejected by virtue of being dependent upon claim 10.
In regards to claim 10, line 21 recites “the blocking wall”. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 10, line 21. Claims 11-12 and 16-18 are rejected by virtue of being dependent upon claim 10.
In regards to claim 11, line 2 recites “the blocking wall”. Claim 11 depends upon claim 10. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 11, line 2. Claims 12 and 16-18 are rejected by virtue of being dependent upon claim 11.
In regards to claim 11, line 4 recites “the blocking wall”. Claim 11 depends upon claim 10. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 11, line 4. Claims 12 and 16-18 are rejected by virtue of being dependent upon claim 11.
In regards to claim 12, line 2 recites “the blocking wall”. Claim 12 depends upon claim 11, which depends upon claim 10. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 12, line 2.
In regards to claim 18, line 2 and line 4 recite “a side wall”/“the side wall”. Claim 18 depends upon claim 11, which depends upon claim 10. Claim 10, line 13 previously recites “side walls”. It is unclear whether the two recitations are the same or different.
In regards to claim 18, line 2 recites “the blocking wall”. Claim 18 depends upon claim 11, which depends upon claim 10. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 18, line 2.
In regards to claim 18, line 4 recites “the blocking wall”. Claim 18 depends upon claim 11, which depends upon claim 10. Claim 10, line 13 previously recites “the blocking wall” and line 17 previously recites “a blocking wall”. It is unclear which blocking wall is referred to in claim 18, line 4.
In regards to claim 19, line 8 and line 12 recite “an inner”/“the inner”. It is unclear which component is being referred to by said term. Claims 20 and 22 are rejected by virtue of being dependent upon claim 19.
In regards to claim 22, line 2 recites “a filling sleeve”. Claim 22 depends upon claim 19. Claim 19, line 11 previously recites “a fillable sleeve”. It is unclear whether the two recitations are the same or different.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bostrom et al (US 9,656,025).
In regards to claim 10, Bostrom et al teaches a medicament delivery device (Figures 1-17) comprising:
a housing (2)
a plunger rod (20) biased in a proximal direction of the medicament delivery device (Figure 15)
a plunger holder (35) 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 (Figure 15), and wherein the plunger holder has a radial recess (column 11, line 29: notch)
an inner body (50) arranged radially outside the plunger holder and provided with a radially flexible gripping member (51) configured to engage with the radial recess to hold the plunger holder in a fixed axial position (Figure 9) and with an outer sleeve (labeled in Figure 6 below) contacting an inner surface of the housing (Figure 9)
a movable sleeve (45) configured to be moved axially in the housing from a first position relative to the housing, towards which the movable sleeve is biased (Figure 9), to a second position (Figure 12)
a filling sleeve (52/53) arranged radially outside of the movable sleeve, wherein the filling sleeve comprises side walls (53) arranged to bear against the blocking wall of the movable sleeve when the movable sleeve is in the first position (Figure 9), 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 (Figure 9)
wherein the movable sleeve has a blocking wall (49) 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 (Figure 9), and wherein the movable sleeve has a radial opening (46) 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 (Figures 12-15)
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In regards to claim 11, Bostrom et al 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 9).
In regards to claim 12, Bostrom et al teaches wherein the blocking wall extends all the way to the inner surface of the housing or to the radially outwards arranged surface (Figure 17).
In regards to claim 16, Bostrom et al teaches wherein the filling sleeve is provided with a plurality of outer sleeve ribs (52), wherein the outer sleeve ribs extend all the way to the inner surface of the housing or the radially outwards arranged surface (Figure 17).
In regards to claim 17, Bostrom et al teaches wherein the filling sleeve has an axial through-opening (Figure 6) configured to receive a distal end portion of the movable sleeve when the movable sleeve is moved towards the second position (Figure 17).
In regards to claim 18, Bostrom et al teaches wherein the filling sleeve has a side wall (53) arranged radially outside the blocking wall when the movable sleeve is in the first position (Figure 9), wherein the side wall is provided with a filling sleeve opening (Figure 6) arranged proximally relative to a surface of the side wall that prevents the blocking wall to flex radially outwards in the first position of the movable sleeve (Figure 9), wherein the radial opening is configured to axially align with the filling sleeve opening in the second position of the movable sleeve (Figure 12).
In regards to claim 19, Bostrom et al teaches a medicament delivery device (Figures 1-17) comprising:
a housing (2)
a plunger rod (20)
a plunger holder (35) comprising a radial recess (column 11, line 29: notch), wherein the plunger holder radially engages the plunger rod and wherein the plunger rod holder is biased in a proximal direction (Figure 15)
an inner body (50) surrounding the plunger holder and comprising a radially flexible gripping member (51) that engages the radial recess holding the plunger holder in a fixed axial position (Figure 9), wherein the inner body has an inner (53) and an outer sleeve (labeled in Figure 6 above) arranged concentrically
a movable sleeve (45) biased and movable axially relative to the housing from a first position (Figure 9) to a second position (Figure 12)
a fillable sleeve (3) arranged radially outside the movable sleeve and the radially flexible gripping member and further arranged in a radial space between the inner and the outer sleeve (Figure 17)
wherein the movable sleeve has a blocking wall (49) which in the first position is positioned adjacent the gripping member preventing the gripping member from flexing radially outward and disengaging from the recess (Figure 9)
wherein the movable sleeve has a radial opening (46) 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 (Figures 12-15)
In regards to claim 20, Bostrom et al teaches wherein the blocking wall exerts a radially inward directed force caused by engagement with an inside surface of the housing (Figure 9).
In regards to claim 22, Bostrom et al teaches a filling sleeve (52/53) positioned outside of the movable sleeve and the gripping member and extends between an outer surface of the blocking wall and an inner surface of the housing (Figure 17).
Response to Arguments
Applicant's arguments filed April 29, 2026, have been fully considered but they are not persuasive:
In regards to claim 10, Applicant argued: Applicant submits that these amendments teach elements which are substantive to the function of the present application and that the cited reference does not teach or suggest each and every element of amended claim 10 (Remarks, page 10). Examiner disagrees. Bostrom et al teaches an inner body (50) provided with an outer sleeve (labeled in Figure 6 above) contacting an inner surface of the housing (2) (Figure 9), and a filling sleeve (52/53) arranged radially outside of the movable sleeve (45), wherein the filling sleeve comprises side walls (53) arranged to bear against the blocking wall (49) of the movable sleeve when the movable sleeve is in the first position (Figure 9), 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 (Figure 9).
In regards to claim 19, Applicant argued: Applicant submits that these amendments teach elements which are substantive to the function of the present application and that the cited reference does not teach or suggest each and every element of amended claim 19 (Remarks, page 11). Examiner disagrees. Bostrom et al teaches wherein the inner body (50) has an inner (53) and an outer sleeve (labeled in Figure 6 above) arranged concentrically, and a fillable sleeve (3) arranged radially outside the movable sleeve (45) and the radially flexible gripping member (51) and further arranged in a radial space between the inner and the outer sleeve (Figure 17).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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