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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Element 132 in par. 0151 of the Specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) 4 is/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.
Regarding claim 4, the phrase "preferably by a form-locked engagement" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "preferably"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding claim 4, the phrase "for example by a snap fit connection" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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) 1-5, 7, 10, 13-14, 17, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsh et al. (US 2016/0051766).
Regarding claim 1, Marsh discloses
A cartridge holding unit (10/20, figs. 1-2 and pars. 0127-0129) comprising:
a cartridge container (10, fig. 2 and par. 0128) forming an outer surface of the cartridge holding unit (see fig. 2) and having an inner space (inner space of 10, see fig. 3); and
a cartridge holder (20) forming a tube-shaped holding section (see figs. 1-2) arranged in the inner space of the cartridge container (inner space of 10, see figs. 1-3),
the cartridge holder (20) configured to firmly hold a cartridge (130) in parallel with the cartridge holder (20, see fig. 3), and
the cartridge holder (20) and the cartridge container (10) are firmly coupled to each other regarding their axial orientations (see par. 0129 for 20 being permanently attached to 10).
Regarding claim 2, Marsh discloses
The cartridge holding unit according to claim 1, wherein the cartridge container (10) and the cartridge holder (20) are formed as two separate parts (see fig. 1 and par. 0127).
Regarding claim 3, Marsh discloses
The cartridge holding unit according to claim 2, wherein the cartridge container (10) and the cartridge holder (20) are non-detachably coupled to each other (see par. 0129 for 20 being permanently attached to 10).
Regarding claim 4, Marsh discloses
The cartridge holding unit according to claim 1, wherein the cartridge container (10) and the cartridge holder (20) are axially fixedly connected to each other (see par. 0129 for 20 being permanently attached to 10), preferably by a form-locked engagement, for example by a snap fit connection (Examiner notes: the limitation “preferably by a form-locked engagement, for example by a snap fit connection” is not positively recited in claim 4 and renders the claim indefinite as set forth above).
Regarding claim 5, Marsh discloses
The cartridge holding unit according to claim 2, wherein the cartridge container (10) and the cartridge holder (20) are firmly coupled to each other regarding their axial orientations by a form-locked engagement (see par. 0129 for 20 being permanently attached to 10, see also fig. 3 for the engagement between 20 and 10).
Regarding claim 7, Marsh discloses
The cartridge holding unit according to claim 2, wherein the cartridge holder (20) and the cartridge container (10) are rotationally fixed to each other (see par. 0129 for 20 being permanently attached to 10, see also fig. 3 for the engagement between 20 and 10).
Regarding claim 10, Marsh discloses
The cartridge holding unit according to claim 1, wherein the cartridge holder (20) forms a needle connector (threaded connector of 20, see fig. 2) at its proximal end (see fig. 2 and par. 0127), the needle connector (needle connector of 20) surrounding an opening at a proximal end of the cartridge holder (see figs. 2-3. Examiner notes: proximal direction is towards the injection site), and the opening is configured to receive a needle that is in fluid connection with an interior of the cartridge inserted into the cartridge holder (see figs. 2-3 and par. 0127. See also pars. 0005-0007).
Regarding claim 13, Marsh discloses
The cartridge holding unit according to claim 1, wherein the holding section of the cartridge holder (20) defines a cylindrical receptacle (see fig. 2).
Regarding claim 14, Marsh discloses
The cartridge holding unit according to claim 1, wherein an inner surface of the cartridge holder (20) is configured to be in areal contact with the cartridge (130) inserted into the cartridge holder (see fig. 3).
Regarding claim 17, Marsh discloses
The cartridge holding unit according to claim 1, wherein the holding section is configured to extend over at least 50% of a longitudinal length of an inserted cartridge (see figs. 2-3 for 130 being fully enclosed within the cartridge holder 20).
Regarding claim 19, Marsh discloses
A cartridge unit (see figs. 1-3) comprising: the cartridge holding unit (10/20, figs. 1-2 and pars. 0127-0129) according to claim 1; and a cartridge (130) inserted into the cartridge holder (see figs. 1-3).
Regarding claim 20, Marsh discloses
A reconstitution unit (figs. 1-3) comprising:
a cartridge holder unit (10/20, figs. 1-2 and pars. 0127-0129) according to at least one of the preceding claims; and
a connection section of a dosing mechanism (30) the cartridge container (10) forms a first thread (14, fig. 4a and par. 0128) and the connection section of the dosing mechanism (30) forms a corresponding second thread (31) engageable with each other to cause axial movement of the cartridge container relative to the connection section of the dosing mechanism (axial movement of 30 relative to 10 to deliver the dose, par. 0130) by rotating the cartridge container relative to the connection section of the dosing mechanism (par. 0130), the first thread (14) formed on an inner circumferential surface of the cartridge container (see fig. 4a and par. 0128) and the second thread (31) formed on an outer circumferential surface of the connection section of the dosing mechanism (see fig. 4a and par. 0130).
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) 6, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2016/0051766) in view of Veasey et al. (US 2018/0064876).
Regarding claim 6, Marsh discloses the cartridge holding unit according to claim 2, as set forth above, except for wherein the cartridge holder forms an axial fixation element engageable with an axial fixation element of the cartridge container, and one of the axial fixation elements is a circumferentially extending groove and the other one of the axial fixation elements is a circumferentially extending rib.
However, Veasey teaches a cartridge holder (20, fig. 1 and par. 0075) and a cartridge container (30, fig. 2 and par. 0075) wherein the cartridge holder (20) forms an axial fixation element (125, fig. 1 and par. 0082) engageable with an axial fixation element (135, fig. 2 and par. 0082) of the cartridge container (30), and one of the axial fixation elements is a circumferentially extending groove (see fig. 1 and par. 0082 for 125 being radially extending recess) and the other one of the axial fixation elements is a circumferentially extending rib (see fig. 2 and par. 0082 for 135 being protrusion).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh’s cartridge holding unit by adding a circumferentially extending groove to Marsh cartridge holder and adding a protrusion to Marsh cartridge container, as taught by Veasey, for the purpose of providing an axial interlock between the cartridge holder and the cartridge container (par. 0082 of Veasey).
Regarding claim 8, Marsh discloses the cartridge holding unit according to claim 7, as set forth above, except for wherein the cartridge holder forms a rotation fixation element engageable with a rotation fixation element of the cartridge container.
However, Veasey teaches a cartridge holder (20, fig. 1 and par. 0075) and a cartridge container (30, fig. 2 and par. 0075) wherein the cartridge holder (20) forms a rotation fixation element (27, fig. 1 and pars. 0090-0092) engageable with a rotation fixation element (37, fig. 2 and pars. 0090-0092) of the cartridge container (30).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh’s cartridge holding unit by adding a rotation fixation element to Marsh cartridge holder and adding a complementary-shaped rotation fixation element to Marsh cartridge container, as taught by Veasey, for the purpose of providing rotational interlock between the cartridge holder and the cartridge container (par. 0092 of Veasey).
Regarding claim 9, Marsh in view of Veasey discloses the cartridge holding unit according to claim 8,
Veasey further teaches wherein the cartridge holder (20) and the cartridge container (30) are rotationally fixed (par. 0092 of Veasey) to each other by a form-fitting engagement (figs. 1-2 and pars. 0090-0092) between the rotation fixation element (27) of the cartridge holder (20) and the rotation fixation element (37) of the cartridge container (30), and one of the rotation fixation elements is a radially protruding rib (see fig. 2 for 37 protruding radially inwardly) and the other one of the rotation fixation elements is a radially extending groove (see fig. 1 for 27 extending radially) for receiving the rib (see figs. 1-2).
Claim(s) 11, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2016/0051766) in view of Dittombee et al. (US 2022/0249325).
Regarding claim 11, Marsh discloses the cartridge holding unit according to claim 1, as set forth above, except for wherein the cartridge holder forms a slot extending in the axial direction, the slot enabling reversibly widening of the cartridge holder to axially insert a cartridge, and the slot extends until a distal end of the cartridge holder.
However, Dittombee teaches wherein the cartridge holder (140, fig. 7) forms a slot (167/168/169) extending in the axial direction (see fig. 7), the slot enabling reversibly widening of the cartridge holder to axially insert a cartridge (see fig. 7 and par. 0198 for the slot allowing the ends 176 and 178 to flex radially outwardly as the cartridge is inserted into), and the slot (167/168/169) extends until a distal end of the cartridge holder (see fig. 7. Examiner notes: distal direction is further away from the injection site).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh by adding a slot to Marsh cartridge holder, as taught by Dittombee, for the purpose of allowing the distal end of Marsh cartridge holder to flex radially outwardly as the cartridge is inserted in distal direction (par. 0198 of Dittombee) and also providing and enable visual inspection of the content of the cartridge (par. 0196 of Dittombee).
Regarding claim 15, Marsh discloses the cartridge holding unit according to claim 1, as set forth above, except for wherein the cartridge holder forms a cut-out for receiving a protrusion of an inserted cartridge, the cut-out is located circumferentially offset from a longitudinal slot of the cartridge holder, and the cut-out is a window in the tube-shaped holding section.
However, Dittombee teaches wherein the cartridge holder (140, fig. 7) forms a cut-out (168/169) for receiving a protrusion of an inserted cartridge (Examiner notes: the limitation “for receiving a protrusion of an inserted cartridge” is interpreted as functional limitation, and the limitation “an inserted cartridge” is not positively recited in claim 15. See figs. 6-7 for cut-outs 168 and 169 capable of receiving a protrusion of an inserted cartridge), the cut-out (168/169) is located circumferentially offset from a longitudinal slot (167) of the cartridge holder (140), and the cut-out is a window in the tube-shaped holding section (see pars. 0196).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh by adding a slot and cut-outs to Marsh cartridge holder, as taught by Dittombee, for the purpose of allowing the distal end of Marsh cartridge holder to flex radially outwardly as the cartridge is inserted in distal direction (par. 0198 of Dittombee) and also providing and enable visual inspection of the content of the cartridge (par. 0196 of Dittombee).
Regarding claim 16, Marsh in view of Dittombee discloses the cartridge holding unit according to claim 15,
Dittombee further teaches wherein borders of the cut-out (168/169) are configured to fully enclose a protrusion on an outer surface of an inserted cartridge to prevent rotation of the cartridge around a longitudinal axis thereof or axial movement of the cartridge along the longitudinal axis (Examiner notes: the limitation “configured to fully enclose a protrusion on an outer surface of an inserted cartridge to prevent rotation of the cartridge around a longitudinal axis thereof or axial movement of the cartridge along the longitudinal axis” is interpreted as functional limitation, and the limitations “an inserted cartridge” and “an outer surface of an inserted cartridge” are not positively recited in claim 16. See figs. 6-7 for cut-outs 168 and 169 capable of receiving and fully enclosing a protrusion on an outer surface of an inserted cartridge and therefore preventing movement of the cartridge when the cartridge is inserted into the cartridge holder).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2016/0051766) in view of Hemmingsen et al. (US 2023/0008805).
Regarding claim 12, Marsh discloses the cartridge holding unit according to claim 1, as set forth above, except for wherein, when the cartridge holder is firmly coupled to the cartridge container, a window formed in the cartridge holder is aligned with a window in the cartridge container so that a cartridge arranged inside the cartridge holder is viewable through the windows.
However, Hemmingsen teaches when the cartridge holder (20) is firmly coupled to the cartridge container (10), a window (23) formed in the cartridge holder (20) is aligned with a window (13) in the cartridge container (10) so that a cartridge arranged inside the cartridge holder is viewable through the windows (see par. 0146).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh by adding a window to Marsh cartridge holder and adding a window to Marsh cartridge container, as taught by Hemmingsen, for the purpose of allowing the user to be able to visually inspect the content of the cartridge (par. 0146 of Hemmingsen).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marsh et al. (US 2016/0051766) in view of Moeller (US 2021/0330890).
Regarding claim 18, Marsh discloses the cartridge holding unit according to claim 1, as set forth above, except for wherein the cartridge holder has a connection element configured to connect to a dosing mechanism, the connection element comprises a thread, and the connection element extends into an annular space in between the cartridge holder and the cartridge container.
However, Moeller teaches wherein the cartridge holder (10, fig. 2) has a connection element (see annotated fig. 2 below) configured to connect to a dosing mechanism (Examiner notes: the limitation “configured to connect to a dosing mechanism” is interpreted as functional limitation, and the limitation “a dosing mechanism” is not positively recited in claim 18. See fig. 2 for 10 connecting to the whole system via threaded connection between 10 and 1), the connection element comprises a thread (see annotated fig. 2 below), and the connection element extends into an annular space in between the cartridge holder (10) and the cartridge container (1, see fig. 3 for the connection between 10 and 1).
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It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Marsh by adding a thread to Marsh cartridge holder and adding a thread to Marsh cartridge container, as taught by Moeller, for the purpose of providing connection between the cartridge holder and the cartridge container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783