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 .
Claim Objections
Claims 15-17, 22-24, and 26-27 are objected to because of the following informalities:
-Claim 15, page 47, line 14: please correct “a proximal end” to “a proximal end of the housing”
-Claim 15, page 47, lines 14-15: please correct “a distal end” to “a distal end of the housing”
-Claim 15, page 47, line 23: please correct “the direction” to “a direction”
-Claim 15, page 47, line 27: please correct “the during” to “during”
-Claim 16, page 48, lines 6-7: please correct “the first end” to “a first end”
-Claim 16, page 48, line 7: please correct “the second end” to “a second end”
-Claim 17, page 48, line 15: please correct “a first end” to “a first end of the inclined surface”
-Claim 17, page 48, line 15: please correct “a second end” to “a second end of the inclined surface”
-Claim 17, page 48, line 15: please correct “the direction” to “a direction”
-Claim 22, page 49, lines 6-7: please correct “a proximal end” to “a proximal end of the slider body”
-Claim 22, page 49, line 7: please correct “a distal end” to “a distal end of the slider body”
-Claim 23, page 49, line 10: please correct “the body” to “the slider body”
-Claim 23, page 49, line 11: please correct “surface defined” to “surface is defined”
-Claim 24, page 49, line 15: please correct “a proximal end” to “a proximal end of the elongated plunger rod body”
-Claim 24, page 49, line 15: please correct “a distal end” to “a distal end of the elongated plunger rod body”
-Claim 24, page 49, line 17: please correct “the rest” to “a rest”
-Claim 24, page 49, line 17: please correct “the body” to “the elongated plunger rod body”
-Claim 24, page 49, line 18: please correct “the enlarged portion” to “the enlarged proximal part”
-Claim 24, page 49, line 18: please correct “the body” to “the elongated plunger rod body”
-Claim 26, page 49, line 26: please correct “the wall” to “a wall”
-Claim 26, page 49, lines 26-27: please correct “in first transverse direction” to “in the first transverse direction”
-Claim 26, page 49, line 27: please correct “a first end” to “a first end of the second inclined surface”
-Claim 26, page 49, line 27: please correct “a second end” to “a second end of the second inclined surface”
-Claim 26, page 49, line 30: please correct “the first end” to “the first end of the second inclined surface”
-Claim 26, page 49, line 30: please correct “the second end” to “the second end of the second inclined surface”
-Claim 27, page 50, line 2: please correct “a longitudinal axis” to “the longitudinal axis”
-Claim 27, page 50, lines 2-3: please correct “a proximal end” to “a proximal end of the housing body”
-Claim 27, page 50, line 3: please correct “a distal end” to “a distal end of the housing body”
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 17, 23, and 26 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.
Claim 17 recites the limitation "the inclined surface" on line 15 of page 48. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the inclined surface” in claim 17 should instead be interpreted as introducing “an inclined surface”, or whether claim 17 should be dependent upon claim 16 which introduces “an inclined surface” of the slider. For examination purposes, the Examiner interprets “the inclined surface” in claim 17 as “an inclined surface of the slider”.
Claim 23 recites the limitation "the inclined surface" on line 11 of page 49. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the inclined surface” in claim 23 should instead be interpreted as introducing “an inclined surface”, or whether claim 23 should be dependent upon claim 16 which introduces “an inclined surface” of the slider. For examination purposes, the Examiner interprets “the inclined surface” in claim 23 as “an inclined surface of the slider”.
Claim 26 recites the limitation "the body" on line 26 of page 49. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether “the body” in claim 26 should instead be interpreted as introducing “a body”, or whether claim 26 should be dependent upon claim 22 which introduces “a slider body” of the slider. For examination purposes, the Examiner interprets “the body” in claim 26 as “a slider body of the slider”.
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.
Claims 15-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tschirren et al. (US 2017/0136189 A1).
Regarding claim 15, Tschirren discloses a sub-assembly for a medicament delivery device (see Figs. 1-11c, par. [0079]), the sub-assembly comprising:
a housing (housing 2) (see Fig. 1, par. [0080]);
a slider (displacement unit 11) (see Fig. 1, par. [0092]);
an actuator (first spring 9 and retaining element 6) (see Fig. 1, par. [0091]); and
a plunger rod (plunger rod 7) (see Fig. 1, par. [0085], [0091]),
wherein the slider (displacement unit 11), the actuator (first spring 9 and retaining element 6), and the plunger rod (plunger rod 7) are all at least partially arranged within the housing (housing 2) (see Figs. 1-2c),
wherein the housing (housing 2) extends along a longitudinal axis (longitudinal axis L) between a proximal end and a distal end (see Figs. 1-2c, par. [0080]),
wherein the housing (housing 2) comprises a retaining ledge (housing insert 12) extending in a first transverse direction transverse to the longitudinal axis (longitudinal axis L) from a wall of the housing (housing 2) (see Figs. 1-2c, par. [0080], [0092]),
wherein the slider (displacement unit 11) comprises a holding surface (inner surface of second engagement element 11b) and a retaining surface (outer surface of second engagement unit 11b) (see Figs. 1-2c, par. [0092], [0094]),
wherein the holding surface (inner surface of second engagement unit 11b) is a distally directed surface (see Figs. 1-2c, par. [0092], [0094]),
wherein the retaining surface (outer surface of second engagement unit 11b) is a proximally directed surface (see Figs. 1-2c, par. [0092], [0094]),
wherein the retaining surface (outer surface of second engagement unit 11b) of the slider (displacement unit 11) is adjacent to the retaining ledge (housing insert 12) of the housing (housing 2) (see Figs. 1-2c, par. [0080], [0092], [0094]),
wherein the actuator (first spring 9 and retaining element 6) is movable relative to the housing (housing 2) only in the direction of the longitudinal axis (longitudinal axis L) (see Fig. 1, par. [0091], [0094]),
wherein the plunger rod (plunger rod 7) comprises a counter holding surface (second recess 7b) (see Fig. 1, par. [0092], [0094]),
wherein the counter holding surface (second recess 7b) is a proximally directed surface (see Fig. 1),
wherein during use the actuator (first spring 9 and retaining element 6) is configured to move the slider (displacement unit 11), so that the slider (displacement unit 11) is linearly moved relative to the housing (housing 2) in a second transverse direction transverse to both the longitudinal axis (longitudinal axis L) and the first transverse direction between a holding position where the holding surface (inner surface of second engagement unit 11b) of the slider (displacement unit 11) is engaged with the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) and a released position where the holding surface (inner surface of second engagement unit 11b) of the slider (displacement unit 11) is disengaged with the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) (see Figs. 1-2c, par. [0092], [0094]).
Regarding claim 16, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the slider (displacement unit 11) comprises an inclined surface (surface of displacement unit 11 which receives force from first spring 9), wherein the actuator (first spring 9 and retaining element 6) comprises an actuating surface (surface of first spring 9 which gives force to displacement unit 11) (see Fig. 1, par. [0091], [0094]), wherein during use the actuating surface (surface of first spring 9 which gives force to displacement unit 11) is movable along the inclined surface (surface of displacement unit 11 which receives force from first spring 9) from the first end of the inclined surface (surface of displacement unit 11 which receives force from first spring 9) to the second end of the inclined surface (surface of displacement unit 11 which receives force from first spring 9), so that the slider (displacement unit 11) is linearly moved relative to the housing (housing 2) in the second transverse direction transverse to both the longitudinal axis (longitudinal axis L) and the first transverse direction between the holding position where the holding surface (inner surface of second engagement unit 11b) of the slider (displacement unit 11) is engaged with the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) and the released position where the holding surface (inner surface of second engagement unit 11b) of the slider (displacement unit 11) is disengaged with the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) (see Fig. 1, par. [0094]).
Regarding claim 17, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the inclined surface (surface of protrusion 11c is inclined) extends from a first end (one end of protrusion 11c) to a second end (other end of protrusion 11c) in the direction that is angled relative to both the longitudinal axis (longitudinal axis L) and to a plane transverse to the longitudinal axis (longitudinal axis L) (see Fig. 1, par. [0098]).
Regarding claim 18, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 16, wherein the inclined surface (surface of displacement unit 11 which receives force from first spring 9) faces towards the proximal end of the housing (housing 2) (see Fig. 1, par. [0094]), and wherein the actuating surface (surface of first spring 9 which gives force to displacement unit 11) faces towards the distal end of the housing (housing 2) (see Fig. 1, par. [0094]).
Regarding claim 19, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 16, wherein the actuator (first spring 9 and retaining element 6) comprises a body (proximal base of retaining element 6) and a protrusion (arms 6c) extending from a wall of the body (proximal base of retaining element 6) (see Fig. 1, par. [0091]), and wherein the actuating surface (surface of first spring 9 which gives force to displacement unit 11) of the actuator (first spring 9 and retaining element 6) is arranged on the protrusion (arms 6c) (see Figs. 1-2c, par. [0091], [0094]).
Regarding claim 20, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 19, wherein the slider (displacement unit 11) comprises a transverse surface (see Fig. 2b, interior surface of protrusion 11c which engages arms 6c) extending in the direction of the longitudinal axis (longitudinal axis L) and facing in the second transverse direction (see Fig. 2b), and wherein the protrusion (arms 6c) of the actuator (first spring 9 and retaining element 6) comprises a counter transverse surface (see Fig. 2b, exterior surface of arms 6c which engage protrusion 11c) that is configured to be adjacent to the transverse surface (see Fig. 2b, interior surface of protrusion 11c which engages arms 6c) of the slider (displacement unit 11) before the actuating surface (surface of first spring 9 which gives force to displacement unit 11) contacts the first end of the inclined surface (surface of displacement unit 11 which receives force from first spring 9) (see Figs. 1-2c, par. [0091], [0094]).
Regarding claim 21, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 20, wherein an interface formed between the holding surface (inner surface of second engagement unit 11b) of the slider (displacement unit 11) and the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) is a ramp surface (see Fig. 1, par. [0092], [0094]).
Regarding claim 22, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the slider (displacement unit 11) comprises a slider body (body of displacement unit 11) extending along the longitudinal axis (longitudinal axis L) between a proximal end (proximal end of body of displacement unit 11) and a distal end (distal end of body of displacement unit 11) (see Fig. 1).
Regarding claim 23, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 22, wherein the slider (displacement unit 11) comprises a ledge (protrusion 11c) extending from a surface of the body (body of displacement unit 11) in the first transverse direction (see Fig. 1), and wherein the inclined surface (surface of protrusion 11c is inclined) defined by the ledge (protrusion 11c) (see Fig. 1, par. [0098]).
Regarding claim 24, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the plunger rod (plunger rod 7) comprises an elongated plunger rod body (body of plunger rod 7) extending along the longitudinal axis (longitudinal axis L) between a proximal end (proximal end of body of plunger rod 7) and a distal end (distal end of body of plunger rod 7) (see Fig. 1), wherein the elongated plunger rod body (body of plunger rod 7) of the plunger rod (plunger rod 7) comprises an enlarged proximal part (portion of plunger rod 7 proximal of second recess 7b) (see Fig. 1, par. [0092], [0094]), wherein the enlarged proximal part (body of plunger rod 7) has a diameter greater than a diameter of the rest of the body (body of plunger rod 7) (see Fig. 1), and wherein the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) is arranged on a surface of the enlarged portion (portion of plunger rod 7 proximal of second recess 7b) of the body (body of plunger rod 7) (see Fig. 1, par. [0092], [0094]).
Regarding claim 25, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the counter holding surface (second recess 7b) of the plunger rod (plunger rod 7) comprises a first counter holding surface (horizontal portions of second recess 7b perpendicular to longitudinal axis L) and a second counter holding surface (vertical portions of second recess 7b parallel to longitudinal axis L) (see Fig. 1), and wherein the first counter holding surface (horizontal portions of second recess 7b perpendicular to longitudinal axis L) is contiguous with and axially offset relative to the second counter holding surface (vertical portions of second recess 7b parallel to longitudinal axis L) (see Fig. 1).
Regarding claim 26, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the slider (displacement unit 11) comprises a second inclined surface (surface of displacement unit 11 which receives force from first spring 9) extending from the wall of the body (body of displacement unit 11) in first transverse direction (see Fig. 1, par. [0094]), and extending from a first end to a second end in a direction that is angled relative to both the longitudinal axis (longitudinal axis L) and to a plane transverse to the longitudinal axis (longitudinal axis L) (see Fig. 1), wherein the actuator (first spring 9 and retaining element 6) comprises a second actuating surface (surface of first spring 9 which gives force to displacement unit 11), and wherein the second actuating surface (surface of first spring 9 which gives force to displacement unit 11) is axially movable along the second inclined surface (surface of displacement unit 11 which receives force from first spring 9) from the first end to the second end (see Fig. 1, par. [0091], [0094]).
Regarding claim 27, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 15, wherein the housing (housing 2) comprises a housing body (body of housing 2) extending along a longitudinal axis (longitudinal axis L) between a proximal end (proximal end of the body of housing 2) and a distal end (distal end of the body of housing 2) (see Fig. 1), and a flexible arm (lock-in catch 12c) attached to the proximal end (proximal end of the body of housing 2) of the housing body (body of housing 2) (see Fig. 1, par. [0080]).
Regarding claim 28, Tschirren discloses the sub-assembly of the medicament delivery device according to claim 27, wherein the flexible arm (lock-in catch 12c) extends from the housing body (body of housing 2) towards the longitudinal axis (longitudinal axis L) (see Fig. 1, par. [0080]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783