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
Claim 28 is objected to because of the following informalities:
Regarding claim 28, “the start of an injection and/or an end click to provide an indication of the end of an injection” should be corrected to “a start of an injection and/or an end click to provide an indication of an end of an injection”. 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 26 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.
Regarding claim 26, the limitation of “a second further component” renders the claim unclear. A “first further component” is not introduced in claim 26, 25, or 16. Considering there is no “first further component” claimed in conjunction with the “second further component”, the amount of “further components” being present in the claimed invention is unclear.
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) 16-19 and 21-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plumptre (US 20160008549 A1).
Regarding claim 16, Plumptre discloses a sub-assembly for a medicament delivery device (feedback feature 2 for medicament delivery device 1, [0139]-[0140] & Fig. 3), the sub-assembly extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end (feedback feature 2 extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end, [0140] & see Fig. 3), the sub-assembly comprising: a plunger rod, the plunger rod comprising a proximally facing surface that faces towards the proximal end (driver 7 comprising a proximally facing surface on first feedback element 32, the proximal surface on the proximal end of flexible arm 20, that faces toward a proximal end, [0140] & Fig. 3); and
a feedback component (in an alternative embodiment of Fig. 3 as disclosed in [0144], a snap feature, snap dome 35, supported by second feedback element 42, a protrusion in the inner body 4, is included, see [0143]-[0144] & Fig. 3; snap feature 35 would be positioned in a configuration similar to the embodiment of Fig. 2; “The snap feature could be arranged between the driver 7 and the inner body 4.”, [0144]; the Examiner notes that the disclosed embodiment of Fig. 3 that employs a snap feature supported by element 42 is not illustrated; the structure of the snap feature is illustrated in Fig. 8A-8B; the Examiner also notes that, with respect to the embodiment of Fig. 2, Plumptre discloses that “a further feature could be added to the inner body 4 or the driver 7, which may be impacted by the first feedback element 32 in order to produce a more distinct noise.”, [0138]) comprising a distally facing surface facing towards the distal end (the distal surface of snap feature 35 that faces toward the distal end may be interpreted as a distally facing surface, see Fig. 8B),
so that when the plunger rod moves towards the proximal end during use of the medicament delivery device, the distally facing surface of the feedback component is engaged by the proximally facing surface of the plunger rod, is subsequently moved towards the proximal end by the plunger rod, and is finally disengaged from the proximally facing surface of the plunger rod (as drive member 7 moves proximally, the distal surface of snap feature 35, feature 35 being arranged between the driver 7 and the inner body 4, is engaged by the proximally facing surface of arms 20 and caused to flip inside out, or move toward the proximal end, [0135] and [0143]-[0144] & Fig. 3; the distal surface of snap feature 35 disengages from the proximally facing surface of arms 20 once driver 7 moves into a distal most position, [0135]), wherein the feedback component comprises a spring (spring 21, [0141] & Fig. 3).
Regarding claim 17, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the plunger rod comprises a protrusion, and the proximally facing surface of the plunger rod is on the protrusion (the proximal end of flexible arm 20, which sticks out in a radial direction, is a protrusion with the proximally facing surface positioned on the proximal end of flexible arm 20, [1040] & Fig. 3).
Regarding claim 18, Plumptre discloses all the limitations of claim 17. Plumptre further discloses the sub-assembly wherein the plunger rod comprises a flexible arm, and the protrusion is attached to the flexible arm (the proximal end of flexible arm 20 is attached to flexible arm 20, [0140] & Fig. 3).
Regarding claim 19, Plumptre discloses all the limitations of claim 18. Plumptre further discloses the sub-assembly wherein the protrusion is attached to a distal end of the flexible arm (the proximal end of flexible arm 20 is attached to the distal end of flexible arm 20, Fig. 3).
Regarding claim 21, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the proximally facing surface of the plunger rod is angled away from the longitudinal axis (as seen in Fig. 3, the proximally facing surface of element 32 is angled away from the longitudinal axis).
Regarding claim 22, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a proximally facing surface of a first further component (“second feedback element 42 is configured as a protrusion at the inner body 4.”, [0143]; protrusion 42 including a proximally facing surface, see Fig. 3), and wherein the distally facing surface of the feedback component is adjacent to the proximally facing surface of the first further component (the distal surface of snap feature 35 is next to, or adjacent, the proximally facing surface of protrusion 41 of inner body 4, see Fig. 3).
Regarding claim 23, Plumptre discloses all the limitations of claim 22. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a powerpack comprising the plunger rod (inner body 4 and driver 7 may be interpreted as a powerpack as driver 7 powers injection and is housed in inner body 4, [0019] and [0141] & Fig. 1 and 3), and the first further component is a component of the powerpack other than the plunger rod (inner body 4 is being interpreted as the first further component, [0165] & Fig. 14-15).
Regarding claim 24, Plumptre discloses all the limitations of claim 22. Plumptre further discloses the sub-assembly wherein the first further component is a housing (inner body 4 being a housing for components, [0126] & Fig. 3).
Regarding claim 25, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the feedback component comprises a proximally facing surface facing towards the proximal end (snap feature 35 includes a proximally facing surface facing toward the proximal end, see Fig. 8B).
Regarding claim 26, Plumptre discloses all the limitations of claim 25. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a distally facing surface of a second further component (distally facing surface of protrusion 42 of inner body 4, [0143] & Fig. 3), and wherein the proximally facing surface of the feedback component is arranged adjacent to the distally facing surface of the second further component (proximally facing surface of feature 35 is arranged adjacent to the distally facing surface of protrusion 42, a configuration similar to the illustrated embodiment of Fig. 2).
Regarding claim 27, Plumptre discloses all the limitations of claim 26. Plumptre further discloses the sub-assembly wherein the second further component is a housing (inner body 4 being a housing for components, [0126] & Fig. 3).
Regarding claim 28, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the feedback component provides an end click to provide an indication of the end of an injection ([0132, [0135]-[0136], and [0143]).
Regarding claim 29, Plumptre discloses a medicament delivery device (delivery device 1, abstract & Fig. 1) comprising the sub-assembly of claim 16 (see the rejection of claim 16 above).
Regarding claim 30, Plumptre discloses all the limitations of claim 29. Plumptre further discloses the medicament delivery device wherein the medicament delivery device is an autoinjector ([0030]).
In an alternate interpretation of the prior art, regarding claim 16, Plumptre discloses a sub-assembly for a medicament delivery device (feedback feature 2 and assembly 60 of drug delivery device 1, [0165] & Fig. 1 and 14-15), the sub-assembly extending along a longitudinal axis in a longitudinal direction from a proximal end to a distal end (assembly 60 extends along a longitudinal axis in a longitudinal direction from a proximal end to a distal end as seen in Fig. 14-15), the sub-assembly comprising: a plunger rod, the plunger rod comprising a proximally facing surface that faces towards the proximal end (driver 7 comprising castellations 46, which include a proximally facing surface, the bottom surface of castellations 46, that faces toward the proximal end, [0166] & Fig. 14); and
a feedback component (sleeve member 25, which includes snap feature 35 which is attached to sleeve member 25, and spring 21, see [0166]-[0168] & Fig. 14-15) comprising a distally facing surface facing towards the distal end (sleeve member 25 comprising castellations 47, which include a distally facing surface, the top surface of castellations 47, that face toward the distal end, [0166] & Fig. 14; alternatively, the distal surface of snap feature 35 that faces toward the distal end may be interpreted as a distally facing surface, [0166] & Fig. 8B and 14-15), so that when the plunger rod moves towards the proximal end during use of the medicament delivery device, the distally facing surface of the feedback component is engaged by the proximally facing surface of the plunger rod, is subsequently moved towards the proximal end by the plunger rod, and is finally disengaged from the proximally facing surface of the plunger rod (as drive member 7 moves proximally, the distal surface of castellations 47 are engaged by the proximal surface of castellations 46 causing sleeve member 25 to move toward the proximal end, [0168] & Fig. 14-15; the distal surface of castellations 47 are disengaged from the proximal surface of castellations 46 at the end of injection, [0169] & Fig. 14-15; alternatively, as drive member 7 moves proximally, snap feature 35, which is attached to sleeve member 25, is caused to move toward the proximal end, [0167]-[0168] & Fig. 14-15; the distal surface of snap feature 35 may be interpreted as engaged by the proximal surface of castellations 46 as castellations 46 become operatively connected to snap feature 35 to transmit force and motion to snap feature 35 through sleeve member 25, [0167]-[0168] & Fig. 14-15; the distal surface of snap feature 35 is disengaged from the proximal surface of castellations 46 at the end of injection, as castellations 46 are no longer driving motion of snap feature 35 proximally, [0169] & Fig. 14-15), wherein the feedback component comprises a spring (spring 21, [0166] & Fig. 14-15).
Regarding claim 17, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the plunger rod comprises a protrusion, and the proximally facing surface of the plunger rod is on the protrusion (castellations 46 are being interpreted as protrusions of drive member 7, [0166] & Fig. 14).
Regarding claim 21, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the proximally facing surface of the plunger rod is angled away from the longitudinal axis (as seen in Fig. 14, the proximally facing surface of castellations 46 is curved along its edges; the outward most curve of the proximal surface of castellations 46 is angled away from the longitudinal axis).
Regarding claim 22, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a proximally facing surface of a first further component (second ridge 41 comprising a proximally facing surface, [0165] & see Fig. 15; housing 4 is being interpreted as a first further component, [0165] & Fig. 15), and wherein the distally facing surface of the feedback component is adjacent to the proximally facing surface of the first further component (the distal surface of snap feature 35 is adjacent second ridge 41 of housing 4, [0165] and [0169] & Fig. 14-15).
Regarding claims 23 and 24, Plumptre discloses all the limitations of claim 22. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a powerpack comprising the plunger rod (housing 4 and drive member 7 may be interpreted as a powerpack as drive member 7 powers injection and is housed in housing 4, [0019] and [0120] & Fig. 1 and 14-15), and the first further component is a component of the powerpack other than the plunger rod (housing 4 is being interpreted as the first further component, [0165] & Fig. 14-15).
Regarding claim 25, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the feedback component comprises a proximally facing surface facing towards the proximal end (the bottom surface of sleeve member 25 includes a proximally facing surface that faces toward the proximal end, [0166] & Fig. 15; alternatively, the proximal surface of snap feature 35 that faces toward the proximal end may be interpreted as a proximally facing surface, [0166] & Fig. 8B and 14-15).
Regarding claim 26, Plumptre discloses all the limitations of claim 25. Plumptre further discloses the sub-assembly wherein the sub-assembly comprises a distally facing surface of a second further component (first ridge 40 of housing 4 having a surface facing distally, [0165] and [0168] & Fig. 14-15), and wherein the proximally facing surface of the feedback component is arranged adjacent to the distally facing surface of the second further component (the bottom surface of sleeve member 25 and the proximal surface of snap feature 35 can both be interpreted as arranged next to, or adjacent, the distally facing surface of first ridge 40 of housing 4, [0168] & Fig. 14-15).
Regarding claim 27, Plumptre discloses all the limitations of claim 26. Plumptre further discloses the sub-assembly wherein the second further component is a housing (housing 4, [0165] and [0168] & Fig. 14-15).
Regarding claim 28, Plumptre discloses all the limitations of claim 16. Plumptre further discloses the sub-assembly wherein the feedback component provides an end click to provide an indication of the end of an injection ([0168]-[0169]).
Regarding claim 29, Plumptre discloses a medicament delivery device (delivery device 1, abstract & Fig. 1) comprising the sub-assembly of claim 16 (see the rejection of claim 16 above).
Regarding claim 30, Plumptre discloses all the limitations of claim 29. Plumptre further discloses the medicament delivery device wherein the medicament delivery device is an autoinjector ([0030]).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plumptre (US 20160008549 A1) as applied to claim 18 above, and further in view of Plumptre ‘899 (US 20160015899 A1).
Regarding claim 20, Plumptre discloses all the limitations of claim 18. Plumptre further discloses the sub-assembly wherein the flexible arm extends in the longitudinal direction (arm 20 extends in the longitudinal direction, [0140] & Fig. 3).
However, Plumptre fails to explicitly disclose wherein the flexible arm is attached to the rest of the plunger rod at a proximal end of the flexible arm.
However, Plumptre ‘899 teaches a sub-assembly wherein the flexible arm extends in the longitudinal direction (arm 20 extends in a longitudinal direction, [0124] & Fig. 2), and wherein the flexible arm is attached to the rest of the plunger rod at a proximal end of the flexible arm (arms 20 are attached to actuator 5 at a proximal end of arms 20, [0124] & Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the flexibles arm of Plumptre with Plumptre ‘899 to include the flexible arm attached to the rest of the plunger rod at a proximal end of the flexible arm since Plumptre teaches such to be an art effective configuration for a flexible arm configured to act as a snap feature over an element positioned inside a drug delivery housing ([0124] of Plumptre ‘899) and would yield predictable results pertaining to feature flexibility and the creation of audible feedback ([0126]-[0127] of Plumptre ‘899).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gylleby (US-20170239421-A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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