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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15, 19, 20, 23, 25-28, and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 is amended to recite “that the one or more outwardly directed protrusions comprise an inner portion having a first thickness and an outer portion having a second thickness that is smaller than the first thickness.” Terminology to the thickness is not found in the specification as filed. The drawings are in grayscale and the features are not explicitly pointed to or distinguished such that first and second thickness are clearly disclosed as recited.
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) 15, 19-22, 25-28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karlsson et al. (US 2014/0148763 A1) in view of Cronenberg et al. (US 2017/0354781 A1).
With regard to claims 15 and 30, Karlsson et al. teach a medicament delivery device comprising: a housing having a proximal housing part (Fig. 8 member 2) that is arranged to accommodate a medicament container (Fig. 8 member 12) and a distal housing part (Fig. 8 member 3); and a drive unit operable of exerting a force on the medicament container for expelling a dose of medicament arranged in the distal housing part having a predetermined length, wherein the drive unit comprises a rotatable driver (Fig. 3 member 50, [0104], [0105]) and one or more clock springs arranged in a modular configuration along the predetermined length of the distal housing part, wherein a first end of each of the one or more clock springs is fixed relative to the distal housing part and a second end of each of the one or more clock springs is operatively connected to the rotatable driver such that a movement of the second end of each of the one or more clock springs causes the rotatable driver to rotate and expel the dose of medicament (Fig. 3 one clock spring 40, [0094], [0105]), wherein the rotatable driver includes one or more outwardly directed protrusions for releasable locking the rotatable driver such that the one or more outwardly directed protrusions comprise an inner portion having a first thickness and an outer portion having a second thickness that is smaller than the first thickness, wherein the medicament delivery device further comprises an actuator operably connected to the rotatable driver for releasing the rotatable driver upon activation of the actuator, wherein the actuator includes one or more longitudinally extending ledges, and wherein the actuator is movable from a first position where the one or more longitudinally extending ledges engage with the one or more outwardly directed protrusions thereby locking the rotatable driver to a second position where the one or more longitudinally extending ledges and the one or more outwardly directed protrusions are out of engagement thereby releasing the rotatable driver (member 70 is also considered as part of the driver and comprises protrusions 73, which taper outward to a point such that an outer portion has a second thickness smaller than a first thickness, which engage with ledges 75 on actuator 32 (Figs. 3, 6, and 7, [0086], [0092], [0097], [0105]), wherein, if a force requirement for expelling the dose of medicament is below a predetermined force requirement, the drive unit comprises a first number of the one or more clock springs, the first number being either one clock spring and space for one or more adapters configured to hold the one clock spring in place by having a length equal to three clock springs, two clock springs and space for one or more adapters configured to hold the two clock springs in place by having a length equal to two clock springs, or three clock springs and space for one or more adapters configured to hold the three clock springs in place by having a length equal to one clock spring, and wherein, if the force requirement for expelling the dose of medicament is at or above the predetermined force requirement, the drive unit comprises a second number of the one or more clock springs, greater than the first number, the second number being either two clock springs and space for two or more adapters configured to hold the two clock springs in place by having a length equal to two clock springs, three clock springs and space for one or more adapters configured to hold the three clock springs in place by having a length equal to one clock spring, or four clock springs (this is an optional recitation, Karlsson et al. is necessarily provided with the needed number of springs for delivery, in the case of Karlsson et al. only one spring is needed to provide the required force for delivery). Karlsson et al. do not explicitly disclose the distal housing part fits up to four clock springs. At the outset the Examiner would note this limitation is functional and depending on the size of the springs the distal housing part of Karlsson et al. would be able to fit up to four clock springs. Additionally, Cronenberg et al. teach a drug delivery device and that depending on fluid viscosity and fill-level different numbers of springs may be used for achieve a desired force. A custom spacer may be used for various viscosity and fill-level combinations based on a particular modular spring ([0178], Fig. 64 spacer 226). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention the housing of Karlsson et al. should be able to accommodate up to four clock springs and to adjust the space using an adapter/spacer as Cronenberg et al. teach various numbers of springs may be used depending on viscosity and fill-level combinations in conjunction with a spacer which would achieve a desired force to result in a predictable delivery. Further, one of ordinary skill would be able to determine desired space in the housing based on the desired drug delivery for the pump regarding dosage and drug viscosity as this would inform spring selection. As Cronenberg et al. teach that the number of springs may be selected for the desired conditions and performance one of ordinary skill in the art would have had a reasonable expectation of success in modifying Karlsson et al. to have the desired spring spacing. Therefore, it would have been additionally obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use such a spacing as claimed in Karlsson et al. as Cronenberg et al. teach various numbers of springs may be used depending on viscosity and fill-level combinations in conjunction with a spacer and selected for the desired conditions and performance and having a housing with space to accommodate up to four springs would have been a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105, USPQ 233, 235 (CCPA 1955). Lastly, when using multiple springs Karlsson et al. and Cronenberg et al. are silent as to the relative size of the springs. However, there are a limited number of options, the springs may either be the same size or different sizes. As such it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a space sized for up to four springs of equal length in Karlsson et al. as in light of Cronenberg et al. as discussed above one of ordinary skill would be able to determine the springs needed based on viscosity and fill-level combinations and would be able to select such springs with predictable success for delivery. As combined the housing of Karlsson et al. would be sized to fit up to four clock springs of equal length.
With regard to claim 19, see Fig. 4 plunger 60, driver 50 ([0103], [0104]).
With regard to claim 20, see Fig. 3 member 32 ([0105]).
With regard to claim 23, the activator is guard 17 (Fig. 3).
With regard to claim 25, see Fig. 3, rotator 25, the wedge-shaped tongue is formed by the walls forming the inclined groove 261 (see Reference Figure 1 below, [0086], [0087]).
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With regard to claims 26-28, see Fig. 3 member 10 ([0076]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have 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. Applicant argues 70 is independent from 50. There is nothing in the claim which prevents 70 from also being considered as part of the drive even though it may be referred to with different terminology in the reference. 70 works with 50 to allow movement of the plunger.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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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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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783