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 § 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.
Claims 14-18, 20-23, 27-28, and 30-33 rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 20120010575 A1)in view of Kronestedt et al.(US 20090308386 A1)
Regarding claim 14, Jones discloses an injector device (Fig 1) comprising: an elongate housing (housing 2, Fig 1) having a proximal end (proximal end 3, Fig 1) and a distal end (distal end 4, Fig 1), and configured to receive a container of medicament (cartridge 53, Fig 13; [0241]); a plunger rod (piston rod 6, Fig 1) moveable longitudinally within the housing (2) between a primed position (before dispensing of a dose) and a completed position (after dispensing of a dose) ([0144]), the plunger rod (6) being configured to be engageable with the container (53) ([0156]) of medicament (medicinal product; [0090]) when the container of medicament (53) is received in the housing (2); wherein the housing (2) comprises an indicator (Indicator 5, Fig 1) located in a proximal region (3) of the housing (2), the indicator (5) comprising a spindle (indicator part 12+ rotation member 7, Fig 1), the spindle (7+12) comprising a shaft (rotation member 7, Fig 1) and a dial (indicator part 12, Fig 1), wherein the shaft (7) of the spindle (7+12) comprises a threaded arrangement ([0153]: “indentation 17 can be a thread”) configured to engage with a threaded arrangement (protrusion 18, Fig 1) on the plunger rod (6) ([0153]) such that longitudinal movement of the plunger rod (6) from the primed position (before dispensing of a dose) towards the completed position (after dispensing of a dose) causes the dial (12) of the spindle (7+12) to rotate to provide a user with information associated with progress of an injection process dependent upon a longitudinal position of the plunger rod (6) ([0156]: “This distal movement of the piston rod 6, which is coupled to the indicator 5, causes the indicator 5 to rotate. Thus, movement of the piston rod along the axis is converted into rotational movement of the indicator. Piston rod 6 may drive a piston of a drug cartridge (not explicitly shown) in the distal direction resulting in dispensing a dose of a drug from the cartridge.”).
Jones is silent wherein a biasing element configured to urge the plunger rod distally in a longitudinal direction, the biasing element having a distal end in contact with a proximal end of the plunger rod and a proximal end in contact with the housing at the proximal end of the housing.
Kronestedt teaches a biasing element (plunger rod spring 86, Fig 1) configured to urge the plunger rod (plunger rod 84, Fig 1) distally in a longitudinal direction, the biasing element (86) having a distal end in contact with a proximal end of the plunger rod (84) and a proximal end in contact with the housing (back cover 70, Fig 2) at the proximal end of the housing (70) ([0051]; Fig 3. Note: proximal and distal ends of prior art Kronestedt are opposite to instant application.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Jones with a spring having in having a distal end in contact with a proximal end of the plunger rod and a proximal end in contact with the housing the rod and the housing as taught by Kronestedt for the purpose of bias the rod and assist the actuation of the device using elastic energy to dispense the dose ([0058]).
Regarding claim 15, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the spindle (7+12) is constrained from movement in a longitudinal direction and is rotatable relative to the plunger rod (6) ([0156]).
Regarding claim 16, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the spindle (7+12) is prevented from moving in a longitudinal direction by the housing (2) ([0178]; Fig 1A).
Regarding claim 17, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the dial (7+12) is located at the proximal end (3)of the housing (2) such that a distal surface (1000, Annotated Fig 1) of the dial (7+12) contacts the proximal end (3) of the housing (2) and a proximal surface (indication surface 13, Fig 1) of the dial (7+12) faces outwardly of the device to provide the user with information associated with the progress of the injection process, in use ([0146], [0148]; Indication surface 13 faces radially outward).
Regarding claim 18, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the dial (7+12) is located inside the housing (2) at the proximal end (3) of the housing (2) such that a proximal surface (indication surface 13, Fig 1) of the dial (7+12) faces out of the housing (2) to provide the user with information associated with the progress of the injection process ([0146, [0148]; indication surface 13 faces outward out of housing through window 15).
Regarding claim 20, Jones/Kronestedt discloses the injector device according to claim 18. Jones discloses wherein the housing (3) comprises a cover (1001, Annotated Fig 1) extending from the proximal end (3) of the housing (2) and over the proximal surface (13) of the dial (7+12), the cover (1001, Annotated Fig 1) being configured such that the dial (7+12) can provide visual feedback associated with the progress of the injection progress to the user ([0146, [0148]; indication surface 13 faces outward out of housing through window 15 of cover 1001).
Regarding claim 21, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the dial (7+12) is housed inside the proximal end (3) of the housing (2), and the housing (2) further comprises a display window (window 15, Fig 1) in its side face (Fig 1) through which a side face (indication surface 13, Fig 1) of the dial (7+12) can be seen, the side face (13) of the dial comprising indicia (index element 14, Fig 1) configured to provide visual feedback associated with the progress of the injection progress to the user ([0146, [0148];).
Regarding claim 22, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the threaded arrangement of the spindle (7+12) comprises a continuous thread (indentation 17 can be a thread, Fig 1; [0153]) on the shaft (7) of the spindle (7+12), the continuous thread (17) being configured to provide constant feedback on the progress of the injection process ([0156]-[0157]).
Regarding claim 23, Jones/Kronestedt discloses the injector device according to claim 14. Jones discloses wherein the threaded arrangement (protrusion 18, Fig 1) of the plunger rod (6) comprises a continuous thread on the plunger rod (6)(Fig 1), the continuous thread being configured to provide constant feedback on the progress of the injection process([0155]-[0157]).
Regarding claim 27, Jones/Kronestedt discloses an injector device according to claim 14. Jones discloses further comprising the container (53) of medicament (medicinal product; [0090]) received within the housing (2) between the plunger rod (6) and the distal end of the injector device (distal end of injector at the dispensing end)(50, Fig 13A).
Regarding claim 28, Jones discloses a method of using an injector device (Fig 1, Fig 13 ) comprising an elongate housing (housing 2, Fig 1) having a proximal end (proximal end 3, Fig 1) and a distal end (distal end 4, Fig 1), and configured to receive a container of medicament (cartridge 53, Fig 13; [0241]); a plunger rod (piston rod 6, Fig 1) moveable longitudinally within the housing (2) between a primed position (before dispensing of a dose) and a completed position (after dispensing of a dose), the plunger rod (6) being configured to be engageable with the container (53) ([0156]) of medicament (medicinal product; [0090]) when received in the housing (2); wherein the housing (2) comprises an indicator (Indicator 5, Fig 1) located in a proximal region (proximal end 3, Fig 1) of the housing (2); the indicator (5) comprising a spindle (indicator part 12+ rotation member 7, Fig 1), the spindle (7+12) comprising a shaft (rotation member 7, Fig 1) and a dial (indicator part 12, Fig 1), wherein the shaft (7) of the spindle (7+12) comprises a threaded arrangement ([0153]: “indentation 17 can be a thread”) configured to engage with a threaded arrangement (protrusion 18, Fig 1) on the plunger rod (6) ([0153]) such that longitudinal movement of the plunger rod (6) from the primed position (before dispensing of a dose) towards the completed position (after dispensing of a dose) is configured to cause the dial (12) of the spindle (7+12) to rotate to provide a user with information associated with progress of an injection process dependent upon a longitudinal position of the plunger rod (6) ([0156]: “This distal movement of the piston rod 6, which is coupled to the indicator 5, causes the indicator 5 to rotate. Thus, movement of the piston rod along the axis is converted into rotational movement of the indicator. Piston rod 6 may drive a piston of a drug cartridge (not explicitly shown) in the distal direction resulting in dispensing a dose of a drug from the cartridge.”), the method comprising: actuating the injector device (50) such that the plunger rod (6) is moved longitudinally within the housing (2) from the primed position (before dispensing of a dose) to the completed position (after dispensing of a dose); providing information via the indicator (5) associated with the longitudinal position of the plunger rod (6) with the indicator (5)([0151]; [0156]).
Jones is silent wherein a biasing element configured to urge the plunger rod distally in a longitudinal direction, the biasing element having a distal end in contact with a proximal end of the plunger rod and a proximal end in contact with the housing at the proximal end of the housing.
Kronestedt teaches a biasing element (plunger rod spring 86, Fig 1) configured to urge the plunger rod (plunger rod 84, Fig 1) distally in a longitudinal direction, the biasing element (86) having a distal end in contact with a proximal end of the plunger rod (84) and a proximal end in contact with the housing (back cover 70, Fig 2) at the proximal end of the housing (70) (([0051]), Fig 3;Note: proximal and distal ends of prior art Kronestedt are opposite to instant application.)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Jones with a spring having in having a distal end in contact with a proximal end of the plunger rod and a proximal end in contact with the housing the rod and the housing as taught by Kronestedt for the purpose of bias the rod and assist the actuation of the device using elastic energy to dispense the dose ([0058]).
Regarding claim 30 Jones/Kronestedt discloses the method of claim 28. Jones discloses wherein providing the information comprises providing visual information via the dial (12) of the indicator (5) ([0151]).
Regarding claim 31 Jones/Kronestedt discloses the method of claim 28. Jones discloses further compromising preventing movement of the spindle (7+12) in the longitudinal direction ([0155]).
Regarding claim 32 Jones/Kronestedt discloses the method of claim 31. Jones discloses wherein preventing movement of the spindle (7+12) comprises preventing movement of the spindle (7+12) with the housing (2) ([0155]).
Regarding claim 33 Jones/Kronestedt discloses the method of claim 28. Jones discloses wherein providing information via the indicator (5) comprises providing constant feedback ([0151]; [0155]).
Response to Arguments
Applicant’s arguments with respect to claims 14-33 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.
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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