DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim(s) 15-31 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of U.S. Patent No. 10,058,659 in view of U.S. Publication No. 2004/0260247 (“Veasey”)
Regarding Claim 15, the reference patent claims (see Clm. 1):
A drive mechanism for use in a drug delivery device, the drive mechanism comprising:
A housing having a proximal end, a distal end, and an internal thread;
A dose setting dial threadedly engaged with the internal thread and configured to simultaneously rotate and traverse axially towards the proximal end during dose setting and to simultaneously rotate and traverse axially towards the distal end during dose dispensing;
A plunger rod rotatably fixed relative to the housing during dose setting and having a distal end configured to abut and move a cartridge piston during dose dispensing;
An inner cylinder engaged with and positioned within the dose setting dial such that axial movement of the dose setting dial causes simultaneous axial movement of the inner cylinder;
A clutch which releasably connects the dose setting dial and the inner cylinder; and
A plunger rod holder rotatably fixed relative to the housing and coupled to the plunger rod to prevent the plunger rod from moving towards the proximal end during dose setting, wherein the plunger rod holder allows the plunger rod to move axially towards the distal end during dose dispensing.
The reference patent fails to explicitly claim:
The plunger rod is rotably fixed during both dose setting and dose dispensing;
The plunger rod has a hollow portion; and
A lead screw threadedly engaged with the threaded hollow portion of the plunger rod such that the lead screw can rotate relative to the plunger rod, where the inner cylinder is rotatably fixed relative to the lead screw.
However, such nominal features are not sufficient to define and distinguish over the claims of the reference patent as they are notoriously well-known features in the prior art in association with this type of drive mechanism for an injection device. For example, Veasey discloses a drive mechanism for an injector having the same principle mode of operation as that claimed in the reference patent. Specifically, Veasey describes an injection drive mechanism which comprises a hollow plunger rod portion (18) which is rotatably fixed during both dose setting and dose dispensing (Par. 50, 52) with a lead screw (14) threadedly engaged with the threaded hollow portion of the plunger rod such that the lead screw can rotate relative to the plunger rod (Par. 55) with the lead screw releasably clutched to the dial sleeve (see at 18) via an element which is rotatably fixed relative to the lead screw such that when the clutch is activated the two components are rotationally slaved together, but when the clutch is disengaged the two components may rotate relative to one another (Par. 33). It would have been obvious for one having ordinary skill in the art at the time the invention was made to recite the claimed invention of the reference patent to include these common and well-known features, as disclosed by Veasey, since the clutchable lead screw received within the hollow interior of a threaded piston rod constitutes a notoriously well-known drive construction which allows for a telescopic arrangement to provide a maximal stroke length displacement in a known and predictable manner.
Clm. 16 maps to Clm. 6.
Clm. 17 maps to Clm. 8.
Regarding Claim 18, this claim presents only a nominal feature indicating the shape of the hollow rod, wherein such a shape is well-known to the art (see Veasey) and clearly obvious to implement into the design of the claimed reference patent, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claims 19-21, the “display window” is a well-known feature (see Veasey – Par. 57) obvious to include as part of the claimed reference patent in order to allow for clear visualization of the set dosage as a numerical value of dosed units.
Regarding Claim 22, the reference patent fails to explicitly claim the “cartridge holder”, however, the inclusion of such a feature is nominal inasmuch as it is implicit to the reference in Clm. 1 of a “cartridge” to which the drive mechanism interfaces and is understood to be a known, obvious and well-known configuration (see Veasey) for automatic syringe injection systems to permit dosing of a medicament via a sealed reservoir to permit storage and dispensing of the medicament. As such, Claim 22 does not define or distinguish over the claims of the reference patent.
Clm. 23-31 correspond to Clm. 16-21 discussed above and are therefore not distinguishing over the reference patent for the same reasons.
Allowable Subject Matter
Claim(s) 15-31 would be allowable over the prior art presuming proper satisfaction of the Double Patenting rejection by filing of a Terminal Disclaimer to U.S. Patent No. 10,058,659.
The following is an examiner’s statement of reasons for indicating allowable subject matter:
U.S. Publication No. 2004/0260247 (“Veasey”) and U.S. Publication No. 2006/0206057 (“DeRuntz”) constitute the closest analogous prior art which pertains to drug delivery devices having drive mechanism comprising telescoping plunger rods which are clutchably slaved to a rotatable dial sleeve in order to rotatably dial up a set dose and then dispense a dose product from the injector. However, the prior art fails to disclose, suggest, or otherwise obviate the specific combination of claimed features directed toward the manner in which the plunger rod is arranged a hollow rod and lead screw wherein the hollow plunger rod does not rotate during dose dispensing or dose setting, and wherein the lead screw is clutched to the dose setting dial via an inner cylinder which is rotatably fixed to the lead screw as presently claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 11/19/2025