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 27 is objected to because of the following informalities: “a piston cap,” a rear barrel section,” and “a piston” should be corrected for antecedent basis due to the amendments to claim 1. Appropriate correction is required.
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) 1-3, 5, 9-11, 13-15, 17, 21, 23, 25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dutcher et al. (US 2009/0082753 A1) in view of Menassa (US 2005/0085767 A1).
With regard to claims 1, 14, 15, 17, and 21, Dutcher et al. teach a needle-free injector for injecting variable, discrete doses of liquids, intradermally or transdermally into a subject in need thereof, the needle-free injector comprising: a barrel having a front section, an intermediate section and a rear section (Fig. 1 member 22); and a cap (Fig. 1 member 16) having a rear end connectable to the front section of the barrel and rotatable about the front section of the barrel (Fig. 4 at 62), the cap having a discharge end for receiving a cartridge containing the liquid to be injected (Fig. 4 end that receives 50); wherein the dose of liquid to be discharged from the cartridge by the injector is adjustable incrementally by one or more dose increments by rotation of the cap, such that increasing the rotation increases the amount of the dose of liquid to be discharged ([0019], [0020]), wherein after the liquid is discharged from the injector, the cap is rotated to reset the cartridge plunger into a position for further injection of the liquid in one or more amounts of discrete dose increments corresponding to the total amount of dose to be administered ([0019], [0020], the device is capable of such function), wherein rotation of the cap about a longitudinal axis of the front section of the barrel adjusts the dose of liquid to be discharged from the cartridge by the injector ([0019], [0020]). Dutcher et al. do not disclose a piston cap, casing, or a magnet. However, Menassa teaches adjusting the stroke using a cap 21 (Figs. 2 and 3), and further using a scale (Fig. 23 161, [0073]). Menassa teaches using a magnet 10, casing 6, connector 11 to retain the piston until desired operation ([0015], [0061], Figs. 2 and 3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a piston cap and scale in Dutcher et al. as in Menassa as this is beneficial to control the stroke length and further to use a magnet, casing, and connector, as Menassa teaches this is beneficial to retain the piston until desired delivery.
With regard to claim 2, Dutcher et al. teach a device substantially as claimed but do not explicitly show how 16 is connected to 22. However, Menassa teaches a cap connecting the cartridge to the barrel is connected via threads (see Figs. 2 and 33 threads connecting 22 and 3, [0062]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a threaded connection in Dutcher et al. as Menassa teaches such is an art effective connection which would yield the same predictable result.
With regard to claim 3, see Fig. 4 connection at 53.
With regard to claim 5, see Fig. 4 orifice at 58 plunger 54.
With regard to claim 9, see [0019], [0020] markings are provided which provide an indication of dose which necessarily results from the position of the plunger.
With regard to claim 10, the threading is considered to lock the cap as it retains the position.
With regard to claim 11, see Fig. 4 64 is taken as an o-ring provided in an annular body, the ring in which 64 is seated provides a U-shaped cross-section.
With regard to claim 13, Dutcher et al. teach a device substantially as claimed and as rejected above in regards to claim 2 it would be obvious to use a threaded connection between the cap and the housing. Dutcher et al. do not disclose a locking mechanism as recited. However, Menassa teaches equivalently using a threaded connection or balls, a groove, and an o-ring ([0074], [0075]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use balls, a groove, and an o-ring in Dutcher et al. as Menassa teaches this to be an art effective equivalent connection means. Menassa do not specifically disclose a helical path. However, as combined with Dutcher et al. in order to allow for adjustment of the cap to be moved rotationally and axially such a path shape would necessarily be required.
With regard to claims 23, 25, and 27, Dutcher et al. teach a method of injecting a liquid from the needle-free injector of claim l, into a subject in need thereof, the method comprising: attaching the cap to the front section of the barrel (Fig. 1 cap 16 is attached to barrel 22); inserting a cartridge into the discharge end of the cap (Fig. 4 cartridge 50), the cartridge comprising a cartridge body, a plunger (Fig. 4 54), and a chamber (Fig. 4 52) having a quantity of liquid to be injected, such that the cartridge is attached to the discharge end of the cap; rotating the cap such that the cartridge moves rearwardly in the front section of the barrel, thereby selecting a dose of liquid to be administered wherein rotating the cap selects discrete dose units, such that one or more dose units are selectable for each injection ([0019], [0020]); and actuating a trigger on the injector to inject the liquid into the subject (Fig. 1 28, [0017], spring is repositioned for reuse). Regarding claim 27, see the rejection to claim 1 above regarding the piston cap.
Claim(s) 7 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dutcher et al. (US 2009/0082753 A1) and Menassa (US 2005/0085767 A1) as applied to claims 1 and 23 above, and further in view of Ismach (US 3,805,783).
With regard to claims 7 and 24, Dutcher et al. teach a device and method substantially as claimed and using markings ([0019]) but do not specifically disclose a window with indicia. However, Ismach teaches using a window to view a plunger against indica to determine dosage (Fig. 4 133). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a window in Dutcher et al. as Ismach teaches this is an art effective means for viewing dosage and would yield the same predictable result as the markings in Dutcher et al.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dutcher et al. (US 2009/0082753 A1) and Menassa (US 2005/0085767 A1) as applied to claim 18 above, and further in view of Newman et al. (US 5,009,637).
With regard to claim 19, Dutcher et al. teach a device substantially as claimed and using markings but do not disclose a specific dosing increment. However, Newman et al. teach markings may be provided in any suitable manner to indicate fractions of capacity (Col. 3 lines 1-12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use increments of 0.025 mL in Dutcher et al. because Newman et al. teach the capacity may be divided into fractions as desired for dose setting. Further, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Depending on a particular dose for a particular medication for a particular treatment one of ordinary skill in the art would be able to mark the volume as needed.
Response to Arguments
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive. Applicant did not provide any specific arguments to the references themselves. The amendments are sufficient to overcome the previous objections and rejections under 35 U.S.C. 112.
Conclusion
THIS ACTION IS MADE FINAL. 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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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783