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
Claims 2, 4-5, and 7 are objected to because of the following informalities:
-Claim 2, line 5: please correct “the radial direction” to “a radial direction”
-Claim 4, line 2: please correct “a flange locking hole” to “the flange locking hole”
-Claim 5, lines 2-3: please correct “the downward direction” to “a downward direction”
-Claim 7, line 3: please correct “the radial direction” to “the radial direction of the rod part”
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.
Claims 4-5 are 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.
Claim 4 recites the limitation "the barrel connection plate" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear what is required by the structure of “the barrel connection plate”. For examination purposes, the Examiner interprets “the barrel connection plate” as “a barrel connection plate” which includes any plate-shaped connection structure related to the barrel.
Claim 5 is rejected by virtue of its dependency on rejected claim 4.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Righi et al. (US 5,163,918 A).
Regarding claim 1, Righi discloses a reuse prevention injection device (see Figs. 1-7, col. 6 lines 43-57, col. 7 lines 30-40) comprising:
a syringe barrel (barrel 1) having a cylinder-shaped internal structure (see Figs. 1-7, barrel 1 comprises a cylindrical inner surface which receives stem 7);
a plunger rod (stem 7) which is coupled to the syringe barrel (barrel 1) and movably disposed to make a sliding reciprocating motion to inject a medicine contained inside (see Figs. 1-7, col. 4 lines 22-29, col. 6 lines 17-42, stem 7 can be slid both backwards and forwards within barrel 1 to fill the syringe and inject the medication, respectively); and
an adaptor (boxlike head 10) which is coupled to an upper end portion of the syringe barrel (barrel 1) to prevent separation of the plunger rod (stem 7) coupled to the syringe barrel (barrel 1) (see Figs. 1-7, col. 4 lines 29-32, col. 4 line 65-col. 5 line 14, col. 6 lines 43-57, col. 7 lines 30-40, once disc-shaped pusher member 19 of stem 7 passes distally beyond slip-back preventing teeth 21/slanted abutment faces 22, the stem 7 is locked to the boxlike head 10 thus preventing retraction of stem 7 from barrel 1),
wherein when the plunger rod (stem 7) moves toward a syringe needle (needle 4) coupled to a lower end of the syringe barrel (barrel 1), a locking flange (disc-shaped pusher member 19) protruding in a radial direction of the plunger rod (stem 7) is inserted into a flange locking hole (central aperture through boxlike head 10) passing through the adaptor (boxlike head 10), and subsequently when the plunger rod (stem 7) is pulled in a rearward direction, the locking flange (disc-shaped pusher member 19) is fit into the flange locking hole (central aperture through boxlike head 10) to restrain movements in the rearward direction, thereby preventing syringe reuse (see Figs. 1-7, col. 4 lines 29-32, col. 4 line 65-col. 5 line 14, col. 6 lines 43-57, col. 7 lines 30-40, once disc-shaped pusher member 19 of stem 7 passes distally beyond slip-back preventing teeth 21/slanted abutment faces 22, the stem 7 is locked to the boxlike head 10 thus preventing retraction of stem 7 from barrel 1).
Regarding claim 2, Righi discloses the reuse prevention injection device according to claim 1, wherein the plunger rod (stem 7) includes a rod part (main body of stem 7) movably coupled in upward and downward directions within the syringe barrel (barrel 1), a button part (knob 9) disposed at an upper end of the rod part (main body of stem 7), and the locking flange (disc-shaped pusher member 19) spaced apart in a downward direction of the button part (knob 9) and protruding in the radial direction of the rod part (main body of stem 7) (see Figs. 1-7, col. 4 lines 22-29, col. 6 lines 22-57, see first annotated Fig. 1 below).
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First annotated Fig. 1
Regarding claim 3, Righi discloses the reuse prevention injection device according to claim 1, wherein the syringe barrel (barrel 1) and the adaptor (boxlike head 10) are integrally formed into a single component (see Figs. 1-7, col. 4 lines 29-32, col. 4 line 65-col. 5 line 3).
Regarding claim 4, Righi discloses the reuse prevention injection device according to claim 1, wherein the adaptor (boxlike head 10) includes an adaptor plate (main cylindrical body of boxlike head 10) having the flange locking hole (central aperture through boxlike head 10), and an adaptor fastening portion (apertures 20) extending in a downward direction from two sides (top surface and cylindrical sidewall of the main cylindrical body of boxlike head 10) of the adaptor plate (main cylindrical body of boxlike head 10) to allow coupling to a barrel connection plate (clamping tongues 16) (see Figs. 1-7, col. 4 line 33-col. 5 line 14, col. 5 line 50-col. 6 line 57, see second annotated Fig. 1 below, see 112b rejection/interpretation of claim 4 above, boxlike head 10 has apertures 20 which lock to clamping tongues 16 which are plate-shaped and allow connection between the barrel 1 and the sleeve 12).
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Second annotated Fig. 1
Regarding claim 5, Righi discloses the reuse prevention injection device according to claim 4, wherein the flange locking hole (central aperture through boxlike head 10) has an upper inclined surface (slanted abutment faces 22) inclined in the downward direction and a central vertical surface connected to a lower end of the upper inclined surface (see Figs. 1-7, col. 5 lines 7-14, see annotated Fig. 3 below).
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Annotated Fig. 3
Regarding claim 6, Righi discloses the reuse prevention injection device according to claim 2, wherein the plunger rod (stem 7) further includes a retraction prevention protrusion (weakened portion 32) along a periphery of the rod part (stem 7) on an upper surface of the locking flange (disc-shaped pushing member 19) (see Figs. 1-2, col. 7 lines 30-40, weakened portion 32 is shown with a protrusion extending outward from stem 7 and upward from disc-shaped pusher member 19).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Righi et al. (US 5,163,918 A), as applied to claim 2 above.
Regarding claim 7, Righi discloses the reuse prevention injection device according to claim 2, wherein the locking flange (disc-shaped pushing member 19) includes a flange bottom portion (bottom horizontal surface of disc-shaped pushing member 19) horizontally extended from the rod part (main body of stem 7) along the radial direction (see Figs. 2-3), a lower inclined portion (inclined side surface of disc-shaped pushing member 19) extended in the upward direction outwards from an outer end of the flange bottom portion (bottom horizontal surface of disc-shaped pushing member 19) (see Figs. 2-3), and a top portion along the radial direction of the rod part (main body of stem 7) (see Figs. 2-3, see annotated Fig. 2 below).
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Annotated Fig. 2
However, Righi fails to expressly state an upper extended portion extended in the upward direction from an outer end of the lower inclined portion, and the top inclined portion inclined downward along the radial direction of the rod part from an outer end of the upper extended portion.
It would have been an obvious matter of design choice to include an upper extended portion in between the lower inclined portion and the top portion, the upper extended portion extended in the upward direction from an outer end of the lower inclined portion, and to modify the top portion to be inclined downward along the radial direction of the rod part from an outer end of the upper extended portion, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the instant case, the reuse prevention injection device of Righi would not operate differently with the claimed shape changes, and an upper extended portion and a top inclined portion on the disc-shaped pushing member 19 of Righi in the claimed manner would appear to retain the ability of the disc-shaped pushing member 19 to pass distally beyond slanted abutment faces 22 and lock against the slip-back prevention teeth 21 to prevent retraction of the stem 7 from the barrel 1 and thus prevent reuse of the device (see Fig. 3, col. 5 lines 3-14, col. 6 lines 43-57). Further, it appears Applicant places no criticality on the upper extended portion or the downward incline of the top portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783