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 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 4-8, 10, 12, 14, 18-19 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.
Regarding claims 4, 6, 19, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 5-6, 18 recite “type” after an already established structure and therefore make it unclear what additional structure this would add.
Claim 8 recites “a second of the barrel”, which appears to mean “a second end of the barrel”, but is presently unclear if a second barrel may have been intended or a second portion thereof.
Claim 10 recites “wherein the vial is inserted into vial adapter”. It is unclear if this recitation of “vial adapter” is the same as that in claim 8 or an additional adapter. Suggested to include “the” before it if the same.
Claim 12 recites “for housing an impactor shaft from a power injection unit”, however “a power injection unit” has already been recited in this claim, making it unclear if this is the same or a different unit.
Claim 12 recites the limitation "the rear end" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “the vial is inserted into the injection end of the vial”, which is unclear as to how the vial can be inserted into itself.
Claim Rejections - 35 USC § 102
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 1-7, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Selvitelli et al. (US 2012/0258421).
Selvitelli shows an adapter (“cartridge receiver” 50) for a needle-free injector (may receive non-needle blunt ended adapters at luer lock 94) comprising a vial cartridge holder (50) comprising a protector tube (surrounding C in Fig. 2) for holding a vial of medicament (C, cartridge) to be injected (for anesthesia); a cutting means for perforating a seal on the vial to form a perforation which allows the medicament to be injected therethrough (this is considered invoking 112 6th as including a type of sharp; needle 58); and a lock at one end of the adapter for releasably connecting with a nozzle (luer lock 94 is a known type of lock and capable thereof). With respect to claim 2, wherein the cutting means is a spike, knife or other sharp (needle 58). With respect to claim 3, wherein the lock is a luer lock (94). With respect to claim 4, for use as a dental tool for injecting the medicament, such as an anesthetic, to a tissue in an oral cavity of a patient in need thereof (while this is considered intended use, this is also the intended use of Selvitelli). With respect to claim 5, wherein the needle-free injector is a gun-type or wand-type needle-free injector (the needle free injector and its structure is not positively recited as part of the adapter; the adapter 50 of Selvitelli is capable of being utilized with either of these types, as it is shown receiving an outside plunger rod 80). With respect to claim 6, wherein the nozzle is straight or angled, and is used for dispensing medicament from the vial to the tissue of patient, such as oral tissue (the nozzle is not positively recited as part of the adapter and its use is considered intended use; Selvitelli’s lock 94 is capable of receiving either a straight or angled nozzle for this purpose). With respect to claim 7, wherein the nozzle is disposable (the nozzle is not positively recited as part of the adapter and any nozzle could be considered disposable). Claims 17-19 are rejected similarly to claims 3, 5, and 6 respectively.
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.
Claims 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Selvitelli in view of Hohlfelder (US 2007/0250010).
Selvitelli discloses the device as previously described above and an impactor shaft (80) and a nozzle (32,42) for releasably attaching to an injection end of the vial adapter (slides over 72/64 as seen in Fig. 2), but fails to show a barrel attached at a first end to a power injector unit having the impactor shaft therein; the vial adapter releasably connected at or insertable into a second end of the barrel for housing a vial of medicament to be injected.
Hohlfelder similarly teaches the use of hand operated syringes ([0005]; similar to Selvitelli) or alternatively powered syringes (Fig. 5 for instance) wherein a barrel (at 30 between 50 and 60 in Fig. 5, which surrounds a portion of the drive/impactor shaft 61) attached at a first end (portion abutting 60) to a power injector unit (portion to the right of 50 in Fig. 5) having the impactor shaft therein (drive shaft 61); the vial and surrounding structure releasably connected at or insertable into a second end (at the connection near 50) of the barrel for housing a vial of medicament to be injected (32 in Hohlfelder and C in Selvitelli).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Selvitelli’s device by substituting the conventional syringe manual drive means with a syringe powered drive means as taught by Hohlfelder in order to have greater control over the administering of the medicament.
With respect to claim 9, wherein the vial is a glass vial (the vial is not positively recited, however Selvitelli teaches vials may be in [0004]). With respect to claim 10, wherein the vial is inserted into vial adapter at a rear end prior to attachment to the second end of the barrel (will not have access to back of adapter after attachment to barrel, so it must be inserted prior). With respect to claim 11, for use as a dental tool in a dental application (considered intended use, however Selvitelli is for dental use).
Regarding assembly claims starting with claim 12, Selvitelli shows an assembly comprising a barrel (50) releasably connected to an impactor shaft (as seen at 80 in Fig. 2 extending through barrel), the barrel comprising a shaft (hollow shaft length thereof at upper half) for housing an impactor shaft (80 shown within the hollow shaft in Fig. 2) at the rear end (near top of 50), and a vial adapter component (64) at an injection end of the barrel (bottom of 50 within 64) for housing a vial adapter (vial adapter not positively recited, however shown housed in component 64) comprising a vial of medicament (vial of medicament not positively recited, however C); and a nozzle (42+32+92) which is releasably attachable to the injection end of the barrel (shown releasably attached around barrel 50 in Fig. 2), whereby by attaching the nozzle to the injection end a spike (spike not positively recited as it would be part of the vial adapter, but 58 functions in this manner) perforates a seal on the vial thereby releasing medicament (58 penetrates the seal when nozzle fully engaged, such as in Fig. 1b). However, Salvitelli fails to show the barrel attached to a power injector unit having the impactor shaft therein.
Hohlfelder similarly teaches the use of hand operated syringes ([0005]; similar to Selvitelli) or alternatively powered syringes (Fig. 5 for instance) wherein the impactor shaft is of a power injector unit (61, Fig. 5).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Selvitelli’s device by substituting the conventional syringe manual drive means with a syringe powered drive means as taught by Hohlfelder in order to have greater control over the administering of the medicament.
With respect to claim 13, wherein the barrel is a single machined barrel (considered product-by-process, however the barrel is of a singular construction as seen in Fig. 2 of Selvitelli). With respect to claim 14, wherein the vial is inserted into the injection end of the vial after the barrel is connected to the power unit (see 112 above; will not have access to back of adapter after attachment to barrel, so it must be inserted prior). With respect to claim 15, for use as a dental tool in dental applications (considered intended use, however Selvitelli is used in this manner).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772