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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
Claims 13-16 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 claim 13, the phrase "preferably" 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 14-16 are rejected for incorporating the above limitation due to their respective dependencies on claim 1.
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 1-4, 7, 8, 11-13, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glines et al (US 6309375).
Regarding claim 1, Glines discloses:
An injection device (200; Fig. 2A) having a longitudinal axis X (axis of hollow tube 208) generally defining distal and proximal axial directions and comprising a needle (186; Fig. 2B) formed from relative rigid and inflexible material (needle is relatively rigid), the injection device (200) further comprising an abutment member (210) at its distal side and the needle (186) being movable to project in a distal direction beyond the abutment member (210) along an axis T (axis along needle tip 186) that is inclined relative to the longitudinal axis X (Col. 32:23-32).
Regarding claim 2, Glines discloses:
The injection device of claim 1, wherein the abutment member (210) comprises a distally facing abutment face and the needle (186) being movable to project through the abutment face (Fig. 2C; Col. 32:23-32).
Regarding claim 3, Glines discloses:
The injection device of claim 2 and comprising a generally straight needle guide (706; Fig. 6A) formed through the abutment member (210) and opening out at the abutment face, wherein moving the needle (186) to project in the distal direction beyond the abutment member comprises moving the needle (186) through the needle guide (706) (Col. 33:39-67).
Regarding claim 4, Glines discloses:
The injection device of claim 3 and comprising an actuating mechanism (Fig. 6A), the actuating mechanism comprising: an actuator (607) and a sliding carriage (605), wherein movement of the actuator (607) distally along axis X is configured to move the sliding carriage (605) along axis T together with the needle (186) that is fitted thereto (Col. 33:56-67, Col. 34:1-7).
Regarding claim 7, Glines discloses:
The injection device of claim 1 and comprising a flexible minimal volume tubing (706) for communicating between an upstream end (702) of the needle (186) and a downstream end of a syringe (50; Fig. 1E) included or associated with the injection device (200).
Regarding claim 8, Glines discloses:
The injection device of claim 7 and being formed as two separate main members (Fig. 1C, Fig. 2D) connected by the tubing (706), wherein one of the main members (Fig. 1C) being a syringe hub member (Col. 22:11-18) and the other main member (Fig. 2D) being an injector member (Col. 29:40-46), and wherein the injector member (Fig. 2D) comprising the abutment member (210) and the needle (186) and the syringe hub member (Fig. 1C) being configured to connect to the syringe (50).
Regarding claim 11, Glines discloses:
A method for administrating a medication substance into a target layer within a body tissue (Abstract) that comprises the steps of: providing an injection device (200; Fig. 2A) having a longitudinal axis X (axis of hollow tube 208) generally defining distal and proximal axial directions, the device (200) comprising a needle (186; Fig. 2B) formed from relative rigid and inflexible material (needle is relatively rigid) and an abutment member (210) at its distal end comprising an abutment face, engaging an outer side of the body tissue with the abutment face (Col. 36:1-3), and then urging the needle (186) to penetrate into the body tissue towards the targeted layer along an axis T (axis along needle tip 186) that is inclined to axis X (Col. 32:23-32).
Regarding claim 12, Glines discloses:
The method of claim 11, wherein the abutment face (210) is concave (Fig. 6A) and in a cross section including axes X and T the abutment face follows a contour generally defined by a radius Rb (Fig. 6A) and urging the abutment face (210) against the body tissue is arranged to urge the body tissue (Col. 36:1-3), and possibly tissue layers immediately below it, to generally conform to radius Rb of the abutment face (Col. 36:1-14).
Regarding claim 13, Glines discloses:
The method of claim 12 wherein an internal bevel angle of a chamfer formed at a distal sharp edged tip (702) of the needle forms an angle smaller than about 45 degrees (Fig. 5A) and preferably smaller than about 25 or possibly 15 degrees, and as the needle (186) advances towards the outer side of the body tissue it exposes its sharp edged tip (702) to the outer side of body tissue in a position/orientation suitable for penetrating into the body tissue (Col. 32:45-52).
Regarding claim 17, Glines discloses:
The method of claim 11 and comprising an actuating mechanism (Fig. 6A) for moving the needle (186) to protrude beyond the abutment face (210), wherein the actuating mechanism comprises a manually movable actuator (607) and a sliding carriage (605) for supporting and moving the needle (186) along an axis generally parallel or collinear to axis T (Col. 33:56-67, Col. 34:1-7).
Regarding claim 19, Glines discloses:
An injection device (200; Fig. 2A) comprising a needle (186; Fig. 2B), an abutment face (210) and an opening at the abutment face (Fig. 4B), wherein the needle (186) being movable to protrude beyond the abutment face through the opening along an axis T (axis of curved section 612) that is inclined relative to a tangent to the abutment face at the opening (Col. 32:23-32), wherein the abutment face (210) is at least partially concave (Fig. 4B) and the opening is comprised at the concave portion of the abutment face (Fig. 4B), and wherein the needle (186) is formed from relative rigid and inflexible material (needle is relatively rigid).
Regarding claim 20, Glines discloses:
The injection device of claim 19 and being formed as two separate main members (Fig. 1C, Fig. 2D) connected by a connecting tubing (308; Fig. 3A), wherein one of the main members (Fig. 1C) being a syringe hub member (Col. 22:11-18) and the other main member (Fig. 2D) being an injector member (Col. 29:40-46), and wherein the injector member (Fig. 2D) comprising the abutment member (210) and the needle (186) and the syringe hub member (Fig. 1C) being configured to connect to the syringe (50).
Allowable Subject Matter
Claims 5, 6, 9, 10, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 14-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
