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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/17/2024 and 6/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
On line 1 of claim 9, “the tab comprises is” should read “the tab is” to correct a minor grammatical error.
Appropriate correction is required.
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.
Claim(s) 1-3, 7-8, 14 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olympus Corp (JP2001-058006; hereafter Olympus).
In regard to claim 1, Olympus discloses a medical device, comprising: a handle (4), including: a movable portion (9); and a stationary portion (6); a shaft (2) extending from a distal portion of the handle, wherein a distal portion of the shaft includes a needle (3); wherein movement of the movable portion (9) of the handle relative to the stationary portion (6) of the handle controls an extension or retraction of the needle (see par. [0012]), and wherein the movable portion includes a tab (18/19), wherein a position of the tab relative to the stationary portion releasably secures a position of the movable portion relative to the stationary portion and also secures a position of the needle relative a distal end of the shaft (see par. [0018]-[0020].
In regard to claim 2, Olympus discloses wherein the stationary portion (6) includes a track (22) to movably receive a portion of the tab (see par. [0020]).
In regard to claim 3, Olympus discloses wherein the track (22) includes one or more locking portions (see par. [0020]).
In regard to claim 7, Olympus discloses wherein the movable portion (9) further comprises a first grip portion (16) configured to accept an applied force, the applied force causing the movable portion to move relative to stationary portion (see par. [0018]).
In regard to claim 8, Olympus discloses wherein the movable portion (9) is disposed on a first face (see Fig. 1), wherein the stationary portion (6) further comprises a second grip portion (21) disposed on a second face, the second face opposite the first face (see Figs. 1-2).
In regard to claim 14, Olympus discloses wherein the movable portion (9) is configured to mate with the stationary portion (6) (see Figs. 1-3).
In regard to claim 16-17, please see the rejection above as the examiner believes all of the limitations are adequately addressed.
Claim(s) 1-5, 7-8, 12-14, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kullas et al. (US 4,723,547; hereafter Kullas).
In regard to claim 1, Kullas discloses a medical device, comprising: a handle (14), including: a movable portion (42); and a stationary portion (40); a shaft (12 or 30 alone) extending from a distal portion of the handle, wherein a distal portion of the shaft includes a needle (26); wherein movement of the movable portion (42) of the handle relative to the stationary portion (40) of the handle controls an extension or retraction of the needle (see Fig. 4 and 6), and wherein the movable portion includes a tab (80), wherein a position of the tab relative to the stationary portion releasably secures a position of the movable portion relative to the stationary portion and also secures a position of the needle relative a distal end of the shaft (see Figs. 4 and 6 and col. 7, line 7- col. 8, line 2).
In regard to claim 2, Kallas discloses wherein the stationary portion (40) includes a track (defined by rails 46, 48) to movably receive a portion of the tab (see at least Figs. 4-6).
In regard to claim 3, Kallas discloses wherein the track (defined by rails 46, 48) includes one or more locking portions (70, 72).
In regard to claim 4, Kallas discloses further comprising a trigger (76), wherein the trigger is pivotable relative to the stationary portion of the handle (see Figs. 8 and 9).
In regard to claim 5, Kallas discloses wherein the trigger (76) is configured to interact with the tab (80) of the movable portion to limit proximal movement of the movable portion (the tab 80 cannot move from locking portions unless moved by trigger 76).
In regard to claim 7, Kallas disclose wherein the movable portion (42) further comprises a first grip portion (finger handles) configured to accept an applied force, the applied force causing the movable portion to move relative to stationary portion.
In regard to claim 8, Kallas discloses wherein the movable portion (42) is disposed on a first face, wherein the stationary portion (40) further comprises a second grip portion (52) disposed on a second face, the second face opposite the first face.
In regard to claim 12, Kallas discloses wherein the tab (80) comprises a cantilevered projection (78, 76) disposed within an opening (defined by rails 46, 48) on the stationary portion (40).
In regard to claim 13, Kallas discloses wherein a position of the tab (80) and the opening define a range of movement of the needle (the position of the tab along the opening defines the position of the needle).
In regard to claim 14, Kallas discloses wherein the movable portion (42) is configured to mate with the stationary portion (40) (see Figs. 4-6).
In regard to claim 16-17, please see the rejection above as the examiner believes all of the limitations are adequately addressed.
In regard to claim 18, Kallas discloses a trigger (76), wherein the trigger is pivotable relative to the stationary portion of the handle (the trigger is rotated into and out of locking portions), wherein the handle includes a depression (space defined by rails 46, 48) configured to receive the trigger, wherein the trigger comprises a prong (78) configured to engage the tab (see Fig. 7).
In regard to claim 19, Kallas discloses a medical device, comprising: a handle (14), including: a movable portion (42) comprising a knob (76; 76 rotates into and out of locking portions); and a stationary portion (40); a shaft (12 or 30 alone) extending from a distal portion of the handle, wherein a distal portion of the shaft includes a needle (26); wherein movement of the movable portion of the handle relative to the stationary portion of the handle controls an extension or retraction of the needle (see Fig. 4 and 6), and wherein the movable portion includes a tab (80), wherein a position of the tab relative to the stationary portion releasably secures a position of the movable portion relative to the stationary portion and also secures a position of the needle relative a distal end of the shaft (see Figs. 4 and 6 and col. 7, line 7- col. 8, line 2), wherein rotation of the knob rotates the movable portion relative to the stationary portion (76 rotates into and out of locking portions).
In regard to claim 20, Kallas discloses wherein the stationary portion includes a track (defined by rails 46, 48) to movably receive a portion of the tab, wherein the track is angled relative to a longitudinal axis of the stationary portion (the locking portions 70 and 72 are at a 90 degree angle to the longitudinal axis).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kallas in view of Tang et al. (US 2014/0323991; hereafter Tang).
In regard to claims 6 and 15, Kallas fails to disclose further comprising one or more springs, wherein the one or more springs bias the distal movement of the movable portion relative to the stationary portion of the handle.
In a similar art, Tang discloses one or more springs (8), wherein the one or more springs (8) bias the distal movement of the movable portion relative to the stationary portion of the handle (see par. [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kallas with the spring of Tang in order to provide an automated means for withdrawing the needle from the extended position.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kallas.
In regard to claims 9-11, Kallas discloses wherein the tab is circular and extends radially from an extension portion, wherein the one or more locking portions comprise a circular opening configured to engage the tab and, wherein force applied to the tab causes the tab to release from the recessed opening. The instant disclosure describes the parameters of tab shape and locking portion shape as being merely preferable, and does not describe tab shape and locking portion shape as contributing any unexpected results to the system. As such, parameters such as the tab shape and locking portion shape are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the tab shape and locking portion shape would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. In regard to claim 9, Kallas discloses an extension portion (76).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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