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 § 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.
Claim(s) 1-8 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toomey (US PGPub 2015/0265258).
Regarding Claim 1, Toomey teaches a puncture device (120; Figures 2B-2D) comprising:
a puncture portion (124; Figure 2B) having a sharp distal end (Paragraph 0024); and
a shaft portion (122) provided on a proximal end side of the puncture portion (124; Figure 2B; Paragraph 0021 and 0026),
wherein the shaft portion (122) includes a core member (121; Figures 2C-2D; Paragraph 0026) and an outer layer body (123) on an outer peripheral surface of the core member (121; Figures 2B-2C; Paragraph 0026).
Regarding Claim 2, Toomey teaches the puncture device according to claim 1, wherein a distal end portion of the core member (121) is positioned inside the puncture portion (124; Figure 2D).
Regarding Claim 3, Toomey teaches the puncture device according to claim 2, wherein the distal end portion of the core member (121) is inserted in an insertion hole (the proximal opening of needle tip 124) in the puncture portion (124; Figure 2D; Paragraph 0027).
Regarding Claim 4, Toomey teaches the puncture device according to claim 1, wherein a proximal end of the puncture portion (124) is in contact with a distal end of the outer layer body (123; Figure 2B; Paragraph 0031).
Regarding Claim 5, Toomey teaches the puncture device according to claim 1, wherein an outer diameter of the puncture portion (124) is substantially the same as an outer diameter of the shaft portion (122; Paragraph 0031).
Regarding Claim 6, Toomey teaches the puncture device according to claim 1, wherein the sharp distal end of the puncture portion (124) is a needle tip (Paragraph 0024).
Regarding Claim 7, Toomey teaches the puncture device according to claim 1, wherein the sharp distal end of the puncture portion is a blade (Paragraph 0024, the Examiner notes a blade is an object with a sharp end, but see also Paragraph 0035 which discloses a lancet tip).
Regarding Claim 8, Toomey teaches the puncture device according to claim 1, wherein flexibility of the shaft portion is higher than that of the puncture portion (Paragraph 0031, 0035-0038).
Regarding Claim 11, Toomey teaches the puncture device according to claim 1, wherein a distal end portion of the core member (121) extends into the puncture portion (124) beyond the outer layer body (123; as seen in Figures 2B-2D; Paragraph 0026-0027).
Claim Rejections - 35 USC § 103
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 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) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toomey (US PGPub 2015/0265258) as applied to claim 1 above, and further in view of Davis (US Patent 5,490,521).
Regarding Claim 9, Toomey teaches the puncture device according to claim 1, but fails to explicitly teach wherein the core member includes a core main body and a core distal end portion positioned inside the puncture portion, wherein, a diameter of the core distal end portion is smaller than a diameter of the core main body.
Davis teaches a puncture device/biopsy needle (abstract) comprising a puncture portion (18; Figure 8; Column 5, Lines 1-11) and a core member (12; stylet; Figure 8; Column 5, Lines 1-11), wherein the core member (12) includes a core main body and a core distal end portion positioned inside the puncture portion (see annotated Figure 8, provided below), wherein, a diameter of the core distal end portion is smaller than a diameter of the core main body (see annotated Figure 8, provided below).
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Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute core member taught by Toomey with the core member as taught by Davis since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; The core member taught by Davis would be sufficient to deliver the needle tip and give structural support to the shaft of Toomey,
Regarding Claim 10, the combination of references disclosed above teaches the puncture device according to claim 9, wherein Davis teaches the core member (12) further includes a tapered portion between the core main body and the core distal end portion (see annotated Figure 8 of Davis, provided above), the tapered portion having a diameter decreasing from the diameter of the core main body to the diameter of the core distal end portion (see annotated Figure 8, provided above).
Claim(s) 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toomey (US PGPub 2015/0265258) as applied to claim 1 above, and further in view of Toomey (US PGPub 2014/0357983; now referred to as Toomey-2)
Regarding Claim 12, Toomey teaches the puncture device according to claim 1, further but fails to disclose comprising an inner sheath that houses the puncture portion and the shaft portion, wherein a distal end of puncture portion protrudes beyond the inner sheath.
Toomey-2 teaches a puncture device (abstract) comprising a puncture portion (204; Figure 2)(304; Figure 3), a shaft portion (105; Figure 2-3), and an inner sheath (102) houses the puncture portion (shown as 102 in Figures 1, 4, and 6) and the shaft portion (105), wherein a distal end of puncture portion (104) protrudes beyond the inner sheath (102; Figure 1; Paragraph 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Toomey in include the inner sheath taught by Toomey-2 for the advantage of providing an echogenic tip which allows for being visible ultrasonically to provide location and navigation data (Paragraph 0031; Toomey-2)
Regarding Claim 13, the combination of references disclosed above teaches the puncture device according to claim 12, wherein Toomey-2 teaches the inner sheath (102) completely surrounds the shaft portion (105; Figures 1, 4, and 6)).
Regarding Claim 14, the combination of references disclosed above teaches the puncture device according to claim 12, but Toomey fails to disclose wherein an outer surface of the outer layer body in contact with the inner sheath has an irregular surface.
Toomey-2 discloses, in Figure 1 and 3, wherein the shaft portion comprises a core member (106) and an outer layer body (105) which is designed as a coil (Paragraph 0037-0038). In Figures 4-6, Toomey-2 discloses that the outer layer body (205) can be formed of multiple wires (Paragraph 0039-0044) which has an irregular outer surface (best seen in Figure 4 and Figure 6).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute outer body layer taught by Toomey with the outer body layer as taught by Toomey-2 since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; The outer layer body taught by Toomey-2 would be sufficient to deliver the needle tip to the tissue which is to be punctured.
Regarding Claim 15, the combination of references disclosed above teaches the puncture device according to claim 12, wherein Toomey-2 teaches further comprising an outer sheath (101) having a larger inner diameter than an outer diameter of the inner sheath (102) to allow the inner sheath (102) to relatively move in an axial direction, wherein a distal end of the inner sheath (102) protrudes from a distal end of the outer sheath (101; Paragraph 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include an outer sheath, as taught by Toomey-2, for the advantage of providing a protective sheath during delivery towards the tissue which is to be punctured.
Regarding Claim 16, the combination of references disclosed above teaches the puncture device according to claim 15, wherein Toomey-2 the outer sheath (101) has a diameter to be coupled with an insertion channel of a treatment tool (Paragraph 0035, 0042, 0050, and 0051; Toomey-2). Furthermore, Toomey teaches an outer sheath (112) which has a diameter to be coupled with an insertion channel of a treatment tool (Figure 1; Paragraph 0019).
Regarding Claim 17, the combination of references disclosed above teaches the puncture device according to claim 16, wherein Toomey teaches further comprising an operation portion (101; Figure 1) that includes a connection portion (116; Figure 1) to be connected to the insertion channel of the treatment tool (Paragraph 0019), the operation portion (101) to move outer sheath relative to the insertion channel of the treatment tool in the axial direction (Paragraph 0018-0019).
Regarding Claim 18, the combination of references disclosed above teaches the puncture device according to claim 17, wherein Toomey teaches the operation portion (101; Figure 1) includes a scale (117; Figure 1) that represents a length from a distal end of the connection portion to the distal end of the outer sheath (112) (Paragraph 0019).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771