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 . Claims 1-10 are pending and examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference character 21 not shown in drawings as disclosed in paragraph 0045 of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
-Paragraph 0013 recites “a bolt wire assembly including an bolt wire and an bolt wire…” It appears “bolt wire” is recited twice here.
-Paragraphs 0013 and 0047 appears to have a typographical error. The examiner recommends “an bolt” to be “a bolt”.
Appropriate correction is required.
Claim Objections
Claim 5 objected to because of the following informalities:
Claim 5 recites “an bolt wire and an bolt wire base…” in line 6. It appears to have a typographical error. The examiner recommends “a bolt wire” and “a bolt wire base”.
Appropriate correction is required.
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) 1-7 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le et al. (US 20090281619 A1) hereinafter, Le.
Regarding claim 1, Le teaches
a valve delivery device (10, Fig. 1), comprising:
a bending adjustment tube (14 or 152, Figs. 1 or 36);
a withdrawing assembly (32 or 588, Figs. 1 or 39B) connected to the bending adjustment tube (14, Fig. 1) and configured to install a valve (12, Fig. 1);
a bending adjustment wheel (70 or 155, Figs. 1 or 36F) provided with a traction block (192, Fig. 36);
a traction wire (174, Fig. 36), comprising an end connected to the withdrawing assembly (distal end of 188 where 32 would be, Fig. 36, ¶0172) and another end connected to the traction block (192, Fig. 36, ¶0172); and
a stabilizing tube (526, Fig. 39B) that sleeves the bending adjustment tube (188 or 506, Figs. 36 or 39B) and is arranged between the withdrawing assembly (32 or 508, Figs. 1 or 39B) and the bending adjustment wheel (70 or 155, Figs. 1 or 36), wherein
the bending adjustment wheel (70 or 155, Figs. 1 or 36) is configured to adjust a position of the traction block (155 is rotated to move 192 in the proximal direction, ¶0173);
the traction block (192, Fig. 36) drives the withdrawing assembly to move by means of the traction wire, to adjust a bending degree of the bending adjustment tube (when 155 is rotated to move 192 in the proximal direction, 174 also is moved in the proximal direction, thereby bending the steerable section and reducing its radius of curvature, ¶0173); and
the stabilizing tube (526, Fig. 39B) is configured to limit a bending position of the bending adjustment tube (preserving the shape of the bend in the steerable section, ¶0173).
The phrase “…configured to limit a bending position of the bending adjustment tube” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the delivery device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to deliver such an implant in order to meet the claim requirements. In this case, the Le device discloses all the claimed structural features and is considered to be capable of limiting a bending position of the bending adjustment tube.
Regarding claim 2, Le teaches
further comprising a bending adjustment tube base (190, Fig. 36) connected to the bending adjustment tube (14 or 152, Figs. 1 or 36) and configured to fix the bending adjustment tube (190 surrounds a portion of 152, Fig. 36).
Regarding claim 3, Le teaches
wherein the bending adjustment wheel (70 or 155, Figs. 1 or 36) is provided with internal threads (160, Fig. 32), the traction block (192, Fig. 36) is provided with external threads (slide nut (192) that has male threads, ¶0165), and the bending adjustment wheel (155, Fig. 36) sleeves the traction block (192, Fig. 36) and is configured to drive the traction block (192, Fig. 36) to move along an axial direction of the bending adjustment tube (152, Fig. 36) when the bending adjustment wheel rotates (154 is rotated, the 192 translates along the internally threaded surface portion, ¶0165).
Regarding claim 4, Le teaches
wherein the withdrawing assembly comprises a withdrawing base (left portion of connected 96 & 100, Fig. 23A), the withdrawing base is provided with a first connection hole (bigger opening at end of 96, Fig. 22A) and a second connection hole (smaller opening at end of 96, Fig. 22A), the first connection hole is arranged at an axis of the withdrawing base (Fig. 22A) and is configured for connecting the bending adjustment tube (14, Fig. 23A) , and the second connection hole is configured for connecting the traction wire (distal end portion of 174 is secured to the distal end portion of 188, ¶0172).
The phrase “…configured for connecting the traction wire” is a functional recitation that is not given full patentable weight. The implant is not positively recited here, but is instead merely recited as part of the intended use of the delivery device. Therefore, the prior art is not required to explicitly disclose the particular features of the implant, but merely have the capability of being used to deliver such an implant in order to meet the claim requirements. In this case, the Le device discloses all the claimed structural features and is considered to be capable of the second connection hole is configured for connecting the traction wire.
Regarding claim 5, Le teaches
further comprising a bolt wire assembly (96, Fig. 22A), wherein the bolt wire assembly comprises an bolt wire (98, Fig. 22A) and an bolt wire base (bottom portion of 96, Fig. 22A), the bolt wire is installed at the bolt wire base (Fig. 22A), the bolt wire assembly is arranged in the withdrawing base (100, Fig. 23B) and is able to slide along an inner wall of the withdrawing base (100 overmold 98 and 98 can push outward, therefore 98 can slide along inner wall of 100, ¶0142-0143).
Regarding claim 6, Le teaches
wherein the withdrawing base (left portion of connected 96 & 100, Fig. 23A) is provided with a guide groove (groove of 100, Fig. 22A), the bolt wire base (bottom portion of 96, Fig. 22A) is provided with a guide boss (left portion of where 98 extends out of 96, Fig. 22A), the guide boss is able to slide along the guide groove (groove of 100, Fig. 22A), and the bolt wire (98, Fig. 22A) is arranged in the guide boss (left portion of where 98 extends out of 96, Fig. 22A).
Regarding claim 7, Le teaches
wherein the bolt wire base is provided with a plurality of guide bosses (left portion of where 98 extends out of 96, Fig. 22A) distributed along a circumferential direction of the bolt wire base (bottom portion of 96, Fig. 22A), and the bolt wire (98, Fig. 22A) is arranged corresponding to the guide boss.
Regarding claim 9, Le teaches
further comprising a wire guide tube (175, Fig. 36), wherein the wire guide tube comprises an end connected to the bolt wire assembly (96, Fig. 22A), and another end provided with a locking device (166, Fig. 42) for limiting movement of the wire guide tube.
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) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Pham et al. (US 20230225864 A1) hereinafter, Pham.
Regarding claim 8, Le does not teach the withdrawing assembly comprises a fixing claw. However, Pham teaches a delivery system for implantable medical device (abstract, Pham)
wherein the withdrawing assembly (127, Fig. 2, Pham) comprises a fixing claw (121, Fig. 2, Pham),
the fixing claw is fixedly installed at the withdrawing base (129, Fig. 1A, Pham), and the fixing claw (121, Fig. 2, Pham) and the guide groove (inside of 129, Fig. 1A, Pham) are arranged at a same straight line in a radial direction of the withdrawing base (straight line at 121 & 129, Fig. 1A, Pham).
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 teachings of Le by incorporating the teaching above as taught by Pham in order to restrain the implantable medical device (¶0271, Pham).
Regarding claim 10, Le teaches
further comprising an outer tube (510, Fig. 39A, Le). Le does not teach an outer tube and a release wheel. However, Pham teaches
further comprising an outer tube (123, Fig. 20, Pham) and a release wheel (232, Fig. 31, Pham), wherein
the outer tube (123, Fig. 20, Pham) sleeves the withdrawing assembly (127, Fig. 20, Pham) and the bending adjustment tube,
the outer tube (123, Fig. 20, Pham) is configured to store the valve (100, Fig. 18, Pham), and
the release wheel (232, Fig. 31, Pham) is configured to control linear movement of the outer tube (drive 123 to slide, ¶0351, Pham).
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 teachings of Le by incorporating the teaching above as taught by Pham in order to drive the sheath to cover/expose the catheter (¶0351, Pham).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774