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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
The drawing objections have been overcome.
Claims 1-6 and 11-18 are examined below.
Claim Objections
Claim 13 objected to because of the following informalities: "a rigid part" in line 2 should read "the rigid part". Appropriate correction is required.
Claim13 objected to because of the following informalities: "a flexible part" in line 2 should read "the flexible part". Appropriate correction is required.
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 11, 13 and 16-18 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.
Claim 11 recites the limitation "the hardness ratio" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the length ratio" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the hardness ratio" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the length ratio" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the longitudinal center axis" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “a plurality of groups of assemblies” in line 2. However, it is unclear if the “assemblies” assembly instruments or assembly parts. The Examiner understands the “plurality of groups of assemblies” to be refereeing to assembly parts. Dependent claim 17 is likewise rejected.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 12, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan (US 2004/0106977 A1) in view of Xiao-176 (CN 108186176 A as translated by Espacenet).
Regarding claim 1, Sullivan discloses a stent assembly system (36, stent delivery systems, fig. 2B), comprising
a stent (34, stent, fig. 2B) and an assembly instrument (30, stabilizer, fig. 2B), wherein the assembly instrument is used to assemble and deliver the stent;
the assembly instrument comprises a sheath core tube (32, inner core, fig. 2B), an outer sheath tube (40, sheath, fig. 2B) and an assembly part (60, protrusion, fig. 5);
the outer sheath tube slidably surrounds the sheath core tube in an axial direction (fig. 2B, ¶ [0035]), and an accommodating cavity for accommodating the stent is formed between the inner wall of the outer sheath tube and the outer wall of the sheath core tube (fig. 2B);
the assembly part has a fixed end (see annotated fig. 5, below) and a free end opposite to the fixed end (see annotated fig. 5, below); the fixed end is connected to the sheath core tube (fig. 5);
and when the stent is radially crimped on the sheath core tube, the free end is hooked to the stent to limit the stent (¶ [0032]).
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Sullivan fails to teach the assembly part includes a rigid part and a flexible part. However, Ciao-176 teaches an implant delivery system that includes wherein the assembly part includes a rigid part (221, fixing portion, fig. 4a) and a flexible part (222, deformation portion, fig. 4a), wherein the rigid part is the fixed end of the assembly part (fig. 15a, hooding units 91, 92, 93 are disposed above outer surface of inner sheath core tube 83) and one end of the flexible part is connected to the end of the rigid part away from the sheath core tube (fig. 15a, deformation portions extend from hooking unit) and the other end of the flexible part is the free end of the assembly part (9111, 9211, 9311, deformation portions, fig. 15a). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include a rigid part and a flexible part as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Regarding claim 2, Sullivan further teaches a plurality of assembly parts (fig. 5);
the plurality of assembly parts are arranged on the sheath core tube at intervals (fig. 5);
when the stent is radially crimped on the sheath core tube, wherein the ratio of an axial distance between the assembly part located at the most proximal end and the proximal end surface of the stent to the axial length of the stent is not greater than 1/3 (fig. 2B).
Regarding claim 3, Sullivan further teaches the free end of the assembly part has a spherical structure (fig. 5).
Regarding claim 4, Sullivan and Xiao-176 fail to teach when the hardness of the assembly part is 25D-85D, there is the relationship 0.5d1<h1<0.8d1. It would have been obvious to one having ordinary skill in the art at the time the invention was made for when the hardness of the assembly part is 25D-85D, there is the relationship 0.5d1<h1<0.8d1, since it has been held that where the general conditions of a claim are disclosed in the prior art (a stent assembly system intended for navigation in the vascular system), discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 12, Sullivan fails to teach the assembly part includes a base and a protrusion . However, Xiao-176 further teaches the assembly part includes a base (21, tightening member, fig. 3c) and a protrusion arranged on the base (221, 222, fixed part and deformation part, fig. 4a). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include the assembly part includes a base and a protrusion arranged on the base as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Regarding claim 15, Sullivan fails to teach the base is an arc-shaped housing. However, Xiao-176 further teaches the base is an arc- shaped housing (21, rightening member, fig. 3c), and the are-shaped housing has a surface that extends away from the protrusion (fig. 3c), and the shape of the surface of the are-shaped housing that extends away from the protrusion adapts to an arc-shaped surface of the sheath core tube (fig. 5c). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include the base is an arc-shaped housing as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Regarding claim 16, Sullivan fails to teach the assembly part is inclined relative to the longitudinal center axis. However, Xiao-176 further teaches the assembly part is inclined relative to the longitudinal center axis (¶ [0068]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include the assembly part is inclined relative to the longitudinal center axis as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Regarding claim 17, Sullivan further teaches the stent assembly system comprises a plurality of groups of assemblies (60A-60C, protrusions, fig. 5), each group of assemblies comprises two assemblies (2 rows of 60A-C, fig. 5), in the plurality of groups of assemblies.
Sullivan fails to teach some of the assemblies are inclined toward the distal end and some are inclined toward the proximal end. However, Xiao-176 further teaches some of the assemblies are inclined towards the distal end of the assembly instrument (931, hook member, fig. 15a), and some of the assemblies are inclined towards the proximal end of the assembly instrument (911, hook member, fig. 15a), the plurality of groups of assemblies inclined towards the distal end are closer to the distal end of the assembly instrument than the plurality of groups of assemblies inclined towards the proximal end (fig. 15a). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include some of the assemblies are inclined toward the distal end and some are inclined toward the proximal end as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Regarding claim 18, Sullivan fails to teach the plurality of groups of assemblies are disposed at unequal intervals. However, Xiao-176 further teaches the plurality of groups of assemblies inclined towards the distal end and the plurality of groups of assemblies inclined towards the proximal end are disposed at unequal intervals (¶ [0128]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include the plurality of groups of assemblies are disposed at unequal intervals as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xiao-176 as applied to claim 1 above, and further in view of Xiao-568 (CN 109419568 A).
Regarding claim 5, Sullivan further teaches the stent comprises a supporting framework (¶ [0031], fig. 2B).
Sullivan and Xiao-176 fail to teach the stent is covered with a film comprising an inner layer and an outer layer. However, Xiao-568 teaches a stent (10, endograft, fig. 3) comprising a supporting framework (100, stent, fig. 3) that includes
a covered film that surrounds the supporting framework (200, cover, fig. 3);
the supporting framework has a grid structure formed by weaving metal wires (¶ [0040]);
at least some metal wires are intersected and mutually hooked to form a plurality of intersections (¶ [0041], fig. 4);
the covered film comprises an inner-layer film (210, first diaphragm, fig. 3) and an outer-layer film (220, second diaphragm, fig. 3);
the inner-layer film is arranged in the supporting framework (¶ [0039]);
the outer-layer film is attached to an outer surface of the supporting framework and an outer surface of the inner-layer film (¶ [0039]);
and the plurality of intersections are not covered by the outer-layer film (fig. 3).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Sullivan and Xiao-176 to include a covered film that comprises an inner-layer and an outer-layer as taught by Xiao-568 in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao-568).
Regarding claim 6, Sullivan and Xiao-176 fail to teach the metal wires are intersected and mutually hooked to form a plurality of intersections. However, Xiao-568 further discloses at least some metal wires are intersected and mutually hooked to form a plurality of intersections that are spaced apart from each other in the axial direction (fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the stent of Sullivan to include the metal wires are intersected and mutually hooked to form a plurality of intersections as taught by Xiao-568 in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao-568).
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xiao-176 as applied to claim 1 above, and further in view of Rosenman (US 2006/0135961 A1).
Regarding claims 11 and 13, Sullivan fails to teach the length ratio of the rigid part and the flexible part. However, Xiao-176 further teaches wherein the protrusion includes a rigid part and a flexible part (fig. 4a) and the length ratio of the rigid part to the flexible part is 1:5-5:1 (fig. 4b, length L1 of deformation portion 222 ranges from 3-50 mm and length L2 of fixing portion ranges from 2-10 mm). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan to include the length ratio of the rigid part to the flexible part as taught by Xiao-176 in order to limit implant movement (abstract, Xiao-176).
Sullivan and Xiao-176 fail to teach the hardness ratio of the rigid part to the flexible part. However, Rosenman teaches a catheter that includes the hardness ratio of the rigid part (fig. 9d, segment 50) to the flexible part (fig. 9d, segment 5) is 0.3-0.9 (¶ [0050], fig. 9d, segment 50 comprises a hardness of 50D and segment 5 comprises a hardness of 35D). Rosenman discloses that the guide is able to execute very tight turns in order to direct the device throughout tortuous vasculature ¶[0047]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hardness ratio of the rigid part to the flexible part of 0.3-0.9, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the hardness ratio, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xiao-176 and Rosenman as applied to claim 12 above, and further in view of Lostetyter (WO 2017/176678 A1).
Regarding claim 14, Sullivan, Xiao-176 and Rosenman fails to teach the base is a hollow circular truncated cone. However, Lostetyter teaches an implant delivery device that includes the base (58, filler tubes, fig. 9A) is a hollow circular truncated cone having an outer contour which is a circular truncated cone (figs. 5 and 9A )and an inner cavity of which is a cylinder (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the assembly part of Sullivan, Xiao-176 and Rosenman to include the base is a hollow circular truncated cone as taught by Lostetyter in order to prevent longitudinal compression of the stent graft.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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