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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6) in the reply filed on 12/03/2025 is acknowledged.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fixed end and the free end must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "200" and "120" have both been used to designate stent.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: II.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Double Patenting
Claim 1 of this application is patentably indistinct from claim 25 of Application No. 17/914,148. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of copending Application No. 17/914,148 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘148 claim 25 does not anticipate claim 1 because it does not positively claim a stent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of copending Application No. 17/914,148 in view of Sullivan (US 2004/0106977 A1) and Xiao (CN 109419568 A).
Regarding claim 2, all of the claimed limitations are disclosed in copending Application No. 17/914,148 except 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. However, Sullivan teaches 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). It would have been obvious to one of ordinary sill in the art to have modified the assembly instrument to have a 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 in order to avoid collapse of the stent (¶ [0008], Sullivan).
Regarding claim 3, all of the claimed limitations are disclosed in copending Application No. 17/914,148 except the free end of the assembly part has a spherical structure. However, Sullivan further teaches the free end of the assembly part has a spherical structure (fig. 5). It would have been obvious to one of ordinary sill in the art to have modified the assembly part to have a spherical structure in order to avoid collapse of the stent (¶ [0008], Sullivan).
Regarding claim 4, all of the claimed limitations are disclosed in copending Application No. 17/914,148 except when the hardness of the assembly part is 25D-85D, there is the relationship 0.5d1<h1<0.8d1. However, 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, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 5, all of the claimed limitations are disclosed in copending Application No. 17/914,148 except the stent comprises a supporting framework and a covered film. However, Xiao discloses 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). 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 delivery device of copending Application No. 17/914,148 to include a stent comprising a supporting framework and a covered film that comprises an inner-layer and an outer-layer as taught by Xiao in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao).
Regarding claim 6, all of the claimed limitations are disclosed in copending Application No. 17/914,148 except a plurality of intersections. However, Xiao 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). 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 delivery device of copending Application No. 17/914,148 to include the metal wires are intersected and mutually hooked to form a plurality of intersections as taught by Xiao in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao).
This is a provisional nonstatutory double patenting rejection.
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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan (US 2004/0106977 A1).
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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Regarding claim 2, Sullivan further discloses 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 discloses the free end of the assembly part has a spherical structure (fig. 5).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan.
Regarding claim 4, Sullivan fails 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).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan in view of Xiao (CN 109419568 A).
Regarding claim 5, Sullivan further discloses the stent comprises a supporting framework (¶ [0031], fig. 2B).
Sullivan fails to teach the stent is covered with a film comprising an inner layer and an outer layer. However, Xiao discloses 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 to include a covered film that comprises an inner-layer and an outer-layer as taught by Xiao in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao).
Regarding claim 6, Sullivan fails to teach the metal wires are intersected and mutually hooked to form a plurality of intersections. However, Xiao 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 in order to provide the relative displacement space for the metal stent to realize the flexibility of the covered stent (¶ [0003], Xiao).
Conclusion
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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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799