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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "202" and "382" have both been used to designate first hooking member.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "203" and "383" have both been used to designate second hooking member.
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: 53, 202 and 203.
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: A, B, C, D and 521a.
The drawings are objected to because there is no corresponding Fig. 8a referenced on pag.
The drawings are objected to because page 22 line 2 of the specification should refer to Fig. 22
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.
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 22-28 and 32-33 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 22 recites “at least on mesh support structure” in lines 5-6. It is unclear if this is the same mesh support structure recited in claim 21 line 2 or a separate and distinct mesh support structure. The Examiner interprets them to be the same. Dependent claim 23-28 are likewise rejected.
Claim 22 recites “a gap” in line 7 and “the gap” in lines 8-9. It is unclear if this is the same gap in claim 21 line 15 or a separate and distinct gap. The Examiner interprets them to be separate and distinct. Dependent claim 23-28 are likewise rejected.
Claim 32 recites “a first mesh region” in line 2. It is unclear if this is the same first mesh region recited in claim 31 line 2 or a separate and distinct first mesh region. The Examiner interprets them to be the same and recommends amended “a first mesh region” in claim 32 to “the first mesh region”.
Claim 33 recites “a first side” in line 4. It is unclear if this is the same first side recited in claim 33 line 2 or a separate and distinct first side.
Claim 33 recites “a second side” in line 5. It is unclear if this is the same second side recited in claim 33 line 3 or a separate and distinct second side.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 39 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 39 is a replication of claim 30 from which claim 39 depends from. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 21, 30-36 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armstrong (US 2002/0198588 A1).
Regarding claim 21, Armstrong teaches a lumen stent, comprising:
a mesh support structure (10, endoprosthesis, fig. 3),
wherein the mesh support structure comprises a first mesh region (upper part of 16, second segment, fig. 3) and a second mesh region connected to the first mesh region in a circumferential direction in a naturally deployed state (lower part of 16, second segment, fig. 3);
the first mesh region comprises a plurality of rows of intersecting units (fig. 3) formed by a plurality of first direction support wires spaced apart and a plurality of second direction support wires spaced apart overlapping each other (63, cross-over pattern, fig. 3, ¶ [0084]);
the second mesh region comprises at least one row of hooking units (20, interlocked stent patter, fig. 3, ¶ [0083]), each row of the hooking units comprising one or more hooking units arranged axially, and the hooking unit comprising a first hooking member (62, 3rd undulating patter, fig. 3) and a second hooking member (58, 2nd undulating pattern, fig. 3); and
the first hooking member and the second hooking member in at least portion of the hooking units are mutually hooked substantially in an axial direction (fig. 3), or the first hooking member and the second hooking member in at least portion of the hooking units are mutually separated substantially in the axial direction to form a gap (fig. 3), or the first hooking member and the second hooking member in at least portion of the hooking units abut, but do not hook.
Regarding claims 30 and 39, Armstrong further teaches a distal end of the first hooking member and a proximal end of the second hooking member are mutually hooked (fig. 3, ¶ [0083]), and the distal end of the first hooking member and/or the proximal end of the second hooking member are bent inward (the peaks and troughs of the hooking units are bent as they go from outside the stent toward inside the stent as they hook onto their respective peak/trough).
Regarding claim 31, Armstrong further teaches a lumen stent, comprising:
a first mesh region (upper part of 16, second segment, fig. 3) and a second mesh region connected to the first mesh region in a circumferential direction in a naturally deployed state (lower part of 16, second segment, fig. 3);
the first mesh region comprises a plurality of rows of intersecting units (fig. 3) formed by a plurality of first direction support wires spaced apart and a plurality of second direction support wires spaced apart overlapping each other (63, cross-over pattern, fig. 3, ¶ [0084]);
the second mesh region comprises at least one row of hooking units (20, interlocked stent patter, fig. 3, ¶ [0083]), each row of the hooking units comprising one or more hooking units arranged axially, and the hooking unit comprising a first hooking member (62, 3rd undulating patter, fig. 3) and a second hooking member (58, 2nd undulating pattern, fig. 3); and
the first hooking member and the second hooking member in at least portion of the hooking units are mutually hooked substantially in an axial direction (fig. 3), or the first hooking member and the second hooking member in at least portion of the hooking units are mutually separated substantially in the axial direction to form a gap (fig. 3), or the first hooking member and the second hooking member in at least portion of the hooking units abut, but do not hook.
wherein the lumen stent has a tubular shape (fig. 3).
Regarding claim 32, Armstrong further teaches the lumen stent comprises a first mesh region (upper part of 16, second segment, fig. 3) and two second mesh regions in the circumferential direction (see annotated fig. 3, below), the two second mesh regions connecting to two sides of the first mesh region, respectively (fig. 3, ¶ [0020]).
PNG
media_image1.png
212
341
media_image1.png
Greyscale
Regarding claim 33, Armstrong further teaches the first direction support wire extends to a first side for connection with the second hooking member (see annotated Fig. 3, below), and the first direction support wire extends to a second side for connection with the first hooking member (¶ [0084], see annotated fig. 3, below) the second direction support wire extends to a first side for connection with the first hooking member(¶ [0084], see annotated fig. 3, below), and the second direction support wire extends to a second side for connection with the second hooking member (¶ [0084], see annotated fig. 3, below).
PNG
media_image2.png
252
314
media_image2.png
Greyscale
Regarding claim 34, Armstrong further teaches the first hooking member comprises a wave trough (see annotated fig. 3, below) and two wave rods connected to the wave trough (see annotated fig. 3, below), and the second hooking member comprises a wave peak (see annotated fig. 3, below) and two wave rods connected to the wave peak (see annotated fig. 3, below), and the first hooking member and the second hooking member in at least portion of the hooking units are mutually hooked such that the wave trough of the first hooking member and the wave peak of the second hooking member are relatively movable in the axial direction (¶ [0083]).
PNG
media_image3.png
229
356
media_image3.png
Greyscale
Regarding claim 35, Armstrong further teaches a third mesh region in the circumferential direction (see annotated fig. 3, below);
two sides of the third mesh region are each connected to one second mesh region (see annotated fig. 3, below); or
two sides of the third mesh region are each connected to one first mesh region (see annotated fig. 3, below); or
two sides of the third mesh region are each connected to the first mesh region and the second mesh region, respectively (see annotated fig. 3, below).
PNG
media_image4.png
233
389
media_image4.png
Greyscale
Regarding claim 36, Armstrong further teaches the third mesh region comprises one or more waveform unit groups spaced apart in an axial direction, the waveform unit group comprising two waveform units mutually hooked in the axial direction (fig. 3, ¶ [0083]).
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) 22-25, 28 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Liu (US 2020/0188083 A1).
Regarding claim 22, Armstrong fails to teach a main body stent wherein at least a portion of the mesh support structure and an outer surface of the intermediate unit forming a gap in a radial direction. However, Liu teaches a covered stent with mesh support structure (12) that includes a main body stent (11, main stent, fig. 1),
and the main body stent comprises a proximal segment (see annotated fig. 1, below), a distal segment (see annotated fig. 1, below), and an intermediate segment positioned between the proximal segment and the distal segment (see annotated fig. 1, below), the intermediate segment comprising an intermediate unit (the part of the main stent that is in the intermediate segment denoted in annotated fig. 1, below) and at least one mesh support structure (see annotated fig. 1, below), and at least a portion of the mesh support structure and an outer surface of the intermediate unit forming a gap in a radial direction (see annotated fig. 1, below); the main body stent has an inner cavity extending through the proximal segment, the distal segment, and the intermediate unit (lumen of main stent 11, ¶ [0039]), the gap being in communication with the inner cavity (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 lumen stent of Armstrong to include a main body stent wherein at least a portion of the mesh support structure and an outer surface of the intermediate unit forming a gap in a radial direction as taught by Liu in order to reconstruct a blood flow channel and isolating a lesion (¶ [0038], Liu).
PNG
media_image5.png
334
392
media_image5.png
Greyscale
Regarding claim 23, Armstrong further teaches the mesh support structure comprises two second mesh regions in the circumferential direction (see annotated fig. 3, below), the two second mesh regions connecting to two sides of the first mesh region, respectively (fig. 3, ¶ [0020]).
PNG
media_image6.png
233
341
media_image6.png
Greyscale
Armstrong fails to teach the mesh support structure is connected to the intermediate region. However, Liu further teaches the mesh support structure is connected to the intermediate unit through the second mesh regions on two sides (fig. 2). 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 lumen stent of Armstrong to include the mesh support structure is connected to the intermediate region as taught by Liu in order to reconstruct a blood flow channel and isolating a lesion (¶ [0038], Liu).
Regarding claim 24, Armstrong further teaches the first hooking member comprises a wave trough (see annotated fig. 3, below)and two wave rods connected to the wave trough (see annotated fig. 3, below), and the second hooking member comprises a wave peak and two wave rods connected to the wave peak (see annotated fig. 3, below); and
the first hooking member and the second hooking member are mutually hooked such that the wave trough of the first hooking member and the wave peak of the second hooking member are relatively movable in the axial direction (¶ [0083]).
PNG
media_image7.png
229
356
media_image7.png
Greyscale
Regarding claim 25, Armstrong as modified by Liu discloses the invention substantially as claimed and as discussed above with respect to claim 23, and additionally teaches the mesh support structure further comprises at least one connector connected to the second mesh region (L, connection line fig. 2), and the mesh support structure is connected to the intermediate unit through the connector (fig. 2, ¶ [0039]).
Regarding claim 28, Armstrong as modified by Liu discloses the invention substantially as claimed and as discussed above with respect to claim 23, and additionally teaches at least one support unit (the connection between the fixed segment 121 and the side wall of the main stent 11 supports the mesh support structure), wherein the support unit is provided at a peripheral edge of the mesh support structure (fig. 1).
Regarding claim 40, Armstrong fails to teach a stent system comprising a lumen stent and a covered stent connected to the lumen stent. However, Liu further teaches a stent system (10, covered stent, fig. 5a), comprising the lumen stent according to claim 30 and a covered stent connected to the lumen stent (11, main stent, fig. 5a), wherein the lumen stent is sleeved outside the covered stent (¶ [0044], fig. 5a, the connection stent is covered where it is outside the boundary of the main stent), and the lumen stent forms a gap with an outer surface of the covered stent in a radial direction (123, gap, figs 1 and 5a). 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 lumen stent of Armstrong to include a stent system comprising the lumen stent and a covered stent connected to the lumen stent as taught by Liu in order to reconstruct a blood flow channel and isolating a lesion (¶ [0038], Liu).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Liu as applied to claim 25 above, and further in view of Treacy (US 2019/0262151 A1).
Regarding claim 26, Armstrong in view of Liu fails to teach the connector is comprises a wave and shares the wave rods with the first and second hooking member. However, Treacy teaches a woven stent that includes the connector is connected to one first hooking member and one second hooking member (104, 106, wires, fig. 7), and the connector comprises a wave towards a circumferential direction (200c, bend point, fig. 14; and the wave shares one wave rod with the first hooking member (200e, leg, figs. 9 and 14) and one wave rod with the second hooking member (200d, leg, figs. 9 and 14). 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 connector of Armstrong and Liu to include a wave and shares the wave rods with the first and second hooking member as taught by Treacy in order to cover sharp ends, (abstract, Treacy).
Regarding claim 27, Armstrong in view of Liu fails to teach two waists and a bottom edge. However, Treacy teaches a woven stent that includes the connector is connected to one first hooking member and one second hooking member (fig. 8), and the connector comprises two waists (200e and 106, 200d and 104, leg and wire make a waist, fig. 8) and a bottom edge connecting the two waists (200c, bend point, fig. 8); and one waist is formed by extending one wave rod of the first hooking member fig. 8), the other waist is formed by extending one wave rod of the second hooking member (fig. 8), and the two waists slidably move relative to each other at an intersection (where 104 and 106 intersect). 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 connector of Armstrong and Liu to include two waists and a bottom edge as taught by Treacy in order to cover sharp ends, (abstract, Treacy).
Claim(s) 29 and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong in view of Xiao (US 2019/0290460 A1).
Regarding claim 29, Armstrong further teaches the second mesh region comprises a proximal region (see annotated fig. 3, below), an intermediate region (see annotated fig. 3, below), and a distal region (see annotated fig. 3, below) from a proximal end (30, proximal end, fig. 1) to a distal end (24, distal end, fig. 1).
PNG
media_image8.png
402
291
media_image8.png
Greyscale
Armstrong fails to teach different hooking gap sizes. However, Xiao teaches a vascular stent that includes hooking gaps of varied sizes (¶ [0063-0065], fig. 7-2). 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 hooking gaps of Armstrong in view of Liu to include varied sizes as taught by Xiao in order to not have too many warping wave crests/wave troughs that are produced on the inner wall of the stent (¶ [0063], Xiao). Further, it would have been an obvious matter of design choice to make the different portions of the hooking gaps of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (see MPEP 2144)
Regarding claim 37, Armstrong further teaches at least one set of two waveform units mutually hooked in the axial direction in the third mesh region has a hooking gap (fig. 3).
Armstrong fails to teach different hooking gap sizes. However, Xiao teaches a vascular stent that includes hooking gaps of varied sizes (¶ [0063-0065], fig. 7-2). 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 hooking gaps of Armstrong in view of Liu to include varied sizes as taught by Xiao in order to not have too many warping wave crests/wave troughs that are produced on the inner wall of the stent (¶ [0063], Xiao). Further, it would have been an obvious matter of design choice to make the different portions of the hooking gaps of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (see MPEP 2144)
Regarding claim 38, Armstrong further teaches the second mesh region comprises a proximal region (see annotated fig. 3, below), an intermediate region (see annotated fig. 3, below), and a distal region (see annotated fig. 3, below) from a proximal end (30, proximal end, fig. 1) to a distal end (24, distal end, fig. 1).
PNG
media_image8.png
402
291
media_image8.png
Greyscale
Armstrong fails to teach different hooking gap sizes. However, Xiao teaches a vascular stent that includes hooking gaps of varied sizes (¶ [0063-0065], fig. 7-2). 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 hooking gaps of Armstrong in view of Liu to include varied sizes as taught by Xiao in order to not have too many warping wave crests/wave troughs that are produced on the inner wall of the stent (¶ [0063], Xiao). Further, it would have been an obvious matter of design choice to make the different portions of the hooking gaps of whatever relative sizes were desired, since such a modification would have involved a mere change in the proportions of components. A change in proportion is generally recognized as being within the level of ordinary skill in the art. (see MPEP 2144)
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 - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights