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 .
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:
Paragraph [0039] and “List of Elements” at the end of the specification, ratio (37).
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
Applicant is reminded of the proper content of an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because:
The abstract is longer than 150 words.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Paragraph [0010], “A stent includes a framework having with a length along a stent axis…” should be “A stent includes a framework having a length along a stent axis…”.
Appropriate correction is required.
Double Patenting
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.
Claims 1-5, 8, 14-19, 27-28, 31-32, and 51-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,896,507 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are either anticipated by or an obvious variation of the patented claims.
Claim 1 of the instant application recites a stent comprising a framework having a hollow cylindrical shape with a length along a stent axis, including a sequence of cells (each with struts connected at vertices), wherein adjacent cells are attached by a plurality of T-bars (each with a column defining a long axis parallel to the stent axis and a top bar). This is fully met by or an obvious variation of claim 1 of the ‘507 patent, which recites the identical core structure plus additional details (e.g., column width wider than struts with at least one slot, and top bar with a curved edge straddling the long axis). The omission of these specifics in the instant independent claim renders it broader but not patentably distinct.
Dependent claims 2, 3, 16, and 17 recite features such as movability among loading/tube/expanded diameters, strut orientation parallel to the stent axis at tube diameter, wider/slotted columns, and curved/straddling/concave top bar edges. These are directly met by or obvious in view of claims 1, 3, 5, and 13-14 of the ‘507 patent.
Claims 4, 8, 14, 27, 28, and 51 recite strut width-to-thickness ratios, specific cell types (flex/hoop), vertex inner curves/radii/peaks, and longitudinal cell separation distances (<0.08 mm or 0.04-0.08 mm). These correspond to claims 2, 6, 12, and related limitations in the ‘507 patent (and are further suggested by the family).
Claims 31-32 (coating with therapeutic agent) are obvious over the stent platform in view of the Armstrong (US PGPUB No. 20130197617) prior art reference.
Claims 1-5, 8, 14-19, 27-28, 31-32, and 51-53 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 (and dependents) of U.S. Patent No. 12,263,104 B2 and over claims 1-2 (and dependents) of U.S. Patent No. 12,465,509 B2.
The reasoning is analogous: the instant claims represent obvious variations or direct anticipations of the T-bar stent platform, peak/concave top bar geometry, vertex peak alignments/offsets/separation distances, coatings, nitinol/self-expanding features, and loading methods claimed in these patents. For example, the concave straddling top bar edges with convex flanks and specific cell separation distances in the ‘104 and ‘509 patents render the instant features non-distinct.
Claim Objections
Claim 53 is objected to because of the following informalities:
Claim 53 should be amended to the following, “every strut of the self expanding stent is parallel to every other strut of the self expanding stent at the tube diameter.”
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 15 and 51 are 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 15 recites the limitation "the curved edge". There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from claim 1, claim 1 also did not introduce/recite the limitation, leading to confusion as to what exactly the Applicant intends to claim. Each of claims 3 and 18 introduce the limitation/component/feature that Applicant intends to recite/claim, as such for purposes of examination, it will be interpreted as, “The stent of claim 1, wherein a curved edge on a side opposite from the column is a concave edge that faces away from the column.”
Claim 51 recites the limitation "the tube diameter" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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, 15-16, 18, 31, & 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armstrong (US PGPUB No. 20130197617).
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Regarding claim 1, Armstrong discloses, a stent (Figure 1, self-expanding stent (100); Paragraph [0061]) comprising:
a framework (Figure 1; Paragraph [0040]) having a hollow cylindrical shape (Figure 1, cylindrical body (101); Paragraph [0061]) with a length (Figure 1) along a stent axis (Figure 1, longitudinal axis (102); Paragraph [0062]), and the framework including a sequence of cells (Figures 2A-3B; closed cells (104) & open cells (105); Paragraphs [0069]-[0071]) that each occupy a discrete segment (Figures 2A-3B, circumferential members (110p & 110d) and undulating helical element (120); Paragraphs [0069]-[0071]) of the stent length (Figures 1-2A), and each of the cells (closed cells (104) & open cells (105)) including a plurality of struts (Figure 1, struts (124); Paragraph [0063]) with ends connected at respective vertices (Figure 1, apices (123); Paragraph [0063]);
an adjacent pair of the cells being attached to one another by a plurality of T-bars (Figure 2A, axial connectors (125); Paragraphs [0065]-[0066]) that each include a column (See annotated Figure 4B above, (Column)) defining a long axis (See annotated Figure 4B above, (Long axis)) extending parallel to the stent axis (longitudinal axis (102)) and a top bar (See annotated Figure 4B above, (Top bar)) attached to one end of the column (Column), and an opposite end of the column (Column) being attached to a first cell of the adjacent pair of cells (Figure 2B), and the top bar (Top bar) being attached at opposite ends to a second cell of the adjacent pair of cells (Figure 2B).
Regarding claim 8, Armstrong further discloses, wherein: the sequence of cells includes at least one end cell, at least one flex cell, and at least one hoop cell (Armstrong discloses a sequence of cells/segments: circumferential members (closed cells (104) at ends) and interposed helical element (open cells (105)) (Paragraphs [0051]-[0055], Figures 1-3B & 5). The end circumferential members function as “end cells,” the helical/open-cell portions provide flexibility (“flex cells”), and the more rigidly connected circumferential rings provide hoop strength (“hoop cells”)); and
the adjacent pair of cells includes exactly one flex cell and exactly one hoop cell (Adjacent pairs connect closed-cell-like and open-cell-like regions).
Regarding claim 15, Armstrong further discloses, wherein the top bar (Top bar) has a curved edge wherein the top bar (Top bar) has a curved edge (See annotated Figure 4B above, (Curved edge)) on a side opposite from the column (Column) and the curved edge (Curved edge) is a concave edge that faces away from the column (See annotated Figure 4B above, as clearly illustrated, the (Curved edge) is indeed a concave edge that faces away from the (Column)).
Regarding claim 16, Armstrong further discloses, wherein: the hollow cylindrical shape (cylindrical body (101)) is movable among a loading diameter that is smaller than a tube diameter which is smaller than an expanded diameter (Paragraph [0041], where it is disclosed, “a sheath can compress the stent so that it can be inserted into a patient, and removal of the compressive force applied by the sheath (such as by retracting the sheath) allows the stent to self-expand for deployment.” and Paragraph [0042] , where it is disclosed “the stent has an insertion configuration with a reduced profile that permits intraluminal or endoluminal delivery of the stent into a vessel lumen, and a deployed configuration with an enlarged profile greater than the insertion profile that provides structural support for the vessel.” Additionally, Paragraph [0128] discloses, “The stent can be compressed and mounted on a delivery system as described previously.”);
the framework is biased toward the expanded diameter (Paragraphs [0041], [0061], & [0089]); and
every strut of the framework is oriented parallel to the stent axis when the hollow cylindrical shape is at a tube diameter (Inherent: struts align axially under radial compression in a cylindrical sheath).
Regarding claim 18, Armstrong further discloses, wherein the top bar (Top bar) has a curved edge (See annotated Figure 4B above, (Curved edge)) on a side opposite from the column (Column) and the curved edge (Curved edge) straddles the long axis (See annotated Figure 4B above, as clearly illustrated, the (Curved edge) does indeed straddle the (Long axis)).
Regarding claim 31, Armstrong further discloses, also comprising a coating on a surface of the framework (Paragraph [0123]).
Regarding claim 32, Armstrong further discloses, wherein the coating includes a therapeutic agent (Paragraph [0123]).
Claim Rejections - 35 USC § 102/103
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.
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) 2 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Armstrong.
Regarding claim 2, Armstrong further teaches, wherein: the hollow cylindrical shape (cylindrical body (101)) is movable among a loading diameter that is smaller than a tube diameter which is smaller than an expanded diameter (Paragraph [0041], where it is disclosed, “a sheath can compress the stent so that it can be inserted into a patient, and removal of the compressive force applied by the sheath (such as by retracting the sheath) allows the stent to self-expand for deployment.” and Paragraph [0042], where it is disclosed “the stent has an insertion configuration with a reduced profile that permits intraluminal or endoluminal delivery of the stent into a vessel lumen, and a deployed configuration with an enlarged profile greater than the insertion profile that provides structural support for the vessel.” Additionally, Paragraph [0128] discloses, “The stent can be compressed and mounted on a delivery system as described previously.”); and
every strut (struts (124)) of the framework (Figure 1) is oriented parallel to the stent axis (longitudinal axis (102)) when the hollow cylindrical shape (cylindrical body (101)) is at the tube diameter (Examiner notes that given that the stent (self-expanding stent) is compressible, it is expected that struts (124) which connect at apices (123) with adjacent struts, will move closer to each other such that they are aligned/parallel with the longitudinal axis (102) when the cylindrical body (101) is at the tube diameter).
While Armstrong does not expressly state, the hollow cylindrical shape is movable among a loading diameter that is smaller than a tube diameter which is smaller than an expanded diameter; and every strut of the framework is oriented parallel to the stent axis when the hollow cylindrical shape is at the tube diameter. Armstrong teaches, Paragraph [0041], where it is disclosed, “a sheath can compress the stent so that it can be inserted into a patient, and removal of the compressive force applied by the sheath (such as by retracting the sheath) allows the stent to self-expand for deployment.” and Paragraph [0042] , where it is disclosed “the stent has an insertion configuration with a reduced profile that permits intraluminal or endoluminal delivery of the stent into a vessel lumen, and a deployed configuration with an enlarged profile greater than the insertion profile that provides structural support for the vessel.” Additionally, Paragraph [0128] discloses, “The stent can be compressed and mounted on a delivery system as described previously.” Also given that the stent (self-expanding stent) is compressible, it is expected that struts (124) which connect at apices (123) with adjacent struts, will move closer to each other such that they are aligned/parallel with the longitudinal axis (102) when the cylindrical body (101) is at the tube diameter. Accordingly, Armstrong either anticipates the claimed invention or the invention is obvious over Armstrong. It would have been obvious to have the cylindrical body (101) to be movable among a loading diameter, given that the stent needs to be compressed to a point where the diameter of the stent is smaller than the diameter of the sheath/lumen of the delivery system in order to enter, then after insertion, the cylindrical body (101) will expand to a diameter (tube diameter) that allows the stent to conform to the inner surface of the sheath/lumen of the delivery system in order to apply a compressive force to retain the stent within the delivery system, and lastly the release of the stent will result in the deployment of the stent where the cylindrical body (101) expands to a diameter (expanded diameter) larger than the previous two diameters. Additionally, it is obvious for every strut of the framework to be oriented parallel to the stent axis when the hollow cylindrical shape is at the tube diameter, given that the stent moves between an insertion configuration and a deployed configuration, which permits for the struts (124) connected at apices (123) to be movable relative to the longitudinal axis (102), such that they become aligned/parallel to the axis as compression is applied to the cylindrical body (101) of the stent (100) when in the delivery system (tube diameter).
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) 4-5, 14, 19, and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong.
Regarding claim 4, Armstrong further teaches, wherein each of the struts (struts (124)) has a width to thickness ratio about equal to one (Paragraphs [0081], [0087], & [0136]; struts having a defined width and thickness (e.g., Table 2: strut width ~0.1 mm; wall thickness of nitinol tubing ~0.15 mm in examples).
While Armstrong does not expressly recite a strut width-to-thickness ratio of “about equal to one,” the reference teaches struts with rectangular or near-rectangular cross-sections (typical of laser-cut tubing) and provides specific dimensions where width and thickness are in a comparable range (0.1 mm width vs. 0.15 mm thickness yields a ratio close to 1:1.5). It would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the strut width-to-thickness ratio to about 1:1 (square or near-square cross-section). Such a ratio is a known result-effective variable for balancing radial strength, flexibility, fatigue resistance, and crimpability in self-expanding nitinol stents (MPEP § 2144.05). Armstrong already recognizes the importance of strut geometry for performance (Paragraphs [0040]-[0049], & [0087]). Adjusting the ratio involves routine optimization within predictable ranges. In re Aller.
Regarding claim 5, Armstrong further teaches, wherein: the hollow cylindrical shape (cylindrical body (101)) is movable among a loading diameter that is smaller than a tube diameter which is smaller than an expanded diameter (Paragraph [0041], where it is disclosed, “a sheath can compress the stent so that it can be inserted into a patient, and removal of the compressive force applied by the sheath (such as by retracting the sheath) allows the stent to self-expand for deployment.” and Paragraph [0042] , where it is disclosed “the stent has an insertion configuration with a reduced profile that permits intraluminal or endoluminal delivery of the stent into a vessel lumen, and a deployed configuration with an enlarged profile greater than the insertion profile that provides structural support for the vessel.” Additionally, Paragraph [0128] discloses, “The stent can be compressed and mounted on a delivery system as described previously.”); and
the framework is biased toward the expanded diameter (Paragraphs [0041], [0061], & [0089]).
Armstrong does not expressly limit the tube diameter to “5 French or less.” However, Armstrong teaches stents sized for various vessels, including smaller peripheral applications (e.g., carotid, infrainguinal (Paragraph [0124])), with compacted profiles compatible with 5F or 6F introducer systems (Paragraph [0126]: “5F (for 6-8 mm) or 6F (for 9-10 mm)”). Smaller French sizes (≤5F) are explicitly contemplated for lower-profile delivery in tortuous or smaller anatomy.
It would have been obvious to configure the stent for a tube diameter of 5 French or less for smaller-vessel applications. This is a predictable design choice based on vessel size and delivery system compatibility. One of skill would select appropriate tubing diameter and strut parameters to achieve the desired crimp profile (MPEP § 2144.05; routine optimization of stent diameter and delivery profile). In re Aller.
Regarding claim 14, Armstrong further teaches, wherein each of the vertices define a continuous inner curve with a radius that is less than one half of a width of the struts joined by a respective vertex of the vertices (Armstrong discloses apices/vertices formed by interconnected struts with curvature (Figures 3A-4C; apex radius ~0.2 mm per Table 2 in Paragraph [0087]; struts ~0.1 mm width). The reference shows continuous curved transitions at apices (typical laser-cut nitinol design to reduce stress concentrations)).
While not expressly stating the inner curve radius is less than one-half the strut width, the disclosed dimensions (apex radius 0.2 mm vs. strut width 0.1 mm) are close, and Armstrong emphasizes smooth apex geometry for fatigue and manufacturability (Paragraph [0073]). It would have been obvious to select an inner radius <1/2 strut width as a routine optimization to minimize stress risers while maintaining strut integrity (predictable result; In re Aller). Smaller radii relative to strut width are common in stent art for crimpability and durability.
Regarding claim 19, Armstrong further teaches, wherein each adjacent pair of cells in the sequence of cells is separated by a distance that is less than a minimum width of every strut of the plurality of struts (Armstrong discloses close spacing of adjacent cell portions/turns (Figures 2A-3B; axial connectors (125) between helical turns; minimal gaps in closed-cell regions). Cell separation is a result-effective variable affecting column strength, crimp profile, and loading behavior).
While Armstrong does not expressly claim separation “less than a minimum width of every strut,” the reference’s laser-cut design with tight patterns and teachings on packing/column strength (Paragraphs [0086]-[0087]) render the specific tight spacing obvious. One of skill would optimize the gap to enhance longitudinal support during loading without sacrificing flexibility, per routine experimentation (MPEP § 2144.05; In re Aller).
Regarding claim 27, Armstrong discloses the claimed invention except for, wherein each of the vertices (apices (123)) define a peak (Figures 1-2B) and wherein peaks on adjacent cells are separated by a longitudinal cell separation distance of less than 0.08 millimeters. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a longitudinal cell separation distance of less than 0.08 millimeters to separate peaks on adjacent cells, 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 involve only routine skill in the art. In re Aller.
Regarding claim 28, Armstrong discloses the claimed invention except for, wherein each of the vertices (apices (123)) define a peak (Figures 1-2B) and wherein peaks on adjacent cells are separated by a longitudinal cell separation distance of less than 0.06 millimeters. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a longitudinal cell separation distance of less than 0.06 millimeters to separate peaks on adjacent cells, 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 involve only routine skill in the art. In re Aller.
Claim(s) 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Layman (US Patent No. 9498360), in view of Abunassar (US PGPUB No. 20130123905).
Regarding claim 52, Layman discloses a stent that has a relaxed, axially contracted configuration in which the connecting member is contracted axially and each circumferential segment is nested with at least one adjacent circumferential segment. Layman teaches, a method of loading a self-expanding stent into a catheter of a stent delivery system (Figure 4; Col. 10, line 38-50; Where the method involves the step (102) of axially expanding the stent (10) and radially contracting it into a delivery configuration to be later constrained in its delivery configuration with a sheath in step (104)), comprising the steps of:
putting the stent in a loading configuration (Figure 4, step (102); Col. 10, line 38-42), which includes compressing the self expanding stent circumferentially (Figures 1A-1B; Col. 6, line 36-41; Where it is stated that stent (10) is radially compressed for delivery through a catheter and “radially compressed” being equivalent to “compressing the self-expanding stent circumferentially”).
Layman fails to teach, compressing the self expanding stent longitudinally; and moving adjacent cells of the self expanding stent from out of contact into contact responsive to the longitudinal compression.
Abunassar discloses a stent that is highly flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in its expanded condition to maintain the patency of a body lumen such as an artery when the stent is implanted therein. Abunassar teaches, the stent (10) as shown in Figure 19 is susceptible to longitudinal compressive loads which encourages ring-to-ring contact and that through this ring-to-ring contact, the stent structure’s ability to resist longitudinal compression is enhanced in situations when longitudinal loads are imparted on the stent (Figure 19; Paragraph [0102]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Layman such that the method also includes compressing the self expanding stent longitudinally and moving adjacent cells of the self expanding stent from out of contact into contact responsive to the longitudinal compression as taught by Abunassar to allow for putting the stent in a loading configuration, which includes simultaneously compressing the self expanding stent circumferentially and longitudinally while sliding the stent into the catheter, as both references and the claimed invention are directed to stents to be deployed within blood vessels to treat vascular disorders. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Layman such that the method also includes compressing the self expanding stent longitudinally and moving adjacent cells of the self expanding stent from out of contact into contact responsive to the longitudinal compression as taught by Abunassar to allow for putting the stent in a loading configuration, which includes simultaneously compressing the self expanding stent circumferentially and longitudinally while sliding the stent into the catheter, as such a modification would have been predictable, namely, to encourage ring-to-ring contact, which enhances the stent’s ability to resist longitudinal compression in situations when longitudinal loads are imparted on the stent.
Regarding claim 53, modified Layman teaches, wherein: the circumferential compression includes moving a hollow cylindrical shape of the self expanding stent from a tube diameter to a loading diameter (Layman discloses that the stent is formed by laser cutting (e.g., Nitinol or other superelastic/shape-memory material suitable for self-expanding stents) (Col. 7, line 28-42), Layman further discloses, radially compressing the stent from a larger (as manufactured or heat-set) diameter for loading into a delivery catheter/sheath, which inherently involves moving the hollow cylindrical shape from a tube (or intermediate) diameter to a smaller loading/crimped diameter (Figures 1A-1B; Col. 6, line 36-49 and Col. 6, line 65-Col. 7, line 16); Abunassar similarly discloses, laser-cut stents formed from a metallic tube (e.g., Nitinol), with the as-cut pattern on the tube providing the initial geometry before crimping/expansion, and discusses compression to low profiles for delivery (Figures 10-24; Paragraphs [0003]-[0004], [0026], [0102], [0104], and [0106] describing tube-cut patterns and crimping considerations)); and
every strut of the self expanding stent is parallel to every other strut of the self expanding strut at the tube diameter (Both Layman and Abunassar disclose laser-cut tubular stent patterns in which, in the as-cut (tube) configuration prior to expansion or full crimping, the primary strut elements are indeed formed with longitudinal/axial alignment or near-axial orientation in the unrolled/flat pattern view (Layman Figures 1A-3B showing chevron/sinusoid patterns cut from tube stock with axial components; Abunassar Figures 10-24 showing bar arms, peaks, and links in tubular laser-cut patterns where struts/bar arms have defined axial orientations in the manufactured tube state)).
A person of ordinary skill would recognize that tube-cut self-expanding stent patterns (especially Nitinol) are routinely designed with struts having axial alignment at the intermediate tube diameter to facilitate uniform crimping, controlled expansion, and loading without twisting or excessive deformation. 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 loading method of Layman (as modified by Abunassar’s longitudinal compression teachings) such that the circumferential compression step includes moving the hollow cylindrical shape from a tube diameter (as-cut/heat-set intermediate diameter) to a smaller loading diameter, with every strut oriented parallel to the stent axis (and thus to each other) at the tube diameter. The motivation would be to achieve a predictable, low-profile crimped configuration suitable for 5 Fr or smaller delivery systems while maintaining uniform strain, column strength during loading/pushing into the catheter, and avoiding buckling or twisting - predictable benefits well-known in the laser-cut self-expanding Nitinol stent art for smaller-diameter peripheral or coronary applications (as recognized in both references). This modification yields no more than the predictable result of improved loadability and controlled deployment.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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