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 .
Election/Restrictions
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/17/2025.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/03/2024 and 01/03/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. However, Examiner notes, minor errors were noted in two of the information disclosure statements filed. The appropriate information disclosure statements were annotated to address these errors.
Drawings
The drawings are objected to because:
Reference number (600) in Figure 2C should be omitted. Reference number (600) as disclosed in the specification refers to the manufacturing method of Figure 6, as such, its use in Figure 2C is unnecessary and confusing.
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.
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:
Figure 3F, reference number (150).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0012] should be amended to the following, “In some examples, a method of manufacturing a tubular braid is disclosed. The method can include: shaping a tubular braid to a predetermined shape; heat setting the tubular braid in the predetermined shape in an inert environment; and reducing the braid thickness at the first inversion while retaining braid thickness in portions of the first segment and the second segment. Shaping the tubular braid to the predetermined shape can include: inverting the tubular braid to form a second inversion, shaping a third segment of the tubular braid extending from the second inversion to a pinched end of the tubular braid, inverting the tubular braid to form a first inversion by moving an open end of the tubular braid over at least a portion of the braid, shaping a second segment of the tubular braid extending between the first inversion and the second inversion, positioning the second segment to surround the third segment, and shaping a first segment of the tubular braid extending between the open end and the first inversion.”
Paragraph [0017] should be amended to the following, “In some examples, a method of manufacturing a tubular braid is disclosed. The method can include: shaping a tubular braid of thicker wire to a predetermined shape; and reducing the braid thickness at the first inversion while retaining braid thickness in portions of the first segment and the second segment. Shaping the tubular braid of thicker wire to the predetermined shape can include: inverting the tubular braid to form a second inversion, shaping a third segment of the tubular braid extending from the second inversion to a pinched end of the tubular braid, inverting the tubular braid to form a first inversion by moving an open end of the tubular braid over at least a portion of the braid, shaping a second segment of the tubular braid extending between the first inversion and the second inversion, positioning the second segment to surround the third segment, and shaping a first segment of the tubular braid extending between the open end and the first inversion.”
Paragraph [0022] should be amended to the following, “In some examples, a method of manufacturing a tubular braid is disclosed. The method can include: shaping a tubular braid of electropolished wire to a predetermined shape; heat setting the tubular braid in the predetermined shape in an inert environment; and reducing the braid thickness at the first inversion while retaining braid thickness in portions of the first segment and the second segment. Shaping the tubular braid of electropolished wire to the predetermined shape can include: inverting the tubular braid to form a second inversion, shaping a third segment of the tubular braid extending from the second inversion to a pinched end of the tubular braid, inverting the tubular braid to form a first inversion by moving an open end of the tubular braid over at least a portion of the braid, shaping a second segment of the tubular braid extending between the first inversion and the second inversion, positioning the second segment to surround the third segment, and shaping a first segment of the tubular braid extending between the open end and the first inversion.”
Paragraph [0026] should be amended to the following, “In some examples, reducing braid thickness at the first inversion while retaining thickness in portions of the first segment and the second segment can result in the material of the tubular braid being less rigid at the first inversion compared to the first segment and the second segment in order to induce folding of the tubular braid at the first inversion during implantation of the implant.”
Paragraph [0043] should be amended to the following, “In some examples, the strands 111 of the tubular braid 110 can be configured to induce folding of the tubular braid 110 at the first inversion 122 during implantation of the implant 100. Due to reduced braid 110 thickness and/or oxide removal at the first inversion 122, a physician is able to easily fold the tubular braid into the predetermined shape without damaging the device or the vessel wall. This also allows the device to easily expand from the predetermined shape into the implanted shape. Areas of the braid 110 with reduced thickness and/or oxide removal can have a greater flexibility than areas of the braid 110 having a greater thickness and/or thicker oxide. The difference in flexibility can result in the areas with reduced thickness and/or oxide removal having a greater propensity to form a fold. In the illustrated example, reduced thickness and/or oxide removal at the first inversion 122 results in the braid 110 having a greater propensity to fold at the first inversion 122 compared to a braid 110 having a uniform strand thickness and/or uniform oxide coverage. The resulting fold at the first inversion 122 allows for inversion of the second segment 144 and layering of the second segment 144 against the first segment 142.”
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12446886 B2 and claim 7 of U.S. Patent No. 11278292 B2 in view of Zaidat (US 2023/0355243 A1).
Claim 1 of the current application states, “An implant comprising: a tubular braid comprising an open end, a pinched end, and a predetermined shape, wherein, in the predetermined shape, the tubular braid comprises a first segment extending from the open end to a first inversion, a second segment extending from the first inversion to a second inversion, and a third segment surrounded by the second segment and extending from the second inversion to the pinched end, and wherein strands of the tubular braid have a smaller diameter at the first inversion compared to a strand diameter of the first segment and a strand diameter of the second segment.”
Claims 1 and 7 of the '886 Patent and claim 7 of the '292 Patent already claim the apparatus (implant/system) with substantially the same fundamental structure in a predetermined shape: a tubular braid with an open end, a pinched end, a first segment extending to a first inversion, a second segment to a second inversion, and a third segment surrounded by the second segment and extending from the second inversion to the pinched end.
The only feature distinguishing the instant application's claim 1 from the apparatus of claims 1 and 7 of the '886 Patent and claim 7 of the '292 Patent is the limitation: "wherein strands of the tubular braid have a smaller diameter at the first inversion compared to a strand diameter of the first segment and a strand diameter of the second segment."
It would have been obvious to a person of ordinary skill in the art (POSITA) to modify the strand diameter of the apparatus in the '886 and '292 Patents based on the teachings of Zaidat. The Zaidat reference is in the same field of endeavor and teaches a known technique for adjusting the mechanical properties of braided medical devices:
Paragraph [0096] of Zaidat discloses, “In any of the braided embodiments, braided elements can be subsequently etched (chemical etch, photochemical etch) to decrease the overall wire diameter and decrease the stiffness.”
A POSITA, motivated to optimize the folding or inversion mechanism of the '886 and '292 apparatus, would have found it an obvious design choice to apply this known etching technique to specific sections (like the first inversion) to achieve the predictable result of localized reduction in stiffness and induced folding. This modification is supported by the explicit teaching of the Zaidat reference and results in only an obvious variation of the existing patented invention.
Therefore, claim 1 of the instant application is an obvious variation of the claims in the '886 and '292 Patents and thus falls under the doctrine of Obviousness-Type Non-statutory Double Patenting.
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 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gorochow (US 2021/0085333 A1), in view of Lubock (US 2018/0242980 A1).
Regarding claim 1, Gorochow discloses, embolic implants for aneurysm therapy. Gorochow teaches, an implant (Figure 1A, implant (100); Paragraph [0083]) comprising:
a tubular braid (Figure 1A, tubular braid (110)) comprising an open end (Figure 1A, open end (114)), a pinched end (Figure 1A, pinched end (112)), and a predetermined shape (Figure 1A; Paragraph [0083]),
wherein, in the predetermined shape (Figure 1A), the tubular braid (braid (110)) comprises a first segment (Figure 1A, outer segment (142)) extending from the open end (end (114)) to a first inversion (Figure 1A, inversion (122)) (Paragraph [0084]), a second segment (Figure 1A, middle segment (144)) extending from the first inversion (inversion (122)) to a second inversion (Figure 1A, inversion (124)) (Paragraph [0084]), and a third segment (Figure 1A, inner segment (146)) surrounded by the second segment (segment (144)) and extending from the second inversion (inversion (124)) to the pinched end (end (112)) (Figure 1A; Paragraphs [0084]).
Gorochow fails to explicitly teach, wherein strands of the tubular braid have a smaller diameter at the first inversion compared to a strand diameter of the first segment and a strand diameter of the second segment. However, Gorochow does disclose in paragraph [0224] the following, “Stiffness/flexibility of the braid portions can be controlled by … strand diameter ... A stiffer portion can have … a larger strand diameter … .”
Lubock discloses, a medical device comprises and expandable mesh for closing a vascular defect. Lubok teaches, strands (Figure 8, filaments (30); Paragraph [0057]) of the tubular braid (Figure 3, occlusion device (10); Paragraph [0047]) have a smaller diameter at the first inversion (Figure 3, core section (14); As disclosed in paragraph [0047], core section (14) is defined as the tubular braided connecting region of reduced radius (0.25mm-1mm (Paragraph [0056])) and length (<3mm) between adjacent radially extending occlusion regions/discs (12), where axial inversion/flattening of the discs occurs under vessel constraint during deployment to form a constrained configuration with decreased disc angle (from 70-90° to 25-70° relative to the longitudinal axis) (Paragraphs [0014] and [0050])) compared to a strand diameter of the first segment (Figure 3, proximal radially extending occlusion region/disc (12) adjacent to the proximal/hub end, providing residual radial force for stability and anchoring with larger structural filaments; Paragraphs [0047], [0069], and [0070]) and a strand diameter of the second segment (Figure 3, adjacent middle radially extending occlusion region/disc (12), over-sized relative to the vessel for outward force against the endoluminal wall with larger structural filaments; Paragraphs [0047], [0050], [0069], and [0070]) (Paragraph [0047], discloses, “Each radially extending occlusion region 12 … is separated from the nearest adjacent radially extending disc 12 by a tubular braided connecting region or core section 14 of reduced radius relative to the occlusion regions 12. The core sections 14 separate each adjacent pair of discs 12 by a core length that is advantageously less than about 3.0 mm…”; Paragraph [0050], discloses, “… the angle θ1 may advantageously be between 70° and 90° … The disc angle decreases to a second disc angle θ2 that is smaller than the first disc angle θ1 when the device is partially constrained owing to the engagement of the peripheral edges 16 of the discs 12 with an endoluminal wall upon deployment … The second disc angle θ2 may be as small as 25° …”; Paragraphs [0055]-[0056], disclose, “Disc and core portion diameters … the core portion diameter may range between 0.25mm and 3mm… The core portions 14 between adjacent discs may advantageously define a core radius Rc of between about 0.25 mm and 1.0 mm.”; Paragraph [0070], discloses, “When deployed in an over-sized and thus partially compressed state, the discs assume a constrained configuration … in which at least a portion of the external surface of each disc 12 forms the aforementioned second disc angle θ2 with respect to the longitudinal axis X of the device …”; Paragraph [0070], also disclosed, “… the device is generally selected so that the diameter of its occlusion regions in the expanded state is larger than the diameter … and, thus over-sized, provides a residual radial force, lending stability to the device.”; Paragraph [0069], discloses, “… braid filaments of varying diameters may be combined in the mesh to impart different characteristics including, e.g., stiffness … larger, structural filaments may be fabricated from wires with diameters ranging from about 0.025 mm to about 0.25 mm … the thickness of the smaller braid filaments would be between about 0.01 mm about 0.05 mm. The ratio of the number of small filaments to the number of large filaments may be between about 2 and 20 … An exemplary embodiment comprising filaments of two different sizes (cross-sectional areas) is shown, for example, in FIG. 8, in which an array of larger filaments 30L is integrated into an array of smaller filaments 30S.”; Figure 8, depicting the integrated array of smaller filaments (30S) in the core/transition for reduced stiffness versus larger filaments (30L) in the expanded occlusion regions/discs).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tubular braid of Gorochow such that the strands of the tubular braid have a smaller diameter at the first inversion compared to a strand diameter of the first segment and a strand diameter of the second segment, as taught by Lubock, as both references and the claimed invention are directed to self-expanding braided implants for aneurysm occlusion. 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 tubular braid of Gorochow such that the strands of the tubular braid have a smaller diameter at the first inversion compared to a strand diameter of the first segment and a strand diameter of the second segment, as taught by Lubock, as such a modification would have been predictable, namely, result in reduced stiffness/flexibility at the inversion to facilitate controlled folding and high packing density within the aneurysm while maintaining anchoring in the outer/middle segments (Paragraphs [0224]-[0225] of Gorochow and Paragraph [0069] of Lubock).
Regarding claim 4, Gorochow teaches, wherein the smaller diameter of the strands of the tubular braid induces folding of the tubular braid during implantation of the implant (Paragraph [0224], discloses, “… portions of the braid pushed into the aneurysm … are weaker compared to stiffer portions of the braid that expand to anchor the braid within the aneurysm. Stiffness/flexibility of the braid portions can be controlled by … strand diameter …”; Paragraph [0225], discloses, “Portions of the braid which have the most flexibility can be dynamically deformed to loop or nest within the aneurysm, folding within the stiffer, anchoring portions of braid.” – the weaker/smaller-diameter portions are the ones that fold and nest during implantation).
Gorochow fails to explicitly teach, that it is the smaller diameter of the strands at the first inversion that induces the folding.
Lubock teaches, strands (filaments (30)) of the tubular braid (occlusion device (10)) have a smaller diameter at the first inversion (core section (14) between adjacent radially extending occlusion regions/discs (12)) (Paragraph [0047], discloses, “Each radially extending occlusion region 12 … is separated from the nearest adjacent radially extending disc 12 by a tubular braided connecting region or core section 14 of reduced radius relative to the occlusion regions 12. The core sections 14 separate each adjacent pair of discs 12 by a core length that is advantageously less than about 3.0 mm…”; Paragraph [0050], discloses, “… the angle θ1 may advantageously be between 70° and 90° … The disc angle decreases to a second disc angle θ2 that is smaller than the first disc angle θ1 when the device is partially constrained owing to the engagement of the peripheral edges 16 of the discs 12 with an endoluminal wall upon deployment … The second disc angle θ2 may be as small as 25° …”; Paragraphs [0055]-[0056], disclose, “Disc and core portion diameters … the core portion diameter may range between 0.25mm and 3mm… The core portions 14 between adjacent discs may advantageously define a core radius Rc of between about 0.25 mm and 1.0 mm.”; Paragraph [0070], discloses, “When deployed in an over-sized and thus partially compressed state, the discs assume a constrained configuration … in which at least a portion of the external surface of each disc 12 forms the aforementioned second disc angle θ2 with respect to the longitudinal axis X of the device …”; Paragraph [0070], also disclosed, “… the device is generally selected so that the diameter of its occlusion regions in the expanded state is larger than the diameter … and, thus over-sized, provides a residual radial force, lending stability to the device.”; Paragraph [0069], discloses, “… braid filaments of varying diameters may be combined in the mesh to impart different characteristics including, e.g., stiffness … larger, structural filaments may be fabricated from wires with diameters ranging from about 0.025 mm to about 0.25 mm … the thickness of the smaller braid filaments would be between about 0.01 mm about 0.05 mm. The ratio of the number of small filaments to the number of large filaments may be between about 2 and 20 … An exemplary embodiment comprising filaments of two different sizes (cross-sectional areas) is shown, for example, in FIG. 8, in which an array of larger filaments 30L is integrated into an array of smaller filaments 30S.”; Figure 8, depicting the integrated array of smaller filaments (30S) in the core/transition for reduced stiffness versus larger filaments (30L) in the expanded occlusion regions/discs).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gorochow such that the smaller diameter strands that induce folding are located at the first inversion, as taught by Lubock, as both references and the claimed invention are directed to self-expanding braided implants for aneurysm occlusion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gorochow such that the smaller diameter strands that induce folding are located at the first inversion, as taught by Lubock, as such a modification would have been predictable, namely, create a preferential hinge point that induces the exact folding behavior of Gorochow already desired in paragraph [0225], thereby improving packing density and conformability while maintaining secure anchoring of the stiff outer segments (Paragraphs [0224]-[0225] of Gorochow and Paragraph [0069] of Lubock).
Regarding claim 5, Gorochow teaches, wherein the tubular braid (tubular braid (110)) expands from the predetermined shape into an implanted shape (Paragraph [0087]), and
wherein the smaller diameter of the strands of the tubular braid inducing folding of the tubular braid allows the expansion (Paragraph [0224], discloses, “To meet the competing needs for braid stiffness to achieve secure anchoring within the aneurysm and braid softness to deform the braid to a high packing density within the aneurysm, the braid can be made such that portions of the braid pushed into the aneurysm when the aneurysm has a higher packing density are weaker compared to stiffer portions of the braid that expand to anchor the braid within the aneurysm. Stiffness/flexibility of the braid portions can be controlled by … strand diameter … A stiffer portion can have … a larger strand diameter … compared to a weaker portion.”; Paragraph [0225], discloses, “… Weaker portions of the braid can be positioned near the proximal end of the braid when the braid is delivered through the catheter. Portions of the braid which have the most flexibility can be dynamically deformed to loop or nest within the aneurysm, folding within the stiffer, anchoring portions of braid.” Thus, it is expressly disclosed that the smaller-diameter strands the weaker/most-flexible portions that fold and nest during deployment, and that this folding of the smaller-diameter portions is what allows the braid to achieve its final implanted shape with high packing density while the stiffer portions expand to anchor).
Gorochow fails to explicitly teach, that it is the smaller diameter of the strands at the first inversion that induces the folding.
Lubock teaches, strands (filaments (30)) of the tubular braid (occlusion device (10)) have a smaller diameter at the first inversion (core section (14) between adjacent radially extending occlusion regions/discs (12)) (Paragraph [0047], discloses, “Each radially extending occlusion region 12 … is separated from the nearest adjacent radially extending disc 12 by a tubular braided connecting region or core section 14 of reduced radius relative to the occlusion regions 12. The core sections 14 separate each adjacent pair of discs 12 by a core length that is advantageously less than about 3.0 mm…”; Paragraph [0050], discloses, “… the angle θ1 may advantageously be between 70° and 90° … The disc angle decreases to a second disc angle θ2 that is smaller than the first disc angle θ1 when the device is partially constrained owing to the engagement of the peripheral edges 16 of the discs 12 with an endoluminal wall upon deployment … The second disc angle θ2 may be as small as 25° …”; Paragraphs [0055]-[0056], disclose, “Disc and core portion diameters … the core portion diameter may range between 0.25mm and 3mm… The core portions 14 between adjacent discs may advantageously define a core radius Rc of between about 0.25 mm and 1.0 mm.”; Paragraph [0070], discloses, “When deployed in an over-sized and thus partially compressed state, the discs assume a constrained configuration … in which at least a portion of the external surface of each disc 12 forms the aforementioned second disc angle θ2 with respect to the longitudinal axis X of the device …”; Paragraph [0070], also disclosed, “… the device is generally selected so that the diameter of its occlusion regions in the expanded state is larger than the diameter … and, thus over-sized, provides a residual radial force, lending stability to the device.”; Paragraph [0069], discloses, “… braid filaments of varying diameters may be combined in the mesh to impart different characteristics including, e.g., stiffness … larger, structural filaments may be fabricated from wires with diameters ranging from about 0.025 mm to about 0.25 mm … the thickness of the smaller braid filaments would be between about 0.01 mm about 0.05 mm. The ratio of the number of small filaments to the number of large filaments may be between about 2 and 20 … An exemplary embodiment comprising filaments of two different sizes (cross-sectional areas) is shown, for example, in FIG. 8, in which an array of larger filaments 30L is integrated into an array of smaller filaments 30S.”; Figure 8, depicting the integrated array of smaller filaments (30S) in the core/transition for reduced stiffness versus larger filaments (30L) in the expanded occlusion regions/discs).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Gorochow such that the smaller diameter strands that induce folding are located at the first inversion, as taught by Lubock, as both references and the claimed invention are directed to self-expanding braided implants for aneurysm occlusion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gorochow such that the smaller diameter strands that induce folding are located at the first inversion, as taught by Lubock, as such a modification would have been predictable, namely, create a preferential hinge point that induces the exact folding behavior of Gorochow already desired in paragraph [0225], thereby improving packing density and conformability while maintaining secure anchoring of the stiff outer segments (Paragraphs [0224]-[0225] of Gorochow and Paragraph [0069] of Lubock).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gorochow, in view of Lubock, and further in view of Zaidat (US 2023/0355243 A1).
Regarding claim 2, Gorochow teaches, the tubular braid (tubular braid (110)) which comprises the first inversion (inversion (122)).
Gorochow fails to teach, wherein material of the tubular braid at the first inversion is weakened by oxide removal.
Lubock teaches, aspects of the implant according to claim 1 (See above rejection of claim 1).
Zaidat discloses, an apparatus for treating an aneurysm in a blood vessel. Zaidat teaches, that post-braiding chemical or photochemical etching of braided elements in aneurysm occlusion devices is a known method to decrease wire diameter and stiffness (Paragraph [0097]).
Furthermore, the limitation “wherein material of the tubular braid at the first inversion is weakened by oxide removal” is a product-by-process limitation. The prior art discloses the identical structure (a braided Nitinol implant with localized weaker strands at the inversion/transition for enhanced flexibility). Chemical etching of Nitinol braided elements, as taught by Zaidat, inherently involves removal of the native surface oxide layer during diameter reduction to achieve the recited stiffness decrease. The patentability of the product does not depend on its process of production (MPEP 2113 (I)). Accordingly, claim 2 is rendered obvious over Gorochow, in view of Lubok, and further in view of Zaidat.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the weaker inversion portions of Gorochow such that the material is weakened by etching, as taught by Zaidat, as all the references and the claimed invention are directed to self-expanding braided implants for aneurysm occlusion. 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 weaker inversion portions of Gorochow such that the material is weakened by etching, as taught by Zaidat, as such a modification would have been predictable, namely, result in precise control of diameter/stiffness reduction at the inversion to optimize packing and conformability without altering braid construction (Paragraph [0224] of Gorochow and Paragraph [0097] of Zaidat).
Regarding claim 3, Gorochow teaches, the tubular braid (tubular braid (110)) which comprises the first inversion (inversion (122)), the first segment (outer segment (142)), and the second segment (middle segment (144)). , Gorochow further teaches, wherein the strands of the tubular braid comprise a layer of oxide (Nitinol strands forming tubular braid (110) inherently possess a native titanium-oxide surface layer after heat-setting and standard processing (Paragraphs [0083], [0156]-[0157], [0224], [0231], and [0234])
Gorochow fails to explicitly teach, wherein the layer of oxide is thinner at the first inversion compared to a layer of oxide of the first segment and a layer of oxide of the second segment.
Lubock teaches, aspects of the implant according to claim 1 (See above rejection of claim 1).
Zaidat teaches, that post-braiding chemical or photochemical etching of braided elements in aneurysm occlusion devices is a known method to decrease wire diameter and stiffness (Paragraph [0097]).
Furthermore, the limitations “wherein the strands of the tubular braid comprise a layer of oxide, wherein the layer of oxide is thinner at the first inversion compared to a layer of oxide of the first segment and a layer of oxide of the second segment” are product-by-process limitations. The prior art discloses the identical structure (a braided Nitinol implant having strands that are weaker and thinner at the inversion/transition zone). Chemical or photochemical etching of Nitinol strands, as taught by Zaidat, inherently removes or significantly thins the native titanium-oxide surface layer in the etched region while leaving the oxide layer substantially intact in non-etched regions. The patentability of the product does not depend on its process of production (MPEP 2113 (I)). Accordingly, claim 3 is rendered obvious over Gorochow, in view of Lubok, and further in view of Zaidat.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the weaker inversion portions of Gorochow /Lubock such that the oxide layer is thinner at the first inversion via the chemical/photochemical etching taught by Zaidat, as all the references and the claimed invention are directed to self-expanding braided implants for aneurysm occlusion. It would have been obvious to one of ordinary skill in the art to perform localized or selective post-braiding etching on the inversion zone, as taught by Zaidat, as such a modification would have been predictable, namely, controlled thinning of both the wire diameter and the native oxide layer exactly where maximum flexibility and packing density are needed, without altering the braid construction itself (Paragraphs [0224]-[0225] of Gorochow and Paragraph [0097] of Zaidat).
Conclusion
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771