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 .
Claim Objections
Claims 1- 15 are objected to because of the following informalities:
Claim 1, Line 14 states “when in the compacted state, the fabric”, it is suggested to change this to “when the device is in the compacted state, a fabric”.
Claims 2- 15 are objected to for being dependent on or from objected claim 1.
Claim 2, Line 3 states “between the compacted and expanded states”, it is suggested to change this to “between the compacted and expanded states of the device”.
Claim 3, Line 2 states “around the surface”, it is suggested to change this to “around a surface”.
Claim 4, Lines 1- 2 state “in a compacted configuration”, it is suggested to change this to “in the compacted configuration”.
Claim 5, Line 2 states “in the range 0.08 to 0.24 mm”, it is suggested to change this to “in a range of 0.08 mm to 0.24 mm”.
Claim 9, Lines 2- 3 state “the distance axial distance”, it is suggested to change this to “the axial distance”.
Claim 11, Line 2 states “of folded fabric”, it is suggested to change this to “of a folded fabric”.
Claims 12- 15 are objected to for being dependent on or from objected claim 11.
Claim 14, Line 2 states “of a stent device”, it is suggested to change this to “of the stent device”.
Claim 15 is objected to for being dependent on claim 14.
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 1- 15 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 1 recites the limitation “the fabric between adjacent spring ring elements is in tension”, it is unclear if this fabric is the fabric of the sleeve, or if is a different fabric that exists between adjacent spring ring elements. For purposes of examination, this limitation is herein interpreted as a fabric of the sleeve.
Claims 2- 15 are rejected for being on or from rejected claim 1.
Claim 11 recites the limitation “tail element of a folded fabric”, it is unclear if this folded fabric is the fabric of the sleeve, the fabric that exists between adjacent spring ring elements as established in claim 1, or is a different fabric that is folded. For purposes of examination, this limitation is herein interpreted as a fabric of the sleeve.
Claims 12- 15 are rejected for being dependent on or from rejected claim 11.
Claim 12 recites the limitation “The stent device as claimed in claim 11, further including a deployment apparatus configured to receive the stent device therein”, it is unclear how the stent device can comprise a deployment apparatus and receive itself within the apparatus. For purposes of examination, this limitation is herein interpreted as a system that comprises the stent device and the deployment apparatus, wherein the deployment apparatus is configured to receive the stent device.
Claims 13- 15 are rejected for being dependent on or from rejected claim 12.
Claim 13 recites the limitation "the crimped portion of the stent device" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the crimped portion of the stent device is a new portion of the stent device, for which there is no antecedent basis establish, or if the crimped portion of the stent device is intended to be the non-stented section established in claim 11. For purposes of examination, this limitation is herein interpreted as either a new portion of the stent device separate from the non-stented section, or the non-stented section.
Claims 14 and 15 are rejected for being dependent on or from rejected claim 13.
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.
Examiner’s note: It is noted that there is no prior art for claims 13- 15.
Claim(s) 1- 6 and 8- 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald et al. (GB 2491477) in view of Duong et al. (U.S. 2015/0257910) as evidenced by Merriam-Webster Dictionary.
Regarding claim 1, McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising:
A sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14);
Wherein each spring ring element has an undulating profile (On Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5, McDonald teaches that the rings have a saddle- shaped profile. According to the Merriam- Webster Dictionary, saddle- shaped is defined as “bent down at the sides so as to give the upper part a rounded form”, which is well known in the art to be a curve. Merriam- Webster also defines to undulate as “having a wavy surface, edge or markings”. It is well known in the art that a synonym of wavy is “curved”. Therefore, since the rings are taught to be saddle-shaped, with multiple curves, they are considered to have an undulating profile) with adjacent ring elements at least partially overlapping along the length of the device (It would be obvious to one of ordinary skill in the art that when the stent device is compressed, due to the rings being a saddle- shaped, that when they are bent, the peak of one ring element would partially overlap with the valley of the ring in front of it along the length of the device.),
the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (McDonald teaches on Page 5, Lines 22- 24 and 28- 29 that the ring elements are made of nitinol, which is well known in the art to be a self- expanding material. Therefore, when the ring elements are compressed within the sleeve, they would have a resilience to being compacted. However, one of ordinary skill in the art, would know that the ring elements would reduce the outer diameter of the sleeve when they are compressed, due to the fact that McDonald teaches on Page 10, Lines 25- 29 that the rings elements are disposed along the surface of the sleeve.) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16);
wherein the spring ring elements are inter-coupled (McDonald teaches on Page 15, Lines 11- 15, that the stents rings are attached to the graft sleeve. Merriam- Webster defines inter-coupled as “to couple together”, since each ring is taught to be attached to the sleeve, and are therefore inseparable, the rings are considered to be coupled together. Therefore McDonald teaches that the adjacent ring elements are inter-coupled.) such that where adjacent ring elements overlap axially, a circumferential spacing of the adjacent ring elements, when in an open configuration of the device, is less than or equal to a maximum change in axial extent of each ring element when moving from an expanded to a compacted configuration (Since McDonald teaches that the ring elements have the same structure as those claimed, it would be obvious to one of ordinary skill in the art that they would have the same abilities as claimed.)(Alternatively, on Page 5, Lines 31- Page 6, Lines 23, McDonald teaches that the height of the saddle for each ring and axial displacement between each ring can be modified, thus establishing the parameters as result effective variables. Thus, it would have alternatively been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the claimed circumferential spacing, when in an open configuration of the device, less than or equal to the maximum change in axial extent of each ring element when moving from an expanded to a compacted configuration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.); and
when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (McDonald teaches on Page 15, Lines 20- 29 that the ring elements fold and “adopt a compact configuration”. Since McDonald teaches that the ring elements are attached to the fabric sleeve (Page 15, Lines 11- 15), and one of ordinary skill in the art would recognize that through folding the ring elements the fabric between the peaks of adjacent ring elements would be stretched, McDonald teaches that the sleeve fabric is in tension when the device is in the compacted state.).
McDonald does not teach wherein the compacted stent device is housed in a frangible sheath.
Duong (Duong et al.) teaches a stent device (abstract) with a frangible sheath (In Paragraph 0077, Duong teaches that the sheath has a slot that forms an upper half 28 and a lower half 29. Duong further teaches wherein the halves are configured to “freely move apart when the sheath 30 is positioned towards the distal end 20b”. According to the Merriam- Webster Dictionary, frangible is defined as “readily or easily broken” and to break is defined as “to split into smaller units, parts, or processes”. Since the sheath is taught to separate into two parts, the upper half and lower half, and it is well known in the art that a half is less than a whole, Duong therefore teaches a frangible sheath.) used in delivering a stent device (Paragraph 0014).
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the delivery sheath as taught by McDonald to be the frangible sheath as taught by Duong, since Duong teaches that the frangible sheath “provides easy removal of sheath 20 from the scaffold 10, with minimal disruption to the scaffold- balloon structural integrity, after sheath 30 is moved towards distal end 20b” (Paragraph 0077).
Regarding claim 2, McDonald and Duong make obvious the invention as discussed above.
McDonald does not teach in the current embodiment wherein adjacent spring ring elements maintain their axial spacing from the proximal end to the distal end between the compacted and expanded states.
However, McDonald teaches that stent grafts can have a plurality of stents spaced along the graft, which are evenly spaced (Page 3, Lines 8- 10). Therefore, it would have been obvious to one of ordinary skill in the art to modify the spacing of the adjacent spring ring elements as taught by McDonald to be evenly spaced, since McDonald teaches that evenly spaced ring elements, otherwise known as stents, are well known in the art and “ensures that the crush strength of the graft does not vary along its length” (Page 3, Lines 9- 10).
Regarding claim 3, McDonald and Duong make obvious the invention as discussed above.
Regarding wherein the undulating profile of each spring ring element extends circumferentially around the surface of the sleeve, Fig. 2 of McDonald demonstrates that the ring has a saddle profile on both sides of it. As discussed above, the saddle profile is well known in the art to be an undulating profile as it is sinusoidal. Furthermore, it would have been obvious to one of ordinary skill in the art that as the profile of the ring continues through it, and the rings are taught to be sewn to the surface of the sleeve (Page 10, Lines 25- 29), the undulating profile would extend circumferentially around the surface of the sleeve.
Regarding claim 4, McDonald and Duong make obvious the invention as discussed above.
McDonald further teaches wherein when in the compacted configuration, a plurality of peaks of one ring element overlie a plurality of valleys of an axially adjacent ring element (Page 10, Lines 19 - 23).
Regarding claim 5, McDonald and Duong make obvious the invention as discussed above.
McDonald further teaches wherein the ring elements are formed of a nitinol wire (Page 10, Line 25) with a diameter in the range of 0.1 mm to 2 mm (Page 7, Lines 5- 6).
McDonald does not teach wherein the diameter of the ring elements has a diameter in the range of 0.08 mm to 0.24 mm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by McDonald to be from 0.08 mm to 2 mm, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 6, McDonald and Duong make obvious the invention as discussed above.
McDonald further teaches wherein the ring elements have an arcuate profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5)(According to the Merriam- Webster Dictionary, saddle- shaped is defined as “bent down at the sides so as to give the upper part a rounded form”, which is well known in the art to be a curve, or arc. Therefore, McDonald teaches wherein the ring elements have an arcuate profile.).
Regarding claim 8, McDonald and Duong make obvious the invention as discussed above.
McDonald further teaches wherein the ring elements have a saddle profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5).
Regarding claim 9, McDonald and Duong make obvious the invention as discussed above.
McDonald further wherein a distance between a peak and a trough of a first spring ring element defines a saddle height (Page 4, Lines 27- 30).
Regarding the axial distance between adjacent ring elements being less than the saddle height, McDonald teaches on Page 5, Lines 24- 25 that the saddle height of the first stent portion can be 4 to 8mm, and on Page 5, Line 31- Page 6, Line 2 that the distance between the ring elements is 5 to 13 mm, on Page 6, Lines 9- 13 that the saddle height of the second stent portion is 8 to 15 mm and the distance between the ring elements is 12 to 25 mm, and on Page 6, Lines 16- 23, that the saddle height of the third stent portion can be 10 to 25 mm, and the distance can be 12 to 30 mm. Therefore for the first stent portion, one of ordinary skill in the art can choose a saddle height of 8 mm and a distance of 5 to 7 mm between the ring elements, a saddle height of 15 mm and a distance of 12mm to 14 mm for the second stent portion, and a saddle height of 25 mm and a distance of 12 mm to 24 mm as these values are within the ranges taught by McDonald, thus having the axial distance be less than the saddle height for each stent portion.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald (GB 2491477) in view of Duong (U.S. 2015/0257910), as applied to claim 1 above as evidenced by the Merriam Webster Dictionary and the Collins Dictionary.
Regarding claim 7, McDonald and Duong make obvious the invention as discussed above.
Regarding wherein the spring ring elements have a hyperbolic paraboloid profile, according to the Merriam-Webster Dictionary, saddle-shaped is defined as “bent down at the sides so as to give the upper part a rounded form”, which is well known in the art to be a curve or arc. Likewise, a known synonym of parabola is arch, curvature, or hyperbola. Therefore, one of ordinary skill in the art would recognize that a saddle-shape can be considered a parabola- shape and, likewise a hyperbola- shape. Furthermore, the Collins Dictionary defines a paraboloid as “a surface or solid formed so that sections parallel to the plane of symmetry are parabolas and sections perpendicular to it are ellipses, hyperbolas, or circles”, which, as the saddle- shaped rings are three-dimensional objects, it would be obvious that the rings are paraboloids. Therefore McDonald teaches that each spring ring element has a hyperbolic paraboloid profile.
Claim(s) 10- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald (GB 2491477) in view of Duong (U.S. 2015/0257910, as applied to claim 1 above, in further view of To (U.S. 2009/0043330).
Regarding claim 10, McDonald and Duong make obvious the invention as discussed above.
McDonald and Duong do not teach the device further comprising a non- stented section at a distal end.
To teaches a similar stent device (abstract)(Fig. 4C) comprising: a sleeve covering a stent (As shown in Fig. 4, the stent can be a plurality of rings), the sleeve being self- expanding (Paragraph 0043). To further teaches wherein the stent is made of nitinol (Paragraph 0043) and wherein the sheath extends past the proximal and distal ends of the stent (Paragraphs 0014 and 0015)(Since To teaches that the sleeve can extend past “the proximal and distal margins of the stent” in Paragraph 0014, the sleeve therefore has a non-stented section at the distal end.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sleeve of the stent device as taught by McDonald to extend beyond the rings as taught by To, since To teaches that the sheath “improves both the safety and efficacy of stenting by reducing the risk of embolism during implantation, acutely post-implantation and in the long- term while controlling immune responses encouraging endothelization in the vicinity of lesion and stent” (Paragraph 0014).
Regarding claim 11, McDonald, Duong, and To make obvious the invention as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sleeve of the stent device as taught by McDonald to extend beyond the rings as taught by To, since To teaches that the sheath “improves both the safety and efficacy of stenting by reducing the risk of embolism during implantation, acutely post-implantation and in the long- term while controlling immune responses encouraging endothelization in the vicinity of lesion and stent” (Paragraph 0014).
Regarding wherein the non-stented section includes a tail element of the folded fabric, as the combination teaches that the sleeve, which has the fabric of the stent device (McDonald, Page 15, Lines 11- 15), extends past the distal end of the spring ring elements, then the non-stented section includes a tail element of the fabric. Furthermore, when the stent is compressed, the fabric of the sleeve would be folded and therefore the tail element of the sleeve would be a folded fabric.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McDonald (GB 2491477) in view of Duong (U.S. 2015/0257910) and in view of To (U.S. 2009/0043330), as applied to claim 11 above, in further view of Mogenson (EP 3323385) as evidenced by Merriam-Webster Dictionary.
Regarding claim 12, McDonald, Duong, and To make obvious the invention as discussed above.
McDonald does not teach the device further including a deployment apparatus configured to receive the stent device therein, the deployment apparatus having a body with a window providing a pathway for a crimped portion of the stent device to pass throughout.
Duong teaches a deployment apparatus (catheter assembly 2)(Figs. 1- 1B and 4C) configured to receive a stent device (scaffold 10) therein (Paragraph 0070), the deployment apparatus having a body (sheath 30) with a window providing a pathway for a portion of the stent device to pass throughout (see annotated Fig. 1A below). Duong further teaches a stent device (abstract) with a frangible sheath (In Paragraph 0077, Duong teaches that the sheath has a slot that forms an upper half 28 and a lower half 29. Duong further teaches wherein the halves are configured to “freely move apart when the sheath 30 is positioned towards the distal end 20b”. According to the Merriam- Webster Dictionary, frangible is defined as “readily or easily broken” and to break is defined as “to split into smaller units, parts, or processes”. Since the sheath is taught to separate into two parts, the upper half and lower half, and it is well known in the art that a half is less than a whole, Duong therefore teaches a frangible sheath.) used in delivering a stent device (Paragraph 0014).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the combination to have a deployment apparatus as taught by Duong, since McDonald teaches that the device can be delivered by a catheter assembly, To teaches a known catheter assembly for delivery a stent device (Paragraph 0070) and To teaches that the deployment apparatus reduces recoil in the scaffold in addition to protecting the scaffold and the balloon prior to use (Paragraph 0071).
The combination does not teach a crimped portion of the stent device.
Mogensen teaches a similar stent device (abstract) with a sleeve (40, 150) formed with a plurality of ring elements (56). Mogensen further teaches a non-stented section at a proximal end (152) and wherein the non-stented section includes a crimped fabric (Paragraph 0032, Line 43 says that the non-stented section is “a corrugated elephant trunk”. According to the Merriam- Webster Dictionary, “corrugated” is a synonym of “crimped”.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify a section of the device to have a crimped fabric as taught by Mogensen, since Mogensen teaches that the “elephant trunk section” is a known medical device (Paragraph 0080)” and that the elephant trunk provides an extension of the graft to reach an adjacent vessel (In Paragraph 0080, Mogensen teaches that the elephant trunk section “can be sutured to the walls of the remaining aortic vessels and cut as appropriate to provide fluid passage to the arteries 104- 108. In order to provide fluid passage, that section of the stent would need to be able to reach the vessels).
Regarding the window providing a pathway for a crimped portion of the stent to pass throughout, as the combination has a crimped portion and the combination teaches that the apparatus has a window to allow for a portion of the stent to pass through (To, Paragraph 0070), then the window allows for the crimped portion to pass throughout.
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- 3 and 10- 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,127,961 (‘961). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current invention are broader in scope than the listed patent.
Regarding claim 1, ‘961 claims a stent device (claim 1 of ‘961) comprising: a sleeve having a plurality of compactable spring ring elements disposed along its length, the sleeve having compacted and expanded states (claim 1 of ‘961); wherein each spring ring element has an undulating profile with adjacent ring elements at least partially overlapping along the length of the device (claim 1 of ‘961), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve for housing of the compacted stent device in a frangible sheath (claim 1 of ‘961); wherein the spring ring elements are inter-coupled such that where adjacent ring elements overlap axially (claim 1 of ‘961), a circumferential spacing of the adjacent ring elements, when in an open configuration of the device, is less than or equal to a maximum change in axial extent of each ring element when moving from an expanded to a compacted configuration (claim 6 of ‘961); and when in the compacted state, the fabric between adjacent spring ring elements is in tension (As ‘961 claims that the spring ring elements are on the sleeve, and that the sleeve and the rings are collapsible (claim 1 of ‘961), when the device is collapsed, the fabric between the rings would be in tension.).
Regarding claim 2, ‘961 claims the stent device of claim 1.
‘961 further claims wherein the adjacent spring ring elements maintain their axial spacing from the proximal end to the distal end between the compacted and expanded states (claim 1 of ‘961).
Regarding claim 3, ‘961 claims the stent device of claim 1.
‘961 further claims wherein the undulating profile of each spring ring element extends circumferentially around the surface of the sleeve (As ‘961 claims that each spring ring element has an undulating profile at a surface of the sleeve, and the spring ring elements surround the sleeve (claim 1 of ‘961), then the undulating profile of each spring ring extends circumferentially around the surface of the sleeve.).
Regarding claim 10, ‘961 claims the stent device of claim 1.
‘961 further claims the stent device further comprising a non-stented section at a distal end (sheath material, claim 1 of ‘961).
Regarding claim 11, ‘961 claims the stent device of claim 10.
‘961 further claims wherein the non-stented section includes a tail element of folded fabric (When the device is collapsed, the sheath material would be folded, claim 1 of ‘961).
Claims 4- 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,127,961 (‘961) in view of McDonald et al. (GB 2491477).
Regarding claim 4, ‘961 claims the stent device of claim 1.
‘961 does not claim wherein when in a compacted configuration, a plurality of peaks of one spring ring element overlie a plurality of valleys of an axially adjacent spring ring element.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5) with adjacent ring elements at least partially overlapping along the length of the device (It would be obvious to one of ordinary skill in the art that when the stent device is compressed, due to the rings being a saddle- shaped, that when they are bent, the peak of one ring element would partially overlap with the valley of the ring in front of it along the length of the device.), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). McDonald further teaches wherein when in the compacted configuration, a plurality of peaks of one ring element overlie a plurality of valleys of an axially adjacent ring element (Page 10, Lines 19 - 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the plurality of peaks of one ring element overlie a plurality of valleys of an axially adjacent ring element as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 5, ‘961 claims the device of claim 1.
‘961 does not claim wherein the spring ring elements are formed of a nitinol wire with a diameter in the range of 0.08 to 0.24 mm.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). McDonald further teaches wherein the ring elements are formed of a nitinol wire (Page 10, Line 25) with a diameter in the range of 0.1 mm to 2 mm (Page 7, Lines 5- 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the spring ring elements with their distance and material as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
‘961 and McDonald do not claim wherein the diameter of the ring elements has a diameter in the range of 0.08 mm to 0.24 mm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by McDonald to be from 0.08 mm to 2 mm, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Regarding claim 6, ‘961 claims the device of claim 1.
‘961 does not claim wherein the spring ring elements have an arcuate profile.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). McDonald further teaches wherein the ring elements have an arcuate profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5)(According to the Merriam- Webster Dictionary, saddle- shaped is defined as “bent down at the sides so as to give the upper part a rounded form”, which is well known in the art to be a curve, or arc. Therefore, McDonald teaches wherein the ring elements have an arcuate profile.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the spring ring elements have an arcuate profile as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 7, ‘961 claims the device of claim 1.
‘961 does not claim wherein the spring ring elements have a hyperbolic paraboloid profile.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). Regarding wherein the spring ring elements have a hyperbolic paraboloid profile, according to the Merriam-Webster Dictionary, saddle-shaped is defined as “bent down at the sides so as to give the upper part a rounded form”, which is well known in the art to be a curve or arc. Likewise, a known synonym of parabola is arch, curvature, or hyperbola. Therefore, one of ordinary skill in the art would recognize that a saddle-shape can be considered a parabola- shape and, likewise a hyperbola- shape. Furthermore, the Collins Dictionary defines a paraboloid as “a surface or solid formed so that sections parallel to the plane of symmetry are parabolas and sections perpendicular to it are ellipses, hyperbolas, or circles”, which, as the saddle- shaped rings are three-dimensional objects, it would be obvious that the rings are paraboloids. Therefore McDonald teaches that each spring ring element has a hyperbolic paraboloid profile.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the spring ring elements have a hyperbolic paraboloid profile as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 8, ‘961 claims the device of claim 1.
‘961 does not claim wherein the spring ring elements have a saddle profile.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). McDonald further teaches wherein the ring elements have a saddle profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the spring ring elements have a saddle profile as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 9, ‘961 claims the device of claim 1.
‘961 does not claim wherein a distance between a peak and a trough of a first spring ring element defines a saddle height, with the axial distance between adjacent ring elements being less than the saddle height.
McDonald (McDonald et al.) teaches a stent device (10)(abstract)(Fig. 3) comprising: a sleeve (20) having a plurality of compactable spring ring elements (stent elements 11, 11’, 12, 12’, 13, 13’, 14) disposed along its length (Page 3, Line 31- Page 4, Line 6), the sleeve having compacted and expanded states (Page 7, Lines 8 - 14); wherein each spring ring element has an undulating profile (Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5), the spring ring elements being compactable against their natural resilience to reduce an outer diameter of the sleeve (Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29) for housing of the compacted stent device in a delivery sheath (Page 9, Lines 10- 16), wherein the spring ring elements are inter-coupled (Page 15, Lines 11- 15) and when the device is in the compacted state, a fabric between adjacent spring ring elements is in tension (Page 15, Lines 20- 29). McDonald further wherein a distance between a peak and a trough of a first spring ring element defines a saddle height (Page 4, Lines 27- 30).
Regarding the axial distance between adjacent ring elements being less than the saddle height, McDonald teaches on Page 5, Lines 24- 25 that the saddle height of the first stent portion can be 4 to 8mm, and on Page 5, Line 31- Page 6, Line 2 that the distance between the ring elements is 5 to 13 mm, on Page 6, Lines 9- 13 that the saddle height of the second stent portion is 8 to 15 mm and the distance between the ring elements is 12 to 25 mm, and on Page 6, Lines 16- 23, that the saddle height of the third stent portion can be 10 to 25 mm, and the distance can be 12 to 30 mm. Therefore for the first stent portion, one of ordinary skill in the art can choose a saddle height of 8 mm and a distance of 5 to 7 mm between the ring elements, a saddle height of 15 mm and a distance of 12mm to 14 mm for the second stent portion, and a saddle height of 25 mm and a distance of 12 mm to 24 mm as these values are within the ranges taught by McDonald, thus having the axial distance be less than the saddle height for each stent portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as claimed by ‘961 to have the spring ring elements have a saddle height greater than an axial distance between adjacent rings as taught by McDonald for the purpose of providing structural support and be compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one set of spring ring elements for another because both spring ring elements are disclosed as equivalent structures for providing structure support and being compactable (‘961, claim 1; McDonald, Page 5, Lines 22- 24 and 28- 29, Page 10, Lines 25- 29, Page 15, Lines 6- 9, 14- 17, 24- 26, and Page 16, Lines 2- 5). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 12- 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,127,961 (‘961) in view of Mogenson (EP 3323385).
Regarding claim 12, ‘961 claims the stent device of claim 11.
‘961 further claims a deployment apparatus configured to receive the stent device therein (claim 1 of ‘961), the deployment apparatus having a body with a window providing a pathway for a portion of the stent device to pass throughout (claim 1 of ‘961).
‘961 does not claim wherein the portion of the stent device includes a crimped fabric.
Mogenson teaches a similar stent device (abstract) with a sleeve (40, 150) formed with a plurality of ring elements (56). Mogenson further teaches a non-stented section at a proximal end (152) and wherein the non- stented section includes a crimped fabric (Paragraph 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the portion of the stent as claimed by ‘961 to have a crimped fabric as taught by Mogenson, since Mogensen teaches that the “elephant trunk section” is a known medical device (Paragraph 0080) and that the elephant trunk provides an extension of the graft to reach an adjacent vessel (In Paragraph 0080, Mogensen teaches that the elephant trunk section “can be sutured to the walls of the remaining aortic vessels and cut as appropriate to provide fluid passage to the arteries 104- 108. In order to provide fluid passage, that section of the stent would need to be able to reach the vessels.).
Regarding claim 13, ‘961 and Mogenson claim the stent device of claim 12.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the portion of the stent as claimed by ‘961 to have a crimped fabric as taught by Mogenson, since Mogensen teaches that the “elephant trunk section” is a known medical device (Paragraph 0080) and that the elephant trunk provides an extension of the graft to reach an adjacent vessel (In Paragraph 0080, Mogensen teaches that the elephant trunk section “can be sutured to the walls of the remaining aortic vessels and cut as appropriate to provide fluid passage to the arteries 104- 108. In order to provide fluid passage, that section of the stent would need to be able to reach the vessels.).
‘961 further claims wherein the deployment apparatus is configured to receive the stent device within the body, with the portion of the stent device passing substantially perpendicularly to the axis of the stent device within the body (claim 1 of ‘961, the portion of the stent device of the combination is now crimped).
Regarding claim 14, ‘961 and Mogenson claim the stent device of claim 12.
‘961 further teaches wherein the deployment apparatus includes a restriction configured to obstruct travel of a stent device within the body, but allow passage of the tail element out of a distal end of the body (claim 1 of ‘961).
Allowable Subject Matter
Claim 15 is rejected for being dependent upon a rejected base claim due to a 112(b) issue, but would be allowable if rewritten to overcome the 112(b) issues and in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is McDonald (GB 2491478), Austin (US 2006/0184226), and Duong (US 2015/0257910).
Austin discloses an aperture extending in a longitudinal direction of a restriction (pusher 14, pusher springs 15)(see Fig. 1)(Paragraph 0064).
McDonald teaches a sleeve (20)(Fig. 3) with a plurality of compactable spring ring elements (11, 11’, 12, 12’, 13, 13’, 14)(Fig. 3)(Page 3, Line 31- Page 4, Line 6).
Duong teaches a deployment apparatus (catheter assembly 2)(Figs. 1- 1B and 4C) configured to receive a stent device (scaffold 10) therein (Paragraph 0070), the deployment apparatus having a body (sheath 30) with a window providing a pathway for a portion of the stent device to pass throughout (see annotated Fig. 1A below).
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However, the prior art does not teach or suggest wherein the sheath fabric is configured to be split within the deployment apparatus in claim 15.
Conclusion
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771