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
Applicant's election with traverse of invention 1 (claims 1-29), species in the reply filed on 05/27/25 is acknowledged. The traversal is on the ground(s) that the subject matter of most species groups are “not recited in claim 1” and restriction is only proper if species are identified in claims. This is not found persuasive because the MPEP does not require every embodiment of every species to be claimed to still create a search burden on the Examiner, since the generic claims still require a search that encompass all the species. See MPEP 808.01(a).
The requirement is still deemed proper and is therefore made FINAL.
Claims 30-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/27/25.
Additionally, claims 22, and 26 are withdrawn for being drawn towards non-elected species.
Claim Objections
Claims 1-8, 10, 14-17, 19-20, 27-28 are objected to because of the following informalities:
Claim 1 is objected to for referring to “different angles” multiple times, but it is unclear if this is the same “different angles” which was previously referred to, or whether this “different angles” the second marker is viewed from are distinct.
Claim 2 is objected to for referring to “a loop” (multiple times) and “a strut”, when the claim has previously identified a plurality of “struts” and “loops”, making it unclear which loop and which strut is being referenced here. Further, the claim also refers to “adjacent loops”, but it is unclear how, if at all, these “adjacent loops” relate back towards the previously claimed “adjacent loops”. Further, the claim also makes reference to “an adjacent strut” but it is unclear how, if at all, this refers back to the previously claimed “struts”.
Further, the claim is unclear for referring to “the lengthwise direction” with improper antecedent basis.
Further, the claim is unclear for referring to “an end of an adjacent strut” since it is unclear how, if at all, this relate to the previously claimed “end of a strut”.
Claim 3 is objected to for referring to “at least one strut” when it is unclear how, if at all, this relates to the previously claimed “struts”.
Claim 4 is objected to for claiming the bent pattern comprises “first and second bent sections in opposite curvature” when it is unclear what it means to be/have sections “in opposite curvature”. It appears the claim might intend to claim that the sections have opposite curvatures, but it is not clear.
Further, the claim is unclear for claiming the length of the bent strut include “a concave curvature and a convex curvature” when it is unclear how, if at all, this relates to the previous recitation that the bent sections of the bent strut [are/have] “in opposite curvature”.
Claim 5 is objected to for referring to “the end of the loop” when it is unclear how, if at all, this relates to the previously referred to “each end” of a loop, and how, if at all, the “loop” relates to the previously claimed “loops”.
The claim is further objected to since the “pair of struts” has been defined as including “each end of a loop is coupled to an end of a strut”, making it unclear how the now claimed “an opposing strut of the pair” relates to the previously claimed “strut” (or “struts” of the pattern, or “the adjacent strut”).
The claim is further unclear for claiming “the first bent section extends from the end of the loop” when it is unclear how the bent section extends from the loop that is coupled to the pair of struts, and unclear if this bent section is extending from the loop in addition to the pair that extend from the loop, or how this configuration works.
Claim 6 is objected to for potentially missing a word between “wherein” and “the”, as well as between “diameter,” and “the loops”. It also appears the word “being” might be mis-used.
Claim 7 is objected to for referring to “the struts” when it is unclear which of the plurality of struts is being referenced herein (the “struts”, “opposing struts”, “adjacent struts”, etc.
The claim also appears to be missing a word between “lengths,” and “the”.
Claim 8 is objected to for referring to “at least one strut”, and “the strut” (multiple times) when it is unclear which of the previously referenced strut(s) (if at all), these are intended to refer back to (or not refer back to).
The claim also includes improper antecedent basis for “a width” multiple times.
The claim also refers to “ends of the strut” when it is unclear how (if at all) this relates to the previously identified “ends” of the struts, and for referring to “the loop” when it is unclear which of the previously claimed loops this refers to.
Claim 10 is objected to for referring to “the struts” when it is unclear which of the previously claimed struts is being referenced here.
Claim 14 is objected to for referring to “drug elution profile” when this is understood to require a hyphen.
Claim 15 is objected to for referring to “the winding” when it is unclear which of the previously claimed windings this is intending to refer to.
Claim 16 is objected to for referring to “the undulating pattern of loops coupled to the pair of struts” when the claims from which this depend have identified the undulating pattern to be of the “struts and loops”, making it unclear if this is the same pattern or not (and so unclear if there is an issue with antecedent basis or not).
The claim is further objected to for referring to “struts” and “axially offset loops” when multiple instances of “loops” and “struts” have already been claimed, making it unclear how, if at all, these recitations refer back to (and which recitation they refer back to).
Further the claim is unclear since it isn’t certain whether or not the “undulating pattern of loops” from the claim refer to the same loops or not as the “axially offset loops”.
Claim 17 is objected to for referring to “at least one loop” and “at least one bent strut” when it is unclear which loop(s) or which strut(s) of the many recited loops/struts is being referenced here.
Further, the claim is unclear for referring to “at least one loop” again, since it is unclear if this is referring to the same “at least one loop” in the same claim, or again, whether/how it is related to other claimed loops.
Claim 19 is objected to for referring to “the pores” with improper antecedent basis.
Claim 20 is objected to for claiming “drug eluting” when it is believed a hyphen is needed.
Claim 27 is objected to for referring to “at least two adjacent windings” when it is unclear which of the plurality of previously identified windings this is referring to (if they are even considered to be related at all).
The claim is further objected to for referring to “the longitudinal direction” with improper antecedent basis. It is further unclear since it isn’t understood how (if at all) this relates to the previously claimed “lengthwise direction” of the stent.
Claim 28 is objected to for referring to “adjacent windings” when it is unclear which of the plurality of previously identified windings (or “at least two adjacent windings”) this is referring to (if they are even considered to be related at all).
The claim is further objected to for referring to “adjacent struts” since it is unclear how (if at all) these relate to all the previously identified instances of “struts”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10, 15, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 is rejected for having new matter for claiming the thickness of the struts is less than 70 picometers, when this is new matter which is unsupported by the originally filed invention.
Claim 15 is rejected for having new matter for claiming there is a “second end ring (HOB)” when there is no support for a second end ring HOB in the originally filed invention.
Claim 19 is rejected for having new matter, for claiming the size of some of the pores is greater than 100 picometers squared, when this is not supported by the originally filed invention.
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 1-21, 23-25, 27-28 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for referring to “a first said first radiopaque marker”, “a second said first radiopaque marker”, “a first said second radiopaque marker”, and “a second said second radiopaque marker” since it is unclear how there can be a first and second “first radiopaque marker” and “second radiopaque marker”, since these are singular elements. The Applicant appears to be claiming a single marker is now two markers, which is indefinite.
The claim is further indefinite for claiming “the first and second radiopaque markers” when it is unclear which of the first said first, first said second, second said first, or second said second radiopaque markers are being referred to.
Further, the claim is unclear since it isn’t clear what it means to be “about” 90 degrees. The specification does not appear to elaborate on the scope of what might or might not be included within “about 90 degrees”, making the Examiner unclear what ranges this actually encompasses.
Further, the claim is indefinite for its last paragraph, which states that “each first radiopaque marker and each second radiopaque marker is offset by about 90 degrees circumferentially relative to the other” when there are multiple first markers and multiple second markers (as the Examiner best understands, anyways), making it unclear if the 90 degree offset is from each and every marker (meaning any marker on the device is offset 90 degrees from every other marker), or whether the first markers are offset 90 degrees relative only to the second markers, or some other explanation.
Claim 2 is indefinite for claiming the undulating pattern has a turn of “about” 180 degrees, when the Examiner is unclear what it means to be “about” 180 degrees, as compared for example, to 180 degrees, or not 180 degrees. It is unclear to the Examiner what values fall within the claimed range, and what values lay outside the range, making the scope of the claim unclear to the Examiner. The specification does not appear to elaborate with examples or definitions.
Further, the claim is indefinite for claiming “a loop is positioned to align with an end of an adjacent strut within each winding” when the claim has previously claimed that “each end of a loop is coupled to an end of a strut”, making it unclear how the loops both connect to the strut as well as have a staggered pattern of alignment with the strut.
Claim 6 is indefinite, as its entirety does not make sense to the Examiner. It is unclear whether this is due to grammatical issues, or whether this is attempting to claim something which isn’t supported. However, as the Examiner can best understanding, it is claiming that when the device is compressed, loops adjacent to bent sections align with/nestle within the bent sections to form a nestled arrangement. However, it is unclear how the loops align with the loops (which they are presumably connected to?), and align/nestle therein, since this requires the bent sections and loops to be positioned in two distinct locations at the same time.
Claim 10 is indefinite for claiming the thickness of the struts is less than 70 picometers when this is unclear. The description appears to put the dimensions of the device at least 6 orders of magnitude larger than a picometer, making this unclear.
Claim 15 is indefinite for claiming “a second end ring (HOB)” when it is unclear what “HOB” refers to. This is not present in the specification, giving the Examiner no understanding as regards what it could mean.
The claim is further indefinite for claiming the rings “form approximately a right-angled cylinder” when it is unclear how one could “form approximately” a shape. The specification does not appear to elaborate on what it means to “form approximately”, and does not give any examples or guidance regarding what would be considered to form approximately a right-handed cylinder, as opposed to (for example) not form approximately a right-handed cylinder or to form a right-handed cylinder.
Claim 16 is indefinite for claiming each end ring comprises one or more bands which are “interconnected in the lengthwise direction” when it is unclear how one band can be “interconnected” and what it might be interconnected to.
Further, the claim is indefinite for claiming the end bands comprise “the undulating pattern of loops coupled to the pair of struts”, when it is unclear what the scope of this requirement actually entails. Claim 16 depends from claim 15, 4, 3, 2, and 1, and while claim 2 indicates the undulating pattern comprises “struts and loops”, it is unclear whether further requirements such as the loops having a turn of about 180 degrees, each end of a loop has to be coupled to a bend of a strut, adjacent loops being axially offset with respect to an axis perpendicular to the lengthwise direction to form a staggered pattern of alignment of adjacent loops such that a loop is positioned to align with an end of an adjacent strut within each winding, the strut being a bent strut with a bent pattern, the bent pattern including first/second bent sections in opposite curvature, etc. Since the Examiner is unclear on what exactly is required for the end bands to comprise “the undulating pattern of loops coupled to the pair of struts”, the boundaries/scope of the claim cannot be determined.
Claim 17 is indefinite for similar reasons as claim 6 (above). The claim also appears to have a run-on sentence, or be missing some words.
The claim is also indefinite for the same reasons as claim 16, above, since it is unclear exactly is required for end ring’s one loop to have the “staggered pattern of alignment”, or for the bent strut to comprise “the bent pattern”, since this claim depends on so many and it is unclear what limitations are intended to be read into this or not.
Claim 19 is indefinite for claiming the pore size between fibers is greater than 100 picometers square, when this is unclear. The description appears to put the dimensions of the device at least 6 orders of magnitude larger than a picometer, making this unclear.
The claim is further indefinite for claiming the mesh is between “about” 3-5 microns, when it is unclear what values would fall within the range of “about 3-5 microns” and which values would fall outside the claimed range. The specification does not appear to elaborate on the term or give examples, making the boundaries of the claim unclear.
Remaining claims are rejected for depending on a rejected claim.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 21, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky et al. (US 6331189) hereinafter known as Wolinsky in view of Wolinsky et al. (US 20030149469 A1) hereinafter known as Wolinsky ‘469.
Regarding claim 1 Wolinsky discloses an endovascular device (Column 3 lines 37-38 expandable stent) comprising:
a main stent component with a tubular shape (Figure 7; see also Col 1 line 52), a first end and a second end (Figure 7),
a first radiopaque marker (Figure 6 item 9; Column 12 lines 29-32) with a shape with at least two distinct profiles when viewed from different angles (Column 12 lines 2-6), the first marker being attached to the main stent component, with a first said first marker at the first end and a second said first marker at the second end (Column 12 lines 12-16), and
a second radiopaque marker (Figure 6 item 9; Column 12 lines 29-32; Column 12 lines 12-14) with a shape with at last two distinct profiles when viewed from different angles (Column 12 lines 2-6), the second marker being attached to the main stent component, with a first said second marker at the first end, and a second said second marker at the second end (Column 12 lines 12-16),
wherein each first marker and each second marker is offset circumferentially relative to the other (Column 12 lines 9-16),
but is silent with regards to the markers being offset by about 90 degrees relative to each other.
However, regarding claim 1 Wolinsky ‘469 teaches radiopaque markers can be offset by about 90 degrees from one another ([0027]). Wolinsky and Wolinsky ‘469are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Wolinsky by having the offset markers be about 90 degrees from one another as is taught by Wolinsky ‘469 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 ordinary skill in the art. See MPEP 2144.05(II)(A). In this case, Wolinsky already establishes that the markers should be offset so they can always been seen in a flat configuration, and so the specific degree(s) the markers should offset while successfully being viewable in all angles would have been obvious to discover.
Regarding claim 21 see the rejection to claim 1 above.
Regarding claim 24 the Wolinsky Wolinsky ‘469 Combination teaches the device of claim 1 substantially as is claimed,
wherein Shanley further teaches the main stent component comprises a helical stent pattern, with a plurality of continuous windings that are oriented in a helical direction of the device (Figure 1).
Claims 2-3, 9, 25, 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469 as is applied above, further in view of Shanley et al. (US 20080097579 A1) hereinafter known as Shanley.
Regarding claim 2 the Wolinsky Wolinsky ‘469 Combination teaches the device of claim 1 substantially as is claimed,
wherein Wolinsky further discloses the main stent component comprises a plurality of windings (each respective band in the main stent component is understood to be a “winding”) having a crimped delivery diameter and an expanded diameter (Column 3 lines 41-42, lines 44-45),
wherein the windings have an undulating pattern comprising struts and loops, wherein the loops are portions of the pattern having a turn of 180 degrees, and each end of a loop is coupled to an end of a strut to form a pair of struts (Annotated Figure 7.1),
but is silent with regards to adjacent loops within each winding are axially offset from an axis perpendicular to the lengthwise direction to form a staggered pattern of alignment of adjacent loops such that a loop is positioned to align with an end of an adjacent strut within each winding.
However, regarding claim 2 Shanley teaches that stents with helical windings are well-known in the art, and wherein helical stents includes a plurality of windings (Figure 1 shows windings 41a, 41b, etc.); and
wherein adjacent loops within each winding are axially offset with respect to an axis perpendicular to the lengthwise direction to form a staggered pattern of alignment of adjacent loops such that a loop is positioned to align with an end of an adjacent strut within each winding (Figure 1). Wolinsky and Shanley are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of Wolinsky to have the windings be helical such as is taught by Shanley since this is a well-known, well-understood, successful configuration for stent loops. Further, this is known to favorably affect flexibility of a stent ([0002]).
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Regarding claim 3 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein Wolinsky further discloses at least one strut is a bent strut comprising a bent pattern along its length when in the delivery diameter (see Annotated Figure 7.1 which shows both struts in the pair being bent).
Regarding claim 9 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein Shanley further teaches the main component comprises cobalt chromium ([0022] the stent can be made of cobalt chromium alloys). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the material of the main component of the stent of Wolinsky so it includes cobalt chromium as is taught by Shanley since this is a known biocompatible material suitable for stent production, and since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). Any material identified for stent manufacture would have been obvious to try.
Regarding claim 25 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein Shanley further teaches each winding comprises two interconnected bands to form cells therebetween (Figure 1 shows how one winding can be considered to be two bands (e.g. 41a, 41b) for the purposes of this claim, which are interconnected via item 39, to form large cells therebetween).
Regarding claim 27 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein Shanley further teaches two adjacent windings are interconnected in the longitudinal direction of the stent by a flexible connection (Figure 1 item 39; [0025]).
Regarding claim 28 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 27 substantially as is claimed,
wherein Wolinsky further discloses the flexible connection is an indirect, curved connector connecting adjacent struts of adjacent windings (Column 4 lines 55-57).
Claims 4-5, 15, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley as is applied above, and further in view of Pazienza et al. (US 20020111669 A1) hereinafter known as Pazienza.
Regarding claim 4 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 3 substantially as is claimed,
but is silent with regards to the bent pattern having first and second bent sections opposite in curvature extending from each end of the strut.
However, regarding claim 4 Pazienza teaches stent strut bent patterns can include first and second bent sections having opposite curvature extending from each end of the strut towards a midsection such that the length comprises a concave curvature and a convex curvature (see Annotated Figure 2, below). Wolinsky and Pazienza are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the bend of the struts of Wolinsky by having them include opposite curvatures as is taught by Pazienza since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Wolinsky.
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Regarding claim 5 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 4 substantially as is claimed,
wherein the Combination further teaches the first bent section extends from the end of the loop coupled to the pair of struts so the first bent section curves inward toward an opposing strut of the pair, and the second bent section curves outward away from the opposing strut of the pair (Pazienza Annotated Figure 2 shows how the two bent sections curve as the claim requires; see the corresponding features described in the rejection to claims 1-2 above (for the loop, strut pair, etc.), with relation to the Combination as a whole),
wherein the bent strut maintains the bent pattern in both the delivery and expanded diameter (Pazienza Figures 3 and 6).
Regarding claim 15 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 4 substantially as is claimed,
wherein Wolinsky further discloses the first end of the main component is a first end ring, and the second end of the main component is a second end ring (Annotated Figure 7),
wherein the end rings extend from the windings (each respective band in the main stent component is understood to be a “winding”, so the end rings extend therefrom),
and wherein the end rings are oriented in a circumferential direction and form a right-angled cylinder at lengthwise ends of the device (Annotated Figure 7).
See also Shanley, who teaches the inclusion of right-angled cylinder, circumferentially oriented end rings 151, 149 in conjunction with helical windings.
See also Pazienza, who teaches the inclusion of right-angled cylinder, circumferentially oriented end rings Figure 1 items 600, 610 in conjunction with windings.
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Regarding claim 23 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 15 substantially as is claimed,
wherein Wolinsky further discloses the first/second markers are attached to the first end ring (Figure 6 item 9; Column 12 lines 29-32, along with Annotated Figure 7 explaining the extent of the end rings).
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley and Pazienza as is applied above, further in view of Chanduszko et al. (US 10588765 B2) hereinafter known as Chanduszko.
Regarding claim 6 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 4 substantially as is claimed,
but is silent with regards to loops adjacent the first/second bent sections in each winding being positioned to align with and nestle in the two bent sections to form a nestled arrangement.
However, regarding claim 6 Chanduszko teaches that in a delivery diameter, helical windings have bent sections which align with and nestle to form a nestled arrangement (Figure 3c). Wolinsky and Chanduszko are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Combination so that the features of the helical windings of the Combination (e.g. including bent struts, loops, etc.) align with and nestle together to form a nestled arrangement as is taught by Chanduszko in order to allow the system to be compressed for delivery with as many helical connectors as is possible, thus maintaining the compressed delivery diameter for navigation through a tortuous vasculature, and also ensuring maximum amounts of support when deployed.
Regarding claim 7 the Wolinsky Wolinsky ‘469 Shanley Pazienza Chanduszko Combination teaches the device of claim 6 substantially as is claimed,
wherein Shanley further teaches the struts comprise varying lengths, so the pair of struts comprise a long strut and a short strut (Figure 1 and 4b; [0028]).
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley as is applied above, and further in view of Lin et al. (US 20200206004 A1), hereinafter known as Lin, further in view of Lee et al. (US 10881540 B2) hereinafter known as Lee.
Regarding claim 8 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
but is silent with regards to the strut having a varying width, so a width near a mid-section is smaller than the width near the ends of the strut, and a width of the loop is greater than the width of any portion of the strut.
However, regarding claim 8 Lin teaches a stent with at least one strut that has a varying width, wherein the width near a mid-section of the strut is smaller than the width near ends of the strut (Figure 11 item 711; [0108]), and
wherein Lee teaches a width of a loop is greater than the width of any portion of a strut to which it connects (Column 22 lines 56-59 with reference to Figure 2c, showing the maximum strut width 84 at 0.0045 inches and the area of the loop 86 at 0.0047 inches). Wolinsky, Lin, and Lee are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the stent of the Combination so that the strut has a smaller width at the midsection of the strut as opposed to the ends as is taught by Lin, and so the loop has a width greater than the width of any portion of the strut as is taught by Lee in order to adjust the mechanical properties of the strut, thereby preventing fracture at the thicker areas.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley as is applied above, and further in view of Vyas et al. (US 20130178928 A1) hereinafter known as Vyas.
Regarding claim 10 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein Shanley teaches the thickness of the struts is about 0.004 inches ([0051]),
but is silent with regards to the thickness of the struts being less than 70 microns.
However, regarding claim 10 Vyas teaches the thickness of struts of a stent can be less than 70 microns (Abstract). Wolinsky and Vyas are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the thickness of the struts of the Combination so they have a thickness less than 70 microns as is taught by Vyas 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 ordinary skill in the art. See MPEP 2144.05(II)(A). In this case, the ranges of thickness that work for a stent intended to be implanted within a patient, with a specific flexibility and desired level of support would have been obvious to optimize.
Claim 16is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, Shanley and Pazienza, as is applied above, further in view of Schlun (US 20100234936 A1).
Regarding claim 16 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 15 substantially as is claimed,
wherein Wolinsky further discloses each end ring of the device comprises one or more circumferential end bands interconnected in the lengthwise direction (Annotated Figure 7), and comprises the undulating pattern of loops coupled to the pair of struts (Annotated Figure 7, in conjunction with Annotated Figure 7.1 which shows the loop/pair of strut pattern),
but is silent with regards to the end bands having variable lengths to produce axially offset loops in the circumferential direction.
However, regarding claim 16 Schlun teaches a stent with an end ring band has struts with variable lengths to produce axially offset loops in the circumferential direction (Figure 3 shows the end by P with axially offset loop ends in the circumferential direction). Wolinsky and Schlun are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Combination so that the end bands have axially offset loops in the circumferential direction in order to give a desired variation in the annular hoop stress imparted to a sheath as it is withdrawn over the stent ([0034]).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, Shanley and Pazienza, and Schlun, further in view of Chanduszko as is applied above.
Regarding claim 17 the Wolinsky Wolinsky ‘469 Shanley Pazienza Combination teaches the device of claim 15 substantially as is claimed,
wherein Wolinsky further discloses each end ring comprises at least one bent strut having the bent pattern (Annotated Figure 7.1),
but is silent with regards to the end ring comprising at least one loop with the staggered pattern of alignment, and the loop being positioned to align with and nestle in one of the bent sections of the bent strut adjacent in the circumferential direction in the delivery diameter.
However, regarding claim 17 Schlun teaches a stent with end ring bands having at least one loop with a staggered pattern of alignment (Figure 3 shows the end by P with axially offset loop ends in the circumferential direction). Wolinsky and Schlun are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Combination so that the end bands have axially offset loops in the circumferential direction in order to give a desired variation in the annular hoop stress imparted to a sheath as it is withdrawn over the stent ([0034]).
Further, regarding claim 17 Chanduszko teaches that in a delivery diameter, windings have bent sections which align with and nestle to form a nestled arrangement (Figure 3c). Wolinsky and Chanduszko are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Combination so that the features of the helical windings of the Combination (e.g. including bent struts, loops, etc.) align with and nestle together to form a nestled arrangement as is taught by Chanduszko in order to allow the system to be compressed for delivery with as many longitudinal connectors as is possible, thus maintaining the compressed delivery diameter for navigation through a tortuous vasculature, and also ensuring maximum amounts of support when deployed.
Claims 11-13, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley as is applied above, and further in view of Hoffman et al. (US 20130103139 A1) hereinafter known as Hoffman.
Regarding claim 11 the Wolinsky Wolinsky ‘469 Shanley Combination teaches the device of claim 2 substantially as is claimed,
but is silent with regards to the device including a degradable polymer mesh.
However, regarding claim 11 Hoffman teaches a stent can include a polymer mesh ([0037]) made of a biodegradable material ([0053]). Wolinsky and Hoffman are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Combination so that it includes a degradable polymer mesh as is taught by Hoffman in order to provide a mechanism for the device to elute a drug after it is implanted in place, thus allowing therapeutic benefits to the patient after implantation.
Regarding claim 12 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 11 substantially as is claimed,
wherein Hoffman further teaches the material is DL-lactide/glycolide copolymer (PDLG) ([0054]; see also [0138]).
Regarding claim 13 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 12 substantially as is claimed,
wherein Hoffman further teaches the mesh comprises ridaforolimus ([0100]; [0083]-[0084]).
Regarding claim 18 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 11 substantially as is claimed,
wherein Hoffman further teaches the polymer mesh is electrospun onto the device (Hoffman claim 13 spraying or electrospinning).
Regarding claim 19 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 18 substantially as is claimed,
wherein Hoffman further teaches a diameter of individual polymer fibers of the mesh is between 3-5 microns ([0040]), and
wherein the device includes pores between the fibers ([0044]) which have a size greater than 100 microns squared ([0111] a pore diameter of 200 microns indicates a radius of 100 microns, and so an area larger than this).
Regarding claim 20 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 2 substantially as is claimed,
wherein Hoffman further teaches the device is a drug-eluting stent ([0071]).
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky in view of Wolinsky ‘469, further in view of Shanley and Hoffman as is applied above, and further in view of Ding et al. (US 20150217029 A1) hereinafter known as Ding.
Regarding claim 14 the Wolinsky Wolinsky ‘469 Shanley Hoffman Combination teaches the device of claim 13 substantially as is claimed,
wherein Hoffman further teaches a controlled drug-elution profile of the ridaforolimus released from fibers of the mesh ([0083]) is over a period ([0009]),
but is silent with regards to the span of time.
However, regarding claim 14, Ding teaches ridaforolimus can elute from a medical device over the time period of 1-3 months ([0033], [0087]). Wolinsky and Ding are involved in the same field of endeavor, namely stents. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the drug elution profile of the Combination so that it medicates a patient for a time period of 1-3 months as is taught by Ding in order to provide a suitable duration of therapeutic treatment after the stent implantation.
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 08/26/25