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 .
Response to Amendment
The amendments filed on 05/21/2026 have been entered. Claims 1-20 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 05/21/2026, with respect to the rejection(s) of claim(s) 1, 19, and 20 under 35 USC 102(a)(1) and 103 in view of under Folan et al. (US 2021/0015598) have been fully considered and are persuasive. Although applicants’ arguments are directed towards the membrane at the locations of the recessed sections 450, 550,60, and not what is outlined as the first and second circumferential attachment regions, examiner agrees that Folan does not explicitly teach that the membrane is attached in a continuous annular manner around an entire inner circumference of the scaffold at these points. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Folan (US 2020/0253759) to teach the newly recited claim limitations.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Folan et al. (US 2021/0015598; hereinafter “Folan ‘598”) in view of Folan (US 2020/0253759; hereinafter “Folan ‘759”).
Regarding claim 1, Folan ‘598 discloses an expandable medical device (400, 500, or 600, FIGs 4A, 5A, 6A), comprising: a tubular scaffold (402, 502, 602), the tubular scaffold including an inner surface (Side facing lumen), an outer surface (Radially outer surface), a proximal end region (406 and right side of 500 and 600), a distal end region (404 and left side of 500 and 600), a lumen extending from the proximal end region to the distal end region (405, [0055], and respective lumens of 500 and 600), and a portion of the tubular scaffold defining a retention member extending radially away from the outer surface (440, [0056-0059], 540, [0060], and 640, [0061]) wherein the retention member has a distally facing surface (Left side of the retention member) and a proximally facing surface (Right side of the retention member); and a membrane (420, [0055 and 0057], 520, [0060], and 620, [0061]) disposed within the lumen of the tubular scaffold ([0057] and see FIGs 4A, 5A, 6A; the membrane is within the lumen of the scaffold); wherein the membrane is secured to the inner surface of the tubular scaffold at a first circumferential attachment region (At least some point of contact of the membrane to the scaffolding at the distal end of the device. FIGs 4A, 5A, and 6A show different embodiment of attachment points where the figures show whether the membrane is in contact with the scaffold or spaced apart. See rejection below for specific indication of first circumferential attachment region), and wherein the membrane is secured to the inner surface of the tubular scaffold at a second circumferential attachment region (At least some point of contact of the membrane to the scaffolding at a more proximal end of the device. See rejection below for specific indication of first circumferential attachment region) axially spaced apart from the first circumferential attachment region (There are at least regions of attachment of the membrane along the axial length of the scaffold); wherein the membrane is unattached to the inner surface of the tubular scaffold between the first circumferential attachment region and the second circumferential attachment region (FIGs 4A, 5A, and 6A each show region of unattached membrane) to define a tissue ingrowth region between the inner surface of the tubular scaffold and an outwardly-facing surface of the membrane (The pocket created between the outer surface at the unattached membrane position and the inner surface of the scaffolding creates a region configured to allow tissue ingrowth, [0057, 0060, 0061]).
Folan ‘598 fails to show a cross section at the first and second circumferential attachment regions and therefore is silent regarding each of the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold.
However, Folan ‘759 teaches in the same field of endeavor an expandable medical device (10, FIG 1-2) having a tubular scaffold (12, [0065]) and a membrane (20, [0071]) disposed within the inner lumen of the tubular scaffold (FIG 2, [0071]) wherein the membrane is secured to the inner surface of the tubular scaffold at first and second circumferential attachment regions (See contact of the membrane 20 with the inner surface 24 at two distinct regions 27, [0074]) and wherein the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold ([0074] discloses “Liner 20 may extend circumferentially around the lumen of stent member 10. In other words, it can be appreciated that liner 20 may be defined as an annular layer that extends continuously around the lumen of stent member 10. Further, liner 20 may extend continuously (e.g., uninterrupted) around the lumen of stent 10, from the first end 21 to the second end 23”. FIG 3 also shows a cross section at 27 where the liner forms a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Folan ‘598 such that the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold, as taught by Folan ‘759, for the purpose of spanning across interstices of the tubular scaffold may prevent tissue ingrowth along their respective surfaces and interstices therebetween (Folan ‘759: [0080]).
Regarding claim 2, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 1. Folan ‘598 further discloses the membrane is configured to maintain a passageway therethrough (The membrane maintains the shape of the lumen which acts as a passageway through the device).
Regarding claim 3, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 2.
Folan et al. discloses a tissue ingrowth region extends circumferentially around the inner surface of the tubular scaffold (See FIG 4A where the ingrowth region at 435 extends circumferentially around the scaffolding) but fails to teach the ingrowth regions extending the entire circumference of the inner surface.
However, Folan ‘759 teaches a tissue ingrowth region (36, FIG 2, [0081-0082]) which extends the entire circumference of the inner surface (FIG 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Folan ‘598 such that the tissue ingrowth region extends the entire circumference of the inner surface, as taught by Folan ‘759, for the purpose of utilizing a commonly known technique for forming a region for tissue ingrowth by spacing apart the membrane form the scaffold along an entire circumference to ensure even distribution of the tissue ingrowth.
Regarding claim 4, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 3. Folan ‘598 further discloses the membrane is formed from an elastic material ([0046]).
Regarding claim 5, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 1. Folan ‘598 further discloses the membrane is designed to permit tissue ingrowth between the inner surface of the tubular scaffold and an outwardly-facing surface of the membrane ([0046, 0056-0057, 0060-0061], FIGs show the ingrowth pocket is formed between the outer surface of the membrane and inner surface of the scaffolding)
Regarding claim 6, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 5. Folan ‘598 further discloses the first circumferential attachment region is secured to the inner surface of the tubular scaffold along the distal end region and wherein the second circumferential attachment region is secured to the inner surface of the tubular scaffold at a position distal to the retention member (See annotated FIG 4A below).
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Regarding claim 7, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 6. Folan ‘598 further discloses the tubular scaffold includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold ([0046] describes the interstices of the scaffold), and wherein the membrane spans the interstices of the portion of the tubular scaffold which defines the retention member (The membrane spans the interstices of the retention member 440 because 420 does not directly contact 440 but instead spans the gap across).
Regarding claim 8, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 7. Folan ‘598 further discloses the tubular scaffold includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold ([0046] describes the interstices of the scaffold), and wherein the membrane encapsulates the interstices of the portion of the tubular scaffold which defines the retention member (The membrane encapsulates this portion by creating a pocket between the membrane and the scaffold of the retention member).
Regarding claim 9, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 5. Folan ‘598 further discloses the first circumferential attachment region is secured to the inner surface of the tubular scaffold along the distal end region and wherein the second circumferential attachment region is secured to the inner surface of the tubular scaffold at a position proximal to the retention member (See annotated FIG 4A below).
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Regarding claim 10, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 9. Folan ‘598 further discloses the tubular scaffold includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold ([0046] describes the interstices of the scaffold), wherein tissue is permitted to grow through the interstices of the portion of the tubular scaffold between the first circumferential attachment region and the second circumferential attachment region (Tissue is permitted to grow at least in the pocket created at the region of 440, which is positioned between the first and second circumferential attachment region as claimed).
Regarding claim 11, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 5. Folan ‘598 further discloses the distal end region of the tubular scaffold further includes a flared portion (425, [0057], also shown but not numbered in FIG 5A and 6A).
Regarding claim 12, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 11. Folan ‘598 further discloses the first circumferential attachment region is secured to the inner surface of the tubular scaffold at a position proximal to the flared portion and wherein the second circumferential attachment region is secured to the inner surface of the tubular scaffold at a position distal to the retention member (See annotated FIG 5A below).
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Regarding claim 13, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 12. Folan ‘598 further discloses the membrane is in direct contact with the inner surface of the portion of the tubular scaffold defining the retention member (See bottom side of 540 on FIG 5A and 5B wherein the membrane directly contacts and follows the contour of the retention member).
Regarding claim 14, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 13. Folan ‘598 further discloses the flared portion includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold ([0046] describes the interstices of the scaffold), wherein the flared portion is devoid of the membrane such that tissue is permitted to grow through the interstices of the tubular scaffold along the flared portion (FIG 5A shows the membrane is not in direct contact with the flared portion, thereby creating a pocket/space therebetween which allows for tissue ingrowth).
Regarding claim 15, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 14. Folan ‘598 further discloses the retention member has a diameter (Widened diameter taken at 540 in FIG 5A), wherein the flared portion has a diameter (Any diameter taken along the tapered flared section), and wherein the diameter of the retention member is greater than the diameter of the flared portion (FIG 5A shows the retention member has a greater diameter than at least some smaller diameter taken along the tapered region of the flared portion).
Regarding claim 17, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 1. Folan ‘598 further discloses the membrane is further secured to the inner surface of the tubular scaffold at a plurality of spaced-apart discrete attachment points positioned between the first circumferential attachment region and the second circumferential attachment region (See annotated FIG 6A below).
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Regarding claim 18, Folan ‘598/Folan ‘759 disclose the invention substantially as claimed, as set forth above for claim 17. Folan ‘598 further discloses regions of the membrane between the plurality of spaced-apart discrete attachment points are radially spaced from the inner surface of the tubular scaffold (FIG 6A), creating a plurality of tissue ingrowth regions positioned between the first circumferential attachment region and the second circumferential attachment region (635, [0061]).
Regarding claims 16, 19, and 20, Folan ‘598 discloses an expandable medical device (400, 500, or 600, FIGs 4A, 5A, 6A), comprising: a tubular scaffold (402, 502, 602), the tubular scaffold including an inner surface (Side facing lumen), an outer surface (Radially outer surface), a proximal end region (406 and right side of 500 and 600), a distal end region (404 and left side of 500 and 600)including a flared portion (425, [0057], also shown but not numbered in FIG 5A and 6A), a lumen extending from the proximal end region to the distal end region (405, [0055], and respective lumens of 500 and 600), and a retention member extending radially away from the outer surface (440, [0056-0059], 540, [0060], and 640, [0061]) wherein the retention member has a distally facing surface (Left side of the retention member) and a proximally facing surface (Right side of the retention member); and a membrane (420, [0055 and 0057], 520, [0060], and 620, [0061]) disposed within the lumen of the tubular scaffold ([0057] and see FIGs 4A, 5A, 6A; the membrane is within the lumen of the scaffold); wherein the membrane is secured to the inner surface of the tubular scaffold at a first circumferential attachment region (At least some point of contact of the membrane to the scaffolding at the distal end of the device. FIGs 4A, 5A, and 6A show different embodiment of attachment points where the figures show whether the membrane is in contact with the scaffold or spaced apart. See rejection above for specific indication of first circumferential attachment region), and wherein the membrane is secured to the inner surface of the tubular scaffold at a second circumferential attachment region (At least some point of contact of the membrane to the scaffolding at a more proximal end of the device. See rejection above for specific indication of first circumferential attachment region) axially spaced apart from the first circumferential attachment region (There are at least regions of attachment of the membrane along the axial length of the scaffold); wherein the membrane is configured to maintain a passageway therethrough (The membrane maintains the shape of the lumen which acts as a passageway through the device); wherein the flared portion includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold ([0046] describes the interstices of the scaffold), wherein the flared portion is devoid of the membrane such that tissue is permitted to grow through the interstices of the tubular scaffold along the flared portion (FIG 5A shows the membrane is not in direct contact with the flared portion, thereby creating a pocket/space therebetween which allows for tissue ingrowth).
Folan ‘598 fails to show a cross section at the first and second circumferential attachment regions and therefore is silent regarding each of the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold.
However, Folan ‘759 teaches in the same field of endeavor an expandable medical device (10, FIG 1-2) having a tubular scaffold (12, [0065]) and a membrane (20, [0071]) disposed within the inner lumen of the tubular scaffold (FIG 2, [0071]) wherein the membrane is secured to the inner surface of the tubular scaffold at first and second circumferential attachment regions (See contact of the membrane 20 with the inner surface 24 at two distinct regions 27, [0074]) and wherein the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold ([0074] discloses “Liner 20 may extend circumferentially around the lumen of stent member 10. In other words, it can be appreciated that liner 20 may be defined as an annular layer that extends continuously around the lumen of stent member 10. Further, liner 20 may extend continuously (e.g., uninterrupted) around the lumen of stent 10, from the first end 21 to the second end 23”. FIG 3 also shows a cross section at 27 where the liner forms a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Folan ‘598 such that the first circumferential attachment region and the second circumferential attachment region comprises a continuous annular attachment extending around an entire circumference of the inner surface of the tubular scaffold, as taught by Folan ‘759, for the purpose of spanning across interstices of the tubular scaffold may prevent tissue ingrowth along their respective surfaces and interstices therebetween (Folan ‘759: [0080]).
Folan ‘598 is further silent regarding the distally facing surface being positioned substantially parallel to the proximally facing surface.
However, Folan’598 discloses in FIGs 4A-4E a variety of different shapes that can be formed by the retention member including spherical, trapezoidal, pentagonal, and chordal ([0058]) Folan further discloses “Embodiments herein are not limited in this context”.
Therefore, it would have been an obvious matter of design choice to modify the cross sectional shape of the retention member to be rectangular or square, thereby providing a distally facing surface that is substantially parallel to the proximally facing surface, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ47 (CCPA 1976).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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