Patent Application 17353500 - KIRIGAMI-INSPIRED STENTS FOR SUSTAINED LOCAL - Rejection
Patent Application 17353500 - KIRIGAMI-INSPIRED STENTS FOR SUSTAINED LOCAL
Title: KIRIGAMI-INSPIRED STENTS FOR SUSTAINED LOCAL DELIVERY OF THERAPEUTICS
Application Information
- Invention Title: KIRIGAMI-INSPIRED STENTS FOR SUSTAINED LOCAL DELIVERY OF THERAPEUTICS
- Application Number: 17353500
- Submission Date: 2025-05-20T00:00:00.000Z
- Effective Filing Date: 2021-06-21T00:00:00.000Z
- Filing Date: 2021-06-21T00:00:00.000Z
- National Class: 623
- National Sub-Class: 001220
- Examiner Employee Number: 84399
- Art Unit: 3771
- Tech Center: 3700
Rejection Summary
- 102 Rejections: 0
- 103 Rejections: 1
Cited Patents
The following patents were cited in the rejection:
Office Action Text
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 Rejections - 35 USC § 103
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 non-obviousness.
Claims 1-8 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Hakim et al. (US 2021/0346180) in view of Xie et al. (US 2015/0100133) and Melsheimer (US 2011/0034860).
Regarding claim 1, Al-Hakim et al. disclose a stent (Figures 15 and 16) capable of treating submucosal tissue of a subject (¶[0103]), the stent comprising: a tubular body (1600) extending along a central axis and configured to move between a retracted position (Figure 16 - lower stent) and an elongated position (Figure 16 - upper stent).
Al-Hakim et al. fail to disclose a plurality of cuts formed into the tubular body to create projections as claimed. Al-Hakim et al. et al. disclose that the stent may have barbs along the length of the stent and that the barbs may be micro-barbs (¶[0084]). Al-Hakim et al. disclose that the stent may be used in the sinus tract (¶[0103]). Al-Hakim et al. disclose that the stent may be expanded by a balloon (¶[0061]).
Xie et al. disclose stent-like structure (40; Figure 4) for the sinus tract (¶[0080]) having a plurality of cuts (43) formed into a tubular body to create projections or micro-barbs (42), each projection configured to pierce submucosal tissue (¶[0080]; capable of piercing such tissue within a gastrointestinal tract); wherein each projection among the plurality of projections is configured to deform when a strain is applied to the tubular body to cause a change orientation relative to the central axis when the tubular body moves between the retracted position and an expanded position (¶[0080]; the projections can be deformed by a balloon at any time during deployment)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the balloon-expandable projections of Xie et al. in/through the tubular body of Al-Hakim et al. (anywhere in/through the struts along the length of the stent) in order to better anchor the stent within the sinus. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the projections with cutting edges in order to better pierce tissue as this is their stated purpose.
Al-Hakim et al. in view of Xie et al. fail to disclose that the projections each have a pattern formed in/through the outer surface for loading therapeutic agents or coatings thereon. Xie et al. teach coating a stent-like structure with a drug to treat a sinus tract (¶[0088]-[0090]).
Melsheimer disclose a plurality of cuts formed into a tubular body to create similar projections as Xie et al. (10; Figures 1-4E), each projection having a pattern (18 or 18/26) formed in/through the outer surface to deliver a therapeutic agent to tissue (¶[0028]-[0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention when providing the above projections of Xie et al. to have formed them with the pattern of Melsheimer in order to allow them to deliver a drug or therapeutic agent to tissue.
Regarding claim 2, when the tubular body is in the retracted position, the plurality of projections form part of the cylindrical outer surface of the tubular body (¶[0080] of Xie et al.) and wherein when the tubular body is in the elongated position, the plurality of projections extend radially outward from the tubular body into a deployed position to pierce the submucosal tissue proximate to the tubular body (evident in view of Figure 4 and ¶[0080] of Xie et al.).
Regarding claim 3, the projections define a needle angle between about 1 degrees and about 90 degrees relative to the central axis when the projections are in a deployed position (the projections of Xie et al. are expandable to various degrees using a balloon and could be expanded to within the claimed range).
Regarding claim 4, the projections are triangular-shaped (Figure 4 of Xie et al.), with a first edge and a second edge defining the cutting edge (obvious as explained above), and a base of the triangular-shaped projections defining an uncut portion of the tubular body (evident from Figure 4 and ¶[0080] of Xie et al.).
Regarding claim 5, the elongated position of the tubular body defines an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position (evident from Figure 16 of Al-Hakim et al.).
Regarding claim 6, the plurality of projections are formed by a pattern of interconnected cuts into the tubular body (evident from Figure 4 of Xie et al. - such interconnected cuts would be present when providing these cuts to the struts of Al-Hakim et al.).
Regarding claim 7, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the plurality of projections circumferentially around the tubular body since they are depicted as surrounding a tubular body in Figure 4 of Xie et al. and this would allow the stent to deliver a drug to all parts of a surrounding vessel. Furthermore, Al-Hakim et al. disclose providing projections anywhere throughout the length of their stent (¶[0084]).
Regarding claim 8, as modified in view of Melsheimer, a portion of the stent would be coated with a therapeutic agent. (¶[0023], [0050], [0052] of Melsheimer).
Regarding claim 21, the pattern formed into the outer surface of the projections includes a plurality of striations (¶[0049] of Melsheimer).
Regarding claim 22, Melsheimer fails to teach triangular striations as claimed. However, it would have been an obvious matter of design choice to one skilled in the before the effective filing date of the claimed invention to have made the striations in a triangular shape since applicant has not disclosed that the claimed striation shape solves any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of adhering a therapeutic agent to the surface. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding claim 23, each of the plurality of projections are triangular (Figure 4 of Xie et al.).
Allowable Subject Matter
Claims 9-20 allowed.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
