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 .
Information Disclosure Statement
The information disclosure statement(s) (IDSs) submitted on 11/8/24 and 12/11/24 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Application
This application claims priority to US 63/519375, filed 8/14/23.
Status of the Claims
Claims 1-20 are pending in the application, with claims 1-16 under consideration and claims 17-20 withdrawn.
Election/Restriction
Applicant's election without traverse of Group I claims 1-16 in the 7/31/26 Restriction Response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Stangenes (US 2017/0252195 A1).
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As to independent claims 1 and 16, Stangenes teaches a transluminal implant 100 (gastrointestinal device or implant 100 Abstract; Fig.4,7; [0050]; [0045]-[0110]), comprising: an elongated tubular body 110 extending from a first end region 130 (proximal portion 130 Fig.4; [0052],ll.6) to a second end region 132 (distal portion 132; Fig.4; [0052],ll.6) and [further] comprising:
a scaffolding 160 (hollow tubular braided structure 160; Fig.4; [0064]) forming a plurality of cells (as braided structure 160 of wire weaved to form a mesh structure 162; Fig.4;[0064],ll.7-8, where mesh structure necessarily comprises cells [0064]);
a first flange 132 adjacent to the first end region (distal portion 132; Fig.4; [0052],ll.5-6);
a second flange 130 adjacent to the second end region (proximal portion 132; Fig.4; [0052],ll.5-6); and
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a saddle region 134 (neck portion 134 Fig.4) extending between the first flange 132 and the second flange 130 (Fig.4; saddle region as neck portion 134 Fig.4; [0052],ll.5-6), the saddle region 134 having an outer diameter less than an outer diameter of the first flange 132 and the second flange 130 (Fig.4); and
a self expanding reinforcement member 176/172 disposed within a lumen of the elongated tubular body (within lumen of tubular body 110 Fig.4,7) and within the first flange 132 (within flange 132 of tubular body 110 Fig.4,7), the reinforcement member 172/176 comprising at least one curved wire and configured to exert a radially outward force on the elongated tubular body 110 (structural/stiffening elements 172/176 in lumen extending through and against inside diameter of tubular body 110 Fig.7,4; [0073]; as ring of metal wire, such as Nitinol™ wire; Fig.7; [0073] with expansive strength configured to exert radially outward force on body 110; Fig.7; [0084],ll.14-17).
As to claim 2, Stangenes teaches wherein the reinforcement member 176/172 is configured to exert a radially outward force on the elongated tubular body 110 (as ring shaped Fig.7; [0073] made of Nitinol™ wire with expansive strength [0084],ll.14-17).
As to claim 3, Stangenes teaches wherein an outer diameter of the reinforcement member 172/176 is similar to an outer diameter of the first flange 132 (Fig.7; [0071],ll.3-5; [0073]).
As to claim 4, Stangenes teaches wherein an outer diameter of the reinforcement member is greater than an outer diameter of the first flange (where wire rings of reinforcement member 172/176 press against inner surface of first flange 132 at an angle Fig.7, such that the outer diameter of the reinforcement member is greater than the outer diameter of the first flange 132 Fig.7).
As to claim 5, Stangenes teaches wherein the at least one curved wire (of structural/stiffening reenforcing member 176/172 Fig.4,7) includes at least one winding extending about an inner surface of the first flange 132 (structural/stiffening elements 172/176 in lumen extending through and against inner surface of tubular body 110 Fig.7,4; [0073]; as ring of wound metal wire, such as Nitinol™ wire; Fig.7; [0073] with expansive strength against inner surface of first flange [0084],ll.14-17).
As to claim 6, Stangenes teaches wherein the at least one curved wire includes at least two windings extending about an inner surface of the first flange (wire rings 172 and 176 forming two windings Fig.7 on inner surface of flange 132 Fig.7).
As to claim 7, Stangenes teaches wherein the at least one curved wire includes less than one winding (where each of 172 and 176 do not provide a single winding (as less than diameter, such that each of 172 and 176 provide less than one winding Fig.7).
As to claim 8, Stangenes teaches wherein the reinforcement member comprises two or more curved wires (Fig.7: as 172 and 176).
As to claim 9, Stangenes teaches wherein the at least one curved wire has a diameter of about 0.013 inches (0.010 to 0.015 inches; [0085],ll.3-4).
As to claim 10, Stangenes teaches wherein a proximal end of the at least one curved wire is secured to a distal end of the at least one curved wire (as ring of wound metal wire, such as Nitinol™ wire; Fig.7; [0073], necessarily where each end secured to each other to form ring).
As to claim 11, Stangenes teaches wherein the at least one curved wire 172/176 comprises a shape memory material (as ring of shape memory metal wire, such as Nitinol™ wire; Fig.7; [0073]).
As to claim 12, Stangenes teaches wherein the transluminal implant further comprises a second reinforcement member 172 disposed within the lumen of the elongated tubular body 110 and within the second flange 130 (Fig.6; [0072],ll.3-6).
As to claim 13, Stangenes teaches wherein the elongated tubular body comprises a stent (where scaffolding as hollow tubular braided structure 160; Fig.4; [0064] forming a plurality of cells as braided structure 160 of wire weaved to form a mesh structure 162; Fig.4;[0064],ll.7-8, is in the form of a stent Fig.4).
As to claim 14, Stangenes teaches wherein the elongated tubular body comprises a pyloric closure device (as GI implant to fit within the pylorus; Abstract)
As to claim 15, Stangenes teaches wherein the reinforcement member further comprises a hardening material (where Nitinol forms hardened shape materal as resisting change from a particular shape to maintain the shape of the reinforcement member; [0069],ll.2,4-6).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art, e.g., Behle ‘351 (US 2013/030351 A1) ([0117];[0121]; Fig.23); Behle ‘574 (US 2021/030574 A1) (Fig.2 and accompanying description); and Barham (US 2022/125434 A1) ([0050]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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