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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 11 recites the limitation “wherein the esophageal stent is placed within the lumen of an esophagus”. This limitation positively recites the esophagus as part of the invention and thus attempt to claim a portion of a human organism. The examiner suggests amending the claims to include a recitation of “configured to” or “capable of” so as not to directly claim the esophagus as part of the claimed invention (e.g., wherein the esophageal stent is configured to be placed within the lumen of an esophagus…).
Claim 12 recites the limitation “wherein the magnetic ring is placed superior to a fundus of a stomach and inferior to a diaphragm”, which positively recites the stomach and diaphragm as part of the invention and thus attempt to claim a portion of a human organism. The examiner suggests amending the claims to include a recitation of “configured to” or “capable of” so as not to directly claim the esophagus as part of the claimed invention.
Claim 13 recites the limitation “wherein the magnetic ring is placed at an extraluminal location, wherein the extraluminal location is at a fixed location within the body”, which positively recites a part of a human organism as part of the invention. The examiner suggests amending the claims to include a recitation of “configured to” or “capable of” so as not to directly claim the esophagus as part of the claimed invention.
For treating claims 11-13 on the merits, the examiner will interpret these limitations as functional.
Claim Rejections - 35 USC § 102
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 person shall be entitled to a patent unless –
(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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8702642 to Belhe et al.
Regarding claim 1, Belhe discloses a stent system (see at least Fig. 27) comprising: a magnetic stent (internal tubular implant 111 with stent 263) comprising an outer surface, a proximal end, and a distal end; wherein the distal end comprises a plurality of magnets 136 disposed thereon; wherein the plurality of magnets are configured to form a ring (see Fig. 27); and a magnetic ring 110 comprising a plurality of magnets configured to form a ring (see Fig. 27 below; 110 is an external band); wherein the plurality of magnetic magnets on the magnetic stent and the plurality of magnets on the magnetic ring 110 are configured such that they repulse each other (col. 11, ll. 60-62).
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Regarding claim 2, Belhe discloses the magnetic ring is disposed distally to the plurality of magnets on the magnetic stent (see Fig. 27 above).
Regarding claim 3, Belhe discloses the stent system of claim 1, wherein the plurality of magnets on the magnetic stent 110 does not extend beyond the magnetic ring 111 (see Fig. 27).
Regarding claim 4, Belhe discloses the stent system of claim 1, wherein the magnetic stent comprises a medical-grade plastic, metal, or other biocompatible material (col 8, ll. 34-40).
Regarding claim 5, Belhe discloses the stent system of claim 1, wherein the magnetic ring comprises an expandable polymer (elastic materials listed in col. 7, ll. 30-34; the elastic material will allow the band to expand/deform and allow to return to shape).
Regarding claim 6, Belhe discloses the expandable polymer is braided around the plurality of magnets on the magnetic ring (111 can have braided reinforcement; col. 17, ll. 21-47).
Regarding claim 7, Belhe discloses the stent system of claim 1, wherein the plurality of magnets in the magnetic ring is entirely encased (col. 7, ll. 36-38) with an expandable rigid device.
Regarding claim 8, Belhe discloses the stent system of claim 1, wherein the plurality of magnets are selected from neodymium, samarium cobalt, alnico, ceramic, or ferrite magnets, or a combination thereof (col. 7, ll. 38-41).
Regarding claims 9-13, Belhe discloses the stent system of claim 1, wherein the magnetic stent capable of being used as a bariatric stent or an esophageal stent (col. 1, ll. 19-24), wherein the stent is capable of being placed within the lumen of an esophagus, such that an outer surface of the esophageal stent engages an inner surface of the esophagus, wherein the magnetic ring is capable of being placed superior to a fundus of a stomach and inferior to a diaphragm, or at an extraluminal location, wherein the extraluminal location is at a fixed location within the body.
Regarding claim 14, Belhe discloses that the magnetic repulsion between the plurality of magnetic magnets on the magnetic stent and the plurality of magnets on the magnetic ring prevents migration of the magnetic stent (col. 11, ll. 60-63).
Regarding claim 15, Belhe discloses a method of preventing stent migration (col. 2, ll. 20-32) comprising:
implanting a magnetic stent (internal tubular implant 111 with stent 263) in a gastrointestinal tract (Fig. 27), wherein the magnetic stent comprises an outer surface, a proximal end, and a distal end; wherein the distal end comprises a plurality of magnets 136 disposed thereon; wherein the plurality of magnets are configured to form a ring (Fig. 27); and
implanting a magnetic ring 110 distally to the plurality of magnets on the magnetic stent (see Fig. 27 above), wherein the magnetic ring comprises a plurality of magnets configured to form a ring;
wherein the plurality of magnetic magnets on the magnetic stent and the plurality of magnets on the magnetic ring are configured such that they repulse each other and prevent migration of the magnetic stent (col. 11, ll. 60-62).
Regarding claim 16, Belhe discloses wherein the magnetic stent is implanted endoscopically (col. 3, ll. 41-19).
Regarding claim 17, Belhe discloses wherein the magnetic ring is implanted via a laparoscopically (col. 2, ll. 46-50).
Regarding claims 18-19, Belhe discloses that the device can be placed within the gastrointestinal system, including the esophagus, the stomach and the intestines (col. 1, ll. 19-21; col. 18, ll. 5-14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2026/0108372 to Kemmeter et al discloses magnetic fasteners
US 2011/0106723 to Belhe et al discloses magnetic retention.
US 2011/0009690 to Belhe et al discloses magnetic retention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARWIN P EREZO whose telephone number is (571)272-4695. The examiner can normally be reached M-Th 7am-3pm.
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DARWIN P. EREZO
Supervisory Patent Examiner
Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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