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 without traverse of Group I, claims 1-10 in the reply filed on 5/4/2026 is acknowledged.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by La Francesca et al. (Pub. No.: US 2017/0151049).
La Francesca et al. (hereinafter, La Francesca) discloses a method for reducing remodeling formation of fibrotic tissue in a tubular organ comprising the steps of:
resecting a portion of a tubular organ in a subject producing a resected organ portion, the resected organ portion remaining in the subject (e.g., para. 115);
removing a portion of the tubular organ from the subject (e.g., para. 114-115)
replacing the removed portion with a synthetic support structure at an implantation site (e.g., para. 116), the synthetic support structure having a first end, a second end opposed to the first end and middle section extending between the first end and the second end (e.g., fig. 1A, para. 117), wherein at least a portion of the synthetic support structure is configured as a tubular member defining an interior lumen (e.g., fig. 1A), the synthetic support structure further having an outer polymeric surface extending from the first end to the second end, and a cellularized sheath layer adhering to at least a portion of the outer polymeric surface (e.g., para. 117);
maintaining the first end of the synthetic support structure in direct contact and sutured to a distal section of the tubular organ creating a first tubular organ-synthetic support anastomosis (e.g., para. 116-118);
maintaining the second end of the synthetic support structure in direct contact and sutured to a second section of the tubular organ creating a first tubular organ-synthetic support anastomosis (e.g., para. 118), wherein the first end and the second end are maintained in contact for a period of time sufficient to achieve guided tissue growth along the synthetic support structure the guided tissue growth derived from and in contact with the tissue present in the resected organ portion remaining in the subject, the guided tissue growth occurring around the synthetic support structure (e.g., para. 118); and
after achieving guided tissue growth, removing the synthetic support structure from the implantation site, the step of removing the circumferential portion of the tubular organ occurring in a manner such that the guided tissue growth is continuous and remains in the contact with the resected portion of the tubular organ remaining in the subject (para. 119).
For claim 2, La Francesca discloses the method of claim 1 further comprising: imparting cellular material onto the polymer surface of the synthetic support structure; and allowing the cellular material to grow to form the cellular sheath layer, the imparting and allowing steps occurring prior to the step of resecting the portion of the tubular organ (e.g., para. 122).
For claim 3, La Francesca discloses the method of claim 2 wherein the synthetic structural support is a tubular member and wherein the outer polymeric surface includes outwardly positioned electrospun polymeric fibers (e.g., para. 123).
For claim 4, La Francesca discloses the method of claim 3 wherein the cellularized sheath layer spans at least a portion outwardly positioned electrospun fibers (e.g., para. 123).
For claim 5, La Francesca discloses the method of claim 1 wherein the cellularized sheath layer is composed of cellular material, the cellular material including at least one of mesenchymal cells, stem cells, pluripotent cells (e.g., para. 123).
For claim 6, La Francesca discloses the method of claim 1 wherein the tubular organ is a gastrointestinal organ structure that includes an esophagus, a stomach or a combination of an esophagus and a stomach (e.g., abstract).
For claim 7, La Francesca discloses the method of claim 1 wherein the removing step is achieved intrascopically (e.g., para. 119).
For claim 8. La Francesca discloses the method of claim 2, comprising:
resecting a portion of a tubular organ in a subject producing a resected organ portion, the resected organ portion remaining in the subject and having a resection edge and forming a resection site (e.g., para. 115);
implanting a synthetic support structure at the resection site, the synthetic structural support having an outer polymeric surface and including a first end and a second end opposed to the first end, an outer polymeric surface positioned between the first end and the second end and a cellularized sheath layer overlying at least a portion of the outer polymeric surface, wherein at least a portion of the celluralized sheath layer is proximate to the resection edge of the resected organ portion (e.g., para. 116-118); and
maintaining contact between the synthetic support structure and the resection edge for an interval sufficient to achieve guided tissue growth along the synthetic support structure (e.g., para. 118),
wherein at least a portion of the synthetic support structure is absorbed at the resection site within a period of time sufficient to achieve guided tissue growth along the synthetic support structure (e.g., para. 120).
For claim 9, La Francesca discloses the method of claim 8 wherein the synthetic support structure is completely absorbed (e.g., para. 120)
For claim 10, La Francesca discloses the method of claim 1, further comprising monitoring tissue regeneration endoscopically (e.g., para. 121).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774
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