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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 13, 2026 has been entered.
The amendments of claims 1, 5-6, 8-9, 11, 13-16 are acknowledged.
Response to Amendment
Previous claim objections are withdrawn in response to amendments to the claims.
Response to Arguments
Applicant’s arguments regarding Behan are not persuasive. Applicant argues that Behan does not disclose the required liner as element in Figure 136 of Behan does not show or suggest an element may be considered a liner. However, as a liner may be interpreted as one that lines or is used to line and element 962 lines element 963, element 962 is considered a liner. Furthermore, element 962 extends across the lumen of the primary implantable device 961 to occlude the lumen (see par. 48, 71, 73, 113, 423).
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 (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 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) 1-5 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Behan et al. (US 2014/0350694).
Regarding claim 1, Behan discloses an occlusion device (see Figs. 138-139) comprising: a primary implantable device 961 defining a lumen therethrough and including at least one radially-outwardly extending retention member 971 configured to anchor said primary implantable device with respect to tissue of a body passage (see Figs. 136-139); a secondary implantable device 963, 962 (see Fig. 136) including at least one radially-outwardly extending retention member (see Figs. 138-139, bulbous region similar to bulbous region/retention member of primary implantable device) operatively engaged with said at least one radially-outwardly extending retention member of said primary implantable device (see Figs. 138-169, par. 422); and an occlusion structure operatively 962 associated with said secondary implantable device, said occlusion structure comprising a liner (see Figs. 136, 138, liner interpreted as one that lines or is used to line something, and the occlusion structure 962 includes parts that line the secondary implantable device) and extending across and occluding the lumen of said primary implantable device (see Fig. 138, par. 48).
Regarding claim 2, Behan discloses said primary implantable device is a stent (see Figs. 136-139) with at least a portion thereof configured to promote tissue ingrowth (see par. 411, 421).
Regarding claim 3, Behan discloses said secondary implantable device 963, 962 is a stent (see Figs. 136, 138) extending through at least a part of the lumen of said primary implantable device (see Fig. 138); said primary implantable device has a saddle region (see Fig. 136, narrow portion between flare portion 970 and bulbous region 971) with a proximal end and a distal end (there are two opposite ends of the saddle), said at least one radially-outwardly retention member extending from the proximal end of said saddle region (see Fig. 136); and said at least one radially-outwardly extending retention member of said secondary implantable device extends from a proximal end of said secondary implantable device and is configured to operatively engage with said radially-outwardly extending retention member of said primary implantable device to be anchored with respect to the body passage (see Fig. 138).
Regarding claim 4, Behan discloses said occlusion device is a material capable of preventing flow of materials therethrough (see Figs. 136-138, par. 48, 71, 73, 113, 423), and is operatively associated with said proximal retention member of said secondary implantable device to extend across the lumen of said primary implantable device (see Fig. 138).
Regarding claim 5, Behan discloses said at least one radially-outwardly extending retention member of said secondary implantable device fits within a retention space defined between walls of said at least one radially-outwardly extending retention member of said primary implantable device (see Figs. 137-138).
Regarding claim 8, Behan discloses wherein said liner (see Fig. 136) is formed within the lumen of said primary implantable device (see Figs. 138-139) and shiftable into an occlusion configuration defining said occlusion structure across the lumen of said primary implantable device (see par. 422-423).
Regarding claim 9, Behan discloses said liner comprises an occlusive material capable of preventing flow of materials therethrough (see Figs. 136-138, par. 48, 71, 73, 113, 423).
Regarding claim 10, Behan discloses said secondary implantable device is selectively removable from said primary implantable device (see Figs. 136-139, par. 422-423, the primary and secondary implantable devices are two separate parts that are separable and therefore removable from one another ).
Regarding claim 11, Behan discloses a method of forming an occlusion device (see Figs. 136-139), said method comprising: engaging a secondary implantable device 963, 962 within a lumen of a primary implantable device 961 configured to anchor with respect to tissue at a deployment site (see Figs. 136-139); engaging a radially-outwardly extending retention member of the secondary implantable (see Figs. 138-139, bulbous region similar to bulbous region/retention member 971 of primary implantable device) device with a radially-outwardly extending retention member 971 of the primary implantable device (see Figs. 138-139, par. 422); and extending an occlusion structure 962 of the secondary implantable device across the lumen of the primary implantable device to occlude flow therethrough (see Fig. 138, par. 48), the occlusion structure comprising a liner (see Figs. 136, 138, liner interpreted as one that lines or is used to line something, and the occlusion structure 962 includes parts that line the secondary implantable device).
Regarding claim 12, Behan discloses the primary implantable device is a stent with uncoated regions configured to encourage tissue ingrowth (see Fig. 56, par. 324, 337, 394 describing stent and par. 41 of current application describing uncovered/are metal portions exposed to tissue at deployment site being tissue ingrowth promoting regions), said method further comprising deploying the primary implantable device and allowing tissue ingrowth (see Fig. 53) with respect to the primary implantable device before engaging the secondary implantable device within the lumen of the primary implantable device (see Figs. 54-55).
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.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Behan in view of Gupta et al. (US 2019/0298559).
Regarding claim 13, Behan discloses the method further comprising extending the liner in a direction transverse to the longitudinal axis of the primary implantable device to occlude the lumen thereof (see Figs. 136-139) but does not disclose the occlusion structure comprising a material inhibiting tissue ingrowth.
Gupta discloses a pyloric device that is fully coated to minimize and/or prevent tissue ingrowth (see par. 41). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the pyloric device of Behan (see par. 34-42) also be fully coated to minimize and/or prevent tissue ingrowth, as disclosed with Gupta, thereby helping with removal later on. Consequently, due to the fully coating of the device, the liner would also be coated.
Regarding claim 14, Behan and Gupta disclose the limitations of claim 13 and Behan further discloses the primary device is a stent (see Figs. 136, 139) with a saddle region (see Fig. 136, narrow portion between flare portion 970 and bulbous region 971) and the radially-outward extending retention member extends radially outwardly from the saddle region and transverse to the longitudinal axis of the primary implantable device (see Fig. 136), and engaging the radially-outwardly extending retention member of the secondary implantable device with the radially-outwardly extending retention member of the primary implantable device extends the occlusion structure operatively associated with the radially-outwardly extending retention member of the secondary implantable device across the lumen of the primary implantable device (see Fig. 138).
Regarding claim 15, Behan and Gupta disclose the limitations of claim 13 and Behan further discloses the primary device is a stent (see Figs. 136, 139) with a saddle region (see Fig. 136, narrow portion between flare portion 970 and bulbous region 971) defining the primary implantable device lumen therethrough (see Fig. 136), said method further comprising extending at least a portion of the liner across the primary implantable device lumen to occlude the primary implantable device lumen (see Fig. 138).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art found is Behan, which does not disclose the required secondary implantable device the required saddle region. Furthermore, while Drasler (US 2018/0360461) discloses the secondary implantable device has a saddle region with a proximal end and distal end, this is in the form of a balloon laying outside of the stent of the primary implantable device, and one of ordinary skill in the art would not be motivated to apply such teachings to the secondary implantable device of Behan that is fully inside the primary implantable device, being also a stent, as the creation of the saddle of Drasler is because the secondary implantable device falls outside the stent and such a configuration would change the operation/design of the device of Behan so that it would not work as intended.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781