DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimers filed on 12/31/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of (11, 690, 744 and 9,314359) has been reviewed and is NOT accepted. The terminal disclaimer does not comply with 37 CFR 1.321 because: It fails to disclaim the terminal portion of the subject patent. The terminal disclaimers filed on 12/31/25 include patents 11/690,744 and 9,314,359 however does not provide a terminal disclaimer for patent 10/092,432. The double patenting rejection is thus maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 4-6, 8-9 are rejected on the ground of non-statutory double patenting
as being unpatentable over claims 1-20 of U.S. Patent 11,690,744.
Current application claim 1 recites:
"2. (New) A stent delivery system, comprising: an elongate pusher shaft including a
proximal end, a distal end, and a lumen extending therebetween; a stent having an
anchoring mechanism comprising a proximal portion and a distal portion; and a tubular
body fixedly attached to the distal end of the pusher shaft; wherein the tubular body
extends distally of the distal end of the pusher shaft; and wherein the tubular body
covers the proximal portion of the anchoring mechanism."
Patent claim '744, claim 9
"9. A stent delivery system, comprising: a push catheter (this equates to the claimed
pusher shaft) comprising a proximal end, a distal end, and a lumen extending
therebetween (this is an inherent feature); a stent comprising a proximal end, a distal
end, a lumen extending therebetween, and at least one anchor, the stent positioned
distal to the push catheter; a tubular body disposed about the distal end of the push
catheter and at least the proximal end of the stent, the tubular body configured to
constrain the at least one anchor of the stent in an undeployed configuration; and a
constraining member disposed about the push catheter and configured to reversibly
engage the tubular body."
It is obvious to one having ordinary skill in the art that the limitations of the
current application are recited in the patent in a varied manner and that the patent has
more limitations than the current application.
Regarding claim 4, see' 744 claim 10. Regarding the limitations of claim 8 see
'744 claim 7. Regarding claim 9, see '744 claim 11.
Claim 2-6, 9 are rejected on the ground of non-statutory double patenting as
being unpatentable over claims 2-18 of U.S. Patent No. 9,314,359 (hereafter '359).
Regarding claims 2-3 and noting claims 1-9, patent '359 discloses in part:
"1. A drainage stent delivery system, comprising: a drainage stent delivery device
including a distal end and a handle disposed at a proximal end thereof; and a tubular
body having a proximal end, a distal end, and a lumen extending therebetween, the
lumen being sized to slidably fit about an outer diameter of the delivery device and an
outer diameter of a drainage stent having an anchoring mechanism, the drainage stent
disposed at the distal end of the delivery device; wherein the delivery device includes a
constraining member configured to form an interference fit with an external portion of
the tubular body at the proximal end of the delivery device.
2. The drainage stent delivery system of claim 1, wherein the anchoring mechanism includes one or more flaps formed in the stent.
7. The drainage stent delivery system of claim 1, wherein the stent is disposed about a guide catheter.
8. The drainage stent delivery system of claim 7, wherein a push catheter is disposed
about the guide catheter and positioned adjacent to the stent.
It is obvious to one having ordinary skill in the art that the limitations of claims 2-
3 are recited in independent and dependent form. It is further obvious that because
claim 2 does not limit where the one or more flaps are placed that the limitation is
broader and can encompass that the flaps are distally-facing and that the distal portion
of the anchoring mechanism comprise at least one proximally facing flap.
Regarding claim 4, patent '359 claim 3 states that the constraining member is
configured to engage "the proximal" end of the tubular body. Therefore it is obvious to
one having skill in the art that this meets the limitation of "wherein the distal portion of
the anchoring mechanism is not covered by the tubular body".
Regarding claims 5-6, patent 359 claim 8 states "the stent is disposed in abutting
contact with the distal end of the pusher shaft." Patent '359 claim 8 recites a push
catheter is disposed about the guide catheter and positioned adjacent to the stent.". It
is obvious that the term "abut" is synonymous with "adjacent". Claim 8 is broad and
encompasses the distal end of the pusher shaft.
Regarding claim 9 see patent '359 claim 6.
Claims 11-12, 14-17 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 2-18 of U.S. Patent No. 9,314,359 (hereafter '359)
in view of 10/092,432 (hereafter '432).
Patent '359 has been disclosed however does not recite a guidewire and guidewire port. Patent '432 claim 1 recites the use of a guidewire and guidewire port. It would be obvious to utilize a guidewire and guidewire port with patent '359 in order to
assist the guide catheter navigation.
Claims 7 and 18 are rejected on the ground of non-statutory double patenting as
being unpatentable over claims 2-18 of U.S. Patent No. 9,314,359 (hereafter '359) in
view of 10/092,432 (hereafter '432) and further in view of Hardin et al.
2008/0086214.
Patents '359 and '432 have been disclosed however do not specify that the stent
is specifically a biliary or pancreatic tree stent. It would be obvious to one having
ordinary skill in the art apply the stent as a biliary or pancreatic stent because patent
'359 claim 1 recites the use of a drainage stent.
Allowable Subject Matter
Claims 19-21 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 Suzette Gherbi whose telephone number is (571)272-
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 January 22, 2026