DETAILED ACTION
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 1-5, 7 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-5, 7of U.S. Patent No. 11,179,156 in
view of Cully et al U.S 2012/0065652.
Here, claim 1 of U.S Pat 11,179,156, recites
A method of installing a tubular prosthesis through a sidewall of a native lumenal vessel, comprising: providing a prosthesis having: a distal annular flange configured to help seat the prosthesis when it is pulled proximally; a distal tubular segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture in an open condition that is formed through a first vessel wall through which the distal segment passes; a proximal tubular segment that is sufficiently stiff to seat within and urge against a second vessel wall; and collapsing the prosthesis onto a delivery system; delivering a distal end of the delivery system to an opening defined through a native lumenal vessel wall; and deploying the distal annular flange inside of the native luminal vessel wall; further comprising de-tensioning a tether directed through a proximal end of the prosthesis to open the proximal end of the prosthesis; wherein both ends of the tether are directed proximally through and out of a proximal region of the delivery system, and further wherein tension is applied from outside a patient being treated.
. Claim 1 of U.S PAT '156 differs from claim 1 herein in that it fails to disclose a proximal annular flange coupled to a proximal tubular segment; deploying the proximal annular flange inside of the second luminal vessel against an inner wall of the second luminal vessel. Cully et al teach that a tubular prosthesis through a sidewall of a native luminal vessel as best seen in fig. 21, paragraphs 55,61 with a prosthesis 223 that comprising a proximal annular flange 221 coupled to a proximal tubular segment 223; deploying the proximal annular flange 221 inside of the second luminal vessel against an inner wall of the second luminal vessel as best seen in figures 2a,2c. Therefore, it would have been obvious to modify the apparatus of claim 1 U.S Pat'156 with a proximal annular flange coupled to a proximal tubular segment; deploying the proximal annular flange inside of the second luminal vessel against an inner wall of the second luminal vessel as taught by Cully et al in order to anchor and sealing efficiency during the vascular operation procedure
As to claims 2-5, 7 are not patentably distinct from each other because they are
essentially the same to claims 2-5, 7 in the U.S Pat 11,179,156.
Claims 8-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10 of U.S. Patent No. 11,179,156. Although the claims at issue are not identical, they are not patentably distinct from each other because the features of claims 1,8-10 of U.S Pat 11,179,156 anticipate the features of pending claim 8 as set forth in the comparison tables below.
Pending claim 8:
A method of installing a tubular prosthesis through a
sidewall of a native lumenal vessel, comprising:
providing a prosthesis having:
a distal annular flange configured to help seat the prosthesis when it is
pulled proximally;
a distal tubular segment extending proximally from the distal flange that
has sufficient stiffness to maintain a puncture in an open condition that is formed through
a first vessel wall through which the distal segment passes;
a proximal tubular segment that is sufficiently stiff to seat within and urge
against a second vessel wall; and collapsing the prosthesis onto a delivery system;
delivering a distal end of the delivery system to an opening defined through a
native lumenal vessel wall deploying the distal annular flange inside of the native lumenal vessel wall; and ,further comprising de-tensioning a tether directed through a proximal end of the implant or tubular prosthesis to open the proximal end of the implant.
Claim 1, of U.S Pat 11,179,156
A method of installing a tubular prosthesis through a sidewall of a native lumenal vessel, comprising: providing a prosthesis having: a distal annular flange configured to help seat the prosthesis when it is pulled proximally; a distal tubular segment extending proximally from the distal flange that has sufficient stiffness to maintain a puncture in an open condition that is formed through a first vessel wall through which the distal segment passes; a proximal tubular segment that is sufficiently stiff to seat within and urge against a second vessel wall; and collapsing the prosthesis onto a delivery system; delivering a distal end of the delivery system to an opening defined through a native lumenal vessel wall; and deploying the distal annular flange inside of the native luminal vessel wall; further comprising de-tensioning a tether directed through a proximal end of the prosthesis or implant to open the proximal end of the prosthesis; wherein both ends of the tether are directed proximally through and out of a proximal region of the delivery system, and further wherein tension is applied from outside a patient being treated.
2. As to claims 9-12 are not patentably distinct from each other because they are essentially the same limitations as claims 8-10 in U.S Pat 11,179,156. (See In re Goodman, 11 f. 3D 1048, 29 USPG2d 2010 (Fed Cir. 1993); once an applicant has received a patent for a species or a more specific embodiment, he or she is not entitled to a patent for the generic or broader invention without filing a terminal disclaimer.
Allowable Subject Matter
Claims 13-18 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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