DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement, filed July 23, 2024, November 15, 2024, March 9, 2025 and September 3, 2025, were received and entered into the record. However, it is impractical for the examiner to review the references thoroughly with the number of references cited in this case. By initializing each of the cited references on the accompanying PTO-1449 forms, the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review has been made of the cited references.
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 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, which is dependent on claim 1, of U.S. Patent No. 12,076,258 (hereinafter “the patent”) in view of Yribarren (US 2007/0129750, hereinafter “Yribarren”).
The claims match-up with respect to one another as listed below:
U.S. Application No. 18/781,585
U.S. Patent No. 12,076,258
Claim 1. A method for treating a bifurcated blood vessel, the method comprising:
providing a first delivery catheter having a first elongate shaft, and a first expandable member disposed adjacent a distal end of the first elongate shaft, and a first stent disposed over the first expandable member;
providing a second delivery catheter having a second elongate shaft, a second expandable member disposed adjacent a distal end of the second elongate shaft, and a second stent disposed over the second expandable member;
advancing the first and second delivery catheters toward a bifurcation in the blood vessel,
wherein the bifurcation comprises a main branch vessel and a side branch vessel, wherein the main branch vessel and the side branch vessel form a bifurcation angle of less than 60-70 degrees, and the advancing comprises disposing the first stent into the side branch vessel, and disposing the second stent into the main branch vessel;
wherein the second stent is partially crimped to the second expandable member to prevent movement of the second stent relative to the second expandable member during the advancement while permitting movement of the first expandable member relative to the second expandable member to enable deployment of the first stent through the bifurcation angle into the side branch vessel;
radially expanding the first stent into engagement with a wall of the side branch vessel; and
proximally retracting the first delivery catheter through a side hole in the second stent and out a proximal end of the second stent so that a proximal end of the first expandable member is aligned with the side hole in the second stent.
Claim 1. A method for treating a bifurcated blood vessel, the method comprising:
providing a first delivery catheter having a first elongate shaft, and a first expandable member disposed adjacent a distal end of the first elongate shaft; (claim 1 fails to discloses a first stent, however, claim 4, which is dependent on claim 1, discloses a first stent)
providing a second delivery catheter having a second elongate shaft, a second expandable member disposed adjacent a distal end of the second elongate shaft, and a second stent disposed over the second expandable member;
advancing the first and second delivery catheters together, and toward a treatment region in the bifurcated blood vessel;
(claim 1 fails to discloses “wherein the main branch vessel and the side branch vessel form a bifurcation angle of less than 60-70 degrees and the advancing comprises disposing the first stent into the side branch vessel, and disposing the second stent into the main branch vessel”)
wherein the second stent is partially crimped to the second expandable member to prevent movement of the second stent relative to the second expandable member during the advancement while permitting movement of the first expandable member relative to the second expandable member during the advancement; radially expanding the second stent into engagement with the treatment region;
(claim 1 fails to disclose the step “radially expanding the first stent into engagement with a wall of the side branch vessel)
proximally retracting the first catheter through a side hole in the second stent and out a proximal end of the second stent so that a proximal end of the first expandable member is aligned with the side hole in the second stent.
Claim 4. The method of claim 1, further comprising providing a first stent disposed over the first expandable member.
Referring to claim 1, claim 1 of the patent discloses fails to disclose a first stent, wherein the main branch vessel and the side branch vessel form a bifurcation angle of less than 60-70 degrees and the advancing comprises disposing the first stent into the side branch vessel, and disposing the second stent into the main branch vessel, and radially expanding the first stent into engagement with a wall of the side branch vessel.
Referring again to claim 1, however, in the same field of endeavor, which is a method for treating a bifurcated blood vessel, Yribarren discloses bifurcated vessel that includes a side branch and a main branch and the bifurcation angles in the range of 60-90 degrees is well known in the art (para. [0007]) and it is desirable to stent both branches of a bifurcated vessel to treat a bifurcated vessel with a plurality of obstructions at the ostium of the bifurcated vessel (para. [0005]). It would have been obvious to one of ordinary skill in the art to have suggested the surgeon to deploy first stent into the side branch vessel to treat a bifurcated vessel with a plurality of obstructions at the ostium of the bifurcated vessel.
Allowable Subject Matter
Claims 1-13 would be allowable if a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection set forth above.
Claims 14-20 are allowable.
Hilaire et al. (US 2007/0282419, which is cited in the IDS filed on 07/23/24) discloses a method for treating a bifurcation in a vessel (abstract; Figs. 10-13; and paras. [0109]-[0113]), said method comprising:
providing a first delivery catheter having a first elongate shaft 104 (catheter 104 as shown Figs. 10-12 has been interpreted “a first elongate shaft”) and a first expandable member 132 (para. [0112]: “second inflatable balloon 132”) disposed adjacent a distal end of the first elongate shaft, and a first stent 178 (para. [0112]: “side branch stent 178”) disposed over the first expandable member 132;
providing a second delivery catheter (Figs. 10-13; and para. [0112]) having a second elongate shaft 102 (catheter 102 as shown Figs. 10-12 has been interpreted “a second elongate shaft”) and a second expandable member 130 (para. [0112]: “first inflatable balloon 130”) disposed adjacent a distal end of the second elongate shaft, and a second stent 170 (para. [0112]: “main stent 170”) disposed over the first expandable member 130;
advancing the first 104 and second 102 delivery catheters together and toward a treatment region in the bifurcated blood vessel (Fig. 10);
radially expanding the second stent 170 into engagement with the main branch (Fig. 11).
Figures 11-12 and paragraph [0112] clearly disclose that first catheter 104 and second catheter 102 being configured to allow longitudinal sliding of the first expandable member 132 under a proximal portion of the second stent 170 in order to position the side branch stent 178 with respect to the side hole of the main stent 170 to treat a bifurcation (para. [0112]: “Once the main stent 170 is in the desired position, the first inflatable balloon 130 is inflated to expand the main stent 170 and to seat it securely within the vessel, as shown in FIG. 11. Then, the first inflatable balloon 130 is deflated and the linking device 160 is released so that the second balloon catheter 104 can be advanced into the second sidebranch. The second inflatable balloon 132 is inflated to expand the sidebranch stent 178 and to seat it securely within the second sidebranch vessel, while simultaneously opening the side opening 172 in the main stent 170, as shown in FIG. 12.”) Further, a person of ordinary skill in the art would recognize there to be a finite number solutions that may be pursued with reasonable expectation of success to positioning the side branch stent 178 within a side branch lumen and with respect to the side hole of the main branch stent 170 to align the side branch stent 178 with the side hole 172 in the main branch stent 170 in a longitudinal manner as depicted in figure 12. Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to try advancing the first catheter 104 or proximally retracting the first catheter 104, depended on the location of the first stent/side branch stent 178 with respect to the opening 172 of the second/main stent 170, relative to the second catheter 102 so that the expandable member 132 is located a desired position, in order to properly position the first stent/side branch stent 178 with respect to the side hole of the second/main stent 170 for proper treatment of lesions at the bifurcation and since it has been held that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1390 (U.S. 2007).
Yribarren (US 2007/0129750, hereinafter “Yribarren”) discloses bifurcated vessel that includes a side branch and a main branch and the bifurcation angles in the range of 60-90 degrees is well known in the art (para. [0007]). Yribarren also discloses it is desirable to stent both branches of a bifurcated vessel to treat a bifurcated vessel with a plurality of obstructions at the ostium of the bifurcated vessel (para. [0005]).
There is no art of record alone or in combination that teaches a method for treating a bifurcated blood vessel that includes the combination of recited limitation in claims 1 and 14.
As to claim 1, prior art of record alone or in combination did not teach the limitation of the second stent is partially crimped to the second expandable member to prevent movement of the second stent relative to the second expandable member during the advancement while permitting movement of the first expandable member relative to the second expandable member to enable deployment of the first stent through the bifurcation angle into the side branch vessel.
As to claim 14, prior art of record alone or in combination did not teach the limitation of the first stent is partially crimped to the first expandable member to prevent movement of the first stent relative to the first expandable member during the advancement while permitting movement of the second expandable member relative to the first expandable member to enable deployment of the second stent through the bifurcation angle into the side branch vessel.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771