DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 11, 14, 17-18, 22-21, 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-10 of U.S. Patent No. 11,938,284 (hereafter ‘284) in view of Kratoska et al. patent 6,090,072 (hereafter ‘072).
For example, claim 11 recites:
“11. (New) A method, comprising: providing an introducer comprising: a main body; a tubular introducer sheath projecting from the main body; and a first seal portion, wherein the first seal comprises a hemostasis valve and an annular rubber seal; and wherein the introducer is configured to be used with a catheter comprising a main body and an outer sheath projecting from the main body, the outer sheath is configured to be at least partially advanced through the main body of the introducer, the catheter is configured to be placed in the introducer, and an inner core of the catheter is configured to be advanceable through the main body of the catheter and the outer sheath.”
Pat. ‘284 claims 7-10 recite:
“7. A method of placing a catheter into a blood vessel comprising: placing into a patient's vessel, an introducer comprising a main body and a tubular introducer sheath projecting from the main body; and passing a catheter through the introducer sheath, wherein the catheter comprises an inner core that is configured to be advanceable through the main body of the catheter, and wherein the inner core is configured to be advanceable over a guidewire, wherein the introducer comprises a first seal portion, and wherein the first seal comprises a hemostasis valve and an annular rubber seal.
8. The method of claim 7, wherein the catheter retains a stent or stent graft.
9. The method of claim 8, further comprising placing at least one stent or stent graft in the patient's blood vessel.
10. The method of claim 8, further comprising placing multiple stents or stent grafts in the patient's vessel.
However, pat. ‘284 does not recite “a catheter comprising a main body and an outer sheath projecting from the main body, the outer sheath is configured to be at least partially advanced through the main body of the introducer”. Pat. ‘072 teaches:
“The delivery devices may comprise “…an inner sheath 150 and outer sheath 160 comprise conventional introducer sheaths made of conventional sheath materials such as. The inner sheath 150 typically has a length of about 10-12 inches so that the sheath 150 can extend within the vessel 56 while still having a sufficient length remaining outside the patient's body to carry the outer sheath 160 thereon until ready for use. The second outer sheath 160 is preferably one or two French sizes larger than the inner sheath 150. For example, the inner sheath 150 can have a size 6 French diameter suitable for angiographic catheters and the second outer sheath 160 can have a size 8 French diameter more suitable for accommodating angioplasty catheters. The first and second sheaths also have conventional wall thicknesses ranging from 0.006 inches to 0.011 inches.”
It would have been obvious to one having ordinary skill in the art to modify pat. ‘284 to provide a catheter with a main body and an outer sheath projecting from the main body, the outer sheath is configured to be at least partially advanced through the main body of the introducer to deliver the prosthetic device without injuring the surrounding tissue.
Pat. ‘072 further teaches that a stent may be used for deployment, and that a threaded Luer lock fitting releasably secures the proximal end of the guide catheter to a distal end of a Y-adaptor manifold to form a seal which forms a fluid-tight seal around a shaft of an angioplasty dilatation balloon catheter.
Claims 14-16, 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-10 of U.S. Patent No. 11,938,284 (hereafter ‘284) in view of Kratoska et al. patent 6,090,072 (hereafter ‘072) and further in view of Mackenzie 6,019,777 (hereafter ‘777).
Pat. ‘284 and Pat. ‘072 have been disclosed regarding methods of deploying a stent however don’t give specific details regarding the stent structure. Pat. ‘777 discloses the use of a stent (12) with fenestrations/ individual stent segment throughout the stent. It would have been obvious to one having ordinary skill in the art to utilize a fenestrated stent and/or stent graft with individual stent segments in order to treat a variety of occluded vascular vessels.
Allowable Subject Matter
Claims 12-13, 19-21, 24-30 are 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 has been disclosed supra however does not disclose or teach in combination with the independent claims the features recited in claims 12-13, 19-21, 24-30.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 August 26, 2026
Prosecution Insights