Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 8/6/2026 have been fully considered but they are not persuasive. Regarding the combination of Selmon in view of Chee, Applicant notes that the apertures taught by Chee are not disclosed as re-entry apertures through which a re-entry device exits toward the vascular lumen. However, the claims do not require that the claimed first aperture, which is considered one of the apertures taught by Chee and added to the prior art of Selmon, has a re-entry device exiting therefrom. The claim requires the step of “advancing a re-entry device within the guidewire lumen of the elongate catheter shaft such that a distal tip of the re-entry device exits one of the first aperture and the second aperture toward the vascular lumen distal of the occlusion” (emphasis added). Aperture 22/122 of Selmon (figs. 3C,3D, 9) is considered the claimed second aperture, and Selmon discloses advancing the reentry device such that its distal tip exits the second aperture toward the vascular lumen distal of the occlusion (see figs. 3C-3D, 7; par. [0048]). The rejection does not assert that it would have been obvious to advance a re-entry device such that its distal tip exits the first aperture (i.e., aperture taught by Chee), and this step is not required by the claims. As noted by applicant, Chee would lead a person having ordinary skill in the art to add medication delivery holes to the catheter of Selmon. The examiner considers one of these delivery holes to be the claimed first aperture.
Applicant also argues that Selmon discloses deflecting structure associated with the re-entry aperture 122 and it would not have been obvious to add such a deflecting structure to any of the apertures taught by Chee, one of which is considered the claimed first aperture. The examiner agrees, noting that the rejection does not suggest adding such a deflecting structure to any of the apertures taught by Chee. Applicant also argues that additional holes may undermine Selmon’s controlled orientation re-entry. This is not found persuasive as only the claimed second aperture (122 of Selmon) includes a deflecting mechanism and the holes taught by Chee are not sized to accommodate re-entry device 114/116 and thus the additional holes will not undermine controlled orientation of the re-entry device through the second aperture (122 of Selmon). As noted above, the rejection does not suggest modifying Selmon to advance a re-entry device such that its distal tip exits the first aperture (i.e., aperture taught by Chee).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 11-17 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Selmon (US 2001/0000041) in view of Chee (US 5,380,307).
Regarding claim 1, Selmon discloses a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion (“TO” in figs. 3E) therein, comprising: advancing an elongate catheter shaft (20/102) through a vascular lumen proximal of an occlusion within the vascular lumen (figs. 3A-3B; figs. 8-9), wherein the elongate catheter shaft includes a guidewire lumen extending to a distal guidewire opening (32/124; fig. 9), an aperture (122; figs. 8, 9) extending through a wall of the elongate catheter shaft to the guidewire lumen, advancing a distal region of the elongate catheter shaft, including the aperture, between an adventitia and an intima of the vascular wall until the aperture is disposed distal of the occlusion (figs. 3C-3D); and advancing a re-entry device (114/116) within the guidewire lumen of the elongate catheter shaft such that a distal tip of the re-entry device exits the aperture toward the vascular lumen distal of the occlusion (see fig. 9, as understood in view of fig. 3D-3E).
Regarding claim 13, the method also includes advancing a guidewire (10) through the vascular lumen, advancing a distal end of the guidewire between an intima and adventitia of the vascular wall until the distal end of the guidewire is distal of the occlusion (see figs. 3A-3B), advancing the elongate catheter (20/108) over the guidewire with the guidewire disposed within the guidewire lumen of the elongate catheter shaft, until a distal region of the elongate catheter shaft is positioned between the intima and the adventitia of the vascular wall distal of the occlusion, wherein the distal region includes an aperture (22/122) extending through a wall of the elongate catheter shaft to the guidewire lumen; withdrawing the guidewire from the guidewire lumen ([0011], noting guidewire can be withdrawn and exchanged for second wire or other device suitable); and advancing a re-entry device through the guidewire lumen of the elongate catheter shaft such that a distal tip of the re-entry device exits the aperture toward the vascular lumen distal of the occlusion ([0048]).
Selmon fails to disclose another aperture extending through a wall of the elongate catheter shaft to the guidewire lumen, this additional aperture on a distal region of the elongate catheter shaft such that both apertures are advanced to a position distal of the occlusion.
Chee discloses another elongate catheter shaft having a guidewire lumen therethrough, wherein the catheter further comprises multiple apertures (7A-7E) longitudinally spaced apart from each other and extending through the wall in communication with the guidewire lumen in order to allow delivery of drugs along the length of a blood vessel. Each aperture opens in a different opening direction (figs. 2,3). It would have been obvious to add a plurality of longitudinally spaced apart apertures all opening in different directions to the prior art of Selmon as taught by Chee because such a modification merely combines known elements by known methods with no change in their respective functions, and the combination yields the predictable result of allowing drug delivery along a length of the vessel. With such a modification, any of the drug- delivery apertures taught by Chee which open in a different direction than that of aperture (22/122) of Selmon can be considered the claimed first aperture of Selmon as modified by Chee. Since the apertures taught by Chee may all be positioned within the distal-most 5mm of the catheter (col. 5, ll. 5-6; distal end region 8 understood to be infusion section), and Selmon discloses that the deflecting mechanism (adjacent aperture 22/122) of the catheter shaft should be advanced up to 2 cm beyond the distal end of the total occlusion ([0041]), it is understood that the first and second apertures are advanced to a position distal of the occlusion.
Regarding claim 2, Selmon discloses rotating the elongate catheter shaft about its central longitudinal axis between the adventitia and the intima of the vascular wall to face the first aperture or the second aperture toward the vascular lumen ([0042], [0047], [0048]).
Regarding claim 3, advancing the re-entry device within the guidewire lumen comprises the distal tip of the re-entry device exits whichever aperture of the first aperture and the second aperture faces toward the vascular lumen, noting Selmon discloses positioning aperture 22/122 (considered the claimed second aperture) to face the vascular lumen and further discloses advancing the re-entry device through this aperture.
Regarding claims 11 and 14, the first aperture and the second aperture are positioned on opposing sides of the elongate catheter shaft, noting Chee teaches adding a plurality of apertures disposed about the entire circumference of the catheter shaft such that an aperture opposite the aperture (22/122) of Selmon can be considered the claimed first aperture.
Regarding claim 12, Selmon further discloses advancing the distal tip of the re-entry device through the intima of the vascular wall and into the vascular lumen distal of the occlusion ([0048]).
Regarding claim 15, the first aperture (one of apertures taught by Chee, which extend along entire distal region of catheter) is located proximal of the second aperture (22/122).
Regarding claim 16, Selmon discloses rotating the elongate catheter shaft about its central longitudinal axis between the adventitia and the intima of the vascular wall while monitoring radiopaque markers positioned proximate the first aperture and the second aperture to face the first aperture or the second aperture toward the vascular lumen ([0041], [0045]).
Regarding claim 17, Selmon discloses that advancing the re-entry device within the guidewire lumen comprises the distal tip of the re-entry device exits whichever aperture of the first aperture and the second aperture faces toward the vascular lumen. In particular, Selmon discloses facing the claimed second aperture (22/122) toward the vascular lumen and advancing the re-entry device through this aperture.
Regarding claim 20, Selmon discloses advancing the distal tip of the re-entry device through the intima of the vascular wall and into the vascular lumen distal of the occlusion ([0048], with the first aperture (22/122) positioned beyond the occlusion similar to figures 3D and 3E.
Claims 4-6 and 18-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Selmon in view of Chee as applied to claims 1 and 13, and further view of Lary et al. (US 6,117,153)). Selmon in view of Chee discloses the invention substantially as stated above except for a first radiopaque marker positioned between the first and second apertures and a second radiopaque marker positioned distal of the second aperture.
Lary discloses another medical apparatus for treating vasculature, the apparatus including an elongate catheter shaft having first and second apertures (30; fig. 1) through which a piercing member (14) may be advanced. Lary discloses a radiopaque marker (25) disposed around each of the first and second apertures to facilitate quick evaluation of the position of each aperture within the patient (col. 5, ll. 19-25). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Selmon in view of Chee to include first and second radiopaque markers surrounding each of the first and second apertures, respectively, as taught by Lary for the predictable result of allowing the practitioner to fluoroscopically determine the location of each of the apertures relative to the desired treatment site during the intravascular procedure (col. 5, ll. 19-25). With such a modification, a portion of the radiopaque marker encircling the first (more proximal) aperture is positioned between first and second apertures and a portion of the radiopaque marker encircling the second (more distal aperture) is positioned distal of the second aperture (noting it surrounds entire second aperture and thus has a portion distal thereto).
Regarding claim 4, it would have been obvious to visualize the radiopaque markers during rotation of the elongate catheter shaft of Selmon in view of Lary in order to ascertain when the apertures are positioned in the correct orientation.
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Selmon in view of Chee as applied to claim 1, and further view of Kugler et al. (US 2007/0093781). Note that the earliest effective filing date of instant claim 7 is 8/14/2008, the filing date of the oldest application (US Patent App. No. 12/222,737) to which the instant application claims priority that fully supports the invention of claim 7. Selmon in view of Chee discloses the invention substantially except for rotating the catheter shaft by expanding an orienting element on the distal region of the elongate catheter shaft between the adventitia and the intima of the vascular wall.
Kugler discloses another method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion. Kugler discloses advancing a distal region of an elongate catheter shaft (3400) between an adventitia and intima of the vascular wall until an aperture is disposed distal of the occlusion. Kugler further discloses an expandable orienting element (3440) on a distal region of the elongate shaft, wherein expansion of the orienting element rotates the shaft such that the aperture (3425; fig. 34H and [0153]) in the catheter shaft is oriented in one of only two positions, one of which is toward the true lumen of the artery. It would have been obvious to one of ordinary skill in the art to provide the rotation of the catheter shaft of Selmon such that the aperture is in the desired direction relative to the true lumen of the vessel by expanding an orienting element as taught by Kugler in order to provide an additional means of ensuring proper orientation of the aperture relative to the true lumen.
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, 13, 14, 15, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, 14, 15, 17, and 20, respectively, of U.S. Patent No. 10,537,716. Claims 4, 14, 15, 17 and 20 of ‘716 claim the invention of instant claims 1, 13, 14, 15, and 20, respectively, including advancing the catheter shaft until a distal region is positioned between the intima and the adventitia, but do not claim that the catheter shaft is advanced until the distal region and the first and second apertures are distal of the occlusion. However, claim 4, 14, 15, 17, and 20 of ‘716 include that the distal tip of the re-entry device exits one of the first or second apertures toward the lumen distal of the occlusion and thus placement of the distal region and both apertures of the distal region distal of the occlusion would have been considered obvious to one of ordinary skill in the art in order to ensure that the re-entry device enters into the true lumen of the vessel distal of the occlusion as claimed in claims 4, 14, 15, 17 and 20 of ‘716, regardless of which aperture the re-entry device exits.
Allowable Subject Matter
Claims 8-10 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 closet prior art of Selmon in view of Chee and Kugler fails to disclose or fairly suggest wherein rotating the catheter shaft comprises expanding an orienting element, that includes first and second inflatable members extending in an opposite direction when the orienting element is expanded, between the adventitia and intima of the vascular wall. Although Jen et al. (US 2003/0109809) includes a balloon (168; fig. 7) on the distal region of a catheter shaft advanced between the adventitia and intima of the vascular wall, the balloon is not used to rotate the shaft, and inflation of the balloon is not part of a rotating step, and the balloon does not include first and second inflatable members. Jen discloses only that the balloon is used to anchor the shaft in a desired position.
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 8/31/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Prosecution Insights