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 8/17/2026 with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “the second material of the body” in lines 1-2 and “the first material of the first or second radiopaque marker” in line 2, each of which lacks antecedent basis (noting amendment to claim 1). For purposes of claim interpretation, “the second material” and “the first material” are being treated as though they read “a second material” and “a first material”, respectively.
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.
Claim(s) 1-4, 6, 8-12, 14-18, and 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Krivoruchko (US 2008/0243069) in view of Cox (US 6,884,257). Regarding claims 1 and 16, Krivoruchko discloses an endovascular delivery system comprising an inner tubular member (24) comprising a body (24), a lumen (25), a longitudinal axis and a proximal portion comprising a rotatable prosthesis holder (noting entire device can be rotated) comprising a body (44) and a plurality of radiopaque markers (46), and an outer surface (e.g., outer surface of balloon 18 or outer surface of body 24) upon which a prosthesis may be secured prior to delivery ([0024]; the stent can be considered secured upon an outer surface of the body 24 of the inner tubular member by way of the balloon). The plurality of radiopaque markers comprises a first marker (one platinum strip 46; fig. 2) having a body and a longitudinal axis aligned in a direction generally parallel to the inner tubular member longitudinal axis and a second marker (another one of the platinum strips 46; fig. 2) having a body and a longitudinal axis aligned in a direction generally parallel to the inner tubular member longitudinal axis. The body of the first or second radiopaque marker is a distinct elongate structure disposed on an outer surface of the inner tubular member (i.e., outer surface of rotatable prosthesis holder body 44, which is claimed as part of the inner tubular member; it is noted that the outer surface of line 9 of claim 1 and the outer surface of line 15 of claim 1 need not be the same).
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Krivorcuchko fails to expressly disclose a retractable elongate outer tubular device having an open lumen and opposed proximal and distal ends with a medial portion therein, the inner tubular member configured to be disposed within the outer tubular device, wherein retraction of the retractable elongate outer tubular device exposes the rotatable prosthesis holder.
Like the prior art of Krivorcuchko, Cox discloses a balloon catheter system (fig. 1) comprising an inner member (48) having radiopaque markers (70) thereon, the inner member including a balloon (28) attached thereto that may have a stent (26) mounted thereon. Cox discloses that the balloon catheter system includes a retractable elongate outer tubular device (24) having an open lumen and opposed proximal and distal ends with a medial portion therein, the inner tubular member (48) configured to be disposed within the outer tubular device (fig. 1), wherein retraction of the retractable elongate outer tubular device exposes the balloon (see figs. 9-12). According to Cox, the retractable outer tubular device may be used to control the inflated length of the balloon in order to better match the length of the stent or the desired treatment area (abstract; col. 3, ll. 56-col. 4, ll. 19; col. 8, ll. 40-61). Additionally, the retractable outer tubular device provides improved pushability of the catheter and a smooth outer surface to help prevent a stent mounted to the balloon from abrading the vessel wall as it is being delivered through the vasculature into the target area (col. 3, ll. 47-56; col. 4, ll. 20-24).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Krivorcuchko to include a retractable outer tubular device which can be retracted to expose the balloon as taught by Cox in order to improve pushability of the catheter system, provide a means of adjusting the inflated length of the balloon to better match the length of a stent or desired treatment area, and prevent a stent mounted on the balloon from abrading the vessel wall during delivery through the vasculature. When the outer tubular device is retracted to expose the entire working length of the balloon as taught by Cox (see fig. 10,11), the rotatable prosthesis holder positioned between the ends of the balloon of the delivery system of Krivorcuchko as modified in view of Cox will be exposed (i.e., the outer tubular device no longer covers the rotatable prosthesis holder).
Regarding claim 2, see element (26) in fig. 1 of Krivorcuchko, which one skilled in the art would understand to be an axial guidewire.
Regarding claims 3 and 20, the first and second radiopaque marker longitudinal axes are radially offset from the inner tubular member longitudinal axis (figs. 1-3 of Krivorcuchko).
Regarding claim 4, Krivoruchko further discloses a third marker having a longitudinal axis aligned in a direction generally parallel to the inner tubular member longitudinal axis, the third marker disposed at an approximately 90-degree interval from the first maker as measured from the inner tubular as measured from the inner tubular member longitudinal axis (figs. 1-3; see examiner-annotated figure below).
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Regarding claims 6 and 16, the bodies of the first and second markers 46 do not envelop the inner tubular member longitudinal axis (figs. 1-3 of Krivorcuchko).
Regarding claim 8, the second material (material of 24) of the body of the inner tubular member does not enclose the first material of the first or second radiopaque marker (see fig. 3 of Krivorcuchko).
Regarding claim 9, the first and/or second marker is made of platinum ([0026] of Krivorcuchko).
Regarding claim 10, the first and second markers are disposed at an approximately 180 degree interval from each other as measured from the inner tubular member longitudinal axis (See annotated fig. 3 above).
Regarding claim 11, as noted above, the first and/or second marker is made of platinum and thus meets the limitations of claims 9 and 11, noting claim 11 does not require that the first and second markers are made of radiopaque polymeric materials. Rather, claim 11 further defines the radiopaque materials.
Regarding claim 12, the body of the rotatable prothesis holder is not radiopaque (radiolucent material according to par. [0024] of Krivorcuchko).
Regarding claim 14, the first and second markers each comprise a solid construction as understood in view of figs. 1-3 of Krivorcuchko. It is noted that any construction would appear to fall within the group “consisting of a hollow construction, a partially hollow construction and a solid construction”.
Regarding claim 15, the limitation “wherein a first interior portion of the body of the prosthesis holder is different from a second interior portion of the body of the prosthesis holder” is extremely broad in that the portions may be any size and the claim does not specify a particular property which must be different. Since a first interior portion of the body can be chosen that is twice as big as a second interior portion of the body and therefore different in size from the second interior portion of the body, the prior art of Krivorcuchko as modified by Cox meets this limitation. Even if two portions of equal size are chosen, as long as they occupy different space, they can be considered different.
Regarding claim 18, the first marker (46) has a longitudinal axis radially displaced from the axial guidewire (26) longitudinal axis (figs. 1-3 of Krivorcuchko).
Regarding claim 21, the body of the first or second radiopaque marker comprises a first material (platinum; [0026] of Krivoruchko) and the body of the inner tubular member comprises a second material (radiolucent material; [0024] of Krivoruchko), and the second material (material forming tube 24) of the body (24) of the inner tubular member does not enclose the first material of the first or second radiopaque markers (See figs. 1-3).
Regarding claim 17, see the discussion of claim 1 above. Krivoruchko discloses that the first and second markers may be spaced at an approximately 90-degree interval as measured around a longitudinal axis formed by the axial guidewire (26). See the examiner-annotated figure below, on which the first and second markers are labelled (for claim 17).
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Claims 7, 19, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krivoruchko in view of Cox and Weber et al. (US 2012/0259405)). Regarding claims 7 and 19, Krivoruchko in view of Cox discloses the invention substantially as stated above (regarding claim 19, see discussion of claim 1 above; see figs. 1-3) except for a marker (claimed “second marker” in claim 19) having a body and a longitudinal axis along the body of the second marker aligned in a direction generally perpendicular to the inner tubular member longitudinal axis.
Weber discloses another endovascular delivery system including a tubular member (unnumbered, but shown in fig. 4) having a longitudinal axis, wherein the tubular member has at least one radiopaque marker (20; fig. 5A) provided on a balloon portion (30) of the tubular member, the radiopaque marker having a longitudinal axis (70; fig. 5) aligned in a direction generally perpendicular to the tubular member longitudinal axis ([0051] – in inflated configuration). The radiopaque markers are releasably attached to the balloon such that they may be delivered to a treatment site upon inflation of the balloon. According to Weber, the detachable radiopaque markers identify areas which have been subjected to medical balloon procedures well after the procedure is complete and the balloon has been removed. Such identification is useful in order to avoid double treatment, particularly in the timeframe in which the initial treatment is still of influence ([0007]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Krivoruchko to include an additional radiopaque marker (considered claimed “second marker” in claim 19) disposed on the balloon, the marker having a longitudinal axis aligned in a direction generally perpendicular to the inner tubular member longitudinal axis in view of the teachings of Weber in order to provide a radiopaque marker that may be delivered to a treatment site to allow identification of the location of the treatment site after the balloon has been removed.
Regarding claim 20, the longitudinal axis of the first marker (44; fig. 1-2 of Krivoruchko) is radially offset from the inner tubular member longitudinal axis (which passes through center of rotatable prosthesis holder body 44).
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krivoruchko in view of Cox as applied to claim 1 and further in view of Vrba et al. (US 2002/0072705). Krivoruchko in view of Cox disclose the invention substantially including a rotatable prosthesis holder comprising a body (44; fig. 1, 3) and a plurality of radiopaque markers (46), but fails to disclose that the body of the first or second radiopaque markers is disposed between the lumen (25) of the inner tubular member (24) and the body (44) of the rotatable prosthesis holder, and instead discloses the markers on an outer surface of the body (see figs. 1, 3).
Vrba discloses another catheter that includes radiopaque marker. Vrba discloses, as an alternative to a marker (98; fig. 8A,8B and [0060]) attached to the external surface of a tubular member (76), a marker (94; fig. 6a,6b) completely embedded in the wall of the tubular member (76). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Krivoruchko to completely embed the radiopaque markers (46) within the wall of the body (44) of the rotatable prosthesis in view of Vrba’s disclosure that a radiopaque marker completely embedded within the wall of a tubular member is a known alternative to a radiopaque marker attached to an outer surface of the wall of a tubular member, and such a modification can be consider a simple substitution of one known radiopaque placement for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success. With such a modification, the radiopaque markers are disposed between the lumen (25) of the inner tubular member of Krivoruchko and an outermost surface of the body (44) of the rotatable prosthesis holder since the markers are completely embedded within the material of the body (44) of the rotatable prosthesis holder as made obvious by Vrba (figs. 6a, 6b).
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 10/5/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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