Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Response to Arguments
The amendments have overcome the previously presented claim objections and 35 USC 112b rejections.
Applicant's arguments filed 2/3/2026 with respect to the prior art of Krivoruchko have been fully considered but they are not persuasive. Applicant asserts that the amendments to claims 1, 16 and 17 distinguish the claimed invention from the prior art of Krivoruchko. The examiner respectfully disagrees. Krivoruchko discloses a rotatable prosthesis holder comprising a body (44) and a plurality of radiopaque markers (46) (see figs. 1-3). The body of the first and second radiopaque markers (44) are disposed on an outer surface of the inner tubular member (24) because the rotatable prosthesis holder (44) is claimed as part of the inner tubular member (“said inner tubular member comprising a body, a lumen, a longitudinal axis and a proximal portion comprising: a rotatable prosthesis holder comprising a body….”). Additionally, though not currently required by the claims, the radiopaque markers are considered disposed on an outer surface of the body (tube 24) of the inner tubular member, by way of the rotatable prosthesis holder, which contacts an outer surface of the body of the inner tubular member.
With respect to claim 7, Applicant’s argument with respect to the combination of Krivoruchko in view of Tanabe is not found persuasive. Applicant asserts that “it is extremely challenging to envisage how a coating would be applied on the surface such that it would have a longitudinal axis in a direction generally perpendicular to the inner tubular member longitudinal axis”, but provides no evidence to support this assertion. The marker taught by Tanabe is provided as a ring having a diameter (“D”; fig. 5) that is larger than the axial length (“L”; fig. 5) of the ring. Thus, the longitudinal axis of the marker extends in the diameter direction of the ring as this is the longer dimension. The longitudinal axis of the ring (i.e., the axis in the diameter direction) is perpendicular to the longitudinal axis of the tubular member upon which the marker is disposed. It is unclear why such a ring shape could be applied to the surface of the body (44) of the prothesis holder of Krivoruchko, and thus the rejection is maintained.
The amendment to claim 19 requiring a second marker having a longitudinal axis aligned in a direction generally perpendicular to the inner tubular member has overcome the previously presented 35 USC 102 rejection of claims 19 and 20 over Krivoruchko. However, claims 19 and 20 are now rejected under 35 USC 103 over Krivoruchko in view of Tanabe as discussed below.
The amendments to claim 5 have overcome the previous rejection. However, claim 5 is now rejected over Krivoruchko in further view of Vrba et al. (US 2002/0072705).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-4, 6, 8-12, 14-18, and 21 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Krivoruchko (US 2008/0243069). Regarding claims 1 and 16, Krivoruchko discloses an endovascular delivery system comprising an elongate outer tubular device (20) having an open lumen and opposed proximal and distal end with a medial portion therein between, an inner tubular member (24) configured to be disposed within the outer tubular device (fig. 1), the inner tubular member 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 (noting prosthesis is not positively recited; a stent can be mounted onto the outer surface of the balloon and thus the prior art of Krivorcuchko meets this recitation of intended use; it is also noted that 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). The body of the first and second radiopaque marker comprises a first material (platinum; [0026]), and the body of the inner tubular member comprises a second material (radiolucent material according to par. [0024]).
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Regarding claim 2, see element (26) in fig. 1, 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).
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).
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).
Regarding claim 9, the first and/or second marker is made of platinum ([0026]).
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]).
Regarding claim 14, the first and second markers each comprise a solid construction as understood in view of figs. 1-3. 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 Krivoruchko 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).
Regarding claim 21, 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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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 7, 19, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krivoruchko in view of Tanabe (US 4,838,879). Regarding claims 7 and 19, Krivoruchko discloses the invention substantially as stated above (regarding claim 19, see discussion of claim 1 above, noting first marker 44 does not envelop the inner tubular member longitudinal axis; see figs. 1-3) except for a marker (claimed “second marker” in claim 19) having a body and a longitudinal axis aligned in a direction generally perpendicular to the inner tubular member longitudinal axis.
Tanabe discloses another catheter having a longitudinal axis, wherein the catheter has at least one radiopaque marker (3) provided on the catheter for indicating the direction of the end portion, the radiopaque marker having a longitudinal axis aligned in a direction generally perpendicular to the inner tubular member longitudinal axis (col. 3, ll. 13-27; col. 4, ll. 17-21). According to Tanabe, the orientation of the radiopaque marker allows the direction of the distal end of the catheter to be easily identified. 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), 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 Tanabe in order to allow the direction of the distal end of the catheter to be easily identified to facilitate insertion into the location of interest.
Regarding claim 20, as discussed above with respect to claim 1, 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 Vrba et al. (US 2002/0072705). Krivoruchko 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
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 3/13/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771