DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/14/26 have been fully considered but they are not persuasive. First the Applicant presented arguments that claims were amended and that a broad interpretation is to be given consistent with the specification. The examiner notes that the amended claims (1,14) had included inconsistencies in claim limitations to cause ambiguity in scope and thus warranted a 112 (b) rejection. As far as the interpretation in scope of the frame member configuration, the examiner is aware of the disclosure and has addressed the claims in view of the teaching to Allen that suggests a frame member for a marker can be a quadrilateral shape, see paragraph 45.
Applicant had presented arguments that Yang did not have a quadrilateral frame member for the marker and did not project from an end of the stent. First it is noted that Fig. 7 of Yang shows an embodiment in which a marker frame member projects from an end of the stent. It is also noted Allen et al. teach (Fig. 1) to provide a marker frame member 122 is configured to project from end 102,104 of a stent 100 and has a longitudinal projection extending from the frame member. Thus, per the combined teachings it is clear that this feature is rendered obvious over Yang in view of Allen.
Regarding the comments about the limitation of a recess portion on an abluminal portion of the frame member, this teaching or feature can be said to be rendered obvious in view of Drasler which shows providing a recess in the abluminal surface and the frame members are “substantially coplanar with a luminal aspect of the frame” and Yang clearly taught or shows recessing the frame members laterally. As mentioned in the rejection below, Yang has the marker on the abluminal surface, along with Wu showing that abluminal surface feature markers are in recesses of the surface. Thus, the modification with Drasler teaching a recessed abluminal surface can be said to render the claims obvious over Yang.
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.
Claims 1,5,6,9,11-14,16-18,21 are 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 1 recites combinations or in other words two variations in scope for defining the frame member, “a substantially quadrilateral frame member” in numerous instances of the claim but also had in at least two instances recited “the quadrilateral frame member” to thus create ambiguity for what exact configuration is required. Please note Claim 6 further supports the indefinite issue as the axis does not have to be exactly orthogonal since it can be “substantially” orthogonal, but the frame member can be “substantially quadrilateral” as recited in the claim. Thus, the claim and its dependents are indefinite. Claim 14 also recites combinations or in other words two variations in scope for defining the frame member, “a quadrilateral frame member” in numerous instances of the claim but also had recited “the substantially quadrilateral frame member” to thus create ambiguity for what exact configuration is required. Thus, the claim and its dependents are indefinite.
Which way does Applicant want the frame to be? An exact “quadrilateral” or a deviation of such as structure, a broader version recited as “substantially quadrilateral” cannot be both used in a claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,5,6,9,11-14,16-18,21,22 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (2004/0254637) in view of Allen et al. (2009/0204203) in view of Drasler et al. (6245101) as evidenced by Wu et al. (6805898). Yang et al. show (Fig. 10) a radiopaque marker 20 coupled to a stent 10 (see Fig. 1). Fig. 10 shows a substantially quadrilateral frame member 52 at an end of the stent, the quadrilateral frame member having a central open region 55, a recessed portion (sections 61,62), and a radiopaque cuff coupled to the substantially quadrilateral frame member and positioned in the recessed portion such that the radiopaque cuff is substantially co-planar with non-recessed portions of the substantially quadrilateral frame member. It can be said Fig. 10 of Yang shows the quadrilateral frame member includes a first end frame member, a second end frame member, and at least two lateral frame members in spaced apart relationship from one another. It can also be said that Yang does illustrate (Fig. 10) the at least two lateral frame member being laterally inset (61,62) from opposing ends of each of the first end frame member and the second end frame member, with the at least two lateral frame members and the first end frame member and the second end frame member being substantially co-planar on a luminal aspect of the substantially quadrilateral frame member. However, embodiment Fig. 10 of Yang was not configured to project from the end of the stent and a longitudinal projection extending from the substantially quadrilateral frame member. It is noted Fig. 7 of Yang shows an embodiment in which a marker frame member projects from an end of the stent. It is also noted Allen et al. teach (Fig. 1) to provide a marker frame member 122 is configured to project from end 102,104 of a stent 100 and has a longitudinal projection extending from the frame member. It would have been obvious to one of ordinary skill in the art to alternatively provide the frame member to project from an end of the stent via a longitudinal projection as taught by Allen et al. with the substantially quadrilateral frame member of Yang et al. such that it is establishing a clear distinction where the end of the stent is for the surgeon, paragraph 42. It is noted that Yang discloses (paragraphs 27,28) modifications of the frame thickness can be made, but did not explicitly state the recessed portion comprise the first end frame member and the second end frame member having greater thicknesses than the at least two lateral frame members such that the recessed portion is on an abluminal aspect and lateral aspects of the substantially quadrilateral frame member. Drasler et al. teach (Fig. 21) that a stent has frame members with first and second end frame members 340 that are thicker than lateral frame members such that the strength to prevent crushing (cols. 9,10) is prevented due to end members greater thickness. Drasler et al. further show (Fig. 3) that the recessed portion is on an abluminal aspect of the stent frame member. It is noteworthy that Wu et al. disclosed (Fig. 1G) that an abluminal surface of the stent 100 has the marker material 132 disposed in a recess 130 to be coplanar. It would have been obvious to one of ordinary skill in the art to modify the thinner portions to be relative to end portions of a quadrilateral frame member as taught by Drasler et al. with the stent of Yang et al. to improve the compression strength when the marker is applied on the quadrilateral frame member, see paragraph 27 of Yang and abstract of Drasler that the crush resistance of ends would enhance the retention of the marker on the substantially quadrilateral frame member from sliding off using larger end members for a frame member. It is also noted the cuff circumscribes the abluminal surface of the quadrilateral frame member of the stent of Yang and thus per the modification with Drasler the cuff is substantially co-planar with non-recessed portions of the quadrilateral frame member as one knows to arrange it this way, see evidence of Wu. Regarding claim 5, Figs. 4,5 of Yang show a portion of the radiopaque cuff recessed within the central open region of the frame member. With respect to claims 6,16,18 each of the first end frame member and the second end frame member have a longitudinal axis substantially orthogonal to a longitudinal axis of the substantially quadrilateral frame and lateral frame members 18 as seen below. Regarding claim 17, it can be seen below “each of the at least two lateral frame members have a longitudinal axis co-axial with [AltContent: textbox (Lateral frame member axes)]the longitudinal axis of the substantially quadrilateral frame” via axes shown.
[AltContent: connector][AltContent: arrow][AltContent: textbox (Axis of frame)][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (End member axes)][AltContent: arrow][AltContent: arrow]
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Regarding claim 9, Yang et al. illustrate (Figs. 4,5) the radiopaque cuff 20 encircling the at least two lateral frame members and is substantially co-planar with a surface of the first end frame member and the second end frame member as modified with Drasler and evidenced by Wu to thus establish a substantial co-planar arrangement of the cuff on the abluminal aspect of the first end and second end of the frame member. Regarding claim 11, it can be seen (Fig. 10) that Yang shows to position the radiopaque cuff in a laterally recessed area. Regarding claim 12, per the modification with Drasler it can be construed that the radiopaque cuff is substantially co- planar with the lateral surfaces of the first end frame member and the second end frame member. With respect to claim 13, Fig. 1 of Yang shows a stent 10 joined to the substantially quadrilateral frame 12. Regarding claim 14, the same motivations and teachings are used to render the claim obvious over Yang with Allen and Drasler and evidenced with Wu since the limitations are similar to claim 1. Regarding claim 21, it is noted that Yang does not disclose the first end frame member and the second end frame member each have opposing lateral ends thereof that extend laterally beyond a length of the first end frame member and the second end frame member with the lateral frame members. It is noted Yang shows (Fig. 10) the end members extend laterally beyond lateral frame members to define recesses. It is also noted Allen teaches (paragraph 45) the frame member for a marker can be a rectangle. Thus per the modification of Allen to use a rectangle with the substantial quadrilateral frame member of Yang it would be obvious to provide the first end frame member and the second end frame member each have opposing lateral ends thereof that extend laterally beyond a length of the first end frame member and the second end frame member with the lateral frame members in order to sufficiently establish a solid retaining seat via the recess about the quadrilateral frame member. With respect to claim 22, the same explanations can be used from above for the teachings to render the claim obvious over Yang in view of Allen and Drasler and evidenced with Wu. It would have been obvious to one of ordinary skill in the art to alternatively form the frame member for the marker as a quadrilateral as taught by Allen for the substantially quadrilateral frame member of Yang such that it is providing more balanced support at both ends and be projecting from an end of the stent via a longitudinal projection as taught by Allen et al. with the substantially quadrilateral frame member of Yang et al. such that it is establishing a clear distinction where the end of the stent is for the surgeon, paragraph 42. It would have been obvious to one of ordinary skill in the art to modify the thinner portions to be relative to end portions of a quadrilateral frame member as taught by Drasler et al. with the stent of Yang et al. to improve the compression strength when the marker is applied on the quadrilateral frame member, see paragraph 27 of Yang and abstract of Drasler that the crush resistance of ends would enhance the retention of the marker on the substantially quadrilateral frame member from sliding off using larger end members for a frame member. It is also noted the cuff circumscribes the abluminal surface of the quadrilateral frame member of the stent of Yang and thus per the modification with Drasler the cuff is substantially co-planar with luminal and abluminal surfaces of the first end member and the second end member as one knows to arrange it this way, see evidence of Wu. Flush with outer surface to contact wall and maintain a minimally invasive profile as known in art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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