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 .
Response to Amendment
Applicant's request for reconsideration of the drawing and specification objections presented in the last Office action is persuasive, per the amendment made to the claims, therefore, the drawing and specification objections are withdrawn.
Response to Arguments
Applicant's arguments filed 8/18/25 have been fully considered but they are not persuasive. Applicant argues the amendment to the claims is sufficient to overcome the 112 (b) rejections. However, the examiner respectfully disagrees because the use of open-ended clauses, i.e. in claim 1 the recitation of “the longitudinal projection configured to connect to at least one end of the stent” is not understood how this is feasible and the same for the clause “quadrilateral frame member projecting from at least one end of a stent” in claim 22 is not clear how the frame could project from both ends. These open-ended clauses can be understood that both ends can be within the scope of “at least one end” and thus it is not seen or described in the written disclosure how this is feasible to join to both ends of the stent or in other words a looping connection. It presents an issue of indefiniteness and the indefiniteness rejections are maintained. In addition it is noted Applicant argues the rejection under 112 (b) for indefiniteness on use of a relative term alleging there is some special definition to suffice a clear meaning of the term. However, the examiner disagrees as while there was a statement in the specification made for what the term could possibly mean in terms of boundaries for its use, but it fails to set forth any parameters and also uses vague terms (great or significant extent and less than totally) that are relative in scope also. Thus, the interpretation of the prior art of Yang, especially for claims 1, 14 meets the scope of the clause “substantially quadrilateral frame member” and the frame member 52 of Yang is clearly a “substantial quadrilateral” structure with four side regions. However, with respect to claim 22, regarding the specific configuration of the frame member being quadrilateral exactly, the examiner addressed this with the teaching of Allen, that stated (paragraph 45) a quadrilateral shape can be used for the frame member that holds the radiopaque marker.
In addressing the next point or argument made against the Yang rejection, the examiner must note that in all instances or independent claims and their dependents, the device being claimed is solely directed to a radiopaque marker as recited in the preambles. Thus, the claims are directed to a subcombination and not necessarily to a combination of a stent with the marker frame, but more so the marker held by some arbitrary “substantial quadrilateral frame member” with no specific requirements to a stent structure. Thus, Yang already meets the claims regarding the radiopaque cuff defined or recited as the marker element. In addition, Yang also disclosed the frame configuration as recited since the claims 1 and 14 used broadening language of substantially, but claim 22 recited the frame to be specifically a quadrilateral shape and is this feature is met as modified with Allen for a frame to hold a marker.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the first argument, Applicant alleges that the frame member of Yang is not an extension from the end of the stent. However, the examiner disagrees because first there is no specificity defined in the claim how much a frame member has to extend from a stent end, but it is also important to note that the claims are directed to the frame holding the radiopaque cuff and not the stent, see the preamble of the claims.
Applicant argues that one would not use the teaching of Drasler for frame members having greater thickness end members and thinner lateral members. The argument is that such an arrangement is used for more than just an end projection on a stent. The examiner notes that the claims are not limited to just one frame member for a radiopaque marker and modifying an end projecting quadrilateral frame member or more than that on a stent would only improve its functional properties. Thus there is a clear motivation for improving its structural integrity and therefore thinner lateral members in thickness with the end members being thicker only enhances the securing the radiopaque cuff on the frame member and the integrity of any frame member modified as such.
It must be noted that Yang discloses modifications can be made to frame members for the radiopaque cuffs for a stent, see paragraphs 24-28 and thus, a distance from an end of a stent along with dimensions of frame members is clearly within the skill and suggestions of Yang. Again the claims use no specificity on distance or space from an end nor any particular thickness differences.
Applicant argues you would not use Allen with since it is not evident why one of ordinary skill would have used Allen with Yang. However, Allen was only used to modify a shape and distance from an end, thus there was no change in function of the radiopaque marker. Selecting placement of a marker that can project from an end of a stent is just arbitrary as the claim(s) fail to set forth any particular direction or distance, thus establishing no criticality whatsoever. Therefore if one wants to modify with Allen, it would be obvious to one of ordinary skill in the art to select whatever is appropriate to assist the user/surgeon/radiologist in positioning appropriately to give the best placement and visibility reference frame for the stent implantation.
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 1,4-6,9,11-14,16-19,21,22 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.
In claim 1, lines 8, 9 of the claim recite the “longitudinal projection extending from one of the first end frame member or the second end frame member” but then also recites in lines, 9,10 the “longitudinal projection configured to connect to at least one end of the stent” which is contradictory. Additionally the recitation of “quadrilateral frame member projecting from at least one end of a stent” as recited in claim 22 is ambiguous. MPEP 2173.05 (c) states open-ended limitations can be indefinite. In this instance claim 1 first had stated the longitudinal projection is connected to one of the ends only and then the claim uses an open-ended limitation to suggest the longitudinal projection could be connected possibly to both ends which is within the scope of the open-ended limitation, but not evident how it is possible. In claim 21, the recitation of “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” is ambiguous because it is not evident where this arbitrary length is present for each of the end frame members. Do the points of termination of the lateral members define the length? Applicant is reminded antecedent basis must be present and no explanation is found to detail the feature. In claim 22, the potential of the frame being connected to both ends seems confusing as to how it is possible to be at both ends of the stent, which is within the scope of the claim.
Claim 14 recites the limitation "the stent" in line 2 of the claim. It is noted the phrase “and end portion of the stent” is improper grammatically, but more importantly the preamble is to a stent radiopaque marker alone, not a combination with a stent. There is insufficient antecedent basis for this limitation in the claim. All dependent claims inherit ambiguity or indefinite issues from an independent.
Thus these claims are indefinite.
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) 1,4-6,9,11-14,16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (2004/0254637) in view of Drasler et al. (6245101). Please note the use of the term “substantially” in the claims is a relative term which renders the claim broader in scope and essentially unlimited in any sense of providing a specific range of boundaries. The term “substantially” is not defined by the claim, the specification does not provide any clear standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the examiner is giving the broadest reasonable interpretation of the clauses using that term that essentially broadens every feature in which itis used therewith. Yang et al. disclose (abstract) a radiopaque marker comprising, (see Fig. 10) a substantially quadrilateral frame (paragraph 20) member 52 configured to project from at least one end of a stent, the substantially quadrilateral frame member having a central open region 55, a recessed portion (sections 61,62), and a radiopaque cuff 20 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, wherein the substantially 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, and a longitudinal projection extending from one of the first end frame member or the second end frame member, the longitudinal projection configured to
connect to at least one end of the stent, wherein the lateral frame members each have a width, a length, and a thickness, and wherein the first end frame member and the second end frame member each have a width , a length and a thickness. It is noted that Yang discloses (paragraphs 27,28) modifications of the frame thickness can be made, but did not explicitly state each of the first end frame member and the second end frame member are thicker than the lateral frame members, thereby defining a recessed portion of which the thickness of each of the lateral frame members along the length of each lateral frame member is thinner than the thickness of each of the first end frame member and the second end frame member, thereby defining a first recessed portion, and wherein the at least two lateral frame members are laterally recessed relative to lateral surfaces of the first end frame member and the second end frame member and form a first and second lateral recessed areas there between. 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. 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. With respect to claim 4, Yang et al. show (Fig. 10) the substantially quadrilateral frame has at least one surface defining the recessed portion. Regarding claim 5, Figs. 4,5 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 [AltContent: textbox (End member axes)]frame members 18 as seen below.
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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. Regarding claim 11, as best understood, 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 explanation of features is the same as for claim 1 in view of the prior art of Yang and Drasler. In addition it is noted that it can be construed that an outer surface of the radiopaque cuff is substantially co-planar with outer surfaces of the first end frame member and the second end frame member of the quadrilateral frame member since it can be any portion of an outer surface of the end members. Regarding claim 19, it can be seen (Fig.10) Yang has two lateral frame members 64,65 are laterally recessed 61,62 respectively relative to lateral surfaces of the first end frame member and the second end frame member and form a lateral recess area there between.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (2004/0254637) in view of Drasler et al. (6245101) and Allen et al. (2009/0204203).
Yang et al. show (Fig. 3) a radiopaque marker 20. Fig. 1 of Yang shows a frame member 12 projecting from at least one end of a stent 10, along with the frame member including a first end frame member oriented parallel to a circumferential axis of the stent, a second end frame member oriented parallel to a circumferential axis of the stent and spaced apart from the first frame member along a longitudinal axis of the stent. Fig. 2 of Yang illustrates each of the first end frame member 14 and the second end frame member 16 having a length, a width, and a thickness, and at least two lateral frame members 17,18 in spaced apart relationship from one another and orthogonal to the first end frame member and the second end frame member, wherein the lateral frame members each have a length, a width and a thickness. However, Yang did not explicitly disclose the frame member is quadrilateral in shape. Allen et al. teach (paragraph 45) that a frame member for the end of a stent be quadrilateral in shape. It would have been obvious to one of ordinary skill in the art to provide the frame member as quadrilateral in shape as taught by Allen et al. with the stent of Yang et al. as modified by Drasler such that an appropriate dimension is provided for the radiopaque marker that is detectable and distinct from the stent end. A modification of a shape only involves routine skill in the art and is an obvious expedient when the results are expected. Thus changing from a “substantially quadrilateral” shape that Yang discloses to be more of an exact quadrilateral shape specifically is a result dependent variable with enlarging the frame and therefore enlarges and improves visibility. It must be noted Fig. 10 of Yang illustrate a radiopaque cuff 20 coupled to the quadrilateral frame member and positioned in a recessed portion 61,62 such that the radiopaque cuff is about co-planar with surfaces of the end members. However, Yang did not show the thickness of each of the lateral frame members that is thinner than the thickness of each of the first end frame member and the second end frame member, and a central open region bounded by the at least two lateral frame members, the first end member and the second end member, a recessed portion defined by the thinner thickness of the lateral frame members relative to the thickness of each of the first end frame member and the second end frame member, such that the cuff is about co-planar with luminal and abluminal surfaces of the first end member and the second end 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. 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 frame member for the radiopaque cuff. Moving the recessed portions in the lateral members on the frame member of Yang is an obvious expedient and does not materially affect the function of the marker, such that a placement in a different plane to be placed on surfaces of the lateral members to be co-planar with luminal and abluminal surfaces only involves routine skill in the art..
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fulkerson et al. (2004/0015229) teach a radiopaque marker on a frame member extending from a stent end and is coplanar with lateral members by placement in recessed portions of the lateral members.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799