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 .
Information Disclosure Statement
The information disclosure statement filed 11/17/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Foreign Patent Documents 3 and 5 (KR 1020120092627 & CN 113260336) have been placed in the application file, but the information referred to therein has not been considered, because the copy provided was illegible.
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any specific references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Objection
Claim 8 is objected to because of the following informalities: line 2 repeats the word “that”. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the branching stent prosthesis comprising a strap extending from a first side of the trunk portion stent frame, between the first and second branching portions, to a second side of the trunk portion stent frame opposite the first side (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5, 6, 8 and 17-20 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.
Regarding claim 5, which sets forth the parameter of “a longitudinal beading of a reinforcing material that extends from the trunk...”, on line 2; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the term “beading”. Specifically, is the term “beading” meant to recite a structure (if so, what exactly is said structure), or is it meant to recite a pattern (if so, what exactly is said pattern), or is it meant to recite a procedure of applying the reinforcing material (if so, what exactly is said procedure), or is it meant to recite/mean something else completely different. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 8, which sets forth the parameter of “a strap that that extends from a first side of the trunk portion stent frame between the first branching portion and the second branching portion to a second side of the trunk portion stent frame opposite the first side”; however, this parameter is found to be confusing for a few reasons. Firstly, it is unclear if the term “strap” is actually meant to recite a specific structure, and if so, what exactly is said structure, or is it just meant to recite a generic piece of material, without a specific structure. Secondly, it is unclear what exactly, location-wise, is meant by the term “first side of the trunk portion stent frame between the first branching portion and the second branching portion”, specifically, no side of the trunk portion stent frame seems to be between the first and second branching portions; and thereby, since the location of the first side is unclear, the location of the “second side”, which is opposite the first side is unclear too. Moreover, the originally filed disclosure does not aid in clarifying, either by illustration or explanation in the specification, the structure of the above mentioned parameter. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claims 17 and 20, which set forth the parameters of “manufacturing a stent frame for the stent at a nominal diameter” (emphasis added), on line 2 of claim 17, and “the stent expands to a diameter forty percent greater than the nominal diameter” (emphasis added), on lines 1-2 of claim 20; however, these parameters are found to be confusing since it is not clear what exactly is meant by the term “nominal diameter”. Specifically, what exact diameter would be considered “nominal”, is it the diameter the stent frame is manufactured at, or is it a crimped diameter for delivery, or is it a diameter when the stent is delivered/implanted, or is it some other diameter in between any of these above mentioned diameter. Furthermore, since it is not clear what exact diameter is considered “the nominal diameter”, it is further unclear what “forty percent greater” would be. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claim 20, which recites the limitation “the tie layer”, on line 2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the claim be amended to depend from claim 19 (which introduces the limitation of “a tie layer”), instead of depending from claim 17.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perkins et al. (US PG Pub. 2020/0375724), hereinafter Perkins.
Regarding claims 1, 2 and 4, Perkins discloses a balloon expandable branching stent prosthesis (100), illustrated in Figure 1, comprising a trunk portion (106) including a trunk portion stent frame; a first branching portion (110) including a first branching portion stent frame; a second branching portion (112) including a second branching portion stent frame; the trunk portion stent frame (stent in portion 106), the first branching stent frame (stent in portion 110), and the second branching stent frame(stent in portion 112) are spaced apart from each other with a cover (102) disposed therebetween coupling all the stent frame portions together forming a bifurcated stent; and a lumen (114) that extends through the trunk portion (106), the first branching portion (110), and the second branching portion (112), wherein the balloon expandable branching stent prosthesis is expandable by an inflatable balloon disposed within the lumen of the expandable branching stent prosthesis, illustrated in Figure 1 ([0020]; [0021] & [0024] – it is noted that though it is not specifically disclosed that the balloon is inflatable, this is considered an inherent limitation of a balloon used to expand stents; additionally, it is further noted that the inflatable balloon is not actually part of the claimed invention, and the branching stent prosthesis of Perkins has the ability/structure to be expanded by an inflatable balloon, thereby meeting the parameter), wherein a crotch portion (605) of the balloon expandable branching stent prosthesis is disposed between the trunk portion (106/606), the first branching portion (110/610/910), and the second branching portion (112/612), illustrated in Figures 6A and 9, and wherein the crotch portion (605) is reinforced to prevent radial infolding of the cover (102), specifically by the trunk portion stent frame (stent in portion 106/606) comprising a flared end that flares radially outward, and comprises an oval cross-section, in the crotch portion (605), illustrated in Figure 9 ([0049] & [0061]).
Regarding claim 12, Perkins discloses the balloon expandable branching stent prosthesis of claim 1, wherein the cover (102 )comprises a tissue impermeability layer, and wherein the tissue impermeability layer maintains tissue impermeability when the cover is expanded beyond a nominal diameter ([0021]).
Claims 1, 5, 7, 8 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shaolian et al. (US PG Pub. 2006/0212113), hereinafter Shaolian.
Regarding claims 1 and 7, Shaolian discloses a balloon expandable branching stent prosthesis (100), illustrated in Figure 1A, comprising a trunk portion (120) including a trunk portion stent frame; a first branching portion (130) including a first branching portion stent frame; a second branching portion (140) including a second branching portion stent frame; the trunk portion stent frame (portion of stent 114 in trunk portion 120), the first branching stent frame (portion of stent 114 in first branching portion 130), and the second branching stent frame (portion of stent 114 in second branching portion 140) are spaced apart from each other with a cover (112) disposed therebetween coupling all the stent frame portions together forming a bifurcated stent; and a lumen that extends through the trunk portion (120), the first branching portion (130), and the second branching portion (140), wherein the balloon expandable branching stent prosthesis is expandable by an inflatable balloon disposed within the lumen of the expandable branching stent prosthesis, illustrated in Figure 1A ([0025]; [0080]; [0081]; [0085], Lines 20-21 & [0098], Lines 7-10 – it is noted that though it is not specifically disclosed that the balloon is inflatable, this is considered an inherent limitation of a balloon used to expand stents; additionally, it is further noted that the inflatable balloon is not actually part of the claimed invention, and the branching stent prosthesis of Shaolian has the ability/structure to be expanded by an inflatable balloon, thereby meeting the parameter), wherein a crotch portion of the balloon expandable branching stent prosthesis is disposed between the trunk portion (120), the first branching portion (130), and the second branching portion (140), and wherein the crotch portion is reinforced to prevent radial infolding of the cover, by a composite material ([0082]; [0083], Lines 10-13 & [0084], Lines 2-5).
Regarding claim 5, Shaolian discloses the balloon expandable branching stent prosthesis of claim 1, further comprising a longitudinal beading of a reinforcing material (LBR) that extends from the trunk portion (120) into the first branching portion (130) through the crotch portion and from the trunk portion (120) into the second branching portion (140) through the crotch portion, illustrated in Figure 1A and modified figure 1A, below.
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Regarding claim 8, Shaolian discloses the balloon expandable branching stent prosthesis of claim 1, further comprising a strap (S – thickened for clarity) that that extends from a first side (FS) of the trunk portion stent frame between the first branching portion and the second branching portion to a second side (124) of the trunk portion stent frame opposite the first side (FS), illustrated in Figure 1A and modified figure 1A, above.
Regarding claim 12, Shaolian discloses the balloon expandable branching stent prosthesis of claim 1, wherein the cover (112 )comprises a tissue impermeability layer, and wherein the tissue impermeability layer maintains tissue impermeability when the cover is expanded beyond a nominal diameter ([0082]).
Claims 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gregorich (US PG Pub. 2005/0149168).
Regarding claims 13-16, Gregorich discloses a stent frame (100), illustrated in Figure 1, for a balloon expandable stent comprising a plurality of arms (112) that form a plurality of apexes (114), the plurality of arms (112) are formed in a plurality of circumferential rows/rings (110) that are longitudinally spaced apart along a length of the stent frame, wherein apexes (114) of adjacent rows (110) are coupled together by a plurality of struts (118) and/or the plurality of circumferential rows/rings (110) are coupled together by a cover; wherein a thickness of the arms vary, such that the plurality of arms comprise a plurality of thickness zones, wherein each thickness zone comprises a predetermined thickness, and are designed to be expanded by a balloon in a predetermined order based on the thickness of the arms, illustrated in, at least, Figure 1 ([0070]; [0076], Last 4 Lines; [0081], Lines 1-2; [0086] & [0088], 3rd -2nd to Last Lines).
Claims 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall et al. (US PG Pub. 2013/0184810), hereinafter Hall.
Regarding claims 17 and 18, Hall discloses a method of manufacturing a stent comprising manufacturing a stent frame (420) for the stent, at a nominal diameter, by laser cutting the stent frame; manufacturing a cover (430) for the stent at a diameter that is greater than the nominal diameter of the stent frame; and coupling the stent frame (420) to the cover (430), illustrated in Figure 4E ([0016]; [0132], Last 4 Lines; [0148], Lines 3-5 & [0150], Last 3 Lines).
Regarding claim 19, Hall discloses the method of claim 17, wherein the cover comprises a tie layer that is tissue impermeable ([0112] –[0114]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins as applied to claim 2 above, and in view of Gregorich.
Regarding claim 3, Perkins discloses the balloon expandable branching stent prosthesis of claim 2, but does not specifically disclose the trunk stent frame is fabricated from a non-superelastic material.
However, Gregorich teaches that it is well known in the art to fabricate stents from non-superelastic materials, such as stainless steel or tantalum ([0078], Lines 5-7).
In view of the teachings of Gregorich, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material to fabricate the ballon expandable trunk stent frame from, including a non-superelastic material, such as stainless steel or tantalum, as taught by Gregorich; and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Perkins as applied to claim 1 above, and in view of Henderson et al. (US PG Pub. 2008/0103587), hereinafter Henderson.
Regarding claim 7, Perkins discloses the balloon expandable branching stent prosthesis of claim 1, but does not specifically disclose the crotch portion comprising a composite material.
However, Henderson teaches a bifurcated graft comprising a crotch portion (116) which is made of four layers of sintered ePTFE, resulting in a composing material, in order to quadruple reinforce the crotch portion, illustrated in Figure 5K ([0082], specifically Last 5 Lines).
In view of the teachings of Henderson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the crotch portion, of the balloon expandable branching stent prosthesis of Perkins, to comprise a composite material, such as four layers of sintered ePTFE, in order to quadruple reinforce the crotch portion, as taught by Henderson.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shaolian.
Regarding claim 6, Shaolian discloses the balloon expandable branching stent prosthesis of claim 5, and though it is not specifically disclosed that the reinforcing material is fluorinated ethylene propylene (FEP) or polytetrafluoroethylene (PTFE), it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material, including FEP or PTFE, as claimed, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to, the parameter of the reinforcing material being FEP or PTFE, as opposed to any other suitable material.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over both Perkins and Shaolian as applied to claim 1 above, and in view of Howard et al. (US PG Pub. 2015/0250579), hereinafter Howard.
Regarding claims 9-11, Perkins and Shaolian both disclose the balloon expandable branching stent prosthesis of claim 1, wherein each stent frame (104/114) comprises a plurality of arms that form a plurality of apexes, illustrated in Figures 1 and 9 of Perkins and Figure 1A of Shaolian; but do not teach a thickness of the arms vary, wherein the plurality of arms comprise a plurality of thickness zones, having predetermined thickness, arranged longitudinally such that an arm thickness of the arms in the thickness zones of a central portion of each stent frame are thinner than an arm thickness of the arms in the thickness zones of a distal portion and a proximal portion of each stent frame.
However, Howard teaches that it is well-known in the art to vary the mechanical characteristic along the length of a stent by varying the thickness of the struts/arms, such that distal/proximal portions of a stent can be radially stiffer, by increasing the width/thickness of the struts/arms in these portions, compared to the width/thickness of the struts/arms in a central portion, which have a lower/less width/thickness, such that the central portion of the stent is radially less stiff/more flexible; such an arrangement would improve retention of the stent, while also allowing for flexibility to accommodate curvature and movement ([0034], Last 9 Lines).
In view of the teachings of Howard, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to vary the thickness of the plurality of arms, of each stent frame of the balloon expandable branching stent prosthesis of both Perkins and Shaolian, such that the plurality of arms comprise a plurality of thickness zones, having predetermined thickness, arranged longitudinally such that an arm thickness of the arms in the thickness zones of a central portion of each stent frame are thinner than an arm thickness of the arms in the thickness zones of a distal portion and a proximal portion of each stent frame, in order to improve retention of the stents, while also allowing for flexibility to accommodate curvature and movement, as taught by Howard.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hall.
Regarding claim 20, Hall discloses the method of claim 17, wherein the stent expands to a diameter greater than the nominal diameter and the tie layer remains tissue impermeable ([0124]; [0127], Last 3 Lines & [0152]).
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 03/06/2026