DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
This office action is responsive to the amendment filed on 06/11/2026. As directed by the amendment: claims 1, 2, 5, 8, 13-17 and 20 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
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. Lines 2 and 3-4 recite the limitation “the stent frame”; there is insufficient antecedent basis for this limitation in the claim. Specifically, it is not clear what structure is meant by “the stent frame”, which stent frame is this actually referring to, the trunk portion stent frame, the first branching portion stent frame, the second branching portion stent frame, or some other completely different/distinct stent frame. Furthermore, the wording of the parameter is found to be confusing, specifically the meaning of “extends from a first side of the stent frame between the first branching portion and the second branching portion”; is this limitation meant to indicate where on the stent frame the first side is, i.e. the first side is centered between the first and second branching portions, or is it meant to indicate where the strap is extending to/the direction the strap is extending in (i.e. the strap extending from a first side of the trunk portion stent frame, between the first and second branching portions, around the crotch portion and to a second side of the trunk portion stent frame), or is it meant to indicate 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.
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), as previously disclosed, 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, wherein the trunk portion (106/606) comprises a flared end (FE) having a non-circular/oval cross-section that flares radially outward in the crotch portion (605), and wherein the crotch portion (605) is reinforced via the flared end (FE) of the stent frame to prevent radial infolding of the cover (102), illustrated in Figure 9 and modified figure 9, below ([0049] & [0061]).
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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), as previously disclosed, hereinafter Shaolian.
Regarding claims 1, 5 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), a longitudinal portion 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, and wherein the crotch portion is reinforced, via the laminate/composite material(s) of the cover and/or longitudinal portion of a reinforcing material (LBR) of the stent frame, to prevent radial infolding of the cover, illustrated in Figure 1A and modified figure 1A, below ([0082]; [0083], Lines 10-13 & [0084], Lines 2-5).
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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 stent frame between the first branching portion and the second branching portion to a second side (124) of the 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), as previously disclosed.
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 circumferential rows/rings (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 and are designed to be expanded by a balloon in a predetermined order based on the thickness of the arms, wherein each circumferential row (110) comprises a first thickness zone and second thickness zone that alternate along a circumference of each circumferential row, and the first and second thickness zones are align along a length of the stent frame ([0070]; [0076], Last 4 Lines; [0081], Lines 1-2; [0086] & [0088], 3rd -2nd to Last Lines).
Claims 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myers et al. (US Patent No. 5,735,892), hereinafter Myers.
Regarding claims 17, 19 and 20, Myers discloses a method of manufacturing a stent comprising manufacturing a stent frame/Palmaz stent at a first/collapsed diameter; manufacturing a cover/coating for the stent at a second/enlarged outside diameter that is at least 20 percent greater than the a first/collapsed diameter of the stent frame, wherein the cover/coating comprises a tie layer (FEP adhesive) that is tissue impermeable; coupling the stent frame/Palmaz stent to the cover/coating, and wherein the stent expands to a diameter forty percent greater than the first first/collapsed and the tie layer (FEP adhesive) remains tissue impermeable (Column 2, Line 64 – Column 3, Line 7 & Column 7, Lines 1-60).
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 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.
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), as previously disclosed, 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.
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), as previously disclosed, 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Myers as applied to claim 17 above, and in view of Palmaz (US Patent No. 4,776,337).
Regarding claim 18, Myers discloses the method of claim 17, but does not specifically teach manufacturing the stent frame by laser cutting the stent frame.
However, Palmaz teaches a stent frame (71) which is manufactured by laser cutting/etching, illustrated in Figures 1A-2B (Column 7, Lines 22-28).
In view of the teachings of Palmaz, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the Palmaz stent frame, of Myers, to be manufactured by laser cutting/etching, since this is a well-known way in the art of manufacturing a Palmaz stent, as taught by Palmaz.
Response to Arguments
Applicant’s arguments with respect to independent claim 17 have been considered but are moot because the arguments do not apply to the current rejection presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Myers in rejecting independent claim 17.
Applicant's arguments filed 06/11/20206, regarding independent claims 1 and 13, have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 1 as being unpatentable over Perkins or Shaolian stating that the newly added parameter of the crotch portion being reinforced “via the cover or stent frame” to prevent radial infolding of the cover is not taught by either Perkins or Shaolian. Examiner respectfully disagrees with Applicant’s assertion. As detailed in the rejection section above, both Perkins and Shaolian clearly teach the above mentioned parameter. Regarding the prior art of Perkins, the flared end/ring (FE), of the trunk portion stent frame (106/606), reinforces crotch portion (605) “via the stent frame”, i.e. the flared end/ring (FE) of the stent frame, as illustrated in Figure 9 and modified figure 9, above; the flared end/ring of the stent frame prevents radial infolding of the cover by holding it open, as is the common/inherent function of a stent. Regarding the prior art of Shaolian, paragraph [0083] states that the cover/graft “comprises a laminate and/or composite having two or more layers” and that “the laminate comprises one or more mechanical and/or reinforcing layers, comprising, for example mesh and/or fabric layers, and/or reinforcing fibers” (emphasis added). Therefore, since the crotch portion is part/section of the whole cover/graft member (112), it is reinforced via the cover due to its laminate/composite material/make-up. It is further noted that the crotch portion is also reinforced via the stent frame, by the longitudinal portion of a reinforcing material (LBR) of the stent frame, illustrated in Figure 1A and modified figure 1A, above. Both ways/forms of reinforcing the crotch, i.e. via the cover or the stent frame, would prevent radial infolding of the cover/graft member by reinforcing/holding the cover/crotch portion open. Thus, rejections of independent claim 1, as being unpatentable over Perkins or Shaolian, are deemed to be proper since all the structural limitations set forth in the claim have been taught; hence, the rejections stand.
Applicant further argues the rejection of independent claim 13 as being unpatentable over the prior art of Gregorich stating that the newly added parameter of “each circumferential row comprises a first thickness zone and a second thickness zone that alternate along a circumference of each circumferential row” is not taught, and that Gregorich “merely describes that the thickness of struts 112 may be adjusted to change flexibility of the struts”. Again, Examiner respectfully disagrees with Applicant’s assertion. Gregorich teaches “Each closed serpentine circumferential band 110 comprises a plurality of struts 112” ([0029], Lines 6-7), that “portions of a serpentine circumferential band 110 may be more or less flexible than other portions of the serpentine circumferential band 110” ([0070], Lines 5-8), and that changes in flexibility are provided “by adjusting the width, thickness and/or cross-sectional area of portions of serpentine circumferential band 110” ([0070], Lines 10-13). Thus, Gregorich clearly teaches the above mentioned parameter, specifically, each serpentine circumferential band/circumferential row (110) has first and second zones, of varying flexibility, which alternate along the circumference of each row, and since flexibility can be varied by adjusting the width/thickness, the first and second zones of varying flexibility are also considered first and second thickness zones. Therefore, the rejection of independent claim 13, as being unpatentable over Gregorich, is deemed to be proper since all the structural limitations set forth in the claim has been taught; hence, the rejection stands.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 07/30/2026
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