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
This office action is responsive to the amendment filed on 03/27/2026. As directed by the amendment: claims 1, 4-5, 7, and 11-12 have been amended, claims 18-20 have been cancelled and claims 2-3 and 13-14 remain withdrawn. Thus, claims 1-17 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 03/27/2026, with respect to the rejection(s) of claim(s) 1 and 12 under 35 U.S.C. 103 as being unpatentable over Rudakov et al (US 20140371777 A1), herein referenced to as “Rudakov” in view of Chan et al (US 20200229924 A1), herein referenced to as “Chan” have been fully considered and are persuasive.
The applicant has amended claims 1 and 12 to further recite “the membrane comprises a distal end and a proximal end… at least one of the distal end and the proximal end extends axially beyond the structural component... and includes a sintered seal that closed the proximal end of the membrane and a correspond end of the structural component”.
The examiner agrees that this overcomes the rejection of Rudakov in view of Chan, as Rudakov does not explicitly disclose a closed proximal end.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lubock et al (US 20150133989 A1) in view of Chan et al (US 20200229924 A1), herein referenced to as “Chan”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-10, 12, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock et al (US 20150133989 A1), herein referenced to as “Hadley” in view of Chan et al (US 20200229924 A1), herein referenced to as “Chan”.
Claim 1
Lubock discloses: A vascular occlusion device 10 (see Fig. 6A-6B, [0083], [0082], occluding a vascular structure, including a blood vessel) comprising: a structural component 18 (see Fig. 6B, [0084]) comprising an axis the longitudinal axis of 18 (see Fig. 6B); and a membrane 16 (see Fig. 6A-6B, [0084]) that contacts 23/22 (see Fig. 6B, [0090], 18 contacts 16 at 23) the structural component 18 and is constructed of a polymeric material (see [0088], polymer materials), wherein: the membrane 16 comprises a distal end 16b (see Fig. 6B, [0084]) and a proximal end 16a (see Fig. 6B, [0084]), and at least one of the distal end 16a and the proximal end 16b extends axially beyond (see Fig. 6B, 16a and 16b extend axially beyond 18) the structural component 18 along the axis the longitudinal axis of 18 (see Fig. 6B).
Lubock does not explicitly disclose: includes a sintered seal that closes the proximal end of the membrane and a corresponding end of the structural component.
However, Chan in a similar field of invention teaches an occlusion device 1200 (see Fig. 12) with a structural component 212 + 214 (see Fig. 12) and a membrane 520 (see Fig. 12) that is constructed of a polymeric material (see [0096], ePTFE) and a proximal end 108 (see Fig. 12) and a distal end 110 (see Fig. 12). Chan further teaches: includes a sintered seal (see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”) that closes the proximal end 108 of the membrane 520 and a corresponding end the proximal end of 212 of the structural component 212 + 214.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock to incorporate the teachings of Chan and teach a vascular occlusion with a sintered seal that closes an end of the structural component. Motivation for such can be found in Chan as this allows for the use of a biodegradable structural component that when it breaks down it does not release the particulates from the sealing membrane, allowing for better integration of the implant into the body while facilitating healthy tissue ingrowth (see [0118]-[0119]).
Claim 4
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 1, see 103 rejection above. Lubock further discloses: wherein both the distal end 16b and the proximal end 16a extend axially (see Fig. 6B, 16a and 16b both extend beyond 18, see also Fig. 6C, 16a is beyond 18a which terminates at 40) beyond the structural component 18.
Claim 5
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 4, see 103 rejection above. Chan further teaches: wherein both the distal end 110 and the proximal end 108 comprise sintered seals see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”).
Claim 6
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 1, see 103 rejection above. Chan further teaches: wherein the sintered seal (see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”) comprises a melted joint of the polymeric material (see [0096], ePTFE and [0155] absorbable polymers).
Claim 7
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 6, see 103 rejection above. Chan further teaches: wherein the melted joint 108 + 110 (see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”) extends an entirety of a distance between two opposing portions the top and bottom portions of 520 that join at 108 + 110 (see Fig. 12) of an outer surface of the membrane 520 such that a cavity the cavity within 520 that 212 + 214 is in (see Fig. 12, [0118]-[0121], the structural component 212 + 214 is completely closed so that fragments of them do not escape from 520) is completely closed off from an environment external to the vascular occlusion device 1200 at the at least one of the distal end 110 and the proximal end 108.
Claim 8
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 6, see 103 rejection above. Chan further teaches: wherein the polymeric material 520 (see [0096], ePTFE) comprises expanded polytetrafluoroethylene (ePTFE) (see [0096], ePTFE).
Claim 9
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 1, see 103 rejection above. Lubock further discloses: further comprising one or more anchors 14 (see Figs. 6A-6B and 7A-7B, [0083] and [0097]) extending radially outward from the membrane 16.
Claim 10
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 9, see 103 rejection above. Lubock further discloses: wherein the one or more anchors 14 comprises portions (see Figs. 7A-7B, [0097], “the retention members 14 may be contiguous or integrated with the structural braid 18 and pulled through the outer occlusive braid 16 to a point beyond the exterior of the device 10”) of the structural component 18 extending through the membrane 16.
Claim 12
Lubock discloses: A vascular occlusion device 10 (see Fig. 6A-6B, [0083], [0082], occluding a vascular structure, including a blood vessel) comprising: a structural component 18 (see Fig. 6B, [0084]) comprising an axis the longitudinal axis of 18 (see Fig. 6B); and an expanded polytetrafluoroethylene (ePTFE) membrane 16 (see Fig. 6A-6B, [0084], [0121], ePTFE) surrounding the structural component 18, wherein the ePTFE membrane comprises: a substantially cylindrical-shaped tube 16 (see Fig. 6B, 16 is substantially cylindrically tube shaped) having a distal end 16b (see Fig. 6B, [0084]) and an opposite proximal end 16a (see Fig. 6B, [0084]) and a wall thickness the thickness of 16 (see Figs. 6B and 7B), there being a distance (see Figs. 6B-6C) between the proximal end 16a and an end 18a (see Figs. 6B-6C, [0087], 18a/18 terminates at 40, while 16a is further proximal such that there is a gap or distance between the two) of the structural component 18.
Lubock does not explicitly disclose: the proximal end being a sintered end comprising melted and re-solidified ePTFE.
However, Chan in a similar field of invention teaches an occlusion device 1200 (see Fig. 12) with a structural component 212 + 214 (see Fig. 12) and an ePTFE membrane 520 (see Fig. 12, [0096], ePTFE) and an end 108 + 110 (see Fig. 12). Chan further teaches: the end 108 + 110 comprising a sintered end (see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock to incorporate the teachings of Chan and teach a vascular occlusion with the end comprising a sintered end. Motivation for such can be found in Chan as this allows for the use of a biodegradable structural component that when it breaks down it does not release the particulates from the sealing membrane, allowing for better integration of the implant into the body while facilitating healthy tissue ingrowth (see [0118]-[0119]).
Lubock and Chan teaches that the sintered end of the ePTFE membrane comprises an ePTFE material, but is silent as to the method of reforming. The claimed phrase “comprising melted and re-solidified ePTFE” is being treated as a product by process limitation; that is, that the sintered is made by melting and then re-solidifying the ePTFE. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Lubock and Chan is silent as to the process used to form the sintered end, it appears that the product in Lubock and Chan would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of an ePTFE material (see instant spec at [0005]).
Claim 15
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 12, see 103 rejection above. Chan further teaches: wherein the sintered end 108 + 110 (see [0121], the ends 108 and 110 are melted with attached with 520 to form the closed off ends, meets the definition of a sintered seal according to applicant’s patent application publication which is melting of polymeric material, see [0023], which is different than the commonly accepted definition, per the online Merriam-Webster dictionary of “to cause to become a coherent mass by heating without melting”) extends an entirety of a distance (see Fig. 12, [0118]-[0121], the structural component 212 + 214 is completely closed so that fragments of them do not escape from 520) between two opposing portions the top and bottom portions of 520 that join at 108 + 110 (see Fig. 12) of an outer surface of the ePTFE membrane 520.
Claim 16
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 12, see 103 rejection above. Lubock further discloses: further comprising one or more anchors 14 (see Figs. 6A-6B and 7A-7B, [0083] and [0097]) extending radially outward from the membrane 16.
Claim 17
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 16, see 103 rejection above. Lubock further discloses: wherein the one or more anchors 14 comprises portions (see Figs. 7A-7B, [0097], “the retention members 14 may be contiguous or integrated with the structural braid 18 and pulled through the outer occlusive braid 16 to a point beyond the exterior of the device 10”) of the structural component 18 extending through the membrane 16.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lubock in view of Chan as applied to claim 10 above, and further in view of Bastin (US 20110160753 A1), herein referenced to as “Bastin”.
Claim 11
The combination of Lubock and Chan teaches: The vascular occlusion device of claim 10, see 103 rejection above. The combination of Lubock and Chan does not explicitly teach: wherein the one or more anchors comprises a first anchor extending through a first portion of the membrane proximate the distal end and a second anchor extending through a second portion of the membrane proximate the proximal end.
However, Bastin in a similar field of invention teaches a vascular occlusion device 100 (see Figs. 1-2) with a structural component 110 (see Figs. 1-2), a membrane 112 (see Figs. 1-2), one or more anchors 134 (see Figs. 1-2, [0033]) extending radially outward from the membrane 112, wherein the one or more anchors 134 comprises portions (see Figs. 1-2, [0033], the frame 110 includes 134) of the structural component 110 extending through the membrane 112. Bastin further teaches: wherein the one or more anchors 134 comprises a first anchor 170 (see Fig. 2, [0046]) extending through a first portion 144 (see Fig. 2, [0035]) of the membrane 112 proximate (146 is in the vicinity or proximate to 126) the distal end 126 (see Fig. 2) and a second anchor 172 extending through a second portion 146 (see Fig. 2, [0035]) of the membrane 112 proximate (see Fig. 2) the proximal end 124 (see Fig. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lubock to incorporate the teachings of Bastin and teach a vascular occlusion device with the one or more anchors comprises a first anchor extending through a first portion of the membrane proximate the distal end and a second anchor extending through a second portion of the membrane proximate the proximal end. Motivation for such can be found in Rudakov as this assists in engaging adjacent tissue when the occlusion device is implanted at a point of treatment (see [0033]) and particularly useful to have two series of barbs facing each other for use in blind passages that have an annular opening as the proximal barbs prevent the device from proceeding to far distally while the distal barbs prevent the device from being retracted out of the opening (see [0047] and [0011]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hadley et al (US 20150305750 A1) teaches a vascular occlusion device with a membrane 150 that extends beyond the structural component 120
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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