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 .
Election/Restrictions
Claims 2-3, 13-14, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/11/2025.
Applicant's election with traverse of Invention I and Species A in the reply filed on 12/11/2025 is acknowledged. The traversal is on the ground(s) that Tang does not disclose a sintered end because the sintered end is an opening to allow access into a distal opening of the passageway formed by the membrane structure and it is the membrane structure that is sintered onto an anchor portion. This is not found persuasive because the claim calls for a “sintered seal that closes an end of the structural component” in this case, the seal closed off the structural component 402 of Tang by means of covering it, hence isolating and sealing it from the environment. Hence the limitations of the claim are met and technical feature is not a specifical technical feature as it does not make a contribution over the prior art in view of Tang.
The requirement is still deemed proper and is therefore made FINAL.
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, 4-8, 12, and 15 is/are rejected 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”.
Claim 1
Rudakov discloses: A vascular occlusion device 600 (see Figs. 6A-7B, [0469]) comprising: a structural component 610 (see Figs. 6A-7B, [0469]) comprising an axis the longitudinal axis that 610 extends along (see Figs. 6A-7B); and a membrane 650 (see Figs. 7A-7B, [0469]) that contacts the structural component 610 (se Figs. 7A-7B, [0469]) and is constructed of a polymeric material (see [0017], cover material comprise ePTFE, which is a polymeric material), wherein: the membrane 650 comprises a first end distal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469], 650 extends outside out of 610) and a second end proximal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469]), and at least one of the first end distal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469], 650 extends outside out of 610) and the second end proximal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469]) extends axially beyond the structural component 610 along the axis the longitudinal axis that 610 extends along.
Rudakov does not explicitly disclose: includes a sintered seal that closes an 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 first end 108 (see Fig. 12) and a second 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 an end 108 + 110 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 Rudakov 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 Rudakov and Chan teaches: The vascular occlusion device of claim 1, see 103 rejection above. Rudakov further discloses: wherein both the first end distal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469], 650 extends outside out of 610) and the second end proximal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469]) extend axially beyond the structural component 610.
Claim 5
The combination of Rudakov and Chan teaches: The vascular occlusion device of claim 4, see 103 rejection above. Chan further teaches: wherein both the first end 108 and the second end 110 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 Rudakov 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 Rudakov 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 first end 108 and the second end 110.
Claim 8
The combination of Rudakov 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 12
Rudakov discloses: A vascular occlusion device 600 (see Figs. 6A-7B, [0469]) comprising: a structural component 610 (see Figs. 6A-7B, [0469]); and an expanded polytetrafluoroethylene (ePTFE) membrane 650 (see Figs. 7A-7B, [0469] and [0017], ePTFE) surrounding the structural component 610, wherein the ePTFE membrane 650 comprises: a substantially cylindrical-shaped tube 650 forms a substantially cylindrical-shaped tube (see Figs. 7A-7B) having a wall thickness the thickness of 650 (see Figs. 7A-7B); and an end distal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469], 650 extends outside out of 610) and proximal end of 650 that extends beyond 610 (see Figs. 7A-7B, [0469]), wherein there is a distance between the end distal end of 650 that extends beyond 610 and proximal end of 650 that extends beyond 610 (see Fig. 12) and an end the proximal/distal ends of 610 (see Fig. 12) of the structural component 610.
Rudakov does not explicitly disclose: the end comprising 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 Rudakov 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]).
Rudakov 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 Rudakov and Chan is silent as to the process used to form the sintered end, it appears that the product in Rudakov 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 Rudakov 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(s) 9-11 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Chan as applied to claims 1 and 12 respectively above, and further in view of Bastin (US 20110160753 A1), herein referenced to as “Bastin”.
Claim 9
The combination of Rudakov and Chan teaches: The vascular occlusion device of claim 1, see 103 rejection above. The combination of Rudakov and Chan does not explicitly teach: further comprising one or more anchors extending radially outward from the membrane.
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) and a membrane 112 (see Figs. 1-2). Bastin further teaches: further comprising one or more anchors 134 (see Figs. 1-2, [0033]) extending radially outward from the membrane 112.
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 Rudakov to incorporate the teachings of Bastin and teach a vascular occlusion device with one or more anchors extending radially outward from the membrane. 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]).
Claim 10
The combination of Rudakov, Chan, and Bastin teaches: The vascular occlusion device of claim 9, see 103 rejection above. Bastin further teaches: 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.
Claim 11
The combination of Rudakov, Chan, and Bastin teaches: The vascular occlusion device of claim 10, see 103 rejection above. 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 the first end 124 (see Fig. 2) and a second anchor 172 extending through a second portion 146 (see Fig. 2, [0035]) of the membrane 112 proximate (146 is in the vicinity or proximate to 126) the second end 126 (see Fig. 2).
Claim 16
The combination of Rudakov and Chan teaches: The vascular occlusion device of claim 12, see 103 rejection above. The combination of Rudakov and Chan does not explicitly teach: further comprising one or more anchors extending radially outward from the membrane.
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) and a membrane 112 (see Figs. 1-2). Bastin further teaches: further comprising one or more anchors 134 (see Figs. 1-2, [0033]) extending radially outward from the membrane 112.
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 Rudakov to incorporate the teachings of Bastin and teach a vascular occlusion device with one or more anchors extending radially outward from the membrane. 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]).
Claim 17
The combination of Rudakov, Chan, and Bastin teaches: The vascular occlusion device of claim 16, see 103 rejection above. Bastin further teaches: wherein the one or more anchors 134 comprises a portion (see Figs. 1-2, [0033], the frame 110 includes 134) of the structural component 110 extending through the membrane 112.
Conclusion
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 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771