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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 01/12/2026, with respect to the rejection(s) of claim(s) 1, 12, and 17 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Spencer (US 2013/0041391). Applicant argues on page 7 that the spines of Kanazawa could not be modified to comprise one solid and one hollow spine because the spines do not extend the full length of the device and therefore “it would be counterintuitive if not meaningless to include an internal lumen therethrough: a lumen that does not traverse the full length of the device would serve no practical purpose for fluid delivery or actuation”. However, the modification in the rejection as presented below does not rely on fluid delivery or actuation as a motivation for altering the construction of a spine of Kanazawa. Instead, the art teaches that constructing support element struts of a solid wire or a tubular member is interchangeable, as further outlined below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 1-4, 12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 2018/0235644) in view of Kanazawa et al. (US 2005/0149111), further in view of Spencer et al. (US 2013/0041391).
Regarding claim 1, Jaffe discloses a system (System of FIG 1A including sheath 23, catheter 12, and retrieval device 14, [0034-0038]) for retrieving an obstruction in a blood vessel (Obstruction 18, [0034, 0038, 0039-0042]), the system comprising: an outer catheter (23, FIG 2A or in the alternative interpretation, 16, FIGs 1A-1I, [0036]); and an inner clot retrieval catheter (12, FIGs 2A-2B 6A-7B) disposed within the outer catheter (FIG 2A or in the alternative interpretation, FIGs 1A-1F), the inner clot retrieval catheter comprising: an expansile tip (20, FIG 2B and 6A-6B) having a folded delivery state (Unexpanded, as shown in FIG 1A-1C and 7B) and an expanded deployed state ([0039-0051 and 0061-0062], expanded as shown in FIG 1D-1F); and a support tube (neck 26) proximal to the expansile tip (FIGs 6A-6B).
Jaffe is silent regarding the support tube comprising: a plurality of longitudinally extending continuous spines comprising a first spine and a second spine located on opposing sides of the support tube, the first spine constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of each of the first spine and the second spine and extending from and connecting each of the first spine and second spine.
However, Kanazawa et al. discloses a retrieval catheter (10, FIGs 1-2) having an expansile tip (10b, 10c, [0056-0061]) having a folded delivery state (FIG 1) and an expanded deployed state (FIG2); and a support tube (10a) proximal to the expansile tip (FIG 1) having a plurality of longitudinally extending continuous spines (26a, 26b, [0060]) comprising a first spine (26a) and a second spine (26b) located on opposing sides of the support tube (FIG 1 shows 26a and 26b are disposed on opposing sides), the first spine constructed of a solid wire (FIG 1-2, the device is molded or laser cut and therefore understood to comprise solid struts), and a plurality of loop ribs (21a-d) fixedly connected along the length of each of the first spine and second spine ([0060], FIG 1) and extending from and connecting each of the first spine and second spine (FIG 1-2). Kanazawa further discloses the purpose of the spines and loop rib construction to form the proximal section is to for a non-expandable section such that the expansile tip can expand but such expansion will be prohibited at the support tube ([0060]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the support tube of Jaffe such that it is formed of a plurality of longitudinally extending continuous spines, at least one of which is constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of the first spine and second spine and extending from and connecting each of the first spine and second spine, as taught by Kanazawa, for the purpose of providing a structure of the support tube which is known to resist expansion, thereby limiting the expansion to the expansile tip and forming a reliable connection therebetween. Examiner notes that this modification only apples to the support tube of the inner catheter and the expansile tip would maintain the structure taught by Jaffe. [0044] discloses 20 and 26 as separate structures which meet at merge 30, therefore it is understood that the structure of the support tube could be altered without impacting the function of the expansile tip.
The device as modified is further silent regarding the second spine defining an internal lumen within the second spine.
However, Spencer et al. teaches in the same field of endeavor an expandable clot retrieval device (10, FIG 1) having an outer catheter (34), an inner clot retrieval catheter disposed within the outer catheter (remainder of device shown in FIG 1) having an expansile tip (14, [0032]) and a support structure (32, 22, FIG 1, [0036, 0045]) having spines which can be solid member or tubular members ([0045]), wherein the use of a tubular structure or a solid structure is interchangeable so long as the support member has “sufficient rigidity to be pushed distally (e.g., apply an axially compressive force) and pulled proximally (e.g., apply an axially tensile force) to manipulate the expandable scaffold 14” ([0045]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second spine to be tubular (and therefore comprise an internal lumen within the spine), instead of being solid, because solid and tubular spines are disclosed as equivalent structures for forming part of a push/pull support member, and substitution of one for the other would achieve the predictable result of attaining the desired rigidity for pushing and pulling of the support tube to extend and retract the expansile tip. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). Further, the specification of the present invention lacks criticality as to the particular use and arrangement of solid versus hollow spines, indicating in [0096] “The spine can be of tubular or wire construction such that is has good axial stiffness for advancing and retracting the catheter while having excellent lateral flexibility for navigating within bends in the vasculature”.
Regarding claim 2, Jaffe/ Kanazawa et al./ Spencer disclose the invention substantially as claimed, as set forth above for claim 1. Jaffe further discloses in the folded delivery state, at least a portion of the expansile tip between a proximal end and a distal end and the outer catheter have a common radial dimension (FIG 2A shows the radial constrained delivery state wherein the diameter of 20 is the same as the inner diameter of 23 because it is being held in the collapsed state by 23, [0050]).
Regarding claim 3, Jaffe/ Kanazawa et al./ Spencer disclose the invention substantially as claimed, as set forth above for claim 1. Jaffe further discloses in in the expanded deployed state (FIG 2B), the expansile tip is tapered (See tapering from the distal end towards 30) such that a proximal end of the expansile tip has a first radial dimension and a portion of the expansile tip approximate a distal end of the expansile tip has a second radial dimension larger than the first radial dimension (FIG 2B shows the larger distal diameter and smaller proximal diameter); and when the expansile tip is unconstrained, the second radial dimension is sized to be larger than an inner diameter of the blood vessel ([0042] discloses casing 20 contacts the blood vessel wall to create a seal. Therefore, it is understood that the expanded diameter is at least slightly larger than the inner diameter of a blood vessel in order to apply a force to engage the wall and create a seal such that embolic material cannot pass therethrough).
Regarding claim 4, Jaffe/ Kanazawa et al./ Spencer disclose the invention substantially as claimed, as set forth above for claim 1. Jaffe further discloses in the inner clot retrieval catheter further comprises a tubular liner disposed within and lining a lumen of the support tube ([0060], polymer inner liner).
Regarding claim 12, Jaffe discloses a system (System of FIG 1A including sheath 23, catheter 12, and retrieval device 14, [0034-0038]) for retrieving an obstruction in a blood vessel (Obstruction 18, [0034, 0038, 0039-0042]), the system comprising: an outer catheter (23, FIG 2A); and an inner clot retrieval catheter (12, FIGs 2A-2B 6A-7B) disposed within the outer catheter (FIG 2A), the inner clot retrieval catheter comprising: an expansile tip (20, FIG 2B and 6A-6B) comprising a porous framework (20 is formed of the braided mesh material and therefore is made of a porous framework, FIG 6A), the expansile tip having a folded delivery state (Unexpanded, as shown in FIG 1A-1C and 7B) and an expanded deployed state ([0039-0051 and 0061-0062], expanded as shown in FIG 1D-1F); and a support tube (neck 26) proximal to the expansile tip (FIGs 6A-6B) comprising: two longitudinally extending spines located on opposing sides of the support tube (Inflation tube 40, FIG 7B, wherein [0063] discloses there can be multiple to service multiple inflatable members 24); and a support tube (neck 26) proximal to the expansile tip (FIGs 6A-6B).
Jaffe is silent regarding the support tube comprising: a plurality of longitudinally extending continuous spines comprising a first spine and a second spine located on opposing sides of the support tube, the first spine constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of each of the first spine and the second spine and extending from and connecting each of the first spine and second spine.
However, Kanazawa et al. discloses a retrieval catheter (10, FIGs 1-2) having an expansile tip (10b, 10c, [0056-0061]) having a folded delivery state (FIG 1) and an expanded deployed state (FIG2); and a support tube (10a) proximal to the expansile tip (FIG 1) having a plurality of longitudinally extending continuous spines (26a, 26b, [0060]) comprising a first spine (26a) and a second spine (26b) located on opposing sides of the support tube (FIG 1 shows 26a and 26b are disposed on opposing sides), the first spine constructed of a solid wire (FIG 1-2, the device is molded or laser cut and therefore understood to comprise solid struts), and a plurality of loop ribs (21a-d) fixedly connected along the length of each of the first spine and second spine ([0060], FIG 1) and extending from and connecting each of the first spine and second spine (FIG 1-2). Kanazawa further discloses the purpose of the spines and loop rib construction to form the proximal section is to for a non-expandable section such that the expansile tip can expand but such expansion will be prohibited at the support tube ([0060]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the support tube of Jaffe such that it is formed of a plurality of longitudinally extending continuous spines, at least one of which is constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of the first spine and second spine and extending from and connecting each of the first spine and second spine, as taught by Kanazawa, for the purpose of providing a structure of the support tube which is known to resist expansion, thereby limiting the expansion to the expansile tip and forming a reliable connection therebetween. Examiner notes that this modification only apples to the support tube of the inner catheter and the expansile tip would maintain the structure taught by Jaffe. [0044] discloses 20 and 26 as separate structures which meet at merge 30, therefore it is understood that the structure of the support tube could be altered without impacting the function of the expansile tip.
The device as modified is further silent regarding the second spine defining an internal lumen within the second spine.
However, Spencer et al. teaches in the same field of endeavor an expandable clot retrieval device (10, FIG 1) having an outer catheter (34), an inner clot retrieval catheter disposed within the outer catheter (remainder of device shown in FIG 1) having an expansile tip (14, [0032]) and a support structure (32, 22, FIG 1, [0036, 0045]) having spines which can be solid member or tubular members ([0045]), wherein the use of a tubular structure or a solid structure is interchangeable so long as the support member has “sufficient rigidity to be pushed distally (e.g., apply an axially compressive force) and pulled proximally (e.g., apply an axially tensile force) to manipulate the expandable scaffold 14” ([0045]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second spine to be tubular (and therefore comprise an internal lumen within the spine), instead of being solid, because solid and tubular spines are disclosed as equivalent structures for forming part of a push/pull support member, and substitution of one for the other would achieve the predictable result of attaining the desired rigidity for pushing and pulling of the support tube to extend and retract the expansile tip. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). Further, the specification of the present invention lacks criticality as to the particular use and arrangement of solid versus hollow spines, indicating in [0096] “The spine can be of tubular or wire construction such that is has good axial stiffness for advancing and retracting the catheter while having excellent lateral flexibility for navigating within bends in the vasculature”.
Regarding claim 17, Jaffe discloses a method of retrieving an occlusive thrombus (18) from a blood vessel of a patient (FIGs 1A-1I, [0034-0041]), the method comprising: providing an outer catheter (23, FIG 2A or in the alternative interpretation, 16, FIGs 1A-1I, [0036]) and an inner clot retrieval catheter (12, FIGs 2A-2B 6A-7B), the inner clot retrieval catheter comprising: a self-expandable tip (20, FIG 2B and 6A-6B), and a support tube (neck 26) comprising: two longitudinally extending spines located on opposing sides of the support tube (Inflation tube 40, FIG 7B, wherein [0063] discloses there can be multiple to service multiple inflatable members 24); and a support tube (neck 26) proximal to the expansile tip (FIGs 6A-6B); restricting flow in a lumen between at least a portion of an inner wall of the outer catheter and at least a portion of an outer wall of the inner clot retrieval catheter (FIG 2A shows that flow in a lumen between 22 and 23 is restricted due to the expandable nature of 20 such that it engages 23 and is held in the collapsed state); accessing an arterial blood vessel of a patient ({0036]; advancing a pre-deployed wire to the vasculature requires accessing the blood vessel); advancing the outer catheter and inner clot retrieval catheter to a target site ([0036-0037], FIG 1A); deploying the inner clot retrieval catheter adjacent to the occlusive thrombus to radially expand the self-expandable tip (FIG 1D, [0039]); aspirating through one or both of the outer catheter and inner clot retrieval catheter to stimulate the occlusive thrombus into the inner clot retrieval catheter and capture the occlusive thrombus ([0041-0042]); and withdrawing the inner clot retrieval catheter with the captured occlusive thrombus from the patient (FIGs 1E-1I, [0039]). Jaffe further discloses that the braided mesh structure 22 is positioned between inner and outer liners/films ([0060 and 0063]) and provides axial support to the catheter.
Jaffe is silent regarding the support tube comprising: a plurality of longitudinally extending continuous spines comprising a first spine and a second spine located on opposing sides of the support tube, the first spine constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of each of the first spine and the second spine and extending from and connecting each of the first spine and second spine.
However, Kanazawa et al. discloses a retrieval catheter (10, FIGs 1-2) having an expansile tip (10b, 10c, [0056-0061]) having a folded delivery state (FIG 1) and an expanded deployed state (FIG2); and a support tube (10a) proximal to the expansile tip (FIG 1) having a plurality of longitudinally extending continuous spines (26a, 26b, [0060]) comprising a first spine (26a) and a second spine (26b) located on opposing sides of the support tube (FIG 1 shows 26a and 26b are disposed on opposing sides), the first spine constructed of a solid wire (FIG 1-2, the device is molded or laser cut and therefore understood to comprise solid struts), and a plurality of loop ribs (21a-d) fixedly connected along the length of each of the first spine and second spine ([0060], FIG 1) and extending from and connecting each of the first spine and second spine (FIG 1-2). Kanazawa further discloses the purpose of the spines and loop rib construction to form the proximal section is to for a non-expandable section such that the expansile tip can expand but such expansion will be prohibited at the support tube ([0060]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the support tube of Jaffe such that it is formed of a plurality of longitudinally extending continuous spines, at least one of which is constructed of a solid wire, and a plurality of loop ribs fixedly connected along the length of the first spine and second spine and extending from and connecting each of the first spine and second spine, as taught by Kanazawa, for the purpose of providing a structure of the support tube which is known to resist expansion, thereby limiting the expansion to the expansile tip and forming a reliable connection therebetween. Examiner notes that this modification only apples to the support tube of the inner catheter and the expansile tip would maintain the structure taught by Jaffe. [0044] discloses 20 and 26 as separate structures which meet at merge 30, therefore it is understood that the structure of the support tube could be altered without impacting the function of the expansile tip.
The device as modified is further silent regarding the second spine defining an internal lumen within the second spine.
However, Spencer et al. teaches in the same field of endeavor an expandable clot retrieval device (10, FIG 1) having an outer catheter (34), an inner clot retrieval catheter disposed within the outer catheter (remainder of device shown in FIG 1) having an expansile tip (14, [0032]) and a support structure (32, 22, FIG 1, [0036, 0045]) having spines which can be solid member or tubular members ([0045]), wherein the use of a tubular structure or a solid structure is interchangeable so long as the support member has “sufficient rigidity to be pushed distally (e.g., apply an axially compressive force) and pulled proximally (e.g., apply an axially tensile force) to manipulate the expandable scaffold 14” ([0045]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second spine to be tubular (and therefore comprise an internal lumen within the spine), instead of being solid, because solid and tubular spines are disclosed as equivalent structures for forming part of a push/pull support member, and substitution of one for the other would achieve the predictable result of attaining the desired rigidity for pushing and pulling of the support tube to extend and retract the expansile tip. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007). Further, the specification of the present invention lacks criticality as to the particular use and arrangement of solid versus hollow spines, indicating in [0096] “The spine can be of tubular or wire construction such that is has good axial stiffness for advancing and retracting the catheter while having excellent lateral flexibility for navigating within bends in the vasculature”.
Regarding claim 18, Jaffe/ Kanazawa et al./Spencer disclose the invention substantially as claimed, as set forth above for claim 17. Jaffe further discloses covering a perimeter of a distal mouth of the inner clot retrieval catheter with an elastomeric lip (FIG 3A shows a distal mouth 34 comprising an elastomeric lip 24, [00048, 0054]).
Regarding claim 19, Jaffe/ Kanazawa et al./Spencer disclose the invention substantially as claimed, as set forth above for claim 17. Jaffe further discloses covering at least part of the inner clot retrieval catheter with a low-friction coating ([0050 and 0065-0066]).
Regarding claim 20, Jaffe/ Kanazawa et al./Spencer disclose the invention substantially as claimed, as set forth above for claim 17. Jaffe further discloses capturing the occlusive thrombus with a mechanical thrombectomy device (14, [0034, 0038, 0039]) and withdrawing the mechanical thrombectomy device into a distal mouth of the inner clot retrieval catheter ([0039], FIG 1E-1F).
Claim(s) 5, 6, 8-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 2018/0235644) in view of Kanazawa et al. (US 2005/0149111), further in view of Spencer et al. (US 2013/0041391), further in view of Barry et al. (US 2019/0216476).
Regarding claim 5, Jaffe/ Kanazawa et al./ Spencer disclose the invention substantially as claimed, as set forth above for claim 1.
Jaffe is silent regarding the expansile tip comprising a porous framework comprising a plurality of crowns and a plurality of support arms terminating in proximal crown troughs; and in the folded delivery state, the porous framework folds about the proximal crown troughs.
However, Barry et al. discloses a system (10, FIG 1, paragraph [0075]) for retrieving an obstruction (100) in a blood vessel (102) comprising a catheter (14) having an expansile tip (146, FIG 4A) comprising a porous framework (FIG 4A shows the framework wherein openings 149 between the struts are interpreted as pores) and an open distal mouth disposed at the distal end of the expansile tip (FIGs 4A-AC show the distal opening of 146 which forms a mouth), the expansile tip having a folded delivery state (Paragraphs [0081-0082] discloses “a constrained form or shape prior to deployment”) and an expanded deployed state (State shown in FIG 4A, paragraph [0083]) and the porous framework of the expansile tip further comprises: a plurality of crowns (See FIG 4C below) and a plurality of support arms (See FIG 4C below and 150, FIG 4A) terminating in proximal crown troughs (See FIG 4C below, proximal V-shaped portion of 160 and 152, FIG 4A forms proximal crown troughs of support arms 150); wherein in the folded delivery state the framework folds about the proximal crown troughs (Paragraph [0087]).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the expansile tip of Jaffe to comprise the structure taught by Barry et al. for the purpose of achieving the predictable result of expanding to engage the vessel wall for emboli capture, with the additional benefit of forming a structure which reliably expands to a predetermined shape and collapses with predictable force [0082-0088]).
Regarding claim 6, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 5. Jaffe further discloses the inner clot retrieval catheter further comprises a cover that is radially disposed around at least a part of the porous framework ([0060], outer film which extends along the length of 22 and therefore can include at least a proximal portion of the porous framework in the device as modified).
Regarding claim 6, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 5. Jaffe further discloses in the alternative interpretation of claim 1, the inner clot retrieval catheter further comprises a cover (23) that is radially disposed around at least a part of the porous framework FIG 2A shows 23 is radially disposed around the expansile tip 20, which would include the porous framework in the device as modified).
Regarding claim 8, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 6. Jaffe further discloses in an alternative interpretation the porous framework is at least partially encapsulated by the cover (In the delivery configuration shown in FIG 2A, the porous framework is encapsulated by the cover).
Regarding claim 9, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 6. Jaffe further discloses in an alternative interpretation the cover is adhered to the porous framework (The framework is at least frictionally adhered to the cover 23 because it is radially constrained within 23).
Regarding claims 10 and 11, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 6. Jaffe further discloses the cover further comprises one or more polymer jackets ([0060] discloses the outer membrane can be a polymer jacket) and wherein at least one of the one or more polymer jackets is impregnated with particles having material properties to decrease a surface’s coefficient of friction ([0050] discloses the polymer jacket can be PTFE. The material properties of PTFE are interpreted to comprise particles which decrease a surface’s coefficient of friction such that the lubricious properties are achieved).
Regarding claim 13 and 14, Jaffe/ Kanazawa et al./Spencer disclose the invention substantially as claimed, as set forth above for claim 12.
Jaffe is silent regarding the expansile tip comprising a plurality of crowns and a plurality of support arms terminating in proximal crown troughs; and wherein each of the plurality of support arms of the porous framework comprise radial undulations.
However, Barry et al. discloses a system (10, FIG 1, paragraph [0075]) for retrieving an obstruction (100) in a blood vessel (102) comprising a catheter (14) having an expansile tip (146, FIG 4A) comprising a porous framework (FIG 4A shows the framework wherein openings 149 between the struts are interpreted as pores) and an open distal mouth disposed at the distal end of the expansile tip (FIGs 4A-AC show the distal opening of 146 which forms a mouth), the expansile tip having a folded delivery state (Paragraphs [0081-0082] discloses “a constrained form or shape prior to deployment”) and an expanded deployed state (State shown in FIG 4A, paragraph [0083]) and the porous framework of the expansile tip further comprises: a plurality of crowns (See FIG 4C below) and a plurality of support arms (See FIG 4C above and 150, FIG 4A) terminating in proximal crown troughs (See FIG 4C above, proximal V-shaped portion of 160 and 152, FIG 4A forms proximal crown troughs of support arms 150); wherein each of the plurality of support arms of the porous framework comprise radial undulations (FIG 4A shows that at least support arms 150 comprise radial undulations 168).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the expansile tip of Jaffe to comprise the structure taught by Barry et al. for the purpose of achieving the predictable result of expanding to engage the vessel wall for emboli capture, with the additional benefit of forming a structure which reliably expands to a predetermined shape and collapses with predictable force [0082-0088]).
Regarding claim 15, Jaffe/ Kanazawa et al./Spencer/Barry et al. disclose the invention substantially as claimed, as set forth above for claim 13. Jaffe further discloses at least one of the two spines of the support tube is respectively aligned with a support arm of the plurality of support arms (Because the spines extend along a longitudinal axis of the device and the support arms extend along a longitudinal axis of the device, they are interpreted as being aligned).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 2018/0235644) in view of Kanazawa et al. (US 2005/0149111), further in view of Spencer et al. (US 2013/0041391), further in view of Barry et al. (US 2019/0216476), further in view of Hogendijk (US 2002/0022859).
Regarding claim 7, Jaffe/ Kanazawa et al./Spencer/ Barry et al. disclose the invention substantially as claimed, as set forth above for claim 6.
Jaffe is silent regarding at least a portion of the cover being permeable.
However, Hogendijk teaches in the same field of endeavor of systems for retrieving an obstruction in a blood vessel (Abstract, removing emboli, paragraph [0029] discloses system 20 is an embolic protection device) a device having a cover (45) which is permeable (Paragraph [0036] discloses cover 45 can be made of latex, which is known to be permeable to at least water and blood).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the cover to be made of latex and therefore have at least a portion which is permeable, as taught by Hogendijk, for the purpose of substituting one commonly known elastic polymer for another and achieving the predictable result of forming a cover having the desired elastic and lubricious properties with the additional benefit of permitting particles of a chosen size to pass through the cover and into the support tube.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Jaffe (US 2018/0235644) in view of Kanazawa et al. (US 2005/0149111), further in view of Spencer et al. (US 2013/0041391), further in view of Hogendijk (US 2002/0022859).
Regarding claim 16, Jaffe/ Kanazawa et al./Spencer disclose the invention substantially as claimed, as set forth above for claim 12.
Jaffe is silent regarding a dip zone defining a length of the porous framework encased by a low-friction elastomeric lip.
However, Hogendijk teaches in the same field of endeavor of systems for retrieving an obstruction in a blood vessel (Abstract, removing emboli, paragraph [0029] discloses system 20 is an embolic protection device) wherein an expansile tip (Distal end of 21, FIGs 2B-2C, paragraphs [0034- 0035]) having an open distal mouth (52) comprises a dip zone or perimeter of the mouth which is encased by a low-friction elastomeric lip (45, paragraph [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal mouth of the framework of the modified device to comprise an elastomeric covering/encasement of an elastomeric lip, as taught by Hogendijk, for the purpose of creating an impermeable distal end of the expansile tip which contacts the inner wall of the blood vessel to ensure the obstruction is captured within the tip and does not pass through the blood stream external to the retrieval system (Hogendijk: Abstract, paragraphs [0019, 0036)).
Conclusion
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771