DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 12 June 2026.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 12 June 2026, Applicant argues Groh’923, Roeder’096 and Brady’687 do not teach “the inner filter comprises body pleats in the deployed configuration that are configured to accommodate the reduction in length of the outer scaffold during the reconfiguration of the embolic material filter assembly from the insertion configuration to the deployed configuration”. This argument is persuasive. However, upon further search and consideration, a new reference is relied on to render this limitation obvious. See the updated rejection below.
Claim Objections
Claims 14 and 15 are objected to because of the following informalities. Each claim recites “the embolic material filter assembly comprises an outer scaffold and an inner filter”. This limitation was already presented in amended claim 1 and should be deleted from claims 14 and 15 because it is redundant.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-8, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Groh et al. (US Patent Publication 2020/0107923) in view of Quadri et al. (US Patent Publication 2010/0082094) in view of Roeder (US Patent 10,350,096).
Claim 1: Groh’923 disclose an embolic material filter catheter (10) comprising:
an introducer sheath (18) defining an introducer sheath lumen (paragraph [0062] discloses this is a tube);
an inner sheath (22) slidably disposed in the introducer sheath lumen and defining an inner sheath lumen (paragraph [0062] discloses this is a tube);
an embolic material filter assembly (36a) having a proximal end portion (40) and a distal end portion (38),
wherein the embolic material filter assembly comprises an outer scaffold (44) and an inner filter (46, 48),
wherein the proximal end portion is attached to a distal end portion of the inner sheath (paragraph [0073]),
wherein the embolic material filter assembly is reconfigurable between an insertion configuration (Figures 1, 2) and a deployed configuration (Figure 10, paragraph [0039]),
wherein the outer scaffold (44) is configured to interface with an inner surface of a blood vessel in the deployed configuration (paragraph [0016]), and
wherein the inner filter (46, 48) is configured to filter embolic material from blood flowing through the embolic material filter assembly (paragraph [0082], and
wherein the outer scaffold (44) undergoes a reduction in length during a reconfiguration of the embolic material filter assembly from the insertion configuration to the deployed configuration (paragraph [0081], [0082]), and
wherein the inner filter accommodates the reduction in length of the outer scaffold during the reconfiguration of the embolic material filter assembly from the insertion configuration to the deployed configuration (paragraph [0082]);
a dilator assembly (16) having a holding configuration (Figure 1, 2) and a non-holding configuration (Figure 12), wherein the dilator assembly comprises a dilator shaft (26), a dilator distal end member (30);
wherein the dilator shaft (26) is configured to be extended through the inner sheath lumen (22) (paragraph [0062]), wherein the dilator distal end member (30) is attached to a distal end of the dilator shaft (Figures 3, 4), wherein a distal end portion of the embolic material filter (36) assembly is restrained in the insertion configuration via engagement with the dilator distal end member in the holding configuration (Figures 1, 2),
and wherein the dilator assembly (16) is removable from the inner sheath lumen while the embolic material filter assembly is in the deployed configuration via proximal retraction of the dilator assembly relative to the inner sheath (Figure 11; paragraph [0040]).
Groh’923 teaches the inner filter can accommodate the reduction in length of the outer scaffold (paragraph [0082]) but does not teach the inner filter comprises body pleats to perform this function.
Quadri’094 teaches an expandable tubular element (Figure 16a, 16b) for implantation into a vessel. The tubular element as an outer scaffold (500b) that reduces in length in the expanded configuration (paragraph [0125]) and an inner flexible material (810). The inner material forms body pleats (“creased so as to preferentially fold, accordion style, as the stent shortens during expansion”, paragraph [0125]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the inner filter portion has body pleats in the expanded configuration, as taught by Quadri’094 to accommodate the reduced length of the outer scaffold (paragraph [0125]).
Groh’923 does not teach the dilator assembly includes pull wires which restrain the distal end of portion of the filter assembly in the constrained configuration.
Like Groh’923, Roeder’096 teaches a delivery device for an expandable tubular element (112). Like Groh’923, the delivery device includes a dilator assembly comprising a dilator shaft (106), a dilator distal end member (102, 154) and dilator pull wires (150). A distal end portion (110) of the expandable tubular element (112) is restrained in the insertion configuration (Figure 2 or 5) via engagement with the dilator pull wires (150). The pull wires (110) are configured to be translated proximally relative to the dilator distal end member (102, 154) to reconfigure the dilator assembly from the holding configuration (Figures 2 or 5) to a non-holding configuration (Figure 1, 6 or 7 and column 6, lines 37-39).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the release mechanism for allowing the distal end of the filter assembly to expand includes pull wires, as taught by Roeder’096, in order to allow the filter to move into the expanded configuration without needing to move the dilator shaft or dilator distal end, which could cause the filter to be unintentionally moved from the target location prior to filter expansion.
Further, all of the claimed elements were known in the prior art, as outlined above. One skilled in the art could have combined the elements, as claimed (e.g. embolic filter of Groh’923 expanded via retraction of pull wires of Roeder’096) by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art as of the effective filing date of the invention. In this case, modifying Groh’923 such that the release mechanism for allowing the distal end of the filter assembly to expand includes pull wires, as taught by Roeder’096, would allow the filter to move into the expanded configuration without needing to move the dilator shaft or dilator distal end, which could cause the filter to be unintentionally moved from the target location prior to filter expansion.
Claim 2: Roeder’096 teaches the dilator distal end member (102, 154) comprises dilator pull wire recesses (Figure 2 shows pull wires 150 extending through a passage in 154 and opening in 102);
each of the dilator pull wires comprises a respective dilator pull wire distal end portion (156) that is disposed within a corresponding one of the dilator pull wire recesses when the dilator assembly is in the holding configuration (Figure 1); and
each of the dilator pull wire distal end portions is pulled out of the corresponding one of the dilator pull wire recesses during reconfiguration of the dilator assembly from the holding configuration to the non-holding configuration (Figure 2).
Claim 3: Quadri’094 teaches the body pleats are arranged axial-symmetrically to a centerline of the implantable device (Figure 16a, 16b; paragraph [0125]).
Claim 4: Groh’923 teaches the embolic material filter assembly (16) can be restrained to conform to an outer surface of the dilator shaft (26) from the proximal end portion of the embolic material filter assembly to the distal end portion of the embolic material filter assembly when the embolic material filter assembly is in the insertion configuration and disposed distal to the introducer sheath (Figure 2).
Claim 6: Groh’923 teaches the inner filter does not comprise body pleats in the insertion configuration (Figures 21, 27, 28).
Quadri’094 teaches the body folds form in the expanded configuration (paragraph [0125]).
Claim 7: Groh’923 teaches the inner sheath (22) accommodates insertion of a treatment catheter into the inner sheath lumen and advancement of a distal portion of the treatment catheter to a position distal to the distal end portion of the embolic material filter assembly in the deployed configuration (paragraph [0067]); and
the distal end portion of the treatment catheter is configured for accomplishing a surgical task (the treatment catheter is not a positively recited element; paragraph [0067]).
Claim 8: Groh’923 teaches the embolic material filter assembly (36) is configured to, in the deployed configuration, interface with a patient's aorta and substantially block flow of embolic material through the patient's aorta past the embolic material filter assembly (paragraph [0069]; Figure 12); and
the treatment catheter is configured for deploying a prosthetic aortic valve (paragraph [0069]).
Claim 10: Groh’923 teaches the embolic material filter catheter is configured for coupling with an embolic material extraction device operable to draw embolic material through the inner sheath lumen (22) while the embolic material filter assembly is in the deployed configuration (paragraph [0013]).
Claim 11: Quadri’094 does not specifically teach the body pleats are formed via heat setting. However, this limitation is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
In this case, Quadri’094 teaches a body pleats formed in the inner flexible material that preferentially fold during expansion (i.e. the structure implied by the recited step of heat setting).
Claim 12: Groh’923 teaches the outer scaffold (44) comprises distally extending loops of wires configured for atraumatic engagement of the blood vessel (paragraph [0125]).
Claim 13: Groh’923 teaches a middle portion (66; Figure 28) of the embolic material filter assembly (36) has a middle portion external diameter in the deployed configuration (Figure 28); the distal end portion (64) of the embolic material filter assembly has a distal end portion external diameter in the deployed configuration (Figure 28); and
the middle portion external diameter is less than the distal end portion external diameter (Figure 28).
Claim 14: Groh’923 teaches the embolic material filter assembly comprises an outer scaffold (44) and an inner filter (46); and
the inner filter is separated from the outer scaffold by an intervening annular space in the deployed configuration along a length of the inner filter (Figure 29; paragraphs [0092], [0117]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Groh’923 in view of Quadri’094 in view of Roeder’096, as applied to claim 1, further in view of Colgan et al. (US Patent 6,264,689).
Claim 9: Groh’923 teaches the inner filter (46, 48) and outer scaffold (44) can be attached via any suitable approach (paragraph [0087]), but does not specifically disclose a distal end of the inner filter has a zig-zag configuration that is woven into the outer scaffold.
Interweaving an inner element having distal zigzag pattern interwoven into the outer element is old and well known. For example, Colgan’689 teaches an inner element (162) and a braided outer layer (164). The inner element (162) has a zig-zag configuration at its distal end (Figure 9) which is interwoven into the braid of the outer layer (164) (column 7, lines 50-52) to secure the inner and outer elements relative to each other.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the inner filter has a distal end interwoven with the outer scaffold, as taught by Colgan’689, in order to secure the two elements to each other via a known, suitable approach so the inner and outer layers cannot inadvertently become separated via a failed connection.
Claims 15, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Groh’923 in view of Quadri’094 in view of Roeder’096, as applied to claim 1, further in view of Brady et al. (US Patent Publication 2003/0144687).
Claim 15, 16: Groh’923 teaches the embolic material filter assembly comprises an outer scaffold (44) and an inner filter (46).
Groh’923 does not teach the proximal end of the outer scaffold has an unbraided segment bonded to an outer surface of the inner sheath.
Like Groh’923, Brady’687 teaches a filter (100) attached to a shaft (108). Brady’697 shows that the proximal end of the filter (104) is an unbraided portion (Figure 2) bonded to an outer surface of the shaft (Figure 1; paragraph [0252]). Brady’689 further teaches the proximally extending unbraided wire segments (109) have a reduced diameter portion (paragraph [0269]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the wires are attached to the outer surface of the inner sheath, as taught by Brady’687, so that lumen of the inner sheath is not obstructed by the filter wires. This will allow Groh’923 to achieve the function of performing a procedure through the inner sheath.
Brady’687 does not specifically disclose this is achieved via electropolishing. However, this phase is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
In this case, Brady’687 teaches a reduced diameter wire attached to the shaft (i.e. the structure implied by the recited step of electropolishing).
Claims 62, 64 are rejected under 35 U.S.C. 103 as being unpatentable over Groh’923 in view of Quadri’094.
Claim 62: An embolic material filter catheter (10), comprising:
an introducer sheath (18) defining an introducer sheath lumen (paragraph [0062] discloses this is a tube);
an inner sheath (22) slidably disposed in the introducer sheath lumen and defining an inner sheath lumen (paragraph [0062] discloses this is a tube);
an embolic material filter assembly (36a) coupled to a distal portion of the inner sheath (22; paragraph [0073]),
wherein the embolic material filter assembly comprises an outer scaffold (44) and an inner filter (46, 48),
wherein the embolic material filter assembly is reconfigurable between an insertion configuration (Figures 1, 2) and a deployed configuration (Figure 10, paragraph [0039]),
wherein the insertion configuration accommodates insertion of the distal portion of the inner sheath and the embolic material filter assembly into a blood vessel of a patient to position the embolic material filter assembly downstream of a treatment site (paragraphs [0030], [0031]);
wherein in the deployed configuration the outer scaffold has an outer circumference configured to interface with the blood vessel and positions the inner filter to filter embolic material from blood flowing through the embolic material filter assembly (paragraph [0016]), paragraph [0082]).
wherein the outer scaffold (44) undergoes a reduction in length during a reconfiguration of the embolic material filter assembly from the insertion configuration to the deployed configuration (paragraph [0081], [0082]), and
wherein the inner filter is configured to accommodate the reduction in length of the outer scaffold during the reconfiguration of the embolic material filter assembly from the insertion configuration to the deployed configuration (paragraph [0082]); and
a dilator assembly (16) having a holding configuration (Figure 1, 2) and a non-holding configuration (Figure 12),
wherein in the holding configuration the dilator assembly restrains a distal end portion of the embolic material filter assembly in the insertion configuration (via 30, as discussed in paragraph [0062]), and
wherein reconfiguration of the dilator assembly from the holding configuration to the non- holding configuration releases the distal end portion of the embolic material filter assembly to accommodate reconfiguration of the embolic material filter assembly to the deployed configuration (paragraph [0062]).
Groh’923 teaches the inner filter can accommodate the reduction in length of the outer scaffold (paragraph [0082]) but does not teach the inner filter comprises body pleats to perform this function.
Quadri’094 teaches an expandable tubular element (Figure 16a, 16b) for implantation into a vessel. The tubular element as an outer scaffold (500b) that reduces in length in the expanded configuration (paragraph [0125]) and an inner flexible material (810). The inner material forms body pleats (“creased so as to preferentially fold, accordion style, as the stent shortens during expansion”, paragraph [0125]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the inner filter portion has body pleats in the expanded configuration, as taught by Quadri’094 to accommodate the reduced length of the outer scaffold (paragraph [0125]).
Claim 64: Groh’923 teaches the inner filter does not comprise body pleats in the insertion configuration (Figures 21, 27, 28).
Quadri’094 teaches the body folds form in the expanded configuration (paragraph [0125]).
Claims 65 is rejected under 35 U.S.C. 103 as being unpatentable over Groh’923 in view of Quadri’094, as applied to claim 62, further in view of Colgan’689.
Groh’923 teaches the inner filter (46, 48) and outer scaffold (44) can be attached via any suitable approach (paragraph [0087]), but does not specifically disclose a distal end of the inner filter has a zig-zag configuration that is woven into the outer scaffold.
Interweaving an inner element having distal zigzag pattern interwoven into the outer element is old and well known. For example, Colgan’689 teaches an inner element (162) and a braided outer layer (164). The inner element (162) has a zig-zag configuration at its distal end (Figure 9) which is interwoven into the braid of the outer layer (164) (column 7, lines 50-52) to secure the inner and outer elements relative to each other.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Groh’923 such that the inner filter has a distal end interwoven with the outer scaffold, as taught by Colgan’689, in order to secure the two elements to each other via a known, suitable approach so the inner and outer layers cannot inadvertently become separated via a failed connection.
Allowable Subject Matter
Claims 5 and 63 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 18 August 2026
/SARAH A LONG/Primary Examiner, Art Unit 3771
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