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 (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.
Claim Objections
Claim 1 is objected to because of the following informalities: lines 15-16 refer to “a distal end portion of the embolic material filter assembly”. This should read “[[a]] the distal end portion of the embolic material filter assembly” because it was previously introduced in lines 5-6.
Appropriate correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Groh et al. (US Patent Publication 2020/0107923) 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 (36) having a proximal end portion (40) and a distal end portion (38), 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 embolic material filter assembly is configured to interface with an inner surface of a blood vessel in the deployed configuration (Figure 12), and wherein the embolic material filter assembly is configured to filter embolic material from blood flowing through the embolic material filter assembly (paragraph [0069]; and
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 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: Groh’923 teaches embolic material filter assembly (36) is reconfigurable from the deployed configuration to a captured configuration in which the embolic material filter assembly is disposed in the introducer sheath lumen via proximal retraction of the inner sheath relative to the introducer sheath (Figure 15; paragraph [0071]).
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 5: Groh’923 teaches the embolic material filter assembly (16) has an outer surface that extends between the proximal end portion of the embolic material filter assembly and the distal end portion of the embolic material filter assembly (Figures 2-4); and
the outer surface of the embolic material filter assembly is disposable distal to the introducer sheath with the embolic material filter assembly in the insertion configuration (Figure 2; paragraph [0031]).
Claim 6: Groh’923 teaches the embolic material filter assembly (16) is configured to be retained in the insertion configuration at least partially via axial tension imparted into the embolic material filter assembly via the dilator assembly (paragraph [0063]).
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 9: Groh’923 teaches the embolic material filter assembly (36) comprises an outer scaffold (44) and an inner filter (46) mounted to the outer scaffold and configured to filter embolic material from blood flowing through the inner filter (Figures 27, 28).
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: Groh’923 teaches the embolic material filter assembly (10) comprises an outer scaffold (44) and an inner filter (46) attached to the outer scaffold;
the outer scaffold is configured to radially expand into contact with a blood vessel along which embolic material is blocked from traversing (paragraph [0007], [0092]); and
the inner filter is configured to prevent emboli of greater than a particular size from passing through the inner filter (paragraph [0007]).
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]).
Claims 15, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Groh’923 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).
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 19 March 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771