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Claims 13-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups II-III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/25/2026.
Additionally, claims 2, 5, and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species A-F, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/25/2026.
Applicant argues that species restriction between B, C, F, and G should be withdrawn because species G requires all of the elements of species B, C and F. The Office agrees, and species B, C, F and G are grouped together into a single species.
Applicant's election with traverse of group I and species G in the reply filed on 08/25/2026 is acknowledged. The traversal is on the ground(s) that group III depends from group I and there is not a serious search or examination burden between groups I and III. This is not found persuasive because group III does not depend from group I (claim 21 does not recite back to claim 1) and The Office maintains there is a search and examination burden between groups I and III. Specifically group I includes features such as a filler material and support member requiring a separate search. Additionally, group III requires limitations of translating the device to denude a vessel wall requiring a separate search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 7, and 9, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wall et al. (WO 2020211943 A1).
Regarding claim 1 Wall discloses (fig. 1-2 and 13) a venous ablation device for denuding a vessel wall, comprising:
a bristle portion, the bristle portion comprising a core 1110 and a plurality of resiliently flexible bristles 1120 extending at least radially outwardly from the core 1110 (see fig. 13 and pg. 39 lines 23-32), the bristles having a collapsed delivery configuration (see fig. 2 and pg. 24 ln. 33-34) and an expanded deployed configuration (see fig. 13) in which the bristles are configured to contact and denude the vessel wall (see pg. 6 ln. 33-34 and note below); and
a delivery portion (delivery wire) configured to deliver the bristle portion through a delivery catheter c, the delivery portion at least partially integral with the core (stem, see pg. 23 ln. 24-28);
wherein the plurality of bristles 1120 penetrate through the core 1110 such that the core secures the bristles (see fig. 13 and pg. 39 ln. 27-32).
Note: The language “configured to denude the vessel wall” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Wall meets the structural limitations of the claim, and the bristles are capable of denude the vessel wall since they contact the vessel wall.
Regarding claim 3 Wall further discloses (fig. 1-2 and 13) the core comprises a tubular wall, and the plurality of bristles each penetrate the tubular wall so that the tubular wall secures the plurality of bristles to the core (see fig. 13 and pg. 39 ln. 27-32).
Regarding claim 4 Wall further discloses (fig. 1-2 and 13) the core further comprises a filler material disposed within a lumen defined by the tubular wall, the filler material surrounding and securing portions of the flexible bristles which are disposed within the lumen (see fig. 13 and pg. 36 ln. 26-36).
Regarding claim 7 Wall further discloses (fig. 1-2 and 13) the core comprises a volume of material and the plurality of bristles are each partially disposed within the volume of material such that the material surrounds and secures the plurality of bristles (see fig. 13 and pg. 36 ln. 26-36).
Regarding claim 9 Wall further discloses (fig. 1-2 and 13) the plurality of bristles comprise a first set of bristles and a second set of bristles, the first set of bristles configured to extend in a proximal direction in the expanded deployed configuration and the second set of bristles configured to extend in a distal direction opposite to the proximal direction in the expanded deployed configuration (see pg. 25 ln. 14-18).
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wall.
Regarding claim 8, Wall discloses the claimed invention substantially as claimed, as set forth above for claim 1. Wall further discloses (fig. 1, 2, and 13) the core 1110 comprises a structural member 1113 disposed at least partially within the volume of material (see fig. 13 and pg. 39 ln. 34-37).
Wall fails to expressly disclose the structural member having a lower flexibility than the material.
However, it is noted that there are a limited number of flexibility options: the structural member having a lower flexibility than the material, the structural member having a higher flexibility than the material, or the structural member having the same flexibility as the material.
Therefore, it would have been obvious to one of ordinary skill in the art, at before the effective filing date of the claimed invention, to try having the structural member having a lower flexibility than the material since it has been held “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 10, Wall discloses the claimed invention substantially as claimed, as set forth above for claim 1. Wall further discloses (fig. 1, 2, and 13) each of the plurality of bristles comprises a thick portion (see pg. 15 ln. 35 – pg. 16 ln. 3).
Wall fails to expressly disclose the thick portion being thicker than a portion of the bristle extending through the core.
However, it is noted that there are a limited number of thickness options: the thick portion being thicker than a portion of the bristle extending through the core or the portion extending through the core being thicker.
Therefore, it would have been obvious to one of ordinary skill in the art, at before the effective filing date of the claimed invention, to try having t the thick portion being thicker than a portion of the bristle extending through the core since it has been held “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103.” KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wall in view of Duncan et al. (US 20130184658 A1).
Regarding claim 11, Wall discloses the claimed invention substantially as claimed, as set forth above for claim 1. Wall is silent regarding at least some of the plurality of bristles comprise barbs or hooks disposed along the length of the bristles and/or at the tips of the bristles.
However Duncan, in the analogous art of bristle medical devices, teaches of a device comprising a plurality of bristles, wherein the plurality of bristles comprise barbs or hooks disposed along the length of the bristles and/or at the tips of the bristles (see [0045]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wall to have at least some of the plurality of bristles comprise barbs or hooks disposed along the length of the bristles and/or at the tips of the bristles as taught by Duncan, for the purpose of increasing the grip of the bristles to the vessel wall / plaque (see Duncan [0045]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wall in view of Allen et al. (US 20160166257 A1).
Regarding claim 12, Wall discloses the claimed invention substantially as claimed, as set forth above for claim 1. Wall is silent regarding one or more radiopaque markers.
However Allen, in the same filed of endeavor, teaches of a device comprising a plurality of bristles, wherein the device comprises one or more radiopaque markers (see [0190]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wall to have the device comprise one or more radiopaque markers as taught by Allen, for the purpose of the physician being able to see where the device is located under x-ray (see Allen [0392] and [0705]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 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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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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