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 .
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, it is unclear what is meant by the material coating having “a diameter larger than a diameter of the proximal bond” since lines 4-7 of claim 1 appear to claim the material coating as part of the proximal bond (“the proximal bond comprising a weld….and a material coating…). As best understood in view of the last two lines of claim 1, the material coating is not being considered part of the proximal bond. This is consistent with language in paragraph [0055] of the spec (…providing a material coating 124 on and/or over the proximal bond 123). In order to clarify that the material coating is not part of the claimed proximal bond (such that it has a diameter larger than the proximal bond), it is suggested that “and” at the end of line 3 be deleted, and a semicolon and paragraph break be added between “and the second tapered portion” and “and a material” in line 6 of the claim.
Lines 8-10 of claim 1 require a first weld at a distal end of the first tapered portion and a second laser weld at a distal end of the second tapered portion. However, this is inconsistent with figure 3 of the instant application, which appears to show a first weld at a proximal end of the first tapered portion and a second weld at a distal end of the second tapered portion, as proximal and distal are defined in the rest of the claim with respect to the cage and shaft (note: alternatively, fig. 3 shows a first weld at a distal end of the first tapered portion and a second weld at a proximal end of the second tapered portion depending on which weld 133 in fig. 3 is considered the claimed “first weld”). An annotated reproduction of fig. 3 of the instant application is provided below:
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Thus, the scope of what is considered a distal end and a proximal end of a tapered portion is unclear. See MPEP 2173.03: "A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970).” Because this appears to be a typographical error, the claim is being treated as though it reads “a first weld at a proximal end of the first tapered portion” in the interest of compact prosecution.
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.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al. (US 6,660,021) in view of Matthews et al. (US 2007/0282270). Palmer discloses a clot removal device comprising a cage structure (20) comprising a first portion (174) at a proximal end of the cage structure, a shaft (160) comprising a second tapered portion (164) at a distal end of the shaft, and a proximal bond in which the first portion is positioned in a non-engaging overlap with the second tapered portion (see figs. 13, 14), the proximal bond comprising a solder bond (176) between the first and second portions.
Palmer fails to expressly disclose first and second welds between the first and second portions and instead discloses the use of solder (176; fig. 14). Palmer also fails to expressly disclose a material coating as claimed, and that the first portion (174) is tapered.
Palmer does however disclose joining other elements of the device via laser welding, and discloses such a joining method as an alternative to soldering. Matthews teaches forming a proximal bond between a first tapered portion (60) at a proximal end of a first section (15) of a surgical instrument positioned in a non-engaging overlap (due to weld with filler material; [0094]) with a second tapered portion (55) formed at a distal end of a shaft (10), the bond comprising a weld (filler material weld) between the first and second tapered portions ([0027]; fig. 17). The non-engaging overlap comprises a first weld (between 25A,30A; fig. 17) at a proximal end of the first tapered portion 60 (see 35 USC 112b rejection above) extending to the second tapered portion and a second weld (between 25B,30B; fig. 17) at a distal end of the second tapered portion (55) extending to the first tapered portion. Matthews further teaches a material coating bonded to the two wires (shrink wrap polymer sleeve; [0093]) at a first point proximal of the non-engaging overlap and a second point distal of the non-engaging overlap (as understood in view of fig. 18,19, noting sleeve in addition to material 70). The material coating has a diameter larger than a diameter of the proximal bond (see fig. 18 and 35 USC 112b rejection above). Matthews discloses welding as an alternative to soldering ([0027]). Matthews discloses that the joint formed by overlapping tapered portions welded together provides adequate tensile strength, torque strength, bending movement performance and failure mode characteristics ([0071]). Matthews discloses that the material coating provides a tether to hold the two tapered portions together in the event that bond breakage (i.e., weld breakage) occurs ([0104]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Palmer to include first and second welds at either ends of the non-engaging overlap of Palmer as taught by Matthews in place of the solder since Palmer and Matthews disclose welding and soldering as art recognized equivalents, and such a modification can be considered a substitution of one known bonding method for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success. It would have also been obvious to one of ordinary skill in the art to have modified the prior art of Palmer to taper the first portion (174) where the first portion overlaps with the second tapered portion (164) of Palmer as taught by Matthews to ensure a gradual transition between the properties of the cage structure and shaft, and to include a material coating as further taught by Matthews in order to provide a tether to hold the two tapered portions together in the event that bond breakage occurs ([0104] of Matthews). The term “laser” before “weld” is considered a product-by-process limitation as it is drawn to the process used to form the weld, not the structure of the weld. The claims are drawn to the product, not its method of manufacture. Nonetheless, Palmer discloses using laser-welding as the particular type of welding used to connect elements of the device (col. 5, ll. 12-15) and thus it would have been considered obvious to use a laser to form the welds taught by Matthews.
Regarding claim 3, the second tapered portion is narrower distally and wider proximally (see fig. 12 of Palmer).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer in view of Matthews as applied to claim 1 above, and further in view of Casey et al. (US 2019/0000492). Regarding claims 4 and 5, Palmer in view of Matthews discloses a cage structure, but fails to disclose an open distal end, a proximal spiral section, and a cylindrical body section as claimed.
Casey discloses another clot removal device (e.g., fig. 59) including a cage structure, the cage structure comprising an open distal end, and a proximal spiral section (3021; fig. 59) comprising a first plurality of struts extending distally from the proximal end of the cage structure and configured to pinch a clot between at least one strut of the first plurality of struts ([0201]). Although Casey does not expressly disclose that the drawings are drawn to scale, the proximal spiral section is illustrated as being longer than the cylindrical portion in at least figure 59, and thus one skilled in the art would have found it obvious to size the spiral section such that it extends over a majority (i.e., more than half) of a length of the cage structure from the proximal end to the open distal end as suggested by fig. 59. The cage structure further comprises a cylindrical body section (3022) distal to the proximal spiral section, wherein the cylindrical body section comprises a second plurality of struts larger than the first plurality of struts (e.g., second plurality of struts together forms a section having a larger diameter than the first plurality of struts), and the cylindrical body section comprise a length measuring less than a length of the proximal spiral section (as made obvious at least in view of figs. 57, 59, and 63). According to Casey, a proximal spiral section provides performance benefits for clot dislodgement as the device engages more with the clot than for a straight configuration ([0168]-[0169]). The cylindrical body section having a larger diameter than the spiral section provides clot grip and retention during retraction of the clot past vessel bends and branches ([0177], [0196]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Palmer to include an open distal end, a proximal spiral section, and a cylindrical body section having the claimed structure in view of the teachings of Casey in order to provide performance benefits for clot dislodgement, clot grip and clot retention ([0168]-[0169], [0177]).
Regarding claim 6, as taught by Casey, the cylindrical body section comprises an outer diameter of approximately 2.5mm ([0185] – body section (1901) can have a diameter of 1.0mm to 8mm, which includes 2.5mm). See also [0192] of Casey, wherein a diameter of between 2 to 3mm is disclosed, which facilitates shorter strut lengths which allow higher crown expansion angles during the re-sheathing process than standard stent retrievers.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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KSH 10/10/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771