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
Applicant’s election without traverse of Group I in the reply filed on 8/14/2026 is acknowledged.
Drawings
The drawings are objected to because Figures 2, 3A-B, and 9 have dark shaded areas that obscure the illustration. The drawings should be black and white line drawings, with cross-hatch patterns in cross-section to show different components instead of solid gray. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 19-25 and 27 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.
Claim 19 recites limitation (a) having two contradictory ranges, wherein the claim first states the outer layer is 50-100% the catheter length and then subsequently states the outer layer runs along 80-100% the catheter length. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 19 recites limitation (b) “inner layer” and then subsequently recites limitation (c) “a flexible inner layer”. Subsequent recitations of “said inner layer” unclear, due to the similarity in claim terminology.
Claim 19 recites limitation (e) which has contradicting limitations, first stating the pull ring is “at or distal to a distal end of the flexible inner layer” and then stating “the pull ring is positioned at a distal location to said flexible inner layer.” Therefore, it is unclear what arrangement is being claimed.
Claims 20-25 and 27 depend from claim 19 and are indefinite for the same reasons.
Claim 25 recites “said flexible hypotube or spring”, which lacks proper antecedent basis, because a spring is not recited in claim 24 or 19.
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, 2, 4-6, 8, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2013/0030520 (Lee et al.).
Lee discloses a delivery handle arrangement that facilitates a delivery of a medical device to a treatment site that comprises
a housing (handle 46) having an inner core (see interior in cross-section of Figure 2A) that at least partially extends linearly between a proximal end and a distal end of said housing;
a flexible catheter (22) that is connected to said housing;
and a flex adjustment mechanism that is configured to controllably bend a distal region said flexible catheter that includes a flex knob (56) that is movably connected to said housing [0484];
said flex knob (56) includes a body portion that is at least partially positioned in said inner core of said housing (see Fig. 2A; knob 56 has portions that extend into housing interior to be coupled to steering wires 78 at 72);
a flex insert/flex actuator (slide nut 72) positioned within the housing and moveable when the knob is rotated (see Fig. 2A; [0094-0095]),
a wire member (pull wire 78) that is coupled at a proximal end to the flex insert/actuator (72); and a distal region (68) of said flexible catheter;
and a first flex indicator arrangement (see indicator pin 52 that indicates a degree of catheter bending [0487]) located on said housing that provides information to a user about a degree or amount of bending of said distal region of said flexible catheter prior, during and/or after said flex knob (214) is rotated [0092]).
Although Lee fails to include a second flex indicator, it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to add a second flex indicator on an opposite side of the housing, since it has been held that a mere duplication of the elements of a device involves only routine skill in the art. St. Regis Paper Co. v Bemis Co., 193 USPQ 8.
In regard to claim 2, Lee explains that the knob can be rotated in a first direction to draw the wire further into the housing to bend the catheter and rotated in a second direction to extend the wire and straighten the catheter [0094-0095].
Regarding claim 4, the flex indicator arrangement comprises a window defined by the housing that overlies a base portion (64) of the indicator pin (52) (see Figure 2B; [0098]). It would have been further obvious to duplicate this structure on the second flex indicator of modified Lee.
Regarding claim 5, Lee includes a moveable needle (pin 52) and a flex bend graphic (visual indicia [0099]).
Regarding claim 6, the indicator (52) is rearward of the knob (56). It would have been further obvious to duplicate this structure on the second flex indicator of modified Lee.
In regard to claim 8, the knob (50) does not move longitudinally [0093].
In regard to claim 15, Lee discloses the catheter defines a wire cavity that slidably receives the wire (“pull wire lumen” in the shaft 22 [0094]). Since the claim doesn’t require more than one layer, the wall of the catheter meets the requirement “inner layer.”
Regarding claim 18, Lee discloses a heart valve (12) (entire document; Fig. 56-57).
Claim(s) 9-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2013/0030520 (Lee et al.) in view of USPAP 2015/0272734 (Sheps).
Lee discloses the wire is fixed to a distal portion of the catheter [0094] but fails to disclose a pull ring at the distal end of the catheter to which the pull wire is attached. Sheps discloses another delivery handle that comprises a housing (handle 22), a flexible catheter (12), and a flex adjustment mechanism including a flex knob (214) [0484] that actuates a wire member (see 29a and 29b; 31a and 31b in Fig. 32A; [0483]) and an indicator (215) of the degree of bending [0487]. Sheps teaches a pull ring (11 or 13) at the distal end of the catheter to which the wire is attached (see Fig. 13; [0467]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the pull ring taught by Sheps with the Lee device, as the modification merely involves a combination of known catheter steering mechanisms according to known methods that obtains a predictable result of steering a catheter by tension applied to a pull wire.
Regarding claim 10, Sheps teaches the wire (29a or 29b) is attached to an outer surface of the pull ring (11) (Fig. 32A; [0749]). Therefore, it would have been further obvious to attach the wire and pull ring of modified Lee in this way.
Regarding claims 11 and 12, Lee fails to disclose the catheter (22) having a spring or hypotube positioned distally of the pull ring. Sheps teaches a bending portion (1203) of the catheter comprises a coil (1208) that is positioned proximal to the pull ring (11) (Fig. 4 and 6; [0521]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the coil bending section taught by Sheps with the Lee catheter, in order to achieve efficient and durable bending of the distal portion of the catheter to which the pull ring is attached.
Regarding claim 13: The metal coil (1203) of Sheps [0521] meets the requirements of both a “spring” and a “hypotube.” Further regarding claim 13, the phrase “laser cut” is not given patentable weight, as the process by which a product is made is not germane to the issue of patentability of the device itself.
Regarding claim 14: Sheps teaches the coil hypotube/spring (1208) is embedded in the wall of the catheter along the bending section (1203) along which the pull wire cavities (1211) are defined in the catheter wall (see cross section A of Fig. 4). Although Sheps fails to specify that the wire is positioned in a cavity (or lumen) of the coil (1208), there are only a finite number of options for arranging both the wires and coil within the catheter wall. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to position the wire within the coil lumen/cavity as an obvious matter of design choice.
Regarding claims 16-17: Sheps teaches the catheter can comprise a braid (1207) embedded within the catheter wall (1206) that extends proximally of the spring/hypotube (coil 1203) (see Figure 4; [0519]; [0523]). Since the claims do not require any other layers of the catheter, the catheter wall (1206) comprising the braid (1207) therein meets the requirement of “inner layer.”
Claim(s) 19-25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. in view of Sheps, as applied above, and further in view of USPAP 2012/0123327 (Miller).
Regarding claim 19: Lee discloses all the limitations of the handle arrangement, as discussed above in regard to claim 1, and further explains the flex insert/actuator translates linearly along a longitudinal axis when the knob is rotated (see Fig. 2A; [0094-0095]). A balloon catheter (26) received within the lumen of the steerable catheter (22) in a rotatable manner (Fig. 1; [0101]).
In regard to the catheter limitations (from previous claim 26), the catheter cavity (lumen) runs 80%-100% of the length. The wire extends along the length of the catheter within a cavity (“pull wire lumen” in the shaft 22 [0094]). Lee discloses the wire is fixed to a distal portion of the catheter [0094] but fails to disclose a pull ring at the distal end of the catheter to which the pull wire is attached. Sheps discloses another delivery handle that comprises a housing (handle 22), a flexible catheter (12), and a flex adjustment mechanism including a flex knob (214) [0484] that actuates a wire member (see 29a and 29b; 31a and 31b in Fig. 32A; [0483]) and an indicator (215) of the degree of bending [0487]. Sheps teaches a pull ring (11 or 13) at the distal end of the catheter to which the wire is attached (see Fig. 13; [0467]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the pull ring taught by Sheps with the Lee device, as the modification merely involves a combination of known catheter steering mechanisms according to known methods that obtains a predictable result of steering a catheter by tension applied to a pull wire.
Lee and Sheps fail to disclose the claimed layers of the catheter construction having a hypotube between inner and outer layers. Miller discloses another steerable catheter with a pull wire (20) attached to a pull ring (28). The catheter further includes an inner layer (24) [0031], pull wire lumen (25) formed with the inner layer [0032]; a flexible inner layer (braided layer 32)[0033], a hypotube (coil 26) distal to the flexible inner layer (32) and proximal to the pull ring (28) [0033]; and an outer layer (outer jacket 34) [0035] (see Figure 3). Miller teaches that the combination of these catheter components provides kink resistance and desirable torque transmission to maneuver around tortuous anatomy [0033]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to construct the modified Lee catheter according to Miller’s teachings, to include a combination of an inner layer, a hypotube, a flexible inner layer, and an outer layer, in order to improve its mechanical properties desirable for maneuvering through tortuous anatomy.
Regarding claims 20-22, Lee discloses a first flex indicator arrangement (see indicator pin 52 that indicates a degree of catheter bending [0487]) located on said housing that provides information to a user about a degree or amount of bending of said distal region of said flexible catheter prior, during and/or after said flex knob (214) is rotated [0092]). The flex indicator arrangement comprises a window defined by the housing, a moveable needle (pin 52) and a flex bend graphic (visual indicia [0099] (see Figure 2B; [0098]).
Regarding claim 23: Although Lee fails to include a second flex indicator, it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to add a second flex indicator on an opposite side of the housing, since it has been held that a mere duplication of the elements of a device involves only routine skill in the art. St. Regis Paper Co. v Bemis Co., 193 USPQ 8.
Regarding claim 24, Sheps teaches the wire (29a or 29b) is attached to an outer surface of the pull ring (11) (Fig. 32A; [0749]). Therefore, it would have been further obvious to attach the wire and pull ring of modified Lee in this way.
Regarding claim 25: the hypotube (coil 26) taught by Miller is configured to a) bend when said distal region of said flexible catheter is caused to bend by said flex adjustment mechanism, and b) unbend when said flex adjustment mechanism allows said distal region of said flexible catheter to unbend from a bent position by said flex adjustment mechanism; said flexible hypotube (26) is positioned further from said distal end of said flexible catheter than said pull ring (28) (see Figure 3 of Miller).
Regarding claim 27: the flexible catheter of modified Lee includes one or more of
a) said flexible hypotube (coil 26 taught by Miller) is a laser cut hypotube (this is a product-by-process limitation that is not given patentable weight);
b) said hypotube includes a plurality of laser cut slots (this is a product-by-process limitation that is not given patentable weight); and the flexible inner layer of material is a braided material layer (see braid 32 of Miller).
c) said pull ring (28) is connected to said distal end of said flexible hypotube (coil 26) (see Fig. 3 of Miller);
e) a pull-wire jacket that is positioned in said wire cavity (pull wire tube 25) of said flexible inner layer, and wherein said wire member is located in a cavity of said pull-wire jacket, and wherein said wire member is movable within said cavity of said pull-wire jacket, and wherein said pull-wire jacket extends 60-100% of a longitudinal length of said wire cavity of said flexible inner layer;
f) the pull wire member (20) and/or said pull ring are formed of stainless steel (see [0058] of Miller).
g) said outer layer (34) includes polyether block amide (PEBA) thermoplastic elastomer (see [0038] of Miller).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USPAP 2007/0299424 discloses catheter construction with pull wires, pull ring, and multiple layers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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