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 claim(s) 1, 4-6 (and dependent claims 2, 3, 7, 8) 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. A new reference Seto is introduced to address the new limitations to the design of the openings.
Applicant's arguments with respect to claim have been fully considered but they are not persuasive. Applicant states there is nothing in either Gardeski or Karkarmar that suggests that the second tubular sleeve should be aligned curved portion of the slot openings or that any such alignment of the second tubular sleeve with the slot openings would be desired. However, as noted in the rejection Gardeski discloses the second tubular sleeve (46) is arranged on the inner curve of the device (Fig. 1) and Karmarkar discloses the openings arranged on the inner curve of the device. Thus it is understood that the lumen and the openings both being arranged on the inner curve would meet the limitation of the sleeve being circumferentially aligned with the openings.
Applicant’s response obviates the 112(b) rejection of claim 7 as well as the drawing objections. However, a new issue is set forth with respect to amended claim 3.
Drawings
The replacement drawings were received on 12/23/2022 and 12/18/2025. These drawings are accepted.
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.
Claim 3 is 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.
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). In the present instance, claim 3 recites the broad recitation “the outer polymer layer comprises a polyamide, or a polyether block amide, or a combination thereof”, and the claim also recites “wherein the outer polymer layer is the polyamide comprising nylon 12”. which is the narrower statement of the range/limitation. 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 Rejections - 35 USC § 103
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.
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 1-8, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gardeski et. al. (US PGpub 2004/0116848) in view of Karmarkar et al (US PGPub 2006/0142732) and Seto (US 20160100745).
Gardeski discloses a delivery system for deploying a prosthetic valve comprising: an elongated polymeric sleeve (see Fig. 1, 2, [0048-0050])) having a proximal end and a distal end and comprising an inner polymer layer (44/46) and an outer polymer layer (40/42) extending around the inner polymer layer (see Fig. 2); the inner polymer layer forms:
a first tubular sleeve (44) having an inner surface defining a first lumen (24) having a first diameter, an outer surface, and a first longitudinal axis;
and a second tubular sleeve (46) that is adjacent to the first tubular sleeve, the second tubular sleeve having:
an inner surface defining a second lumen (26) having a second diameter smaller than the first diameter (see Fig. 2); and
an outer surface that is an extension of the outer surface of the first tubular sleeve (see Fig. 2 – note that the outer surface of the second tubular sleeve is an extension of the first tubular sleeve since they are in contact with each other);
wherein the second tubular sleeve has a second longitudinal axis offset from the first longitudinal axis and substantially parallel to the first longitudinal axis along a length of the elongated polymeric sleeve (see Fig. 2, [0060]); and
wherein the outer surface of the first tubular sleeve and the second tubular sleeve define an outer surface of the inner polymer layer; and
wherein an inner surface of the outer polymer layer is adjacent and bonded to the outer surface of the inner polymer layer ([0061]).
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and a selectively steerable section (52/54) coupled to the distal end of the elongate polymeric sleeve including a flexible tubular portion movable between a first straight position (Fig. 4) and a second curved position (Fig. 3)
Gardeski does not disclose the flexible portion including a plurality of spaced apart openings.
However, Karmarkar, in the same field of endeavor, discloses a flexible steerable tubular delivery system having a flexible portion (16,24) movable between a first straight position (Fig. 1) and a second curved position (Fig. 2) and includes axially spaced apart circumferentially extending openings (26). Karmarkar discloses the slots enhance the deflection by offering a collapsible space that can reduce the resistance of the tube to bending and by helping direct the tip along the axis of deflection induced when pull wire is retracted [0029].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to enhance the device of Gardeski by incorporating the slotted tube of Karmarkar as the flexible portion in order to provide the same advantages noted above.
Modified Gardeski does not explicitly disclose the slots comprising two elongate openings connected by a curved opening, the curved opening extending in a direction axially away from the elongate openings.
However, Seto, in the same field of endeavor, discloses a flexible steerable medical tube incorporating slots to enhance its bendability. The slots (33, 34) comprise two elongate openings connected by a curved opening (35) extending in a direction axially away from the elongate openings as seen in Fig. 2. The curved opening allows for a torsion preventing tab to prevent torsion of the tube during bending [0039].
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further enhance the device of modified Gardeski by incorporating the curved opening connecting two elongate openings in order to provide the advantage of preventing torsion during bending.
Claim 2, the claimed phrase “wherein the inner polymer layer and the outer polymer layer of the elongated polymeric sleeve are co-extruded” is being treated as a product by process limitation; that is to say the sleeve is formed by the process of co-extrusion. 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 the structure of the prior art is the same or similar to that which is disclosed regardless of how it was manufactured. Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the process of co-extrusion since using a known technique to form a known device would yield predictable results.
Claim 3: Gardeski discloses all the limitations of the claims as noted above and further discloses with respect to claim 3: wherein the inner polymer layer comprises a fluoropolymer ([0050]); and wherein the outer polymer layer comprises a polyamide, or a polyether block amide, or a combination thereof ([0048-0049] outer sheath made from Pebax), wherein the fluoropolymer comprises an ethylene-perfluoroethylenepropene copolymer (FEP [0050]). Note the limitation “wherein the outer polymer layer is the polyamide comprising nylon” is considered to be claimed in the alternative and would not need to be addressed since the reference teaches polyether block amide.
Claim 4: the elongated polymeric sleeve further comprises an outer jacket (40/42), wherein the outer jacket is disposed outward of the outer surface of the outer polymer layer of the elongated polymeric sleeve, wherein the elongated polymeric sleeve further comprises a braided layer (28) disposed between the outer jacket and the outer surface of the outer polymer layer of the elongated polymeric sleeve, wherein the inner and outer polymer layers of the elongated polymeric sleeve and/or the braided layer and/or the outer jacket are fused together ([0060-0061]), wherein the outer jacket comprises a polyether block amide (Pebax [0048]).
Claim 5: Modified Gardeski discloses the selectively steerable section (52,54 [0041] of Gardeski and 16 of Karmarkar) has a proximal end and a distal end, wherein the proximal end of the steerable section is coupled to the distal end of the elongated polymeric sleeve (see for example at 20 where 16 is coupled to 14 in Fig. 2 of Karmarkar). Gardeski further discloses wherein the steerable section comprises a central lumen having an inner diameter (Iumen 24 extends to distal end 16 ([0041]), wherein the central lumen is coaxial with the first lumen of the first tubular sleeve (central lumen is continuous with first lumen and therefore coaxial) , wherein the selectively steerable section is substantially more flexible than the elongated polymeric sleeve (the steerable section has cutouts allowing it to be more flexible for bendability), and wherein the selectively steerable section provides a sufficient curvature to navigate around an aortic arch (the steerable section navigates the curvature of the catheter with a sufficient curvature as seen in Fig. 1).
Claim 6: Gardeskli further discloses a pull wire (110, 210) having a proximal end and a distal end, wherein the distal end of the pull wire is coupled with a distal end of the steerable section, and wherein actuation of the pull wire selectively controls a curvature of the steerable section, and the pull wire is extending through the second lumen of the second tubular sleeve and is configured to pass through the steerable section to the distal end of the steerable section ([0073]).
Claim 7: Gardeski does not disclose an exterior cover.
However, Karmarkar an exterior cover (102) extending over at least a portion of the flexible tubular portion (Fig. 6), the exterior cover being less flexible than the tubular portion and providing a fulcrum for the tip 16 so that varying the longitudinal position of the sleeve 102 causes a corresponding increase or decrease of the radius of curvature of the tip 16. ([0035]).
Based on the teachings of Karmarkar, it would have been obvious to one having ordinary skill in the art as of the effective filing date to incorporate an outer cover as taught by Karmarkar into the device of Gardeski to allow for varying degrees of bending.
As to the limitation of the second lumen of the second tubular sleeve is circumferentially aligned with the curved portion of the openings: Gardeski discloses the second tubular sleeve (46) is arranged on the inner curve of the device (Fig. 1). Karmarkar discloses the openings arranged on the inner curve of the device. Seto discloses the curved portion of the opening (35) at the middle of the opening arranged on and aligned with the inner curve (Fig. 4 and 5). Overlapping these three concepts, one of skill would recognize that the second lumen is circumferentially aligned with the curved portion of the openings.
Claim 8: Gardeski further discloses a handle (120 Fig. 3 OR 220 Fig. 6) coupled to the proximal end of the elongated polymeric sleeve, wherein the handle is coupled to the proximal end of the pull wire (112 or 212), wherein the handle comprises a steering mechanism (114, 214), that actuates actuating the pull wire to selectively control a curvature of the steerable section during advancement of the delivery ([0075]). The incorporation of the flexible bendable tube of Karmarkar allows for the steering mechanism to be effective to move the pull wire such that the elongated polymeric sleeve exhibits substantially no deflection during a movement of the pull wire.
Further Karmarkar discloses the use of an exterior cover (102) extending over at least a portion of the flexible tubular portion (Fig. 6), the exterior cover being less flexible than the tubular portion and providing a fulcrum for the tip 16 so that varying the longitudinal position of the sleeve 102 causes a corresponding increase or decrease of the radius of curvature of the tip 16. ([0035]).
Based on the teachings of Karmarkar, it would have been obvious to one having ordinary skill in the art as of the effective filing date to incorporate an outer cover into the device of Gardeski to allow for varying degrees of bending. The use of the sleeve would also provide the feature of the polymeric sleeve exhibiting deflection during movement of the pull wire.
Claim 21: Regarding the limitation that the polymer layer is free of delamination, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to manufacture the polymer layer to be free of delamination as one would not desire the device to fail during use. If a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. (KSR, 550 U.S. at 401.)
Claim 22: Seto discloses wherein the curved opening includes a proximal and distal edge, the proximal edge of the curved opening extending in a direction away from a corresponding proximal edge of each of the elongate openings in an axial direction, the distal edge of the curved opening extending in a direction away from a corresponding distal edge of each of the elongate openings in the axial direction (see Fig. 2).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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