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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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 Status
The drawing objections and 35 U.S.C. 112(b) rejections have been overcome.
Claims 1-20 are examined below.
Claim Objections
Claim 1 recites “a portion of the first length” in line 10. It is unclear if this is the same portion of the first length recited in line 6 or a separate and additional portion of the first length. Dependent claims 2-20 are likewise objected.
Claim 1 recites “a portion of the second length” in line 10. It is unclear if this is the same portion of the second length recited in line 7 or a separate and additional portion of the second length. Dependent claims 2-20 are likewise objected.
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 1-20 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 1 recites “a lumen” in line 19. It is unclear is this is the same lumen recited in line 12 or a separate and additional lumen. Dependent claims 2-20 are likewise rejected.
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.
The factual inquiries 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.
Claim(s) 1-3, 9, 14-15, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish (US 2016/0074067 A1) in view of Herrig (US 2009/0227932 A1), as evidenced by Hammerslag (US 5,203,772 A).
Regarding claim 1, Furnish teaches an expandable sheath (10, expandable introducer sheath, fig. 1) for deploying a medical device comprising (¶ [0028], 12, medical device):
at least one plurality of struts (40, ribs, fig. 7B) arranged to form an expandable cylindrical frame (figs. 7A-7C) having a proximal (16, proximal end, fig. 1) and distal end (18, distal end, fig. 1), an inner surface (22, inner layer, fig. 7A) and an outer surface (24, outer layer, fig. 7A), and a central axis (A, axis, figs. 1 & 7A) extending along a length of the frame (fig. 7A);
wherein the expandable cylindrical frame has a first length (see annotated fig. 7B, below) and an opposite second length (see annotated fig. 7B, below), and wherein, in a first position (fig. 7B), at least a portion of the first length and at least a portion of the second length are substantially the same (see annotated 7B, below);
wherein the inner surface of the expandable cylindrical frame defines a lumen (fig. 7A) configured to receive a medical device (¶ [0029]);
wherein the expandable cylindrical frame is configured to expand from a first diameter d1 in an unexpanded position (fig. 7B) to a second diameter d2 in an expanded position (fig. 7C) upon passage of a medical device (¶ [0029] and ¶ [0036]).
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Furnish fails to teach a radius of curvature between about 1 inch and about 3 inches. However, Herrig discloses another tubular member with reinforcement that is configured to bend to access the vascular system. Herrig that teaches that the radius of curvature can be between about 1 inch and about 3 inches (¶ [0057]) and that the tubular member should be kink resistant so that the lumen remains patent during bending (¶ [0057]).
The phrase “a lumen defined by the inner surface remains patent along a bent segment of the frame without local collapse of the lumen” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. Furnish, as modified above by Herrig, is considered to be capable of remaining patent along a bent segment of the frame without local collapse of the lumen. Herrig explicitly describes the lumen remaining patent (¶ [0057]). Further, it has to stay open for the delivery device to perform its function of delivery a medical device.
The phrase “the expandable cylindrical frame is kink-resistant” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. Furnish as modified above by Herrig, is considered to be capable of being kink-resistant. By the nature of the prior are disclosing all the physical limitations of the device it is understood to be kink-resistant. Herrig explicitly describes the lumen as kink-resistance (¶ [0057]).
In light of Herrig’s teachings, one of ordinary skill in the art would have found it obvious to configure the Furnish device to have a radius of curvature in the range of 1-3 inches for the purpose of traversing the natural bends of a patients vasculature (¶ [0057], Herrig) , as well as configuring the device to be kink resistant so that the lumen remains patent during bending.
Although Furnish does not explicitly show at the second position at least a portion of the first length shortens and at least a portion of the second length elongates when the expandable cylindrical frame is curved away from the central axis, Hammerslag provides evidence that it is known in the art when a cylindrical frame is curved away from the central axis, one side will shorten and the opposite side will elongate as shown in Fig 2 and column 7 lines 39-50, for a tubular article to function in this way to provide bending.
Regarding claim 2, Furnish further teaches the portion of the first length and the portion of the second length in the second position are located along a curved portion of the frame (This is inherent, in order for one side to condense and the other to elongate the frame must be curved, without a curve the two sides would be an equal length).
Regarding claim 3, Furnish further teaches the first length is provided on a first portion of an outer diameter of the expandable cylindrical frame and the second length is provided on a second portion of the outer diameter of the expandable cylindrical frame, wherein the first portion is circumferentially opposite to the second portion of the outer diameter (see annotated fig. 7B, below).
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Regarding claim 9, Furnish further teaches the plurality of struts are arranged in a configuration wherein each strut of the plurality of struts is able to individually elongate in a circumferential direction along the length of the frame upon introduction of the medical device (¶ [0036], as the medical device passes through each strut 40 the strut will expand to allow its passage and then collapse down to its contracted position, the entire sheath does not expand in unison).
Regarding claim 14, Furnish further teaches the cylindrical frame is formed by a first plurality of struts arranged along a first edge (see annotated fig. 7C, below) of a singular vertical member (38, spine, fig. 7C) and a second plurality of struts arranged along an opposite second edge (see annotated fig. 7C) of the singular vertical member, wherein each strut of the first plurality of struts is spaced from each other such that a first gap (see annotated fig. 7C) is formed between two adjacent struts in the first plurality of struts; wherein each strut of the second plurality of struts is spaced from each other such that a second gap (see annotated fig. 7C) is formed between two adjacent struts in the second plurality of struts; wherein each strut of the first plurality of struts is axially offset along the singular vertical member from each strut of the second plurality of struts (fig. 7C); and wherein in the unexpanded position, each strut of the first plurality of struts is disposed within the second gap, and each strut of the second plurality of struts is disposed within the first gap (fig. 7A).
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Regarding claim 15, Furnish further teaches a width of the first gap and/or a width of the second gap is greater than a width of each strut of the first and second plurality of struts (fig. 7A), wherein the frame is in the expanded position, at least a portion of the first plurality of struts remains at least partially disposed within the second gap and at least a portion of the second plurality of struts remains at least partially disposed within the first gap (fig. 7C).
Regarding claim 18, applicant claims: the frame is configured to contract to a diameter that is from about 10% to about 90% larger than the first diameter d1 upon removal of the medical device. A recitation of functional language of the claimed invention/structure must result in a structural difference between the claimed invention/structure and the prior art in order to patentably distinguish the claimed invention/structure from the prior are. If the prior art structure is capable of performing the functional language, then it meets the claim. Examiner is considering the expandable reinforcement member, as disclosed by Furnish, as capable of contracting to a diameter that is from about 10% to about 90% larger than the first diameter d1 upon removal of the medical device. Further, this is a result effective variable as it would be obvious to find the best value for the optimal function of the device.
Regarding claim 20, teaches the sheath exhibits a decrease in an insertion force by greater than 0% to about 70% compared to a sheath without the expandable cylindrical frame of claim 1. The phrase “the sheath exhibits a decrease in an insertion force by greater than 0% to about 70% compared to a sheath without the expandable cylindrical frame of claim 1” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the expandable introducer sheath is considered to be capable of exhibiting a decrease in an insertion force by greater than 0% to about 70% compared to a sheath without the expandable cylindrical frame of claim 1.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Herrig evidenced by Hammerslag as applied to claim 1 above, and further in view of Snow (US 2008/0132989 A1).
Regarding claim 4, Furnish in view of Herrig evidenced by Hammerslag fails to teach a zig-zag configuration. However, Snow teaches an expandable tubular medical device that teaches the plurality of struts are arranged to form a zig-zag configuration (figs. 6A-6C, ¶ [0065]) comprising a plurality of substantially straight portions (620, struts, fig. 6C, ¶ [0065]) circumferentially followed by a plurality of substantially bend portions (622, U-shaped connector, fig. 6C, ¶ [0065])and wherein the zig-zag configuration is wound along a central axis to form the frame (¶ [0065]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a zig-zag configuration as taught by Snow in order to be flexible and offer radial strength as the sheath moves through the body.
Regarding claim 5, Furnish in view of Herrig evidenced by Hammerslag fails to teach a bisection line. However, Snow further teaches the plurality of substantially bend portions define a bisecting line extending through an apex of the plurality of substantially bend portions (see annotated fig. 6C, below) and extending longitudinally along a length of the sheath (fig. 6C), and wherein each substantially straight portion of the plurality of substantially straight portions has a first angle from the bisecting line from 00 to about 900 (fig. 6A, unexpanded configuration), wherein, when the frame is in the expanded position, the first angle increases by an amount greater than 0% to about 600% of its original value (fig. 6C, expanded configuration, ¶ [0069]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a bisecting line as taught by Snow in order to be flexible and offer radial strength as the sheath moves through the body.
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Claim(s) 6-8 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Herrig evidenced by Hammerslag as applied to claims 1 and 9 above, and further in view of Lau (US 6,309,412 B1).
Regarding claim 6, Furnish teaches the plurality of parallel circumferential rows are axially coupled to each other by a singular vertical strut member disposed along a length of the frame (38, spine fig. 7B).
Furnish in view of Herrig evidenced by Hammerslag fails to teach a zig-zag configuration. However, Lau discloses an expandable tubular medical device that teaches the plurality of struts are arranged in a zig-zag configuration to form a plurality of parallel circumferential rows (12, cylindrical elements, fig. 7), wherein each row of the plurality of parallel circumferential rows comprises a plurality of substantially straight portions (see annotated fig. 11, below) circumferentially followed by a plurality of substantially bend portions (see annotated fig. 11, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a zig-zag configuration as taught by Lau in order to achieve maximum flexibility (col 5, lines 33-54, Lau).
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Regarding claim 7, Furnish in view of Herrig evidenced by Hammerslag fails to teach a bisecting line. However, Lau further teaches the plurality of substantially bend portions define a bisecting line extending through an apex of the plurality of substantially bend portions and extending longitudinally along a length of the sheath (see annotated fig. 11, below), and wherein each substantially straight portion of the plurality of substantially straight portions has a first angle from the bisecting line 00 to about 900 (fig. 11), wherein, when the frame is in the expanded position, the first angle increases by an amount greater than 0% to about 600% of its original value (the expansion occurs when the bend portions move from a u like configuration to a v like configuration, this will inherently increase the angle by greater than 0%). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a bisecting line as taught by Lau in order to achieve maximum flexibility (col 5, lines 33-54, Lau).
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Regarding claim 8, Furnish teaches the singular vertical strut member extends longitudinally along a length of the sheath (fig. 7B and during expansion the frame expands circumferentially in a direction opposite to the single vertical strut member (figs. 7B-7C), and wherein the frame does not expand along the singular vertical strut member (the singular vertical strut is a single straight piece of stainless steel or nitinol, it is only expandable when moving from a bent configuration to a straight configuration since it is already in a straight configuration it would not expand any further).
Furnish in view of Herrig evidenced by Hammerslag fails to teach the connecting member connects apexes of the substantially bend portions. However, Lau further teaches the vertical strut member connects apexes of the substantially bend portions of each row of the plurality of parallel circumferential rows (col 5, lines 50-54), and the vertical strut member forms a second angle with each substantially straight portion of the corresponding adjacent substantially straight portions of line 00 to about 900 (fig. 11 shows the connecting member 13 is parallel to the straight portion 12, this makes a 00 angle) . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include the connecting member connects apexes of the substantially bend portions as taught by Lau in order to achieve maximum flexibility (col 5, lines 33-54, Lau).
Regarding claim 10, Furnish in view of Herrig evidenced by Hammerslag fails to teach an undulating pattern. However, Lau further teaches the plurality of struts is arranged in a plurality of parallel axial rows (fig. 5), each row of the plurality of parallel axial rows comprises an undulating pattern unit (fig. 5), wherein each unit comprises a first valley having a substantially straight bottom portion (see annotated fig. 5, below), wherein the substantially straight bottom portion of the first valley has a first width (see annotated fig. 5, below), wherein the first valley is followed by a first apex (see annotated fig. 5, below), a second valley (see annotated fig. 5, below), a second apex (see annotated fig. 5, below), and a third valley (see annotated fig. 5, below), and wherein a total width of the second and third valleys and the second apex (see annotated fig. 5, below) is substantially the same as the first width of the substantially straight bottom portion of the first valley (fig. 5), wherein the third valley is followed by a third apex (see annotated fig. 5, below) and a first valley of a next undulating pattern unit in the same row (see annotated fig. 5, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include an undulating pattern as taught by Lau in order to facilitate maneuvering in a variety of body lumen shapes (col 4, lines 55-59, Lau).
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Regarding claim 11, Furnish in view of Herrig evidenced by Hammerslag fails to teach a bridging member. However, Lau further teaches the plurality of parallel axial rows are arranged such that a second apex in each repetitive pattern unit of each row is positioned above and is coupled with at least a portion of a substantially straight bottom portion of a first valley of an adjacent row (This is obvious to try, Lau shows a second apex in each repetitive pattern unit of each row is positioned above at least a portion of a substantially straight bottom portion of a first valley of an adjacent row, placing the coupling member from the apex down to valley or from the valley down to the apex would be obvious to try to one having ordinary skill in the art at the time of filling.) by a bridging member (see annotated fig. 5, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a bridging member as taught by Lau in order to facilitate maneuvering in a variety of body lumen shapes (col 4, lines 55-59, Lau).
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Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Herrig evidenced by Hammerslag as applied to claim 1 above, and further in view of Shaolian (US 2003/0055492 A1).
Regarding claim 12, Furnish in view of Herrig evidenced by Hammerslag fails to teach a zig-zag configuration. However, Shaolian discloses an expandable tubular medical device that teaches the plurality of struts are arranged in a zig-zag configuration to form a plurality of parallel circumferential rows (50, 52, 54, zigzag sections, fig. 4), wherein each row of the plurality of parallel circumferential rows comprises a plurality of substantially straight portions (51, 53, straight segments, fig. 4) circumferentially followed by a plurality of substantially bend portions (55, 59, bend, fig. 4); wherein adjacent rows of the plurality of parallel circumferential rows are coupled together by a singular bridging member (56, 58, connector, fig. 4) extending from a substantially bend portion in a first row to a corresponding substantially bend portion in an adjacent second row (fig. 4), and wherein the singular bridging member coupling any two adjacent rows is circumferentially offset from a bridging member coupling any following two adjacent rows (fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include zig-zag configuration as taught by Shaolian in order to allow for radial compression and self-expansion (¶ [0053], Shaolian).
Regarding claim 13, Furnish in view of Herrig evidenced by Hammerslag fails to teach a bisecting line. However, Shaolian further teaches the plurality of substantially bend portions in each row of the plurality of parallel circumferential rows define a bisecting line extending through an apex of each substantially bend portion of the plurality of substantially bend portions (see annotated fig. 4, below), the bisecting line extending longitudinally along a length of the sheath (see annotated fig. 4, below), and wherein each substantially straight portion of the plurality of substantially straight portions has a first angle from the bisecting line from line 00 to about 900 (fig. 4), wherein, when the frame is in the expanded position, the first angle increases by an amount greater than 0% to about 600% of its original value (the expansion occurs when the bend portions move from a condensed and tight configuration to an expanded and widened configuration, this will inherently increase the angle by greater than 0). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include a bisecting line as taught by Shaolian in order to allow for radial compression and self-expansion (¶ [0053], Shaolian).
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Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Herrig evidenced by Hammerslag as applied to claim 1 above, and further in view of Belding (US 6,676,693 B1).
Regarding claim 16, Furnish in view of Herrig evidenced by Hammerslag fails to teach a pre-shaped flare. However, Belding discloses a delivery sheath that teaches the distal end of the frame comprises a pre-shaped flare (16, second portion, fig. 8) that is configured to stay in a compressed state at the unexpanded position and to assume a flared configuration upon passing the medical device (col 7, lines 41-50). Belding teaches that the pre-formed flare smooths and controls expansion of a self-expanding stent (col 7, lines 42-50), and that the compliant material forming a flare portion more easily adapts to tortuous anatomy and reduces trauma to surrounding tissue (col 5, lines 18-27). Since Furnish is directed towards the delivery of implantable medical devices ([0027], Furnish), one of ordinary skill in the art before the effective filling date of the claimed invention would have found it obvious to have modified the device of Furnish, Herrig and Hammerslag to include a pre-shaped flare, as taught by Belding, in order to provide a sheath that aids in controlling expansion of a medical device, more easily adapts to tortuous anatomy and reduces trauma to surrounding tissue (col 5, lines 18-27, Belding).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view of Hammerslag, Herrig and Belding as applied to claim 16 above, and further in view of Faber (US 2016/0184118 A1).
Regarding claim 17, Furnish in view of Herrig and Belding evidenced by Hammerslag fails to teach a filament. However, Faber discloses an expandable tubular medical device that teaches the pre-shaped flare is kept in the compressed state by a filament (184, ties, fig. 6) attached to one or more of the plurality of struts at the distal end of the frame(¶ [0048]) and extending circumferentially around the plurality of struts at the distal end (fig. 6, ¶ [0048]), wherein, when the distal end of the frame is in the expanded position, the filament stays attached to one or more of the plurality of struts at the distal end of the frame and does not extend circumferentially around the plurality of struts at the distal end thereby allowing the distal end of the frame to flare radially outward (The language “when the distal end of the frame is in the expanded position, the filament stays attached to one or more of the plurality of struts at the distal end of the frame and does not extend circumferentially around the plurality of struts at the distal end thereby allowing the distal end of the frame to flare radially outward” is functional language that is not given full patentable weight. The prior art is not required to explicitly disclose that the filament remains attached to the frame after being expanded. The capability for the tie taught by Faber to remain attached to the frame after expansion meets the functional claim requirements. As shown in fig. 7, Faber illustrates that the filament remains attached to the frame after expansion, at least for some period of time, and no longer encircles the frame. Since the modified Furnish assembly teaches all the claimed structural elements and is capable of performing the functional requirement, the modified Furnish device is considered to meet all the claim requirements.). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Hammerslag, Herrig and Belding to include a filament, as taught by Faber, in order to maintain the sheath in a compressed configuration until the sheath is positioned at the treatment location.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Herrig evidenced by Hammerslag as applied to claim 1 above, and further in view of Coyle (US 2017/0014157 A1).
Regarding claim 19, Furnish teaches the sheath further comprises one or more polymeric layers (22, inner layer, 24, outer layer, fig. 7A), wherein at least a portion of the frame is embedded within the one or more polymeric layers (fig. 7A, embedded is interpreted as surrounded).
Furnish in view of Herrig evidenced by Hammerslag fails to teach longitudinally extending folds. However, Coyle discloses an expandable introducer sheath that teaches the one or more polymeric layers comprise a plurality of longitudinally extending folds (see annotated fig. 13, below) wherein the sheath is at the first diameter d1, and wherein the longitudinally extending folds create a plurality of circumferentially spaced ridges (see annotated fig. 13, below) and a plurality of circumferentially spaced valleys (see annotated fig. 13, below), wherein, as the medical device passes through the sheath, the ridges and valleys level out to allow the sheath to radially expand (¶ [0038]), wherein the one or more polymeric layers have a first thickness wherein the sheath at the first diameter d1, and wherein, as the medical device passes through the sheath, the one or more polymeric layers are thinning out to a second thickness to allow the sheath to radially expand (polymer material is known for being elastic and stretching, when the medical device is passed through the sheath the polymeric layers would stretch and thin out). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Furnish, Herrig and Hammerslag to include longitudinally extending folds as taught by Coyle in order to reduce the diameter of the sheath (¶ [0027], Coyle).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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