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 .
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 12 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.
Regarding claim 12, the claim recites “the method of claim 1, wherein the knitted, braided, or woven stent blank has a constant diameter along an entire length of the stent” which renders the claim indefinite because claim 1 discloses that the mandrel on which the stent blank is placed has a tapered outer surface, i.e., when the blank is positioned on the mandrel it will have a portion that engages the tapered surface which would cause it to have a variance in diameter. It is unclear if the blank is supposed to have a contact diameter at all times, before it is placed on the mandrel or when it is on the mandrel before it becomes a stent (it is noted that the method steps before the final disengaging step still refer to this component as the stent blank, such as “annealing the knitted braided, or woven stent blank while disposed on the mandrel”). For the purpose of examination, this claim will be interpreted as the stent has a constant diameter over an entire length of a portion of the stent, e.g., the portions on either side of the taper.
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 1-4, 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0043373 A1 to Arnault in view of US 2016/0213498 A1 to Wang.
Regarding claim 1, Arnault teaches a method of manufacturing a stent having anti-migration features (Abstract; Figs. 1-5) comprising:
disposing a knitted, braided, or woven stent blank in position over a mandrel 110 (Para. [0058]; Fig. 7), the mandrel 110 including one or more anti-migration feature forming elements 114 (Fig. 7; Para. [0058]; the mandrel includes pins inserted into the pinholes 114, and the blank is secured to the pins to prevent migration);
engaging a wire of the knitted, braided, or woven stent blank with the one or more anti-migration feature forming elements to form an anti-migration feature (Fig. 7; Para. [0058]; it is noted that anti-migration forming elements are being interpreted as elements on the mandrel that prevents migration and the method step includes engaging the anti-migration elements to form anti-migration features, i.e., the anti-migration elements do not perform the function of forming anti-migration features and are therefore not interpreted under 112f because an engaging step is being performed using the anti-migration elements to form these features.);
annealing the knitted, braided, or woven stent blank while disposed on the mandrel to form a shaped stent with the anti-migration feature (Para. [0062]); and
disengaging the one or more anti-migration feature forming elements and removing the shaped stent from the mandrel (Para. [0062]; the pins are removed after the mandrel and blank has cooled after the heating process, and then the stent is removed from the mandrel).
Arnault fails to explicitly teach the mandrel including a tapered outer surface.
Wang teaches a method for forming a stent using a mandrel (Abstract; Figs. 18-21) wherein the mandrel includes a first section with a first diameter, a second section with a second diameter and a tapered outer surface extending between the two sections (Figs. 18-21; Para. [0075]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include a tapered outer surface extending between two sections as taught by Wang so that a stent with different shapes and sizes may be produced to have a form corresponding to situations requiring such changes in shape (Wang, Paras. [0075]-[0076]).
Regarding claim 2, modified Arnault teaches the method of claim 1 (Fig. 7), wherein the one or more anti-migration feature forming elements comprise a plurality of pins (Para. [0058]; pins are inserted into the pin holes 114) that are configured to be driven in a radially outward direction relative to a central longitudinal axis of the mandrel (Fig. 7; Para. [0062]; the pins are engaged by an inner piece within the mandrel that moves them into or out of the holes in the mandrel depending on the state of the process), and engaging the wire with the one or more anti-migration feature forming elements comprises driving the pins in the radially outward direction relative to the central longitudinal axis of the mandrel (Para. [0062]; the pins engage the wire when they are driven outwardly from the holes to perform the forming operation).
Regarding claim 3, modified Arnault teaches the method of claim 2 (Fig. 7), wherein disengaging the one or more anti-migration feature forming elements comprises permitting the pins to move in a radially inward direction relative to the central longitudinal axis of the mandrel (Para. [0062]; the movement of the inner piece within the mandrel can also move the pins radially inward, such as at the end of the operation when the pins are moved in to disengage the stent to allow it to be removed from the mandrel).
Regarding claim 4, modified Arnault teaches the method of claim 2 (Fig. 7), wherein disposing the knitted, braided, or woven stent blank in position over the mandrel comprises stretching the knitted, braided, or woven stent blank over the mandrel and allowing the knitted, braided, or woven stent blank to conform to the tapered outer surface of the mandrel (Wang, Figs. 18-21; modified Arnault includes the tapered surface of Wang, which teaches the wire is stretched over the tapered surface such that it conforms to the shape of the mandrel).
Regarding claim 12, modified Arnault teaches the method of claim 1 (Fig. 7), wherein the knitted, braided, or woven stent blank has a constant diameter along an entire length of the stent (Fig. 7; as discussed in the indefiniteness rejection above, this limitation is interpreted as the blank has a constant diameter along an entire length of a portion of the stent, and Arnault teaches that at least one of the segments has a portion with constant diameter, e.g., the portion on the other side of the taper that does not include any segments 116).
Regarding claim 20, Arnault teaches a method of manufacturing a stent having anti-migration features (Abstract; Figs. 1-5) comprising:
disposing a stent formed from one or more wires over a mandrel 110 (Fig. 7; Para. [0058]);
engaging a portion of at least one wire of the stent with at least some of the plurality of pins (Fig. 7; Paras. [0058] and [0062]);
moving the plurality of pins radially outward to form a plurality of anti-migration features (Para. [0062]);
annealing the stent while disposed on the mandrel to form a shaped stent with the anti-migration features (Para. [0062]); and
removing the shaped stent from the mandrel 110 (Para. [0062]).
Arnault fails to explicitly teach the mandrel including a tapered region and a plurality of moveable pins extending through a plurality of apertures in the tapered region.
Wang teaches a method for forming a stent using a mandrel (Abstract; Figs. 18-21) wherein the mandrel includes a first section with a first diameter, a second section with a second diameter and a tapered outer surface extending between the two sections (Figs. 18-21; Para. [0075]) with a plurality of pins extending through the tapered region (Figs. 18-21 show the pins at the top and bottom of the tapered region).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include a tapered outer surface extending between two sections with pins in the tapered region as taught by Wang so that a stent with different shapes and sizes may be produced to have a form corresponding to situations requiring such changes in shape (Wang, Paras. [0075]-[0076]). It is noted that modifying Arnault to include the pins in the tapered region results in movable pins and apertures in the tapered region as Arnault teaches the pins of the mandrel being movable through apertures.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of US 1,945,195 to Kellem.
Regarding claim 5, modified Arnault teaches the method of claim 2 (Fig. 7).
Arnault fails to explicitly teach wherein an end of each of the pins includes a recessed slot, wherein engaging the wire of the knitted, braided, or woven stent blank with the one or more anti-migration feature forming elements includes placing a section of the wire of the knitted, braided, or woven stent blank into the recessed slot of each pin.
Kellem teaches a method for forming a stent using a mandrel having a plurality of pins (Figs. 1-5), wherein an end of each of the pins 2 includes a recessed slot, wherein engaging the wire of the knitted, braided, or woven stent blank with the one or more anti-migration feature forming elements includes placing a section of the wire of the knitted, braided, or woven stent blank into the recessed slot of each pin (Figs. 1, 3, 5; P. 2, Lns. 98-112; the pins 2 each include a recessed slot at the end of the pin and the wire is received within the slots to prevent displacement during formation).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include a recessed slot on each pin as taught by Kellem so that the pins can receive and temporarily retain the wire during formation operations and prevent accidental displacement of the wire during forming operations (Kellem, P. 2, Lns. 98-112).
Regarding claim 6, modified Arnault teaches the method of claim 5 (Fig. 7), wherein the mandrel includes a main bore extending within the mandrel, a plurality of apertures 114 formed in the mandrel, and an actuation element configured to be inserted into the main bore (Para. [0062]; Fig. 7; the mandrel includes an inner piece that moves within the mandrel to extend or retract the pins through the pin holes 114, i.e., apertures, and the inner piece and retracted pins would be positioned within main bore, e.g., a bore must be present for the inner piece to be moveable and the pins to be retracted within the mandrel), wherein the plurality of pins extend through the plurality of apertures 114 (Para. [0062]), wherein placing the section of the wire into the recessed slot of each pin includes moving the actuation element into the main bore causing the pins and the section of the wire in the recessed slot of each pin to be urged radially outward from the knitted, braided, or woven stent blank forming the anti-migration feature (Para. [0062] and Kellem, Figs. 1, 3, and 5; P. 2, Lns. 98-112; modified Arnault includes the recessed slots on each pin of Kellem, and Arnault teaches extending the pins outwardly from the apertures which would cause the pins and the wire in the slot to be urged radially outward).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of Kellem in further view of GB 2399837 A to Weatherford.
Regarding claim 7, modified Arnault teaches the method of claim 6 (Fig. 7).
Arnault fails to explicitly teach wherein the actuation element includes a tapered surface configured to engage the plurality of pins, wherein moving the actuation element into the main bore causes the tapered surface to support and move the plurality of pins radially outward.
In the field of mandrels used for forming products on the outer surface of the mandrel, Weatherford teaches a mandrel 14 having a body with a bore (Figs. 7-10) including at least one aperture, at least one pin 16 that may be moved to extend through the at least one aperture (P. 22, Ln. 16 through P. 23, Ln. 7; Figs. 1 and 7-10) and an actuation element 26b including a tapered surface configured to support the pins extending from one or more apertures (Figs. 7-10; P. 35, Ln. 3 through P. 36, Ln. 22).
It would have been obvious to substitute the inner piece of Arnault with the inner piece of Weatherford as these components and their functions were well known in the art and a person of ordinary skill in the art could substitute each of these known elements for another with the predictable result of providing an actuation element within a mandrel to position the movable pins in the mandrel.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of Kellem in further view of US 2009/0285925 A1 to Myers.
Regarding claim 8, modified Arnault teaches the method of claim 6 (Fig. 7).
Arnault fails to explicitly teach the actuation element threadably engages the main bore, wherein moving the actuation element includes rotating the actuation element in a first direction into the main bore.
In the field of mandrels, Myers teaches a mandrel 10 including an actuating element 18 that is threadably engaged with the bore of the mandrel and wherein moving the actuation element includes rotating the actuation element in a first direction into the main bore (Figs. 1-5; Para. [0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the actuating element of Arnault to be threadably engaged with the bore and movable via rotation of the actuation element as taught by Myers so that the movement and position of the actuating element may be precisely controlled via the rotation of the actuating element.
Regarding claim 9, modified Arnault teaches the method of claim 8 (Fig. 7), wherein disengaging the one or more anti-migration feature forming elements includes rotating the actuation element in a second direction opposite the first direction (Para. [0062]; modified Arnault includes the actuation element being threadably engaged and moving the element via rotation as taught by Myers, which would result in the actuation element disengaging the pins by rotating the actuation in the second direction to move it in the opposite direction).
Claims 10-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of US 2005/0283962 A1 to Boudjemline.
Regarding claim 10, modified Arnault teaches the method of claim 1 (Fig. 7).
Arnault fails to explicitly teach wherein the mandrel includes a first stent shaping segment having a first diameter, a second stent shaping segment having a second diameter less than the first diameter, and a third stent shaping segment having a third diameter larger than the second diameter. Arnault teaches the mandrel having multiple shaping segments that “may have any suitable shape, size, length, diameter, etc. to form the desired stent configuration” (Para. [0058]), but is silent regarding the size of the diameters of each segment relative to each other.
Boudjemline teaches a mandrel comprising a first stent shaping segment 20 having a first diameter (Figs. 7-9), a second shaping segment having a second diameter that is less than the first diameter (Figs. 7-9) and a third stent shaping segment having a third diameter larger than the second (Figs. 7-9).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include the stent shaping segments of varying diameter as taught by Boudjemline so that a stent having a central narrowing could be produced and used in situation that require such a structure (Boudjemline, Para. [0073]).
Regarding claim 11, modified Arnault teaches the method of claim 10 (Fig. 7), wherein the third stent shaping segment is defined by a mandrel cap releasably secured to the mandrel, wherein after disengaging the one or more anti-migration feature forming elements, the method further comprises removing the mandrel cap and then removing the shaped stent from the mandrel (Boudjemline, Figs. 7-8; Paras. [0074]-[0075]; modified Arnault includes the shaping segments of Boudjemline, which teaches that “[o]ne of the portions 21 is dismountable with respect to the portion 21,” thus the disengaging step would include both removing the third shaping segment after disengaging the anti-migration features to remove the shaped stent).
Regarding claim 13, Arnault teaches a method of manufacturing a stent having anti-migration features (Abstract, Figs. 1-5) comprising:
disposing a stent formed from one or more wires over a mandrel 110 (Para. [0058]; Fig. 7), the mandrel 110 including a plurality of moveable pins extending through apertures in the tapered region (Fig. 7; Para. [0058]; the mandrel includes pins inserted into the pinholes 114, and the blank is secured to the pins to prevent migration);
engaging a portion of a wire of the stent with at least some of the plurality of pins to form a plurality of anti-migration features (Fig. 7; Para. [0058]);
annealing the stent while disposed on the mandrel 110 to form a shaped stent with the anti-migration features (Para. [0062]);
disengaging the plurality of pins (Para. [0062]); and
removing the shaped stent from the mandrel 110 (Para. [0062]).
Arnault fails to explicitly teach the mandrel including a first stent shaping segment having a first diameter, a second stent shaping segment having a second diameter smaller than the first diameter, a tapered region connecting the first and second stent shaping segments.
Boudjemline teaches a mandrel comprising a first stent shaping segment 20 having a first diameter (Figs. 7-9), a second shaping segment having a second diameter that is less than the first diameter (Figs. 7-9) and a third stent shaping segment having a third diameter larger than the second (Figs. 7-9).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include the stent shaping segments of varying diameter as taught by Boudjemline so that a stent having a central narrowing could be produced and used in situation that require such a structure (Boudjemline, Para. [0073]).
Wang teaches a method for forming a stent using a mandrel (Abstract; Figs. 18-21) wherein the mandrel includes a first section with a first diameter, a second section with a second diameter and a tapered outer surface extending between the two of differing diameter sections (Figs. 18-21; Para. [0075]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include a tapered outer surface extending between two sections as taught by Wang so that a stent with different shapes and sizes may be produced to have a form corresponding to situations requiring such changes in shape (Wang, Paras. [0075]-[0076]) as well as supporting the blank extending between the sections of varying diameter.
Regarding claim 14, modified Arnault teaches the method of claim 13 (Fig. 7), wherein disposing the stent over the mandrel includes stretching a knitted, braided, or woven stent blank over the mandrel and allowing the stent blank to conform to the first and second stent shaping segments and the tapered region (Fig. 7; Para. [0058]; modified Arnault includes the tapered surface and segments with various diameters taught by Wang and Boudjemline, and the stretching step in Arnault would include stretching over these components in the modified device).
Regarding claim 15, modified Arnault teaches the method of claim 13 (Fig. 7), wherein disposing the stent over the mandrel includes braiding the stent onto the mandrel (Para. [0058]; the wire is positioned on the pins of the mandrel, and it is noted that braided is interpreted as the engaging of the wires of the stent with the pins).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of Boudjemline in further view of Kellem.
Regarding claim 16, modified Arnault teaches the method of claim 13 (Fig. 7).
Arnault fails to explicitly teach wherein an end of each of the pins includes a recessed slot, wherein engaging the portion of the wire of the stent with at least some of the plurality of pins includes placing the portion of the wire of the stent into the recessed slot of each pin.
Kellem teaches a method for forming a stent using a mandrel having a plurality of pins (Figs. 1-5), wherein an end of each of the pins 2 includes a recessed slot, wherein engaging the wire of the knitted, braided, or woven stent blank with the one or more anti-migration feature forming elements includes placing a section of the wire of the knitted, braided, or woven stent blank into the recessed slot of each pin (Figs. 1, 3, 5; P. 2, Lns. 98-112; the pins 2 each include a recessed slot at the end of the pin and the wire is received within the slots to prevent displacement during formation).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the mandrel of Arnault to include a recessed slot on each pin as taught by Kellem so that the pins can receive and temporarily retain the wire during formation operations and prevent accidental displacement of the wire during forming operations (Kellem, P. 2, Lns. 98-112).
Regarding claim 17, modified Arnault teaches the method of claim 16 (Fig. 7), wherein the mandrel 110 includes a main bore extending within the mandrel and an actuation element configured to be inserted into the main bore (Para. [0062]; Fig. 7; the mandrel includes an inner piece that moves within the mandrel to extend or retract the pins through the pin holes 114, i.e., apertures, and the inner piece and retracted pins would be positioned within main bore, e.g., a bore must be present for the inner piece to be moveable and the pins to be retracted within the mandrel), wherein placing the portion of the wire into the recessed slot of each pin includes moving the actuation element into the main bore causing the pins and the section of the wire in the recessed slot of each pin to be urged radially outward from the knitted, braided, or woven stent blank forming the plurality of anti-migration features (Para. [0062] and Kellem, Figs. 1, 3, and 5; P. 2, Lns. 98-112; modified Arnault includes the recessed slots on each pin of Kellem, and Arnault teaches extending the pins outwardly from the apertures which would cause the pins and the wire in the slot to be urged radially outward).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of Boudjemline in further view of Kellem in further view of Weatherford.
Regarding claim 18, modified Arnault teaches the method of claim 17 (Fig. 7).
Arnault fails to explicitly teach the actuation element includes a tapered surface configured to engage the plurality of pins, wherein moving the actuation element into the main bore causes the tapered surface to support and move the plurality of pins radially outward.
In the field of mandrels used for forming products on the outer surface of the mandrel, Weatherford teaches a mandrel 14 having a body with a bore (Figs. 7-10) including at least one aperture, at least one pin 16 that may be moved to extend through the at least one aperture (P. 22, Ln. 16 through P. 23, Ln. 7; Figs. 1 and 7-10) and an actuation element 26b including a tapered surface configured to support the pins extending from one or more apertures (Figs. 7-10; P. 35, Ln. 3 through P. 36, Ln. 22).
It would have been obvious to substitute the inner piece of Arnault with the inner piece of Weatherford as these components and their functions were well known in the art and a person of ordinary skill in the art could substitute each of these known elements for another with the predictable result of providing an actuation element within a mandrel to position the movable pins in the mandrel.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Arnault in view of Wang in further view of Boudjemline in further view of Kellem in further view of Myers.
Regarding claim 19, modified Arnault teaches the method of claim 17 (Fig. 7).
Arnault fails to explicitly teach wherein the actuation element threadably engages the main bore, wherein moving the actuation element includes rotating the actuation element in a first direction into the main bore.
In the field of mandrels, Myers teaches a mandrel 10 including an actuating element 18 that is threadably engaged with the bore of the mandrel and wherein moving the actuation element includes rotating the actuation element in a first direction into the main bore (Figs. 1-5; Para. [0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the actuating element of Arnault to be threadably engaged with the bore and movable via rotation of the actuation element as taught by Myers so that the movement and position of the actuating element may be precisely controlled via the rotation of the actuating element.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2020/0121444 A1 teaches a mandrel for forming a stent including apertures on a tapered surface of the mandrel (Figs. 1-5). US 2004/0098099 A1 teaches a mandrel for forming a stent including a tapered surface and pins on the surface of the mandrel (Fig. 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW STEPHENS whose telephone number is (571)272-6722. The examiner can normally be reached M-F 930-630.
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/MATTHEW STEPHENS/Examiner, Art Unit 3725
/Christopher L Templeton/Supervisory Patent Examiner, Art Unit 3725