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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/7/2026 has been entered.
Response to Amendments/ Arguments
Applicant’s arguments/ amendments, filed 8/7/2026, presented no arguments/ remarks concerning the priority of claims. As such, the previously established priority date of April 25, 2025 is being maintained for claim(s) 1-30.
Applicant's arguments/ amendments, with respect to the rejection of claim(s) 1-7, 10-17, 20-27, 30 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Lee et al. (US 2009/0105809 A1 – as previously cited), filed 8/7/2026, have been fully considered but they are not persuasive. Applicant argues:
Independent claims 1, 11, and 21 have been amended such that the first and second strut junction configure the stent frame to subsequently expand from the first stable expanded state to a second stable expanded state as the selected lumen grows while maintaining the axial flexibility of the stent frame; this amendment is a structural difference between the growth stent and the methods of use thereof (of claims 1, 11, 21) and are not part of an “intended use clause” (as argued by Examiner in the rejection dated 5/13/2026). Additionally, Lee et al. fails to teach or suggest the crossovers/ connections 30 (which Examiner was considering to be the first and second strut junctions as claimed) between the peak-to-peak interfaces enabling the stent to subsequently expand from the first stable expanded state to the second stable expanded state. Examiner disagrees with this argument. The crossovers/ connections 30 (which Examiner was and still is considering to be the first and second strut junctions as claimed) allow (and as such “enable”, which it appears Applicant is arguing as equivalent to “configure” within the claim) the stent (20, 70, 150) to expand from first stable expanded state (after initial balloon expansion) to a second stable expanded state (from balloon expansion after stent implantation) (paragraph [0105]).
Additionally, within the advisory action, dated 7/24/2026, Examiner argued that support could not be found within the originally filed disclosure for the first and second strut junctions configure the stent frame to subsequently expand from the first stable expanded state to a second stable expanded state as the selected lumen grows while maintaining the axial flexibility of the stent frame (which Examiner was/ can interpret as the first and second strut junctions have a structure which will result in the expansion from the first stable expanded state to a second stable expanded state). Applicant argues: the aforementioned claim amendment is fully supported by the original disclosure and the present patent application teaches “the size of each junction 170 of the flexible stent frame 110, for example can be optimized to allow re-expansion of the stent frame 110 over the large range of the growth stent 100” (citing paragraph [0115] of Applicant’s specifications). Applicant further argues that in selected embodiments the junction width 168 of the junctions 170 are optimized by balancing radial strength, crimp diameter and re-expansion range of the growth stent based on equation 1 (from Applicant’s specifications). As discussed below (see the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph below), when “the first and second strut junctions configure said flexible stent frame to subsequently expand from the first stable expanded state to a second stable expanded state as the selected lumen grows while maintaining the axial flexibility” is interpreted as the first and second strut junctions have a structure which will result in the expansion from the first stable expanded state to a second stable expanded state the Examiner still does not agree that the aforementioned citations provide support for the aforementioned claim requirement. First, Examiner can not find the aforementioned quote within paragraph [0115] of Applicant’s disclosure nor anywhere else within Applicant’s disclosure. The best Examiner can seem to find is in paragraph [0111] of Applicant specifications which discloses that a junction width is large enough to expand over a large range of diameters (i.e. the large range of diameters which could be associated with the first or second stable expanded states are not inhibited due to the width of the strut junctions). However, the strut junctions not failing (being capable of still working over a large range of diameters) does not equate to the strut junctions having a structure such that they (the struct junctions) are responsible for/ configure the overall expansion of the stent from the first to the second stable expanded state. Second, Equation 1 from Applicant’s disclosure is used to calculate the minimum/ smallest crimp diameter of the stent; while this does create a relationship between the junction width and the minimum crimp diameter it does not create a relationship with either the junction width nor the minimum crimp diameter and the strut junctions themselves being responsible for the expansion between the first and second stable expanded states. As can best be understood by Examiner, the expansion/ change in diameter of the stent between the initial cross section and the first and second stable expanded states is created by the change in angle between/ curvatures of the frame strut members, as can be seen in figs. 5A-5D; there does not appear to be any changes to the strut junctions, as seen in figs. 5A-5D, which would CAUSE/ configure the change of the stent from the first to the second stable expanded state.
Applicant’s arguments, filed 8/7/2026, presented no arguments/ remarks concerning the rejection of claim(s) 8-9, 18-19, 28-29 under 35 U.S.C. 103 based on Lee et al. (US 2009/0105809 A1 – as previously cited) and Harris et al. (US 2016/0095724 A1 – as previously cited).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-30 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 1, lines, 32-35 (and claim 11, lines 31-34; and claim 21, lines 35): Applicant claims, “wherein the first and second strut junctions configure said flexible stent frame to subsequently expand from the first stable expanded state to a second stable expanded state as the selected lumen grows while maintaining axial flexibility of said flexible stent frame” (which Examiner is interpreting as the first and second strut junctions have a structure which will cause/ result in the expansion from the first stable expanded state to a second stable expanded state); Applicant’s original disclosure fails to provide support for the aforementioned claim requirement. As can best be understood by Examiner, the expansion/ change in diameter of the stent between the initial cross section and the first and second stable expanded states is created by the change in angle between frame strut members/ change in curvatures of the frame strut members, as can be seen in figs. 5A-5D. There do not appear to be any changes to the strut junctions, as seen in figs. 5A-5D, which would CAUSE/ configure the change of the stent from the first to the second stable expanded state as required by the aforementioned claim requirement. Claim(s) 2-10, 12-20 and 22-30, which depend from claim(s) 1, 11 and 21, inherit all the problems associated with claim(s) 1, 11 and 21. (PLEASE NOTE: The aforementioned claim clause can be interpreted in one of two ways, see the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph (below); as such, the aforementioned 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection is only relevant in one the two interpretations.)
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(s) 1-30 is/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.
Within claim 1, lines, 32-35 (and claim 11, lines 31-34; and claim 21, lines 35): Applicant claims, “wherein the first and second strut junctions configure said flexible stent frame to subsequently expand from the first stable expanded state to a second stable expanded state as the selected lumen grows while maintaining axial flexibility of said flexible stent frame”; it is unclear, and therefore indefinite, what is meant by the first and second strut junctions configure said […] stent to subsequently expand. A first interpretation of the aforementioned claim requirement would be that the first and second strut junctions have a structure which will cause/ result in the expansion from the first stable expanded state to a second stable expanded state (which would be consistent with Applicant’s arguments that this is a structural difference from Lee et al. and would also explain Applicants’ referencing of optimization of the size for the junctions (170) and equation 1). However, strut junctions themselves don’t appear to cause (i.e. configure) the expansion/ change in diameter of the stent between the initial cross section and the first and second stable expanded states – instead the expansion/ change in diameter of the stent appears to be created by the change in angle between frame strut members/ change in curvatures of the frame strut members, as can be seen in figs. 5A-5D. A second interpretation of the aforementioned claim requirement would equate “configure” with “enable”. Support for this interpretation can be found within Applicant’s arguments/ remarks, dated 8/7/2026, Applicant argues Lee et al. does not disclose the cross-overs (or connections) 30 between the interfaces enable the stent to subsequently expand from the first to the second stable expanded state (see page 13 of Applicants’ response); as such, it appears Applicant is equating “configure” within the aforementioned claim requirement to “enable”. As such, it is unclear, and therefore indefinite, which of the two interpretations is intended for the aforementioned claim requirement. However, Claim(s) 2-10, 12-20 and 22-30, which depend from claim(s) 1, 11 and 21, inherit all the problems associated with claim(s) 1, 11 and 21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 10-17, 20-27, 30 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US 2009/0105809 A1 – as previously cited).
With respect to claim 1:
Lee et al. discloses a catheter-expandable and re-expandable flexible growth stent (stent 150), as can be seen in figs. 7A-7D, for implantation in a patient (paragraph [0169]), comprising:
an elongated flexible stent frame comprising first, second and third annular frame strut arrangements (three middle segments/ section 22, as seen in fig. 1A) being disposed in axial alignment between a proximal end region and a distal end region of said flexible stent frame (paragraphs [0122, 0169]), the first annular frame strut arrangement (one of segments/ section 22) having a first zigzag arrangement of first frame strut members (struts 24) with first peaks and first valleys (crowns 26, 28) (paragraph [0122]), the second annular frame strut arrangement (one of segments/ section 22) having a second zigzag arrangement of second frame strut members (struts 24) with second peaks and second valleys (crowns 26, 28) (paragraph [0122]), the third annular frame strut arrangement (one of segments/ section 22) being disposed between the first and second annular frame strut arrangements (adjacent segments/ sections 22) and having a third zigzag arrangement of third frame strut members (struts 24) with a third peak (crowns 26, 28) being coupled with a corresponding one of the first valleys to form a first strut junction (crossover 30, 152) and a fourth peak being disposed adjacent to a corresponding one of the first valleys to define a first intermediate gap (gap 34) and a third valley being coupled with a corresponding one of the second peaks to form a second strut junction (crossover 30, 152) and a fourth valley being disposed adjacent to a corresponding one of the second peaks to define a second intermediate gap (gap 34) (paragraphs [0122, 0169]), each of the third frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the first frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the first frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the third frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the second frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the second frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), the first and second intermediate gap (gaps 34) enhancing an axial flexibility of said flexible stent frame,
wherein said flexible stent frame has an initial cross-section (crimped configuration) for facilitating implantation within a selected lumen of the patient (paragraph [0129]), said flexible stent frame being configured to expand from the initial cross-section (crimped configuration) to a first stable expanded state (after initial balloon expansion) for supporting the selected lumen at implantation (paragraph [0129]), said flexible stent frame in the first stable expanded state (after initial balloon expansion) defining an internal channel with a first cross-section, and
wherein the first and second strut junctions (crossovers 30, 152) configure (i.e. enable) said flexible stent frame to subsequently expand from the first stable expanded state (after initial balloon expansion) to a second stable expanded state (from balloon expansion after stent implantation) as the selected lumen grows while maintaining the axial flexibility of said flexible stent frame (paragraph [0105]), said flexible stent frame in the second stable expanded state (from balloon expansion after stent implantation) continuing to support the selected lumen and defining the internal channel with a second cross-section being larger than the first cross-section (Please note: the aforementioned claim requirement is considered intended use language; a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior are in order to be patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner argues the first and second strut junctions (crossovers 30, 152), as disclosed by Lee et al., configure (i.e. enable/ allow) this subsequent expansion to a second stable expanded state. To support this, Examiner reads paragraph [0105] of Lee et al. - in a first clause from paragraph [0105] (including “The balloon expandable type of stent […] with the catheter)” Lee discloses an embodiment of the stent which is balloon expandable; in a second clause from paragraph [0105] (including “The self-expanding type […] recovery for ‘self-expansion’.”) discloses an embodiment of the stent which is self-expanding; in a third clause from paragraph [0105] Lee et al. states: “It is appreciated in either case, balloon dilation may be performed adjunctively to stenting, e.g. either before, during, or after stent implantation”. It is this third clause that Examiner would like to highlight - the “in either case” of the aforementioned clause is referring to either the balloon expandable stent (from the first aforementioned clause) OR the self-expanding stent (from the second aforementioned clause). Thus, in the case of a self-expanding stent Lee et al. is specifically disclosing the ability of the stent to self-expand (to a first stable state) and then (due to the “adjunctively” and the “after stent implantation”) being additionally dilated (i.e. expanded) by a balloon (to a second stable state). The “adjunctively” of this subsequent balloon expansion (as opposed to an expansion after the lumen grows) is irrelevant as the timing of the expansion (after the lumen grows) is an intended use clause. The self-expanding stent, as disclosed by Lee et al., is expanded to a first stable expanded state, then is expanded (dilated) to a second expanded state and this second round of expansion IS CAPABLE OF being done immediately OR at a later time after the lumen grows – there are no STRUCTURAL DIFFERENCES between the claimed intention and the stent, as disclosed by Lee et al..)
With respect to claim 2:
Wherein each third peak of the zigzag arrangement of the third frame strut members is coupled with a respective first valley of the zigzag arrangement of the first frame strut members to form respective first strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, and
wherein each third valley of the zigzag arrangement of the third frame strut members is coupled with a respective second peak of the zigzag arrangement of the second frame strut members to form respective second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D.
With respect to claim 3:
Wherein at least one of the first and second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, comprises an arcuate member (U-shape) for providing the axial flexibility of said flexible stent frame (paragraph [0169]).
With respect to claim 4:
Wherein the arcuate member (U-shape) is configured to (is capable of) provide a lever point for enabling said flexible stent frame to bend during implantation within the selected lumen (paragraph [0169]).
With respect to claim 5:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) collapse upon itself for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 6:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) open into a straighten member for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 7:
Wherein said flexible stent frame is made from cobalt chromium (paragraph [0104]).
With respect to claim 10:
Wherein the initial-first cross-section is less than or equal to eight millimeters (in order for the stent to have an expanded diameter of 2.5-4.5 mm, the initial (crimped) first cross section must be smaller than 2.5-4.5 mm) (paragraph [0165]);
wherein the first cross-section is between eight millimeters and ten millimeters; or
wherein the second cross-section is between fifteen millimeters and twenty millimeters.
With respect to claim 11:
Lee et al. discloses a method for implanting a catheter-expandable and re-expandable flexible growth stent (stent 150), as can be seen in figs. 7A-7D, for implantation in a patient (paragraph [0169]), comprising:
implanting an elongated flexible stent frame within a selected lumen of the patient, the flexible stent frame having an initial cross-section (crimped configuration) for facilitating implantation within the selected lumen and comprising first, second and third annular frame strut arrangements (three middle segments/ section 22, as seen in fig. 1A) being disposed in axial alignment between a proximal end region and a distal end region of the flexible stent frame (paragraphs [0122, 0129, 0169]), the first annular frame strut arrangement (one of segments/ section 22) having a first zigzag arrangement of first frame strut members (struts 24) with first peaks and first valleys (crowns 26, 28) (paragraph [0122]), the second annular frame strut arrangement (one of segments/ section 22) having a second zigzag arrangement of second frame strut members (struts 24) with second peaks and second valleys (crowns 26, 28) (paragraph [0122]), the third annular frame strut arrangement being disposed between the first and second annular frame strut arrangements and having a third zigzag arrangement of third frame strut members with a third peak being coupled with a corresponding one of the first valleys to form a first strut junction and a fourth peak being disposed adjacent to a corresponding one of the first valleys to define a first intermediate gap and a third valley being coupled with a corresponding one of the second peaks to form a second strut junction and a fourth valley being disposed adjacent to a corresponding one of the second peaks to define a second intermediate gap, the third annular frame strut arrangement (one of segments/ section 22) being disposed between the first and second annular frame strut arrangements (adjacent segments/ sections 22) and having a third zigzag arrangement of third frame strut members (struts 24) with a third peak (crowns 26, 28) being coupled with a corresponding one of the first valleys to form a first strut junction (crossover 30, 152) and a fourth peak being disposed adjacent to a corresponding one of the first valleys to define a first intermediate gap (gap 34) and a third valley being coupled with a corresponding one of the second peaks to form a second strut junction (crossover 30, 152) and a fourth valley being disposed adjacent to a corresponding one of the second peaks to define a second intermediate gap (gap 34) (paragraphs [0122, 0169]), each of the third frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the first frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the first frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the third frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the second frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the second frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), the first and second intermediate gap (gaps 34) enhancing an axial flexibility of said flexible stent frame; and
expanding the flexible stent frame from the initial cross-section (crimped configuration) to a first stable expanded state (after initial balloon expansion) for supporting the selected lumen at implantation (paragraph [0129]), said flexible stent frame in the first stable expanded state (after initial balloon expansion) defining an internal channel with a first cross-section, and
wherein the first and second strut junctions (crossovers 30, 152) configure (i.e. enable) said flexible stent frame to subsequently expand from the first stable expanded state (after initial balloon expansion) to a second stable expanded state (from balloon expansion after stent implantation) as the selected lumen grows while maintaining the axial flexibility of said flexible stent frame (paragraph [0105]), said flexible stent frame in the second stable expanded state (from balloon expansion after stent implantation) continuing to support the selected lumen and defining the internal channel with a second cross-section being larger than the first cross-section (Please note: the aforementioned claim requirement is considered intended use language; a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior are in order to be patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner argues the first and second strut junctions (crossovers 30, 152), as disclosed by Lee et al., configure (i.e. enable/ allow) this subsequent expansion to a second stable expanded state. To support this, Examiner reads paragraph [0105] of Lee et al. - in a first clause from paragraph [0105] (including “The balloon expandable type of stent […] with the catheter)” Lee discloses an embodiment of the stent which is balloon expandable; in a second clause from paragraph [0105] (including “The self-expanding type […] recovery for ‘self-expansion’.”) discloses an embodiment of the stent which is self-expanding; in a third clause from paragraph [0105] Lee et al. states: “It is appreciated in either case, balloon dilation may be performed adjunctively to stenting, e.g. either before, during, or after stent implantation”. It is this third clause that Examiner would like to highlight - the “in either case” of the aforementioned clause is referring to either the balloon expandable stent (from the first aforementioned clause) OR the self-expanding stent (from the second aforementioned clause). Thus, in the case of a self-expanding stent Lee et al. is specifically disclosing the ability of the stent to self-expand (to a first stable state) and then (due to the “adjunctively” and the “after stent implantation”) being additionally dilated (i.e. expanded) by a balloon (to a second stable state). The “adjunctively” of this subsequent balloon expansion (as opposed to an expansion after the lumen grows) is irrelevant as the timing of the expansion (after the lumen grows) is an intended use clause. The self-expanding stent, as disclosed by Lee et al., is expanded to a first stable expanded state, then is expanded (dilated) to a second expanded state and this second round of expansion IS CAPABLE OF being done immediately OR at a later time after the lumen grows – there are no STRUCTURAL DIFFERENCES between the claimed intention and the stent, as disclosed by Lee et al..)
With respect to claim 12:
Wherein each third peak of the zigzag arrangement of the third frame strut members is coupled with a respective first valley of the zigzag arrangement of the first frame strut members to form respective first strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, and
wherein each third valley of the zigzag arrangement of the third frame strut members is coupled with a respective second peak of the zigzag arrangement of the second frame strut members to form respective second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D.
With respect to claim 13:
Wherein at least one of the first and second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, comprises an arcuate member (U-shape) for providing the axial flexibility of said flexible stent frame (paragraph [0169]).
With respect to claim 14:
Wherein the arcuate member (U-shape) is configured to (is capable of) provide a lever point for enabling said flexible stent frame to bend during implantation within the selected lumen (paragraph [0169]).
With respect to claim 15:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) collapse upon itself for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 16:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) open into a straighten member for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 17:
Wherein said flexible stent frame is made from cobalt chromium (paragraph [0104]).
With respect to claim 20:
Wherein the initial-first cross-section is less than or equal to eight millimeters (in order for the stent to have an expanded diameter of 2.5-4.5 mm, the initial (crimped) first cross section must be smaller than 2.5-4.5 mm) (paragraph [0165]);
wherein the first cross-section is between eight millimeters and ten millimeters; or
wherein the second cross-section is between fifteen millimeters and twenty millimeters.
With respect to claim 21:
Lee et al. discloses a method of manufacturing a catheter-expandable and re-expandable flexible growth stent (stent 150), as can be seen in figs. 7A-7D, for implantation in a patient (paragraph [0103, 0128, 0169]), comprising:
Forming an elongated flexible stent frame having an initial cross-section (crimped configuration) and an axial flexibility for facilitating implantation within a selected lumen of the patient and comprising first, second and third annular frame strut arrangements (three middle segments/ section 22, as seen in fig. 1A) being disposed in axial alignment between a proximal end region and a distal end region of said flexible stent frame (paragraphs [0122, 0169]), the first annular frame strut arrangement (one of segments/ section 22) having a first zigzag arrangement of first frame strut members (struts 24) with first peaks and first valleys (crowns 26, 28) (paragraph [0122]), the second annular frame strut arrangement (one of segments/ section 22) having a second zigzag arrangement of second frame strut members (struts 24) with second peaks and second valleys (crowns 26, 28) (paragraph [0122]), the third annular frame strut arrangement (one of segments/ section 22) being disposed between the first and second annular frame strut arrangements (adjacent segments/ sections 22) and having a third zigzag arrangement of third frame strut members (struts 24) with a third peak (crowns 26, 28) being coupled with a corresponding one of the first valleys to form a first strut junction (crossover 30, 152) and a fourth peak being disposed adjacent to a corresponding one of the first valleys to define a first intermediate gap (gap 34) and a third valley being coupled with a corresponding one of the second peaks to form a second strut junction (crossover 30, 152) and a fourth valley being disposed adjacent to a corresponding one of the second peaks to define a second intermediate gap (gap 34) (paragraphs [0122, 0169]), each of the third frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the first frame strut members (struts 24) associated with the first strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the first frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the third frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the third frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), each of the second frame strut members (struts 24) associated with the second strut junction (crossover 30, 152) having proximal and distal end regions (minimum filament width 100, as can be seen in fig. 2A) with respective cross-sections that are less than a cross-section of a central region (maximum strut width 54) of the second frame strut member (struts 24) (paragraphs 0126, 0128, 0132]), the first and second intermediate gap (gaps 34) enhancing an axial flexibility of said flexible stent frame,
wherein the flexible stent frame is configured to be expandable from the initial cross-section (crimped configuration) to a first stable expanded state (after initial balloon expansion) for supporting the selected lumen at implantation (paragraph [0129]), the flexible stent frame in the first stable expanded state (after initial balloon expansion) defining an internal channel with a first cross-section, and
wherein the first and second strut junctions (crossovers 30, 152) configure (i.e. enable) said flexible stent frame to subsequently expand from the first stable expanded state (after initial balloon expansion) to a second stable expanded state (from balloon expansion after stent implantation) as the selected lumen grows while maintaining the axial flexibility of said flexible stent frame (paragraph [0105]), said flexible stent frame in the second stable expanded state (from balloon expansion after stent implantation) continuing to support the selected lumen and defining the internal channel with a second cross-section being larger than the first cross-section (Please note: the aforementioned claim requirement is considered intended use language; a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior are in order to be patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner argues the first and second strut junctions (crossovers 30, 152), as disclosed by Lee et al., configure (i.e. enable/ allow) this subsequent expansion to a second stable expanded state. To support this, Examiner reads paragraph [0105] of Lee et al. - in a first clause from paragraph [0105] (including “The balloon expandable type of stent […] with the catheter)” Lee discloses an embodiment of the stent which is balloon expandable; in a second clause from paragraph [0105] (including “The self-expanding type […] recovery for ‘self-expansion’.”) discloses an embodiment of the stent which is self-expanding; in a third clause from paragraph [0105] Lee et al. states: “It is appreciated in either case, balloon dilation may be performed adjunctively to stenting, e.g. either before, during, or after stent implantation”. It is this third clause that Examiner would like to highlight - the “in either case” of the aforementioned clause is referring to either the balloon expandable stent (from the first aforementioned clause) OR the self-expanding stent (from the second aforementioned clause). Thus, in the case of a self-expanding stent Lee et al. is specifically disclosing the ability of the stent to self-expand (to a first stable state) and then (due to the “adjunctively” and the “after stent implantation”) being additionally dilated (i.e. expanded) by a balloon (to a second stable state). The “adjunctively” of this subsequent balloon expansion (as opposed to an expansion after the lumen grows) is irrelevant as the timing of the expansion (after the lumen grows) is an intended use clause. The self-expanding stent, as disclosed by Lee et al., is expanded to a first stable expanded state, then is expanded (dilated) to a second expanded state and this second round of expansion IS CAPABLE OF being done immediately OR at a later time after the lumen grows – there are no STRUCTURAL DIFFERENCES between the claimed intention and the stent, as disclosed by Lee et al..)
With respect to claim 22:
Wherein each third peak of the zigzag arrangement of the third frame strut members is coupled with a respective first valley of the zigzag arrangement of the first frame strut members to form respective first strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, and
wherein each third valley of the zigzag arrangement of the third frame strut members is coupled with a respective second peak of the zigzag arrangement of the second frame strut members to form respective second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D.
With respect to claim 23:
Wherein at least one of the first and second strut junctions (crossover 30, 152), as can be seen in figs. 7A-7D, comprises an arcuate member (U-shape) for providing the axial flexibility of said flexible stent frame (paragraph [0169]).
With respect to claim 24:
Wherein the arcuate member (U-shape) is configured to (is capable of) provide a lever point for enabling said flexible stent frame to bend during implantation within the selected lumen (paragraph [0169]).
With respect to claim 25:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) collapse upon itself for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 26:
Wherein the arcuate member (U-shape) comprises a c-shaped member (the curving portion at the base of the “U”) that is configured to (is capable of) open into a straighten member for providing the bend in said flexible stent frame (paragraph [0169]).
With respect to claim 27:
Wherein said flexible stent frame is made from cobalt chromium (paragraph [0104]).
With respect to claim 30:
Wherein the initial-first cross-section is less than or equal to eight millimeters (in order for the stent to have an expanded diameter of 2.5-4.5 mm, the initial (crimped) first cross section must be smaller than 2.5-4.5 mm) (paragraph [0165]);
wherein the first cross-section is between eight millimeters and ten millimeters; or
wherein the second cross-section is between fifteen millimeters and twenty millimeters.
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) 8-9, 18-19, 28-29is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2009/0105809 A1 – as previously cited) in view of Harris et al. (US 2016/0095724 A1 – as previously cited).
Lee et al. discloses the invention substantially as claimed, as discussed above. However, Lee et al. does not disclose the growth stent (stent 150) to further comprises a fluid-impermeable covering for enclosing a periphery of the stent frame and preventing leaks due to in-growth (as required by claims 8-9, 18-19, 28-29).
Harris et al. teaches a vascular stent (stent 10), as can be seen in figs. 1-13B (paragraphs [0054, 0060]). The vascular stent (stent 10) comprising a stent frame (scaffold 18) and a covering (cover 60) for enclosing the periphery of the stent frame (scaffold 16) (paragraphs [0055, 0072-0073]), wherein said covering (cover 60) comprises a fluid-impermeable covering for preventing leaks (paragraphs [0072-0073]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the fluid-impermeable covering (cover 60), as taught by Harris et al., on the growth stent (stent 150), as disclosed by Lee et al., in order to prevent the tissue from growing through the growth stent (stent 150) an occluding the vessel (Harris et al. paragraph [0073]).
Conclusion
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
