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(s) 9, 12-15 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 9, lines 1-2: Applicant claims, “a diameter of the inflatable body increases upon inflation of the inflatable body”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the scope of the claim is determined by the preamble, which is to the dilation device; however, the aforementioned claim requirement is claiming a step of method of using the dilation device by positively reciting the diameter change due to the inflation of the inflatable body.
Within claim 12, lines 1-2: Applicant claims, “the lubricious exterior surface comprises a lubricious coating on the inflatable body”; it is unclear, and therefore indefinite, whether the lubricious coating/ lubricious exterior surface is: ON as in NOT part of the inflatable body (as required by the aforementioned claim requirement); OR is part of the inflatable body (as required by the claim 11, lines 4-5). Claim(s) 13-14, which depend from claim 12, inherit all the problems associated with claim 12.
Within claim 15, lines 1-2: Applicant claims, “the lubricious exterior surface comprises a surface thermally bonded to the inflatable body”; it is unclear, and therefore indefinite, whether the thermally bonded surface/ lubricious exterior surface is: bonded TO as in NOT part of the inflatable body (as required by the aforementioned claim requirement); OR is part of the inflatable body (as required by the claim 11, lines 4-5).
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) 1-3, 6-19 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Holman et al. (US 2008/0114331 A1).
With respect to claim 1:
Holman et al. discloses a dilation device (balloon catheter 100), as can be seen in figs. 1-4, for an implant (stent 147) (paragraph [0054]), the dilation device (balloon catheter 100) comprising:
An inflatable body (balloon 105) having a proximal end (proximal waist portion 140) and a distal end (distal waist portion 145) (paragraph [0054]), and a central body (body portion 125) positioned between the proximal end (proximal waist portion 140) and the distal end (distal waist portion 145) and having a length (paragraph [0054]), the central body (body portion 125) configured to press an inner surface of the implant to dilate the implant (stent 147) (paragraph [0056]), the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than or equal to one half a thickness of the inflatable body (balloon 105), as can be seen in figs. 6C-6D (paragraph [0063]) (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/ unfolding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than or equal to one half a thickness of the inflatable body (balloon 105)).
With respect to claim 2:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body. (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than a thickness of the inflatable body (balloon 105)).
With respect to claim 3:
Wherein the at least one outer inflatable body fold radius of curvature is greater than two times the thickness of the inflatable body. (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than two times a thickness of the inflatable body (balloon 105)).
With respect to claim 6:
Wherein the inflatable body (balloon 105) includes an interior lumen (inflation lumen 120) for fluid flow (paragraph [0059]).
With respect to claim 7:
Wherein the inflatable body (balloon 105) includes a plurality of folds (four wings when fully folded) (paragraphs [0063, 0065]).
With respect to claim 8:
Wherein the plurality of folds (four wings when fully folded) are configured to unfurl during inflation of the inflatable body (balloon 105), as can be seen in figs. 3-4 (paragraph [0056]).
With respect to claim 9:
Wherein a diameter of the inflatable body (balloon 105) is configured to increase upon inflation of the inflatable body (balloon 105), as can be seen in figs. 3-4 (paragraph [0056]).
With respect to claim 10:
Wherein the inflatable body (balloon 105) includes a distal shoulder (distal cone portion 135) (paragraph [0054]).
With respect to claim 11:
Holman et al. discloses a dilation device (balloon catheter 100), as can be seen in figs. 1-4, for an implant (stent 147) (paragraph [0054]), the dilation device (balloon catheter 100) comprising:
An inflatable body (balloon 105) having a proximal end (proximal waist portion 140) and a distal end (distal waist portion 145) (paragraph [0054]), and a central body (body portion 125) positioned between the proximal end (proximal waist portion 140) and the distal end (distal waist portion 145) and having a length (paragraph [0054]), the central body (body portion 125) configured to press an inner surface of the implant to dilate the implant (stent 147) (paragraph [0056]), the inflatable body (balloon 105) including a lubricious exterior surface (exterior surface of balloon 105 with lubricant coating 160) (paragraph [0055]).
With respect to claim 12:
Wherein the lubricious exterior surface (exterior surface of balloon 105 with lubricant coating 160) comprises a lubricious coating (lubricant coating 160) on the inflatable body (balloon 105) (paragraph [0055]).
With respect to claim 13:
Wherein the lubricious coating (lubricant coating 160) comprises a biocompatible material (paragraph [0058]).
With respect to claim 14:
Wherein the biocompatible material comprises a silicone-based lubricant (silicone hydrophobic material) (paragraph [0058]).
With respect to claim 15:
Wherein the lubricious exterior surface (exterior surface of balloon 105 with lubricant coating 160) comprises a surface thermally bonded to the inflatable body (balloon 105). (PLEASE NOTE: Claim 15 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a bonded connection between the lubricious exterior surface (lubricant coating 160) and the inflatable body (balloon 105). Manufacturing steps such as thermal bonding are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 16:
Wherein the lubricous exterior surface (exterior surface of balloon 105 with lubricant coating 160) comprises a textured surface (the lubricant coating (160) is not uniform on the outer surface of the balloon (105), thus creating regions without lubricant coating (160)/ outer fold regions (155); as such, the exterior surface of balloon is considered by Examiner to be “textured” (has protrusions of the lubricant coating (160))).
With respect to claim 17:
Holman et al. discloses an implant delivery system (balloon catheter 110) comprising:
A delivery apparatus (outer tubular member 110) (paragraph [0054]); and
An inflatable body (balloon 105) coupled to the delivery apparatus (outer tubular member 110) and having a proximal end (proximal waist portion 140) and a distal end (distal waist portion 145) (paragraph [0054]), and a central body (body portion 125) positioned between the proximal end (proximal waist portion 140) and the distal end (distal waist portion 145) and having a length (paragraph [0054]), the central body (body portion 125) configured to press an inner surface of the implant to dilate the implant (stent 147) (paragraph [0056]), the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than or equal to one half a thickness of the inflatable body (balloon 105), as can be seen in figs. 6C-6D (paragraph [0063]) (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/ unfolding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than or equal to one half a thickness of the inflatable body (balloon 105)).
With respect to claim 18:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body. (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/ unfolding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than a thickness of the inflatable body (balloon 105)).
With respect to claim 19:
Wherein the at least one outer inflatable body fold radius of curvature is greater than two times the thickness of the inflatable body. (PLEASE NOTE: Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/ unfolding process which would result in the claimed range – as can be seen in figs. 6C-6D the inflatable body (balloon 105) including at least one outer inflatable body fold radius of curvature (radius of peak 180 in fig. 6C or radius of peak after continued folding in fig. 6D) greater than two times a thickness of the inflatable body (balloon 105)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-10, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stupecky et al. (US 2016/0008589 A1).
With respect to claim 1:
Stupecky et al. discloses the invention substantially as claimed. Specifically, Stupecky et al. discloses a dilation device (catheter), as can be seen in fig. 31, for an implant (stent), the dilation device (catheter) comprising:
An inflatable body (nested balloon 2) having a proximal end (at proximal neck weld 4) and a distal end (opposite to proximal neck weld) (paragraph [0186]), and a central body (portion of nested balloon 2 with a constant diameter) positioned between the proximal end (at proximal neck weld 4) and the distal end (opposite to proximal neck weld) and having a length, the central body (portion of nested balloon 2 with a constant diameter) configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraph [0112]), the inflatable body (nested balloon 2) including at least one outer inflatable body fold radius of curvature (bend radius 10) greater than zero but smaller than previous single layer balloons of equal thickness (paragraphs [0098, 0197]). Stupecky et al. is silent regarding the specific relationship of the at least one outer inflatable body fold radius of curvature (bend radius 10) being greater than or equal to one half a thickness of the inflatable body (nested balloon 2). However, Stupecky et al. discloses the advantages of having a reduced/ as small as possible outer inflatable body fold radius of curvature (bend radius 10) to reduce the delivery dimensions of the inflatable body (nested balloon 2) allowing for easier delivery (paragraph [0099]), but the inability to reduce the outer inflatable body fold radius of curvature (bend radius 10) down to zero as this can negatively impact the flexibility and burst pressure of the inflatable body (nested balloon 2) (paragraphs [0106-0111, 0162, 0197]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer inflatable body fold radius of curvature (bend radius 10) since this is a result effective variable that contributes to the burst strength/ flexibility/ overall thickness of the inflatable body (nested balloon 2) and it has been held that where the general conditions of a claim are disclosed in prior art, discovering the optimum of workable ranges involves only routine skill in the art and modifying the outer inflatable body fold radius of curvature (bend radius 10), as taught and suggested by Stupecky et al., would allow for reduced delivery dimensions. In re Aller, 105 USPQ 233. (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 2:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is greater than the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 3:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is greater than two times the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 4:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is between one and five times the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 5:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is between one half the thickness of the inflatable body and the thickness of the inflatable body (nested balloon 2) (PLEASE NOTE: Stupecky et al. is silent regarding the specific relationship of the at least one outer inflatable body fold radius of curvature (bend radius 10) being one half to one time a thickness of the inflatable body (nested balloon 2). However, Stupecky et al. discloses the advantages of having a reduced/ as small as possible outer inflatable body fold radius of curvature (bend radius 10) to reduce the delivery dimensions of the inflatable body (nested balloon 2) allowing for easier delivery (paragraph [0099]), but the inability to reduce the outer inflatable body fold radius of curvature (bend radius 10) down to zero as this can negatively impact the flexibility and burst pressure of the inflatable body (nested balloon 2) (paragraphs [0106-0111, 0162, 0197]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer inflatable body fold radius of curvature (bend radius 10) since this is a result effective variable that contributes to the burst strength/ flexibility/ overall thickness of the inflatable body (nested balloon 2) and it has been held that where the general conditions of a claim are disclosed in prior art, discovering the optimum of workable ranges involves only routine skill in the art and modifying the outer inflatable body fold radius of curvature (bend radius 10), as taught and suggested by Stupecky et al., would allow for reduced delivery dimensions. In re Aller, 105 USPQ 233.)
With respect to claim 6:
Wherein the inflatable body (nested balloon 2) includes an interior lumen for fluid flow 9there inherently must be an inflation lumen to inflate the nested balloon 2).
With respect to claim 7:
Wherein the inflatable body (nested balloon 2) includes a plurality of folds (plurality of flutes) (paragraph [0177]).
With respect to claim 8:
Wherein the plurality of folds (plurality of flutes) are configured to unfurl during inflation of the inflatable body (nested balloon 2) (paragraphs [0029, 0096]).
With respect to claim 9:
Wherein a diameter of the inflatable body (nested balloon 2) is configured to increase upon inflation of the inflatable body (nested balloon 2) (paragraphs [0029, 0096]).
With respect to claim 10:
Wherein the inflatable body (nested balloon 2) includes a distal shoulder (tapering between the constant larger diameter and the distal neck weld/ opposite to proximal neck weld), as can be seen in fig. 31.
With respect to claim 17:
Stupecky et al. discloses the invention substantially as claimed. Specifically, Stupecky et al. discloses an implant delivery system (catheter), as can be seen in fig. 31 (paragraph [0186]), comprising:
A delivery apparatus (proximal shaft) (paragraph [0187]); and
An inflatable body (nested balloon 2) coupled to the delivery apparatus (proximal shaft) and having a proximal end (at proximal neck weld 4) and a distal end (opposite to proximal neck weld) (paragraph [0186]), and a central body (portion of nested balloon 2 with a constant diameter) positioned between the proximal end (at proximal neck weld 4) and the distal end (opposite to proximal neck weld) and having a length, the central body (portion of nested balloon 2 with a constant diameter) configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraph [0112]), the inflatable body (nested balloon 2) including at least one outer inflatable body fold radius of curvature (bend radius 10) greater than zero but smaller than previous single layer balloons of equal thickness (paragraphs [0098, 0197]). Stupecky et al. is silent regarding the specific relationship of the at least one outer inflatable body fold radius of curvature (bend radius 10) being greater than or equal to one half a thickness of the inflatable body (nested balloon 2). However, Stupecky et al. discloses the advantages of having a reduced/ as small as possible outer inflatable body fold radius of curvature (bend radius 10) to reduce the delivery dimensions of the inflatable body (nested balloon 2) allowing for easier delivery (paragraph [0099]), but the inability to reduce the outer inflatable body fold radius of curvature (bend radius 10) down to zero as this can negatively impact the flexibility and burst pressure of the inflatable body (nested balloon 2) (paragraphs [0106-0111, 0162, 0197]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer inflatable body fold radius of curvature (bend radius 10) since this is a result effective variable that contributes to the burst strength/ flexibility/ overall thickness of the inflatable body (nested balloon 2) and it has been held that where the general conditions of a claim are disclosed in prior art, discovering the optimum of workable ranges involves only routine skill in the art and modifying the outer inflatable body fold radius of curvature (bend radius 10), as taught and suggested by Stupecky et al., would allow for reduced delivery dimensions. In re Aller, 105 USPQ 233. (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 18:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is greater than the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 19:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is greater than two times the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
With respect to claim 20:
Wherein the at least one outer inflatable body fold radius of curvature (bend radius 10) is between one and five times the thickness of the inflatable body (nested balloon 2). (PLEASE NOTE: Alternatively, Applicant has not claimed which state the relationship between the at least one outer inflatable body fold radius of curvature and the thickness of the inflatable body is measured; as such, Examiner can measure this relationship at any point in the folding/unfolding process which would result in the claimed range).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774