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 .
Double Patenting
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-5, 8-9, and 11-19 of co-pending Application No. 18/193,214 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1 discloses, as applied to instant claim 1: a catheter, comprising: a catheter tube defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough (lines 1-6); and a first zone having a first cut pattern segment therein, wherein the first cut pattern segment defines a plurality of first spiral cuts spaced around a circumference of the tube (lines 7-12), wherein each of the plurality of first spiral cuts defines a width between 0.015 mm and 0.040 mm (lines 20-21), wherein each of the plurality of first spiral cuts is spaced from an adjacent cut by a filar having a width between 0.015 mm and 0.125 mm (lines 22-23), and wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis between 30 degrees and 70 degrees (lines 24-25).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 2, the subject matter is known from claim 2 of the reference application.
Regarding claim 3, the subject matter is known from claim 1 of the reference application.
Regarding claim 4, the subject matter is known from claim 4 of the reference application.
Regarding claims 5-7, the subject matter is known from claim 5 of the reference application.
Regarding claim 8, the subject matter is known from claim 8 of the reference application.
Regarding claim 9, the subject matter is known from claim 9 of the reference application.
Regarding claim 10, the subject matter is known from claim 8 of the reference application (plurality implies at least two).
Regarding claim 11, the subject matter is known from claim 11 of the reference application.
Regarding claim 12, the subject matter is known from claim 12 of the reference application.
Regarding claim 13, the subject matter is known from claim 13 of the reference application.
Regarding claim 14, the subject matter is known from claim 14 of the reference application.
Regarding claim 15, the subject matter is known from claim 15 of the reference application.
Regarding claim 16, the subject matter is known from claim 16 of the reference application.
Regarding claim 17, the subject matter is known from claim 17 of the reference application.
Regarding claim 18, the reference application discloses, in claim 18, a catheter, comprising: a catheter tube defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough (lines 1-6); and a first zone having a first cut pattern segment therein, wherein the first cut pattern segment defines a plurality of first cuts spaced around a circumference of the tube, wherein the plurality of first cuts includes between 16 and 24 cuts, wherein each of the plurality of first cuts defines a pitch angle with the longitudinal axis between 60 degrees and 70 degrees (lines 7-24); and a second zone having a second cut pattern segment therein, wherein the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube, wherein the plurality of second cuts includes between 16 and 24 cuts, wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis between 45 degrees and 55 degrees (lines 26-41).
Regarding claim 19, the subject matter is known from claim 19 of the reference application which discloses a catheter, comprising: a catheter tube defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough (lines 1-6); a first zone having a first cut pattern segment therein, wherein the first cut pattern segment defines a plurality of first cuts spaced around a circumference of the tube (lines 7-12); and wherein the distal end includes a tip segment having a plurality of helical segments extending around the longitudinal axis, wherein each helical segment includes two substantially parallel filars connected at distal ends thereof (lines 20-22).
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) 1-5 and 7-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone et al. (US 2019/0160259).
Regarding claim 1, Cottone et al. (henceforth Cottone) discloses (Figures 1-3) catheter, comprising: a catheter tube (1005) defining: a proximal end; a distal end; a longitudinal axis (along the tubing length); a lumen therethrough; and a first zone (1011) having a first cut pattern segment therein (Figures 1b and 1c), wherein the first cut pattern segment defines a plurality of first spiral cuts (1015) spaced around a circumference of the tube, wherein each of the plurality of first spiral cuts defines a width between 0.015 mm and 0.040 mm (¶ [0099] discloses the cut width varying from about 1 micron to 100 microns), and wherein each of the plurality of first spiral cuts defines a pitch angle with the longitudinal axis between 30 degrees and 70 degrees (Figure 3, pitch angle theta is less than 90 degrees as per ¶ [0095]). Cottone fails to explicitly disclose the spacing between the cuts as within 0.015 mm and 0.125 mm. However, Cottone discloses (¶¶ [0099]-[0100]) varying the number, width, and pitch of the spiral cuts along the length to achieve the claimed function. It would have been obvious to one of ordinary skill in the art to form the width of the uncut portions between the spiral cuts to be in the claimed range of 0.015 mm - 0.125mm as Cottone teaches that varying such measures results in changing the flexibility of the shaft along the length. Therefore, the width between cuts is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary to be within the claimed range of 0.015 mm – 0.125 mm depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, Cottone further discloses wherein the first zone has a stiffness between approximately 0.1 gF/mm and 0.75 gF/mm (Figure 9a; ¶ [0120] discloses a stiffness of 0.002-0.004 N/mm which overlaps the claimed range for an embodiment comprising the same interrupted or discontinuous spiral pattern of Figures 1-3; the stiffness disclosed in ¶ [0120] is relevant to just the interrupted spiral section of the shaft and not the embodiment as a whole of connected segments).
Regarding claim 3, Cottone fails to explicitly discloses wherein the plurality of first spiral cuts includes between 10 and 40 cuts (see e.g., ¶¶ [0099]-[0100] for examples of numbers of cuts). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the claimed number of cuts between 10 and 40 as Cottone discloses that such a feature is known to control the flexibility of the shaft and provides for any number of cuts depending on the desired characteristics of the end use of the device. Therefore, the number of cuts is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary to be within the claimed range of 10-40 depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Cottone fails to explicitly disclose wherein the first zone has a length between 1 mm and 100 mm (¶ [0081] discloses an overall length of between 45 cm and 300 cm which is based upon the target location of the procedure). However, Cottone discloses that varying the cuts along the length of the device (e.g., including sections 1011 and 1010) will change the flexibility of the device during use. One of ordinary skill in the art would understand from the disclosure of Cottone that varying the length of the distal segment 1011 along with the width and spacing of the cuts of said section would change the flexibility profile of the distal segment in a predictable manner. Therefore, the length of section 1011 is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary the length of the section to be within the claimed range of 1 mm – 100 mm depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 5 and 7, Cottone further discloses wherein the catheter tube is constructed from a nitinol or stainless steel (¶ [0088] discloses both materials) and has a wall thickness between approximately 0.0254 mm and approximately 0.254 mm (¶ [0094] discloses the wall thickness).
Regarding claim 8, Cottone further discloses wherein the distal end includes a tip segment having a plurality of helical segments extending around the longitudinal axis (e.g., Figure 1b, the distal segment 1011 comprises helical cuts).
Regarding claim 9, Cottone further discloses wherein each helical segment includes two substantially parallel filars connected at distal ends thereof (e.g. Figure 3, it can be seen that the cuts form filars therebetween that may be considered connected at their distal ends).
Regarding claim 10, Cottone further discloses wherein the plurality of helical segments includes at least two helical segments (e.g., Figures 1-3 depict a number of helical segments).
Regarding claim 11, Cottone further discloses a polymer liner disposed within the lumen (Figure 30, liner 3101; ¶¶ [0144]-[0145]; the liner member is applied to any desired embodiment).
Regarding claim 12, Cottone further discloses (Figure 30) a polymer jacket (1020; ¶ [0163]; the jacket may be applied to any desired embodiment) disposed around the outer dimeter of the cut tube.
Regarding claim 13, Cottone further discloses the second zone (e.g., proximal zone 1010) comprises a second cut pattern (Figure 1a) comprising the same properties as the first segment (the values set forth for the first zone of claim 1 are applicable to zone 2 as set forth in the cited paragraphs which also anticipate the narrower pitch angle range of 45 degrees to 55 degrees).
Regarding claim 14, Cottone further discloses wherein the second zone is located proximal of the first zone (Figure 1a, zone 1010 is proximal to zone 1011; in addition, the claim fails to establish the relative orientation of the device and as such either zone 1011 or 1010 may be interpreted as proximal).
Regarding claim 15, Cottone further discloses wherein the second zone has a stiffness between approximately 0.75 gF/mm and 1.25 gF/mm (Figure 9a; ¶ [0120] discloses a stiffness of 0.002-0.004 N/mm which overlaps the claimed range for an embodiment comprising the same interrupted or discontinuous spiral pattern of Figures 1-3; the stiffness disclosed in ¶ [0120] is relevant to just the interrupted spiral section of the shaft and not the embodiment as a whole of connected segments).
Regarding claim 16, Cottone further discloses wherein the plurality of second spiral cuts includes between 10 and 40 cuts (see e.g., ¶¶ [0099]-[0100] for examples of numbers of cuts). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the claimed number of cuts between 10 and 40 as Cottone discloses that such a feature is known to control the flexibility of the shaft and provides for any number of cuts depending on the desired characteristics of the end use of the device. Therefore, the number of cuts is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary to be within the claimed range of 10-40 depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, Cottone further discloses wherein the second zone has a length between 1 mm and 100 mm (¶ [0081] discloses an overall length of between 45 cm and 300 cm which is based upon the target location of the procedure). However, Cottone discloses that varying the cuts along the length of the device (e.g., including sections 1011 and 1010) will change the flexibility of the device during use. One of ordinary skill in the art would understand from the disclosure of Cottone that varying the length of the distal segment 1011 along with the width and spacing of the cuts of said section would change the flexibility profile of the distal segment in a predictable manner. Therefore, the length of section 1011 is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary the length of the section to be within the claimed range of 1 mm – 100 mm depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, Cottone discloses a catheter, comprising: a catheter tube (1005) defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough; and a first zone (1011) having a first cut pattern segment therein (Figures 1b and 1c), wherein the first cut pattern segment defines a plurality of first cuts spaced around a circumference of the tube (¶ [0099]), wherein the plurality of first cuts includes between 16 and 24 cuts (see e.g., ¶¶ [0099]-[0100] for examples of numbers of cuts). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the claimed number of cuts between 16 and 24 as Cottone discloses that such a feature is known to control the flexibility of the shaft and provides for any number of cuts depending on the desired characteristics of the end use of the device. Therefore, the number of cuts is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary to be within the claimed range of 10-40 depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); wherein each of the plurality of first cuts defines a pitch angle with the longitudinal axis between 60 degrees and 70 degrees (¶ [0095] discloses pitch angles of less than 90 degrees which includes the claimed range; the paragraph further notes that the precise pitch angle can be adjusted to determine the degree of pushability and flexibility and as such it teaches support for any angle from 0-90 based upon the desired characteristics); and a second zone (1010) having a second cut pattern segment therein (Figure 1b), wherein the second cut pattern segment defines a plurality of second cuts spaced around a circumference of the tube, wherein the plurality of second cuts includes between 16 and 24 cuts (see e.g., ¶¶ [0099]-[0100] for examples of numbers of cuts). It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the claimed number of cuts between 16 and 24 as Cottone discloses that such a feature is known to control the flexibility of the shaft and provides for any number of cuts depending on the desired characteristics of the end use of the device. Therefore, the number of cuts is considered a result effective variable which one of ordinary skill would find obvious, given the disclosure of Cottone, to vary to be within the claimed range of 16-24 depending on the flexibility characteristics desired for the end device as a matter of routine optimization; and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); wherein each of the plurality of second cuts defines a pitch angle with the longitudinal axis between 45 degrees and 55 degrees (¶ [0095] discloses pitch angles of less than 90 degrees which includes the claimed range; the paragraph further notes that the precise pitch angle can be adjusted to determine the degree of pushability and flexibility and as such it teaches support for any angle from 0-90 based upon the desired characteristics).
Regarding claim 19, Cottone discloses a catheter, comprising: a catheter tube (1005) defining: a proximal end; a distal end; a longitudinal axis; a lumen therethrough (Figure 1a); a first zone (1010) having a first cut pattern segment therein (Figures 1a-1c), wherein the first cut pattern segment defines a plurality of first cuts (1015) spaced around a circumference of the tube; and wherein the distal end includes a tip segment having a plurality of helical segments extending around the longitudinal axis, wherein each helical segment includes two substantially parallel filars connected at distal ends thereof (e.g. Figure 3, it can be seen that the cuts form filars therebetween that may be considered connected at their distal ends).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jenson et al. (US 2006/0293612).
Regarding claim 6, Cottone discloses the claimed invention substantially as set forth above for claim 1, and further discloses the use of a variety of metals and metal alloys for the tube (¶ [0088]), but does not explicitly disclose the use of inconel for the catheter tube.
Jenson et al. (henceforth Jenson) teaches a catheter tube (14) formed from inconel (¶ [0084]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the catheter tubing material of Cottone to be formed from Inconel as Jenson teaches that such a material is suitable for use in intravascular catheter devices as a tubing material. It’s further noted that Cottone discloses the claimed wall-thickness as set forth above for claims 5 and 7, and which would be obvious to apply to the inconel body of Jenson in the cited combination.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783