DETAILED ACTION
Response to Amendment
The amendment filed May 6, 2026 has been entered. Claims 1, 5, 13, 16, 18, and 19 have been amended. Claims 3, 6, 7, 10, and 20-88 have been cancelled and therefore claims 1, 2, 4, 5, 8, 9, 11-19, and 89-92 are currently pending in the application.
Response to Arguments
Applicant's arguments filed May 6, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that Cottone fails to teach the claimed device, as claimed, with respect to the result effective variables, the Examiner respectfully disagrees. As set forth below, Cottone provides disclosure for a variety of cut and uncut sections of the catheter tube. Cottone clearly describes how varying the type of cut, the features of the cut (e.g., pitch, length, configuration) have a clear impact on the flexibility characteristics of the catheter during use. Cottone considers pushability, lateral flexibility, torqueability, and the like with respect to designing the catheter body. Therefore, Cottone provides clear disclosure that manipulating the design parameters of any of these features is acceptable so as to arrive at the desired usability characteristics. The use of zones of continuous spiral cuts is known as is the use of intermittent uncut portions. Cottone discloses that these are the design values to be manipulated to achieve the desired flexibility and therefore, they are clear result effective variables which are used independently or together to determine how the device will move during a procedure. For this reason, the rejection is considered proper and is maintained below.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 2, 4-5, 8-9, 11-19, and 89-92 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of co-pending Application No. 19/380,084 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Regarding claim 1, the claim is identical to claim 1 of the reference application.
Regarding claim 2, the subject matter is identical to claim 2 of the reference application.
Regarding claim 4, the subject matter is identical to claim 3 of the reference application.
Regarding claim 5, the subject matter is identical to claim 4 of the reference application.
Regarding claim 8, the subject matter is identical to claim 5 of the reference application.
Regarding claim 9, the subject matter is identical to claim 6 of the reference application.
Regarding claim 11, the subject matter is identical to claim 7 of the reference application.
Regarding claim 12, the subject matter is identical to claim 8 of the reference application.
Regarding claim 13, the subject matter is identical to claim 9 of the reference application.
Regarding claim 14, the subject matter is identical to claim 10 of the reference application.
Regarding claim 15, the subject matter is identical to claim 11 of the reference application.
Regarding claim 16, the subject matter is identical to claim 12 of the reference application.
Regarding claim 17, the subject matter is identical to claim 13 of the reference application.
Regarding claim 18, the subject matter is identical to claim 14 of the reference application.
Regarding claim 19, the subject matter is identical to claim 15 of the reference application.
Regarding claim 89, the subject matter is identical to claim 16 of the reference application.
Regarding claim 90, the subject matter is identical to claim 17 of the reference application.
Regarding claim 91, the subject matter is identical to claim 18 of the reference application.
Regarding claim 92, the subject matter is identical to claim 20 of the reference application.
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) 1-2, 4-5, 8-9, 11-19, and 89-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone et al. (US 2019/0160259).
Regarding claims 1, 13, and 16, 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 plurality of cut pattern segments therein, wherein the plurality of cut pattern segments in the first zone includes at least a first zone first zone first cut pattern segment and a first zone second cut pattern segment therein (Figures 1b and 1c; any sections along the length may be considered first zone first cut patterns or first zone second cut patterns as claimed; the catheter body may be arbitrarily broken into a series of zones with various combinations of cut or uncut portions which may vary or repeat depending on the desired flexibility characteristics of the device during use), wherein the first zone first cut pattern segment defines a plurality of first zone first spiral cuts (1015) spaced around a circumference of the tube, wherein the plurality of first zone first spiral cuts are in a continuous spiral-cut pattern, wherein the first zone second cut pattern segment defines a plurality of first zone second spiral cuts spaced around a circumference of the tube, wherein the plurality of first zone second spiral cuts are in a continuous spiral-cut pattern (see e.g., ¶ [0096] which discloses continuous spiral cuts for any section which can be applied to any of the first or second zone cuts along the length since any pattern of cuts is disclosed by Cottone; wherein the first zone comprises an uncut segment that defines a first uncut region between the first zone first cut pattern and the first zone second cut pattern segment, wherein the first uncut region is a circumferential ring that defines a first uncut length along the longitudinal axis (see e.g., Figure 4a which depicts an uncut region between the cuts 4000 and the distal second; this ring of uncut section may be anywhere along the length or repeating between sections or zones as desired to arrive at the target flexibility characteristics; as per claim 13, the first and second zones may have first and second cut portions as claimed); wherein each of the plurality of first spiral cuts defines a width between 0.015 mm to less than 0.050 mm (¶ [0099] discloses the cut width varying from about 1 micron to 100 microns), and wherein each of the plurality of first zone 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]), wherein the plurality of first zone first spiral cuts includes between 10 and 40 cuts, and wherein each of the first zone first spiral cuts begin at the same longitudinal location on the longitudinal axis, each of the first zone first spiral cuts terminate at the same location on the longitudinal axis, each of the first zone second spiral cuts begin at the same longitudinal location on the longitudinal axis, and each of the first zone second spiral cuts terminate at the same longitudinal location on the longitudinal axis (see e.g., Figure 9a of Cottone, section 9002 can be considered to start and end at the same points on the longitudinal axis of the body as claimed; Cottone provides support, as above, for using any sequence of patterns or cuts along the length as desired to achieve the target flexibility characteristics). Cottone fails to explicitly disclose the spacing between the cuts as within 0.015 mm and 0.05 mm., as well as the number of first zone first spiral cuts. 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 - 0.05 mm 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 – 0.05 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 the first zone first spiral cuts, first zone second spiral cuts, second zone first spiral cuts, second zone second spiral cuts (second zone first and second spiral cut sections 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 (for either the first zone or second zone first or second 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 claims 2 and 89, 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). Claim 1 is considered to disclose all of the remaining structure of claim 89. The stiffness for either the first zone or second zone, as disclosed by Cottone, are used based upon the desired flexibility characteristics of the device during use.
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 claim 5, 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 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 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, as above for claim 1, further discloses wherein the plurality of first zone first spiral cuts or second zone 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 (for either the first zone or second zone first or second 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 the invention substantially as set forth above for claim 1 and further 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) in the range from 2 to 12 and the number of helical segments is in the range of 1-6 (see e.g., ¶ [0099] which discloses any number of sections or segments as desired).
Regarding claim 89, Cottone teaches the structure substantially as set forth above for claim 2.
Regarding claim 90, Cottone teaches the invention substantially as set forth above for claim 89 and further teaches the number of substantially parallel filars connected at distal ends thereof is in the range from 2-12 and the number of helical segments is in the range from 1-6 (see e.g., ¶ [0099] which discloses any number of sections or segments as desired along the length).
Regarding claim 91, Cottone further discloses wherein the second zone has a stiffness between approximately 0.45 gF/mm and 0.75 gF/mm. 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). The stiffness for either the first zone or second zone, as disclosed by Cottone, are used based upon the desired flexibility characteristics of the device during use and are taught as claimed.
Regarding claim 92, Cottone fails to explicitly disclose wherein the first zone uncut segment has a length in the range from 0.25 mm to 0.5 mm. However, Cottone discloses that varying the length of uncut portions along the length of the device will change the flexibility of the device during use (see e.g., ¶¶ [0116]-[0117]. One of ordinary skill in the art would understand from the disclosure of Cottone that varying the length of the uncut segments between the spiral cut zones would change the flexibility profile of the distal segment in a predictable manner (and in the manner explicitly disclosed by Cottone). Therefore, the length of the uncut sections 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 uncut section to be within the claimed range of 0.25 mm – 0.5 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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