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 § 102
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.
Claim(s) 1, 13-16, 18, 19, and 31-33, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim et al. (US 2017/0072165 A1).
With regard to claim 1, Lim et al. teach a catheter comprising: an elongated catheter body (Fig. 1A catheter 100); a penultimate distal-most length of the elongated catheter body (Fig. 1B member 140) having a first stiffness; and a distal-most length of the elongated catheter body having a second stiffness, wherein the second stiffness is greater than the first stiffness ([0026], Fig. 1B, stiffness can increase in a proximal to a distal direction such that 150 which is the distal-most length is stiffer than penultimate distal-most length 140).
With regard to claim 13, see Fig. 1B and at least [0022] and [0028].
With regard to claim 14, see Fig. 1B outer jacket 116 which can vary in stiffness ([0026]).
With regard to claims 15-16, see Fig. 1B coiled wire 170 may vary in pitch along the length ([0036]), as the stiffness is increasing from the proximal to distal ends the braid pitch would vary accordingly, see an exemplary change in spacing in Fig. 5, [0059].
With regard to claim 18, see Fig. 1B braid 162 may vary in pitch ([0034]), as the stiffness is increasing from the proximal to distal ends the braid pitch would vary accordingly.
With regard to claim 19, Lim et al. teach using an inner liner 114 which increases in stiffness to the distal end (Fig. 1B, [0023]).
With regard to claim 31, Lim et al. teach using an inner liner 114 which increases in stiffness to the distal end in conjunction with outer jacket 116 (Fig. 1B, [0023]).
With regard to claim 32, see Fig. 1B coiled wire 170.
With regard to claim 33, see Fig. 1B braid 162 which can extend the entire length of the shaft ([0033]).
Alternatively with regard to claim 1, Lim et al. teach a catheter comprising: an elongated catheter body (Fig. 1A catheter 100); a penultimate distal-most length of the elongated catheter body (Fig. 8 portion 874) having a first stiffness ([0072]); and a distal-most length of the elongated catheter body having a second stiffness, wherein the second stiffness is greater than the first stiffness (Fig. 8 portion 876 extending to the distal most end includes a stiffness greater than the first, [0072]).
Claim(s) 20, 21, 24, and 25, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson et al. (US 2016/0346506 A1).
With regard to claim 20, Jackson et al. teach a catheter comprising: an elongated catheter body having an outer jacket (Fig. 7 jacket 24) and an inner layer (Fig. 7 liner 18), the elongated catheter body comprising a penultimate distal-most length (Fig. 7 length including 40H) and a distal-most length (Fig. 7 40I), and wherein a stiffness of the penultimate distal-most length is less than a stiffness of the distal-most length ([0255]); and wherein a first combined stiffness of the outer jacket and the inner layer at the distal-most length of the elongated catheter body is greater than a second combined stiffness of the outer jacket and the inner layer at the penultimate distal-most length of the catheter body ([0256], [0260], Jackson et al. teach that the outer jacket together with the inner line defines the distal opening and that it is desired that the opening be stiffer to resist geometric deformation. As the outer jacket 40I is stiffer than 40H the stiffness of the combined stiffness of 40I and 18 is greater than the combined stiffness of 40H and 18.).
With regard to claims 21, 24, and 25, Jackson et al. teach a catheter comprising: an elongated catheter body comprising an inner layer (Fig. 7 liner 18), an outer jacket (Fig. 7 jacket 24), and coil layer between the inner layer and the outer jacket (Fig. 7 member 20, [0267] may extend through 40I), the elongated catheter body comprising a penultimate distal-most length (Fig. 7 length including 40H) and a distal-most length (Fig. 7 length including 40I), and wherein a stiffness of the penultimate distal-most length is less than a stiffness of the distal-most length ([0255]); and, wherein the inner layer, the outer jacket, and the coil layer of the elongated catheter body have a distal region (Fig. 7); wherein the distal region has a variable hardness that, in a distal direction along a longitudinal axis, decreases in hardness toward a distal end of the catheter body and then increases in hardness until a distal-most end of the catheter body ([0255] decrease 40A-40H and increase 40I, [0262]).
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) 2-12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2017/0072165 A1) as applied to claim 1 above.
With regard to claims 2 and 3, Lim et al. teach the length may be selected for use ([0017]) but in the embodiment used does not disclose an explicit value for the distal portion. However, in reference to a later embodiment Lim et al. recites the distal portion may be between 0.5mm and 5cm ([0051]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the distal portion extend in a range as recited in the claims in Lim et al. as Lim et al. teach the length is selected for use and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Further, it would be obvious to select a value in the ranges as claimed given the teachings of Lim et al. since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990). Further, as Lim et al. teach that the length may be selected for the desired use one of ordinary skill in the art would have had a reasonable expectation of success in modifying Lim et al. of the embodiment of Fig. 1 to have the necessary length 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).
With regard to claims 4-12, considered under the alternate interpretation of claim 1, Lim et al. teach the overall catheter may have a stiffness which decreases from the proximal end to the distal end ([0023]) with distal portions which have differing stiffness characteristics to provide improved navigation ([0040], [0075]). This results in a catheter with an overall decrease in stiffness except for at the distal tip as shown in Fig. 8, which would yield a greater stiffness at a second point farther from the distal tip than at a point closer to the distal tip. Lim et al. also teach the length and stiffness are selected based on desired use (see at least [0017], [0022]-[0024]). Lim et al. do not disclose explicit distances or stiffness values. However, as Lim et al. teach the stiffness characteristics as described above and that the length and stiffness are selected based on desired use it would have been obvious to a person having ordinary skill in the art at the time the invention was made to select stiffness values recited at the claimed distances 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).
With regard to claim 17, Lim et al. teach the stiffness may vary due to the configuration of the coil or braid ([0034], [0036]) but do not explicitly disclose changing the diameter of the coiled wire to alter the stiffness. However, elsewhere Lim et al. discloses that filaments may have varying diameters when discussing the braid ([0034]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a coil with varying dimeters for 170 in Lim et al. since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009 as Lim et al. teach filaments may have differing diameters and altering the stiffness of coiled sections. This would yield the same desired stiffness result.
Claim(s) 22, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 2016/0346506 A1) as applied to claim 21 above.
With regard to claims 22 and 23, Jackson et al. teach the distal-most end is harder than an area proximal to the distal most end but do not explicitly disclose the combined hardness values. Jackson et al. teach that components are configured to define desired flexibility, kink resistance, and pushability characteristics ([0249]). However, as Jackson et al. teach the stiffness characteristics as described above and that the stiffness is selected based on desired use it would have been obvious to a person having ordinary skill in the art at the time the invention was made to select hardness values recited at the claimed distances 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).
With regard to claim 26, Jackson et al. teach smooth transitions ([0206]) but do not disclose a specific interference region length. Jackson et al. teach that components are configured to define desired flexibility, kink resistance, and pushability characteristics ([0249]). However, as Jackson et al. teach the stiffness characteristics as described above and that the stiffness is selected based on desired use and various means for attachment it would have been obvious to a person having ordinary skill in the art at the time the invention was made to select an interference length as needed to achieve stiffness values as desired 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).
With regard to claim 34, Jackson et al. teach a braid may be used with a coil ([0226]) and that components are configured to define desired flexibility, kink resistance, and pushability characteristics ([0249]) but does not explicitly disclose the braid is between the coil and the outer jacket. However, there are a limited number of options for placement, the braid can either be between the coil or outer jacket or not. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place the braid between the coil and outer jacket in Jackson et al. as there are a limited number options for placement and Jackson et al. teach configuring the layers as needed to achieve desired flexibility, kink resistance, and pushability characteristics.
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2017/0072165 A1).
With regard to claims 27-30, Lim et al. teach a catheter comprising: an elongated catheter body including an outer jacket (Fig. 1B jacket 116), an inner layer (Fig. 1B inner liner 114), a coil layer (Fig. 1B coil 170), and a braided layer (Fig. 1B braid 162 which can extend the entire length of the shaft, [0033]) having a distal-most length, a proximal length, and a medial length therebetween (Fig. 1A catheter 100); wherein the distal-most length has a first stiffness, wherein the medial length has a second stiffness, and the proximal length has a third stiffness; wherein the second stiffness is a variable stiffness range between the first stiffness and the third stiffness (Lim et al. teach the overall catheter may have a stiffness which decreases from the proximal end to the distal end ([0023]) with distal portions which have differing stiffness characteristics to provide improved navigation ([0040], [0075]). This results in a catheter with an overall decrease in stiffness except for at the distal tip as shown in exemplary Fig. 8 resulting in a distal region proximal to the distal most tip with a lower stiffness, a medial length with a variable stiffness, and a proximal length with the highest stiffness). Lim et al. also teach the length and stiffness are selected based on desired use (see at least [0017], [0022]-[0024]). Lim et al. teach stiffness is selected based on desired use and may be achieved via variations in size, shape, thickness, or material composition (see at least [0017], [0022]-[0024]). Lim et al. do not disclose explicit distances or stiffness values/rates of change. However, as Lim et al. teach the stiffness characteristics as described above and that the length and stiffness are selected based on desired use it would have been obvious to a person having ordinary skill in the art at the time the invention was made to select stiffness values recited at the claimed distances 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).
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (US 2017/0072165 A1) in view of Jackson et al. (US 2016/0346506 A1).
With regard to claims 27-30, Lim et al. teach a catheter comprising: an elongated catheter body including an outer jacket (Fig. 1B jacket 116), an inner layer (Fig. 1B inner liner 114), a coil layer (Fig. 1B coil 170), and a braided layer (Fig. 1B braid 162 which can extend the entire length of the shaft, [0033]) having a distal-most length, a proximal length, and a medial length therebetween (Fig. 1A catheter 100). Lim et al. also teach the length and stiffness are selected based on desired use (see at least [0017], [0022]-[0024]). Lim et al. teach stiffness is selected based on desired use and may be achieved via variations in size, shape, thickness, or material composition (see at least [0017], [0022]-[0024]). Lim et al. do not disclose explicit distances or stiffness values/rates of change. Alternatively, if Lim et al. is not found to teach the stiffnesses of the first second and third sections as recited. Jackson et al. teach that the outer jacket together with the inner line defines the distal opening and that it is desired that the opening be stiffer to resist geometric deformation ([0256], [0260]). The catheter of Jackson can also include a braid and coil into the distal end ([0226], [0267]). The stiffness decreases from the proximal end through a medial portion and then increases at the distal most length to a stiffness greater than the medial length but less than the proximal length ([0262]). Jackson et al. teach that components are configured to define desired flexibility, kink resistance, and pushability characteristics ([0249]). It would have been obvious to a person having ordinary skill in the art at the time the invention was made to select stiffness values recited at the claimed distances as Jackson et al. teach such stiffness allows for needed flexibility while having a distal tip which can resist geometric deformation. Further, as both Jackson et al. and Lim et al. teach varying stiffness and length based on desired used one of ordinary skill in the art at the time the invention was made would be able to select stiffness and length values 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).
Response to Arguments
Applicant's arguments filed December 30, 2025 have been fully considered but they are not persuasive regarding claim 1 which has not been amended. Regarding Lim et al. the claim recites the catheter body includes penultimate and distal most lengths. As rejected, these are provided by lengths of at least the outer jacket under the first rejection of claim 1. The Examiner maintains that as other structures are not claimed they do not necessarily need to be included in consideration of the catheter body. However, even if they were Lim et al. discloses that the braid may continue the length of the catheter, in which case if the jacket in the area of 150 is stiffer and the other components are the same, the distal-most portion which includes 150 is stiffer than portion 140. Further, under the other rejection of claim 1 referring to embodiment of Fig. 8, Applicant points to the area of the distal end where the coil is not present. However, the distal most length as rejected includes the section 876, thus making the entirety of the distal most length stiffer than section 874. It is not only the length where the coil is absent that is considered as the distal-most length. The rejections to claims 20 and 27 have been modified in light of the amendments to the claims.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783