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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8, 11, 12, 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”).
Regarding Claim 1, McFerran discloses an access catheter (10) comprising:
An elongate, flexible tubular body (Abstract; see Fig. 1) comprising:
a proximal end (see circa 34);
a distal end (24);
a side wall (see Fig. 2) at least partially defining a central lumen (20), the central lumen extending axially therethrough (see Fig. 1 and 2);
a distal microcatheter segment (18) extending proximally from the distal end (see Fig. 2), the distal microcatheter segment comprising:
a length (see Fig. 2 – Par. 19);
an outer diameter (see Fig. 2) ranging from about 0.02” to about 0.033”, (see Par. 21 and 26, wherein the diameter of the lumen is provided with an exemplary range from about 0.012 to 0.021” and the distal segment is provided with an exemplary wall thickness range of about 0.004 to 0.006” and wherein the outer diameter of the distal microcatheter segment must therefore be understood to be equal to twice the thickness in addition to the diameter of the lumen); and
a wall thickness ranging from 0.004 to 0.006” (Par. 26);
a proximal shaft segment (14 inclusive to 16 proximal to 60) extending distally from the proximal end (see Fig. 1), the proximal shaft segment comprising:
a length (see Fig. 1); and
an outer diameter of at least about 0.055 inches (see Par. 21 and 26 – wherein the proximal section will be understood to range from about 0.032 to 0.061”, which overlaps with the instantly claimed range and therefore obviates the claimed range with values from 0.055 to about 0.061”); and
a wall thickness of more than about 0.01 inches (see Par. 26); and
a tapered dilator segment (60) being positioned in between the distal
microcatheter segment and the proximal shaft segment (see Fig. 2);
wherein a diameter of the central lumen is constant throughout an entire
length of the tubular body from the proximal end to the distal end (see Fig. 2; Par. 21).
McFerran discloses the invention substantially as claimed except for disclosing the length of the distal microcatheter segment is between about 2 cm to about 10 cm, and the length of the proximal catheter segment is at least 140 cm. Specifically, McFerran does acknowledge that the overall length of the catheter shaft and the length of the segments 14, 16 and 18 may vary depending upon application of the catheter (Par. 19). Here McFerran provides exemplary overall lengths inclusive to 150cm (Par. 19) wherein the segment (14) can be an exemplary length of 125cm, whereby it would thereby be understood that in this exemplary configuration the length of the proximal segment (i.e. 14 and 16 proximal to 60) is larger than 125cm, but less than 150cm, while the distal segment must be understood to be less than 25cm.
Given the fact that McFerran acknowledges that the length(s) “may vary depending on the particular location within the body to be traversed, and the performance characteristics (e.g. flexibility, column strength, etc.) desired in the catheter” (Par. 19) and the fact that ranges in the prior art which overlap with, approach, or are merely similar to the claimed range present as prima facie obviousness, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the length of the proximal segment, in some configurations of the invention of McFerren, to have a length of at least about 140cm and a distal segment with a length between 2cm and 10cm, as a product of routine customization, experimentation, and optimization of clearly established result effective variables in order to adapt the catheter system to any particular location of the vasculature in any particular patient to conduct an interventional procedure while controlling for result effective variables of catheter flexibility, column strength…etc.
Furthermore, it has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Regarding Claim 2, McFerran discloses a coil (68) being in the side wall (see Fig. 2), the coil extending proximally through the distal microcatheter segment and
at least partially through the tapered dilator segment (see Fig. 2), wherein a distal end of the coil is spaced apart from the distal end of the tubular body (see 70, 62 which are spaced distally of the distal terminus of the coil).
Regarding Claim 3, McFerran discloses a tubular braid (64) in the side wall, the tubular braid extending distally from the proximal end (see Par. 27) wherein the reinforcement layer may comprise “a braid, weave, etc.” provided in a layered fashion so as to be distinctive from the single wire coil layer (68).
Regarding Claim 4, McFerran discloses at least a portion of the tubular
braid extends over a proximal end of the coil (see at 66).
Regarding Claim 5, McFerran discloses a radiopaque marker (70) at the distal end.
Regarding Claim 6, McFerran discloses at least a distal end of the tapered dilator segment is visible under fluoroscopy (Par. 30).
Regarding Claim 7, McFerran discloses the tapered dilator segment comprises a radiopaque dopant (see marker 70).
Regarding Claim 8, McFerran discloses a radiopaque marker (72) positioned adjacent (i.e. “not distant : NEARBY” – see Merriam-Webster’s Online Dictionary) a transition between the tapered dilator segment and the distal microcatheter segment (see Fig. 2).
Regarding Claim 11, McFerran discloses the invention substantially as claimed except that a length of the tubular body between the distal microcatheter segment and the proximal shaft segment is between about 0.5 cm and about 2.5 cm. However, as discussed above, McFerran does acknowledge that the overall length of the catheter shaft and the length of the segments 14, 16 and 18 may vary depending upon application of the catheter (Par. 19). Here McFerran provides exemplary overall lengths inclusive to 150cm (Par. 19) wherein the segment (14) can be an exemplary length of 125cm, whereby it would thereby be understood that in this exemplary configuration the transition segment must comprise the total length of the catheter less the length of the proximal segment and the distal segment, wherein the transition is comparatively substantially shorter than either two segments.
Given the fact that McFerran acknowledges that the length(s) “may vary depending on the particular location within the body to be traversed, and the performance characteristics (e.g. flexibility, column strength, etc.) desired in the catheter” (Par. 19) and the fact that ranges in the prior art which overlap with, approach, or are merely similar to the claimed range present as prima facie obviousness, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the length of the proximal segment, in some configurations of the invention of McFerren, to have a transition segment length (i.e. a distance between the proximal and distal segments) to be between about 0.5 cm and about 2.5 cm, as a product of routine customization, experimentation, and optimization of clearly established result effective variables in order to adapt the catheter system to any particular location of the vasculature in any particular patient to conduct an interventional procedure while controlling for result effective variables of catheter flexibility, column strength…etc.
Furthermore, it has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Regarding Claim 12, McFerran discloses the tapered dilator segment comprises:
a distal section comprising an outer diameter of no more than about 0.040 inches (Par. 21, 26 – i.e. the distal end of the tapered dilator segment is equal to the diameter of the distal segment and therefore ranges 0.004 to 0.006”, a range which lies wholly within Applicant’s claimed range); and
a proximal section comprising an outer diameter of no more than about 0.070 inches (Par. 21, 26 – i.e. the proximal end of the tapered segment is equal to the diameter of the proximal section and therefore ranges from 0.032 to 0.061”, a range which lies wholly within Applicant’s claimed range).
Regarding Claim 27, McFerran discloses the wall thickness of the distal microcatheter segment is no more than about 0.005 inches (see Par. 26 – wherein the range is inclusive to values of about 0.004 to 0.006” and therefore obviates Applicant’s claimed range for at least about 0.004 to about 0.005”).
Regarding Claim 28, McFerran discloses the wall thickness of the distal microcatheter segment is no more than about 0.007 inches (Par. 26).
Regarding Claim 29, McFerran discloses the wall thickness of the distal microcatheter segment is no more than about 0.008 inches (Par. 26).
Regarding Claim 30-32, McFerran dislcoses an access catheter (10) comprising:
an elongate, flexible tubular body comprising:
a proximal end (circa 34);
a distal end (24);
a side wall at least partially defining a central lumen (20), the central lumen
extending axially therethrough (see Fig. 2), wherein a diameter of the central lumen is constant throughout a length of the tubular body (Fig. 2; Par. 21);
a distal microcatheter segment (18) extending proximally from the distal end, the
distal microcatheter segment comprising:
a length (Par. 19 – see Fig. 2), and
an outer diameter of no more than about 0.04 inches (see Par. 21, 26 – re: 0.012 to 0.021” for the central lumen in addition to the wall thickness of 0.004 to 0.006” which creates a range of 0.02” to 0.033” which is entirely encompassed by the range of “no more than about 0.04 inches”);
a wall thickness (Par. 26);
a proximal shaft segment (14 in addition to 16 proximal to 60) extending distally from the proximal end (see Fig. 1), the proximal shaft segment comprising:
a length (Par. 19);
an outer diameter of at least about 0.055 inches (see Par. 21 and 26 – wherein the proximal section will be understood to range from about 0.032 to 0.061”, which overlaps with the instantly claimed range and therefore obviates the claimed range with values from 0.055 to about 0.061”); and
a wall thickness of more than about 0.01 inches (Par. 0026); and
a tapered dilator segment (60) being positioned in between the distal
microcatheter segment and the proximal shaft segment (see Fig. 2);
wherein the wall thickness of the proximal shaft segment is at least about
300% larger than the wall thickness of the distal microcatheter segment (re: McFerran obviates configurations with a proximal wall thickness of at least about 0.02” and a distal wall thickness as small as about 0.004” – Par. 26 – which presents obvious configurations wherein the wall thickness of the proximal shaft segment is 5 times as large as the wall thickness of the distal microcatheter segment, i.e. a difference of up to 500%).
McFerran discloses the invention substantially as claimed except for disclosing the length of the distal microcatheter segment is between about 2 cm to about 10 cm, and the length of the proximal catheter segment is at least 140 cm. Specifically, McFerran does acknowledge that the overall length of the catheter shaft and the length of the segments 14, 16 and 18 may vary depending upon application of the catheter (Par. 19). Here McFerran provides exemplary overall lengths inclusive to 150cm (Par. 19) wherein the segment (14) can be an exemplary length of 125cm, whereby it would thereby be understood that in this exemplary configuration the length of the proximal segment (i.e. 14 and 16 proximal to 60) is larger than 125cm, but less than 150cm, while the distal segment must be understood to be less than 25cm.
Given the fact that McFerran acknowledges that the length(s) “may vary depending on the particular location within the body to be traversed, and the performance characteristics (e.g. flexibility, column strength, etc.) desired in the catheter” (Par. 19) and the fact that ranges in the prior art which overlap with, approach, or are merely similar to the claimed range present as prima facie obviousness, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the length of the proximal segment, in some configurations of the invention of McFerren, to have a length of at least about 140cm and a distal segment with a length between 2cm and 10cm, as a product of routine customization, experimentation, and optimization of clearly established result effective variables in order to adapt the catheter system to any particular location of the vasculature in any particular patient to conduct an interventional procedure while controlling for result effective variables of catheter flexibility, column strength…etc.
Furthermore, it has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) as applied above, and further in view of U.S. Publication No. 2017/0072163 (“Lim”).
Regarding Claim 4, should Applicant argue that the transition at (66) does not create a distinction wherein a portion of the tubular braid (i.e. the braided outer layers of 64) “extends over a proximal end of the coil” (i.e. the singular innermost coil layer), the following is presented. Lim discloses a related, reinforced catheter which comprises distinct reinforcement layers comprising a distally located wire coil (370) which extends in the proximal direction before terminating (see Fig. 2) and a distinct tubular braid (162b) which begins at an overlapping intermediate section and extends in the proximal direction toward the proximal end (see Fig. 2), wherein the braid can extend over the coil or vise versa (Abstract). Lim discloses that these distinct reinforcement layers provide for better control over the relative flexibility and pushability for the various section and that the overlap eliminates an abrupt transition between reinforcement layers (Abstract; Par. 2, 23, 33, 34). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide distinct braided and coiled sections to the invention of McFerran with a discrete overlapping section wherein the braided section overlies the coil section, as disclosed by Lim, in order to provide better control over the flexibility of the proximal and distal sections to optimize flexibility and pushability while eliminating any abrupt transitions.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) as applied above, and further in view of U.S. Publication No. 2013/0035628 (“Garrison”).
Regarding Claim 7, should Examiner’s argument that the marker (70) of McFerran may properly be considered a “dopant” not be found persuasive the following is presented. Garrison discloses a related catheter wherein the distal section of the catheter can be rendered radiopaque for visualization under fluoroscopy by impregnating/doping the polymer of the catheter with a radiopaque material, such as tantalum (Par. 76). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the catheter device of McFerran to have a radiopaque distal tip produced via the use of a radiopaque dopant, as disclosed by Garrison, in order to permit the distal section to be visualizable under fluoroscopy via a known predictable solution to thereby obtain only an expected outcome of assisting a user in guiding the catheter within the vasculature.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) and U.S. Publication No. 2013/0035628 (“Garrison”) as applied above, and further in view of U.S. Publication No. 2010/0114017 (“Lenker”).
Regarding Claim 8, should Examiner’s argument concerning the adjacency of the marker (72) of McFerran not be found persuasive the following is presented. Lenker discloses that radiopaque markers may be provided at both distal ends and transition regions of such catheters to assist in navigation (Par. 138). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an additional radiopaque marker at the transition between the tapered distal segment and the distal microcather segment of McFerran, as disclosed by Lenker, in order to differentiate between the dilation section and the distal microcatheter section to assist in positioning of the catheter. It has been held that rearrangement of the location of the parts of an invention is obvious requiring only routine and customary skill in the art when expected and predictable results are obtained, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), wherein in the instant case Lenker establishes indexing radiopaque markers to transition sections is useful for delineating differences in catheter
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
04/13/2026
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