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 .
Information Disclosure Statement
One or more information disclosure statements filed on the record comply with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 08/17/2026.
Applicant traversed the restriction requirement, arguing that the claims of Groups I and II are directed to unrelated inventions (see arguments accompanying election, pgs. 1-2) that are not distinct because they do not overlap in scope (see pg. 2, arguing that claims 1 and 17 both recite some of the same subject matter).
Related inventions in the same statutory class are considered mutually exclusive, or not overlapping in scope, if a first invention would not infringe a second invention, and the second invention would not infringe the first invention (see MPEP 806.05). In this case, Applicant has not asserted that Group I would infringe on Group II and vice versa. A review of the claims shows that Group I would not infringe on Group II, and vice versa.
Applicant also appeared to allege that it would not be a serious burden to search for the two groups of claims (see pg. 3, alleging that “the search required for the elected Group I claims would extend into the same areas of search required for the non-elected Group II claims”). While the two groups of claims may be classified in the same area, a serious search burden may be shown by a different field of search as defined in MPEP 808.02 (see MPEP 803). In this case, different search queries would be required (e.g., Group I recites the specific ratio of cross-sectional area of the round wire group of wires to a total cross-sectional area of the plurality of flat wires, but is silent on the ratio of the round wires to the flat wires, while Group II recites that "a ratio of the outer diameter of the round wires to the thickness of the flat wires is larger than 1.5” but is silent as to the ratio of the cross-sectional area of the round wire group of wires to a total cross-sectional area of the plurality of flat wires).
The requirement is still deemed proper and is therefore made FINAL.
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 7 is 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.
Regarding claim 7, the limitation “the flat wire” lacks antecedent basis in the claim. Since a plurality of flat wires are claimed, it is unclear which specific flat wire is referred to in the claim, and, therefore, a skilled artisan would not be able to ascertain the metes and bounds of the claim with reasonable certainty.
For the purpose of examination, the limitation will be interpreted to mean one of the flat wires of the plurality of flat wires.
Regarding claim 19, the limitation “closest pair of flat wires” is unclear because claim does not recite a reference point, feature, or set of wires relative to which the “closest pair” is determined. Accordingly, it is unclear which pair of flat wires satisfies the limitation (i.e., it is unclear what the flat wires are required to be closest to), and, therefore, a skilled artisan would not be able to ascertain the metes and bounds of the claim with reasonable certainty.
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.
Claims 1-3, 5-8, 17, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stern (U.S. Pub. 2018/0250498 A1, hereinafter “Stern”).
Regarding claim 1, Stern discloses a catheter comprising:
a shaft 12 (see Fig. 1) possessing proximal and distal ends, the shaft having a lumen 24 (see Fig. 2) extending from the distal end of the shaft to the proximal end of the shaft, the shaft possessing an inner surface 18A (see Fig. 2) surrounding the lumen and an outer surface 22 (see Fig. 2).
the shaft including a reinforcing member 20 (see Fig. 2) disposed on at least a part between the inner surface of the shaft and the outer surface of the shaft;
the reinforcing member including plural wires that are braided in a tubular shape (see Fig. 2 and para [0069]);
the plural wires comprising the reinforcing body including a round wire group of wires 20A (see para [0079]) and a plurality of flat wires 20B (see para [0079]), the round wire group of wires being comprised of a plurality of round wires each of which is a wire having a circular cross-section (a plurality of round wires with a diameter of, e.g., 0.002 inches; see para [0080]), the plurality of flat wires intersecting the round wire group of wires (round wires 20A are woven against flat wires 20B, such that there is no cross braiding of the respective round wires 20A or flat wires 20B; see para [0080]).
It is noted that Stern does not appear to disclose, in a single expressly described embodiment, a cross-sectional area ratio of a total cross-sectional area of the plurality of wires comprising the round wire group of wires to a total cross-sectional area of the plurality of flat wires is larger than 0.5.
However, Stern discloses round wires having a cross-sectional diameter of 0.002 inches and flat wires having a cross-sectional dimension of 0.001 × 0.005 inches (see para. [0080]). Stern further discloses an exemplary braid having eight wires, including four round wires woven against four flat wires (see para. [0080]). When the disclosed values are used together (i.e., four 0.002-inch diameter round wires and four 0.001×0.005-inch flat wires) the resulting cross-sectional area ratio is calculated as follows:
Wire configuration
Total Cross-Sectional Area (in²)
4 × 0.002-inch round wires
0.000012566
4 × 0.001" × 0.005-inch flat wires
0.00002
A
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a
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t
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=
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d
w
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e
a
r
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a
F
l
a
t
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i
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a
r
e
a
=
0.000012566
0.00002
=
0.628
The resulting ratio is 0.628, which is larger than the claimed ratio of 0.5.
A skilled artisan would have found it obvious at the time of the invention to use the expressly disclosed 0.002-inch round wires, 0.001 × 0.005-inch flat wires, along with four wires per group, with a reasonable expectation of success. The dimensions and number of wires are all disclosed by Stern as exemplary configurations for the same braided support element, and Stern provides no indication that these disclosed values are incompatible or that the particular combination would require undue experimentation. Indeed, Stern describes the various wire dimensions and numbers of wires as exemplary configurations of the wire braid (see para [0080]). Selecting the disclosed 0.002-inch round wire and 0.001 × 0.005-inch flat wire dimensions, together with the disclosed four-round-wire/four-flat-wire arrangement, would have been immediately apparent to one of ordinary skill in the art, there being a reasonable basis for the skilled person to associate these parts with one another (e.g., the values all appear in the same paragraph of the disclosure, and, in the case of the above-described round wire and flat wire areas, in the same exemplary embodiment) particularly because Stern identifies improved ovalization resistance and tensile strength as benefits of its braided support element (see para [0081]).
Moreover, Applicant’s disclosure does not explain the criticality of the claimed ratio range, contemplating that the ratio is “preferably larger than 0.5 or even more than 2.0 or more (see instant specification at para [0036]). Although Applicant discusses the desirability of a ratio to “sufficiently secure the …round wires 22 and improve the effect of maintaining the shape of the cut end portion of the reinforcing body by the plastically deformed round wires 22”, Applicant does not appear to disclose any specific ratio, or range of ratios, is critical for this function, nor a ratio that would lead to an unexpected result. Moreover, the claims do not recite or identify the anatomical access site (e.g., the type, size or length of the body lumen desired to be accessed) that would have provided a reason to select a particular wire combination leading to the claimed ratio; in the absence of any intended use, it would have been routine, and not beyond ordinary creativity, to select the disclosed wire dimensions and numbers to arrive at the claimed cross-sectional area ratio from Stern's expressly contemplated configurations.
Regarding claim 2, Stern does not appear to disclose, in a single embodiment, that the cross-sectional area ratio is larger than 1.
However, Stern discloses round wires having a cross-sectional diameter of .0015-inch or 0.002-inch, and flat wires having various cross-sectional diameters such as of 0.001×0.002-inch, 0.001×0.005-inch or 0.001×0.008-inch (see col. 10, lines 44-46). Stern further discloses a braid having eight wires, including four round wires woven against four flat wires (see para. [0080]). Using a group of round wires with a cross-sectional diameter of 0.002-inch along with flat wires with a cross-sectional diameter of 0.001×0.002-inch, with four wires per group, the area ratio can be determined as follows:
Wire configuration
Total Cross-Sectional Area (in²)
4 × 0.002-inch round wires
0.000012566
4 × 0.001" × 0.002-inch flat wires
0.000008
R
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a
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l
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=
0.000012566
0.000008
=
1.571
A skilled artisan would have found it obvious at the time of the invention to use the disclosed 0.002-inch round wires, 0.001 × 0.002-inch flat wires, and four round wires woven against four flat wires in combination, with a reasonable expectation of success. The dimensions and number of wires are all disclosed by Stern as exemplary configurations for the same braided support element, and Stern provides no indication that these disclosed values are incompatible or that the particular combination would require undue experimentation. Indeed, Stern describes the various wire dimensions and numbers of wires as exemplary configurations of the wire braid (see para [0080]). Selecting the disclosed 0.002-inch round wire and 0.001 × 0.005-inch flat wire dimensions, together with the disclosed four-round-wire/four-flat-wire arrangement, would have been immediately apparent to one of ordinary skill in the art, there being a reasonable basis for the skilled person to associate these parts with one another (e.g., the values all appear in the same paragraph of the disclosure, and, in the case of the above-described round wire and flat wire areas, in the same exemplary embodiment) particularly because Stern identifies improved ovalization resistance and tensile strength as benefits of its braided support element (see para [0081]).
Moreover, Applicant’s disclosure does not explain the criticality of the claimed ratio range, contemplating that the ratio is “preferably larger than 0.5 or even more than 2.0 or more (see instant specification at para [0036]). Although Applicant discusses the desirability of a ratio to “sufficiently secure the …round wires 22 and improve the effect of maintaining the shape of the cut end portion of the reinforcing body by the plastically deformed round wires 22”, Applicant does not appear to disclose any specific ratio, or range of ratios, is critical for this function, nor a ratio that would lead to an unexpected result. Moreover, the claims do not recite or identify the anatomical access site (e.g., the type, size or length of the body lumen desired to be accessed) that would have provided a reason to select a particular wire combination leading to the claimed ratio; in the absence of any intended use, it would have been routine, and not beyond ordinary creativity, to select the disclosed wire dimensions and numbers to arrive at the claimed cross-sectional area ratio from Stern's expressly contemplated configurations.
Regarding claim 3, Stern discloses the catheter according to claim 1, but does not appear to disclose, in a single embodiment, that all of the plurality of wires comprising the round wire group of wires are in contact with one another.
However, Stern discloses that in some examples, the round wires are coiled such that each loop of the wire is in continuous contact with an adjacent loop (see para [0086]).
A skilled artisan would have found it obvious at the time of the invention to coil the round wires of the above-discussed device, such all of the plurality of wires comprising the round wire group of wires are in contact with one another, as a tightly braided catheter would have led to numerous benefits for kink resistance, resistance of ovalization, improved torque transmission, improved pushability and better burst/pressure resistance.
Regarding claim 5, Stern discloses the catheter according to claim 1, wherein the reinforcing body includes a plurality of round wire groups of wires each of which includes a plurality of round wires (e.g., two groups of two wires apiece for a total of four wires).
Regarding claim 6, Stern discloses the catheter according to claim 5, wherein the round wire groups of wires and the plurality of flat wires are positioned so that in a cross-section of the shaft perpendicular to a central axis of the shaft, the round wire group of wires and the flat wires alternate with one another in a circumferential direction (see Fig. 2; although this is a plan view, it shows alternating flat and round wires that, when viewed in cross-section, would have the claimed configuration).
Regarding claim 7, Stern discloses the catheter according to claim 1, wherein each of the round wires in the round wire group of wires is made of a material having a yield point that is lower than a yield point of a material from which the flat wire is made.
However, Stern discloses that the materials of the reinforcing member, i.e., the round group of wires and the flat wires, can be made of a combination of materials such as metal, polymer or fiber (see para [0069]), which would have been known to have different yield points.
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the materials of the reinforcing member to choose a yield point for the round wires that is lower than a yield point of the flat wire, with a reasonable expectation of success, as a matter of ordinary creativity and without undue experimentation.
Moreover, Applicant’s disclosure does not explain the criticality of the claimed material properties, merely disclosing that the yield point of the material of the round wire 22 should be lower than that of the flat wire 23 so that “the braided shape is easily maintained” (see instant specification at para [0054]). However, the claims do not recite or identify the anatomical access site (e.g., the type, size or length of the body lumen desired to be accessed) that would have provided a reason to select a particular yield point for the materials or any expected reason why the yield point of the materials were necessary to maintain a braided shape; for at least this reason, it would have been routine, and not beyond ordinary creativity, to select the yield point for the materials of the round and flat wires to arrive at the claimed invention.
Regarding claim 8, Stern discloses the catheter according to claim 1, wherein each of the round wires in the round wire group of wires is plastically deformed (i.e., the deformation occurs as the wires are wound around the inner liner during production; see paras [0120], [0121]).
Regarding claim 17, Stern discloses a catheter comprising:
a shaft 12 (see Fig. 1) possessing proximal and distal ends, the shaft having a lumen 24 (see Fig. 2) extending from the distal end of the shaft to the proximal end of the shaft, the shaft possessing an inner surface 18A (see Fig. 2) surrounding the lumen and an outer surface 22 (see Fig. 2);
the shaft including a reinforcing member 20 (see Fig. 2) disposed on at least a part between the inner surface of the shaft and the outer surface of the shaft;
the reinforcing member including plural wires that are braided in a tubular shape (see Fig. 2 and para [0069]);
the plural wires comprising the reinforcing body including a plurality of round wires each of which is a wire having a circular cross section (a plurality of wires 20A with a diameter of, e.g., 0.002 inches; see para [0080]), and a plurality of flat wires intersecting the round wires (flat wires 20B, as disclosed in para [0079]; and see para [0080], disclosing that round wires 20A are woven against flat wires 20B, such that there is no cross braiding of the respective round wires 20A or flat wires 20B).
It is noted that Stern does not appear to disclose, in a single expressly described embodiment, a cross-sectional area ratio of a total cross-sectional area of the plurality of round wires of wires to a total cross-sectional area of the plurality of flat wires is larger than 0.5.
However, Stern discloses round wires having a cross-sectional diameter of 0.002 inches and flat wires having a cross-sectional dimension of 0.001 × 0.005 inches (see para. [0080]). Stern further discloses an exemplary braid having eight wires, including four round wires woven against four flat wires (see para. [0080]). When the disclosed values are used together (i.e., four 0.002-inch diameter round wires and four 0.001×0.005-inch flat wires) the resulting cross-sectional area ratio is calculated as follows:
Wire configuration
Total Cross-Sectional Area (in²)
4 × 0.002-inch round wires
0.000012566
4 × 0.001" × 0.005-inch flat wires
0.00002
A
r
e
a
r
a
t
i
o
=
R
o
u
n
d
w
i
r
e
a
r
e
a
F
l
a
t
w
i
r
e
a
r
e
a
=
0.000012566
0.00002
=
0.628
The resulting ratio is 0.628, which is larger than the claimed ratio of 0.5.
A skilled artisan would have found it obvious at the time of the invention to use the expressly disclosed 0.002-inch round wires, 0.001 × 0.005-inch flat wires, along with four wires per group, with a reasonable expectation of success. The dimensions and number of wires are all disclosed by Stern as exemplary configurations for the same braided support element, and Stern provides no indication that these disclosed values are incompatible or that the particular combination would require undue experimentation. Indeed, Stern describes the various wire dimensions and numbers of wires as exemplary configurations of the wire braid (see para [0080]). Selecting the disclosed 0.002-inch round wire and 0.001 × 0.005-inch flat wire dimensions, together with the disclosed four-round-wire/four-flat-wire arrangement, would have been immediately apparent to one of ordinary skill in the art, there being a reasonable basis for the skilled person to associate these parts with one another (e.g., the values all appear in the same paragraph of the disclosure, and, in the case of the above-described round wire and flat wire areas, in the same exemplary embodiment) particularly because Stern identifies improved ovalization resistance and tensile strength as benefits of its braided support element (see para [0081]).
Moreover, Applicant’s disclosure does not explain the criticality of the claimed ratio range, contemplating that the ratio is “preferably larger than 0.5 or even more than 2.0 or more (see instant specification at para [0036]). Although Applicant discusses the desirability of a ratio to “sufficiently secure the …round wires 22 and improve the effect of maintaining the shape of the cut end portion of the reinforcing body by the plastically deformed round wires 22”, Applicant does not appear to disclose any specific ratio, or range of ratios, is critical for this function, nor a ratio that would lead to an unexpected result. Moreover, the claims do not recite or identify the anatomical access site (e.g., the type, size or length of the body lumen desired to be accessed) that would have provided a reason to select a particular wire combination leading to the claimed ratio; in the absence of any intended use, it would have been routine, and not beyond ordinary creativity, to select the disclosed wire dimensions and numbers to arrive at the claimed cross-sectional area ratio from Stern's expressly contemplated configurations.
Regarding claim 18, Stern discloses the catheter according to claim 1, wherein each of the round wires in the round wire group of wires is plastically deformed (i.e., the deformation occurs as the wires are wound around the inner liner during production; see paras [0120], [0121]).
Regarding claim 20, Stern discloses the catheter according to claim 17, wherein the plurality of round wires and the plurality of flat wires extend helically along the shaft (see Fig. 2).
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stern, in view of McDonnell (U.S. Pat. 8,956,394 B1, hereinafter “McDonnell”).
Regarding claim 4, Stern does not appear to disclose that the round wire group of wires and the plurality of flat wires are positioned so that in a cross-section of the shaft perpendicular to a central axis of the shaft, the plurality of wires comprising the round wire group of wires are positioned between two of the flat wires; or as per claim 19, the round wire group of wires and the plurality of flat wires are positioned so that in a cross-section of the shaft perpendicular to a central axis of the shaft, the plurality of round wires are positioned between each closest pair of flat wires.
McDonnell discloses a catheter having a reinforcing liner, comprising a plurality of round wires 140 (see Fig 10A) arranged in groups between a closest pair of flat wires 142 (see Fig. 10A); see annotated Fig. 10A, below, for explanation.
A skilled artisan would have found it obvious at the time of the invention to choose this winding configuration for the device of Stern with a reasonable expectation of success, as it was a well-known weaving pattern that a skilled artisan would find to yield sufficient stability, rigidity, compressibility, sheer strength, and/or tensile strength (see McDonnell at col. 15, lines 25-30).
Moreover, Applicant’s specification makes no mention of the configurations recited in claims 4 and 19, and thus, is per se silent about a particular advantage (much less criticality) conveyed by the claimed configuration of the round and flat wires. Moreover, the claims do not recite or identify the anatomical access site (e.g., the type, size or length of the body lumen desired to be accessed) that would have provided a reason to select a particular configuration of the wires; in the absence of any intended use, it would have been routine, and not beyond ordinary creativity, to select the disclosed wire configuration to arrive at the claimed invention from McDonnell’s expressly contemplated configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 08/26/2026
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