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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed 26 April 2026 (“Reply”). As directed in the Reply:
no claims have been amended;
no claims have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-15 are presently pending in this application, with Claims 12-15 having been previously withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to Claims 1-11 have been considered but are not persuasive.
Applicant’s sole argument concerning Tegg, Olson ‘688, and Olson ‘820 is that none are read on by the claim clause “a guide lumen around which the mesh is braided” because, in essence, there are other catheter features in these disclosures’ devices around which their meshes extend. The word “around” is not limited to exclude other such features being within the bounds of the claimed mesh, i.e., the foregoing clause is significantly broader than Applicant asserts, and therefore Applicant’s arguments are not persuasive. Note the additional discussion below.
Claim Interpretation
The Claim Interpretation section from the Action dated 28 January 2026 is incorporated by reference herein.
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
Applicant’s arguments, addressed in part above, rely entirely on the meaning of the word “around” in the claim clause “a guide lumen around which the mesh is braided.” The Applicant has not engaged in any lexicography related to, or disclaimer of any scope of, the word “around” and therefore it is afforded its ordinary and customary meaning in the art. The word “around” is not an art-recognized technical word, and therefor the following general dictionary definitions are information of what the word means to a person of ordinary skill in the art.
www.merriam-webster.com/dictionary/around
1a: in a circle or in circumference
The wheel goes around.
a tree five feet around
b: in, along, or through a circuit
The road goes around by the lake.
2a: on all or various sides : in every or any direction
papers lying around
There was nothing for miles around.
b: in close from all sides so as to surround
People crowded around.
c: in or near one's present place or situation
We had to wait around awhile.
3a: here and there : from one place to another
She travels around on business.
b: to a particular place
You should come around for dinner.
c—used with some verbs to indicate repeated or continued action
He's always joking around when he should be serious.
Don't play around with your food.
4a: in rotation or succession
Another winter has come around.
b: from beginning to end : through
The weather is mild the year around.
c: in order
the other way around
5: in or to an opposite direction or position
turn around
6: with some approach to exactness : approximately
It costs around $5.
around 2 of 3 preposition
1a: on all sides of
a yard with a fence around it
b: so as to encircle or enclose
seated around the table
c: so as to avoid or get past : on or to another side of
trying to find a way around their objections
We went around the lake.
around the corner
d: near
lives around Chicago
around the turn of the century
2: in all directions outward from
Look around you.
3: here and there in or throughout
They went barnstorming around the country.
4: so as to have a center or basis in
a society organized around kinship ties
around 3 of 3 adjective
1: about sense 1
He has been up and around for two days.
2: being in existence, evidence, or circulation
… the most intelligent of the artists around today.—R. M. Coates
dictionary.cambridge.org/us/dictionary/english/around
in a position or direction surrounding, or in a direction going along the edge of or from one part to another (of):
We sat around the table.
He put his arm around her.
A crowd had gathered around the scene of the accident.
She had a scarf around her neck.
The moon goes around the earth.
I walked around the side of the building.
The children were dancing around the room.
I spent a year traveling around Africa and Asia.
The museum's collection includes works of art from all around the world.
She passed a plate of cookies around (= from one person to another).
This virus has been going around (= from one person to another).
in a position or direction surrounding, along the outside of, or from one part of to another:
We sat around the table.
Go around to the back of the house and come in through the kitchen.
We drove around town for a while, looking for a place to park.
She turned around (= so that she was facing in the opposite direction) and waved goodbye.
fig. He built his story around the theme of spiritual loneliness.
www.collinsdictionary.com/us/dictionary/english/around
1. preposition
To be positioned around a place or object means to surround it or be on all sides of it. To move around a place means to go along its edge, back to your starting point.
She looked at the papers around her.
Today she wore her hair down around her shoulders.
Synonyms: surrounding, about, enclosing, encompassing
adverb [n ADV]
Around is also an adverb. ...a village with a rocky river, a ruined castle and hills all around.
2. preposition
If you move around a corner or obstacle, you move to the other side of it. If you look around a corner or obstacle, you look to see what is on the other side.
The photographer stopped clicking and hurried around the corner.
3. preposition
If you move around a place, you travel through it, going to most of its parts. If you look around a place, you look at every part of it.
I've been walking around Moscow and the town is terribly quiet.
Synonyms: about, all over, everywhere in More Synonyms of around
adverb [ADV after v] Around is also an adverb.
He backed away from the edge, looking all around at the flat horizon.
From the foregoing, it is clear that the word “around” is not limited in any meaningful way to exclude other objects or features “around” which the claimed mesh is braided, in the clause “a guide lumen around which the mesh is braided.” This is, however, the very limited meaning that Applicant assumes - wrongly - that the term has in the context of this application.
Claim Rejections - 35 USC § 102
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2018/0296801, by Tegg et al. (“Tegg”).
Tegg discloses a device as claimed by Applicant, as follows.
Claim 1: A catheter tube for a steerable catheter (100), comprising a tube wall (110) surrounding a tube lumen (208), the tube wall comprising the following:
- a mesh (204); and
- a guide lumen around which the mesh is braided (214) and in which a pull element (210) extends from a proximal portion of the catheter tube to a distal portion of the catheter tube ([0043]: “Pull wires 210 extend from a proximal end 310 of steerable sheath 106 to distal end 108”, Figs. 1 and 3),
wherein the pull element is guided axially along the catheter tube (at section 116 in Fig. 4) within the tube wall via the guide lumen (as shown in Fig. 2),
the pull element being connected in a tension-resistant manner to the tube wall in the distal portion ([0037]: "Pull wires 210 are connected to at least one steering ring (not shown in FIG. 2) typically located near the distal end 108 (shown in FIG. 1) of steerable introducer assembly 100"),
the guide lumen guiding the pull element at least partially around the tube lumen ([0005]-[0007], [0044]: " helical path around the circumference of the inner liner"; [0032]: " pull wires 210 rotate around a circumferential direction 220 of steerable sheath 106 as they extend along the non-deflectable portion 114 of steerable sheath 106") and wherein the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube (at least at the section immediately proximal of section 116 in Fig. 4) so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube (same).
Claim 2: (The catheter tube according to claim 1,) wherein the section of the helical path within the tube wall (Figs. 3, 4) is also in the proximal portion of the catheter tube (the claim puts no other restrictions on the definition of the “proximal portion” and thus reads on a portion of the helical path on the left end of Fig. 4).
Claim 3: (The catheter tube according to claim 1,) wherein the guide lumen extends across a circumferential angle of at least 30° in the tube wall (id.).
Claim 4: (The catheter tube according to Claim 1,) wherein the guide lumen is delimited by a guide lumen tube (212).
Claim 6: (The catheter tube according to claim 1,) wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element ([0032]: deflected in two opposite directions by coordinated manipulation of the pull wires 210, Fig. 3).
Claim 7: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion (id.).
Claim 8: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path (id.).
Claim 9: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle in the range of 0 degrees to 30 degrees (id.; the angles shown include angles on the claimed range, through which the device passes on its way to reaching the illustrated angles, including an angle just slightly more than zero degrees, as claimed).
Claim Rejections - 35 USC § 103
Claims 1-3, 6-9, and 11 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2019/0201688, by Olson (“Olson ‘688”) in view of U.S. Patent App. Pub. No. 2019/0192820, by Olson et al. (previously of record; “Olson ‘820”).
Of the fifteen (15) documents cited by the Examiner on the record, eleven (11) describe the use of an additional guide tube, in a catheter’s wall, through which a pull wire extends, for the purpose of better assuring that the pull wire does not snag on the catheter wall during retraction, e.g., by being made of a different material; however, these eleven are representative of a much larger set of patent disclosures in the art of pull wire steerable catheters which also teach this feature. Olson ‘820 is one of these eleven:
U.S. Patent No. 5,507,725, Fig. 3, tube 24
U.S. Patent App. Pub. No. 20220168041, Fig. 3Aii, tube 1254
U.S. Patent App. Pub. No. 20210121663, Fig. 2, 212
U.S. Patent App. Pub. No. 20200061340, Fig. 3Aii, tube 1254
U.S. Patent App. Pub. No. 20190192820, Fig. 2, 212
U.S. Patent App. Pub. No. 20180296801, Fig. 2, 212
U.S. Patent App. Pub. No. 20160001038, Fig. 19, tubes 1902, 1903, 1904, 1905, and 1906
U.S. Patent App. Pub. No. 20140323964, Fig. 2, tube 118b
U.S. Patent App. Pub. No. 20120232563, Fig. 3B, tube 312
U.S. Patent App. Pub. No. 20070270679, Fig. 7A, tube 31
U.S. Patent App. Pub. No. 20040122360, Fig. Fig. 8, tube 48
Olson ‘688 discloses a device substantially as claimed by Applicant, as follows.
Claim 1: A catheter tube for a steerable catheter (see [0033], [0038] - [0042], [0045]; Figs. 2-3D), comprising a tube wall (110) surrounding a tube lumen (106), the tube wall comprising the following:
- a mesh ([0042], braid); and
- a guide lumen around which the mesh is braided ([0045]; see discussion above concerning the placement of the wire between two tubes) and in which a pull element ("loop member pull wire 108") extends from a proximal portion of the catheter tube to a distal portion of the catheter tube (Fig. 2),
wherein the pull element is guided axially along the catheter tube within the tube wall via the guide lumen (Fig. 2: wire 108 is shown extending axially in section 104; the space between the “two tubes” is a lumen in which wire 108 extends, and that lumen includes a helical path, and does not require an additional tube for this function, see above),
the pull element being connected in a tension-resistant manner to the tube wall in the distal portion ("attachment point 112"),
the guide lumen guiding the pull element at least partially around the tube lumen ([0040]: "spiral configuration", Fig. 2) and
wherein the guide lumen includes a section of a helical path within the tube wall in the distal portion of the catheter tube (see discussion above; the space between the “two tubes” is a lumen in which wire 108 extends, and that lumen includes a helical path).
While Olson’ 688 describes its pull wire extending in a helical path in a space between two tubes, which are part of its catheter tube, it does not expressly indicate that it does so as to guide the pull element helically around the tube lumen in the distal portion of the catheter tube (emphasis added).
Olson ‘820 relates to catheters that are steerable through the use of pull wires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant's claims. Olson '820 teaches that, when constructing such pull wire catheters, the lumen in which the pull wire(s) pass may be formed of a separate PTFE tube, to reduce sliding friction between the wire and the tube, thus making the device easier to use ([0026]).
It 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, to construct Olson’ 688’s catheter such that its guide lumen guides the pull element and comprises a lubricous coating, because Olson '820 teaches doing so in a closely-related pull wire catheter, to reduce sliding friction between the wire and the tube, thus making the device easier to use.
Claim 2: (The catheter tube according to claim 1,) wherein the section of the helical path within the tube wall (Olson’ 688 Fig. 2) is also in the proximal portion of the catheter tube (proximal portion of the tube can be the left portion of section 102 in Fig. 2 of Olson’ 688).
Claim 3: (The catheter tube according to claim 1,) wherein the guide lumen extends across a circumferential angle of at least 30° in the tube wall (id.).
Claim 6: (The catheter tube according to claim 1,) wherein the distal portion can be deformed three-dimensionally by an actuation of the pull element (Olson’ 688 Figs. 3C, 3D).
Claim 7: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion is bent with respect to a main extension axis of the proximal portion (id.).
Claim 8: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that the distal portion describes at least a section of a spiral-shaped or helical path (id.).
Claim 9: (The catheter tube according to claim 6,) wherein the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, as seen in a projection along a main extension axis of the catheter tube, pass over an angle in the range of 0 degrees to 30 degrees (id.; the angles shown include angles on the claimed range, through which the device passes on its way to reaching the illustrated angles, including an angle just slightly more than zero degrees, as claimed).
Claim 11: (The catheter tube according to claim1, wherein the catheter tube comprises a plurality of tube segments having differing rigidities (Olson’ 688 [0042]: “. . . the catheter shaft may include one or more layers of a polyether block amide material that transition from harder to softer along that catheter shaft from the proximal end portion to the distal end portion.”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tegg as applied against Claim 4, above, and further in view of Olson ‘820.
Tegg discloses a device substantially as claimed by Applicant; see above. It does not, however, indicate that the guide lumen tube comprises Teflon (see treatment above; lubricious coating).
Olson ‘820 relates to catheters that are steerable through the use of pull wires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Olson ‘820 teaches that, when constructing such pull wire catheters, the tube in which the pull wire(s) pass may be lined with PTFE (a lubricious coating), to reduce sliding friction between the wire and the tube, thus making the device easier to use ([0026]).
It 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, to form Tegg’s catheter such that its guide lumen tube comprises a lubricous coating, because Olson ‘820 teaches doing so to reduce sliding friction between the wire and the tube, thus making the device easier to use.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Olson ‘688 in view of Olson ‘820, and Tegg, as separately applied against Claim 6, above, alone.
Olson ‘688 with Olson ‘820, and Tegg, disclose a device substantially as claimed by Applicant; see above. Each is, however, silent about the radius of curvature achievable by the distal end of their devices, and thus does not expressly disclose that the catheter tube can be deformed, by an actuation of the pull element, in such a way that local extension axes of the distal portion, in a projection along a main extension axis of the catheter tube, describe at least approximately a section of a circular arc having a radius in the range of 2 mm to 100 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the devices of Olson ‘688-Olson‘820, and Tegg, to have a distal end radius of curvature, upon actuation of their pulling elements, in the range of 2 mm to 100 mm, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984). In the instant case, the devices of Olson ‘688 and Tegg would not operate differently with the claimed radius of curvature, as they would still curve as they otherwise disclose and be useful for their stated purposes. Furthermore, Applicant assigns no criticality to the claimed distal end radius of curvature, indicating simply that, “[a] resulting radius is, for example, between 2 mm and 100 mm ” (Specification, pg. 10, lines 21-22) and “f]urthermore, as is likewise illustrated in FIG. 5, the formed distal portion 1-2, in the projection along the main extension axis Z, can at least approximately describe a section of a circular arc, wherein an associated radius R is preferably in the range of 2 mm to 100 mm” (Specification, pg. 15, lines 1-3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, and particularly to the well-known option in the art of pullwire steerable catheters of reinforcing the pullwire tube, including:
U.S. Patent App. Pub. No. 2016/0158497, at [0030]:
In another example, the pull-wire sleeve 28 can comprise a polymeric tube reinforced with a braided metal layer, such as polyimide tube reinforced with a braided stainless steel layer. In this example, an inner polymeric layer can be secured to the inner surface of the braided layer and/or an outer polymeric layer can be secured to the outer surface of the braided layer.
U.S. Patent App. Pub. No. 2014/0005647, [0071], [0091], & [0092]; and
U.S. Patent App. Pub. No. 2004/0044350, [0079].
THIS ACTION IS MADE FINAL. 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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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