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.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-18, in the reply filed on 18 December 2025 (“Reply“) is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner, on form PTO-892, or cited by Applicant in compliance with 37 C.F.R. §§ 1.97, 1.98, they have not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figs. 2, 9, #87 (87a, 87b are); and
Fig. 18, #152.
The drawings are objected to because, in Fig. 22B, the lead lines for #178 and #41 do not agree with those in Fig. 22A.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
[0055], #44;
[0062], first sentence, #24 not shown in Figs. 5, 6;
[0104], #140; and
[0112], passim, #160.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
generally, the specification refers to reference numbers without identifying the figure(s) in which they are used, inviting confusion, see, e.g., [0055], in which the structures described are not illustrated in Fig. 2;
[0086], line 1, “cover” is misspelled; and
[0104], #150 is used for both “distal end” and “first section.”
Appropriate correction is required.
Claim Interpretation
In the Specification and claims, Applicant has used the word “circumference” to refer to the positioning of apertures in the rings, e.g., Claim 1, “the plurality of apertures positioned at spaced distances around a circumference of the first steering ring . . . .” A full and fair reading of this application reveals that the meaning of the term “circumference,” as used in this specific context, indicates that the apertures are positioned at different angles in a polar coordinate system, and not that the apertures extend through the rings radially through the outer, circumferential surface of the rings.
In the Specification and claims, Applicant has used the word “direction” to refer to the orientation of a force that acts on a wire. A full and fair reading of this application reveals that the meaning of the term “direction,” as used in this specific context, indicates that the vectors of these forces can be parallel to each other, but not necessarily coincident.
In the Specification and claims, Applicant has used the term “return cable” to refer to some of the wires of the device. A full and fair reading of this application reveals that the meaning of the term “return cable,” as used in this specific context, indicates that it is not limited to being the same physical cable as a “steering cable” which is connected to the same “control member.”
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.
Claims 1, 14, 15, and 18 are 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.
In Claim 1, line 11, “a third aperture” renders the scope of the claim indefinite, because no ‘second aperture’ is defined by the claim, and therefore it is unclear if the claim requires two or three apertures. The claim has been treated as requiring two apertures.
In Claim 1, line 20, “a third direction” renders the scope of the claim indefinite, because no ‘second direction is defined by the claim, and therefore it is unclear if the claim requires two or three directions. The claim has been treated as requiring two “directions” (see treatment above).
Claim 2, and the claims which depend from it, are not rejected because of the foregoing deficiencies of Claim 1, because Claim 2’s requirements for a “second aperture” and a “second direction” cure them.
In Claim 14, the “hypotube” is not placed relative to the other claimed structures, and thus it is unclear if the hypotube must be integrated, in some unknown way, into the catheter, or is a freestanding element of the claimed “system.” The claim has been treated as if the hypotube were physically integrated into the device.
In Claim 15, lines 2, 3, and 5, the term “corresponding” renders the scope of the claim indefinite, because it is unclear how bending “corresponds” structurally or functionally to a “pull direction;” the claim has been treated as requiring that the hypotube bends toward the tensioned steering cable.
Claim 18 is rejected because it depends from Claim 15, inherits but does not cure its deficiencies, and is therefore also unclear.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent App. Pub. No. 2024/0316318, by Shaolian et al. (“Shaolian”).
Shaolian describes a system as claimed by Applicant, as follows and with reference to the annotated copy of its Fig. 12 below (“AnnFig”).
Claim 1: A medical device delivery system (Figs. 10-13; [0224]-[0232]) comprising:
a steering catheter (200) including:
a first steering ring (204) having a proximal end (right in Fig. 10), a distal end (left in Fig. 10), an outer surface (to which the lead line for #204 indicates in Fig. 10), an inner surface (it is a ring, so it has an inner surface), a wall defined between the outer surface and inner surface (solid portion of the ring), and a central lumen defined by the inner surface along a longitudinal direction (L in AnnFig);
a plurality of apertures (216; AP in AnnFig) positioned in the wall of the first steering ring, the plurality of apertures positioned at spaced distances around a circumference of the first steering ring (as illustrated);
a first steering cable (SC1 in AnnFig) passing through a first aperture of the plurality of apertures (as shown);
a second steering cable (SC2 in AnnFig) passing through a third aperture (see treatment above) of the plurality of apertures (as shown), wherein the first steering cable is positioned about 180 degrees from the second steering cable (as shown in AnnFig); and
a handle (900 in Figs. 38, 39) operably coupled to a proximal end of the steering catheter (id.), the handle including:
a first control member (905), the first steering cable coupled to the first control member so that actuation of the first control member in a first direction pulls the first steering cable ([0256]);
a second control member (906), the second steering cable coupled to the second control member so that actuation of the second control member in a third direction pulls the second steering cable ([0256]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-9, 14-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shaolian as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2023/0116038, by Farnan et al. (“Farnan”).
Shaolian describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the steering catheter includes a first return cable passing through a second aperture of the plurality of apertures and a second return cable passing through a fourth aperture of the plurality of apertures, the first return cable being coupled to the first control member so that actuation of the first control member in a second direction opposite the first direction pulls the first return cable, the second return cable being coupled to the second control member so that actuation of the second control member in a fourth direction opposite the third direction pulls the second control member.
Farnan relates to pull wire steerable interventional medical devices and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Farnan teaches that a pair of pull wires (212, 214; 218, 220) which oppositely bend the catheter shaft can be connected to the same control member at the proximal end of the device (304, 306, respectively; see [0107] and Fig. 8) so that a single control motion can be used to tension one wire of the pair while simultaneously reducing tension in the other wire of the pair, so that the catheter shaft better responds to wire tensioning and reduces residual stresses in the catheter’s bending portion(s). Applying this teaching to Shaolian’s device results in the addition of first and second return cables to its device, coupled to controllers as claimed.
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 Shaolian’s device to further include the subject matter of Claim 2, because Farnan teaches doing so in a closely related pull wire, steerable catheter so that the catheter shaft better responds to wire tensioning and reduces residual stresses in the catheter’s bending portion(s).
Claim 3: (The system of claim 2,) further comprising a third steering cable (SC3 in AnnFig) passing through a fifth aperture of the plurality of apertures of the first steering ring and a third return cable (RC3 in AnnFig) passing through a sixth aperture of the plurality of apertures.
Claim 4: (The system of claim 3,) further comprising a third control member, the third steering cable and the third return cable coupled to the third control member so that actuation of the third control member in a fifth direction pulls the third steering cable, and actuation of the second control member in a sixth direction opposite the fifth direction pulls the third return cable (applying Farnan’s teaching to pair together steering cables and return cables led proximally to a single controller, results in the subject matter of Claim 4).
Claim 5: (The system of claim 4,) further comprising a second steering ring (206 in Shaolian’s device), the second steering ring spaced apart from the first steering ring in a longitudinal direction (Fig. 10) and including a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, a central lumen defined by the inner surface along a longitudinal direction, and a plurality of apertures positioned in the wall at spaced distances around a circumference of the second steering ring (Shaolian describes rings 204, 205, 206 as being the same).
Claim 6: (The system of claim 5,) wherein the second steering cable extends through a first aperture of the second steering ring and the second return cable extends through a second aperture of the second steering ring (Shaolian [0228]).
Claim 7: (The system of claim 6,) wherein the first steering cable extends through a third aperture of the second steering ring and the first return cable extends through a fourth aperture of the second steering ring (id.).
Claim 8: (The system of claim 7,) wherein the first aperture of the second steering ring and the third aperture of the second steering ring are diametrically opposed to each other and the second aperture of the second steering ring and the fourth aperture of the second steering ring are diametrically opposed to each other (as shown in AnnFig).
Claim 9: (The system of claim 5,) further comprising a third steering ring (Shaolian 204), the third steering ring spaced apart from the first steering ring and the second steering ring in a longitudinal direction (Shaolian Fig. 10) and including a proximal end, a distal end, an outer surface, an inner surface, a wall defined between the outer surface and inner surface, a central lumen defined by the inner surface along a longitudinal direction, and a plurality of apertures positioned in the wall at spaced distances around a circumference of the third steering ring (Shaolian describes rings 204, 205, 206 as being the same).
Claim 14: (The system of claim 9,) further comprising a hypotube (Shaolian 201 in Fig. 10) having a proximal section, an intermediary section, and distal section (between rings 204, 205, 206).
Claim 15: (The system of claim 14,) wherein the proximal section has slits (Shaolian Fig. 10, unlabeled, and [0226]; 156, [0221] and [0223]) to allow for bending of the hypotube corresponding (see treatment above) to a pull direction of the first steering ring, the intermediary section has slits to allow for bending of the hypotube corresponding to a pull direction of the second steering ring, and the distal section has slits to allow for bending of the hypotube corresponding to a pull direction of the third steering ring (id.).
Claim 16: (The system of claim 4,) wherein each of the first control member, the second control member, and the third control member is a knob (Shaolian 907, Fig. 38).
Claim 18: (The system of claim 15,) wherein the bending of the hypotube corresponding to the pull direction of the second steering ring (see treatment above) is coplanar with the bending direction of the hypotube corresponding to the pull direction of the third steering ring (as best understood because of the ambiguity of the word “corresponds,” and in view of the fact that the second pull ring has multiple bending planes in Shaolian - Farnan’s device, Claim 18 reads on Shaolian - Farnan’s device).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shaolian and Farnan as applied to Claim 9 above, and further in view of U.S. Patent App. Pub. No. 2020/0155804, by van Oepen et al. (“van Oepen”).
Shaolian and Farnan together describe a device substantially as claimed by Applicant; see above. They do not, however, describe that each of the first steering cable, the second steering cable, and the third steering cable is a pair of cables and each of the plurality of apertures of the first steering ring, second steering ring, and third steering ring is a corresponding pair of apertures.
Van Oepen relates to pull wire steerable catheters having pull rings and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Van Oepen teaches that the pull wires (not illustrated; see [0112]) of such catheters can be provided in pairs (id.) which extend through a pull ring (810) in closely spaced apart lumens (822), which “beneficially reduces the need to rely solely on welding or adhesives to attach the tension cables to the tip ring” (id.).
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 a Shaolian - Farnan pull wire steerable catheter so that each of the first steering cable, the second steering cable, and the third steering cable is a pair of cables and each of the plurality of apertures of the first steering ring, second steering ring, and third steering ring is a corresponding pair of apertures, because Van Oepen teaches doing so in a closely related catheter to beneficially reduce the need to rely solely on welding or adhesives to attach the tension cables to the tip ring.
Claim 13: (The system of claim 12,) wherein each of the first steering ring, the second steering ring, and the third steering ring comprises a step between each aperture of the pairs of apertures (Van Oepen, 824, 826).
Allowable Subject Matter
Claims 10, 11, and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
The prior art of record, taken both alone and in permissible combination, fails to identically disclose or fairly suggest the combinations of features recited in Claim 10, taken with the features of the claims from which they depend. More specifically, there is not sufficient evidence in the record to support a conclusion that it would have been obvious to modify any of the devices described in the prior art of record, including those of Shaolian and U.S. Patent App. Pub. No. 2022/0126060 (“Shia”) (the two being considered the closest prior art), such that the first steering cable extends through a first aperture of a third steering ring and the first return cable extends through a second aperture of the third steering ring. The cables 214 do not extend to Shaolian’s third ring 204, but instead terminate at its ring 205; while Shia’s support wires 216 are not connected to a control member, i.e., are not pull wires and also do not extend to its ring 120. It would require very significant reworking of both devices to arrive at a device which could be read on by Claim 10, which a person of ordinary skill in the art would not find to be obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2016/0096004 describes looping back, proximally, a single pull wire to the same a tensioner ([0087]).
The balance of the documents cited with this Office Action relate generally to pull wire steerable catheters and their pull ring configurations.
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://www.uspto.gov/interviewpractice.
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