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 § 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 1-18 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.
Claims 1 and 18 recite the limitation “aligned with a longitudinal axis” in line 5 and “about a longitudinal axis” in the last line of the claims. This limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know if the claimed “longitudinal axis” in line 5 is the same and/or different axis than claimed in the last line of the claims. The scope of the claim remains indeterminate because of the claimed “longitudinal axis”. The Examiner respectfully note, for the purpose of examination the claimed axis in line 5 will be interpreted as the same axis claimed in the last line of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10, 12, 14, 15, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abdul-Karim et al (US 2014/0046356).
As to claims 1, 18 and 19, Abdul-Karim teaches a guidewire (guidewire 10, par.39, fig.1c) and a method for guidewire deployment to an off-lumen lesion (deploying guidewire 10 into heart lumen, fig.1d-1e, and fig.5) comprising:
an elongate wire body extending between a proximal end portion and a distal end portion (elongate body 10 extending between proximal portion 10b and distal portion 10a, par.39, fig.1c), the distal end portion having a traumatic distal tip (distal end 12, par.39, fig.1c) extending distally therefrom, the traumatic distal tip including single or more cutting elements (cutting element/tool 16, par.39, fig.1c having multiple sharp cutting edge/surfaces/blades 24, 28 and 38 in FIGS. 2A-4B, par.46) extending a length of the traumatic distal tip (cutting element/tool 16 extends along tip 12, as best seen in fig.1c-1e) and aligned with the longitudinal axis of the elongate wire body (cutting element/tool 16 is aligned with longitudinal axis of wire body 10, as best seen in reproduced fig.1d and 2a below), the single cutting element selected from a weld bead (positive/protruding cutting edges 24 in fig.2a and/or positive/protruding cutting edges 38 in fig.4a, par.48-51) or flute (cutting element/tool 16 in fig.2a includes negative/inner cutting feature between outer cutting surfaces 24, and/or inner cutting surfaces in fig.4a between cutting edges 38, par.48-51); and
a control handle (torquing member 22, par.44 at proximal portion, fig.1c) positioned on the proximal end portion of the elongate wire body, the control handle configured to rotate the elongate wire body and the distal tip about a longitudinal axis thereof (torquing member 22 is adapted to assist in the rotational movement of guidewire 10 and, more particularly, rotational movement of the rotatable, septal tissue cutting elements 16, par.44, fig.1c-1e),
positioning the guidewire through a lumen of a patient to a selected exit point in a wall of the lumen near the off-lumen lesion (deploying guidewire 10 into heart lumen, fig.1d-1e, and fig.5);
rotating the guidewire and the traumatic distal tip, via the handle operably coupled thereto outside the patient (medical practitioner, for example, may rotate torquing member 22 in a clockwise or counterclockwise direction, thus imparting rotational movement to the rotatable, septal tissue cutting elements 16 when flexible distal section 10a is situated within the patient's vasculature in close proximity to septal tissue 8, par.44, fig.1c), through the wall of the lumen (through tissue wall 8, par.44, fig.1c), and creating a path beyond the lumen to the off-lumen lesion by rotating and advancing the guidewire outside the lumen and in a direction towards the lesion (par.45-47, as best seen in fig.1d-1e, and par.52-58, fig.5).
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As to claims 2 and 3, Abdul-Karim teaches the guidewire, wherein the one or more cutting elements include two or three facets (cutting elements 16 includes multiple facets (more than three facets), as best see in fig.2a and 4a, par.48-51).
As to claim 4, Abdul-Karim teaches the guidewire, wherein the one or more cutting elements include a plurality of striations defining alternating ridges and valleys (cutting element/tool 16 includes multiple striations 24having alternating ridges and valleys 24, 28 and 38, as best see in fig.2a, 3a and 4a, par.48-51).
As to claim 5, Abdul-Karim teaches the guidewire, wherein the one or more cutting elements includes a negative cutting feature defined within a portion of an outer surface of the distal tip (cutting element 16 in fig.2a includes negative/inner cutting feature between outer cutting surfaces 24, and/or inner cutting surfaces between cutting edges 38, par.48-51).
As to claim 6, Abdul-Karim teaches the guidewire, wherein the negative cutting feature includes a flute (cutting element 16 in fig.2a includes negative/inner cutting feature between outer cutting surfaces 24, and/or inner cutting surfaces in fig.4a between cutting edges 38, par.48-51).
As to claim 7, Abdul-Karim teaches the guidewire, wherein the one or more cutting elements includes a positive cutting feature extending away from a portion of an outer surface of the tip (positive/protruding cutting edges 24 in fig.2a and/or positive/protruding cutting edges 38 in fig.4a, par.48-51).
As to claim 8, Abdul-Karim teaches the guidewire, wherein the positive cutting feature includes a weld bead (positive/protruding cutting edges 24 in fig.2a and/or positive/protruding cutting edges 38 in fig.4a, par.48-51).
As to claim 9, Abdul-Karim teaches the guidewire, wherein the elongate wire body is made from a single wire (guidewire 10 is made from single wire, par.39-41, fig.1c-1e).
As to claim 10, Abdul-Karim teaches the guidewire, wherein the elongate wire body maintains a constant diameter along an entire length of the body (guidewire has constant diameter (no tapering) along its length, par.41, as best seen in fig.1c-1e).
As to claim 12, Abdul-Karim teaches the guidewire, wherein wire body defines a constant stiffness along an entire length of the body (sections 10a and 10b may possess substantially equivalent flexibility, particularly if fabricated from the same material, par.42)(Examiner notes guidewire 10 has almost constant flexibility/stiffness through the entire length).
As to claim 14, Abdul-Karim teaches the guidewire, wherein the handle is manually-operated (medical practitioner, for example, may rotate torquing member 22 in a clockwise or counterclockwise direction, thus imparting rotational movement to the rotatable, septal tissue cutting elements 16, par.44).
As to claim 15, Abdul-Karim teaches the guidewire, wherein the handle includes a planetary gear (torquing gear member 22, par.44, fig.1c).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being obvious over Abdul-Karim et al (US 2014/0046356).
As to claims 11 and 13, Abdul-Karim teaches the guidewire as claimed above, but failed to explicitly teaches the wire body defines a diameter ranging from about 0.02 to about 0.04 inches, and the elongate wire body defines a length ranging from about 10 cm to about 500 cm.
However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to design guidewire 10 having diameter ranging from about 0.02 to about 0.04 inches, and a length ranging from about 10 cm to about 500 cm, because the Applicant has not disclosed that these specific dimensions provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected guidewire 10 of Abdul-Karim’s invention and the Applicant’s invention, to perform equally well with either the guidewire taught by Abdul-Karim’s invention or the claimed guidewire because both guidewires would perform the same function of passing through body lumens
Therefore, it would have been prima facie obvious to modify guidewire taught by Abdul-Karim’s invention to obtain the invention as specified in claims 11 and 13 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Abdul-Karim’s invention. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being obvious over Abdul-Karim et al (US 2014/0046356), in view of Look et al (US 2017/0065396).
As to claims 16 and 17, Abdul-Karim teaches rotating torquing member 22 manually, but failed to teach the handle is power-operated.
However, Look teaches an analogous rotatable guidewire 102 (abstract, par.45, fig.1-5 and/or fig.19, fig.31), comprises: power rotated handle (guidewire manipulation device 100, par.45, fig.1-5),
wherein the power-operated handle includes at least a motor (motor 116, par.51, fig.4-5) configured to rotate the elongate wire body, a coupler (rollers 120, par.50-51, fig.4-5) connecting the proximal end portion of the elongate wire body to the motor, a power source (battery 114, par.51, fig.4-5), and a slidable switch (button 108 may include multiple actuation techniques for determining clockwise or counter-clockwise rotation (e.g., sliding forward or backward, par.48, fig.1-5) configured to control at least the speed of rotation of the elongate wire body (controls rotation direction, par.48, exponentially increasing rotational speed, par.61, The shape of the wedges 900 defines, in part, the distance travelled, the rate of acceleration of the guidewire 2102, and the speed of the oscillation of the guidewire 2102, par.89).
Since powered handles are well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to substitute manual torquing member 22 taught by Abdul-Karim’s invention, with motor-powered handle 10 taught by Look’s invention, to more precisely control guidewire rotation and speed of rotation, as taught by Look’s invention (par.48, par.61 and par.89).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being obvious over Abdul-Karim et al (US 2014/0046356).
As to claim 20, Abdul-Karim teaches the guidewire as claimed above, but failed to explicitly teaches rotating the guidewire and the distal tip includes rotating at a speed ranging from about 100 to about 3000 rpms.
However, it would have been obvious to one having an ordinary skill in the art at the time the invention was made to rotate the guidewire and the distal tip at a speed ranging from about 100 to about 3000 rpms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art, In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed 05/28/2026 regarding Abdul-Karim’s invention does not teach the claimed limitation “the traumatic distal tip including the one or more cutting elements include extending along a length of the traumatic distal tip and aligned with the longitudinal axis of the elongate wire body” in claim 1, 18 and 19 have been fully considered but they are not persuasive, because under the broadest reasonable interpretation the claimed subject matter “cutting element” may be interpreted as the cutting tool itself, and does not necessarily mean the sharp cutting edge, surface or blade of the cutting tool. Since Abdul-Karim’s invention teaches distal tip (12, par.39, fig.1c) including cutting element/tool (16, par.39, fig.1c and 2-3) having multiple sharp cutting edge/surfaces/blades (24, 28 and 38 in FIGS. 2A-4B, par.46), so cutting element 16 taught by Abdul-Karim’s invention can be fairly interpreted as the claimed “cutting element” that is aligned with the longitudinal axis of the wire body (as best seen in reproduced fig.1D below of Abdul-Karim’s invention). Examiner respectfully notes, that Abdul-Karim’s invention calls element 16 “cutting element” and/not cutting edge/blade (par.39 and par.43), which is the same term/limitation recited in the claims.
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Conclusion
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 MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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