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
It is noted that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 450 references for consideration. The Examiner has considered the references submitted as part of the Information Disclosure Statements, but has found the majority have no relevance to patentability. Applicants are encouraged to provide a concise explanation of the information if Applicants are aware of document(s) or a section of a document that is highly relevant to patentability. See MPEP 609.04(a)(III) and MPEP 2004.13:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the references have been considered in a cumulative manner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 4 – 5, 10 – 13, 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.
The term “between about 0.5 mm and about 3.5 mm” in claim 4 is a relative term which renders the claim indefinite. The term “about 0.5mm and about 3.5 mm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 0.5 mm and 3.5 mm a dimension would need to be to satisfy the “about 0.5 mm” and “about 3.5 mm” limitations. For the purposes of examination, the term “between about 0.5 mm and about 3.5 mm” is deemed to claim “between 0.5 mm and 3.5 mm.”
The term “about 5° and about 85°” in each of claim 5 (line 3) and 11 (lines 3 - 4) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 5° and 85° a dimension would need to be to satisfy the “about 5°”and “about 85°” limitations. For the purposes of examination, the term “between about 5° and about 85°” is deemed to claim “between 5° and 85°”. Claim 12 is similarly rejected due to its dependence on Claim 11.
The term “greater than about 0.5 mm” in claim 10 is a relative term which renders the claim indefinite. The term “about 0.5 mm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 0.5 mm a dimension would need to be to satisfy the “about 0.5 mm” limitation. For the purposes of examination, the term “greater than about 0.5 mm” is deemed to claim “greater than 0.5 mm.”
The term “between about 10° and about 60°” in claim 12 is a relative term which renders the claim indefinite. The term “about 10° and about 60°” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 5° and 85° a dimension would need to be to satisfy the “about 10°”and “about 60°” limitations. For the purposes of examination, the term “about 10° and about 60°” is deemed to claim “between 10° and 60°”.
The term “between about 0.3 mm and about 4 mm” in claim 13 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 0.3 mm and 4 mm a dimension would need to be to satisfy the “about 0.3 mm” and “about 4 mm” limitations. For the purposes of examination, the term “between about 0.3 mm and about 4 mm” is deemed to claim “between 0.3 mm and 4 mm.”
The term “between about 0.5 mm and about 0.8 mm” in claim 15 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 0.5 mm and 0.8 mm a dimension would need to be to satisfy the “about 0.5 mm” and “about 0.8 mm” limitations. For the purposes of examination, the term “between about 0.5 mm and about 0.8 mm” is deemed to claim “between 0.5 mm and 0.8 mm.”
The term “between about 0.8 mm and about 1 mm” in claim 18 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the claim are indefinite, as it is unclear how close to 0.8 mm and 1 mm a dimension would need to be to satisfy the “about 0.8 mm” and “about 1 mm” limitations. For the purposes of examination, the term “between about 0.8 mm and about 1 mm” is deemed to claim “between 0.8 mm and 1 mm.”
Claim Rejections - 35 USC § 102
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 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babic (United States Patent Application Publication 2011/0230821 A1), hereinafter Babic.
Regarding Claim 1, Babic discloses A guidewire configured to traverse a catheter having one or more side holes (Fig 4A and 4B, “long guiding wire 326” traverses through “transvascular cannula 300”, with “transvascular cannula 300“ having a “longer braided part 302” with “side holes 308”; [0095]), the guidewire comprising:
a proximal end (End of “long guiding wire 326” at the bottom of Fig 4A near “proximal end 314”);
a distal end (End of “long guiding wire 326” at the top of Fig 4A near “distal tapered end 322”), the distal end comprising a distal advance segment (Fig 4A, distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322”) comprising a length greater than a maximum diameter of the one or more side holes (Fig 4A, the end length of “long guiding wire 326” exposed outside of “distal tapered end 322” section of “long guiding wire 326” is longer relative to the small “side holes 306” between the stripes near call-out 306.) and configured to traverse distally through the catheter without exiting the one or more side holes of the catheter (Fig 4A and Fig 4B, distal-most portion of “long guiding wire 326” that has exited through “distal tapered end 322” and not through “side holes 308” on “cannula 300”; [0095]) and
an elongate flexible body extending between the proximal end and the distal end (Figs 4A and 4B; “long guiding wire 326” and “distal tapered end 322” section of “long guiding wire 326” in “pigtail catheter 320”), the elongate flexible body comprising a distal region (Figs 4A and 4B; “distal tapered end 322” section of “long guiding wire 326” in “pigtail catheter 320”) extending between a distal transition and the distal end (Figs 4A and 4B, “distal tapered end 322” section of “long guiding wire 326” in “pigtail catheter 320”, shown between a thicker portion at “distal dilator port for pigtail catheter 318” and the distal end of “long guiding wire 326” near the top of Fig 4A), the distal region comprising a spiral coil geometry (Figs 4A and 4B; “distal tapered end 322” section of “long guiding wire 326” in “pigtail catheter 320” shown in a spiral coil shape).
Claim Rejections - 35 USC § 103
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 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 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Babic in view of Maguire et. al., (United States Patent Application Publication US 2016/0361088 A1), hereinafter Maguire.
Regarding Claim 2, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 2, Babic broadly discloses wherein the distal advance segment comprises an elongate straight tip (Fig 4A, distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322”)(Examiner notes that the guide wire itself is elongate, as it is “long”. The actual tip of the guide wire has a bit of a straight portion at the end of the curve.)
For a more particular teaching of a wherein the distal advance segment comprises an elongate straight tip, Maguire teaches wherein the distal advance segment comprises an elongate straight tip (Fig 5A, straight segment “distal end 120” of “guide wire 155-b” protruding through the curved distal region end of “distal section 130 of the cannula 105-c”; [0052])
Maguire provides a motivation to combine at [0058] with “a clinician may use any combination of rotation, straightening, bending, or longitudinal (i.e., axial) movement to adjust the orientation of the distal end 120 so that the guide wire 155 exits the cannula 105 in a preferred direction within the body lumen, as required by the particular medical procedure.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that it would be useful to control the directionality of the guide wire’s distal advance segment by having the guide wire progress with a straight section after a controlled bend.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322” disclosed in Fig 4A of Babic with the straight section of guidewire 155-b that is outside of “cannula 105-c” taught by Maguire, creating a single guidewire and catheter system with orientation of the guide wire and catheter that allow for enhanced steerability for the device.
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Figure A: Examiner-Annotated Maguire Figure 8B, showing “thickness” on the minor axis diameter of the ellipse
Regarding Claim 16, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 16, Babic does not specifically disclose wherein a diameter at a largest cross-section of the distal advance segment is greater than or equal to a diameter of the one or more side holes.
Maguire teaches a system for accessing a body lumen, using a guidewire inside the lumen of a cannula with aperture holes in its side. Specifically for Claim 16, Maguire teaches wherein a diameter at a largest cross-section of the distal advance segment ([0064] “the outer diameter of the guide wire 155 is approximately 0.035 inches”) is greater than or equal to a diameter of the one or more side holes ([0099] “elliptical-shaped central portions 835-a with a thickness of approximately 0.0030 inches.”; Fig 8B, Detail B; [0087] “the apertures 190 extend through the entire thickness of the wall of the cannula 105.”; Fig 6A, “guide wire 155 b”)(Examiner notes that the central portions 835-a are “elliptical-shaped”, and the “thickness value” refers to the minor axis diameter of the ellipse, as annotated in Figure A: Examiner-Annotated Maguire Fig. 8B.)
Maguire provides a motivation to combine at [0046] with “The apertures may be sized and located along the cannula to facilitate the advancement of the internal stylet or guide wire without catching on the apertures.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including a diameter for the guidewire larger than the diameter of the side apertures would be useful to prevent the guidewire from becoming caught in the side aperture and passing through it (instead of the hole at the distal tip).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter with small side holes and a guidewire inside passing through to a hole at the distal tip of the catheter, with Maguire’s taught guidewire with a diameter larger than the size of the apertures side holes in the surrounding cannula, creating a single guidewire and catheter system with dimensions for the guidewire and side holes that minimize the ability for the guidewire to erroneously pass through the side holes.
Claims 4, 6 – 8, 11 - 13, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Babic in view of Feng et. al., (United States Patent Application Publication US 2014/0094836 A1), hereinafter Feng.
Regarding Claim 4, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 3, Babic does not specifically disclose wherein a minimum length of the distal advance segment is between about 0.5 mm and about 3.5 mm.
Feng teaches a pericardiocentesis device with a guide wire that passes through a sheath and has a curled end. Specifically for Claim 4, Feng teaches wherein a minimum length of the distal advance segment is between about 0.5 mm and about 3.5 mm ([0006] “the sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire.”).
Feng provides a motivation to combine at [Abstract] with “The pointed end rotates at least 90 degrees within a range of no more than 3 mm starting from the pointed end at the bent section (32) of the guide wire. The pericardiocentesis needle component (10) of the present invention is less likely to damage a heart during a pericardiocentesis procedure.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a curled section of the guidewire curl in a short distance would be useful for navigating the assembly through a small lumen without damaging the surrounding tissue during maneuvers.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the pointed end section that curls within a length of no more than 3 mm taught by Feng, creating a single guidewire and catheter system with dimensions for the guidewire that promote travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 6, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 6, Babic discloses wherein the distal advance segment comprises a curved advance segment (Fig 4A, curved distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322”)
Babic does not disclose extending from an inflection point at a distal end of the spiral coil geometry.
Feng teaches a curved advance segment extending from an inflection point at a distal end of the spiral coil geometry (Figure 10, portion of “curved distal section 32” distal to an inflection point in the center of the S curve.; [0057] “…an irregular curve…”)
Feng provides a motivation to combine at [0049] with “The curved distal section 32 may be in any other suitable curved shape“ and “pericardiocentesis needle component…less likely to damage a heart during a pericardiocentesis procedure”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that an s-curved shape is taught among curved shapes of the distal end of a guidewire that are seen as “suitable” to perform pericardiocentesis procedure while minimizing the probability of damage to the heart.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 7, Babic in view of Feng discloses as described above, The guidewire of Claim 6. For the remainder of Claim 7, Babic discloses wherein the spiral coil geometry is concave in a first direction (Fig 4A, curved distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322”, concave )
Babic does not disclose and the distal advance segment is concave in a second direction
Feng teaches and the distal advance segment is concave in a second direction (Figure 10; portion of “curved distal section 32” proximal to an inflection point in the center of the S curve is concave left and portion of “curved distal section 32” distal to (top) an inflection point in the center of the S curve is concave right; [0057] “…an irregular curve…”)
The motivation for Claim 7 to combine Babic with Feng is the same as that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
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Figure B: Examiner-Annotated Feng Figure 10, labelling 4 inflection points, according to curved and straight portions of the distal end 32
Regarding Claim 8, Babic in view of Feng discloses as described above, The guidewire of Claim 6. For the remainder of Claim 8, Babic discloses wherein the distal advance segment comprises a first curved region (Fig 4A, curved distal-most portion of “long guiding wire 326” that is outside of “distal tapered end 322”, concave )
Babic does not disclose with a first inflection point and a second curved region with a second inflection point
Feng teaches wherein the distal advance segment comprises a first curved region with a first inflection point (Figure 10; Figure B, Examiner-annotated Figure 10, “distal section 32” with Inflection Point 1 touching Curved Region A). and a second curved region with a second inflection point (Feng : Figure 10; Figure B, Examiner-annotated Figure 10, “distal section 32” with Inflection Point 2 touching Curved Region B).
The motivation for Claim 8 to combine Babic with Feng is the same as that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
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Figure C: Examiner-Annotated Feng Figure 10, adding axes lines.
Regarding Claim 11, Babic in view of Feng discloses as described above, The guidewire of Claim 8. For the remainder of Claim 11, Babic does not disclose wherein a maximum angle between a longitudinal axis of the catheter and a central axis of a portion of the distal advance segment extending distally from the second inflection point is between about 5° and about 85°
Feng teaches wherein a maximum angle between a longitudinal axis of the catheter and a central axis of a portion of the distal advance segment extending distally from the second inflection point is between about 5° and about 85° (Fig 10, Figure C: Examiner-Annotated Figure 10, with the acute angle Θ being illustrated between 5° and 85°, where 90° is a right angle)(Examiner notes that the maximum angle could broadly be the angle that a user could push the wire to, such that the wire can be extended to be maintained within a spiral shape at any angle between 5° and 85°. The drawn Figure 10 shows an angle, but that angle could be increased or decreased through a 5° - 85° range by deeming the “maximum” extension to hold as having less guidewire length extended outside of the “needle tube 12”/”outer sheath 18”).
The motivation for Claim 11 to combine Babic with Feng is similar to that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end orientation taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 12, Babic in view of Feng discloses as described above, The guidewire of Claim 11. For the remainder of Claim 12, Babic does not disclose wherein the maximum angle between the longitudinal axis of the catheter and the central axis of the portion of the distal advance segment extending distally from the second inflection point is between about 10° and about 60°.
Feng teaches (Fig 10, Figure C: Examiner-Annotated Figure 10, with the acute angle Θ being illustrated between 10° and 60°, where 90° is a right angle)(Examiner notes that the maximum angle could broadly be the angle that a user could push the wire to, such that the wire can be extended to be maintained within a spiral shape at any angle between 10° and 60°. The drawn Figure 10 shows an angle, but that angle could be increased or decreased through an acute angle 10° - 60° range by deeming the “maximum” extension to hold as having less guidewire length extended outside of the “needle tube 12”/”outer sheath 18”).
The motivation for Claim 12 to combine Babic with Feng is similar to that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end orientation taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 13, Babic in view of Feng discloses as described above, The guidewire of Claim 8. For the remainder of Claim 13, Babic does not specifically disclose wherein a maximum length of a portion of the distal advance segment extending distally from the second inflection point is between about 0.3 mm and about 4 mm.
Feng teaches wherein a maximum length of a portion of the distal advance segment extending distally from the second inflection point is between about 0.3 mm and about 4 mm ([0057] “The sharp tip bend…a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire. “)
The motivation for Claim 13 to combine Babic with Feng is similar to that described in more detail in Claim 4. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the pointed end section that curls within a length of no more than 3 mm taught by Feng, creating a single guidewire and catheter system with dimensions for the guidewire that promote travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 18, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 18, Babic does not disclose wherein a diameter at a largest cross-section of the distal advance segment is between about 0.8 mm and about 1 mm. Babic broadly discloses flexibility in sizing, with its cannula being within a range of different sizes, including a “2 – 8 mm inner lumen” for its cannula.
Feng teaches wherein a diameter at a largest cross-section of the distal advance segment is between about 0.8 mm and about 1 mm ([0014] “a part of the curved distal end extending from the proximal end of the sharp tip structure to the proximal end of the guide wire is in cylindrical shape, which has a diameter of 0.2-1 mm.”).
Feng provides a motivation to combine at [0037] with “The diameter of puncture needle 12 may be set according to actual need of applications by those skilled in the art. “). A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that curved distal end on a guidewire could be sized for the size of particular target lumen, an example being Feng’s taught diameter within 0.8 – 1 mm being useful for pericardium applications.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the particular sizing of the diameter of the curved distal end of the guidewire taught by Feng, creating a single guidewire and catheter system with dimensions for the guidewire that is appropriate for pericardium applications.
Regarding Claim 21, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 21, Babic does not disclose wherein the elongate flexible body comprises a core comprising a plurality of segments having different diameters.
Feng teaches wherein the elongate flexible body comprises a core comprising a plurality of segments ([0016] “puncture needles is formed by connecting two tubes…distal end tube…proximal end tube…”) having different diameters ([0017] “The diameter of distal end of the puncture needle is smaller than the diameter of its proximal end.”)
Feng provides a motivation to combine at [0037] with “the puncture needle 12 has different diameters at the distal end and proximal end, preferably, the diameter of the distal end is smaller than the diameter of proximal end, because the puncture needle 12 needs to provide some supporting force at the proximal end, while the distal end of the puncture needle needs to be flexible in order to bend.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that manufacturing a flexible body of two segments with different diameters would be useful for giving support to a section and more flexibility to another, increasing maneuverability of the device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “long guiding wire 326” and “distal tapered end 322” section of “long guiding wire 326” in “pigtail catheter 320” disclosed in Babic with the two-section flexible member with different diameters for each section taught by Feng, creating a guidewire and catheter system with increased maneuverability using sections of varying dimensions.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Babic.
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Figure D: Examiner-Annotated top (distal) section of Babic Figure 4A, adding axes lines.
Regarding Claim 5, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 5, Babic broadly discloses wherein a maximum angle between a central axis of the distal advance segment and a longitudinal axis of the catheter is between about 5° and about 85° (Fig 4A, Figure D: Examiner-Annotated Figure 4A, with the acute angle Θ being between 5° and 85°,where 90° is a right angle)(Examiner notes that the maximum angle could broadly be the angle that a user could push the wire to, such that the wire can be extended to be maintained within a spiral shape at any angle between 5° and 85°.) Babic does not specifically disclose that the angle is numerically between 5° and 85°.
The Applicant’s specification provides no specific reasoning or critical functionality for the use of the numeric range for maximum angle between a central axis of the distal advance segment and a longitudinal axis of the catheter is between about 5° and about 85°, thus the claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use the 5° and about 85° as desired by the user as a matter of routine engineering design choice which would yield predictable results.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Babic in view of Feng, further in view of Maguire.
Regarding Claim 9, Babic in view of Feng discloses as described above, The guidewire of Claim 8. For the remainder of Claim 9, Babic discloses wherein the first curved region and/or the second curved region comprises an arc length greater than a maximum diameter of the one or more side holes. However, Babic does broadly illustrate in Fig 4A and arc length at the distal end 326 that is relatively greater than the illustrated diameter of the one or more side holes 308 between the horizontal lines near the call-out 306.
Maguire teaches a maximum diameter of the one or more side holes ([0099] “elliptical-shaped central portions 835-a with a thickness of approximately 0.0030 inches.”; Fig 8A and B, Detail B; [0087] “the apertures 190 extend through the entire thickness of the wall of the cannula 105.”; Fig 6A, “guide wire 155 b”)
Babic and Maguire both disclose and teach curved guidewires inside a catheter with side holes for use in body lumens: Babic with the “long guiding wire 326” within “cannula 300” with “side holes 308” with a distal end shown curved in Fig 4A, and Maguire with the “guide wire 155-b” within “sheath 180” having “apertures 190”. Maguire provides a motivation to combine at [0046] with “the distal section includes a plurality of apertures to increase the flexibility of the distal section” and [0099] “The spacing between dogbone apertures 190-b may be uniform or may instead be varied to impart variable flexibility along the distal section 130”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that including side holes (apertures) in a catheter would allow for additional flexibility for the member, and that the flexibility can be affected by the size of the side holes.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “side holes 308” in a distal end of “cannula 300” (shown curved in Fig 4A with the “long guiding wire 326” therein) disclosed in Babic with the dogbone apertures with elliptical portions of 0.0030” taught by Maguire, creating a single guidewire and catheter system with dimensions for the holes in the catheter surrounding the guidewire that promote flexibility and maneuverability for the device.
Maguire does not specifically numerically teach an arc length greater than a maximum diameter of the one or more side holes. Maguire does broadly illustrate in Figs 7a and 7b of the arc length in the curved, exposed guidewire (155-b) is relatively greater than that of an individual hole diameter (190).
Feng teaches an arc length ([0006] “the sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire.”)(Examiner notes that this arc length in combination with the hole diameter provided by the aforementioned combination of Babic and Maguire, is greater than a maximum diameter of the one or more side holes, where the diameter of the one or more side holes of the combination of Babic and Maguire is 0.0030 inches, 0.0762 mm.)
Babic in view of Feng and Maguire both teach guidewires of similar diameter: Babic: provides general scale of cardiac applications, with multiple sizes of cannula to accommodate a guidewire (2 – 8 mm); Maguire portion with (Maguire: [0064]) = “…the outer diameter of the guide wire 155 is approximately 0.035 inches (0.889 mm), and Feng with (Feng: [0014]) “the guide wire…which has a diameter of 0.2 – 1 mm.”. Feng provides a motivation to combine at [Abstract] with “The pointed end rotates at least 90 degrees within a range of no more than 3 mm starting from the pointed end at the bent section (32) of the guide wire. The pericardiocentesis needle component (10) of the present invention is less likely to damage a heart during a pericardiocentesis procedure.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a curled section of the guidewire curl in a short distance would be useful for navigating the assembly through a small lumen without damaging the surrounding tissue during maneuvers.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic in view of Maguire’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) passing through a catheter with side holes with a 0.0030” dimension, with the pointed end section that curls within a length of no more than 3 mm taught by Feng, creating a single guidewire and catheter system with dimensions for the guidewire that promote travel through small lumens and minimizing damage to the tissue therein.
Regarding Claim 10, Babic in view of Feng, further in view of Maguire discloses as described above, The guidewire of Claim 9. For the remainder of Claim 10, Babic does not disclose wherein the arc length is greater than about 0.5 mm.
Feng teaches wherein the arc length is greater than about 0.5 mm ([0006] “the sharp tip bends at least 90 degrees within a length range of no more than 3 mm starting from the sharp tip of the curved distal section of the guide wire.”)(Examiner notes that with arc length of 3 mm for the entire s-curve, then with the presence of both a top and a bottom concave curve, there will be at least one of the two that is greater than 0.5 mm. For example, if one is only 0.4 mm of the total arc length, then the other could still be 2.6 mm.)
The motivation for Claim 10 to combine Babic with Feng is similar to that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the “irregular curve” s-shaped distal guidewire end orientation taught by Feng, creating a single guidewire and catheter system with distal end curvature for the guidewire that promotes travel through small lumens and minimizing damage to the tissue therein.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Babic in view of Feng, further in view of Maguire, further in view of Belson et. al., (United States Patent Application Publication US 2008/0300574 A1), hereinafter Belson.
Regarding Claim 14, Babic in view of Feng discloses as described above, The guidewire of Claim 8. For the remainder of Claim 14, Babic does not specifically disclose wherein a radius of curvature of the first inflection point and/or the second inflection point is greater than a radius of the one or more side holes. Babic does broadly illustrate at Fig 4A, the end length of “long guiding wire 326” exposed outside of “distal tapered end 322” section of “long guiding wire 326” is longer relative to the small “side holes 306” between the stripes near call-out 306.
Maguire teaches a radius of the one or more side holes ([0099] “elliptical-shaped central portions 835-a with a thickness of approximately 0.0030 inches.”; Fig 8A and B, Detail B; [0087] “the apertures 190 extend through the entire thickness of the wall of the cannula 105.”; Fig 6A, “guide wire 155 b”)(Examiner notes that the radius would be 0.0015 inches.)
The motivation for Claim 14 to combine Babic with Maguire is the same as that described in more detail in Claim 9. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “side holes 308” in a distal end of “cannula 300” (shown curved in Fig 4A with the “long guiding wire 326” therein) disclosed in Babic with the dogbone apertures with elliptical portions of 0.0030” taught by Maguire, creating a single guidewire and catheter system with dimensions for the holes in the catheter surrounding the guidewire that promote flexibility and maneuverability for the device.
Maguire does not specifically numerically teach wherein a radius of curvature of the first inflection point and/or the second inflection point is greater than. Maguire does broadly illustrate in Figs 7a and 7b of the arc length in the curved, exposed guidewire (155-b) is relatively greater than that of an individual hole diameter (190).
Belson teaches an intravenous catheter insertion device with a pigtail curved guidewire that passes through a catheter. Specifically for Claim 14, Belson teaches wherein a radius of curvature of the first inflection point and/or the second inflection point (Belson: Fig 5B., radius 0.75 mm”).
Belson provides a motivation to combine at [0024] with “the distal end of the safety guidewire 11 is preformed into a tightly wound spiral with an outer diameter smaller than the internal diameter of the target vessel into which it will be inserted. The spiral tip acts as a safety bumper on the guidewire to avoid puncturing or damaging the inside of target vessels.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a curled section of the guidewire curl in a short distance would be useful for navigating the assembly through a small lumen without damaging the surrounding tissue during maneuvers.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic in view of feng, further in view of Maguire’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) passing through a catheter with side holes with a 0.0015” (0.381 mm) radius dimension, with the pointed end section that curls within a radius of curvature of 0.75 mm” taught by Belson, creating a single guidewire and catheter system with dimensions for the guidewire and catheter that promote maneuverable travel through small lumens while minimizing damage to the tissue therein.
Regarding Claim 15, Babic in view of Feng, further in view of Maguire, further in view of Belson discloses as described above, The guidewire of Claim 14. For the remainder of Claim 15, Babic does not disclose wherein the radius of curvature of the first inflection point and/or the second inflection point is between about 0.5 mm and about 0.8 mm.
Belson teaches wherein the radius of curvature of the first inflection point and/or the second inflection point is between about 0.5 mm and about 0.8 mm (Belson: Fig 5B., radius 0.75 mm”)
Babic and Belson both teach pig-tail curved distal end guidewires that pass through a catheter portion for use in body lumens: Babic with the “long guiding wire 326” within “cannula 300” with a distal end shown curved in Fig 4A, and Belson with “safety guidewire 11” in “intravenous catheter insertion device 20”, with the distal end shown curved in Fig 5A and 5B. Belson provides a motivation to combine at [0024] with “the distal end of the safety guidewire 11 is preformed into a tightly wound spiral with an outer diameter smaller than the internal diameter of the target vessel into which it will be inserted. The spiral tip acts as a safety bumper on the guidewire to avoid puncturing or damaging the inside of target vessels.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that curved distal end on a guidewire with small dimensions could be useful for safely maneuvering the guidewire assembly into small vessels, an exemplar small dimension being Belson’s taught radius of curvature of 0.75 mm.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Babic’s disclosed catheter and guidewire with a distal curved exposed section (distal advance segment) with the particular sizing of the radius of curvature of the curved distal end of the guidewire taught by Belson, creating a single guidewire and catheter system with dimensions for the guidewire that can be safely maneuvered in small vessel applications.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Babic in view of Hansen (United States Patent Application Publication US 2016/0089515 A1), hereinafter Hansen.
Regarding Claim 17, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 17, Babic does not disclose wherein the distal advance segment is spheroidal in shape.
Hansen teaches a wire guide for feeding a medical catheter through a body passage of a patient, including spheroidal members at the distal end. Specifically for Claim 17, Hansen teaches wherein the distal advance segment is spheroidal in shape (Fig 1, “flexible portion 108” with “spheroidal members 112”; [0022])
Babic and Hansen both teach curved distal end guidewires that pass through a cannula portion with side holes: Babic with the “long guiding wire 326” within “cannula 300” with a distal end shown curved in Fig 4A, and Hansen with “core wire 128” within “cannula portion” 100 section with holes (“cuts” in Fig 6B), with the distal end shown curved in Fig 1. Hansen provides a motivation to combine at [0025] with “the second member 122 is a blunt form to reduce the risk of wall penetration. The second member 122 can have a spheroidal shape.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a spheroidal blunt end to a guidewire would be useful for not unintentionally penetrating internal tissue.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the catheter and guidewire with a distal curved exposed section (distal advance segment) disclosed in Babic with the spheroidal shaped distal guidewire tip taught by Hansen, creating a single guidewire system with a spheroidal tip to minimize tissue injury during use.
Regarding Claim 19, Babic discloses as described above, The guidewire of Claim 1. For the remainder of Claim 19, Babic does not disclose wherein the distal end is rounded in shape.
Hansen teaches wherein the distal end is rounded in shape (Fig 1, “flexible portion 108” with “spheroidal members 112”; [0022])
The motivation for Claim 19 to combine Babic with Maguire is the same as that described in more detail in Claim 17. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the catheter and guidewire with a distal curved exposed section (distal advance segment) disclosed in Babic with the spheroidal shaped distal guidewire tip taught by Hansen, creating a single guidewire system with a spheroidal tip to minimize tissue injury during use.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Babic in view Feng, further of Mathews (United States Patent Application Publication US 2015/0290432 A1), hereinafter Mathews.
Regarding Claim 25, Babic in view of Feng discloses as described above, The guidewire of Claim 21. For the remainder of Claim 25, Babic does not disclose wherein the elongate flexible body further comprises one or more coils of wire surrounding the core.
Mathews teaches a preformed guidewire for use in percutaneous medical procedures (including cardiac applications), including a curled tip with a flexible outer casing of spring coil wire. Specifically for Claim 25, Mathews teaches wherein the elongate flexible body further comprises one or more coils of wire surrounding the core ([0041] “outer casing 15 is represented herein as a segment of spring wire”; Fig 1; Fig 2, “outer casing 15” around “corewire 13”; [0040]).
Babic and Mathews both teach curved distal end guidewires used in cardiac applications that pass through a cannula portion: Babic with the “long guiding wire 326” within “cannula 300” with a distal end shown curved in Fig 4A, and Mathews with “preformed guidewire 11” surrounded by “outer casing 15” passing through “a straightened guide catheter” (Mathews: [Abstract], Fig 1), with the distal end shown curved in Fig 1. Mathews provides a motivation to combine at [Abstract] with “the distal region is optimally configured to limit the risk of trauma to the immediate site of treatment when inserted through a straightened guide catheter.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a wire coil tip on a curled tip guidewire would be useful for navigating cardiac regions and minimizing risk of unintended tissue damage therein.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the catheter and core guidewire with a distal curved exposed section (distal advance segment) disclosed in Babic with the coiled wire casing guidewire tip taught by Mathews, creating a single guidewire system with a curved wire coil tip to minimize tissue injury during use.
Conclusion
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791