DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 5 is objected to because of the following informalities: the claim should be amended to recite “wherein [[the]] a thickness” in line 1 to correct for grammar. Appropriate correction is required.
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 10, 11, and 16 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.
Claim 10 recites the limitations "the lateral major axis" and “the vertical minor axis” in line 2. There is insufficient antecedent basis for these limitation in the claim. It is unclear if these limitations are drawn to the same axes as recited in claim 3 or if these are two different axes. For examination purposes, the first interpretation was used. It is recommended to amend the claim limitations by removing the words “lateral” and “vertical”.
Claim 11 recites the limitation "the central portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is the same as “the center” recited in claim 3 or if this limitation is drawn to a portion of the center. For examination purposes, the first interpretation was used. It is recommended to delete the word “portion” from the claim.
Regarding claim 16, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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(s) 1-3, 5-10 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein (WO 9640346).
Regarding claim 1, Klein discloses a catheter (fig. 1) comprising a shaft portion (shaft 80 in fig. 14) defining a non-circular transverse cross-section (fig. 14 shows an ovular cross-sectional shape), the shaft portion including an exterior sidewall and an interior sidewall (see below) defining two or more asymmetrical working channels therein (lumens 84 and 86 are asymmetrical with respect to each other).
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Regarding claim 2, Klein discloses the non-circular transverse cross-section defines an elliptical transverse cross-section (fig. 14 shows an ovular cross-section which is equivalent in shape to Applicant’s elliptical transverse cross-section, as seen in fig. 1B of the Drawings).
Regarding claim 3, Klein discloses the elliptical cross-section of the shaft portion includes a major axis and a minor axis which cross at a center of the elliptical transverse cross-section (see below), the major axis and the minor axis defining a first and second upper quadrant and a first and second lower quadrant of the elliptical transverse cross-section (see below).
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Regarding claim 5, Klein discloses a thickness of the exterior sidewall is generally uniform throughout (fig. 14 shows the exterior sidewall as a generally uniform thickness about the cross-section) and a thickness of the interior sidewall is generally non-uniform (see area between dotted lines below, the thickness of the interior sidewall gradually increases as it connects to the exterior sidewall).
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Regarding claim 6, Klein discloses the interior sidewall includes a first end portion (see dotted line below), a second end portion opposite the first end portion (see dotted line below) and body portion positioned therebetween (see gray dashed line below), the first end portion connected to a first portion of the exterior sidewall (see below) and the second end portion connected to a second portion of the exterior sidewall (see below).
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Regarding claim 7, Klein discloses the body portion of the inner sidewall is curved (see above) and offset from the minor axis (see below, at least a portion of the sidewall is offset from the minor axis).
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Regarding claim 8, Klein discloses the two or more working channels include a first working channel including a circular transverse cross-section (lumen 84 in fig. 14) and a second working channel including a non-circular transverse cross-section (lumen 86 in fig. 14).
Regarding claim 9, Klein discloses the two or more working channels include a first working channel including a circular transverse cross-section (lumen 84 in fig. 14) and a second working channel including a reniform transverse cross-section (lumen 86 in fig. 14 is equivalent in cross-sectional shape to lumen 87 in fig. 1B of the Drawings).
Regarding claim 10, Klein discloses the first and second working channels are each centered on the lateral major axis and not centered on the vertical minor axis (fig. 14).
Regarding claim 15, Klein discloses a catheter (fig. 1) comprising a handle portion on a proximal end (hub 18 in fig. 10) and a shaft portion on a distal end thereof (portion of shaft 16 taken at cross-section 11 in fig. 10), the shaft portion including an exterior wall and an interior sidewall (see below; fig. 14 is an embodiment of cross-section 11 in fig. 10), the exterior sidewall defining an elliptical transverse cross-section (fig. 14 shows an ovular cross-section which is equivalent in shape to Applicant’s elliptical transverse cross-section, as seen in fig. 1B of the Drawings) and the interior sidewall defining a first and second working channel within the exterior wall (lumens 84 and 86 in fig. 14, respectively), the first working channel defining a generally circular transverse cross- section (fig. 14 shows lumen 84 as being circular) and the second working channel defining a generally reniform transverse cross-section (lumen 86 in fig. 14 is equivalent in cross-sectional shape to lumen 87 in fig. 1B of the Drawings).
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Claim(s) 1-3, 6-8, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forsberg (US 7648493).
Regarding claim 1, Forsberg discloses a catheter (apparatus 100 in fig. 1) comprising a shaft portion (insertion sheath 102 in fig. 1) defining a non-circular transverse cross-section (fig. 5A; 7:38-42 discloses an “elliptical outer diameter”), the shaft portion including an exterior sidewall (reinforced wall 128 in fig. 5A) and an interior sidewall (internal portion 146 in fig. 5A) defining two or more asymmetrical working channels therein (first flexible lumen 110 and first collapsible lumen 120 in fig. 5A are asymmetric with respect to each other).
Regarding claim 2, Forsberg discloses the non-circular transverse cross-section defines an elliptical transverse cross-section (fig. 5A; 7:38-42 discloses an “elliptical outer diameter”).
Regarding claim 3, Forsberg discloses the elliptical cross-section of the shaft portion includes a major axis and a minor axis which cross at a center of the elliptical transverse cross-section (see below), the major axis and the minor axis defining a first and second upper quadrant and a first and second lower quadrant of the elliptical transverse cross-section (see below).
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Regarding claim 6, Forsberg discloses the interior sidewall includes a first end portion (see dotted line below), a second end portion opposite the first end portion (see dotted line below) and body portion positioned therebetween (see dashed line below), the first end portion connected to a first portion of the exterior sidewall and the second end portion connected to a second portion of the exterior sidewall (see below).
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Regarding claim 7, Forsberg discloses the body portion of the inner sidewall is curved and offset from the minor axis (see annotated figure above; the body portion delimited above is curved and positioned to the right of the minor axis defined above).
Regarding claim 8, Forsberg discloses the two or more working channels include a first working channel including a circular transverse cross-section (lumen 110 is circular in fig. 5A) and a second working channel including a non-circular transverse cross-section (lumen 120 in fig. 5A is non-circular).
Regarding claim 11, Forsberg discloses at least a portion of the first working channel is positioned on the central portion of the elliptical transverse cross-section (see below).
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Regarding claim 12, Forsberg discloses at least a portion of the first working channel is positioned in each of the first and second upper quadrants and the first and second lower quadrants of the elliptical transverse cross-section (see annotated figure above; lumen 110 is at least positioned in all four quadrants).
Regarding claim 13, Forsberg discloses at least a first lumen and a second lumen extending therethrough (lumen 126 in fig. 6 extends longitudinally through the distal end 112 of the shaft and port 114 forms a lumen which extends laterally through wall 128).
Regarding claim 14, Forsberg discloses the second working channel, the first lumen and the second lumen are positioned only in the second upper and lower quadrants of the elliptical transverse cross-section (taking a cross-section through port 114, the lumen formed by port 114 and lumens 120 and 126 would be positioned only in the second upper and lower quadrants).
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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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsberg, as applied to claims 1, 2, and 3, above, in view of Oborn (US 20150088100).
Regarding claim 4, Forsberg discloses all of the claimed limitations set forth in claims 1, 2, and 3, as discussed above, and further appears to disclose a thickness of the exterior sidewall and a thickness of the interior sidewall is equal along the major axis (fig. 5A-C); however, Forsberg does not explicitly teach or disclose this limitation.
Oborn teaches a similar catheter (fig. 26) and further teaches a thickness of an exterior sidewall and a thickness of an interior sidewall is equal along the major axis (paragraph 101 discloses a thickness of septum, equated to an interior sidewall, 1390 is 0.015 in and a thickness of the outer wall, equated to an exterior sidewall, at the midpoint of arc 1398 is 0.015 so that the thicknesses of the exterior wall and interior wall are equal along the major axis). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the thicknesses of the exterior and interior sidewalls of Forsberg to be equal along the major axis, as taught by Oborn, as Forsberg appears to already disclose such feature and such modification would not appear to modify operation of the device of Forsberg.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dickhans (US 20180085173) in view of Belson (US 20060235458).
Regarding claim 16, Dickhans discloses an electromagnetic navigation system for navigating through a luminal network of a patient's lung (fig. 1), the system comprising: a computing device (computing device 100 in fig. 1), a monitoring device (display 110 in fig. 1), an electromagnetic board (table 120 having an electromagnetic field generator 121 in fig. 1; paragraph 31), a tracking device (imaging device 140 in fig. 1; paragraph 39), and a catheter (catheter guide assembly 200 in fig. 2) including a shaft portion (extended working channel 220 in fig. 2).
However, Dickhans does not teach or disclose the shaft portion defining a non-circular transverse cross-section, the shaft portion including an exterior sidewall and an interior sidewall defining two or more asymmetrical working channels therein.
Belson is directed towards a catheter (fig. 4A) comprising a shaft portion (instrument 400 in fig. 4A) comprising a non-circular transverse cross-section (fig. 4A shows an elliptical cross-section), the shaft portion including an exterior sidewall (external surface 407 in fig. 4A) and an interior sidewall (wall formed between lumens 410 and 425 in fig. 4A) defining two or more asymmetrical working channels therein (lumens 410 and 425 in fig. 4A). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the shaft portion of Dickhans so that the shaft portion defines a non-circular transverse cross-section, the shaft portion including an exterior sidewall and an interior sidewall defining two or more asymmetrical working channels therein, as taught by Belson. This modification would enable two lumens to introduce fluid or other instruments and would provide for lumens which are appropriately shaped/sized for the instruments passing through the lumens (paragraph 89).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oborn is capable of being used in a 102(a)(1) rejection for claim 1 and several dependent claims. For example, Oborn discloses a catheter (fig. 1) comprising an elliptical transverse cross-section (fig. 26) comprising a first working channel having a circular cross-section (third lumen 1315 in fig. 26) and a second working channel having a non-circular cross-section (second lumen 1314 in fig. 26). Oborn further discloses a first and second lumen extending therethrough (first lumen 1312 and fourth lumen 1410 in fig. 26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 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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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783