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 .
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 recites “includes sixth lumen” in line 1 which should read “includes a sixth lumen”. 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 11, 25 and 29-31 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 11 recites the limitation "each internal wall" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites “a catheter”, “a first expandable occlusion element”, and “a second expandable occlusion element” which should read “the catheter”, “the first expandable occlusion element”, and “the second expandable occlusion element” for proper antecedent basis.
Claims 29-31 are rejected based on their dependency on rejected claim 25.
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, 15-21, 25 and 29-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macoviak et al. (US 6,585,689 B1).
Regarding claim 1, Macoviak discloses a catheter (catheter 100; Fig. 1), comprising: a tubular body (catheter shaft 102) having a first end (proximal end 104) and a second end (distal end 106; Fig. 1), the tubular body defining a plurality of lumen (lumens 108, 110, 112, 114, 116, 118) extending at least partially through the catheter (Figs. 1-3); and wherein the plurality of lumen include: a first lumen (guide wire and cardioplegia lumen 116) is configured to slidably receive a guidewire (column 11, lines 45-47); a second lumen (at least one of balloon inflation lumen 114) is configured to inflate and/or deflate a first expandable occlusion element (anchoring member 122; as common balloon inflation lumen 114 may instead be two separate inflation lumens for independently inflating occlusion member 120 and anchoring member 122; column 8, lines 52-62); a third lumen (other of inflation lumen 114) is configured to inflate and/or deflate a second expandable occlusion element (occlusion member 120); and a plurality of additional lumen (108, 110, 112, 118; Fig. 2); wherein an outer diameter of the tubular body is no more than 9 Fr (as the outer diameter of the shaft 102 may be 9 French; column 6, lines 43-48).
Regarding claim 3, Macoviak discloses wherein at least two lumen have a same cross-sectional area (at least 112 and 118 or 110 and 108 have the same cross-sectional area; Fig. 2).
Regarding claim 4, Macoviak discloses wherein the plurality of lumen includes a fifth lumen (any one of 108, 110, 112, or 118; Fig. 2).
Regarding claim 5, Macoviak discloses wherein the plurality of lumen includes a sixth lumen (any one of 108, 110, 112, or 118; Fig. 2).
Regarding claim 15, Macoviak discloses wherein at least one lumen (arch perfusion lumen 110) of the plurality of additional lumen is configured to terminate on an external surface of the catheter (100) at an intermediate location between the first end (proximal end 104) and the second end (distal end 106) of the tubular body (as lumen 110 terminates at one or more arch perfusion ports 126; Fig. 1).
Regarding claim 16, Macoviak discloses wherein the at least one lumen (110) of the plurality of additional lumen is configured to transmit a fluid to the intermediate location (as lumen 110 extends through the catheter shaft 102 from the proximal end 104 to one or more arch perfusion ports 126 to allow for fluid flow to the aortic arch; column 8, lines 36-43).
Regarding claim 17, Macoviak discloses wherein the at least one lumen (110) of the plurality of additional lumen is configured to draw fluid from the intermediate location (as lumen 110 extends through the catheter shaft 102 from the proximal end 104 to one or more ports 126, therefore, depending on the user’s manipulation of the device an injection or withdrawing device may be coupled to the lumen 110; column 8, lines 36-43; column 11, lines 8-18).
Regarding claim 18, Macoviak discloses wherein at least one of the plurality of additional lumen (root pressure lumen 118) defines a fluid-filled pressure transducer (as the root pressure lumen 118 monitors pressure in the aortic root i.e., senses pressure; column 9, lines 63-66; and applicant defines a fluid-filled pressure transducer as a pressure sensor; [0033]).
Regarding claim 19, Macoviak discloses wherein the second lumen (one of lumens 114 split) is not adjacent to any lumen coupled to or defining a fluid-filled pressure transducer (as 114 is not adjacent 118; Fig. 2).
Regarding claim 20, Macoviak discloses wherein the third lumen (other one of lumens 114 split) is not adjacent to any lumen coupled to or defining a fluid-filled pressure transducer (as 114 is not adjacent 118; Fig. 2).
Regarding claim 21, Macoviak discloses wherein at least one of the plurality of additional lumen is configured to receive one or more optical fibers (wherein at least one of 110, 112, 118, or 108 is capable of receiving an optical fiber as each lumen has an open proximal end that a user may insert additional tools; Fig. 14).
Regarding claim 25, Macoviak discloses a system, comprising: a catheter (100) of claim 1 (see claim 1 above); a first expandable occlusion element (anchoring member 122) operably coupled to the second lumen (one of 114 split; column 8, lines 56-62); and a second expandable occlusion element (occlusion member 120) operably coupled to the third lumen (other of 114 split; column 8, lines 56-62).
Regarding claim 29, Macoviak discloses wherein the first expandable occlusion element (122) is coupled to an external surface of the catheter (100) at an intermediate point between the first end (proximal end 104) and the second end (distal end 106) of the catheter (Fig. 1).
Regarding claim 30, Macoviak discloses wherein the second expandable occlusion element (120) is coupled to an external surface of the catheter (100) at the second end (distal end 106) of the catheter (Fig. 1).
Regarding claim 31, Macoviak discloses further comprising a controller (three-way Y-fitting 170; Fig. 14) operably coupled to the first end (proximal end 104) of the catheter (as Y-fitting 170 includes at least guidewire port 176 which controls the direction the guide wire is inserted into the catheter).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (US 6,585,689 B1) in view of Kallmes et al. (US 2022/0096257 A1).
Regarding claim 2, Macoviak fails to explicitly disclose wherein eachlumen has a different cross-sectional area.
However, Kallmes teaches a catheter (elongated sheath 12; Figs. 1-5), comprising a tubular body (body of 12) having a plurality of lumen (6, 15, 24, 30, 22; Fig. 7), at least one lumen (30) can be used to inflate an expandable occlusion element (balloon 18a; [0084]), where each lumen has a different cross-sectional area (many different shapes can be used with the elongated sheath 12; Fig. 7; [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Macoviak wherein each lumen has a different cross-section area as taught by Kallmes since changing the shape of each lumen is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed lumen is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
3. Claim(s) 8-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (US 6,585,689 B1) in view of Lampropoulous et al. (US 2016/0250444 A1).
Regarding claims 8-9 and 11, Macoviak fails to explicitly disclose wherein a total cross-sectional area of material defining the tubular body is less than 2.5 mm2, wherein an average thickness of an internal wall separating one lumen from an adjacent lumen is less than 0.2 mm, and an average thickness of each internal wall is 0.1 mm - 0.2 mm.
However, Macoviak teaches the tubular body (102) of the catheter (100) is no more than 9 Fr (as the outer diameter of the shaft 102 may be 9 French; column 6, lines 43-48) and includes at least six lumen (108, 110, 112, 114, 116, 118; Fig. 2), such that a majority of the tubular body at the cross-section taken in Fig. 2 is open lumen rather than material defining the tubular body, similar to applicant’s invention shown in Fig. 2.
Lampropoulous teaches a catheter (catheter 300; Fig. 10) wherein a thickness of both an outer tubular body (tube 374) and internal walls (septal walls 394, tube 376) is 0.7 inches i.e., 0.1778 mm ([0088]-[0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the average thickness of each internal wall of Macoviak to be between 0.1778 mm as taught by Lampropoulous as applicant appears to have placed no criticality on the claimed range (see [000] indicating the thickness “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The modification of Macoviak in view of Lampropoulous would make a total cross-sectional area of material defining the tubular body less than 2.5 mm2 because the structural elements making up the tubular body and lumen of modified Macoviak are equivalent to applicant’s. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Macoviak to have a total cross-sectional area of material defining the tubular body to be less than 2.5 mm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the catheter of Macoviak would not operate differently with the claimed cross-sectional area. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the cross-sectional area of material “may” be within the claimed ranges ([0010]).
3. Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (US 6,585,689 B1).
Regarding claim 14, Macoviak fails to explicitly disclose wherein the outer diameter is no more than 7 Fr.
However, Macoviak teaches wherein the outer diameter of the tubular body (102) of the catheter (100) may be 9 French for adult human patients and wherein catheters for pediatric patients may be somewhat smaller (column 6, lines 46-51).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter to be no more than 7 Fr in light of the teachings of Macoviak in order to allow the catheter to be used on pediatric patients.
3. Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (US 6,585,689 B1) in view of Ehrenreich et al. (US 2011/0288478 A1).
Regarding claim 23, Macoviak an inflation/deflation lumen (114) operably coupled to the first expandable occlusion element (122) or the second expandable occlusion element (120) but fails to disclose wherein at least one of the plurality of additional lumen defines a vacuum lumen operably coupled to the first expandable occlusion element or the second expandable occlusion element.
However, Ehrenreich teaches a catheter (elongate shaft 200; Figs. 4A-4C) comprising an expandable occlusion element (expandable member 300), the catheter comprising a plurality of lumen (203, 204, 205, 206; Fig. 4B) with a first lumen (inflation lumen 203) configured to inflate the expandable occlusion element (300; [0093]) and an additional lumen (deflation lumen 204) configured to deflate the expandable member ([0093]). The independent deflation lumen allows for rapid deflation of the expandable occlusion element (balloon; [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Macoviak to include a separate vacuum lumen (deflation lumen) operably coupled to the first or second expandable occlusion element as taught by Ehrenreich in order to rapidly deflate the expandable occlusion element.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Glover et al. (US 2020/0022587 A1) is noted for teaching a multi-lumen balloon catheter with sensors.
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/SARAH A LONG/Primary Examiner, Art Unit 3771