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 .
Response to Arguments
The previous objection of claim 5 due to minor informalities has been withdrawn in light of applicant’s amendments made 7/01/2026.
The previous rejection of claim(s) 11, 25 and 29-31 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 11 and 25 on 7/01/2026.
The rejection of claims 1, 3-5, 15-21, 25 and 29-31 under 35 U.S.C. 102(a)(1) as being anticipated by Macoviak et al. (US 6,585,689 B1) has been withdrawn in light of applicant’s amendment made 7/01/2026. Specifically, Macoviak does not teach wherein the second lumen, third lumen, and the plurality of additional lumen are adjacent to the first lumen.
Applicant’s arguments with respect to claims 1-5, 8-9, 11, 14-21, 23, 25 and 29-31 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Glover et al. (US 2020/0022587 A1) teaches said limitation.
Claim Objections
Claims 29-31 are objected to because of the following informalities: Claims 29-30 recite “the second end of the catheter” which should read “the second end of the tubular body.” Claim 31 recites “the first end of the catheter” which should read “the first end of the tubular body.” Appropriate correction is required.
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) 1, 3-5, 14-21, 25 and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (US 6,585,689 B1) in view of Glover et al. (US 2020/0022587 A1).
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). It is noted that both Macoviak (as 114 is split into two lumen) and Glover teach a catheter with seven lumen, i.e., the same number.
Macoviak fails to disclose wherein the second lumen, third lumen, and the plurality of additional lumen are adjacent to the first lumen.
However, Glover teaches a catheter (apparatus 2001), comprising: a tubular body (catheter tubing 2002; Figs. 6-8) having a first end (proximal end 2102) and a second end (distal tip 2120), the tubular body defining a plurality of lumen (lumen 2004-1 thru 2004-6; Figs. 6-8) extending at least partially through the catheter (Figs. 6-8); and wherein the plurality of lumen include: a first lumen (2004-7) configured to slidably receive a guidewire (sized to receive a standard guidewire; [0099]), a second lumen (2004-1) configured to inflate a first expandable occlusion element (balloon inflation lumen of inflatable balloon 2160; [0099]), a third lumen (2004-6) capable of inflating a second expandable occlusion element (as the lumen provides for fluid injection; [0099]); and a plurality of additional lumen (2004-2, 2004-3, 2004-4, 2004-5); wherein an outer diameter of the tubular body is no more than 9 Fr (catheter tubing 2002 has an outside diameter in the range of about 3-8 Fr; [0095]); and wherein the second lumen, third lumen, and the plurality of additional lumen are adjacent to the first lumen (Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify shape of the cross-section of the tubular body of Macoviak such that the second lumen, third lumen, and the plurality of additional lumen are adjacent the first lumen as taught by Glover since the configuration of the claimed multi-lumen catheter 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 catheter was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements by known methods with no change in their respective functions, and the combination would have yielded the predictable result of a multi-lumen catheter. It is noted that both Macoviak (as 114 is split into two lumen) and Glover teach a catheter with seven lumen, i.e., the same number. Thus, changing the shape of the lumen when viewing the cross-section of the tubular body of Macoviak would not change the function thereof, just the placement.
Regarding claim 3, Macoviak modified discloses wherein at least two lumen have a same cross-sectional area (Fig. 7 of Glover).
Regarding claim 4, Macoviak modified discloses wherein the plurality of lumen includes a fifth lumen (any one of 108, 110, 112, or 118; Fig. 2 of Macoviak).
Regarding claim 5, Macoviak modified discloses wherein the plurality of lumen includes a sixth lumen (any one of 108, 110, 112, or 118; Fig. 2 of Macoviak).
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) and Glover teaches the catheter has an outside diameter in the range of about 3-8 Fr ([0095]).
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 of modified Macoviak to be no more than 7 Fr in light of the teachings of Macoviak and Glover in order to allow the catheter to be used on pediatric patients.
Regarding claim 15, Macoviak discloses the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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). 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 second lumen to not be adjacent to any lumen coupled to or defining a fluid-filled pressure transducer, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 20, Macoviak discloses the invention as claimed above, and Macoviak further 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). 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 third lumen to not be adjacent to any lumen coupled to or defining a fluid-filled pressure transducer, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 21, Macoviak discloses the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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 the invention as claimed above, and Macoviak further 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(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 Glover et al. (US 2020/0022587 A1), as applied to claim 1, and further in view of Kallmes et al. (US 2022/0096257 A1).
Regarding claim 2, Macoviak fails to explicitly disclose wherein each lumen 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 (22b, 6b, 30b; Fig. 8), with a first lumen (22b) and additional lumen (6b, 30b), wherein the additional lumen are adjacent to the first lumen (Fig. 8), and where each lumen has a different cross-sectional area (many different shapes can be used with the elongated sheath 12; Fig. 8; [0084]-[0086]). The sizes of the lumens (6a, 30a, 22a can be increased and decreased; [0085]).
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 modified Macoviak wherein each lumen has a different cross-section area as taught by Kallmes since changing the shape/size 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 and a catheter having different sized lumen would not perform differently than the prior art device. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
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 Glover et al. (US 2020/0022587 A1), as applied to claim 1, and further in view of Lampropoulous et al. (US 2016/0250444 A1).
Regarding claims 8-9 and 11, Macoviak modified 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 modified 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) 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 Glover et al. (US 2020/0022587 A1), as applied to claim 1, and further in view of Ehrenreich et al. (US 2011/0288478 A1).
Regarding claim 23, Macoviak discloses the invention as claimed above, and further discloses 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 modified 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights