DETAILED ACTION
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
Claims 1, 4, 6, 7, 12, 17 and 20 are objected to because of the following informalities:
change claim 1 line 7 accordingly: “each of or the at least one first inflatable balloon”
change claim 4 line 2 accordingly: “connected to each other by at least one beam”
change claim 6 line 2 accordingly: “the first distal end of the first tube”
change claim 7 lines 7-8 accordingly: “the second central lumen: [[and]] at least one second peripheral lumen extending longitudinally along the second tube: and”
change claim 12 line 6 accordingly: “a first inflatable balloon and a second inflatable balloon connected to the tube, the first inflatable balloon and the second inflatable balloon”
change claim 17 lines 1-2 accordingly: “the first inflatable balloon and the second inflatable balloon”
change claim 20 line 1 accordingly: “the first inflatable balloon or the second inflatable balloon”
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.
Claim 4, 5 and 15-17 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.
Regarding claim 4, the meaning of the phrase “one … tube segment connected to each other by at least one beam” is unclear. It appears that there needs to be at least two tube segments in order for instant tube segments to be connected to each other and the claim is interpreted this way.
Regarding claim 14, the term the metes and bounds of the term “solid” is unclear in light of applicant specification. For example solid can be interpreted as “being without an internal cavity” (Merriam-Webster online). Applicant par. 49 states “intra-atrial region 505 between inflatable balloon 504a and 504b is solid and devoid of any holes connecting to the central lumen”. Therefore it appears that there is a central lumen cavity associated with the intra-atrial region and it is unclear what is the meaning of “solid” that is in addition to “and devoid of any holes”. For purposes of compact prosecution the claim is interpreted as solid material.
Regarding claim 15, the meaning of “a third hole” is unclear because there has been no first and second holes recited previously and examiner could not find any discussion in applicant specification that “third” can be a generic placeholder for example. For purposes of compact prosecution the claim is interpreted such that only one hole is required.
Claim 16 recites the limitation "the size" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the distance" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent thereon are rejected for the same reasons.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,192,290 (Hilal) (embodiment figs. 5-5A) as evidenced by US 20230405303 A1 (Boyce) and US Patent 5746717 (Aigner).
Regarding claim 1, Hilal discloses (see the embodiment of figs. 5-5A wherein some of the reference characters are shown in figs. 4-4A; i.e., the former is similar to the latter, see col. 5, ll. 50-55) a cannula comprising: a first tube (418 or 418,420) having a first distal end (the portion of the first tube that the balloon 414 covers) for placement in a first vein (see col. 4, ll. 10-15; see placement in example vein 22 in fig. 2C) of a patient; a first central (i.e., closer to the heart) lumen (lumen 419 portion at annotated figure below) extending longitudinally along the first tube 418,420; at least one first hole (holes 424 and annotated hole below) positioned on the first distal end (the portion of the first tube that the balloon 414 covers), the at least one first hole fluidly connected (see annotated figures below) to the first central lumen (lumen 419 portion at annotated figure below): at least one first peripheral (i.e., farther from the heart; it is noted that the claim does not require the peripheral lumen to be for example radially outward from the central lumen; when this is required then it is recited in the claims as evidenced by Boyce claim 2; a peripheral location can refer to a location farthest from the heart, for example the peripheral end of a lumen can be that end farthest from the heart as evidenced by Aigner pointing out at col. 5, ll. 50-55 that the “peripheral” end of lumen 6 is that end farther from the heart at the location of the catheter 1 in fig. 1 outside of the body) lumen (lumen 419 portion at annotated figure below) extending longitudinally along the first tube; and at least one first inflatable (see inflation holes 424) balloon 414 connected to the first tube, each of or the at least one first inflatable balloon 414 fluidly connected (see col. 5, ll. 40-45) to one of the at least one first peripheral lumen (lumen 419 portion at 424).
Regarding claim 2, Hilal discloses (see the embodiment of figs. 5-5A wherein some of the reference characters are shown in figs. 4-4A; i.e., the former is similar to the latter, see col. 5, ll. 50-55) wherein the at least one first inflatable balloon 414 is adapted to occlude the first central lumen (lumen 419 portion at annotation below; the first central lumen is directly occluded by the balloon at holes 424 and occluded by the balloon at the annotated hole below) and the first vein (22; the ballon is capable of occluding a vein; see fig. 2C) of the patient when inflated (cavity 428 is inflated in fig. 5A; see col. 5, ll. 40-45).
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[AltContent: textbox (first peripheral lumen)][AltContent: arrow][AltContent: textbox (first central lumen)][AltContent: arrow][AltContent: textbox (hole, tip)][AltContent: arrow]
Regarding claim 3, Hilal discloses wherein the at least one first inflatable ballon 414 is positioned at a tip (see annotated figures above) of the first tube within the first central lumen (see balloon extends into hole in annotated fig. 5A above).
Regarding claim 6, Hilal discloses wherein the first at least one inflatable balloon 414 is wrapped around the first distal end (portion of tube 418,420 the balloon is wrapped around in fig. 5A) of the first tube 418,420, the first at least one inflatable balloon adapted to occlude (intended use; see occlusion of vein 22 in fig. 2C) the first vein of the patient when inflated.
Claim(s) 1, 2 and 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hilal (embodiment figs. 4-4A).
Regarding claim 1, Hilal discloses (see the embodiment of figs. 4-4A) a cannula comprising: a first tube 418 having a first distal end (the portion of the first tube that the balloon 414 covers) for placement in a first vein (see col. 4, ll. 10-15; see placement in example vein 22 in fig. 2C) of a patient; a first central lumen (lumen 419 portion at annotated figure below) extending longitudinally along the first tube 418; at least one first hole (holes 424 and annotated hole below and it appears there is a hole at 416) positioned on the first distal end, the at least one first hole fluidly connected (see annotated figures below) to the first central lumen (lumen 419 portion at annotated figure below): at least one first peripheral lumen (lumen 419 portion at annotated figure below) extending longitudinally along the first tube; and at least one first inflatable (see inflation holes 424) balloon 414 connected to the first tube, each of or the at least one first inflatable balloon 414 fluidly connected (via the first central lumen) to one of the at least one first peripheral lumen (lumen 419 portion at annotation). The Hilal central and peripheral lumen are consistent with locations of central 124 and perimeter 128 lumen in applicant fig. 1A.
Regarding claim 2, Hilal discloses (see the embodiment of figs. 4-4A) wherein the at least one first inflatable balloon 414 is adapted to occlude the first central lumen (lumen 419 portion at annotation below; the first central lumen is directly occluded by the balloon at holes 424 and occluded by the balloon at the annotated hole below) and the first vein (22; the ballon is capable of occluding a vein; see fig. 2C) of the patient when inflated (cavity 428 is inflated in fig. 4A; see col. 5, ll. 40-45).
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[AltContent: textbox (first peripheral lumen)][AltContent: arrow][AltContent: textbox (first central lumen)][AltContent: arrow][AltContent: textbox (tube segment)][AltContent: arrow][AltContent: textbox (tube segment)][AltContent: arrow]
Regarding claim 4, Hilal discloses (see the embodiment of figs. 4-4A) the first tube 418 comprises one or more tube segments, the one or more tube segments (see annotated figures above) connected to each other (the two annotated segments are connected directly to each other and connected to each other via tubular beam 420) by at least one beam 420.
Regarding claim 5, Hilal discloses (see the embodiment of figs. 4-4A) wherein each of the at least one first inflatable balloon 414 is wrapped around (see fig. 4A) each of the at least one beam 420.
Regarding claim 6, Hilal discloses wherein the first at least one inflatable balloon 414 is wrapped around the first distal end (portion of tube 418 the balloon is wrapped around in fig. 4A) of the first tube 418, the first at least one inflatable balloon adapted to occlude (intended use; see occlusion of vein 22 in fig. 2C) the first vein of the patient when inflated.
Claim(s) 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170232238 A1 (Biller).
Regarding claim 12, Biller discloses (see figs. 1-2) a cannula 100 comprising a tube 100 having a distal end 102 for placement (see par. 39 regarding balloons located at IVC and SVC; this is consistent with balloons placement at IVC 557 and SVC 555 in applicant fig. 5D) in a first vein, an atrium, and a second vein of a patient: a central lumen 144 extending longitudinally (see figs. 1-2) along the tube: at least one peripheral lumen 148,150,152,150 extending longitudinally (see figs. 1-2) along the tube: and a first inflatable balloon and a second inflatable balloon 116,118 connected to the tube, the first inflatable balloon and the second inflatable balloon each fluidly connected (see par. 40) to one of the at least one peripheral lumen.
Regarding claim 13, Biller discloses (see figs. 1-2) wherein the first inflatable balloon 116 and the second inflatable balloon 118 are interspersed with an intra-atrial region 106 (this is consistent with applicant intra-atrial region 505 in fig. 5D).
Regarding claim 14, Biller discloses (see figs. 1-2) wherein the intra-atrial region is 106 solid (the region 106 is a portion of cannula 300 and such cannula is formed from a solid material as pointed out in par. 56; it is further noted that there can by any number of ports 124 and thus zero ports 124; see par. 37).
Regarding claim 15, Biller discloses (see figs. 1-2) a third hole 124 (this is interpreted as one hole total; see 112(b) section above) in the intra-atrial region 106, the third hole 124 connected (see par. 38) to one of the at least one peripheral lumen 148,150,152,150 extending longitudinally along the tube.
Regarding claim 16, Biller discloses wherein the size of the first 116 and second 118 inflatable balloon is the same. The balloons 116,118 are shown as the same size in fig. 1. Also, Fig. 7 shows that when balloons are inflated they are also the same size (see par. 14).
Regarding claim 17, Biller discloses (see fig. 10 showing example dimensions) the distance 1004 between the first inflatable balloon 116 and second inflatable balloon 118 is between 6 to 14 cm (see par. 62).
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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilal (embodiment figs. 5-5A) in view of US 6142973 (Carleton).
Regarding claim 7, Hilal (embodiment figs. 5-5A) discloses the current invention as claimed and discussed above. Hilal discloses (see the claim 1 analysis above regarding the first tube, first distal end, first vein, first hole, first peripheral lumen and first inflatable balloon) a cannula, the cannula comprising: a tube having a distal end for placement in a vein of the patient; a central lumen extending longitudinally along the tube: at least one hole positioned on the distal end, the at least one hole fluidly connected to the central lumen; and at least one peripheral lumen extending longitudinally along the tube; at least one inflatable balloon connected to the tube, each of the at least one inflatable balloon fluidly connected to one of the at least one peripheral lumen. Hilal does not disclose the tube, the distal end, the hole, the peripheral lumen and inflatable balloon are a second tube, a second distal end, first vein, a second hole, a second peripheral lumen and a second inflatable balloon; and the second central lumen fluidly connected to the first central lumen. It is further “the duplication of parts has no patentable significance unless a new and unexpected result is produced” (in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); MPEP 2144.04 VI. B.).
Carleton teaches a cannula for blood vessels (see title) with balloons 28,30 and further teaches (see fig. 1 and col. 3, ll. 3-15) a second central lumen fluidly connected to a first central lumen (the lumens of arms 18 and 20 are both supplied with fluid from main body 12; thus first cannula 12,18 and branch cannula 20 are each supplied with fluid from hub 14.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide to duplicate the first tube, first distal end, first vein, first hole, first peripheral lumen and first inflatable balloon of Hilal such to arrive at a second tube, a second distal end, first vein, a second hole, a second peripheral lumen and a second inflatable balloon such that the second central lumen fluidly connected to the first central lumen as taught by Carleton because no new and unexpected result is produced and to facilitate treating blood clots (such as discussed in Hilal col. 1, ll. 5-10) or performing other procedures in neighboring blood vessels such as veins (see Carleton col. 1, ll. 20-25 regarding preventing collapse of neighboring vessels).
Regarding claim 8, Hilal in view of Carleton teach the current invention as claimed and discussed above. Hilal discloses wherein the at least one inflatable balloon 414 is wrapped around the distal end (portion of tube 418,420 the balloon is wrapped around in fig. 5A) of the tube 418,420, the at least one inflatable balloon adapted to occlude (intended use; see occlusion of vein 22 in fig. 2C) the second vein of the patient when inflated. The second inflatable balloon, the second distal end, the second tube the at least one second inflatable balloon resulted from duplication of parts in the claim 8 analysis above.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilal in view of Carleton as applied to claim 7 above, and further in view of US 6726651 B1 (Robinson).
Regarding claims 9-10, Hilal in view of Carleton teach the current invention as claimed and discussed above. Hilal does not disclose wherein the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug, anti- inflammatory drug, anti-thrombogenic agent or mixture thereof.
Robinson teaches a cannula/catheter (see col. 5, ll. 5-10) and further teaches the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug (see col. 11, ll. 60-68), anti- inflammatory drug (see col. 11, ll. 60-68), anti-thrombogenic agent (see col. 11, ll. 60-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Hilal in view of Carleton with the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug, anti-inflammatory drug, or anti-thrombogenic agent (see col. 11, ll. 60-68) as taught by Robinson in order to facilitate aid in the insertion and removal of the catheter as well as aid in hemocompatibility (see Robinson col. 11, ll. 60-65).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hilal in view of Carleton as applied to claim 7 above, and further in view of US 10821273 B1 (Sardesai).
Regarding claim 11, Hilal in view of Carleton teach the current invention as claimed and discussed above. Hilal does not disclose the at least one first inflatable balloon or the at least one second inflatable balloon is a serrated inflatable balloon.
Sardesai teaches a cannula (see col. 17, ll. 25-30) and further teaches (see col. 13, ll. 5-10 and figs. 8a-8b) an inflatable balloon is a serrated inflatable balloon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Hilal in view of Carleton with the at least one first inflatable balloon or the at least one second inflatable balloon is a serrated inflatable balloon as taught by Sardesai in order to facilitate preventing slippage and to anchor the balloon after inflation (see Sardesai col. 13, ll. 5-10).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biller in view of Robinson.
Regarding claims 18-19, Biller discloses the current invention as claimed and discussed above. Biller does not disclose wherein the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug, anti- inflammatory drug, anti-thrombogenic agent or mixture thereof.
Robinson teaches a cannula/catheter (see col. 5, ll. 5-10) and further teaches the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug (see col. 11, ll. 60-68), anti- inflammatory drug (see col. 11, ll. 60-68), anti-thrombogenic agent (see col. 11, ll. 60-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Biller with the cannula is coated by one or more layers of drug; wherein the drug is an anticoagulant drug, anti-inflammatory drug, or anti-thrombogenic agent (see col. 11, ll. 60-68) as taught by Robinson in order to facilitate aid in the insertion and removal of the catheter as well as aid in hemocompatibility (see Robinson col. 11, ll. 60-65).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biller in view of Sardesai.
Regarding claim 20, Biller discloses the current invention as claimed and discussed above. Biller does not disclose the first inflatable balloon or the second inflatable balloon is a serrated inflatable balloon.
Sardesai teaches a cannula (see col. 17, ll. 25-30) and further teaches (see col. 13, ll. 5-10 and figs. 8a-8b) an inflatable balloon is a serrated inflatable balloon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Biller with the first inflatable balloon or the second inflatable balloon is a serrated inflatable balloon as taught by Sardesai in order to facilitate preventing slippage and to anchor the balloon after inflation (see Sardesai col. 13, ll. 5-10).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. :
drug coatings applicable to catheter and cannula: US 20070270775 (par. 43).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC J AMAR whose telephone number is (571)272-9948. The examiner can normally be reached M-F 9:00-6:00.
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/MARC AMAR/Examiner, Art Unit 3741
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