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 .
Election/Restrictions
Applicant’s election without traverse of claim 1-16 in the reply filed on 6/2/2026 is acknowledged. Claims 17-20 are canceled by the Applicant.
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) 1-2, 4-9, 11 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zawacki et al. (US 20040167463 A1).
Regarding claim 1, Zawacki discloses a catheter (10) for embolization of an anatomic vessel of a subject (Figure 3A-D), the catheter comprising:
a first tube (40) having a first proximal portion (58), a first distal portion (distal end of 40), and a first lumen (lumen of 40) defined therebetween (Figure 1; Paragraph 0058), the first distal portion defining a first orifice (44) in fluid communication with the first lumen (Figure 4; Paragraph 0061); and
a second tube (50) having a second proximal portion (54), a second distal portion (distal end of 50), and a detachment zone (30) therebetween (Paragraph 0058), the second tube defining a second lumen from the second proximal portion to the second distal portion, the second distal portion defining a second orifice (54) in fluid communication with the second lumen (Figure 4; Paragraph 0061), the first tube coupled to the second tube from the second proximal portion to at least the detachment zone (Figure 1; Paragraph 058), and the second distal portion of the second tube detachable from the second proximal portion along the detachment zone (Figure 1; Paragraph 0058).
Regarding claim 2, Zawacki further discloses wherein the second distal portion of the second tube becomes decoupled from at least a portion of the first tube upon detachment of the second distal portion of the second tube from the second proximal portion along the detachment zone (Figure 1; Paragraph 0058).
Regarding claim 4, Zawacki further discloses wherein at least the first lumen remains operable following detachment of the second distal portion from the second proximal portion along the detachment zone (there is no indication that the first lumen is not operable).
Regarding claim 5, Zawacki further discloses wherein the second distal portion of the second tube extends distally beyond the first distal portion of the first tube (Figure 1).
Regarding claim 6, Zawacki further discloses wherein the first distal portion of the first tube and the second distal portion of the second tube are split from one another distal to the detachment zone (Figure 1, 4; Paragraph 0058).
Regarding claim 7, Zawacki further discloses wherein, at least at the detachment zone, the first tube and the second tube collectively form a curvilinear outer circumference having a major dimension and a minor dimension, and the major dimension is greater than the minor dimension (Figure 3).
Regarding claim 8, Zawacki further discloses wherein the first proximal portion of the first tube defines a first access port (62 corresponding with 40) in fluid communication with the first lumen, the second proximal portion of the second tube defines a second access port (62 corresponding with 50) in fluid communication with the second lumen, and the first lumen and the second lumen are each fluidically isolated from one another (Figure 1; Paragraph 0058).
Regarding claim 9, Zawacki further discloses wherein the first lumen has a first cross-sectional area from the first proximal portion to the first orifice, and the second lumen has a second cross- sectional area from the second proximal portion to the second orifice (Figure 3).
Regarding claim 11, Zawacki further discloses wherein the first tube and the second tube are each at least partially formed of one or more polymers (Paragraph 0057) (the preferred material for the catheter is polyurethane, which is a polymer).
Regarding claim 15, Zawacki further discloses wherein the first tube and the second tube are directly coupled to one another from the second proximal portion to at least the detachment zone (Figure 1).
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.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 102/103 as being unpatentable over Zawacki.
Regarding claim 3, Zawacki discloses the catheter of claim 1, but fails to explicitly disclose wherein the second distal portion of the second tube is detachable from the second proximal portion in response to an axial stress less than a first failure stress of the first tube coupled to the second tube and less than a second failure stress of the second distal portion of the second tube.
However, Zawacki teaches bonding the catheters in a way that they can be separated utilizing constant separation stress with a variable area and using a variable separation stress with a constant area (Paragraph 0104-106). Although Zawacki does not explicitly mention the applied axial stress is less than a first failure stress of the first tube coupled to the second tube and less than a second failure stress of the second distal portion of the second tube, the first failure stress and second failure stress would be inherent properties of the materials, thus one of ordinary skill in the art would be motivated to apply a separation stress that is less than that of the respective failure stresses to prevent breakage of the catheters.
There are a number of choices available to a person of ordinary skill in the art for applying a stress in relation to a first and second failure stress. Either the applied force can be less than, equal to, or greater than the first and second failure stresses. Therefore, “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under 103” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. __, 82 USPQ2d 1385 (2007).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zawacki in view of Tassoni et al. (US 20150217084 A1).
Regarding claim 10, Zawacki discloses the catheter of claim 1, but fails to explicitly disclose wherein the first tube is hydrophobic along the first lumen, and the second tube is hydrophobic along the second lumen.
However, Tassoni is directed to a dual lumen catheter and teaches a hydrophobic coating along the first lumen (604) and the second lumen (804) (Figure 12; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Zawacki such that the first tube is hydrophobic along the first lumen, and the second tube is hydrophobic along the second lumen, as taught by Tassoni, as both references and the claimed invention are directed to catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawacki with the teachings of Tassoni by incorporating wherein the first tube is hydrophobic along the first lumen, and the second tube is hydrophobic along the second lumen in order to provide a dry lubricity which may improve steerability and lesion crossing capability (Tassoni Paragraph 0052).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zawacki in view of Walzman (US 20210236768 A1).
Regarding claim 12, Zawacki discloses the catheter of claim 1, further comprising a proximal radiopaque marker proximal and adjacent to the detachment zone of the second tube.
However, Walzman is directed to a dual lumen catheter and teaches a proximal radiopaque marker proximal and adjacent to the detachment zone of the second tube (“at the end of the other lumen/the side hole”) (Paragraph 0026).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Zawacki such that to include a proximal radiopaque marker proximal and adjacent to the detachment zone of the second tube, as taught by Walzman, as both references and the claimed invention are directed to dual lumen catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawacki with the teachings of Walzman by incorporating a proximal radiopaque marker proximal and adjacent to the detachment zone of the second tube in order to be able to identify the location of the catheter in the patient and prevent the catheter from being inserted too far to where it would damage the vessel.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zawacki in view of Raijman et al. (US 20040064128 A1).
Regarding claim 13, Zawacki discloses the catheter of claim 1, but fails to explicitly disclose a first distal radiopaque marker and a second distal radiopaque marker, wherein the first distal radiopaque marker is adjacent to the first orifice of the first tube, and the second distal radiopaque marker is adjacent to the second orifice of the second tube.
However, Rajiman is directed to a multi-lumen catheter and teaches a first distal radiopaque marker (34) and a second distal radiopaque marker (36), wherein the first distal radiopaque marker is adjacent to the distal end of the first tube (12) (which would correspond with being adjacent to the first orifice of the first tube of Zawacki), and the second distal radiopaque marker is adjacent to the second orifice of the second tube (14) (Figure 7; Paragraph 0020).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Zawacki such that a first distal radiopaque marker and a second distal radiopaque marker, wherein the first distal radiopaque marker is adjacent to the first orifice of the first tube, and the second distal radiopaque marker is adjacent to the second orifice of the second tube, as taught by Rajiman, as both references and the claimed invention are directed to multi-lumen catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawacki with the teachings of Rajiman by incorporating a first distal radiopaque marker and a second distal radiopaque marker, wherein the first distal radiopaque marker is adjacent to the first orifice of the first tube, and the second distal radiopaque marker is adjacent to the second orifice of the second tube in order to identify the distal end of the tube as it is inserted in the patient.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zawacki in view of Lentz et al. (US 20120316436 A1).
Regarding claim 14, Zawacki discloses the catheter of claim 1, but fails to explicitly disclose wherein the first lumen and the second lumen each have a diameter greater than 0.05 mm and less than 0.5 mm.
However, Lentz is directed to a multi-lumen catheter and teaches the inner diameter of the first lumen 16 may be about 0.015'' to about 0.018'' (equating to 0.381-0.457 mm, which is within the claimed range of 0.05-0.5mm) and the inner diameter of the third lumen 20 may be about 0.012'' to about 0.025'' (equating to 0.3-0.6 mm, which encompasses the claimed range of 0.05-0.5mm) (Paragraph 0031).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Zawacki such that the first lumen and the second lumen each have a diameter greater than 0.05 mm and less than 0.5 mm, as taught by Letz, as both references and the claimed invention are directed to multi-lumen catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawacki with the teachings of Lentz by incorporating wherein the first lumen and the second lumen each have a diameter greater than 0.05 mm and less than 0.5 mm in order to be small enough to prevent damage to the surrounding tissue.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zawacki in view of Schon et al. (US 20050096585 A1).
Regarding claim 16, Zawacki discloses the catheter of claim 1, but fails to further disclose an intermediate member, wherein the first tube and the second tube are coupled to one another from the second proximal portion to at least the detachment zone via the intermediate member, and Shore D hardness of the intermediate member is different from respective Shore D hardness of each of the first tube and the second tube.
However, Schon is directed to a multi-lumen catheter and teaches an intermediate member (125) (Figure 1; Paragraph 0060; 0065), wherein the first tube (110) and the second tube (130) are coupled to one another from the second proximal portion to at least the detachment zone (area where 125 is located) via the intermediate member (Figure 1; Paragraph 0043; 0065), and Shore D hardness of the intermediate member is different from respective Shore D hardness of each of the first tube and the second tube (the material of cuff 125 is a fabric while the catheters 110, 130 are made of polyurethane, which would have different Shore D hardness) (Paragraph 0060-62).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Zawacki to include an intermediate member, wherein the first tube and the second tube are coupled to one another from the second proximal portion to at least the detachment zone via the intermediate member, and Shore D hardness of the intermediate member is different from respective Shore D hardness of each of the first tube and the second tube, as taught by Schon, as both references and the claimed invention are directed to multi-lumen catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawacki with the teachings of Schon by incorporating an intermediate member in order to ensure attachment of the tubes prior to the desired splitting (Schon Paragraph 0065) and prevent insertion of the catheters to deep (Schon Paragraph 0060).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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