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
Applicant’s amendment filed 07/14/2026 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 16, and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 3-9, 12, 13, 16, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahlmann (US 6068477).
Regarding Claim 1, Mahlmann discloses a medical device (10, Figs. 1-7), comprising:
a tube (12, Figs. 1-7); and
a porous body (14, Figs. 1-7; abstract, Col. 3 lines 44-55) fixedly coupled (Col. 3 line 62 – Col. 4 line 8) to and surrounding a distal portion (20, Figs. 1-7) of the tube (12, Figs. 1-7),
wherein the tube (12, Figs. 1-7) is configured to be transitioned from a first configuration (as seen in Fig. 1) to a second configuration (as seen in Fig. 5; Col. 3 lines 3-13),
wherein, in the first configuration, the tube (12, Fig. 1) is in a flat or straight configuration (Fig. 1); and
wherein, in the second configuration, the tube (12, Fig. 5) is expanded to a curved or helical shape (Fig. 5; Col. 3 lines 3-13 indicates the aspirator can be bent to a desired configuration, and therefore is fully capable of being bent into a helical shape).
Regarding Claim 3, Mahlmann discloses the tube (12, Figs. 1-7) is a vacuum tube (12, Figs. 1-7) configured to be coupled to a negative pressure source (Col. 1 lines 57-62, Col. 2 lines 10-13).
Regarding Claim 4, Mahlmann discloses the vacuum tube (12, Figs. 1-7) is cylindrical with a central lumen extending along a central longitudinal axis of the vacuum tube (12, Figs. 1-7).
Regarding Claim 5, Mahlmann discloses the vacuum tube (12, Figs. 1-7) includes a plurality of ports (22, Fig. 2) disposed along a length of the distal portion (20, Fig. 2; the ports are present in the tube 12 in Fig. 2 not just in the foam 14), and wherein the plurality of ports (22, Fig. 2) are configured to apply negative pressure provided by the negative pressure source (Col. 3 lines 27-32).
Regarding Claim 6, Mahlmann discloses in the second configuration (Fig. 5), the curved or helical shape of the tube (12, Fig. 5) causes the porous body (14, Fig. 5) to have a helical shape (Fig. 5; Col. 3 lines 3-13 indicates the aspirator can be bent to a desired configuration, and therefore is fully capable of being bent into a helical shape, in which both the tube and the porous body would have a helical shape).
Regarding Claim 7, Mahlmann discloses the porous body (14, Figs. 1-7) is a sponge (Col. 3 lines 44-55).
Regarding Claim 8, Mahlmann discloses the porous body (14, Figs. 1-7) is cylindrical (Figs. 1-7).
Regarding Claim 9, Mahlmann discloses the tube (12, Figs. 1-7) is configured to be deployed into a wound cavity, and wherein a length of the tube (12, Figs. 1-7) within the wound cavity is configured to be reduced as the wound cavity reduces in size (the tube is fully capable of being placed within a wound cavity and being pulled out from the wound cavity over time as the wound heals).
Regarding Claim 12, Mahlmann discloses the porous body (14, Fig. 6) covers only a portion of a distal end (20, Fig. 6) of the tube (12, Fig. 6; Fig. 6 has open end 26 where the porous body does not cover the open end).
Regarding Claim 13, Mahlmann discloses the porous body (14, Figs. 1-5 and 7) covers an entirety of a distal end (20, Figs. 1-5 and 7) of the tube (12, Figs. 1-5 and 7).
Regarding Claim 16, Mahlmann discloses a medical device (10, Figs. 1-7), comprising:
a vacuum tube (12, Figs. 1-7; Col. 1 lines 57-62, Col. 2 lines 10-13) configured to be inserted into a working channel of an endoscope (the aspirator is fully capable of being inserted into the working channel of an endoscope), and further configured to be coupled to a negative pressure source (Col. 1 lines 57-62, Col. 2 lines 10-13); and
a porous body (14, Figs. 1-7; abstract, Col. 3 lines 44-55) coupled (Col. 3 line 62 – Col. 4 line 8) to a distal portion (20, Figs. 1-7) of the vacuum tube (12, Figs. 1-7),
wherein the vacuum tube (12, Figs. 1-7) is configured to be transitioned from a first configuration (as seen in Fig. 1) to a second configuration (as seen in Fig. 5; Col. 3 lines 3-13),
wherein, in the first configuration, the vacuum tube (12, Fig. 1) is flat or straight (Fig. 1), and
wherein, in the second configuration, the vacuum tube (12, Fig. 5) is expanded and distal portions of the vacuum tube (12, Fig. 5) and the porous body (14, Fig. 5) have a helical shape (Fig. 5; Col. 3 lines 3-13 indicates the aspirator can be bent to a desired configuration, and therefore is fully capable of being bent into a helical shape, in which both the tube and the porous body would have a helical shape).
Regarding Claim 20, Mahlmann discloses the vacuum tube (12, Figs. 1-7) includes a central lumen extending along a central longitudinal axis of the vacuum tube (12, Figs. 1-7), and
wherein the vacuum tube (12, Figs. 1-7) includes a plurality of ports (22, Fig. 2) disposed along a length of the distal portion (20, Fig. 2; the ports are present in the tube 12 in Fig. 2 not just in the foam 14), and wherein the plurality of ports (22, Fig. 2) are configured to apply negative pressure provided by the negative pressure source (Col. 3 lines 27-32).
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) 2, 10, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahlmann (US 6068477) in view of Bortz et al (US 2024/0293606).
Regarding Claims 2, 10, and 17, Mahlmann is silent whether the distal portion of the wire or tube includes or is formed of a shape memory material, and wherein the wire or tube remains in the first configuration when exposed to a first temperature, and transitions to the second configuration upon being exposed to a second temperature.
Bortz teaches a cannula formed of a shape memory material (¶ [0023]) which remains in the first configuration when exposed to a first temperature, and transitions to the second configuration upon being exposed to a second temperature (¶ [0023, 0098]). Shape memory materials are well known in the art to actuate and change configurations upon reaching a set temperature point, and are frequently used in medical devices to allow a device to have a storage configuration and a use configuration that occurs when the device is exposed to body temperature.
Therefore, 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 vacuum tube of Mahlmann to be made of a shape memory material and to remain in the first configuration when exposed to a first temperature, and transition to the second configuration upon being exposed to a second temperature, as taught by Bortz. This allows the catheter to move to the second position automatically upon reaching a set temperature, without the user having to manually change the position of the catheter during the procedure.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahlmann (US 6068477) in view of Bortz et al (US 2024/0293606) further in view of Erbey et al (US 2022/0184342).
Regarding Claim 11, Mahlmann/Bortz is silent whether the second temperature is body temperature.
Erbey teaches a negative pressure catheter, thus being in the same field of endeavor, comprises a shape memory material that is configured to transition to a deployed position when it is warmed to a sufficient temperature such as body temperature (¶ [0440]). This allows the catheter to actuate to the deployed position automatically after being placed in the body for a sufficient amount of time to warm to body temperature.
Therefore, it would have been obvious to modify the second temperature of Mahlmann/Bortz to be body temperature, as taught by Erbey, to allow the catheter to actuate to the deployed position automatically after being placed in the body for a sufficient amount of time to warm to body temperature.
Claim(s) 14, 15, 18, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahlmann (US 6068477) in view of Bashir et al (US 2018/0049761).
Regarding Claims 14 and 15, Mahlmann is silent regarding a plurality of markers disposed along a length of a portion of the wire or tube, wherein the plurality of markers are radiopaque.
Bashir teaches an infusion catheter, thus being in the same field of endeavor of medical catheters, where the catheter has a plurality of radiopaque markers on the surface of the catheter (¶ [0012]). This allows the catheter to be visible under medical imaging techniques.
Therefore, it would have been obvious to modify the catheter of Mahlmann to include a plurality of radiopaque markers disposed along a length of a portion of the catheter, as taught by Bashir, to allow the catheter to be visible under medical imaging techniques.
Regarding Claim 18, Mahlmann is silent regarding a plurality of markers disposed along a length of a portion of the wire or tube, wherein the plurality of markers are radiopaque and/or color coded.
Bashir teaches an infusion catheter, thus being in the same field of endeavor of medical catheters, where the catheter has a plurality of radiopaque markers on the surface of the catheter (¶ [0012]). This allows the catheter to be visible under medical imaging techniques.
Therefore, it would have been obvious to modify the catheter of Mahlmann to include a plurality of radiopaque markers disposed along a length of a portion of the catheter, as taught by Bashir, to allow the catheter to be visible under medical imaging techniques.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bortz et al (US 2024/0293606) in view of Hou et al (US 2022/0160997).
Regarding Claim 19, Bortz discloses a medical device (system 100, Fig. 1), comprising:
a wire (128, Fig. 2A), wherein at least a distal portion of the wire (128, Fig. 2A) includes or is formed of shape memory material (¶ [0065]); and
a porous body (elongate tube 102/122, Figs. 1 and 2A; ¶ [0056, 0230]) coupled to the distal portion of the wire (128, Fig. 2A); and
an outer tube (delivery device) configured to couple to a source of negative pressure (¶ [0031, 0033] since the fluid tight lumen and the elongate tube pass through the delivery device, the delivery device will be coupled to the source of negative pressure via the fluid tight lumen), wherein the wire (128, Fig. 2A) and the porous body (122, Fig. 2A) are moveable together within and relative to the outer tube (¶ [0031]),
wherein the wire (128, Fig. 2A) is configured to be transitioned from a first configuration to a second configuration (¶ [0196] indicates the wire is configured to act as a frame for the formation of the coil; ¶ [0006-0008] indicates the device has a delivery state and coiled operative state),
wherein, in the first configuration, the wire (128, Fig. 2A) is in a flat or straight configuration (¶ [0006, 0018]), and
wherein, in the second configuration, the wire (128, Fig. 2A) is expanded to a curved or helical shape (¶ [0006]; in the operative state the device has a coil shape).
Bortz indicates that the porous body may comprise a radiopaque marker (¶ [0194]), but does not specifically indicate that the wire may comprise a plurality of radiopaque markers.
Hou teaches a medical system, thus being in the same field of endeavor, with an implant-depth wire (1004, Fig. 20) including a plurality of radiopaque markers (1028a-f, Fig. 20; ¶ [0136]), where the wire (1004, Fig. 20) is surrounded by an additional lumen (1010, Fig. 20). The plurality of radiopaque markers allows the medical professional to tell the depth of insertion of the device within the patient (¶ [0136]).
Therefore, it would have been obvious to modify the wire of Bortz to include a plurality of radiopaque markers, as taught by Hou, to allow the medical professional to tell how far the aspiration catheter has been inserted into the patient (as motivated by Hou ¶ [0136]).
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 Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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