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 .
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional App. no. 63/589,357 filed on 10/11/2023.
Claims 1-20 receive priority to the prior-filed application, filed on 10/11/2023.
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 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.
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.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over US/2015/0148785 A1 to Kleiner in view of US/2017/0196577 A1 to Sperry.
Regarding claims 1-4, 6, and 8-9, Kleiner discloses (Claim 1) a medical system (para. 0109-0110; Fig. 13; para. 0117; para. 0121; Fig. 19A-19D and 21A-21C, methods for placing devices of the present invention) comprising: a guidewire including a distal portion and a proximal portion (Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end); and a porous body coupled to a distal end of a tube (Fig. 13, porous body 14 coupled to distal end of combined tube 22/30), wherein the tube includes a first lumen and a second lumen (Fig. 13, first lumen through tube 22 and second lumen 84 through tube 30), wherein the first lumen is configured to receive at least the proximal portion of the guidewire (para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, first lumen through tube 22 configured to receive guide member), and wherein the second lumen is configured to be coupled to a source of suction (para. 0110).
Kleiner differs from the instantly claimed invention in that Kleiner fails to disclose (Claim 1) wherein the distal portion of the guidewire is configured to transition from an expanded configuration to a straightened configuration, and wherein, in the expanded configuration, the distal portion is configured to anchor to a target site in an anatomy;
(Claim 2) wherein, in the expanded configuration, the distal portion has a sinuous, coil, or spiral shape;
(Claim 3) wherein the distal portion includes a plurality of securement structures;
(Claim 4) wherein the plurality of securement structures include at least one of a burr, a barb, a ridge, a protrusion, or an adhesive;
(Claim 6) wherein the distal portion is configured to transition from the expanded configuration to the straightened configuration when a proximal end of the distal portion moves proximally relative to a distal end of the distal portion;
(Claim 8) wherein, in the expanded configuration, the distal portion is wider in a direction perpendicular to a longitudinal axis of the proximal portion than the proximal portion is; and
(Claim 9) wherein the distal portion is biased to the expanded configuration.
Sperry teaches a guidewire for percutaneous medical procedures (Claim 1) wherein a distal portion of the guidewire is configured to transition from an expanded configuration to a straightened configuration (para. 0072-0075; Fig. 3-4, guidewire 10 formed from outer member 14 and inner member 12 comprising distal end 16; para. 0085-0086, Fig. 10A-10B, guidewire 510 comprising securement structures at distal end 522);
(Claim 2) wherein, in the expanded configuration, the distal portion has a sinuous, coil, or spiral shape (para. 0072-0075; Fig. 3-4);
(Claim 3) wherein the distal portion includes a plurality of securement structures (para. 0085-0086; Fig. 10A-10B);
(Claim 4) wherein the plurality of securement structures include at least one of a burr, a barb, a ridge, a protrusion, or an adhesive (para. 0085-0086, Fig. 10A-10B, guidewire 510 comprising securement structures at distal end 522);
(Claim 6) wherein the distal portion is configured to transition from the expanded configuration to the straightened configuration when a proximal end of the distal portion moves proximally relative to a distal end of the distal portion (para. 0072-0075, outer member 14 formed of a relatively stiff material would force transition of distal portion 16 to a straightened configuration when distal portion 16 is pulled proximally back into outer member 14);
(Claim 8) wherein, in the expanded configuration, the distal portion is wider in a direction perpendicular to a longitudinal axis of the proximal portion than the proximal portion is (Fig 4, distal end 16 wider than proximal end of guidewire 10; Fig. 10B, distal end 522 wider than proximal end of guidewire 510); and
(Claim 9) wherein the distal portion is biased to the expanded configuration (para. 0072-0074; para. 0085-0086); and
wherein the guidewire provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the guidewire of Kleiner to comprise the guidewire components of Sperry, because Sperry teaches that the guidewire of their invention provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Kleiner further discloses wherein the proximal portion of the guidewire includes a portion that is straight (Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end).
Regarding claim 7, the cited prior art suggests the invention of claim 1. Kleiner further discloses wherein the proximal portion and the distal portion are integrally formed (Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end).
Regarding claim 10, the cited prior art suggests the invention of claim 1. Kleiner further discloses wherein the tube includes a main portion including an outer wall and an inner wall, and wherein the inner wall separates the first lumen and the second lumen (Fig. 13, main portion considered section of combined tube 22/30 comprising both tubes 22 and 30; wall of tube 22 considered inner wall and wall of tube 30 considered outer wall).
Regarding claim 11, the cited prior art suggests the invention of claim 10. Kleiner further discloses wherein a proximal end of the tube includes a first branch and a second branch extending proximally from the main portion, wherein the first lumen extends through the first branch, and wherein the second lumen extends through the second branch (para. 0109, [specification determination of distal is considered proximal for purposes of rejection] tube 22 may sealingly pass through the tube 30 at a proximal end for connection of tube 22 to a collection receptacle or suction pump, tube 30 at a proximal end can open to an external port for connection to the same or a different suction source; extension of tube 22 passing through tube 30 considered first branch and extension of tube 30 beyond the section wherein tube 22 passes through considered second branch).
Regarding claim 12, the cited prior art suggests the invention of claim 11. Kleiner further discloses wherein the outer wall is a first outer wall, wherein the first branch includes a second outer wall and the second branch includes a third outer wall, and wherein the second outer wall of the first branch of the tube and the third outer wall of the second branch of the tube are each continuous with the first outer wall of the main portion of the tube (para. 0109, [specification determination of distal is considered proximal for purposes of rejection] tube 22 may sealingly pass through the tube 30 at a proximal end for connection of tube 22 to a collection receptacle or suction pump, tube 30 at a proximal end can open to an external port for connection to the same or a different suction source; extension of tube 22 passing through tube 30 considered first branch including a second outer wall and extension of tube 30 beyond the section wherein tube 22 passes through considered second branch including a third outer wall that is directly continuous from the first outer wall).
Regarding claim 13, the cited prior art suggests the invention of claim 11. Kleiner further discloses wherein the second branch is configured to couple to the source of suction to deliver negative pressure to the porous body via the second lumen of the tube (para. 0109).
Regarding claim 15, the cited prior art suggests the invention of claim 1. Kleiner further discloses wherein a proximal end of the proximal portion of the guidewire is configured to be inserted into the porous body and into a distal opening of the first lumen (para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal opening of first lumen through tube 22 configured to receive guide member).
Regarding claims 16-17, Kleiner discloses (Claim 16) a medical system (para. 0109-0110; Fig. 13; para. 0117; para. 0121; Fig. 19A-19D and 21A-21C, methods for placing devices of the present invention) comprising: a guidewire including a distal portion and a proximal portion (Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end); and a porous body coupled to a distal end of a tube (Fig. 13, porous body 14 coupled to distal end of combined tube 22/30), wherein the tube includes a first lumen and a second lumen (Fig. 13, first lumen through tube 22 and second lumen 84 through tube 30), wherein a proximal end of the proximal portion is configured to be inserted into a distal opening of the first lumen so that the porous body and the tube are advanced along and relative to the guidewire in order to position the porous body and the tube at a target site (para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; Fig. 19A-19D, guide member comprised of guide wire 130 and guide tube 132, distal opening of first lumen through tube 22 configured to receive guide member).
Kleiner differs from the instantly claimed invention in that Kleiner fails to disclose (Claim 16) wherein the distal portion of the guidewire is biased to an expanded configuration;
(Claim 17) wherein, in the expanded configuration, the distal portion has a sinuous, coil, or spiral shape.
Sperry teaches a guidewire for percutaneous medical procedures (Claim 16) wherein a distal portion of the guidewire is biased to an expanded configuration (para. 0072-0075; Fig. 3-4, guidewire 10 formed from outer member 14 and inner member 12 comprising distal end 16; para. 0085-0086, Fig. 10A-10B, guidewire 510 comprising securement structures at distal end 522);
(Claim 17) wherein, in the expanded configuration, the distal portion has a sinuous, coil, or spiral shape (para. 0072-0075; Fig. 3-4) ; and
wherein the guidewire provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the guidewire of Kleiner to comprise the guidewire components of Sperry, because Sperry teaches that the guidewire of their invention provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
Regarding claims 18-20, Kleiner discloses (Claim 18) a method of treating a target site of a body lumen of a patient via a medical device (para. 0009; para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; para. 0109-0110; Fig. 13; para. 0117; para. 0121; Fig. 19A-19D and 21A-21C, methods for placing devices of the present invention), the method comprising: advancing a distal portion of a guidewire into the target site; inserting a proximal end of the guidewire through a porous body and into an opening of a first lumen at a distal end of a tube coupled to the porous body; moving the tube and the porous body distally along the guidewire to position the porous body proximate to the target site; removing the guidewire from the body lumen by pulling the guidewire proximally through the porous body and through the first lumen of the tube (para. 0009; para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; para. 0109-0110; Fig. 13; para. 0117; para. 0121; Fig. 19A-19D and 21A-21C, methods for placing devices of the present invention, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end, guide member passed through opening at distal portion into first lumen of tube 22 of combined tube 22/30); and supplying a negative pressure to the porous body through a second lumen of the tube (para. 0110, second lumen of tube 30 of combined tube 22/30); and
(Claim 19) wherein removing the guidewire from the body lumen includes pushing the porous body distally before pulling the guidewire proximally (para. 0009; para. 0051, device embodied by the invention can be moved along the guide wire into position and the guide wire then withdrawn; para. 0109-0110; Fig. 13; para. 0117; para. 0121; Fig. 19A-19D and 21A-21C, methods for placing devices of the present invention, guide member comprised of guide wire 130 and guide tube 132, distal portion considered right end, proximal portion considered left end, guide member passed through opening at distal portion into first lumen of tube 22 of combined tube 22/30); and supplying a negative pressure to the porous body through a second lumen of the tube (para. 0110, second lumen of tube 30 of combined tube 22/30).
Kleiner differs from the instantly claimed method in that Kleiner fails to disclose (Claim 18) wherein the distal portion of the guidewire is biased to an expanded configuration to anchor the distal portion relative to the target site; and
(Claim 20) wherein pulling the guidewire proximally transitions the guidewire from the expanded configuration to a straightened configuration.
Sperry teaches a guidewire for percutaneous medical procedures (Claim 18) wherein the distal portion of the guidewire is biased to an expanded configuration to anchor the distal portion relative to the target site (para. 0072-0075; Fig. 3-4, guidewire 10 formed from outer member 14 and inner member 12 comprising distal end 16; para. 0085-0086, Fig. 10A-10B, guidewire 510 comprising securement structures at distal end 522);
(Claim 20) wherein pulling the guidewire proximally transitions the guidewire from the expanded configuration to a straightened configuration (para. 0072-0075, outer member 14 formed of a relatively stiff material would force transition of distal portion 16 to a straightened configuration when distal portion 16 is pulled proximally back into outer member 14); and
wherein the guidewire provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the guidewire of Kleiner to comprise the guidewire components of Sperry, because Sperry teaches that the guidewire of their invention provides improved maneuverability and anchoring during a medical procedure to ensure that the guidewire does not become dislodged from a desired percutaneous placement site (para. 0071).
Further, Kleiner differs from the instantly claimed invention in that Kleiner fails to disclose (Claim 19) wherein removing the guidewire from the body lumen includes pushing the porous body distally while pulling the guidewire proximally.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to push the porous body distally while pulling the guidewire proximally since there are only a finite number of predictable solutions (i.e. before, during, after). Thus, pushing the porous body distally while pulling the guidewire proximally would have been obvious because “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 that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kleiner and Sperry as applied above, and further in view of US/2003/0153898 A1 to Schon.
Regarding claim 14, the cited prior art suggests the invention of claim 10.
Kleiner discloses a connector coupled to a proximal end of the second branch (para. 0109, [specification determination of distal is considered proximal for purposes of rejection] tube 22 may sealingly pass through the tube 30 at a proximal end for connection of tube 22 to a collection receptacle or suction pump, tube 30 at a proximal end can open to an external port for connection to the same or a different suction source; extension of tube 22 passing through tube 30 considered first branch and extension of tube 30 beyond the section wherein tube 22 passes through considered second branch).
The prior art differs from the instantly claimed invention in that the prior art fails to disclose a connector configured to be removably coupled to a proximal end of the main portion, wherein the connector includes a first tube defining a third lumen and a second tube defining a fourth lumen, and wherein, in a state in which the connector is coupled to the proximal end of the main portion, the third lumen is in fluid communication with the first lumen and the fourth lumen is in fluid communication with the second lumen.
Schon teaches a connector configured to be removably coupled to a proximal end of a dual lumen tube (para. 0065; Fig. 3), wherein the connector includes a first tube defining a third lumen and a second tube defining a fourth lumen, wherein, in a state in which the connector is coupled to the proximal end of the main portion of the dual lumen tube, the third lumen is in fluid communication with the first lumen and the fourth lumen is in fluid communication with the second lumen (Fig. 3, hub connector 18 including first and second tubes comprising third and fourth lumens 20/22 fluidly connected to first and second lumens 24/26 of dual lumen tube 12), and wherein the connector acts as a reinforced area for the termination of the tubes and can act as a securement mechanism to the body (para. 0065).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the proximal end of the first and second branches of Kleiner to comprise the removable connector as taught by Schon, because Schon teaches that the connector acts as a reinforced area for the termination of the tubes and can act as a securement mechanism to the body (para. 0065).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2017/0239448 A1 to Cao discloses an anchoring guidewire for use in endoscopy. US/2015/0250979 A1, US/2014/0005479 A1, and US/2013/0023840 A1 to Loske disclose endoscopy arrangements comprising tubes with porous bodies and guidewire lumens.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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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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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 10 June 2026
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