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 Amendment
The Amendment filed 01/30/26 has been entered. Claims 22 and 34 have been amended, and claims 30 and 36 have been cancelled. Claims 22-29, 32-35, and 38-42 are addressed in the following office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-29, 32-35, and 38-42 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Concerning claim 22, the original disclosure fails to divulge “wherein sliding the interventional catheter within the central lumen comprises advancing the interventional catheter over a guidewire extending within the central lumen of the tubular body, the guidewire extending through the single lumen and out the distal opening of the interventional catheter”. Hence, the limitation is considered new matter. Claims 23-29, 32-35, and 38-42 are rejected for the same reasons as claim 22 by virtue of dependency on claim 22.
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.
Claims 22-23, 25, 28-29, 34-35, and 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0018773) in view of Garrison (US 2013/0281788) and Stivland (US 2010/0030186), all cited in previous office action.
Concerning claim 22, an invention relating to guide extension catheter, Wang discloses (Figs. 1-4) a method of performing a medical procedure at a treatment site in a blood vessel of a patient (Par. 0036), the method comprising: introducing through an insertion site [i.e. the initial point from which element 10 is advanced through the blood vessel] of the patient an access catheter (10) comprising a tubular body with a central lumen having an inner diameter, a proximal end and a distal opening (Fig. 4 & Par. 0036, 0051); sliding an interventional catheter (14) within the central lumen of the tubular body to change a relative position of the interventional catheter within the central lumen (Par. 0037 & 0044), the interventional catheter comprising a distal portion (26) and a proximal tether (16) extending proximally from a point of attachment (42) between the proximal tether and the distal portion (Par. 0042), wherein the interventional catheter comprise a single lumen (28) that is the only lumen of the distal portion and wherein the proximal tether has a distal end (see annotated figure below) connected to a proximal end region (see annotated figure below) of the distal portion (Par. 0042); advancing the interventional catheter through the access catheter such that a distal opening (36) of the interventional catheter is located at an occlusion in the vasculature [Note, the interventional catheter would be located near the occlusion when element 26 is arranged to extend distally of element 10] (Par. 0055-0056) and an overlap region is formed between the interventional catheter and the access catheter (Fig. 4), wherein a lumen is collectively formed by the single lumen of the interventional catheter and the central lumen of the access catheter [i.e. the lumen the guide wire occupies] (Par. 0055-0056), and wherein a sealing element [i.e. one or more structural features] positioned on an external surface of the interventional catheter seals against the inner diameter of the access catheter (Par. 0047), and wherein an inner diameter (see annotated figure below) of the single lumen between the distal opening through the proximal end region remains unchanged (Fig 3).
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However, Wang fails to disclose wherein the access catheter is attachable to an aspiration line that connects to an aspiration source; coupling a rotating hemostasis valve to a connector of the access catheter; the proximal tether has a proximal end that extends outside the proximal end of the central lumen; wherein an aspiration lumen is collectively formed by the single lumen of the interventional catheter and the central lumen of the access catheter; wherein the proximal end region of the distal portion comprises a thickened wall portion forming an inclined surface that flares outward so as to increase the outer diameter of the proximal end region, and wherein the inclined surface forms a sealing element positioned on an external surface of the proximal end region of the distal portion that seals against the inner diameter of the access catheter creating a seal sufficient for aspirating the occlusion; and transmitting aspiration force from the aspiration source through the connector via a side arm and through the central lumen to the distal opening of the interventional catheter to capture the occlusion.
In the same field of endeavor, which is guide extension catheters, Garrison teaches (Figs. 1, 13, 15) wherein an access catheter (2010) is attachable to an aspiration line that connects to an aspiration source (Par. 0053, 0084-0085); coupling a rotating hemostasis valve to a connector (2027) of the access catheter; a proximal tether (2835) has a proximal end that extends outside the proximal end of the central lumen (Par. 0082 & 0139); and transmitting aspiration force from the aspiration source through the connector via a side arm and through the central lumen to the distal opening of the interventional catheter to capture the occlusion (Par. 0048, 0053, 0084-0085).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to have wherein an access catheter is attachable to an aspiration line that connects to an aspiration source; coupling a rotating hemostasis valve to a connector of the access catheter; the proximal tether has a proximal end that extends outside the proximal end of the central lumen; and transmitting aspiration force from the aspiration source through the connector via a side arm and through the central lumen to the distal opening of the interventional catheter to capture the occlusion. Doing so would facilitate removal of the occlusion as well as minimizing distal emboli (Par. 0010), and doing so would shunt blood from the arterial access device and provide controlled aspiration and would allow introduction of devices while preventing or minimizing blood loss during the procedure (Par. 0048 & 0053), as taught by Garrison.
In the analogous art of catheters, Stivland teaches (Fig. 8) wherein an aspiration lumen is collectively formed by a single lumen (see annotated figure below) of an interventional catheter (60) and a central lumen [i.e. aspiration lumen] of an access catheter (70; Par. 0030); wherein a proximal end region (see annotated figure below) of a distal portion (62) comprises a thickened wall portion (66) forming an inclined surface that flares outward so as to increase the outer diameter of the proximal end region, the inclined surface forms a sealing element positioned on an external surface of the proximal end region of the interventional catheter that seals against the inner diameter of the access catheter creating a seal sufficient for aspirating the occlusion; and transmitting aspiration force from the aspiration source to the distal opening of the interventional catheter to capture the occlusion (Par. 0030-0031).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, as modified by Garrison, to have wherein an aspiration lumen is collectively formed by the single lumen of the interventional catheter and the central lumen of the access catheter; wherein a proximal end region of the interventional catheter comprises a thickened wall portion forming an inclined surface that flares outward so as to increase the outer diameter of the proximal end region, the inclined surface forms a sealing element positioned on an external surface of the proximal end region of the interventional catheter that seals against the inner diameter of the access catheter creating a seal sufficient for aspirating the occlusion; and transmitting aspiration force from the aspiration source to the distal opening of the interventional catheter to capture the occlusion. Doing so would improve aspiration performance (Par. 0030-0031), as taught by Stivland.
Regarding claim 23, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang discloses further comprising advancing a treatment device [i.e. therapeutic medical device] into the single inner lumen of the interventional catheter so that the treatment device resides at or near the occlusion (Par. 0039 & 0055).
Regarding claim 25, Wang, as modified by Garrison and Stivland, discloses further wherein the aspiration source is a syringe or a pump [i.e. vacuum source such as a syringe, see Stivland paragraph 0023].
Regarding claim 28, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang further discloses wherein the interventional catheter comprises a radiopaque marker near the proximal end region and a radiopaque marker near the distal opening (Par. 0040-0041).
Regarding claim 29, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang further discloses (Fig. 3) wherein the point of attachment is positioned within a transition zone (42) that bridges a flexibility [i.e. elastic material] of the proximal tether to a flexibility [i.e. elastic material] distal portion of the interventional catheter and the proximal tether within the transition zone comprises a flattened distal end region [i.e. necking or pinching down of ribbon portion (20)] (Par. 0042, 0048, 0062-0063, 0070).
Regarding claim 34, Wang, as modified by Garrison and Stivland, discloses the method of claim 33. Wang further discloses wherein the inner diameter of the single inner lumen of the interventional catheter is about 0.035" to about 0.060" or about 0.070" to about 0.095" [i.e. the outer diameter of the proximal portion (144) of the distal sheath, 0.03 to 0.010 inches, minus two time the wall thickness of the distal sheath, 0.001 to 0.010 inches, equals the inner diameter of the single inner lumen] (Par. 0035 & 0051-0052).
Regarding claim 35, Wang, as modified by Garrison and Stivland, discloses the method of claim 29. Wang further discloses (Fig. 3) wherein the proximal end region of the interventional catheter within the transition zone comprises a reinforcement structure (32; Par. 0040).
Regarding claim 38, Wang, as modified by Garrison and Stivland, discloses the method of claim 37. Wang fails to further disclose wherein the aspirating comprises aspirating through the central lumen at a flow rate of at least about 321 mL/min.
In the same field of endeavor, which is guide extension catheter, Garrison teaches wherein the aspirating comprises aspirating through the central lumen at a flow rate of at least about 321 mL/min (Par. 0067). Garrison teaches that the length and diameter of a distal catheter needs to be optimized for “increased flow rate” (Par. 0029). Paragraph 0029 explains that the distal catheter can have various lengths and diameters, and as such the flow rate of the catheter is disclosed to be a result effective variable in that changing the length and/or diameter changes the aspiration flow rate through the catheter. One having ordinary skill in the art, given the teachings of Garrison, would have had a reasonable expectation of success in selecting a suitable catheter having the required length and diameter for the catheter to have an increased flow rate. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have the aspirating comprises aspirating through the central lumen at a flow rate of at least about 321 mL/min as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 39, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang further discloses wherein introducing the access catheter comprises introducing the access catheter over a guidewire towards the treatment site (Par. 0055 & 0071).
Regarding claim 40, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang fails to disclose further comprising coupling a rotating hemostasis valve to a connector of the access catheter; attaching the aspiration line to the rotating hemostasis valve; and connecting the aspiration line coupled to the rotating hemostasis valve to a reservoir.
Garrison teaches (Figs. 1 & 15) coupling a rotating hemostasis valve to a connector (2027) of an access catheter (2010); attaching an aspiration line (2045) to the rotating hemostasis valve; and connecting the aspiration line coupled to the rotating hemostasis valve to a reservoir (3105; Par. 0053 & 0084-0085).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have a rotating hemostasis valve to a connector of the access catheter; attaching the aspiration line to the rotating hemostasis valve; and connecting the aspiration line coupled to the rotating hemostasis valve to a reservoir. Doing so would shunt blood from the arterial access device and provide controlled aspiration (Par. 0048 & 0053), as taught by Garrison.
Regarding claim 41, Wang, as modified by Garrison and Stivland, discloses the method of claim 40. Wang fails to disclose further comprising actively controlling transmitting of aspiration force using a flow control switch.
Garrison further teaches comprising actively controlling transmitting of aspiration force using a flow control switch (Par. 0087).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have the method step of actively controlling transmitting of aspiration force using a flow control switch. Doing so would facilitate the breaking up and aspiration of the cerebral occlusion (Par. 0087), as taught by Garrison.
Regarding claim 42, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang further discloses (Figs. 1-2) wherein sliding the interventional catheter within the central lumen comprises advancing the interventional catheter over a guidewire (50) extending within the central lumen of the tubular body, the guidewire extending through the single lumen and out the distal opening of the interventional catheter (Par. 0055-0056 & 0071).
Claims 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0018773) in view of Garrison (US 2013/0281788) and Stivland (US 2010/0030186), as applied to claims above, and further in view of Turjman et al. (US 2014/0155980), cited in previous office action.
Regarding claim 24, Wang, as modified by Garrison and Stivland, discloses the method of claim 23. However, Wang fails to explicitly disclose wherein the treatment device is a retrievable stent device configured to capture the occlusion.
Turjman teaches wherein a treatment device is a retrievable stent device configured to capture the occlusion (Par. 0255).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have wherein the treatment device is a retrievable stent device configured to capture the occlusion. Doing so would achieve desired patient outcomes because of its ability to successfully enmesh and drag out large portions of clots, and increase the simplicity and safety of clot capture member (Par. 0255), as taught by Turjman.
Regarding claim 27, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. However, Wang is silent about the inclined surface forms a compressible external surface feature.
In the analogous art of catheters, Turjman teaches wherein the inclined surface forms a compressible external surface feature [i.e. silicon rubber a compressible material] (Par. 0092, 0096, 0162).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Wang, in view of Garrison and Stivland, to have the inclined surface forms a compressible external surface feature [i.e. silicon rubber], as taught by Turjman. It has been held to be within the general skill of a worker, in the art, to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0018773) in view of Garrison (US 2013/0281788) and Stivland (US 2010/0030186), as applied to claim 22 above, and further in view of Ressemann et al. (US 2002/0165574), cited in previous office action.
Regarding claim 26, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. However, Wang fails to disclose wherein further comprising advancing the access catheter into a carotid artery prior to sliding the interventional catheter within the central lumen.
In the same field of endeavor which is guide extension catheters, Ressemann further teaches wherein further comprising advancing the access catheter into a carotid artery prior to sliding the interventional catheter within the central lumen (Par. 0103 & 0140-0142).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have the method step: wherein further comprising advancing the access catheter into a carotid artery prior to sliding the interventional catheter within the central lumen. Doing so would allow treatment of a fragile lesion within a carotid artery (Par. 0103), as taught by Ressemann.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0018773) in view of Garrison (US 2013/0281788) and Stivland (US 2010/0030186), as applied to claim 22 above, and further in view of Walker et al. (US 5,454,788), cited in previous office action.
Regarding claim 32, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Stivland fails to teach wherein the inclined surface is biased outward and compressible against the inner diameter of the access catheter.
In the analogous art of catheters, Walker teaches (Figs. 1 & 22) an inclined surface (46’) is biased outward and compressible against an inner diameter of a sleeve (42) of the catheter assembly (10; Col. 22, lines 27-31 & 39-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have the method step: wherein the inclined surface is biased outward and compressible against the inner diameter of the access catheter. Doing so would providing excellent sealing cooperation with these structural elements and allowing relative rotation therebetween (Col. 22, lines 48-54), as taught by Walker.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0018773) in view of Garrison (US 2013/0281788) and Stivland (US 2010/0030186), as applied to claim 22 above, and further in view of Connors, III (US 6,295,989), cited in previous office action.
Regarding claim 33, Wang, as modified by Garrison and Stivland, discloses the method of claim 22. Wang fails to disclose wherein the inner diameter of the central lumen of the tubular body is about 0.086" to about 0.088" and corresponds to a 6 French sheath size.
In the analogous art of guide catheters, Connors teaches wherein the inner diameter of the central lumen of the tubular body is about 0.086" to about 0.088" and corresponds to a 6 French sheath size (Col. 6, lines 44-49).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang, in view of Garrison and Stivland, to have the method step: wherein the inner diameter of the central lumen of the tubular body is about 0.086" to about 0.088" and corresponds to a 6 French sheath size. The claim would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (Col. 6, lines 44-49), as taught by Connors.
Response to Arguments
Applicant’s arguments with respect to claims 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.
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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 27, 2026