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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/26 has been entered.
Response to Amendment
The Amendment filed 06/30/26 has been entered. Claims 22-29, 32-35, and 38-42 are addressed in the following office action.
Claim Objections
Claim 22 objected to because of the following informalities:
In line 5, “attachable” should reach “attached”, because “an aspiration line” and “an aspiration source” that follow the “attached” language are being interpreted as positively recited. Applicant presents claims limitations that suggest “an aspiration line” and “an aspiration source” are intended to be part of the claimed invention. Specifically, the following limitation: “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 claim 22, lines 26-28; “the aspiration source is a syringe or a pump” in claim 25, line 1; “further comprising attaching the aspiration line to the rotating hemostasis valve; and connecting the aspiration line coupled to the rotating hemostasis valve to a reservoir” in claim 40, lines 1-3. Appropriate correction is required.
In line 13, “the proximal end of the central lumen” should read “the proximal end of the tubular body”, because claim 1 details in lines 3-4 that “a tubular body with a central lumen having an inner diameter, a proximal end, and a distal opening” and Examiner interprets the limitation as the tubular body having an inner diameter, a proximal end, and a distal opening. Appropriate correction is required.
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 22-26, 33-34, 38, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 2013/0281788) in view of Stivland (US 2010/0030186), both cited in previous office action.
Regarding claim 22, an invention relating to guide extension catheter, Garrison discloses (Figs. 1, 13, 16) a method of performing a medical procedure at a treatment site in a blood vessel of a patient [Note, certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment] (Par. 0044 & 0139), the method comprising: introducing through an insertion site [i.e. incision or puncture in the skin] of the patient an access catheter (2010) comprising a tubular body [i.e. sheath] with a central lumen [i.e. internal lumen] having an inner diameter (Par. 0045-0046), a proximal end (Par. 0047), and a distal opening (Par. 0065), wherein the access catheter is attachable to an aspiration line (2025) that connects to an aspiration source (3125; Par. 0053 & 0084-0085) [Note, “attachable” is being read as “attached”, see detailed explanation in the claim objection above]; coupling a rotating hemostasis valve [i.e. a proximal port (2015) with a rotating hemostasis valve] to a connector [i.e. Y-arm (2027)] of the access catheter (Par. 0053); sliding an interventional catheter [i.e. distal catheter (2830 & 2835)] within the central lumen of the tubular body to change a relative position of the interventional catheter within the central lumen (Par. 0082), the interventional catheter comprising a distal portion (2830) and a proximal tether (2835) extending proximally from a point of attachment between the proximal tether and the distal portion [i.e. the proximal end of the distal portion where the distal end of the proximal tether connects (Fig. 13)], wherein the interventional catheter comprises a single lumen that is the only lumen (see annotated figure below) of the distal portion and wherein the proximal tether has a distal end connected to a proximal end region of the distal portion and a proximal end that extends outside the proximal end of the central lumen [Note, “the central lumen” is being read as “the tubular body”, see detailed explanation in the claim objection above] (Par. 0082); advancing the interventional catheter through the access catheter such that a distal opening (see annotated figure below) of the interventional catheter is located at an occlusion (10) in the vasculature and an overlap region (see annotated figure below) is formed between the interventional catheter and the access catheter (Par. 0065 & 0082), wherein an aspiration lumen is collectively formed by the single lumen [i.e. continuous inner lumen] of the interventional catheter and the central lumen of the access catheter (Par. 0082), wherein an inner diameter of the single lumen between the distal opening through the proximal end region remains unchanged [i.e. a single value for the diameter is disclosed, the diameter in figure 13 is illustrated as constant, and no tapering/ flaring of diameter is disclosed (Par. 0067)]; and transmitting aspiration force from the aspiration source through the connector via a side arm (see annotated figure below) and through the central lumen to the distal opening of the interventional catheter to capture the occlusion [Note, the transmitting aspiration force… through the central lumen to the distal opening of the interventional catheter to capture the occlusion method step is possible given Garrison’s disclosure of the continuous inner lumen created by distal catheter 2830 and arterial access device 2820, which is used in place of figure 1’s distal catheter 2030 and arterial access device 2010] (Par. 0048, 0085, 0139). However, Garrison fails to disclose 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 an 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.
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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 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 the proximal end region of the distal portion comprises a thickened wall portion forming an inclined surface that flares outward so as to increase an 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 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. Note, Stivland’s teachings about an aspiration lumen is collectively formed by the single lumen of the interventional catheter and the central lumen of the access catheter; and transmitting aspiration force from the aspiration source to the distal opening of the interventional catheter to capture the occlusion, are taught in the alternative to Garrison’s disclosure.
Regarding claim 23, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison discloses (Figs. 1 & 22) further comprising advancing a treatment device (4100) into the single lumen of the distal portion so that the treatment device resides at or near the occlusion (Par. 0050 & 0099).
Regarding claim 24, Garrison, as modified by Stivland, discloses the method of claim 23. Stivland further discloses wherein the treatment device is a retrievable stent device [i.e. stentriever or a coil retriever] configured to capture the occlusion (Par. 0050).
Regarding claim 25, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison further discloses wherein the aspiration source is a syringe or a pump (Par. 0085 & 0088).
Regarding claim 26, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison discloses further comprising advancing the access catheter into a carotid artery prior to sliding the interventional catheter within the central lumen (Par. 0126-0129).
Regarding claim 33, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison 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.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Garrison to have 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 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Garrison would not operate differently with the claimed inner diameter and since the central lumen is intended to house the distal catheter/interventional catheter having an inner diameter of 0.057” or 0.035” to 0.060” the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating that the central lumen of the tubular body can about 0.086" to about 0.088" and corresponds to a 6 French sheath size, or the central lumen of the tubular body is about 0.074” to 0.0760” and corresponds to a 5 French sheath size, or other diameter combinations are possible as warranted by the procedure, see paragraph 00124 of applicant’s original specification.
Regarding claim 34, Garrison, as modified by Stivland, discloses the method of claim 33. Garrison further discloses wherein the inner diameter of the single lumen of the interventional catheter is about 0.035" to about 0.060" or about 0.070" to about 0.095" (Par. 0067). Note, although the diameter of element 2830 is not explicitly disclosed, element 2830 is understood to have the same inner diameter of element 2030 since both elements are referring to embodiments of distal catheters. Furthermore, certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination (Par. 0139).
Regarding claim 38, Garrison, as modified by Stivland, discloses the method of claim 25. Garrison fails to explicitly further disclose wherein the aspirating comprises aspirating through the central lumen at a flow rate of at least about 321 mL/min. Garrison teaches that the length and diameter of a distal catheter needs to be optimized for “increased flow rate” (Par. 0067). Paragraph 0067 explains that the distal catheter can have various lengths and diameters, and as such the flow rate of the distal catheter is disclosed to be a result effective variable in that changing the length and/or diameter changes the aspiration flow rate through the distal catheter. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Garrison’s device to have a suitable catheter with the required length and diameter for the catheter to have an increased flow rate within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. 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 Garrison, in view of 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 40, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison discloses (Figs. 1 & 16) further comprising attaching the aspiration line to the rotating hemostasis valve [i.e. attaching flow line to the Y-arm with the attached valve that can be Tuohy-Borst or rotating hemostasis valve (RHV)] (Par. 0053); and connecting the aspiration line coupled to the rotating hemostasis valve to a reservoir (3100; Par. 0053 & 0084-0085).
Regarding claim 41, Garrison, as modified by Stivland, discloses the method of claim 40. Garrison discloses (Fig. 18) further comprising actively controlling transmitting of aspiration force using a flow control switch (3429; Par. 0087). Note, certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment (Par. 0139).
Regarding claim 42, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison further discloses 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 [i.e. when the interventional device is being advanced the guidewire will be extending out the distal opening of the interventional catheter] (Par. 0048 & 0073).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 2013/0281788) in view of Stivland (US 2010/0030186), as applied to claim 22, and further in view of Turjman et al. (US 2014/0155980), cited in previous office action.
Regarding claim 27, Garrison, in view of 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 is known in the art as a suitable material for the construction of an inclined surface forming a compressible external surface feature] (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 Garrison, in view of Stivland, to have the inclined surface forms a compressible external surface feature [i.e. have the inclined surface constructed from silicon rubber to form a compressible external surface feature], 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 28-29 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 2013/0281788) in view of Stivland (US 2010/0030186), as applied to claim 22, and further in view of Itou et al. (US 2006/0069381).
Regarding claim 28, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison discloses wherein the interventional catheter comprises a radiopaque marker near the distal opening (Par. 0066). However, Garrison fails to disclose wherein the interventional catheter comprises a radiopaque marker near the proximal end region.
In the same field of endeavor, which is guide extension catheter, Itou teaches (Fig. 3) wherein an interventional catheter (2) comprises a radiopaque marker (23) near a proximal end region (see annotated figure below; Par. 0029).
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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 Garrison, in view of Stivland, to have wherein the interventional catheter comprises a radiopaque marker near the proximal end region. Doing so would allow the operator can confirm the position of the proximal end portion of the tubular portion in the body of the patient on an X-ray image (Par. 0029), as taught by Itou.
Regarding claim 29, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison discloses wherein the point of attachment is positioned within a transition zone (see annotated figure below) that bridges a flexibility of the proximal tether [Note, the proximal tether would be flexible in order to navigate through bends in the atrial access device that would have to navigate through bends in the vasculature (Par. 0061-0062 & 0065)] to a flexibility of the distal portion (Par. 0065 0130 & 0066). However, Garrison fails to disclose the proximal tether within the transition zone comprises a flattened distal end region.
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In the same field of endeavor, which is guide extension catheter, Itou teaches (Fig. 4) a proximal tether (25) within a transition zone (see annotated figure below) comprises a flattened distal end region [i.e. flat plate] (Par. 0030).
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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 Garrison, in view of Stivland, to have the proximal tether within the transition zone comprises a flattened distal end region. Doing so would prevent the connection between the distal portion and proximal tether from breaking (Par. 0030), as taught by Itou.
Regarding claim 35, Garrison, as modified by Stivland and Itou, disclose the method of claim 29. Garrison fails to further disclose wherein the proximal end region of the distal portion within the transition zone comprises a reinforcement structure.
Itou further teaches (Figs. 3 &4) wherein a proximal end region (see annotated figure below) of the distal portion within the transition zone comprises a reinforcement structure (211 & 232; Par. 0027 & 0030).
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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 Garrison, in view of Stivland and Itou, to have wherein the proximal end region of the distal portion within the transition zone comprises a reinforcement structure. Doing so would prevent kinking (Par. 0007), as taught by Itou.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 2013/0281788), in view of 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, Garrison, in view of Stivland, discloses the method of claim 22. Stivland fails to expressly 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 Garrison, in view of 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 motion therebetween (Col. 22, lines 48-54), as taught by Walker.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US 2013/0281788), in view of Stivland (US 2010/0030186), as applied to claim 22 above, and further in view of Schweich, Jr. et al. (US 5,358,493).
Regarding claim 39, Garrison, as modified by Stivland, discloses the method of claim 22. Garrison fails to disclose wherein introducing the access catheter comprises introducing the access catheter over a guidewire towards the treatment site.
In the analogous art of access catheters, Schweich teaches wherein introducing the access catheter comprises introducing the access catheter over a guidewire towards the treatment site (Col. 7, lines 18-22).
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 Garrison, in view of Stivland, to have wherein introducing the access catheter comprises introducing the access catheter over a guidewire towards the treatment site. Doing so would have been obvious because a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art (Col. 7, lines 18-22), as taught by Schweich.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 06/30/26, with respect to claims 22-29, 32-35, and 38-42 have been fully considered and are persuasive. The 35 USC § 112 rejection of claims 22-29, 32-35, and 38-42 has been withdrawn.
Applicant’s remaining arguments with respect to claims 22-29, 32-35, and 38-42 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
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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/CHIMA U IGBOKO/ Examiner, Art Unit 3771
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