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 arguments, see pg. 6 of Remarks, filed 05/14/2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see pg. 6-7 of Remarks, filed 05/14/2026, with respect to the objection to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant's arguments filed on pg. 7 of Remarks, filed 05/14/2026, have been fully considered but they are not persuasive regarding rejections under 35 USC 112(b). It is asserted that the claim rejections under 35 USC 112(b) have been traversed. However, no amendment was made to overcome the rejection of claim 3 detailed on pg. 6 of Non-final rejection, filed 12/16/2025. The rejections under 35 USC 112(b) of claims 3-6 are maintained.
Applicant's arguments filed on pg. 7-8 of Remarks, filed 05/14/2026 in regards to rejections under 35 USC 102, have been fully considered. The Examiner agrees that the amendment to claim 1 to include the added limitation, “wherein the distal end of the flexible tubular polymer layer is configured as an inflow mesh” overcomes the rejection under 35 USC 102 detailed in the Non-final filed on 12/16/2025. Since the claim 1 is amended to include new limitations, new grounds for rejection are warranted for independent claim 1 and dependent claims 2-6. See prior art rejections below.
Applicant's arguments filed on pg. 8-9 of Remarks, filed 05/14/2026 in regards to rejections under 35 USC 103, have been fully considered. The Examiner disagrees with the assertion that, “The Examiner has acknowledged this was not rendered obvious by any of the cited prior art (Remarks, pg. 8).” Since the claim 1 is amended to include new limitations: “of a flexible tubular polymer layer” (cl. 1, ln. 6 and 8), new grounds for rejection are warranted for independent claim 1 and dependent claims 2-6. See prior art rejections below.
Response to Amendment
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, applicant claims “an expandable housing defining an inflow and outflow”. Claim 3 further states “a one-piece outflow tube balloon according to claim 1”, wherein claim 1 also uses the term “an expandable housing” in the last line of the claim. Claim 3 then states “coupled to the expandable housing”. Applicant has effectively claimed two separate expandable housings, and it is unclear which housing is being referred to with the phrase “the expandable housing” in the last line of claim 3. It is also unclear if applicant intended only one expandable housing instead of two. Therefore, the metes and bounds of the claim cannot be determined.
Claims 4-6 are rejected due to their dependency from claim 3.
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 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lostetter (US 20190247213 A1), Brady (US 20030093106 A1, “Brady”), and Kleshinski (US 6245012 B1).
Regarding claim 1, since the phrase “a one-piece outflow tube balloon” is located in the preamble of the claim, and the body of the claim does not require any specific balloon structure, the claims do not require a balloon as currently constructed. Furthermore, the claim structure only requires four components, and therefore, the structure having those components can be considered the claimed “one-piece outflow tube balloon.” Lostetter’s flexible sheath meets the broadest reasonable interpretation of the claimed ‘balloon’, which is a flexible layer capable of holding fluid with at least one hole or opening.
Lostetter teaches a flexible tubular layer (28, Fig. 3A-B, para. [0042]), having a distal end (Fig. 3A-B; the right end of the sheath) and a proximal end (Fig. 3A-B; the left end of the sheath), and having an outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) and an inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28)); one or more openings (Fig. 3A; 34; [0042] - [0043]; at the proximal end (Fig. 3A-B; the left end of the flexible sheath (28)), the one or more openings (Fig. 3A; 34; para. [0042] - [0043]) extending from the outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) to the inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28)); and a slot (Fig. 3B; The slit formed between the fenestration (34) and the left end of the flexible sheath (28)) extending from the proximal end (Fig. 3A-B; the left end of the flexible sheath (28)) of the flexible tubular r layer to a proximal end (Fig. 3A; The left end of flexible sheath (34)) of one of the one or more openings (Fig. 3A; 34; para. [0042] - [0043]); wherein the distal end (Fig. 3A-B: The right end of the flexible sheath (28)) of the flexible tubular polymer layer is configured to be disposed over an expandable housing (Fig 3A-B; para. [0043]; “radial expansion of a self-expanding stent graft (not shown) previously radially constricted within flexible sheath 28”; The flexible sheath is the distal end, and the stent graft is configured to be disposed within the expandable stent graft.). However, Lostetter’s flexible sheath is not disclosed as being made of a polymer, nor does Lostetter disclose wherein the distal end of the flexible tubular polymer layer is configured as an inflow mesh.
Brady, in the same field of endeavor of delivery of medical devices through blood vessels, discloses a catheter device for delivery to a vascular site. Brady discloses a flexible tubular polymeric layer (Abstract; Fig. 1-2; para. [0136]; 10; "A suitable material for the sheath 10 is polyethyleneterephthalate (PET)"; para. [0137); “the relatively flexible sheath 10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Lostetter with the flexible polymeric layer, as disclosed by Brady. One of ordinary skill in the art would recognize that incorporating the polymeric sheath of Brady into the design of Lostetter would improve the efficiency and delivery of the vascular device (see Brady para. [0002] and [0003]). The material properties would facilitate efficianet delivery of the device. Therefore, it would have been an obvious improvement to use a polymeric material for the sheath since Brady discloses using PET.
However, neither reference discloses wherein the distal end of the flexible tubular polymer layer is configured as an inflow mesh. Kleshinski, in the same field of endeavor of delivering a device into the vasculature of a patient, discloses a filter device with an expandable and contractable frame. Kleshinski discloses wherein a distal end (the left end of cylindrical section 32) of a flexible tubular polymer layer is configured as an inflow mesh (Fig. 2; flexible, fine mesh filter material 22; para. (3): “Thus when the stent expands as shown in the drawings, the mesh filter material forms a substantially cylindrical section 32 which opens at the proximal end of the stent and a flexible, closed conical section 26 which extends beyond the distal end of the stent to catch and collect small particles…The fine filter mesh may be formed of suitable biocompatible material such as polyester or a PTFE material and is coated with thromboresistant materials such as, for example, Phosphoral Choline or Hyaluronic Acid.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Lostetter with the flexible, polymeric outflow tubular layer configured as an inflow mesh, as disclosed by Kleshinski. One of ordinary skill in the art would recognize that incorporating the mesh of Kleshinski into the design of Lostetter would improve the efficacy of blood clot removal (stenosis) procedures (see Kleshinski para. (14)). The mesh would facilitate improved removal of blood clots. Therefore, it would have been an obvious improvement to use a mesh in the device of Lostetter.
Regarding claim 3, Lostetter, in combination with Brady and Kleshniski, discloses an outflow tube assembly (see claim 1). Lostetter further discloses an expandable housing (Fig 3A-B; para. [0043]; “radial expansion of a self-expanding stent graft (not shown) previously radially constricted within flexible sheath 28”; The flexible sheath is the distal end, and the stent graft is configured to be disposed within the expandable stent graft.) defining an inflow (the right side of the expandable stent graft previously radially constricted within the flexible sheath 28) and an outflow (the left side of the expandable stent graft previously radially constricted within the flexible sheath 28). Additionally, Lostetter, in combination with Brady and Kleshinski, discloses the one-piece outflow tube balloon of claim 1 (see above).
Kleshinski discloses an expandable housing (Abstract; “expandable and contractible frame surrounds the elongate guidewire receiving member”) defining an inflow and an outflow (see Fig. 2; “blood flow” labeled with arrows defining the inflow and outflow of the expandable housing); an inner coating (Fig. 1-2; Abstract; col. 4, line 21-25; “The fine filter mesh may be formed of suitable biocompatible material such as polyester or material and is coated with thromboresistent materials such as, for example, Phosophoral Chlorine or Hylauronic Acid”) disposed against an inner surface (Fig. 2; column 5, lines 55-67) of the expandable housing (Abstract; “expandable and contractible frame surrounds the elongate guidewire receiving member”) between the inflow (Fig. 2; Left end of the mesh (82)) and outflow (Fig. 2; Right end of the mesh (82)).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Lostetter with the expandable housing with an inner coating, as disclosed by Kleshinski. One of ordinary skill in the art would recognize that incorporating the expandable housing with an inner coating of Kleshinski into the design of Lostetter would improve the efficacy of blood clot removal procedures (see Kleshinski para. (14)). The expandable housing with an inner coating would facilitate improved removal of blood clots. Therefore, it would have been an obvious improvement to use a mesh in the device of Lostetter. Further, it would have been obvious for one of ordinary skill in the art to operably couple the expandable housing to the one-piece outflow tube balloon since doing so would implement the improvements and benefits of an expandable housing into the device of claim 1, as disclosed by Lostetter, Brady and Kleshinski.
Regarding claim 4, Lostetter, in combination with Brady and Klshinski, discloses the outflow tube assembly according to claim 3 (see above). Further, Kleshinski discloses a filter portion at the inflow (Fig. 1; filter 10 shown with blood flowing into it (as depicted by the arrow 38)).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Lostetter with a filter at the inflow of the device, as disclosed by Kleshinski. One of ordinary skill in the art would recognize that incorporating the filter at the inflow would provide an improvement to the treatment of occluded vessels by capturing disloged embolic material (see Kleshinski para. (13)). Therefore, it would have been an obvious improvement to include this feature in the device of Lostetter.
Regarding claim 5, Lostetter, in combination with Brady and Kleshinski, discloses an outflow tube assembly according to claim 3 (see above). Lostetter further discloses a catheter (para. [0005]: “In one embodiment, a stent graft delivery system of the invention includes a handle, a guidewire catheter, an outer catheter, a flexible sheath…”; guidewire catheter 82; Fig. 5). Lostetter also discloses where a proximal end of a one-piece outflow tube balloon (introducer sheath 110) is operably coupled to the catheter (Fig. 5; para. [0049]: “Distal handle 116 is fixed to proximal end 112 of introducer sheath 110, and releasably fixed to guidewire catheter 82.”). However, Lostetter does not expressly disclose that the catheter is operably coupled to the one-piece outflow tube balloon of claim 1. The one piece outflow tube balloon, and its particulars, are disclosed by the combination of Lostetter, Brady and Kleshinski (see claim 1 rejection).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ouflow tube balloon device of the Lostetter, Brady, and Kleshinski with a catheter operably coupled to the proximal end, as disclosed by Lostetter. One of ordinary skill in the art would recognize that a catheter can be used for the delivery of a device into the vasculature, as Lostetter discloses using it for this purpose. It would have been obvious to include a catheter in the outflow tube balloon assembly since the devices of Lostetter, Brady, and Kleshinski all require insertion into vasculature. This would have been an obvious improvement to include a catheter with the device of claim 1 since the insertion of devices into vasculature would be improved.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lostetter (US 20190247213 A1), Brady (US 20030093106 A1, “Brady”), Kleshinski (US 6245012 B1), and Nash (US 20020198550 A1, “Nash”)
Regarding claim 6, Lostetter, in combination with Brady and Kleshinski, discloses the medical device according to claim 5 (see 103 rejection above). However, the references do not disclose an impeller.
Nash, in the same field of endeavor of devices for treating occluded vessels, discloses a system for treating target vasculature. Nash discloses an impeller (Fig. 3; para. [0075]: “Impeller 44”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of claim 5, as disclosed by the combination of Lostetter, Brady and Kleshinski, to further include an impeller, as disclosed by Nash, and to dispose the impeller within the outflow tube balloon assembly. One of ordinary skill in the art would have recognized that including an impeller would improve the speed of blood flow and effectively revascularizing occluded vessels (see para. [0018] of Nash). Thus, it would have been an obvious improvement to the device of Lostetter to further include an impeller for improving the revascularization of blood vessels.
Conclusion
THIS ACTION IS MADE FINAL. 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 OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Additionally, SPE Carl Layno may be reached at (571) 272-4949.
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/O.L.M./
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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