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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/3/2026 has been entered.
Acknowledgment
Claims 1, 12, 18 are amended and filed on 3/26/2026
Claim 19 is canceled and 21 is newly added.
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.
Claim(s) 1-4, 7, 9, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller.
Miller et al. (US. 5256143) (“Miller”) in view of Andersen (WO-2006108420-A1).
Re claim 1, Miller discloses a medical device (Figs. 1-6) comprising: a tubular element (12 and 16) comprising a tubular wall ( wall of 12, Fig. 1-5, Col. 2, lines 35-37) with a distal end (upper end) and a proximal end ( lower end of 16), the tubular element comprising an inner lumen (13) and one or more holes through the tubular wall between the distal and proximal ends ( at least hole 42, Col. 5, lines 1-13); an air-permeable barrier (43, Col. 5, lines 1-20) extending around the tubular element and covering the one or more holes (Fig, 5); and a balloon extending diametrically around the tubular wall (Fig. 5, 43, Col. 5, lines 1-20), the balloon (18) comprising a proximal portion ( left end of 18, Fig. 5) bonded to the tubular wall (wherein the layer 43 is just located over the hole 42, Col. 5, lines 63-68), a distal portion (right portion of 18) disposed distally of the barrier and bonded to the tubular wall ( Col. 5, lines 63-68), and an inflatable middle portion ( middle potion of 18) extending from the proximal portion to the distal portion and formed over the barrier (Fig. 5), wherein the inflatable middle portion of the balloon is configured to be inflated with inflation fluid and to release from the barrier and inflate to air pushed into the tubular element (Col. 3, 5-10, the balloon 18 is capable to inflate from a deflating/ collapsing on the tubular member configuration and wherein the balloon touching the layer 43 to an expanding configuration as inflate media pushes the air in the balloon and the tubular member toward the balloon and then out of the balloon through the hole 42, Col. 6, line 64 up to Col. 7, line 2, abstract), but it fails to disclose that the proximal portion of the balloon disposed proximally of the barrier and bonded to the tubular wall, and the air-permeable barrier being configured to allow passage of an inflations fluid therethrough wherein the inflatable middle portion of the balloon is configured to be inflated with inflation fluid through the one or more holes and the air-permeable barrier.
However, the embodiment of Fig. 6 of Miller discloses that the proximal portion of the balloon (left section of the balloon) disposed proximally of the barrier (47) and bonded to the tubular wall (Fig. 7).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the tubular wall of the embodiment of Fig. 5 of Miller so that the proximal portion of the balloon disposed proximally of the barrier and bonded to the tubular wall as taught by the embodiment of Fig. 6 of Miller the purpose of having desired covering only the hole with desired length (Miller, Col. 5, lines 29-46).
The modified Miller fails to disclose the air-permeable barrier being configured to allow passage of an inflations fluid therethrough wherein the inflatable middle portion of the balloon is configured to be inflated with inflation fluid through the one or more holes and the air-permeable barrier.
However, Andersen discloses a catheter (abstract, Fig.1-3) with a balloon (5) and a gas-permeable barrier (2 a first layer, page 2, lines 19-25, and Page 9, lines 8-11) being configured to allow passage of an inflations fluid therethrough wherein the inflatable middle portion of the balloon is configured to be inflated with inflation fluid through the one or more holes and the air-permeable barrier ( Page 8, lines 10-26, and claim 10) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the inflation of Miller so that air-permeable barrier being configured to allow passage of an inflations fluid therethrough wherein the inflatable middle portion of the balloon is configured to be inflated with inflation fluid through the one or more holes and the air-permeable barrier as taught by Andersen for the purpose of inflating the balloon with specific media and preventing unwanted material from contacting the tissue that may harm the tissue (Andersen, abstract, page 7, lines 1-7).
Re claim 2, Miller fails to discloses wherein at least one end of the proximal end and the distal end of the tubular element is sealed.
However, the embodiment of Fig. 7 of Miller discloses that at least one end of the proximal end and the distal end of the tubular element is sealed. (26, Col. 3, lines 41-46).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the tubular wall of the embodiment of Fig. 5 of Miller to include more holes so that the tubular element comprises more than one hole through the tubular wall as taught by the embodiment of Fig. 2of Miller the purpose of having desired numbers of holes for rapid inflation (Col. 3, lines 41-46).
Re claim 3, the embodiment of Fig. 5 of Miller discloses fails to disclose the one or more holes through the tubular wall comprises more than one hole through the tubular wall.
However, the embodiment of Fig. 2 of Miller discloses that the one or more holes through the tubular wall comprises more than one hole through the tubular wall (26, Col. 3, lines 41-46).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the tubular wall of the embodiment of Fig. 5 of Miller so that the one or more holes through the tubular wall comprises more than one hole through the tubular wall as taught by the embodiment of Fig. 2 of Miller the purpose of having desired numbers of holes for rapid inflation (Miller, Col. 3, lines 41-46).
Re claim 4, Miller discloses wherein the tubular wall comprises polymer, glass, or metal (Col. 2, lines 43-46, plastic is a polymer).
Re claim 7, Miller discloses wherein the proximal and distal portions of the balloon are configured to remain bonded to the tubular element when the inflatable middle portion is inflated (, Fig. 1, Fig. 5, Col. 5, lines 63-68).
Re claim 9, Miller discloses wherein the barrier has a wall thickness of 0.2 mm or less ( Col. 3, lines 34-37 and wherein thickness ranges from 0.0002 inches to 0.1 inches or equivalent to 0.00508 mm to 2.54 mm).
Re claim 20, Miller discloses a method of using the medical device of claim 1 ( see rejection of claim 1), the method comprising pushing air through the proximal end to permeate the barrier and expand the balloon (the medium will be introduced from 24, it will pushes the air in the catheter from 24 to the balloon and through the vent 43, Col. 3, lines 5-10, Col. 5, lines 5-15).
Re claim 21, Miller discloses wherein the air-permeable barrier has a length, wherein the inflatable middle portion has a length, and wherein the length of the inflatable middle portion is defined by the length of the air-permeable barrier (Fig. 5-6).
Claim(s) 5-6 , 8, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Andersen and further in view of Campbell et al. (US 20130253426 A1) (“Campbell”).
. Re claim 5, Miller fails to disclose wherein the balloon comprises an elastomer.
However, Campbell a balloon catheter (Fig. 6) and wherein the balloon comprises an elastomer (¶0104, ¶0106, silicon).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the balloon of Miller so that the balloon comprises an elastomer as taught by Campbell the purpose of having desired material for the balloon (Campbell, ¶0106).
. Re claim 6, Miller fails to disclose wherein the elastomer comprises silicone, natural rubber, neoprene, nitrile, or a combination thereof.
However, Campbell a balloon catheter (Fig. 6) and wherein the balloon comprises silicone, natural rubber, neoprene, nitrile, or a combination thereof (¶0104, ¶0106, silicon).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the balloon of Miller so that the elastomer comprises silicone, natural rubber, neoprene, nitrile, or a combination thereof as taught by Campbell the purpose of having desired material for the balloon (Campbell, ¶0106).
Re claim 8, Miller fails to disclose wherein the barrier has a density of 1.0 g/cm3 or less.
However, Campbell a balloon catheter (Fig. 6) and wherein air permeable material (¶0107) has a density of 1.0 g/cm3 or less. (ePTFE, ¶0277).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the material of the barrier of Miller so that the barrier has a density of 1.0 g/cm3 or less as taught by Campbell the purpose of having desired material for the balloon (Campbell, ¶0107).
Re claim10, Miller fails to disclose wherein the barrier comprises polytetrafluoroethylene (PTFE).
However, Campbell a balloon catheter (Fig. 6) and wherein air permeable material (¶0107) comprises polytetrafluoroethylene (PTFE, ePTFE, ¶0277).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the material of the barrier of Miller so that the barrier comprises polytetrafluoroethylene (PTFE) as taught by Campbell the purpose of having desired material for the balloon (Campbell, ¶0107).
Re claim11, Miller fails to disclose wherein the PTFE comprises expanded PTFE (ePTFE).
However, Campbell a balloon catheter (Fig. 6) and wherein air permeable material (¶0107) comprises polytetrafluoroethylene (PTFE, ePTFE,¶0107, ¶0277).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the material of the barrier of Miller so that the PTFE comprises expanded PTFE (ePTFE) as taught by Campbell the purpose of having desired material for the balloon (Campbell, ¶0107).
Response to Arguments
Applicant’s arguments, see remark, filed 4/3/2026, with respect to the rejection(s) of claim(s) 1 under 102 Miller with regards to the new limitation using have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Miller in view of Andersen
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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