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 .
Amendment
This office action is responsive to the amendment filed on 4/3/26. As directed by the amendment: claims 1-9, 11-16 and 20-29 have been amended, claims 10 and 17-19 have been canceled, and no new claims been added. Thus, claims 1-9, 11-16 and 20-29 are presently pending in the application.
Claim Objections
Claims 15-16, 21-22 and 29 are objected to because of the following informalities:
Claims 15-16 recite “ballon” in line 4, suggested to be changed to --balloon-- to correct a spelling error.
Claim 16 recites “5mbar” suggested to be changed to --5 mbar-- to have proper spacing.
Claim 21 recites “the partial wall thickness of the inner layer” and “the partial wall thickness of the outer layer” suggested to be changed to --the proportional wall thickness of the inner layer” and “the proportional wall thickness of the outer layer--, respectively, for consistency.
Claim 22 recites “the partial wall thickness of the inner layer” suggested to be changed to --the proportional wall thickness of the inner layer” for consistency.
Claims 29 (lines 6 and 8) recites “the multilayer balloon” suggested to be changed to --the balloon-- for consistency.
Claim Rejections - 35 USC § 112
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 6, 9 and 22 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.
Claim 6 recites “the turned formation” in lines 4, however it is unclear which turned formation of the plurality of turned formations this recitation is referring back to.
Claim 6 recites “a formation” in lines 6-7, however it is unclear if applicant is referring back to “the turned formations” of claim 5.
Claim 6 recites “of a similar material” however it is unclear what the scope of this language includes.
Claim 6 recites “having the same layer thickness” however it is unclear what structure is being referred to here.
Claim 22 recites “the partial wall thickness of the gas and/or water vapor-tight barrio layer,” which lacks proper antecedent basis.
Any remaining claims are rejected as being dependent on a rejected base claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-9, 11-16 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Prindle et al. (2017/0143943) in view of Clayton (2008/0078403) and Gobel (2007/0213661).
Regarding claim 1, in fig. 1-2 Prindle discloses a structure comprising a balloon 100 for positioning within a cavity or a lumen or some other interior space in the human or animal body [0076], in such a way that the stated cavity on the one hand is filled without residual space, but on the other hand largely maintains its shape or is not deformed by the balloon body, characterized in that the balloon is made of a multilayer balloon film material (PVC coated with PUR [0080][0082]) comprising, an outer layer 121 being made of an elastically deformable polyurethane (PUR) [0082] and an inner layer 120 being made of plastically deformable polyvinyl chloride (PVC) [0080], but is silent regarding that the outer layer has a proportional wall thickness of 5 to 10 microns and the inner layer has a proportional wall thickness of 15 to 20 microns and a ratio of a proportional wall thickness of the outer layer (2) to a proportional wall thickness of the inner layer (3) is between 1:2 and 1:4. However, Clayton teaches that an outer layer (elastic outer layer [0029]) has a proportional wall thickness of 5 to 10 microns (the outer layer being 0.0002 inches thick = 5.8 microns) and an inner layer (inner layer of PVC [0034]) has a proportional wall thickness of 15 to 20 microns (inner layer providing support to the outer, thinner elastic member [0029][0034-0035] describes the thickness of the inner layer of PVC being 0.0003-.00025 inches = 7.62-63.5 microns) and a ratio of a proportional wall thickness of the elastic outer layer [0029] to a proportional wall thickness of a PVC inner layer (inner layer of PVC [0034]), is between 1:2 and 1:4 (the outer layer being 0.0002 inches thick and inner layer providing support to the outer, thinner elastic member [0029][0034-0035] describes the thickness of the inner layer of PVC being 0.0003-.00025 inches, which forms a ratio between 1:2 and 1:4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prindle’s PUR and PVC layers with an outer layer proportional wall thickness of 5 to 10 microns, an inner layer proportional wall thickness of 15 to 20 microns forming a thickness ratio between 1:2 and 1:4, as taught by Clayton, for the purpose of providing an alternate thicknesses and ratio having the predictable results of providing an inflated seal within a user. The modified Prindle is silent regarding that the elastically deformable PUR has a water absorption of 5% or less according to DIN ISO 62. However, Gobel teaches a thermoplastic PUR of a type having a water absorption of 5% or less according to DIN ISO 62 ([0027] Pellethane 2363). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s PUR layer with a thermoplastic PUR of a type having a water absorption of 5% or less according to DIN ISO 62, as taught by Gobel, for the purpose of providing an alternate PUR layer having the predictable result of providing an outer layer to in inflatable balloon cuff.
Regarding claim 2, the modified Prindle discloses that the outer layer is combined with the inner layer ([0082][0080] Prindle and [0027] Gobel).
Regarding claim 3, the modified Prindle discloses that typical invaginations of an excess residual balloon envelope, provided in the balloon interior, adapted to be formed upon an in situ placement of the balloon preformed residually namely formed with excess balloon material along the circumference of the balloon (depending on the pressure reapplied and the application, invaginations will occur due to the balloon materials).
Regarding claim 4, the modified Prindle discloses that the invaginations provided in the balloon interior have turned formations with a cross-section in the form of a loop (depending on the pressure reapplied and the application, invaginations will occur in this formation due to the balloon materials).
Regarding claim 5, the modified Prindle discloses that the turned formations with a cross section in the form of a loop, extend or continue as formations in the form of channels in the longitudinal direction of the balloon (due to the same balloon materials, the opening diameter and loop diameter will be as claimed).
Regarding claim 6, the modified Prindle discloses that an opening diameter of the turned formation having the form of a loop or channel is reduced compared to the opening diameter of a formation in the form of a loop or channel for the pure PUR layer of the same material without an inner layer of PVC and having the same layer thickness of the multilayer balloon film material (due to the same balloon materials, this limitation is met).
Regarding claim 7, the modified Prindle discloses that the inner layer has a plastic, nonelastic quality such that its planar deformation, bending, or torsion under filling pressures of the balloon that are adapted to change in situ exerts an attenuating effect on opening kinetics of formations in the form of loops or channels (Prindle discloses PVC [0080]).
Regarding claim 8, the modified Prindle discloses that an elastically caused opening or expansion of loops or channels upon a transient or cyclically fluctuating pressure drop in the balloon is slowed down due to the combination of the outer layer with the inner layer ([0082][0080] Prindle and [0027] Gobel).
Regarding claim 9, the modified Prindle discloses that the elastic straightening effect in a region of turned formations in the form of a loop or a channel is reduced in such a way that the cross-sectional areas of the turned formations having the form of a loop or a channel are reduced compared to a single-layer elastic balloon film made only of PUR (due to the same balloon materials, this limitation is met).
Regarding claim 11, the modified Prindle is silent regarding that the overall wall thickness of the balloon is less than or equal to 50 microns, or is less than or equal to 40 microns, or is less than or equal to 30 microns. However, Gobel teaches a balloon having a thickness of less and 30 microns [0027]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s balloon thickness with a thickness less than 30 microns, as taught by Gobel, for the purpose of providing an alternate balloon thickness having the predictable results of inflating within a body lumen.
Regarding claim 12, the modified Prindle discloses that the ratio of the proportional wall thickness of the outer layer to the proportional wall thickness of the inner layer is approximately 1:3 ([0029][0034-0035] Clayton).
Regarding claim 13, the modified Prindle discloses that a migration of fluids, or of polar liquids, through a wall of the balloon is reduced due to the combination of the inner layer with the outer layer (this will occur due since the modified Prindle teaches the same materials as claimed).
Regarding claim 14, the modified Prindle discloses that the turned formations in the form of a loop or a channel maintain a sealing property with respect to fluids when the balloon is filled at a pressure at or above 5 mbar (this limitation will occur due to the modified Prindle teaching the same materials).
Regarding claim 15, the modified Prindle discloses that the cross-sectional areas of turned formations in the form of a loop or a channel increase by no more than 25%, or only by 20% or less, when the balloon is filled at a pressure at or above 5 mbar (this limitation will occur due to the modified Prindle teaching the same materials).
Regarding claim 16, the modified Prindle discloses that the cross-sectional areas of the turned formations in the form of a loop or channel increase by no more than 25%, or only by 20% or less, when the balloon is filled at a pressure in a range between 5 mbar and 30 mbar (this limitation will occur due to the modified Prindle teaching the same materials).
Regarding claim 25, the modified Prindle discloses that the balloon is an integral part of a catheter (Fig. 1 [0076] Prindle).
Regarding claim 26, the modified Prindle discloses that the outer layer is made of a thermoplastic PUR of a type having a water absorption of 2% or less according to DIN ISO 62 ([0027] Gobel).
Regarding claim 27, the modified Prindle discloses that turned formations with a cross-section having the form of a loop extend or continue as formations in the form of channels in the longitudinal direction of the balloon between distal and proximal end-face sides of the balloon (this limitation will occur due to the modified Prindle teaching the same materials).
Regarding claim 28, the modified Prindle discloses that the turned formations with a cross-section having the form of a loop, which extend or continue as formations in the form of channels in the longitudinal direction of the balloon, have an opening diameter between 30 microns and 120 microns, or a loop diameter between 40 microns and 80 microns, at a filling pressure of the balloon of 30 mbar (this limitation will occur due to the modified Prindle teaching the same materials).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Prindle, Clayton and Gobel, as applied to claim 1 above, in further view of Cully et al. (2016/0096006).
Regarding claim 20, the modified Prindle is silent regarding that a gas- and/or water vapor-tight barrier layer, made of PVDC or EVOH, is situated between the outer layer and the inner layer. However, Cully teaches a gas- and/or water vapor-tight barrier layer, made of PVDC (adherent layer between a coating 124 and a structural layer 122 [0056]) or EVOH, is situated between an outer coating layer 124 and a nonelastically deformable layer made of PVC (structural layer 122 [0027]), for example. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s PUR and PVC layers with an inner PVDC layer, as taught by Cully, for the purpose of added adherence ([0056] Cully).
Regarding claim 21, the modified Prindle discloses that that the partial wall thickness of the inner layer is greater than the partial wall thicknesses of the outer layer ([0029][0034-0035] Clayton) and/or of the gas- and/or water vapor-tight barrier layer.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Prindle, Clayton, Gobel and Cully, as applied to claim 20 above, in further view of Martens (2008/0078404).
Regarding claim 22, the modified Prindle is silent regarding that that the ratio of the partial wall thickness of the gas- and/or water vapor- tight barrier layer, made of PVDC or EVOH, to the partial wall thickness of the inner layer, is between 1:1 and 1:5, or is between 1:2 and 1:4, and or is approximately 1:3. However, in fig. 4 Martens teaches that that the partial wall thickness of the gas- and/or water vapor- tight barrier layer, made of PVDC or EVOH, to the partial wall thickness of the nonelastically deformable layer, is between 1:1 and 1:5 (the ratio of the layer 32 PVDC to layer 12 PVC is between 1:1 and 1:5), or is between 1:2 and 1:4, and or is approximately 1:3. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s PVDC layer with a PVDC at a ratio from 1:1 and 1:5 with respect to the inner layer, as taught by Martens, for the purpose of providing an alternately sized PVDC layer having the predictable results of providing a gas barrier ([0030] Martens) and added adhesion ([0056] Cully).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Prindle, Clayton, Gobel and Cully, as applied to claim 20 above, in further view of Gobel (2017/0312112).
Regarding claim 23, the modified Prindle is silent regarding that a joining of the outer layer, the inner layer, and the gas- and/or water-tight barrier layer is brought about by coextrusion. However, Prindle discloses co-extrusion of three layers [0080] and Gobel ‘112 teaches coextrusion of raw tube material, which is formed by blow-molding to form a balloon [0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s layers with coextrusion, as taught by Prindle and Gobel ‘112, for the purpose of providing an alternate method of joining layers of a balloon, having the predictable results of a multilayered balloon.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Prindle, Clayton and Gobel, as applied to claim 1 above, in further view of Gobel (2017/0312112).
Regarding claim 24, the modified Prindle is silent regarding that the balloon is manufactured by blow molding of a multilayer extruded tube blank. However, Prindle discloses co-extrusion of three layers [0080] and Gobel ‘112 teaches coextrusion of raw tube material, which is formed by blow-molding to form a balloon [0035]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s layers with blow molding of a multilayer extruded tube blank, as taught by Prindle and Gobel ‘112, for the purpose of providing an alternate method of joining layers of a balloon, having the predictable results of a multilayered balloon.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Prindle et al. (2017/0143943) in view of Clayton (2008/0078403), Gobel (2007/0213661) and Shah (2005/0222329).
Regarding claim 29, in fig. 1-2 Prindle discloses a structure comprising a balloon 100 for positioning within a cavity or a lumen or some other interior space in the human or animal body [0076], in such a way that the stated cavity on the one hand is filled without residual space, but on the other hand largely maintains its shape or is not deformed by the balloon body, characterized in that the balloon is made of a multilayer balloon film material (PVC coated with PUR [0080][0082]) comprising, an outer layer 121 being made of an elastically deformable polyurethane (PUR) [0082] and an inner layer 120 being made of plastically deformable polyvinyl chloride (PVC) [0080], but is silent regarding that the outer layer has a proportional wall thickness of 5 to 10 microns and the inner layer has a proportional wall thickness of 15 to 20 microns and a ratio of a proportional wall thickness of the outer layer (2) to a proportional wall thickness of the inner layer (3) is between 1:2 and 1:4. However, Clayton teaches that an outer layer (elastic outer layer [0029]) has a proportional wall thickness of 5 to 10 microns (the outer layer being 0.0002 inches thick = 5.8 microns) and an inner layer (inner layer of PVC [0034]) has a proportional wall thickness of 15 to 20 microns (inner layer providing support to the outer, thinner elastic member [0029][0034-0035] describes the thickness of the inner layer of PVC being 0.0003-.00025 inches = 7.62-63.5 microns) and a ratio of a proportional wall thickness of the elastic outer layer [0029] to a proportional wall thickness of a PVC inner layer (inner layer of PVC [0034]), is between 1:2 and 1:4 (the outer layer being 0.0002 inches thick and inner layer providing support to the outer, thinner elastic member [0029][0034-0035] describes the thickness of the inner layer of PVC being 0.0003-.00025 inches, which forms a ratio between 1:2 and 1:4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prindle’s PUR and PVC layers with an outer layer proportional wall thickness of 5 to 10 microns, an inner layer proportional wall thickness of 15 to 20 microns forming a thickness ratio between 1:2 and 1:4, as taught by Clayton, for the purpose of providing an alternate thicknesses and ratio having the predictable results of providing an inflated seal within a user. The modified Prindle is silent regarding that the elastically deformable PUR has a water absorption of 5% or less according to DIN ISO 62. However, Gobel teaches a thermoplastic PUR of a type having a water absorption of 5% or less according to DIN ISO 62 ([0027] Pellethane 2363). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Prindle’s PUR layer with a thermoplastic PUR of a type having a water absorption of 5% or less according to DIN ISO 62, as taught by Gobel, for the purpose of providing an alternate PUR layer having the predictable result of providing an outer layer to in inflatable balloon cuff. The modified Prindle is silent regarding a gas- and/or water vapor-tight barrier layer (10) made of EVOH is situated between the outer layer (2) and the inner layer (3). However, Shah teaches a gas- and/or water vapor-tight barrier layer (12, [0056]) made of EVOH is situated between the elastically deformable PUR layer [0047] and the nonelastically deformable layer or the layer made of PVC [0049]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Prindle’s PUR and PVC layers with the addition of an EVOH layer in between, as taught by Shah, for the purpose of providing a gas barrier to prevent leakage.
Response to Arguments
Applicant’s arguments, see pages 8-11, filed 4/3/26, with respect to the rejection of claim 1 under Prindle, Gobel and Clayton have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Prindle, Clayton and Gobel.
Applicant's arguments filed 4/3/26 have been fully considered but they are not persuasive. Applicant argues on pages 11-12 that Clayton’s outer layer is not made of polyurethane and that the inner layer is made of polyurethane.
This argument is not taken well since Clayton teaches a multilayer balloon having a nonelastic PVC inner layer and an elastic outer layer having the claimed proportional thickness ratio. The specific elastic outer layer is already disclosed by Prindle. It would have been obvious to rely on Clayton to teach the claimed ratio of layers and the thicknesses of a nonelastic inner layer to an elastic outer layer, regardless of the specific materials.
Applicant argues on page 12-13 that Shah does not teach different thicknesses for their inner and outer layers.
This argument is not taken well since Shah is not relied upon to teach the differing thicknesses, but rather the claimed gas barrier.
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 RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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