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 .
Election/Restrictions
Applicant’s election of Species A in the reply filed on 06/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-20 are hereby considered for examination.
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.
Claim 15 is 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 15 recites “further comprising a distal member” in lines 1-2. However, claim 11 already recites “a distal member” in line 5. It is unclear is claim 15 is intending to recite an additional distal member or to further define the distal member previously set forth. Similarly, it is unclear if “a distal side of the shaft” and “a distal region of the distal portion” are referring to the same limitations as set forth in claim 11 or intending to recite additional elements. For the purpose of examination, “a distal member”, “a distal side of the shaft”, and “a distal region of the distal portion” are interpreted to be the same elements referenced in claim 11, not additional elements.
Claim Objections
Applicant is advised that should claims 9 and 10 be found allowable, claims 17 and 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 1-7, 9-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613) in view of Burgmeier et al. (US 2005/0142314).
Regarding claim 1, Katsurada et al. discloses a balloon catheter (10, FIG 1, particularly having the joining portion 80A of FIG 2-3C or alternatively, 80C of FIG 5) comprising: a shaft (50A or 50C) that extends in an axial direction (FIG 1); a balloon (20A or 20C, [0021-0039 or 0044]) that is disposed on an outer periphery of the shaft (FIG 2 and 5).
Katsurada et al. is silent regarding in a distal portion of the balloon, a crystallinity on a distal side is lower than a crystallinity on a proximal side.
However, Burgmeier teaches in the same field of endeavor a balloon (10, FIG 1) for attachment to a catheter ([0058]) wherein in a distal portion (Region 3 and 2) of the balloon, a crystallinity on a distal side is lower than a crystallinity on a proximal side ([0058-0059] discloses that the distal end of the balloon at a positioned where the balloon is bonded to the shaft and in the tapered region of the balloon is constructed to have a lower crystallinity than a remainder of the balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of Katsurada such that crystallinity on a distal side is lower than a crystallinity on a proximal side, as taught by Burgmeier, for the purpose of configuring the attachment site to have reduced stiffening and therefore produce a balloon waist portion which undergoes very little crystallization as a consequence of heat bonding to the catheter distal tip ([0058]) and using a lower crystallinity in the cone region (Distal portion) but not in the balloon body portion (proximal side), when forming a heat set balloon, can allow the increased burst strength advantages of heat set balloons to be retained while the disadvantage of reduced re-inflation cycle integrity is minimized or eliminated ([0059]).
Regarding claim 2, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the crystallinity of the distal portion of the balloon gradually decreases from the proximal side toward the distal side ([0058] teaches distal region 3 has the lowest crystallinity, and region 2 is a “transition region as the composition changes over to an unmodified polymer composition in region 1”. The stepped change in crystallinity is interpreted as a gradual decrease from proximal to distal end).
Regarding claim 3, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding the specific crystallinity of any portions of the balloon and therefore fails to disclose the crystallinity on the distal side of the distal portion of the balloon is 1.5% to 6% lower than the crystallinity on the proximal side.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention select a crystallinity distal side to be 1.5% to 6% lower than the proximal side 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 Katsurada/Burgmeier would not operate differently with the claimed change in crystallinity and crystallinity of the distal side is discloses as being lower than on the proximal side, the device would function appropriately having the claimed crystallinity. Further, applicant places no criticality on the range claimed, indicating simply that in one example, the crystallinity on the distal side is about 1.5% to 6% lower than the crystallinity on the proximal side the diameter (specification pp. [0297]).
Regarding claim 4, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. Katsurada further discloses in a cross-sectional view in the axial direction (FIG 5), the distal portion of the balloon includes a wedge portion that is wedge-shaped (FIG 5, 22C forms a wedge shape. [0044]), and the wedge portion includes a parallel portion parallel to the axial direction (25c forms a parallel portion parallel to the axial direction).
Regarding claim 5-6, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 4.
Katsurada is silent regarding the balloon including an inner layer, a base layer, and an outer layer; and in the parallel portion, a crystallinity of the outer layer is lower than a crystallinity of the inner layer and wherein the inner layer and the outer layer contain an elastomer.
However, Burgmeier teaches in the same field of endeavor another embodiment of a balloon (20, FIG 2) for attachment to a catheter, the balloon including an inner layer (21), a base layer (22), and an outer layer (24); a crystallinity of the outer layer is lower than a crystallinity of the inner layer ([0061] discloses “the crystallinity variation may step up or down linearly as one passes through the thickness dimension of the tube” therefore teaching the outer layer having a lower crystallinity than the base and inner layer) and wherein the inner layer and the outer layer contain an elastomer ([0061] discloses each layer being formed of the same polymer and [0021] discloses the polymer can be an elastomer).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of Katsurada such that the balloon is formed of an elastomer and includes an inner layer, a base layer, and an outer layer wherein a crystallinity of the outer layer is lower than a crystallinity of the inner layer, as taught by Burgmeier, for the purpose of altering the rigidity of the ballon along its length while using the same material without the need to manufacture the device in different segments of different polymer ([0060]). In the device as modified, it is understood that the layers having different crystallinity are present throughout the length of the balloon and therefore exists in the parallel portion as claimed.
Regarding claim 7, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. Katsurada further discloses a distal member (60) that is fused to a distal side of the shaft (at step 62, [0032], FIG 2 and 5) and is more flexible than the shaft ([0028] discloses “the inner shaft 50A preferably comprises a resin such as a polyethylene, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer. The tip 60 is preferably formed with a soft resin such as polyurethane or polyurethane elastomer”), wherein a crystallinity of a proximal portion of the distal member is less than 40% ([0028] discloses the material of 60 is a soft resin such as polyurethane, which is commonly known in the art to have a crystallinity of less than 40%).
The device as modified fails to explicitly disclose the distal portion of the balloon has a crystallinity of less than 40%.
However, Burgmeier discloses that the crystallinity along particular regions of the balloon can be controlled by altering the polymer composition to have the desired properties to achieve a desired effect ([0050-0053]). Therefore, it is shown that altering the crystallinity is a result effective variable in that “varying the amount of the crystallization modifier by location within the inventive device part allows a more effective tailoring of properties of such part to localized differences in desired properties such as strength, softness, flexibility, distension and the like” ([0052]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the distal portion of the balloon to have a crystallinity of less than 40% 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 9, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. Katsurada further discloses the distal portion of the balloon is where the balloon and the shaft are bonded to each other (FIGs 2 and 5).
Regarding claim 10 and 18, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the crystallinity is an index indicating a degree of crystallinity of a resin, and is represented by (crystalline band intensity (absorbance)/amorphous band intensity (absorbance)) x 100 (%) (It is commonly known in the art that crystallinity is a percentage which represents the fractions of a crystalline intensity over amorphous intensity).
Regarding claims 11-12, Katsurada discloses a balloon catheter (10, FIG 1, particularly having the joining portion 80A of FIG 2-3C or alternatively, 80C of FIG 5) comprising: a shaft (50A or 50C) comprising a distal side (Segment shown in FIG 2); a balloon (20A or 20C, [0021-0039 or 0044]) disposed on an outer periphery of the shaft (FIG 2 and 5), the balloon including a distal portion having a distal region (22A, [0030-0032] or 22C); a distal member (60) disposed to the distal side of the shaft (FIG 2) and including a proximal portion (64); and wherein a crystallinity of the proximal portion of the distal member is less than 40% ([0028] discloses the material of 60 is a soft resin such as polyurethane, which is commonly known in the art to have a crystallinity of less than 40%).
Katsurada is silent regarding the distal region of the distal portion of the balloon having a crystallinity of less than 40% and wherein the crystallinity of the distal portion of the balloon gradually decreases from a proximal side toward a distal side of the distal portion of the balloon.
However, Burgmeier teaches in the same field of endeavor a balloon (10, FIG 1) for attachment to a catheter ([0058]) wherein in a distal portion (Region 3 and 2) of the balloon, a crystallinity on a distal side is lower than a crystallinity on a proximal side ([0058-0059] discloses that the distal end of the balloon at a positioned where the balloon is bonded to the shaft and in the tapered region of the balloon is constructed to have a lower crystallinity than a remainder of the balloon) and gradually decreases from a proximal side toward a distal side of the distal portion of the balloon ([0058] teaches distal region 3 has the lowest crystallinity, and region 2 is a “transition region as the composition changes over to an unmodified polymer composition in region 1”. The stepped change in crystallinity is interpreted as a gradual decrease from proximal to distal end).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of Katsurada such that crystallinity on a distal side is lower than a crystallinity on a proximal side and gradually decreases form the proximal to distal side, as taught by Burgmeier, for the purpose of configuring the attachment site to have reduced stiffening and therefore produce a balloon waist portion which undergoes very little crystallization as a consequence of heat bonding to the catheter distal tip ([0058]) and using a crystallization inhibitor (i.e. lower crystallinity) in the cone region (Distal portion) but not in the balloon body portion (proximal side), when forming a heat set balloon, can allow the increased burst strength advantages of heat set balloons to be retained while the disadvantage of reduced re-inflation cycle integrity is minimized or eliminated ([0059]).
The device as modified fails to explicitly disclose the distal portion of the balloon has a crystallinity of less than 40%.
However, Burgmeier discloses that the crystallinity along particular regions of the balloon can be controlled by altering the polymer composition to have the desired properties to achieve a desired effect ([0050-0053]). Therefore, it is shown that altering the crystallinity is a result effective variable in that “varying the amount of the crystallization modifier by location within the inventive device part allows a more effective tailoring of properties of such part to localized differences in desired properties such as strength, softness, flexibility, distension and the like” ([0052]).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the distal portion of the balloon to have a crystallinity of less than 40% 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 13, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 11.
The device as modified is silent regarding the specific crystallinity of any portions of the balloon and therefore fails to disclose the crystallinity on the distal side of the distal portion of the balloon is 1.5% to 6% lower than the crystallinity on the proximal side.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention select a crystallinity distal side to be 1.5% to 6% lower than the proximal side 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 Katsurada/Burgmeier would not operate differently with the claimed change in crystallinity and crystallinity of the distal side is discloses as being lower than on the proximal side, the device would function appropriately having the claimed crystallinity. Further, applicant places no criticality on the range claimed, indicating simply that in one example, the crystallinity on the distal side is about 1.5% to 6% lower than the crystallinity on the proximal side the diameter (specification pp. [0297]).
Regarding claim 14, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. Katsurada further discloses in a cross-sectional view in the axial direction (FIG 5), the distal portion of the balloon includes a wedge portion that is wedge-shaped (FIG 5, 22C forms a wedge shape. [0044]), and the wedge portion includes a parallel portion parallel to the axial direction (25c forms a parallel portion parallel to the axial direction).
Katsurada is silent regarding the balloon including an inner layer, a base layer, and an outer layer; and in the parallel portion, a crystallinity of the outer layer is lower than a crystallinity of the inner layer.
However, Burgmeier teaches in the same field of endeavor another embodiment of a balloon (20, FIG 2) for attachment to a catheter, the balloon including an inner layer (21), a base layer (22), and an outer layer (24); a crystallinity of the outer layer is lower than a crystallinity of the inner layer ([0061] discloses “the crystallinity variation may step up or down linearly as one passes through the thickness dimension of the tube” therefore teaching the outer layer having a lower crystallinity than the base and inner layer).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of Katsurada such that the balloon is formed to include an inner layer, a base layer, and an outer layer wherein a crystallinity of the outer layer is lower than a crystallinity of the inner layer, as taught by Burgmeier, for the purpose of altering the rigidity of the ballon along its length while using the same material without the need to manufacture the device in different segments of different polymer ([0060]). In the device as modified, it is understood that the layers having different crystallinity are present throughout the length of the balloon and therefore exists in the parallel portion as claimed.
Regarding claim 15, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 11. Katsurada further discloses a distal member (60) that is fused to a distal side of the shaft (at step 62, [0032], FIG 2 and 5) and is more flexible than the shaft ([0028] discloses “the inner shaft 50A preferably comprises a resin such as a polyethylene, polyamide, polyamide elastomer, polyolefin, polyester, or polyester elastomer. The tip 60 is preferably formed with a soft resin such as polyurethane or polyurethane elastomer”), wherein a crystallinity of each of a proximal portion of the distal member and a distal region of the distal portion of the balloon is less than 40% (As established above in claim 11).
Regarding claim 17, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1. Katsurada further discloses the distal portion of the balloon is where the balloon and the shaft are bonded to each other (FIGs 2 and 5).
Claim(s) 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613) in view of Burgmeier et al. (US 2005/0142314), further in view of Gui et al. (US 2013/0158590).
Regarding claim 8 and 16, Katsurada/Burgmeier discloses the invention substantially as claimed, as set forth above for claim 1 and 11.
Katsurada is silent regarding a thickness at a distal end of the balloon positioned at a portion fused to the shaft is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft, and is larger than a thickness of the shaft at a portion bonded to the balloon.
However, Gui et al. teaches in the same field of endeavor a balloon (1, [0020], FIGs 1-3) bonded to a catheter (2) wherein a thickness at a distal end of the balloon positioned at a portion fused to the shaft (See FIGs 2 and 3 which show a tapering ballon wall thickness at the region where the ballon is fused to the shaft) is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft (As shown in FIG 3, there is at least some thickness that can be taken in the tapered region of the balloon that is smaller than a thickness of the untampered proximal region of the shaft), and is larger than a thickness of the shaft at a portion bonded to the balloon (See the tapered distal end of the shaft where the balloon bonds. There is at least some measurement of the shaft which is smaller in thickness than the balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Katsurada such that at a distal portion where the balloon is fused to the catheter, both the catheter and the balloon taper as taught by Gui, for the purpose of forming a gradual decrease in thickness of the catheter and balloon to thereby evenly form the catheter wall thickness such that a complex catheter with unhindered and smooth bonds is formed to facilitate the surgery operation ([0022]). The device as modified meets the limitation of a thickness at a distal end of the balloon positioned at a portion fused to the shaft is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft, and is larger than a thickness of the shaft at a portion bonded to the balloon.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613) in view of Gui et al. (US 2013/0158590).
Regarding claims 19, Katsurada discloses a balloon catheter (10, FIG 1, particularly having the joining portion 80A of FIG 2-3C or alternatively, 80C of FIG 5) comprising: a shaft (50A or 50C) extending in an axial direction (FIG 1); a balloon (20A or 20C, [0021-0039 or 0044]) disposed on an outer periphery of the shaft (FIG 2 and 5) and comprising a distal end (22A, [0030-0032] or 22C).
Katsurada is silent regarding a thickness in the distal end of the balloon positioned at a portion fused to the shaft is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft, and is larger than a thickness of the shaft at a portion bonded to the balloon.
However, Gui et al. teaches in the same field of endeavor a balloon (1, [0020], FIGs 1-3) bonded to a catheter (2) wherein a thickness at a distal end of the balloon positioned at a portion fused to the shaft (See FIGs 2 and 3 which show a tapering ballon wall thickness at the region where the ballon is fused to the shaft) is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft (As shown in FIG 3, there is at least some thickness that can be taken in the tapered region of the balloon that is smaller than a thickness of the untampered proximal region of the shaft), and is larger than a thickness of the shaft at a portion bonded to the balloon (See the tapered distal end of the shaft where the balloon bonds. There is at least some measurement of the shaft which is smaller in thickness than the balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Katsurada such that at a distal portion where the balloon is fused to the catheter, both the catheter and the balloon taper as taught by Gui, for the purpose of forming a gradual decrease in thickness of the catheter and balloon to thereby evenly form the catheter wall thickness such that a complex catheter with unhindered and smooth bonds is formed to facilitate the surgery operation ([0022]). The device as modified meets the limitation of a thickness at a distal end of the balloon positioned at a portion fused to the shaft is equal to or smaller than a thickness of the shaft at a site closer to a proximal-side than a portion where the balloon is bonded to the shaft, and is larger than a thickness of the shaft at a portion bonded to the balloon.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Katsurada et al. (US 2017/0071613) in view of Gui et al. (US 2013/0158590), further in view of Burgmeier et al. (US 2005/0142314).
Regarding claim 20, Katsurada/Gui discloses the invention substantially as claimed, as set forth above for claim 19. Katsurada further discloses the distal portion of the balloon is where the balloon and the shaft are bonded to each other (FIG 2 and 5).
Katsurada is silent regarding in a distal portion of the balloon, a crystallinity on a distal side is lower than a crystallinity on a proximal side.
However, Burgmeier teaches in the same field of endeavor a balloon (10, FIG 1) for attachment to a catheter ([0058]) wherein in a distal portion (Region 3 and 2) of the balloon, a crystallinity on a distal side is lower than a crystallinity on a proximal side ([0058-0059] discloses that the distal end of the balloon at a positioned where the balloon is bonded to the shaft and in the tapered region of the balloon is constructed to have a lower crystallinity than a remainder of the balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of Katsurada such that crystallinity on a distal side is lower than a crystallinity on a proximal side, as taught by Burgmeier, for the purpose of configuring the attachment site to have reduced stiffening and therefore produce a balloon waist portion which undergoes very little crystallization as a consequence of heat bonding to the catheter distal tip ([0058]) and using a crystallization inhibitor (i.e. lower crystallinity) in the cone region (Distal portion) but not in the balloon body portion (proximal side), when forming a heat set balloon, can allow the increased burst strength advantages of heat set balloons to be retained while the disadvantage of reduced re-inflation cycle integrity is minimized or eliminated ([0059]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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