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
Claims 8-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/31/2026.
Applicant’s election without traverse of claims 1-7 in the reply filed on 07/31/2026 is acknowledged.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
Claim 5, line 3: “redistributrion” should recite “redistribution”.
Claim 6, line 4: “downsream” should recite “downstream”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-7 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 1 recites the limitation "the primary load-bearing chassis" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the primary load-bearing chassis” is interpreted as “a primary load-bearing chassis”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7 recites “the folds defining flow channels with inner surfaces of the target blood vessel”. As written, the language describing the structural component of the occlusion balloon (i.e. the folds) require and therefore positively claim the “inner surfaces of the target blood vessel” to meet the limitation. For examination purposes, the limitation is interpreted and should be written as “the folds are configured to define flow channels with inner surfaces of the target blood vessel”.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 20180236203) [hereinafter Franklin] in view of Kölbel (US 20200015825) and Jamous et al. (US 20180015265) [hereinafter Jamous].
Regarding claim 1, Franklin discloses a vascular occlusion catheter 100 configured for insertion, and at least partial inflation, into a target blood vessel (para. 0002: “The present invention pertains generally to vascular occlusion catheters and methods of vascular pre-conditioning while controlling occlusion and perfusion during an occlusion procedure”), the vascular occlusion catheter comprising:
a proximal catheter shaft 110 (Fig. 1, para. 0155);
a distal catheter shaft 120 (Fig. 1, para. 0155);
a semi-compliant or non-compliant occlusion balloon 140 (Fig. 1, para. 0152: “it is preferable that the balloon be of a compliant or partially compliant balloon material…The balloon may alternatively be constructed of a non-compliant material”) mounted at a proximal side 144 thereof to the proximal catheter shaft 110, and mounted at a distal side 146 thereof to the distal catheter shaft 120 (Figs. 1-2 and 5, para. 0156: “When a balloon is the occlusion member 140, balloon 140 is attached, at its proximal end 144 to a distal end of the second catheter member 110 and at its distal end 146 to a proximal end of the third catheter member 120”);
a central catheter shaft 130 extending through the proximal catheter shaft 110, the occlusion balloon 140 and into the distal catheter shaft 120 (Fig. 1, para. 0155: “As best seen in FIG. 1, the second catheter member 110 and the third catheter member 120 are positioned in longitudinal co-axial spaced apart relationship from one and other along a longitudinal axis 131 of the first catheter member 130 thereby defining an intermediate region 115 of the first catheter member 130 within the space 142 that is not covered by either the second catheter member 110 or the third catheter member 120”), the central catheter shaft 130 constructed as the primary load-bearing chassis of the vascular occlusion catheter (para. 0163: “The first catheter member 130 lends columnar strength to the balloon catheter system 100 and provides a functional backbone for carrying the second catheter member 110, the third catheter member 120 and the inflatable balloon”).
However, Franklin fails to disclose wherein the occlusion balloon defines a blown diameter between approximately twenty-five and approximately thirty-five millimeters.
Kölbel teaches that it is known in the art for a semi-compliant occlusion balloon 20b to have a blown diameter (interpreted as the inflated diameter) between 20-40 mm (Fig. 1B, para. 0026, 0033).
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 occlusion balloon of Franklin to have the blow diameter between 25-35 mm, as taught by Kölbel, since Kölbel teaches that it is a known diameter range in the art for semi-compliant occlusion balloons (see para. 0026 of Kölbel) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, modified Franklin fails to disclose that the occlusion balloon defines a double-wall thickness of between approximately 0.0003" and approximately 0.0020".
Jamous teaches that it is known in the art for a semi-compliant occlusion balloon 224 or 226 (para. 0042) to define a double-wall thickness of 0.0012 inches (para. 0043).
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 occlusion balloon of modified Franklin to have a double-wall thickness of 0.0012 inches, as taught by Jamous, since Jamous teaches that it is a known double-wall thickness in the art for semi-compliant occlusion balloons (see para. 0043 of Jamous) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, modified Franklin discloses wherein the occlusion balloon defines a functional working length of approximately 80 mm or less.
Kölbel further teaches that it is known in the art for a semi-compliant occlusion balloon 20b to have a functional working length of approximately 80 mm (para. 0026).
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 occlusion balloon of Franklin to have the functional working length of approximately 80 mm, as taught by Kölbel, since Kölbel teaches that it is a known working length in the art for semi-compliant occlusion balloons (see para. 0026 of Kölbel) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 3, modified Franklin discloses wherein the proximal catheter shaft, the occlusion balloon, and the distal catheter shaft have a greatest outer diameter of seven French (7 Fr) or less in an uninflated condition (para. 0162 of Franklin: “the balloon catheter system 100, when the inflatable balloon 140 is in an uninflated condition, is of sufficiently small cross-segmental dimension to pass through a 6 to 8 French (2-2.67 mm)-percutaneous sheath, such as, for example 7 French (2.33 mm”). The examiner notes that the balloon catheter system 100 includes the proximal catheter shaft, the occlusion balloon, and the distal catheter shaft.
Regarding claim 4, modified Franklin discloses wherein upon inflation of the occlusion balloon into apposition with the target blood vessel, the occlusion balloon is configured to automatically adjust shape in response to diametric autoregulation of the target blood vessel, and, thereby, continue in apposition therewith (see note below in regards to functional language).
Note: The limitation “the occlusion balloon is configured to automatically adjust shape in response to diametric autoregulation of the target blood vessel, and, thereby, continue in apposition therewith” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the occlusion balloon is capable of doing. Since modified Franklin discloses the structural component required i.e. a semi-compliant/non-compliant occlusion balloon having a blown diameter between approximately 25-35 mm and a double-wall thickness of between approximately 0.0003” - 0.0020” for the functional limitation, modified Franklin thereby discloses the functional limitation of an occlusion balloon capable of undergoing intra-balloon inflation medium volume redistribution as claimed. The modification of Franklin in view of Kölbel and Jamous results in an occlusion balloon with the claimed structural dimensions in combination with a system that can perform the same function. Franklin further discloses that “The occlusion catheter system 100, 300, 500, 700, itself, can also be configured to regulate the degree of occlusion and perfusion” in para. 0215. Furthermore, para. 0041 of the instant application states “Stated differently, the balloon 16 does not experience intra-balloon inflation medium volume change, but rather an intra-balloon inflation medium volume redistribution. Therefore, and as previously described, the wall thinness of the semi-compliant or substantially non-compliant, oversized balloon 16, e.g., between approximately 0.0003" and approximately 0.0020" as well as the relatively inelastic nature of the balloon material, in combination with the relatively low intra-balloon pressure, play a prominent role in enabling the balloon 16 to readily adjust shape”. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 5, modified Franklin discloses wherein upon inflation of the occlusion balloon into apposition with the target blood vessel, the occlusion balloon is configured to undergo intra-balloon inflation medium volume redistributrion, without altering intra-balloon inflation medium volume, in response to diametric autoregulation of the target blood vessel, and, thereby, automatically continue in apposition therewith (see note below in regards to functional language).
Note: The limitation “the occlusion balloon is configured to undergo intra-balloon inflation medium volume redistributrion, without altering intra-balloon inflation medium volume, in response to diametric autoregulation of the target blood vessel, and, thereby, automatically continue in apposition therewith” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the occlusion balloon is capable of doing. Since modified Franklin discloses the structural component required i.e. a semi-compliant/non-compliant occlusion balloon having a blown diameter between approximately 25-35 mm and a double-wall thickness of between approximately 0.0003” - 0.0020” for the functional limitation, modified Franklin thereby discloses the functional limitation of an occlusion balloon capable of undergoing intra-balloon inflation medium volume redistribution as claimed. The modification of Franklin in view of Kölbel and Jamous results in an occlusion balloon with the claimed structural dimensions in combination with a system that can perform the same function. Franklin further discloses that “The occlusion catheter system 100, 300, 500, 700, itself, can also be configured to regulate the degree of occlusion and perfusion”) in para. 0215. Furthermore, para. 0041 of the instant application states “Stated differently, the balloon 16 does not experience intra-balloon inflation medium volume change, but rather an intra-balloon inflation medium volume redistribution. Therefore, and as previously described, the wall thinness of the semi-compliant or substantially non-compliant, oversized balloon 16, e.g., between approximately 0.0003" and approximately 0.0020" as well as the relatively inelastic nature of the balloon material, in combination with the relatively low intra-balloon pressure, play a prominent role in enabling the balloon 16 to readily adjust shape”. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 6, modified Franklin discloses wherein upon inflation of the occlusion balloon into apposition with the target blood vessel, the occlusion balloon is configured to automatically transition from defining a generally cylindrically-shaped mid-portion bookended by generally conically-shaped portions (see Fig. 1 of Franklin which illustrates the occlusion balloon in an inflated state) to a tear-drop shape at a downstream end of the occlusion balloon in response diametric autoregulation of the target blood vessel into a normotensive state (see note below regarding functional language and intended use).
Note: The limitation “the occlusion balloon is configured to automatically transition from defining a generally cylindrically-shaped mid-portion bookended by generally conically-shaped portions to a tear-drop shape at a downstream end of the occlusion balloon in response diametric autoregulation of the target blood vessel into a normotensive state” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the occlusion balloon is capable of doing. Since modified Franklin discloses the structural component required i.e. a semi-compliant/non-compliant occlusion balloon having a blown diameter between approximately 25-35 mm and a double-wall thickness of between approximately 0.0003” - 0.0020” for the functional limitation, modified Franklin thereby discloses the functional limitation of an occlusion balloon capable of undergoing a change in shape from the generally cylindrical shape to the tear-drop shape as claimed. The modification of Franklin in view of Kölbel and Jamous results in an occlusion balloon with the claimed structural dimensions in combination with a system that can perform the same function. Franklin further discloses that “The occlusion catheter system 100, 300, 500, 700, itself, can also be configured to regulate the degree of occlusion and perfusion”) in para. 0215. Furthermore, para. 0041 of the instant application states “Stated differently, the balloon 16 does not experience intra-balloon inflation medium volume change, but rather an intra-balloon inflation medium volume redistribution. Therefore, and as previously described, the wall thinness of the semi-compliant or substantially non-compliant, oversized balloon 16, e.g., between approximately 0.0003" and approximately 0.0020" as well as the relatively inelastic nature of the balloon material, in combination with the relatively low intra-balloon pressure, play a prominent role in enabling the balloon 16 to readily adjust shape”. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 7, modified Franklin discloses all of the limitations set forth above in claim 1. Modified Franklin further wherein the occlusion balloon is configured such that an outer surface of the occlusion balloon comes into full diametric apposition with an inner surface of the target blood vessel upon partial inflation of the occlusion balloon (para. 0159 of Franklin: “the present invention also includes alternative embodiments of occlusion control systems that regulate the position of the occlusion member 140 and the apposition of the occlusion member 140 against a vascular wall surface”; para. 0202 of Franklin: “Control over the apposition of the occlusion member against the vessel walls is preferably accomplished by controlling the inflation of the preferred balloons, selection of the size of the occlusion member, placement of the occlusion member or other methods and techniques that provide control to users of the preferred systems”; see note below in regards to intended use and functional language).
However, modified Franklin fails to disclose whereby folds are formed in the outer surface of the occlusion balloon, the folds defining flow channels with inner surfaces of the target blood vessel or with portions of the outer surface of the occlusion balloon that allow partial blood flow past the occlusion balloon.
Franklin further discloses an alternative semi-compliant balloon 1201 (Fig. 23, para. 0217: “The balloon 1201 of the occlusion/perfusion balloon system 1200 may alternatively be constructed of a substantially compliant material”) that includes folds 1206a formed in an outer surface of the occlusion balloon 1201 (Figs. 23, 25, para. 0219: “Landing areas 1206 and channels 1206a are preferably defined between adjacent pairs of the projecting members 1204 when the balloon 1201 is partially-inflated to nearly fully-inflated”, the folds defining flow channels with inner surfaces of the target blood vessel or with portions of the outer surface of the occlusion balloon that allow partial blood flow past the occlusion balloon (para. 0220: “the channels 1206a of the balloon 1201 permit flow of fluid and blood past the balloon 1201, substantially parallel or along the longitudinal axis 1200a when the system 1200 is inserted into a patient's vessel… For example, in a minimal inflation configuration (FIGS. 23-25), the balloon 1201 has relatively deep and large channels 1206a to accommodate relatively significant blood and fluid flow”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the occlusion balloon of modified Franklin to have the folded shape of the embodiment shown in Figs. 23-28A of Franklin, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Note: The limitation “wherein the occlusion balloon is configured such that an outer surface of the occlusion balloon comes into full diametric apposition with an inner surface of the target blood vessel upon partial inflation of the occlusion balloon” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the occlusion balloon is capable of doing. Since modified Franklin discloses the structural component required i.e. a semi-compliant/non-compliant occlusion balloon having a blown diameter between approximately 25-35 mm and a double-wall thickness of between approximately 0.0003” - 0.0020” for the functional limitation, modified Franklin thereby discloses the functional limitation of an occlusion balloon capable of coming into full diameter apposition with the inner surface of the target blood vessel upon partial inflation of the occlusion balloon as claimed. The modification of Franklin in view of Kölbel and Jamous results in an occlusion balloon with the claimed structural dimensions in combination with a system that can perform the same function. Franklin further discloses that the occlusion balloon is intended to occlude and come into contact of the blood vessel wall as described above in para. 0159 and 0202. Furthermore, full apposition of the vessel while the balloon is partially inflation can depend on the vessel size such that if the vessel is sized to only allow partial inflation of the balloon for full contact of the vessel wall, the limitation would be met. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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