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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7 November 2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDSs), submitted on 7 November 2025, 18 November 2025, and 16 December 2025, have been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 7 November 2025. As directed by the amendment: claims 1-4, 6-10, 13-15, 17, 26-31, and 70-71 have been amended, claims 5, 11-12, 16, and 33-69 have been or remain canceled. Thus claims 1-4, 6-10, 13-15, 17-32, and 70-71 are presently pending in this application, and claims 18-25 and 32 remain withdrawn.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The prior rejection relied upon a modification with Korkuch to have a blood pump attached to the distal end of the catheter, however, the examiner has withdrawn this rejection and the modification in this new ground of rejection results in the blood pump coupled to the distal end of the catheter by its relationship extending through the distal end of the catheter. The examiner notes changing the word “coupled” to “attached” would overcome this rejection.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “a first medical device, the first medical device comprising a blood pump”. There is already antecedent basis for a first medical device in the preamble.
Appropriate correction is required.
Applicant is advised that should claim 8 be found allowable, claim 70 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). The inner layer being removably attached to the outer layer is the same as the outer layer being removably attached to the inner layer. The layers are removably attached relative to each other.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6, 15, and 26-31, are rejected under 35 U.S.C. 103 as being unpatentable over a first interpretation of Athas (WO 2009/036343 A1) in view of Korkuch (US 2018/0256859 A1).
Regarding claim 1, in a first interpretation, Athas discloses an intravascular system (Fig 1) for insertion of first and second medical devices into a vasculature of a patient (the device is fully capable of being used for insertion into a vasculature of a patient), the intravascular system comprising: an introducer sheath (12 Fig 1) configured to be inserted percutaneously into the vasculature (the device is fully capable of being inserted percutaneously into a vasculature), the introducer sheath comprising a lumen (See the interior lumen of 12 in Fig 3) having a fixed inner diameter (The inner diameter of 12 shown in Fig 3) and a fixed inner circumference (see the inner circumference of 12 in Fig 3); and a catheter (18 Fig 1) having a proximal end (20 Fig 1), a distal end (22 Fig 1), and an exterior circumference (see the exterior circumference of 24 in Figs 2A and 2B), and wherein a portion of the exterior circumference of the catheter is (intermediate section 24 Figs 1-2B) configured to adjustably take first (The first dimension is the larger dimension shown in Fig 2B) or second (The second dimension is the smaller dimension shown in Fig 2A) dimensions when positioned within the lumen of the introducer sheath (As shown in Fig 3), so that the catheter can be positioned within the lumen of the introducer sheath and leave an annular gap between the exterior circumference of the catheter and the inner circumference of the lumen of the introducer sheath (the annular gap around each catheter 18 shown in Fig 3, the spacing is maintained by the membrane 28), wherein the portion of the exterior circumference of the catheter extends across an entire length of the catheter configured to be positioned within the lumen of the introducer sheath (See the intermediate section 24 of each catheter 18 extending across the entire length of 12 in Fig 1).
However, Athas fails to teach a first medical device, the first medical device comprising a blood pump wherein the distal end of the catheter is coupled to the first medical device.
Korkuch et al. teaches a first medical device, the first medical device comprising a blood pump ([0040] “a percutaneous heart pump”, [0044] “pump blood from a location within the body”) wherein the distal end of the catheter (220 Fig 2) is coupled to the first medical device (the blood pump is inserted into the catheter and extends out of the distal end, the blood pump is functionally coupled to the distal end of the catheter by extending therethrough, [0061] “As the diameter 140 of the pump head 130 is larger than the unexpanded diameter 218 of the lumen 202, the pump head 130 causes the sheath body 210 to expand as it progresses through the lumen 202 from the proximal end 230 to the distal end 220.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the intravascular system of Athas to include the first medical device as taught by Korkuch to “enable the device to perform various tasks within the body of a patient, such as pump blood from a location within the body.” [0044]
Regarding claim 2, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein the catheter is configured so that the annular gap while the exterior circumference of the catheter takes the second dimension is sized to allow passage of the second medical device therethrough (the annular gap shown in Fig 3 would allow passage of a second medical device when the catheter is in either the first or second dimension, Page 4 lines 17-18 “As instrument changes are made throughout the procedure, different combinations of the tubes 18 are utilized.”).
Regarding claim 3, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein the catheter is configured so that the annular gap, while the exterior circumference of the catheter takes the second dimension, is larger than the annular gap while the exterior circumference of the catheter takes the first dimension (the space around the catheter 12 as shown in the second dimension in Fig 2A is larger since the catheter has a smaller cross section).
Regarding claim 4, the modified first interpretation of Athas teaches the intravascular system of claim 2. Athas further teaches wherein the exterior circumference of the catheter is configured to take: the second dimension when the second medical device is within the annular gap (Page 4 lines 17-18 “As instrument changes are made throughout the procedure, different combinations of the tubes 18 are utilized.”, the catheter 18 is fully capable of collapsing to the dimension shown in Fig 2A when the second medical device is within a different lumen in the annular gap); and the first dimension when the second medical device is not in the annular gap (the catheter 18 is fully capable of being in the larger dimension shown in Fig 2B where the second medical device is not in the annular gap).
Regarding claim 6, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein the second medical device comprises a percutaneous coronary intervention device (the catheter is fully capable of use as a percutaneous coronary intervention device).
Regarding claim 15, the modified first interpretation of Athas teaches the intravascular system of claim 2. Athas further teaches wherein the second medical device exerts a normal force against an outer surface of the catheter while the second medical device is introduced into the introducer sheath, the normal force constraining the exterior circumference of the catheter to the second dimension (Claim 2 functionally recites the second medical device, the annular gap of Athas is fully capable of allowing passage of a second medical device that exerts a normal force and constrains the exterior circumference of the catheter to the second smaller dimension as claimed, such a medical device could take up the rest of the space in the annular gap and prevent the catheter from expanding to its larger dimension).
Regarding claim 26, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches “For example, five collapsible tubes having diameters of 3mm, 5mm, 5mm, 10mm and 15mm” (Page 3 lines 4-5), the smallest listed example diameter is 3mm which is 9 Fr.
However, while the second dimension would necessarily be less than about 9 Fr since it would be smaller than the first dimension having a dimension of 9 Fr, a lower limit of the size range of the second dimension is not described.
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 device of Athas to have the second dimension greater than about 7 Fr and less than about 9 Fr 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 Athas would not operate differently with the claimed dimension, since the catheter is intended to be inserted into the body of a patient the device would function appropriately having the claimed dimension.
Further, it appears that applicant places no criticality on the range claimed, indicating that “In some implementations, the first dimension Y is between 8 Fr and 11 Fr.” and “the size of the annular gap can be tuned to a desired size by changing the configuration of catheter 106, such that a dimension of catheter 106 in a new configuration is not equal to Y.” (specification pp. [0022]).
Regarding claim 27, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein a first portion of the catheter is within the lumen of the introducer sheath and a second portion of the catheter is not within the lumen of the introducer sheath (As shown in Fig 1, part of the intermediate portion 24 of the catheter 18 is within the lumen of the introducer sheath 12 and part 20 and 22 are not within the lumen).
Regarding claim 28, the modified first interpretation of Athas teaches the intravascular system of claim 27. Athas further teaches wherein the first portion of the catheter is configured to change from the first dimension to the second dimension while the second portion of the catheter is configured to remain in the first dimension (See the changes in dimension as claimed in Figs 2A and 2B).
Regarding claim 29, the modified first interpretation of Athas teaches the intravascular system of claim 2. Athas further teaches wherein the second dimension allows the catheter and the second medical device to fit within the lumen of the introducer sheath and adjacent to each other (the annular gap shown in Fig 3 would allow a second medical device to fit adjacent the catheter when the catheter is in either the first or second dimension, Page 4 lines 17-18 “As instrument changes are made throughout the procedure, different combinations of the tubes 18 are utilized.”).
Regarding claim 30, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein the first dimension and the second dimension are measurements of a length of a cross-section of the catheter (As shown in Figs 2A and 2B, the diameter of the intermediate section 24 is a measurement of a length of a cross-section).
Regarding claim 31, the modified first interpretation of Athas teaches the intravascular system of claim 1. Athas further teaches wherein the cross-section of the catheter is circular (See the circular cross section in Figs 2A-3), and the first and second dimensions are diameters of the circular cross-section (See Figs 2A and 2B).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Athas (WO 2009/036343 A1) in view of Korkuch (US 2018/0256859 A1) and Seiss et al. (US 2015/0051435 A1).
Regarding claim 17, the modified first interpretation of Athas teaches the intravascular system of claim 2. Athas further teaches wherein the catheter comprises a polymer (Col 3 lines 13-14 “Suitable materials for the tubes 18 include thin walled or highly flexible polymeric materials.”).
However, Athas is silent to a specific polymer.
Seiss et al. teaches a catheter (14 Fig 1) comprises a polymer ([0031] “an abrasion-resistant polymer”), and wherein the polymer comprises polyamide ([0031] “an abrasion-resistant polymer, such as polyamide”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the catheter of Scopton et al. to comprise a polymer, and wherein the polymer comprises polyamide so the catheter is made of a bendable material that is abrasion-resistant [0031].
Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over a second interpretation of Athas (WO 2009/036343 A1) in view of Korkuch (US 2018/0256859 A1).
Regarding claim 1, in a second interpretation, Athas discloses an intravascular system (Fig 1) for insertion of first and second medical devices into a vasculature of a patient (the device is fully capable of being used for insertion into a vasculature of a patient), the intravascular system comprising: an introducer sheath (12 Fig 1) configured to be inserted percutaneously into the vasculature (the device is fully capable of being inserted percutaneously into a vasculature), the introducer sheath comprising a lumen (See the interior lumen of 12 in Fig 3) having a fixed inner diameter (The inner diameter of 12 shown in Fig 3) and a fixed inner circumference (see the inner circumference of 12 in Fig 3); and a catheter (18 Fig 1) having a proximal end (20 Fig 1), a distal end (22 Fig 1), and an exterior circumference (see the exterior circumference of 24 in Figs 2A and 2B), and wherein a portion of the exterior circumference of the catheter is (intermediate section 24 Figs 1-2B) configured to adjustably take first (The first dimension is the smaller dimension shown in Fig 2A) or second (The second dimension is the larger dimension shown in Fig 2B) dimensions when positioned within the lumen of the introducer sheath (As shown in Fig 3), so that the catheter can be positioned within the lumen of the introducer sheath and leave an annular gap between the exterior circumference of the catheter and the inner circumference of the lumen of the introducer sheath (the annular gap around each catheter 18 shown in Fig 3, the spacing is maintained by the membrane 28), wherein the portion of the exterior circumference of the catheter extends across an entire length of the catheter configured to be positioned within the lumen of the introducer sheath (See the intermediate section 24 of each catheter 18 extending across the entire length of 12 in Fig 1).
However, Athas fails to teach a first medical device, the first medical device comprising a blood pump wherein the distal end of the catheter is coupled to the first medical device.
Korkuch et al. teaches a first medical device, the first medical device comprising a blood pump ([0040] “a percutaneous heart pump”, [0044] “pump blood from a location within the body”) wherein the distal end of the catheter (220 Fig 2) is coupled to the first medical device (the blood pump is inserted into the catheter and extends out of the distal end, the blood pump is functionally coupled to the distal end of the catheter by extending therethrough, [0061] “As the diameter 140 of the pump head 130 is larger than the unexpanded diameter 218 of the lumen 202, the pump head 130 causes the sheath body 210 to expand as it progresses through the lumen 202 from the proximal end 230 to the distal end 220.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the intravascular system of Athas to include the first medical device as taught by Korkuch to “enable the device to perform various tasks within the body of a patient, such as pump blood from a location within the body.” [0044]
Claims 7-10, 13-14, and 70-71 are rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Athas (WO 2009/036343 A1) in view of Korkuch (US 2018/0256859 A1), and Trudell et al. (US 5,158,545 A).
Regarding claim 7, the modified second interpretation of Athas teaches the intravascular system of claim 1. However, Athas fails to teach wherein the catheter comprises an inner layer and an outer layer.
Trudell et al. teaches a catheter comprises an inner layer (12 Fig 2) and an outer layer (18 Fig 2). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the catheter of Athas to include an inner layer and an outer layer as taught by Trudell et al. to controllably maintain the catheter in its first and second dimensions without the need for a device inserted into the lumen of the catheter.
Regarding claim 8, the modified second interpretation of Athas teaches the intravascular system of claim 7. Modified Athas further teaches wherein the inner layer is removably attached to the outer layer (Trudell et al.- the outer layer is peeled apart to remove it from the inner layer as shown in Fig 3).
Regarding claim 9, the modified second interpretation of Athas teaches the intravascular system of claim 7. Modified Athas further teaches the outer layer is flexible (Col 5 lines 16-17 “Sheath 18 is preferably made of Teflon.RTM. or other suitable material which is both flexible and peelable”).
However, modified Athas fails to teach the inner layer is rigid.
Korkuch teaches an expandable layer of a catheter is rigid ([0046] “The sheath body 210 comprises flexible sections 211-217 and rigid sections 281-287.” The inner layer is rigid at the rigid sections). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the rigidity as taught by Korkuch in the inner layer of Athas to “provide column strength and stiffness for axial compressive loading” [0046].
Regarding claim 10, the modified second interpretation of Athas teaches the intravascular system of claim 7. Modified Athas further teaches wherein the exterior circumference of the catheter is configured to change from the first dimension to the second dimension after removal of the inner layer or after removal of the outer layer (the catheter having the layers taught by Trudell et al. would result in the removal of the outer layer allowing the exterior of the catheter to expand, Col 6 lines 60-62 “Upon removal of sheath 18, cannula 12 is allowed to expand back to its pre-tensioned, heat-set (original) configuration.”).
Regarding claim 13, the modified second interpretation of Athas teaches the intravascular system of claim 10. Modified Athas further teaches wherein the inner layer or the outer layer is configured to be removed in a proximal direction (the outer layer as taught by Trudell et al. can be split and removed from the inner layer in the proximal direction relative to the inner layer).
Regarding claim 14, the modified second interpretation of Athas teaches the intravascular system of claim 8. However, modified Athas fails to teach wherein the inner layer comprises at least one peel-away slit which allows for removal of the inner layer.
Trudell et al. teaches a peel-away slit (score line 28 on sheath 18 as shown in Fig 3) which allows for removal of a layer from a device radially inside of it (As shown in Fig 3, the outer layer must be peeled to allow for removal of the outer layer from the body while leaving an inner component in place). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner layer of modified Athas to include a peel-away slit as taught by Trudell et al. to allow for removal of the catheter from around an element placed within it.
Regarding claim 70, the modified second interpretation of Athas teaches the intravascular system of claim 7. Modified Athas further teaches wherein the outer layer is removably attached to the inner layer (Trudell et al.- the outer layer is peeled apart to remove it from the inner layer as shown in Fig 3).
Regarding claim 71, the modified second interpretation of Athas teaches the intravascular system of claim 70. Modified Athas further teaches wherein the outer layer comprises at least one peel- away slit which allows for removal of the outer layer (Trudell et al.- score line 28 on sheath 18 as shown in Fig 3).
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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