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 .
Response to Amendment
This office action is responsive to the amendment filed on 6 July 2026. As directed by the amendment: claims 7-10 have been amended, claims 21-28 have been added, claims 1-5 and 11-20 have been or remain canceled. Thus claims 6-10 and 21-28 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6 July 2026 have been fully considered but they are not persuasive. Applicant argues achieving the arrangement of claim 6 necessarily requires eliminating the connector tubing which would make it impossible to span the anatomical distance between the carotid access site in the neck and the venous return site and leave no location within the flow path for Criado’s flow control assembly, which would result in the structure being inoperable for Criado’s stated purpose of establishing and regulating retrograde blood flow from the carotid artery to a remote return site.
The examiner respectfully disagrees. Criado teaches embodiments that do not require a long span of connector tubing or additional flow control components. The Internal jugular vein and common carotid artery are directly adjacent to each other as shown in Fig 1A, and the tubing 214 Fig 3 would be long enough to make the connection with length to spare, and as shown in Fig 3, no filter, pump or additional component needs to be positioned along the shunt in all embodiments. Further even if the resulting modification needed to be functional for all embodiments taught by Criado, a modification of one of the luer connectors of one of the stopcocks to allow the stopcocks to connect to each other and eliminate the need for additional tubing does not require elimination of the possibility of using connector tubing altogether. One of ordinary skill in the art would be capable of using a tubing with one male luer end and one female luer end, or more simply, using the same tubing with two male luer ends as shown in Fig 3, and connecting it to the other unmodified female luer connector on the three way stopcock to span any required length if the length of the shunt needs to be longer or include any additional components along the flow path.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-10 and 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criado et al. (US 2019/0262530 A1) in view of Ueda et al. (US 2017/0113031 A1).
Regarding claim 6, Criado et al. discloses a medical device assembly (Fig 3), comprising: a first sheath (210 Fig 3) comprising: a first hub (see the first hub in annotated Fig 3); a first body portion (see the first body in annotated Fig 3) coupled to the first hub, the first body portion arranged to be disposed in a patient ([0013] “The arterial sheath is placed in the common carotid artery CCA”); a first access conduit (see the first access conduit in annotated Fig 3) coupled to the first hub; a first three-way stopcock (see the first three-way stopcock in annotated Fig 3) coupled to the first access conduit, the first three-way stopcock comprising a luer connector (while the connectors shown in Fig 3 are not individually described as luer fittings, Fig 9 which includes identical fittings, describes the fitting as being a “conventional luer fitting” [0086]); a second sheath (212 Fig 3) comprising: a second hub (see the second hub in annotated Fig 3); a second body portion (see the second body portion in annotated Fig 3) coupled to the second hub, the second body portion arranged to be disposed in the patient ([0013] “The venous return sheath 212 is placed in the internal jugular vein UV”); a second access conduit (see the second access conduit in annotated Fig 3) coupled to the second hub; and a second three-way stopcock (see the second three-way stopcock in annotated Fig 3) coupled to the second access conduit, the second three-way stopcock comprising a female luer connector (see the 1st female luer connector in annotated Fig 3) arranged to be coupled to the luer connector of the first sheath (as shown in Fig 3, the connectors are fluidically coupled through tubing 218).
However, Criado fails to teach the first three-way stopcock comprising a male luer connector, and the female luer connector of the second three-way stopcock arranged to be coupled to the male luer connector of the first sheath.
Ueda et al. teaches a first three-way stopcock (20 on the left side of Fig 2) comprising a male luer connector (23 Fig 2, [0055] “The medical connector 20 has a luer lock male connector part 23”), and a second three-way stopcock (20 on the right side of Fig 2) comprising a female luer connector (24 which is obscured by 22 in Fig 2) arranged to be coupled to the male luer connector ([0055] “A cylindrical body 22 having a female screw is fit with and held by the male connector part 23”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the stopcocks of modified Criado et al. to include the limitations as taught by Ueda et al. to provide structure for the stopcocks to connect to each other [0055], such a configuration would eliminate the need for additional tubing between the connectors, simplifying the surgical area and reducing the contamination risk that comes from additional components.
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Regarding claim 7, modified Criado et al. teaches the medical device assembly of claim 6. Criado et al. further teaches wherein the first body portion has a first size, the second body portion has a second size (the first and second body portions necessarily have sizes).
However, modified Criado et al. is silent to the second size is less than the first size.
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 Criado et al. to have the second size less than the first size 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 Criado et al. would not operate differently with the claimed proportion and since the sizes of the body portions do not affect each other, the device would function appropriately having the claimed ratio. Further, it appears that applicant places no criticality on the proportion claimed, indicating that the sheaths “may” have different sizes (specification pp. [0059]).
Regarding claim 8, modified Criado et al. teaches the medical device assembly of claim 7. However, modified Criado et al. is silent to wherein the first size is 16 French and the second size is 6 French.
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 Criado et al. to have the first size is 16 French and the second size is 6 French 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 Criado et al. would not operate differently with the claimed sizes and since the sizes of the body portions do not affect each other and in another embodiment, Criado et al. describes using sheaths with a range of possible sizes ([0072] “The inner diameter is typically in the range from 7 Fr (1 Fr=0.33 mm), to 10 Fr, usually being 8 Fr”) the device would function appropriately having the claimed sizes. Further, it appears that applicant places no criticality on the range claimed, indicating that “In other embodiments, the first sheath 100 and/or the second sheath 300 may have other sizes.” (specification pp. [0059]).
Regarding claim 9, modified Criado et al. teaches the medical device assembly of claim 6. Criado et al. further teaches further comprising a medical device configured to be advanced through the first body portion ([0014] “an interventional catheter is inserted into the arterial access sheath”).
Regarding claim 10, modified Criado et al. teaches the medical device assembly of claim 6. Criado et al. further teaches wherein the female luer connector is a first female luer connector, and the second three-way stopcock further comprises a second female luer connector (the second three way stopcock of Criado et al. Fig 3 includes two female luer connectors, see in annotated Fig 3 below).
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Regarding claim 22, modified Criado et al. teaches the medical device assembly of claim 9. Modified Criado et al. further teaches wherein the medical device is configured to be advanced through the first body portion of the first sheath and not through the second body portion of the second sheath ([0014] “an interventional catheter is inserted into the arterial access sheath”, the interventional catheter would be advanced through the first body potion while not also being advanced through the second body portion, it would only be advanced through the one access sheath).
Regarding claim 23, modified Criado et al. teaches the medical device assembly of claim 6. Modified Criado et al. further teaches wherein the male luer connector of the first three-way stopcock is configured to be directly coupled to the female luer connector of the second three-way stopcock without a separate connector therebetween (the stopcock of the first sheath of Criado et al. modified in view of Ueda et al. as outlined in the rejection of claim 6 above would include a female luer connector to allow the male luer connector of the first three-way stopcock to be directly coupled to the female luer connector of the second three-way stopcock without a separate connector therebetween).
Regarding claim 24, modified Criado et al. teaches the medical device assembly of claim 6. Modified Criado et al. further teaches wherein the first body portion and the second body portion are each arranged to be disposed in a common blood vessel of the patient (the first and second body portions are fully capable of being disposed in a common blood vessel, such as in the embodiments shown in Figs 2B and 2C).
Regarding claim 25, modified Criado et al. teaches the medical device of claim 24. Modified Criado et al. further teaches wherein the common blood vessel has a blood flow direction (the first and second body portions are fully capable of being disposed in a common blood vessel that has a blood flow direction such as the common carotid artery shown in Figs 2B and 2C, with blood flow direction as shown in Fig 4), and wherein the first body portion is configured to be arranged within the common blood vessel such that the first body portion faces a direction opposite the blood flow direction (the claimed arrangement of the first and second body portions in the common blood vessel is functional, the first and second body portions are fully capable of being disposed in a common blood vessel such that the first body portion faces a direction opposite the blood flow direction).
Regarding claim 26, modified Criado et al. teaches the medical device of claim 25. Modified Criado et al. further teaches wherein the second body portion is configured to be arranged within the common blood vessel such that the second body portion faces a same direction as the blood flow direction (the claimed arrangement of the first and second body portions in the common blood vessel is functional, the second body portion is fully capable of being disposed in a common blood vessel such that the second body portion faces a same direction as the blood flow direction).
Regarding claim 27, modified Criado et al. teaches the medical device of claim 9. Modified Criado et al. further teaches wherein the medical device is configured to be positioned at a target cardiac location ([0014] “an interventional catheter is inserted into the arterial access sheath”, the interventional catheter is fully capable of being positioned at a target cardiac location).
Regarding claim 28, Criado et al. discloses a medical device assembly (Fig 3), comprising: a first sheath (210 Fig 3) comprising: a first hub (see the first hub in annotated Fig 3) defining a first hub lumen (there is necessarily a lumen within the hub for blood to flow from 210 to 214 in Fig 3, [0013] “Retrograde flow from the internal carotid artery ICA and the external carotid artery ECA may then be established by opening the stopcock 216”); a first body portion (see the first body in annotated Fig 3) coupled to the first hub, the first body portion defining a first body portion lumen extending therethrough, the first hub lumen fluidly coupled to the first body portion lumen; a first access conduit (see the first access conduit in annotated Fig 3) defining a first access lumen, the first access conduit coupled to the first hub such that the first access lumen is fluidly coupled to the first hub lumen (there is necessarily a lumen within the first access conduit coupled to the first hub lumen for blood to flow from 210 to 214 in Fig 3, [0013] “Retrograde flow from the internal carotid artery ICA and the external carotid artery ECA may then be established by opening the stopcock 216”); a first three-way stopcock (see the first three-way stopcock in annotated Fig 3) coupled to the first access conduit, the first three-way stopcock comprising a luer connector (while the connectors shown in Fig 3 are not individually described as luer fittings, Fig 9 which includes identical fittings, describes the fitting as being a “conventional luer fitting” [0086]); a second sheath (212 Fig 3) comprising: a second hub (see the second hub in annotated Fig 3) defining a second hub lumen (there is necessarily a lumen within the hub for blood to flow from 210 to 214 in Fig 3, [0013] “Retrograde flow from the internal carotid artery ICA and the external carotid artery ECA may then be established by opening the stopcock 216”); a second body portion (see the second body portion in annotated Fig 3) coupled to the second hub, the second body portion defining a second body portion lumen extending therethrough, the second hub lumen fluidly coupled to the second body portion lumen; a second access conduit (see the second access conduit in annotated Fig 3) defining a second access lumen, the second access conduit coupled to the second hub such that the second access lumen is fluidly coupled to the second hub lumen (there is necessarily a lumen within the second access conduit coupled to the second hub lumen for blood to flow from 212 to 214 in Fig 3, [0013] “Retrograde flow from the internal carotid artery ICA and the external carotid artery ECA may then be established by opening the stopcock 216”); and a second three-way stopcock (see the second three-way stopcock in annotated Fig 3) coupled to the second access conduit, the second three-way stopcock comprising a female luer connector (see the 1st female luer connector in annotated Fig 3).
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However, Criado et al. fails to teach the first three-way stopcock comprising a male luer connector, and the female luer connector of the second three-way stopcock couplable directly to the male luer connector of the first sheath.
Ueda et al. teaches a first three-way stopcock (20 on the left side of Fig 2) comprising a male luer connector (23 Fig 2, [0055] “The medical connector 20 has a luer lock male connector part 23”), and a second three-way stopcock (20 on the right side of Fig 2) comprising a female luer connector (24 which is obscured by 22 in Fig 2) couplable directly to the male luer connector ([0055] “A cylindrical body 22 having a female screw is fit with and held by the male connector part 23”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the stopcocks of modified Criado et al. to include the limitations as taught by Ueda et al. to provide structure for the stopcocks to connect to each other [0055], such a configuration would eliminate the need for additional tubing between the connectors, simplifying the surgical area and reducing the contamination risk that comes from additional components.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Criado et al. (US 2019/0262530 A1) in view of Ueda et al. (US 2017/0113031 A1) and Viole et al. (US 2002/0151761 A1).
Regarding claim 21, modified Criado et al. teaches the medical device assembly of claim 9. However, modified Criado et al. fails to teach wherein the medical device is a blood pump.
Viole et al. teaches a medical device configured to be advanced through a body portion is a blood pump ([0088] “an intrasvascular pumping means may be positioned within one lumen of a multilumen catheter so that, for example, where the catheter is applied at the left femoral artery, a first lumen may extend into the aorta proximate the left subclavian and the pumping means may reside at any point within the first lumen, and the second lumen may extend much shorter just into the left femoral or left iliac”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the medical device of modified Criado et al. to be a blood pump as taught by Viole et al. “to supplement the kinetic energy of the blood flow through the blood vessel in which the pump is positioned.” [0086]
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.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
