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 without traverse of Invention II in the reply filed on 12 January 2026 is acknowledged.
Claims 1-5 and 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 January 2026.
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.
Claims 6-10 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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Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783