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 Group II and Species A, corresponding to claims 17-20, in the reply filed on 10/21/25 is acknowledged. Claims 1-16 are withdrawn from consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiba et al. (WO 2015147173).
Regarding claim 17, Chiba et al. discloses a method for priming a medical device 1 (see fig. 7) including a liquid delivering lumen (internal space of inner needle 2) having a first opening portion 2b and a discharge lumen (internal space of outer needle 3) having a second opening portion 17, the method comprising: inserting a distal portion of the medical device from an insertion port 6c of an instrument body 6 (see fig. 7) and disposing the first opening portion and the second opening portion of the medical device in a hollow portion of the instrument body (see fig. 7); sealing an inside of the hollow portion with a sealing portion provided in the insertion port of the instrument body (using threaded connection between 6c and 15; see fig. 7); and injecting a fluid into the liquid delivering lumen from a proximal side, causing the fluid to flow into the hollow portion from the first opening portion of the liquid delivering lumen into which the fluid is injected, and causing the fluid to flow into the discharge lumen from the hollow portion via the second opening portion to fill the liquid delivering lumen and the discharge lumen with the fluid (process described on pg. 7-8 of the translated specification).
Regarding claim 20, Chiba et al. discloses the distal portion of the hollow portion of the priming instrument facing a distal portion of the medical device has a concave curved surface shape (see at least the portion of the surface that transitions into the corners of the distal, inwardly facing surface of 6 in fig. 7).
Claim Rejections - 35 USC § 103
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.
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiba et al. in view of Sinelnikov et al. (US 20150257779).
Regarding claim 18, Chiba et al. discloses the method as claimed, except for the medical device including a guidewire lumen having a third opening portion, inserting the third opening portion into the hollow portion, and causing fluid to flow into the guidewire lumen from the hollow portion via the third opening portion as claimed. However, Sinelnikov et al. teaches inclusion of, and priming of, a guidewire lumen in a medical device (par. 0187). 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 method of Chiba et al. to utilize a guidewire lumen, as taught by Sinelnikov et al., for the purpose of providing sufficient structure for accurate placement of the medical device within the patient. It would further have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the methodology of Chiba et al. to prime the guidewire lumen in the same way as the discharge lumen is primed, since Sinelnikov et al. teaches priming the guidewire lumen, and in order to prime multiple lumens simultaneously to create a fully primed closed circuit, as desired by Chiba et al. (see pg. 7-8 of the translated specification).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiba et al. in view of Brugger et al. (US 20030010717).
Regarding claim 19, Chiba et al. discloses the method as claimed, except for providing a filter at the distal portion of the hollow portion, and allowing air and fluid to pass therethrough. However, Brugger et al. teaches utilizing a filter 32 at the end of a priming device (see fig. 3B), the filter allowing air and fluid to pass therethrough (see fig. 3B). 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 hollow portion of Chiba et al. to utilize a filter, as taught by Brugger et al., for the purpose of separating air from fluid within the fluid circuit (see fig. 3B; par. 0048).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ludt et al. (US 6454736) - end cap structure with seal and filter, see fig. 2
Childers et al. (US 20040019312) - cap for priming a multi-lumen device out of one lumen and into the other; see fig. 2
Further references provided in the attached notice of references cited
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783