DETAILED ACTION
Response to Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/8/2026 has been entered.
Claim Objections
Claims 1 and 8 objected to because of the following informalities:
On line 13 of claim 1, “the portion puncturing a blood vessel” should read “the portion configured for puncturing a blood vessel” to properly recite a functional limitation.
On line 12 of claim 8, “the portion puncturing a blood vessel” should read “the portion configured for puncturing a blood vessel” to properly recite a functional limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 5-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 1, the limitation “the small-diameter part includes a distal end of the flexible tube” fails to comply with the written description requirement because the limitation is not originally disclosed. The small-diameter part does not include the distal end of the flexible tube. See annotated Figure 3 below which clearly shows that the small-diameter part does not include the distal end of the flexible tube.
The examiner suggests deleting the phrase from each of the independent claims 1 and 8.
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Claim 8 includes the same limitation and is rejected for similar reasons. The dependent claims are rejected by virtue of their dependency on rejected claim 1.
Allowable Subject Matter
Claims 1 and 5-8 will be considered allowable upon resolution of the 112 rejection.
The closest prior art of Cox US 4,935,010 and Nipro (WO 2019/146791) fails to disclose or suggest:
An outer needle assembly comprising: an inner needle; an outer needle of hollow shape through which the inner needle is inserted; a passage forming member connected to the outer needle and including a flexible tube which allows bending of the flexible tube itself; a passage connecting member connected to the flexible tube; and a valve body arranged inside the passage connecting member, a first internal space on a distal end side with respect to the valve body being longer than a second internal space on a proximal end side with respect to the valve body, wherein a ventilation path for discharging air in the first internal space to an outside communicates with the first internal space in a vicinity of the valve body, the first internal space comprises: a puncture part formed in a portion of the outer needle, the portion configured for puncturing a blood vessel; a tapered part formed on the proximal end side with respect to the puncture part, the tapered part having an inner diameter dimension which increases toward the proximal end side; and a small-diameter part formed on the proximal end side with respect to the tapered part, the small-diameter part having an inner diameter dimension which is smaller than or equal to an inner diameter dimension of a proximal end of the tapered part and which is smaller than an inner diameter dimension of a proximal end of the first internal space.
Claim 8 includes similar limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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