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 .
Drawings
The drawings were received on 11/17/2025. These drawings are acceptable and approved.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiba et al (WO 2015147172 A1).
Regarding Claims 1-3, Chiba discloses an indwelling needle comprising:
an inner needle 2 that punctures a living body;
an outer needle 3 that is penetrated by the inner needle and is inserted into the living body together with the inner needle as the inner needle punctures the living body;
an outer needle hub 15 including a main body that is arranged along an axis of the inner needle and a branch part 22 that branches from the main body, the outer needle hub having a passage communicating with an inside of the outer needle;
an elastic member 23 (fig 4) that is disposed inside the outer needle hub, is penetrated by the inner needle, and has a soft solid part that blocks a fluid flow to a proximal end side of the main body in a case where the inner needle is removed; and
a holder 31 that is attached to a proximal end of the elastic member,
wherein the elastic member has an end surface (toward the left side in 23) that forms at least a part of the passage bringing the inside of the outer needle and the branch part into communication, and the end surface forming at least the part of the passage bringing the inside of the outer needle and the branch part into communication is inclined with respect to a direction of the axis, and
the outer needle hub 15 has a guiding part that is engaged with the elastic member or the holder to guide a rotational orientation of the elastic member or the holder around the axis of the elastic member (see narrow section at left in 23).
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miyake (JP 2016158888 A).
Regarding Claims 1-3, Miyake discloses an indwelling needle comprising:
an inner needle 13 that punctures a living body;
an outer needle 12 that is penetrated by the inner needle and is inserted into the living body together with the inner needle as the inner needle punctures the living body;
an outer needle hub 11 including a main body that is arranged along an axis of the inner needle and a branch part 22 that branches from the main body, the outer needle hub having a passage communicating with an inside of the outer needle;
an elastic member 5 (fig 5) that is disposed inside the outer needle hub, is penetrated by the inner needle, and has a soft solid part that blocks a fluid flow to a proximal end side of the main body in a case where the inner needle is removed; and
a holder 15 that is attached to a proximal end of the elastic member (see 15b),
wherein the elastic member has an end surface (figs 4-6) that forms at least a part of the passage bringing the inside of the outer needle and the branch part into communication, and the end surface forming at least the part of the passage bringing the inside of the outer needle and the branch part into communication is inclined with respect to a direction of the axis, and
the outer needle hub 11 has a guiding part that is engaged with the elastic member or the holder to guide a rotational orientation of the elastic member or the holder around the axis of the elastic member in a certain direction (see interior of the hub around elastic member 5).
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikura (CN 203634624 U).
Regarding Claims 1-3, Ishikura discloses an indwelling needle comprising:
an inner needle 11 that punctures a living body;
an outer needle 13 that is penetrated by the inner needle and is inserted into the living body together with the inner needle as the inner needle punctures the living body;
an outer needle hub 14 including a main body that is arranged along an axis of the inner needle and a branch part 24 that branches from the main body, the outer needle hub having a passage communicating with an inside of the outer needle;
an elastic member 3 that is disposed inside the outer needle hub, is penetrated by the inner needle, and has a soft solid part that blocks a fluid flow to a proximal end side of the main body in a case where the inner needle is removed; and
a holder 31,25,29 (claims 4-6) that is attached to a proximal end of the elastic member (see figs 2 and 6),
wherein the elastic member has an end surface that forms at least a part of the passage bringing the inside of the outer needle and the branch part into communication, and the end surface forming at least the part of the passage bringing the inside of the outer needle and the branch part into communication is inclined with respect to a direction of the axis, and
the outer needle hub 14 has a guiding part that is engaged with the elastic member or the holder to guide a rotational orientation of the elastic member or the holder around the axis of the elastic member (see interior of the hub around elastic member 3).
Regarding claim 4-6, the holder 31,25,29 includes an attachment-target part at 26d and 31a (see fig 6) to which the elastic member is attached, and the elastic member includes, on a proximal end side of the solid part, a cylindrical part whose inner diameter side is supported by the attachment-target part, the cylindrical part having a radial thickness larger than an interval between the attachment-target part and a surface of the outer needle hub radially facing the attachment-target part in a state before being mounted to the outer needle hub.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
In regards to arguments to Chiba, Miyake, and Ishikura are mostly similar and the examiner will address them together. Applicant’s remarks with respect to pages 9-12 of the Remarks. The examiner disagrees.
In 1a to Chiba, claims 1-3 set forth “the inner needle is not removed from the sealing member (asserted to correspond to the claimed "elastic member") at the retracted position, and therefore the elastic member that "has a soft solid part that blocks a fluid flow to a proximal end side of the main body in a case where the inner needle is removed," as recited in claims 1-3.”. Chiba discloses in figures 2b and 3b shows that the needle is substantially removed inside the outer needle after piercing the skin. Furthermore, on page 5 paragraph 2 of the translation, it states that the needle 2 with base portion 7 is removed inside the outer cylinder needle.
In 1b), 2a), and 3a), the language “the end surface forming at least the part of the passage bringing the inside of the outer needle and the branch part into communication is inclined with respect to a direction of the axis," as recited in claims 1 to 3” appears more like a run-on sentence (no punctuation to define the structures within the sentence). Consequently, it does not specifically state that the elastic member is the feature that has the inclination, but the branch part which communicates with the outer needle. It is recommended to be more specific to what limitations are included in the elements.
In 1c), 2b), and 3b), the added language in claims 1-3 is not sufficient to overcome Chiba, Miyake, and Ishikura. Since the elastic member is located in a circular area within the holder, therefore there is a rotational orientation upon insertion of the elastic member within the holder around the axis of the elastic member. Upon review of Applicant’s specification, it confirms that the elastic member has minimal rotation along the axis similar to Chiba. Therefore, Chiba Miyake, and Ishikura meet the limitations in the claims.
With respect to applicant’s arguments about claims 4-6, arguments are narrower than the scope of the claims. The references meet the claimed limitations as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783