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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/14/2026 has been entered.
Acknowledgment
Claim 1 is amended and filed on 4/14/2026.
Claim 5 is canceled
Specification is amended and field on 4/14/2026.
Canceling claim 5 and amending the specification overcome the 112f and specification objection in the action mailed on 1/29/2026.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ayuzawa (US 20190290887 A1) in view of Kitrilakis et al. (US. 3699956) (“Kitrilakis”).
Re Claim 1, Ayuzawa discloses a holding mechanism assembly (Fig. 1-6) comprising: a tubular inserting member (10. Fig. 6) comprising one end configured for arrangement inside a living body (right end, Fig. 6) and another end configured for arrangement outside of the living body (left end, Fig. 6); a fixing device (110, 130, 120) having a fixing portion configured for fixation beneath a skin of the living body (110, is under the skin portion 500a) and a cylindrical communicating portion (120, 130, Fig. 1b) where the inserting member is insertable (Fig. 6); and a holding structure (210, 230, 220, 300) provided in the communicating portion to hold the inserting member to the fixing device in a liquidtight manner (¶0065), wherein the holding structure comprises a chuck member (210) to tighten and grasp the insertion member inside the cylindrical communication portion (¶0071, Fig. 6), the communicating portion has a first opening opened toward the outside of the living body ( left opening of 120 , Fig. 3) when the fixing device is fixed beneath the skin (Fig. 6); a second opening opened toward the inside of the living body when the fixing device is fixed beneath the skin (right end of 130, Fig. 6); a communication path formed between the first opening and the second opening ( path for 10, Fig. 6); and a space between an inner wall of the communicating portion at the second opening side of the communication path and an outer surface of the inserting member defines a portion of the communication path ( Fig. 5b-6, space between 144 and 10); wherein the space is located on the second opening side relative to the chuck member (Figs. 3, 6); the inserting member is configured as a single flexible tube configured to penetrate through the fixing device and chuck member so as to extend toward the outside of the living body from the first opening and toward the inside of the living body from the second opening (Fig. 6); the outer surface of the inserting member has a non-covered region not covered with the fiber ( portion of the tube inside 130 is not covered); the non-covered region is region of the outer surface of the inserting member, wherein the covered region and the non- covered region are separated in an axial direction of the inserting member with a border between the covered region and the non-covered region, and when the fixing device is fixed beneath the skin, the non-covered region of the inserting member extends between the chuck member and the second opening in the communication path (Fig. 6), but it fails to disclose that the outer surface of the inserting member has a covered region covered with fiber that can guide cells and the covered region is region of the outer surface of the inserting member and the covered region extends from the second opening toward the inside of the living body with the border between the non-covered region and the covered region positioned outside the fixing device at the second opening in the communication path.
However, Kitrilakis discloses an implantable access device (Fig. 1-2) and the device comprising: a tubular member (10), and a fixing device (14, Fig. 1) and wherein holding structure (16, Fig. 1) provided in the communicating portion to hold the inserting member to the fixing device in a liquid tight manner (Fig. 1), the inserting member is configured as a single flexible tube (10) configured to penetrate through the fixing device and the holding structure (Fig. 1) so as to extend toward the outside of the living body from the first opening ( top opening of 16 for 10) and toward the inside of the living body from the second opening (opening of 16 close to 17 for 10 to exit) and the outer surface of the inserting member has a covered region (13, Fig. 2, Col. 2, lines 20-28) covered with the fiber that guide the cell (between the microcavities, fiber, Col. 2, lines 20-28); the covered region and the non-covered region are regions of the outer surface of the inserting member (Fig. 1), wherein the covered region and the non- covered region are separated in an axial direction of the inserting member with a border between the covered region and the non-covered region (right side of 14, Fig. 2), and when the fixing device is fixed beneath the skin (Fig. 1), the non-covered region of the inserting member extends between the holding structure and the second opening in the communication path (Fig. 1) and the covered region extends from the second opening toward the inside of the living body with the border between the non-covered region and the covered region positioned outside the fixing device at the second opening in the communication path (Fig. 2)
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ayuzawa to include a covered portion so that the outer surface of the inserting member has a covered region covered with fiber that can guide cells and the covered region is region of the outer surface of the inserting member and the covered region extends from the second opening toward the inside of the living body with the border between the non-covered region and the covered region positioned outside the fixing device at the second opening in the communication path as taught by Kitrilakis for the purpose anchoring the device to the tissue firmly (Kitrilakis, abstract, Col. 2, lines 20-28).
Re Claim 2, Ayuzawa discloses wherein the non-covered region is formed with a smooth curved surface (surface portion of 10).
Re Claim 3, Ayuzawa fails to disclose wherein the inserting member insertable into the fixing device is configured such that the covered region is arranged in a predetermined region at a side toward the inside of the living body with respect to the second opening.
However, Kitrilakis discloses an implantable access device (Fig. 1-2) and wherein inserting member inserted (Fig. 2) into the fixing device is configured such that the covered region is arranged in a predetermined region (31, Fig.1) at a side toward the inside of the living body with respect to the second opening (Fig. 2).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ayuzawa so that the inserting member insertable into the fixing device is configured such that the covered region is arranged in a predetermined region at a side toward the inside of the living body with respect to the second opening as taught by Kitrilakis for the purpose anchoring the device to the tissue firmly (Kitrilakis, abstract, Col. 2, lines 20-28).
Re Claim 4, Ayuzawa fails to disclose wherein the covered region is formed in a porous shape.
However, Kitrilakis discloses an implantable access device (Fig. 1-12) and the covered region is formed in a porous shape (Col. 2, lines 20-28).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ayuzawa so that the covered region is formed in a porous shape as taught by Kitrilakis for the purpose anchoring the device to the tissue firmly (Kitrilakis, abstract, Col. 2, lines 20-28).
Response to Arguments
Applicant’s arguments, see remark, filed 4/14/2026 with respect to the rejection(s) of claim(s) 1 under 103 using Bousquetin view of Porter and regards to newly added limitation have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Ayuzawa in view of Kitrilakis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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