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 .
Acknowledgment
Claim 1 is amended and filed on 11/18/2025.
Claim 5 is newly added.
Specification is amended and field on 11/18/2025.
Specification
The amendment filed 11/18/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The newly added limitation “ the fiber of the covered region A1 is integral with the driveline 2 so that the driveline 2 in the form of a single flexible medical tube, including the non-covered region A2 and the covered region A1, altogether form a unitary structure” is new matter as it seems that the fiber of the covered region A1 is integral with the driveline 2 was not disclosed 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, at the time the application was filed, had possession of the limitation such as “ the fiber of the covered region A1 is integral with the driveline 2 so that the driveline 2”. See ¶0067, the driveline 2 has the covered region A1 covered with fiber ..a polyester fiber can be used for the covered region A1 (two different elements). However, it seems that covered region A1 formed in a porous shape (a single element).
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claim 5 is 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. The newly added limitation “wherein the covered region is integrally with the formed in the outer surface if the single flexible tube so as to form a unitary structure” 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. specifically “the covered region is integrally formed in the outer surface of the single flexible tube”. It seems that the covered region (
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "wherein the covered region is integrally formed in the outer surface of the single flexible tube so as to form a unitary structure" in lines 1-3. It is unclear limitation if it means "wherein the covered region and non- covered region are integrally formed the fiber of the covered region is integrally formed in the outer surface of the single flexible tube so as to form a unitary structure". For the purpose of examination, the examiner will interpret the limitation as "wherein the covered region and non- covered region are integrally formed
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 Bousquet (US. 5882341) in view of Kitrilakis et al. (US. 3699956) (“Kitrilakis”).
Re Claim 1, Bousquet discloses a holding mechanism assembly (abstract, Fig. 1-3) comprising: a tubular inserting member (42, 44) comprising one end configured for arrangement inside a living body (lower end of 44g under the skin 36, Fig. 2) and another end configured for arrangement outside of the living body (top end of 42); a fixing device (16, 10) having a fixing portion (10 including 14) configured for fixation beneath a skin of the living body (Fig. 2, Col. 3, lines 25-35) and a communicating portion (neck of 16) where the inserting member is insertable (12, Fig. 1, has the lumen for the tubular member 44, 42); and a holding structure (24, 22), wherein the communicating portion has a first opening (top opening of 25) opened toward the outside of the living body when the fixing device is fixed beneath the skin (Fig. 1); a second opening ( lower end of the passage 16) opened toward the inside of the living body when the fixing device is fixed beneath the skin (Fig. 2); and a communication path formed between the first opening and the second opening ( passage of in 16, 22, Figs. 1-2); and a space between an inner wall of the communicating portion (space within 16 and 44b) at the second opening side of the communication path and outer surface of the inserting member outer surface of 44) defines a portion the communication path (Fig. 2); and the outer surface of the inserting member has a non-covered region not covered with the fiber (portion of 44b within 16) and the non-covered region of the inserting extends between the holding structure and the second opening in the communication path (from 25 to the lower end of 16), but it fails to specifically disclose that the holding structure provided in the communicating portion to hold the inserting member to the fixing device in a liquid tight manner, the inserting member is configured as a single flexible tube configured to penetrate through the fixing device and the holding structure 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 and the outer surface of the inserting member has a covered region covered with the fiber that guide the cell; the covered region and the non-covered region are regions 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 holding structure and the second opening in the communication path 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 Bousquet to include a covered portion so that the holding structure provided in the communicating portion to hold the inserting member to the fixing device in a liquid tight manner, the inserting member is configured as a single flexible tube configured to penetrate through the fixing device and the holding structure 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 and the outer surface of the inserting member has a covered region covered with the fiber that guide the cell; the covered region and the non-covered region are regions 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 holding structure and the second opening in the communication path 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, Bousquet discloses wherein the non-covered region is formed with a smooth curved surface (surface portion of 44).
Re Claim 3, Bousquet 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 Bousquet 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, Bousquet 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 Bousquet 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).
Re Claim 4, Bousquet fails to disclose wherein the covered region is integrally formed in the outer surface of the single flexible tube so as to form a unitary structure.
However, Kitrilakis discloses an implantable access device (Fig. 1-12) and wherein the covered region is integrally formed in the outer surface of the single flexible tube so as to form a unitary structure (Fig. 1-2, 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 Bousquet so that the covered region is integrally formed in the outer surface of the single flexible tube so as to form a unitary structure 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 11/18/2025 with respect to the rejection(s) of claim(s) 1 under 103 using Bousquetin view of Porter and regards to the covered region and location of the cover region 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 Bousquet in view of Kitrilakis.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783