CTNF 18/518,973 CTNF 91138 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-34 AIA Claim s 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-15 of U.S. Patent No. 12208229B1 . Although the claims at issue are not identical, they are not patentably distinct from each other because - claim 1 recites the limitation a method of connecting a first tubing to a second tubing for aseptic fluid transfer (Patent, Claim 1, Col. 6, lines 37-67), comprising: placing the first tubing within a first channel and the second tubing within an opposing channel (Patent, Claim 1, Col. 6, lines 37-67); attaching a male connector to a female connector (Patent, Claim 1, Col. 6, lines 37-67); attaching a first tape with adhesive on one surface to a portion of the first tubing (Patent, Claim 1, Col. 6, lines 37-67); attaching the second tape with adhesive on one side to a portion of the second tubing (Patent, Claim 1, Col. 6, lines 37-67), wherein the second tape has sufficient length to extend past the distal end of the female connector and placing the mating surfaces of the holders (Patent, Claim 1, Col. 7, lines 1-6). Claim 1 of the current application is border that claim of the patent as it is has no tape adhesive on tape that extend from the end of the connectors. Also, the limitation of claims 2-18 of the current application can be found in claims 1-15 of the patent such as: claim 2 ( Patent, Claim 2), claim 3 (Patent, Claim 1), claim 4 (Patent, Claim 4), claim 5 (Patent, Claim 5), claim 6 (Patent, Claim 6), claim 7 (Patent, Claim 7), claim 8 (Patent, Claim 8), claim 9 (Patent, Claim 9), claim 10 (Patent, Claim 10), claim 11(Patent, Claim 11), claim 12 (Patent, Claim 12), claim 13 ( Patent, Claim 13), claim 14 (Patent, Claim 1), claim 15 (Patent, Claim 1), claim 16 (Patent, Claim 1), claim 17 (Patent, Claim 13), claim 18 (Patent, Claim 18) . Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-18 are 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 1 recites the limitation "a tapered distal end" in line 8. It is unclear if it is referring to the limitation in line 6 of claim 1 or it is referring to the new limitation. For the purpose of examination, the examiner will inter pert the limitation as it is referring to the limitation in claim 1, line 6. 07-34-05 AIA Claim 1 recites the limitation " the mating surfaces of the holders and puling the ends of the first tape and the second tape " in lines 24-25 . There is insufficient antecedent basis for this limitation in the claim. Claim 3 recites the limitation "a first holder…and a second holder" in lines 1-2. It is unclear if it is referring to the limitation in line 24 of claim 1 or it is referring to the new limitation. For the purpose of examination, the examiner will inter pert the limitation as it is referring to the limitation in claim 1, line 24. Claim 7 recites the limitation "a robotic mechanism" in lines 1-2. It is unclear if it is referring to the limitation in line 1 of claim 6 or it is referring to the new limitation. For the purpose of examination, the examiner will inter pert the limitation as it is referring to the limitation in claim 6, line 1. Claim 9 recites the limitation " a flexible layer on the mating surfaces…form a seal " in lines 1-2. It is unclear if it is referring to the limitation in line 26 of claim 1 or it is referring to the new limitation. For the purpose of examination, the examiner will inter pert the limitation as it is referring to the limitation in claim 1, line 26. 07-34-05 AIA Claim 16 recites the limitation " the flexible layer/layers " in lines 24-25 . There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 3-4, 6-7, 9-16 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tenczar (US. 4019512) . Re Claim 1 , Tenczar discloses a method (abstract, Figs. 1-11) of connecting a first tubing (16) to a second tubing (23) for aseptic fluid transfer (abstract), comprising: placing the first tubing (16) within a first channel (channel 14) and the second tubing (23) within an opposing channel (channel of 12); attaching a male connector (18, Col. 3, lines 40-45) having a central bore (Fig. 4) and a tapered end (bore of 18, Fig. 2, 8) to a female connector ( 24, 25) having a central bore (bore of 25) that is an elastic material (flex layer such as 34, Fig. 1, Fig. 8), wherein the male connector has a tapered distal end (18) furthest from the first tubing when the first tubing is connected to a proximal end of the male connector (close to 26, Fig. 8) and the female connector has a distal end (close to 29) furthest from the second tubing when a proximal end of the female connector (close to 38, Fig. 2) is connected with the second tubing (Fig. 2); attaching a first tape (right portion of 60, Col. 5, lines 20-26) with adhesive on one surface (61) to a portion of the first tubing (Fig. 2), wherein the first tape has sufficient length to extend past the distal end of the male connector (Fig. 2); attaching the second tape (left 60) with adhesive on one side (56) to a portion of the second tubing (Fig. 2, Col. 5, lines 20-26), wherein the second tape has sufficient length to extend past the distal end of the female connector (Fig. 2); and placing the mating surfaces of the holders (21 and 50, Fig. 1-2) adjacent and pulling the ends of the first tape and the second tape ( Fig. 6) such that the male connector is pulled inside the female connector and forms a seal and provides a fluid connection from the first tubing to the second tubing (Fig. 8, Col. 3, lines 17-30). Re Claim 3, Tenczar discloses further including a first holder (21) containing the first channel (Fig. 1) and a second holder (12) containing the opposing channel (Fig. 1) and fastening the first holder and the second holder using bolts, screws, magnets, straps, elastic straps or adhesive, or opposed fixtures which twist and lock together ((pin 21b, groove 52, Fig. 2 are opposed fixture twist and lock together, Col. 4, lines 64- 68, Col. 5, lines 1-10). Re Claim 4, Tenczar discloses wherein a visual, auditory or tactile feedback indicates when the connection is made (visual or tactile indication as 21a reaches the end of 52). Re Claim 6, Tenczar discloses further comprising a mechanism to pull the ends of the first tape and the second tapes to establish the connection (clamping means Col. 1, lines 48-52). Re Claim 7, Tenczar discloses further comprising a robotic mechanism that automatically pulls the ends of the first tape and the second tape to establish the connection (clamping means Col. 1, lines 48-52). Re Claim 9, Tenczar discloses wherein the first and second holders include a flexible layer (53) on the mating surfaces, which are pressed together to form a seal (Col. 5, lines 10-25). Re Claim 10, Tenczar discloses wherein the connection is made or broken autonomously, triggered by a detected external event (rotating he tube so 21bis inserted in 52). Re Claim 11, Tenczar discloses further comprising an autonomous sterilisation procedure (Col. 5, lines 34-45, abstract). Re Claim 12, Tenczar discloses wherein the method is used in applications that require the connection between tubing be performed in a controlled environment (Col. 5, lines 34-45, abstract). Re Claim 13, Tenczar discloses wherein the applications include: cell and gene therapy applications, stem cell therapy, regenerative medicine and tissue engineering applications, cell banking applications, pharmaceutical manufacturing applications, bio-manufacturing and biotechnology research applications, cell expansion applications, cell culture bioprocessing applications, and chemical processing applications (Col. 6, lines 42-48 such as blood transfer, abstract). Re Claim 14, Tenczar discloses wherein the first tape has no adhesive on the surfaces which extend from the end of the male connector to the end of the first tape ( close to the finger , there is no adhesive). Re Claim 15, Tenczar discloses wherein the second tape has no adhesive on the surfaces which extend from the end of the female connector to the end of the second tape (close to the finger , there is no adhesive). Re Claim 16, Tenczar discloses wherein the elastic material is formed from flexible layer/layers (34, Col. 4, line 15) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tenczar in view of Kellogg (US. 4418945) . Re Claim 2, Tenczar fails to disclose further including attaching a third tape with adhesive on one surface to a portion of the male connector and to a portion of the first tubing such that said third tape opposes said first tape, and adhering the adhesive surface of said third tape to the opposed adhesive surface of the first tape; attaching a fourth tape with adhesive on one surface to a portion of the female connector and a portion of the second tubing such that said fourth tape opposes said second tape, and adhering the adhesive surface of said fourth tape to the opposed adhesive surface of the second tap; pulling the ends of the first tape and the third tape apart and pulling the ends of the second tape and the fourth tape apart so that the male connector is pulled inside the female connector. However, Kellogg discloses a method of connecting tubings (abstract, Figs. 11-13) including attaching a third tape (13 tape attaches to left 16 on top side) with adhesive on one surface to a portion of the male connector (left 1, Fig. 11) and to a portion of the first tubing (left 16 on right side) such that said third tape opposes said first tape (left 15), and adhering the adhesive surface of said third tape to the opposed adhesive surface of the first tape (Col. 4, lines 25-40, Fig. 11); attaching a fourth tape (13 tape attaches to right 16 on lower side) with adhesive on one surface to a portion of the female connector (right 1) and a portion of the second tubing such that said fourth tape opposes said second tape (right 16 on the left side), and adhering the adhesive surface of said fourth tape to the opposed adhesive surface of the second tap (right 15); pulling the ends of the first tape and the third tape apart (left and top 20, 12) and pulling the ends of the second tape and the fourth tape apart so that the male connector is pulled inside the female connector lower 12 and right 20, Col. 6, line 60 up to Col 7 lines 10). Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify method of Tenczar to include including attaching a third tape with adhesive on one surface to a portion of the male connector and to a portion of the first tubing such that said third tape opposes said first tape, and adhering the adhesive surface of said third tape to the opposed adhesive surface of the first tape; attaching a fourth tape with adhesive on one surface to a portion of the female connector and a portion of the second tubing such that said fourth tape opposes said second tape, and adhering the adhesive surface of said fourth tape to the opposed adhesive surface of the second tap; pulling the ends of the first tape and the third tape apart and pulling the ends of the second tape and the fourth tape apart so that the male connector is pulled inside the female connector as taught by Kellogg for the purpose of keeping the tube in a sterilized status in an art recognized sterilization (Kellogg, Col. 6, line 60 up to Col 7 lines 10) . 07-21-aia AIA Claim (s) 5, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tenczar in view of Johnson et al. (US. 20030030272A1) ("Johnson") . Re Claim 5, Tenczar fails to disclose a pinch valve on the first or second tubing to prevent fluid flow to the male or female connector before the connection is made. However, Johnson discloses a pinch valve on the first or second tubing to prevent fluid flow to the male or female connector before a connection is made (Fig. 6, 200 valve, tube 190). Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify method of Tenczar to include a pinch valve on the first or second tubing to prevent fluid flow to the male or female connector before a connection is made as taught by Johnson for the purpose of keeping the tube in a sterilized status (Johnson, ¶0081). Re Claim 17, Tenczar fails to disclose a secondary sterilisation procedure using an aerosolized or gaseous sterilisation applied to the connector to further reduce the risk of contamination. However, Johnson discloses connected tube comprising a secondary sterilisation procedure using an aerosolized or gaseous sterilisation applied to the connector to further reduce the risk of contamination (¶0081). Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify method of Tenczar to include a secondary sterilisation procedure using an aerosolized or gaseous sterilisation applied to the connector to further reduce the risk of contamination as taught by Johnson for the purpose of keeping the tube in a sterilized status in an art recognized sterilization (Johnson, ¶0081). Re Claim 18, Tenczar fails to disclose wherein sterilisation is performed using steam, atomised ethanol or ethylene gas. However, Johnson discloses connected tube comprising sterilisation is performed using steam, atomised ethanol or ethylene gas (¶0081). Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify method of Tenczar so that sterilisation is performed using steam, atomised ethanol or ethylene gas as taught by Johnson for the purpose of keeping the tube in a sterilized status in an art recognized sterilization (Johnson, ¶0081) . 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tenczar in view of Faldt et al. (US. 10946183B2) ("Faldt") . Re Claim 8 , Tenczar fails to disclose a plurality of first and second tubings to form multiple fluid networks. However, Faldt discloses a multiple connector together to join multiple fluid networks at once (Fig. 1, 120 tubes and 126 connectors, abstract). Thus, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have modify method of Tenczar to have plurality of first and second tubings to form multiple fluid networks as taught by Faldt for the purpose connecting multiple lines together for multiple fluid flow at once (Faldt, Col. 4, lines 50-65). 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). 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 Application/Control Number: 18/518,973 Page 2 Art Unit: 3783 Application/Control Number: 18/518,973 Page 3 Art Unit: 3783 Application/Control Number: 18/518,973 Page 4 Art Unit: 3783 Application/Control Number: 18/518,973 Page 5 Art Unit: 3783 Application/Control Number: 18/518,973 Page 6 Art Unit: 3783 Application/Control Number: 18/518,973 Page 7 Art Unit: 3783 Application/Control Number: 18/518,973 Page 8 Art Unit: 3783 Application/Control Number: 18/518,973 Page 9 Art Unit: 3783 Application/Control Number: 18/518,973 Page 10 Art Unit: 3783 Application/Control Number: 18/518,973 Page 11 Art Unit: 3783