CTNF 18/448,278 CTNF 83718 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. Information Disclosure Statement The information disclosure statement (IDS) submitted on 08/11/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 05/04/2026 is acknowledged. 08-06 AIA Claim s 8-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026 . 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claims 1-7 are r ejected under 35 U.S.C. 103 as being unpatentable over K arnieli US 2019/0211294. R egarding claim 1 , Karnieli discloses a culture vessel ( bioreactor 10/1110 and first chamber 1114A ) comprising: a bottom part (see Figs. 12A reproduced below and 12B); and a wall part having a culture medium inlet ( port 11127A ) and comprising a deformable portion ( tiltable perforated barrier 12/1112 ) [0329-0331]. As to the bottom part being rigid, Karnieli does not expressly disclose that the bottom part is rigid. However, Karnieli does discloses that According to some embodiments, the bioreactor 10 can be made from any suitable biocompatible material known in the art, such as a suitably biocompatible plastic or polymer based material. In some embodiments, the reactor 10 is made from a transparent material to enable an operator to see the contents of the bioreactor 10. In some embodiments, non-limiting examples of materials that can be used in the construction of the bioreactor 10 include but are not limited to, polystyrene , stainless steel , polyetheretherketone (PEEK) , polysulfone, and various types of polytetrafluoroethylene (PTFE) plastics, for example Rulon®. In some embodiments, materials for use in the construction of a bioreactor described herein are selected based on their low coefficient of friction, excellent abrasion resistance, Gamma radiation sterilization, wide range of operating temperatures, or chemical inertness, or any combination thereof [0192]. Further, A skilled artisan would recognize that other methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments disclosed herein. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting [0185]. Absent unexpected results, it would have been obvious to one having ordinary skill in the art to provide a rigid bottom part, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. The culture vessel of Karnieli is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Karnieli is capable allowing the deformable portion to deform so as to change a capacity of the culture vessel when a pressure of an internal space of the culture vessel varies. See MPEP § 2114. PNG media_image1.png 384 626 media_image1.png Greyscale Regarding claim 2 , Karnieli discloses wherein the bottom part has a light transmitting property ( In some embodiments, the reactor 10 is made from a transparent material to enable an operator to see the contents of the bioreactor 10.) [0117 and 0192]. Regarding claim 3 , Karnieli discloses wherein the deformable portion is an elastic member ( In some embodiments, the types of materials from which the perforated barriers can be made can include but are not limited to aliphatic or semi-aromaticpolyamides—for example Nylon®, and polyethylene.) [0194]. Regarding claim 4 , Karnieli discloses that According to some embodiments, the bioreactor 10 can be made from any suitable biocompatible material known in the art, such as a suitably biocompatible plastic or polymer based material. In some embodiments, the reactor 10 is made from a transparent material to enable an operator to see the contents of the bioreactor 10. In some embodiments, non-limiting examples of materials that can be used in the construction of the bioreactor 10 include but are not limited to, polystyrene , stainless steel , polyetheretherketone (PEEK) , polysulfone, and various types of polytetrafluoroethylene (PTFE) plastics, for example Rulon®. In some embodiments, materials for use in the construction of a bioreactor described herein are selected based on their low coefficient of friction, excellent abrasion resistance, Gamma radiation sterilization, wide range of operating temperatures, or chemical inertness, or any combination thereof [0192]. Further, A skilled artisan would recognize that other methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments disclosed herein. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting [0185]. Absent unexpected results, it would have been obvious to one having ordinary skill in the art to provide a ratio E1/E2 of an elastic modulus E1 of the deformable portion to an elastic modulus E2 of the bottom part is 0.1 or lower, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. Regarding claim 5 , Karnieli discloses wherein the deformable portion is recessed toward the internal space as shown Fig. 12B. Regarding claim 6 , claim 6 has been interpreted as a closed container with an internal volume. Karnieli discloses a closed container ( bioreactor 10/1110 and first chamber 1114A ) with an internal volume as shown Figs. 12A reproduced below and 12B, i.e., wherein the wall part comprises a top part facing the bottom part, and a side part between the bottom part and the top part, the top part comprising the deformable portion. PNG media_image2.png 384 626 media_image2.png Greyscale Regarding claim 7 , Karnieli discloses wherein the top part further comprises a portion ( annular member 1113 ) [0329 and 0331]. While Karnieli does not expressly disclose that the annular is rigid, Karnieli does disclose that According to some embodiments, the bioreactor 10 can be made from any suitable biocompatible material known in the art, such as a suitably biocompatible plastic or polymer based material. In some embodiments, the reactor 10 is made from a transparent material to enable an operator to see the contents of the bioreactor 10. In some embodiments, non-limiting examples of materials that can be used in the construction of the bioreactor 10 include but are not limited to, polystyrene , stainless steel , polyetheretherketone (PEEK) , polysulfone, and various types of polytetrafluoroethylene (PTFE) plastics, for example Rulon®. In some embodiments, materials for use in the construction of a bioreactor described herein are selected based on their low coefficient of friction, excellent abrasion resistance, Gamma radiation sterilization, wide range of operating temperatures, or chemical inertness, or any combination thereof [0192]. Further, A skilled artisan would recognize that other methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments disclosed herein. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting [0185]. Absent unexpected results, it would have been obvious to one having ordinary skill in the art to provide a rigid annular portion, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07 . 07-21-aia AIA Claim s 1-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Welch et al. (hereinafter Welch) US 2009/0272748 . Regarding claim 1 , Welch discloses a culture vessel ( cell container 710 and cell compartment 741 ) comprising: a bottom part (see Figs. 7A reproduced below and 7C); and a wall part having a culture medium inlet ( septum 772 ) and comprising a deformable portion ( fluid displacement member 732 ) [0071-0072]. As to the bottom part being rigid, Welch does not expressly disclose that the bottom part is rigid. However, Welch does disclose Skilled artisans will recognize that a wide variety of published information is available for guidance in the specific choice of material selection for various aspects, features, or components of the present invention. All materials used for cell culture devices or for containers that house biological materials are options. USP Class VI materials that can be gamma irradiated are preferred [0082]. Therefore, absent unexpected results, it would have been obvious to one having ordinary skill in the art to provide a rigid bottom part, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. The culture vessel of Welch is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Welch is capable allowing the deformable portion to deform so as to change a capacity of the culture vessel when a pressure of an internal space of the culture vessel varies [0059 and 0065]. See MPEP § 2114. PNG media_image3.png 322 298 media_image3.png Greyscale Regarding claim 2 , Welch does not expressly disclose that wherein the bottom part has a light transmitting property. However, Welch does disclose Skilled artisans will recognize that a wide variety of published information is available for guidance in the specific choice of material selection for various aspects, features, or components of the present invention. All materials used for cell culture devices or for containers that house biological materials are options. USP Class VI materials that can be gamma irradiated are preferred [0082]. Therefore, absent unexpected results, it would have been obvious to one having ordinary skill in the art to provide a bottom part that has a light transmitting property, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP §2144.07. Regarding claim 3 , Welch discloses wherein the deformable portion is an elastic member [0071]. Regarding claim 6 , claim 6 has been interpreted as a closed container with an internal volume. Welch discloses a closed container ( cell container 710 and cell compartment 741 ) with an internal volume as shown Figs. 7A reproduced above, i.e., wherein the wall part comprises a top part facing the bottom part, and a side part between the bottom part and the top part, the top part comprising the deformable portion. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 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, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LYDIA EDWARDS/Primary Examiner, Art Unit 1796 Application/Control Number: 18/448,278 Page 2 Art Unit: 1796 Application/Control Number: 18/448,278 Page 3 Art Unit: 1796 Application/Control Number: 18/448,278 Page 4 Art Unit: 1796 Application/Control Number: 18/448,278 Page 5 Art Unit: 1796 Application/Control Number: 18/448,278 Page 6 Art Unit: 1796 Application/Control Number: 18/448,278 Page 7 Art Unit: 1796 Application/Control Number: 18/448,278 Page 8 Art Unit: 1796 Application/Control Number: 18/448,278 Page 9 Art Unit: 1796
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