CTNF 18/223,329 CTNF 83718 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 statements (IDS) submitted on 07/18/2023 and 04/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Election/Restrictions 08-25 AIA Applicant’s election with traverse of Group I, claims 1-13 in the reply filed on 12/10/2025 is acknowledged. The traversal is on the ground(s) that claims 1-20 are related to a single general inventive concept . This is not found persuasive because the fact that applicant has described a preferred manner in which the method of claim 18 can be interpreted does not preclude the fact that the method of claim 18 can still be used with a materially different device . The requirement is still deemed proper and is therefore made FINAL. 08-05 AIA Claim s 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/10/2025 . 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 1-13 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. Regarding claim 1, a vessel does not appear to be positively recited and thus claimed as part of the apparatus. It is unclear if the claim actually recites the inclusion of the vessel. Further, a sensor does not appear to be positively recited and thus claimed as part of the apparatus. It is unclear if the claim actually recites the inclusion of the sensor. Lastly, a bioprocessing device does not appear to be positively recited and thus claimed as part of the apparatus. It is unclear if the claim actually recites the inclusion of the bioprocessing device. Claims 2-13 depend on independent claim 1 and are therefore, rejected for the same reason. 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 Claim s 1-2, and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Barnfield Frej et al. (hereinafter Barnfield Frej ) US 2012/0291238 . Regarding claim 1 , Barnfield Frej discloses an apparatus for facilitating use of a sensor ( sensor 13 ) with a vessel ( bioreactor 1 ) comprising: a body having an upper portion [31] and a lower portion [33] ( According to the invention the sensor holding part 11 comprises two parts. One bag attachment part 31 adapted to be welded to the bag and one sensor attachment part 33 where the sensor 13 is provided. ), the body comprising: a sensor recess ( opening 34 ) formed in the upper portion of the body [0026-0027], the sensor recess configured to receive a sensor so that the sensor is at least partially recessed within the body as shown in Figs. 3a, 3b and 3c; wherein, in use, the body is situated between the surface of the bioprocessing device and the vessel as shown in Fig. 1b. See [0022, 0030, 0031 and 0033]; also see whole document. Further, the body of Barnfield Frej is capable of being selectively placed on a surface of a bioprocessing device as shown in Fig. 1b via adaptor part 41. The body of Barnfield Frej extends along the bottom the bioreactor as shown in Fig. 1b. However, the body does not extend across substantially an entire width of the entire vessel. Since providing the body with a width that extends across substantially an entire width of the entire vessel would only require a mere change in the size (or dimension) of a component which is generally recognized as being within the level of ordinary skill in the art, a mere change in size or dimension of the device, i.e. width, would have been prima facie obvious to one of ordinary skill in the art. Furthermore, where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device. See MPEP §2144.04 (IV)(A). As to the body allowing for retention of liquid in the vessel in proximity to the sensor, facilitating use of the sensor with low vessel fill levels the device disclosed by Barnfield Frej is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Barnfield Frej is capable of providing the claimed operating conditions. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . Regarding claim 2 , Barnfield Frej discloses wherein the surface of the bioprocessing device is a tray as shown in Fig. 1b configured for attachment to a platform of the bioprocessing device that is capable of rocking ( rocking support structure 3 , [0022]) about an axis to facilitate a bioprocessing procedure within the vessel. Regarding claim 5 , Barnfield Frej discloses wherein the upper portion [31] of the body includes a first angled surface and a second angled surface, the first angled surface including the sensor recess [34] as shown in Fig. 3c reproduced below. Also see [0026-0027]; and Fig. 3a. PNG media_image1.png 526 852 media_image1.png Greyscale As wherein, in use, the body is located proximate to a first end of the surface of the bioprocessing device with the first angled surface facing the first end of the surface of the bioprocessing device and the second angled surface facing a second end of the surface of the bioprocessing device, opposite the first end, the device disclosed by Barnfield Frej is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Barnfield Frej is capable of providing the claimed operating conditions. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . Regarding claim 6 , Barnfield Frej does not explicitly disclose the claimed body shape i.e., wherein the body has a substantially triangular profile or cross-section with a substantially obtuse angle between the first angled surface and the second angled surface. However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed body was significant. See MPEP §2144.04 (IV)(B). Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent body shape and since the same expected sensor use would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration. Regarding claim 7 , Barnfield Frej does not explicitly disclose the claimed body shape i.e., wherein the first angled surface is at an angle of approximately 15 degrees from the surface of the bioprocessing device. However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed body was significant. See MPEP §2144.04 (IV)(B). Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent body shape and since the same expected sensor use would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration. Regarding claim 8 , Barnfield Frej discloses wherein the upper portion of the body includes an angled surface, the angled surface including the sensor recess ( opening 34 in the bag attachment part 31 ) as shown in Fig. 3c reproduced below. Also see [0026-0027]; and Fig. 3a. PNG media_image2.png 526 852 media_image2.png Greyscale As wherein, wherein, in use, the body is located proximate to a first end of the surface of the bioprocessing device and the angled surface is facing a second end of the surface of the bioprocessing device, opposite the first end, the device disclosed by Barnfield Frej is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Barnfield Frej is capable of providing the claimed operating conditions. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . Regarding claim 9 , Barnfield Frej does not explicitly disclose the claimed body shape i.e., wherein the body has a profile or cross section of a substantially right triangle with a longest side of the triangle being the angled surface having the sensor recess. However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed body was significant. See MPEP §2144.04 (IV)(B). Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent body shape and since the same expected sensor use would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration. Regarding claim 10 , Barnfield Frej does not explicitly disclose the claimed body shape i.e., wherein the angled surface is at an angle of approximately 15 degrees from the surface of the bioprocessing device. However, the shape of a device component has been held to be a matter of design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed body was significant. See MPEP §2144.04 (IV)(B). Therefore, one having ordinary skill in the art would have found it obvious to make such a change as a mere alternative and functionally equivalent body shape and since the same expected sensor use would have been achieved. The use of alternative and functionally equivalent shapes would have been desirable to those of ordinary skill in the art based on the desired device configuration. Regarding claims 11, as to wherein the low vessel fill level is less than approximately 50 percent of a total volume of the vessel, the device disclosed by Barnfield Frej is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Barnfield Frej is capable of providing the claimed operating conditions. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . Regarding claim 12 , Barnfield Frej discloses wherein the lower portion of the body includes an attachment mechanism for securing the body to the surface of the bioprocessing device ( In FIG. 4a it is shown how the first locking means 17 a, b, c, d of the sensor holding part 11 are fitted into second locking means 43 a, b, c, d, in the adaptor part 41 in a non locked position . [0033]). Regarding claims 13, as to wherein the sensor recess is formed to allow a first portion of the sensor located within the sensor recess to be rotated so that it can be aligned with and engage a second portion of the sensor that is fixed to the vessel, the device disclosed by Barnfield Frej is structurally the same as the instantly claimed. Thus, in the absence of further positively recited structure the device of Barnfield Frej is capable of providing the claimed operating conditions. Further, it is noted that apparatus claims cover what a device is, not what a device does or how it is to be used. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP § 2114 . 07-22-aia AIA Claim s 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Barnfield Frej et al. (hereinafter Barnfield Frej) US 2012/0291238 as applied to claim s 1-2 and 5-13 above, and further in view of Bruninghaus et al. (hereinafter Bruninghaus) US 2015/0353896 . Regarding claim 3 , Barnfield Frej does not explicitly disclose wherein the sensor is a viable cell density sensor. Barnfield Frej does not explicitly disclose wherein the sensor in the sensor recess is a first portion of a viable cell density sensor that is configured to selectively engage a second portion of a viable cell density sensor that is fixed to the vessel. Bruninghaus discloses a bioreactor comprising a viable cell density sensor [0163]. It would have been obvious to one of ordinary skill in the art to modify Barnfield Frej with a viable cell density sensor as taught by Bruninghaus in order to detect early-stage process deviations. Regarding claim 4 , Barnfield Frej discloses wherein the vessel is a bioreactor bag [0038]. However, Barnfield Frej does not expressly disclose that the bioreactor bag is single-use. Bruninghaus discloses a single-use bioreactor bag [0013, 0061 and 0073]. 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: 18/223,329 Page 2 Art Unit: 1796 Application/Control Number: 18/223,329 Page 3 Art Unit: 1796 Application/Control Number: 18/223,329 Page 4 Art Unit: 1796 Application/Control Number: 18/223,329 Page 5 Art Unit: 1796 Application/Control Number: 18/223,329 Page 6 Art Unit: 1796 Application/Control Number: 18/223,329 Page 7 Art Unit: 1796 Application/Control Number: 18/223,329 Page 8 Art Unit: 1796 Application/Control Number: 18/223,329 Page 9 Art Unit: 1796 Application/Control Number: 18/223,329 Page 10 Art Unit: 1796 Application/Control Number: 18/223,329 Page 11 Art Unit: 1796 Application/Control Number: 18/223,329 Page 12 Art Unit: 1796