CTNF 18/573,196 CTNF 101318 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. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) filed on 2/19/2024 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Drawings 06-22-06 AIA The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Connector tube 340 in [0053] is absent from Fig. 3 . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 1-6, 9, 14, 16, 17-19, 21, 23, 25-27, 29, 30, and 34 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, the limitations “a cylindrical body” and “wherein the top surface and bottom surface are substantially oval-shaped” render the claim indefinite. It is unclear if the recited sparging elements are cylindrical or ovular in shape, as a standard cylinder is defined by a circular base. Additionally, it is unclear if the benchtop bioreactor is intended to be positively recited. The benchtop bioreactor is simultaneously recited in the intended use of the macrosparger, but the interior of a benchtop bioreactor is positively recited. Subsequent dependent claims of claim 1 are similarly rejected. Claim 3 recites the limitation "the compartment" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination on the merits, the compartment will be interpreted as the internal compartment . Each of claims 26, 30, and 34 recite the limitation “the bioreactor”. There is insufficient antecedent basis for this limitation in the claims. For examination on the merits, the bioreactor will be interpreted as the benchtop bioreactor . 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 1-3, 6, 16, 18, 19, 21, 23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh (EP 0407180 A2) (see PTO-892, copy provided) . Regarding claim 1, Satoh in the art of spargers discloses a macrosparger (abstract, “gas sparger unit”) comprising: a tubing (Fig. 3, gas inlet tube 4 – see annotated figure below); and a base comprising a plurality of sparging elements (Fig. 3 shows base comprising plurality of gas sparger boxes 3, i.e., sparging elements – see annotated figure below) in gaseous communication with the tubing (Fig. 3, gas inlet tube 4 connected with sparging elements 3) and an interior of a bioreactor (p. 2, lines 9-10 disclose it is usable for culturing, i.e., a bioreactor), each sparging element comprising: a cylindrical body having an internal compartment formed by a top surface and a bottom surface, the top surface and bottom surface connected by a sidewall (Fig. 1 – see figure below). PNG media_image1.png 475 324 media_image1.png Greyscale PNG media_image2.png 337 337 media_image2.png Greyscale The limitation in the preamble “for a benchtop bioreactor” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II). Regarding the limitation “wherein the bioreactor is a benchtop bioreactor”, modifying the size of Satoh’s gas sparger unit such that it is compatible with a benchtop bioreactor would merely amount to a change in proportion. It has been held that that changes in proportion are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A). The gas sparger unit of Satoh would perform the same function of introducing gas into a liquid, only at a different scale. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the proportions of the prior art sparger to fit in a benchtop bioreactor. Regarding the limitation “wherein the top surface and bottom surface are substantially oval-shaped”, Satoh is silent to the surfaces being substantially oval-shaped. However, modifying the shape of the top and bottom surface such that they are substantially oval-shaped would merely amount to a change in shape. It has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP § 2144.04 IV B). Regarding claim 2, Satoh teaches the macrosparger of claim 1, wherein the top surface and bottom surface are substantially flat (Figs. 1 and 3 shows flat top and bottom surfaces). Regarding claim 3, Satoh teaches the macrosparger of claim 1, wherein the top surface comprises a plurality of openings (Fig. 1, shows that perforated plate 1 has openings), the compartment in gaseous communication with the interior of the benchtop bioreactor through the plurality of openings (claim 1). Regarding claim 6, Satoh teaches the macrosparger of claim 1, wherein the tubing is in gaseous communication with the sparging elements and a gas supply source (abstract implicitly discloses gas supply source, “the upper surface of which is provided with perforations through which the gas is bubbled, communicating with the gas inlet tube”). Regarding claim 16, Satoh teaches macrosparger of claim 1, wherein each sparging element is interchangeable (Fig. 1 shows that gas sparger box 3 is removable, i.e., interchangeable). Regarding claim 18, Satoh teaches the macrosparger of claim 1. Satoh discloses that the gas sparger unit, i.e., macrosparger, is capable of use in a vessel of 3.5 m 3 (pg. 4, lines 9-10). Although Satoh does not teach the volume claimed, modifying the size of the vessel, i.e., benchtop bioreactor, such that it meets the claimed size would merely amount to a change in size. Modifying the macrosparger such that it is capable of use in a vessel of the claimed size would also merely amount to a change in size. It has been held that that changes in size are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A). Regarding claim 19, 21, and 23, such claims are directed to the size and proportion of the claimed apparatus. Although the prior art of record fails to meet the claimed size or proportion, forming the gas sparger box with the claimed dimensions would merely amount to a change in size or proportion. It has been held that that changes in proportion are not sufficient to patentably distinguish over the prior art (MPEP § 2144.04 IV A). Regarding claim 30, such claims are directed toward the intended manner of operating the claimed tubing and does not differentiate the claimed tubing from the prior art tubing because all structural limitations are taught in the prior art (MPEP § 2114 II). The tubing disclosed by Satoh would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure (MPEP § 2112.01 I) . 07-22-aia AIA Claim s 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh as applied to claim 1 above, and further in view of Castan et al. (US 2022/0234012 A1 – Family member of WO 2020/234425, copy provided) (see PTO-892; hereinafter referred to as Castan) . Regarding claim 4, Satoh teaches the macrosparger of claim 1. Satoh is silent to each of the openings in the plurality of openings being uniformly spaced on the top surface. However, Castan in the art of spargers for bioprocessing teaches it is known in the art to form spargers with a plurality of uniform openings on a top surface ([0075], “all openings, holes or pores are at equal distances from adjacent openings, holes or pores”; Figs. 21 and 25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the macrosparger of Satoh to form each of the openings in the plurality of openings such that they are uniformly spaced on the top surface, as taught by Castan. One of ordinary skill in the art would have found a reasonable expectation of success in such a modification, as the modification is well known in the art. Regarding claim 5, Satoh teaches the macrosparger of claim 1. Satoh does not teach wherein the top surface and bottom surface of each sparging element are configured to be parallel with a bottom of the benchtop bioreactor. However, Castan in the art of spargers for bioprocessing teaches it is known in the art to form spargers wherein a top surface and bottom surface of a sparging element is parallel. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the macrosparger of Satoh to form the top surface and bottom surface of each sparging element parallel to one another. One of ordinary skill in the art would have found a reasonable expectation of success in such a modification, as the modification is well known in the art. Regarding the limitation “configured to be parallel with a bottom of the benchtop bioreactor”, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). Modifying the prior art combination macrosparger such that the top surface and bottom surface of each sparging element are configured to be parallel with a bottom of the benchtop bioreactor would amount to merely rearrangement of parts, as such a modification would predictably result in the macrosparger providing gas to the benchtop bioreactor . 07-22-aia AIA Claim s 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh as applied to claim 1 above, and further in view of Ludwig et al. (US 2011/0013474 A1) (see PTO-892; hereinafter referred to as Ludwig) . Regarding claim 9, Satoh teaches the macrosparger of claim 1, wherein the base comprises a connector tube connects two sparging elements to each other (Fig. 3, two-way manifold 5). Satoh is silent to a first portion which is substantially vertical and a second portion which is substantially horizontal, wherein the second portion connects to the base, wherein the connector tube connects two sparging elements to the second portion, the connector tube intersecting the second portion, and wherein the second portion connects to a sparging element. However, Ludwig teaches that it is known in the art to form tubing with a substantially vertical portion, i.e., first portion (Fig. 5, first portion shown – see annotated figure below), a substantially horizontal portion connected to a base of a sparger, i.e., second portion connected to the base (Fig. 5, second portion and base shown). PNG media_image3.png 419 470 media_image3.png Greyscale The configuration taught by Ludwig shows that a connector tube connects two sparging elements to the second portion, the connector tube intersects the second portion, and wherein the second portion connects to a sparging element (Fig. 5). Ludwig teaches that the sparger line, i.e., tubing, is capable of transferring gas into a vessel and feeding the spargers (Col. 5, lines 61-63). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the base and tubing taught by Satoh with that of Ludwig as such a modification would predictably result in gas being fed to the spargers in the vessel, i.e., benchtop bioreactor. Regarding claim 14, the prior art combination teaches the macrosparger of claim 9, wherein the first portion is connected to a first end of the second portion (Ludwig, Fig 5). The prior art combination is silent to the tubing further comprising a third portion which is substantially vertical, and an opposite end of the second portion is connected to the third portion. However, modifying the prior art combination to include a third portion would have been obvious to one of ordinary skill in the art. The addition of a third portion which is substantially vertical merely amounts to a duplication of parts. It has been held that the duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04 VI B). The inclusion of the third portion as claimed would predictably result in the extension of the tubing from an end of the second portion . 07-22-aia AIA Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Satoh as applied to claim 1 above, and further in view of Nakai et al. (WO 2020/003833 A1, English machine translation provided) (see PTO-892; hereinafter referred to as Nakai) . Regarding claim 17, Satoh teaches the macrosparger of claim 1. Satoh teaches that the gas sparger box may be formed of a metal plate or rubbery elastomer (Satoh pg. 3, lines 15-16), but is not specific as to the metal plate or rubbery elastomer being non-leachable or non-extractable. However, Nakai teaches it was known in the art before the effective filing date of the claimed invention to form spargers of stainless steel ([0018], “Metal sintering filters in metal sintering spargers are used by sintering fine powders such as copper, nickel, titanium, tantalum, aluminum, platinum, tungsten carbide, titanium carbide, stainless steel, or alloys containing them”), a non-leachable, non-extractable according to the instant specification (instant specification, [0050]). Nakai teaches that the sparger is usable in a cell culturing environment (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the sparging element of Satoh of stainless steel, as taught by Nakai, with a reasonable expectation of success for culturing cells . 07-22-aia AIA Claim s 25-27, 29, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh as applied to claim 1 above, and further in view of De et al. (US 2019/0048305 A1) (presented in IDS filed 02/19/2024; hereinafter referred to as De) . Regarding claim 25, Satoh teaches the macrosparger of claim 1. Satoh is silent to the benchtop bioreactor being a perfusion bioreactor. However, De discloses a perfusion bioreactor incorporating a gas sparger ([0006]). De teaches that the gas sparger provides oxygen to cells for culturing ([0034], [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try to use the gas sparger unit, i.e., macrosparger, of Satoh in the perfusion bioreactor of De because the gas sparger box would provide oxygen to cells for culturing. Regarding claim 26, Satoh teaches the macrosparger of claim 1. Satoh is silent to the benchtop bioreactor being a perfusion spinner flask. However, De discloses a mixing perfusion bioreactor (reads on the broadest reasonable interpretation of perfusion spinner flask) incorporating a gas sparger ([0006]). De teaches that the gas sparger provides oxygen to cells for culturing ([0034], [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gas sparger unit in the mixing perfusion bioreactor, i.e., perfusion spinner flask, of De with the macrosparger taught by Satoh because it would predictably provide oxygen to cells for culturing. Regarding the limitation “wherein the base of the macrosparger rests on the bottom of the bioreactor”, modifying the apparatus taught by the prior art combination such that it meets the limitation as claimed would merely amount to a rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). The apparatus taught by the prior art combination would successfully provide gas to a bioreactor. Regarding the limitation “wherein the base of the macrosparger rests in a space below a bottom end of a mixer disposed in the bioreactor”, De teaches a mixer and a sparger disposed in the mixing perfusion bioreactor (Fig. 4, impeller 232 and gas sparger 244). Although De is silent to the location of the sparger relative to the mixer, modifying the device taught by the prior art combination such that it meets the limitation as claimed would merely amount to a rearrangements of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). The apparatus taught by the prior art combination would successfully culture cells. Regarding claim 27, Satoh teaches the macrosparger of claim 1. Satoh is silent to the tubing of the macrosparger extending through an opening or port of the benchtop bioreactor, and wherein the opening or port is disposed on a lid of the benchtop bioreactor. PNG media_image4.png 311 420 media_image4.png Greyscale However, De teaches it is known in a bioreactor using a gas sparger, where tubing of a sparger extends through an opening of the benchtop bioreactor, and wherein the opening is disposed on a lid of the bioreactor (Fig. 4 – see figure below). De teaches that a gas sparger provides gas to cells for culturing ([0034], [0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the gas sparger of De for the macrosparger taught by Satoh because it would predictably provide gas to cells for culturing. Regarding claim 29, the prior art combination teaches the macrosparger of claim 27. De of the prior art combination discloses wherein the lid is removably attached to the benchtop bioreactor ([0039], “the lid 204 may be removably attached to the vessel”). Regarding claim 34, the prior art combination teaches the macrosparger of claim 26. De of the prior art combination teaches that the mixer is rotatable by a magnetic stir plate located external to the bioreactor ([0033], “The impeller 232 would be rotated by a magnetic stir plate 255 located under the vessel 202”) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Seletzky et al. (US 2012/0234394 A1) discloses a sparger made of non-leachable, non-extractable materials Stankowski (US Patent 12,324,895 B2) discloses a sparger device with two opposing sparge tubes connected by a feed tube. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM. 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, Michael Marcheschi can be reached at 571-272-1374. 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. /A.J.C./Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799 Application/Control Number: 18/573,196 Page 2 Art Unit: 1799 Application/Control Number: 18/573,196 Page 3 Art Unit: 1799 Application/Control Number: 18/573,196 Page 4 Art Unit: 1799 Application/Control Number: 18/573,196 Page 5 Art Unit: 1799 Application/Control Number: 18/573,196 Page 6 Art Unit: 1799 Application/Control Number: 18/573,196 Page 7 Art Unit: 1799 Application/Control Number: 18/573,196 Page 8 Art Unit: 1799 Application/Control Number: 18/573,196 Page 9 Art Unit: 1799 Application/Control Number: 18/573,196 Page 10 Art Unit: 1799 Application/Control Number: 18/573,196 Page 11 Art Unit: 1799 Application/Control Number: 18/573,196 Page 12 Art Unit: 1799 Application/Control Number: 18/573,196 Page 13 Art Unit: 1799 Application/Control Number: 18/573,196 Page 14 Art Unit: 1799 Application/Control Number: 18/573,196 Page 15 Art Unit: 1799 Application/Control Number: 18/573,196 Page 16 Art Unit: 1799
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