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 .
Response to Arguments and Amendments
Claim 3 has been canceled in the claim amendments dated 8/19/2026.
New claim 35 has been added in the claim amendments dated 8/19/2026.
The objections to the drawings are withdrawn in view of the drawings filed 8/19/2026.
The claim amendments dated 8/19/2026 have overcome the rejection with respect to claim 1 (and dependent claims thereof) under 35 U.S.C. 112(b) presented in the prior Office Action. However, the claim amendments warrant a new rejection under 35 U.S.C. 112(b) discussed below.
Applicant’s arguments with respect to claims 1-6, 9, 14, 16, 17-19, 21, 23, 25-27, 29, 30, and 34 filed 8/19/2026 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 6/10/2026 and 9/10/2026 are in compliance with 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claims 1-2, 4-6, 9, 14, 16, 17-19, 21, 23, 25-27, 29, 30, and 34-35 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 metes and bounds of the claim are unclear. The limitation “for a benchtop bioreactor” in the preamble is merely a recitation of a purpose or intended use of the invention (MPEP § 2111.02 II). Moreover, the limitation “configured to fit within the benchtop bioreactor, the benchtop bioreactor having a cylindrical base with a radius” is directed toward the intended manner of operating the claimed base and does not positively recite the benchtop bioreactor (MPEP § 2114 II). Therefore, the limitation wherein a length of each of the plurality of sparging elements is greater than 60% of the radius of the cylindrical base of the benchtop bioreactor in lines 14-15 would leave one of ordinary skill in the art unapprised as to what the limitation is directed to. I.e., is it intended to limit the size of the sparging element or is it merely drawn to the intended use of the sparging element? For examination on the merits, the limitation of note will be interpreted as if it is drawn to the intended use of the sparging elements because the macrosparger is intended to be used within the benchtop bioreactor as described in the instant specification dated 12/21/2023 (see at least in [0007] and [0041]).
Subsequent dependent claims are similarly rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 6, 16, 18, 19, 21, 23, 25-27, 29, 30, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh (EP 0407180 A2) (previously presented) in view of Brahmbhatt (US 2015/0191689 A1) (see PTO-892).
Regarding claim 1, Satoh discloses a macrosparger (abstract, “gas sparger unit”) comprising for a benchtop bioreactor comprising:
a tubing (Fig. 3, gas inlet tube 4 – see annotated figure below); and
a base comprising a plurality of sparging elements in gaseous communication with the tubing (Fig. 3 shows base comprising plurality of gas sparger boxes 3, i.e., sparging elements – see annotated figure below), each sparging element comprising:
a 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),
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the top surface comprising a plurality of openings (Fig. 1 – see figure below),
Satoh does not disclose or teach the claimed shape of the top surface and bottom surface.
However, Brahmbhatt in the art of sparging units teaches it is known in the art to form a sparging element with the claimed shape ([0015], “sparger 16 having holes sufficiently small in size is oval shaped”; Fig. 2 is a plan view of sparger 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Satoh’s sparging elements to have a substantially oval-shaped top surface and bottom surface because Brahmbhatt teaches that such a shape is known the art, and the ordinarily skilled artisan would be motivated to imitate a sparger element shape known in the art.
The preamble limitation “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).
The limitations “wherein the base is configured to fit within the benchtop bioreactor, the benchtop bioreactor having a cylindrical base with a radius” and “wherein a length of each of the plurality of sparging elements is greater than 60% of the radius of the cylindrical base of the benchtop bioreactor” are directed toward the intended manner of operating the claimed macrosparger and does not differentiate the claimed structure from the prior art structure because all structural limitations are taught in the prior art (MPEP § 2114 II).
Regarding claim 2, the prior art combination teaches the macrosparger of claim 1, wherein the top surface and bottom surface are substantially flat (Satoh: Figs. 1 and 3).
Regarding claim 6, the prior art combination teaches the macrosparger of claim 1, wherein the tubing is in gaseous communication with the sparging elements and a gas supply source (Satoh: 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, the prior art combination teaches the macrosparger of claim 1, wherein each sparging element is interchangeable (Satoh: Fig. 1 shows that gas sparger box 3 is removable, i.e., interchangeable).
Regarding claim 18, the prior art combination teaches the macrosparger of claim 1.
The limitation “wherein the benchtop bioreactor is a 500 mL capacity benchtop bioreactor” appears to be drawn toward the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 18 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 19, 21, 23, the prior art combination teaches the macrosparger of claim 18.
The prior art combination does not disclose or teach the dimensions of each sparging elements.
Nonetheless, 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 25, the prior art combination teaches the macrosparger of claim 1.
The limitation “wherein the benchtop bioreactor is a perfusion bioreactor” appears to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 25 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 26, the prior art combination teaches the macrosparger of claim 1.
The limitation “wherein the benchtop bioreactor is a perfusion spinner flask”, “wherein the base of the macrosparger rests on the bottom of the benchtop bioreactor”, and “wherein the base of the macrosparger rests in a space below a bottom end of a mixer disposed in the benchtop bioreactor” each appear to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 26 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 27, the prior art combination teaches the macrosparger of claim 1.
The limitation “wherein the tubing of the macrosparger extends through an opening or port of the benchtop bioreactor”, and “wherein the opening or port is disposed on a lid of the benchtop bioreactor” each appear to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 27 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 29, the prior art combination teaches the macrosparger of claim 27.
The limitation “wherein the lid is removably attached to the benchtop bioreactor” appears to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1, which claim 29 ultimately depends upon, is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 27 above meets claim 29 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 30, the prior art combination teaches the macrosparger of claim 1.
The limitation “wherein the tubing is configured to follow an interior wall of the benchtop bioreactor” appears to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 30 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Regarding claim 34, the prior art combination teaches the macrosparger of claim 26.
The limitation “wherein the mixer is rotatable by a magnetic stir plate located external to the benchtop bioreactor” appears to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1, which claim 26 ultimately depends upon, is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 34 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh in view of Brahmbhatt as applied to claim 1 above, and further in view of Castan et al. (US 2022/0234012 A1 – US equivalent of WO 2020/234425) (hereinafter referred to as Castan, previously presented).
Regarding claim 4, the prior art combination teaches the macrosparger of claim 1.
The prior art combination does not disclose or teach wherein each of the openings in the plurality of openings is 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 prior art combination macrosparger 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. The ordinarily skilled artisan would be motivated to imitate a sparger structure known in the art.
Regarding claim 5, the prior art combination teaches macrosparger of claim 1.
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 prior art combination macrosparger to form the top surface and bottom surface of each sparging element parallel to one another. The ordinarily skilled artisan would be motivated to imitate a sparger structure known in the art.
The limitation “configured to be parallel with a bottom of the benchtop bioreactor” appears to be drawn to the intended manner of operating the claimed macrosparger, as the benchtop bioreactor as recited in claim 1 is directed to the intended operational environment for the macrosparger. Therefore, the prior art applied to claim 1 above meets claim 5 because the claim does not differentiate the claimed macrosparger from the prior art macrosparger (MPEP § 2114 II).
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Satoh in view of Brahmbhatt as applied to claim 1 above, and further in view of Ludwig et al. (US 2011/0013474 A1) (hereinafter referred to as Ludwig, previously presented).
Regarding claim 9, the prior art combination teaches the macrosparger of claim 1.
The prior art combination does not disclose or teach the tubing as claimed in claim 9.
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).
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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 prior art combination base and tubing with that of Ludwig as such a modification would predictably result in gas being fed to the spargers in the vessel.
Regarding claim 14, the prior art combination teaches the macrosparger of claim 9.
The prior art combination does not disclose or teach 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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Satoh in view of Brahmbhatt as applied to claim 1 above, and further in view of Nakai et al. (WO 2020/003833 A1) (hereinafter referred to as Nakai, previously presented).
Regarding claim 17, the prior art combination teaches the macrosparger of claim 1.
Satoh of the prior art combination teaches that the gas sparger box may be formed of a metal plate or rubbery elastomer (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 prior art combination sparging element using stainless steel, as taught by Nakai, with a reasonable expectation of success for culturing cells. The ordinarily skilled artisan would be motivated to prevent contamination within a bioreactor using the macrosparger.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Satoh in view of Brahmbhatt as applied to claim 1 above, and further in view of Measuring kLa for Better Bioreactor Performance, James Kane (hereinafter referred to as Kane, see PTO-892) and Introduction to mass transfer in single-use bioreactors, ThermoFisher Scientific™ (hereinafter referred to as Fisher, see PTO-892).
Regarding claim 35, the prior art combination teaches the macrosparger of claim 1.
The prior art combination does not explicitly disclose or teach wherein the macrosparger is configured to provide a mass transfer coefficient (kLa) greater than or equal to 100 (1/hr) at a gas flow rate of 0.3 vvm for a culture medium disposed within a 500 mL capacity benchtop bioreactor.
However, Kane and Fisher teach that it is well known in the art of bioreactors that mass transfer coefficient (kLa) is dependent on various factors such as bioreactor size and geometry (Kane: pgs. 3 and 7), molecular solubility, and bubble geometry (Fisher: p. 3). Fisher further discloses that bubble geometry, e.g., size and shape, can be tuned by changing different characteristics of a sparger, i.e., pore size or distribution (Fisher: pgs. 5-7).
It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation , when the particular parameter is recognized as a result-effective variable (MPEP § 2144.05). The prior art combination discloses the general conditions for the macrosparger structure (geometry and sparger pores). Kane and Fisher disclose that the parameter is a result-effective variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to discover an optimum or workable range for kLa for the prior art combination macrosparger in the claimed conditions (0.3 vvm within a 500 mL capacity benchtop bioreactor).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Amer M, Feng Y, Ramsey JD. Using CFD simulations and statistical analysis to correlate oxygen mass transfer coefficient to both geometrical parameters and operating conditions in a stirred-tank bioreactor teaches that shape of a sparger affects kLa.
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 ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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/A.J.C./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
