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 .
Status of the Claims
The amendment filed 3/3/2026 has been entered. Claims 1-16 remain pending in the application and claims 12-16 remain withdrawn. Applicant’s amendments to the claims have overcome each objection, 112(f) claim interpretation, and 112(a) rejection previously set forth in the Non-Final Office Action mailed 12/5/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure remains objected to because it . A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure remains objected to because of the following informalities: it is recommended that "This application claims benefit to PCT application PCT/EP2021/080498, filed November 3, 2021; Appropriate correction is required.
Response to Arguments
Applicant’s arguments filed 3/3/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant argues on pp. 10-11 of Remarks that while Blanchard teaches quick couplings, Blanchard does not teach or suggest applying quick couplings in a hygienic, releasable manner and there is therefore no motivation to combine Blanchard and Dong et al. to arrive at the invention as specified in claims 1 and 6. This is not persuasive, as applying the couplings in a hygienic, releasable manner is a recitation of the intended use of the device and does not distinguish the claimed invention over the prior art. It has been held that apparatus claims cover what a device is, not what a device does (MPEP § 2114 II), and a user applying the claimed quick couplings in a hygienic and releasable manner does not introduce a structural difference between the prior art and the claimed invention as Blanchard teaches the structural feature of quick couplings as part of a cell culture vessel, even if the quick couplings were not applied in a hygienic manner or in a manner which allowed them to be detached. As for motivation, Blanchard discloses that quick couplings establish gas-tight seals, and one of ordinary skill in the art would be motivated to incorporate quick couplings to achieve a gas tight seal in a cell processing device.
Claim Objections
Claim 1 is objected to because of the following informalities: It is recommended that "said bioreactor" in line 4 read "said at least one bioreactor" as "at least one" is recited in the rest of claim 1 and the depending claims. It is also recommended that “there are provided” in line 7 be deleted as this phrase could be interpreted as a method step limitation and render the claim indefinite (see MPEP § 2173.05(p)). Appropriate correction is required.
Claim 5 is objected to because of the following informalities: I. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: It is recommended that “a device according to claim 1” in lines 2-3 read “the device according to claim 1”. It is recommended that “and additional at least one bioreactor for taking up a fluid” in line 3 read “and an additional at least one bioreactor for taking up a fluid”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: It is recommended that “are movably arranged so that they can sequentially be moved into a connecting position where they can be connected” in line 2 read “is movably arranged so that it can sequentially be moved into a connecting position where it can be connected”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: It is recommended that “are movably arranged so that they can sequentially be moved into a connecting position where they can be connected” in lines 2-3 read “is movably arranged so that it can sequentially be moved into a connecting position where it can be connected”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: It is recommended that “of” in “of said at least one bioreactor” be deleted and “of” in “of said lines” be deleted. It is recommended that “configured as sterilized” in line 4 read “configured to be sterilized”. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The limitations recited in claim 6 are already recited in lines 11-12 of claim 1, which claim 6 depends from.
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 7, 9, and 11 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 7 still recites the limitation “the two or more electrodes” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination on the merits, the Examiner is interpreting claim 7 as if dependent on claim 2, which provides antecedent basis for two or more electrodes.
Claim 9 recites the limitation “wherein said at least one bioreactor for taking up a fluid” in line 1. It is unclear whether the “said at least one bioreactor for taking up a fluid” is referring to the “at least one bioreactor for taking up a fluid” recited in claim 1 or the “additional at least one bioreactor for taking up a fluid” recited in claim 8.
Claim 11 recites the limitation “said at least one bioreactor for taking up a fluid” in lines 3-4. It is unclear which “at least one bioreactor for taking up a fluid” is being referred to, as claim 8 (of which claim 11 depends from) recites an additional “at least one bioreactor for taking up a fluid” in line 3.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. (CN 102337205) (already of record) (machine translated) in view of Blanchard (US 2021/0214665 A1) (already of record).
Regarding claim 1, Dong et al. teaches a device for treating cells (para. 0008 “bioreactor… activation of microorganisms during fermentation”), comprising at least one bioreactor for taking up a fluid (31 tank body), at least one container and electrode assembly configured for emitting electric pulses (41 insulating discharge cavity, 421 upper electrode plate, 422 lower electrode plate), wherein said at least one bioreactor for taking up a fluid and said at least one container and electrode assembly configured for emitting electric pulses are connected with each other via lines so as to form a circuit (Fig. 1 31 tank body connected to 41 insulating discharge cavity via 2 elastic hose), wherein there are provided connections for connecting the lines arranged at said at least one bioreactor for taking up a fluid (Fig. 1 32 sample outlet, 33 sample inlet) with the lines arranged at said at least one container and electrode assembly configured for emitting electric pulses (Fig. 1 4241 sample inlet, 4242 sample outlet) in a releasable, hygienic and leakage-free manner (para. 0014 “the outer wall of the elastic flexible tube is sealed to the insulating discharge cavity”).
Dong et al. teaches a device wherein said connections are sealed (para. 0014 “the outer wall of the elastic flexible tube is sealed to the insulating discharge cavity”), but does not explicitly teach that the connections are quick couplings. However, Blanchard teaches that a quick coupling is known in the art (para. 0031). Blanchard teaches that quick couplings establish gas-tight seals (para. 0031). Though Dong et al. does not explicitly teach a quick coupling, it would have been obvious to a person of ordinary skill in the art to use a quick coupling because the substitution of one known element for another would have predictably resulted in a device that has gas-tight seals, with reasonable expectation. Therefore, 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 teachings of Dong et al. with the teachings of Blanchard to obtain the invention as specified in claim 1.
Regarding claim 2, Dong et al. teaches a device wherein said at least one container and electrode assembly configured for emitting electric pulses comprises two or more electrodes or plates that are arranged in one electric circuit (Fig. 1 421 upper electrode plate, 422 lower electrode plate), and a treatment space arranged between said electrodes or plates so that the treatment space can be penetrated by the emitted electric pulses and an electric field resulting therefrom (Fig. 1 space between 421 upper electrode plate, 422 lower electrode plate).
Regarding claim 3, Dong et al. teaches a device wherein said at least one container and electrode assembly configured for emitting electric pulses has an inlet connected to one of said lines on a side of said unit (Fig. 1 4241 sample inlet), and an outlet connected to another of said lines on another side of said unit (Fig. 1 4242 sample outlet). Dong et al. does not teach the inlet and outlet arranged on the top and bottom faces of the at least one container and electrode assembly configured for emitting electric pulses, respectively. Nonetheless, 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 device of Dong et al. such that the inlet and outlet are arranged on the top and bottom of the unit, respectively instead of on the sides of the unit would amount to merely rearrangement of parts, as such a modification would predictably result in inlet and outlet ports on opposite sides of the unit, which allows the fluid to flow through the circuit and enter and exit the insulating discharge cavity.
Regarding claim 4, Dong et al. teaches a device wherein said at least one bioreactor for taking up a fluid has an inlet connected to one of said lines which is formed in a top face of said at least one bioreactor for taking up a fluid (Fig. 1 33 sample inlet connected to 2 elastic hose), and an outlet connected to another of said lines which is formed in a bottom face of said at least one bioreactor for taking up a fluid (Fig. 1 32 sample outlet connected to 2 elastic hose).
Regarding claim 5, Dong et al. teaches a device wherein said device further comprises a pump for conveying the fluid through the circuit formed by said at least one bioreactor for taking up a fluid, said at least one container and electrode assembly configured for emitting electric pulses, and said lines (11, 12 peristaltic pump).
Regarding claim 6, Dong et al. teaches a device wherein said connections are sealed (para. 0014 “the outer wall of the elastic flexible tube is sealed to the insulating discharge cavity”), but does not explicitly teach that the connections are quick couplings. However, Blanchard teaches that a quick coupling is known in the art (para. 0031). Blanchard teaches that quick couplings establish gas-tight seals (para. 0031). Though Dong et al. does not explicitly teach a quick coupling, it would have been obvious to a person of ordinary skill in the art to use a quick coupling because the substitution of one known element for another would have predictably resulted in a device that has gas-tight seals, with reasonable expectation. Therefore, 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 teachings of Dong et al. with the teachings of Blanchard to obtain the invention as specified in claim 6.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. (CN 102337205) (already of record) (machine translated) in view of Blanchard (US 2021/0214665 A1) (already of record) as applied to claim 2 above, and further in view of Frey et al. (EP 2308969) (already of record) (machine translated).
Regarding claim 7, Dong et al. teaches a device wherein said at least one container and electrode assembly configured for emitting electric pulses discharge voltage in the range of 10-100 kV (para. 0021). It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed range is obvious in view of Dong et al. because Dong et al. discloses a range of 10-100 kV, which overlaps the claimed range of 0.5-100 kV. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the broader prior art range because the prior art teaches the same utility over the entire range.
Dong et al. teaches a discharge time of 10 seconds to 30 minutes (para. 0021), but does not teach a discharge time of 5 ns to 50000 ns. However, Frey et al. teaches a duration of pulsed voltage of 5 ns to 5000 ns (para. 0016). Frey et al. teaches that pulse durations in this time range have a positive effect on the efficiency of cell proliferation (para. 0016). It would have been obvious to a person of ordinary skill in the art to use the Frey et al. configuration of a pulse duration of 5 ns to 5000 ns in Dong et al.’s device with a reasonable expectation that it would have a positive effect on the efficiency of cell proliferation. This method for improving Dong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Frey et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dong et al. and Frey et al. to obtain the invention as specified in claim 7.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. (CN 102337205) (already of record) (machine translated) in view of Veraitch et al. (WO 2018/087558 A1) (already of record).
Regarding claim 8, Dong et al. teaches an apparatus for treating cells for targeted inactivation, the extraction of bioactive compounds, and the stimulation of cell growth and/or cellular compounds (para. 0008 “bioreactor… activation of microorganisms during fermentation”), comprising a device according to claim 1 (see claim 1 above), but does not teach additional bioreactors for taking up a fluid that can be connected. However, Veraitch et al. teaches multiple cell culture containers connected together (Figs. 1(a), 4, 16(a), 19(a)). Veraitch et al. teaches that connecting multiple containers together allows transfer of the contents between containers (p. 5, lines 37-38). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of multiple containers connected together in Dong et al.’s device with a reasonable expectation that it would allow transfer of the contents between containers. This method for improving Dong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dong et al. and Veraitch et al. to obtain the invention as specified in claim 8.
Regarding claim 9, Dong et al. teaches an apparatus comprising at least one bioreactor for taking up a fluid (31 tank body) and at least one container and electrode assembly configured for emitting electric pulses (41 insulating discharge cavity, 421 upper electrode plate, 422 lower electrode plate), but does not teach that the units are movably arranged. However, Veraitch et al. teaches containers that are detachably connected together which permits containers to be individually filled then attached together (p. 2, lines 29-32). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of multiple containers detachably connected together in Dong et al.’s device with a reasonable expectation that it would permit containers to be individually filled then attached together. This method for improving Dong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dong et al. and Veraitch et al. to obtain the invention as specified in claim 9.
Regarding claim 10, Dong et al. teaches an apparatus comprising at least one bioreactor for taking up a fluid (31 tank body) and at least one container and electrode assembly configured for emitting electric pulses (41 insulating discharge cavity, 421 upper electrode plate, 422 lower electrode plate), but does not teach that the units are movably arranged. However, Veraitch et al. teaches containers that are detachably connected together which permits containers to be individually filled then attached together (p. 2, lines 29-32). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of multiple containers detachably connected together in Dong et al.’s device with a reasonable expectation that it would permit containers to be individually filled then attached together. This method for improving Dong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dong et al. and Veraitch et al. to obtain the invention as specified in claim 10.
Regarding claim 11, Dong et al. teaches an apparatus comprising at least one bioreactor for taking up a fluid (31 tank body) and at least one container and electrode assembly configured for emitting electric pulses (41 insulating discharge cavity, 421 upper electrode plate, 422 lower electrode plate), but is silent to these structures being configured to be sterilized. However, Veraitch et al. teaches containers that are sterilized prior to use (p. 14, line 28) so that the container is in suitable condition for cell culture and processing cells (p. 14, line 26). It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of sterilized containers in Dong et al.’s device with a reasonable expectation that the container would be in suitable condition for cell culture and processing cells. This method for improving Dong et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Veraitch et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dong et al. and Veraitch et al. to obtain the invention as specified in claim 11.
Conclusion
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 ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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