DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/29/2025 has been entered.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-8 and 21-23 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 1 and its dependent claims are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. For example, Claim 1 is vague and unclear reciting “the compartment configured to receive a culture having a top surface; [...] the outlet disposed above the top surface of the culture; [...] the tube configured to be advanced into the container as the top surface of the culture rises within the compartment such that the outlet remains disposed above the top surface of the culture” because it is unclear what structural configurations of the compartment and the tube are being claimed. In addition, it is unclear if the culture having a top surface is the same culture as the biological culture as recited in the preamble. Further, as the culture having a top surface is not a positive element of the claim, the limitations: the outlet disposed above the top surface of the culture and the tube configured to be advanced into the container as the top surface of the culture rises within the compartment such that the outlet remains disposed above the top surface of the culture are indefinite. Furthermore, the phrase “to be advanced [...]” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For these reasons, the dependent claims relating to above elements are similarly unclear.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 6-8 & 21 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Kelly, Jr. et al. (US 2009/0311776).
Regarding claim 1, Kelly, Jr. et al. teach:
1. A system comprising:
a) a container (e.g., 22) bounding a compartment (i.e., compartment formed by 6, 8, 10 in Fig. 1) and having a top wall (e.g., 16), a bottom wall (e.g., 28), and an encircling sidewall (e.g., 26) extending therebetween, the compartment having an upper end terminating at the top wall and an opposing lower end terminating at the bottom wall (see Figs. 2, 3, 5, 8+), the compartment configured to receive a culture having a top surface (see i.e., It is an object of the present invention to provide a bioreactor for culturing or processing a biomass formed of a presterilized, disposable housing made of a plastic selected from the group consisting of semi-rigid and rigid plastic, said housing having a top and a body integrally sealed to each other, the body having an interior space, one or more ports formed in the top and the body respectively of the housing and in fluid communication with the interior of the housing, the one or more ports having a cap to isolate the interior space of the body from the environment. ¶ 0011; see also claim 1);
b) a gas delivery system (i.e., upper most port 32a in Fig. 1) comprising a tube projecting into the compartment of the container (¶ 0037) and terminating at an outlet disposed at a first end thereof (see Figs. 2, 3+ for example), the outlet is capable of being disposed above the top surface of the culture (i.e., the device is drained and all connections removed, this feature would be taught ¶ 0068);
c) the gas delivery system further comprising a gas supply (e.g., gas line) coupled with the tube at a second end thereof, the gas supply capable of delivering gas through the tube for passage through the outlet (¶ 0015, 0038-0040+);
d) a mixing element (e.g., 14) disposed within the compartment of the container at a location between the first end of the tube and the bottom wall of the container (see Fig. 4 for example), the mixing element being capable of mixing a liquid (¶ 0041+); and
e) the tube is capable of being in the container (see Figs. 2, 3+ for example) and the outlet is capable of being disposed above the top surface of the culture (i.e., the device is drained and all connections removed, this feature would be taught ¶ 0068).
With regard to limitations in claims 1, 21, 23 (e.g., [...] to receive a culture having a top surface; [...] to be advanced into the container as the top surface of the culture rises within the compartment such that the outlet remains disposed above the top surface of the culture, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-4, 6-8, 21, Kelly, Jr. et al. teach:
2. The system as recited in claim 1, wherein the first end of the tube is disposed proximal to the upper end of the compartment, whereas the mixing element is disposed proximal to the lower end of the compartment (see Fig. 3 for example).
3. The system as recited in claim 1, wherein the first end of the tube is spaced apart from the mixing element (see Fig. 3 for example).
4. The system as recited in claim 1, wherein the tube passes through the sidewall of the container (i.e., one or more of the ports can be made in the plastic top 16 and/or body 22 by drilling or burning a hole and then mounting (such as by heat bonding or adhesives) a port in place through or around the hole. ¶ 0037).
6. The system as recited in claim 1, wherein the mixing element comprises an impeller (e.g., 42).
7. The system recited in claim 1, wherein the container comprises a flexible bag comprised of one or more sheets of polymeric film (¶ 0034, 0051-0054+).
8. The system recited in claim 1, wherein the outlet comprises a nozzle (a nozzle is sufficiently broad to have read on one or more ports 32a capable of delivering a fluid ¶ 0015, 0038-0040+).
21. The system as recited in claim 1, wherein the gas delivery system is capable of applying the gas over a top surface of the fluid (the claim is sufficiently broad to hare read on teachings in Fig. 3 & ¶ 0038-0040+).
Claim(s) 1, 3, 4, 6-8 & 21-23 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Goodwin et al. (US 2006/0240546).
Regarding claim 1, Goodwin et al. teach:
1. A system comprising:
a) a container (e.g., 32) bounding a compartment (e.g., 20) and having a top wall, a bottom wall, and an encircling sidewall extending therebetween, the compartment having an upper end terminating at the top wall and an opposing lower end terminating at the bottom wall (see annotated Fig. 1 & ¶ 0032-0033 for example), the compartment configured to receive a culture (e.g., 41) having a top surface (see i.e., fluid 41 can comprise a growth media that is dependent upon the type of cells or microorganism being cultured ¶ 0087);
b) a gas delivery system (e.g., tube ports 33, tubular stem 56, probe 84, ¶ 0044, 0048, 0054 & Figs. 1, 4) comprising a tube (e.g., 84; 52) projecting into the compartment of the container and terminating at an outlet (e.g., 88) disposed at a first end thereof (see annotated Fig. 1 & Fig. 4 for example), the outlet is capable of being disposed above the top surface of the culture (see i.e., Prior to filling container 32 with a fluid, distal end 88 of probe 84 is advanced through tubular stem 56 of tube port 33 and past lip seal 76 so that distal end 88 projects freely into chamber 40 of container 32. ¶ 0048; see also tube ports 33 can be coupled with a tube, such as fluid line 52, for dispensing fluid or other components into chamber 40 or withdrawing fluid from chamber 40. ¶ 0043; as the fluid is dispensed into an empty chamber, this feature would be taught);
c) the gas delivery system further comprising a gas supply (¶ 0054) coupled with the tube at a second end (e.g., 87) thereof, the gas supply capable of delivering gas through the tube for passage through the outlet (see ¶ 0054 for example);
d) a mixing element (e.g., 114, 116) disposed within the compartment of the container at a location between the first end of the tube and the bottom wall of the container (see annotated Fig. 1; and incorporated reference listed in ¶ 0093, Kunas et al. US 2005/0239199 Fig. 3B), the mixing element being capable of mixing a liquid (¶ 0093-0094); and
e) the tube configured to be advanced into the container (see i.e., Prior to filling container 32 with a fluid, distal end 88 of probe 84 is advanced through tubular stem 56 of tube port 33 and past lip seal 76 so that distal end 88 projects freely into chamber 40 of container 32. ¶ 0048; see annotated Fig. 1 & Fig. 4 for example) and the outlet is capable of being disposed above the top surface of the culture (see i.e., Prior to filling container 32 with a fluid, distal end 88 of probe 84 is advanced through tubular stem 56 of tube port 33 and past lip seal 76 so that distal end 88 projects freely into chamber 40 of container 32. ¶ 0048; see also tube ports 33 can be coupled with a tube, such as fluid line 52, for dispensing fluid or other components into chamber 40 or withdrawing fluid from chamber 40. ¶ 0043; as the fluid is dispensed into an empty chamber, this feature would be taught).
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With regard to limitations in claims 1, 21, 23 (e.g., [...] to receive a culture having a top surface; [...] to be advanced into the container as the top surface of the culture rises within the compartment such that the outlet remains disposed above the top surface of the culture, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 3, 4, 6-8 & 21-23, Goodwin et al. teach:
3. The system as recited in claim 1, wherein the first end of the tube is spaced apart from the mixing element (see Fig. 1 for example).
4. The system as recited in claim 1, wherein the tube passes through the sidewall of the container (see ¶ 0054 & Fig. 1 for example).
6. The system as recited in claim 1, wherein the mixing element comprises an impeller (e.g., 116).
7. The system recited in claim 1, wherein the container comprises a flexible bag (¶ 0033) comprised of one or more sheets of polymeric film (see ¶ 0034-0035 for example).
8. The system recited in claim 1, wherein the outlet comprises a nozzle (a nozzle is sufficiently broad to have read on one or more tube ports 33 capable of delivering a fluid ¶ 0029, 0033, 0054).
21. The system as recited in claim 1, wherein the gas delivery system is capable of applying the gas over a top surface of the fluid (the claim is sufficiently broad to hare read on teachings in Fig. 1).
22. The system as recited in claim 1, wherein at least a portion of the tube comprises a resilient (i.e., flexible ¶ 0028+) arch (see 52 in Fig. 5 for example).
23. The system as recited in claim 1, wherein the tube of the gas delivery system is disposed within a sleeve (see e.g., 33/94/104 in Fig. 5) capable of enabling the tube to be advanced into the container (see Fig. 5 for example).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goodwin et al. (US 2006/0240546) in view of Kelly, Jr. et al. (US 2009/0311776).
Regarding claim 2, Goodwin et al. teach: “Mounted on side walls 42 and top end wall 48 are a plurality of tube ports 33 which are in fluid communication with chamber 40. Although four tube ports 33 are shown, it is appreciated that one, two, three, or more tube ports 33 can be present depending on the intended use of container 32. As such, each tube port 33 can serve a different purpose depending on the type of processing to be undertaken.” ¶ 0043; wherein the first end of the tube is disposed proximal to the encircling sidewall of the compartment, whereas the mixing element is disposed proximal to the lower end of the compartment (see i.e., 116 is disposed proximal to the lower end in annotated Fig. 1).
However, Goodwin et al. do not explicitly teach: 2. The system as recited in claim 1, wherein the first end of the tube is disposed proximal to the upper end of the compartment.
See Kelly, Jr. et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the system of Goodwin et al. with the teachings of Kelly, Jr. et al. to dispose a tube at a desired location, such as proximal to the upper end of the compartment, to provide gases to the compartment (Kelly, Jr. et al. ¶ 0015, 0037+). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
Response to Arguments
Applicant's arguments filed 08/29/2025 have been fully considered but they are not persuasive.
Claim objection has been withdrawn.
Applicant’s amendments have been considered and have been addressed within the above new rejections and amended art rejections.
Applicant is encouraged to amend the claims to include additional structural elements of the system.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798