DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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, 21 and 23-25 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 is unclear reciting “wherein advancement of the tube into the compartment causes the resilient arch to curve upward within the compartment such that the outlet remains disposed above the top surface of the biological culture” because it is unclear whether the applicant is claiming a structure of the tube, method of forming a resilient arch, or method of using the system.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation ‘configured to [...]’ has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because: the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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.
Claims 1, 3, 4, 6-8 & 21-23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goodwin et al. (US 2006/0240546 A1) in view of Kelly, Jr. et al. (US 2009/0311776 A1).
Regarding claim 1, Goodwin et al. teach:
1. A system for oxygenating a biological culture (e.g., 41) 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 the biological culture (e.g., 41), the biological culture 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 tube comprising a resilient (i.e., flexible ¶ 0028+) arch (see 52 in Fig. 5 for example), the outlet capable of being disposed above the top surface of the biological 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 the biological culture (¶ 0093-0094); and
e) the tube capable of being advanced into the compartment as the top surface of the biological culture rises within the compartment (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), wherein advancement of the tube into the compartment such that the outlet is capable of being disposed above the top surface of the biological 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).
However, Goodwin et al. do not explicitly teach: the resilient arch curve upward within the compartment.
It is well known in the art that a tube can have a variety of shapes of configurations, including straight, L-shaped, arch shaped (Fig. 5) (as evidenced by Goodwin et al., Figs. 1, 4, 5). The change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141. Therefore, although the specific claimed elements are not explicitly taught, selecting appropriate configuration of shape for the design of the device for its suitability and intended use would have been obvious to one of ordinary skill in the art.
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With regard to limitations in claims 1, 23, 25 (e.g., [...] to receive the biological culture, the biological culture having a top surface; [...] the outlet being disposed above the top surface of the biological culture; [...] the tube configured to be advanced into the compartment as the top surface of the biological culture rises within the compartment, wherein advancement of the tube into the compartment causes the resilient arch to curve upward within the compartment such that the outlet remains disposed above the top surface of the biological 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, 23-25, modified 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).
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).
24. The system as recited in claim 1, wherein the tube projects into the compartment through a port having a passageway (e.g., 68) that communicates with the compartment (see Figs. 1-2, 4-5 & ¶ 0043-0044 for example), the passageway configured to receive the tube (see i.e., a tube, probe, or other device to be inserted through passage 68, ¶ 0047).
25. The system as recited in claim 24, wherein the tube is advanced into the container such that: a) the outlet remains disposed within the passageway (see Fig. 1 for example); and b) the outlet is advanced from the passageway into the compartment (see Figs. 1, 4, 8, 10 & ¶ 0047.
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 A1) in view of Kelly, Jr. et al. (US 2009/0311776 A1).
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.
Kelly, Jr. et al. teach:
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).
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).
wherein the first end of the tube is spaced apart from the mixing element (see Fig. 3 for example).
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).
wherein the mixing element comprises an impeller (e.g., 42).
wherein the container comprises a flexible bag comprised of one or more sheets of polymeric film (¶ 0034, 0051-0054+).
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+).
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+).
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 have been considered but are moot in view of the new ground(s) of rejection. Applicant is thanked for their thoughtful amendments to the claims.
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 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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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