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 .
Notes
The objections and rejections in the previous Office action not reiterated herein have been withdrawn.
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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a closing member” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 9-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (already of record, CN 201924014-U; English machine translation has been provided) in view of Baldwin (already of record, US 3,148,624).
Regarding claim 1, Sn discloses a bioreactor comprising: a vessel defining an inner volume configured to contain liquid contents (FIG. 1: fermentation tank 1; [0020]-[0021]); an agitation means (FIG. 1: biogas stirring device 3; [0020], [0023]); at least one addition tube configured to introduce reagents from outside the bioreactor, the at least one addition tube having a first end protruding into the inner volume of the vessel to be in direct contact with the liquid contents of the vessel wherein cultivation takes place and a second end residing outside of the bioreactor (FIG. 1: feeding pipe 64; [0026]); and a check valve, and a one-way delivery orifice at the first end of the at least one addition tube, with the one-way delivery orifice configured to be immersed in direct contact with the liquid contents of the vessel wherein cultivation takes place, the check valve comprising a closing member covering the one- way delivery orifice of the at least one addition tube allowing flow of a fluid in a downward direction along gravity from the second end while blocking flow of the fluid in an upward direction against gravity from the second end, through the addition tube and through the one-way delivery orifice into the inner volume of the vessel and blocking flow in the reverse direction, wherein the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the check valve (FIG. 1: one-way valve is arranged at an output end (orifice) of the feeding pipe 64; the configuration of the feeding pipe prevents clogging issue during introduction of materials into the vessel; [0026]). Sun does not explicitly disclose wherein the check valve that, when open, defines a one-way delivery orifice at the first end of the at least one addition tube, and wherein the first end of the at least one addition tube is an outlet of the at least one addition tube. Baldwin discloses a valve having a pair of flexible bands or projections that, when open, defines a one-way delivery orifice of an opening of a chamber (FIG. 2: a pair of flexible bands or projections (27) connected to an outlet (17) of a chamber (16); col. 4, lines 4-6). Baldwin discloses wherein said pair of flexible bands or projections can be used in place of other valves such as ball check valves (col. 3, ll. 59-64). A first end of the chamber (16) is an outlet of the chamber. In view of Baldwin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the valve having a pair of flexible bands or projections of Baldwin with the at least one addition tube of Sun such that the pair of flexible bands or projections, when open, defines the one-way delivery orifice at the first end of the at least one addition tube. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known fluid flow regulation means for another for the predictable result of regulating fluid flow through an orifice as disclosed by Baldwin (col. 3, ll. 59-64). Furthermore, with respect to the limitation “wherein the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the one-way check valve,” it is noted the arrangement of the check valve into the delivering orifice of modified Sun is structurally the same as the instant delivering orifice having a one-way check valve. Thus, the check valve of modified Sun is fully capable of meeting said limitation.
Regarding claim 2, modified Sun discloses wherein the check valve has an opening pressure (Sun at [0026]) but does not disclose wherein the opening pressure is between 10 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Sun to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Regarding claims 3-4, modified Sun discloses wherein the closing member is an elastomeric closing member selected from the group consisting of tubes, lips, flaps and split disks (Baldwin at FIG. 2: valve 26; col. 3, line 59 to col. 4, line 12).
Regarding claim 9, modified Sun discloses wherein the addition tube is fluidically connected to a supply vessel containing a liquid solution comprising a pH regulator, a nutrient and/or a growth factor (FIG. 1: feeding tank 61).
Regarding claim 10, modified Sun discloses wherein the check valve has an opening pressure (Sun at [0026]) but does not disclose wherein the opening pressure is between 100 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Sun to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Regarding claim 11, Sn discloses a bioreactor comprising: a vessel defining an inner volume configured to contain liquid contents (FIG. 1: fermentation tank 1; [0020]-[0021]); an agitation means (FIG. 1: biogas stirring device 3; [0020], [0023]); at least one addition tube configured to introduce reagents from outside the bioreactor, the at least one addition tube having a first end protruding into the inner volume of the vessel to be in direct contact with the liquid contents of the vessel wherein cultivation takes place (FIG. 1: feeding pipe 64; [0026]); and a check valve, and a one-way delivery orifice at the first end of the at least one addition tube, with the one-way delivery orifice configured to be immersed in direct contact with the liquid contents of the vessel wherein cultivation takes place, for allowing flow of a fluid in a downward direction along gravity from the addition tube into the inner volume through the one-way delivery orifice while blocking flow in an upward direction against gravity from the inner volume into the addition tube through the delivery orifice, such that the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the check valve (FIG. 1: one-way valve is arranged at an output end (orifice) of the feeding pipe 64; the configuration of the feeding pipe prevents clogging issue during introduction of materials into the vessel; [0026]). Sun does not explicitly disclose wherein the check valve that, when open, defines a one-way delivery orifice at the first end of the at least one addition tube, and wherein the first end of the at least one addition tube is an outlet of the at least one addition tube. Baldwin discloses a valve having a pair of flexible bands or projections that, when open, defines a one-way delivery orifice of an opening of a chamber (FIG. 2: a pair of flexible bands or projections (27) connected to an outlet (17) of a chamber (16); col. 4, lines 4-6). Baldwin discloses wherein said pair of flexible bands or projections can be used in place of other valves such as ball check valves (col. 3, ll. 59-64). A first end of the chamber (16) is an outlet of the chamber. In view of Baldwin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the valve having a pair of flexible bands or projections of Baldwin with the at least one addition tube of Sun such that the pair of flexible bands or projections, when open, defines the one-way delivery orifice at the first end of the at least one addition tube. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known fluid flow regulation means for another for the predictable result of regulating fluid flow through an orifice as disclosed by Baldwin (col. 3, ll. 59-64). Furthermore, with respect to the limitation “wherein the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the one-way check valve,” it is noted the arrangement of the check valve into the delivering orifice of modified Sun is structurally the same as the instant delivering orifice having a one-way check valve. Thus, the check valve of modified Sun is fully capable of meeting said limitation.
Regarding claim 12, modified Sun discloses wherein the at least one addition tube is further configured such that the first end protruding into the inner volume of the vessel is located at least 50% of a distance from a top wall to a bottom wall of the vessel (see FIG. 1).
Regarding claim 13, modified Sun discloses wherein the check valve has an opening pressure (Sun at [0026]) but does not disclose wherein the opening pressure is between 10 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Sun to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Regarding claim 14, modified Sun discloses wherein the closing member is an elastomeric closing member selected from the group consisting of tubes, lips, flaps and split disks (Baldwin at FIG. 2: valve 26; col. 3, line 59 to col. 4, line 12).
Regarding claim 19, modified Sun discloses wherein the addition tube is fluidically connected to a supply vessel containing a liquid solution comprising a pH regulator, a nutrient and/or a growth factor (FIG. 1: feeding tank 61).
Regarding claim 20, modified Sun discloses wherein the check valve has an opening pressure (Sun at [0026]) but does not disclose wherein the opening pressure is between 100 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Sun to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Claims 1-2, 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsden (already of record; U.S. Pat. No. 4,713,345) in view of Sun (already of record; CN 201924014-U; English machine translation has been provided), Lucido et al. (already of record; U.S. Pat. Appl. Pub. No. 2002/0053537; hereinafter “Lucido”) and Baldwin (US 3,148,624).
Regarding claim 1, Ramsden discloses a bioreactor comprising: a vessel defining an inner volume configured to contain liquid contents (FIG. 2: reaction vessel 11; col. 2, ll. 57-59); an agitation means (FIG. 2: col. 4, ll. 13-14); and at least one addition tube configured to introduce reagents from outside the bioreactor, the at least one addition tube having at a first end a delivery orifice, with the delivery orifice configured to be immersed in direct contact with the liquid contents of the vessel wherein cultivation takes place, the at least one addition tube protruding into the inner volume of the vessel to be in direct contact with the liquid contents of the vessel wherein cultivation takes place and a second end residing outside of the bioreactor (FIG. 2: medium introduction line (15) having an opening at an end thereof adjacent the bottom of the vessel; col. 2, ll. 63-66). Ramsden does not explicitly disclose wherein the delivery orifice of the first end of the at least one addition tube has a check valve that, when open, defines a one-way delivery orifice, the check valve comprising a closing member covering the delivery orifice allowing flow of a fluid in a downward direction along gravity from the second end while blocking flow of the fluid in an upward direction against gravity from the second end, through the addition tube and through the delivery orifice into the inner volume of the vessel and blocking flow in the reverse direction, wherein the delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the check valve. Sun discloses a system comprising a fermentation tank (FIG. 1: tank 1; [0026]), at least one feeding pipe (FIG. 64) having at a first end immersed in a fluid in the fermentation tank, and a one-way valve provided at a first end of the feeding pipe (one-way valve arranged at an output end (orifice) of the feeding pipe 64; [0026]; FIG. 1). Sun further discloses wherein the feeding pipe introduces materials into the fermentation tank without clogging issues ([0026]). Lucido discloses a bioreactor comprising a vessel (FIG. 1: vessel 11), an addition tube (43) for supplying a medium into the vessel ([0038]) and a backflow valve (44) coupled to the addition tube ([0038]). The backflow valve prevents the contamination of the medium supply source with the content of the vessel ([0038]). Baldwin discloses a check valve that, when open, defines a one-way delivery orifice of a chamber (FIG. 2: valve 26; col. 3, line 59 to col. 4, line 12). Baldwin discloses wherein said check valve can be used in place of other valves such as ball check valves (col. 3, ll. 59-64). In view of Sun, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the check valve of Sun into the delivery orifice of Ramsden for the purpose of preventing back flow of materials into the vessel as disclosed by Sun (one-way valve prevents back flow of materials into the fermentation tank 1; see Sun at [0023]). Further, one of ordinary skill in the art would have made said modification for the purpose of preventing contamination of the media source as disclosed by Lucido ([0038]). Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the check valve of Baldwin with the at least one addition tube of modified Ramsden such that the check valve, when open, defines the one-way delivery orifice at the first end of the at least one addition tube. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known check valve for another for the predictable result of regulating fluid flow through an orifice as disclosed by Baldwin (col. 3, line 59 to col. 4, line 12). Furthermore, with respect to the limitation “wherein the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the one-way check valve,” it is noted the arrangement of the check valve into the delivering orifice of modified Ramsden is structurally the same as the instant delivering orifice having a one-way check valve. Thus, the check valve of modified Ramsden is fully capable of meeting said limitation.
Regarding claim 2, modified Ramsden discloses wherein the check valve has an opening pressure but does not disclose wherein the opening pressure is of between 10 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Ramsden to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Regarding claim 7, modified Ramsden discloses wherein the agitation means comprises an impeller (FIG. 2: impeller 32; col. 4, ll. 13-14).
Regarding claim 9, modified Ramsden discloses wherein the addition tube is fluidically connected to a nutrient source (Ramsden, col. 2, ll. 66-68, col. 3, ll. 53-59). Modified Ramsden does not explicitly disclose wherein the nutrient source is a vessel containing the nutrient. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a vessel with the nutrient source since such a component is well-known in the art.
Regarding claim 10, modified Ramsden discloses wherein the check valve has an opening pressure but does not disclose wherein the opening pressure is between 100 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Ramsden to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Claim 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsden in view of Sun, Lucido and Baldwin as applied to claim 1 above, and further in view of Stobbe (previously cited; U.S. Pat. Appl. Pub. No. 2011/0223581).
Regarding claims 3-4, modified Ramsden discloses the bioreactor according to claim 1, but does not explicitly disclose wherein the closing member is an elastomeric closing member selected from the group consisting of tubes, lips, flaps and split disks. Stobbe discloses wherein check valves of bioreactor systems can have the shape of flaps made of a rigid or flexible material ([0104] and [0105]). In view of Stobbe, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the check valve of modified Ramsden with a check valve having flexible flaps as disclosed by Stobbe to arrive at the claimed invention (Stobbe, [0104] and [0105]). One of ordinary skill in the art would have made said modification since Stobbe discloses that check valves of bioreactor systems can have various shapes and can be made of rigid or flexible materials (Stobbe, [0104] and [0105]). Further, one of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known valve for another to obtain predictable result of preventing media back flow.
Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsden in view of Sun, Lucido and Baldwin as applied to claim 1 above, and further in view of Ho et al. (previously cited, U.S. Pat. Appl. Pub. No. 2005/0186669; hereinafter “Ho”).
Regarding claim 5, modified Ramsden discloses the bioreactor according to claim 1, but does not explicitly disclose wherein the vessel is a flexible plastic bag. Ho discloses wherein bioreactor vessels can be made of a rigid or flexible materials ([0030] and [0055]). In view of Ho, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the vessel of modified Ramsden with a flexible material, because Ho discloses that bioreactor vessels can be made of a rigid or flexible materials (Ho, [0030] and [0055]). Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 6, modified Ramsden discloses all the structural features of the claimed flexible plastic bag and thus viewed to be “arranged to be supported by a rigid support structure during use.”
Regarding claim 8, modified Ramsden further discloses wherein the flexible plastic bag is inflatable (Ho, [0030]). Modified Ramsden does not explicitly disclose wherein the agitation means comprises a movable support platform for the flexible plastic bag. Ho further discloses wherein a movable support platform can be used in place of impellers for agitating contents within the flexible plastic bag ([0015] and [0056]). In view of Ho, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the agitation means of modified Ramsden with the movable support platform of Ho to arrive at the claimed invention. One of ordinary skill in the art would have made said modification since Ho discloses that a movable support platform can be used in place of impellers for agitating contents within bioreactors (Ho, ([0015] and [0056]).
Claims 11-13, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsden (previously cited; U.S. Pat. No. 4,713,345) in view of Sun et al. (CN 201924014-U), Lucido et al. (previously cited, U.S. Pat. Appl. Pub. No. 2002/0053537; hereinafter “Lucido”) and Baldwin (US 3,148,624).
Regarding claim 11, Ramsden discloses a bioreactor comprising: a vessel defining an inner volume configured to contain liquid contents (FIG. 2: reaction vessel 11; col. 2, ll. 57-59); an agitation means (FIG. 2: col. 4, ll. 13-14); and at least one addition tube configured to introduce reagents from outside the bioreactor, the at least one addition tube having at a first end a delivery orifice, with the delivery orifice configured to be immersed in direct contact with the liquid contents of the vessel wherein cultivation takes place, for allowing flow of a fluid in a downward direction along gravity from the addition tube into the inner volume through the delivery orifice, and the at least one addition tube protruding into the inner volume of the vessel to be in direct contact with the liquid contents of the vessel wherein cultivation takes place (FIG. 2: medium introduction line (15) having an opening at an end thereof adjacent the bottom of the vessel; col. 2, ll. 63-66). Ramsden does not explicitly disclose wherein the delivery orifice of the first end of the at least one addition tube has a check valve that, when open, defines a one-way delivery orifice, for allowing flow of the fluid in a downward direction along gravity from the addition tube into the inner volume through the delivery orifice while blocking flow in an upward direction against gravity from the inner volume into the addition tube through the delivery orifice, such that the delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the check valve. Sun discloses a system comprising a fermentation tank (FIG. 1: tank 1; [0026]), at least one feeding pipe (FIG. 64) having at a first end immersed in a fluid in the fermentation tank, and a one-way valve provided at a first end of the feeding pipe (one-way valve arranged at an output end (orifice) of the feeding pipe 64; [0026]; FIG. 1). Sun further discloses wherein the feeding pipe introduces materials into the fermentation tank without clogging issues ([0026]). Lucido discloses a bioreactor comprising a vessel (FIG. 1: vessel 11), an addition tube (43) for supplying a medium into the vessel ([0038]) and a backflow valve (44) coupled to the addition tube ([0038]). The backflow valve prevents the contamination of the medium supply source with the content of the vessel ([0038]). Baldwin discloses a check valve that, when open, defines a one-way delivery orifice of a chamber (FIG. 2: valve 26; col. 3, line 59 to col. 4, line 12). Baldwin further discloses wherein said check valve can be used in place of other valves such as ball check valves (col. 3, ll. 59-64). In view of Sun, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the check valve of Sun into the delivery orifice of Ramsden for the purpose of preventing back flow of materials into the vessel as disclosed by Sun (one-way valve prevents back flow of materials into the fermentation tank 1; see Sun at [0023]). Further, one of ordinary skill in the art would have made said modification for the purpose of preventing contamination of the media source as disclosed by Lucido ([0038]). Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the check valve of Baldwin with the at least one addition tube of modified Ramsden such that the check valve, when open, defines the one-way delivery orifice at the first end of the at least one addition tube. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known check valve for another for the predictable result of regulating fluid flow through an orifice as disclosed by Baldwin (col. 3, line 59 to col. 4, line 12). Furthermore, with respect to the limitation “wherein the one-way delivery orifice only permits flow in the downward direction and there is no or minimal stagnant zones outside the one-way check valve,” it is noted the arrangement of the check valve into the delivering orifice of modified Ramsden is structurally the same as the instant delivering orifice having a one-way check valve. Thus, the check valve of modified Ramsden is fully capable of meeting said limitation.
Regarding claim 12, modified Ramsden discloses wherein the at least one addition tube is further configured such that the first end protruding into the inner volume of the vessel is located at least 50% of a distance from a top wall to a bottom wall of the vessel (FIG. 2; col. 2, ll. 64-65).
Regarding claim 13, modified Ramsden discloses wherein the check valve has an opening pressure but does not disclose wherein the opening pressure is between 10 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Ramsden to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Regarding claim 17, modified Ramsden discloses wherein the agitation means comprises an impeller (FIG. 2: impeller 32; col. 4, ll. 13-14).
Regarding claim 19, modified Ramsden discloses wherein the addition tube is fluidically connected to a nutrient source (Ramsden, col. 2, ll. 66-68, col. 3, ll. 53-59). Modified Ramsden does not explicitly disclose wherein the nutrient source is a vessel containing the nutrient. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a vessel with the nutrient source since such a component is well-known in the art.
Regarding claim 20, modified Ramsden discloses wherein the check valve has an opening pressure but does not disclose wherein the opening pressure is between 100 Pa and 10 kPa. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the opening pressure of the check valve of modified Ramsden to have the claimed opening pressure to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice depending on the desired pressure within the bioreactor or a method of operating the claimed apparatus (see M.P.E.P. § 2114).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ramsden in view of Sun, Lucido and Baldwin as applied to claim 1 above, and further in view of Stobbe (previously cited, U.S. Pat. Appl. Pub. No. 2011/0223581).
Regarding claim 14, modified Ramsden discloses the bioreactor according to claim 1, but does not explicitly disclose wherein the closing member is an elastomeric closing member selected from the group consisting of tubes, lips, flaps and split disks. Stobbe discloses wherein check valves of bioreactor systems can have the shape of flaps made of a rigid or flexible material ([0104] and [0105]). In view of Stobbe, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the check valve of modified Ramsden with a check valve having flexible flaps as disclosed by Stobbe to arrive at the claimed invention (Stobbe, [0104] and [0105]). One of ordinary skill in the art would have made said modification since Stobbe discloses that check valves of bioreactor systems can have various shapes and can be made of rigid or flexible materials (Stobbe, [0104] and [0105]). Further, one of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known valve for another to obtain predictable result of preventing media back flow.
Claims 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ramsden in view of Sun, Lucido and Baldwin as applied to claim 1 above, and further in view of Ho et al. (previously cited, U.S. Pat. Appl. Pub. No. 2005/0186669; hereinafter “Ho”).
Regarding claim 15, modified Ramsden discloses the bioreactor according to claim 1, but does not explicitly disclose wherein the vessel is a flexible plastic bag. Ho discloses wherein bioreactor vessels can be made of a rigid or flexible materials ([0030] and [0055]). In view of Ho, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the vessel of modified Ramsden with a flexible material, because Ho discloses that bioreactor vessels can be made of a rigid or flexible materials (Ho, [0030] and [0055]). Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 16, modified Ramsden discloses all of the structural features of the claimed flexible plastic bag and thus viewed to be “arranged to be supported by a rigid support structure during use.”
Regarding claim 18, modified Ramsden further discloses wherein the flexible plastic bag is inflatable (Ho, [0030]). Modified Ramsden does not explicitly disclose wherein the agitation means comprises a movable support platform for the flexible plastic bag. Ho further discloses wherein a movable support platform can be used in place of impellers for agitating contents within the flexible plastic bag ([0015] and [0056]). In view of Ho, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the agitation means of modified Ramsden with the movable support platform of Ho to arrive at the claimed invention. One of ordinary skill in the art would have made said modification since Ho discloses that a movable support platform can be used in place of impellers for agitating contents within bioreactors (Ho, ([0015] and [0056]).
Double Patenting
The no statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,549,091. Although the claims at issue are not identical, they are not patentably distinct from each other because despite difference of wording each of the limitation of the instant claims, and claims 1-11, each taken as a whole, commonly recite substantially all the features of bioreactor, except differing in claim construction and in order of recitation of the bioreactor components. Furthermore, although patent ‘091 recites additional elements not recited in the instant claims, the instant claims use open claim language “comprising” and therefore do not exclude the presence of additional elements.
Response to Arguments
Applicant's arguments filed on June 22, 2026, have been fully considered but they are not persuasive.
Applicant argues that: “Here, the Examiner concludes without basis that the modified delivery tube of Sun would necessarily demonstrate the same flow characteristics as the claimed delivery tube and valve, even though there are no teachings in either of Sun or Baldwin to support such a conclusion. That is, both Sun and Baldwin are silent regarding the fluid delivery characteristics from the valves and delivery tubes disclosed therein, and each structure differs from that claimed in such a way that would not necessarily suggest that delivery without stagnant zones is possible. For example, the valve of Sun is not present at the end of the delivery tube as claimed,
which would result in different flow delivery characteristics than if the valve were placed at the
end of the delivery tube as claimed. Similarly, the valve of Baldwin is not delivering liquid into a
chamber where the tip of the delivery tube and valve is submerged, and therefore is not predictive of fluid delivery characteristics in the claimed bioreactor. It therefore cannot be concluded that the modified valve would necessarily function as recited in Applicant's claims, based on the teachings of Sun and Baldwin themselves and not hindsight conclusions gleaned from Applicant's disclosure.” See pages 6 to 9 of the Remarks dated June 22, 2026.
Examiner respectfully disagrees. Applicant’s argument is not persuasive because Sun explicitly discloses that the output end of the delivery tube (pipe 64) is provided with a one-way valve (see [0026] of the English machine translation). Further, as to Applicant’s argument regarding Baldwin, it is noted that Baldwin was relied upon for disclosing various types of check valves for regulating fluid flow including flapper valves. Baldwin does not need to disclose the valve to be submerged in fluid. Sun is the primary reference and discloses an addition tube having a check valve at its end that is submerged in a fluid (the output end of pipe 64 passes through from above the liquid surface in the fermentation tank 1 and enters the lower part of the fermentation tank 1 to introduce material into the fermentation tank 1; see [0026]). In response to the Applicant’s that Sun and Baldwin are silent regarding the fluid delivery characteristics from the valves and delivery tubes, Applicant’s argument is not persuasive. Applicant’s specification states that elastomeric closing members of a check valve (e.g., FIG. 4) facilitate the construction of check valves without stagnant zones and are well compatible with single use bioreactor vessels (see [0022] of the application publication). Sun in view of Baldwin discloses a check valve comprising elastomeric closing members. Therefore, since the structure of the claimed check valve and that of the prior art are structurally the same, the examiner is of the position that the check valve of modified Sun is fully capable of meeting the claimed functions. Moreover, it is noted that the liquid contents recited in the claims are material worked on and not elements of the claimed bioreactor. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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