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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/18/2025 has been entered.
Response to Arguments
Applicant’s arguments filed 12/18/2025 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. 6-7 of Remarks that Melchiorri et al. does not anticipate the claimed invention under 35 USC § 102 as Melchiorri et al. does not teach each and every element as set forth in claim 1 of the claimed invention. Applicant argues that Melchiorri et al. fails to teach a chamber housing a bioreactor comprising a gaseous atmosphere and a control system which controls the composition of the atmosphere within the chamber, and the Examiner agrees. However, these limitations do not distinguish the claimed invention over the prior art as it would have been obvious to modify the system of Melchiorri et al. in view of Ahsan (US 2018/0057782 A1) which will be discussed in further detail in the 35 USC § 103 section below.
Claim Objections
Claim 1 is objected to because of the following informalities: i; and it is recommended that “a control system which controls” should read “a control system configured to control” as “configured to” positively recites the function of the control system rather than the intended use. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: it is recommended that "and cellulose esters" should read "or cellulose esters". Appropriate correction is required.
Claim 1 objected to because of the following informalities: it is recommended that "at least 80000 . Appropriate correction is required.
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, 11-13 and 19-20 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation "assembly…elongate bioreactor within", and the claim also recites "preferably wherein the assembly…array" which is the narrower statement of the limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 is indefinite because it depends on indefinite claim 7.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation "cradle substantially encloses…bioreactor", and the claim also recites "preferably wherein the cradle…such that…material" which is an example of a what the cradle is (a narrower statement of the cradle limitation) . The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad
range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation "cellulose", and the claim also recites "(including…bacterial cellulose)" which is the narrower statement of the limitation. In addition, claim 11 recites the broad recitation "cellulose acetate", and the claim also recites "(celluloid)" which is the narrower statement of the limitation (different). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitations "an oxygen permeability of at least 350"; "a carbon dioxide permeability of at least 2000";, and the claim also recites "an oxygen permeability... at least 400, at least 450, at least 550, at least 650, at least 750, which is the narrower statement of the ranges/limitations, respectively. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation "wherein the membrane has a thickness of at least 10 , and the claim also recites "suitably which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation "…green filamentous bacteria", and the claim also recites "such as…" which is the narrower statement of the limitation. In addition, claim 19 recites the broad recitation ", and the claim also recites "such as…" which is the narrower statement of the limitation (different). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation "eukaryotic cell culture", and the claim also recites "suitably an animal, or plant cell culture; optionally a mammalian cell culture" which is the narrower statement of the limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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, 10-14, and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Melchiorri et al. (WO 2017/093744 A1) (already of record) in view of Ahsan (US 2018/0057782 A1).
Regarding claim 1, Melchiorri et al. teaches an apparatus for the production of biomass or a bioproduct (abstract “Photobioreactor devices and units for the production of biomass”), the apparatus comprising: at least one elongate bioreactor (abstract “photobioreactor”; Fig. 1 unit 10), the bioreactor comprised of at least one outer membrane layer (abstract) that defines a substantially tubular compartment that is capable of being filled with a liquid or gel (p. 9, line 34 “the liquid media inside the unit”), wherein the membrane layer is comprised of a material that is permeable to gas transfer across the membrane layer (abstract; claims 1-4; p. 10, lines 27-29); a control system (claim 15), and wherein gas transfer occurs across the membrane layer of the bioreactor between the compartment and the gaseous atmosphere outside (p. 25, lines 22-23; Fig. 34).
Melchiorri et al. teaches a photobioreactor system with gas permeating in and out of the bioreactor (Figs. 34-35), but does not explicitly teach that the bioreactor is inside a chamber. However, Ahsan teaches a photobioreactor system housed in a room (para. 0030 “a room (and/or other location) that houses system”) and a control system that controls the composition of gases within the room (para. 0030), which control the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a photobioreactor system housed in a room and a control system that controls the composition of gases within the room in Melchiorri et al.’s device with a reasonable expectation that they would control the environment surrounding the photobioreactor. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. 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 Melchiorri et al. and Ahsan to obtain the invention as specified in claim 1.
Regarding claim 2, Melchiorri et al. teaches a photobioreactor system with gas permeating in and out of the bioreactor (Figs. 34-35), but does not explicitly teach that the bioreactor is inside a chamber. However, Ahsan teaches a photobioreactor system housed in a room (para. 0030 “a room (and/or other location) that houses system”) which controls the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a photobioreactor system housed in a room in Melchiorri et al.’s device with a reasonable expectation that it would control the environment surrounding the photobioreactor. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. 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 Melchiorri et al. and Ahsan to obtain the invention as specified in claim 2.
Regarding claim 3, Melchiorri et al. teaches an apparatus for production of biomass comprising a temperature control system (p. 3, line 26), but does not teach wherein the atmosphere within the chamber is capable of being elevated to a pressure greater than or less than atmospheric pressure. However, Ahsan teaches a control system that controls the composition of gases within the room (para. 0030) and a heating/cooling device which adjusts the temperature of the room (para. 0030), which control the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a control system that controls the composition of gases within the room and a heating/cooling device in Melchiorri et al.’s device with a reasonable expectation that they would control gaseous pressure within the room. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. 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 Melchiorri et al. and Ahsan to obtain the invention as specified in claim 3.
Regarding claim 4, Melchiorri et al. teaches an apparatus for production of biomass comprising control systems (claim 15), but does not teach wherein the control system is configured to alter the atmospheric composition of the chamber by introducing an O2-containing gas; depleting CO2 concentration; and/or introducing steam. However, Ahsan teaches a control system that controls the composition of oxygen and carbon dioxide within the room (para. 0030), which control the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a photobioreactor system housed in a room and a control system that controls the composition of oxygen and carbon dioxide within the room in Melchiorri et al.’s device with a reasonable expectation that they would control the environment surrounding the photobioreactor. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. 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 Melchiorri et al. and Ahsan to obtain the invention as specified in claim 4.
Regarding claim 5, Melchiorri et al. teaches an apparatus for production of biomass wherein the chamber further comprises a sterilization system (p. 26, line 13); a gas circulatory apparatus (p. 26, lines 8-12); and/or a source of illumination (p. 22, line 7 “Artificial light source”), optionally wherein the source of illumination emits visible and/or UV light (p. 22, lines 15-17).
Regarding claim 6, Melchiorri et al. teaches an apparatus for production of biomass wherein the system permits transmission of visible light (Fig. 35 artificial light source 93), but does not teach that the bioreactor is housed within a chamber. However, Ahsan teaches a that photobioreactor system housed in a room (para. 0030 “a room (and/or other location) that houses system”) with control of light level of lights in the room (para. 0030) which controls the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a photobioreactor system housed in a room with control of light levels in the room in Melchiorri et al.’s device with a reasonable expectation that it would control the environment surrounding the photobioreactor. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. 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 Melchiorri et al. and Ahsan to obtain the invention as specified in claim 6.
Regarding claim 10, Melchiorri et al. teaches an apparatus for production of biomass wherein the elongate bioreactor is comprised of one or more hose sections (Fig. 26), wherein each hose section is comprised of a gas permeable polymer membrane (p. 13, lines 7-8).
Regarding claim 11, Melchiorri et al. teaches an apparatus for production of biomass wherein the gas permeable polymer membrane is selected from: silicones, polysiloxanes, polydimethylsiloxanes (PDMS), fluorosilicone, organosilicones, cellulose (including plant cellulose and bacterial cellulose), cellulose acetate (celluloid), nitrocellulose, and cellulose esters (p. 13, lines 16-19).
Regarding claim 12, Melchiorri et al. teaches an apparatus for production of biomass wherein the membrane has an oxygen permeability of at least 350, at least 400, at least 450, at least 550, at least 650, at least 750, suitably at least 820 Barrers (claim 1; claim 5); a carbon dioxide permeability of at least 2000, at least 2500, at least 2600, at least 2700, at least 2800, at least 2900, at least 3000, at least 3100, at least 3200, at least 3300, at least 3400, at least 3500, at least 3600, at least 3700, at least 3800, suitably at least 3820 Barrers (claim 6); and/or a water vapour permeability of at least 5000, at least 10000 Barrer, at least 15000 Barrer, at least 20000 Barrer, at least 25000 Barrer, at least 30000 Barrer, at least 35000 Barrer, at least 40000, at least 60000 and typically at least 80000 Barrer.
Regarding claim 13, Melchiorri et al. teaches an apparatus for production of biomass wherein the membrane has a thickness of at least 10 µm and at most 1 mm, suitably at least 20 µm and at most 500 µm, optionally at least 20 µm and at most 200 µm (p. 36, line 31 “100 microns thick”).
Regarding claim 14, Melchiorri et al. teaches an apparatus for production of biomass wherein the one or more hose sections are joined by one or more connectors (p. 21, line 36-p. 22, line 2) that facilitate fluid communication between the one or more hose sections (p. 3, line 29).
Regarding claim 16, Melchiorri et al. teaches an apparatus for production of biomass wherein the bioreactor is in fluid communication with an auxiliary system (claim 14).
Regarding claim 17, Melchiorri et al. teaches an apparatus for production of biomass wherein the one or more bioreactors comprise a liquid cellular growth medium (p. 9, line 34 “liquid media inside the unit, used to grow the microorganisms”; p. 11, line 35-p. 12, line 4).
Regarding claim 18, Melchiorri et al. teaches an apparatus for production of biomass wherein the one or more bioreactors comprise a microbial or algal organism selected from: a photoautotroph, a chemotroph, and a mixotroph (p. 3, lines 10-19).
Regrading claim 19, Melchiorri et al. teaches an apparatus for production of biomass housing an organism selected from one or more of Cyanobacteria; Protobacteria; Spirochaetes; Gram Positive bacteria; green filamentous bacteria; such as Chloroflexia; Planctomycetes; Bacteroides cytophaga; Thermotoga; aquifex; halophiles; Methanosarcina; Methanobacterium; Methanococcus; Thermococcus celer; Thermoproteus; Pyrodictium; Entamoebae; slime moulds; such as Mycetozoa; Ciliates; Trichomonads; Microsporidia; Diplomonads; Excavata; Amoebozoa; Choanoflagellates; Rhizaria; Foraminifera; Radiolaria; Diatoms; Stramenopiles; brown algae; red algae; green algae; snow algae; Haptophyta; Cryptophyta; Alveolata; Glaucophytes; phytoplankton; plankton; Percolozoa; Rotifera; and cells or whole organisms from animals, fungi, or plants (p. 3, lines 10-19).
Regarding claim 20, Melchiorri et al. teaches an apparatus for production of biomass wherein the bioreactor is capable of comprising a eukaryotic cell culture; suitably an animal, or plant cell culture; optionally a mammalian cell culture (p. 3, lines 10-19; p. 10, lines 10-12).
Regarding claim 21, Melchiorri et al. teaches an apparatus for production of biomass wherein the bioreactor is capable of comprising a human cell culture. Regarding the preamble limitation of the apparatus being an apparatus for production of biomass, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Melchiorri et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for growing microorganisms (p. 9, line 34) and would be structurally capable of comprising a human cell culture.
Regarding claim 22, Melchiorri et al. teaches an apparatus for production of biomass wherein the control system is further configured to control the temperature of the atmosphere within the chamber (p. 3, line 26 “temperature control systems”).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Melchiorri et al. (WO 2017/093744 A1) (already of record) in view of Ahsan (US 2018/0057782 A1) as applied to claim 1 above, and further in view of Cizek et al. (US 2016/0289625 A1) (already of record).
Regarding claim 7, Melchiorri et al. teaches an apparatus for production of biomass. Melchiorri et al. does not teach an assembly for supporting the at least one elongate bioreactor within preferably wherein the assembly comprises a plurality of armatures arranged in either a horizontal or vertical parallel or anti-parallel array. However, Cizek et al. teaches an assembly for supporting the at least one elongate bioreactor within preferably wherein the assembly comprises a plurality of armatures arranged in either a horizontal or vertical parallel or anti-parallel array (Fig. 4 423 support structure). Cizek et al. teaches that the support structure mechanically supports a bioreactor in interposition between a first and second frame (paragraph 0032).
It would have been obvious to a person of ordinary skill in the art to use the Cizek et al. configuration of an assembly for supporting in Melchiorri et al.’s device with a reasonable expectation that it would mechanically support a bioreactor in interposition between a first and second frame. This method for improving Melchiorri et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Cizek 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 Melchiorri et al. and Cizek et al. to obtain the invention as specified in claim 7.
Regarding claim 8, Melchiorri et al. teaches an apparatus for production of biomass wherein the assembly comprises at least one cradle configured to support the at least one elongate bioreactor (p. 22, line 38-p. 23, line 1 “containment structure”).
Regarding claim 9, Melchiorri et al. teaches an apparatus for production of biomass wherein the cradle substantially encloses all or a part of the elongate bioreactor, preferably wherein the cradle is comprised of a mesh (p. 23, line 1) or a perforated sheet material, such that atmospheric circulation may be permitted via the perforations of the sheet material.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Melchiorri et al. (WO 2017/093744 A1) (already of record) in view of Ahsan (US 2018/0057782 A1) as applied to claim 14 above, and further in view of Veraitch et al. (WO 2018/087558 A1) (already of record).
Regarding claim 15, Melchiorri et al. teaches one or more hose sections joined by one or more connectors. Melchiorri et al. does not teach that the one or more connectors comprise a valve which is operable to reduce or stop fluid communication between the one or more hose sections. However, Veraitch et al. teaches a valve (p. 10, line 14). Veraitch et al. teaches that the valve permits fluid communication to be controlled (p. 10, line 14).
It would have been obvious to a person of ordinary skill in the art to use the Veraitch et al. configuration of a valve in Melchiorri et al.’s device with a reasonable expectation that it would permit fluid communication to be controlled. This method for improving Melchiorri 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 Melchiorri et al. and Veraitch et al. to obtain the invention as specified in claim 15.
Conclusion
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