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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/08/2025 has been entered.
DETAILED ACTION
Claim 17 has been amended. Claim 18 has been cancelled. Claim 35 has been added. Claims 14, 17, 19 and 21-35 are currently pending. Claim 14 remains withdrawn. Claims 17, 19 and 21-35 have been treated on the merits.
The amendment to claim 17 has obviated the previous objection of this claim.
Further due to amendment the double patenting rejection over 10723992 and 11702620, and 10808215 have been withdrawn.
Response to Arguments
Applicant asks the double patenting rejection be held in abeyance. There is no mechanism by which a double patenting rejection may be held in abeyance. Remaining rejections are maintained below.
Applicant argues that the claims require a sealed container and an effective amount of enzyme for an oxygen scavenging component and that the claims are intentionally broadly worded to encompass any amount of volume necessary. Applicant argues that the limitation calling for an effective amount is not unclear; however, it is unclear for the reasons noted. There is no defined volume, there is no defined concentration of oxygen present, there is no defined ratio of components nor defined sample or specific bacteria. Further applicant states that the effective amount will vary depending on sample being cultured, applicant demonstrates the uncertainty of the limitation as the same exact product falls within or without of the scope of the claims based on the sample, volume or oxygen concentration. Applicant states that one of ordinary skill would calculate how much to add the achieve a desired level of oxygen depletion; however, the composition does not require a specific calculation or ratio.
Applicant argues that Farneth does not teach “wherein the enzyme is allocated in one or more first vessel, each first vessel having an amount of enzyme effective to react with the enzyme substrate to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates the growth of an anaerobic microorganism or a microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less”, as noted in the rejection any vessel may be considered the first vessel. Further as argued by applicant the quantity of enzyme and substrate is left undefined intentionally so that it may vary by sample and volume. Thus, any functional amount of enzyme and substrate as taught by Farneth will be capable of achieving these results for some volume.
It is further noted that the claims are further rejected based on the ability of one of ordinary skill in the art to determine an effective amount of components, which as applicant states “The person of ordinary skill in the art can readily calculate the amount of enzyme needed for a given volume of aqueous media to achieve the claimed level of oxygen depletion”.
Applicant further argues that Farneth only teaches phenolic substrates and does not specifically list the phenolic substates claimed and that one of ordinary skill in the art would not be able to arrive substrates like phenol from such a teaching. For sake of clarity a secondary reference has been added.
Applicant further argues that Farneth does not teach the removal of dissolved oxygen, and cannot due to the separation of the scavenging composition and media. This argument has been fully considered and is not persuasive. The claims do not require media to be present and thus do not require the removal of dissolved oxygen. The claims refer to an amount of oxygen scavenging enzyme and substrate to be present in the kit in the form of a tablet, sachet, coating or powder. These limitations have been addressed and are anticipated and rendered obvious by Farneth. Applicant claims an intended result (oxygen concentration in an amount of time) of an intended use wherein a predetermined volume of media is added. As applicant has argued the claims are intentionally worded this way to accommodate any amount of oxygen scavenging system as any volume may be used.
Further, Farneth teaches the systems for use in culturing including with petri dishes and bottles and that the system may be used to create media for anaerobic culture ([0148]). The equilibrium between gas in the atmosphere with the amount of gas dissolved in a liquid, has been known for over 200 years and has been named Henry’s Law. The original manuscript establishing this fundamental relationship has been previously cited Henry (“III. Experiments on the quantity of gases absorbed by water, at different temperatures, and under different pressures”, Phil. Trans. R. Soc. Lond. 93: 29-43, 1803/previously cited).
Applicant further argues that the kit of the instant invention can be added directly to media to achieve low oxygen levels. Applicant argues limitations that are not part of the claim. If such limitations are added they will be examined.
Claim Objections
Claim 17 is objected to because of the following informalities:
The claim recites “…o-diphenol, p-diphenol…” these terms are singular and thus refer to a single compound. These are not the IUPAC name or a common name for these compounds. The IUPAC and common names for these compounds are Benzene-1,2-diol/catechol and Benzene-1,4 diol/hydroquinone.
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.
Claim 17, 19 and 21-35 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.
Regarding claim 17 and claims dependent thereon, are rendered indefinite by reference to an object which is a variable, the claims state ”having an amount of enzyme effective to react with the enzyme substrate to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates growth of an anerobic microorganism or microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less.”. See MPEP 2173.05(b) II. The Board has held that a limitation in a claim to a bicycle that recited “said front and rear wheels so spaced as to give a wheelbase that is between 58 percent and 75 percent of the height of the rider that the bicycle was designed for” was indefinite because the relationship of parts was not based on any known standard for sizing a bicycle to a rider, but on a rider of unspecified build. Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). The predetermined volume is variable as is the initial amount of dissolved oxygen, and thus the reference to these components references a variable. The predetermined volume may be any volume, and thus the same quantity of enzyme and substrate may fall within or without the scope of the claims depending on the variable of the predetermined volume. Further the same amount of enzyme system may fall within and without the scope of the claims depending on the concentration of dissolved oxygen. As more substrate and enzyme will be necessary in environments or solutions with higher oxygen. This makes it unclear what the applicant is attempting to claim and further makes it unclear what the metes and bounds of applicant’s invention is. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 17 and claims dependent thereon, and the limitation “selected from the group consisting of a tablet, a sachet, a coating disposed on an inside surface of a wall of the container, or a powder”, It is unclear what applicant is claiming as currently constructed as the claim does not recite a specific group denoted with a definitive article “the” and it is unclear what is within the Markush group. Amendment to recite “selected from the group consisting of a tablet, a sachet, a coating disposed on an inside surface of a wall of the container, and a powder”, would provide clarity.
Regarding claim 17 and claims dependent thereon and the limitation “the group consisting of ascorbic acid or a salt thereof, a derivative of ascorbic acid or a salt thereof, hydroquinone, pyrogallol, catechol, or a mixture of any two or more of the foregoing substrates”, It is unclear what applicant is claiming as currently constructed as it is unclear what is within the Markush group. Amendment to recite “the group consisting of ascorbic acid or a salt thereof, a derivative of ascorbic acid or a salt thereof, hydroquinone, pyrogallol, catechol, and a mixture of any two or more of the foregoing substrates” would provide clarity.
Regarding claim 22 and the limitation “a polymeric material selected from a group consisting of polyvinyl chloride, polyethylene, polycarbonate, polystyrene, polyvinyledene chloride, polyacrylonitriles, ethylene vinyl acetate copolymers, polyethylene vinyl acetate copolymer, polyvinylidene chloride copolymer, ethylene vinyl alcohol copolymer, polyamide, polymethacrylonitrile, cellulose acetate, cellulose acetate butyrate, cellulose diacetate, polychloroprene, polytetrafluoroethylene, polysiloxane or mixtures or laminates thereof;”, It is unclear what applicant is claiming as currently constructed as the claim does not recite a specific group denoted with a definitive article “the” and it is unclear what is within the Markush group. It is further unclear if the alternates listed “or mixtures”, “Or laminates” are part of the Markush group and it is unclear what they refer to, i.e. is the limitation drawn to mixtures/laminates of polysiloxanes or of all of the listed materials. As the claim is amenable to multiple interpretations of different scope it is indefinite. If applicant is claiming mixtures or laminates of all of the components of the Markush group, then amendment to the following would provide clarity “a polymeric material selected from the group consisting of polyvinyl chloride, polyethylene, polycarbonate, polystyrene, polyvinyledene chloride, polyacrylonitriles, ethylene vinyl acetate copolymers, polyethylene vinyl acetate copolymer, polyvinylidene chloride copolymer, ethylene vinyl alcohol copolymer, polyamide, polymethacrylonitrile, cellulose acetate, cellulose acetate butyrate, cellulose diacetate, polychloroprene, polytetrafluoroethylene, polysiloxane, mixtures thereof, and laminates thereof;””.
Further regarding claim 22 and the limitations “polymeric film selected from a group consisting of oriented polypropylene, oriented nylon, or oriented polyethylene terephthalate” and “from a group consisting of polyvinyl alcohol coated oriented polypropylene, polyvinyledene chloride coated oriented polyethylene terephthalate, polyvinyledene chloride copolymer coated oriented polyethylene terephthalate, polyvinyledene chloride coated oriented polypropylene, or polyvinyledene chloride copolymer oriented polypropylene” I It is unclear what applicant is claiming as currently constructed as the claim does not recite a specific group denoted with a definitive article “the” and it is unclear what is within the Markush group(s). Amendment to “polymeric film selected from the group consisting of oriented polypropylene, oriented nylon, and oriented polyethylene terephthalate” and “from the group consisting of polyvinyl alcohol coated oriented polypropylene, polyvinyledene chloride coated oriented polyethylene terephthalate, polyvinyledene chloride copolymer coated oriented polyethylene terephthalate, polyvinyledene chloride coated oriented polypropylene, and polyvinyledene chloride copolymer oriented polypropylene”recite would provide clarity.
Regarding claim 26 and the limitation “selected from a group consisting of a pouch, an envelope, a sealed wrapping, a bag, a can, a jar, a barrel, a box, a barrier bag, a zippered bag, a storage bag, a dense lab bag, a flask, a flask with stopper, a bottle, a bottle with stopper, a tube, or a multi-layer polymeric film laminate” It is unclear what applicant is claiming as currently constructed as the claim does not recite a specific group denoted with a definitive article “the” and it is unclear what is within the Markush group. Amendment to recite “selected from the group consisting of a pouch, an envelope, a sealed wrapping, a bag, a can, a jar, a barrel, a box, a barrier bag, a zippered bag, a storage bag, a dense lab bag, a flask, a flask with stopper, a bottle, a bottle with stopper, a tube, and a multi-layer polymeric film laminate”, would provide clarity.
Claim 27 recites an open Markush group, "selected from a group consisting of a stopper, a septum, a screwcap, or a heat seal." The word "or" renders the claim indefinite because the list of alternatives is not a closed grouping and one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the members defined by the Markush group. This rejection can be obviated by amending the Markush group, for example, "selected from the group consisting of a stopper, a septum, a screwcap, and a heat seal" would be acceptable.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 21-28 and 32-35 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Farneth (USPGPub 20050205840/previously cited).
Regarding claim 17 and the limitation “A kit, comprising: a sealable container; and an oxygen scavenging system comprising i) an enzyme of an oxidoreductase family and ii) a substrate for said enzyme, wherein the enzyme is selected from a group consisting of ascorbic acid oxidase and laccase” Farneth teaches systems comprising an oxygen scavenging system of laccase of ascorbic acid oxidase and an effective amount of substrate ([0011]-[0039], [0059]-[0085]). Farneth teaches the system can be placed in a sealed container ([0011]-[0039], [0042]-[0046]), as the system is placed in the sealed container it is sealable.
Regarding claim 17 and the limitation “wherein, when the enzyme is ascorbic acid oxidase, said substrate is selected from the group consisting of ascorbic acid or a salt thereof, a derivative of ascorbic acid or a salt thereof, hydroquinone, pyrogallol, catechol, or a mixture of any two or more of the foregoing substrates wherein,” Farneth teaches that ascorbic acid or ascorbate salts may be used as substrate for ascorbic acid oxidase ([0006], [0052])
Regarding claim 17 and the limitation “wherein the enzyme and/or the substrate is disposed in the kit in a form selected from the group consisting of a tablet, a sachet, a coating disposed on an inside surface of a wall of the container, or a powder.” Farneth teaches that enzymatic ascorbate oxygen scavenging systems are known in the art ([0006]), and teaches the current system can be incorporated into a sachet ([0125]), and further teaches the system may be disposed as a coating ([0095]-[0096], [0070], [0077], [0084], [0085]).
Regarding claims 17 and 19 and the limitation “wherein the enzyme is allocated in one or more first vessel, each first vessel having an amount of enzyme effective to react with the enzyme substrate to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates the growth of an anaerobic microorganism or a microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less.” and “wherein the substrate is allocated in the one or more first vessel or one or more second vessel, each first vessel or second vessel having an amount of substrate effective to react with the enzyme to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates the growth of an anaerobic microorganism or a microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less.” the amount of enzyme and substrate contained within the device of Farneth can be considered to have an amount of substates and enzyme effective to deplete dissolved oxygen to a desired oxygen content that facilitates growth of a microaerophilic or anaerobic microorganism in the time frame specified, as the predetermined volume is not defined, and thus predetermined volume can be defined as an amount that this level can be achieved in by the components present. As admitted in arguments, this limitation is intentionally worded to encompass embodiments of varying volumes and samples. Farneth further expressly teaches the system may be used for culturing anaerobic microbes ([0148]). Further the container in which it is located can be considered a first or second vessel or alternatively in embodiments in which the oxygen scavenging system is in a sequestered area can be considered the first or second vessel. The amount present can be considered to achieve the concentration claimed in the time frame claimed, as the predetermined volume is not defined. Thus any functional quantity in Farneth is capable of doing so for some volume.
Regarding claim 21 and the limitation “, wherein the first vessel and/or the second vessel is the container”, The container in which it is located can be considered a first or second vessel.
Regarding claim 22 and the limitation “wherein the container is made of: glass; ora polymeric material selected from a group consisting of polyvinyl chloride, polyethylene, polycarbonate, polystyrene, polyvinyledene chloride, polyacrylonitriles, ethylene vinyl acetate copolymers, polyethylene vinyl acetate copolymer, polyvinylidene chloride copolymer, ethylene vinyl alcohol copolymer, polyamide, polymethacrylonitrile, cellulose acetate, cellulose acetate butyrate, cellulose diacetate, pholychoropene, polytetrafluoroethylene, poolysiloxane or mixtures or laminates thereof; or a polymeric film comprising an oriented polymeric film selected from a group consisting of oriented polypropylene, oriented nylon, or oriented polyethylene terephthalate; or a polymeric film comprising a metalized film; or a polymeric film comprising polyvinyledene chloride, polyvinyledene chloride copolymer or polyvinyl alcohol coated film selected from a group consisting of polyvinyl alcohol coated oriented polypropylene, polyvinyledene chloride coated oriented polyethylene terephthalate, polyvinyledene chloride copolymer coated oriented polyethylene terephthalate, polyvinyledene chloride coated oriented polypropylene, or polyvinyledene chloride copolymer oriented polypropylene”, Farneth discloses that the container can be in the form of jar or box ([0046]), and further demonstrates examples in which glass containers are used ([0177], [0185], [0211]).
Regarding claim 23 and the limitation “wherein the container is resealable”, Farneth teaches the containers may be designed such that material or the oxygen scavenging system is placed inside and the container sealed ([0124]-[0134]). Farneth further teaches multiple container closures ([0142]-[0148]) Farneth thus teaches resealable containers.
Regarding claim 24 and the limitation “wherein the container is single-use or disposable”, The containers of Farneth may be disposed of or used a single time.
Regarding claim 25 and 26 and the limitation “wherein the container is flexible”, and “wherein the container is selected from a group consisting of a pouch, an envelope, a sealed wrapping, a bag, a can, a jar, a barrel, a box, a barrier bag, a zippered bag, a storage bag, a dense lab bag, a flask, a flask with stopper, a bottle, a bottle with stopper, a tube, or a multi-layer polymeric film laminate.”, Farneth teaches the container may be in the form of flexible containers such as bags, envelopes, pouches or wrapping ([0046]). Farneth additionally teaches numerous designs including barrel, jar, box, etc ([0046]).
Regarding claims 27 and 28 and the limitations “wherein the container is sealed using a seal selected from a group consisting of a stopper, a septum, a screwcap, or a heat seal” and “wherein the container comprises a sealable port”, Farneth teaches that the container may be sealed by various closure methods including plugs, caps and corks ([0143]-[0146]). Farneth further exemplifies the use of septums, stoppers and screwcaps ([0148], [0177], [0185], [0219], [0224]-[0225]). These closures can be considered sealable ports as they are opening or ports which can be sealed.
Regarding claim 32 and the limitation “wherein the container has a headspace volume of about 0 mL to about 50 mL” Farneth teaches that the system removes oxygen from headspace, and thus teaches containers with headspace ([0003], [0048], [0222], [0158]-[0159]). Farneth further exemplifies embodiments with headspace of 250 mL ([0222]), and bottles of various sizes such as 125 mL to 20 mL ([0161], [0177], [0188], [0191]), and thus exemplifies the method of headspaces of less than 20 mL.
Regarding claim 33. And the limitation “wherein the kit further comprises a material that can be placed into the container to indicate the presence or absence of oxygen in the container” Farneth exemplifies the method using devices to detect oxygen, such as an oxygen sensor ([0159]-[0232]), this sensor can be considered a material to indicate the presence or absence of oxygen. In addition the substrate of the enzymes used can also be considered to be a material which indicates the presence of oxygen as its consumption will occur in the presence of oxygen.
Regarding claim 34 and the limitation “further comprising an anerobic or microaerophilic bacteria”, The system and method of Farneth results in the culturing or, i.e. addition of, oxygen sensitive bacteria such as anaerobic bacteria, and thus the system of Farneth will comprise these bacteria.
Regarding claim 35 and the limitation “herein the dissolved oxygen concentration that facilitates the growth is 1 µM or less.” The amount present can be considered to achieve the concentration claimed in the time frame claimed, as the predetermined volume is not defined. Thus any functional quantity in Farneth is capable of doing so for some volume.
The above reference anticipates the claim subject matter.
Claim Rejections - 35 USC § 103
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.
Claims 17, 19, 21-28 and 32-35 are further rejected under 35 U.S.C. 103 as being unpatentable over Farneth as applied to claims 17, 19, 21-28 and 32-35 above,
Regarding claims 17 and 19 and claims dependent thereon and the limitations “wherein the enzyme is allocated in one or more first vessel, each first vessel having an amount of enzyme effective react with the enzyme substrate to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates the growth of an anaerobic microorganism or a microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less.”, and “wherein the substrate is allocated in the one or more first vessel or one or more second vessel, each first vessel or second vessel having an amount of substrate effective to react with the enzyme to deplete dissolved oxygen in a predetermined volume of aqueous medium to a dissolved oxygen concentration that facilitates the growth of an anaerobic microorganism or a microaerophilic microorganism in about 60 minutes or less; wherein the dissolved oxygen concentration that facilitates the growth is 10 µM or less.”, the amount of enzyme and substrate contained within the device of Farneth can be considered to have an amount of substates or enzyme effective to deplete dissolved oxygen to a desired oxygen content that facilitates growth of a microaerophilic or anaerobic microorganism by defining the volume as an amount that this level can be achieved in. Farneth further expressly teaches the system may be used for culturing anaerobic microbes ([0148]). Further the container in which it is located can be considered a first or second vessel or alternatively in embodiments in which the oxygen scavenging system is in a sequestered area can be considered the first or second vessel. The amount present can be considered to achieve the concentration claimed in the time frame claimed, as the predetermined volume is not defined. Thus any practical quantity would be capable of doing so for some small volume.
In addition, one of ordinary skill would view the amount of oxygen scavenging system and the level of oxygen remaining and the time to get to an acceptable level for culturing anaerobic bacteria to be a result effective variable effective variable, and would find it obvious to determine workable ranges for the amount of oxygen scavenging system present to achieve the desired levels for culturing the anaerobic bacteria.
Further as noted in submitted arguments, “The person of ordinary skill in the art can readily calculated the amount of enzyme needed for a given volume of aqueous media to achieve the claimed level of oxygen depletion”.
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
One of ordinary skill in the art would thus find it obvious to determine workable ranges or optimize the amount of oxygen scavenging system present to achieve a low level of oxygen quickly so that the bacteria may be cultured in an anaerobic culturing system.
Claims 17, 19, 21-28 and 32-35 are further rejected under 35 U.S.C. 103 as being unpatentable over Farneth as applied to claims 17, 19, 21-28 and 32-35 above, in view of Chatterjee (“Evaluation of the Potenial of Fungal and Plant Laccases for Active-Packaging Applications” Journal of Agricultural and Food Chemistry, 2011, 59, 5390-5395).
Regarding claim 17 and the limitation “when the enzyme is laccase, said substrate is selected from the group consisting of phenol, L-tyrosine, o-diphenol, p-diphenol, 2,6-dimethoxyphenol, and mixtures of any two or more of the foregoing substrates;” Farneth discloses that laccase can work with multiple substrates giving flexibility in formulating deoxygenating systems ([0007]), Farneth teaches that a wide range of phenolic compounds may be used ([0071]-[0072]). Farneth teaches a preference for commercially available laccase and exemplifies the use of a laccase from Myceliophthora thermophilia ([0063]-[0064], [0153]-[0155], [0167]).
Farneth does not specifically teach the use of substrates m-diphenol and p-diphenol substrates, i.e. catechol and hydroquinone. This difference however would have been obvious to one of ordinary skill in the art as these substrates are taught by Chatterjee in the same field of endeavor as substrates for commercially available laccases for use in oxygen scavenging compositions.
In the same field or endeavor Chatterjee teaches numerous phenolic compounds including ortho and para diphenols, catechol, and hydroquinone as well as 2,6-dimethoxyphenol (Figure 1). Chatterjee teaches that all of these compounds are substrates for the commercially available laccases from T. versicolor from Julich and M. thermophila from Novozyme, (Materials and Methods, Figure 2, substrates 1, 2, and 7), hydroquinone and 2,6-dimethoxyphenol yielding the highest activity for the enzymes respectively.
One of ordinary skill in the art would find it obvious that these laccases could be used in the device and method of Farneth as the M. thermophila enzyme is exemplified by Farneth, and further both enzymes are commercially available and known laccases. One of ordinary skill in the art would find it obvious that any of the any of these compounds taught could be used as the substrates for laccase as they are demonstrated to be substrates for these enzymes. One of ordinary skill in the art would further have a reasonable expectation of success in doing so as the compounds have been shown to be substrates for the enzymes by Chatterjee.
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Farneth or Farneth in view of Chatterjee as applied to claims 17, 19, 21-28 and 32-35 above, and further in view of Williams (USP6649406/previously cited).
Regarding claims 29 and 30 and the limitations “wherein the container has an oxygen permeability of less than about 100 nmol/(m x s x Gpa)” and “wherein the container has an oxygen permeability of from about 6 to about 8 nmol/(m x s x Gpa)”, Farneth teaches that he container should be designed to be largely impermeable to oxygen ([0046]). Farneth further teaches that oxygen can permeate through walls of containers ([0119]), and that materials of various oxygen permeability are known in the art ([0119], [0091]).
Farneth does not teach a specific material with low permeability of thickness to the material, this however would have been obvious to one of ordinary skill in the art as it is taught in the same field of endeavor as low oxygen permeable materials used for culturing oxygen sensitive microorganisms.
In the same field of endeavor Williams teaches that thin polymer films are known such as polyester films that can have a thickness of 0.001 inches, ~0.025 mm, (Col4, Ln 47-67).
Based on the teaching of Farneth and Williams one of ordinary skill in the art would further find the selection of material and oxygen permeability to be a result effective variable to the creation and maintenance of low oxygen environment within the container and thus would find it obvious to develop containers using materials and thickness which lead to optimal or workable ranges or oxygen.
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
One of ordinary skill in the art would thus find it obvious for the container to have low permeability such as less than 100 nmol/(m x s x Gpa), or from about 6 to about 8 nmol/(m x s x Gpa) and below.
Regarding claim 31 and the limitation “wherein the container has a thickness of about 0.025 mm”, Farneth teaches that the composition or container may include bags, films ([0048], [0085], [0119], [0141]). Williams teaches that thin polymer films are known such as polyester films that can have an thickness of 0.001 inches, ~0.025 mm, (Col4, Ln 47-67).
One of ordinary skill would thus find it obvious that the container could have a thickness of about 0.025 mm.
Double Patenting
The nonstatutory 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 17, 19, 23-26, and 32-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11685944. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘944 claims a method requiring the use of devices comprising an oxygen scavenging reagent comprising laccase or ascorbate oxidase (claim 1, 13) and all of the substrates instantly claimed (claim 4-5 and 14-17). The device in which the reagent is disposed in constitutes a container as a sample if placed within it is resealable (claim 1). The amount present is capable of lowering the oxygen level to a required level to support growth, and teaches the concentration as less than 10 µM in 60 minutes or less (Claims 1 and 13). Further any device may be considered disposable as it is capable of being disposed of.
The device comprising the enzymes may be considered the first or second vessel in which the enzyme and substrate are disposed in as well as the container. The device as described is made of polymeric films such as those claimed and multilayered, as the cover may be lifted and resealed the container is flexible. Further as the device seals it has little to no headspace. And its use will result in the presence of anaerobic or microaerophilic bacteria. Further less than 1 µM falls within the range of less than 10 µM and is thus rendered obvious by the claims of ‘944.
The above claims render obvious the instant claims as embodiment of the claims fall within the scope of each other.
Claims 17, 19, 23-26, and 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-22 of copending Application No. 16288712 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘712 comprise methods and devices comprising an oxygen scavenging system of ascorbate oxidase and L-ascorbic acid and salts (Claims 2-10, 16-18). The device in which the reagent is disposed in constitutes a container as it is resealable after a sample is placed within. The amount of enzyme and substrate present is capable of lowering the oxygen level to a required level to support growth. One of ordinary skill in the art would thus find it obvious to determine workable ranges or optimize the amount of oxygen scavenging system present to achieve a low level of oxygen quickly so that the bacteria may be cultured in an anaerobic culturing system, and thus render obvious doing so in 60 minutes or less and to a concentration of less than 10 µM or 1µM . Further any device may be considered disposable as it is capable of being disposed of.
The device comprising the enzymes may be considered the first or second vessel in which the enzyme and substrate are disposed in as well as the container. The device as described is made of polymeric films such as those claimed and multilayer, as the cover may be lifted and resealed the container is flexible. Further as the device seals it has little to no headspace. And its use will result in the presence of anaerobic or microaerophilic bacteria.
The above claims render obvious the instant claims as embodiment of the claims fall within the scope of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657