DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 33-35, 37 and 39-45 are pending in this application.
Applicant’s amendment to the claims filed 03/13/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 03/13/2026 in response to the non-final rejection mailed on 11/13/2025 are acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election
The elected subject matter is
Group I, corresponding to claims 33-35, 37, and 39-45, drawn to the technical feature of a composition comprising a microbial population, lactate and trehalose,
elected without traverse in the reply filed 05/07/2024.
Claims 33-35, 37, and 39-45 are being examined on the merits.
Claim Rejections - 35 USC § 112(b)
Claim 39 is newly rejected under 35 U.S.C. 112(b) as being indefinite for railing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor regards as the invention.
The instant rejection is newly stated and necessitated by claim amendment.
Claim 39 is indefinite for the recitation of the phrase “about”. The term “about” is a term of approximation that renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, the limitation of the amount of trehalose and lactate in the composition is rendered indefinite by the use of the term.
Claim Rejections - 35 USC § 103
Claims 33-35, 37, 39-42 and 44-45 are rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. (US 9,504,275 B2; cited on the IDS submitted 07/22/2022; herein referred to as Harel) in view of Pendulum et al. (US 2017/0027996 A1; cited on the Form PTO-892 mailed 07/09/2024; herein referred to as Pendulum).
The instant rejection is maintained from the previous Office Action. Any newly recited portion is necessitated by claim amendment.
Claim 33 (claims 34-35, 37, 39-42 and 44-45 dependent therefrom) is drawn to a composition comprising a powdered microbial population, lactate, trehalose, and a desiccant, wherein the lactate and trehalose are present in an amount effective to act as a cryoprotectant for the powdered microbial population to increase the viability of the powdered microbial population.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58]. Harel further discloses the use of trehalose as a common stabilizer for cryoprotection [col 1, lines 40-55] used in combination of certain formulations and vacuum drying in a glassy state [col 2, lines 13-16], wherein glass-enhancing compounds include lactate [col 4, lines 4-6].
While Harel discloses dry storage stabilizing compositions for biological materials [title] and methods of drying and preservation of the dry state [col 1, lines 19-35], Harel does not teach the inclusion of a desiccant in the composition.
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding claim 33 and the limitation of a desiccant, Pendulum teaches a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further teaches compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum teaches therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine Harel and Pendulum to modify the composition of Harel by using the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of Harel by using the desiccant of Pendulum, because Pendulum teaches microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders and may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes. One of ordinary skill in the art would have had a reasonable expectation of success because both Harel and Pendulum discuss compositions comprising microbial populations, wherein Harel is concerned with preserving sensitive bioactive materials such as bacteria, and Pendulum teaches including silica gel in a microbial composition to enhance shelf-life.
Regarding claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding claim 35, Pendulum teaches a pharmaceutical composition comprising a population of microbes that include Akkermansia muciniphila, Bifidobacterium adolescentis, Bifidobacterium infantis, Bifidobacterium longum, Clostridium beijerinckii, Clostridium butyricum, Clostridium indolis, and Eubacterium hallii [para 0061].
Regarding claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding claim 39, Harel teaches that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and teaches the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally teaches formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding claim 40, Harel discloses the composition described in the rejection to claim 31 that is dairy-free.
Regarding claim 41, Harel discloses the composition described in the rejection to claim 31 that comprises no animal products.
Regarding claim 42, Pendulum teaches a composition that includes silica gel [para 0416]. Regarding claim 44, Pendulum teaches the composition is formulated as an enterically-coated pill [para 0101].
Regarding claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not teach cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Therefore, the invention of claims 33-35, 37, 39-42 and 44-45 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum et al. (US 2010/0151026 A1; cited on the Form PTO-892 mailed 07/09/2024; herein Pendulum2).
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 43 is drawn to the composition of claim 33, wherein the composition has a moisture content of 2.8% to 5.6%.
The teachings of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are described above. These references do not teach the moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding claim 43, Pendulum2 teaches a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of Harel and Pendulum by using the desiccation of Pendulum2, because Pendulum2 teaches a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because both Harel and Pendulum2 discuss compositions comprising microbial populations.
Therefore, the invention of claim 43 would have been obvious to one of ordinary skill in the art before the effective filing date.
Response to Remarks: beginning page 7 of Applicant’s response addressing rejections under 35 USC 103; Applicant in summary contends the rejections are improper as they presume the silica gel of the prior art increases the viability of the bacterial population due to its desiccant properties despite no teaching or suggestion of such; Applicant further contends it is improper to use the routine optimization rational to state that one of skill in the art would optimize the amount of desiccant to achieve or enhance viability, and it would not be considered a result effective variable.
Applicant’s remarks are considered and found not convincing.
As described in the rejection above, Harel teaches dry storage stabilizing compositions for biological materials and methods of drying and preservation of the dry state, but does not teach the inclusion of a desiccant in the composition. Pendulum teaches a composition comprising a microbial population which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further teaches compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108], indicating one of skill in the art would recognize silica gel is a common desiccant. As Pendulum teaches therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the inclusion of the silica gel in the combined composition of Harel and Pendulum is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, corresponding to an amount effective to increase the viability of the population.
Regarding the assertion that the routine optimization rationale was improperly used, the rejections of record do not include a routine optimization rationale for obvious.
Double Patenting
A. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 16 of U.S. Patent No. 9,486,487 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a method of treating insulin insensitivity comprising administering a composition comprising a population of microbes.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 16 of U.S. Patent No. 9,486,487, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
B. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,931,387
(cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising A. muciniphila.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,931,387, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
C. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,364,270
(cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a method of producing a microbial composition comprising formulating the cultured A. muciniphila into unit dosage form.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is newly rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,364,270, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
D. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,278,580
(cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising A. muciniphila.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,278,580, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
E. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,213,556 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising E. hallii.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,213,556, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
F. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,842,831 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising A. muciniphila.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,842,831, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
G. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,842,830 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a dosage form comprising A. muciniphila, E. hallii and C. beijerinckii.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,842,830, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
H. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,675,312 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a method of treating a metabolic disorder comprising administering a composition comprising A. muciniphila, E. hallii and C. beijerinckii.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,675,312, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
I. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,668,116 (cited on the Form PTO-892 mailed 07/09/2024; herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising C. beijerinckii, A. muciniphila, C. butyricum, and E. hallii.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,668,116, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
J. Claims 33-35, 37, 39-42 and 44-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Application No. 17/787880 (herein “reference application”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the reference application recites a composition comprising Akkermansia sp., Bifidobacterium sp., Clostridium sp., and Eubacterium sp.
The claims of the reference application do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the reference application by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the reference application because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Application No. 17/787880, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the reference application and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the reference application do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the reference application, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the reference application, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application, Harel and Pendulum2 discuss compositions comprising microbial populations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
K. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 212 of U.S. Patent No. 12,343,360 (granted from co-pending Application No. 17/150501, herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 212 of the patent recites a method comprising administering a composition comprising a mucin-degrading microbe in combination with a butyrate-producing microbe.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 212 of U.S. Patent No. 12,343,360 (granted from co-pending Application No. 17/150501, herein “patent”), Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
L. Claims 33-35, 37, 39-42 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,544,412 (granted from co-pending Application No. 18/589142, herein “patent”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 1 of the patent recites a composition comprising microbes with >97% sequence identity to Clostridium beijerinckii and Akkermansia muciniphila.
The claims of the patent do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claim of the patent by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the patent because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,544,412 (granted from co-pending Application No. 18/589142, herein “patent”) in view of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the patent and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the patent do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the patent, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the patent, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the patent, Harel and Pendulum2 discuss compositions comprising microbial populations.
M. Claims 33-35, 37, 39-42 and 44-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of Application No. 18/847148 (herein “reference application”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
Claim 5 of the reference application recites a composition comprising bacteria, comprising Akkermansia muciniphila.
The claims of the reference application do not recite the inclusion of lactate, trehalose and a desiccant in the composition.
Harel discloses compositions and drying methods for preserving sensitive bioactive materials such as bacteria [abstract].
Regarding instant claim 33, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], and wherein the salts may include cations such as sodium, potassium calcium, magnesium and the like [col 4, lines 9-10]. Harel further discloses that carbohydrate comprises a disaccharide fraction that includes sugar and sugar alcohols [col 10, lines 23-24] which include lactose, trehalose, sucrose, and so on [col 3, lines 56-58].
Pendulum describes methods and compositions relating to microbial treatment [title], wherein microbial compositions are described for the treatment of metabolic conditions [abstract].
Regarding instant claim 33 and the limitation of a desiccant, Pendulum discloses a composition comprising a microbial population [para 0061] which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further discloses compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108]. As Pendulum discloses therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the silica gel is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, which corresponds to an amount effective to increase the viability of the population.
In view of Harel and Pendulum, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the reference application by using the components of Harel and the desiccant of Pendulum to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the composition of the reference application because Harel discloses drying methods for preserving sensitive bioactive materials such as bacteria and Pendulum discloses microbial populations that can be used in a therapeutic compositions for the treatment of metabolic disorders. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application, Harel and Pendulum discuss compositions comprising microbial populations.
Regarding instant claim 34, Harel discloses the biological material of the composition comprises live bacteria including Clostridium butyricum [col 3, lines 10-43].
Regarding instant claim 35, claims 1-4 and 16 of the patent recite the microbial population comprises C. beijerinckii, A. muciniphila, C. butyricum, E. hallii, B. longum, B. adolescentis, B. infantis, and C. indolis,
Regarding instant claim 37, Harel discloses compositions comprising a carbohydrates mixture of polysaccharides and ions of organic acids [col 2, lines 59-61], wherein the organic acids are also described as glass enhancers [col 9, lines 56-58] that are defined as salts of organic acids such as lactic acid [col 11, lines 12-16], understood in the art as lactate.
Regarding instant claim 39, Harel discloses that lactate, ascorbate and citrate can be interchangeably used as an organic acid component of the composition [col 11, lines 12-16], and discloses the addition of 70 g trehalose and 5 g of organic acid added to 100 ml bacterial culture [col 15, Example 1], which amount to 70% trehalose and 5% organic acid as lactate. Regarding the claimed amount of trehalose, Harel additionally discloses formulations comprising carbohydrate mixtures in which the bioactive material is embedded preferably contain 10-90% disaccharide such as trehalose [col 3, lines 44-62]. Therefore the disclosure of Harel corresponds to a composition comprising 5% lactate and between 10-90% trehalose, which is considered to encompass a composition comprising the combination of lactate and trehalose of about 20% weight by volume recited by the claims. According to MPEP 2144.05.I, in the case where the claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 40, Harel discloses the composition described in the rejection to instant claim 31 that is dairy-free.
Regarding instant claim 41, Harel discloses the composition described in the rejection to instant claim 31 that comprises no animal products.
Regarding instant claim 42, Pendulum discloses a composition that includes silica gel [para 0416].
Regarding instant claim 44, Pendulum discloses the composition is formulated as an enterically-coated pill [para 0101].
Regarding instant claim 45, Harel discloses the composition maintains viability (live cell counts) within 0.3 log units after approximately 20 days incubating at 30 °C, wherein a reduction of 0.3 log units is understood to represent approximately 52% reduction [Figure 1, Example 1]. While Harel does not disclose cell viability after room temperature incubation as recited in the claims, Harel shows the claimed cell viability after incubating at a higher temperature. With respect to the temperatures of Harel of 30 °C and the claimed room temperature, understood in the art to be 25 °C, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05(I)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 43 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of Application No. 18/847148, Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 above, and further in view of Pendulum2.
The instant rejection is maintained from the previous Office Action. Any newly recited portions are necessitated by claim amendment.
The claims of the reference application and the disclosure of Harel and Pendulum as applied to claims 33-35, 37, 39-42 and 44-45 are discussed above. The claims of the reference application do not recite a moisture content of a composition.
Pendulum2 discusses a novel strain of Lactobacillus crispatus [title], and describes pharmaceutical compositions comprising the bacterium [para 0007].
Regarding instant claim 43, Pendulum2 discloses a composition comprising the bacteria that is desiccated for easy storage and transport [para 0029], wherein the dried formulation has less than about 5%, 4%, 3%, 2%, 1% or less water content [para 0081].
In view of Pendulum2, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined composition of the reference application, Harel and Pendulum by using the desiccation of Pendulum2 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined composition of the reference application, Harel and Pendulum, because Pendulum2 discloses a desiccated pharmaceutical composition for easy storage and transport. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application, Harel and Pendulum2 discuss compositions comprising microbial populations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks: beginning on page 9 of Applicant’s response to rejections on the ground of non-statutory double patenting; Applicant contends the double patenting rejections are improper for the reasons set forth in the response to rejections under 35 USC 103.
Applicant’s remarks are considered and found not convincing. The response to remarks regarding rejections under 35 USC 103 are stated in the section above and will be repeated here.
As described in the rejections above, Harel teaches dry storage stabilizing compositions for biological materials and methods of drying and preservation of the dry state, but does not teach the inclusion of a desiccant in the composition. Pendulum teaches a composition comprising a microbial population which may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes [para 0399], such as with the addition of one or more agents to the therapeutic composition that enhances stability and/or survival of the microbial formulation [para 0407]. Pendulum further teaches compositions for therapeutic use can further include silica gel [para 0416], wherein silica gel is disclosed as a commonly used desiccant in the specification [para 00108], indicating one of skill in the art would recognize silica gel is a common desiccant. As Pendulum teaches therapeutic compositions can be formulated with additives that enhance the survival of the microbial population, and that the silica gel is included in said therapeutic compositions, the inclusion of the silica gel in the combined composition of Harel and Pendulum is presumed to be in an amount to enhance the therapeutic activity and the survival of the microbial population, corresponding to an amount effective to increase the viability of the population.
Regarding the assertion that the routine optimization rationale was improperly used, the rejections of record do not include a routine optimization rationale for obvious.
Conclusion
Status of the Application:
Claims 33-35, 37 and 39-45 are pending.
Claims 33-35, 37 and 39-45 are rejected.
No claim is in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
Prosecution Insights