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 39-52 are pending in this application.
Applicant’s amendment to the claims filed 09/08/2025 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 09/08/2025 in response to the non-final rejection mailed on 03/07/2025 is acknowledged and has 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Claims 46-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 03/06/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Foreign Patent document 3 and Non-Patent Literature document 3 have been lined through because there are no copies of these documents in the application file.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 38 under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends is withdrawn in view of the cancelation of the claim.
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.
Claim 33 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, which satisfies the limitation in the claim regarding the amount of 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]. 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.
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 p 4 of Applicant’s response rejections under 35 USC 103; Applicant in summary contends the prior art of record does not disclose an amount of a desiccant effective to increase viability of a powdered microbial population, and that Pendulum (referred to as Pendulum996 by Applicant), while teaching silica gel as an excipient, does not teach silica gel as a desiccant in a microbial composition to enhance shelf-life; Applicant further contends the use of a desiccant is not a known result effective variable for viability and there would be no motivation for one of skill in the art to experiment with the amount of desiccant to achieve increased viability.
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 Applicant’s assertion that the silica gel of Pendulum is an excipient and not a desiccant, one of skill in the art would recognize that silica gel is a desiccant, as disclosed in the instant specification at [para 00108] and as characterized by applicant’s instant remarks as being “a known dessicant.” Applicant’s argument that the silica gel of Pendulum is used for a different function than in the instant application does not preclude the inclusion of silica gel in the combined composition for the reasons set forth in the rejection above. In the proposed combination, the combined composition meets all of the structural limitations of the claimed composition.
Regarding the assertion that Pendulum does not teach the inclusion of silica gel in a microbial composition to enhance shelf-life, Pendulum teaches compositions that enhance the shelf-life of microorganisms, and those compositions comprise silica gel, which is a common desiccant in the art. Therefore, the teachings of Pendulum encompass the inclusion of silica gel, which is an example of and can act as a desiccant, in compositions that enhance shelf-life.
Regarding the assertion that the use of a desiccant is not a known result effective variable for viability and there would be no motivation for one of skill in the art to experiment with the amount of desiccant to achieve increased viability, the rejection under 35 USC 103 does not use the result effective variable or the motivation to experiment with an amount of desiccant to achieve increased viability as the obviousness rationale to combine Harel and Pendulum. The rejection instead sets forth that 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 that these compositions may be formulated in a manner wherein the microbes are able to survive a non-natural environment, or enhance the shelf-life of microbes.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of Application No. 18/589142 (herein “reference application”) in view of Harel and Pendulum.
The instant rejection is maintained from the previous Office Action.
Claim 18 of the reference application recites a composition comprising microbes with >97% sequence identity to Clostridium beijerinckii and 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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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 18 of Application No. 18/589142, 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.
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.
M. Claims 33-35, 37, 39-42 and 44-45 are newly 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.
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, which satisfies the limitation in the instant claim regarding the amount of 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]. 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 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 newly 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 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 p 6 of Applicant’s response to rejections on the ground of non-statutory double patenting; Applicant requests the rejections be held in abeyance until it is determined the pending independent claims are indicated to be allowable subject matter.
Applicant’s request is acknowledged, and the rejections of record are maintained and updated in view of the amendments to the instant claims.
Conclusion
Status of the Application:
Claims 33-35, 37 and 39-52 are pending.
Claims 46-52 are withdrawn.
Claims 33-35, 37 and 39-45 are rejected.
No claim is in condition for allowance.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
Prosecution Insights