DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 21-26, in the reply filed on 8/25/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 27-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Double Patenting
1. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
2. Claims 21-26 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,610,547. Although the claims at issue are not identical because instant claim 21 makes no mention of culturing on BBE. However, it uses the open language ‘comprising’ and specifically recites the PEG solution recite the specific use polyethylene glycol (PEG) in saline at a concentration of 25-75 g/L and 30-90g/L which the specification teaches advantageously balances viability and diversity of particular microbes, including Bacteroides. (See instant specification, Example 4). Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L. Accordingly, the patented claims and the instant claims are not patentably distinct from one another with some Genus claims in the instant application which encompass the compositions/kits in the patented application.
3. Claims 21-32 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 21-26 of U.S. Patent No. 10,624,932. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of the patented claims, e.g., independent claim drawn to a fecal microbiota suspension, recites that the microbes from the fecal sample are cultured on BBE culture medium and instant claim 21 does not require that medium. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L. Accordingly, the patented claims and the instant claims are not patentably distinct from one another with some Genus claims in the instant application which encompass the compositions/kits/methods in the patented application. The scope of the claim are not patentably distinct.
4. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,433,651.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method and the method produces the same compound as recite instant claim 21, e.g., the composition produced from the method comprises a population of microbes from a fecal sample and PEG (cryoprotectant) in a concentration of about 30-90 g/L , 25-75 mg/L so the claimed composition is obvious. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L. Accordingly, the patented claims and the instant claims are not patentably distinct from one another
5. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,642,880.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method which uses the same fecal microbiota suspension, e.g., the method of patented claim 1 uses a “pre-screened microbiota restoration therapy composition includes bacteria from at least seven different families and has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level; and wherein the microbiota restoration therapy composition comprises a mixture of an effective amount of fecal microbiota from a fresh human fecal sample and a mixture of polyethylene glycol and saline, the polyethylene glycol added to the fresh human stool sample at a concentration of 30-90 g/L.” Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L. Patented claim 12 teaches the bacteria are from the family Bacteroidaceae. Accordingly, the patented claims and the instant claims are not patentably distinct from one another
6. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,675,648.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to producing MRT compositions, these methods would yield the compositions of the instant claims. This grandparent application did not have composition claims originally or subsequently claimed, so it the double patenting rejection is applicable. Patented claim 13 comprises collecting a fecal sample from a pre-screened donor; transferring, the fecal sample to a filter bag; adding a diluent to the filter bag; wherein the diluent includes 30-90 g/L polyethylene glycol in saline. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
7. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,511,100
Although the claims at issue are not identical as the patented claims they use the same or similar composition which is instantly claimed. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
8. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,511,099.
Although the claims at issue are not identical, the method in the patent uses the same composition which is instantly claimed. For example, patented claim 1 administers:
administering a first dose of a microbiota restoration therapy composition to the patient; wherein the first dose of the microbiota restoration therapy composition is manufactured by: collecting a fresh stool sample from a human donor, adding saline and polyethylene glycol to the fresh stool sample, the polyethylene glycol being added at a concentration of 30-90 g/L.
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
9. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,694,039.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the patented claims are drawn to a method for treating hepatic encephalopathy this is encompassed in instant claims 29-32 which allows for a generic method of treatment. Patented claim 1 also uses
A microbiota restoration therapy composition comprises a mixture of an effective amount of fecal microbiota from a fresh fecal sample and a cryoprotectant, the cryoprotectant comprising polyethylene glycol at a concentration of 30-90 g/L in saline.
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
10. Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,782,445.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method which uses the same composition which is instantly claimed, e.g., the patented claims uses
a first microbiota restoration therapy composition comprises: collecting a human fecal sample; adding a mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline to the human fecal sample to form a diluted sample; mixing the diluted sample with a mixing apparatus; filtering the diluted sample; wherein filtering forms a filtrate; transferring the filtrate to a sample bag .
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
11. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US Patent Serial No. 10,603,341.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to the same microbiota restoration therapy composition which comprises in an enema bag and the instant claims only recite a “sample bag”. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
12. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US Patent serial No. 10,610,547.
Although the claims at issue are not identical because instant claim 1 makes no mention of CFU amounts or culturing on BBE. However, it uses the open language ‘comprising’ and specifically recites the PEG solution of 30-90 g/L as the cryoprotectant and a population of fecal-derived microbes. The plate is a Bacteriodes culture plate. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another with some Genus claims in the instant application which encompass the compositions/kits in the patented application. Accordingly, the patented claims and the instant claims are not patentably distinct from one another
13. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent serial No. 10,434,124.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a microbiota restoration therapy composition which comprises in a bag with the same composition. An ‘enema bag’ is not used in the instant claims, but the term a ‘sample bag’ is used. The composition in the bag would be the same product. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
14. Claims 21-26 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent Serial No. 10,391,129.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are for manufacturing a composition which comprises the instantly claimed compositions, e.g.,
pooling the plurality of fresh human fecal samples; adding a diluent to the pooled fresh human fecal samples to form a diluted sample; wherein the diluent includes 30-90 g/L polyethylene glycol in saline; mixing the diluted sample with a mixing apparatus; filtering the diluted sample; wherein filtering forms a filtrate; transferring the filtrate to a sample bag; and sealing the sample bag.
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
The patented claims do not specify Bacteroides in the sample but Bacteriodes is a common fecal microorganism and therefore included in the scope of the patented claims. Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
15. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent Serial No. 10,434,125.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method which used the same composition. Although the instant claims do not specify a method of treating drug-resistant or antibiotic resistant infection, instant claims 29-32 are drawn to a generic ‘method of treatment’ and therefore the patented claims are included in their scope. The patented claims uses
a microbiota restoration therapy composition to a patient with an antibiotic-resistant bacterial infection; and wherein the microbiota restoration therapy composition comprises a mixture of an effective amount of fecal microbiota from a fresh human fecal sample from a human donor and polyethylene glycol at a concentration of 30-90 g/L.
The fecal bacteria, Bacteroides, would be included in the scope. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another
16. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US Patent Serial No. 10,383,901.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method and the patented claims would be included in the generic ‘method of treatment’ instantly claimed. However, the method in the patent uses the same composition which is instantly claimed, e.g., the patented method claim comprises:
administering a microbiota restoration therapy composition to a patient with a urinary tract infection, the microbiota restoration therapy composition comprising a processed fecal sample and a diluent, the diluent including 30-90 g/L polyethylene glycol in saline.
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.The fecal bacteria, Bacteroides, would be included in the scope. Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
17. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent Serial No. 10,471,107.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method and the patented claims would be included in the generic ‘method of treatment’ instantly claimed. The method in the patent uses the same composition, which is instantly claimed, e.g., the patented method claim comprises:
administering a microbiota restoration therapy composition to a patient with dysbiosis; and wherein the microbiota restoration therapy composition is manufactured by: collecting a fresh human fecal sample, and adding a diluent to the fresh human fecal sample, the diluent including 30-90 g/L polyethylene glycol in saline and, subsequentlywherein the microbiotia restoration therapy composition includes bacteria from at least two orders and at least seven different families and has a Shannon Diversity Index of 0.4-2.5 when calculated at the family level.
Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
The fecal bacteria, Bacteroides, would be included in the scope of the patented claims. Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
18. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent Serial No. 10,493,111.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented claims are drawn to a method and the method in the patent uses the same composition which is instantly claimed, e.g., the patented method claim comprises administering:
A microbiota restoration therapy composition comprises a fresh human fecal sample and a diluent, the diluent including 30-90 g/L polyethylene glycol in saline.
The fecal bacteria, Bacteroides, would be included in the scope of the patented claims. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
19. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of US Patent Serial No. 10,434,126.
Although the claims at issue are not identical, they are not patentably distinct from each other the method in the patent uses the same composition which is instantly claimed, e.g., the patented method claim comprises administering:
A microbiota restoration therapy composition comprises a fresh human fecal sample and a diluent, the diluent including 30-90 g/L polyethylene glycol in saline.
The fecal bacteria, Bacteroides, would be included in the scope of the patented claims. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
20. Claims 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 US Patent Serial No. 10,688,137.
Although the claims at issue are not identical, they are not patentably distinct from each other the method in the patent uses the same composition which is instantly claimed, e.g., the patented method claim comprises manufacturing a microbiota composition which comprises:
collecting a human fecal sample, and adding a mixture of polyethylene glycol and saline having a concentration of 30-90 grams of polyethylene glycol per liter of saline to the human fecal sample; administering a first dose of the microbiota restoration composition to a patient with a gastrointestinal disorder;
Bacteroides is a common fecal bacteria. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another.
21. Claims 21-26 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 US Patent Serial No. 11,554,143.
Although the claims at issue are not identical because instant claim 1 makes no mention of culturing on BBE. However, it uses the open language ‘comprising’ and specifically recites the PEG solution of 30-90 g/L as the cryoprotectant and a population of fecal-derived microbes. Both sets of claims require a suspension of 10-5 CFU Bacteroides per ml and the PEG concentration instantly claimed is about 30-90 g/L. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem and the instant specification teaches at page 20, lines 14-17, that the range may be 25-75 or 30-90 g/L and methods often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by normal optimization procedures known in the art. The specification does not teach a specific advantage of 25-75 g/L over 30-90 g/L.
Accordingly, the patented claims and the instant claims are not patentably distinct from one another with some Genus claims in the instant application which encompass the compsitions/kits in the patented application.
Status of Claims
22. No claims are allowed. The claims would be allowable if the proper Terminal Disclaimers were filed to obviate the double patenting rejections.
The closest prior art of record is Borody et al (WO 2012/016287). While Borody mentions the use polyethylene glycol (PEG) as a stabilizer, the reference does not recite the specific use polyethylene glycol (PEG) in saline at a concentration of 25-75 g/L advantageously balances viability and diversity of particular microbes, including Bacteroides. (See instant specification, Example 4). The claims require a suspension of of 10-5 CFU Bacteroides per ml. As such, the claimed parameters are critical with respect to both viability and diversity of specific flora, including Bacteroides, which could not have been appreciated or predicted from the teachings of Borody.
It is also noted the presence of 25-75 g/L of PEG in saline imparts a distinct physical and/or functional property to the composition; specifically, it permits the composition to be cryopreserved, i.e., frozen without developing ice crystals, allowing the bacteria to be revived upon thawing. Accordingly, the bacteria of the claimed composition possess markedly different characteristics with respect to structure and/or function when compared to their naturally occurring counterparts.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 9/28/26
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