DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7, 13, 21-26, 30 and 31 in the reply filed on 4/10/26 is acknowledged.
Claims 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112-Deposit Information
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain Christensenella sp. deposited as GDMCC No: 61117. Because it is not clear that the properties of the strain are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the strain a suitable deposit for patent purposes is required.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
© the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become non-viable or non-replicable.
In addition, a deposit of the biological material that is capable of self-replication either directly or indirectly must be viable at the time of the deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1)The name and address of the depository;
2)The name and address of the depositor;
3)The date of deposit;
4)The identity of the deposit and the accession number given by the depository;
5)The date of the viability test;
6)The procedures used to obtain a sample if the test is not done by the depository; and
7)A statement that the deposit is capable of reproduction.
If the deposit was made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by Applicants, assignees or a statement by an attorney of record over his or her signature and registration number stating that deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when a deposit is made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and address of the depository is required.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112-2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7, 13, 21-26, 30 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is vague and indefinite due to the term “Christensenella sp. Species” because it appears to be redundant, e.g., “sp.” is used in the art to mean “species.” It is unclear if something else is intended. Appropriate clarification and/or correction is required.
Claim 26 is vague and indefinite due to the term “subclone strain thereof” as it is unclear what structures are encompassed by this language. The progeny strain is clear as it is the offspring or descendants of the strain with the same genetic characteristics, while a subclone strain does not necessarily contain the same genetic make-up, etc. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5, 7, 13, 21-26, 30 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rawadi et al (WO2020/182916A1, 9/17/2020; provided by Applicants), Vincent, C. (WO 2018/162738; 9/13/2018) and Vincent, C (WO2018/162726; 9/13/2018) and Ley et al (US Patent No. 10,206,958, 6/13/19) in view of Rawadi et al (WO 2020/216929; 10/29/2020 provided by Applicants).
Rawadi et al (9/17/2020) discloses: "One subject of the present invention is the use of at least one bacterium from the Christensenellaceae family, preferably the genus Christensenella, or a composition comprising at least one such bacterium and/or culture supernatant of at least the Christensenella genus, for the prevention and/or treatment of chronic inflammatory diseases and/or inflammatory gastrointestinal diseases and/or cancers in humans or animals, particularly inflammatory cancers. Christensenellaceae bacteria, especially those of the Christensenella genus, can be used to treat at least one chronic inflammatory disease selected from chronic inflammatory bowel disease, chronic inflammatory liver disease. Particularly, they demonstrate efficacy in preventing and/or treating at least one disease selected from Crohn's disease, hemorrhagic proctocolitis, enterocolitis, ulcerative colitis, celiac disease, autoimmune gastritis, hepatitis, non-alcoholic steatohepatitis. Additionally, Christensenellaceae bacteria, especially Christensenella The bacterial strains belong to the genus Christensenella and can be used to treat at least one inflammatory gastrointestinal discase, such as inflammatory bowel discase (IBD), particularly colitis. The colitis can be specifically selected from the group consisting of Crohn's disease, hemorrhagic proctocolitis, and bag-like colitis, with particular emphasis on the combination of Crohn's discase and hemorrhagic proctocolitis. One or more beneficial bacterial strains according to the present invention are those belonging to the genus Christensenella. Preferred strains include Christensenella massiliensis, Christensenella timonensis, Christensenella intestinihominis, and/or Christensenella minuta (see paragraphs 42,48-49, and 51 of the specification). It should be noted that the reference discloses at least one bacterial strain from the Christensenella genus, such as Christensenella massiliensis, Christensenella timonensis, and Christensenella intestinihominis. The Rawadi (9/17/20) reference recites at paragraph [0011] that Applications WO2018/162738 and WO2018/162726 teach that specific bacteria from the Christensenellaceae family, defined as species particularly distantly related to the genus Christensenella and especially Christensenella minuta and Christensenella timonensis, can combat overweight and obesity by targeting factors such as visceral fat accumulation and intestinal permeability. One aspect of the present invention is the use of at least one bacterium from the Christensenellaceae family, preferably the genus Christensenella, or a composition comprising at least one such bacterium and/or the culture supernatant of at least one such bacterium, for preventing and/or treating chronic inflammatory diseases, inflammatory gastrointestinal diseases, and/or cancers in humans or animals, particularly inflammatory cancers. Christensenellaceae bacteria, particularly Christensenella. The bacteria from the genus Christensenella can be used to treat at least one chronic inflammatory disease, such as chronic inflammatory bowel disease or chronic inflammatory liver disease. Notably, they are effective in preventing and/or treating at least one condition selected from Crohn's disease, hemorrhagic proctocolitis, entropion, ulcerative colitis, celiac disease, autoimmune gastritis, hepatitis, and non-alcoholic steatohepatitis. Additionally, bacteria from the Christensenellaceae family, particularly those from the Christensenella genus, can be used to treat at least one inflammatory gastrointestinal disorder, such as inflammatory bowel disease, especially colitis. According to the invention, one or more beneficial bacterial strains are those from the Christensenella genus. Preferred options include Christensenella massiliensis, Christensenella timonensis, Christensenella intestinihominis, and/or Christensenella minuta. SEQ ID NO:1 represents the 16S rRNA gene sequence of the bacterium * Christensenella minuta* DSM 22607, isolated from human fecal samples (see paragraphs 11,42,48-49,51, and 99 in the specification). Christensenella minuta DSM 22607 strain isolated from human fecal samples, which can be used to treat or prevent non-alcoholic fatty hepatitis (a liver function impairment and related diseases), inflammatory bowel disease (a gastrointestinal mucosal injury and related conditions), as well as combat overweight and obesity through interventions such as regulating visceral fat accumulation and intestinal permeability. The 16srRNA sequence of Rawadi et al is 98.7% identical to Applicants’ SEQ ID NO: 1.
Ley et al teaches compositions that have substantially purified Christensenellaceae bacteria, and uses of these compositions to alter the microbiome of an individual. The addition of Christensenellaceae bacteria, such as Christensenella, to the microbiome of an individual can treat or prevent weight gain, reduce body weight, inhibit fat accumulation, reduce excess adiposity, and reduce a high body mass index (BMI), and can also treat or prevent conditions correlating with excess weight and fat and a high BMI, such as insulin sensitivity, metabolic syndrome, excess adiposity, and diabetes. Ley et al teach a sequence 97.9% identical to Applicants’ SEQ ID NO: 1.
Vincent, C. (WO 2018/162738; 9/13/2018) teaches Christensenella bacterium for use in the treatment of overweight, obesity, cardiometabolic diseases and/or inflammatory bowel diseases and, additionally, for use in the treatment, metabolic syndrome, pre-diabetes, diabetes, vascular and cardiac diseases, atherosclerosis, hyperlipidemia, hyperglycemia, NASH and/or NAFLD, Crohn's disease.
Vincent, C (WO2018/162726; 9/13/2018) relates to a heritable, commensal, gram-negative bacterium that is strictly anaerobic and non-spore-forming, from the family Christensenellaceae as a drug to combat overweight, obesity, cardiometabolic diseases and inflammatory bowel disease. Advantageously, the bacteria according to the invention are in particular capable of:
reduce the weight, and/or
decrease the visceral fat and the subcutaneous fat, and/or
preserve the lean mass, and/or
decrease liver fat and block fibrosis of the liver, and/or
decrease the size turn, and/or
normalize the blood pressure, and/or
reduce the inflammation of the intestinal barrier, of the organs and of the muscular or adipose tissues, in particular of the colon, and/or
reduce the permeability of the intestinal barrier by the action on the reconstitution of mucus, the closing of the tight junctions, the reactivation of hormonal receptors such as in particular TLR4, GPL2, CCK and/or regulate HDL cholesterol, LDL and total cholesterol and/or
regulate triglycerides, and/or
decrease blood sugar level and/or postprandial glycemia, and/or insulin resistance and/or insulin sensitivity.
reduce the inflammation of the intestine, in particular in inflammatory bowel diseases and in particular Crohn's disease.
However, the primary references do not particularly exemplify inclusion of a hypoglycemic or lipid-lowering drug or the Christensenella strain GDMCC No. 61117 as recited in claims 5 and 26.
Rawadi et al (WO 2020/216929; 10/29/2020 provided by Applicants) discloses the use of a bacterium of the Genus Christensenella in the prevention and/or treatment of hypertriglyceridemia in humans or animals, and also discloses a pharmaceutical composition containing the bacteria and also may contain statins, niacin, etc., e.g., lipid-lowering drugs.
Both the claimed Christensenella strain GDMCC No.61117 and the Christensenella minuta DSM 22607 strain disclosed in Rawadi were isolated from human feces, belonging to the same microbial genus. Microbial screening methods are conventional techniques in the field, and practitioners would readily employ standard screening protocols to obtain another Christensenella strain. Furthermore, both the claimed strain GDMCC No.61117 and the Christensenella minuta DSM 22607 strain disclosed in can be utilized to treat or prevent non-alcoholic fatty hepatitis, inflammatory bowel disease, and to combat overweight and obesity through interventions such as addressing visceral fat accumulation and intestinal permeability. The comparison between the Christensenella strain GDMCC No.61117 and the Christensenella minuta DSM 22607 strain in the claims did not yield any unforeseen technical effects. Subsequent propagation of the strains and the acquisition of sub clonal cells represent routine practices in the field, whose technical outcomes are reasonably predictable.
Although the Vincent references, Ley and Rawadi references do not disclose the deposit number to be GDMCC No: 61117, Rawadi does specifically recite a sequence at least 98.7% identity to SEQ ID NO: 1, the disclosed strain and the strains of the prior art reference appear to be identical to Applicants' given the source and the same recited functional abilities. If the claimed Christensenella strain and the Christensenella strains of the prior art are not the same, they appear to be obvious or analogous variants of the strain because they appear to possess the same or similar functional characteristics (i.e., treating the same conditions, from the same source, and of the same Genus/sp.). Since the Patent Office does not have the facilities for examining and comparing Applicant's strain with the strains of the prior art, the burden of proof is upon applicants to show an unobvious distinction between the material structural and functional characteristics of the claimed strains and those of the prior art. See In re Best, 195 USPQ 430, 433 (CCPA 19&&). It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the Christensenella bacteria with a hypoglycemic or lipid-lowering drug because these are drugs commonly used to treat obesity and high cholesterol, etc. and Rawadi et al (WO 2020/216929; 10/29/2020 provided by Applicants) specifically discloses the use of a bacterium of the Genus Christensenella in the prevention and/or treatment of hypertriglyceridemia in humans or animals, and also discloses a pharmaceutical composition containing the bacteria and also may contain statins, niacin, etc., e.g., lipid-lowering drugs. With respect to claim 25, given that GLP-1 drugs are also used to treat high cholesterol, diabetes and obesity, they would have been obvious choices to include in compositions such as those taught by Rawadi. With respect to claim 31, the term “vaccine” is an intended use only. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Prior Art, Not Presently relied upon:
Kenya et al (WO 2019/017389; 1/24/19). Christensenella minuta 16S rDNA sequence, SEQ ID 61 is 99.8% to SEQ ID NO: 1. It is an object of the present invention to provide a composition or the like for treating, ameliorating or preventing diseases such as Crohn's disease targeting oral bacteria inducing Crohn's disease or the like by fixing to the intestinal tract.
Fuenzalida et al (US Patent No. 11,805,774; priority 4/17/19 teaches a sequence 100% identical to SEQ ID NO: 1 -US 17/520,587; US20220144716A1; 5/12/22); Described herein are methods and compositions for improving plant growth and other properties. The methods and compositions utilize bacteria and bacterial exudates incorporated into plant seeds for improvement of plant growth and other properties.
Honda et al (Us Patent 11,633,433 99.8% identical to SEQ ID NO: 1- 16/633,433) and Honda et al (WO 20200179868, 9/10/2020 - PCT/JP2020/009423) Obtained from Intestinal Bacteria, K61 99.8%; an antibacterial composition against oral bacteria and the like capable of inducing Th1 cell proliferation or activation in an intestinal tract, the present inventors have found out that bacteria that suppress colonization and the like of the oral bacteria and the like in the intestinal tract are present in an intestinal microbiota. Moreover, the present inventors have succeeded in isolating intestinal bacteria that suppress intestinal colonization and the like of oral bacteria and the like.
(EP 3511407 A1) discloses a composition comprising the bacterial strain Christensenella intestinihominis, and the use of said composition in the treatment of obesity, in reducing blood lipid levels, preventing or treating cardiovascular diseases, and preventing or treating diabetes. D2 discloses Christensenella sp. 16S rRNA sequence SEQ ID NO: 1, which is 98.7% identical to the SEQ ID NO: 1 of the present application.
Rawadi: D8 (WO 2020/82916 A1) discloses a composition comprising a bacterial strain of Christensenella, including from the species Christensenella minuta, Christensenella massiliensis and Christensenella timonensis. D8 discloses Christensenella minuta 16s rRNA encoding gene SEQ ID 1, which is 98.7% identical to SEQ ID NO: 1 of the present application.
D10 (US 2017/042948 A1) discloses the bacterial strain Christensenella minuta 16S ribosomal RNA gene SEQ ID NO: 1, which is 98% identical to SEQ ID NO: 1 of the present application. D10 discloses a composition comprising said bacterial strain, and its use in the treatment of a subject selected from overweight, obesity, metabolic syndrome, excess adiposity, and diabetes.
(JOHNSON J.S. et al. 2019) discloses "that targeting of 16S variable regions with short-read sequencing platforms cannot achieve the taxonomic resolution afforded by sequencing the entire (~1500 bp) gene. We further demonstrate that full-length sequencing platforms are sufficiently accurate to resolve subtle nucleotide substitutions (but not insertions/deletions) that exist between intragenomic copies of the 16S gene".
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 5/22/26
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