Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-15 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements filed 12/8/23, 5/1/25 and 5/22/25 have been considered and initialed copies are enclosed.
Specification
The abstract of the disclosure is objected to because it contains the implied phrase “the present invention relates”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Rejections - 35 USC § 112
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 1-15 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 is drawn to a composition comprising an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity, or a substance derived from the intestinal bacterium and having an inflammation reducing activity.
Claim 6 recites an ameliorating agent for an inflammatory disease, an autoimmune disease, or an infectious disease, the ameliorating agent comprising an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity, or a substance derived from the intestinal bacterium and having an inflammation reducing activity.
Claim 15 is drawn to a method for ameliorating an inflammatory disease, an autoimmune disease, or an infectious disease, the method comprising applying an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity, or a substance derived from the intestinal bacterium and having an inflammation reducing activity.
The claims, in part are drawn to a genus of substances derived from an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity
Substances derived from the intestinal bacterium encompasses different subcellular components, polysaccharide structures, lipids, plasmids, genomic DNA and these can be derived from different members of Bacteroidetes.
The specification describes bacterium belonging to genus Bacteroides that are anti-inflammatory such as Alistipes putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JTKB233), and Bacteroides intestinalis (JKB231). See figures 1-5.
However, the specification does not describe any substance derived from Bacteroidetes that has an inflammation reducing activity. The description of Alistipes putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JTKB233), and Bacteroides intestinalis (JKB231) is insufficient to describe the genus of said substances.
Although one of ordinary skill in the art could have screened for substances that are derived from Bacteroidetes that have inflammation reducing activity, the written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115 and possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895.
In view of these considerations, as of the effective filing date of the instant invention Applicants were not in possession of the genus of substances derived from the intestinal bacterium Bacteroidetes that has inflammation reducing activity.
Claims 5, 10 and 14 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 Alistipes putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JKB233), and Bacteroides intestinalis (JKB231). Because it is not clear that these bacteria are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims these bacteria, a suitable deposit for patent purposes is required. Exact replication of these bacteria is an unpredictable event.
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 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 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 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 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;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of 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 nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of 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.
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.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is 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.
The method of claim 15 comprises applying an intestinal bacterium belonging to Bacteroidetes. The metes and bounds of “applying” is indefinite. It is not clear how or where or to whom the intestinal bacterium is “applied”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 is drawn to a composition comprising an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity, or a substance derived from the intestinal bacterium and having an inflammation reducing activity.
Claim 6 recites an ameliorating agent for an inflammatory disease, an autoimmune disease, or an infectious disease, the ameliorating agent comprising an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity, or a substance derived from the intestinal bacterium and having an inflammation reducing activity.
Claim 12 recites a pharmaceutical product comprising the ameliorating agent and claim 13 recites a food comprising the ameliorating agent.
Claim 14 recites a microorganism selected from the group consisting of Alistipes
putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JKB233), and Bacteroides intestinalis (JKB23 1).
STEP 1: THE CLAIMS ARE DRAWN TO A COMPOSITION OF MATTER
STEP 2A PRONG ONE – THE CLAIM RECITES A JUDICIAL EXCEPTION -SEE MPEP 2106.4
The claims recite bacterial strains which can be isolated from the intestine of a human such as intestinal Bacteroidetes. Alistipes putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JKB233), and Bacteroides intestinalis (JKB23 1) were isolated from the feces of a patient with ulcerative colitis. Substances derived from the intestinal bacterium are recited at a high level of generality and are nature based and are not substantially different from the substance as it exists in the bacteria. The substances are interpreted broadly to include subcellular component, proteins, DNA and RNA of the bacteria. These are products of nature that are not markedly different as they were from the bacteria.
Thus, the bacteria and substances derived from the bacteria are products of nature.
Regarding combination of one or more intestinal bacteria, there is no evidence that combining the bacteria results in markedly different characteristic of any of the bacteria Therefore, the combination of bacteria is nature-based and each bacteria in the combination is compared to its natural counterpart. As set forth above, each of the bacteria is a product of nature.
The food of claim 13 is recited at a high level of generality and encompasses a food such as milk or wheat grain, for example. This combination does not exist in nature and therefore each component is compared to its natural counterpart. There is no evidence that the combination of grains or an edible plant results in markedly different characteristic of any of the component. This each component is a product of nature.
STEP 2A PRONG TWO – THE CLAIM DOES NOT RECITE ADDITIONAL ELEMENTS THAT INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION. SEE MPEP 2106.4
Next, the claim as a whole is analyzed to determine whether any additional element or combination of elements that integrates the judicial exception into a practical application is recited. The claims do not recite additional elements that integrate the judicial exception into a practical application such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of administering the intestinal bacteria to a subject and not an intended use of the composition. See MPEP 2106.04(d)(2).
STEP 2B – THE CLAIMS DO NOT AMOUNT TO SIGNIFICANTLY MORE. SEE MPEP 2106.05.
Next, the claims as a whole is analyzed to determine whether any additional element, or combinations of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. The claims does not recite any additional elements that is sufficient that the claim amounts to significantly more than the exception.
These claims do not recite any meaningful additional limitations, modification(s) or transformation(s) of the products of nature.
Thus, the claims as a whole does not amount to significantly more than the “product of nature” by itself. Thus, the claims do not qualify as eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-9, 11, 12 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neff et al. Cell Host Microbe., 2016, vol. 20, no. 4, pp. 535-547 cited in IDS.
Neff et al discloses a composition comprising Bacteroides cellulosilyticus bacterial strain DSM 14838, which produces zwitterionic capsular polysaccharides and administered to TNBS-induced colitis model mice reduced histological evidence of inflammation in TNBS-induced colitis model mice and attenuated the colitis in the mice; and that said bacterial strain exhibits an IL-10 induction effect (abstract, p, 6 third paragraph, p. 7 2nd and 3rd to p. 8 and under discussion and p. 12 paragraph 3).
Thus, said Bacteroides cellulosilyticus bacterial strain DSM 14838 exhibits an anti-inflammatory activity and is therefore an ameliorating agent for an inflammatory disease, an autoimmune disease or an infectious disease which belongs to Bacteroidetes.
Claim(s) 1-4, 6-9, 11-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry et al. US 2016/0271188 9/22/2016.
Berry et al disclose a composition comprising at least one intestinal bacteria selected from the group consisting of Alistipes putredinis, Bacteroides intestinalis, Bacteroides cellulosilyticus and Bacteroides dorei. See paragraph 665 and 666.
Berry et al disclose a pharmaceutical product comprising the intestinal bacterium. See paragraphs 846-876.
Berry et al disclose a food product comprising the intestinal bacterium. See paragraphs 867-869.
Berry et al disclose the intestinal bacteria are anti-inflammatory and are used for prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health. Berry et al disclose compositions comprising the bacterium are advantageous in being suitable for safe administration to humans and other mammalian subjects and are efficacious for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of a subject and for the treatment, prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health. See paragraph 639.
Thus, the intestinal bacteria of Berry et al are the same as claimed and can perform the intended use as an ameliorating agent for an inflammatory disease, an autoimmune disease, or an infectious disease, the ameliorating agent comprising an intestinal bacterium.
Berry et al disclose a method for ameliorating inflammation, autoimmune and inflammatory disorders the method comprising applying the intestinal bacterium belonging Bacteroidetes such as Alistipes putredinis, Bacteroides cellulosilyticus or Bacteroides dorei having an inflammation reducing activity.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 9-10 and 13 of copending Application No. 18/549,832 (‘832).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘832 claims disclose:
A composition comprising an intestinal bacterium belonging to Bacteroidetes wherein the intestinal bacterium is at least one selected from the group consisting of Alistipes putredinis, Bacteroides cellulosilyticus, Bacteroides dorei, and Bacteroides intestinalis. The ‘832 claims disclose the intestinal bacterium are Alistipes putredinis (JKB232A), Bacteroides cellulosilyticus (JKB161), Bacteroides dorei (JTKB233), and Bacteroides intestinalis (JKB231).
The ‘832 claims disclose the same bacteria and they inherently possess an inflammation reducing activity selected from anti-inflammatory activity, an immunoregulation activity, an epithelial barrier restoring activity, an IL-10 inducing activity and an IL-22 inducing activity.
The ‘832 claims disclose the bacteria is an ameliorating agent (see claim 8) and thus is a pharmaceutical product. The ‘832 claim 13 discloses that a food can comprise an ameliorating agent. Therefore, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to make a food comprising the ameliorating agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 9-10 and 13 of copending Application No. 18/549,832 (‘832) as applied to claims 1-14, further in view of Berry et al. US 2016/0271188 9/22/2016.
The ‘832 claims do not disclose a method for ameliorating an inflammatory disease, an autoimmune disease or an infectious disease, the method comprising applying an intestinal bacterium belonging to Bacteroidetes and having an inflammation reducing activity.
Berry et al disclose a composition comprising at least one intestinal Bacteroidetes bacteria selected from the group consisting of Alistipes putredinis, Bacteroides cellulosilyticus, Bacteroides intestinalis and Bacteroides dorei. See paragraph 665 and 666.
Berry et al disclose a pharmaceutical product comprising the intestinal bacterium. See paragraphs 846-876.
Berry et al disclose a food product comprising the intestinal bacterium. See paragraphs 867-869.
Berry et al disclose the intestinal bacteria are anti-inflammatory and are used for prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health. Berry et al disclose compositions comprising the bacterium are advantageous in being suitable for safe administration to humans and other mammalian subjects and are efficacious for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of a subject and for the treatment, prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health. See paragraph 639.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have applied the composition of the ‘832 claims comprising Bacteroidetes bacteria to a subject in need thereof, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Berry et al disclose that intestinal bacteria such as Alistipes putredinis, Bacteroides intestinalis, Bacteroides cellulosilyticus and Bacteroides dorei are anti-inflammatory and are used for prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health.
Berry et al further discloses that intestinal bacteria are suitable for safe administration to humans and other mammalian subjects and are efficacious for the reconstitution, modulation, or creation of a beneficial bacterial flora in the gastrointestinal tract of a subject and for the treatment, prevention, reduction and amelioration of inflammation, autoimmune and inflammatory disorders, gastrointestinal disorders, dysbiosis, e.g., gastrointestinal or distal dysbiosis, disorders associated with dysbiosis, and for general nutritional health.
Status of Claims
Claims 1-15 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645