DETAILED ACTION
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 .
The Preliminary Amendment filed on 11/24/2021 amending claims 5 and 6 and adding new claims 10 – 14 is acknowledged. Claims 1-14 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 11/24/2021 is acknowledged and has been considered.
Priority
This application claims benefit of priority to People’s Republic of China Application No. CN202010110327.X filed on February 24, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, a translation of the certified copy of the Chinese patent document was not provided. As such, the priority date of the instant application is January 08, 2021, the PCT filing date.
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 1-14 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 claims 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 invention appears to employ novel biological materials, specifically a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 deposited on October 08, 2019. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials. Applicant noted the strain, Blautia sp. B2132 was deposited on October 08, 2019 at the Common Microorganism Center of China Committee for Culture Collection of Microorganisms (Specification, Page 6, Line 3-4). It appears this deposit was not made under the Budapest Treaty. Additionally, Applicant has not provided an assurance statement.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 6 recites the limitation “the application according to claim 1” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. It is not clear what application is being referred to as claim 1 only encompasses a Blautia sp. B2132 strain, not an application.
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 non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claim 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a microorganism comprising a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296. This judicial exception is not integrated into a practical application because only an isolated strain of a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only an isolated strain of a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is claimed.
With regard to Step 1, the composition as claimed in claims 1-14 is a composition of matter.
With regard to Step 2A, prong one, claims 1, 2, 7 and 9 encompass a microorganism comprising a Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296. Thus, claims 1, 2, 7 and 9 are generally directed to a microorganism. It is indicated in the Specification that Blautia sp. B2132 strain was separated and identified from feces. Thus, it appears that the Blautia sp. B2132 strain is a natural strain that has been isolated. It is noted that isolating a natural microorganism, and then placing the isolated microorganism in a non-natural environment does not alter the structure of the microorganism. As such, the microorganism of claims 1, 2, 7 and 9, which only includes a Blautia sp. B2132 strain, is deemed a natural product.
With regard to Step 2A, prong two, claims 1, 2, 7 and 9 do not recite any additional elements in addition to Blautia sp. B2132 strain. As such, there is no additional element in claims 1, 2, 7 or 9 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the natural microorganism Blautia sp. B2132 strain, such that the claims as a whole are more than a drafting effort designed to monopolize the exception.
With regard to Step 2B, claims 1, 2, 7 and 9 do not recite any additional elements in addition to Blautia sp. B2132 strain. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
With regard to dependent claims 3, 4, 5, 6, 8 and 10-14, it is noted that these claims only recite elements that further characterize the natural product, or further natural components that can be included with the composition. With regard to dependent claim 3, water, which is a carrier, is an element abundantly found in nature, where the combination of water and Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is not deemed to render the composition non-natural. With regard to dependent claims 4 and 8, the recitation of the number of microbes present in the composition is not deemed to render the composition non-natural. With regard to dependent claims 5 and 10, it is noted lactose is naturally present in the milk of mammals, which is abundantly found in nature, where the combination of lactose and microbes of Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is not deemed to render the composition non-natural. With regard to dependent claims 6 and 11-14, it is noted these claims simply recite inflammatory bowel diseases the natural composition of Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296 is claimed to treat.
For the forgoing reasons, the microorganism as claimed is not deemed to encompass patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 101 and 112(b)
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.
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 2-6 and 10-14 recite the method of an application of the Blautia sp. B2132 strain in the preparation of a medicine for regulating the intestinal flora and preventing and/or treating an inflammatory bowel disease, but, since the claims do not set forth any steps involved in the method, it is unclear what method Applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delineating how this use is actually practiced.
Additionally, claims 2-6 and 10-14 are also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-5 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jeffery et al. (WO2018109461A1, 06/21/2018) (IDS Reference).
Regarding claims 1, 2 and 7, Jeffery et al. disclose a composition comprising a bacterial strain of the genus Blautia, for use in a method of treatment or prevention of IBS (irritable bowel syndrome) or IBD (inflammatory bowel disease) (Claim 10). It is noted the composition from the instant application as claimed is intended to be usable for preventing and/or treating an inflammatory bowel disease (Claim 2). As it does not appear the claimed microbe has been genetically modified and the prior art teaches a microbe with the same properties, preventing or treatment an inflammatory bowel disease, absent evidence to the contrary, the instant and prior art microbes appear to be the same. However, although the prior art teaches the same identifying properties, the art does not disclose the instant deposit number CGMCC NO. 1.5296. If the microbe taught by Jeffery et al. is not the same as the instant microbe and there is a slight variation, it would have been obvious to utilize the instant microbe since both have the same identifying properties
Regarding claim 3, Jeffery et al. disclose wherein the composition comprises one or more pharmaceutically acceptable excipients or carriers (Claim 28).
Regarding claims 4 and 8, Jeffery et al. disclose a suitable daily dose of the bacteria, for example for an adult human, may be from about 1 x 103 to about 1 x 1011 (Page 20, Lines 1-2).
Regarding claims 5 and 10, Jeffery et al. disclose the compositions of the invention may comprise pharmaceutically acceptable excipients or carriers. Examples of suitable carriers include lactose, starch, glucose, methyl cellulose, magnesium stearate, mannitol, sorbitol and the like (Page 20, Lines 29-30).
Regarding claim 9, Jeffery et al. disclose the compositions of the invention may be formulated as a food product (Page 21, Line 7).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffery et al. (WO2018109461A1, 06/21/2018) as applied to claim 1 above, and further in view of Crouzet et al. (CN 109789170 A, 05/21/2019) (IDS Reference).
Regarding claims 6 and 11-14, Jeffery et al. do not disclose the inflammatory bowel disease is ulcerative colitis or Crohn’s disease.
However, Crouzet et al. disclose a composition comprising a bacterial strain of the genus Blautia for use in a method of reducing the levels of Enterobacteriaceae in the gastrointestinal tract (Claim 1). Crouzet et al. further disclose wherein the composition is used in IBS, Crohn’s disease and ulcerative colitis (Claim 3).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that a Blautia sp. strain, including Blautia sp. B2132 strain with deposit number CGMCC NO. 1.5296, would be a preventative and/or treatment option for ulcerative colitis or Crohn’s disease since it was known in the art that strains of Blautia are used in the treatment of IBS, Crohn’s disease and ulcerative colitis as taught by Crouzet et al. Therefore, it would have been obvious the composition of Jeffery et al. would be used to treat Crohn’s disease and ulcerative colitis as it was disclosed the composition comprising a bacterial strain of the genus Blautia was for use in a method of treatment or prevention of IBS (irritable bowel syndrome) or IBD (inflammatory bowel disease) and Crohn’s disease and ulcerative colitis are types of inflammatory bowel disease and Crouzet et al. disclose a method for treating both with a probiotic composition comprising a bacterial strain of the genus Blautia.
Conclusion
Claims 1-14 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/J. E. ANGELL, Ph.D./Primary Examiner, Art Unit 1637
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