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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of the prior-filed applications PCT/CN2024/078282 and CN 202310169904.6 is acknowledged.
The disclosures of the prior-filed applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the phrase “subject in need thereof” recited in claim 1 is not supported by the prior filed applications.
Therefore, the priority date afforded to the present claims is October 16, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 16, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 – 8 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.
Claims 1 – 8 are drawn to a method for preventing hyperuricemia in a subject in need thereof, by administering a specific bacterial strain.
“Prevention” provides the expectation that the disorder/condition does not occur in response to a challenge or initiating event. While there is no requirement that prevention must be absolute in all cases, there is a reasonable expectation that some element of prevention can be shown. The standard for such is extremely high, and it is expected that the showing will be actual rather than implied, prophetic, or with a model. The standard of enablement is higher for such inventions because effective preventions of disease conditions are relatively rare and may even be unbelievable in the absence of strong supporting evidence.
The analysis of whether a claim is supported by the disclosure requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the art to make and use the claimed invention. The standards for determining whether this burden has been met, is by posing the question: is the experimentation needed to practice the invention undue or unreasonable? While a patent need not teach what is well known in the art, it must teach one in the art how to make and/use the claimed invention without undue experimentation. There are many factors to be considered when determining whether the disclosure satisfies the enablement requirement. These factors include but are not limited to the breadth of the claims; the nature of the invention; the state of the prior art; the level of one of ordinary skill in the art; the level of predictability in the art; the amount of direction provided by the inventor; the existence of working examples; and the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The claims are drawn to preventing hyperuricemia in a subject in need thereof. Because a “subject is need” is not defined in the specification and the claims recite “preventing,” the claims are not limited as it pertains to the treating population. Moreover, the treating population is interpreted to include any subject.
While it is known that gut microbiota is associated with serum urate levels, gout diagnosis and asymptomatic hyperuricemia, the little direct functional evidence that gut microbiome regulates urate serum levels is primarily based on animal models rather than humans and it remains unknown which genes are expressed in the human gut and which are involved in hyperuricemia (See Martínez-Nava et al., background). As such, the level of predictability in treating or preventing hyperuricemia any subject with a bacterial strain is high.
The specification fails to provide a sufficient amount of direction to carry out the claimed invention. The specification does not define who a subject might be let alone a subject in need of preventing hyperuricemia. In this regard, the specification fails to teach who an appropriate subject is such that the method can be practiced without undue practice and experimentation. The specification identifies a single dose administered to a single mouse population under a single set of circumstances with no discussion of extrapolation of the data point to other doses, other subjects or even other conditions, e.g., preventing versus treating hyperuricemia.
The specification includes a single example, wherein a specific mouse strain is treated with uric acid and uricase inhibitor oxalic acid to approximate a subject with hyperuricemia, followed by treatment with the claimed strain at a single dose. It is known in the art that rodents “exhibit significant differences in uric acid metabolic patterns from humans due to endogenous uricase activity, which” “limits the clinical translational value of relevant research findings” (See Cheng et al., p.7). In this regard, the single example fails to enable one in the art to practice the full scope of the claimed method, that is to prevent or treat hyperuricemia by administering any amount of the claimed strain to any subject. No examples demonstrate preventing hyperuricemia in any subject administered any dose of the claimed bacterial strain.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure is significant. The specification is silent on preventing hyperuricemia beyond an assertion that the bacterial strain will prevent the condition. No guidance or discussion is provided as it pertains to differences between a dose for treating versus preventing the condition; a dose for treating or preventing any other subject under any other condition; or any particular regimen that must be followed.
Therefore, the specification fails to describe the claimed invention 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.
Claims 1 – 8 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 does not provide clear evidence that the claimed biological material is known and readily available to the public; reproducible; and deposited per the deposit rules under 37 C.F.R 1.801 - 1.809.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001) (explaining how deposit may help satisfy enablement requirement); Merck and Co., Inc. v. Chase Chemical Co., 273 F. Supp. 68, 155 USPQ 139 (D. N.J. 1967); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 - 1.809) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts. (MPEP 2402).
Since the microorganism Alistipes indistinctus GDMCC 62983 is recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, a deposit of the microorganism may satisfy the requirements of 35 U.S.C. § 112. The specification does not disclose a repeatable process to obtain the microorganism and it is not apparent if the microorganism is readily available to the public. Moreover, because no taxonomic information appears in the specification, it is not clear what the microorganism actually is.
However, since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
Claims 2 and 8 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.
Claims 2 and 8 are drawn to a method of preventing or treating hyperuricemia in a subject by administering a bacterial strain thereto, wherein the bacteria is “a bacterial cellular component,” “a bacterial cellular extract,” and is formulated with a “plant extract” or “immunomodulator.”
These claims are considered genus claims that encompass a wide array of components and extracts. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of components and extracts, particularly with regard to any component that is allegedly the active agent (e.g., a cellular “component” or “extract”).
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all bacterial cellular components, bacterial cell extracts or plant extracts that might result from any single method of extraction, let alone any and all components and extracts that might arise from any extraction method. Examples of extraction methods include water extraction, ethanolic extraction, supercritical carbon dioxide extraction, microwave or ultrasound assisted extraction, and Soxhlet extraction. The various methods use different solvents, e.g., polar, intermediate polar, and non-polar, to yield differently soluble components; they may involve different methods of fractionation or purification, e.g., paper chromatography, thin layer chromatography, gas chromatography, and high-performance liquid chromatography; and may be obtained via mass spectrometry, infrared spectrometry, ultraviolet spectrometry, or nuclear magnetic resonances spectrometry (Abubakar et al.). Moreover, the various parameters of any given extraction method significantly influence what “extract” is obtained. The possible variations of extracts are limitless with potentially millions of types of extracts let alone any bioactive component. The instant disclosure fails to identify a single component or extract or how one might be obtained. In addition, the phrase “immunomodulator” encompasses agents that are known and also not yet known to have immunomodulating activity. The specification fails to recite any single agent with immunomodulating activity.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of “components” and “extracts” to reflect this variance in the genus since the specification does not provide any examples of such a genus of “bacterial cellular components,” “bacterial cellular extracts,” “plant extracts,” or “immunomodulator.” Accordingly, the specification fails to provide adequate written description for the genus of “bacterial cellular components,” “bacterial cellular extracts,” “plant extracts,” and “immunomodulator” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these components and extracts, the specification does not describe the claimed genera in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these components and extracts at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
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 – 8 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 and its dependents are drawn to a method of preventing or treating hyperuricemia, however are rendered indefinite for reciting “the subject in need” as the phrase lacks proper antecedent basis.
Claim 2 is rendered indefinite for reciting “a bacterial cellular component,” “a bacterial cellular extract” and “a supernatant” as these elements are not gut bacteria but products derived therefrom. Regarding a supernatant, the element is specifically a liquid broth remaining after removal of bacteria. Moreover, the limitations fail to further limit the claim on which it depends and are improper Markush members.
In claims 3 and 5, lines 1, the phrase “is formulated” renders the claims indefinite because it is unclear if the phrase intends to encompass unrecited steps of formulating, or if the phrase is merely referring to the form of a composition. Clarification is required.
In claim 7, the recitation of “a cell structure component” renders the claim indefinite because a cell structure component is not a metabolite. In this regard, the phrase does not further limit the claim on which it depends and is an improper Markush member.
Claim Rejections - 35 USC § 103
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 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.
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 1 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Henn et al. (US 2014/0199281) in view of Parker et al. (2020).
Regarding claim 1, Henn teaches methods of administering gut bacterium Alistipes indistinctus to reduce symptoms of dysbiosis and conditions such as hyperuricemia (abstract, 0008, 0017, 0039, p. 27, p. 257). Although the reference does not teach the claimed strain of A. indistinctus, the species was known in the art to have beneficial effects on human health, or was generally regarded as safe. In support, Parker teaches A. indistinctus is correlated in healthy control patients and has a protective role in liver disease (p.7). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to substitute various strains in the methods of Henn with a reasonable expectation for successfully administering the bacterium for treating the instant conditions.
Further, since the claims are drawn to preventing hyperuricemia and a “subject in need” is not defined, the treating population is not limited to any particular subject. As such, by administering the bacteria obtained by the teachings of Henn, one would be practicing the method as claimed.
Regarding claim 2, the bacterium is in the form of spores, or viable bacteria (0014).
Regarding claims 3 and 4, the bacteria is administered in the form of a solid or liquid (0119) for oral or injection administration (0118, 0120); a pharmaceutical (0015), dietary, nutritional, nutraceutical, food or feed (0016).
Regarding claims 5 – 8, the bacteria is formulated with pharmaceutical adjuvants, excipients, disintegrants, lubricants, sweeteners, binders, polysaccharides, vitamins, minerals, plant extracts, carbohydrates, gelatin (protein) and/or lipids (0014, p. 14 - 15).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 1 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rey et al. (US 2016/0000837) in view of Parker et al. (2020).
Regarding claim 1, Rey teaches methods of administering gut bacterium Alistipes indistinctus to subjects (abstract, 0058, 0101). Although the reference does not teach the claimed strain of A. indistinctus, the species was known in the art to have beneficial effects on human health, or was generally regarded as safe. In support, Parker teaches A. indistinctus is correlated in healthy control patients and has a protective role in liver disease (p.7). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to substitute various strains in the methods of Rey with a reasonable expectation for successfully administering the bacterium for treating the instant conditions.
Further, since the claims are drawn to preventing hyperuricemia and a “subject in need” is not defined, the treating population is not limited to any particular subject. As such, by administering the bacteria obtained by the teachings of Rey, one would be practicing the method as claimed.
Regarding claim 2, the bacteria are administered in viable form (0068).
Regarding claims 3 and 4, the bacteria is administered in the form of a solid, semi-solid or liquid (0069) for oral or injection administration (0067); a pharmaceutical, dietary, nutritional, food or feed (0067).
Regarding claims 5 – 8, the bacteria is formulated with pharmaceutical adjuvants, excipients, disintegrants, lubricants, binders, sweeteners (0069 – 0070, 0074), polysaccharides (abstract, 0007, claims), vitamins, minerals, carbohydrates, amino acids (0035), prebiotics, proteins, lipids (0037) and/or plant extracts (0074).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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