DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claim 15 has been canceled.
Claims 1-14 and 16-18 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 1-3, in the reply filed on 7/22/2026 is acknowledged. The traversal is on the ground(s) that the prior art does not disclose, suggest, or make obvious the specific strain CNCM I-5828 claimed in the present application. This is found persuasive. Requirement for Restriction/Election filed on 6/4/2026 has been withdrawn.
Claims 1-14 and 16-18 are being examined in this application.
Claim Objections
Claims 4, 6, 9, and 16 are objected to because of the following informalities:
Claim 4, the recitation of “a bacterial strain” on line 1-2 is suggested to read “the bacterial strain”.
Claim 6, the recitation of “a bacterial strain” on line 4 is suggested to read “the bacterial strain”.
Claim 9, the recitation of “Parabacteroides distasonis” on line 4 should be italicized.
Claim 16, the recitation of “Parabacteroides distasonis” on line 3 should be italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 and 16-18 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention employs a Parabacteroides distasonis strain deposited under accession number CNCM I-5828. It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention. Therefore, a deposit for patent purposes is required.
It appears that a deposit was made in this application as filed as noted on page 24 para 190-193 of the instant specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Both Budapest Treaty and non-Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35 U.S.C. 122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985)(citing 35 U.S.C. 114)); and
(2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
In the instant case, it is not clear if a viability statement for the Parabacteroides distasonis strain deposited under accession number CNCM I-5828 is available (NOTE: The deposit filed on 9/26/2024 is acknowledged and reviewed). A statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that: (a) During the pendency of the 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 enforceable life of the patent, whichever is longer; and (d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 6-8, 12-14 and 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome, by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828, does not reasonably provide enablement for a method of treating the full scope of diseases and/or conditions, as well as preventing any or all of the diseases and/or conditions, by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828, as instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
The breadth of the claims – The breadth of the claims is drawn to a method of treating visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome, by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828.
The Nature of the invention – The nature of the invention is drawn to the administration of Parabacteroides distasonis strain deposited under accession number CNCM I-5828 for treating visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome.
The state of the prior art / The predictability or lack thereof in the art – The state of the prior art is that the pharmacological art involves screening in vitro and in vivo of the selected composition to determine the desired pharmacological activities (i.e. what compositions can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
Langtree (https://www.disabled-world.com/definitions/lists/incurable.php. 2020;1-8.) teaches a list of incurable diseases including terminal illnesses, which can not be treated (p.2 Overview).
Li (Molecular Pain. 2024;20:1-13.) teaches that since the underlying mechanisms of visceral pain remain largely unclear, clinical management is often limited and ineffective (Abstract). In addition, Li teaches that the mechanisms behind chronic visceral pain remain largely unknown, with symptoms that are often difficult to localize and describe, complicating both diagnosis and treatment (p.1 col left – para 1). Finally, Li teaches that the pathology of visceral pain is highly complex, and its exact mechanisms have not yet been fully elucidated, the specific molecular targets and neural circuits related to visceral pain remain incompletely understood, presenting significant challenges for developing targeted treatments (p.7 col right – para 3).
“Prevention” provides the expectation that the diseases and/or conditions do 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.
With respect to Applicant’s claim(s) to prevention, there are no known compositions that have been demonstrated to prevent any diseases and/or conditions including visceral pain instantly claimed.
The relative skill of those in the art – The relative skill of those in the art is high, with a typical practitioner possessing commensurate degree level, as well as several years of professional experience.
The amount of direction or guidance present – There is no direction or guidance present for the treatment of diseases and/or conditions other than visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome, as well as the prevention of any or all of the diseases and/or conditions, by administering the instant composition.
Examples 1-3 are provided in the specification for treating visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828, however, the disclosure does not provide how the in vivo data correlates to the treatment of the assorted diseases and/or conditions of the instant claims.
The presence or absence of working examples – The working examples present in the instant specification are directed to treating visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome (Examples 1-3). There are no working examples present for the treatment of diseases and/or conditions other than visceral pain induced by Ulcerative Colitis and Irritable Bowel Syndrome, by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828.
With respect to the prevention of instant diseases and/or conditions, there is no evidence of record, which would enable the skilled artisan in the identification of the subjects who have the potential of becoming afflicted with the numerous diseases and/or conditions claimed herein. That a single composition can be used to treat or prevent all diseases and/or conditions embraced by the claim(s) is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating or preventing any or all of the diseases and/or conditions by administering the instant claimed composition.
The quantity of experimentation needed – The quantity of experimentation needed is undue experimentation. One skill in the art would need to determine what diseases and/or conditions out of all the diseases and/or conditions instantly encompassed by the claims would be benefited by administering Parabacteroides distasonis strain deposited under accession number CNCM I-5828 and would furthermore then have to determine the claimed composition in the instant invention would provide treatment of the diseases and/or conditions. Furthermore, one of ordinary skill in the art would need to determine which patients not having particular diseases would otherwise develop them and administer the instant composition over such an extended period of time as to determine true prevention. Such a task has yet to be accomplished in the art and the instant specification provides no particular guidance on how to accomplish such a task.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genetech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases and/or conditions can be treated by the composition encompassed in the instant claims, with no assurance of success.
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 5, 9, 13, and 16 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 pre-AIA the applicant regards as the invention.
Claim 5, line 2, the recitation of “preferably” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
Claim 9, line 3, the recitation of “preferably” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
Claim 13, line 4, the recitation of “preferably” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
Claim 16, line 2, the recitation of “preferably” is indefinite as it is unclear if the limitation that follows is required to meet the scope of the invention.
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 1-5 and 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to a Parabacteroides distasonis strain deposited under accession number CNCM I-5828. Although applicant has discovered that Parabacteroides distasonis CNCM I-5828 occurs in nature, this discovery does not, by itself, render Parabacteroides distasonis CNCM I-5828 patent eligible. Based on the information provided in the instant specification, there is no indication that Parabacteroides distasonis CNCM I-5828 isolated from healthy human feces has any characteristics that are different from naturally occurring Parabacteroides distasonis strain. The claim therefore encompasses Parabacteroides distasonis CNCM I-5828 that is structurally and functionally identical to naturally occurring Parabacteroides distasonis strain. Because there is no difference between the claimed and naturally occurring strain, the claimed strain does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, claim 1 is directed to an exception. Claim 1 does not recite additional elements. Thus, claim 1 does not amount to significantly more than the judicial exception itself. Therefore, claim 1 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 2 recites the sequence structure of Parabacteroides distasonis CNCM I-5828. Based on the information provided in the instant specification, there is no indication that Parabacteroides distasonis CNCM I-5828 shown in the claimed SEQ ID No has any characteristics that are different from naturally occurring Parabacteroides distasonis strain. Therefore, Parabacteroides distasonis CNCM I-5828 is structurally and functionally identical to naturally occurring Parabacteroides distasonis strain. Because claim 2 does not amount to significantly more than the judicial exception itself. Therefore, claim 2 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 3 recites the source of Parabacteroides distasonis CNCM I-5828. Based on the information provided in the instant specification, Parabacteroides distasonis CNCM I-5828 is isolated from healthy human feces, there is no indication that the isolated Parabacteroides distasonis CNCM I-5828 has any characteristics that are different from naturally occurring Parabacteroides distasonis strain. Therefore, Parabacteroides distasonis CNCM I-5828 is structurally and functionally identical to naturally occurring Parabacteroides distasonis strain. Because claim 3 does not amount to significantly more than the judicial exception itself. Therefore, claim 3 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 4 recites a nutritional supplement composition comprising the Parabacteroides distasonis CNCM I-5828. Claim 4 does not recite additional elements. Thus, claim 4 does not amount to significantly more than the judicial exception itself. Therefore, claim 4 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 5 recites at least one acceptable nutritional ingredient. Vitamins and minerals are examples of acceptable nutritional ingredients. Based on the information provided in the instant specification, there is no indication that said acceptable nutritional ingredients including vitamins and minerals have any characteristics that are different from naturally occurring vitamins and minerals. In addition, the combination of Parabacteroides distasonis CNCM I-5828 and said acceptable nutritional ingredients does not change any characteristics of Parabacteroides distasonis CNCM I-5828 and said acceptable nutritional ingredients individually. Thus, the combination of Parabacteroides distasonis CNCM I-5828 and said acceptable nutritional ingredients does not amount to significantly more than the judicial exception itself. Therefore, claim 5 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 9 recites an amount of the Parabacteroides distasonis CNCM I-5828. Claim 9 does not recite additional elements. Thus, claim 9 does not amount to significantly more than the judicial exception itself. Therefore, claim 9 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 10 recites said Parabacteroides distasonis CNCM I-5828 are alive. Based on the information provided in the instant specification, there is no indication that live Parabacteroides distasonis CNCM I-5828 has any characteristics that are different from naturally occurring live Parabacteroides distasonis strain. Thus, claim 10 does not amount to significantly more than the judicial exception itself. Therefore, claim 10 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 11 recites said Parabacteroides distasonis CNCM I-5828 are dead. Based on the information provided in the instant specification, there is no indication that dead Parabacteroides distasonis CNCM I-5828 has any characteristics that are different from naturally occurring dead Parabacteroides distasonis strain. Thus, claim 11 does not amount to significantly more than the judicial exception itself. Therefore, claim 11 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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