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
Claims 1-15 have been canceled.
Claims 16-31 are currently pending.
Election/Restrictions
Applicant’s election with traverse of Group I, Claims 16-28 and 30, and without traverse of species Akkermansia nuciniphila, a mental disorder, a nutritional agent, and in the form of a nutritional composition, in the reply filed on 7/20/2026 is acknowledged. The traversal is on the ground(s) that there would be no undue burden to search all groups together, and that Kim does not teach the administration of Akkermansia to populations having neurodegenerative or metabolic diseases. This is not found persuasive because as indicated by the rejections below, the groups do not share the special technical feature which contributes over the prior art at the time the invention was made.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-23, 26-27, 29, and 31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Note: In the requirement for Restriction/Election filed on 5/21/2026, Applicants were asked to elect a single discrete and disclosed species of a reward dysregulation disorder. Since Applicants failed to elect a proper species of the disorder, a mental disorder in claim 18 is being examined and claims 19-23 have been withdrawn from further consideration.
Claims 16-18, 24-25, 28, and 30 are being examined in this application, insofar as they read on the elected species of Akkermansia nuciniphila, a mental disorder, a nutritional agent, and in the form of a nutritional composition.
Claim Objections
Claims 17 and 25 are objected to because of the following informalities:
Claim 17, the recitation of “said bacterium” on line 1 is suggested to read “said one or more bacteria from the genus Akkermansia” to be consistent with the language recited in claim 16, since claim 17 is dependent from claim 16.
Claim 25, the recitation of “said active agent” on line 1 is suggested to read “said one or more active agent(s)” to be consistent with the language recited in claim 24, since claim 25 is dependent from claim 24.
Appropriate correction is required.
Claim Rejections – 35 USC § 112
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 16-18, 24-25, 28, and 30 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 restoring food reward behavior during obesity, and/or modulating inflammatory profile of microglial cells during obesity, by administering Akkermansia muciniphila, does not reasonably provide enablement for a method of treating the full scope of reward dysregulation disorders, including the claimed mental disorders, neurological disorders, and disorders due to side effects of a treatment, as well as preventing any or all of reward dysregulation disorders, by administering Akkermansia and/or extracts and/or fragments thereof, 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 restoring food reward behavior during obesity, and/or modulating inflammatory profile of microglial cells during obesity, by administering Akkermansia muciniphila.
The Nature of the invention – The nature of the invention is drawn to the administration of Akkermansia muciniphila for restoring food reward behavior during obesity, and/or modulating inflammatory profile of microglial cells during obesity.
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.
While a full discussion of each disorder which is encompassed by Applicant’s claim language will not be given, the following examples teach that the state of the prior art with respect to diagnosis and treatment of disorders has not advanced to the point of being predictive of the treatment of the breadth of disorders instantly claimed.
For instance, Hershfield (https://www.sheppardpratt.org/news-views/story/how-having-no-cure-for-ocd-is-the-cure/. 2019;1-3.) teaches that obsessive compulsive disorder involves ongoing intrusive thoughts and urges to repeat certain behaviors, and that treatments involve accepting uncomfortable physical sensations and unwelcome thoughts (p.1 para 2, p.2 para 6). In other words, accepting uncomfortable sensations and thoughts helps improve obsessive compulsive disorder.
In addition, Mayo Clinic (https://www.mayoclinic.org/diseases-conditions/autism-spectrum-disorder/diagnosis-treatment/drc-20352934. 2025;1-16.) teaches that there is no cure for autism spectrum disorder, that there is no one-size-fits-all treatment (p.2 para 3), and that there is little or no research on alternative or complementary therapies to show whether they are helpful, and some alternative treatments could be dangerous (p.5 para 2). Furthermore, Autism (https://autismsciencefoundation.org/beware-of-non-evidence-based-treatments/. 2025;1-4.) teaches that a treatment must be thoroughly investigated in multiple well-designed scientific studies and show measurable, sustained improvements in targeted areas (p.1 para 4).
“Prevention” provides the expectation that the diseases/disorders 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 reward dysregulation disorders 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 mental disorders, neurological disorders, and disorders due to side effects of a treatment, as well as the prevention of any or all of the reward dysregulation disorders, by administering the instant composition.
Examples 3-4 are provided in the specification for restoring food reward behavior during obesity, and Examples 5-6 are provided for modulating inflammatory profile of microglial cells during obesity, however, the disclosure does not provide how the in vivo data correlates to the treatment of the assorted disorders of the instant claims.
The presence or absence of working examples – The working examples present in the instant specification are directed to restoring food reward behavior during obesity and modulating inflammatory profile of microglial cells during obesity (Examples 3-6). There are no working examples present for the treatment of mental disorders, neurological disorders, and disorders due to side effects of a treatment, by administering the instant composition.
With respect to the prevention of instant diseases, 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/disorders or conditions claimed herein. That a single composition can be used to treat or prevent all diseases/disorders and 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/disorders 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, disorders, or conditions out of all the diseases, disorders, or conditions instantly encompassed by the claims would be benefited by administering Akkermansia muciniphila and would furthermore then have to determine the claimed composition in the instant invention would provide treatment of the diseases. 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 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.
Claim 18 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 pre-AIA the applicant regards as the invention.
Claim 18, line 1, the recitation of “said reward dysregulation disorder” is indefinite. Claim 18 is dependent from claim 16, and claim 16 recites “reward dysregulation disorders”. It is unclear what / which reward dysregulation disorder is referred to in claim 18.
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 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.
(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.
Claims 16-18, 24-25 and 28 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Cani et al (US 2018/0250347 A1; 9/6/2018.).
The instant claims recite a method of preventing and/or treating reward dysregulation disorders; comprising administering, to a subject in need thereof, a composition comprising one or more bacteria from the genus Akkermansia and/or extracts and/or fragments thereof.
A method of preventing reward dysregulation disorders is interpreted as a method comprising administering a composition comprising one or more bacteria from the genus Akkermansia and/or extracts and/or fragments thereof to any subjects, said subjects do not have to have reward dysregulation disorders.
Cani teaches a method for treating a metabolic disorder in a subject in need thereof comprising administering Akkermansia muciniphila or fragments thereof to the subject (Claim 17), wherein Akkermansia muciniphila is co-administered with one or more prebiotics (a nutritional agent) (Claim 23), Akkermansia muciniphila or fragment thereof is contained in a nutritional composition further comprising a nutritionally acceptable carrier (Claim 25, para 0024, 0162-0163), and said composition is orally administered (Claim 20, para 0024).
Therefore the reference anticipates the claimed subject matter.
Claims 16-18, 24-25, 28, and 30 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Hsiao et al (WO 2018/119048 A1; 6/28/2018. Cited on IDS).
The instant claims recite a method of preventing and/or treating reward dysregulation disorders; comprising administering, to a subject in need thereof, a composition comprising one or more bacteria from the genus Akkermansia and/or extracts and/or fragments thereof.
Hsiao teaches methods and compositions for the treatment or prevention of seizures in a subject with a neurodevelopmental disorder (mental disorders, reward dysregulation disorders), such as autism spectrum disorder, attention deficit/hyperactivity disorder (ADHD), depression, etc., comprising administering to the subject a composition comprising Akkermansia nuciniphila (p.2 line 3-13 & 18, p.9 line 15-26), wherein said compositions are food products (in the form of a nutritional composition) comprises vitamins, minerals (a nutritional agent), antioxidants, buffering agents, and flavorings (a nutritionally acceptable carrier) to achieve desirable nutrition (p.17 line 23 & 29 & 31-32). Hsiao teaches kits comprising compositions comprise Akkermansia nuciniphila (p.16 line 24-26), and said compositions may be formulated for oral or rectal delivery (p.2 line 28, p.13 line 4-6).
Therefore the reference anticipates the claimed subject matter.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16, 18, 28, and 30 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16, 18-21, 24, 26-27, and 29-30 of co-pending Application No. 18/580,828 (referred to as the ‘828 application).
Claims 16, 18-21, 24, 26-27, and 29-30 of the ‘828 application recite a method of reducing the likelihood of occurrence or re-occurrence of reward dysregulation disorders, and/or of treating reward dysregulation disorders; comprising administering, to an individual in need thereof, a composition comprising one or more bacteria from the genus Parabacteroides and/or an extract thereof, wherein the reward dysregulation disorder is selected in a group consisting of mental disorders, neurological disorders, and combinations thereof. The composition further comprises one or more beneficial microbe(s) including the genus Akkermansiaceae. The composition is in the form of a nutritional composition further comprising a nutritionally acceptable carrier, and the composition is comprised in a kit, which further comprises means to administer said composition.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17 and 24-25 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16, 18-21, 24, 26-27, and 29-30 of co-pending Application No. 18/580,828 (referred to as the ‘828 application) in view of Hsiao et al (WO 2018/119048 A1; 6/28/2018. Cited on IDS).
Claims 16, 18-21, 24, 26-27, and 29-30 of the ‘828 application recite a method of reducing the likelihood of occurrence or re-occurrence of reward dysregulation disorders, and/or of treating reward dysregulation disorders; comprising administering, to an individual in need thereof, a composition comprising one or more bacteria from the genus Parabacteroides and/or an extract thereof, wherein the reward dysregulation disorder is selected in a group consisting of mental disorders, neurological disorders, and combinations thereof. The composition further comprises one or more beneficial microbe(s) including the genus Akkermansiaceae.
The ‘828 application does not teach Akkermansia nuciniphila (claim 17), and a nutritional agent (claims 24-25).
However, the ‘828 application does teach a method of reducing the likelihood of occurrence or re-occurrence of reward dysregulation disorders, and/or of treating reward dysregulation disorders; comprising administering, to an individual in need thereof, a composition comprising one or more beneficial microbe(s) from the genus Akkermansiaceae, wherein said reward dysregulation disorders include mental disorders such as autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD). Hsiao teaches methods and compositions for the treatment or prevention of seizures in a subject with a neurodevelopmental disorder (mental disorders, reward dysregulation disorders), such as autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD), comprising administering to the subject a composition comprising Akkermansia nuciniphila (p.2 line 3-13 & 18, p.9 line 15-26), wherein said compositions are food products (in the form of a nutritional composition) comprises vitamins or minerals (a nutritional agent) to achieve desirable nutrition (p.17 line 23 & 29 & 31-32).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate Akkermansia nuciniphila and a nutritional agent, since the ‘828 application and Hsiao both disclose a method of treating reward dysregulation disorders include mental disorders such as autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD), comprising administering one or more beneficial microbe(s) from the genus Akkermansiaceae, and Hsiao specifically discloses that Akkermansia nuciniphila is preferably used in the treatment of mental disorders such as autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD), and that the treatment method comprises a nutritional agent. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate Akkermansia nuciniphila and a nutritional agent, with a reasonable expectation for successfully treating reward dysregulation disorders.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
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
Prosecution Insights