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 .
Detailed Action
Response to Amendments
The amendments made to the claims, drawings, and specification on 06/11/2026 have been entered.
Information Disclosure Statement
The information disclosure statement submitted 06/01/2026 has been considered.
Restriction/Species Election
Examiner has expanded search and examination to include the bacteria of claims 54 and 55. Claims 54 and 55 are rejoined.
Withdrawn Rejections
In view of the amendments made, the 112(b) rejections, the 102 rejection, and the 103 rejection made in the prior office action have been withdrawn.
New Rejection
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 51, 56-64, and 72 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 the treatment of dysbiosis characterized by a malcolonization of the human intestine via pathogenic germs of the family Prevotellaceae and/or the genus Prevotella, does not reasonably provide enablement for all pathogenic germs. Similarly, the claims are also enabled for the health-promoting and non-pathogenic germs of the family Ruminococcacea and/or the genus Ruminococcus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly discussed:
(A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth of the claims
Claim 51 states “A method for the treatment of dysbiosis characterized by a malcolonization of the human intestine with pathogenic germs…wherein the method comprises…reducing pathogenic germs in the human intestine and reducing the colonization of the human intestine with pathogenic germs and additionally comprises increasing the colonization of the human intestine with at least one of health-promoting and non-pathogenic germs, wherein the pathogenic germs are selected from the group consisting of inflammation-causing bacteria, inflammation-inducing bacteria and bacteria associated with inflammations in the human body and combinations thereof and wherein the health-promoting and non-pathogenic germs are selected from the group consisting of inflammation-reducing germs, anti-inflammatory germs and inflammation-inhibiting germs and combinations thereof.”
Claims 52-55 specify the family and/or genus of these pathogen and non-pathogenic germs.
The instant specification does not define either of these terms. Therefore, the broadest reasonable interpretation includes all pathogenic germs of the group consisting of “inflammation-causing bacteria, inflammation-inducing bacteria and bacteria associated with inflammations in the human body” and all non-pathogenic germs of the group consisting of “inflammation-reducing germs, anti-inflammatory germs and inflammation-inhibiting germs”.
Nature of the invention
The invention is a clinical method that involves identifying a subject suffering from dysbiosis characterized by malcolonization and administering 1,8-cineole in a dosage form that is resistant to gastric acid.
State of the prior art
Gastric acid-resistant forms of 1,8-cineole are known within the art as discussed by Juergens (cited in the prior office action). Juergens also discusses the efficacy of this dosage form in treatment of acute bronchitis, sinusitis, and respiratory infections.
1,8-cineole’s efficacy against germs of Prevotella intermedia are discussed in Ramak (cited in the prior office action).
Where the prior art differs from the instant claims is that the instant claims are drawn to infection in the human intestine as opposed to the sinus and respiratory system. A search of the art does not give any teachings that would indicate to one of ordinary skill in the art that administration of 1,8-cineole would be effective for treating intestinal malcolonization by germs of the family and/or genus Prevotella or family Prevotellaceae. The critical difference here is a difference in the patient population.
A review of the connection between Prevotella bacteria and the immune response in chronic inflammatory disease is found in Larsen (Immunology, 2017, 151, 363-374). The review does not show a strong connection between the malcolonization of the gut and the current use of Soledum® to treat respiratory issues.
Guidance and Working Examples
The instant specification discusses the effect on the intestinal microbiome after administering 1,8-cineole (p. 52, Example 1). The specification (p. 53, l. 14-19) states “The relevant studies show a clear shift in the composition of the intestinal microbiome of patients with polyposis nasi after taking 1,8-cineole for 2 weeks. Fig. 2 illustrates the influence of 1,8-cineole on the intestinal microbiome of patients with polyposis nasi.”
The instant specification on p. 54, l. 12-15 discloses that “Further evaluations of the microbiome sequencing performed also lead to the identification of a significant increase in bacteria of the family Ruminococcacea or the genus Ruminococcus as a result of ingestion of 1,8-cineole…”.
These are the only bacteria genera discussed in the specification. No working examples for other bacteria are shown.
Predictability
The art regarding Prevotella bacteria and 1,8-cineole is well known as applied to respiratory systems. However, in regards to the full scope of all pathogenic bacteria, the art does not clearly show that 1,8-cineole can predictably treat dysbiosis characterized by malcolonization by all pathogenic germs and does not predictably increase the colonization of all non-pathogenic, health-promoting germs.
This new rejection has been necessitated as applicant as amended the claims to exclude dysbiosis in the respiratory system.
Allowable Subject Matter
Claims 52-55 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 51, 56-64 are rejected.
Claims 52-55 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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