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
Filing Receipt and Priority
The filing receipt mailed 03/04/2024 states that the instant application is a 371 of PCT/EP21/77049, filed 10/01/2021.
The filing receipt also states that the instant application claims foreign benefit of German application GERMANY 10 2020 134 587.9, filed 12/22/2020.
The instant claims find support in the certified copy of the German application. The effective filing date is 12/22/2020.
Information Disclosure Statement
As of the date of this action, no information disclosure statement has been received.
Restriction/Species Election
Applicant’s election of Group I, claims 51-64 s acknowledged. Applicant has canceled claims 65-71.
Applicant’s election of “bacterial belonging to the family of Prevotellaceae” and a excipient “miscible with 1,8-cineole selected from the group consisting of triglycerides of C6-C12-fatty acids”. Examiner notes that the species election stated to elect one species from pathogenic germ and triglycerides. At examiner’s discretion, search and examination included the elected genera.
Claims 54 and 55 are withdrawn being drawn to a non-elected species.
Drawings
The drawings have been objected to for the following reasons:
-Figure 1 lacks a legend,
-Figures 5A and 5B lack an X-axis title.
Claim Objections
Claims 52-53, 61, and 62 are objected to for the following informalities.
Claim 52 states “wherein the pathogenic germs are selected from the group consisting of bacteria belonging to the family Prevotellaceae”.
Claim 53 states “wherein the pathogenic germs are selected from the group consisting of bacteria belonging to the Genus Prevotella.”
The claims should instead state “wherein the pathogenic germs are bacteria belonging to the family Prevotellaceae” (claim 52) and “wherein the pathogenic germs are from bacteria belonging to the family Prevotella”.
Similarly, claims 61 and 62 state “wherein the physiologically acceptable excipient…is selected from the group consisting of triglycerides of C6-C12-fatty acids.” The claims should state “wherein the physiologically acceptable excipient…is a triglyceride of C6-C12-fatty acids.”
Essentially, the above claims use Markush language but list only one species. It not necessary to claim a group when there is only one member of said group.
Claim 51 is objected to for alternating between “active ingredient” and “active agent”. Claim 51 states “a therapeutically effective amount of a 1,8-cineole as an active ingredient…wherein the 1,8-cineole is administered as the only active agent and in the absence of any further active ingredients other than 1,8-cineole”.
Rejections
Claim Rejections - 35 USC § 112(b)
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.
Indefinite Claim Language
Claims 51-53 and 56-64 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 51 states “A method for the treatment of a dysbiosis including a malcolonization of the human intestine with pathogenic germs…”. This limitation is indefinite because dysbiosis is broader than “malcolonization of the human intestine with pathogenic germs”.
“Dysbiosis” is not defined within the specification. The broadest reasonable interpretation from within the art includes “an imbalance in the different types of microscopic organisms living in [the] body” (taken from Cleveland Clinic, url= https://my.clevelandclinic.org/health/diseases/dysbiosis, accessed 03/04/2026). Therefore, including the narrow limitation “malcolonization of the human intestine with pathogenic germs” is indefinite because it is unclear if applicant is claiming a method to treat dysbiosis (general) or a method to treat dysbiosis of the human intestine specifically. Further it is unclear from the claim language if the “pathogenic germs” are causing the “dysbiosis” or if they are causing the “malcolonization”.
Similarly, claims 56 and 57 are drawn to broader methods. Claim 56 states “wherein the method additionally comprises, via administering the 1,8-cineole, the regeneration and rehabilitation of the microbial colonization of the human intestine including the human intestinal flora.” Claim 57 states “wherein the method additionally comprises, via administering the 1,8-cineole, increasing the germ diversity and diversifying the germ colonization of the human intestine including the human intestinal flora.
As stated above, the broadest reasonable interpretation from within the art includes “an imbalance in the different types of microscopic organisms living in [the] body”. The claims are unclear, especially when including claims 56 and 57, because the claim language does not specify whether the method is treating general dysbiosis or malcolonization of the gut.
Claim 51 states “inflammation inducing bacteria” and “bacteria associated with inflammations”. Additionally, claim 51 states “inflammation-reducing germs”, ”anti-inflammatory germs”, and “inflammation-inhibiting germs”. The specification on p. 53, states “the analyses of the microbiome show that the bacterial genus Prevotella is very prominently present at a pathogenic or pro-inflammatory germ in the intestines…” and the specification further contemplates “health-promoting or non-pathogenic germs” on p. 21, l. 25-29, and on p. 22, l. 1-6. However, none of these terms are explicitly defined within the specification. Because of this, the terms are indefinite because the claim does not state specific “inflammation inducing bacteria” and “bacteria associated with inflammations.” Similarly, the claim does not state specific “anti-inflammatory germs”, “inflammation-reducing germs”, or “inflammation-inhibiting germs.” The specification is also silent regarding what germs and/or bacteria would be represented by these terms. Therefore, one of ordinary skill in the art would not know the metes and bounds of the claim.
Claim 51 states “wherein the 1,8-cineole is administered as the only active agent and in the absence of any further active ingredients other than 1,8-cineole.” The term “active ingredients” is not defined. The instant specification contemplates 1,8-cineole as the sole active ingredient used in the composition. Examples of other “active ingredients” are contemplated in the specification, such as on p. 38, l. 18-24. Contemplated active ingredients include “anti-inflammatory active ingredients”, “non-steroidal anti-inflammatory drugs”, “steroidal anti-inflammatory drugs” such as corticosteroids, antibiotics, prebiotics, and microorganisms positively influencing the intestinal flora. Therefore, the term “active ingredients” one of ordinary skill in the art would not know the metes and bounds of the claim.
Claim 51 states “wherein the method comprises, via administering the 1,8-cineole, reducing pathogenic germs…”. From the claim language it is unclear if the claimed method further comprises “reducing pathogenic germs…” or if the claimed method also includes “reducing pathogenic germs…” in one step with the claimed ‘first step of administering…”.
Regarding the rejections above, as claims 52-53 and 56-64 are dependent on claim 51, they are also rejected within the above rejections.
Claim 60 states “Wherein the 1,8-cineole is administered as a pure substance having a purity degree of at least 95 wt.-%, based on the 1,8-cineole, and in the absence of any other terpenes.”
The claim does not specify how purity can be assessed. The instant specification also does not discuss how this purity is determined. The instant specification does state on p. 17 “Technically or pharmaceutically purified 1,8-cineole, which can generally be present with a 99.6% to 99.8% purity, is generally obtained by fractional distillation of eucalyptus oil.” However, it is not clear from the specification or the claim how one of ordinary skill in the art would be able to determine the purity of the 1,8-cineole.
Additionally, claim 60 states “in the absence of any other terpenes”. Claim 51 states “wherein the 1,8-cineole is administered as the only active agent.” The use of “in the absence of any other terpenes” introduces indefiniteness.
Claims 61 and 62 state “wherein the 1,8-cineole is administered together with at least on physiologically acceptable excipient”. Claim 51 states “wherein the 1,8-cineole is applied as a systemic dosage form which is resistant to gastric juice but soluble in the small intestine”. Claims 61 and 62 introduce indefiniteness as the method implied a physiologically acceptable excipient (“form which is resistant to gastric juice but soluble in the small intestine”. Applicant may amend the claim to state “further comprises at least one physiologically acceptable excipient”.
Claim 62 states “wherein the composition comprises the 1,8-cineole in relative amounts, based on the composition, in the range of from 0.01 to 60 wt.-%.” The claim language is not clear regarding the exact meaning of “relative amounts”. Examiner recommends amending the claim to read “wherein the composition comprises the 1,8-cineole in a range of from 0.01 to 60 wt.-% based on the total weight of the composition”.
Claim Rejections - 35 USC § 102
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.
Claim(s) 51, 56-64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Juergens (Respiratory Medicine, Vol. 97, 2003, 250-256) as evidenced by NIH (Dietary Supplemental Label Databse, Soledum, url= https://dsld.od.nih.gov/label/64978, accessed 03/04/2026) and My Dr. XM (My Dr. XM, Product Page, Soledum®, url= https://mydrxm.com/products/soledum-100-mg-20-capsules, accessed 03/03/2026).
Juergens on 251, left col., para. 2 states “In Germany, 1,8-cineol is registered as a licensed medicinal product and available since many years in small gut-soluble capsules (Soledum™ capsules, Cassella-med, Cologne, Germany) containing 100mg cineol per capsule for the treatment of acute and chronic bronchitis, sinusitis, and respiratory infections. 1,8-Cineol is well tolerated at a dosage of 600 mg/day (3x2 capsules)…” Juergens continues stating “1,8-Cineol is extensively distributed into tissues and has a long terminal half-life, which reflects the slow release of the monoterpene from these tissues back into plasma after dosing has ceased.”
NIH and My Dr. XM disclose the ingredients of Soledum, shown below.
NIH Label Database
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My Dr. XM Ingredient Listing
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See attached references for full details.
The instant specification on p. 29, l. 1-5 states “For the application of Cineole, especially 1,8-cineole, various preparations are commercially available, especially on the basis of generally entericcoated (resistant to gastric juice), but small intestine soluble dosage forms or capsules (e.g. Soledum® capsules or Soledum® forte capsules…)”.
Additionally, the instant specification on p. 31, l. 14-24 states “medium-chain triglycerides, such as are preferably used according to the invention as a carrier or excipient for the monoterpene-containing active ingredient, are especially semisynthetic neutral glycerol esters of saturated, generally unbranched monocarboxylic acids of medium chain length (i.e. C6-C12-chains). Especially, the term medium -chain triglycerides refers to mixtures of triglycerides of saturated fatty acids, mainly caprylic acid (octanoic acid) and capric acid (decanoic acid). Medium-chain triglycerides can generally be produced from oil extracted from the solid and dried part of the endosperm of Cocos nucifera L. [coconut]…).
Regarding claims 51, 56-57, which include limitations under the condition “via administering the 1,8-cineole”, the limitations are considered intended uses and do not give patentable weight to the claims. Claim 51 states “wherein the method comprises, via administering the 1,8-cineole, reducing the pathogenic germs in the human intestine and reducing the colonization of the human intestine with pathogenic germs…”. Similar language is found in claims 56 and 57. Essentially, the administration of the 1,8-cineole leads to these effects. Any method that involves administering 1,8-cineole would lead to these effects. Therefore, one of ordinary skill would recognize that the disclosure in Jurgens anticipates these claims.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 51-53 and 56-64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Juergens (cited above) in view of Ramak (Microbial Pathogensis, 124, 2018, 272-278) as evidenced by NIH (cited above) and My Dr. XM (cited above).
Discussion of Juergens, NIH, and My. Dr XM from the 102 rejection above is incorporated here.
Claims 52 and 53 specify pathogenic germs consisting of bacteria belonging to the family Prevotellaceae (claim 52) and belonging to the genus Prevotella (claim 53).
Juergens does not specifically discuss bacteria belonging to the family Prevotellaceae or the genus Prevotella. This is addressed by the combination of Ramak.
Ramak on p. 275, Fig. 2 teaches that 1,8-cineole has antibacterial effects against Prevotella intermedia.
Ramak, Fig. 2
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Considering this teaching from Ramak, one of ordinary skill in the art could apply the Soledum® of Juergens to treat infections of Prevotellaceae bacteria as Ramak directly teaches that 1,8-cineole, the main ingredient of Soledum®, inhibits growth of Prevotella intermedia.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to take Soledum® and treat dysbiosis caused by bacteria of the family Prevotellaceae and genus Prevotella.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624