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
This office action is in response to applicant’s reply filed on April 22, 2026.
Previous office action mailed on July 15, 2026, is withdrawn and it is being replaced with this one.
Restrictions/Elections.
Applicant election of the following species: COPD, as the condition requiring an anti-inflammatory agent, is acknowledged.
Since the above species is free of prior art, the examination was expanded to melanoma cancer (a skin inflammatory disease).
Status of Claims
Claims 9-18 are currently pending and are the subject of this office action.
The elected species (COPD) is encompassed by claims 9-18.
The expanded species (melanoma) is encompassed by claims 9-18.
The combined set of claims that read on one or both species, and consequently are under examination, are claims 9-18.
Priority
The present application is a 371 of PCT/EP2022/25336 filed on 07/20/2022 and claims priority to foreign application ITALY IT102021000019355 filed on 07/21/2021.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (New Rejection not Necessitated by Amendment).
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 9-18 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 the treatment of certain conditions requiring an anti-inflammatory agent or anti-asthmatic agent in a subject in need thereof (see next scope of enablement rejection below), does not reasonably provide enablement for the prevention of a condition requiring an anti-inflammatory agent or anti-asthmatic agent in a subject in need thereof. 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. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 9-18 recite:
A method of preventing and/or treating a condition requiring an anti-inflammatory agent or anti-asthmatic agent in a subject in need thereof, comprising administration of an effective amount of budesonide 21-phosphate sodium salt of Formula (II) FORMULA II:
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2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with an M.D. degree and several years of experience.
3. The state and predictability of the art
First, the term prevention is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of a condition requiring an anti-inflammatory agent or anti-asthmatic agent do not yet suffer from a condition requiring an anti-inflammatory agent or anti-asthmatic agent, and if they were to be administer a compound of Formula (II) according to the instant claims, they will never ever suffer from a condition requiring an anti-inflammatory agent or anti-asthmatic agent. The general knowledge of the prior art clearly indicates that the art of preventing any diseases including a condition requiring an anti-inflammatory agent or anti-asthmatic agent is highly unpredictable.
Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of a conditions requiring an anti-inflammatory agent or anti-asthmatic agent with any drug.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure.
The instant claims recite a broad spectrum of conditions requiring an anti-inflammatory agent or anti-asthmatic agent.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with specific and useful teaching.’ The law requires an enabling disclosure of nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification teaches some examples (see specification pages 15-24) that correlate with the administration of a compound of Formula (II) with the treatment of certain conditions requiring an anti-inflammatory agent or anti-asthmatic agent.
Thus, while the specification provides a procedure for treating certain conditions requiring an anti-inflammatory agent or anti-asthmatic agent, the specification appears to be silent on a nexus between treating conditions requiring an anti-inflammatory agent or anti-asthmatic agent and preventing a conditions requiring an anti-inflammatory agent or anti-asthmatic agent.
As such, if there is no correlation then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the prevention (100% success) of conditions requiring an anti-inflammatory agent or anti-asthmatic agent, is required for practice of the claimed invention.
6. The Quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 5), the skilled in the art will not accept that the administration of a composition a compound of Formula (II), can prevent (100% success) conditions requiring an anti-inflammatory agent or anti-asthmatic agent as inferred by the claims and contemplated by the specification.
7. Conclusion
Accordingly, the inventions of claims 9-18 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
Claim Rejections - 35 USC § 112 (New Rejection not Necessitated by Amendment).
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 9-18 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 the treatment of asthma, COPD, pulmonary fibrosis, psoriasis, rheumatoid arthritis, lupus and arthralgia, does not reasonably provide enablement for the treatment of any other condition requiring an anti-inflammatory agent or anti-asthmatic agent. 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. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 9-18 recite:
A method of preventing and/or treating a condition requiring an anti-inflammatory agent or anti-asthmatic agent in a subject in need thereof, comprising administration of an effective amount of budesonide 21-phosphate sodium salt of Formula (II) FORMULA II:
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2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with an M.D. degree and several years of experience.
3. The state and predictability of the art
A search of the prior art shows that the compound of Formula (II) has been previously used only to treat melanoma (a skin inflammatory disease) (Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant). There is no prior art regarding the efficacy of the compound of Formula (II) in any other type of disease.
Further, there is no single active agent that is effective in treating all types of inflammatory diseases as suggested by the instant claims.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure.
The instant claims recite a broad spectrum of conditions requiring an anti-inflammatory agent or anti-asthmatic agent. In fact, the phrases “condition requiring anti-inflammatory agent” or “condition requiring anti-asthmatic agent” are so broad that they encompass unlimited number of diseases, since inflammation is a component of a large and diverse set of disease, besides the ones disclosed in claim 18. Examples of “conditions requiring an anti-inflammatory agent” are encephalitis, meningitis, neuritis, scleritis, myelitis, arachnoiditis, dacryoadenitis, episcleritis, type 1 diabetes, ulcerative colitis, Crohn’s disease, gout, certain types of cancer, etc.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification teaches some examples (see specification pages 15-24) that correlate with the administration of a compound of Formula (II) with the treatment of some respiratory diseases like asthma, COPD, pulmonary fibrosis and some skin inflammatory diseases like: psoriasis, rheumatoid arthritis, and lupus.
Thus, while the specification provides a procedure for treating the above conditions, the specification appears to be silent on a nexus between: the examples disclosed on pages 15-24 of the specification and any other condition requiring an anti-inflammatory agent or condition requiring an anti-asthmatic agent, except for the ones mentioned above.
As such, if there is no correlation then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of conditions requiring an anti-inflammatory agent or anti-asthmatic agent, is required for practice of the claimed invention.
6. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is a high unpredictability in the art of treating all types of inflammatory diseases with a single active agent. Based on this and in the absence of experimental evidence commensurate in scope with the claims (see: 5. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that a compound of Formula (II), will be effective in treating all type of “conditions requiring anti-inflammatory agents” or “conditions requiring anti-asthmatic agents as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose enough examples that correlates with the treatment of all of the above diseases
So, determining which other diseases, except for like asthma, COPD, pulmonary fibrosis and some skin inflammatory diseases like psoriasis, rheumatoid arthritis, and lupus, can be treated with a compound of Formula (II) will require assaying a compound of Formula (II) in assays that correlate with the treatment of all other inflammatory diseases like encephalitis, meningitis, neuritis, scleritis, myelitis, arachnoiditis, dacryoadenitis, episcleritis, type 1 diabetes, ulcerative colitis, Crohn’s disease, gout, certain types of cancer, etc.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
7. Conclusion
Accordingly, the invention of claims 9-18 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 112
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the phrase "including" renders the claim indefinite because it is unclear what other diseases are “included” or not.
The transitional term “including” is synonymous of “comprising” and is inclusive and open-ended and does not exclude additional unrecited elements or methods steps (see MPEP 2111.03)
In other words, it is not clear what other diseases, besides psoriasis, rheumatoid arthritis, lupus and arthralgia are “included” in skin inflammatory diseases.
For example, the disease “melanoma” is considered a “skin inflammatory disease” (see 102 rejection below) as such, due to the use of the word “including” instead of “consisting of”, melanoma is encompassed by claim 18.
Claim Rejections - 35 USC § 102 (Modified Rejection not Necessitated by Amendment).
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 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.
1) Claim(s) 9-10 and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant).
For claim 9, Banciu teaches (see section 2.6) a method of treating melanoma (a condition requiring an anti-inflammatory agent and a skin inflammatory disease, see discussion below) comprising the administration to mice suffering from melanoma (see section 2.3) a composition comprising an effective amount of BUP (Budesonide 21-phosphate disodium salt).
The authors conclude: “The differences in antitumor activity correlate with their inhibitory activity towards the production of pro-angiogenic/pro-inflammatory factors involved in tumor angiogenesis and inflammation, among the four GC (Glucocorticoid) compounds studies, BUP show the highest antitumor activity, which is likely related to the strong potency of this GC to reduce the production of pro-angiogenic and pro-inflammatory factors in tumors” (see page 109, left column, last paragraph). This means that BUP is considered an anti-inflammatory agent and melanoma is, therefore, a condition requiring an anti-inflammatory agent (BUP).
For claim 10, Banciu teaches that the BUP compound was formulated in long-circulated liposomes (LCL, which is considered a physiologically acceptable excipient) (see abstract and entire document and in particular section 2.1).
For claims 14-15, Banciu teaches that the formulation was administered intravenously (i.e. parenteral route, see section 2.6, second paragraph).
2) Claim(s) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant) as evidenced by Ben Neriah et. al. (WO 2005/123772, 12/29/2005, cited in previous office action)
Melanoma is considered a chronic inflammatory disease of the skin as evidenced by Ben Neriah (see page 4, line 19 from the top)
Claim Rejections - 35 USC § 103 (Maintained Rejection).
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.
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.
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.
1) Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant) in view of Hu et. al. (US 6,482,802, cited in previous office action).
Banciu teaches all the limitations of claims 11-12 (see 102(a)(1) above), except for the co-administration of an antibiotic. However, Hu teaches a method of treating angiogenic-related diseases comprising the administration of the antibiotic neomycin (see title for example), wherein the angiogenic related disease can be cancer (see column 16, last line), and more specifically melanoma (see column 17, line 23).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to treat melanoma combining two compositions (BUP and the antibiotic neomycin) each of which is taught by the prior art to be useful for the same purpose (treating melanoma), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: Inre Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
All this would result in the practice of claims 11-12 with a reasonable expectation of success.
Regarding claim 13, the prior art is silent regarding the sequence of administration. However, there are only three possible options: 1-simultaneous administration, 2- separate administration and 3- sequential administration, thus resulting in the practice of claim 13 with a reasonable expectation of success.
2) Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banciu et. al. (Journal of Steroid Biochemistry and Molecular Biology (2008) 111:101-110, cited by Applicant).
Banciu teaches all the limitations of claim 16 (see above 102(a)(1) rejection), except for the composition being a metered dose inhalation aerosol formulated as a suspension or solution. However, aerosol formulations are standard practice in the pharmaceutical art, thus resulting in the practice of claim 16 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 26. 2026.
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