DETAILED ACTION
Status of Application, Amendments, And/Or Claims
The present application is being examined under the pre-AIA first to invent provisions.
The amendment of 15 August 2025 has been entered in full. Claims 4, 12, and 17-25 are canceled. Claims 1-3, 5-11, and 13-16 are under examination.
Withdrawn Objections And/Or Rejections
The objection to the disclosure for informalities as set forth at p. 2 of the previous Office action (mailed 16 May 2025) is withdrawn in view of the amendment correcting said informalities (received 15 August 2025).
The objection to claim 15 for informalities as set forth at p. 2 of the previous Office action (mailed 16 May 2025) is withdrawn in view of the amended claim (received 15 August 2025).
The rejection of claims 1-11 under 35 U.S.C. 112(b) as set forth at p. 3 of the previous Office action (mailed 16 May 2025) is withdrawn in view of Applicant’s remarks (received 15 August 2025).
The rejection of claims 1-3, 5-7, 11, and 13-16 under 35 U.S.C. 102(e) as being anticipated by Hokenson et al. as set forth at pp. 4-6 of the previous Office action (mailed 16 May 2025) is withdrawn in view of the amended claims (received 15 August 2025).
The rejection of claims 1-3 and 7-11 under 35 U.S.C. 102(b) as being anticipated by Nilsson et al. as set forth at pp. 6-8 of the previous Office action (mailed 16 May 2025) is withdrawn in view of the amended claims (received 15 August 2025).
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.
Claims 1-3, 5-11, and 13-16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claims 1 and 13 have been amended to recite, “wherein the inhalable dry powder formulation further comprises a therapeutically effective amount of a DPP-IV inhibitor, wherein said therapeutically effective amounts are reduced as compared to the therapeutically effective amounts needed in the absence of co-administration of the GLP-1 and the DPP-IV inhibitor.” It is unclear if the reduced therapeutically effective amounts are intended to concern the therapeutically effective amount of the GLP-1, the therapeutically effective amount of the diketopiperazine, the therapeutically effective amount of the DPP-IV inhibitor, or some combination thereof. The metes and bounds of the claims cannot be determined.
Dependent claims 2, 3, 5-11, and 14-16 are included in this rejection since they depend from independent claim 1 or 13 and do not resolve the issue.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 5-7, 11, and 13-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hokenson et al. (US 2008/0260838 A1; effectively filed 14 April 2006) in view of Caplan et al. (US 2002/0065239 A1; published 30 May 2002) and Madar et al. (US 2004/0121964 A1; published 24 June 2004).
The rejection is maintained essentially for the reasons set forth at pp. 9-11 of the previous Office action (mailed 16 May 2025). However, in view of the claim amendments, the rejection is repeated herein, edited to address the limitations of the amended claims.
Hokenson et al. teach a method for the treatment of hyperglycemia and/or diabetes in a patient, comprising the step of administering prandially to a patient in need of treatment an inhalable dry powder formulation comprising a therapeutically effective amount of a native GLP-1 molecule. See, for instance, Example 10, wherein Zucker diabetic rats (phenotypically Type 2 diabetic) were administered GLP-1/FDKP via pulmonary insufflation immediately following glucose injection. This meets the broadest reasonable interpretations of “prandially” (including at the time of a meal), and treatment of Type 2 diabetes in a mammal. See also [0101]. Note that FDKP is a type of diketopiperazine which is 2,5-diketo-3,6-di(4-fumaryl-aminobutyl)piperazine. See [0010]. This is relevant to claims 1, 2, and 5-7.
The limitations of claim 1 regarding “wherein said administration does not result in at least one side effect selected from the group consisting of nausea, vomiting and profuse sweating” is a recited effect of practicing the method step. Since Hokenson et al. teach administering the same therapeutic agent at the same dosage and via the same delivery route, it would have been reasonable to assume the effects of the administration would have been inherent thereto. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Regarding claim 3, the formulation comprised 2 mg of GLP-1. See [0189]-[0190].
Natural and analog forms of GLP-1 are taught at [0013]. This is relevant to claim 7.
The limitations of claim 11 regarding “the inhalable dry powder formulation lacks inhibition of gastric emptying” is a recited activity of the composition. Since Hokenson et al. teach administering the same therapeutic agent at the same dosage and via the same delivery route, it would have been reasonable to assume the effects of the administration would have been inherent thereto. . See In re Papesch, supra, and In re Von Schickh, supra.
Hokenson et al. further teach a method for reducing glucose levels in a Type 2 diabetic patient suffering with hyperglycemia, comprising the step of administering to said patient in need of treatment an inhalable dry powder formulation for pulmonary administration, comprising a therapeutically effective amount of GLP-1; and a diketopiperazine or pharmaceutically acceptable salt thereof. See abstract, [0017], [0019], [0031], [0032], [0106], [0107]. This is relevant to claim 13.
Regarding claim 14, reduction of glucose levels by from about 0.1 mmol/L to about 3 mmol/L (compared to control) is taught at [0107], Figure 24.
Regarding claim 15, Hokenson et al. teach administration to a Type 2 diabetic patient immediately after glucose administration (meeting the broadest reasonable interpretation of “prandially” and meeting the limitations of postprandially). See [0189].
Regarding claim 16, formulations comprising GLP-1 at 0.02 mg to about 2 mg is taught at [0172], [0196], [0241].
Hokenson et al. do not teach the newly added limitations to independent claims 1 and 13 wherein the inhalable dry powder formulation further comprises a therapeutically effective amount of a DPP-IV inhibitor, wherein said therapeutically effective amounts are reduced as compared to the therapeutically effective amounts needed in the absence of co-administration of the GLP-1 and the DPP-IV inhibitor.
However, Hokenson et al. acknowledge that GLP-1 has short in vivo half-life when administered due to the degradation of GLP-1 by in vivo protease “DPP-IV" (see [0068]; and [0091]).
To this point, Caplan et al. teach treating diabetes by administering to a subject in need thereof GLP-1 in combination with a DPP-IV inhibitor (see PGPUB claims 9, 12 and 14, and [0013]); and teach that diabetes is characterized by the presence of elevated blood glucose such as hyperglycemic disorder (see [0015], lines 3-4). Madar et al. teach that the short half-life of GLP-1 in the circulation (1-1.5 minutes) is a major obstacle to its use as a therapeutic agent; and overcoming this obstacle by using the DPP-IV inhibitor to increase the level of active circulating GLP-1 to thereby improve the diabetic treatment (see Madar et al., [0004]). If the half-life of the therapeutic agent is increased, and the level of active circulating GLP-1 is increased, sound scientific reasoning would have held that a requirement for repeated or high dosage administrations would have been reduced, thus addressing the new limitations regarding reducing therapeutically effective amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of administering to a diabetic patient a formulation comprising GLP-1/FDKP as taught by Hokenson et al. by co-administering a DPP-IV inhibitor in view of Caplan et al. and Madar et al. with a reasonable expectation of success. The motivation to do so could have been found in the teachings of both Hokenson et al. and Caplan et al. regarding the use of GLP-1 to treat diabetes, Hokenson et al.’s recognition that GLP-1 is degraded by DPP-IV, and Caplan et al.’s teachings that co-administered GLP-1 and the DPP-IV inhibitor for treating diabetes enhances the biological half-life of GLP-1 thereof. Further motivation could have been found in the teaching of Madar et al. that GLP-1 has short biological half-life. Thus, one of ordinary skill in the art would have been motivated to modify the Hokenson et al. method by formulating GLP-1/FDKP with the DPP-IV inhibitor in view of the teachings of Caplan et al. and Madar et al. and use said formulation to treat diabetes with reasonable expectation of success in the absence of any unexpected results. Therefore, the combination of the references’ teachings renders the claims prima facie obvious.
Applicant’s arguments (pp. 7-8, remarks received 15 August 2025) have been fully considered but are not found to be persuasive for the following reasons.
Applicant argues that there is no reason to combine the references in the manner claimed. Specifically, Applicant contends that neither Caplan nor Madar mention “inhalable” or “pulmonary.” Applicant concludes that the person of ordinary skill would not combine the teachings of the references.
This has been fully considered but Is not found to be persuasive. Hokenson et al. tech inhalable dry powder formulations comprising GLP-1 and other active therapeutic agents. See Example 10. Caplan et al. teach that the DPP-IV inhibitors can be administered by “any” route of administration, including parenteral. See [0100]. Therefore, the combination of references fairly suggests adding the DPP-IV inhibitor to GLP-1/FDKP inhalable dry powder formulations.
Applicant also argues that the cited references do not teach or suggest each element of the instant claims. Specifically, Applicant urges that the cited prior art does not teach or suggest the newly recited limitation “wherein the inhalable dry powder formulation further comprises a therapeutically effective amount of a DPP-IV inhibitor, wherein said therapeutically effective amounts are reduced as compared to the therapeutically effective amounts needed in the absence of co-administration of the GLP-1 and DPP-IV inhibitor.”
This has been fully considered but is not found to be persuasive. As discussed above, Hokenson et al. acknowledge that GLP-1 has short in vivo half-life when administered due to the degradation of GLP-1 by in vivo protease “DPP-IV" (see [0068]; and [0091]). Caplan et al. teach treating diabetes by administering to a subject in need thereof GLP-1 in combination with a DPP-IV inhibitor to inhibit the enzyme that inactivates GLP-1 (see [0077]). Madar et al. teach that the short half-life of GLP-1 in the circulation (1-1.5 minutes) is a major obstacle to its use as a therapeutic agent; and overcoming this obstacle by using the DPP-IV inhibitor to increase the level of active circulating GLP-1 to thereby improve the diabetic treatment (see Madar et al., [0004]). If the half-life of the therapeutic agent is increased, and the level of active circulating GLP-1 is increased, sound scientific reasoning would have held that a requirement for repeated or high dosage administrations would have been reduced, thus addressing the new limitations regarding reducing therapeutically effective amounts.
Claims 1-3 and 7-11 are rejected under 35 U.S.C. 102(b) as being anticipated by Nilsson et al. (US 2006/0120969; issued 08 June 2006) in view of Caplan et al. (US 2002/0065239 A1; published 30 May 2002) and Madar et al. (US 2004/0121964 A1; published 24 June 2004).
Nilsson et al. teach treating diabetes in a human subject comprising administering a medical dry powder product (composition) comprising GLP-1 derivative and insulin (reference claim 1) wherein the dry powder product is inhalable. See [0016]. Nilsson et al. further teach wherein combination of GLP-1 dose with insulin dose by inhalation is administered before or in connection with each meal. See [0059]. This is considered equivalent to instant administering “prandially” (related to eating a meal) to a patient in need of treatment an inhalable dry powder formulation in claim 1. The diabetes is type 2 diabetes. See [0032]. These teachings are relevant to instant claims 1, 2, 7 and 8.
The limitations of claim 1 regarding “wherein said administration does not result in at least one side effect selected from the group consisting of nausea, vomiting and profuse sweating” is a recited effect of practicing the method step. Since Nilsson et al. teach the same method step, it would have been reasonable to assume the effects of the administration would have been inherent thereto. Chemical compounds and their properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA1963)), as are their processes and yields (In re Von Schickh, 362 F.2d 821, 150 USPQ 300 (CCPA 1966)).
Nilsson et al. teach the total mass of GLP-1 in the dose can be 0.5 – 1 mg (see [0067]), meeting the limitations of the instant dose range of 0.5-3 mg of GLP-1 set forth in claim 3. This is relevant to claim 3.
Nilsson et al. teach insulin administration in combination with GLP-1 administration. See [0016], [0059]. This is relevant to claim 9.
Nilsson et al. teach insulin administration separately from GLP-1 administration by teaching separate inhalation steps. See [0016]. This is relevant to claim 10.
Nilsson et al. do not expressly teach that the formulation further comprises a DPP-IV inhibitor as per claim 1.
Caplan et al. teach treating diabetes by administering to a subject in need thereof GLP-1 in combination with a DPP-IV inhibitor (see PGPUB claims 9, 12 and 14, and [0013]); and teach that diabetes is characterized by the presence of elevated blood glucose such as hyperglycemic disorder (see [0015], lines 3-4). Madar et al. teach that the short half-life of GLP-1 in the circulation (1-1.5 minutes) is a major obstacle to its use as a therapeutic agent; and overcoming this obstacle by using the DPP-IV inhibitor to increase the level of active circulating GLP-1 to thereby improve the diabetic treatment (see Madar et al., [0004]). If the half-life of the therapeutic agent is increased, and the level of active circulating GLP-1 is increased, sound scientific reasoning would have held that a requirement for repeated or high dosage administrations would have been reduced, thus addressing the new limitations regarding reducing therapeutically effective amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of administering to a diabetic patient a formulation comprising GLP-1/insulin as taught by Nilsson et al. by co-administering a DPP-IV inhibitor in view of Caplan et al. and Madar et al. with a reasonable expectation of success. The motivation to do so could have been found in the teachings of both Nilsson et al. and Caplan et al. regarding the use of GLP-1 to treat diabetes, and Caplan et al.’s teachings that co-administered GLP-1 and the DPP-IV inhibitor for treating diabetes enhances the biological half-life of GLP-1 thereof. Further motivation could have been found in the teaching of Madar et al. that GLP-1 has short biological half-life. Thus, one of ordinary skill in the art would have been motivated to modify the Nilsson et al. method by formulating GLP-1/insulin with the DPP-IV inhibitor in view of the teachings of Caplan et al. and Madar et al. and use said formulation to treat diabetes with reasonable expectation of success in the absence of any unexpected results. Therefore, the combination of the references’ teachings renders the claims prima facie obvious.
Applicant’s arguments (p. 9, remarks received 15 August 2025) have been fully considered but are not found to be persuasive for the following reasons.
Applicant argues that there is no reason to combine the references in the manner claimed. Specifically, Applicant contends that neither Caplan nor Madar mention “inhalable” or “pulmonary.” Applicant concludes that the person of ordinary skill would not combine the teachings of the references.
This has been fully considered but Is not found to be persuasive. Nilsson et al. tech inhalable dry powder formulations comprising GLP-1 and other active therapeutic agents. See [0016]. Caplan et al. teach that the DPP-IV inhibitors can be administered by “any” route of administration, including parenteral. See [0100]. Therefore, the combination of references fairly suggests adding the DPP-IV inhibitor to GLP-1/insulin inhalable dry powder formulations.
Applicant also argues that the cited references do not teach or suggest each element of the instant claims. Specifically, Applicant urges that the cited prior art does not teach or suggest the newly recited limitation “wherein the inhalable dry powder formulation further comprises a therapeutically effective amount of a DPP-IV inhibitor, wherein said therapeutically effective amounts are reduced as compared to the therapeutically effective amounts needed in the absence of co-administration of the GLP-1 and DPP-IV inhibitor.”
This has been fully considered but is not found to be persuasive. As discussed above, Caplan et al. teach treating diabetes by administering to a subject in need thereof GLP-1 in combination with a DPP-IV inhibitor to inhibit the enzyme that inactivates GLP-1 (see [0077]). Madar et al. teach that the short half-life of GLP-1 in the circulation (1-1.5 minutes) is a major obstacle to its use as a therapeutic agent; and overcoming this obstacle by using the DPP-IV inhibitor to increase the level of active circulating GLP-1 to thereby improve the diabetic treatment (see Madar et al., [0004]). If the half-life of the therapeutic agent is increased, and the level of active circulating GLP-1 is increased, sound scientific reasoning would have held that a requirement for repeated or high dosage administrations would have been reduced, thus addressing the new limitations regarding reducing therapeutically effective amounts.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 8,377,869 B2:
Claims 1-3, 5-11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Pat. No. 8,377,869 B2 (‘869). Although the conflicting claims are not identical, they are not patentable distinct from each other for reasons of record.
US 9,078,866 B2:
Claims 1-3, 5-11, and 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of US Pat. No. 9,078,866 B2 (‘866) in view of Nilsson et al. (US 2006/0120969; issued 08 June 2006). Although the conflicting claims are not identical, they are not patentable distinct from each other for reasons of record.
Applicant indicates (p. 9, remarks received 15 August 2025) that the rejections are traversed, but that the filing of terminal disclaimers will be considered if the claims are found to be otherwise allowable.
This has been fully considered but is not found to be persuasive. Applicant’s attention is respectfully directed to M.P.E.P. § 804(I)(B)(1), which states:
A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.
As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03.Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804.02, subsection VI, for filing terminal disclaimers required to overcome nonstatutory double patenting rejections in applications filed on or after June 8, 1995. (emphasis added)
Accordingly, the rejection is maintained and is expressly not held in abeyance.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH C. KEMMERER whose telephone number is (571)272-0874. The examiner can normally be reached M-F 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH C. KEMMERER/ Primary Examiner, Art Unit 1674
/ECK/
13 September 2025
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