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
Applicant’s amendment of 16 January 2026, in which claims 31, 32, 35, 37, 38, 39 have been amended, is acknowledged.
Claims 30-43 are pending in the instant application.
Claims 30-43 are being examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5 November 2025 is acknowledged and considered.
Response to arguments of 16 January 2026
In view of Applicant’s amendment of 16 January 2026, the objection to claims 39, 31, 34, 37, 32, 35, 38, are herein withdrawn. Applicant has amended/corrected/clarified the claim language.
Applicant argues (page 8, first 4 paragraphs) against the rejection of claims 30-43 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. Applicant argues that a POSITA would understand that the language in claim 31 refers to an incremental dosage increase over the previous daily dosage. This is not persuasive; the claim recites an increase in daily dosage without reciting that the increase is over the previous daily dosage. It is noted that the claims, as written, do not require 3 consecutive intervals of time. This rejection is maintained.
Applicant arguments against the rejection of claims 30-43 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description/new matter, have been considered. Applicant has not addressed the limitation “less than 90 days” in instant claims. Applicant has not addressed the fact that there is no support in the Specification for the claimed increase of 120 mg per day celiprolol, and no support for said increase taking place in a first, second and third interval of time, as claimed. This rejection is herein maintained.
Applicant’s arguments (page 9) against the rejection of claims 30-43 under 35 U.S.C. 103 over Ong, have been considered.
Applicant has referred to (Remarks of 5 May 2025, page 6, last paragraph, page 7, first paragraph, also Remarks of 22 September 2025, page 8, last paragraph) a literature reference by Baderkhan, previously submitted in U.S. patent application 16/930,208. Applicant argues that Baderkhan discloses that some patients on a 90-day up-titration schedule reported side effects that require a slower up-titration schedule. Applicant argues that, since Baderkhan teaches against a fast up-titration schedule in order to avoid side effects, a POSITA would not be motivated to increase the dosage escalation schedule to less than 90 days.
Applicant submits the reference. In response, the instant claims, as written, allow for dosage escalation at three time intervals so that the patient is administered 400 mg celiprolol at 89 days from the initial dosage of 100 mg celiprolol. That is consistent with a 89-day up-titration schedule, which is close to 90 days in Baderkham; it is not a slower up-titration schedule compared to 90-day in Baderkham.
Applicant’s arguments (page 9, last paragraph) against the rejection of claims 30-43 on the ground of nonstatutory obviousness-type double patenting over claims 1-15 of U.S. Patent 11,523,997, in view of Ong, have been considered. Applicant argues that the instant claims recite that there are 3 dosage increases within 90 days and the maximum dose is reached in less than 90 days; claims 1-15 of U.S. Patent 11,523,997 recite that the 400 mg daily dose is reached 120 days after initiating celiprolol treatment. This is not persuasive.
Claims 1-15 of U.S. Patent 11,523,997 teach a celiprolol dose escalation regimen at 3 intervals of time, as in the instant claims, where the first interval of time has a 100 mg celiprolol HCl/day dose increase from the initial daily dose; the second time interval has a 100 mg increase from the dose administered in the first interval of time; and the third interval of time has a 100 mg per day dose increase from the dose in the second time interval.
Contrary to Applicant’s argument (page 9, last paragraph) that the claims of U.S. Patent 11,523,997 recite 400 mg celiprolol daily dosage is reached 120 days after initiating treatment, the 400 mg daily dosage is achieved at 3 months (90 days) from initial daily dosage of 100 mg, which is very close to 89 days (less than 9 days) in the instant claims.
The rejections are herein maintained and are reproduced below.
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 30-43 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 30 recites a method […] comprising
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Claim 30 is drawn to a method of treatment comprising administering an “initial” daily dose of 80-100 mg celiprolol or salt thereof, and increasing the initial daily dosage at 3 intervals of time. It is unclear, reading claim 30, whether the initial dosage amount of 80 to 100 mg celiprolol or salt thereof is administered for one day, or multiple days, or for a period of time, and it is unclear whether the “3 intervals of time” in claim 30 in which the daily dose is increased from the 80-100 mg initial daily dose, are, for example, intercalated between administration of 80-100 mg celiprolol; this scenario brings lack of clarity regarding how the 90 days are counted. Further, it is unclear how the “3 intervals of time” are related to the less than 90 days in claim 30.
The same confusion related to how the 90 days, or 30 days, or 60 days, or 30 days from administering the initial daily dosage are counted exists in claims 33, 36, 32, 35, 38, 43.
Further, regarding the recitation in claim 30 “400 mg of celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof”, the Specification teaches [0016] 400 mg per day celiprolol, or a pharmaceutically acceptable salt thereof. This teaching ([0016] Specification) is different from an amount of a pharmaceutically acceptable salt of celiprolol equivalent to 400 mg celiprolol, which is now being claimed. The same analysis applies to claims 33, 36.
The Specification also teaches [0017] administering a first daily dosage of 100 mg celiprolol, or a pharmaceutically acceptable salt thereof; followed by a daily dosage of 200 mg for one month […]; to a daily dosage of 400 mg celiprolol, or a pharmaceutically acceptable salt thereof.
The Specification also teaches [0021] administering an initial daily dosage of 91.25 mg celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof; followed by 182.5 mg celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof; followed by 273.75 mg celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof; followed by 365 mg celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof (which corresponds to 400 mg celiprolol hydrochloride salt).
The Specification also teaches [0060] administering to a patient in need thereof a 80 to 110 mg (e.g., about 91.25 mg) daily dose of celiprolol or an equivalent amount of a pharmaceutically acceptable salt of celiprolol.
Further, claim 32 depends on claim 30 and recites that 400 mg of celiprolol hydrochloride is administered per day; yet, claim 30 recites that 400 mg of celiprolol or an equivalent amount of a pharmaceutically acceptable salt thereof (438 mg celiprolol hydrochloride salt is the equivalent amount to 400 mg celiprolol), is administered. As such, there is insufficient antecedent basis for the recitation 400 mg of celiprolol hydrochloride is administered per day of claim 32, in claim 30.
The same analysis applies to claims 35 and 38.
Claim 30 recites increasing the initial daily dosage at 3 intervals of time; claim 31, which depends on claim 30, recites
the first intervals of time the daily dosage increases by about 80 to 120 mg per day of celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof;
at the second intervals of time the daily dosage increases by about 80 to 120 mg per day of celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof
at the third intervals of time the daily dosage increases by about 80 to 120 mg per day of celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof.
It is unclear how the increase in each of the three intervals of time is to be measured, as the claim fails to establish a standard or threshold level. For example, if the “first” interval of time (which is not defined) is characterized by an increase in the daily dose of celiprolol or salt thereof from the initial daily dosage of 80-100 mg, that would mean that the daily dose administered in the first interval of time is (80 to 100 mg) + (80 to 120 mg) = 160 mg to 220 mg/day celiprolol or equivalent amount of salt thereof.
It is unclear whether the second or the third interval of time are characterized by the same increase (which would mean that the same daily dose is being administered in the first, second and third interval of time), or rather the daily dose increase in the second interval of time is relative to a different threshold, perhaps the daily dose in the first interval. If the first scenario applies, it is unclear how the daily dose of celiprolol would reach the 400 mg (as in claim 30, upon which claim 31 depends) in less than 90 days.
The same analysis applies to claims 34, 37.
Appropriate clarification of the claim language is required.
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 30-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 30 is drawn to
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The analysis below focusses on the recitation in claims 30, 33, 36 “increasing the initial dosage amount by an amount of celiprolol or […] salt thereof at 3 intervals of time, such that the patient is administered 400 mg celiprolol […] per day in less than 90 days from the initial daily dosage”.
The claims, as written, include administration of an initial daily dosage of celiprolol of 80-100 mg, for any length of time (could be one day, several days, more than 2 months), interrupted by 3 intervals of time, of unspecified length (could be one day each, could be weeks or months each) in which an increase (unspecified) in the daily dose of celiprolol occurs, such that by day 89 the daily dose of celiprolol is 400 mg.
The original Specification discloses [0060] treating vascular Ehlers-Danlos syndrome in a patient, wherein treatment begins with 80 to 110 mg (e.g., about 91.25 mg) daily celiprolol or an equivalent amount of a pharmaceutically acceptable salt of celiprolol and increases to 300 to 440 mg (e.g., about 365 mg) daily celiprolol or an equivalent amount of a pharmaceutically acceptable salt of celiprolol within six months.
In some embodiments, at least a 80 to 110 mg daily (e.g., about 91.25 mg) dose increase is made within two months.
In some embodiments, at least a 170 to 210 mg (e.g., about 182.5 mg) daily dose increase is made within four months.
In some embodiments, at least a 260 to 310 mg (e.g., about 273.75 mg) daily dose increase is made within six months.
In some embodiments, at least a 260 to 310 mg (e.g., about 273.75 mg) daily dose increase is made within four months.
[0062] In the dose escalation regimen described herein, the first daily dosage is about 100 mg during the initial month; the second daily dosage is about 200 mg during the second month; the third daily dosage is about 300 mg during the third month; and the fourth daily dosage is about 400 mg daily. The method of the present disclosure can further comprise additional steps after the three-month dose escalation/up-titration period, to further increase the daily dose of celiprolol administered to the patient. […]
The Specification discloses [0064] that each period of time associated with a particular daily dosage is about one month, about 30 days, or about 28 days. [0065] Although the present disclosure exemplifies dose escalation and up-titration regimens having particular dosage increases over time, the present disclosure further contemplates additional dose escalation and up-titration steps in the same amount of time, such that the daily dosage escalates in smaller steps and more frequently. Indeed, if desired, each dosage for a particular period of time can be incrementally larger than the previous dosage, or the dosage can escalate, for example, every week, every 2- weeks, every 3-weeks.
The Specification discloses [0067] a method of treating vascular Ehlers-Danlos syndrome, comprising administering celiprolol to a patient in need thereof, wherein treatment begins with a titration period wherein celiprolol, or a pharmaceutically acceptable salt thereof, is administered at a dosage of 100 mg daily during one month and increased by steps of 100 mg/day every month over a 3-month period to reach a dosage of 400 mg per day.
The original Specification does not disclose “increasing the initial dosage amount by an amount of celiprolol or […] salt thereof at 3 intervals of time, such that the patient is administered 400 mg celiprolol […] per day in less than 90 days from the initial daily dosage”,
as in instant claims 30, 33, 36.
The language of the claims is broader than the teachings in the Specification, and causes the claims to read literally on embodiments outside the dosage escalation amounts disclosed in the Specification, the intervals of time and dose escalation regimen disclosed in the Specification.
The limitation “less than 90 days” in claims 30, 33, 36, 32, 35, 38, or intervals of time of less than 30 days, or less than 60 days, or less than 90 days in claim 43, do not meet the written description requirement because the phrase “less than” has no lower limit (or the lower limit is day 1) and causes the claims to read literally on embodiments outside the time intervals disclosed in the Specification. The Specification teaches that [0011] the first period of time is about one month, about 30 days, or about 28 days; the second period of time is about one month, about 30 days, or about 28 days; the third period of time is about one month, about 30 days, or about 28 days.
Further, regarding claims 31, 34, 37, which recite
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the Specification does not recite any increase in daily dosage of 120 mg per day celiprolol, as now claimed. As such, there is no support in the Specification for the claimed increase of 120 mg per day celiprolol, and no support for said increase taking place in a first, second and third interval of time, as claimed.
This is new matter and does not have support in the specification.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 30-43 are rejected under 35 U.S.C. 103 as being unpatentable over Ong et al. (Lancet 2010, 376, 1476-1484, cited in IDS; Supplementary webappendix, cited in PTO-892 of 4 December 2024).
Ong (Lancet 2010, 376, 1476-1484) teaches a method for treating Ehlers-Danlos syndrome, comprising administering to a patient in need thereof a 100 mg daily dose of celiprolol, and increasing the daily dose to 400 mg according to the following schedule (Figure 1, and page 1477, left column, first paragraph under study design):
celiprolol was started at 100 mg daily dose and was uptitrated by 100 mg steps (titrated to 200 mg/day, 300 mg/day and 400 mg per day) every six months.
Thus, the method taught by Ong teaches a celiprolol dose escalation as follows:
100 mg/day for 6 months, 200 mg/day for 6 months, 300 mg/day for 6 months, 400 mg/day until the 5-year intervention point is reached, which is consistent with several dose increases in increments of 100 mg within the treatment regimen, as in instant claims 31, 34, 37.
Ong teaches (Supplementary material webappendix, page 9, attached) patients suffering from Ehlers-Danlos treated with both celiprolol and blockers of the renin angiotensin system, namely ACEi and/or ARB, which are cardiovascular drugs of instant claims 39, 41, 42. Ong teaches (Ong page 1481, left column, first paragraph) that said blockers of the renin angiotensin system did not change the effect of celiprolol in these patients.
Ong also teaches (page 1478, right column, last paragraph, also Figure 1) that patients treated with beta blockers (which are cardiovascular drugs of instant claims 39, 40) for arterial dissection or rupture or another cardiovascular indication were included in the cohort of patients suffering from Ehlers-Danlos treated with celiprolol.
Ong does not teach the method, where the daily dose of 100 mg celiprolol hydrochloride is increased to 400 mg/day within 90 days (three months), as in the instant claims.
It would have been obvious to a person of ordinary skill in the art to use the teachings of Ong to arrive at the instantly claimed dosing schedule of celiprolol used in a method of treating Ehlers-Danlos syndrome in a patient in need thereof. The person of ordinary skill in the art would have explored a celiprolol dosing regimen encompassing dose escalation based on patient monitoring, starting from the initial 100 mg celiprolol (commercially available celiprolol is hydrochloride salt, thus 100 mg celiprolol in Ong is actually 100 mg celiprolol hydrochloride salt) daily taught by Ong, the daily dose being uptitrated in 100 mg increments, as in Ong, to the 400 mg daily taught by Ong, and would have varied the dose escalation period, so that the maximum therapeutic dose of 400 mg taught by Ong is reached faster (in 90 days), with the expectation of achieving therapeutic effect.
With respect to duration and frequency of treatment, it is typical for skilled clinicians to monitor subjects in order to determine when the treatment is providing therapeutic benefit, and to determine whether to increase or maintain/decrease dosage, increase or maintain/decrease administration frequency, discontinue treatment, resume treatment or make other alteration to treatment regimen. In this case, the initial dose of celiprolol (100 mg/day) and the final/maintenance/maximum therapeutic dose of celiprolol (400 mg/day) are the ones taught by Ong; further, the daily dose is uptitrated in steps of 100 mg increments as in Ong; determining the dosing schedule, i.e. the appropriate intervals of time for dose escalation, in order to reach the maximum dose faster and safely for the patients, is routine for the skilled artisan/clinician.
Further, with respect to claims 39-42, it would have been obvious to administer celiprolol in combination with a beta blocker, or an ARB, or an ACEi, in a method of treating Ehlers-Danlos, because Ong teaches patients suffering from Ehlers-Danlos treated with both celiprolol and blockers of the renin angiotensin system, or with both celiprolol and a beta blocker, where blockers of the renin angiotensin system did not change the effect of celiprolol in said patients.
As such, claims 30-43 are rejected as prima facie obvious.
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.
Claims 30-43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent 11,523,997 (cited in IDS), in view of Ong et al. (Lancet 2010, 376, 1476-1484, cited in IDS; Supplementary webappendix, cited in PTO-892 of 4 December 2024).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-15 of U.S. Patent 11,523,997 anticipate or render obvious the instant claims.
Instant claims are drawn to a method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof an initial dosage amount of 80 to 100 mg daily dose of celiprolol, or an equivalent amount of a pharmaceutically acceptable salt thereof, and increasing the daily dose at 3 intervals of time, such that 400 mg per day of celiprolol is administered within 90 days of the initial dosage of celiprolol.
Claims 1-15 of U.S. Patent 11,523,997 are drawn to a method for treating vascular Ehlers-Danlos syndrome, comprising administering to a patient in need thereof an initial daily dose of about 91.25 mg celiprolol (or 100 mg celiprolol hydrochloride in claim 8) for about 1 month, followed by administering to the patient a second daily dose of about 182.5 mg celiprolol (or 200 mg celiprolol hydrochloride in claim 8) for about 1 month, followed by administering to the patient a third daily dose of about 273.75 mg celiprolol (or 300 mg celiprolol hydrochloride in claim 8) for about 1 month, followed by administering to the patient a fourth daily dose of about 365 mg celiprolol (or 400 mg celiprolol hydrochloride in claim 8). As such, claims 1-15 of U.S. Patent 11,523,997 teach a celiprolol dose escalation regimen at 3 intervals of time, as in the instant claims, where the first interval of time has a 100 mg celiprolol HCl/day dose increase from the initial daily dose; the second time interval has a 100 mg increase from the dose administered in the first interval of time; and the third interval of time has a 100 mg per day dose increase from the dose in the second time interval.
Ong is as above.
The method of claims 1-15 of U.S. Patent 11,523,997, drawn to treating vascular Ehlers-Danlos syndrome, comprises administering an initial dosage amount of 100 mg celiprolol, and increasing the daily dose to 400 mg celiprolol within 90 days of the initial dosage, as in instant claims 30, 33, 36, using dose escalation in increments of 100 mg, as in instant claims 31, 34, 37. As such, there is a significant overlap between the method of claims 1-15 of U.S. Patent 11,523,997 and the instant method.
Further, with respect to claims 39-42, it would have been obvious to administer celiprolol in combination with a beta blocker, or an ARB, or an ACEi, in a method of treating Ehlers-Danlos because Ong teaches patients suffering from Ehlers-Danlos treated with both celiprolol and blockers of the renin angiotensin system, or with both celiprolol and a beta blocker, where blockers of the renin angiotensin system did not change the effect of celiprolol in said patients.
As such, claims 30-43 are rejected as prima facie obvious.
Conclusion
Claims 30-43 are rejected.
THIS ACTION IS MADE FINAL. 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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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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