DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The examiner acknowledges receipt of preliminary amendment and IDS filed 09/03/2025.
Claims 1, 3, 6-13, 16-17 and 19-21 are amended.
Claim 18 is canceled.
Claims 1-17 and 19-21 are pending.
Priority
The examiner acknowledges this applicant as a Continuation of 18/531,424 filed 12/06/2023, now US 12275704 B2, which is a Continuation of 17/806,033 filed 06/08/2022, now US 11884630 B2, which is a Continuation of 16/579,360 filed 09/23/2019, now US 11384053 B2, which is a Continuation of 15/926,411 filed 03/20/2018, now US 10,421,726 B2, which is a Divisional of 14/210,713 filed 03/14/2014, now US 9,951,015 B2; and which claims benefit of 61/785,763 filed 03/14/2013.
Information Disclosure Statement
The IDS filed 09/03/2025 has been considered by the examiner.
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 1-13, 17 and 19-21 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 1 states “wherein the exposure of omecamtiv mecarbil ….”
In claim 1 “exposure” is the first occurrence. Thus, the recitation of “the exposure” in line 9 of the claim does not have sufficient antecedent basis for this limitation in the claim.
Correction is respectfully requested.
Also, claims 1 and 19 recite exposure of omecamtiv mecarbil …, from two to twelve hours after dosing in humans remains between 40 and 70 ng/ml. The claim and indeed, the specification, see paragraphs [0030], [0031] does not say what the omecamtiv mecarbil is exposed to for the duration of time recited or disclosed. It is unclear and the boundaries of what the omecamtiv mecarbil is exposed to has not been articulated.
Correction and/or explanation is respectfully requested.
Claims 7-9 contains the trademark/trade name METHOCELL. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe cellulose ethers including methylcellulose (MC) or hydroxypropyl methylcellulose (HPMC) polymers and, accordingly, the identification/description is indefinite.
Correction is respectfully requested.
Claim Rejections - 35 USC § 102
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1, 3, 4, 6, 11, 12 and 16-17 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) and 102(s)(2) as being anticipated by Morgan et al. (US 20070161617 A1).
Claim 1 is a pharmaceutical composition. Exposing the omecamtiv mecarbil or the salt of omecamtiv mecarbil of claim 1 to the gastrointestinal environment for a period of two to twelve hours after dosing would inherently reduce the amount of the omecamtiv mecarbil and the recited amount would be inherent. No specific amount of the omecamtiv mecarbil or omecamtiv mecarbil pharmaceutical salt is claimed in claim 1.
Morgan et al. (US 20070161617 A1) discloses the compound of formula I: paragraph [0018]) and in paragraph [0146] Morgan provides compound having structure:
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(paragraph [0018]) and in paragraph [0146] Morgan provides compound having structure):
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which is the compound of formula I when W, X, Y and Z are -C=, n is one, R1 is substituted piperazinyl, R2 is 6-methyl-pyridin-3-yl, R18, R19, R3, R4, R5, R6 and R7 are each hydrogen, and R3 is fluoro and the compound is named:
3-fluoro-5-(3-pyridin-3-yl-ureido)-benzyl]-methyl-carbamic acid methyl ester or
methyl 4-[(2-fluoro-3-{[(6-methyl(3-pyridyl))amino]carbonylamino} phenyl)methyl]piperazinecarboxylate, and this compound is the claimed compound omecamtiv mecarbil.
In paragraph [0985], Morgan discloses that the compounds of formula I, which includes
the compound in paragraph [0146] in pharmaceutical compositions are used to heart disease such
as congestive heart failure and chronic congestive heart failure by administration (see paragraph
[0998]). The composition is in the form of pill or tablet or capsule (paragraphs [0997], [1000], claims 11, 30) with the tablet meeting the requirement of claim 12. The pharmaceutical composition in Morgan comprises conventional pharmaceutical carrier or excipient such as mannitol, lactose, starch, magnesium stearate, sodium saccharine, talcum, cellulose, sodium croscarmellose, glucose, gelatin, sucrose, magnesium carbonate; and can also contain nontoxic auxiliary substances such as wetting agents, emulsifying agents, solubilizing agents, pH buffering agents and the like (e.g., sodium acetate, sodium citrate, cyclodextrin derivatives, sorbitan monolaurate, triethanolamine acetate, triethanolamine oleate (paragraph [0998]). In paragraph [1000], it is said that the composition contains lactose, sucrose or dicalcium phosphate with the lactose meeting the limitation of filler of claims 1 and 6, magnesium stearate lubricant that meets the limitation of lubricant of claims 1 and 11, starch, gum acacia, polyvinylpyrrolidone, gelatin, cellulose, cellulose derivatives and polyethylene glycol (paragraphs [0110], [0998], [1000]) meeting control release agent of claim 1.
Morgan discloses pH buffering agents (paragraph [0998]) and specifically names citric
acid, as specific pH buffering agent (paragraphs [1149], [1150]) which meets the limitation of the pH modifying agent of claims 1, 3 and 4.
The omecamtiv mecarbil is present as pharmaceutically acceptable salts and hydrates (paragraphs [0128]-[0130], [0164], [0127], [0132], [0164], [0165], [0168], [1077], [1080]).
For claim 16, the pharmaceutical composition described above anticipates the claim. Claim 16 is a product by process.
For claim 17, Morgan administers its composition (paragraphs [0131], [0136], [0984], [0985], [0995]-[0998], [1001], [1002]) to treat congestive heart failure.
Therefore, Morgan teaches all the elements of claims 1, 3, 4, 6, 11-12 and 16-17
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.
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 2, 5, 7-9, 13, 14, 15 and 19-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morgan et al. (US 20070161617 A1) view of Siepe et al. ("Strategies for the design of hydrophilic matrix tablets with controlled microenvironmental pH" in International Journal of Pharmaceutics 316 (2006) 14-20).
Claims 2, 5, 13 and 19-21 depend on claim 1. Morgan is described above to teach claim 1.
Morgan et al. (US 20070161617 A1) discloses the compound of formula I
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(paragraph [0018]) and in paragraph [0146] Morgan provides compound having structure:
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which is the compound of formula I when W, X, Y and Z are -C=, n is one, R1 is substituted piperazinyl, R2 is 6-methyl-pyridin-3-yl, R18, R19, R3, R4, R5, R6 and R7 are each hydrogen, and R3 is fluoro and the compound is named:
3-fluoro-5-(3-pyridin-3-yl-ureido)-benzyl]-methyl-carbamic acid methyl ester or
methyl 4-[(2-fluoro-3-{[(6-methyl(3-pyridyl))amino]carbonylamino} phenyl)methyl]piperazinecarboxylate, and this compound is the claimed compound omecamtiv mecarbil.
In paragraph [0985], Morgan discloses that the compounds of formula I, which includes
the compound in paragraph [0146] in pharmaceutical compositions are used to heart disease such
as congestive heart failure and chronic congestive heart failure by administration (see paragraph
[0998]). The composition is in the form of pill or tablet or capsule (paragraphs [0997], [1000], claims 11, 30). The pharmaceutical composition in Morgan comprises conventional pharmaceutical carrier or excipient such as mannitol, lactose, starch, magnesium stearate, sodium saccharine, talcum, cellulose, sodium croscarmellose, glucose, gelatin, sucrose, magnesium carbonate; and can also contain nontoxic auxiliary substances such as wetting agents, emulsifying agents, solubilizing agents, pH buffering agents and the like (e.g., sodium acetate, sodium citrate, cyclodextrin derivatives, sorbitan monolaurate, triethanolamine acetate, triethanolamine oleate (paragraph [0998]). In paragraph [1000], it is said that the composition contains lactose, sucrose or dicalcium phosphate with the lactose meeting the limitation of filler, magnesium stearate lubricant that meets the limitation of lubricant of claim 11, starch, gum acacia, polyvinylpyrrolidone, gelatin, cellulose, cellulose derivatives.
Morgan discloses pH buffering agents (paragraph [0998]) and specifically names citric
acid, as specific pH buffering agent (paragraphs [1149], [1150]).
While Morgan teaches the use of pH modifiers (paragraph 0998) and citric acid is used (paragraphs [1149], [1150]) and sodium citrate is also specifically named in paragraph [0998] as pH buffering agent, Morgan does not use fumaric acid as the pH modifying agent required by claim 5. However, it is known that fumaric acid and citric acid are both used as pH modifying agents in matrix tablet formulations. For example, Siepe teaches that pH modifiers such as citric acid and fumaric acid and sorbic acid are commonly used in matrix systems (paragraph bridging pages 14 and 15) and in paragraph 3.1.1 determined that fumaric acid as a pH modifier led to highest enhancement of drug release.
Therefore, one having ordinary skill in the art at the time the invention was made would
have been motivated to use fumaric acid in place of citric acid to have higher enhancement of
drug release as taught by Siepe. Thus, the modification of Morgan by the teaching of Siepe renders claim 5 prima facie obvious with regards to using fumaric acid in place of citric acid.
Morgan also specifically discloses that the compound of formula I are chemical entities
in the form of hydrates (paragraph [0127]) and pharmaceutically acceptable salts (paragraph [0128]) and the hydrate includes hemi-hydrate, monohydrate, dihydrate and trihydrate (paragraph [0132] such that the requirement for pharmaceutically acceptable salt of omecamtiv mecarbil or the dihydrochloride hydrate in claims 2 and 15 is rendered prima facie obvious.
With respect to amount of omecamtiv mecarbil salt in claims 13, Morgan teaches that the chemically active agent, in this case, omecamtiv mecarbil, the salt or solvate is present in the composition at about 0.5% to 50%. This disclosed amount allows for the % amounts in claim 13 in the range of 3-30% w/w which lies within the disclosed range. The artisan would have been motivated to use citric acid (pH modifying agent), magnesium stearate (lubricant), polyethylene glycol (control release agent) and lactose or dicalcium phosphate (filler) in amounts that would produce desired pH in which the omecamtiv mecarbil is stable for controllable release.
For claims 7-9, Siepe has used HPMC or METHOCEL KlO0 LV (paragraphs 2.1 and 2.2.1 and 3; Table 2) in combination with pH modifiers such as fumaric acid and citric acid or citrate buffer to achieve enhanced drug release. Therefore, the artisan looking to enhance the release of the drug from the tablet would be motivated to use HPMC or METHOCEL KlO0LV, a cellulose derivative, in combination with the fumaric acid pH modifier to achieve desired enhanced drug release. The various METHOCEL, METHOCEL KlO0 L V Prem CR and METHOCEL KlO0 M Prem CR are functionally equivalent.
For claim 14, the pharmaceutical composition of Morgan comprises mixture of omecamtiv mecarbil or hydrate or salt thereof, control release agent, pH modifying agent, fille and lubricant and the mixing process leading to the pharmaceutical composition renders the process of claim 14 prima facie obvious.
For claims 19-21, exposing the omecamtiv mecarbil or the salt of omecamtiv mecarbil of claim 1 to the gastrointestinal environment for a period of two to twelve hours after dosing would inherently be reasonably expected to be predictably reduced to the amount of claim 19; and the disclosed omecamtiv mecarbil composition would be expected to reasonably undergo the dissolution profile recited in claims 20 and 21, Claim 1 does not recite specific amount of omecamtiv mecarbil or omecamtiv mecarbil pharmaceutical salt.
Therefore, Morgan in combination with Siepe and renders claims 2, 5. 7-9, 13, 14, 15 and 19-21 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-17 and 19-21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-24; 1-20; 1-21; 1-22 and 1-2 and 9-17 of U.S. Patent Nos. 9951015 B2; 10421726 B2; 11384053 B2; 11884630 B2; and 12275704 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because:
For US 9951015 B2: The issued composition teaches the examined claimed composition by teaching omecamtiv mecarbil dihydrochloride hydrate that is the same as in the examined claims.
For US 10421726 B2: The issued method uses the examined composition
For US 11384053 B2 and US 11884630 B2 and 12275704 B2: The issued composition teaches the examined claimed composition.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached on 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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