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 .
Claims 3-9 are presented for examination.
Claims 1-2, 10 and 11 are withdrawn from examination.
Restriction/Election
Applicant’s election without traverse of Group II, claims 3-8 in the reply filed on 01/16/2026
is acknowledged. Applicant added claim 9, which is dependent on claim 3.
Claims 1, 2, 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/16/2026
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.
The term “preferably” in claims 4 and 7 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 4 is indefinite in using improper Markush language. The use of the phrase “selected from the group consisting of “ after “is” in line 1, related to tonicity adjusting agent, the thickener, the sweller, glidant, lubricant and colorant will overcome the rejection.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 3-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (US 20200222326) in view of Liu et al. (CN 106176681 submitted by the applicant).
The claims are drawn to A sacubitril valsartan sodium sustained-release composition,
comprising a drug-containing layer core and a coating film, wherein a pore is provided on one side
of the drug-containing layer; the drug-containing layer core comprises an active pharmaceutical
ingredient and a carrier; the active pharmaceutical ingredient is selected from one, two, or more of
sacubitril valsartan sodium, or other pharmaceutically acceptable salts, solvates, and hydrates
thereof; the carrier is one or more of a tonicity adjusting agent, a sweller, thickener, a glidant, and
a lubricant;
the sustained-release composition optionally further comprises or does not comprise a
boosting layer core, and the boosting layer core comprises one or more of a tonicity adjusting
agent, a sweller, a colorant and a lubricant; the coating film is a semipermeable film; and optionally, the drug-containing layer core further comprises a colorant.
Regarding claim 3, Sharma teaches a pharmaceutical composition comprising fixed dose combination of valsartan or pharmaceutically acceptable salts thereof and sacubitril or pharmaceutically acceptable salts thereof. See the abstract. Sharma teaches that he present invention provides a pharmaceutical composition, wherein valsartan is present in form of disodium salt. See Para [0031]. Sharma teaches that the first or second component is present in the form of powder, slugs, compacts, granules, beads, pellets, or minitablets. See Para [0035]. Sharma teaches the term “composition” or “dosage form” or “pharmaceutical composition” as used herein synonymously include tablet such as mono-layered/single layer tablets, bilayered tablets, trilayered tablet, multilayer tablet, drug layered tablet, caplets, minitablets, capsules, tablet in tablet, tablets in a capsule, granules in a capsule, pellets, pellets in a capsule, beads, powder, granules, sachets, suspension or any other suitable dosage form meant for oral administration. See Para [0090]. Sharma teaches that the pharmaceutical composition comprising valsartan and sacubitril and one or more pharmaceutically acceptable excipients, wherein said composition is a mono-layer table. See Para [0085]. Sharma teaches that the pharmaceutical composition comprises a film coating. See Para [0092]. Sharma teaches that the pharmaceutically acceptable excipients of the present invention may include filler, binder, disintegrant, lubricant, diluent, plasticizer, pH adjusting agent, pigment, opacifier, surfactant, glidant, and/or any combinations thereof. Some of the excipients may have two or more functions at the same time. See Para [0097]. Sharma teaches the core layer comprises sacubitril layer and valsartan layer. See Example 3, Para [0119]. Sharma teaches the use of microcrystalline cellulose, colloidal silicone dioxide and magnesium stearate in the drug layer. See Example 8, para [0161]. The use of mannitol, sorbitol, hydroxypropyl methylcellulose and povidone is taught in Para [0098] and [0099]. The use of a colorant is taught in Para [0107]. Sharma differs from the claimed invention in having a pore in one side of the drug -containing layer.
Liu teaches a composition for resisting cardiac failure LCZ696 (sacubitril/valsartan) oral sustained-release pellet and its preparation method. The slow-release micro-pill comprises is composed of slow-release material, pore-forming agent, plasticizer and ant sticking agent is comprised of LCZ696, diluent and adhesive pellet core and pellet core and outer coating, the weight of each component is as follows: LCZ696 2-55 parts, 15-90 parts of diluent, 1-15 parts of adhesive, 1-35 parts of slow release material, 0.1-5 parts of pore-forming agent, 0.1-5 parts of plasticizer and 0.1-25 parts of ant sticking agent. See the abstract. Liu teaches the pore-forming agent is one or more of hydroxypropyl methyl cellulose, polyethylene glycol 4000 and polyvinylpyrrolidone. See claims 1 and 6.
It would have been obvious to a person skilled in the art to create a pore in the tablet of Sharma, motivated by the teachings of Liu, which teaches the use of pore forming agents in the drug forming layer of a sacubitril valsartan sodium sustained release formulation as old and well known. The determination of the location of the pore is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 4, Sharma teaches the use of a tonicity adjusting agent, such as mannitol and sorbitol, the use of a thickener, such as hydroxypropyl methylcellulose, the use of a sweller, such as povidone, the use a colorant, such as iron oxide red, the use of a lubricant, such as silicone dioxide. See Para [0098] and [0099] and table 1.
Regarding claim 5, Sharma teaches the amount of sacubitril 10-40% and the amount of valsartan 10-40%. The combination of these two ingredients equals to 20-80% in the tablet. See Example 1, Para [0114]. The concentration of silicone dioxide as a lubricant is taught to be 0.1-5%. See Example 1.
Regarding claim 6, Sharma teaches the use of a colorant, but does not teach the concentration of such agent. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Sharma does not teach the concentration of a tonicity agent. However, Liu teaches the concentration of mannitol being 5 g and the concentration of sucrose is 30 g. See Examples 2 and 3.
Regarding claim 7, Sharma teaches the use of a plasticizers. See Para [0097]. The use of povidone is taught in Para [0099].
Regarding claim 8, Sharma teaches the use of sacubitril valsartan sodium, hydroxyethyl cellulose, colloidal silica and magnesium stearate and povidone. See Paras [0093] and [0098]. The components taught by Sharma read on the ingredients of the claimed Formula VII, XI and XII. Sharma does not teach the concentration of each component. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), wherein the court states “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Regarding claim 9, Sharma teaches the film-coating provides for immediate release, extended release, sustained release, delayed release, enteric release, or intestinal release of the active agent. See Para [0095]. Sharma teaches the term “composition” or “dosage form” or “pharmaceutical composition” as used herein synonymously include tablet such as mono-layered/single layer tablets, bilayered tablets, trilayered tablet, multilayer tablet, drug layered tablet, caplets, minitablets, capsules, tablet in tablet, tablets in a capsule, granules in a capsule, pellets, pellets in a capsule, beads, powder, granules, sachets, suspension or any other suitable dosage form meant for oral administration. See Para [0090].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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