DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-9) in the reply filed on 02 June 2026 is acknowledged. The traversal is on the ground(s) that the claimed inventions are not independent or distinct and that there is no serious search or examination burden and that a product-process relationship supports examination together. This is not found persuasive because the inventions are distinct because the product as claimed can be made by another and materially different process such as tablet molding; burden was shown in the restriction requirement because of their different classifications; and a product-process relationship does not rebut the distinctness and burden demonstrated.
The requirement is still deemed proper and is therefore made FINAL.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02 June 2026.
Claims 1-9 are under current consideration.
Claim Objections
Claims 3-4 are objected to because of the following informalities: the last lines of both claims erroneously recite levocarnitine rather than trimetazidine dihydrochloride. Appropriate correction is required.
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 5 and 9 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 5 recites the limitation "the adhesive" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the filler" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the filler A" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the lubricant" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the lubricant" in line 2. There is insufficient antecedent basis for this limitation in the claim, in that parent claim 2 contains two different recitations of lubricant and it is not clear which is referred to.
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 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.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. (CN 107693521 A; published 16 February 2018; citations herein to English machine translation made 24 July 2026) in view of Jadhav et al. (International Journal of Creative Research Thoughts, Vol. 9, Issue 5, May 2021, pages 816-831) as evidenced by Fang (US 2019/0381034 A1; published 19 December 2019).
Xie et al. discloses a tablet of actives levocarnitine and trimetazidine or pharmaceutically acceptable salt thereof at a weight ratio of 200:1, and pharmaceutically acceptable auxiliary materials of adhesive, wetting agent, filling agent, disintegrating agent, and lubricating agent (claim 1) wherein the pharmaceutically acceptable salt of trimetazidine comprises hydrochloric acid (claim 5) wherein 500 g levocarnitine can be mixed with 50 g povidone (i.e., adhesive, binder) and 95 g microcrystalline cellulose (i.e., filler) and adding ethanol and granulating and drying and dry granulating to obtain levocarnitine particles which can be thereafter mixed with 30 g talcum powder (i.e., lubricant, glidant) and 5 g magnesium stearate (i.e., lubricant) (Example 1), and 2.5 g trimetazidine can be mixed with 45 g mannitol (i.e., filler A) to obtain trimetazidine particles (Example 2) wherein trimetazidine particles can be thereafter mixed with 5 g magnesium stearate (i.e., lubricant) (Example 1) wherein the trimetazidine can be trimetazidine hydrochloride (Example 1) wherein povidone is a binder (i.e., an adhesive) (claim 6) wherein microcrystalline cellulose and mannitol are filling agents (claim 6) wherein talcum powder is a lubricant (i.e., a glidant) (claim 6) wherein magnesium stearate is a lubricant (claim 6).
As evidenced by Fang, trimetazidine hydrochloride is also referred to as trimetazidine dihydrochloride (abstract).
Xie et al. does not disclose that the tablet is a bilayer tablet as claimed.
Jadhav et al. discloses that a bilayer tablet is a type of tablet having two layers that can have two different drugs with many advantages such as maintaining physical and chemical stability and maximizing the efficacy of a combination of two drugs (abstract; page 820).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Xie et al. and Jadhav et al. to make the tablet of Xie et al. as discussed above as a bilayer tablet as suggested by Jadhav et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make such tablet as a type of tablet known to be useful for tableting two different drugs as suggested by Jadhav et al. given that the tablet of Xie et al. comprises two different drugs, and also to make such tablet with advantages of the bilayer tablet type such as maintaining physical and chemical stability and maximizing the efficacy of a combination of two drugs as suggested by Jadhav et al.
Further regarding claims 3-4, although Xie et al. does not disclose such specific ranges of parts by weight as claimed, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize levocarnitine drug efficacy, trimetazidine dihydrochloride drug efficacy, adhesive/binder efficacy, filler efficacy, glidant/lubricant efficacy, and lubricant efficacy in the bilayer table of Xie et al. in view of Jadhav et al. as discussed above by varying the amounts in the bilayer table of Xie et al. in view of Jadhav et al. as discussed above of levocarnitine drug, trimetazidine dihydrochloride drug, povidone adhesive/binder, microcrystalline cellulose filler, mannitol filler A, talcum powder lubricant/glidant, and magnesium stearate lubricant through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Xie et al. teaches that levocarnitine and trimetazidine dihydrochloride are actives (i.e., drugs), povidone is a binder (i.e., an adhesive), microcrystalline cellulose is a filler, mannitol is a filler A, talcum powder is a lubricant (i.e., a glidant), and magnesium stearate is a lubricant, and thus each such component was a known result-effective variable.
Further regarding claim 5, although Xie et al. does not disclose the ethanol as absolute ethanol, such claim is a product-by-process claim, which is therefore only limited to the structure implied by the process steps rather than the manipulations of the process steps themselves per MPEP 2113(I), and given that the levocarnitine composition of Xie et al. appears substantially identical to the claimed levocarnitine composition, such compositions are presumed to be the same per MPEP 2113(II) and the burden shifts to applicant to provide evidence establishing a nonobvious difference between them.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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