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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on July 10, 2026 is acknowledged.
Claims 1-22 and 28 are pending in this application.
Claims 23-27 have been cancelled.
Claims 12, 13, and 20 have been amended.
Claims 1-11 remain withdrawn from consideration per the Restriction Requirement dated June 23, 2025.
Claims 12-22 and 28 are under examination in this application.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 20 because the claim recites polyvinylpyrrolidone (povidone), however, povidone is a synonym for polyvinylpyrrolidone and is therefore redundant and unnecessary has been withdrawn in view of the amendment to the claim to delete povidone.
Claim Rejections - 35 USC § 112
The rejection of claim 20 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 because the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention has been withdrawn in view of the amendment to delete “in particular copovidone (a copolymer of polyvinylpyrrolidone and vinyl acetate”.
Claim Rejections - 35 USC § 102
The rejection of claims 12-22 under 35 U.S.C. 102(a)(1) as being anticipated by Hoy et al. (EP 0523847) has been withdrawn in view of the amendment to independent claims to recite the amphiphilic active ingredient is in crystalline form.
Newly Applied Rejections
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-18, 20-22, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP S6144811A; hereinafter referred to as JP811.
JP811 discloses granules of diclofenac sodium treated with a usual excipient or binder and a film of an enteric substance e.g. methacrylic-acid methyl methacrylate copolymer or water insoluble substance e.g. ethyl cellulose (abstract).
The diclofenac sodium is initially coated with a solvent of acetone prior to the enteric coating application. Diclofenac sodium is a crystalline powder. Applicant has disclosed said crystalline structure is preserved by a coating of a polar aprotic solvent, such as acetone.
Binding agents including polyvinylpyrrolidone can be used.
Claim 12 has been amended to recite product by process limitations. Applicant’s attention is directed to MPEP 2113 which discloses "[E]Ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Additionally, it is noted the claim language states, “A granule that can be obtained by”. Thereby indicating the granule does not need to be produced by the process recited, but only that it “can” be produced according to the method steps recited.
Regarding claims 14-18, as noted above, diclofenac sodium is disclosed, which is an amphiphilic active ingredient. Table 1 of the instant specification discloses it to be an arylacetic acid.
Regarding claim 20, as noted above, binding agents including polyvinylpyrrolidone can be used.
Regarding claim 21, diclofenac sodium is 10-45% v/w% of coating.
Regarding claim 22, the granules can be prepared into capsules or formulated into tablets.
Regarding claim 28, Diclofenac sodium is a non-steroid system medicine which has painkilling, anti-inflammation, and an anti-rheumatism operation, therefore, its administration would necessarily provide a treatment for such.
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 19 is rejected under 35 U.S.C. 103 as being unpatentable over JP S6144811; hereinafter referred to as JP811 in view of Manrique-Moreno et al. (Biophysical study of the non-steroidal anti-inflammatory (NSAID) ibuprofen, naproxen and diclofenac with phosphatidylserine bilayer membranes, Biochimica et Biophysica Act, 1858 (2016) 2123-2131).
The teachings of JP811 are discussed above.
JP811 does not disclose ibuprofen sodium or lysine.
Manrique-Moreno discloses NSAIDs mechanism of action is based on the inhibition of cyclooxygenase (COX) pathways, blocking the production of prostaglandins (Introduction).
Manrique-Moreno disclosed he structures of Ibuprofen and Naproxen.
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Structure of Ibuprofen Sodium
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Structure of Naproxen Sodium
As noted by the structures, the compounds would react similarly in formulation.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have substituted ibuprofen sodium for the naproxen sodium in the formulation of JP811 since they are both NSAIDS with similar structures and would be expected to react similarly when formulated into dosage units.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kawashima et al. (US 4,726,966) which discloses preparation of coated granular ibuprofen microspheres. Method of preparation includes dissolving ibuprofen with acrylic acid resin into lower aliphatic alcohol, acetone, methylene chloride, or N,N-dimethylformamide (abstract).
Applicants’ 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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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