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 response and amended claims filed on September 23, 2025 is acknowledged.
Claims 1-22 and 28 are pending in this application.
Claims 1, 13, 17, and 18 have been amended. Claims 23-27 are cancelled.
Election/Restrictions
Applicant's election with traverse of Group II (claims 12-22) in the reply filed on September 23, 2025 is acknowledged. The traversal is on the ground(s) that claim 1 has been amended to recite the particle has a density of 0.5 to 0.7 g/mL and/or a flow rate of 3 to 15 g/sec, therefore there is unity of invention. This is not found persuasive because density and flow rate are considered physical properties of the granules themselves. Applicant’s attention is directed to MPEP 2112.01 which recites where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Applicant has additionally elected the sodium salt of ibuprofen.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups I and III, there being no allowable generic or linking claim.
Claims 12-22 are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on April 8, 2022 is acknowledged. A signed copy is attached to this office action.
Claim Objections
Claim 20 is objected to because of the following informalities: the claim recites polyvinylpyrrolidone (povidone), however, povidone is a synonym for polyvinylpyrrolidone and is therefore redundant and unnecessary.
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.
Claim 20 is 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.
Regarding claim 20, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
(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 12-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoy et al. (EP 0523847).
Hoy discloses a chewable medicament tablet made from coated granules of a medicament wherein the coating comprises a mixture of methylaminoethyl methacrylate and neutral methacrylic acid ester and a cellulose ester and optional polyvinyl pyrrolidone (abstract).
The coated medicament can be ibuprofen, ibuprofen sodium, naproxen, naproxen sodium and other similar NSAID’s (page 3, lines 1-3). It is noted that ibuprofen, ibuprofen sodium, naproxen, and naproxen sodium are arylpropionic NSAIDs.
Regarding claim 13, as noted above, the granule comprises ibuprofen coated with a mixture of methylaminoethyl methacrylate and neutral methacrylic acid ester and a cellulose ester and optional polyvinyl pyrrolidone. Regarding the recitation of the density and/or flow rate is considered a property of the granule. Since the prior art discloses the same granule as recited in the instant claims, it would necessarily have the same properties. Applicant’s attention is directed to MPEP 2112.01 which recites where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 14-17, as noted above, the coated medicament can be ibuprofen, ibuprofen sodium, naproxen, naproxen sodium and other similar NSAID’s (page 3, lines 1-3). It is noted that ibuprofen, ibuprofen sodium, naproxen, and naproxen sodium are arylpropionic NSAIDs.
Regarding claims 18-19, as noted above, the NSAID can be a sodium salt of ibuprofen.
Regarding claim 20, as noted above, the granules of the NSAID include a mixture of methylaminoethyl methacrylate and neutral methacrylic acid ester and a cellulose ester and optional polyvinyl pyrrolidone. It is noted a mixture of methylaminoethyl methacrylate and neutral methacrylic acid ester and a cellulose ester include a methacrylate copolymer.
Regarding claim 21, the polymer coating comprises 2-25% by weight of the total weight of the coated medicament (page 3, line 6-7).
Regarding claim 22, the coated particles may then be compressed into a tablet form together with excipients and flavoring agents (page 3, lines 8-9).
Hoy, therefore, anticipates the rejected claims.
Conclusion
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.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615