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 . Claims included in prosecution are claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56.
Claim Rejections - 35 USC § 101 / § 112 – Hybrid Claim
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the indicated claims recite “the use of a combination” and do not claim an invention that falls under at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
Claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 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.
A single claim which recites both a product and a method of using that product is indefinite under 35 USC 112, second paragraph. Se Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990).
Note, for the sake of compact prosecution, the instant claims are being interpreted as composition claims and any claimed limitations directed to active steps will be interpreted as intended use limitations or product by process limitations.
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.
1. Claim(s) 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douroumis et al. (US 2018/0021263, Jan. 25, 2018) (hereinafter Douroumis).
Douroumis discloses a composition comprising an inorganic excipient and ibuprofen within a hydrophilic polymer (Abstract). Douroumis also teaches a method of producing a tablet comprising providing ibuprofen, a hydrophilic polymer, and an inorganic excipient and processing them by an extrusion process to produce an extruded composition wherein the ibuprofen forms a solid dispersion/solution within the hydrophilic polymer (¶ [0005-0009]). In one embodiment, the extruded composition comprises ibuprofen in an amount less than or equal to 50 wt. % (satisfies claim 3, 5, & 55) (¶ [0012]). In preferred aspects of all embodiments, the ibuprofen is amorphous ibuprofen (satisfies amorphous active of claim 1 and 55) (¶ [0052]). Suitable polymers include vinylpyrrolidone-vinyl acetate copolymers (Kollidon), having a Tg of 101 °C and copolymers based on dimethylaminoethyl methacrylate (EPO), having a Tg of 45 °C (satisfies polymers of claim 1, 7-9, 13-14, 17, & 46) (¶ [0057-0058]). Exemplary embodiments contained the polymer in amounts ranging from 15-40 wt.% (¶ [0110]). Taste masking evaluation was conducted and the bitter taste of ibuprofen was successfully masked. The polymers EPO and Kollidon were successful in masking the bitter taste (satisfies taste masking of claim 1) (¶ [0120-0122]). In vitro dissolution studies were also carried out at pH 1.2 on the example products (satisfies claim 24) (¶ [0126]).
Douroumis differs from the instant claims insofar as not explicitly disclosing wherein two polymers (i.e., dimethylaminoethyl methacrylate co-polymer and polyvinylpyrrolidone-vinyl acetate co-polymer) were used together in the extrudate composition.
However, since the use of various hydrophilic polymers is known individually, the use of the individual species in combination would have been obvious since it is prima facie obvious to combine two compositions, each of which is taught to be useful for the same purpose, in order to form a third composition to be used for the very same purpose; the idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. Therefore, it would have been obvious to one of ordinary skill in the art, prior to filing the instant application, to have combined two hydrophilic polymers, i.e., dimethylaminoethyl methacrylate co-polymer and polyvinylpyrrolidone-vinyl acetate co-polymer, because they are both used for the same purpose as disclosed Douroumis.
Regarding the amounts of API recited in instant claims 5, 46, and 55, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, the extruded composition comprises ibuprofen in an amount less than or equal to 50 wt. %. Accordingly, because the amounts recited in the instant claims lie inside the range disclosed by Douroumis, the range disclosed by Douroumis meets the instantly recited limitations.
Regarding the amounts and ratios of the two polymers recited in instant claims 11, 15, and 53-55, where 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. See MPEP 2144.05(II)(A). As discussed above, EPO and Kollidon are hydrophilic polymers utilized for bitter taste masking, which makes amounts/ratios thereof a result effective variable, since amounts directly impact the taste masking effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts/ratios of EPO and Kollidon to yield the desired taste masking profile.
Regarding the active steps recited in claims 28 and 35, "[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." "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. See MPEP § 2113. Therefore, the steps of making the composition of the instant claims does not distinguish the composition from that of the prior art.
Double Patenting
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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.
1. Claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10-11, 14-15, 17-18, 21, 23, 34-35, and 47-53 of copending Application No. 18/548,645 in view of Douroumis et al. (US 2018/0021263, Jan. 25, 2018) (hereinafter Douroumis).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose a solidified melt extrudate comprising an NSAID and two polymers, namely dimethylaminoethyl methacrylate co-polymer and polyvinylpyrrolidone-vinyl acetate co-polymer {PVPVA64).
The difference between the instant claims and the copending claims lies in the fact that the instant claims further recite wherein the extrudate is used for taste masking.
However, Douroumis discloses a composition comprising an inorganic excipient and ibuprofen within a hydrophilic polymer (Abstract). It is an object of the invention to improve various characteristics of ibuprofen extrudates and pharmaceutical forms derived therefrom for pharmaceutical use, such as taste-masking (¶ [0004]). Suitable polymers include vinylpyrrolidone-vinyl acetate copolymers and copolymers based on dimethylaminoethyl methacrylate (¶ [0057-0058]). Taste masking evaluation was conducted and the bitter taste of ibuprofen was successfully masked. The polymers EPO and Kollidon were successful in masking the bitter taste (¶ [0120-0122]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have utilized the extrudate of the copending claims in an attempt to mask the bitter taste of ibuprofen since this is a known use of such extrudates containing such polymers as taught by Douroumis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3, 5, 7-9, 11, 13-15, 17, 24, 28, 35, 46, and 53-56 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached at (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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