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 the Claims
Claims 170-175 and 177-192 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants Claims 170 and 192 are directed to compressed solid oral dosage forms having any of 7 concentrations of oxycodone and at least about 30% of a polyethylene oxide having a molecular weight falling within a defined range that are resistant to alcohol extraction and possess a certain hardness. These dosage forms are configured in a manner to provide for a particular range of blood plasma concentrations within a defined range of time following administration. Applicants Claims 170 and 192, as well as dependent Claims 180-187, each recite a variety of what is commonly recognized as “product by process” language, with each of Claims 170 and 192 newly requiring that the process now requires that the compositions are to first be compressed to form the tablets claimed, and subsequently subjected to a “curing” step whereby the formed tablets are subjected to elevated temperatures absent pressure. “[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). Dependent Claims 171-175 place further limitations on the molecular weight of the PEO to be found in the compressed tablets of the claims. Claim 177 excludes PEO having a molecular weight of less than 1 million Da, with Claims 178 and 179 requiring the inclusion of an anti-tacking agent, specifically magnesium stearate. Claims 185-187 incorporate a coating on the tablet, with Claims 188 and 189 certain dissolution parameters the tablet is to b possess, and Claims 190 and 191 additional hardness parameters.
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.
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.
Claims 170-175 and 177-192 are rejected under 35 U.S.C. 103 as being unpatentable over Bartholomaus (U.S. PGPub. 2005/0031546), in view of Wright (U.S. PGPub. 2003/0068375), and Abreu (WO2005/097075).
Bartholomaus describes dosage forms containing active agents with abuse potential that have been abuse proofed and have a breaking strength in excess of 500N, addressing elements of the instant claims. (Abs.). In addition to the active with abuse potential, at least one polymer is found in these dosage forms. [0009]. The oxycodone, and salts thereof, of the instant claims is identified as just such an active with abuse potential, with Bartholomaus establishing that the amounts of each to be present in such dosage forms are well-known to those of ordinary skill in the art. [0014-16]. This renders the oxycodone dosages, as well as the physiologically observed plasma concentrations, time to maximum blood concentration, and drug release rate limitations of instant claims 170, 188, 189, and 192 result-effective variables suitable for optimization via routine experimentation, and prima facie obvious as a result. [0014-16], See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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 also Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012)( It is well established that “an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations.”), accord Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (indicating that every ordinary artisan in medicine performs "merely routine optimization of drug dosage to maximize therapeutic effect."). Polyethylene oxide, and more specifically a polyethylene oxide preferably with a molecular weight in excess of 0.5 million up to 15 million, a range overlapping and therefore rendering obvious that of the instant claims, is identified as a particularly preferred polymer to be used in conveying the desired breaking strength. [0018], See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). As there is no requirement per the teachings of Bartholomaus concerning the inclusion of polyethylene oxide with a molecular weight below 1 million Da, the limitations of Claim 177 are met by the teachings of Bartholomaus. While Bartholomaus does not require any particular concentration of the polymer be present in these dosage forms, exemplary embodiments contain between 60-66% PEO, addressing the limitations of the instant claims. [0116; 0122; 0126; 0131; 0136]. In addition to the polymer conveying break resistance, Bartholomaus advocates incorporating additional abuse proofing components, including but not being limited to viscosity increasing agents and antagonists for each active with abuse potential. [0021-29; 0042-45; 0051-53]. Bartholomaus indicates these dosage forms may be made by the compression of the chosen ingredients accompanied by preceding, simultaneous, or subsequent application of heating the composition to at least the softening temperature of the polymer present in the composition. [0065-68]. Bartholomaus therefore describes as an embodiment of the tablet formation processes one whereby the mixture of tablet components are subject to tableting, and then “the formed tablets are briefly heated at least to the softening temperature (glass transition temperature, melting temperature, sintering temperature) of component (C ) and cooled again,” a recitation of the process steps newly added to the Claims, rendering them prima facie obvious as a result. [0067]. Oral tablets and osmotic dosage forms are particularly described as suitable physical forms of the abuse-resistant dosage form. [0069]. Bartholomaus indicates that tablets formed according to these teachings using a polyethylene oxide of 7 million Da possess breaking strength in excess of 500N, addressing limitations of the present claims, and include both tablets which remain unbroken as well as those simply undergoing plastic deformation. [0110-13; 0118; 0124; 0128; 0133]. While not phrased in the same language nor tested under the precise circumstances recited by Claim 191, by indicating that the compositions are made using the materials required by the claims, and whereing the process steps of the claims are recited as an embodiment of the tableting process, which result in tablets that are unbroken or merely plastically deformed when subjected to pressure, the Examiner presumes, absent a showing to the contrary, that the properties recited by Claim 191 are necessarily present in the compositions of Bartholomaus. This is because where the claimed invention and prior art 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) (indicating that “products of identical chemical composition cannot have mutually exclusive properties.”).
The art at the time of the instant application advocated forming abuse deterrent dosage forms of oxycodone or its salts combined with high molecular weight polyethylene oxide and additional abuse-deterring components, including viscosity agents and opioid antagonists, into tablets designed to resist breakage by combining the tablet components, forming them into tablets under pressure, then subjecting the formed tablets to a defined level of heat before cooling.
Despite these teachings, formulation of the dosage form to resist alcohol extraction, the use of a 4 million Da PEO, oxycodone hydrochloride, inclusion of an anti-tacking agent, or the inclusion of a film coating are not specifically taught by Bartholomaus.
Wright also concerns the extended release formulations of abuse-resistant dosage forms of drugs susceptible to abuse and the use of aversive agents to provide a composition unsuitable for parenteral or nasal administration. (Abs.). Aversive agents per the teachings of Wright are suitably provided in a “sequestered” form when administered as intended. [0027]. Aversive agents include gelling agents [0023], as well as opioid antagonists [0031], suitable for rendering tampering such as by crushing or dissolution in a solvent undesirable. [0031]. Polyethylene oxide is identified as just such a gelling agent. [0049]. Oxycodone, and oxycodone hydrochloride, are identified as suitable opioid agonists for use in these dosage forms, in dosages ranging between about 2.5-320mg, with dosages of 10, 20, 40, and 80mg specifically recited. [0056-58; 0063]. Polyethylene oxides have a molecular weight of between 1,000,000-10,000,000, including specifically each of 5,000,000 and 7,000,000 are particularly identified as suitable for being combined with the opioid and additional averse agents into homogeneous cores provided with a coating. [0081; 0150; 0154]. While not described as taking place at any particular time during the processing, as is set forth by Claims 185-187, applicants are reminded that in the absence of secondary indicia of nonobviousness, any order of performing process steps is prima facie obvious. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). Wright indicates that magnesium stearate, addressing the limitations of Claims 178 and 179 may optionally be included in these dosage forms. [0158].
Abreu also deals with opioid dosage forms containing as an adverse agent an opioid antagonist formulated to deter tampering. (Abs.); [0002]. Oxycodone as well as its pharmaceutical salts is enumerated among the opioids usefully formulated in such a manner. [0084]. Like Wright, Abreu advocates providing an adverse agent in a manner and form whereby if the dosage form is not mistreated or misused, the adverse agent remains in a form rendering it unavailable. [0047]. Abreu indicates that when, on the other hand, the dosage form is mistreated or misused such as by dissolving the dosage form in an organic solvent such as ethanol, the adverse agent is provided in vivo in a significant amount. [0048].
It would have been prima facie obvious for the skilled artisan at the time of the instant application to have utilized a PEO of sufficiently high molecular weight, such as 4 million, 5 million, or 7 million Da, combined with oxycodone hydrochloride and an adverse agent such as an opioid antagonize provided in a form whereby ethanol extraction would render the antagonist bioavailable, in a compressed and coated tablet for oral administration per the instant claims. One having ordinary skill in the art would have been motivated to do so because PEO having molecular weights encompassing these values are taught by the art as providing crush resistance to oral tablets containing them. In addition, the art establishes that polyethylene oxides in general serve as gelation agents which represent a second form of abuse deterrence for dosage forms containing opioids such as oxycodones. Finally, sequestering an opioid antagonist in a form whereby ethanol extraction renders the antagonist bioavailable when tampered with and unavailable when administered as intended such as is required by the instant claims represents another form of abuse deterrent formulation for opioid containing dosage forms and is therefore prima facie obvious per the teachings of the 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.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 8808741. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘741 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 8821929. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘929 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8894988. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘988 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 of U.S. Patent No. 8894987. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘987 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 8911719. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘719 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9492393. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘393 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9492392. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘392 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9492391. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘391 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9492389. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘389 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9763933. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘933 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9763886. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘886 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9770416. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘416 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9775811. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘811 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9775810. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘810 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9775808. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘808 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10076499. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘499 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11298322. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘322 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11304909. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘909 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11304908. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘908 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11826472. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘472 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11904055. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘055 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 178-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11938225. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘225 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11964056. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘056 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12246094. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘094 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12280152. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘152 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Claims 170-175 and 177-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12396955. Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims of the ‘955 patent describe an oxycodone composition falling within the metes and bounds of the present claims, rendering such a dosage form prima facie obvious.
Response to Arguments
Applicant's arguments filed 9 April 2026 have been fully considered but they are not persuasive.
Applicants assert that the newly added process steps, whereby the tablets are formed under pressure and then subsequently subjected to a heating step absent pressure results in a tablet composition, namely tablet density, distinct from that obtained by the exemplified embodiments of the Bartholomaus reference. Applicants are reminded that art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). While it may be true that employing one process disclosed by Bartholomaus results in tablets with a different density from those obtained by the processes of the present invention, a position the Examiner does not concede, this is ultimately irrelevant given the totality of the Bartholomaus disclosure. More specifically, as set forth above, Bartholomaus describes as an embodiment of the tablet formation process one whereby the tablet components are combined, subjected to a tableting process (corresponding to the newly added “compressing a combination…to form the tablet” language newly added to the claims), and subsequently subjecting the formed tablets (corresponding to the “in the absence of elevated pressure” newly added to the claims) to elevated temperatures and cooling them. Because the steps newly added to the claims are explicitly described as an alternative method of forming and “curing” the tablets of the present invention by the teachings of Bartholomaus, the process, and structure implied by the process, are prima facie obvious. See In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(indicating that where the claimed invention and prior art 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). As the heating/curing process of the newly added language of the claims is in fact taught by Bartholomaus, applicants quantification of properties such as a modification of tablet density resulting from employing these art-taught processes cannot be said to overcome the obviousness of compositions formed by such a process. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
The Examiner notes applicants failure to respond in any way whatsoever to the panoply of double patenting rejections asserted previously and again above. For this reason, they are maintained.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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