Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-35 and 39 are cancelled.
Claims 36-38 are pending. Applicant’s amendments have necessitated modification of the existing grounds of rejection. Accordingly, this Action is FINAL. Support for the claimed limitations of “about 4 mg to about 34 mg” and “about 50 mg to about 400 mg” is reasonable found in [0098] such that the ordinary artisan understands the scope of “about”.
Withdrawn rejections
Applicant's amendments and arguments filed 12/26/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 39 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph and claim(s) 35 was rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Colombo et al. (US5549913). Applicant has cancelled these claims.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 36-38 are rejected under 35 U.S.C. 103(a) as being unpatentable over Weber et al. (US20060142290) or Weber et al. (US20040254208; herein after Weber2004) and Colombo et al. (US5549913).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical methods and pharmaceutical dosage forms — without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 36-38, Weber et al. teach methods of affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual (Abstract; claim 8) and methods for the treatment of obesity
and for affecting weight loss in individuals [0003, 0021] by administering naltrexone and bupropion (Claims 7, 8, 12 and 17), wherein they are administered nearly simultaneously (Claim 18). Weber et al. teach tableting processes to make the pharmaceutical compositions [0093] to make tablets with lactose as an excipient [0096]. Weber et al. teaches delivery of the compounds in a sustained release system [0107] where each drug can be present in the oral dosage form between 0.1 and 500 mg [0111]. Weber et al. teach the hydrochloric salt of the drugs [0108].
Regarding claims 36-38, Weber2004 similarly teach methods of affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual (Abstract; claim 10) and methods for the treatment of obesity and for affecting weight loss in individuals [0003, 0020] by administering naltrexone and bupropion (Claim 9), wherein they are administered nearly simultaneously (Claim 19). Weber2004 teach tableting processes to make the pharmaceutical compositions [0093] to make tablets with lactose as an excipient [0096]. Weber2004 teaches delivery of the compounds in a sustained release system [0107] where each drug can be present in the oral dosage form between 0.1 and 500 mg [0111]. Weber2004 teach the hydrochloric salt of the drugs [0108].
Regarding claims 36-38, Colombo et al. is directed to controlled release formulations (Title; Abstract; Claims 1-15) and teach pharmaceutical formulations with an active principle in a first layer, an active principle is a second layer and an intermediate layer that comprises lactose between the two layers that provides a substantially similar release of the active principles as separate formulations of the active principles (Figure 2a-2c; Examples 1-2; column 3, lines 8-57; claims 1-15). Regarding claim 35, Colombo et al. disclose multilayer matrix systems for controlled release of active principles comprising at least one erodible and/or soluble layer comprising excipients (Title; Abstract; claims 1-15) with “the main aspect of this invention is that the C layer plays the ro[sic] of controller of the release of active principles incorporated in the U and L layers.” (Column 3, lines 32-34). Colombo et al. disclose in Figure 2, a tablet where the intermediate layer “C” dissolves to release two halves of the tablet that are separated but substantially intact as shown in Figures 2a-2c below:
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Colombo et al. disclose in Example 1 a 3-layer matrix system with active principle in layers “U” and “L” and spray dried lactose, which is a disaccharide, in layer “C” (Column 4, Example 1) where release profiles showed “fast detachment of the U and L layers” (Column 6, lines 10-13). Thus, the intermediate “C” layer is configured to rapidly dissolve in vivo and leave the “U” and “L” layers substantially intact but physically separated and thereby providing a substantially similar release of the active pharmaceutical ingredients in the “U” and “L” layers as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer “U” and second pharmaceutical composition “L”. Soluble starch is also claimed (Claim 12). Columbo et al. report “constant release rate” (Column 8, lines 27-28; see also column 6, lines 20-21) with time frames measured at 5, 30, 60, 90 and every 30 minutes thereafter (Column 5, lines 65-66 and column 7, lines 12-13), which reasonably reads on a sustained release of the active.
The rate of release is controlled by the type and proportion of the swelling polymers (Column 3, lines 50-58).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Weber et al. or Weber2004 is that Weber et al. or Weber2004 do not expressly teach about 4-35 mg of naltrexone hydrochloride and about 50-400 mg bupropion hydrochloride in sustained release formulations where the pharmaceutical formulation comprises a first pharmaceutical layer comprising the naltrexone, a second pharmaceutical layer comprising the bupropion; and an intermediate layer disposed between said first and said second pharmaceutical layers that provides a substantially similar release of the naltrexone and bupropion as separate formulations of the naltrexone and bupropion and comprises a controlled release formulation. This deficiency in Weber et al. or Weber2004 is cured by the teachings of Colombo et al.
1. It would have been obvious to one of ordinary skill in the art at the time the invention was made to perform the method of Weber et al. or Weber2004 with sustained release formulation comprising about 4-35 mg of naltrexone hydrochloride and about 50-400 mg bupropion hydrochloride in sustained release formulations where the pharmaceutical formulation comprises a first pharmaceutical layer comprising the naltrexone, a second pharmaceutical layer comprising the bupropion; and an intermediate layer disposed between said first and said second pharmaceutical layers that provides a substantially similar release of the naltrexone and bupropion as separate formulations of the naltrexone and bupropion and comprises a controlled release formulation, as suggested by Colombo et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following sound articulated reasoning with rational underpinning based upon the evidence. First of all, both Weber et al. and Weber2004 teach delivery of the compounds in a sustained release system where each drug can be present in the oral dosage form between 0.1 and 500 mg and as the hydrochloric salt of the drugs, which would be naltrexone hydrochloride and bupropion hydrochloride. The range of between 0.1 and 500 mg overlaps the claimed ranges to render the claimed ranges obvious. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Consequently, both Weber et al. and Weber2004 teach and suggest a sustained release system with between 0.1 and 500 mg of naltrexone hydrochloride and between 0.1 and 500 mg of bupropion hydrochloride for use in methods of treating an obesity related condition in a patient.
Secondly, in one embodiment, Weber et al. and Weber2004 intend for the first compound naltrexone and the second compound bupropion to be administered more or less simultaneously [0048]. To this end, the disclosure of Colombo et al. provides a single tablet dosage form that splits into equal parts by a dissolving intermediate lactose containing layer to provide a substantially similar release of the active principles as separate formulations that provides more or less simultaneous administration of the active principles. It is then obvious to provide naltrexone in one layer and bupropion in the other layer of the tablet of Colombo et al. to provide more or less simultaneous sustained release of naltrexone and bupropion in the method of Weber et al. or Weber2004 with a reasonable expectation of success. Employing the controlled release formulation as suggested and described by Colombo et al. to be used in the method of Weber et al. or Weber2004 for sustained release of naltrexone hydrochloride and bupropion hydrochloride is at the discretion of the ordinary artisan in this art with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments: Applicant’s remarks filed 12/26/25 have been carefully considered but are not persuasive.
Applicant asserts that neither reference discloses a pharmaceutical formulation comprising a sustained-release formulation comprising about 4 mg to about 35 mg of naltrexone hydrochloride and a sustained-release formulation comprising about 50 mg to about 400 mg of bupropion hydrochloride. Respectfully, the Examiner does not agree because both references suggest sustained release formulations of the hydrochloride salt of the drugs naltrexone and bupropion as well as oral dosage amounts that overlap the claimed ranges. Both Weber2004 and Weber et al. teach adjusting the dosage amount [0112] and teach: “Determination of a therapeutically effective amount is well within the capability of those skilled in the art” [0109]; thereby instructing the artisan to optimize the dosage amount. Accordingly, the claimed ranges are obvious over the applied disclosures. Applicant’s arguments are not persuasive.
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 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8318788. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented subject matter teaches methods for affecting weight loss in a patient by administering to the patient a layered pharmaceutical formulation comprising sustained release (Claims 4-10, 15-19) a first pharmaceutical layer comprising between about 2-35 mg naltrexone (Claims 6-7) , a second pharmaceutical layer comprising between about 50-200 mg bupropion (Claims 8-9, 17-19), and an intermediate layer disposed between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to rapidly dissolve in vivo, and thereby leave the first and the second pharmaceutical layers Substantially intact but physically separated, and wherein the dissolution profile of naltrexone in the pharmaceutical formulation is substantially the same as a single compressed tablet of naltrexone having the same size and shape as the first pharmaceutical layer, and wherein the dissolution profile of bupropion in the layered pharmaceutical formulation is substantially the same as a single compressed tablet of the same pharmaceutical composition, size and shape as the second pharmaceutical layer (Claims 1, 12) wherein the intermediate layer comprises a monosaccharide, a disaccharide or a starch (Claim 2, 13) lactose (Claim 3, 14) and the sustained-release (Claims 4-5, 9-10, 15-16, 18-19) is interpreted to read on a controlled release. The scope of the claimed drugs includes salts thereof (Column 3, lines 55-60) such as a pharmaceutically acceptable salt thereof includes the hydrochloride salts (Column 11, lines 56-61 and column 15, line 60-65).
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8088786 in view of Weber et al. (US20040254208). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent discloses the composition of comprising between about 2-35 mg sustained release naltrexone, hence controlled release, and between about 50-200 mg of sustained release bupropion (Claim 1 see also claims 3-5) with an intermediate layer of lactose (Claim 2). The patent does not expressly teach a method for treating an obesity related condition in a patient. However, the layered formulation comprising naltrexone and bupropion must be used to treat something and Weber et al. teach that such a combination of active agents is used in methods of affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual (Abstract; claim 10) and methods for the treatment of obesity and for affecting weight loss in individuals [0003, 0020] by administering naltrexone and bupropion (Claim 9). The scope of the claimed drugs includes salts thereof (Column 3, lines 45-50) such as a pharmaceutically acceptable salt thereof includes the hydrochloride salts (Column 11, lines 47-55 and column 15, line 55-60). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Weber et al.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8722085 in view of Colombo et al. (US5549913). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented subject matter teaches methods of administering a pharmaceutical formulation comprising about 4-8 mg naltrexone and about 90 mg bupropion (Claims 1-10, 17) in the form of a sustained release (Claims 9, 11-13) tablet (Claim 5) to treat obesity (Claims 14-16) wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo (Claims 10-11). Sustained release reads on controlled release. Performing the method implicitly treats an obesity related condition. The patent does not expressly teach lactose. However, Colombo et al., discussed in detail above and incorporated by reference, teaches employing lactose in the intermediate layer. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of: “wherein the layered pharmaceutical formulation provides a substantially similar release of the first active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer, wherein the layered pharmaceutical formulation provides a substantially similar release of the second active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the second pharmaceutical layer” is implicit in the layered pharmaceutical formulation. The scope of the claimed drugs includes salts thereof (Column 21, lines 45-50) such as a pharmaceutically acceptable salt thereof includes the hydrochloride salts (Column 9, lines 45-50 and column 13, line 66). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Colombo et al.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9125868 in view of Colombo et al. (US5549913). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented subject matter teaches methods of administering a pharmaceutical formulation comprising about 4-8 mg of naltrexone and about 90 mg bupropion (Claims 1-10, 17) in the form of a sustained release (Claims 9, 11-13) tablet (Claim 5) to treat obesity (Claims 14-16), thereby implicitly treating an obesity related condition, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo (Claims 10-11). Sustained release reads on controlled release. The patent does not expressly teach lactose. However, Colombo et al., discussed in detail above and incorporated by reference, teaches employing lactose in the intermediate layer. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of: “wherein the layered pharmaceutical formulation provides a substantially similar release of the first active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer, wherein the layered pharmaceutical formulation provides a substantially similar release of the second active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the second pharmaceutical layer” is implicit in the layered pharmaceutical formulation. The scope of the claimed drugs includes salts thereof (Column 21, lines 45-50) such as a pharmaceutically acceptable salt thereof includes the hydrochloride salts (Column 9, lines 45-50 and column 13, line 66). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Colombo et al.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10307376 in view of Colombo et al. (US5549913). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented subject matter teaches methods of administering a pharmaceutical formulation comprising about 4-8 mg naltrexone or a pharmaceutically acceptable salt thereof and about 90 mg bupropion or a pharmaceutically acceptable salt thereof (Claims 1-10, 17) in the form of a sustained release (Claims 9, 11-13) tablet (Claim 5) to treat obesity (Claims 14-16, 18 and 20), thereby implicitly treating an obesity related condition, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo (Claims 10-11). Sustained release reads on controlled release. The patent does not expressly teach lactose. However, Colombo et al., discussed in detail above and incorporated by reference, teaches employing lactose in the intermediate layer. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of: “wherein the layered pharmaceutical formulation provides a substantially similar release of the first active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer, wherein the layered pharmaceutical formulation provides a substantially similar release of the second active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the second pharmaceutical layer” is implicit in the layered pharmaceutical formulation. The scope of a pharmaceutically acceptable salt thereof includes the hydrochloride salts (Column 9, lines 63-67 and column 14, lines 19-20). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Colombo et al.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12048769 in view of Colombo et al. (US5549913). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented subject matter teaches methods of administering a pharmaceutical formulation comprising about 8 mg naltrexone and about 90 mg bupropion or the pharmaceutically acceptable salts thereof, (Claims 1-10, 17) in the form of a sustained release (Claims 9, 11-13 and 17) tablet (Claim 5) to treat obesity (Claims 14-20), thereby implicitly treating an obesity related condition, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion and a second pharmaceutical layer comprising the sustained release formulation of naltrexone, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo (Claims 10-11). Sustained release reads on controlled release. The patent does not expressly teach lactose. However, Colombo et al., discussed in detail above and incorporated by reference, teaches employing lactose in the intermediate layer. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of: “wherein the layered pharmaceutical formulation provides a substantially similar release of the first active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer, wherein the layered pharmaceutical formulation provides a substantially similar release of the second active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the second pharmaceutical layer” is implicit in the layered pharmaceutical formulation. The patent teaches that the scope of the pharmaceutically acceptable salts would include naltrexone is marketed as the hydrochloride salt (Column 14, lines 31-32) and bupropion is administered as the hydrochloride salt (Column 10, lines 5-9). Thus, the hydrochloride salts are within the scope of the claimed subject matter.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of Colombo et al.
Claims 36-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-66 of copending Application No. 18770144 in view of Colombo et al. (US5549913). The copending teaches methods of reducing the risk of side effects associated with administration of about 4-8 mg of a pharmaceutically acceptable salt of naltrexone and about 90 mg of a pharmaceutically acceptable salt of bupropion (Claims 47-49 and 63) in sustained release form (Claims 55, 57-59) the form of a tablet (Claim 51) as described in claim 57, for example:
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in patients who are obese (Claims 60-62, 64 and 66), thereby implicitly treating an obesity related condition. The copending does not expressly teach lactose. However, Colombo et al., discussed in detail above and incorporated by reference, teaches employing lactose in the intermediate layer. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of: “wherein the layered pharmaceutical formulation provides a substantially similar release of the first active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the first pharmaceutical layer, wherein the layered pharmaceutical formulation provides a substantially similar release of the second active pharmaceutical ingredient as a singly compressed tablet comprising the same pharmaceutical composition as that of the second pharmaceutical layer” is implicit in the layered pharmaceutical formulation. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter in view of Colombo et al.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments: Applicant submits that none of the cited claims of the previous patents or the copending application disclose a pharmaceutical formulation comprising a sustained-release formulation comprising about 4 mg to about 35 mg of naltrexone hydrochloride and a sustained-release formulation comprising about 50 mg to about 400 mg of bupropion hydrochloride. Applicant is mistaken as pointed out by the Examiner in the rejections above. Also note MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.” Thus, it is permissible to use the specifications to construe the scope of the claimed subject matter.
Applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Applicant's 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613