DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of U.S. Application No. 15/411,585 filed on January 20, 2017, now abandoned, which is a continuation of U.S. Application No. 14/207,077 filed on March 12, 2014, now abandoned which is a continuation of U.S. Application No. 12/903,131 filed on October 12, 2010, now abandoned which is a continuation of U.S. Application No. 11/602,813 filed November 21, 2006, now abandoned which claims priority from U.S. Provisional Application No. 60/739,281, filed on November 23, 2005.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 18, 2025 has been entered.
Response to Amendment
No amendments to the claims were made by Applicant’s reply filed on December 18, 2025. Claims 1-34, 36, 37, 47, 49, 50 and 52 were previously canceled. Claims 35, 38-46, 48, 51 and 53-58 are currently pending and presented for examination.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
With respect to the double patenting rejections, Applicant argues that none of the cited references, alone or in combination, teach that the combination of naltrexone and bupropion provides a synergistic reduction in food cravings. Applicant argues that regardless of whether the claimed dosages of naltrexone and/or bupropion overlap with the cited references, none of the references establish an expectation that the combination of naltrexone and bupropion would provide a synergistic reduction in food cravings. Thus, the unexpected synergism recited in the claims is evidence of nonobviousness (see MPEP 716.02(a)(1)). Therefore, Applicant argues that the claims are not obvious over the claims of the cited patents in view of Bernstein 1, Bernstein 2, and Zimmermann.
These arguments are found not persuasive since each of the cited patents claim treating overweight or obesity comprising the administration of a combination of naltrexone and bupropion in amounts that overlap with the amounts as claimed in the instant claims. Furthermore, the patient population of the cited patents are patients that are overweight or obese and thus have a BMI of greater than 25 as claimed in the instant claims, since Weber teaches a BMI of 25.0-29.9 is considered overweight, and a BMI of 30.0 and above is considered obese [0006]. Furthermore, the cited patents claim amounts of each component that overlap with the amounts as claimed in the instant claims. Thus, the amounts as claimed are not distinct over the amounts taught in each of the cited patents, and therefore a person of ordinary skill in the art would have a reasonable expectation of success in selecting an amount as claimed based on the cited patents which would necessarily result in the effect as claimed which is synergistic reduction in food cravings.
In addition, while the cited patents claim treating overweight or obesity comprising administering a combination of bupropion and naltrexone, it is noted that the secondary references are supplied to teach that the claimed combination of each of the cited patents would have also been expected to further reduce food cravings since prior to the effective filing date of the instant application, as provided for by Bernstein 1, Bernstein 2 and Zimmerman, both bupropion and naltrexone were known in the art to reduce food cravings, including cravings for carbohydrates, fat and sweets as claimed. Therefore, a person of ordinary skill in the art would have been motivated to treat overweight or obesity comprising the administration of naltrexone and bupropion with a reasonable expectation of further treating food cravings which are known to be associated with overeating and weight gain. Moreover, each of the cited patents teach administration of the claimed combination in overlapping amounts and as such, the methods of the cited patents will necessarily achieve the same effect as claimed which is a synergistic reduction in food cravings.
In addition, it is not necessary that the prior art suggests the same advantage or result discovered by applicant when the steps of the claim are the same as those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013 (CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). Here, the latent property identified by Applicant is that the method of each of the cited patents which comprises administration of bupropion and naltrexone in overlapping amounts as claimed will also achieve reductions in food cravings. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In addition, Applicant’s arguments are found not persuasive because Applicant has not provided any evidence of any synergistic combination for the specific amounts as claimed as compared to amounts outside of the claimed range which may be encompassed by the ranges taught in the patents. Moreover, the instant specification merely states without providing any evidence that synergy was achieved. Evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). No such evidence exists in this application.
Furthermore, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. In the instant case, combining two compounds which are known individually to reduce food cravings and are also known to be administered together, and achieving improved results would not have been considered unexpected, but rather expected. Applicant must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991).
No evidence of synergy has been presented and the arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Likewise, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” “[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant’s heat shrinkable articles with those of the closest prior art, we conclude that appellant’s assertions of unexpected results constitute mere argument.”). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).
For these reasons, the double patenting rejections are hereby maintained and reproduced below.
With respect to the rejection under 35 USC 103, Applicant argues that the Office Action alleges on page 9 that "the prior art specifically teaches the administration of the combination as claimed in amounts as claimed and as such the method of the prior art will necessarily have the same effect as claimed which is a synergistic reduction in food cravings." Applicant argues that the question is not whether there is any overlap with the claims over the cited references, but rather whether there is any expectation in the cited references that the features as arranged in the claim would provide the claimed results. Applicant argues that there is no such expectation from the cited references, and thus the claimed unexpected results support the nonobviousness of the claims (see MPEP 716.02(a)(1)).
These arguments are found not persuasive for the same reasons as detailed above. For the rejection under 35 USC 103, the primary reference (Weber) specifically teaches the combination of bupropion and naltrexone for affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual, by antagonizing opioid receptor activity and enhancing a-MSH activity ([0010] [0223]-[0224]). Weber specifically teaches administering naltrexone and bupropion to individuals having a BMI of greater than 25 [0223]. Weber teaches that naltrexone may be administered in doses in the range of between 5 mg and 50 mg, for example 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg or 50 mg which meets Applicant’s claimed limitation of about 16-48 mg/day [0234]. Weber further teaches that dosing of bupropion should begin at 200 mg per day, and may be increased to 300 mg per day given as 100 mg three times daily, and further contemplates single dosages not exceeding 150 mg, suggesting dosages up to 450 mg per day for bupropion (150 mg administered three times per day) which meets Applicant’s claimed limitation of about 300-400 mg/day of bupropion [0223]. Thus the primary reference specifically teaches administration of the claimed combination to the same patient population as claimed which is a patient having a BMI greater than 25, which as taught by Weber is an overweight or obese patient (25.0-29.9 is considered overweight, and 30.0 and above is considered obese [0006]). Furthermore, Weber teaches amounts of each component that overlap with the amounts as claimed in the instant claims. Thus, the amounts as claimed are not distinct over the amounts taught in Weber, and therefore a person of ordinary skill in the art would have a reasonable expectation of success in selecting an amount as claimed based on Weber which would necessarily result in the effect as claimed which is synergistic reduction in food cravings.
In addition, while Weber teaches treating overweight or obesity comprising administering a combination of bupropion and naltrexone, it is noted that the secondary references were provided to demonstrate that the claimed combination of Weber would also have the effect of reducing food cravings as claimed, since it was known in the art that both naltrexone and bupropion could reduce food cravings. Bernstein 1 teaches that patients who are particularly likely to have carbohydrate cravings and overeating are the obese [0018]. Bernstein 1 teaches that the naltrexone dosage for reducing food cravings is between 0.1 mg and 125 mg per day, which are amounts that also treat overweight and obesity [0014]. Thus, the dosages as taught for the treatment of overweight and obesity are the same dosages useful for the reduction of food cravings. Bernstein 2 also provides evidence that the administration as provided for by Weber which includes bupropion will reduce food cravings since Bernstein 2 teaches that compounds such as bupropion can be administered to reduce food cravings. Zimmerman also teaches that naltrexone reduces craving for sweet, and fatty foods. Zimmerman et al. specifically teaches that increase in body weight is often accompanied by continuous hunger or episodes of craving for sweet and fatty food (page 747). Zimmerman et al. further teaches that acute blockade of opiate receptors results in decreased food ingestion, especially of highly palatable food, decreases pleasantness ratings of palatable foodstuffs, and diminishes subjective feeling of hunger (page 747). Thus, it is clear based on the state of the art prior to the effective filing date that one patient in need of reducing food cravings, and having a BMI greater than 25 as claimed is an obese or overweight patient.
Therefore, prior to the effective filing date of the instant claims, a person of ordinary skill in the art would have been motivated to administer the combination of bupropion and naltrexone to a patient having a BMI of greater than 25 with the expectation that the combination would treat overweight in addition to reducing food cravings.
In addition, it is not necessary that the prior art suggests the same advantage or result discovered by applicant when the steps of the claim are the same as those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013 (CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). The mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). Here, the latent property identified by Applicant is that the method of Weber which comprises administration of bupropion and naltrexone in overlapping amounts as claimed will also achieve reductions in food cravings. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In addition, Applicant’s arguments are found not persuasive because Applicant has not provided any evidence of any synergistic combination for the specific amounts as claimed as compared to amounts outside of the claimed range which may be encompassed by the ranges taught in Weber. Moreover, the instant specification merely states without providing any evidence that synergy was achieved. Evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). No such evidence exists in this application.
Furthermore, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. In the instant case, combining two compounds which are known individually to reduce food cravings and are also known to be administered together, and achieving improved results would not have been considered unexpected, but rather expected. Applicant must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991).
No evidence of synergy has been presented and the arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Likewise, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” “[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant’s heat shrinkable articles with those of the closest prior art, we conclude that appellant’s assertions of unexpected results constitute mere argument.”). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).
Thus the prior art specifically teaches the administration of the combination as claimed in amounts as claimed and as such the method of the prior art will necessarily have the same effect as claimed which is a synergistic reduction in food cravings.
For these reasons, the previous rejection under 35 USC 103 is hereby maintained and reproduced below.
This action is FINAL.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 7,462,626 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity in a patient having a BMI of at least 25 comprising administering a combination of about 30 mg- 500 mg per day bupropion and about 5 mg- 50 mg per day naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘626 claims a range of dosages that the claimed amount as claimed in claim 35 is within, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘626 does not claim including the compounds in a craved food or substance, ‘626 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘626 claims a method for treating overweight or obesity and thus the patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of U.S. Patent No. 7,375,111 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising a combination of about 30 mg- 500 mg per day bupropion and about 5 mg- 50 mg per day naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘111 claims a range of dosages that the claimed amount as claimed in claim 35 is within, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘111 does not claim including the compounds in a craved food or substance, ‘111 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘111 claims the composition is for inducing weight loss and thus a patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 8,318,788 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘788 claims a range of dosages that the claimed amount as claimed in claim 35 is within, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘788 does not claim including the compounds in a craved food or substance, ‘788 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘788 claims a method for affecting weight loss and thus the patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. 8,916,195 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity in a patient comprising administering a combination of at least about 90 mg- 360 mg per day bupropion and at least about 4 mg- 32 mg per day naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘195 claims a range of dosages that the claimed amount as claimed in claim 35 is within, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘195 does not claim including the compounds in a craved food or substance, ‘195 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘195 claims a method for treating overweight or obesity and thus the patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9,107,837 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity in a patient comprising administering a combination of about 90 mg- 360 mg per day bupropion and about 4 mg- 32 mg per day naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘837 claims a range of dosages that the claimed amount as claimed in claim 35 is within, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘837 does not claim including the compounds in a craved food or substance, ‘837 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘837 claims a method for treating overweight or obesity and thus the patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-31 of U.S. Patent No. 8,815,889 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-58 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating an obese patient comprising administering a combination of about 200 mg- 400 mg/day bupropion and about 25 mg- 50 mg/day naltrexone.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘889 claims the use of the same dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘889 does not claim including the compounds in a craved food or substance, ‘889 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘889 claims treating obese patients and patients with type 2 diabetes and thus said patients suffer from a condition in which it is undesirable to eat a craved food substance. With respect to claims 57 and 58, ‘889 claims treating insulin resistance in patients with type 2 diabetes and thus the condition is not overweight or obesity. Claim 58 is rendered obvious since said claim recites that the patient’s weight is not substantially reduced which allows for some weight reduction and ‘889 teaches treating insulin resistance in a patient with type 2 diabetes.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-31 of U.S. Patent No. 8,722,085 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
‘085 claims similar dosages as claimed in claim 35, and thus providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘085 does not claim including the compounds in a craved food or substance, ‘085 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘085 claims a method for treating obesity and thus the patient treated suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9,125,868 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘868 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘868 does not teach including the compounds in a craved food or substance, ‘868 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘868 claims treating obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent No. 9,248,123 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘123 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘123 does not teach including the compounds in a craved food or substance, ‘123 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘123 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6 of U.S. Patent No. 8,969,371 B1 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘371 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘371 does not claim including the compounds in a craved food or substance, ‘371 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘371 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3 of U.S. Patent No. 9,119,850 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘850 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘850 does not claim including the compounds in a craved food or substance, ‘850 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘850 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 9,633,575 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘575 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘575 does not claim including the compounds in a craved food or substance, ‘575 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘575 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 9,801,875 B2 (Provided on IDS 04/06/2022) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘875 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘875 does not claim including the compounds in a craved food or substance, ‘875 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘875 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 10,231,964 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘964 claims the use of similar dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘964 does not claim including the compounds in a craved food or substance, ‘964 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘964 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-7 of U.S. Patent No. 11,278,544 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘544 claims the use of a range of dosages in which the amount as claimed in claim 35 falls within, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘544 does not claim including the compounds in a craved food or substance, ‘544 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘544 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. 11,139,056 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘056 claims the use of a range of dosages in which the amount as claimed in claim 35 falls within, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘056 does not claim including the compounds in a craved food or substance, ‘056 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘056 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 11,033,543 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘543 claims the use of a range of dosages in which the amount as claimed in claim 35 falls within, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘543 does not claim including the compounds in a craved food or substance, ‘543 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘543 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 10,828,294 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘294 claims the use of a range of dosages in which the amount as claimed in claim 35 falls within, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘294 does not claim including the compounds in a craved food or substance, ‘294 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘294 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
Claims 35, 38-46, 48, 51 and 53-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 10,835,527 B2 in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-56 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings.
The cited patent claims treating overweight or obesity comprising administering a combination of bupropion and naltrexone in amounts that overlap with the amounts as claimed in the instant claims.
The difference between the cited claims of the instant application and the cited claims of the patent is that the instant application specifically claims reducing food cravings whereas the patents claim treatment of overweight or obese individuals.
However, it would have been obvious to a person of ordinary skill in the art that reducing food cravings (as claimed in the instant application) would necessarily result in decreased food consumption and thus treatment of obesity or overweight as claimed in the cited patents.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in the cited patents for treating obesity and overweight which comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods, since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1, Bernstein 2 and Zimmerman. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
Since ‘527 claims the use of a range of dosages in which the amount as claimed in claim 35 falls within, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although ‘527 does not claim including the compounds in a craved food or substance, ‘527 claims that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, ‘527 claims treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance.
Therefore, the cited claims of the instant application and the cited claims of the cited patent are not mutually exclusive and thus not patentably distinct.
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.
Claims 35, 38-46, 48, 51 and 53-58 are rejected under 35 U.S.C. 103(a) as being unpatentable over Weber et al. U.S. Publication No. 2004/0254208 A1 (Provided on IDS 04/06/2022) (equivalent to WO 2004/096201 A1 (Provided on IDS 04/06/2022)) in view of Bernstein U.S. Publication No. 2002/0198227 A1 (Provided on IDS 04/06/2022) (Bernstein 1); Bernstein U.S. Patent No. 5,716,976 (Provided on IDS 04/06/2022) (Bernstein 2); and Zimmerman et al. (1997, Biol Psychiatry, 41, pages 474-749).
Claims 35, 38-46, 48, 51 and 53-58 of the instant application claim a method of reducing food cravings in a patient suffering therefrom, comprising administering a daily dose of 16-48 mg of naltrexone or a pharmaceutically acceptable salt thereof and 300-400 mg of bupropion or a pharmaceutically acceptable salt thereof to the patient for a period of at least 4 weeks in an amount that is effective to reduce food cravings, wherein the combination of naltrexone and bupropion provides a synergistic reduction in food cravings.
Weber et al. teaches compositions for affecting weight loss comprising a first compound and a second compound, where the first compound is an opioid antagonist and the second compound causes increased agonism of a melanocortin 3 receptor (MC3-R) or a melanocortin 4 receptor (MC4-R) compared to normal physiological conditions (see abstract). Weber et al. further teach methods of affecting weight loss, increasing energy expenditure, increasing satiety, or suppressing the appetite of an individual comprising identifying an individual in need thereof and treating that individual by antagonizing opioid receptor activity and enhancing -MSH activity (see abstract).
Weber et al. specifically teach administering a first compound that is an opioid antagonist and a second compound that enhances -MSH activity [0064]. Weber et al. teach that naltrexone is a suitable -opioid receptor antagonist [0071]. Weber et al. teach that the first and second compound can be administered simultaneously [0062] and [0192], or the first compound can be administered prior to the second compound [0062] and [0193], or the first compound can be administered subsequent to the second compound [0062] and [0194]. Weber et al. teach that the composition can be formulated for sustained release [0092]. Weber et al. teaches that additionally, the compounds may be delivered using a sustained-release system [0107]. Weber et al. also teach that the dosage may be a single one or a series of two or more given in the course of one or more days, as is needed by the patient [0110]. Weber et al. further teach that an individual is given a pharmaceutical composition comprising a combination of two or more compounds to affect weight loss and each compound can be a separate chemical entity or the two compounds may be joined together by a chemical linkage, such as a covalent bond, so that the two different compounds form separate parts of the same molecule [0049] and [0066]. Thus Weber et al. teach the combination of a first and second compound in a single dosage form.
Weber et al. further teaches that the compounds will be administered for a period of continuous therapy, for example a week or more, or for months or years [0111]. Weber teaches that the individuals are monitored for a period of months and it is recommended that the dosage be adjusted so that each individual loses weight at a rate of 10% of initial weight every 6 months [0211].
Weber et al. specifically teach the combination of bupropion and naltrexone in examples 5 and 7 on page 20. Weber et al. further teach that a multi-faceted combination therapy approach is provided to address the problem of weight loss and that it addresses not just single molecules, messengers, or receptors, but instead acts on multiple points in the feeding and satiety pathway such as increasing concentration of -MSH in the CNS by stimulating the release of -MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R, and suppressing any feedback mechanisms that slow or stop its release [0019]. Weber et al. further teach that the compositions achieve one or more of these functions and that a combination of two or more of the compounds disclosed results in a synergistic effect that affects weight loss more quickly and on a more permanent basis [0019].
Weber et al. further teaches treating an individual having a body mass index (BMI) greater than 25, 30 and 40 [0040]. Weber specifically teaches administering naltrexone and bupropion to individuals having a BMI of greater than 25 [0223]. Weber et al. further teaches treating an individual having a BMI of less than 25 wherein it may be beneficial for health or cosmetic purposes to affect weight loss, thereby reducing the BMI even further [0040]. Weber et al. further teaches that although the exact dosage will be determined on a drug by drug basis, in general the daily dosage regimen for an adult human patient may be an oral dose between 0.1 mg and 500 mg, and preferably between 1 mg and 250 mg for each ingredient [0111]. Weber et al. further teaches that the compounds will be administered for a period of continuous therapy, for example for a week or more, or for months or years [0111]. Weber teaches that the total daily dosage by oral administration of each ingredient will typically be in the range of 1 to 2000 mg and the total daily dosage by parenteral administration will typically be in the range of 0.1 to 400 mg [0111]. Weber further teaches that naltrexone may be administered in doses in the range of between 5 mg and 50 mg, for example 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg, 45 mg or 50 mg which meets Applicant’s claimed limitation of about 16-48 mg/day [0234]. Weber further teaches that dosing of bupropion should begin at 200 mg per day, and may be increased to 300 mg per day given as 100 mg three times daily, and further contemplates single dosages not exceeding 150 mg, suggesting dosages up to 450 mg per day for bupropion (150 mg administered three times per day) which meets Applicant’s claimed limitation of about 400 mg/day of bupropion [0223]. Thus Weber specifically teaches administration of the claimed combination to the same patient population as claimed which is a patient having a BMI greater than 25, which as taught by Weber is an overweight or obese patient (25.0-29.9 is considered overweight, and 30.0 and above is considered obese [0006]).
Weber et al. does not specifically teach that the combination reduces food cravings. Weber et al. does not teach treating a pregnant patient. Weber et al. does not teach the specific dosages as claimed.
Although Weber et al. does not specifically teach that the combination reduces food cravings, Weber et al. teach that the composition suppresses the appetite of an individual as well as increases satiety. Thus, it would have been obvious to a person of ordinary skill in the art that the combination would reduce food cravings as the combination will result in decreased consumption of food since the appetite of an individual will be suppressed and satiety increased.
Furthermore, Bernstein 1 teaches methods for curbing dietary cravings in a patient, typically diabetic or obese by the administration of a low dose of naltrexone to the patient (see abstract). Bernstein 1 further teaches a method that has a high success rate in curbing appetite, and especially carbohydrate cravings in patients by administering the patient a low dose of naltrexone [0015]. Bernstein 1 further teaches that naltrexone is preferably taken before any event, such as a meal, to prevent carbohydrate cravings during the meal and in a restaurant at a time to prevent over-ordering [0022].
Bernstein 2 teaches methods for alleviating carbohydrate addiction by the administration of anorexients (abstract). Bernstein 2 teaches that anorexients refer to prescription or non-prescription medication, amino acids, and herbal preparations that can reduce or eliminate carbohydrate craving (column 3 lines 3-10). Bernstein 2 further teaches suitable anorexients that can reduce or eliminate carbohydrate craving including dopamine and norepinephrine agonists such as Wellbutrin® (bupropion) (column 5 lines 17-25). Thus Bernstein 2 teaches that bupropion reduces food cravings, specifically craving for carbohydrates.
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in Weber et al. that comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings since the composition contains naltrexone as well as bupropion which were known at the time of the instant invention to reduce food cravings as taught by Bernstein 1 and Bernstein 2. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings since the composition contains naltrexone, which is known to reduce food cravings and bupropion which is also known to reduce food cravings.
With respect to the limitation of reducing cravings for carbohydrates, sweets and fats, both Bernstein 1 and 2 teach that naltrexone and bupropion reduce carbohydrate cravings which includes cravings for starch and sugar. Thus, reducing craving for carbohydrates and sweets is rendered obvious.
In addition, Zimmerman teaches administration of naltrexone to patients who had daily episodic food craving for chocolate, cookies, custard, ice cream and potato chips (page 747). Zimmerman et al. teaches that all affected patients reported a dramatic decrease in frequency and severity of food craving within a few days on naltrexone (page 748). Zimmerman et al. teaches that the observed hunger and craving for sweet, fatty foods resembles that seen after low-dose administration of exogenous opiates and could be largely reversed by naltrexone (page 748).
Accordingly, it would have been obvious to a person of ordinary skill in the art that the composition disclosed in Weber et al. that comprises bupropion and naltrexone would in addition to suppressing the appetite of an individual and increasing satiety, reduce food cravings specifically for sweet and fatty foods since the composition contains naltrexone which was known at the time of the instant invention to reduce food cravings specifically food cravings for sweet and fatty foods as taught by Zimmerman et al. Thus, it would have been obvious to a person of ordinary skill in the art to administer the composition disclosed in Weber et al. (naltrexone and bupropion) with a reasonable expectation of success in reducing food cravings for sweet and fatty foods since the composition contains naltrexone, which is known to reduce food craving for sweet and fatty foods.
With respect to the specific amounts as claimed, Weber et al. teaches a range of amounts in which the claimed amounts fall within. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). Furthermore, it is noted that “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Moreover, it has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Although Weber et al. does not teach treating a pregnant individual, Weber et al. teaches treating all obese patients in need thereof. Since pregnant individuals can also be obese, treating a pregnant individual is also contemplated by the teachings of Weber et al. Thus, in the absence of secondary considerations, treating a pregnant individual as claimed is rendered obvious in view of the cited prior art teachings.
Since the prior art renders obvious the use of the same dosages as claimed in claim 35, providing a synergistic reduction in food cravings as claimed is also rendered obvious. With respect to claims 53 and 54, Weber teaches that the dosage may be a single one or a series of two or more given in the course of one or more days as need by the patient [0110]. Weber further teaches that the composition may be administered 1 to 4 times per day [0111]. Accordingly, it would have been within the skill of an ordinary artisan to determine the appropriate treatment regimen. Thus, in the absence of a demonstration of criticality or other secondary considerations claims 53 and 54 are rendered obvious.
With respect to claim 55, although the prior art does not teach including the compounds in a craved food or substance, the prior art teaches that the compounds are administered orally. Therefore, it would be within the skill of an ordinary skill artisan to determine the oral formulation. One would contemplate including the compounds in food for ease of administration and improvements in patient compliance. Thus, in the absence of secondary considerations such as unexpected results, claim 55 is rendered obvious in view of the cited prior art teachings.
With respect to claim 56, Weber teaches treating overweight or obese patients and thus said patient suffers from a condition in which it is undesirable to eat a craved food substance. With respect to claims 57 and 58, Weber et al. further teaches treating an individual having a BMI of less than 25 wherein it may be beneficial for health or cosmetic purposes to affect weight loss, thereby reducing the BMI even further [0040]. Claim 58 is rendered obvious since said claim recites that the patient’s weight is not substantially reduced which allows for some weight reduction and Weber teaches treating a patient not overweight or obese but still desiring to lose some weight for cosmetic or health purposes.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 35, 38-46, 48, 51 and 53-58 are rejected. Claims 1-34, 36, 37, 47, 49, 50 and 52 are canceled. No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM